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

takeda pharmaceuticals america, inc. - human c1-esterase inhibitor (unii: 6kic4bb60g) (human c1-esterase inhibitor - unii:6kic4bb60g) - human c1-esterase inhibitor 500 [iu] in 5 ml - cinryze is a c1 esterase inhibitor indicated for routine prophylaxis against angioedema attacks in adults, adolescents, and pediatric patients (6 years old and above) with hereditary angioedema (hae). cinryze is contraindicated in patients who have manifested life-threatening immediate hypersensitivity reactions, including anaphylaxis, to the product. risk summary there are no data with cinryze use in pregnant women to inform a drug associated risk. animal reproduction studies have not been conducted with cinryze. it is unknown whether cinryze can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. cinryze should be given to a pregnant woman only if clearly needed. 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. data animal data in an embryo fetal development study (c1 inhibitor administered during the period of organogenesis) in rats, there

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

takeda pharmaceuticals australia pty ltd - c1 esterase inhibitor, quantity: 500 u - injection, solution - excipient ingredients: water for injections - treatment and pre-procedure prevention of angioedema attacks in adults and adolescents with c1 inhibitor deficiency. routine prevention of angioedema attacks in adults and adolescents with frequent attacks of hereditary angioedema (hae), who are intolerant to or insufficiently protected by oral therapy.

European Union - English - EMA (European Medicines Agency)

takeda manufacturing austria ag - c1 inhibitor (human) - angioedemas, hereditary - c1-inhibitor, plasma derived, drugs used in hereditary angioedema - treatment and pre-procedure prevention of angioedema attacks in adults, adolescents and children (2 years old and above) with hereditary angioedema (hae).routine prevention of angioedema attacks in adults, adolescents and children (6 years old and above) with severe and recurrent attacks of hereditary angioedema (hae), who are intolerant to or insufficiently protected by oral prevention treatments, or patients who are inadequately managed with repeated acute treatment.

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

viropharma pty ltd - c1 esterase inhibitor -

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

shire pharmaceuticals ltd - c1-esterase inhibitor - powder and solvent for solution for injection - 500unit

Canada - English - Health Canada

takeda canada inc - c1 esterase inhibitor (human) - powder for solution - 500unit - c1 esterase inhibitor (human) 500unit - complement inhibitors

Israel - English - Ministry of Health

neopharm cure (2005) ltd - c - 1 esterase inhibitor human 500 units - lyophilized powder for solution for injection - c1-inhibitor - treatment and pre-procedure prevention of angioedema attacks in adults and adolescents with hereditary angioedema (hae). routine prevention of angioedema attacks in adults and adolescents with severe and recurrent attacks of hereditary angioedema (hae), who are intolerant to or insufficiently protected by oral prevention treatments, or patients who are inadequately managed with repeated acute treatment.

United Arab Emirates - English - MOHAP (Ministry of Health & Prevention) - وزارة الصحة ووقاية المجتمع.الإمارات

2 powder glass vials + 2 solvent (wfi) vials (5 ml each) + 2 filter transfer devices + 2 disposable 10 ml syringes + 2 venipuncture sets + 2 protective mats -

United Arab Emirates - English - MOHAP (Ministry of Health & Prevention) - وزارة الصحة ووقاية المجتمع.الإمارات

modern pharmaceutical company austria - 2 powder glass vials + 2 solvent (wfi) vials (5 ml each) + 2 filter transfer devices + 2 disposable 10 ml syringes + 2 venipuncture sets + 2 protective mats - injection - 500iu/vial - respiratory system-allergic , inflammatory disorders