USA - engelsk - NLM (National Library of Medicine)

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 - engelsk - Ministry of Health

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 - engelsk - Department of Health (Therapeutic Goods Administration)

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)

Den europeiske union - dansk - EMA (European Medicines Agency)

biomarin international limited - galsulfase - mucopolysaccharidose vi - andre alimentary tract and metabolism produkter, - naglazyme er indiceret til langsigtet enzym-substitutionsterapi hos patienter med en bekræftet diagnose af mucopolysaccharidosis vi (mps vi; n-acetylgalactosamine-4-sulfatase mangel; maroteaux-lamy syndrom) (se afsnit 5. som for alle lysosomal genetiske sygdomme, er det af afgørende betydning, især i svære former, til at påbegynde behandling så tidligt som muligt, før fremkomsten af ikke-reversible kliniske manifestationer af sygdommen. et centralt problem er at behandle unge patienter i alderen.

Den europeiske union - nederlandsk - EMA (European Medicines Agency)

biomarin international limited - galsulfase - mucopolysaccharidosis vi - andere maagdarmkanaal en metabolisme producten, - naglazyme is geïndiceerd voor de lange termijn enzym-substitutietherapie bij patiënten met een bevestigde diagnose van mucopolysaccharidose vi (mps vi; n-acetylgalactosamine-4-sulfatase deficiency; maroteaux-lamy syndroom) (zie punt 5. zoals voor alle lysosomal genetische aandoeningen, is het van primair belang, vooral in de ernstige vormen, te starten van de behandeling zo vroeg mogelijk vóór de verschijning van niet-omkeerbare klinische manifestaties van de ziekte. een belangrijke kwestie is voor de behandeling van jonge patiënten in de leeftijd van.

Den europeiske union - maltesisk - EMA (European Medicines Agency)

biomarin international limited - galsulfase - mucopolysaccharidosis vi - oħra tal-passaġġ alimentari u tal-metaboliżmu-prodotti, - naglazyme huwa indikat għal terapija s-sostituzzjoni ta ' l-enżima fit-tul fil-pazjenti bl-djanjosi konfermati ta ' mucopolysaccharidosis vi (mps vi; defiċjenza n-acetylgalactosamine-4-sulfatase; maroteaux-lamy syndrome) (ara taqsima 5. kif għall-lisosomali disturbi ġenetiċi, huwa ta'importanza primarja, speċjalment fil-forom severi, li tinbeda l-kura malajr kemm jista 'jkun, qabel id-dehra ta jitfaċċaw manifestazzjonijiet kliniċi mhux reversibbli ta' l-mard. punt kruċjali huwa li tikkura pazjenti żgħar li għandhom bejn.

Den europeiske union - italiensk - EMA (European Medicines Agency)

biomarin international limited - galsulfase - mucopolisaccaridosi vi - altro apparato digerente e metabolismo prodotti, - naglazyme è indicato per la terapia enzimatica sostitutiva a lungo termine in pazienti con una diagnosi confermata di mucopolisaccaridosi vi (mps vi; deficit di n-acetylgalactosamine-4-solfatasi; maroteaux sindrome) (vedere sezione 5. come per tutti lisosomiale malattie genetiche, è di primaria importanza, soprattutto nelle forme più gravi, per iniziare il trattamento il più presto possibile, prima aspetto di non reversibile manifestazioni cliniche della malattia. una questione chiave è per il trattamento di pazienti giovani di età compresa.

Den europeiske union - tysk - EMA (European Medicines Agency)

biomarin international limited - galsulfase - mukopolysaccharidose vi - anderen verdauungstrakt und stoffwechsel-produkte, - naglazyme ist indiziert zur langfristigen enzym-ersatz-therapie bei patienten mit einer bestätigten diagnose von mukopolysaccharidose vi (mps vi; n-acetylgalactosamine-4-sulfatase-mangel; maroteaux-lamy syndrom) (siehe abschnitt 5. wie bei allen lysosomalen erbkrankheiten, ist es von primärer bedeutung, vor allem in schweren formen, um die einleitung der behandlung so früh wie möglich, vor auftreten von nicht-reversible klinische symptome der krankheit. ein zentrales thema ist die behandlung von jungen patienten im alter von.

Den europeiske union - portugisisk - EMA (European Medicines Agency)

biomarin international limited - galsulfase - mucopolissacaridose vi - outro aparelho digestivo e metabolismo produtos, - o naglazyme é indicado para a terapia de reposição enzimática a longo prazo em pacientes com diagnóstico confirmado de mucopolissacaridose vi (mps vi, deficiência de n-acetilgalactosamina-4-sulfatase, síndrome de maroteaux-lamy) (ver seção 5. como para todos os lysosomal distúrbios genéticos, é de fundamental importância, especialmente nas formas graves, para iniciar o tratamento o mais cedo possível, antes que o aspecto da não-reversível manifestações clínicas da doença. uma questão chave é tratar pacientes jovens, com idade entre.

Den europeiske union - engelsk - EMA (European Medicines Agency)

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