Land: Verenigde Staten
Taal: Engels
Bron: NLM (National Library of Medicine)
ACHETA DOMESTICUS (UNII: P9S201X6LH) (ACHETA DOMESTICUS - UNII:P9S201X6LH)
Antigen Laboratories, Inc.
ACHETA DOMESTICUS
ACHETA DOMESTICUS 0.05 g in 1 mL
INTRADERMAL
PRESCRIPTION DRUG
FOR DIAGNOSTIC USE ONLY. This product has not been shown by adequate data to be safe and effective for therapeutic use according to Federal Register Notice dated November 16, 1994, Vol. 59, No. 220. The following allergenic extracts are "For Diagnostic Use Only": Coffee (Coffea arabic ), Cottonseed (Gossypium spp. ), Flaxseed (Linum usitatissimum ), Leafhopper (Cicadellidae), Miller Moth (Night Flying Lepidoptera), Cricket (Gryllidae) and Moth (Frenatae). These extracts are intended for diagnostic testing of patients whose histories indicate that upon natural exposure to the allergen, they experience allergic symptoms. Confirmation is determined by skin testing. Do not administer in the presence of diseases characterized by bleeding diathesis. Individuals with autoimmune disease may be at risk of exacerbating symptoms of the underlying condition, possibly due to routine immunization. Children with nephrotic syndrome should not receive injections due to immunization exacerbating nephrotic diseases. Allergenic
The stock concentrate of allergenic extract is expressed in weight/volume, at 1:50 w/v (2%) or 1:20 w/v (5%). It is supplied in 10, 30 and 50 ml containers. Extracts in 5 ml sterile dropper bottles are available for prick-puncture testing. To insure maximum potency for the entire dating period, all stock concentrates contain 50% glycerine v/v.
Biologic Licensing Application
CRICKET - CRICKET INJECTION, SOLUTION ANTIGEN LABORATORIES, INC. ---------- ALLERGENIC EXTRACT “FOR DIAGNOSTIC USE ONLY” WARNINGS ALLERGENIC EXTRACT IS INTENDED FOR USE BY PHYSICIANS OR UNDER THE GUIDANCE OF PHYSICIANS WHO ARE EXPERIENCED IN THE ADMINISTRATION OF ALLERGENIC EXTRACTS FOR DIAGNOSIS AND THE EMERGENCY CARE OF ANAPHYLAXIS. THIS EXTRACT IS NOT DIRECTLY INTERCHANGEABLE WITH OTHER ALLERGENIC EXTRACTS. PATIENTS SHOULD BE INSTRUCTED TO RECOGNIZE ADVERSE REACTION SYMPTOMS AND CAUTIONED TO CONTACT THE PHYSICIAN'S OFFICE IF REACTION SYMPTOMS OCCUR. AS WITH ALL ALLERGENIC EXTRACTS, SEVERE SYSTEMIC REACTIONS MAY OCCUR._IN CERTAIN INDIVIDUALS, ESPECIALLY IN_ _STEROID-DEPENDENT/UNSTABLE ASTHMATICS, THESE LIFE-THREATENING REACTIONS MAY RESULT IN DEATH._PATIENTS SHOULD BE OBSERVED FOR AT LEAST 20 MINUTES FOLLOWING TESTING. EMERGENCY MEASURES, AS WELL AS TRAINED PERSONNEL, SHOULD BE IMMEDIATELY AVAILABLE IN THE EVENT OF A LIFE-THREATENING REACTION. THIS PRODUCT SHOULD NOT BE INJECTED INTRAVENOUSLY. SEE THE "WARNINGS", "PRECAUTIONS", "ADVERSE REACTIONS" AND "OVERDOSAGE" SECTIONS. SENSITIVE PATIENTS MAY EXPERIENCE SEVERE ANAPHYLACTIC REACTIONS RESULTING IN RESPIRATORY OBSTRUCTION, SHOCK, COMA AND/OR DEATH. REPORT SERIOUS ADVERSE EVENTS TO MEDWATCH, 5600 FISHERS LANE, ROCKVILLE, MD 20852- 9787, PHONE 1-800-FDA-1088. _PATIENTS RECEIVING BETA-BLOCKERS MAY NOT BE RESPONSIVE TO EPINEPHRINE OR INHALED_ _BRONCHODILATORS._RESPIRATORY OBSTRUCTION NOT RESPONDING TO PARENTERAL OR INHALED BRONCHODILATORS MAY REQUIRE THEOPHYLLINE, OXYGEN, INTUBATION AND THE USE OF LIFE SUPPORT SYSTEMS. PARENTERAL FLUID AND/OR PLASMA EXPANDERS MAY BE UTILIZED FOR TREATMENT OF SHOCK. ADRENOCORTICOSTEROIDS MAY BE ADMINISTERED PARENTERALLY OR INTRAVENOUSLY. REFER TO ''WARNINGS", "PRECAUTIONS" AND "ADVERSE REACTIONS" SECTIONS BELOW. 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 biologica Lees het volledige document