Country: Amerika Syarikat
Bahasa: Inggeris
Sumber: NLM (National Library of Medicine)
ALTERNARIA ALTERNATA (UNII: 52B29REC7H) (ALTERNARIA ALTERNATA - UNII:52B29REC7H), ASPERGILLUS FUMIGATUS (UNII: X88DF51T48) (ASPERGILLUS FUMIGATUS - UNII:X88DF51T48), COCHLIOBOLUS SATIVUS (UNII: 3LN5B70U4W) (COCHLIOBOLUS SATIVUS - UNII:3LN5B70U4W), CLADOSPORIUM CLADOSPORIOIDES (UNII: 4ZWY20GTGO) (CLADOSPORIUM CLADOSPORIOIDES - UNII:4ZWY20GTGO), PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM (UNII: 3Y1PE1GCIG) (PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM - UNII:3Y1PE1GCIG)
Antigen Laboratories, Inc.
ALTERNARIA ALTERNATA
ALTERNARIA ALTERNATA 0.01 g in 1 mL
SUBCUTANEOUS
PRESCRIPTION DRUG
When the natural exposure to elevated aeroallergens produces symptoms as described under Clinical Pharmacology, specific diagnosis and therapeutic procedures are indicated. Clearly, important clues to the cause of a person's allergic condition can be gleaned from a thorough history and careful physical examination. Diagnostic tests - in vitro or in vivo - serve only to confirm the physician's suspicions or to improve investigative skills. Specific diagnosis is especially indicated when the patient's symptoms are not controlled by medication. When immunotherapy is contemplated demonstration of sensitivity to a specific allergenic extract is necessary. An orderly approach to the use of diagnostic tests usually begins with direct skin testing. 5,6,11 THIS PRODUCT IS NOT INTENDED FOR TREATMENT OF PATIENTS WHO DO NOT MANIFEST IMMEDIATE HYPERSENSITIVITY REACTIONS TO THE ALLERGENIC EXTRACT FOLLOWING SKIN TESTING. There are no absolute contraindications; however, extreme caution is necessary when using diagnostic ski
Individual treatment sets as prescribed by the physician. The allergenic extract contains a variable number of individual doses depending on the patient's sensitivity and maximum tolerated maintenance treatment dose.
Biologic Licensing Application
TREATMENT SET TS343825 - TREATMENT SET TS343825 INJECTION, SOLUTION TREATMENT SET TS343826 - TREATMENT SET TS343826 INJECTION, SOLUTION TREATMENT SET TS344001 - TREATMENT SET TS344001 INJECTION, SOLUTION TREATMENT SET TS344002 - TREATMENT SET TS344002 INJECTION, SOLUTION TREATMENT SET TS344003 - TREATMENT SET TS344003 INJECTION, SOLUTION TREATMENT SET TS344004 - TREATMENT SET TS344004 INJECTION, SOLUTION TREATMENT SET TS344005 - TREATMENT SET TS344005 INJECTION, SOLUTION ANTIGEN LABORATORIES, INC. ---------- ALLERGENIC EXTRACTS INDIVIDUAL TREATMENT VIAL WARNINGS INDIVIDUAL ALLERGENIC EXTRACT TREATMENT VIAL IS INTENDED FOR USE BY PHYSICIANS WHO ARE EXPERIENCED IN THE ADMINISTRATION OF ALLERGENIC EXTRACTS FOR IMMUNOTHERAPY AND THE EMERGENCY CARE OF ANAPHYLAXIS, OR FOR USE UNDER THE GUIDANCE OF AN ALLERGY SPECIALIST. INDIVIDUAL ALLERGENIC EXTRACT TREATMENT VIALS ARE NOT DIRECTLY INTERCHANGEABLE WITH OTHER ALLERGENIC EXTRACTS. THE INITIAL DOSE MUST BE BASED ON SKIN TESTING AS DESCRIBED IN THE DOSAGE AND ADMINISTRATION SECTION OF THIS INSERT. PATIENTS BEING SWITCHED FROM OTHER TYPES OF EXTRACT TO INDIVIDUAL TREATMENT VIALS SHOULD BE STARTED AS THOUGH THEY WERE COMING UNDER TREATMENT FOR THE FIRST TIME. 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, THESE REACTIONS MAY BE LIFE-THREATENING. PATIENT SHOULD BE OBSERVED FOR AT LEAST 20 MINUTES FOLLOWING TREATMENT AND EMERGENCY MEASURES AS WELL AS PERSONNEL TRAINED IN THEIR USE SHOULD BE IMMEDIATELY AVAILABLE IN THE EVENT OF A LIFE-THREATENING REACTION. THIS PRODUCT SHOULD NOT BE INJECTED INTRAVENOUSLY. DEEP SUBCUTANEOUS ROUTES HAVE PROVEN TO BE SAFE. SEE THE WARNINGS, PRECAUTIONS, ADVERSE REACTIONS AND OVERDOSAGE SECTIONS BELOW. DESCRIPTION Allergenic extract in this vial is referred to as an individual treatment vial since it is designed primarily for the physician equipped to comple Baca dokumen lengkap