Allergy Laboratories, Inc.

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Allergy Laboratories, Inc. Drugs

Standardized Bermuda Gr...

Standardized Bermuda Grass Pollen

DIAGNOSTIC SKIN TESTING: These products are used to determine a patient's sensitivity to specific antigens and aid in the diagnosis and treatment of atopic diseases. After a thorough history, a decision can be made as to which allergens will be appropriate to use for testing. The recommended procedure is to initially perform puncture tests, then follow with intradermal tests. For enhanced safety, scratch or puncture test with 10,000 BAU/ml before testing with 100,000 BAU/ml. See recommended dosage below:
* See Table B for information regarding range of BAU/ml that elicits a 50mm response for highly reactive patients. The negative intradermal control used for the 100 BAU/ml concentration should contain 0.5% (v/v) glycerin. SCRATCH OR PUNCTURE TEST: Concentration BAU/ml Dosage Bermuda Grass 1 drop 10,000 Other Grasses 10,000 1 drop 100,000 1 drop INTRADERMAL TEST: Concentration BAU/ml Dosage ml When scratch or puncture test is negative: 100 0.02 When scratch or puncture test is positive: * 0.02
FREQUENCY OF ADMINISTRATION:

      The number of skin tests applied at one time will depend on the particular patient and their allergic history. These tests should be performed and observed in 15 to 20 minutes. Additional tests may be applied in sequence. Perform tests on the anterolateral aspect of the upper arm on an area that permits the effective application of a tourniquet proximal to the site of the test. The skin at the site of injection should be disinfected with rubbing alcohol before testing.

      Puncture testing: Apply one drop of extract to the skin. Pierce the drop of extract and skin using a sterile hypodermic needle or vaccinating needle. Maintain the needle perpendicular to the skin surface and rock the needle back and forth to produce a small hole without bleeding. Do not rotate or gouge the needle. Remove needle from skin and wipe excess extract from skin surface.

      Scratch testing: Using a scarifier or needle, make a scratch 1/16 inch long on the epidermis penetrating the outer cornified area but being careful not to draw blood. Apply one drop of extract to the scratch.

      Intradermal testing: Use a separate sterile syringe (tuberculin type equipped with a 27 gauge by 3/8 inch needle with intradermal bevel) for each antigen. The tests are made by injecting 0.02ml of allergen into the epidermis. If the test has been performed properly, the solution should raise a bleb 2 to 3mm in diameter. If the bleb does not appear, the injection was made too deeply.

      A negative control consisting of the same solution that the extract was prepared in, should be applied to one of the sites in the same manner as the tests being performed. For example, the negative intradermal control should contain 0.5% (v/v) glycerin, if a 100 BAU/ml concentration grass is used for intradermal testing. Histamine phosphate should be used as a positive control for evaluation of skin testing. Histamine phosphate is available from other manufacturers. See their directions for use, for recommended dosage and interpretation of results.

      A positive reaction usually develops in 15 to 20 minutes. The positive response is a wheal and flare reaction that is larger than the negative control and judged on the size of the reaction. Scratch or puncture tests may not elicit as large and well defined reaction as the intradermal. (5)

The following grading system for intradermal testing is recommended (9):
Reaction Erythema Wheal 0 <5mm <5mm +/- 5-10mm 5-10mm 1+ 11-20mm 5-10mm 2+ 21-30mm 5-10mm 3+ 31-40mm 10-15mm or with pseudopods 4+ >40mm >15mm or with many pseudopods
IMMUNOTHERAPY:

The following are two methods of injection therapy:

      1. Pre-seasonal in which treatment is begun three months before seasonal difficulty begins and brought to maintenance dose by injections 4 to 7 days apart and discontinued after that season ends.

      2. Perennial treatment is the recommended mode of therapy in which the patient is, by injection therapy, brought up to tolerated maintenance dose and remains at that dose until amelioration of allergic symptoms occurs. Injections may be given at intervals of 4 to 7 days.

      Allergenic extracts must be diluted before use. Normally immunotherapy can be started with a 1 BAU/ml dilution. If a patient appears to be extremely sensitive, based on skin testing results, dilutions of the extract can further be made before injections are started. See Table B for additional information. The following are suggested procedures for making a proper dilution series. Recommended diluents contain 0.9% sodium chloride and 0.4% phenol as a preservative. Dlluents with HSA (Human Serum Albumin) as a stabilizer can also be used. Allergenic extracts should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.
TEN FOLD DILUTION SERIES: EXTRACT VOLUME EXTRACT CONCENTRATION BAU/ml DILUENT VOLUME DILUTION CONCENTRATION BAU/ml     1 part 100,000 + 9 parts = 10,000 1 part 10,000 + 9 parts = 1,000 1 part 1,000 + 9 parts = 100 1 part 100 + 9 parts = 10 1 part 10 + 9 parts = 1


      Perennial treatment may be started using the following dosage and dilution schedule. (Modified from Reference 10) This schedule is only illustrative and may not be applicable to all patients, since the degree of sensitivity to grass allergens differs among individuals. The dose administered must be adjusted based on the patient's sensitivity and tolerance. Initial dose can be based on end point titration using a dose that elicits a 1-2+ reaction. Maintenance dose is based on patient tolerance.
Dose # Dose Volume (ml) Concentration 1 0.05 1 BAU/ml 2 0.10 3 0.20 4 0.30 5 0.40 6 0.50                        7 0.05 10 BAU/ml 8 0.10 9 0.20 10 0.30 11 0.40 12 0.50                        13 0.05 100 BAU/ml 14 0.10 15 0.20 16 0.30 17 0.40 18 0.50                        19 0.05 1,000 BAU/ml 20 0.10 21 0.20 22 0.30 23 0.40 24 0.50                        25 0.05 10,000 BAU/ml 26 0.10 27 0.20 28 0.30 29 0.40 30 0.50                        31 0.05 100,000 BAU/ml 32 0.10 33 0.20 34 0.30 35 0.40
Gradually increase the dose as outlined in the schedule. If you give a dose that causes a mild local reaction (manifested by warmth or redness) repeat the same dose. If the reaction is severe or systemic (manifested as hives, asthma, or hay fever) drop back a dose in schedule and build again. If a severe local reaction or a systemic reaction is again encountered, this should be considered more than the maximum tolerance for this patient. The maintenance dose is the largest dose that relieves symptoms without producing local reactions. The size and interval of doses will vary and can be adjusted as necessary. The normal interval between doses is 4 to 7 days. 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.
Standardized Mite D Far...

Standardized Mite D Farinae

DIAGNOSTIC SKIN TESTING:

      Puncture tests performed on 15 highly sensitive patients with 2 separate lots of 10,000 AU/ml Mite Extract (D. farinae) showed a mean sum of diameter wheal of 15.93mm ± 4.92 and a mean sum of diameter erythema of 63.70mm ± 16.46. Puncture tests performed on 10 highly sensitive patients with 10,000 AU/ml Mite Extract (D. pteronyssinus) showed a mean sum of diameter wheal of 17.00mm ± 3.39 and a mean sum of diameter erythema of 84.80mm ± 5.80. Intradermal skin test results in highly sensitive patients is shown below using the same lots as used in the puncture tests above.
AU/ml to elicit 50mm sum of Diameter of Erythema Reaction Extracts Number of Patients Mean Range D. farinae 15 1.328 0.0024-9.410 D. pteronyssinus 10 0.008 0.0009-0.0287


Puncture tests with the mite growth medium as control were negative in 15 patients sensitive to mite.

      These products are used to determine a patient's sensitivity to specific antigens and aid in the diagnosis and treatment of atopic diseases. After a thorough history a decision can be made as to which allergens will be appropriate to use for testing. The recommended procedure is to initially perform puncture tests, then follow with intradermal tests. See recommended dosage below.
* The negative intradermal control used for the 100 AU/ml concentration should contain 0.5% (v/v) glycerin. SCRATCH OR PUNCTURE TEST: Concentration 10,000 AU/ml Dosage 0.05 ml INTRADERMAL TEST: A. Patients with a negative scratch or puncture test Concentration Dosage 1) 50 AU/ml or 0.02 ml 2) 100 AU/ml* if 50 AU/ml is negative 0.02 ml B. Patients tested by intradermal only Concentration Dosage 0.05 AU/ml 0.02 ml If negative repeat tests with stronger concentrations until a maximum of 100 AU/ml* is reached.


FREQUENCY OF ADMINISTRATION:

The number of skin tests applied at one time will depend on the particular patient and their allergic history. These tests should be performed and observed in 15 to 20 minutes. Additional tests may be applied in sequence. Perform tests on the anterolateral aspect of the upper arm on an area that permits the effective application of a tourniquet proximal to the site of the test. The skin at the site of injection should be disinfected with rubbing alcohol before testing.

Puncture testing: Apply one drop (0.05ml) of extract to the skin. Pierce the drop of extract and skin using a sterile hypodermic needle or vaccinating needle. Maintain the needle perpendicular to the skin surface and rock the needle back and forth to produce a small hole without bleeding. Do not rotate or gouge the needle. Remove needle from skin and wipe excess extract from skin surface.

Scratch testing: Using a scarifier or needle, make a scratch 1/16 inch long on the epidermis penetrating the outer cornified area but being careful not to draw blood. Apply one drop (0.05ml) of allergen to the scratch.

Intradermal testing: Use a separate sterile syringe (tuberculin type equipped with a 27 gauge by 3/8 inch needle with intradermal bevel) for each antigen. The tests are made by injecting 0.02ml of allergen into the epidermis. If the test has been performed properly, the solution should raise a bleb 2 to 3mm in diameter. If the bleb does not appear, the injection was made too deeply.

A negative control consisting of the same solution that the extract was prepared in should be applied to one of the sites in the same manner as the tests being performed. For example, the negative intradermal control should contain 0.5% (v/v) glycerin, if a 100 AU/ml concentration mite is used for intradermal testing. Histamine phosphate should be used as a positive control for evaluation of skin testing. Histamine phosphate is available from other manufacturers. See their directions for use, for recommended dosage and interpretation of results.

A positive reaction usually develops in 15-20 minutes. The positive response is a wheal and flare reaction that is larger than the negative control and judged on the size of the reaction. Scratch or puncture tests may not elicit as large and well defined reaction as the intradermal. (5)

The following system is recommended (8):
Reaction Erythema Wheal 0 <5mm <5mm +/- 5-10mm 5-10mm 1+ 11-20mm 5-10mm 2+ 21-30mm 5-10mm 3+ 31-40mm 10-15mm or with pseudopods 4+ >40mm >15mm or with many pseudopods
IMMUNOTHERAPY:

The following are two methods of injection therapy:
Pre-seasonal in which treatment is begun three months before seasonal difficulty begins and brought to maintenance dose by injections four to seven days apart and discontinued after that season ends. Perennial treatment is the recommended mode of therapy in which the patient is, by injection therapy, brought up to tolerated maintenance dose and remains at that dose until amelioration of allergic symptoms occurs. Injections may be given at intervals of 4 to 7 days.
Allergenic extracts must be diluted before use. Normally immunotherapy can be started with a 1 AU/ml dilution. If a patient appears to be extremely sensitive, dilutions of the antigen can further be made before injections are started. The following are suggested procedures for making a proper dilution series. Recommended diluents contain 0.9% sodium chloride and 0.4% phenol as a preservative. Allergenic extracts should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.
TEN FOLD DILUTION SERIES: ExtractVolume ExtractConcentration AU/ml DiluentVolume Dilution Concentration AU/ml 1 part 10,000 + 9 parts = 1,000 1 part 1,000 + 9 parts = 100 1 part 100 + 9 parts = 10 1 part 10 + 9 parts = 1
Perennial treatment may be started using the following dosage and dilution schedule. THIS SCHEDULE IS ONLY ILLUSTRATIVE AND HAS NOT BEEN SUBJECTED TO ADEQUATE OR WELL-CONTROLLED TRIALS TO DETERMINE EITHER ITS SAFETY OR EFFICACY.
Dose # Dose Volume (ml) Concentration 1 0.05 1 AU/ml 2 0.10 3 0.20 4 0.30 5 0.40 6 0 50                        7 0.05 10 AU/ml 8 0.10 9 0.20 10 0.30 11 0.40 12 0 50                        13 0.05 100 AU/ml 14 0.10 15 0.20 16 0.30 17 0.40 18 0 50                        19 0.05 1,000 AU/ml 20 0.10 21 0.20 22 0.30 23 0.40 24 0 50                        25 0.05 10,000 AU/ml 26 0.10 27 0.20 28 0.30 29 0.40 30 0 50
Gradually increase the dose as outlined in the schedule. If you give a dose that causes a mild local reaction manifested by warmth or redness, repeat the same dose. If the reaction is severe or systemic (manifested as hives, asthma, or hay fever), drop back a dose in schedule and build again. If a severe local reaction or a systemic reaction is again encountered, this should be considered more than the maximum tolerance for this patient. The maintenance dose is the largest dose that relieves symptoms without producing local reactions. The size and interval of doses will vary and can be adjusted as necessary. The normal interval between doses is 4 to 7 days.
Standardized Cat Hair

Standardized Cat Hair

DIAGNOSTIC SKIN TESTING:

Puncture tests performed on 10 highly sensitive patients with 10,000 BAU/ml Cat Hair Extract showed a mean sum of diameter wheal of 17.00mm ± 4.59 and a mean sum of diameter Erythema of 71.60 +14.01.

Intradermal skin test results in highly sensitive patients is shown below using the same extract as used in the puncture test above.
BAU/ml to elicit 50mm sum of Diameter of Erythema reaction Number of Patients Mean Range 10 0.0128 0.0021-0.1957
These products are used to determine a patient's sensitivity to specific antigens and aid in the diagnosis and treatment of atopic diseases. After a thorough history a decision can be made as to which allergens will be appropriate to use for testing. The recommended procedure is to initially perform puncture tests, then follow with intradermal tests. See recommended dosage below.
* The negative intradermal control used for the 100 BAU/ml concentration should contain 0.5% (v/v) glycerin. SCRATCH OR PUNCTURE TEST: Concentration Dosage 10,000 BAU/ml 0.05 ml (1 drop) INTRADERMAL TEST: A. Patients with a negative scratch or puncture test. Concentration Dosage 1) 50 BAU/ml 0.02 ml 2) 100 BAU/ml* if 50 BAU/ml is negative B. Patients tested by intradermal only. Concentration Dosage 0.5 BAU/ml 0.02 ml If negative, repeat tests with stronger concentrations until a maximum of 100 BAU/ml* is reached.
Apple

Apple

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

Allergenic extracts may be administered for diagnostic testing or therapeutic purposes. The dosage will depend on the particular use of the extract.

General: When used for diagnostic testing to determine a patient’s sensitivity to specific antigens and aid in the diagnosis and treatment of atopic disease, the recommended procedure is to initially perform puncture tests, then follow with intradermal tests. The number of skin tests applied at one time will depend on the particular patient and their allergic history. These tests should be performed and observed in 15 to 20 minutes. Additional tests may be applied in sequence. Perform tests on the anterolateral aspect of the upper arm on an area that permits the effective application of a tourniquet proximal to the site of the test. The skin at the site of injection should be disinfected with rubbing alcohol before testing. A positive reaction usually develops in 15 to 20 minutes. The positive response is a wheal and flare reaction that is larger than the negative control and evaluated based on the size of the reaction.

Controls: A negative control containing the same solution that the extract was prepared in should be applied to a test site in the same manner as the tests being performed. Histamine phosphate should be used as a positive control for evaluation of skin testing. Refer to manufacturers directions provided with Histamine phosphate for recommended dosage and administration.

Percutaneous testing: In general, skin is scratched, punctured or pricked just before the allergen is applied or through a drop of test allergen which is placed on the skin. There are several devices available for this technique. Refer to the device manufacturers instructions for proper use. Test areas should be no closer than 4-5 cm apart to avoid the interference of multiple reactions. Clean test areas with alcohol and air dry. Place the allergen on the volar surface of the patient’s forearm, upper arm, or back.

1. For puncture tests, apply one drop of extract to the skin. Pierce the drop of extract and skin using a sterile hypodermic needle or vaccinating needle. Maintain the needle perpendicular to the skin surface and rock the needle back and forth to produce a small hole without bleeding. Do not rotate or gouge the needle. Remove needle from skin and wipe excess extract from skin surface.

2. For scratch tests using a scarifier or needle: make a scratch 1/16 inch long on the epidermis penetrating the outer cornified area but being careful not to draw blood. Apply one drop of allergen to the scratch or puncture.

Intracutaneous (Intradermal) testing: If puncture test is negative, proceed with intradermal test. Intradermal tests should not be performed if puncture test is positive. Use a separate sterile syringe (tuberculin type equipped with a 27 gauge by 3/8 inch needle with intradermal bevel) for each antigen. To administer the test, inject 0.02 mL of allergen into the epidermis using dilutions of the concentrated extract; a 1:500 v/v dilution for foods and 1:1,000 v/v dilution for other extracts. If the test has been performed properly, the solution should raise a bleb 2 to 3 mm in diameter. If the bleb does not appear, the injection was made too deeply. To prepare intradermal testing strengths using 1:20 w/v bulk concentrates, use the following example: Add 1 mL of 1:20 w/v to 4 mL diluent to make a 1:100 v/v dilution. Add 1 mL of 1:100 v/v to 4 mL diluent to make a 1:500 v/v dilution. Add 0.5 mL of 1:100 v/v dilution to 4.5 mL diluent to make a 1:1,000 v/v dilution.
Interpretation of results: Percutaneous tests Intradermal tests 1 1+ Erythema with 5mm wheal 0 <5mm Erythema with a <5mm wheal       2+ Erythema with a 5-10mm wheal       +/- 5-10mm Erythema with a 5-10mm wheal 3+ Erythema with a 10-15mm wheal 1+ 11-20mm Erythema with a 5-10mm wheal 4+ Erythema with a wheal 15mm or larger with pseudopodia     2+ 21-30mm Erythema with a 5-10mm wheal 3+ 31-40mm Erythema with a 10-15mm wheal or with pseudopodia    4+ >40mm Erythema with >15mm wheal or with pseudopodia
Immunotherapy:

(1) General: Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit. Injections are given subcutaneously; preferably in the arm. It is advantageous to give injections in alternate arms. Use sterile precautions and a tuberculin syringe when administering each dose. Allergen immunotherapy is typically initiated with a diluted formulation of allergens prescribed by a physician for administration to a patient. Doses are gradually increased over time and ultimately reach a maintenance dose where the patient is maintained for as long as the physician or patient feels is necessary. The formulation and dosage schedule is determined by the physician and is based on diagnostic testing and patient history. Patients with very high sensitivities should be initiated with lower concentrations (higher dilutions) and may need a very relaxed progression to maintenance doses. Pre-seasonal therapy may be initiated three months before seasonal difficulty begins and brought to maintenance dose and discontinued after that season ends. Perennial therapy (recommended) brings the patient up to tolerated maintenance dose where they remain until improvement of allergic symptoms occurs. Injections may be given at intervals of 4 to 7 days with either therapy.

(2) Suggested dilution series: Concentrated Allergenic Extracts must be diluted with Sterile Diluent for Allergenic Extract before using for immunotherapy. A 1:100,000 v/v dilution of concentrate is usually satisfactory to start treatment. To prepare a 10-fold dilution series from concentrated bulk extract, the following is suggested: Add 1 mL of 1:20 w/v extract to 4 mL diluent to make a 1:100 v/v dilution. Add 0.5 mL of the 1:100 dilution to 4.5 mL of diluent to make a 1:1,000 v/v dilution. Add 0.5 mL of the 1:1,1000 dilution to 4.5 mL diluent to make a 1:10,000 v/v dilution. Add 0.5 mL of the 1:10,000 dilution to 4.5 mL of diluent to make a 1:100,000 v/v dilution. The series may be extended to 1:1,000,000 v/v by preparing one more similar dilution as a precaution for sensitive patients.

(3) Maintenance: The maintenance level is the largest dose tolerated by the patient that relieves symptoms without producing undesirable local or general reactions. After immunotherapy has been established, a maintenance dose should be given at weekly intervals. The interval between maintenance doses can be increased gradually from one week to 10 days, to 2 weeks, 3 weeks, or even 4 weeks as allergy symptoms allow. Repeat maintenance doses at a given interval three or four times to check for continued allergy symptom relief before increasing the interval further. If large local (or systemic) reactions occur at one interval, do not increase the interval. Protection is lost rapidly if the interval between doses is more than 4 weeks. It may not be possible for all patients to reach the maximum dose indicated on the suggested dosage schedule.

(4) Suggested dosage schedule: Because the degree of sensitivity varies in many individuals, the dose and interval may need adjustment and should reflect the patient’s tolerance and response. A dose should never be given until all reactions resulting from a previous dose have entirely disappeared. After a period on immunotherapy, better tolerance may permit a longer interval between injections, or a larger maintenance dose, or both.
1:100,000 v/v 1:10,000 v/v 1:1,000 v/v       1:100 v/v Dose Vol. (mL) Dose Vol. (mL)            Dose Vol. (mL)   Dose Vol. (mL) Maintenance 1 0.02 8 0.02 13 0.02 19 0.02 2 0.04 9 0.05 14 0.05 20 0.05 Continue 0.25 mL of 1:100 v/v weekly. 3 0.06 10 0.10 15 0.10 21 0.08 4 0.10 11 0.15 16 0.15 22 0.10 5 0.15 12 0.25 17 0.20 23 0.15 6 0.20 18 0.25 24 0.20 7 0.25 25 0.25


(5) Dose adjustments: Since the individual components of the extract are those to which the patient is allergic and to which he will be exposed, typical allergic symptoms may follow shortly after the injection, particularly those experienced by the patient during exposure when the antigen from the environment plus the injected antigen exceeds the patient’s tolerance to the antigen. In such cases, decrease the size of the next scheduled dose by at least one-half of the previous dose.

(6) Administration: Use aseptic precautions when diluting and/or preparing an injection. To avoid cross-contamination, do not use the same needle to withdraw materials from multiple vials. Use a sterile tuberculin syringe (26 or 27 gauge) with a needle at least 5/8” long and graduated in 0.01 mL units to measure each dose.

Allergy Laboratories, Inc.

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Allergy Laboratories, Inc. Drugs