New Zealand - English - Medsafe (Medicines Safety Authority)

servier laboratories nz ltd - pegaspargase 3750 u (4050u including overage) - powder for injection - 3750 u/5ml - active: pegaspargase 3750 u (4050u including overage) excipient: dibasic sodium phosphate hydrochloric acid monobasic sodium phosphate sodium chloride sodium hydroxide sucrose - oncaspar is indicated as a component of antineoplastic combination therapy in patients with acute lymphoblastic leukaemia (all).

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

servier laboratories (aust) pty ltd - pegaspargase, quantity: 750 u/ml - solution, powder for - excipient ingredients: sucrose; dibasic sodium phosphate; monobasic sodium phosphate; sodium chloride; sodium hydroxide; hydrochloric acid - oncaspar is indicated as a component of antineoplastic combination therapy in patients with acute lymphoblastic leukaemia (all).

European Union - English - EMA (European Medicines Agency)

bristol myers squibb pharma eeig - luspatercept - anemia; myelodysplastic syndromes; beta-thalassemia - other antianemic preparations - reblozyl is indicated for the treatment of adult patients with transfusion-dependent anaemia due to very low, low and intermediate-risk myelodysplastic syndromes (mds) with ring sideroblasts, who had an unsatisfactory response to or are ineligible for erythropoietin-based therapy (see section 5.1).reblozyl is indicated in adults for the treatment of anaemia associated with transfusion dependent and non transfusion dependent beta thalassaemia (see section 5.1).

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.

Australia - English - APVMA (Australian Pesticides and Veterinary Medicines Authority)

pool ranger pty limited - sodium bromide; chlorine present as sodium dichloroisocyanurate - granular formulation - sodium bromide mineral-bromide active 150.0 g/kg; chlorine present as sodium dichloroisocyanurate mineral-chlorine active 530.0 g/kg - pool chlorine

Australia - English - APVMA (Australian Pesticides and Veterinary Medicines Authority)

the pops group pty ltd - chlorine present as sodium dichloroisocyanurate - granular formulation - chlorine present as sodium dichloroisocyanurate mineral-chlorine active 615.0 g/kg - pool chemical

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

forest pharmaceuticals, inc. - flunisolide hemihydrate (unii: qk4dys664x) (flunisolide - unii:qk4dys664x) - aerosol, metered - 80 ug - aerospan inhalation aerosol is indicated for the maintenance treatment of asthma as prophylactic therapy in adult and pediatric patients 6 years of age and older. aerospan inhalation aerosol is also indicated for asthma patients requiring oral corticosteroid therapy, where adding aerospan inhalation aerosol may reduce or eliminate the need for oral corticosteroids. aerospan inhalation aerosol is not indicated for the relief of acute bronchospasm. aerospan inhalation aerosol is contraindicated in the primary treatment of status asthmaticus or other acute episodes of asthma where intensive measures are required. hypersensitivity to flunisolide or any of the ingredients of this preparation contraindicates the use of aerospan inhalation aerosol.

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

servier laboratories australia pty ltd - pegaspargase -

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

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.