Australia - engelsk - 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).

Malta - engelsk - Medicines Authority

bio products laboratory limited - factor ix, human - powder for solution for injection - factor ix, human 50 international unit(s)/millilitre - antihemorrhagics

USA - engelsk - NLM (National Library of Medicine)

biogen inc. - (1-743)-(1638-2332)-blood-coagulation factor viii (synthetic human) fusion protein with immunoglobulin g1 (synthetic human fc domain fragment), (1444-6'),(1447-9')-bis(disulfide) with immunoglobulin g1 (synthetic human fc domain fragment) (unii: 7pcm518ylr) ((1-743)-(1638-2332)-blood-coagulation factor viii (synthetic human) fusion protein with immunoglobulin g1 (synthetic human fc domain fragment), (1444-6'),(1447-9')-bis(disulfide) with immunoglobulin g1 (synthetic human fc domain fragment) - unii:7pcm51 - (1-743)-(1638-2332)-blood-coagulation factor viii (synthetic human) fusion protein with immunoglobulin g1 (synthetic human fc domain fragment), (1444-6'),(1447-9')-bis(disulfide) with immunoglobulin g1 (synthetic human fc domain fragment) 250 [iu] in 3 ml - eloctate, antihemophilic factor (recombinant), fc fusion protein, is a recombinant dna derived, antihemophilic factor indicated in adults and children with hemophilia a (congenital factor viii deficiency) for: - on-demand treatment and control of bleeding episodes, - perioperative management of bleeding, - routine prophylaxis to reduce the frequency of bleeding episodes. limitation of use eloctate is not indicated for the treatment of von willebrand disease. eloctate is contraindicated in patients who have had life-threatening hypersensitivity reactions to eloctate or other constituents of the product. [see description (11 )] risk summary there are no studies of eloctate use in pregnant women to inform a drug-associated risk. the background risk of major birth defects and miscarriage in the indicated population is unknown; however, the background risk of major birth defects in the u.s. general population is 2-4% and of miscarriage is 15-20% of clinically recognized pregnancies. animal reproductive and devel

Israel - engelsk - Ministry of Health

kamada ltd, israel - factor ix - powder for solution for injection - factor ix 50 iu/ml - coagulation factor ix, ii, vii and x in combination - treatment and prophylaxis of bleeding in patients with haemophilia b ( congenital factor ix deficiency).

New Zealand - engelsk - Medsafe (Medicines Safety Authority)

csl behring (nz) ltd - factor ix 1000 [iu] (100iu/ml when reconstituted with 10ml water for injection) - injection with diluent - 1000 iu - active: factor ix 1000 [iu] (100iu/ml when reconstituted with 10ml water for injection) excipient: antithrombin iii chloride citric acid monohydrate heparin phosphorus plasma protein fraction sodium water for injection - 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 of 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.

New Zealand - engelsk - Medsafe (Medicines Safety Authority)

csl behring (nz) ltd - factor ix 500 [iu] (50 iu/ml when reconstituted with 10 ml water for injections) - injection with diluent - 50 iu/ml - active: factor ix 500 [iu] (50 iu/ml when reconstituted with 10 ml water for injections) excipient: antithrombin iii chloride citric acid monohydrate heparin phosphorus plasma protein fraction sodium water for injection - 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 of 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.

Israel - engelsk - Ministry of Health

medici medical ltd, israel - factor viii (human) - powder for solution for injection - factor viii (human) 250 iu - coagulation factor viii - coagulation factor viii - 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.

Israel - engelsk - Ministry of Health

medici medical ltd, israel - factor viii (human) - powder for solution for injection - factor viii (human) 500 iu - coagulation factor viii - coagulation factor viii - 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.

Israel - engelsk - Ministry of Health

medici medical ltd, israel - factor viii (human) - powder for solution for injection - factor viii (human) 1000 iu - coagulation factor viii - coagulation factor viii - 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.

Den europeiske union - engelsk - EMA (European Medicines Agency)

csl behring gmbh - albutrepenonacog alfa - hemophilia b - antihemorrhagics - treatment and prophylaxis of bleeding in patients with haemophilia b (congenital factor ix deficiency).