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

astellas pharma us, inc. - gilteritinib fumarate (unii: 5rzz0z1gjt) (gilteritinib - unii:66d92mgc8m) - xospata is indicated for the treatment of adult patients who have relapsed or refractory acute myeloid leukemia (aml) with a fms-like tyrosine kinase 3 (flt3) mutation as detected by an fda-approved test. xospata is contraindicated in patients with hypersensitivity to gilteritinib or any of the excipients. anaphylactic reactions have been observed in clinical trials [see adverse reactions (6) and description (11)] . risk summary based on findings from animal studies (see data) and its mechanism of action, xospata can cause fetal harm when administered to a pregnant woman [see clinical pharmacology (12.1)] . there are no available data on xospata use in pregnant women to inform a drug-associated risk of adverse developmental outcomes. in animal reproduction studies, administration of gilteritinib to pregnant rats during organogenesis caused adverse developmental outcomes including embryo-fetal lethality, suppressed fetal growth, and teratogenicity at maternal exposures (auc24 ) approximately 0.4 times the auc

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

baxalta us inc. - pegaspargase (unii: 7d96ir0ppm) (pegaspargase - unii:7d96ir0ppm) - pegaspargase 750 [iu] in 1 ml - oncaspar® is indicated as a component of a multi-agent chemotherapeutic regimen for the first-line treatment of pediatric and adult patients with all. oncaspar is indicated as a component of a multi-agent chemotherapeutic regimen for the treatment of pediatric and adult patients with all and hypersensitivity to native forms of l-asparaginase. oncaspar is contraindicated in patients with a: - history of serious hypersensitivity reactions, including anaphylaxis, to oncaspar or to any of the excipients [see warnings and precautions (5.1)] . - history of serious thrombosis with prior l-asparaginase therapy [see warnings and precautions (5.2)] . - history of pancreatitis, including pancreatitis related to prior l-asparaginase therapy [see warnings and precautions (5.3)] . - history of serious hemorrhagic events with prior l-asparaginase therapy [see warnings and precautions (5.5)] . - severe hepatic impairment [see warnings and precautions (5.6)] . risk summary there are no available data on the use of oncaspar i

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

astellas pharma australia pty ltd - gilteritinib fumarate, quantity: 44.2 mg - tablet, film coated - excipient ingredients: hyprolose; magnesium stearate; mannitol; titanium dioxide; macrogol 8000; hypromellose; purified talc; iron oxide yellow - xospata is indicated for the treatment of adult patients who have relapsed or refractory acute myeloid leukaemia (aml) with a flt3 mutation.

European Union - English - EMA (European Medicines Agency)

baxalta innovations gmbh - pegaspargase - precursor cell lymphoblastic leukemia-lymphoma - antineoplastic agents, - oncaspar is indicated as a component of antineoplastic combination therapy in acute lymphoblastic leukaemia (all) in paediatric patients from birth to 18 years, and adult patients.,

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

servier pharmaceuticals llc - pegaspargase (unii: 7d96ir0ppm) (pegaspargase - unii:7d96ir0ppm) - oncaspar® is indicated as a component of a multi-agent chemotherapeutic regimen for the first-line treatment of pediatric and adult patients with all. oncaspar is indicated as a component of a multi-agent chemotherapeutic regimen for the treatment of pediatric and adult patients with all and hypersensitivity to native forms of l-asparaginase. oncaspar is contraindicated in patients with a: - history of serious hypersensitivity reactions, including anaphylaxis, to oncaspar or to any of the excipients [see warnings and precautions (5.1)] . - history of serious thrombosis with prior l-asparaginase therapy [see warnings and precautions (5.2)] . - history of pancreatitis, including pancreatitis related to prior l-asparaginase therapy [see warnings and precautions (5.3)] . - history of serious hemorrhagic events with prior l-asparaginase therapy [see warnings and precautions (5.5)] . - severe hepatic impairment [see warnings and precautions (5.6)] . risk summary based on published literature studies with l-asparaginase in pregnant animals, oncaspar can cause fetal harm when administered to a pregnant woman. there are no available data on oncaspar use in pregnant women to evaluate for a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. published literature studies in pregnant animals suggest asparagine depletion may cause harm to the animal offspring (see data) . advise pregnant women of the potential risk to a fetus. in the u.s. general population, the estimated background risks of major birth defects and miscarriage in clinically recognized pregnancies are 2 to 4% and 15 to 20%, respectively. data animal data animal reproduction studies have not been conducted with oncaspar to evaluate its effect on reproduction and fetal development. published literature studies in which pregnant rabbits were administered l-asparaginase or pregnant rats were deprived of dietary asparagine suggested harm to the animal offspring. risk summary there are no data on the presence of pegaspargase in human milk, the effects on the breastfed child, or the effects on milk production. because of the potential for adverse reactions in the breastfed child, advise women not to breastfeed during treatment with oncaspar and for 1 month after the last dose. oncaspar can cause fetal harm when administered to a pregnant woman [see use in specific populations (8.1)] . pregnancy pregnancy testing is recommended in females of reproductive potential prior to initiating oncaspar. contraception advise females of reproductive potential to use effective non-hormonal contraceptive methods during treatment with oncaspar and for 3 months after the last dose. the safety and effectiveness of oncaspar in the treatment of all have been established in pediatric patients. use of oncaspar in these age groups is supported by evidence of efficacy as first-line treatment from one adequate and well-controlled trial, and evidence of efficacy for treatment of patients with hypersensitivity to asparaginase from four adequate and well-controlled trials [see clinical studies (14.1)] , and safety data from 7 total trials. the pediatric patients treated with oncaspar 2,500 international units/m2 on these trials included 26 infants (1 month to <2 years old), 165 children (2 years to <12 years old), and 39 adolescents (12 to 17 years old). clinical studies of oncaspar did not include sufficient numbers of subjects aged 65 years and older to determine whether they respond differently than younger subjects.

European Union - English - EMA (European Medicines Agency)

astellas pharma europe b.v. - gilteritinib fumarate - leukemia, myeloid, acute - antineoplastic agents - xospata is indicated as monotherapy for the treatment of adult patients who have relapsed or refractory acute myeloid leukaemia (aml) with a flt3 mutation.,

United Arab Emirates - English - MOHAP (Ministry of Health & Prevention) - وزارة الصحة ووقاية المجتمع.الإمارات

opalescence boost 40% intro kit [4-1.2ml opalescence boost/activator syringes+2-1.2 ml opaldam green syringes+2-isoblocks] -

United Arab Emirates - English - MOHAP (Ministry of Health & Prevention) - وزارة الصحة ووقاية المجتمع.الإمارات

elwan technical supplies united states of america - opalescence boost 40% intro kit [4-1.2ml opalescence boost/activator syringes+2-1.2 ml opaldam green syringes+2-isoblocks] - gel - combination - medical devices-medical devices

Canada - English - Health Canada

celgene inc - luspatercept - powder for solution - 25mg - luspatercept 25mg - hematopoietic agents

Canada - English - Health Canada

celgene inc - luspatercept - powder for solution - 75mg - luspatercept 75mg - antianemia drugs