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United States - English - NLM (National Library of Medicine)

busulfan injection

mylan institutional llc - busulfan (unii: g1ln9045dk) (busulfan - unii:g1ln9045dk) - busulfan 6 mg in 1 ml - 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. busulfan injection is contraindicated in patients with a history of hypersensitivity to any of its components. busulfan can cause fetal harm when administered to a pregnant woman based on animal data. busulfan was teratogenic in mice, rats, and rabbits following administration during organogenesis. the solvent, dma, may also cause fetal harm when administered to a pregnant woman. in rats, dma doses of approximately 40% of the daily dose of dma in the busulfan dose on a mg/m2 basis given during organogenesis caused significant developmental anomalies (see data) . there are no available human data informing the drug-associated risk. advise pregnant women of the potential risk to a fetus. the background risk of major birth defects and miscarriage for the indicated populations are unknown. however, the background

United States - English - NLM (National Library of Medicine)

busulfan injection, solution, concentrate

actavis pharma, inc. - busulfan (unii: g1ln9045dk) (busulfan - unii:g1ln9045dk) - busulfan 6 mg in 1 ml - 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. busulfan is contraindicated in patients with a history of hypersensitivity to any of its components. risk summary busulfan injection can cause fetal harm when administered to a pregnant woman based on animal data. busulfan was teratogenic in mice, rats, and rabbits following administration during organogenesis. the solvent, dma, may also cause fetal harm when administered to a pregnant woman. in rats, dma doses of approximately 40% of the daily dose of dma in the busulfan injection dose on a mg/m2 basis given during organogenesis caused significant developmental anomalies (see data ). there are no available human data informing the drug-associated risk. advise pregnant women of the potential risk to a fetus. the background risk of major birth defects and miscarriage for the indicated populations are unknown.

United States - English - NLM (National Library of Medicine)

busulfan injection, solution, concentrate

sagent pharmaceuticals - busulfan (unii: g1ln9045dk) (busulfan - unii:g1ln9045dk) - busulfan 6 mg in 1 ml - 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. busulfan injection is contraindicated in patients with a history of hypersensitivity to any of its components. risk summary busulfan can cause fetal harm when administered to a pregnant woman based on animal data. busulfan was teratogenic in mice, rats, and rabbits following administration during organogenesis. the solvent, dma, may also cause fetal harm when administered to a pregnant woman. in rats, dma doses of approximately 40% of the daily dose of dma in the busulfan injection dose on a mg/m2 basis given during organogenesis caused significant developmental anomalies (see data) . there are no available human data informing the drug-associated risk. advise pregnant women of the potential risk to a fetus. the background risk of major birth defects and miscarriage for the indicated populations are unknown.