galsulfase - search results

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

naglazyme- galsulfase solution

biomarin pharmaceutical inc. - galsulfase (unii: 59ua429e5g) (galsulfase - unii:59ua429e5g) - galsulfase 5 mg in 5 ml - naglazyme is indicated for patients with mucopolysaccharidosis vi (mps vi, maroteaux-lamy syndrome). naglazyme has been shown to improve walking and stair-climbing capacity. none. risk summary available data from case reports and postmarketing experience with naglazyme use in pregnant women are insufficient to evaluate for a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. in animal reproduction studies, galsulfase administered intravenously to pregnant rats and rabbits during the period of organogenesis, showed no evidence of harm to the fetus at doses of about 0.5 and 0.97 times, respectively for rats and rabbits, the recommended human dose of 1 mg/kg based on body surface area (see data) . the estimated background risk of major birth defects and miscarriage for the indicated population is unknown. all pregnancies have a background risk of birth defects, loss, or other adverse outcomes. in the u.s. general population, the estimated background risk of majo

Israel - English - Ministry of Health

naglazyme

medison pharma ltd - galsulfase - concentrate for solution for infusion - galsulfase 1 mg/ml - galsulfase - galsulfase - naglazyme is indicated for long-term enzyme replacement therapy in patients with a confirmed diagnosis of mpsvi (n-acetylglactosamine 4 sulfatase deficiency maroteaux-lamy syndrome).

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

naglazyme galsulfase-rch 5mg/5ml concentrated solution for injection vial

biomarin pharmaceutical australia pty ltd - galsulfase, quantity: 5 mg - injection, concentrated - excipient ingredients: monobasic sodium phosphate monohydrate; water for injections; dibasic sodium phosphate heptahydrate; polysorbate 80; sodium chloride - for the long-term enzyme replacement therapy in patients with mucopolysaccharidosis vi (mps vi - n acetylgalactosamine 4-sulfatase deficiency)

European Union - English - EMA (European Medicines Agency)

naglazyme

biomarin international limited - galsulfase - mucopolysaccharidosis vi - other alimentary tract and metabolism products, - naglazyme is indicated for long-term enzyme-replacement therapy in patients with a confirmed diagnosis of mucopolysaccharidosis vi (mps vi; n-acetylgalactosamine-4-sulfatase deficiency; maroteaux-lamy syndrome) (see section 5.1). as for all lysosomal genetic disorders, it is of primary importance, especially in severe forms, to initiate treatment as early as possible, before appearance of non-reversible clinical manifestations of the disease. a key issue is to treat young patients aged

New Zealand - English - Medsafe (Medicines Safety Authority)

naglazyme

pharmacy retailing (nz) ltd t/a healthcare logistics - galsulfase 1 mg/ml - concentrate for infusion - 1 mg/ml - active: galsulfase 1 mg/ml excipient: polysorbate 80 sodium chloride sodium phosphate water for injection - naglazyme is indicated as long term enzyme replacement therapy in patients with mucopolysaccharidosis vi (mps vi, n-acetylgalactosamine 4-sulfatase deficiency, maroteaux-lamy syndrome).