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)

ksj pharmatech - human thrombin, quantity: 2 iu/cm2; fibrinogen, quantity: 5.5 mg/cm2 - sponge, medicated - excipient ingredients: sodium chloride; riboflavin; collagen; sodium citrate dihydrate; arginine hydrochloride; albumin - ? tachosil? is indicated as an adjunct to haemostasis during surgery when control of bleeding by standard surgical techniques is ineffective or impractical.

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

csl behring australia pty ltd - factor ix, quantity: 500 iu; factor x, quantity: 500 iu; factor ii, quantity: 500 iu - injection, diluent for - excipient ingredients: water for injections - prothrombinex-vf is indicated in - treatment and perioperative prophylaxis of bleeding in acquired deficiency of prothrombin complex factors, such as deficiency caused by treatment with vitamin k antagonists, or in case of overdose of vitamin k antagonists, when rapid correction of the deficiency is required. - treatment and prophylaxis of bleeding in patients with single or multiple congenital deficiency of factor ix, ii or x when purified specific coagulation factor product is not available (see precautions).

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

ethicon, inc - human thrombin (unii: 6k15abl77g) (human thrombin - unii:6k15abl77g) - human thrombin 2000 [iu] in 2 ml - evithrom® thrombin, topical (human), is indicated as an aid to hemostasis whenever oozing blood and minor bleeding from capillaries and small venules is accessible and control of bleeding by standard surgical techniques (such as suture, ligature or cautery) is ineffective or impractical. evithrom® thrombin, topical (human), may be used in conjunction with an absorbable gelatin sponge, usp. - do not use in individuals known to have an anaphylactic or severe systemic reaction to evithrom® or to human blood products. - do not use for the treatment of severe or brisk arterial bleeding. risk summary there are no data with evithrom® use in pregnant women to inform a drug-associated risk. animal reproduction studies have not been conducted with evithrom® . it is not known whether evithrom® can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. evithrom® should be given to a pregnant woman only if clearly needed. in the u.s. general population, the estimated background

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

johnson & johnson medical pty ltd - human thrombin, quantity: 800 iu - solution - excipient ingredients: water for injections; mannitol; sodium acetate; albumin; calcium chloride dihydrate; tributyl phosphate; octoxinol 9 - as supportive treatment in surgery where standard surgical techniques are insufficient, for improvement of haemostasis. as suture support for haemostasis in large vessel vascular surgery. for suture line sealing in dura mater closure.

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

johnson & johnson medical pty ltd - human thrombin, quantity: 4000 iu - solution - excipient ingredients: mannitol; calcium chloride dihydrate; water for injections; sodium acetate; albumin; tributyl phosphate; octoxinol 9 - ? as supportive treatment in surgery where standard surgical techniques are insufficient, for improvement of haemostasis. ? as suture support for haemostasis in large vessel vascular surgery. ? for suture line sealing in dura mater closure.

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

johnson & johnson medical pty ltd - human thrombin, quantity: 1600 iu - solution - excipient ingredients: water for injections; mannitol; sodium acetate; albumin; calcium chloride dihydrate; tributyl phosphate; octoxinol 9 - ? as supportive treatment in surgery where standard surgical techniques are insufficient, for improvement of haemostasis. ? as suture support for haemostasis in large vessel vascular surgery. ? for suture line sealing in dura mater closure.

Ireland - English - HPRA (Health Products Regulatory Authority)

baxter holding b.v. - human fibrinogen; aprotinin; human factor xiii; human thrombin; calcium chloride - solution for sealant - . - local hemostatics; tissue adhesives

European Union - English - myHealthbox

takeda austria gmbh - human fibrinogen / human thrombin - sealant matrix - 5.5 mg human fibrinogen and 2.0 iu human thrombin per cm² - hemostasis, surgical - local haemostatics - indicated in adults for supportive treatment in surgery for improvement of haemostasis, to promote tissue sealing, and for suture support in vascular surgery where standard techniques are insufficient

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

baxter healthcare corporation - fibrinogen human (unii: n94833051k) (fibrinogen human - unii:n94833051k) - fibrinogen human 90 mg in 1 ml