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

dr. reddy's laboratories inc. - azacitidine (unii: m801h13nru) (azacitidine - unii:m801h13nru) - azacitidine 100 mg - azacitidine for injection is indicated for treatment of patients with the following french-american-british (fab) myelodysplastic syndrome subtypes: refractory anemia (ra) or refractory anemia with ringed sideroblasts (if accompanied by neutropenia or thrombocytopenia or requiring transfusions), refractory anemia with excess blasts (raeb), refractory anemia with excess blasts in transformation (raeb-t), and chronic myelomonocytic leukemia (cmmol). azacitidine is contraindicated in patients with advanced malignant hepatic tumors [see warnings and precautions (5.2) ]. azacitidine is contraindicated in patients with a known hypersensitivity to azacitidine or mannitol. risk summary based on its mechanism of action and findings in animals, azacitidine can cause fetal harm when administered to a pregnant woman [see clinical pharmacology (12.1)]. there are no data on the use of azacitidine in pregnant women. azacitidine was teratogenic and caused embryo-fetal lethality in animals at doses lower than the recommended

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

shilpa medicare limited - azacitidine (unii: m801h13nru) (azacitidine - unii:m801h13nru) - azacitidine 100 mg - azacitidine for injection is indicated for treatment of patients with the following french-american-british (fab) myelodysplastic syndrome subtypes: refractory anemia (ra) or refractory anemia with ringed sideroblasts (if accompanied by neutropenia or thrombocytopenia or requiring transfusions), refractory anemia with excess blasts (raeb), refractory anemia with excess blasts in transformation (raeb-t), and chronic myelomonocytic leukemia (cmmol). azacitidine is contraindicated in patients with advanced malignant hepatic tumors [see warnings and precautions (5.2) ]. azacitidine is contraindicated in patients with a known hypersensitivity to azacitidine or mannitol. risk summary based on its mechanism of action and findings in animals, azacitidine can cause fetal harm when administered to a pregnant woman [see clinical pharmacology (12.1) ]. there are no data on the use of azacitidine in pregnant women. azacitidine was teratogenic and caused embryo-fetal lethality in animals at doses lower than the recommended

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

accord healthcare pty ltd - azacitidine, quantity: 100 mg - injection, powder for - excipient ingredients: mannitol - azacitidine accord is indicated for the treatment of patients with,? intermediate-2 and high-risk myelodysplastic syndromes (mds) according to the international prognostic scoring system (ipss), ,? chronic myelomonocytic leukemia (cmmol (10-29 percent marrow blasts without myeloproliferative disorder)), ,? acute myeloid leukemia (aml) with 20-30 percent blasts and multi-lineage dysplasia, according to world health organisation classification (who), ,in whom allogenic stem cell transplantation is not indicated.

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

dr reddys laboratories australia pty ltd - azacitidine, quantity: 100 mg - injection, powder for - excipient ingredients: mannitol - azacitidine juno is indicated for the treatment of patients with intermediate-2 and high-risk myelodysplastic syndromes (mds) according to the international prognostic scoring system (ipss), chronic myelomonocytic leukemia (cmmol (10-29 percent marrow blasts without myeloproliferative disorder)), acute myeloid leukemia (aml) with 20-30 percent blasts and multi-lineage dysplasia, according to world health organisation classification (who), in whom allogenic stem cell transplantation is not indicated.

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

juno pharmaceuticals pty ltd - azacitidine, quantity: 100 mg - injection, powder for - excipient ingredients: mannitol - azacitidine is indicated for the treatment of patients with: ? intermediate-2 and high-risk myelodysplastic syndromes (mds) according to the international prognostic scoring system (ipss), ? chronic myelomonocytic leukemia [cmmol (10%-29% marrow blasts without myeloproliferative disorder)], ? acute myeloid leukemia (aml) with 20-30% blasts and multi-lineage dysplasia, according to world health organisation classification (who), in whom allogenic stem cell transplantation is not indicated.

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

teva pharma australia pty ltd - azacitidine, quantity: 100 mg - injection, powder for - excipient ingredients: monobasic sodium phosphate monohydrate; dibasic sodium phosphate dihydrate; sucrose - azacitidine-teva is indicated for the treatment of patients with: intermediate-2 and high-risk myelodysplastic syndromes (mds) according to the international prognostic scoring system (ipss), chronic myelomonocytic leukemia [cmmol (10 percent-29 percent marrow blasts without myeloproliferative disorder)], acute myeloid leukemia (aml) with 20-30 percent blasts and multi-lineage dysplasia, according to world health organisation classification (who), in whom allogenic stem cell transplantation is not indicated

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

sandoz pty ltd - azacitidine, quantity: 100 mg - injection, powder for - excipient ingredients: mannitol - azacitidine is indicated for the treatment of patients with: ? intermediate-2 and high-risk myelodysplastic syndromes (mds) according to the international prognostic scoring system (ipss), ? chronic myelomonocytic leukemia [cmmol (10%-29% marrow blasts without myeloproliferative disorder)], ? acute myeloid leukemia (aml) with 20-30% blasts and multi-lineage dysplasia, according to world health organisation classification (who), in whom allogenic stem cell transplantation is not indicated.

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

fresenius kabi usa, llc - azacitidine (unii: m801h13nru) (azacitidine - unii:m801h13nru) - azacitidine 100 mg in 30 ml - azacitidine for injection is indicated for treatment of patients with the following french-american-british (fab) myelodysplastic syndrome subtypes: refractory anemia (ra) or refractory anemia with ringed sideroblasts (if accompanied by neutropenia or thrombocytopenia or requiring transfusions), refractory anemia with excess blasts (raeb), refractory anemia with excess blasts in transformation (raeb-t), and chronic myelomonocytic leukemia (cmmol). azacitidine is contraindicated in patients with advanced malignant hepatic tumors [see warnings and precautions (5.2)] . azacitidine is contraindicated in patients with a known hypersensitivity to azacitidine or mannitol. risk summary based on its mechanism of action and findings in animals, azacitidine can cause fetal harm when administered to a pregnant woman [see clinical pharmacology (12.1)] . there are no data on the use of azacitidine in pregnant women. azacitidine was teratogenic and caused embryo-fetal lethality in animals at doses lower than the recommended

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

mylan institutional llc - azacitidine (unii: m801h13nru) (azacitidine - unii:m801h13nru) - azacitidine 100 mg - azacitidine for injection is indicated for treatment of patients with the following french-american-british (fab) myelodysplastic syndrome subtypes: refractory anemia (ra) or refractory anemia with ringed sideroblasts (if accompanied by neutropenia or thrombocytopenia or requiring transfusions), refractory anemia with excess blasts (raeb), refractory anemia with excess blasts in transformation (raeb-t), and chronic myelomonocytic leukemia (cmmol). azacitidine for injection is contraindicated in patients with advanced malignant hepatic tumors [see warnings and precautions (5.2)] . azacitidine for injection is contraindicated in patients with a known hypersensitivity to azacitidine or mannitol. based on its mechanism of action and findings in animals, azacitidine for injection can cause fetal harm when administered to a pregnant woman [see clinical pharmacology (12.1)] . there are no data on the use of azacitidine in pregnant women. azacitidine was teratogenic and caused embryo-fetal lethality in animals at dos

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

wockhardt usa llc. - azacitidine (unii: m801h13nru) (azacitidine - unii:m801h13nru) - azacitidine 100 mg - azacitidine for injection is indicated for treatment of patients with the following french-american-british (fab) myelodysplastic syndrome subtypes: refractory anemia (ra) or refractory anemia with ringed sideroblasts (if accompanied by neutropenia or thrombocytopenia or requiring transfusions), refractory anemia with excess blasts (raeb), refractory anemia with excess blasts in transformation (raeb-t), and chronic myelomonocytic leukemia (cmmol). azacitidine is contraindicated in patients with advanced malignant hepatic tumors [see warnings and precautions (5.2) ]. azacitidine is contraindicated in patients with a known hypersensitivity to azacitidine or mannitol. risk summary based on its mechanism of action and findings in animals, azacitidine can cause fetal harm when administered to a pregnant woman [see clinical pharmacology (12.1) ]. there are no data on the use of azacitidine in pregnant women. azacitidine was teratogenic and caused embryo-fetal lethality in animals at doses lower than the recommended