Ireland - English - HPRA (Health Products Regulatory Authority)

as kalceks - hydromorphone hydrochloride - solution for injection/infusion - hydromorphone

New Zealand - English - Medsafe (Medicines Safety Authority)

pharmacy retailing (nz) ltd t/a healthcare logistics - alglucosidase alfa 52.5mg;  ;  ;   - powder for infusion concentrate - 50 mg/10ml - active: alglucosidase alfa 52.5mg       excipient: dibasic sodium phosphate heptahydrate mannitol monobasic sodium phosphate monohydrate nitrogen polysorbate 80 - myozyme is indicated for the long - term treatment of patients with a confirmed diagnosis of pompe disease (acid alfa - glucosidase deficiency).

Canada - English - Health Canada

sanofi genzyme, a division of sanofi-aventis canada inc - alglucosidase alfa - powder for solution - 50mg - alglucosidase alfa 50mg - enzymes

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

napp pharmaceuticals ltd - hydromorphone hydrochloride - solution for injection - 50mg/1ml

Ireland - English - HPRA (Health Products Regulatory Authority)

s.a.l.f. s.p.a. laboratorio farmacologico - labetalol hydrochloride - solution for injection/infusion - 5 milligram(s)/millilitre - labetalol

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

genzyme therapeutics ltd - imiglucerase - powder for solution for infusion - 400unit

Philippines - English - FDA (Food And Drug Administration)

n/a; importer: sanofi-aventis philippines, inc.; distributor: sanofi-aventis philippines, inc. - alglucosidase alfa - powder for concentrate for solutions for infusion (iv) - 50 mg

Ireland - English - HPRA (Health Products Regulatory Authority)

baxter holding b.v. - mesna - solution for injection/infusion - 100 milligram(s)/millilitre - detoxifying agents for antineoplastic treatment; mesna

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

genzyme corporation - alglucosidase alfa (unii: dti67o9503) (alglucosidase alfa - unii:dti67o9503) - alglucosidase alfa 5 mg in 1 ml - lumizyme® (alglucosidase alfa) [see description (11)] is a hydrolytic lysosomal glycogen-specific enzyme indicated for patients with pompe disease (acid α-glucosidase [gaa] deficiency). none. risk summary data from postmarketing reports and published case reports with alglucosidase alfa use in pregnant women have not identified a lumizyme-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. the continuation of treatment for pompe disease during pregnancy should be individualized to the pregnant woman. untreated pompe disease may result in worsening disease symptoms in pregnant women [see clinical considerations] . reproduction studies performed in mice and rabbits at doses resulting in exposures up to 0.4 or 0.5 times the human steady-state auc (area under the plasma concentration-time curve), respectively, during the period of organogenesis revealed no evidence of effects on embryo-fetal development. in mice there was an increase in pup mortality during lactation

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

napp pharmaceuticals ltd - hydromorphone hydrochloride - solution for injection - 20mg/1ml