국가: 미국
언어: 영어
출처: NLM (National Library of Medicine)
CYNODON DACTYLON POLLEN (UNII: 175F461W10) (CYNODON DACTYLON POLLEN - UNII:175F461W10), CARYA ILLINOINENSIS POLLEN (UNII: PYO4JR720Y) (CARYA ILLINOINENSIS POLLEN - UNII:PYO4JR720Y), CARYA TOMENTOSA POLLEN (UNII: G2A764T54B) (CARYA TOMENTOSA POLLEN - UNII:G2A764T54B), AMARANTHUS RETROFLEXUS POLLEN (UNII: 73B14PX5FW) (AMARANTHUS RETROFLEXUS POLLEN - UNII:73B14PX5FW), AMBROSIA ARTEMISIIFOLIA POLLEN (UNII: K20Y81ACO3) (AMBROSIA ARTEMISIIFOLIA POLLEN - UNII:K20Y81ACO3), RUMEX ACETOSELLA POLLEN (UNII: N52MIQ
Antigen Laboratories, Inc.
CYNODON DACTYLON POLLEN
CYNODON DACTYLON POLLEN 16 [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 TS345463 - TREATMENT SET TS345463 INJECTION, SOLUTION TREATMENT SET TS345476 - TREATMENT SET TS345476 INJECTION, SOLUTION TREATMENT SET TS345694 - TREATMENT SET TS345694 INJECTION, SOLUTION TREATMENT SET TS345784 - TREATMENT SET TS345784 INJECTION, SOLUTION TREATMENT SET TS345825 - TREATMENT SET TS345825 INJECTION, SOLUTION TREATMENT SET TS345883 - TREATMENT SET TS345883 INJECTION, SOLUTION TREATMENT SET TS346157 - TREATMENT SET TS346157 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 전체 문서 읽기