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.

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

csl behring gmbh - human c1-esterase inhibitor (unii: 6kic4bb60g) (human c1-esterase inhibitor - unii:6kic4bb60g) - human c1-esterase inhibitor 2000 [iu] in 4 ml - haegarda is a plasma-derived concentrate of c1 esterase inhibitor (human) (c1-inh) indicated for routine prophylaxis to prevent hereditary angioedema (hae) attacks in patients 6 years of age and older. haegarda is contraindicated in individuals who have experienced life-threatening hypersensitivity reactions, including anaphylaxis, to c1-inh preparations or its excipients [see description (11)]. risk summary there are no prospective clinical data from haegarda use in pregnant women. c1-inh is a normal component of human plasma. animal developmental or reproduction toxicity studies have not been conducted with haegarda. in the u.s. general population, the estimated background risk of major birth defects occurs in 2-4% of the general population and miscarriage occurs in 15-20% of clinically recognized pregnancies. data in a retrospective case collection study, 22 pregnant women with type i hae and ranging in age from 20 to 38 years received c1-inh doses of 500 or 1000 iu per i.v. administration for the treatmen

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

csl behring gmbh - human c1-esterase inhibitor (unii: 6kic4bb60g) (human c1-esterase inhibitor - unii:6kic4bb60g) - human c1-esterase inhibitor 500 [iu] in 10 ml - berinert is a plasma-derived concentrate of c1 esterase inhibitor (human) indicated for the treatment of acute abdominal, facial, or laryngeal hereditary angioedema (hae) attacks in adult and pediatric patients. the safety and efficacy of berinert for prophylactic therapy have not been established. berinert is contraindicated in individuals who have experienced life-threatening hypersensitivity reactions, including anaphylaxis, to c1 esterase inhibitor preparations. risk summary background risk (general population) a review of available data suggests that major birth defects occur in 2-4% of the u.s. general population and that miscarriage occurs in 15-20% of clinically recognized pregnancies, regardless of drug exposure. data risk in berinert patients in a retrospective case collection study, 20 pregnant women ranging in age from 20 to 35 years received berinert with repeated doses up to 3,500 iu per hae attack; these women reported no complications during delivery and no harmful effects on their 34 neonates

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)

csl behring australia pty ltd - c1 esterase inhibitor, quantity: 3000 iu - injection, diluent for - excipient ingredients: - berinert? sc for subcutaneous injection is indicated for prevention of recurrent hereditary angioedema (hae) attacks in patients aged 8 years and older with c1 esterase inhibitor deficiency.

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

csl behring australia pty ltd - c1 esterase inhibitor, quantity: 2000 iu - injection, diluent for - excipient ingredients: - berinert? sc for subcutaneous injection is indicated for prevention of recurrent hereditary angioedema (hae) attacks in patients aged 8 years and older with c1 esterase inhibitor deficiency.

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.

Israel - English - Ministry of Health

csl behring ltd., israel - c - 1 esterase inhibitor human - powder for solution for inj/inf - c - 1 esterase inhibitor human 500 iu/vial - c1- inhibitor,plasma derived - c1- inhibitor,plasma derived - hereditary angioedema type i and ii (hae).treatment and pre-procedure (prior to oral, dental, and upper respiratory tract procedures) prevention of acute episodes

Singapore - English - HSA (Health Sciences Authority)

siemens healthcare pte. ltd. - immunology - n antiserum to human c1-inhibitor is an in vitro diagnostic reagent for the quantitative determination of c1-inhibitor concentration as aid to diagnosis of congenital or acquired c1-inhibitor deficiencies in patients at risk for or suspected to have c1-inhibitor deficiency in human serum and sodium citrated plasma by means of automated siemens healthineers immuno-nephelometry systems. n antiserum to human c1-inhibitor uses a calibration against an internal protein reference preparation.

Canada - English - Health Canada

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