elaprase recombinante concentrado para solución para perfusión 2 - search results

New Zealand - English - Medsafe (Medicines Safety Authority)

elaprase

pharmacy retailing (nz) ltd t/a healthcare logistics - idursulfase 2 mg/ml; - concentrate for infusion - 2 mg/ml - active: idursulfase 2 mg/ml excipient: dibasic sodium phosphate heptahydrate monobasic sodium phosphate monohydrate polysorbate 20 sodium chloride water for injection - elaprase is indicated for the long term treatment of patients with hunter syndrome (mucopolysaccharidosis ii, mps ii).

European Union - English - EMA (European Medicines Agency)

elaprase

takeda pharmaceuticals international ag ireland branch - idursulfase - mucopolysaccharidosis ii - other alimentary tract and metabolism products, - elaprase is indicated for the long-term treatment of patients with hunter syndrome (mucopolysaccharidosis ii, mps ii). heterozygous females were not studied in the clinical trials.

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

elaprase- idursulfase solution, concentrate

takeda pharmaceuticals america, inc. - idursulfase (unii: 5w8jgg2651) (idursulfase - unii:5w8jgg2651) - idursulfase 6 mg in 3 ml - elaprase is indicated for patients with hunter syndrome (mucopolysaccharidosis ii, mps ii). elaprase has been shown to improve walking capacity in patients 5 years and older. in patients 16 months to 5 years of age, no data are available to demonstrate improvement in disease-related symptoms or long term clinical outcome; however, treatment with elaprase has reduced spleen volume similarly to that of adults and children 5 years of age and older. the safety and efficacy of elaprase have not been established in pediatric patients less than 16 months of age [see use in specific populations (8.4)]. none. risk summary there are no adequate and well-controlled studies with elaprase use in pregnant women. available data from a small number of postmarketing cases with elaprase use in pregnancy are insufficient to inform drug-associated risks for major birth defects, miscarriage, or adverse maternal or fetal outcomes. in an animal reproduction study, no evidence of adverse effects on pre- and post-natal development wa

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

elaprase idursulfase-rhu concentrate for solution for iv infusion vial

sanofi-aventis australia pty ltd - idursulfase, quantity: 6 mg - injection, intravenous infusion - excipient ingredients: sodium chloride; water for injections; dibasic sodium phosphate heptahydrate; monobasic sodium phosphate monohydrate; polysorbate 20 - for the long term treatment of patients with hunter syndrome (mucopolysaccharidosis ii, mps ii) for the long term treatment of patients with hunter syndrome (mucoplysaccharidosis ii, mps ii).

Israel - English - Ministry of Health

elaprase

takeda israel ltd - idursulfase - concentrate for solution for infusion - idursulfase 2 mg/ml - idursulfase - idursulfase - long term treatment of patients with hunter syndrome (mps ii).

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

elaprase

genzyme australasia pty ltd - idursulfase -