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

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

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

grifols usa, llc - antithrombin iii human (unii: t0lto7l82x) (antithrombin iii human - unii:t0lto7l82x) - antithrombin iii human 50 [iu] in 1 ml - thrombate iii is a human antithrombin (at) indicated in patients with hereditary antithrombin deficiency for: - treatment and prevention of thromboembolism - prevention of peri-operative and peri-partum thromboembolism none. risk summary there are no data with thrombate iii use in pregnant women to inform a drug-associated risk. however, there are clinical considerations [see clinical considerations] . it is not known whether thrombate iii can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. thrombate iii 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 2-4% and 15-20%, respectively. reproduction studies have been performed in rats and rabbits at doses up to four times the human dose and have revealed no evidence of impaired fertility or harm to the fetus due to thrombate iii. clinical considerations labor or delivery suspend heparin (or low molecular weight heparin) administration and continue thrombate iii administration during labor and delivery. risk summary there is no information regarding the presence of thrombate iii in human milk, the effects on the breastfed infant, or the effects on milk production. the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for thrombate iii and any potential adverse effects on the breastfed infant from thrombate iii or from the underlying maternal condition. safety and effectiveness in the pediatric population have not been established. the safety and effectiveness in the geriatric population have not been established.

Namibia - English - Namibia Medicines Regulatory Council

adcock ingram critical care (pty) ltd - antithrombin iii concentrate - injection - antithrombin iii concentrate lyophilized powder in glass vials with solvent 50 iu/ml