New Zealand - English - Medsafe (Medicines Safety Authority)

pharmacy retailing (nz) ltd t/a healthcare logistics - laronidase 0.58 mg/ml (rch) - concentrate for infusion - 500 u/5ml - active: laronidase 0.58 mg/ml (rch) excipient: dibasic sodium phosphate monobasic sodium phosphate monohydrate polysorbate 80 sodium chloride water for injection - aldurazyme is indicated as long-term enzyme replacement therapy in patients with mucopolysaccharidosis i (mps i; alpha-l-iduronidase deficiency) to treat the non-neurological manifestations of the disease.

New Zealand - English - Medsafe (Medicines Safety Authority)

pharmacy retailing (nz) ltd t/a healthcare logistics - laronidase 0.58 mg/ml (rch) - concentrate for infusion - 500 u/5ml - active: laronidase 0.58 mg/ml (rch) excipient: dibasic sodium phosphate monohydrate monobasic sodium phosphate monohydrate polysorbate 80 sodium chloride water for injection

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

sanofi-aventis australia pty ltd - laronidase, quantity: 0.58 mg/ml - injection, concentrated - excipient ingredients: water for injections; polysorbate 80; sodium chloride; monobasic sodium phosphate monohydrate; dibasic sodium phosphate heptahydrate - aldurazyme is indicated as long term enzyme replacement therapy in patients with mucopolysaccharidosis (mps i; alpha - l - iduronidase deficiency) to treat the non-neurological manifestations of the disease. aldurazyme is indicated as long term enzyme replacement therapy in patients with mucopolysaccharidosis (mps i; alpha - l - iduronidase deficiency) to treat the non-neurological manifestations of the disease.

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

genzyme corporation - laronidase (unii: wp58svm6r4) (laronidase - unii:wp58svm6r4) - laronidase 2.9 mg in 5 ml - aldurazyme® is indicated for the treatment of: - adult and pediatric patients with hurler and hurler-scheie forms of mucopolysaccharidosis i (mps i) and - patients with the scheie form of mps i who have moderate to severe symptoms. limitations of use - the safety and effectiveness of treating mildly affected patients with the scheie form have not been established. - the effect of aldurazyme on central nervous system manifestations of the disorder has not been determined. none. pregnancy exposure registry an mps i registry has been established. pregnant women with mps i and healthcare providers are encouraged to contact the pregnancy sub-registry by visiting www.registrynxt.com or calling 1-800-745-4447 ext. 15500. risk summary available data from the mps i registry pregnancy sub-registry, published case reports, and the global pharmacovigilance database with aldurazyme use in more than 30 pregnant women have not identified a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. the continuation of treatment for mps i during pregnancy should be individualized to the pregnant woman. untreated mps i may result in adverse pregnancy and infant outcomes (see clinical considerations ). no evidence of fetal harm has been observed in rats when laronidase was administered during organogenesis at doses up to 6.2 times the recommended human dose (see data). the background risk of major birth defects and miscarriage for the indicated population is unknown. all pregnancies have a background risk of birth defect, loss, or other adverse outcomes. in the u.s. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. clinical considerations disease-associated maternal and/or embryo-fetal risk pregnancy can exacerbate preexisting clinical manifestations of mps and lead to adverse pregnancy outcomes for both mother and fetus. data animal data when laronidase was administered to pregnant female rats during organogenesis (gestation days [gd] 7-17) at doses of 0, 0.036, 0.36 or 3.6 mg/kg/day intravenously (equivalent to 7.3, 73.1, 730.8 units/kg/day) decreased maternal body weight gains and food consumption were observed with no corresponding effects on reproductive and litter parameters including number and distribution of corpora lutea, implantations and early and late resorptions at doses up to 3.6 mg/kg/day (6.2 times the recommended human dose of 0.58 mg/kg on a mg/kg basis). laronidase has not been evaluated for effects on embryo-fetal development in any other species. risk summary available information from one mother:infant pair are insufficient to evaluate the presence or absence of laronidase in human milk. no adverse effects have been reported in breastfed infants in postmarketing cases of aldurazyme use in lactating women. the developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for aldurazyme and any potential adverse effects on the breastfed child from aldurazyme or from the underlying maternal condition. lactating women with mps i and healthcare providers are encouraged to contact the mps i registry by visiting www.registrynxt.com or calling 1-800-745-4447 ext. 15500. the safety and effectiveness of aldurazyme have been established for the treatment of pediatric patients with hurler and hurler-scheie forms of mucopolysaccharidosis i (mps i) and the treatment of pediatric patients with the scheie form of mps i who have moderate to severe symptoms. the safety and effectiveness aldurazyme for the treatment of mildly affected pediatric patients with the scheie form have not been established. use of aldurazyme for these indications is supported by evidence from an adequate and well-controlled clinical study (study1) with an open label extension (study 2) in adult and pediatric patients with mps i, and from an open label, uncontrolled clinical study in pediatric patients with mps i, 6 months to 5 years of age (study 3). the safety and effectiveness of aldurazyme in pediatric patients 6 months of age to 5 years of age was found to be similar to pediatric patients 6 to 18 years of age and adults for these indications [see adverse reactions (6.1), clinical studies (14)]. clinical studies of aldurazyme did not include patients 65 years of age and older to determine if they respond differently from younger patients.

Israel - English - Ministry of Health

sanofi israel ltd - laronidase - concentrate for solution for infusion - laronidase 500 units / 5 ml - laronidase - laronidase - aldurazyme is indicated for long-term enzyme replacement therapy in patients with a confirmed diagnosis of mucopolysaccharidosis i (mps i alfa-l-iduronidase deficiency) to treat the non-neurological manifestations of the disease.

Malaysia - English - NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

sanofi-aventis (malaysia) sdn. bhd. - laronidase -

European Union - English - EMA (European Medicines Agency)

sanofi b.v. - laronidase - mucopolysaccharidosis i - other alimentary tract and metabolism products, - aldurazyme is indicated for long-term enzyme replacement therapy in patients with a confirmed diagnosis of mucopolysaccharidosis i (mps i; alpha-l-iduronidase deficiency) to treat the nonneurological manifestations of the disease.

Canada - English - Health Canada

sanofi genzyme, a division of sanofi-aventis canada inc - laronidase - solution - 0.58mg - laronidase 0.58mg - enzymes

Singapore - English - HSA (Health Sciences Authority)

sanofi-aventis singapore pte. ltd. - laronidase - injection, solution - 2.9mg - laronidase 2.9mg

United Kingdom - English - MHRA (Medicines & Healthcare Products Regulatory Agency)

genzyme therapeutics ltd - laronidase - solution for infusion - 100unit/1ml