국가: 미국
언어: 영어
출처: NLM (National Library of Medicine)
FELIS CATUS HAIR (UNII: 1564HD0N96) (FELIS CATUS HAIR - UNII:1564HD0N96), CYNODON DACTYLON POLLEN (UNII: 175F461W10) (CYNODON DACTYLON POLLEN - UNII:175F461W10), AMBROSIA ARTEMISIIFOLIA POLLEN (UNII: K20Y81ACO3) (AMBROSIA ARTEMISIIFOLIA POLLEN - UNII:K20Y81ACO3), CARYA ALBA POLLEN (UNII: G2A764T54B) (CARYA TOMENTOSA POLLEN - UNII:G2A764T54B), DERMATOPHAGOIDES FARINAE (UNII: PR9U2YPF3Q) (DERMATOPHAGOIDES FARINAE - UNII:PR9U2YPF3Q), DERMATOPHAGOIDES PTERONYSSINUS (UNII: 57L1Z5378K) (DERMATOPHAGOIDES PTE
Antigen Laboratories, Inc.
FELIS CATUS HAIR
FELIS CATUS HAIR 400 [BAU] 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 TS340074 - TREATMENT SET TS340074 INJECTION, SOLUTION TREATMENT SET TS340153 - TREATMENT SET TS340153 INJECTION, SOLUTION TREATMENT SET TS340525 - TREATMENT SET TS340525 INJECTION, SOLUTION TREATMENT SET TS340526 - TREATMENT SET TS340526 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 complete skin testing and supervise allergenic extract immunotherapy. The extract is sterile and intended for subcutaneous injection. The concentration of allergenic extract supplied will be based on the indivi 전체 문서 읽기