USA - engelsk - 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

Australia - engelsk - 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.

USA - engelsk - 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

USA - engelsk - 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 - engelsk - 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 - engelsk - 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.

Malta - engelsk - Medicines Authority

csl behring gmbh emil-von-behring-strasse 76, 35041 marburg, germany - c, esterase inhibitor, human - powder and solvent for solution for injection - c1-esterase inhibitor, human 3000 iu - other hematological agents

Litauen - litauisk - SMCA (Valstybinė vaistų kontrolės tarnyba)

csl behring gmbh - Žmogaus c1-esterazės inhibitorius - milteliai ir tirpiklis injekciniam ar infuziniam tirpalui - 500 tv - c1-inhibitor, plasma derived

Litauen - litauisk - SMCA (Valstybinė vaistų kontrolės tarnyba)

csl behring gmbh - Žmogaus c1-esterazės inhibitorius - milteliai ir tirpiklis injekciniam tirpalui - 2000 tv - c1-inhibitor, plasma derived

Litauen - litauisk - SMCA (Valstybinė vaistų kontrolės tarnyba)

csl behring gmbh - Žmogaus c1-esterazės inhibitorius - milteliai ir tirpiklis injekciniam tirpalui - 3000 tv - c1-inhibitor, plasma derived