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

accord healthcare pty ltd - azacitidine, quantity: 100 mg - injection, powder for - excipient ingredients: mannitol - azacitidine intas 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 - Kiingereza - Department of Health (Therapeutic Goods Administration)

dr reddys laboratories australia pty ltd - azacitidine, quantity: 100 mg - injection, powder for - excipient ingredients: mannitol - azacitidine-drla 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 - Kiingereza - Department of Health (Therapeutic Goods Administration)

dr reddys laboratories australia pty ltd - azacitidine, quantity: 100 mg - injection, powder for - excipient ingredients: mannitol - azacitidine - dr. reddy's 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.

Singapoo - Kiingereza - HSA (Health Sciences Authority)

advagen pte. ltd. - azacitidine - injection, powder, for suspension - azacitidine 100mg/vial

Armenia - Kiingereza - Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

seacross pharmaceuticals limited - azacitidine - powder for suspension for injection - 100mg

Marekani - Kiingereza - NLM (National Library of Medicine)

celgene corporation - azacitidine (unii: m801h13nru) (azacitidine - unii:m801h13nru) - azacitidine 100 mg - vidaza® is indicated for treatment of adult 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). vidaza is indicated for the treatment of pediatric patients aged one month and older with newly diagnosed jmml. vidaza is contraindicated in patients with advanced malignant hepatic tumors [see warnings and precautions ( 5.3 )] . vidaza is contraindicated in patients with a known hypersensitivity to azacitidine or mannitol. risk summary based on its mechanism of action and findings in animals, vidaza 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 human daily dose (see data). advise pregnant women of the potential risk to the fetus. the background rate of major birth defects and miscarriage is unknown for the indicated population. all pregnancies have a background risk of birth defect, loss, or other adverse outcomes. in the u.s. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2%-4% and 15%-20%, respectively. data animal data early embryotoxicity studies in mice revealed a 44% frequency of intrauterine embryonal death (increased resorption) after a single ip (intraperitoneal) injection of 6 mg/m2 (approximately 8% of the recommended human daily dose on a mg/m2 basis) azacitidine on gestation day 10. developmental abnormalities in the brain have been detected in mice given azacitidine on or before gestation day 15 at doses of ~3-12 mg/m2 (approximately 4%-16% the recommended human daily dose on a mg/m2 basis). in rats, azacitidine was clearly embryotoxic when given ip on gestation days 4-8 (postimplantation) at a dose of 6 mg/m2 (approximately 8% of the recommended human daily dose on a mg/m2 basis), although treatment in the preimplantation period (on gestation days 1-3) had no adverse effect on the embryos. azacitidine caused multiple fetal abnormalities in rats after a single ip dose of 3 to 12 mg/m2 (approximately 8% the recommended human daily dose on a mg/m2 basis) given on gestation day 9, 10, 11 or 12. in this study azacitidine caused fetal death when administered at 3-12 mg/m2 on gestation days 9 and 10; average live animals per litter was reduced to 9% of control at the highest dose on gestation day 9. fetal anomalies included: cns anomalies (exencephaly/encephalocele), limb anomalies (micromelia, club foot, syndactyly, oligodactyly), and others (micrognathia, gastroschisis, edema, and rib abnormalities). risk summary there is no information regarding the presence of azacitidine in human milk, the effects of vidaza on the breastfed infant, or the effects of vidaza on milk production. because many drugs are excreted in human milk and because of the potential for tumorigenicity shown for azacitidine in animal studies [see nonclinical toxicology (13.1)] and the potential for serious adverse reactions in nursing infants from vidaza, advise patients not to breastfeed during treatment with vidaza and for 1 week after the last dose. based on its mechanism of action and findings in animals, vidaza can cause fetal harm when administered to a pregnant woman [see use in specific populations (8.1)]. pregnancy testing verify the pregnancy status of females of reproductive potential prior to initiating vidaza. contraception females advise pregnant women of the potential risk to a fetus. advise females of reproductive potential to use effective contraception during treatment with vidaza and for 6 months after the last dose. males advise males with female partners of reproductive potential to use effective contraception during treatment with vidaza and for 3 months after the last dose. infertility based on animal data, azacitidine could have an effect on male or female fertility [see nonclinical toxicology (13.1)]. safety and effectiveness of vidaza in pediatric patients with mds have not been established. the safety and effectiveness of vidaza have been established in pediatric patients with newly diagnosed jmml aged 1 month and older and the information on this use is discussed throughout the labeling. the safety and effectiveness of vidaza have not been established in pediatric patients younger than 1 month old [see clinical studies (14.2)] . of the total number of patients in studies 1, 2 and 3, 62% were 65 years and older and 21% were 75 years and older. no overall differences in effectiveness were observed between these patients and younger patients. in addition, there were no relevant differences in the frequency of adverse reactions observed in patients 65 years and older compared to younger patients. of the 179 patients randomized to azacitidine in study 4, 68% were 65 years and older and 21% were 75 years and older. survival data for patients 65 years and older were consistent with overall survival results. the majority of adverse reactions occurred at similar frequencies in patients <65 years of age and patients 65 years of age and older. elderly patients are more likely to have decreased renal function. monitor renal function in these patients [see dosage and administration ( 2.7 ) and warnings and precautions ( 5.4 )].

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

cipla australia pty ltd - azacitidine, quantity: 100 mg - injection, powder for - excipient ingredients: mannitol - azacitidine cipla 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% percent blasts and multi-lineage dysplasia, according to world health organisation classification (who) in whom allogenic stem cell transplantation is not indicated

Malta - Kiingereza - Malta Medicines Authority

sandoz pharmaceuticals d.d. verovškova ulica 57, si-1000 ljubljana, slovenia - powder for suspension for injection - azacitidine 25 mg/ml - antineoplastic agents

Israeli - Kiingereza - Ministry of Health

neopharm ltd - azacitidine - lyophilized powder for suspension for sc injection / solution for infusion - azacitidine 100 mg/vial - azacitidine - azacitidine - for the treatment of patients with the following fab myelodysplastic syndromes subtypes: refractory anemia or refractory anemia with ringed sideroblasts ( if accompanied by neutropenia or thrombocytopenia or requiring transfusions),refractory anaemia with excess blasts, refractory anaemia with excess blasts in transformation, and chronic myelomonocytic leukaema.

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

dr reddys laboratories australia pty ltd - azacitidine, quantity: 100 mg - injection, powder for - excipient ingredients: mannitol - azadine 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.