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

sandoz inc - decitabine (unii: 776b62cq27) (decitabine - unii:776b62cq27) - decitabine 50 mg in 50 ml - decitabine for injection is indicated for treatment of patients with myelodysplastic syndromes (mds) including previously treated and untreated, de novo and secondary mds of all french-american-british subtypes (refractory anemia, refractory anemia with ringed sideroblasts, refractory anemia with excess blasts, refractory anemia with excess blasts in transformation, and chronic myelomonocytic leukemia) and intermediate-1, intermediate-2, and high-risk international prognostic scoring system groups. none pregnancy category d [see warnings and precautions (5.2) ]  decitabine for injection can cause fetal harm when administered to a pregnant woman. there are no adequate and well-controlled studies of decitabine for injection in pregnant women. the developmental toxicity of decitabine was examined in mice exposed to single ip (intraperitoneal) injections (0, 0.9 and 3 mg/m2 , approximately 2% and 7% of the recommended daily clinical dose, respectively) over gestation days 8, 9, 10 or 11. no maternal toxicity w

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

dr. reddy's laboratories inc. - decitabine (unii: 776b62cq27) (decitabine - unii:776b62cq27) - decitabine 50 mg in 10 ml - decitabine for injection is indicated for treatment of adult patients with myelodysplastic syndromes (mds) including previously treated and untreated, de novo and secondary mds of all french-american-british subtypes (refractory anemia, refractory anemia with ringed sideroblasts, refractory anemia with excess blasts, refractory anemia with excess blasts in transformation, and chronic myelomonocytic leukemia) and intermediate-1, intermediate-2, and high-risk international prognostic scoring system groups. none risk summary based on findings from human data, animal studies, and the mechanism of action, decitabine for injection can cause fetal harm when administered to a pregnant woman [see clinical pharmacology (12.1) and nonclinical toxicology (13.1)]. limited published data on decitabine for injection use throughout the first trimester during pregnancy describe adverse developmental outcomes including major birth defects (structural abnormalities). in animal reproduction studies, administration of decitabine

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

dr.reddy's laboratories limited - decitabine (unii: 776b62cq27) (decitabine - unii:776b62cq27) - decitabine 50 mg in 10 ml - decitabine for injection is indicated for treatment of adult patients with myelodysplastic syndromes (mds) including previously treated and untreated, de novo and secondary mds of all french-american-british subtypes (refractory anemia, refractory anemia with ringed sideroblasts, refractory anemia with excess blasts, refractory anemia with excess blasts in transformation, and chronic myelomonocytic leukemia) and intermediate-1, intermediate-2, and high-risk international prognostic scoring system groups. none risk summary based on findings from human data, animal studies, and the mechanism of action, decitabine for injection can cause fetal harm when administered to a pregnant woman [see clinical pharmacology (12.1) and nonclinical toxicology (13.1)]. limited published data on decitabine for injection use throughout the first trimester during pregnancy describe adverse developmental outcomes including major birth defects (structural abnormalities). in animal reproduction studies, administration of decitabine

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

northstar rxllc - decitabine (unii: 776b62cq27) (decitabine - unii:776b62cq27) - decitabine 50 mg in 20 ml - decitabine for injection is indicated for treatment of adult patients with myelodysplastic syndromes (mds) including previously treated and untreated, de  novo and secondary mds of all french-american-british subtypes (refractory anemia, refractory anemia with ringed sideroblasts, refractory anemia with excess blasts, refractory anemia with excess blasts in transformation, and chronic myelomonocytic leukemia) and intermediate-1, intermediate-2, and high-risk international prognostic scoring system groups. none risk summary based on findings from human data, animal studies, and the mechanism of action, decitabine for injection can cause fetal harm when administered to a pregnant woman [see clinical pharmacology (12.1)] . limited published data on decitabine for injection use throughout the first trimester during pregnancy describe adverse developmental outcomes including major birth defects (structural abnormalities). in animal reproduction studies, administration of decitabine to pregnant mice and rats durin

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

cipla usa inc. - decitabine (unii: 776b62cq27) (decitabine - unii:776b62cq27) - decitabine 50 mg in 10 ml - decitabine for injection is indicated for treatment of adult patients with myelodysplastic syndromes (mds) including previously treated and untreated, de novo and secondary mds of all french-american-british subtypes (refractory anemia, refractory anemia with ringed sideroblasts, refractory anemia with excess blasts, refractory anemia with excess blasts in transformation, and chronic myelomonocytic leukemia) and intermediate-1, intermediate-2, and high-risk international prognostic scoring system groups. none risk summary based on findings from human data, animal studies, and the mechanism of action, decitabine for injection can cause fetal harm when administered to a pregnant woman [see clinical pharmacology (12.1) and nonclinical toxicology (13.1)] . limited published data on decitabine for injection use throughout the first trimester during pregnancy describe adverse developmental outcomes including major birth defects (structural abnormalities). in animal reproduction studies, administration of decitabin

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

bluepoint laboratories - decitabine (unii: 776b62cq27) (decitabine - unii:776b62cq27) - decitabine 50 mg in 10 ml - decitabine for injection is indicated for treatment of adult patients with myelodysplastic syndromes (mds) including previously treated and untreated, de novo and secondary mds of all french-american-british subtypes (refractory anemia, refractory anemia with ringed sideroblasts, refractory anemia with excess blasts, refractory anemia with excess blasts in transformation, and chronic myelomonocytic leukemia) and intermediate-1, intermediate-2, and high-risk international prognostic scoring system groups. none [click here to enter use in specific populations] risk summary based on findings from human data, animal studies, and the mechanism of action, decitabine for injection can cause fetal harm when administered to a pregnant woman [ see clinical pharmacology (12.1)]. limited published data on decitabine for injection use throughout the first trimester during pregnancy describe adverse developmental outcomes including major birth defects (structural abnormalities). in animal reproduction studies, administra

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

accord healthcare inc. - decitabine (unii: 776b62cq27) (decitabine - unii:776b62cq27) - decitabine 50 mg in 20 ml - decitabine for injection is indicated for treatment of adult patients with myelodysplastic syndromes (mds) including previously treated and untreated, de novo and secondary mds of all french-american-british subtypes (refractory anemia, refractory anemia with ringed sideroblasts, refractory anemia with excess blasts, refractory anemia with excess blasts in transformation, and chronic myelomonocytic leukemia) and intermediate-1, intermediate-2, and high-risk international prognostic scoring system groups. none. risk summary based on findings from human data, animal studies, and the mechanism of action, decitabine for injection can cause fetal harm when administered to a pregnant woman [see clinical pharmacology (12.1) and nonclinical toxicology (13.1)]

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

sun pharmaceutical industries, inc. - decitabine (unii: 776b62cq27) (decitabine - unii:776b62cq27) - decitabine 50 mg in 10 ml - decitabine for injection is indicated for treatment of adult patients with myelodysplastic syndromes (mds) including previously treated and untreated, de novo and secondary mds of all french-american-british subtypes (refractory anemia, refractory anemia with ringed sideroblasts, refractory anemia with excess blasts, refractory anemia with excess blasts in transformation, and chronic myelomonocytic leukemia) and intermediate-1, intermediate-2, and high-risk international prognostic scoring system groups. none risk summary based on findings from human data, animal studies, and the mechanism of action, decitabine for injection can cause fetal harm when administered to a pregnant woman [see clinical pharmacology (12.1) and nonclinical toxicology (13.1)] . limited published data on decitabine use throughout the first trimester during pregnancy describe adverse developmental outcomes including major birth defects (structural abnormalities). in animal reproduction studies, administration of decitabine to pregnan

Israel - English - Ministry of Health

trima israel pharmaceutical products maabarot ltd - decitabine - powder for concentrate for solution for infusion - decitabine 50 mg - decitabine - decitabine trima is indicated for treatment of patients with myelodysplastic syndromes (mds) including previously treated and untreated, de novo and secondary mds of all french-american-british subtypes (refractory anemia, refractory anemia with ringed sideroblasts, refractory anemia with excess blasts, refractory anemia with excess blasts in transformation, and chronic myelomonocytic leukemia) and intermediate-1, intermediate-2 and high-risk international prognostic scoring system groups. decitabine trima is indicated for the treatment of adult patients with newly diagnosed de novo or secondary acute myeloid leukemia (aml), according to the world health organisation (who) classification, who are not candidates for standard induction chemotherapy

Israel - English - Ministry of Health

k.s.kim international (sk- pharma) ltd., israel - decitabine - powder for concentrate for solution for infusion - decitabine 50 mg/vial - decitabine - decitabine s.k. is indicated for treatment of patients with myelodysplastic syndromes (mds) including previously treated and untreated, de novo and secondary mds of all french-american-british subtypes (refractory anemia, refractory anemia with ringed sideroblasts, refractory anemia with excess blasts, refractory anemia with excess blasts in transformation, and chronic myelomonocytic leukemia) and intermediate-1, intermediate-2 and high-risk international prognostic scoring system groups. decitabine s.k. is indicated for the treatment of adult patients with newly diagnosed de novo or secondary acute myeloid leukemia (aml), according to the world health organisation (who) classification, who are not candidates for standard induction chemotherapy