Malta - English - Medicines Authority

baxter healthcare limited - human fibrinogen; aprotinin; human thrombin; calcium chloride dihydrate - solution for sealant - human fibrinogen 455 mg; aprotinin 1500 kiu/ml; human thrombin 2500 iu; calcium chloride dihydrate 200 mmol - antihemorrhagics

Malta - English - Medicines Authority

baxter healthcare limited - human fibrinogen; aprotinin; human thrombin; calcium chloride dihydrate - solution for sealant - human fibrinogen 182 mg; aprotinin 6000 kiu/ml; human thrombin 1000 iu; calcium chloride dihydrate 80 µmol - antihemorrhagics

Malta - English - Medicines Authority

baxter holding b.v. kobaltweg 49, 3542ce utrecht, netherlands - human fibrinogen, aprotinin, human thrombin, calcium chloride, dihydrate - solution for sealant - human fibrinogen 182 mg aprotinin 6000 kiu/ml human thrombin 1000 iu calcium chloride dihydrate 80 µmol - antihemorrhagics

Malta - English - Medicines Authority

baxter holding b.v. kobaltweg 49, 3542ce utrecht, netherlands - human fibrinogen, aprotinin, human thrombin, calcium chloride, dihydrate - solution for sealant - human fibrinogen 455 mg aprotinin 1500 kiu/ml human thrombin 2500 iu calcium chloride dihydrate 200 mmol - antihemorrhagics

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

Ireland - English - HPRA (Health Products Regulatory Authority)

csl behring gmbh - human fibrinogen - powder for solution for injection/infusion - 1 gram(s) - fibrinogen; fibrinogen, human

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

octapharma usa inc - fibrinogen human (unii: n94833051k) (fibrinogen human - unii:n94833051k) - fibryga is a human fibrinogen concentrate indicated for the treatment of acute bleeding episodes in adults and children with congenital fibrinogen deficiency, including afibrinogenemia and hypofibrinogenemia. fibryga is not indicated for dysfibrinogenemia. fibryga is contraindicated in individuals who have manifested severe immediate hypersensitivity reactions, including anaphylaxis, to fibryga or its components (sodium citrate dihydrate; glycine; l-arginine hydrochloride). risk summary there are no data with fibryga use in pregnant women to determine whether there is a drug-associated risk. animal reproduction studies have not been conducted with fibryga. it is not known whether fibryga can cause fetal harm when administered to a pregnant woman or can affect fertility. 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. risk summary there is no information regarding the presence of fibryga

Ireland - English - HPRA (Health Products Regulatory Authority)

octapharma (ip) sprl - human fibrinogen - powder and solvent for solution for injection/infusion - 1 gram(s) - fibrinogen, human

Malta - English - Medicines Authority

csl behring gmbh emil-von-behring-strasse 76, 35041 marburg, germany - human fibrinogen - powder for solution for injection/infusion - human fibrinogen 1 g - antihemorrhagics

Israel - English - Ministry of Health

omrix biopharmaceuticals - human fibrinogen; human thrombin - solutions for sealant - human thrombin 500 iu / 1 ml; human fibrinogen 80 mg / 1 ml - human fibrinogen - supportive treatment in adults where standard surgical techniques are insufficient for improvement of haemostasis, and as suture support in vascular surgery