Israel - English - Ministry of Health

medici medical ltd, israel - factor viii (human) - powder for solution for injection - factor viii (human) 1500 iu/dose - factor viii inhibitor bypassing activity - factor viii inhibitor bypassing activity - is indicated for the prevention and control of bleeding in patients with moderate or severe factor viii deficiency due to classical hemophilia a . fanhdi is not effective in controlling the bleeding of patients with von willebrond's disease.

Ireland - English - HPRA (Health Products Regulatory Authority)

baxalta innovations gmbh - human coagulation factor ii; human coagulation factor vii; human coagulation factor ix; human coagulation factor x; protein c - powder and solvent for solution for injection - 600 international unit(s) - blood coagulation factors; coagulation factor ix, ii, vii and x in combination - antihemorrhagics, coagulation factors ix, ii, vii and x in combination - treatment of bleeding and perioperative prophylaxis of bleeding in acquired deficiency of prothrombin complex coagulation factors, such as a deficiency caused by treatment with vitamin k antagonists or in case of overdose with vitamin k antagonists, when rapid correction of the deficiency is required. treatment and perioperative prophylaxis of hemorrhages in congenital deficiency of vitamin k-dependent coagulation factors, when purified specific coagulation factor concentrate is not available.

European Union - English - EMA (European Medicines Agency)

csl behring gmbh - human coagulation factor viii, human von willebrand factor - hemophilia a; von willebrand diseases - blood coagulation factors, von willebrand factor and coagulation factor viii in combination, antihemorrhagics - von willebrand disease (vwd)prophylaxis and treatment of haemorrhage or surgical bleeding in patients with vwd, when desmopressin (ddavp) treatment alone is ineffective or contraindicated.haemophilia a (congenital factor-viii deficiency)prophylaxis and treatment of bleeding in patients with haemophilia a.

Ireland - English - HPRA (Health Products Regulatory Authority)

octapharma (ip) sprl - human coagulation factor ii; human coagulation factor vii; human coagulation factor ix; human coagulation factor x; protein c; protein s - powder and solvent for solution for infusion - 1000 international unit(s) - blood coagulation factors; coagulation factor ix, ii, vii and x in combination

Canada - English - Health Canada

baxter ag - total protein; factor xiii; fibrinogen (human); plasmafibronectin (cig); plasminogen; aprotinin (bovine); thrombin (human); thrombin (human); calcium chloride - kit - 130mg; 50unit; 110mg; 9mg; 120mcg; 3000kiu; 4unit; 500unit; 40mcmol - total protein 130mg; factor xiii 50unit; fibrinogen (human) 110mg; plasmafibronectin (cig) 9mg; plasminogen 120mcg; aprotinin (bovine) 3000kiu; thrombin (human) 4unit; thrombin (human) 500unit; calcium chloride 40mcmol - hemostatics

Canada - English - Health Canada

baxter ag - total protein; factor xiii; fibrinogen (human); plasmafibronectin (cig); plasminogen; aprotinin (bovine); thrombin (human); thrombin (human); calcium chloride - kit - 650mg; 250unit; 550mg; 45mg; 600mcg; 15000kiu; 20unit; 2500unit; 200mcmol - total protein 650mg; factor xiii 250unit; fibrinogen (human) 550mg; plasmafibronectin (cig) 45mg; plasminogen 600mcg; aprotinin (bovine) 15000kiu; thrombin (human) 20unit; thrombin (human) 2500unit; calcium chloride 200mcmol - hemostatics

Singapore - English - HSA (Health Sciences Authority)

johnson & johnson international (singapore) pte ltd - clottable protein (human fibrinogen); human thrombin - solution - 50-90 mg/ml - clottable protein (human fibrinogen) 50-90 mg/ml; human thrombin 800-1200 iu/ml

Malta - English - Medicines Authority

baxter holding b.v. kobaltweg 49, 3542ce utrecht, netherlands - calcium chloride, aprotinin, fibrinogen, human, thrombin - solution for sealant - calcium chloride 40 µmole/ml aprotinin 3000 kiu/ml fibrinogen, human 91 mg/ml thrombin, human 500 iu/mg - antihemorrhagics

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

grifols usa, llc - human coagulation factor viii/von willebrand factor complex (unii: 5t6b772r4q) (human coagulation factor viii/von willebrand factor complex - unii:5t6b772r4q) - human coagulation factor viii/von willebrand factor complex 250 [iu] in 5 ml - alphanate, (antihemophilic factor/von willebrand factor complex [human]), is indicated for: - control and prevention of bleeding episodes and perioperative management in adult and pediatric patients with factor viii (fviii) deficiency due to hemophilia a. - surgical and/or invasive procedures in adult and pediatric patients with von willebrand disease (vwd) in whom desmopressin (ddavp) is either ineffective or contraindicated.  it is not indicated for patients with severe vwd (type 3) undergoing major surgery. alphanate is contraindicated in patients who have manifested life-threatening immediate hypersensitivity reactions, including anaphylaxis, to the product or its components [see adverse reactions (6) ]. pregnancy category c.  animal reproduction studies have not been conducted with alphanate.  it is also not known whether alphanate can cause fetal harm when administered to a pregnant woman or affect reproductive capacity.  alphanate should be given to a pregnant woman only if clearly needed.   no human o

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

novo nordisk - coagulation factor viia recombinant human (unii: ac71r787ov) (coagulation factor viia recombinant human - unii:ac71r787ov) - coagulation factor viia recombinant human 1 mg in 1 ml - novoseven rt, coagulation factor viia (recombinant), is indicated for: none known. risk summary there are no adequate and well-controlled studies using novoseven rt in pregnant women to determine whether there is a drug-associated risk. treatment of rats and rabbits with novoseven in reproduction studies has been associated with mortality at doses up to 6 mg per kg body weight and 5 mg per kg body weight respectively. at 6 mg per kg body weight in rats, the abortion rate was 0 out of 25 litters; in rabbits at 5 mg per kg body weight, the abortion rate was 2 out of 25 litters. twenty-three out of 25 female rats given 6 mg per kg body weight of novoseven gave birth successfully, however, two of the 23 litters died during the early period of lactation. no evidence of teratogenicity was observed after dosing with novoseven. in the u.s. general population, the estimated background risk of major birth defect and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. risk summary there is