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)

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

United States - English - 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

Malta - English - Medicines Authority

central procurement & supplies unit - busulfan - film-coated tablet - busulfan 2 milligram(s) - antineoplastic agents

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

aspen pharmacare australia pty ltd - busulfan, quantity: 2 mg - tablet, film coated - excipient ingredients: pregelatinised maize starch; magnesium stearate; lactose; titanium dioxide; hypromellose; triacetin - indications as at 10 february 2005: treatment of chronic granulocytic leukaemia. it has been shown to be superior to splenic irradiation when judged by survival times, control of spleen size and maintenance of haemoglobin levels. although not curative, busulfan reduces the total granulocyte mass, relieves disease symptoms and improves the clinical state of the patient. busulfan is not useful once blast transformation has occurred. busulfan produces prolonged remission in polycythaemia vera. it is especially useful in cases resistant to radiophosphorus (32 p) and where there is marked thrombocytosis. busulfan is useful in selected cases of essential thrombocythaemia and myelofibrosis.

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

accord healthcare pty ltd - busulfan, quantity: 60 mg - injection, concentrated - excipient ingredients: dimethylacetamide; macrogol 400 - busulfan intas 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)

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.

Malaysia - English - NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

unimed sdn bhd - busulfan -

Israel - English - Ministry of Health

tzamal bio-pharma ltd - busulfan - solution for injection - busulfan 60 mg / 10 ml - busulfan - for use in combination with other chemotherapeutic agents and/or radiotherapy as a conditioning regimen prior to hematopoietic progenitor cell transplantation.

Israel - English - Ministry of Health

padagis israel agencies ltd, israel - busulfan - tablets - busulfan 2 mg - busulfan - for the palliative treatment of the chronic granulocytic leukemia.