Alvix Laboratories, Llc

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Alvix Laboratories, Llc Drugs

Dsg Pak

Dsg Pak

2.1 Dosing Card [See the patient Instructions for Use]

The dosing card can be found attached to the inside of the carton.

The proper amount of VOLTAREN® GEL should be measured using the dosing card supplied in the drug product carton. The dosing card is made of clear polypropylene. The dosing card should be used for each application of drug product. The gel should be applied within the oblong area of the dosing card up to the 2 gram or 4 gram line (2 g for each elbow, wrist, or hand, and 4 g for each knee, ankle, or foot). The 2 g line is 2.25 inches long. The 4 g line is 4.5 inches long. The dosing card containing VOLTAREN® GEL can be used to apply the gel. The hands should then be used to gently rub the gel into the skin. After using the dosing card, hold with fingertips, rinse, and dry. If treatment site is the hands, patients should wait at least one (1) hour to wash their hands.

2.2 Lower extremities, including the knees, ankles, and feet

Apply the gel (4 g) to the affected foot or knee or ankle, 4 times daily. VOLTAREN® GEL should be gently massaged into the skin ensuring application to the entire affected foot or knee or ankle. The entire foot includes the sole, top of the foot and the toes. Do not apply more than 16 g daily to any single joint of the lower extremities.

2.3 Upper extremities including the elbows, wrists and hands

Apply the gel (2 g) to the affected hand or elbow or wrist, 4 times daily. VOLTAREN® GEL should be gently massaged into the skin ensuring application to the entire affected hand or elbow or wrist. The entire hand includes the palm, back of the hands, and the fingers. Do not apply more than 8 g daily to any single joint of the upper extremities. Total dose should not exceed 32 g per day, over all affected joints.

2.4 Special Precautions
Showering/bathing should be avoided for at least 1 hour after the application. Patient should wash his/her hands after use, unless the hands are the treated joint. If VOLTAREN® GEL is applied to the hand(s) for treatment; patient should not wash the treated hand(s) for at least 1 hour after the application. VOLTAREN® GEL should not be applied to open wounds. Contact of VOLTAREN® GEL with eyes and mucous membranes should be avoided. External heat and/or occlusive dressings should not be applied to treated joints. Exposure of the treated joint(s) to sunlight should be avoided. Avoid concomitant use of VOLTAREN® GEL on the treated skin with other topical products including sunscreens, cosmetics, lotions, moisturizers, insect repellants, or other topical medications [see Drug Interactions (7.9)]. Concomitant use of VOLTAREN® GEL with oral non-steroidal anti-inflammatory drugs (NSAIDs) has not been evaluated, and may increase adverse NSAIDs effects.
Wearing of clothing or gloves should be avoided for at least 10 minutes after applying VOLTAREN® GEL.
Lp Lite Pak

Lp Lite Pak

Adult Patients-Intact Skin

A thick layer of lidocaine and prilocaine cream is applied to intact skin and covered with an occlusive dressing (see INSTRUCTIONS FOR APPLICATION).

Minor Dermal Procedures: For minor procedures such as intravenous cannulation and venipuncture, apply 2.5 grams of lidocaine and prilocaine cream (1/2 the 5 g tube) over 20 to 25 cm 2 of skin surface for at least 1 hour. In controlled clinical trials using lidocaine and prilocaine cream, two sites were usually prepared in case there was a technical problem with cannulation or venipuncture at the first site.

Major Dermal Procedures: For more painful dermatological procedures involving a larger skin area such as split thickness skin graft harvesting, apply 2 grams of lidocaine and prilocaine cream per 10 cm 2 of skin and allow to remain in contact with the skin for at least 2 hours.

Adult Male Genital Skin: As an adjunct prior to local anesthetic infiltration, apply a thick layer of lidocaine and prilocaine cream (1 g/10 cm 2 ) to the skin surface for 15 minutes. Local anesthetic infiltration should be performed immediately after removal of lidocaine and prilocaine cream.

Dermal analgesia can be expected to increase for up to 3 hours under occlusive dressing and persist for 1 to 2 hours after removal of the cream. The amount of lidocaine and prilocaine absorbed during the period of application can be estimated from the information in Table 2, ** footnote, in Individualization of Dose.

Adult Female Patients-Genital Mucous Membranes

For minor procedures on the female external genitalia, such as removal of condylomata acuminata, as well as for use as pretreatment for anesthetic infiltration, apply a thick layer (5 to 10 grams) of lidocaine and prilocaine cream for 5 to 10 minutes.

Occlusion is not necessary for absorption, but may be helpful to keep the cream in place. Patients should be lying down during the lidocaine and prilocaine cream application, especially if no occlusion is used. The procedure or the local anesthetic infiltration should be performed immediately after the removal of lidocaine and prilocaine cream.

Pediatric Patients-Intact Skin

The following are the maximum recommended doses, application areas and application times for lidocaine and prilocaine cream based on a child's age and weight:
Age and Body Weight Requirements Maximum Total Dose of Lidocaine and Prilocaine Cream Maximum Application Area Maximum Application Time 0 up to 3 months or < 5 kg 1 g 10 cm 2 1 hour 3 up to 12 months and > 5 kg 2 g 20 cm 2 4 hours 1 to 6 years and > 10 kg 10 g 100 cm 2 4 hours 7 to 12 years and > 20 kg 20 g 200 cm 2 4 hours
Please note: If a patient greater than 3 months old does not meet the minimum weight requirement, the maximum total dose of lidocaine and prilocaine cream should be restricted to that which corresponds to the patient's weight (see INSTRUCTIONS FOR APPLICATION).

Practitioners should carefully instruct caregivers to avoid application of excessive amounts of lidocaine and prilocaine cream (see PRECAUTIONS).

When applying lidocaine and prilocaine cream to the skin of young children, care must be taken to maintain careful observation of the child to prevent accidental ingestion of lidocaine and prilocaine cream or the occlusive dressing. A secondary protective covering to prevent inadvertent disruption of the application site may be useful.

Lidocaine and prilocaine cream should not be used in neonates with a gestational age less than 37 weeks nor in infants under the age of 12 months who are receiving treatment with methemoglobin-inducing agents (see Methemoglobinemia subsection of WARNINGS).

When lidocaine and prilocaine cream (lidocaine 2.5% and prilocaine 2.5%) is used concomitantly with other products containing local anesthetic agents, the amount absorbed from all formulations must be considered (see Individualization of Dose). The amount absorbed in the case of lidocaine and prilocaine cream is determined by the area over which it is applied and the duration of application under occlusion (see Table 2, ** footnote, in Individualization of Dose).

Although the incidence of systemic adverse reactions with lidocaine and prilocaine cream is very low, caution should be exercised, particularly when applying it over large areas and leaving it on for longer than 2 hours. The incidence of systemic adverse reactions can be expected to be directly proportional to the area and time of exposure (see Individualization of Dose).
Allergen Pack American ...

Allergen Pack American Elm Kit

Diagnostic Testing

For the patient with a suspected diagnosis of allergy to more than one antigen, initial skin testing should include the individual extracts. If a screening skin test with a mixture is used, a positive response should be followed by testing with the individual extracts to determine the degree of sensitivity to each and to guide in the selection of extracts and their concentration for immunotherapy if indicated. However, because a negative skin test with a mixture may not be indicative of the absence of allergy to one or more of the components due to their dilution, testing with individual extracts is more precise. False negative responses may occur if serum levels of antihistamines remain from prior medication administration (see CONTRAINDICATIONS). The use of a positive control is especially recommended for patients on prior medications which may decrease the histamine skin test response.

Scratch or Prick-puncture Skin Testing: Allergenic Extract concentrates may be used for scratch or prick-puncture testing or scratch tests in 50% glycerin, 1:20 w/v or strongest available strength in 5 mL vials may be used. Prick-puncture tests with concentrated extracts in patients highly sensitive to the specific antigen should yield distinctive wheals with diameters of greater than 5 mm and with much larger erythema reactions. Glycerinated histamine phosphate 5 mg/mL (1.8 mg/mL histamine base) or aqueous histamine phosphate 2.75 mg/mL (1 mg/mL histamine base; 1:1,000 W/V) may be used as a positive control.

Intradermal Skin Testing: Extract for intradermal testing must be prepared by diluting the stock concentrate injection vials with sterile diluent (use normal or buffered saline, or normal saline with human serum albumin) or the appropriate dilutions may be purchased.

a. Patients with a negative scratch or prick-puncture test: Patients who do not react to a scratch or prick-puncture test should be tested intradermally, using a 26 or 27 gauge 1/4 inch needle, with 0.02 to 0.05 mL of an appropriate extract dilution from 1/100 to 1/1000 of the concentrate. A negative test should be followed by a repeat test using a higher concentration until significant wheal and flare reaction sizes are attained or until the responses remain negative. As a negative control use the diluent or, in the case of extracts in 50% glycerin, use 0.5% to 1% glycerosaline solution. As a positive control, use glycerinated histamine phosphate diluted to 0.5 mg/mL (0.18 mg/mL histamine base) or aqueous histamine phosphate 0.275 mg/mL (0.1 mg/mL histamine base). b. Patients tested only by the intradermal method: Since highly reactive individuals may react intracutaneously at 1:1 million or even 1:10 million dilutions, any intradermal injection should be preceded by a puncture test and the dose adjusted accordingly. Other patients suspected of being moderately allergic should be tested with 0.02 to 0.05 mL of an appropriate extract dilution on the order of 1/10,000 to 1/100,000 of the concentrate. A negative test should be followed by repeat tests using progressively stronger ten-fold concentrations until significant wheal and flare reaction sizes are attained, or until skin test responses with the higher concentrations remain negative. As a negative control, use the diluent or, in the case of extracts in 50% glycerin, use 0.5% to 1% glycerosaline solution. As a positive control, use glycerinated histamine phosphate diluted to 0.5 mg/mL (0.18 mg/mL histamine base) or aqueous histamine phosphate 0.275 mg/mL (0.1 mg/mL histamine base).

Skin tests are graded in terms of the wheal and erythema response noted at 15 to 20 minutes, and compared to the appropriate controls. Wheal and erythema sizes may be recorded by actual measurement.

Immunotherapy

Immunotherapy is administered by subcutaneous injection. Dosage of Allergenic Extracts is individualized according to the patient's sensitivity, the clinical response, and tolerance to the extract administered during the phases of an injection regimen. The initial dose of the extract should be determined based on the puncture test reactivity. In patients who appear to be exquisitely sensitive by history and skin test, the initial dose of the extract should be 0.05 to 0.1 mL of a low concentration, such as dilution number 5 or 6 in below. Patients with lesser sensitivity may be started with 0.05 to 0.1 mL of the next higher concentration. The amount of Allergenic Extract is increased at each injection by no more than 50% of the previous amount, and the next increment is governed by the response to the last injection. Large local reactions which persist for longer than 24 hours are generally considered an indication for repeating the previous dose or reducing the dose at the next administration. Any evidence of systemic reaction is an indication for a reduction of 75% in the subsequent dose. The upper limits of dosage have not been established; however, doses larger than 0.2 mL of an extract in 50% glycerin may cause discomfort upon injection. The dosage of Allergenic Extract does not vary significantly with the allergic disease under treatment. To prepare dilutions starting from a concentrate such as 1:10 W/V, 1:20 W/V, OR 20,000 PNU/mL, proceed as in Table 1 below. (Note: Add 0.5 mL of concentrate to 4.5 mL of sterile diluent and make additional dilutions in the same manner.)

TABLE 1
TEN-FOLD DILUTION SERIES* Dilution Extract Diluent W/V W/v PNU/mL 0 Concentrate 1:10 1:20 20,000 1 0.5 mL concentrate 4.5 mL 1:100 1:200 2000 2 0.5 mL dilution 1 4.5 mL 1:1000 1:2000 200 3 0.5 mL dilution 2 4.5 mL 1:10,000 1:20,000 20 4 0.5 mL dilution 3 4.5 mL 1:100,000 1:200,000 2 5 0.5 mL dilution 4 4.5 mL 1:1,000,000 1:2,000,000 0.2 6 0.5 mL dilution 5 4.5 mL 1:10,000,000 1:20,000,000 0.02
*There is no direct potency correlation across the table between PNUs and W/V.

The optimal interval between doses of Allergenic Extract has not been established. Injections usually are given 1 or 2 times per week until the maintenance dose is reached. The injection interval then is increased to 2 weeks, then to 3 weeks, and finally to 4 weeks. If the patient does not return for 6 to 8 weeks, the dose should be reduced to 25% of the last dose. If longer than 8 weeks, a dose reduction of one, two or three dilutions may be made considering the components and the patient's sensitivity. The dosage and the interval between injections may need to be modified according to the clinical response of the patient. When switching patients to fresh extract, the initial dose should be reduced to 25% of the previous dose. The usual duration of treatment has not been established. A period of two or three years of injection therapy constitutes an average minimum course of treatment.
Allergen Pack Eastern C...

Allergen Pack Eastern Cottonwood Kit

Diagnostic Testing

For the patient with a suspected diagnosis of allergy to more than one antigen, initial skin testing should include the individual extracts. If a screening skin test with a mixture is used, a positive response should be followed by testing with the individual extracts to determine the degree of sensitivity to each and to guide in the selection of extracts and their concentration for immunotherapy if indicated. However, because a negative skin test with a mixture may not be indicative of the absence of allergy to one or more of the components due to their dilution, testing with individual extracts is more precise. False negative responses may occur if serum levels of antihistamines remain from prior medication administration (see CONTRAINDICATIONS). The use of a positive control is especially recommended for patients on prior medications which may decrease the histamine skin test response.

Scratch or Prick-puncture Skin Testing: Allergenic Extract concentrates may be used for scratch or prick-puncture testing or scratch tests in 50% glycerin, 1:20 w/v or strongest available strength in 5 mL vials may be used. Prick-puncture tests with concentrated extracts in patients highly sensitive to the specific antigen should yield distinctive wheals with diameters of greater than 5 mm and with much larger erythema reactions. Glycerinated histamine phosphate 5 mg/mL (1.8 mg/mL histamine base) or aqueous histamine phosphate 2.75 mg/mL (1 mg/mL histamine base; 1:1,000 W/V) may be used as a positive control.

Intradermal Skin Testing: Extract for intradermal testing must be prepared by diluting the stock concentrate injection vials with sterile diluent (use normal or buffered saline, or normal saline with human serum albumin) or the appropriate dilutions may be purchased.

a. Patients with a negative scratch or prick-puncture test: Patients who do not react to a scratch or prick-puncture test should be tested intradermally, using a 26 or 27 gauge 1/4 inch needle, with 0.02 to 0.05 mL of an appropriate extract dilution from 1/100 to 1/1000 of the concentrate. A negative test should be followed by a repeat test using a higher concentration until significant wheal and flare reaction sizes are attained or until the responses remain negative. As a negative control use the diluent or, in the case of extracts in 50% glycerin, use 0.5% to 1% glycerosaline solution. As a positive control, use glycerinated histamine phosphate diluted to 0.5 mg/mL (0.18 mg/mL histamine base) or aqueous histamine phosphate 0.275 mg/mL (0.1 mg/mL histamine base). b. Patients tested only by the intradermal method: Since highly reactive individuals may react intracutaneously at 1:1 million or even 1:10 million dilutions, any intradermal injection should be preceded by a puncture test and the dose adjusted accordingly. Other patients suspected of being moderately allergic should be tested with 0.02 to 0.05 mL of an appropriate extract dilution on the order of 1/10,000 to 1/100,000 of the concentrate. A negative test should be followed by repeat tests using progressively stronger ten-fold concentrations until significant wheal and flare reaction sizes are attained, or until skin test responses with the higher concentrations remain negative. As a negative control, use the diluent or, in the case of extracts in 50% glycerin, use 0.5% to 1% glycerosaline solution. As a positive control, use glycerinated histamine phosphate diluted to 0.5 mg/mL (0.18 mg/mL histamine base) or aqueous histamine phosphate 0.275 mg/mL (0.1 mg/mL histamine base).

Skin tests are graded in terms of the wheal and erythema response noted at 15 to 20 minutes, and compared to the appropriate controls. Wheal and erythema sizes may be recorded by actual measurement.

Immunotherapy

Immunotherapy is administered by subcutaneous injection. Dosage of Allergenic Extracts is individualized according to the patient's sensitivity, the clinical response, and tolerance to the extract administered during the phases of an injection regimen. The initial dose of the extract should be determined based on the puncture test reactivity. In patients who appear to be exquisitely sensitive by history and skin test, the initial dose of the extract should be 0.05 to 0.1 mL of a low concentration, such as dilution number 5 or 6 in below. Patients with lesser sensitivity may be started with 0.05 to 0.1 mL of the next higher concentration. The amount of Allergenic Extract is increased at each injection by no more than 50% of the previous amount, and the next increment is governed by the response to the last injection. Large local reactions which persist for longer than 24 hours are generally considered an indication for repeating the previous dose or reducing the dose at the next administration. Any evidence of systemic reaction is an indication for a reduction of 75% in the subsequent dose. The upper limits of dosage have not been established; however, doses larger than 0.2 mL of an extract in 50% glycerin may cause discomfort upon injection. The dosage of Allergenic Extract does not vary significantly with the allergic disease under treatment. To prepare dilutions starting from a concentrate such as 1:10 W/V, 1:20 W/V, OR 20,000 PNU/mL, proceed as in Table 1 below. (Note: Add 0.5 mL of concentrate to 4.5 mL of sterile diluent and make additional dilutions in the same manner.)

TABLE 1
TEN-FOLD DILUTION SERIES* Dilution Extract Diluent W/V W/v PNU/mL 0 Concentrate 1:10 1:20 20,000 1 0.5 mL concentrate 4.5 mL 1:100 1:200 2000 2 0.5 mL dilution 1 4.5 mL 1:1000 1:2000 200 3 0.5 mL dilution 2 4.5 mL 1:10,000 1:20,000 20 4 0.5 mL dilution 3 4.5 mL 1:100,000 1:200,000 2 5 0.5 mL dilution 4 4.5 mL 1:1,000,000 1:2,000,000 0.2 6 0.5 mL dilution 5 4.5 mL 1:10,000,000 1:20,000,000 0.02
*There is no direct potency correlation across the table between PNUs and W/V.

The optimal interval between doses of Allergenic Extract has not been established. Injections usually are given 1 or 2 times per week until the maintenance dose is reached. The injection interval then is increased to 2 weeks, then to 3 weeks, and finally to 4 weeks. If the patient does not return for 6 to 8 weeks, the dose should be reduced to 25% of the last dose. If longer than 8 weeks, a dose reduction of one, two or three dilutions may be made considering the components and the patient's sensitivity. The dosage and the interval between injections may need to be modified according to the clinical response of the patient. When switching patients to fresh extract, the initial dose should be reduced to 25% of the previous dose. The usual duration of treatment has not been established. A period of two or three years of injection therapy constitutes an average minimum course of treatment.
Allergen Pack Mountain ...

Allergen Pack Mountain Cedar Kit

Diagnostic Testing

For the patient with a suspected diagnosis of allergy to more than one antigen, initial skin testing should include the individual extracts. If a screening skin test with a mixture is used, a positive response should be followed by testing with the individual extracts to determine the degree of sensitivity to each and to guide in the selection of extracts and their concentration for immunotherapy if indicated. However, because a negative skin test with a mixture may not be indicative of the absence of allergy to one or more of the components due to their dilution, testing with individual extracts is more precise. False negative responses may occur if serum levels of antihistamines remain from prior medication administration (see CONTRAINDICATIONS). The use of a positive control is especially recommended for patients on prior medications which may decrease the histamine skin test response.

Scratch or Prick-puncture Skin Testing: Allergenic Extract concentrates may be used for scratch or prick-puncture testing or scratch tests in 50% glycerin, 1:20 w/v or strongest available strength in 5 mL vials may be used. Prick-puncture tests with concentrated extracts in patients highly sensitive to the specific antigen should yield distinctive wheals with diameters of greater than 5 mm and with much larger erythema reactions. Glycerinated histamine phosphate 5 mg/mL (1.8 mg/mL histamine base) or aqueous histamine phosphate 2.75 mg/mL (1 mg/mL histamine base; 1:1,000 W/V) may be used as a positive control.

Intradermal Skin Testing: Extract for intradermal testing must be prepared by diluting the stock concentrate injection vials with sterile diluent (use normal or buffered saline, or normal saline with human serum albumin) or the appropriate dilutions may be purchased.

a. Patients with a negative scratch or prick-puncture test: Patients who do not react to a scratch or prick-puncture test should be tested intradermally, using a 26 or 27 gauge 1/4 inch needle, with 0.02 to 0.05 mL of an appropriate extract dilution from 1/100 to 1/1000 of the concentrate. A negative test should be followed by a repeat test using a higher concentration until significant wheal and flare reaction sizes are attained or until the responses remain negative. As a negative control use the diluent or, in the case of extracts in 50% glycerin, use 0.5% to 1% glycerosaline solution. As a positive control, use glycerinated histamine phosphate diluted to 0.5 mg/mL (0.18 mg/mL histamine base) or aqueous histamine phosphate 0.275 mg/mL (0.1 mg/mL histamine base). b. Patients tested only by the intradermal method: Since highly reactive individuals may react intracutaneously at 1:1 million or even 1:10 million dilutions, any intradermal injection should be preceded by a puncture test and the dose adjusted accordingly. Other patients suspected of being moderately allergic should be tested with 0.02 to 0.05 mL of an appropriate extract dilution on the order of 1/10,000 to 1/100,000 of the concentrate. A negative test should be followed by repeat tests using progressively stronger ten-fold concentrations until significant wheal and flare reaction sizes are attained, or until skin test responses with the higher concentrations remain negative. As a negative control, use the diluent or, in the case of extracts in 50% glycerin, use 0.5% to 1% glycerosaline solution. As a positive control, use glycerinated histamine phosphate diluted to 0.5 mg/mL (0.18 mg/mL histamine base) or aqueous histamine phosphate 0.275 mg/mL (0.1 mg/mL histamine base).

Skin tests are graded in terms of the wheal and erythema response noted at 15 to 20 minutes, and compared to the appropriate controls. Wheal and erythema sizes may be recorded by actual measurement.

Immunotherapy

Immunotherapy is administered by subcutaneous injection. Dosage of Allergenic Extracts is individualized according to the patient's sensitivity, the clinical response, and tolerance to the extract administered during the phases of an injection regimen. The initial dose of the extract should be determined based on the puncture test reactivity. In patients who appear to be exquisitely sensitive by history and skin test, the initial dose of the extract should be 0.05 to 0.1 mL of a low concentration, such as dilution number 5 or 6 in below. Patients with lesser sensitivity may be started with 0.05 to 0.1 mL of the next higher concentration. The amount of Allergenic Extract is increased at each injection by no more than 50% of the previous amount, and the next increment is governed by the response to the last injection. Large local reactions which persist for longer than 24 hours are generally considered an indication for repeating the previous dose or reducing the dose at the next administration. Any evidence of systemic reaction is an indication for a reduction of 75% in the subsequent dose. The upper limits of dosage have not been established; however, doses larger than 0.2 mL of an extract in 50% glycerin may cause discomfort upon injection. The dosage of Allergenic Extract does not vary significantly with the allergic disease under treatment. To prepare dilutions starting from a concentrate such as 1:10 W/V, 1:20 W/V, OR 20,000 PNU/mL, proceed as in Table 1 below. (Note: Add 0.5 mL of concentrate to 4.5 mL of sterile diluent and make additional dilutions in the same manner.)

TABLE 1
TEN-FOLD DILUTION SERIES* Dilution Extract Diluent W/V W/v PNU/mL 0 Concentrate 1:10 1:20 20,000 1 0.5 mL concentrate 4.5 mL 1:100 1:200 2000 2 0.5 mL dilution 1 4.5 mL 1:1000 1:2000 200 3 0.5 mL dilution 2 4.5 mL 1:10,000 1:20,000 20 4 0.5 mL dilution 3 4.5 mL 1:100,000 1:200,000 2 5 0.5 mL dilution 4 4.5 mL 1:1,000,000 1:2,000,000 0.2 6 0.5 mL dilution 5 4.5 mL 1:10,000,000 1:20,000,000 0.02
*There is no direct potency correlation across the table between PNUs and W/V.

The optimal interval between doses of Allergenic Extract has not been established. Injections usually are given 1 or 2 times per week until the maintenance dose is reached. The injection interval then is increased to 2 weeks, then to 3 weeks, and finally to 4 weeks. If the patient does not return for 6 to 8 weeks, the dose should be reduced to 25% of the last dose. If longer than 8 weeks, a dose reduction of one, two or three dilutions may be made considering the components and the patient's sensitivity. The dosage and the interval between injections may need to be modified according to the clinical response of the patient. When switching patients to fresh extract, the initial dose should be reduced to 25% of the previous dose. The usual duration of treatment has not been established. A period of two or three years of injection therapy constitutes an average minimum course of treatment.
Allergen Pack Johnson G...

Allergen Pack Johnson Grass Kit

Diagnostic Testing

For the patient with a suspected diagnosis of allergy to more than one antigen, initial skin testing should include the individual extracts. If a screening skin test with a mixture is used, a positive response should be followed by testing with the individual extracts to determine the degree of sensitivity to each and to guide in the selection of extracts and their concentration for immunotherapy if indicated. However, because a negative skin test with a mixture may not be indicative of the absence of allergy to one or more of the components due to their dilution, testing with individual extracts is more precise. False negative responses may occur if serum levels of antihistamines remain from prior medication administration (see CONTRAINDICATIONS). The use of a positive control is especially recommended for patients on prior medications which may decrease the histamine skin test response.

Scratch or Prick-puncture Skin Testing: Allergenic Extract concentrates may be used for scratch or prick-puncture testing or scratch tests in 50% glycerin, 1:20 w/v or strongest available strength in 5 mL vials may be used. Prick-puncture tests with concentrated extracts in patients highly sensitive to the specific antigen should yield distinctive wheals with diameters of greater than 5 mm and with much larger erythema reactions. Glycerinated histamine phosphate 5 mg/mL (1.8 mg/mL histamine base) or aqueous histamine phosphate 2.75 mg/mL (1 mg/mL histamine base; 1:1,000 W/V) may be used as a positive control.

Intradermal Skin Testing: Extract for intradermal testing must be prepared by diluting the stock concentrate injection vials with sterile diluent (use normal or buffered saline, or normal saline with human serum albumin) or the appropriate dilutions may be purchased.

a. Patients with a negative scratch or prick-puncture test: Patients who do not react to a scratch or prick-puncture test should be tested intradermally, using a 26 or 27 gauge 1/4 inch needle, with 0.02 to 0.05 mL of an appropriate extract dilution from 1/100 to 1/1000 of the concentrate. A negative test should be followed by a repeat test using a higher concentration until significant wheal and flare reaction sizes are attained or until the responses remain negative. As a negative control use the diluent or, in the case of extracts in 50% glycerin, use 0.5% to 1% glycerosaline solution. As a positive control, use glycerinated histamine phosphate diluted to 0.5 mg/mL (0.18 mg/mL histamine base) or aqueous histamine phosphate 0.275 mg/mL (0.1 mg/mL histamine base). b. Patients tested only by the intradermal method: Since highly reactive individuals may react intracutaneously at 1:1 million or even 1:10 million dilutions, any intradermal injection should be preceded by a puncture test and the dose adjusted accordingly. Other patients suspected of being moderately allergic should be tested with 0.02 to 0.05 mL of an appropriate extract dilution on the order of 1/10,000 to 1/100,000 of the concentrate. A negative test should be followed by repeat tests using progressively stronger ten-fold concentrations until significant wheal and flare reaction sizes are attained, or until skin test responses with the higher concentrations remain negative. As a negative control, use the diluent or, in the case of extracts in 50% glycerin, use 0.5% to 1% glycerosaline solution. As a positive control, use glycerinated histamine phosphate diluted to 0.5 mg/mL (0.18 mg/mL histamine base) or aqueous histamine phosphate 0.275 mg/mL (0.1 mg/mL histamine base).

Skin tests are graded in terms of the wheal and erythema response noted at 15 to 20 minutes, and compared to the appropriate controls. Wheal and erythema sizes may be recorded by actual measurement.

Immunotherapy

Immunotherapy is administered by subcutaneous injection. Dosage of Allergenic Extracts is individualized according to the patient's sensitivity, the clinical response, and tolerance to the extract administered during the phases of an injection regimen. The initial dose of the extract should be determined based on the puncture test reactivity. In patients who appear to be exquisitely sensitive by history and skin test, the initial dose of the extract should be 0.05 to 0.1 mL of a low concentration, such as dilution number 5 or 6 in below. Patients with lesser sensitivity may be started with 0.05 to 0.1 mL of the next higher concentration. The amount of Allergenic Extract is increased at each injection by no more than 50% of the previous amount, and the next increment is governed by the response to the last injection. Large local reactions which persist for longer than 24 hours are generally considered an indication for repeating the previous dose or reducing the dose at the next administration. Any evidence of systemic reaction is an indication for a reduction of 75% in the subsequent dose. The upper limits of dosage have not been established; however, doses larger than 0.2 mL of an extract in 50% glycerin may cause discomfort upon injection. The dosage of Allergenic Extract does not vary significantly with the allergic disease under treatment. To prepare dilutions starting from a concentrate such as 1:10 W/V, 1:20 W/V, OR 20,000 PNU/mL, proceed as in Table 1 below. (Note: Add 0.5 mL of concentrate to 4.5 mL of sterile diluent and make additional dilutions in the same manner.)

TABLE 1
TEN-FOLD DILUTION SERIES* Dilution Extract Diluent W/V W/v PNU/mL 0 Concentrate 1:10 1:20 20,000 1 0.5 mL concentrate 4.5 mL 1:100 1:200 2000 2 0.5 mL dilution 1 4.5 mL 1:1000 1:2000 200 3 0.5 mL dilution 2 4.5 mL 1:10,000 1:20,000 20 4 0.5 mL dilution 3 4.5 mL 1:100,000 1:200,000 2 5 0.5 mL dilution 4 4.5 mL 1:1,000,000 1:2,000,000 0.2 6 0.5 mL dilution 5 4.5 mL 1:10,000,000 1:20,000,000 0.02
*There is no direct potency correlation across the table between PNUs and W/V.

The optimal interval between doses of Allergenic Extract has not been established. Injections usually are given 1 or 2 times per week until the maintenance dose is reached. The injection interval then is increased to 2 weeks, then to 3 weeks, and finally to 4 weeks. If the patient does not return for 6 to 8 weeks, the dose should be reduced to 25% of the last dose. If longer than 8 weeks, a dose reduction of one, two or three dilutions may be made considering the components and the patient's sensitivity. The dosage and the interval between injections may need to be modified according to the clinical response of the patient. When switching patients to fresh extract, the initial dose should be reduced to 25% of the previous dose. The usual duration of treatment has not been established. A period of two or three years of injection therapy constitutes an average minimum course of treatment.
Allergen Pack Dog Epith...

Allergen Pack Dog Epithelia Kit

Diagnostic Testing

For the patient with a suspected diagnosis of allergy to more than one antigen, initial skin testing should include the individual extracts. If a screening skin test with a mixture is used, a positive response should be followed by testing with the individual extracts to determine the degree of sensitivity to each and to guide in the selection of extracts and their concentration for immunotherapy if indicated. However, because a negative skin test with a mixture may not be indicative of the absence of allergy to one or more of the components due to their dilution, testing with individual extracts is more precise. False negative responses may occur if serum levels of antihistamines remain from prior medication administration (see CONTRAINDICATIONS). The use of a positive control is especially recommended for patients on prior medications which may decrease the histamine skin test response.

Scratch or Prick-puncture Skin Testing: Allergenic Extract concentrates may be used for scratch or prick-puncture testing or scratch tests in 50% glycerin, 1:20 w/v or strongest available strength in 5 mL vials may be used. Prick-puncture tests with concentrated extracts in patients highly sensitive to the specific antigen should yield distinctive wheals with diameters of greater than 5 mm and with much larger erythema reactions. Glycerinated histamine phosphate 5 mg/mL (1.8 mg/mL histamine base) or aqueous histamine phosphate 2.75 mg/mL (1 mg/mL histamine base; 1:1,000 W/V) may be used as a positive control.

Intradermal Skin Testing: Extract for intradermal testing must be prepared by diluting the stock concentrate injection vials with sterile diluent (use normal or buffered saline, or normal saline with human serum albumin) or the appropriate dilutions may be purchased.

a. Patients with a negative scratch or prick-puncture test: Patients who do not react to a scratch or prick-puncture test should be tested intradermally, using a 26 or 27 gauge 1/4 inch needle, with 0.02 to 0.05 mL of an appropriate extract dilution from 1/100 to 1/1000 of the concentrate. A negative test should be followed by a repeat test using a higher concentration until significant wheal and flare reaction sizes are attained or until the responses remain negative. As a negative control use the diluent or, in the case of extracts in 50% glycerin, use 0.5% to 1% glycerosaline solution. As a positive control, use glycerinated histamine phosphate diluted to 0.5 mg/mL (0.18 mg/mL histamine base) or aqueous histamine phosphate 0.275 mg/mL (0.1 mg/mL histamine base). b. Patients tested only by the intradermal method: Since highly reactive individuals may react intracutaneously at 1:1 million or even 1:10 million dilutions, any intradermal injection should be preceded by a puncture test and the dose adjusted accordingly. Other patients suspected of being moderately allergic should be tested with 0.02 to 0.05 mL of an appropriate extract dilution on the order of 1/10,000 to 1/100,000 of the concentrate. A negative test should be followed by repeat tests using progressively stronger ten-fold concentrations until significant wheal and flare reaction sizes are attained, or until skin test responses with the higher concentrations remain negative. As a negative control, use the diluent or, in the case of extracts in 50% glycerin, use 0.5% to 1% glycerosaline solution. As a positive control, use glycerinated histamine phosphate diluted to 0.5 mg/mL (0.18 mg/mL histamine base) or aqueous histamine phosphate 0.275 mg/mL (0.1 mg/mL histamine base).

Skin tests are graded in terms of the wheal and erythema response noted at 15 to 20 minutes, and compared to the appropriate controls. Wheal and erythema sizes may be recorded by actual measurement.

Immunotherapy

Immunotherapy is administered by subcutaneous injection. Dosage of Allergenic Extracts is individualized according to the patient's sensitivity, the clinical response, and tolerance to the extract administered during the phases of an injection regimen. The initial dose of the extract should be determined based on the puncture test reactivity. In patients who appear to be exquisitely sensitive by history and skin test, the initial dose of the extract should be 0.05 to 0.1 mL of a low concentration, such as dilution number 5 or 6 in below. Patients with lesser sensitivity may be started with 0.05 to 0.1 mL of the next higher concentration. The amount of Allergenic Extract is increased at each injection by no more than 50% of the previous amount, and the next increment is governed by the response to the last injection. Large local reactions which persist for longer than 24 hours are generally considered an indication for repeating the previous dose or reducing the dose at the next administration. Any evidence of systemic reaction is an indication for a reduction of 75% in the subsequent dose. The upper limits of dosage have not been established; however, doses larger than 0.2 mL of an extract in 50% glycerin may cause discomfort upon injection. The dosage of Allergenic Extract does not vary significantly with the allergic disease under treatment. To prepare dilutions starting from a concentrate such as 1:10 W/V, 1:20 W/V, OR 20,000 PNU/mL, proceed as in Table 1 below. (Note: Add 0.5 mL of concentrate to 4.5 mL of sterile diluent and make additional dilutions in the same manner.)

TABLE 1
TEN-FOLD DILUTION SERIES* Dilution Extract Diluent W/V W/v PNU/mL 0 Concentrate 1:10 1:20 20,000 1 0.5 mL concentrate 4.5 mL 1:100 1:200 2000 2 0.5 mL dilution 1 4.5 mL 1:1000 1:2000 200 3 0.5 mL dilution 2 4.5 mL 1:10,000 1:20,000 20 4 0.5 mL dilution 3 4.5 mL 1:100,000 1:200,000 2 5 0.5 mL dilution 4 4.5 mL 1:1,000,000 1:2,000,000 0.2 6 0.5 mL dilution 5 4.5 mL 1:10,000,000 1:20,000,000 0.02
*There is no direct potency correlation across the table between PNUs and W/V.

The optimal interval between doses of Allergenic Extract has not been established. Injections usually are given 1 or 2 times per week until the maintenance dose is reached. The injection interval then is increased to 2 weeks, then to 3 weeks, and finally to 4 weeks. If the patient does not return for 6 to 8 weeks, the dose should be reduced to 25% of the last dose. If longer than 8 weeks, a dose reduction of one, two or three dilutions may be made considering the components and the patient's sensitivity. The dosage and the interval between injections may need to be modified according to the clinical response of the patient. When switching patients to fresh extract, the initial dose should be reduced to 25% of the previous dose. The usual duration of treatment has not been established. A period of two or three years of injection therapy constitutes an average minimum course of treatment.
Allergen Pack American ...

Allergen Pack American Cockroach Kit

Diagnostic Testing

For the patient with a suspected diagnosis of allergy to more than one antigen, initial skin testing should include the individual extracts. If a screening skin test with a mixture is used, a positive response should be followed by testing with the individual extracts to determine the degree of sensitivity to each and to guide in the selection of extracts and their concentration for immunotherapy if indicated. However, because a negative skin test with a mixture may not be indicative of the absence of allergy to one or more of the components due to their dilution, testing with individual extracts is more precise. False negative responses may occur if serum levels of antihistamines remain from prior medication administration (see CONTRAINDICATIONS). The use of a positive control is especially recommended for patients on prior medications which may decrease the histamine skin test response.

Scratch or Prick-puncture Skin Testing: Allergenic Extract concentrates may be used for scratch or prick-puncture testing or scratch tests in 50% glycerin, 1:20 w/v or strongest available strength in 5 mL vials may be used. Prick-puncture tests with concentrated extracts in patients highly sensitive to the specific antigen should yield distinctive wheals with diameters of greater than 5 mm and with much larger erythema reactions. Glycerinated histamine phosphate 5 mg/mL (1.8 mg/mL histamine base) or aqueous histamine phosphate 2.75 mg/mL (1 mg/mL histamine base; 1:1,000 W/V) may be used as a positive control.

Intradermal Skin Testing: Extract for intradermal testing must be prepared by diluting the stock concentrate injection vials with sterile diluent (use normal or buffered saline, or normal saline with human serum albumin) or the appropriate dilutions may be purchased.

a. Patients with a negative scratch or prick-puncture test: Patients who do not react to a scratch or prick-puncture test should be tested intradermally, using a 26 or 27 gauge 1/4 inch needle, with 0.02 to 0.05 mL of an appropriate extract dilution from 1/100 to 1/1000 of the concentrate. A negative test should be followed by a repeat test using a higher concentration until significant wheal and flare reaction sizes are attained or until the responses remain negative. As a negative control use the diluent or, in the case of extracts in 50% glycerin, use 0.5% to 1% glycerosaline solution. As a positive control, use glycerinated histamine phosphate diluted to 0.5 mg/mL (0.18 mg/mL histamine base) or aqueous histamine phosphate 0.275 mg/mL (0.1 mg/mL histamine base). b. Patients tested only by the intradermal method: Since highly reactive individuals may react intracutaneously at 1:1 million or even 1:10 million dilutions, any intradermal injection should be preceded by a puncture test and the dose adjusted accordingly. Other patients suspected of being moderately allergic should be tested with 0.02 to 0.05 mL of an appropriate extract dilution on the order of 1/10,000 to 1/100,000 of the concentrate. A negative test should be followed by repeat tests using progressively stronger ten-fold concentrations until significant wheal and flare reaction sizes are attained, or until skin test responses with the higher concentrations remain negative. As a negative control, use the diluent or, in the case of extracts in 50% glycerin, use 0.5% to 1% glycerosaline solution. As a positive control, use glycerinated histamine phosphate diluted to 0.5 mg/mL (0.18 mg/mL histamine base) or aqueous histamine phosphate 0.275 mg/mL (0.1 mg/mL histamine base).

Skin tests are graded in terms of the wheal and erythema response noted at 15 to 20 minutes, and compared to the appropriate controls. Wheal and erythema sizes may be recorded by actual measurement.

Immunotherapy

Immunotherapy is administered by subcutaneous injection. Dosage of Allergenic Extracts is individualized according to the patient's sensitivity, the clinical response, and tolerance to the extract administered during the phases of an injection regimen. The initial dose of the extract should be determined based on the puncture test reactivity. In patients who appear to be exquisitely sensitive by history and skin test, the initial dose of the extract should be 0.05 to 0.1 mL of a low concentration, such as dilution number 5 or 6 in below. Patients with lesser sensitivity may be started with 0.05 to 0.1 mL of the next higher concentration. The amount of Allergenic Extract is increased at each injection by no more than 50% of the previous amount, and the next increment is governed by the response to the last injection. Large local reactions which persist for longer than 24 hours are generally considered an indication for repeating the previous dose or reducing the dose at the next administration. Any evidence of systemic reaction is an indication for a reduction of 75% in the subsequent dose. The upper limits of dosage have not been established; however, doses larger than 0.2 mL of an extract in 50% glycerin may cause discomfort upon injection. The dosage of Allergenic Extract does not vary significantly with the allergic disease under treatment. To prepare dilutions starting from a concentrate such as 1:10 W/V, 1:20 W/V, OR 20,000 PNU/mL, proceed as in Table 1 below. (Note: Add 0.5 mL of concentrate to 4.5 mL of sterile diluent and make additional dilutions in the same manner.)

TABLE 1
TEN-FOLD DILUTION SERIES* Dilution Extract Diluent W/V W/v PNU/mL 0 Concentrate 1:10 1:20 20,000 1 0.5 mL concentrate 4.5 mL 1:100 1:200 2000 2 0.5 mL dilution 1 4.5 mL 1:1000 1:2000 200 3 0.5 mL dilution 2 4.5 mL 1:10,000 1:20,000 20 4 0.5 mL dilution 3 4.5 mL 1:100,000 1:200,000 2 5 0.5 mL dilution 4 4.5 mL 1:1,000,000 1:2,000,000 0.2 6 0.5 mL dilution 5 4.5 mL 1:10,000,000 1:20,000,000 0.02
*There is no direct potency correlation across the table between PNUs and W/V.

The optimal interval between doses of Allergenic Extract has not been established. Injections usually are given 1 or 2 times per week until the maintenance dose is reached. The injection interval then is increased to 2 weeks, then to 3 weeks, and finally to 4 weeks. If the patient does not return for 6 to 8 weeks, the dose should be reduced to 25% of the last dose. If longer than 8 weeks, a dose reduction of one, two or three dilutions may be made considering the components and the patient's sensitivity. The dosage and the interval between injections may need to be modified according to the clinical response of the patient. When switching patients to fresh extract, the initial dose should be reduced to 25% of the previous dose. The usual duration of treatment has not been established. A period of two or three years of injection therapy constitutes an average minimum course of treatment.
Allergen Pack Alternari...

Allergen Pack Alternaria Tenuis Kit

Diagnostic Testing

For the patient with a suspected diagnosis of allergy to more than one antigen, initial skin testing should include the individual extracts. If a screening skin test with a mixture is used, a positive response should be followed by testing with the individual extracts to determine the degree of sensitivity to each and to guide in the selection of extracts and their concentration for immunotherapy if indicated. However, because a negative skin test with a mixture may not be indicative of the absence of allergy to one or more of the components due to their dilution, testing with individual extracts is more precise. False negative responses may occur if serum levels of antihistamines remain from prior medication administration (see CONTRAINDICATIONS). The use of a positive control is especially recommended for patients on prior medications which may decrease the histamine skin test response.

Scratch or Prick-puncture Skin Testing

Allergenic Extract concentrates may be used for scratch or prick-puncture testing or scratch tests in 50% glycerin, 1:20 w/v or strongest available strength in 5 mL vials may be used. Prick-puncture tests with concentrated extracts in patients highly sensitive to the specific antigen should yield distinctive wheals with diameters of greater than 5 mm and with much larger erythema reactions. Glycerinated histamine phosphate 5 mg/mL (1.8 mg/mL histamine base) or aqueous histamine phosphate 2.75 mg/mL (1 mg/mL histamine base; 1:1,000 W/V) may be used as a positive control.

Intradermal Skin Testing

Extract for intradermal testing must be prepared by diluting the stock concentrate injection vials with sterile diluent (use normal or buffered saline, or normal saline with human serum albumin) or the appropriate dilutions may be purchased.

a. Patients with a negative scratch or prick-puncture test:

Patients who do not react to a scratch or prick-puncture test should be tested intradermally, using a 26 or 27 gauge 1/4 inch needle, with 0.02 to 0.05 mL of an appropriate extract dilution from 1/100 to 1/1000 of the concentrate. A negative test should be followed by a repeat test using a higher concentration until significant wheal and flare reaction sizes are attained or until the responses remain negative. As a negative control use the diluent or, in the case of extracts in 50% glycerin, use 0.5% to 1% glycerosaline solution. As a positive control, use glycerinated histamine phosphate diluted to 0.5 mg/mL (0.18 mg/mL histamine base) or aqueous histamine phosphate 0.275 mg/mL (0.1 mg/mL histamine base).

b. Patients tested only by the intradermal method: Since highly reactive individuals may react intracutaneously at 1:1 million or even 1:10 million dilutions, any intradermal injection should be preceded by a puncture test and the dose adjusted accordingly. Other patients suspected of being moderately allergic should be tested with 0.02 to 0.05 mL of an appropriate extract dilution on the order of 1/10,000 to 1/100,000 of the concentrate. A negative test should be followed by repeat tests using progressively stronger ten-fold concentrations until significant wheal and flare reaction sizes are attained, or until skin test responses with the higher concentrations remain negative. As a negative control, use the diluent or, in the case of extracts in 50% glycerin, use 0.5% to 1% glycerosaline solution. As a positive control, use glycerinated histamine phosphate diluted to 0.5 mg/mL (0.18 mg/mL histamine base) or aqueous histamine phosphate 0.275 mg/mL (0.1 mg/mL histamine base).

Skin tests are graded in terms of the wheal and erythema response noted at 15 to 20 minutes, and compared to the appropriate controls. Wheal and erythema sizes may be recorded by actual measurement.

Immunotherapy

Immunotherapy is administered by subcutaneous injection. Dosage of Allergenic Extracts is individualized according to the patient's sensitivity, the clinical response, and tolerance to the extract administered during the phases of an injection regimen. The initial dose of the extract should be determined based on the puncture test reactivity. In patients who appear to be exquisitely sensitive by history and skin test, the initial dose of the extract should be 0.05 to 0.1 mL of a low concentration, such as dilution number 5 or 6 in below. Patients with lesser sensitivity may be started with 0.05 to 0.1 mL of the next higher concentration. The amount of Allergenic Extract is increased at each injection by no more than 50% of the previous amount, and the next increment is governed by the response to the last injection. Large local reactions which persist for longer than 24 hours are generally considered an indication for repeating the previous dose or reducing the dose at the next administration. Any evidence of systemic reaction is an indication for a reduction of 75% in the subsequent dose. The upper limits of dosage have not been established; however, doses larger than 0.2 mL of an extract in 50% glycerin may cause discomfort upon injection. The dosage of Allergenic Extract does not vary significantly with the allergic disease under treatment.

To prepare dilutions starting from a concentrate such as 1:10 W/V, 1:20 W/V, OR 20,000 PNU/mL, proceed as in Table 1 below. (Note: Add 0.5 mL of concentrate to 4.5 mL of sterile diluent and make additional dilutions in the same manner.)

TABLE 1 Ten-Fold Dilution Series*
Dilution Extract Diluent W/V W/V PNU/mL 0 concentrate 4.5 mL 1:10 1:20
20,000
1 0.5 mL concentrate 4.5 mL 1:100 1:200 2,000 2 0.5 mL concentrate 1 4.5 mL 1:1000 1:2000 200 3 0.5 mL concentrate 2 4.5 mL 1:10,000 1:20,000 20 4 0.5 mL concentrate 3 4.5 mL 1:100,000 1:200,000 2 5 0.5 mL concentrate 4 4.5 mL 1:1,000,000 1:2,000,000 0.2 6 0.5 mL concentrate 5 4.5 mL 10,000,000 1:20,000,000 0.02
*There is no direct potency correlation across the table between PNUs and W/V.

The optimal interval between doses of Allergenic Extract has not been established. Injections usually are given 1 or 2 times per week until the maintenance dose is reached. The injection interval then is increased to 2 weeks, then to 3 weeks, and finally to 4 weeks. If the patient does not return for 6 to 8 weeks, the dose should be reduced to 25% of the last dose. If longer than 8 weeks, a dose reduction of one, two or three dilutions may be made considering the components and the patient's sensitivity. The dosage and the interval between injections may need to be modified according to the clinical response of the patient. When switching patients to fresh extract, the initial dose should be reduced to 25% of the previous dose.

The usual duration of treatment has not been established. A period of two or three years of injection therapy constitutes an average minimum course of treatment.
Allergen Pack Post Oak ...

Allergen Pack Post Oak Kit

Diagnostic Testing

For the patient with a suspected diagnosis of allergy to more than one antigen, initial skin testing should include the individual extracts. If a screening skin test with a mixture is used, a positive response should be followed by testing with the individual extracts to determine the degree of sensitivity to each and to guide in the selection of extracts and their concentration for immunotherapy if indicated. However, because a negative skin test with a mixture may not be indicative of the absence of allergy to one or more of the components due to their dilution, testing with individual extracts is more precise. False negative responses may occur if serum levels of antihistamines remain from prior medication administration (see CONTRAINDICATIONS). The use of a positive control is especially recommended for patients on prior medications which may decrease the histamine skin test response.

Scratch or Prick-puncture Skin Testing: Allergenic Extract concentrates may be used for scratch or prick-puncture testing or scratch tests in 50% glycerin, 1:20 w/v or strongest available strength in 5 mL vials may be used. Prick-puncture tests with concentrated extracts in patients highly sensitive to the specific antigen should yield distinctive wheals with diameters of greater than 5 mm and with much larger erythema reactions. Glycerinated histamine phosphate 5 mg/mL (1.8 mg/mL histamine base) or aqueous histamine phosphate 2.75 mg/mL (1 mg/mL histamine base; 1:1,000 W/V) may be used as a positive control.

Intradermal Skin Testing: Extract for intradermal testing must be prepared by diluting the stock concentrate injection vials with sterile diluent (use normal or buffered saline, or normal saline with human serum albumin) or the appropriate dilutions may be purchased.

a. Patients with a negative scratch or prick-puncture test: Patients who do not react to a scratch or prick-puncture test should be tested intradermally, using a 26 or 27 gauge 1/4 inch needle, with 0.02 to 0.05 mL of an appropriate extract dilution from 1/100 to 1/1000 of the concentrate. A negative test should be followed by a repeat test using a higher concentration until significant wheal and flare reaction sizes are attained or until the responses remain negative. As a negative control use the diluent or, in the case of extracts in 50% glycerin, use 0.5% to 1% glycerosaline solution. As a positive control, use glycerinated histamine phosphate diluted to 0.5 mg/mL (0.18 mg/mL histamine base) or aqueous histamine phosphate 0.275 mg/mL (0.1 mg/mL histamine base). b. Patients tested only by the intradermal method: Since highly reactive individuals may react intracutaneously at 1:1 million or even 1:10 million dilutions, any intradermal injection should be preceded by a puncture test and the dose adjusted accordingly. Other patients suspected of being moderately allergic should be tested with 0.02 to 0.05 mL of an appropriate extract dilution on the order of 1/10,000 to 1/100,000 of the concentrate. A negative test should be followed by repeat tests using progressively stronger ten-fold concentrations until significant wheal and flare reaction sizes are attained, or until skin test responses with the higher concentrations remain negative. As a negative control, use the diluent or, in the case of extracts in 50% glycerin, use 0.5% to 1% glycerosaline solution. As a positive control, use glycerinated histamine phosphate diluted to 0.5 mg/mL (0.18 mg/mL histamine base) or aqueous histamine phosphate 0.275 mg/mL (0.1 mg/mL histamine base).

Skin tests are graded in terms of the wheal and erythema response noted at 15 to 20 minutes, and compared to the appropriate controls. Wheal and erythema sizes may be recorded by actual measurement.

Immunotherapy

Immunotherapy is administered by subcutaneous injection. Dosage of Allergenic Extracts is individualized according to the patient's sensitivity, the clinical response, and tolerance to the extract administered during the phases of an injection regimen. The initial dose of the extract should be determined based on the puncture test reactivity. In patients who appear to be exquisitely sensitive by history and skin test, the initial dose of the extract should be 0.05 to 0.1 mL of a low concentration, such as dilution number 5 or 6 in below. Patients with lesser sensitivity may be started with 0.05 to 0.1 mL of the next higher concentration. The amount of Allergenic Extract is increased at each injection by no more than 50% of the previous amount, and the next increment is governed by the response to the last injection. Large local reactions which persist for longer than 24 hours are generally considered an indication for repeating the previous dose or reducing the dose at the next administration. Any evidence of systemic reaction is an indication for a reduction of 75% in the subsequent dose. The upper limits of dosage have not been established; however, doses larger than 0.2 mL of an extract in 50% glycerin may cause discomfort upon injection. The dosage of Allergenic Extract does not vary significantly with the allergic disease under treatment. To prepare dilutions starting from a concentrate such as 1:10 W/V, 1:20 W/V, OR 20,000 PNU/mL, proceed as in Table 1 below. (Note: Add 0.5 mL of concentrate to 4.5 mL of sterile diluent and make additional dilutions in the same manner.)

TABLE 1
TEN-FOLD DILUTION SERIES* Dilution Extract Diluent W/V W/v PNU/mL 0 Concentrate 1:10 1:20 20,000 1 0.5 mL concentrate 4.5 mL 1:100 1:200 2000 2 0.5 mL dilution 1 4.5 mL 1:1000 1:2000 200 3 0.5 mL dilution 2 4.5 mL 1:10,000 1:20,000 20 4 0.5 mL dilution 3 4.5 mL 1:100,000 1:200,000 2 5 0.5 mL dilution 4 4.5 mL 1:1,000,000 1:2,000,000 0.2 6 0.5 mL dilution 5 4.5 mL 1:10,000,000 1:20,000,000 0.02
*There is no direct potency correlation across the table between PNUs and W/V.

The optimal interval between doses of Allergenic Extract has not been established. Injections usually are given 1 or 2 times per week until the maintenance dose is reached. The injection interval then is increased to 2 weeks, then to 3 weeks, and finally to 4 weeks. If the patient does not return for 6 to 8 weeks, the dose should be reduced to 25% of the last dose. If longer than 8 weeks, a dose reduction of one, two or three dilutions may be made considering the components and the patient's sensitivity. The dosage and the interval between injections may need to be modified according to the clinical response of the patient. When switching patients to fresh extract, the initial dose should be reduced to 25% of the previous dose. The usual duration of treatment has not been established. A period of two or three years of injection therapy constitutes an average minimum course of treatment.
Allergen Pack Dermatoph...

Allergen Pack Dermatophagoides Farinae Kit

Do not inject intravenously.

Greer Standardized Mite extracts are diluted with sterile diluent for allergenic extracts when used for intradermal testing or subcutaneous immunotherapy. Dosages vary by mode of administration, and by individual response and tolerance. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

Greer Standardized Mite Extracts should be a light brown solution that is free of particulate matter. If particulate matter is observed then the solution should be discarded.

Diagnostic Testing

For diagnosis of a patient with a suspected allergy to either species of dust mite (D. farinae or D. pteronyssinus), diagnostic skin testing should include the standardized mite mixture or the single-species mite extracts.
If a skin test with the standardized mite mixture elicits a positive reaction, then the single-species mite extracts can be used to determine the degree of sensitivity to each, and to guide in the selection of extracts and their concentration for immunotherapy, if indicated. A positive skin test reaction to any allergen must be interpreted in light of the patient’s history of symptoms, the time of year, and known exposure to environmental allergens.
Percutaneous Skin Testing

For percutaneous (scratch, prick, or puncture) testing, use 10,000 Allergy Units/mL Greer Standardized Mite Extract stock concentrate in dropper vials. If patient is suspected of having exquisite sensitivity, such as anaphylaxis, to certain foods and drugs, initiate percutaneous testing with several serial 10-fold dilutions of the usual test concentration.
For scratch tests, scarify the skin, and then apply one drop of the extract to the scratch. For prick tests, place one drop of extract on the skin and pierce through the drop into the skin with a slight lifting motion. For puncture tests, place one drop of extract on the skin and pierce through the drop perpendicular to the skin.
When using percutaneous test devices, follow the directions provided with the test devices.

Include a positive control to detect false negative responses to skin testing, which may occur if serum levels of antihistamines remain from prior medication administration [see Drug Interactions (7.2)]. A glycerinated histamine phosphate diluted to 10mg/mL (6mg/mL histamine base) may be used as the positive control.

Include a negative control to detect false positive responses, which can occur when the patient has a non-specific reaction to the diluent. A 50% gylcerosaline solution may be used as the negative control. Read skin tests 15-20 minutes after exposure. Record the induration (wheal) and erythema (flare) response by noting the longest diameter of each, or by the sum of the longest erythema diameter and the mid-point orthogonal diameters of erythema (ÓE).

Percutaneous testing devices often have their own grading systems, as these devices may cause different degrees of trauma to the skin and deliver different volumes of allergenic extract. Follow grading instructions for the device used.

Intradermal Skin Testing

Intradermal tests are commonly used when the reaction to percutaneous testing is negative or equivocal but the patient has a strong clinical history of symptoms triggered by exposure to a specific allergen. Because immediate systemic reactions are more common with intradermal testing, prescreening with percutaneous testing is a practical safety measure.¹

Dilute the stock concentrate with sterile diluent. Use saline with human serum albumin (HSA), buffered saline, or saline. If prescreening is not done, or if patients are expected to be high risk, precautions should be observed since some patients have experienced anaphylaxis and death.
Patients who do not react to percutaneous skin testing should be tested intradermally at a starting dose of 0.02 to 0.05 mL of a 50 Allergy Units/mL extract dilution. Patients suspected of being highly allergic should first receive a test dose of 0.02 to 0.05 mL of a 0.05 Allergy Units/mL extract dilution. If the intial dose test is negative, subsequent intradermal tests using increasingly stronger doses may be performed up to the maximum recommended strength of 200 Allergy Units / mL. If percutaneous skin testing was not performed, include a positive control to detect false negative responses to skin testing, which may occur if serum levels of antihistamines remain from prior medication administration [see Drug Interactions (7.2)]. A glycerinated histamine phosphate diluted to 0.5 mg/mL (0.18 mg/mL histamine base ) or aqueous histamine phosphate 0.275 mg/mL (0.1 mg/mL histamine base) may be used as the positive control. If percutaneous skin testing was not performed, include a negative control to detect false positive responses, which can occur when the patient has a non-specific reaction to the diluent. A 1% glycerin in 0.9% saline solution may be used as the negative control. Measure the wheal-and-flare response after 15-20 minutes, which may be graded using various methods as described in the instructions for the device used.
The mean dose of Greer dust mite allergen required to elicit a positive intradermal test result (ÓE ³ 50 mm) in a total of 83 mite puncture test

positive (ÓE ³ 20 mm) persons is shown in Table1.

Table 1. Intradermal Reactivity to Mite Allergens
Allergen Number of Persons Dose to Elicit 50 mm Sum of Diameter Erythema Reaction Mean (AU*/mL) Range (AU/mL) D. farinae 46 0.00856 0.00004 - 1.75935 D. pteronyssinus 37 0.00570 0.00002 - 1.36341**
* Allergy Units ** Data is available on file with Greer

Immunotherapy

Subcutaneous injection only.

Subcutaneous injections for immunotherapy should be prepared by dilution of stock concentrate based on patient’s reactivity. Stock concentrations of Greer Standardized Mite Extract are available in 5,000 Allergy Units/mL, 10,000 Allergy Units/mL, 30,000 Allergy Units/mL for immunotherapy. See Table 2 for dilution preparation. Also see Dosage Modification Guidelines. (2.2.1)
The initial dose of the extract should be based on the percutaneous test reactivity. In patients who appear to be exquisitely sensitive by history and skin test, the initial dose of the extract should be 0.1 mL of a 0.005 to 0.05 Allergy Units/mL dilution. Patients with lesser sensitivity may be started at a 0.5 to 5 Allergy Units/mL dilution. The dose of allergenic extract is increased at each injection by no more than 50% of the previous dose, and the next increment is governed by the response to the last injection. Large local reactions which persist for longer than 24 hours are generally considered an indication for repeating the previous dose or reducing the dose at the next administration. Any evidence of a systemic reaction is an indication for a significant reduction (at least 75%) in the subsequent dose. Repeated systemic reactions, even of a mild nature, are sufficient reason for the cessation of further attempts to increase the reaction-causing dose. Severe reactions require a decrease in the next dose by at least 50%. Proceed cautiously in subsequent dosing. A maximum tolerated maintenance dose should be selected based on the patient’s clinical response and tolerance. Doses larger than 0.2 mL of the concentrate are rarely administered because an extract in 50% glycerin may cause discomfort upon injection. Since the two mite species tend to cross-react, consider the total Allergy Units content in determining the maximum maintenance dose of the mixture.
Dosage Modifications Guidelines for Immunotherapy

The following conditions may indicate a need to withhold or reduce the dosage of immunotherapy. In situations prompting dose reduction, once the reduced dose is tolerated, a cautious increase in dosage can be attempted. Immunotherapy should be withheld or reduced in dosage if the following concurrent conditions exist:
Severe symptoms of rhinitis and/or asthma; Infection accompanied by fever; or Exposure to excessive amounts of clinically relevant allergen prior to a scheduled injection.
Changing to a different lot of extract: All extracts lose potency over time. A fresh extract may have an effective potency that is substantially greater than that of older extracts. Therefore, the first dose from the fresh vial should not exceed a 25% increase of the previous dose or a 75% reduction of the previous dose, assuming both extracts contain comparable amounts of allergen, defined by Allergy Units.

Unscheduled Gaps between Treatments: Patients may lose tolerance for allergen injections during prolonged periods between doses, thus increasing their risk for an adverse reaction. The duration of tolerance between injections varies from patient to patient.
During the build-up phase, when patients receive injections 1 to 2 times per week, it is customary to repeat or even reduce the extract dosage if there has been a substantial time interval between injections. This depends on 1) the concentration of allergen immunotherapy extract that is to be administered, 2) a previous history of systemic reactions, and 3) the degree of variation from the prescribed interval of time, with longer intervals since the last injection leading to greater reductions in the dose to be administered. This suggested approach to dose modification due to unscheduled gaps between treatments during the build-up phase is not based on published evidence. The individual physician should use this or a similar protocol as a standard operating procedure for the specific clinical setting. Similarly, if large unscheduled gaps occur during maintenance therapy, it may be necessary to reduce the dosage. The individual physician should devise a protocol as a standard operating procedure for his or her specific clinical setting in determining how to modify doses of allergen immunotherapy due to unscheduled gaps in treatment.
The extract previously used is from another manufacturer: Since manufacturing processes and sources of raw materials differ among manufacturers, the interchangeability of extracts from different manufacturers cannot be assured. The starting dose of the extract from a different manufacturer should be greatly decreased even though the extract is the same formula and dilution. In general, a dose reduction of 50- 75% of the previous dose should be adequate, but each situation must be evaluated separately considering the patient’s history of sensitivity, tolerance of previous injections, and other factors. Dose intervals should not exceed one week when rebuilding dose.

The previous extract has expired or is near expiry: The dating period for allergenic extracts indicates the time that they can be expected to remain potent under ideal storage conditions (2° - 8°C) [see How Supplied/Storage and Handling (16)]. Some loss of potency occurs even when stored under ideal conditions, therefore extracts should not be stored beyond the expiration date. Instead, a new lot should be used (see “Changing to a different lot of extract”, above)

Changing from non-stabilized to human serum albumin (HSA) stabilized diluents: Allergenic extracts diluted with HSA and 0.4% phenol are more potent than extracts diluted with diluents that do not contain stabilizers. When switching from a non-stabilized to an HSA stabilized diluent, consider lowering the dose for immunotherapy.

Administration of Immunotherapy
Administer immunotherapy by subcutaneous injection in the lateral aspect of the arm or thigh. Avoid injection directly into any blood vessel. The optimal interval between doses of allergenic extract varies among individuals. Injections are usually given 1 or 2 times per week until the maintenance dose is reached, at which time the injection interval is increased to 2,3, and finally 4 weeks. Because most adverse reactions occur within 30 minutes after injection, patients should be kept under observation for at least 30 minutes.² For high risk patients 30 minutes of observation may not be sufficient.
Dilution Preparation

To prepare dilutions for intradermal testing and immunotherapy, start with a 5,000, 10,000, or 30,000 Allergy Units/mL stock concentrate, and prepare a 1:10 dilution by adding 0.5 mL of concentrate to 4.5 mL of sterile aqueous diluent. Subsequent dilutions are made in a similar manner (see Table 2).

Table 2. Ten-fold Dilution Series for intradermal testing and immunotherapy
Dilution Extract Diluent AU*/mL AU/mL AU/mL 0 Concentrate 5,000 10,000 30,000 1 0.5 mL Concentrate 4.5 mL 500 1,000 3.000 2 0.5 mL Dilution 1 4.5 mL 50 100 300 3 0.5 mL Dilution 2 4.5 mL 5 10 30 4 0.5 mL Dilution 3 4.5 mL 0.5 1 3 5 0.5 mL Dilution 4 4.5 mL 0.05 0.1 0.3 6 0.5 mL Dilution 5 4.5 mL 0.005 0.01 0.03
*Allergy Units
Dr Deep Multi Emulsion ...

Dr Deep Multi Emulsion Mini

Do not inject intravenously.

Greer Standardized Mite extracts are diluted with sterile diluent for allergenic extracts when used for intradermal testing or subcutaneous immunotherapy. Dosages vary by mode of administration, and by individual response and tolerance. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

Greer Standardized Mite Extracts should be a light brown solution that is free of particulate matter. If particulate matter is observed then the solution should be discarded.

Diagnostic Testing

For diagnosis of a patient with a suspected allergy to either species of dust mite (D. farinae or D. pteronyssinus), diagnostic skin testing should include the standardized mite mixture or the single-species mite extracts.
If a skin test with the standardized mite mixture elicits a positive reaction, then the single-species mite extracts can be used to determine the degree of sensitivity to each, and to guide in the selection of extracts and their concentration for immunotherapy, if indicated. A positive skin test reaction to any allergen must be interpreted in light of the patient’s history of symptoms, the time of year, and known exposure to environmental allergens.
Percutaneous Skin Testing

For percutaneous (scratch, prick, or puncture) testing, use 10,000 Allergy Units/mL Greer Standardized Mite Extract stock concentrate in dropper vials. If patient is suspected of having exquisite sensitivity, such as anaphylaxis, to certain foods and drugs, initiate percutaneous testing with several serial 10-fold dilutions of the usual test concentration.
For scratch tests, scarify the skin, and then apply one drop of the extract to the scratch. For prick tests, place one drop of extract on the skin and pierce through the drop into the skin with a slight lifting motion. For puncture tests, place one drop of extract on the skin and pierce through the drop perpendicular to the skin.
When using percutaneous test devices, follow the directions provided with the test devices.

Include a positive control to detect false negative responses to skin testing, which may occur if serum levels of antihistamines remain from prior medication administration [see Drug Interactions (7.2)]. A glycerinated histamine phosphate diluted to 10mg/mL (6mg/mL histamine base) may be used as the positive control.

Include a negative control to detect false positive responses, which can occur when the patient has a non-specific reaction to the diluent. A 50% gylcerosaline solution may be used as the negative control. Read skin tests 15-20 minutes after exposure. Record the induration (wheal) and erythema (flare) response by noting the longest diameter of each, or by the sum of the longest erythema diameter and the mid-point orthogonal diameters of erythema (ÓE).

Percutaneous testing devices often have their own grading systems, as these devices may cause different degrees of trauma to the skin and deliver different volumes of allergenic extract. Follow grading instructions for the device used.

Intradermal Skin Testing

Intradermal tests are commonly used when the reaction to percutaneous testing is negative or equivocal but the patient has a strong clinical history of symptoms triggered by exposure to a specific allergen. Because immediate systemic reactions are more common with intradermal testing, prescreening with percutaneous testing is a practical safety measure.¹

Dilute the stock concentrate with sterile diluent. Use saline with human serum albumin (HSA), buffered saline, or saline. If prescreening is not done, or if patients are expected to be high risk, precautions should be observed since some patients have experienced anaphylaxis and death.
Patients who do not react to percutaneous skin testing should be tested intradermally at a starting dose of 0.02 to 0.05 mL of a 50 Allergy Units/mL extract dilution. Patients suspected of being highly allergic should first receive a test dose of 0.02 to 0.05 mL of a 0.05 Allergy Units/mL extract dilution. If the intial dose test is negative, subsequent intradermal tests using increasingly stronger doses may be performed up to the maximum recommended strength of 200 Allergy Units / mL. If percutaneous skin testing was not performed, include a positive control to detect false negative responses to skin testing, which may occur if serum levels of antihistamines remain from prior medication administration [see Drug Interactions (7.2)]. A glycerinated histamine phosphate diluted to 0.5 mg/mL (0.18 mg/mL histamine base ) or aqueous histamine phosphate 0.275 mg/mL (0.1 mg/mL histamine base) may be used as the positive control. If percutaneous skin testing was not performed, include a negative control to detect false positive responses, which can occur when the patient has a non-specific reaction to the diluent. A 1% glycerin in 0.9% saline solution may be used as the negative control. Measure the wheal-and-flare response after 15-20 minutes, which may be graded using various methods as described in the instructions for the device used.
The mean dose of Greer dust mite allergen required to elicit a positive intradermal test result (ÓE ³ 50 mm) in a total of 83 mite puncture test

positive (ÓE ³ 20 mm) persons is shown in Table1.

Table 1. Intradermal Reactivity to Mite Allergens
Allergen Number of Persons Dose to Elicit 50 mm Sum of Diameter Erythema Reaction Mean (AU*/mL) Range (AU/mL) D. farinae 46 0.00856 0.00004 - 1.75935 D. pteronyssinus 37 0.00570 0.00002 - 1.36341**
* Allergy Units ** Data is available on file with Greer

Immunotherapy

Subcutaneous injection only.

Subcutaneous injections for immunotherapy should be prepared by dilution of stock concentrate based on patient’s reactivity. Stock concentrations of Greer Standardized Mite Extract are available in 5,000 Allergy Units/mL, 10,000 Allergy Units/mL, 30,000 Allergy Units/mL for immunotherapy. See Table 2 for dilution preparation. Also see Dosage Modification Guidelines. (2.2.1)
The initial dose of the extract should be based on the percutaneous test reactivity. In patients who appear to be exquisitely sensitive by history and skin test, the initial dose of the extract should be 0.1 mL of a 0.005 to 0.05 Allergy Units/mL dilution. Patients with lesser sensitivity may be started at a 0.5 to 5 Allergy Units/mL dilution. The dose of allergenic extract is increased at each injection by no more than 50% of the previous dose, and the next increment is governed by the response to the last injection. Large local reactions which persist for longer than 24 hours are generally considered an indication for repeating the previous dose or reducing the dose at the next administration. Any evidence of a systemic reaction is an indication for a significant reduction (at least 75%) in the subsequent dose. Repeated systemic reactions, even of a mild nature, are sufficient reason for the cessation of further attempts to increase the reaction-causing dose. Severe reactions require a decrease in the next dose by at least 50%. Proceed cautiously in subsequent dosing. A maximum tolerated maintenance dose should be selected based on the patient’s clinical response and tolerance. Doses larger than 0.2 mL of the concentrate are rarely administered because an extract in 50% glycerin may cause discomfort upon injection. Since the two mite species tend to cross-react, consider the total Allergy Units content in determining the maximum maintenance dose of the mixture.
Dosage Modifications Guidelines for Immunotherapy

The following conditions may indicate a need to withhold or reduce the dosage of immunotherapy. In situations prompting dose reduction, once the reduced dose is tolerated, a cautious increase in dosage can be attempted. Immunotherapy should be withheld or reduced in dosage if the following concurrent conditions exist:
Severe symptoms of rhinitis and/or asthma; Infection accompanied by fever; or Exposure to excessive amounts of clinically relevant allergen prior to a scheduled injection.
Changing to a different lot of extract: All extracts lose potency over time. A fresh extract may have an effective potency that is substantially greater than that of older extracts. Therefore, the first dose from the fresh vial should not exceed a 25% increase of the previous dose or a 75% reduction of the previous dose, assuming both extracts contain comparable amounts of allergen, defined by Allergy Units.

Unscheduled Gaps between Treatments: Patients may lose tolerance for allergen injections during prolonged periods between doses, thus increasing their risk for an adverse reaction. The duration of tolerance between injections varies from patient to patient.
During the build-up phase, when patients receive injections 1 to 2 times per week, it is customary to repeat or even reduce the extract dosage if there has been a substantial time interval between injections. This depends on 1) the concentration of allergen immunotherapy extract that is to be administered, 2) a previous history of systemic reactions, and 3) the degree of variation from the prescribed interval of time, with longer intervals since the last injection leading to greater reductions in the dose to be administered. This suggested approach to dose modification due to unscheduled gaps between treatments during the build-up phase is not based on published evidence. The individual physician should use this or a similar protocol as a standard operating procedure for the specific clinical setting. Similarly, if large unscheduled gaps occur during maintenance therapy, it may be necessary to reduce the dosage. The individual physician should devise a protocol as a standard operating procedure for his or her specific clinical setting in determining how to modify doses of allergen immunotherapy due to unscheduled gaps in treatment.
The extract previously used is from another manufacturer: Since manufacturing processes and sources of raw materials differ among manufacturers, the interchangeability of extracts from different manufacturers cannot be assured. The starting dose of the extract from a different manufacturer should be greatly decreased even though the extract is the same formula and dilution. In general, a dose reduction of 50- 75% of the previous dose should be adequate, but each situation must be evaluated separately considering the patient’s history of sensitivity, tolerance of previous injections, and other factors. Dose intervals should not exceed one week when rebuilding dose.

The previous extract has expired or is near expiry: The dating period for allergenic extracts indicates the time that they can be expected to remain potent under ideal storage conditions (2° - 8°C) [see How Supplied/Storage and Handling (16)]. Some loss of potency occurs even when stored under ideal conditions, therefore extracts should not be stored beyond the expiration date. Instead, a new lot should be used (see “Changing to a different lot of extract”, above)

Changing from non-stabilized to human serum albumin (HSA) stabilized diluents: Allergenic extracts diluted with HSA and 0.4% phenol are more potent than extracts diluted with diluents that do not contain stabilizers. When switching from a non-stabilized to an HSA stabilized diluent, consider lowering the dose for immunotherapy.

Administration of Immunotherapy
Administer immunotherapy by subcutaneous injection in the lateral aspect of the arm or thigh. Avoid injection directly into any blood vessel. The optimal interval between doses of allergenic extract varies among individuals. Injections are usually given 1 or 2 times per week until the maintenance dose is reached, at which time the injection interval is increased to 2,3, and finally 4 weeks. Because most adverse reactions occur within 30 minutes after injection, patients should be kept under observation for at least 30 minutes.² For high risk patients 30 minutes of observation may not be sufficient.
Dilution Preparation

To prepare dilutions for intradermal testing and immunotherapy, start with a 5,000, 10,000, or 30,000 Allergy Units/mL stock concentrate, and prepare a 1:10 dilution by adding 0.5 mL of concentrate to 4.5 mL of sterile aqueous diluent. Subsequent dilutions are made in a similar manner (see Table 2).

Table 2. Ten-fold Dilution Series for intradermal testing and immunotherapy
Dilution Extract Diluent AU*/mL AU/mL AU/mL 0 Concentrate 5,000 10,000 30,000 1 0.5 mL Concentrate 4.5 mL 500 1,000 3.000 2 0.5 mL Dilution 1 4.5 mL 50 100 300 3 0.5 mL Dilution 2 4.5 mL 5 10 30 4 0.5 mL Dilution 3 4.5 mL 0.5 1 3 5 0.5 mL Dilution 4 4.5 mL 0.05 0.1 0.3 6 0.5 mL Dilution 5 4.5 mL 0.005 0.01 0.03
*Allergy Units
Allergen Pack Gs Ragwee...

Allergen Pack Gs Ragweed Mix Kit

Testing

1. Scratch and Prick testing normally employ 1:20 glycerinated extracts, which contain 125-250 units Antigen E per mL (Short Ragweed) or 75-150 units Antigen E per mL (Ragweed Mix).

2. Intradermal testing with Short Ragweed and G.S. Ragweed Mix is routinely performed using 1:1000 w/v and 1,000 PNU/mL or more dilute material. It has been reported that as little as 10-6 unit (0.000001 μg) is sufficient to cause a positive skin test. In another study of 25 Antigen E sensitive individuals, the dose required for a 2+ reaction (8-10 mm wheal) ranged from 10-6 to 10-1 μg Antigen per mL using a 0.5 mL dose.

Individual sensitivity to Ragweed extracts will vary greatly and it is recommended that intradermal testing be started at low concentrations (i.e. 0.05 mL at 0.1 μg/mL- dose equals 0.005 μg Antigen E). If no reaction occurs, testing may be repeated with a stonger dilution.

Treatment

Initial and subsequent treatment dosage must be based on careful testing procedures and evaluation of patient history. Studies have shown a definite correlation between symptom amelioration and maximum or cumulative dosage achieved. One study5 has shown significant clinical improvement with an average cumulative preseasonal dosage equivalent to 252 μg of Antigen E, but no significant improvement with an average cumulative dosage of 32 μg Antigen E. In another study8 a mean cumulative dosage of 84.9 μg Antigen E (as whole ragweed extract) was significantly effective in reducing allergenic symptoms compared to placebo.

The dosage schedule shown below, based on Antigen E content, will deliver approximately 85 μg Antigen E in 18 injections. Initial and subsequent treatment dosage must be based on careful testing procedures and patient history. Highly sensitive individuals will require lower initial dosage, more moderate dosage increase, and may not tolerate as high a maintenance dosage as the moderately sensitive individual. The suggested schedule shown below is for a moderately sensitive individual and must be modified by the physician to suit each patient if necessary.

SUGGESTED DOSAGE SCHEDULE OF SHORT RAGWEED AND G.S. RAGWEED MIX ANTIGEN E STANDARD

Injection Number

Vial Number

Antigen E per mL

Volume (mL)

Dose AgE

1

1

0.3

0.05

0.015

2

1

0.3

0.10

0.03

3

1

0.3

0.20

0.06

4

1

0.3

0.40

0.12

5

1

0.3

0.70

0.21

6

2

3.0

0.10

0.30

7

2

3.0

0.20

0.60

8

2

3.0

0.30

0.90

9

2

3.0

0.50

1.50

10

2

3.0

0.70

2.10

11

3

3.0

0.10

3.0

12

3

3.0

0.15

4.50

13

3

3.0

0.20

6.00

14

3

3.0

0.30

9.00

15

3

3.0

0.40

12.00

16

3

3.0

0.50

15.00*

17

3

3.0

0.50

15.00*

18

3

3.0

0.50

15.00*

*Maintenance dosage

It is recommended that patients receive injections at five to seven day intervals until maintenance dosage is achieved. Maintenance dosage can be given at 2 to 4 week intervals. All doses of allergenic extract are administered subcutaneously in the lateral aspect of the upper arm or thigh. Avoid injecting directly into any blood vessel and use a 26 or 27 gauge needle 3/8" in length.

Testing

1. Scratch and Prick testing normally employ 1:20 glycerinated extracts, which contain 125-250 units Antigen E per mL (Short Ragweed) or 75-150 units Antigen E per mL (Ragweed Mix).

2. Intradermal testing with Short Ragweed and G.S. Ragweed Mix is routinely performed using 1:1000 w/v and 1,000 PNU/mL or more dilute material. It has been reported that as little as 10-6 unit (0.000001 μg) is sufficient to cause a positive skin test. In another study of 25 Antigen E sensitive individuals, the dose required for a 2+ reaction (8-10 mm wheal) ranged from 10-6 to 10-1 μg Antigen per mL using a 0.5 mL dose.

Individual sensitivity to Ragweed extracts will vary greatly and it is recommended that intradermal testing be started at low concentrations (i.e. 0.05 mL at 0.1 μg/mL- dose equals 0.005 μg Antigen E). If no reaction occurs, testing may be repeated with a stonger dilution.

Treatment

Initial and subsequent treatment dosage must be based on careful testing procedures and evaluation of patient history. Studies have shown a definite correlation between symptom amelioration and maximum or cumulative dosage achieved. One study5 has shown significant clinical improvement with an average cumulative preseasonal dosage equivalent to 252 μg of Antigen E, but no significant improvement with an average cumulative dosage of 32 μg Antigen E. In another study8 a mean cumulative dosage of 84.9 μg Antigen E (as whole ragweed extract) was significantly effective in reducing allergenic symptoms compared to placebo.

The dosage schedule shown below, based on Antigen E content, will deliver approximately 85 μg Antigen E in 18 injections. Initial and subsequent treatment dosage must be based on careful testing procedures and patient history. Highly sensitive individuals will require lower initial dosage, more moderate dosage increase, and may not tolerate as high a maintenance dosage as the moderately sensitive individual. The suggested schedule shown below is for a moderately sensitive individual and must be modified by the physician to suit each patient if necessary.

SUGGESTED DOSAGE SCHEDULE OF SHORT RAGWEED AND G.S. RAGWEED MIX ANTIGEN E STANDARD

Injection Number

Vial Number

Antigen E per mL

Volume (mL)

Dose AgE

1

1

0.3

0.05

0.015

2

1

0.3

0.10

0.03

3

1

0.3

0.20

0.06

4

1

0.3

0.40

0.12

5

1

0.3

0.70

0.21

6

2

3.0

0.10

0.30

7

2

3.0

0.20

0.60

8

2

3.0

0.30

0.90

9

2

3.0

0.50

1.50

10

2

3.0

0.70

2.10

11

3

3.0

0.10

3.0

12

3

3.0

0.15

4.50

13

3

3.0

0.20

6.00

14

3

3.0

0.30

9.00

15

3

3.0

0.40

12.00

16

3

3.0

0.50

15.00*

17

3

3.0

0.50

15.00*

18

3

3.0

0.50

15.00*

*Maintenance dosage

It is recommended that patients receive injections at five to seven day intervals until maintenance dosage is achieved. Maintenance dosage can be given at 2 to 4 week intervals. All doses of allergenic extract are administered subcutaneously in the lateral aspect of the upper arm or thigh. Avoid injecting directly into any blood vessel and use a 26 or 27 gauge needle 3/8" in length.
Allergen Pack Cat Dande...

Allergen Pack Cat Dander Solution

General

Concentrated standardized cat hair extracts should be diluted prior to intradermal testing or first use in immunotherapy.

Normal or buffered saline or normal saline with human serum albumin may be used to prepare appropriate dilutions. Vials should be visually inspected to ensure particulate free prior to use.

Diagnostic Testing

For the patient with a suspected diagnosis of cat allergy, initial testing may be conducted with the concentrate by means of a puncture test employing a multiple puncture device or other appropriate instrument. Prick testing through a drop of extract or scratch testing with a drop of extract applied to the scratch may also be employed to determine the degree of sensitivity. If the response is negative, this initial test may be followed by intradermal testing where the clinical history is strongly indicative of allergy to cats. Use of a positive and negative control is recommended.

The most frequently used test sites are the back and the volar surface of the forearms. The skin should be cleansed with alcohol and allowed to dry. A minimum of at least 1 inch should be allowed between test sites. A marking pencil may be used to indicate the site locations.

Skin tests read after 15 to 20 minutes are graded in terms of the induration (wheal) and erythema (flare) response compared to the appropriate controls. Wheal and flare sizes may be recorded by actual measurements. The largest diameter of the wheal and flare may be recorded, or the sum of the largest diameter and the orthogonal (right angle) diameter wheal or flare may be used.

Puncture, Prick or Scratch Testing

The skin test concentration of 10,000 BAU/mL is used for puncture, prick or scratch testing. Puncture tests with Standardized Cat Hair Extract performed on ten highly sensitive cat puncture-positive patients showed a mean diameter wheal of 6.0 mm ± 2.2 mm and a mean erythema of 36.7 mm ± 6.7 mm. Glycerinated histamine phosphate 5 mg/mL (1.8 mg/mL histamine base) or aqueous histamine phosphate 2.75 mg/mL (1 mg/mL histamine base; 1:1000 w/v) may be used as a positive control. A 50% glycerosaline solution may be used as the negative control.

A sterile puncture device, needle, scalpel blade, or scarifier is used. A separate sterile device must be used for each patient to prevent transmission of infectious agents. If the device contacts extracts, use a separate device for each antigen to prevent cross-contamination.

The skin is abraded only enough to enter the dermis without drawing blood. Follow the directions for the device being used. The antigen may be applied directly with a puncture device or is introduced by applying a drop of extract to the scratch or prick site, taking care not to touch the skin with the dropper tip.

Intradermal Testing

Extract for intradermal testing must be prepared by diluting the stock concentrate with sterile diluent (use normal or buffered saline or normal saline with human serum albumin) or obtained by ordering the appropriate dilutions ready made. As a positive control, use glycerinated histamine phosphate diluted to 0.5 mg/mL (0.18 mg/mL histamine base) or aqueous histamine phosphate 0.275 mg/mL (0.1 mg/mL histamine base). As a negative control, use 0.5% to 1% glycerosaline solution.

Intradermal skin tests with 0.05 mL of three-fold serial dilutions in ten highly sensitive cat puncture test positive (sum of erythema >57 mm) persons showed the results in Table I:
Table I: BAU/mL to Elicit 50mm Sum of Diameter Erythema Reaction Geometric Mean Range 0.0542 0.0050 - 0.4809
Intradermal extract is used as follows:

a. Patients with a negative scratch or prick-puncture test:

Patients who do not react to a scratch or prick-puncture test should be tested intradermally with 0.02 to 0.05 mL of a 50 BAU/mL extract dilution. If this test is negative, a second intradermal test may be performed using a 200 BAU/mL extract dilution.

b. Patients tested only by the intradermal method:

Since highly reactive individuals may react intracutaneously at 1:1 million or even 1:10 million dilutions, any intradermal injection should be preceded and the dose adjusted according to puncture test reactivity. Other patients suspected of being moderately allergic may be tested with an intradermal test dose of 0.02 to 0.05 mL of a 0.05 BAU/mL dilution. A negative test should be followed by repeat tests using progressively stronger concentrations until the maximum recommended strength of 200 BAU/mL is reached.

Skin tests are graded in terms of the wheal and erythema response noted at 15 to 20 minutes. Wheal and erythema size may be recorded by actual measurement of the extent of both responses.

Immunotherapy

Immunotherapy is administered by subcutaneous injection. Not for intravenous use!

Dosage of allergenic extracts is individualized according to the patient's sensitivity, the clinical response, and tolerance to the extract administered during the early phases of an injection regimen. The initial dose of the extract should be calculated based on the puncture test reactivity. The initial dose of the extract may be as low as 0.1 mL of a 0.005 to 0.05 BAU/mL dilution (dilution 5 or 6 in Table II below) or even less for the exquisitely sensitive patient. Patients with lesser sensitivity may be started at 0.1 mL of a 0.5 to 5 BAU/mL dilution. The amount of allergenic extract is increased at each injection by no more than 50% of the previous amount; the next increment is governed by the response to the last injection. Large local reactions which persist for longer than 24 hours are generally considered an indication for repeating the previous dose or reducing the dose. Any evidence of systemic reaction is an indication for a significant reduction (at least 50%) in the subsequent dose. The upper limits of dosage have not been established; however, doses larger than 0.2 mL of 5,000 BAU/mL may cause discomfort upon injection because of the high glycerin content. The dosage of allergenic extract does not vary significantly with the respiratory allergic disease under treatment.

To prepare dilutions for intradermal and therapeutic use starting from a 5,000 or 10,000 BAU/mL stock concentrate proceed as follows: (Note add 1 mL of concentrate to 9.0 mL of sterile diluent and make additional dilutions in the same manner.)
Table II Dilution Extract Diluent BAU/mL 0 Concentrate 9.0 5,000 10,000 1 1 mL concentrate 9.0 500 1,000 2 1 mL dilution 1 9.0 50 100 3 1 mL dilution 2 9.0 5 10 4 1 mL dilution 3 9.0 0.5 1.0 5 1 mL dilution 4 9.0 0.05 0.1 6 1 mL dilution 5 9.0 0.005 0.01
The optimal interval between doses of allergenic extract has not been definitely established. However, as is customarily practiced, injections are given 1, 2 or 3 times per week until the maintenance dose of extract is reached. At this time, the injection interval is increased to 2 weeks, then to 3 weeks and finally to 4 weeks. If the patient does not return for 6 to 8 weeks after the last injection, the dose should be reduced to 25% of the last dose. If longer than 8 weeks, a dose reduction of one, two or three dilutions may be made depending on a consideration of the components and the patient's sensitivity. The dosage and the interval between injections may need to be modified according to the clinical response of the patient. When switching patients to fresh extract, the initial dose should be reduced to one-quarter of the previous dose.

General

Concentrated standardized cat hair extracts should be diluted prior to intradermal testing or first use in immunotherapy.

Normal or buffered saline or normal saline with human serum albumin may be used to prepare appropriate dilutions. Vials should be visually inspected to ensure particulate free prior to use.

Diagnostic Testing

For the patient with a suspected diagnosis of cat allergy, initial testing may be conducted with the concentrate by means of a puncture test employing a multiple puncture device or other appropriate instrument. Prick testing through a drop of extract or scratch testing with a drop of extract applied to the scratch may also be employed to determine the degree of sensitivity. If the response is negative, this initial test may be followed by intradermal testing where the clinical history is strongly indicative of allergy to cats. Use of a positive and negative control is recommended.

The most frequently used test sites are the back and the volar surface of the forearms. The skin should be cleansed with alcohol and allowed to dry. A minimum of at least 1 inch should be allowed between test sites. A marking pencil may be used to indicate the site locations.

Skin tests read after 15 to 20 minutes are graded in terms of the induration (wheal) and erythema (flare) response compared to the appropriate controls. Wheal and flare sizes may be recorded by actual measurements. The largest diameter of the wheal and flare may be recorded, or the sum of the largest diameter and the orthogonal (right angle) diameter wheal or flare may be used.

Puncture, Prick or Scratch Testing

The skin test concentration of 10,000 BAU/mL is used for puncture, prick or scratch testing. Puncture tests with Standardized Cat Hair Extract performed on ten highly sensitive cat puncture-positive patients showed a mean diameter wheal of 6.0 mm ± 2.2 mm and a mean erythema of 36.7 mm ± 6.7 mm. Glycerinated histamine phosphate 5 mg/mL (1.8 mg/mL histamine base) or aqueous histamine phosphate 2.75 mg/mL (1 mg/mL histamine base; 1:1000 w/v) may be used as a positive control. A 50% glycerosaline solution may be used as the negative control.

A sterile puncture device, needle, scalpel blade, or scarifier is used. A separate sterile device must be used for each patient to prevent transmission of infectious agents. If the device contacts extracts, use a separate device for each antigen to prevent cross-contamination.

The skin is abraded only enough to enter the dermis without drawing blood. Follow the directions for the device being used. The antigen may be applied directly with a puncture device or is introduced by applying a drop of extract to the scratch or prick site, taking care not to touch the skin with the dropper tip.

Intradermal Testing

Extract for intradermal testing must be prepared by diluting the stock concentrate with sterile diluent (use normal or buffered saline or normal saline with human serum albumin) or obtained by ordering the appropriate dilutions ready made. As a positive control, use glycerinated histamine phosphate diluted to 0.5 mg/mL (0.18 mg/mL histamine base) or aqueous histamine phosphate 0.275 mg/mL (0.1 mg/mL histamine base). As a negative control, use 0.5% to 1% glycerosaline solution.

Intradermal skin tests with 0.05 mL of three-fold serial dilutions in ten highly sensitive cat puncture test positive (sum of erythema >57 mm) persons showed the results in Table I:
Table I: BAU/mL to Elicit 50mm Sum of Diameter Erythema Reaction Geometric Mean Range 0.0542 0.0050 - 0.4809
Intradermal extract is used as follows:

a. Patients with a negative scratch or prick-puncture test:

Patients who do not react to a scratch or prick-puncture test should be tested intradermally with 0.02 to 0.05 mL of a 50 BAU/mL extract dilution. If this test is negative, a second intradermal test may be performed using a 200 BAU/mL extract dilution.

b. Patients tested only by the intradermal method:

Since highly reactive individuals may react intracutaneously at 1:1 million or even 1:10 million dilutions, any intradermal injection should be preceded and the dose adjusted according to puncture test reactivity. Other patients suspected of being moderately allergic may be tested with an intradermal test dose of 0.02 to 0.05 mL of a 0.05 BAU/mL dilution. A negative test should be followed by repeat tests using progressively stronger concentrations until the maximum recommended strength of 200 BAU/mL is reached.

Skin tests are graded in terms of the wheal and erythema response noted at 15 to 20 minutes. Wheal and erythema size may be recorded by actual measurement of the extent of both responses.

Immunotherapy

Immunotherapy is administered by subcutaneous injection. Not for intravenous use!

Dosage of allergenic extracts is individualized according to the patient's sensitivity, the clinical response, and tolerance to the extract administered during the early phases of an injection regimen. The initial dose of the extract should be calculated based on the puncture test reactivity. The initial dose of the extract may be as low as 0.1 mL of a 0.005 to 0.05 BAU/mL dilution (dilution 5 or 6 in Table II below) or even less for the exquisitely sensitive patient. Patients with lesser sensitivity may be started at 0.1 mL of a 0.5 to 5 BAU/mL dilution. The amount of allergenic extract is increased at each injection by no more than 50% of the previous amount; the next increment is governed by the response to the last injection. Large local reactions which persist for longer than 24 hours are generally considered an indication for repeating the previous dose or reducing the dose. Any evidence of systemic reaction is an indication for a significant reduction (at least 50%) in the subsequent dose. The upper limits of dosage have not been established; however, doses larger than 0.2 mL of 5,000 BAU/mL may cause discomfort upon injection because of the high glycerin content. The dosage of allergenic extract does not vary significantly with the respiratory allergic disease under treatment.

To prepare dilutions for intradermal and therapeutic use starting from a 5,000 or 10,000 BAU/mL stock concentrate proceed as follows: (Note add 1 mL of concentrate to 9.0 mL of sterile diluent and make additional dilutions in the same manner.)
Table II Dilution Extract Diluent BAU/mL 0 Concentrate 9.0 5,000 10,000 1 1 mL concentrate 9.0 500 1,000 2 1 mL dilution 1 9.0 50 100 3 1 mL dilution 2 9.0 5 10 4 1 mL dilution 3 9.0 0.5 1.0 5 1 mL dilution 4 9.0 0.05 0.1 6 1 mL dilution 5 9.0 0.005 0.01
The optimal interval between doses of allergenic extract has not been definitely established. However, as is customarily practiced, injections are given 1, 2 or 3 times per week until the maintenance dose of extract is reached. At this time, the injection interval is increased to 2 weeks, then to 3 weeks and finally to 4 weeks. If the patient does not return for 6 to 8 weeks after the last injection, the dose should be reduced to 25% of the last dose. If longer than 8 weeks, a dose reduction of one, two or three dilutions may be made depending on a consideration of the components and the patient's sensitivity. The dosage and the interval between injections may need to be modified according to the clinical response of the patient. When switching patients to fresh extract, the initial dose should be reduced to one-quarter of the previous dose.
Allergen Pack Timothy G...

Allergen Pack Timothy Grass Solution

Therapy

Standardized versus Nonstandardized Extracts:

Dosage with extracts standardized in BAU must be derived from a knowledge of the patient’s sensitivity to the specific pollen. Switching from an extract not standardized in BAU cannot be made by a calculated ratio. There are no equivalent dosages in bioequivalent allergy units applicable to all the grass species that can be related to previously marketed nonstandardized extracts labeled in weight-to-volume (w/v), Protein Nitrogen Units (PNU), or Allergy Units (AU). The information about nonstandardized extracts shown in TABLE 3 may be helpful in selecting the initial dose for the side-by-side skin test comparison. Patients being switched from nonstandardized extracts to extracts standardized in BAU can be reevaluated by diagnostic skin testing to judge the dose for starting immunotherapy or building up to new maintenance dosages. When a patient is first being administered a standardized extract labeled in BAU/mL, the new dose can be selected based on a side-by-side comparison with the previously used nonstandardized extract.

Immunotherapy is administered by subcutaneous injection. Dosage is individualized according to the patient’s sensitivity, the clinical response, and tolerance to the extract administered during the early phases of an injection regimen. Extracts for immunotherapy must be prepared by diluting the concentrate with sterile diluent (such as normal or buffered saline, or normal saline with human serum albumin).

The initial dose of an extract in BAU should be calculated based on the puncture test reactivity. Note in TABLE 1 and TABLE 2 the puncture and intradermal skin test reactivity of sensitive subjects evaluated with the US reference extracts.

The initial dose of the extract may be as low as 0.1 mL of a 0.005 to 0.05 BAU/mL dilution (0.0005 to 0.005 BAU) (dilution 5 or 6 in TABLE 4 below) or even less for the exquisitely sensitive patient. Patients with lesser sensitivity may be started at 0.1 mL of a 0.5 to 5 BAU/mL dilution (0.05 to 0.5 BAU).

The amount of allergenic extract is increased at each injection by no more than 50% of the previous amount, and the next increment is governed by the response to the last injection. Large local reactions which persist for longer than 24 hours are generally considered an indication for repeating the previous dose or reducing the dose at the next administration. Any evidence of systemic reaction is an indication for a reduction of 75% in

the subsequent dose. The upper limits of dosage in BAU have not been established. Doses larger than 0.2 mL of an extract in 50% glycerin may cause discomfort upon injection. The dosages of allergenic extracts do not vary significantly with the allergic disease under treatment.

To prepare dilutions starting from a 100,000 BAU/mL concentrate, proceed as in TABLE 4. The 50,000 BAU/mL concentrate can be made by using equal parts of the 100,000 BAU/mL extract and the sterile diluent. The ten-fold dilution series uses 0.5 mL of concentrate to 4.5 mL of sterile diluent with additional dilutions made in the same manner.
TABLE 4: Ten-Fold Dilution Series Dilution Exract Diluent BAU/mL Concentration BAU/mL 0 Concentrate 100,000 10,000 1 0.5 mL concentrate 4.5 mL 10,000 1,000 2 0.5 mL dilution 1 4.5 mL 1,000 100 3 0.5 mL dilution 2 4.5 mL 100 10 4 0.5 mL dilution 3 4.5 mL 10 1 5 0.5 mL dilution 4 4.5 mL 1 0.1 6 0.5 mL dilution 5 4.5 mL 0.1 0.01
*Due to differences such as source material, preservative, potency dilutions, storage conditions, and length of storage, there is no common potency correlation ratio between extracts standardized in Bioequivalent Allergy Units (BAU) and: 1) standardized extracts previously labeled in Allergy Units (AU); 2) nonstandardized extracts labeled weight-to-volume (w/v); 3) nonstandardized extracts labeled in Protein Nitrogen Units (PNU); or 4) alum-precipitated extracts.

The optimal interval between doses of allergenic extracts has not been established. Injections usually are given 1 or 2 times per week until the maintenance dose is reached. The injection interval is then increased to 2 weeks, then to 3 weeks and finally to 4 weeks. If the patient does not return for 6 to 8 weeks, the dose should be reduced to 25% of the last dose. If longer than 8 weeks, a dose reduction of one, two or three dilutions may be made considering the components and the patient’s sensitivity. The dosage and the interval between injections may need to be modified according to the clinical response of the patient. When switching patients to fresh extract, the initial dose should be reduced to 25% of the previous dose.

The usual duration of treatment has not been established. A period of two or three years of injection therapy constitutes an average minimum course of treatment.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Some concentrated extracts naturally develop a cloudy appearance over time under refrigeration, the material settling to the bottom on standing.

Therapy

Standardized versus Nonstandardized Extracts:

Dosage with extracts standardized in BAU must be derived from a knowledge of the patient’s sensitivity to the specific pollen. Switching from an extract not standardized in BAU cannot be made by a calculated ratio. There are no equivalent dosages in bioequivalent allergy units applicable to all the grass species that can be related to previously marketed nonstandardized extracts labeled in weight-to-volume (w/v), Protein Nitrogen Units (PNU), or Allergy Units (AU). The information about nonstandardized extracts shown in TABLE 3 may be helpful in selecting the initial dose for the side-by-side skin test comparison. Patients being switched from nonstandardized extracts to extracts standardized in BAU can be reevaluated by diagnostic skin testing to judge the dose for starting immunotherapy or building up to new maintenance dosages. When a patient is first being administered a standardized extract labeled in BAU/mL, the new dose can be selected based on a side-by-side comparison with the previously used nonstandardized extract.

Immunotherapy is administered by subcutaneous injection. Dosage is individualized according to the patient’s sensitivity, the clinical response, and tolerance to the extract administered during the early phases of an injection regimen. Extracts for immunotherapy must be prepared by diluting the concentrate with sterile diluent (such as normal or buffered saline, or normal saline with human serum albumin).

The initial dose of an extract in BAU should be calculated based on the puncture test reactivity. Note in TABLE 1 and TABLE 2 the puncture and intradermal skin test reactivity of sensitive subjects evaluated with the US reference extracts.

The initial dose of the extract may be as low as 0.1 mL of a 0.005 to 0.05 BAU/mL dilution (0.0005 to 0.005 BAU) (dilution 5 or 6 in TABLE 4 below) or even less for the exquisitely sensitive patient. Patients with lesser sensitivity may be started at 0.1 mL of a 0.5 to 5 BAU/mL dilution (0.05 to 0.5 BAU).

The amount of allergenic extract is increased at each injection by no more than 50% of the previous amount, and the next increment is governed by the response to the last injection. Large local reactions which persist for longer than 24 hours are generally considered an indication for repeating the previous dose or reducing the dose at the next administration. Any evidence of systemic reaction is an indication for a reduction of 75% in

the subsequent dose. The upper limits of dosage in BAU have not been established. Doses larger than 0.2 mL of an extract in 50% glycerin may cause discomfort upon injection. The dosages of allergenic extracts do not vary significantly with the allergic disease under treatment.

To prepare dilutions starting from a 100,000 BAU/mL concentrate, proceed as in TABLE 4. The 50,000 BAU/mL concentrate can be made by using equal parts of the 100,000 BAU/mL extract and the sterile diluent. The ten-fold dilution series uses 0.5 mL of concentrate to 4.5 mL of sterile diluent with additional dilutions made in the same manner.
TABLE 4: Ten-Fold Dilution Series Dilution Exract Diluent BAU/mL Concentration BAU/mL 0 Concentrate 100,000 10,000 1 0.5 mL concentrate 4.5 mL 10,000 1,000 2 0.5 mL dilution 1 4.5 mL 1,000 100 3 0.5 mL dilution 2 4.5 mL 100 10 4 0.5 mL dilution 3 4.5 mL 10 1 5 0.5 mL dilution 4 4.5 mL 1 0.1 6 0.5 mL dilution 5 4.5 mL 0.1 0.01
*Due to differences such as source material, preservative, potency dilutions, storage conditions, and length of storage, there is no common potency correlation ratio between extracts standardized in Bioequivalent Allergy Units (BAU) and: 1) standardized extracts previously labeled in Allergy Units (AU); 2) nonstandardized extracts labeled weight-to-volume (w/v); 3) nonstandardized extracts labeled in Protein Nitrogen Units (PNU); or 4) alum-precipitated extracts.

The optimal interval between doses of allergenic extracts has not been established. Injections usually are given 1 or 2 times per week until the maintenance dose is reached. The injection interval is then increased to 2 weeks, then to 3 weeks and finally to 4 weeks. If the patient does not return for 6 to 8 weeks, the dose should be reduced to 25% of the last dose. If longer than 8 weeks, a dose reduction of one, two or three dilutions may be made considering the components and the patient’s sensitivity. The dosage and the interval between injections may need to be modified according to the clinical response of the patient. When switching patients to fresh extract, the initial dose should be reduced to 25% of the previous dose.

The usual duration of treatment has not been established. A period of two or three years of injection therapy constitutes an average minimum course of treatment.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Some concentrated extracts naturally develop a cloudy appearance over time under refrigeration, the material settling to the bottom on standing.
Allergen Pack Aspergill...

Allergen Pack Aspergillus Fumigatus Solution

Diagnostic Testing

For the patient with a suspected diagnosis of allergy to more than one antigen, initial skin testing should include the individual extracts. If a screening skin test with a mixture is used, a positive response should be followed by testing with the individual extracts to determine the degree of sensitivity to each and to guide in the selection of extracts and their concentration for immunotherapy if indicated. However, because a negative skin test with a mixture may not be indicative of the absence of allergy to one or more of the components due to their dilution, testing with individual extracts is more precise. False negative responses may occur if serum levels of antihistamines remain from prior medication administration (see CONTRAINDICATIONS). The use of a positive control is especially recommended for patients on prior medications which may decrease the histamine skin test response.

Scratch or Prick-puncture Skin Testing

Allergenic Extract concentrates may be used for scratch or prick-puncture testing or scratch tests in 50% glycerin, 1:20 w/v or strongest available strength in 5 mL vials may be used. Prick-puncture tests with concentrated extracts in patients highly sensitive to the specific antigen should yield distinctive wheals with diameters of greater than 5 mm and with much larger erythema reactions. Glycerinated histamine phosphate 5 mg/mL (1.8 mg/mL histamine base) or aqueous histamine phosphate 2.75 mg/mL (1 mg/mL histamine base; 1:1,000 W/V) may be used as a positive control.

Intradermal Skin Testing

Extract for intradermal testing must be prepared by diluting the stock concentrate injection vials with sterile diluent (use normal or buffered saline, or normal saline with human serum albumin) or the appropriate dilutions may be purchased.

a. Patients with a negative scratch or prick-puncture test:

Patients who do not react to a scratch or prick-puncture test should be tested intradermally, using a 26 or 27 gauge 1/4 inch needle, with 0.02 to 0.05 mL of an appropriate extract dilution from 1/100 to 1/1000 of the concentrate. A negative test should be followed by a repeat test using a higher concentration until significant wheal and flare reaction sizes are attained or until the responses remain negative. As a negative control use the diluent or, in the case of extracts in 50% glycerin, use 0.5% to 1% glycerosaline solution. As a positive control, use glycerinated histamine phosphate diluted to 0.5 mg/mL (0.18 mg/mL histamine base) or aqueous histamine phosphate 0.275 mg/mL (0.1 mg/mL histamine base).

b. Patients tested only by the intradermal method: Since highly reactive individuals may react intracutaneously at 1:1 million or even 1:10 million dilutions, any intradermal injection should be preceded by a puncture test and the dose adjusted accordingly. Other patients suspected of being moderately allergic should be tested with 0.02 to 0.05 mL of an appropriate extract dilution on the order of 1/10,000 to 1/100,000 of the concentrate. A negative test should be followed by repeat tests using progressively stronger ten-fold concentrations until significant wheal and flare reaction sizes are attained, or until skin test responses with the higher concentrations remain negative. As a negative control, use the diluent or, in the case of extracts in 50% glycerin, use 0.5% to 1% glycerosaline solution. As a positive control, use glycerinated histamine phosphate diluted to 0.5 mg/mL (0.18 mg/mL histamine base) or aqueous histamine phosphate 0.275 mg/mL (0.1 mg/mL histamine base).

Skin tests are graded in terms of the wheal and erythema response noted at 15 to 20 minutes, and compared to the appropriate controls. Wheal and erythema sizes may be recorded by actual measurement.

Immunotherapy

Immunotherapy is administered by subcutaneous injection. Dosage of Allergenic Extracts is individualized according to the patient's sensitivity, the clinical response, and tolerance to the extract administered during the phases of an injection regimen. The initial dose of the extract should be determined based on the puncture test reactivity. In patients who appear to be exquisitely sensitive by history and skin test, the initial dose of the extract should be 0.05 to 0.1 mL of a low concentration, such as dilution number 5 or 6 in below. Patients with lesser sensitivity may be started with 0.05 to 0.1 mL of the next higher concentration. The amount of Allergenic Extract is increased at each injection by no more than 50% of the previous amount, and the next increment is governed by the response to the last injection. Large local reactions which persist for longer than 24 hours are generally considered an indication for repeating the previous dose or reducing the dose at the next administration. Any evidence of systemic reaction is an indication for a reduction of 75% in the subsequent dose. The upper limits of dosage have not been established; however, doses larger than 0.2 mL of an extract in 50% glycerin may cause discomfort upon injection. The dosage of Allergenic Extract does not vary significantly with the allergic disease under treatment.

To prepare dilutions starting from a concentrate such as 1:10 W/V, 1:20 W/V, OR 20,000 PNU/mL, proceed as in Table 1 below. (Note: Add 0.5 mL of concentrate to 4.5 mL of sterile diluent and make additional dilutions in the same manner.)

TABLE 1 Ten-Fold Dilution Series*
Dilution Extract Diluent W/V W/V PNU/mL 0 concentrate 4.5 mL 1:10 1:20
20,000
1 0.5 mL concentrate 4.5 mL 1:100 1:200 2,000 2 0.5 mL concentrate 1 4.5 mL 1:1000 1:2000 200 3 0.5 mL concentrate 2 4.5 mL 1:10,000 1:20,000 20 4 0.5 mL concentrate 3 4.5 mL 1:100,000 1:200,000 2 5 0.5 mL concentrate 4 4.5 mL 1:1,000,000 1:2,000,000 0.2 6 0.5 mL concentrate 5 4.5 mL 10,000,000 1:20,000,000 0.02
*There is no direct potency correlation across the table between PNUs and W/V.

The optimal interval between doses of Allergenic Extract has not been established. Injections usually are given 1 or 2 times per week until the maintenance dose is reached. The injection interval then is increased to 2 weeks, then to 3 weeks, and finally to 4 weeks. If the patient does not return for 6 to 8 weeks, the dose should be reduced to 25% of the last dose. If longer than 8 weeks, a dose reduction of one, two or three dilutions may be made considering the components and the patient's sensitivity. The dosage and the interval between injections may need to be modified according to the clinical response of the patient. When switching patients to fresh extract, the initial dose should be reduced to 25% of the previous dose.

The usual duration of treatment has not been established. A period of two or three years of injection therapy constitutes an average minimum course of treatment.
Specimen Collection Kit...

Specimen Collection Kit

Edema

Therapy should be individualized according to patient response to gain maximal therapeutic response and to determine the minimal dose needed to maintain that response.

Adults

The usual initial dose of furosemide is 20 to 80 mg given as a single dose. Ordinarily a prompt diuresis ensues. If needed, the same dose can be administered 6 to 8 hours later or the dose may be increased. The dose may be raised by 20 or 40 mg and given not sooner than 6 to 8 hours after the previous dose until the desired diuretic effect has been obtained. The individually determined single dose should then be given once or twice daily (e.g., at 8 am and 2 pm). The dose of furosemide may be carefully titrated up to 600 mg/day in patients with clinically severe edematous states.

Edema may be most efficiently and safely mobilized by giving furosemide on 2 to 4 consecutive days each week.

When doses exceeding 80 mg/day are given for prolonged periods, careful clinical observation and laboratory monitoring are particularly advisable. (See PRECAUTIONS: LABORATORY TESTS)

Geriatric

In general, dose selection for the elderly patient should be cautious, usually starting at the low end of the dosing range (see PRECAUTIONS: GERIATRIC USE).

Pediatric

The usual initial dose of oral furosemide in pediatric patients is 2 mg/kg body weight, given as a single dose. If the diuretic response is not satisfactory after the initial dose, dosage may be increased by 1 or 2 mg/kg no sooner than 6 to 8 hours after the previous dose. Doses greater than 6 mg/kg body weight are not recommended. For maintenance therapy in pediatric patients, the dose should be adjusted to the minimum effective level.

Hypertension

Therapy should be individualized according to the patient’s response to gain maximal therapeutic response and to determine the minimal dose needed to maintain the therapeutic response. Adults The usual initial dose of furosemide for hypertension is 80 mg, usually divided into 40 mg twice a day. Dosage should then be adjusted according to response. If response is not satisfactory, add other antihypertensive agents. Changes in blood pressure must be carefully monitored when furosemide is used with other antihypertensive drugs, especially during initial therapy. To prevent excessive drop in blood pressure, the dosage of other agents should be reduced by at least 50 percent when furosemide is added to the regimen. As the blood pressure falls under the potentiating effect of furosemide, a further reduction in dosage or even discontinuation of other antihypertensive drugs may be necessary. Geriatric Patients In general, dose selection and dose adjustment for the elderly patient should be cautious, usually starting at the low end of the dosing range (see PRECAUTIONS: Geriatric Use).

Adults

The usual initial dose of furosemide for hypertension is 80 mg, usually divided into 40 mg twice a day. Dosage should then be adjusted according to response. If response is not satisfactory, add other antihypertensive agents.

Changes in blood pressure must be carefully monitored when furosemide is used with other antihypertensive drugs, especially during initial therapy. To prevent excessive drop in blood pressure, the dosage of other agents should be reduced by at least 50 percent when furosemide is added to the regimen. As the blood pressure falls under the potentiating effect of furosemide, a further reduction in dosage or even discontinuation of other antihypertensive drugs may be necessary.

Geriatric

In general, dose selection and dose adjustment for the elderly patient should be cautious, usually starting at the low end of the dosing range (see PRECAUTIONS: GERIATRIC USE).
Probenecid

Probenecid

Apply a thin film to the affected area two or three times daily or as directed by a physician.
Nazirex Compounding Kit...

Nazirex Compounding Kit

There is currently no dosage information available for this product. We apologize for any inconvenience.
Gapeam Budibac

Gapeam Budibac

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Equipto – Naproxe...

Equipto – Naproxen External

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Pantoprazole Sodium

Pantoprazole Sodium

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Menopause Hp

Menopause Hp

Adult

The maximum recommended single dose of Lidocaine Hydrochloride Oral Topical Solution, USP (Viscous) 2% for healthy adults should be such that the dose of lidocaine HCI does not exceed 4.5 mg/kg or 2 mg/lb body weight and does not in any case exceed a total of 300 mg.

For symptomatic treatment of irritated or inflamed mucous membranes of the mouth and pharynx, the usual adult dose is one 15 mL tablespoonful undiluted. For use in the mouth, the solution should be swished around in the mouth and spit out. For use in the pharynx, the undiluted solution should be gargled and may be swallowed. This dose should not be administered at intervals of less than three hours, and not more than eight doses should be given in a 24-hour period.

The dosage should be adjusted commensurate with the patient's age, weight and physical condition. (See Precautions).

Pediatric

Care must be taken to ensure correct dosage in all pediatric patients as there have been cases of overdose due to inappropriate dosing.

It is difficult to recommend a maximum dose of any drug for children since this varies as a function of age and weight. For children over 3 years of age who have a normal lean body mass and normal body development, the maximum dose is determined by the child's weight or age. For example: in a child of 5 years weighing 50 lbs., the dose of lidocaine hydrochloride should not exceed 75-100 mg (3/4 to 1 teaspoonful).

For infants and in children under 3 years of age, 1/4 teaspoonful of the solution should be accurately measured and applied to the immediate area with a cotton-tipped applicator. This dose should not be administered at intervals of less than three hours. Not more than four doses should be given in a 12-hour period.
Mucus Relief Cold Flu A...

Mucus Relief Cold Flu And Sore Throat

There is currently no dosage information available for this product. We apologize for any inconvenience.

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