Երկիր: Ամերիկայի Միացյալ Նահանգներ
Լեզու: անգլերեն
Աղբյուրը: NLM (National Library of Medicine)
Busulfan (UNII: G1LN9045DK) (Busulfan - UNII:G1LN9045DK)
ESP Pharma, Inc.
Busulfan
INJECTION
60 mg in 10 mL
INTRAVENOUS
PRESCRIPTION DRUG
BUSULFEX® (busulfan) Injection is indicated for use in combination with cyclophosphamide as a conditioning regimen prior to allogeneic hematopoietic progenitor cell transplantation for chronic myelogenous leukemia. BUSULFEX is contraindicated in patients with a history of hypersensitivity to any of its components.
BUSULFEX is supplied as a sterile solution in 10 mL single-use clear glass vials each containing 60 mg of busulfan at a concentration of 6 mg/mL for intravenous use. NDC 67286-0054-2 10mL (6mg/mL) in packages of eight vials. Unopened vials of BUSULFEX must be stored under refrigerated conditions between 2°-8°C (36°-46°F). HANDLING AND DISPOSAL Procedures for proper handling and disposal of anticancer drugs should be considered. Several guidelines on this subject have been published.1,2,3,4,5,6 There is no general agreement that all of the procedures recommended in the guidelines are necessary or appropriate. Marketed by: PDL BioPharma, Inc. Redwood City, CA 94063 Manufactured by: Ben Venue Labs, Inc. Bedford OH 44146 United States Patent numbers are 5,430,057 and 5,559,148. Canadian Patent number is CA2171738. European Union Patent number is EP 0 725 637 B1. Part No. 131401 Rev Date: April 2007
BUSULFEX- BUSULFAN INJECTION ESP PHARMA, INC. ---------- IV BUSULFEX (BUSULFAN) INJECTION Caution: Must be diluted prior to use. RX ONLY WARNING BUSULFEX (busulfan) Injection is a potent cytotoxic drug that causes profound myelosuppression at the recommended dosage. It should be administered under the supervision of a qualified physician who is experienced in allogeneic hematopoietic stem cell transplantation, the use of cancer chemotherapeutic drugs and the management of patients with severe pancytopenia. Appropriate management of therapy and complications is only possible when adequate diagnostic and treatment facilities are readily available. SEE “WARNINGS” SECTION FOR INFORMATION REGARDING BUSULFAN-INDUCED PANCYTOPENIA IN HUMANS. DESCRIPTION Busulfan is a bifunctional alkylating agent known chemically as 1,4- butanediol, dimethanesulfonate. BUSULFEX (busulfan) Injection is intended for intravenous administration. It is supplied as a clear, colorless, sterile, solution in 10 mL single use vials. Each vial of BUSULFEX contains 60 mg (6 mg/mL) of busulfan, the active ingredient, a white crystalline powder with a molecular formula of CH SO O(CH ) OSO CH and a molecular weight of 246 g/mole. Busulfan is dissolved in N,N-dimethylacetamide (DMA) 33% vol/vol and Polyethylene Glycol 400, 67% vol/vol. The solubility of busulfan in water is 0.1 g/L and the pH of BUSULFEX diluted to approximately 0.5 mg/mL busulfan in 0.9% Sodium Chloride Injection, USP or 5% Dextrose Injection, USP as recommended for infusion reflects the pH of the diluent used and ranges from 3.4 to 3.9. BUSULFEX is intended for dilution with 0.9% Sodium Chloride Injection, USP or 5% Dextrose Injection, USP prior to intravenous infusion. CLINICAL PHARMACOLOGY MECHANISM OF ACTION Busulfan is a bifunctional alkylating agent in which two labile methanesulfonate groups are attached to opposite ends of a four-carbon alkyl chain. In aqueous media, busulfan hydrolyzes to release the methanesulfonate groups. This produces reactive carbonium ions that can a Կարդացեք ամբողջական փաստաթուղթը