Uus-Meremaa - inglise - Medsafe (Medicines Safety Authority)

sandoz new zealand limited - azacitidine 100mg - powder for injection - 100 mg - active: azacitidine 100mg excipient: mannitol - azacitidine sandoz is indicated for the treatment of patients with: - intermediate-2 and high-risk myelodysplastic syndromes (mds) according to the international prognostic scoring system (ipss),

Ameerika Ühendriigid - inglise - NLM (National Library of Medicine)

pilnova pharma inc - azacitidine (unii: m801h13nru) (azacitidine - unii:m801h13nru) - azacitidine for injection 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). azacitidine is contraindicated in patients with advanced malignant hepatic tumors [see warnings and precautions (5.3) ]. 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 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 azacitidine on the breastfed infant, or the effects of azacitidine 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 azacitidine, advise patients not to breastfeed during treatment with azacitidine and for 1 week after the last dose. based on its mechanism of action and findings in animals, azacitidine 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 azacitidine. contraception females advise pregnant women of the potential risk to a fetus. advise females of reproductive potential to use effective contraception during treatment with azacitidine and for 6 months after the last dose. males advise males with female partners of reproductive potential to use effective contraception during treatment with azacitidine 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 azacitidine in pediatric patients with mds have not been established. 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) ].

Austraalia - inglise - Department of Health (Therapeutic Goods Administration)

eugia pharma (australia) pty ltd - azacitidine, quantity: 100 mg - injection, powder for - excipient ingredients: mannitol - eug-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.

Iisrael - inglise - Ministry of Health

bristol, myers squibb (israel) limited, israel - azacitidine - film coated tablets - azacitidine 200 mg - azacitidine - onureg is indicated for continued treatment of adult patients with acute myeloid leukemia who achieved first complete remission (cr) or complete remission with incomplete blood count recovery (cri) following intensive induction chemotherapy and are not able to complete intensive curative therapy

Iisrael - inglise - Ministry of Health

bristol, myers squibb (israel) limited, israel - azacitidine - film coated tablets - azacitidine 300 mg - azacitidine - onureg is indicated for continued treatment of adult patients with acute myeloid leukemia who achieved first complete remission (cr) or complete remission with incomplete blood count recovery (cri) following intensive induction chemotherapy and are not able to complete intensive curative therapy

Saudi Araabia - inglise - SFDA (Saudi Food and Drug Authority)- الهيئة العامة للغذاء والدواء

sudair pharma company, saudi arabia - azacitidine - powder for suspension for injection - 100 mg,

Araabia Ühendemiraadid - inglise - MOHAP (Ministry of Health & Prevention) - وزارة الصحة ووقاية المجتمع.الإمارات

azacitidine -

Araabia Ühendemiraadid - inglise - MOHAP (Ministry of Health & Prevention) - وزارة الصحة ووقاية المجتمع.الإمارات

azacitidine -

Austraalia - inglise - Department of Health (Therapeutic Goods Administration)

celgene pty ltd - azacitidine, quantity: 300 mg - tablet, film coated - excipient ingredients: mannitol; silicified microcrystalline cellulose; croscarmellose sodium; magnesium stearate; titanium dioxide; lactose monohydrate; hypromellose; triacetin; iron oxide yellow; iron oxide red; macrogol 3350; iron oxide black - onureg is indicated for continued treatment of adult patients with acute myeloid leukemia who achieved first complete remission (cr) or complete remission with incomplete blood count recovery (cri) following intensive induction chemotherapy and are not able to complete intensive curative therapy.

Austraalia - inglise - Department of Health (Therapeutic Goods Administration)

celgene pty ltd - azacitidine, quantity: 200 mg - tablet, film coated - excipient ingredients: silicified microcrystalline cellulose; mannitol; croscarmellose sodium; magnesium stearate; titanium dioxide; lactose monohydrate; hypromellose; triacetin; iron oxide red; macrogol 3350 - onureg is indicated for continued treatment of adult patients with acute myeloid leukemia who achieved first complete remission (cr) or complete remission with incomplete blood count recovery (cri) following intensive induction chemotherapy and are not able to complete intensive curative therapy.