Trichophyton For Intradermal Skin Testing (Page 2 of 2)

OVERDOSAGE

The signs and symptoms of overdosage are the same as those listed under ADVERSE REACTIONS, paragraphs 1 and 2.
The treatment of a systemic allergic reaction resulting from skin tests should include the following:

  • The patient should be placed in the recumbent position to maintain blood flow to the head.
  • Aqueous epinephrine 1:1,000 should be administered subcutaneously. See ADVERSE REACTIONS for dose and other supportive measures.
  • Reassurance should be provided.

The above steps should be performed nearly simultaneously and as soon as possible after the reaction begins. Persistent wheezing may necessitate treatment with intravenous aminophylline and inhaled bronchodilators. For profound shock and hypotension, intravenous fluids, vasopressors and oxygen also may be needed. Maintenance of an open airway is critical if upper airway obstruction is present. Corticosteroids may provide benefit if symptoms are prolonged or recurrent.

DOSAGE AND ADMINISTRATION

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.

HOW SUPPLIED

One mL of extract for intradermal skin testing is supplied in 2 mL sealed multidose vials. Each vial contains enough extract for 10 tests.

STORAGE

Extract should be stored at 2°C to 8°C, since higher temperatures may adversely affect the stability of allergens. Do not freeze.

REFERENCES

  1. Turkeltaub, P.C., The allergy unit — clinical relevance: Issues in allergen standardization, In: Lockey, R.F., S.C. Bukantz (Eds), Allergen Immunotherapy, Marcel Dekkar, New York, 171, 1991.
  2. Ting, S., E.H. Dunsky, R.M. Lavker, et al., Patterns of mast cell alterations and in vivo mediator release in human allergic skin reactions, J. Allergy Clin. Immunol., 66:417, 1980.
  3. Zweiman, B., Mediators of allergic inflammation in the skin, Clin. Allergy, 18:419, 1988.
  4. Askenase, Philip W., Effector and regulatory mechanisms in delayed-type hypersensitivity, Allergy Principles and Practice, vol.1, p. 264, third edition, C.V. Mosby, St. Louis, 1988.
  5. Lockey, R.F., L.M. Benedict, P.C. Turkeltaub, S.C. Buicantz, Fatalities from immunotherapy (IT) and skin testing (ST), J. Allergy and Clinical Immunol., 79:660, 1987.
  6. Nelson, H.S., Diagnostic procedures in allergy: I. Allergy skin testing, Ann. Allergy, 51: 411, 1983.
  7. Bierman, C.W., D.S. Pearlman, G.G. Shapiro, W.W. Busse (Eds), Allergic disease from infancy to adulthood, Third edition, W.B. Saunders Co., Philadelphia, 1996.
  8. Middleton, E., Jr., C.E. Reed, E.F. Ellis, N.F. Adkinson, J.W. Yunginger (Eds), Allergy principles and practice, Fourth edition, C.V. Mosby, St. Louis, 1993.
  9. Executive Committee, The American Academy of Allergy and Clinical Immunology, Position Statement, The waiting period after allergen skin testing and immunotherapy, J. Allergy Clin. Immunol., 85:526, 1990.
  10. Turkeltaub, P.C., P.J. Gergen, The risk of adverse reactions from percutaneous prick-puncture allergen skin testing, venipuncture and body measurements: data from the second National Health and Nutrition Examination Survey (NHANES II) 1976-1980, J. Allergy Clin. Immunol., 84:886, 1989.
  11. Jacobs, Robert L., Goeffrey W. Rake, Jr., et al., Potentiated anaphylaxis in patients with drug-induced beta-adrenergic blockade, J. Allergy and Clinical Immunol., 68:125, 1981.
  12. Weinstein, A.M., D.B. Dubin, W. K. Podleski, L.L. Spector, R.S. Farr, Asthma and pregnancy, JAMA 134: 1161, 1979.
  13. Sly, M.R., Pediatric allergy, Medical Examination Publishing Co., Inc., Second edition, p.352, 1981.
  14. Executive Committee, The American Academy of Allergy and Clinical Immunology, Position Statement, Personnel and equipment to treat systemic reactions caused by immunotherapy with allergenic extracts. J. Allergy and Clinical Immunol., 77:271, 1986.
TRICHOPHYTON FOR INTRADERMAL SKIN TESTING trichophyton mentagrophytes and trichophyton rubrum injection
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:49643-128
Route of Administration CUTANEOUS, SUBCUTANEOUS, INTRADERMAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Trichophyton mentagrophytes (Trichophyton mentagrophytes) Trichophyton mentagrophytes 1 g in 1000 mL
Trichophyton rubrum (Trichophyton rubrum) Trichophyton rubrum 1 g in 1000 mL
Inactive Ingredients
Ingredient Name Strength
Sodium chloride 0.25 g in 100 mL
Sodium bicarbonate 0.125 g in 100 mL
Glycerin 53 mL in 100 mL
Phenol 0.4 g in 100 mL
Water
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:49643-128-01 1 mL in 1 VIAL, MULTI-DOSE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102211 08/15/2007
Labeler — Allermed Laboratories, Inc. (073364531)
Establishment
Name Address ID/FEI Operations
Allermed Laboratories, Inc. 073364531 manufacture

Revised: 05/2009 Allermed Laboratories, Inc.

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