Malta - English - Medicines Authority

octapharma (ip) sprl alle de la recherche 65, 1070 (anderlecht), belgium - human von, willebrand factor, human coagulation, factor viii - powder and solvent for solution for injection - human von willebrand factor 500 iu human coagulation factor viii 500 iu - antihemorrhagics

Malta - English - Medicines Authority

octapharma (ip) sprl alle de la recherche 65, 1070 (anderlecht), belgium - human von, willebrand factor, human coagulation, factor xiii - powder and solvent for solution for injection - human von willebrand factor 1000 iu human coagulation factor viii 1000 iu - antihemorrhagics

Israel - English - Ministry of Health

dover medical & scientific equipment ltd, israel - coagulation factor ii (human); coagulation factor ix (human- rfixfc); coagulation factor vii (human); coagulation factor x (human); protein; protein c; protein s antigen - powder and solvent for solution for infusion - coagulation factor ix (human- rfixfc) 25 iu/ml; coagulation factor ii (human) 14 - 38 iu/ml; coagulation factor vii (human) 9 - 24 iu/ml; coagulation factor x (human) 18 - 30 iu/ml; protein 13 - 41 mg/ml; protein c 13 - 31 iu/ml; protein s antigen 12 - 32 iu/ml - coagulation factor 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 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 of bleeding and perioperative prophylaxis in congenital deficiency of any of the vitamin k dependent coagulation factors when purified specific coagulation factor product is not available.

Malta - English - Medicines Authority

csl behring gmbh emil-von-behring-strasse 76, 35041 marburg, germany - human coagulation, factor viii - powder and solvent for solution for infusion or injection - human coagulation factor viii 250 iu - antihemorrhagics

Malta - English - Medicines Authority

csl behring gmbh emil-von-behring-strasse 76, 35041 marburg, germany - human coagulation, factor viii - powder and solvent for solution for infusion or injection - human coagulation factor viii 500 iu - antihemorrhagics

Malta - English - Medicines Authority

csl behring gmbh emil-von-behring-strasse 76, 35041 marburg, germany - human coagulation, factor viii - powder and solvent for solution for infusion or injection - human coagulation factor viii 1000 iu - antihemorrhagics

Malta - English - Medicines Authority

csl behring gmbh emil-von-behring-strasse 76, 35041 marburg, germany - human coagulation, factor viii - powder and solvent for solution for infusion or injection - human coagulation factor viii 2000 iu - antihemorrhagics

New Zealand - English - 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 - English - Medsafe (Medicines Safety Authority)

csl behring (nz) ltd - factor ix 500 [iu] (human coagulation 100iu/ml when reconstituted with 5ml water for injections) - injection with diluent - 500 iu - active: factor ix 500 [iu] (human coagulation 100iu/ml when reconstituted with 5ml 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.

New Zealand - English - 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.