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

Singapore - English - HSA (Health Sciences Authority)

sysmex asia pacific pte. ltd. - hematology - berichrom antithrombin iii (a) is an in vitro diagnostic reagent for the quantitative, who-standardized determination of antithrombin as aid to diagnosis and monitoring of congenital or acquired antithrombin deficiencies in patients at risk for or suspected to have antithrombin deficiency in human sodium citrated plasma by means of automated, chromogenic methods. in addition berichrom antithrombin iii (a)assay can be used for monitoring antithrombin substitution therapy.

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

South Africa - English - South African Health Products Regulatory Authority (SAHPRA)

adcock ingram critical care (pty) ltd - injection - see ingredients - each 1 ml solution contains antithrombin iii 50 iu

South Africa - English - South African Health Products Regulatory Authority (SAHPRA)

adcock ingram critical care (pty) ltd - injection - see ingredients - each 1 ml solution contains antithrombin iii 50 ui

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

csl behring gmbh - factor xiii concentrate (human) (unii: f7r0fbc1xd) (factor xiii concentrate (human) - unii:f7r0fbc1xd) - factor xiii concentrate (human) 1600 [iu] in 20 ml - corifact is a factor xiii concentrate indicated for routine prophylactic treatment and peri-operative management of surgical bleeding in adult and pediatric patients with congenital fxiii deficiency. corifact is contraindicated in patients with known anaphylactic or severe systemic reactions to human plasma-derived products [see description (11)] . risk summary animal reproduction studies have not been conducted with corifact. 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. clinical considerations: disease-associated maternal and/or embryo/fetal risk miscarriage is a known complication of congenital fxiii deficiency with a rate of 91% observed in 136 pregnancies without routine fxiii supplementation prophylaxis and 11% in 45 pregnancies with routine fxiii prophylaxis1 . risk summary there is no information available on the presence of corifact in human milk, the effects on the breastfed

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

csl limited - antithrombin iii -

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

csl behring australia pty ltd - factor ix, quantity: 1000 iu - injection, powder for - excipient ingredients: phosphate; plasma proteins; antithrombin iii; heparin sodium; sodium; citrate; chloride - monofix-vf is indicated for the treatment of haemorrhages, for use in surgery, and as prophylaxis in patients with haemophilia b. monofix-vf is not indicated for the treatment factor ii, vii or x deficiencies because it does not contain therapeutic levels of these coagulation factors. monofix-vf is not indicated for the treatment of haemophilia a patients with factor viii inhibitors.

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

csl behring australia pty ltd - factor ix, quantity: 500 iu - injection, powder for - excipient ingredients: citrate; heparin sodium; antithrombin iii; sodium; chloride; plasma proteins; phosphate - monofix-vf is indicated for the treatment of haemorrhages, for use in surgery, and as prophylaxis in patients with haemophilia b. monofix-vf is not indicated for the treatment factor ii, vii or x deficiencies because it does not contain therapeutic levels of these coagulation factors. monofix-vf is not indicated for the treatment of haemophilia a patients with factor viii inhibitors.