Canada - English - Health Canada

auro pharma inc - busulfan - solution - 60mg - busulfan 60mg - antineoplastic agents

Canada - English - Health Canada

eugia pharma inc. - busulfan - solution - 60mg - busulfan 60mg

Canada - English - Health Canada

marcan pharmaceuticals inc - busulfan - solution - 60mg - busulfan 60mg - antineoplastic agents

Australia - English - Department of Health (Therapeutic Goods Administration)

aspen pharmacare australia pty ltd - busulfan -

Australia - English - Department of Health (Therapeutic Goods Administration)

otsuka australia pharmaceutical pty ltd - busulfan, quantity: 60 mg - injection - excipient ingredients: dimethylacetamide; macrogol 400 - busulfex is indicated for use in combination with cyclophosphamide, melphalan or fludarabine in conditioning prior to haematopoietic stem cell transplantation.

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

hospira, inc. - busulfan (unii: g1ln9045dk) (busulfan - unii:g1ln9045dk) - 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 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

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

apotex corp. - busulfan (unii: g1ln9045dk) (busulfan - unii:g1ln9045dk) - 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 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, t

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

fresenius kabi usa, llc - busulfan (unii: g1ln9045dk) (busulfan - unii:g1ln9045dk) - 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 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/m 2 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 misc

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

celltrion usa, inc. - busulfan (unii: g1ln9045dk) (busulfan - unii:g1ln9045dk) - 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 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 backgrou

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

nexus pharmaceuticals llc - busulfan (unii: g1ln9045dk) (busulfan - unii:g1ln9045dk) - busulfan 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 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 risk