Allermed Laboratories, Inc.

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Allermed Laboratories, Inc. Drugs

Standardized Bermuda Gr...

Standardized Bermuda Grass

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. The product should be discarded if discoloration or particles are observed.DIAGNOSTIC USE: Standardized grass pollen extract may be used to diagnose sensitivity to grass pollen by performing skin tests on persons with a history of grass pollen allergy. Due to the risk of adverse reactions occurring in highly sensitive persons, it is mandatory to initially test all patients percutaneously using the scratch, prick or puncture method. If a properly performed percutaneous test is negative, an intradermal test may be used with caution.PUNCTURE TEST: The puncture test should be performed first with 10,000 BAU/mL extract. Data for the puncture test using 10,000 BAU/mL extract are summarized in Table 1 under CLINICAL PHARMACOLOGY. If the puncture test to 10,000 BAU/mL extract is negative, the test may be repeated using 100,000 BAU/mL extract. Appropriate positive and negative controls for skin test interpretation are necessary. Reactions are quantified based on size of erythema and wheal in relation to controls.INTRADERMAL TEST: An intradermal test should only be performed after a puncture test has been properly administered with a negative result. It is usually safe to initiate intradermal testing with a 1:1,000 v/v dilution of the extract to which a negative puncture test was observed. For example, if a puncture test is done with 10,000 BAU/mL extract and is negative, the intradermal test may be performed with 0.05 mL of 10 BAU/mL extract. The dose may be increased to 0.05 mL of 100 BAU/mL extract if the intradermal test with 10 BAU/mL extract is negative.THERAPEUTIC USE: The dosage of grass pollen extract administered by subcutaneous injection during immunotherapy is highly individualized and varies according to the patient. In patients who appear to be highly sensitive by history and skin test, the initial dose of the extract should be low, such as 0.1 mL of a 0.01 BAU/mL dilution. The amount of extract is increased at each injection, but not more than 50%-100% of the previous amount, and the next increment is governed by the response to the last injection. Local reactions that persist longer than 24 hours are undesirable and any systemic reaction is an indication that the dose should be reduced (at least 50%). The upper limits of dosage have not been established, but doses larger than 0.2 mL of concentrate containing 50% glycerol may be painful due to the glycerol in the extract. The potency of each standardized grass pollen in a final mixture should not exceed that obtained from using a 10,000 BAU/mL stock concentrate of each grass included in the mix. Concentrate containing 100,000 BAU/mL should be diluted to 10,000 BAU/mL before being used to prepare final mixtures, or alternatively, the volume of 100,000 BAU/mL extract added to the mixture should be reduced 10-fold. The optimum interval between doses of grass pollen extract has not been definitely established. However, as is customarily practiced, injections are given one or two times per week until the maintenance dose is reached. At this time, the injection interval may be 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 50% of the last dose. If longer than 8 weeks, a dose reduction of one, two or three dilutions may be made, depending on the amount of time that has elapsed since the last injection. 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 75% [one-quarter (25%) of the previous dose administered from the old lot of extract]. A period of three to five years of injection therapy constitutes an average course of treatment. Children and geriatric patients appear to tolerate injections of allergenic extract well, and no special recommendations need to be made for these groups (see PRECAUTIONS - PEDIATRIC USE).PREPARING DILUTIONS: To prepare dilutions for intradermal skin tests and therapeutic use, the stock concentrate may be diluted as shown in Table 4. Vial #1 is made by adding 1.0 mL of the concentrate to 9.0 mL of sterile diluent. This process is repeated until the desired concentration is achieved. Each new dilution is made by adding 1.0 mL of the previous dilution to 9.0 mL of sterile diluent. The number of allergy units per mL in each dilution is shown in Table 4.
Table 4. Directions for diluting standardized grass pollen extract containing 10,000 BAU/mL.* Extract mL Extract mL Diluent Dilution Strength Dilution Label * If 100,000 BAU/mL extract is used to prepare dilutions, the 100,000 BAU/mL extract should be diluted 1:10 v/v before the directions shown in the table are followed. 10,000 BAU/mL 1.0 9.0 1,000 BAU/mL A Dilution A 1.0 9.0 100 BAU/mL B Dilution B 1.0 9.0 10 BAU/mL C Dilution C 1.0 9.0 1.0 BAU/mL D Dilution D 1.0 9.0 0.1 BAU/mL E Dilution E 1.0 9.0 0.01 BAU/mL F
House Dust Mite

House Dust Mite

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. The product should be discarded if discoloration or particles are observed. The skin test concentration of 10,000 AU/mL in dropper vials is used for scratch or prick-puncture testing. Puncture tests performed with D. farinae extract on 5 persons sensitive to mite showed a mean diameter wheal of 8.8 mm ± 1.8 mm and mean diameter erythema of 39.2 mm ± 5.3 mm. Puncture tests with D. pteronyssinus extract on 10 persons sensitive to mite showed a mean diameter wheal of 7.8 mm ± 4.1 mm and mean erythema of 33.7 mm ± 12.0 mm. Extract for intradermal testing should be prepared by diluting the 10,000 AU/mL stock concentrate in bulk vials with sterile saline with or without human serum albumin. Intradermal skin tests (0.05 mL) in persons highly sensitive to mite showed the following results:
AU/mL to elicit 50 mm sum of diameter erythema reaction Allergen No. of Persons Mean Range D. farinae 5 0.0040 0.0013-0.0124 D. pteronyssinus 10 0.0031 0.0001-0.1416
Intradermal extract should be used as follows: Intradermal tests should only be performed after a scratch or prick-puncture test has been administered with a negative result. Patients who do not react to a valid scratch or prick-puncture test should be tested intradermally with 0.02 to 0.05 mL of a 10 AU/mL (1:1,000 v/v of the 10,000 AU/mL concentrate). If this test is negative, a second intradermal test may be performed using a 100 AU/mL (1:100 v/v dilution of 10,000 AU/mL concentrate). Skin tests are graded in terms of the wheal and erythema response noted at 1 5 to 20 minutes. Wheal and erythema size may be recorded by actual measurement of the extent of both responses.Therapeutic The dosage of mite extract administered by subcutaneous injection is highly individualized and varies according to the degree of sensitivity of the patient, his clinical response and tolerance to the extract administered during the early phases of an injection regimen. In patients who appear to be highly sensitive by history and skin test, the initial dose of the extract should be 0.05 mL of a 0.1 AU/mL dilution or as established by skin test titration. The amount of allergenic extract is increased at each injection by not more than 50% - 100% 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. 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 the concentrate may be painful due to the glycerin content of the extract. The optimal interval between doses of mite extract has not been definitely established. However, as is customarily practiced, injections are given one or two times per week until the maintenance dose of extract is reached. At this time, the injection interval may be 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, too 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 (25%) of the previous dose. The usual duration of treatment has not been established. A period of three to five years of injection therapy constitutes an average course of treatment. Children and older age patients appear to tolerate injections of allergenic extract well, and no special recommendations need to be made for these groups.Preparing Dilutions To prepare dilutions for intradermal skin tests and therapeutic use, the stock concentrate may be diluted as shown in Table 1. Vial #1 is made by adding 1.0 mL of the concentrate to 9.0 mL of sterile diluent. Vial #2 is made by adding 1.0 mL of Vial #1 to 9.0 mL of sterile diluent. This process is repeated until the desired concentration is achieved. In each case, the subsequent vial is made by adding 1.0 mL of the previous dilution to 9.0 mL of sterile diluent. The number of allergy units per mL in each dilution is shown in table below.
Volume per volume dilutions of 5,000 AU/mL and 10,000 AU/mL concentrates to provide a ten-fold dilution series. Vial No. w/v Dilution of Concentrate 5,000 AU/mLConcentrateAU/mL 10,000 AU/mLConcentrateAU/mL 1 1:100,000 0.05 0.1 2 1:10,000 0.5 1.0 3 1:1,000 5.0 10.0 4 1:100 50.0 100.0 5 1:10 500.0 1,000.0 6 No Dilution 5,000.0 10,000.0
Trichophyton For Intrad...

Trichophyton For Intradermal Skin Testing

Prior to administering skin tests, the skin should be cleaned with alcohol and allowed to dry completely. The tests should be placed on the volar surface of the forearm and four rows may be placed on the back. INTRADERMAL TEST The intradermal test is performed by administering 0.1 mL of extract into the skin. The injection should be given as superficially as possible creating a distinct bleb approximately 5 mm in diameter. The tests should be examined after 15 - 20 minutes and read as negative or positive. Test sites that show a wheal and flare response should be measured and reported in mm of edema and erythema or scored as 1+ to 4+ based on a mm reference scale. Induration after 24 - 48 hours can occur in some individuals and also may be recorded in mm.
Allergenic Extract

Allergenic Extract

Diagnosis: Concentrated extract may be used for scratch or prick testing providing the patient is not extremely sensitive. In this case, the extract should be diluted 10 fold before a scratch or prick test is performed. Extract for intradermal testing must be used as follows:a. Patients with a negative scratch or prick test: Patients who do not react who do not react to a valid scratch or prick test should be tested intradermally with 0.05 mL of a 1:1000 v/v dilution of the concentrate. If the test is negative, a second test should be performed with 0.05 mL of a 1:100 v/v dilution or concentrate.b. Patients with positive scratch or prick tests: It is not advisable to perform an intradermal skin test if the patient has a positive scratch or prick test.c. Patients tested only by the intradermal method: Patients suspected of being highly allergic should be tested with 0.05 mL of a 1:100,000 v/v dilution of the concentrate. A negative test should be followed by repeat tests using 10 fold stronger concentrations until the maximum dose of 0.05 mL of a 1:100 v/v dilution is reached.Interpretation of Results Scratch and Prick Test A negative test shows only a slight red area at the site of scarification or prick penetration. Positive tests are scored as follows:1+ Erythema with 5 mm wheal2+ Erythema with a 5-10 mm wheal3+ Erythema with a 10-15 mm wheal4+ Erythema with a wheal 15 mm (or larger) with pseudopodiaIntradermal Test A negative test shows no change in the appearance and size of the 5 mm wheal created by the I.D. injection of 0.05 mL of extract. Positive tests are scored as follows:1+ Erythema 10-20 mm with a 5-10 mm wheal2+ Erythema 20-30 mm with a 5-10 mm wheal3+ Erythema 30-40 mm with a 10-15 mm wheal4+ Erythema greater than 40 mm with a 15 mm wheal (or larger) with pseudopodiaImmunotherapy Allergenic extract should be administered subcutaneously in the outer aspect of the upper arm using a sterile tuberculin syringe and needle. The skin should be cleaned with 70% alcohol and aseptic technique should be observed in removing the extract from the vial. Care must be taken to avoid injecting the extract into a blood vessel because of the risk of anaphylaxis. Concentrated extract must be diluted before administration to new patients. A 1:100,000 v/v dilution of concentrate is usually satisfactory to start treatment. However, as a precaution against overdose, a skin test with the intended starting dose should be done to help evaluate the patient's sensitivity to the product. If the skin response is larger than 5 mm edema/15 mm erythema, the extract is too strong and must be diluted before it is given subcutaneously. The doses shown in the Dosage Schedule (Table 1) below are recommended unless the patient's skin test response and allergic history indicates that more dilute extract should be used. Little is known about the required accumulated dosage of allergen that is needed to relieve symptoms. However, studies have shown that high dose immunotherapy is efficacious in the treatment of allergic rhinitis and asthma. For this reason, treatment with extract from Vial #5 is recommended, providing the patient can tolerate the extract without experiencing local or systemic reactions. Treatment with Vial #6 may be used for patients who have not had adverse reactions to extract in Vial #5 and who require more concentrated extract to control or relieve symptoms.Patients who have received allergenic extract for maintenance therapy SHOULD NOT be given the same dose from a fresh vial of extract. IT IS ADVISABLE TO REDUCE THE DOSAGE OF FRESH EXTRACT TO ONE-FOURTH THE AMOUNT GIVEN FROM A PREVIOUS LOT OF EXTRACT MADE AT THE SAME CONCENTRATION AND BY THE SAME FORMULA.
Table 1 - Suggested Dosage Schedule No. Vial #11:100,000 w/v frequency twiceweeklymL Vial #21:10,000 w/vfrequency twiceweeklymL Vial #31:1,000 w/vfrequency onceweeklymL Vial #41:100 w/vfrequency onceweeklymL Vial #51:10 w/v frequency everytwo-four weeksmL Vial #6Concentratefrequency everytwo-four weeksmL 1 0.025 0.025 0.025 0.025 0.025 0.025 2 0.05 0.05 0.05 0.05 0.05 0.05 3 0.10 0.10 0.10 0.10 0.10 0.10 4 0.15 0.15 0.15 0.15 0.15 0.15 5 0.20 0.20 0.20 0.20 0.20 0.20 6 0.25 0.25 0.25 0.25 0.25 0.25 7 0.30 0.30 0.30 0.30 0.30 0.30
Short Ragweed

Short Ragweed

DIAGNOSIS. If the extract supplied in this package is concentrated product (w/v 1:20), it should not be used for intradermal testing. Concentrated extract may be used for scratch or prick testing providing the patient is not exposed to high levels of ragweed pollen and experiencing pronounced symptoms of hay fever or asthma at the time of testing. Extract for intradermal testing must be diluted to a strength of 0.25 units of antigen E per ml 7. Skin tests should not be performed if the patient has taken antihistamine within 24 hours prior to testing.PROCEDURES Scratch Test: 1 drop of extract concentrate applied to a small scratch or scarification of the volar surface of the forearm or the flat aspect of the back.Prick Test: 1 drop of extract concentrate applied to the unbroken skin of the forearm or the back followed by pricking the skin under the drop.Intradermal Test: 0.05 ml of extract containing 0.25 antigen E units per ml given intradermally on the volar surface of the forearm or outer aspect of the upper arm. This test should not be performed unless the patient is negative to a properly administered and interpreted scratch or prick test. A final intradermal test using 0.05 ml of extract containing 2.5 antigen E units per ml may be used to rule out skin sensitivity to ragweed allergen.INTERPRETATION OF RESULTS Scratch and Prick Test A negative test shows only a slight red area at the site of scarification or prick penetration. Positive tests are scored as follows: 1+ Erythema with 5 mm wheal 2+ Erythema with 5 - 10 mm wheal 3+ Erythema with a 10 - 15 mm wheal 4+ Erythema with a wheal 15 mm (or larger) with pseudopodiaIntradermal Test A negative test shows no change in the appearance and size of the 5 mm wheal created by the I.D. injection of 0.05 ml of extract. Positive tests are scored as follows: 1+ Erythema with 10-20 mm with a 5-10 mm wheal 2+ Erythema with 20-30 mm with a 5-10 mm wheal 3+ Erythema with 30-40 mm with a 10-15 mm wheal 4+ Erythema greater than 40 mm with a 15 mm wheal (or larger) with pseudopodiaIMMUNOTHERAPY Concentrated ragweed extract must be diluted before administration to new patients. As a rule, extract containing 0.01 to 0.05 units of antigen E per ml are safe to initiate immunotherapy. An intradermal skin test with the intended starting dose may be done as an additional precaution in evaluating the patient's sensitivity. Injections should be given subcutaneously in the outer aspect of the upper arm. Care must be taken to avoid injecting the extract into a blood vessel, because of the potential hazard of anaphylaxis. Concentrated extract is usually administered once every two to four weeks at a maximum dose of 0.2 ml. A mild burning sensation immediately following the injection of concentrated extract is due to the glycerol in the extract. It should not be interpreted as an adverse allergic response. A suggested dosage schedule is shown in the Table below.Patients who have received allergenic extract for maintenance therapy should not be given the same dose from a fresh vial of extract. The antigen E content of ragweed pollen extract varies from lot to lot. Although the potency of fresh extract can be compared with that of previously administered product and adjusted accordingly, it is advisable to reduce the dosage of fresh extract to one-half the amount give from a previous lot. The antigen E content of ragweed pollen extract diminishes during storage and use in the physician's office, and, therefore, may be less than that specified on the vial label. In addition, ragweed pollen extract contains other components which may contribute to the overall allergenicity of the product 18.SUGGESTED DOSAGE SCHEDULE FOR RAGWEED EXTRACT BASED ON ANTIGEN E CONCENTRATION (units per ml) Concentrated extracts (w/v 1:20) of short ragweed pollen usually contain between 100 and 300 units antigen E per ml. Mixed short-giant ragweed pollen extracts contain approximately one-half these values.
AgE Units0.01/mlfrequencytwiceweekly AgE Units0.1/mlfrequencytwiceweekly AgE Units1.0/mlfrequencytwiceweekly AgE Units10/mlfrequencytwiceweekly AgE Units100/mlfrequencytwiceweekly No. ml No. ml No. ml No. ml No. ml 1 0.025 1 0.025 1 0.025 1 0.025 1 0.025 2 0.05 2 0.05 2 0.05 2 0.05 2 0.05 3 0.10 3 0.10 3 0.10 3 0.10 3 0.10 4 0.15 4 0.15 4 0.15 4 0.15 4 0.15 5 0.20 5 0.20 5 0.20 5 0.20 5 0.20 6 0.25 6 0.25 6 0.25 6 0.25 6 0.25 7 0.30 7 0.30 7 0.30 7 0.30 7 0.30
Note: Do not exceed a dose of 0.2 ml if the extract being administered contains 50% glycerol by volume Studies 10, 11 have shown that the accumulated pre-seasonal dose of short ragweed pollen extract should be in the range of 250 to 1000 units of antigen E to effectively reduce ragweed-related symptoms 3, 19. This dosage of antigen E is contained in 2.5 ml to 10.0 ml of extract containing 100 antigen E units/ml. Treatment with a maximum tolerated dose is recommended for both short ragweed pollen extract and mixed short-giant ragweed extract. The maintenance dose of ragweed pollen extract is defined as the highest tolerated dose that is consistently well tolerated without undue pain or swelling and which provides maximum relief to symptoms. The interval between maintenance injections should not exceed 4 weeks, since tolerance to the extract may be lost at longer intervals. If the interval exceeds 4 weeks, the dosage should be reduced by one-half for every additional two week period. A reduction in the maintenance dose also may be necessary during the ragweed season, due to the overdosing effects of inhaled allergen combined with injected allergen. As a rule, it is advisable to reduce the dosage by one-half during ragweed pollination and to increase the frequency of injections as needed to provide adequate relief symptoms. The dosage of ragweed pollen extract given to children is the same as the adult dose except for slight modifications due to body size and weight. A child's dose of 0.2 ml is considered comparable to an adult dose of 0.5 ml of the same dilution. Maintenance injection should be continued for a period of two to three years or longer, depending upon patient tolerance and clinical response.
Cat Hair

Cat Hair

Diagnosis: Concentrated extract (10,000 BAU/mL) may be used for scratch or prick-puncture testing. Puncture tests performed with a bifurcated needle in ten cat allergic persons showed a mean wheal diameter of 6.6 mm (S.D. 1.3) with a mean sum of erythema of 57.3 mm (S.D. 10.4). Intradermal tests with serial three-fold dilution of the 10,000 BAU/mL showed the following results:
Serial 3-Fold Dilutions of 10,000 BAU/mL Extract Subject 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 1 X 2 X 3 X 4 X 5 X 6 X 7 X 8 X 9 X 10 X
The mean three-fold dilution eliciting a response of 50 mm sum of erythema diameters was 11.120 (S.D. 2.38). The number of BAU/mL required to elicit this response was 0.05 (range 0.0003 to 9.24 BAU/mL). This concentration is approximately a 1:200,000 v/v dilution of the 10,000 BAU/mL extract. Extract for intradermal testing should be used as follows:
Patients with a positive scratch or prick test to Standardized Cat Hair Extract. It is not advisable to perform an intradermal skin test in these patients. Patients with a negative scratch or prick test to Standardized Cat Hair Extract. Patients who do not react to a scratch or prick test with the 10,000 BAU/mL concentrate maybe tested intradermally with 0.05 mL of a 1:2,000 v/v dilution of the concentrate (5 BAU/mL). If the test is negative, a second test should be performed with 0.05 mL of a 1:200 v/v dilution of concentrate (50 BAU/mL). Patients tested only by the intradermal method with Standardized Cat Hair Extract. Patients suspected of being highly allergic to cats should be tested with 0.05 mL of a 1:200,000 v/v dilution (0.05 BAU/mL) of the concentrate. A negative test should be followed by repeat tests using 10 fold stronger concentrations until the maximum dose of 0.05 mL of a 1:200 v/v dilution (50 BAU/mL) is reached.
Interpretation Of Skin Tests: The interpretation of skin tests should be based on the size of the erythema and wheal response to the allergen compared to a negative saline control. A suggested method of scoring skin tests is shown below. Measurements refer to the longest (single), diameter of erythema and wheal response.Scratch and Prick Test A negative test shows only a slight red area at the site of scarification or prick penetration. Positive tests are scored as follows: 1 + Erythema with a 5 mm wheal 2 + Erythema with a 5 -10 mm wheal 3 + Erythema with a 10 - 15 mm wheal 4 + Erythema with a wheal 15 mm (or larger) with pseudopodiaIntradermal Test A negative test shows no change in the appearance and size of the 5mm wheal created by the I.D. injection of 0.05 mL of extract. Positive tests are scored as follows: 1 + Erythema 10 - 20 mm with a 5 -10 mm wheal 2 + Erythema 20 - 30 mm with a 5 -10 mm wheal 3 + Erythema 30 - 40 mm with a 10 - 15 mm wheal 4 + Erythema greater than 40 mm with a 15 mm wheal (or larger) with pseudopodiaImmunotherapy Allergenic extract should be administered subcutaneously in the outer aspect of the upper arm using a sterile tuberculin syringe and needle. The skin should be cleaned with 70% alcohol and aseptic technique should be observed in removing the extract from the vial. Care must be taken to avoid injecting the extract into a blood vessel because of the potential hazard of anaphylaxis. Standardized Cat Hair Extract must be diluted before administration to new patients. As a precaution against overdose, a skin test with the intended starting dose should be done to help evaluate the patient's sensitivity to the product. If the skin response is larger than 5/15 mm (edema/erythema), the extract should be diluted before it is given subcutaneously. The doses shown in the Dosage Schedule may be followed unless the patient's skin test response and allergic history indicate that more dilute extract should be used. Little is known about the required accumulated dosage of Fel d1 (and other allergens that may be present in cat extract) that is needed to relieve symptoms. However, studies with other allergenic substances have shown that high dose immunotherapy is most efficacious in the treatment of allergic rhinitis and asthma. The amount of cat extract that is tolerated during immunotherapy depends upon the sensitivity of the patient. In one study in which patients with cat asthma were treated for a period of one year, the accumulated dose of Fel d1 varied from 3.6 to 115.8 (median 46.2) units13. A burning sensation immediately following the injection of extract from the concentrate is due to the glycerol in the extract. It should not be interpreted as an adverse allergic response. Patients who have received allergenic extract for maintenance therapy SHOULD NOT be given the same dose from a fresh vial of extract. IT IS ADVISABLE TO REDUCE THE DOSAGE OF FRESH EXTRACT TO ONE-FOURTH THE AMOUNT GIVEN FROM A PREVIOUS LOT.
Dosage Schedule for Standardized Cat Hair Extract (The safety and efficacy of this schedule has not been determined by well-controlled clinical trials.) [BAU = Bioequivalent Allergy Units per mL] Vial #10.05 BAU Vial #20.5 BAU Vial #35 BAU Vial #450 BAU Vial #5500 BAU Vial #65,000 BAU frequency twice weekly No. mL mL mL mL mL mL 1 0.05 0.05 0.05 0.05 0.05 0.05 2 0.1 0.1 0.1 0.1 0.1 0.1 3 0.2 0.2 0.2 0.2 0.2 0.2 4 0.3 0.3 0.3 0.3 0.3 0.3 5 0.4 0.4 0.4 0.4 0.4 0.4 v/v dilutions of concentrate containing 10,000 BAU per mL required to make the above concentrations. BAU per mL v/v Dilution of Concentrate 0.05 1:200,000 0.5 1:20,000 5.0 1:2,000 50.0 1:200 500.0 1:20 5,000.0 1:2
Candin

Candin

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. If particles or discoloration are observed, the product should not be used and it should be discarded. CANDIN® should be administered intradermally on the volar surface of the forearm or on the outer aspect of the upper arm. The test dose is 0.1 mL. The skin should be cleansed with 70% alcohol before applying the skin test. The intradermal injection must be given as superficially as possible causing a distinct, sharply defined bleb. An unreliable reaction may result if the product is injected subcutaneously. A positive DTH reaction to CANDIN® consists of induration ≥ 5 mm. The time required for the induration response to reach maximum intensity varies with the individual. The reaction usually begins within 24 hours and peaks between 24 and 48 hours. The skin test should be read at 48 hours by visually inspecting the test site and palpating the indurated area. Measurements should be made across two diameters as shown in the figure below. The mean of the longest and midpoint orthogonal diameters of the indurated area should be reported as the DTH response. For example, a reaction that is 10 mm (longest diameter) by 8 mm (midpoint orthogonal diameter) has a sum of 18 mm and a mean of 9 mm. The DTH response is therefore 9 mm. Area of induration (shaded area)

Allermed Laboratories, Inc.

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Allermed Laboratories, Inc. Drugs