Negara: Amerika Serikat
Bahasa: Inggris
Sumber: NLM (National Library of Medicine)
FELIS CATUS HAIR (UNII: 1564HD0N96) (FELIS CATUS HAIR - UNII:1564HD0N96)
Antigen Laboratories, Inc.
FELIS CATUS HAIR
FELIS CATUS HAIR 10000 [BAU] in 1 mL
SUBCUTANEOUS
PRESCRIPTION DRUG
INDICATIONS AND USAGE Allergenic extract is indicated for diagnostic testing and for the treatment (immunotherapy) of patients whose histories indicate that upon natural exposure to cat allergen, they experience allergic symptoms. Confirmation is determined by skin testing. An orderly approach to the diagnostic use of allergenic extracts usually begins with direct skin testing. CONTRAINDICATIONS 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 disease, possibly due to routine immunization. Patients who have experienced a recent myocardial infarction may not be tolerant of immunotherapy. Children with nephrotic syndrome probably should not receive injections due to a variety of seemingly unrelated events, such as immunization causing exacerbation of their nephrotic disease. This product is not intended for the treatment of patients who do not experience allerg
HOW SUPPLIED Standardized Cat allergenic extract is expressed in BAU/ml. It is supplied in 10,000 BAU/ml, 5,000 BAU/ml and 1,000 BAU/ml in 5, 10, 30 and 50 ml containers. Extracts in 5 ml dropper bottles are available for prick-puncture testing. To insure maximum potency for the entire dating period, all stock concentrates contain 50% v/v glycerine.
Biologic Licensing Application
STANDARDIZED CAT HAIR - STANDARDIZED CAT HAIR INJECTION, SOLUTION ANTIGEN LABORATORIES, INC. ---------- ALLERGENIC EXTRACT WARNINGS STANDARDIZED CAT HAIR AND CAT PELT EXTRACTS LABELED IN BIOEQUIVALENT ALLERGY UNITS (BAU/ML) ARE NOT INTERCHANGEABLE WITH EACH OTHER AND ARE NOT INTERCHANGEABLE WITH CAT EXTRACTS LABELED IN ALLERGY UNITS (AU/ML). STANDARDIZED CAT ALLERGENIC EXTRACT IS INTENDED FOR USE BY PHYSICIANS WHO ARE EXPERIENCED IN THE ADMINISTRATION OF ALLERGENIC EXTRACTS FOR DIAGNOSIS, IMMUNOTHERAPY AND THE EMERGENCY CARE OF ANAPHYLAXIS, OR FOR USE UNDER THE GUIDANCE OF AN ALLERGY SPECIALIST. THIS EXTRACT IS NOT DIRECTLY INTERCHANGEABLE WITH OTHER ALLERGENIC EXTRACTS. PATIENTS BEING SWITCHED FROM OTHER TYPES OF EXTRACT TO ANTIGEN LABORATORIES’ ALLERGENIC EXTRACTS SHOULD BE STARTED AS THOUGH THEY WERE COMING UNDER TREATMENT FOR THE FIRST TIME. SEE “WARNINGS” SECTION. AS WITH ALL ALLERGENIC EXTRACTS, SEVERE SYSTEMIC REACTIONS MAY OCCUR. IN CERTAIN INDIVIDUALS, THESE LIFE-THREATENING REACTIONS MAY RESULT IN DEATH. PATIENTS SHOULD BE OBSERVED FOR AT LEAST 20 MINUTES FOLLOWING ALLERGENIC EXTRACT INJECTIONS. TREATMENT AND EMERGENCY MEASURES, AS WELL AS PERSONNEL TRAINED IN THEIR USE, SHOULD BE IMMEDIATELY AVAILABLE IN THE EVENT OF A LIFE-THREATENING REACTION. SENSITIVE PATIENTS MAY EXPERIENCE SEVERE ANAPHYLACTIC REACTIONS RESULTING IN RESPIRATORY OBSTRUCTION, SHOCK, COMA AND/OR DEATH. PATIENTS BEING SWITCHED FROM ONE LOT OF EXTRACT TO ANOTHER FROM THE SAME MANUFACTURER SHOULD HAVE THE DOSE REDUCED BY 75%. THIS PRODUCT SHOULD NOT BE INJECTED INTRAVENOUSLY. DEEP SUBCUTANEOUS ROUTES HAVE PROVEN TO BE SAFE, SEE “WARNINGS”, “PRECAUTIONS”, “ADVERSE REACTIONS” AND “OVERDOSAGE” SECTIONS. 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 Baca dokumen lengkapnya