Kraj: Stany Zjednoczone
Język: angielski
Źródło: NLM (National Library of Medicine)
BLEOMYCIN SULFATE (UNII: 7DP3NTV15T) (BLEOMYCIN - UNII:40S1VHN69B)
Amneal Pharmaceuticals LLC
BLEOMYCIN SULFATE
BLEOMYCIN 15000 [iU]
INTRA-ARTERIAL
PRESCRIPTION DRUG
Palliation and treatment adjutant to surgery and radiation therapy of the following neoplasms: - Squamous cell carcinoma of the skin, head and neck, and esophagus (primary indication). - Squamous cell carcinoma of the larynx, penis and uterine cervix. - Squamous cell carcinoma of the bronchus (response infrequent). - Ch0riocarcinoma and embryonal cell carcinoma of the testis. - Advanced Hodgkin’s disease and Other lymphomas. - Mycosis fungoides. Note . Use of bleomycin after radiation therapy is less successful than use before radiation therapy. Bleomycin is bone marrow sparing and may be used when other cytotoxic agents are contraindicated.
Vials (white to cream colored lyophilized powder for reconstitution), equiv. 15,000 IU bleomycin activity: 1's, 10’s. Store at 2-B°C. (Refrigerate. Do not freeze.) Shelf life: 2 years AUST R 157341
Unapproved drug for use in drug shortage
BLEOMYCIN- BLEOMYCIN INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION AMNEAL PHARMACEUTICALS LLC _Disclaimer: This drug has not been found by FDA to be safe and effective, and this_ _labeling has not been approved by FDA. For further information about unapproved_ _drugs, click here._ ---------- BLEO 15K BLEOMYCIN SULFATE. BLEOMYCIN SULFATE POWDER FOR INJECTION CONTAINS BLEOMYCIN SULFATE 15,000 IU PER VIAL IMPORTANT DRUG INFORMATION July 5, 2016 Re: Temporary importation of Bleomycin Sulfate Powder for Injection, 15,000 International Units (IU) to address drug shortage issue Dear Healthcare Professional, IMPORTANT NOTE: EACH VIAL OF AMNEAL BIOSCIENCES’ PRODUCT CONTAINS 15,000 IU OF BLEOMYCIN SULFATE POWDER FOR INJECTION, WHICH IS EQUIVALENT TO BLEOMYCIN SULFATE USP 15 UNITS (1000 IU OF BLEOMYCIN SULFATE POWDER FOR INJECTION = 1 UNIT OF BLEOMYCIN SULFATE USP). PRESCRIBERS AND PHARMACISTS MUST BE ALERT TO THIS DIFFERENCE IN LABELED UNITS IN ORDER TO PREVENT MEDICATION ERRORS. APPROPRIATE QUALITY ASSURANCE MEASURES SHOULD BE ENACTED TO REDUCE THE RISK OF MEDICATION ERRORS. Due to the current critical shortage of Bleomycin Sulfate for Injection, USP, 15 units and 30 units per vial in the United States (U.S.) market, Amneal Biosciences is coordinating with the U.S. Food and Drug Administration (FDA) to increase the availability of Bleomycin Sulfate for Injection, USP, 15 units per vial. Amneal Biosciences has initiated temporary importation of a non-FDA approved product, Bleomycin Sulfate Powder for Injection 15,000 IU per vial to the U.S. market: lot numbers GE50604, GE60003, GE60012. The Bleomycin Sulfate Powder for Injection 15,000 IU product being distributed by Amneal Biosciences was manufactured by Cipla Ltd. from its FDA-inspected facility in Verna, Goa, India, for Amneal Pharma Australia Pty Ltd and was sold in Australia under the WIllow Pharmaceutical label. At this time, no other entity except Amneal Biosciences is authorized by the FDA to import or distribute Amneal Pharma Australia Pty Ltd.’s Bleomycin Przeczytaj cały dokument