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

lundbeck inc. - antithrombin alfa (unii: awv6i5l6h2) (antithrombin alfa - unii:awv6i5l6h2) - antithrombin alfa 1750 [iu] in 10 ml - atryn® is a recombinant antithrombin indicated for the prevention of peri-operative and peri-partum thromboembolic events in hereditary antithrombin deficient patients1 . it is not indicated for treatment of thromboembolic events in hereditary antithrombin deficient patients. atryn is contraindicated in patients with known hypersensitivity to goat and goat milk proteins. pregnancy category c: in rats, a dose of 210 mg/kg/day atryn (5-6 times the human dose for pregnant women) administered during most of the pregnancy and entire lactation showed a slight but statistically significant increase in pup mortality in day one through day four when compared to concurrent control (90% compared to 94% viability index for 210 mg/kg/day versus control). this slight statistical difference does not reflect a true treatment-related effect. this same dose was shown to be safe in a second rat study when administered around parturition and during lactation where the no adverse effect level for dam and pups was 210 mg/kg/day

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

gtc biotherapeutics, inc. - antithrombin alfa (unii: awv6i5l6h2) (antithrombin alfa - unii:awv6i5l6h2) - antithrombin alfa 1750 [iu] - atryn® is a recombinant antithrombin indicated for the prevention of peri-operative and peri-partum thromboembolic events in hereditary antithrombin deficient patients1 . it is not indicated for treatment of thromboembolic events in hereditary antithrombin deficient patients. atryn is contraindicated in patients with known hypersensitivity to goat and goat milk proteins. pregnancy category c: in rats, a dose of 210 mg/kg/day atryn (5-6 times the human dose for pregnant women) administered during most of the pregnancy and entire lactation showed a slight but statistically significant increase in pup mortality in day one through day four when compared to concurrent control (90% compared to 94% viability index for 210 mg/kg/day versus control). this slight statistical difference does not reflect a true treatment-related effect. this same dose was shown to be safe in a second rat study when administered around parturition and during lactation where the no adverse effect level for dam and pups was 210 mg/kg/day

European Union - English - EMA (European Medicines Agency)

laboratoire francais du fractionnement et des biotechnologies - antithrombin alfa - antithrombin iii deficiency - antithrombotic agents - atryn is indicated for the prophylaxis of venous thromboembolism in surgery of patients with congenital antithrombin deficiency. atryn is normally given in association with heparin or low molecular weight heparin.

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

revo biologics, inc. - antithrombin alfa (unii: awv6i5l6h2) (antithrombin alfa - unii:awv6i5l6h2) - antithrombin alfa 525 [iu] in 1 ml - atryn® is a recombinant antithrombin indicated for the prevention of peri-operative and peri-partum thromboembolic events in hereditary antithrombin deficient patients1 . it is not indicated for treatment of thromboembolic events in hereditary antithrombin deficient patients. atryn is contraindicated in patients with known hypersensitivity to goat and goat milk proteins. risk summary atryn is indicated for the treatment of pregnant women during the peri-partum period. pregnant patients who need a surgical procedure other than cesarean section are to be treated according to the dosing formula for pregnant patients. in rats, a dose of 210 mg/kg/day atryn (5-6 times the human dose for pregnant women) administered during most of the pregnancy and entire lactation showed a slight but statistically significant increase in pup mortality in day one through day four when compared to concurrent control (90% compared to 94% viability index for 210 mg/kg/day versus control). this slight statistical difference does no

Malta - English - Medicines Authority

baxalta innovations gmbh industriestrasse 67, 1221, vienna, austria - antithrombin iii - powder and solvent for solution for infusion or injection - antithrombin iii 50 iu - antithrombotic agents

Malta - English - Medicines Authority

baxalta innovations gmbh industriestrasse 67, 1221, vienna, austria - antithrombin iii - powder and solvent for solution for infusion or injection - antithrombin iii 50 iu/ml - antithrombotic agents

Canada - English - Health Canada

takeda canada inc - antithrombin iii (human) - kit - 1100unit - antithrombin iii (human) 1100unit - direct thrombin inhibitors

Canada - English - Health Canada

takeda canada inc - antithrombin iii (human) - kit - 550unit - antithrombin iii (human) 550unit - direct thrombin inhibitors

Canada - English - Health Canada

baxter ag - antithrombin iii (human); water - powder for solution - 1650unit; 30ml - antithrombin iii (human) 1650unit; water 30ml - direct thrombin inhibitors

Malta - English - Medicines Authority

baxter healthcare limited - antithrombin iii 50 iu/ml - powder and solvent for solution for infusion or injection