Allergenic Extract, Cricket

Name: Allergenic Extract, Cricket

Allergenic Extract, Cricket Description

Antigen Laboratories' allergenic extracts are manufactured from source material listed on the vial label. The extract is a sterile solution containing extractables of source materials obtained from biological collecting and/or processing firms. All source materials are inspected by Antigen Laboratories' technical personnel in accordance with 21 CFR 680.1 (b) (I).

The following "For Diagnostic Use Only" allergenic extracts are extracted at a 1:20 w/v or 1:50 w/v ratio of source material to extracting fluid:

The source material for Coffee is prepared by grinding the seed of the coffee plant (Coffea arabic).

The source material for Cottonseed is prepared by grinding the seed of the cotton plant (Gossypium spp.).

The source material for Flaxseed is prepared by grinding the seed of the flax plant (Linum usitatissimum).

Leafhopper source material is pulverized whole bodies of Leafhoppers (Cicadellidae).

Miller Moth source material is pulverized whole bodies of night flying moths (Lepidoptera).

Cricket source material is pulverized whole bodies of crickets (Gryllidae).

Moth source material is pulverized whole bodies of moths of the order Frenatae.

The routes of administration for diagnostic purposes are intradermal or prick-puncture of the skin.

FOR ALLERGENIC EXTRACTS CONTAINING 50% V/V GLYCERINE AS PRESERVATIVE AND STABILIZER:

INACTIVE INGREDIENTS:

Sodium chloride……………………………………………………………………...0.95%

Sodium bicarbonate………………………………………………………………….0.24%

USP Glycerine…………………………………………………………………50% (v/v)

Water for Injection…………………………………………………………q.s. to volume

Active allergens are described by common and scientific name on the stock concentrate container label.

Adverse Reactions

Adverse reactions include, but are not necessarily limited to urticaria, itching, edema of the extremities, respiratory wheezing or asthma, dyspnea, cyanosis, tachycardia, lacrimation, marked perspiration, flushing of the face, neck or upper chest, mild persistent clearing of the throat, hacking cough or persistent sneezing.

1) Local Reactions

A small amount of erythema and swelling at the site of injection is common, the extent varying with the patient. Such reactions should not be considered significant unless they persist for at least 24 hours or exceed 50 mm in diameter.

Large, persistent local reactions or minor exacerbations of the patient's allergic symptoms may be treated by local cold applications and/or the use of oral antihistamines, but they should be considered a warning of possible severe systemic reactions.

A mild burning immediately after the injection is to be expected; this usually is relieved in 10-20 seconds.

2) Systemic Reactions

Systemic reactions may range from mild exaggeration of the patient's allergic symptoms to anaphylactic reactions. Very sensitive patients may show a rapid response. In some instances, a severe systemic reaction with blood pressure fall and/or shock may occur. Quantitation of patient's sensitivity combined with careful early observation is essential for safe skin testing.9

Patients receiving beta-blockers may not be responsive to epinephrine or inhaled bronchodilators. The following are commonly prescribed beta-blockers: Levatol, Lopressor, Propanolol Intersol, Propanolol HCL, Blocadren, Propanolol, Inderal-LA, Visken, Corgard, Ipran, Tenormin, Timoptic. Ophthalmic beta-blockers: Betaxolol, Levobunolol, Timolol, Timoptic. Chemicals that are beta-blockers and may be components of other drugs: Acebutolol, Atenolol, Esmolol, Metoprolol, Nadolol, Penbutolol, Pindolol, Propanolol, Timolol, Labetalol, Carteolol.

Allergenic Extract, Cricket Dosage and Administration

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Some allergenic extracts naturally precipitate. This allergenic extract is "For Diagnostic Use Only". (Refer to STORAGE section.)

PRICK-PUNCTURE TESTING: To identify highly sensitive individuals and as a safety precaution, it is recommended that a prick-puncture test using a drop of the extract concentrate be performed prior to initiating very dilute intradermal testing. Prick-puncture testing is performed by placing a drop of extract concentrate on the skin and puncturing the skin through the drop with a small needle such as a bifurcated vaccinating needle. The most satisfactory sites on the back for skin testing are from the posterior axillary fold to 2.5 cm from the spinal column, and from the top of the scapula to the lower rib margins. The best areas on the arms are the volar surfaces from the axilla to 2.5 or 5 cm above the wrist, skipping the anticubital space. Skin testing should include a positive control of histamine phosphate and a negative control of 50% v/v glycerine in buffered saline. A positive reaction is approximately 10-15 mm erythema with 2.5 mm wheal. Smaller, less conclusive reactions may be considered positive in conjunction with a definitive history of symptoms on exposure to the allergen. Less sensitive individuals can be tested intradermally with an appropriately diluted extract (See "INTRADERMAL TESTING").

INTRADERMAL TESTING: The surface of the upper and lower arm is the usual location for skin testing. A sterile, disposable syringe and needle is used for each extract tested. Intracutaneous test dilutions, five-fold or ten-fold, may be prepared from stock concentrate using physiologic saline as a diluent. (1) Start testing with the most dilute allergenic extract concentration. (2) A volume of 0.02-0.05 ml should be injected slowly into the superficial skin layers making a small bleb (superficial wheal). (3) For patients without a history of extreme sensitivity, or a negative or weakly reactive prick-puncture test, the initial dilution for skin testing should be at least 1:12,500 w/v. This initial dilution can be prepared by diluting 1:20 to 1:50 w/v (2%-5%) extracts five-fold to 5-4 or 1:10 w/v (10%) extracts to 5-5. Dilute 1:10 w/v (10%) extracts to 10-3 if using ten-fold dilutions. (4) Sensitive patients with a positive prick-puncture test require a further dilution to at least 1:312,500 w/v. This dilution can be prepared by diluting 1:20 to 1:50 w/v (2%-5%) extracts to 5-6 or 1:10 w/v (10%) extracts to 5-7 (five-fold dilutions). Ten-fold dilution to 10-6 of a 1:10 w/v (10%) extract would be a safe starting dilution. For interpretation of skin reactions, refer to chart below. If after 20 minutes no skin reaction is observed, continue testing using increasing increments of the concentration until a reaction of 5-10 mm wheal and 11-30 mm erythema is obtained, or a concentration of 5-2 or 10-1 has been tested. A negative control, 50% glycerine diluted with diluent to 5-2 (1:25) or 10-1 (1:10) dilution and a positive control of histamine phosphate, should be tested and included in interpretation of skin reactions.2,4

GRADE mm ERYTHEMA mm WHEAL
0 less than 5 less than 5
± 5-10 5-10
1+ 11-20 5-10
2+ 21-30 5-10
3+ 31-40 10-15 or with pseudopods
4+ greater than 40 greater than 15 or with many pseudopods

INTRADERMAL TESTING–SKIN ENDPOINT TITRATION: The allergenic extracts to which the patient is sensitive and the patient's degree of sensitivity can be determined through the use of intracutaneous skin tests involving progressive five-fold dilutions of allergenic extracts. Intracutaneously inject 0.01 to 0.02 ml of the test allergen to form a 4 mm diameter superficial skin wheal. For patients demonstrating a negative or weakly reactive prick-puncture skin test, an initial screening dilution of 1:12,500 w/v is safe. For patients demonstrating a positive prick-puncture skin test, an initial screening dilution of 1:312,500 w/v is safe (see "Serial Dilution Titration Test Dilutions" chart below).When a sequence of five-fold or ten-fold dilutions of an allergen is injected, the endpoint is determined by noting the dilution that first produces a wheal or erythema (15 minutes after injection) that is 2 mm larger than wheals with erythema produced by weaker, non-reacting dilutions (5 mm negative wheal).

SERIAL DILUTION TITRATION TEST DILUTIONS APPROXIMATE ALLERGENIC EXTRACT CONCENTRATION RESULTING FROM 1:5 DILUTION
Titration Number Dilution Exponent Weight / Volume Allergenic Extract Concentrate
1:50 (2%) 1:40 (2 1/2%) 1:33 1/3 (3%) 1:20 (5%) 1:10 (10%)
No. 1 5-1 1:5 1:250 1:200 1:167 1:100 1:50
No. 2 5-2 1:25 1:1,250 1:1,000 1:835 1:500 1:250
No. 3 5-3 1:125 1:6,250 1:5,000 1:4,175 1:2,500 1:1,250
No. 4 5-4 1:625 1:31,250 1:25,000 1:20,875 1:12,500 1:6,250
No. 5 5-5 1:3,125 1:156,250 1:125,000 1:104,375 1:62,500 1:31,250
No. 6 5-6 1:15,625 1:781,250 1:625,000 1:521,875 1:312,500 1:156,250
No. 7 5-7 1:78,125 1:3,906,250 1:3,125,000 1:2,609,375 1:1,562,500 1:781,250
No. 8 5-8 1:390,625 1:19,531,250 1:15,625,000 1:13,046,875 1:7,812,500 1:3,906,250
No. 9 5-9 1:1,953,125 1:97,656,250 1:78,125,000 1:65,234,375 1:39,062,500 1:19,531,250
No. 10 5-10 1:9,765,625 1:488,281,250 1:390,625,000 1:326,171,875 1:195,312,500 1:97,656,250
No. 11 5-11 1:48,828,125 1:2,441,406,250 1:1,953,125,000 1:1,630,859,375 1:976,562,500 1:488,281,250
No. 12 5-12 1:244,140,625 1:12,207,031,250 1:9,765,625,000 1:8,154,296,875 1:4,882,812,500 1:2,441,406,250

Storage

Store all stock concentrates and dilutions at 2-8 degrees C and keep at this temperature during office use. The expiration date of the allergenic extract is listed on the container label. Dilutions of the allergenic extract concentration containing less then 50% glycerine are less stable. If loss of potency is suspected, potency can be checked using side by side skin testing with freshly prepared dilutions of equal concentration on individuals with known sensitivity to the allergen.

References

1. Holgate, S.T., Robinson, C., Church, Mike: Mediators of Immediate Hypersensitivity, Third Edition, Allergy Principles and Practice, C.V. Mosby Co., Vol. I and II, pp 135-163, 1988.

2. Bousquet, Jean: "In vivo methods for study of allergy: Skin tests" Third Edition, Allergy Principles and Practice, C.V. Mosby Co., Vol. I and II, pp. 419-436, 1988.

3. Seebohm, P.M., et al: Panel on Review of Allergenic Extracts, Final Report, Food and Drug Administration, March 13, 1981, pp. 9-48.

4. Van Metre, T., Adkinson, N., Amodio, F., Lichtenstein, L., Mardinay, M., Norman, P., Rosenberg, G., Sobotka, A., Valentine, M.: "A Comparative Study of the Effectiveness of the Rinkel Method and the Current Standard Method of Immunology for Ragweed Pollen Hay Fever," The Journal of Clinical Allergy and Immunology, Vol. 66, No. 6, pg. 511, December 1980.

5. Wasserman, S.: The Mast Cell and the Inflammatory Response. The Mast CeIl–its role in health and disease. Edited by J. Pepys & A.M. Edwards, Proceedings of an International Symposium, Davos, Switzerland, Pitman Medical Publishing Co., 1979, pp. 9-20.

6. Wasserman, S., Marquart, D.: Anaphylaxis, Third Edition, Allergy Principles and Practice, Vol. I, Chapter 58, p. 1365, edited by Middleton et al.

7. Bullock, J., Frick, O.: Mite Sensitivity in House Dust Allergic Children, Am. J. Dis. Child.,pp. 123-222,1972.

8. Willoughby, J.W.: Inhalant Allergy Immunotherapy with Standardized and Nonstandardized Allergenic Extracts, American Academy of Otolaryngology-Head and Neck Surgery:

Instructional Courses, Vol. 1, Chapter 15, C.V. Mosby Co., St. Louis, Missouri, September 1988.

9. Reid, Michael J., Lockey, Richard F., Turkeltaub M.D., Paul C., Platts-Mills, Thomas: "Survey of Fatalities From Skin Testing and Immunotherapy 1985-1989," Journal of Allergy and Clinical Immunology, Vol. 92, No.1, pp. 6-15, 1993.

Container labeling

CRICKET 
cricket injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:49288-0160
Route of Administration INTRADERMAL, SUBCUTANEOUS DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ACHETA DOMESTICUS (ACHETA DOMESTICUS) ACHETA DOMESTICUS 0.05 g  in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN 0.525 mL  in 1 mL
SODIUM CHLORIDE 0.0095 g  in 1 mL
SODIUM BICARBONATE 0.024 g  in 1 mL
WATER  
Packaging
# Item Code Package Description
1 NDC:49288-0160-1 2 mL in 1 VIAL, MULTI-DOSE
2 NDC:49288-0160-2 5 mL in 1 VIAL, MULTI-DOSE
3 NDC:49288-0160-3 10 mL in 1 VIAL, MULTI-DOSE
4 NDC:49288-0160-4 30 mL in 1 VIAL, MULTI-DOSE
5 NDC:49288-0160-5 50 mL in 1 VIAL, MULTI-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102223 03/23/1974
Labeler - Antigen Laboratories, Inc. (030705628)
Registrant - Antigen Laboratories, Inc. (030705628)
Establishment
Name Address ID/FEI Operations
Antigen Laboratories, Inc. 030705628 manufacture
Revised: 11/2009   Antigen Laboratories, Inc.
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