Vereinigte Staaten - Englisch - 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

Vereinigte Staaten - Englisch - NLM (National Library of Medicine)

meitheal pharmaceuticals 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 backgro

Vereinigte Staaten - Englisch - NLM (National Library of Medicine)

meitheal pharmaceuticals 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 backgro

Vereinigte Staaten - Englisch - NLM (National Library of Medicine)

armas pharmaceuticals 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 backgroun

Vereinigte Staaten - Englisch - 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

Vereinigte Staaten - Englisch - NLM (National Library of Medicine)

aspen global inc. - busulfan (unii: g1ln9045dk) (busulfan - unii:g1ln9045dk) - busulfan 2 mg - myleran (busulfan) is indicated for the palliative treatment of chronic myelogenous (myeloid, myelocytic, granulocytic) leukemia. myleran is contraindicated in patients in whom a definitive diagnosis of chronic myelogenous leukemia has not been firmly established. myleran is contraindicated in patients who have previously suffered a hypersensitivity reaction to busulfan or any other component of the preparation.

Vereinigte Staaten - Englisch - NLM (National Library of Medicine)

otsuka america pharmaceutical, inc. - busulfan (unii: g1ln9045dk) (busulfan - unii:g1ln9045dk) - busulfan 6 mg in 1 ml - busulfex 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. risk summary busulfex 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 busulfex 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

Vereinigte Staaten - Englisch - NLM (National Library of Medicine)

esp pharma, inc. - busulfan (unii: g1ln9045dk) (busulfan - unii:g1ln9045dk) - injection - 60 mg in 10 ml - 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.

Vereinigte Staaten - Englisch - 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

Vereinigte Staaten - Englisch - NLM (National Library of Medicine)

woodward pharma services llc - busulfan (unii: g1ln9045dk) (busulfan - unii:g1ln9045dk) - myleran (busulfan) is indicated for the palliative treatment of chronic myelogenous (myeloid, myelocytic, granulocytic) leukemia. myleran is contraindicated in patients in whom a definitive diagnosis of chronic myelogenous leukemia has not been firmly established. myleran is contraindicated in patients who have previously suffered a hypersensitivity reaction to busulfan or any other component of the preparation.