LAMZEDE Israel - English - Ministry of Health

lamzede

kamada ltd, israel - velmanase alfa - powder for solution for infusion - velmanase alfa 10 mg/vial - velmanase alfa - enzyme replacement therapy for the treatment of non-neurological manifestations in patients with mild to moderate alpha mannosidosis.

LAMZEDE- velmanase alfa-tycv injection, powder, lyophilized, for solution United States - English - NLM (National Library of Medicine)

lamzede- velmanase alfa-tycv injection, powder, lyophilized, for solution

chiesi usa, inc. - velmanase alfa-tycv (unii: m91tg242p2) (velmanase alfa-tycv - unii:m91tg242p2) - lamzede is indicated for the treatment of non-central nervous system manifestations of alpha-mannosidosis in adult and pediatric patients. none. risk summary based on findings from animal reproduction studies, lamzede may cause embryo-fetal harm when administered to a pregnant female. in animal reproduction studies, major visceral malformations were observed in rats and rabbits when velmanase alfa-tycv was administered in pregnant rats and rabbits during the period of organogenesis. these malformations were observed in rats at the highest dose level, at exposures that were approximately 7-fold the recommended dose in patients of 1 mg/kg. malformations occurred at all dose levels in rabbits with the highest dose exposures approximately 2.5-fold the recommended patient dose of 1 mg/kg ( see data ) . there are no available data on lamzede use in pregnant females to evaluate a drug-associated risk of major birth defects, miscarriage or other adverse maternal or fetal outcomes. advise the pregnant female of the po

Lamzede European Union - English - EMA (European Medicines Agency)

lamzede

chiesi farmaceutici s.p.a. - velmanase alfa - alpha-mannosidosis - other alimentary tract and metabolism products, - treatment of non-neurological manifestations in patients with mild to moderate alpha-mannosidosis.,