Austraalia - inglise - Department of Health (Therapeutic Goods Administration)

csl behring australia pty ltd - von willebrand factor, quantity: 1200 iu; factor viii, quantity: 500 iu - injection, powder for - excipient ingredients: sodium citrate dihydrate; trometamol; calcium chloride dihydrate; albumin; sucrose; sodium chloride - von willebrand disease (vwd) - treatment of haemorrhage or prevention and treatment of surgical bleeding in patients with vwd, when desmopressin (ddavp) treatment alone is ineffective or contraindicated. haemophilia a (congenital fviii deficiency) - prophylaxis and treatment of bleeding in patients with haemophilia a.

Austraalia - inglise - Department of Health (Therapeutic Goods Administration)

csl behring australia pty ltd - von willebrand factor, quantity: 600 iu; factor viii, quantity: 250 iu - injection, powder for - excipient ingredients: calcium chloride dihydrate; sodium chloride; trometamol; sucrose; albumin; sodium citrate dihydrate - von willebrand disease (vwd) - treatment of haemorrhage or prevention and treatment of surgical bleeding in patients with vwd, when desmopressin (ddavp) treatment alone is ineffective or contraindicated. haemophilia a (congenital fviii deficiency) - prophylaxis and treatment of bleeding in patients with haemophilia a.

Austraalia - inglise - Department of Health (Therapeutic Goods Administration)

octapharma australia pty ltd - von willebrand factor, quantity: 400 iu; factor viii, quantity: 7.5 mg; factor viii, quantity: 450 iu - injection, powder for - excipient ingredients: tributyl phosphate; sucrose; sodium citrate dihydrate; sodium chloride; calcium chloride dihydrate; octoxinol 9; glycine - 1. von willebrand disease (vwd): treatment of bleeding episodes including surgical bleeding in patients with von willebrand's disease when desmorpressin treatment is effective or contraindicated. 2. haemophilia a: treatment and prophylaxis of bleeding including surgical bleeding in patients with haemophilia a (congenital fviii deficiency). there are insifficient data to recommend the use of wilate in children less than 12 years of age.

Iirimaa - inglise - 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.

Austraalia - inglise - Department of Health (Therapeutic Goods Administration)

csl behring australia pty ltd - factor ix, quantity: 1000 iu - injection, powder for - excipient ingredients: phosphate; plasma proteins; antithrombin iii; heparin sodium; sodium; citrate; chloride - 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 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.

Austraalia - inglise - Department of Health (Therapeutic Goods Administration)

csl behring australia pty ltd - factor ix, quantity: 500 iu - injection, powder for - excipient ingredients: citrate; heparin sodium; antithrombin iii; sodium; chloride; plasma proteins; phosphate - 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 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.

Belgia - inglise - AFMPS (Agence Fédérale des Médicaments et des Produits de Santé)

csl behring gmbh - human factor von willebrand 1200 iu; human coagulation factor viii 500 iu - powder and solvent for solution for injection/infusion - 1200 iu - 500 iu - human coagulation factor viii 500 iu; factor von willebrand 1200 iu - von willebrand factor and coagulation factor viii in combination

Belgia - inglise - AFMPS (Agence Fédérale des Médicaments et des Produits de Santé)

csl behring gmbh - human factor von willebrand 2400 iu; human coagulation factor viii 1000 iu - powder and solvent for solution for injection/infusion - 2400 iu - 1000 iu - human coagulation factor viii 1000 iu; factor von willebrand 2400 iu - von willebrand factor and coagulation factor viii in combination

Belgia - inglise - AFMPS (Agence Fédérale des Médicaments et des Produits de Santé)

octapharma benelux sa-nv - human factor von willebrand 500 iu; human coagulation factor viii 500 iu - powder and solvent for solution for injection - factor von willebrand 100 iu/ml; human coagulation factor viii 100 iu/ml - von willebrand factor and coagulation factor viii in combination

Euroopa Liit - inglise - EMA (European Medicines Agency)

bpl bioproducts laboratory gmbh - human coagulation factor x - factor x deficiency - vitamin k and other hemostatics, antihemorrhagics, coagulation factor x - coagadex is indicated for the treatment and prophylaxis of bleeding episodes and for perioperative management in patients with hereditary factor x deficiency. coagadex is indicated in all age groups.