Australia - English - Department of Health (Therapeutic Goods Administration)

pfizer australia pty ltd - nonacog alfa, quantity: 2000 iu - injection, powder for - excipient ingredients: glycine; sucrose; polysorbate 80; histidine - benefix is indicated for the control and prevention of haemorrhagic episodes in patients with haemophilia b (congenital factor ix deficiency or christmas disease), including control and prevention of bleeding in surgical settings. benefix is not indicated for the treatment of other factor deficiencies (e.g. factors ii, vii and x), nor for the treatment of haemophilia a patients with inhibitors to factor viii, nor for the reversal of coumarin induced anti-coagulation, nor for the treatment of bleeding due to low levels of liver-dependent coagulation factors.

Australia - English - Department of Health (Therapeutic Goods Administration)

pfizer australia pty ltd - nonacog alfa, quantity: 500 iu - injection, powder for - excipient ingredients: sucrose; histidine; polysorbate 80; glycine - benefix is indicated for the control and prevention of haemorrhagic episodes in patients with haemophilia b (congenital factor ix deficiency or christmas disease), including control and prevention of bleeding in surgical settings. benefix is not indicated for the treatment of other factor deficiencies (e.g. factors ii, vii and x), nor for the treatment of haemophilia a patients with inhibitors to factor viii, nor for the reversal of coumarin induced anti-coagulation, nor for the treatment of bleeding due to low levels of liver-dependent coagulation factors.

Australia - English - Department of Health (Therapeutic Goods Administration)

pfizer australia pty ltd - nonacog alfa, quantity: 250 iu - injection, powder for - excipient ingredients: polysorbate 80; histidine; glycine; sucrose - benefix is indicated for the control and prevention of haemorrhagic episodes in patients with haemophilia b (congenital factor ix deficiency or christmas disease), including control and prevention of bleeding in surgical settings. benefix is not indicated for the treatment of other factor deficiencies (e.g. factors ii, vii and x), nor for the treatment of haemophilia a patients with inhibitors to factor viii, nor for the reversal of coumarin induced anti-coagulation, nor for the treatment of bleeding due to low levels of liver-dependent coagulation factors.

Australia - English - Department of Health (Therapeutic Goods Administration)

octapharma australia pty ltd - von willebrand factor, quantity: 800 iu; factor viii, quantity: 900 iu; factor viii, quantity: 15 mg - injection, powder for - excipient ingredients: calcium chloride dihydrate; glycine; sodium chloride; sucrose; octoxinol 9; tributyl phosphate; sodium citrate dihydrate - 1. von willebrand disease (vwd): treatment of bleeding episodes including surgical bleeding in patients with von willebrand's disease when desmopressin treatment is ineffective or contraindicated. 2. haemophilia a: treatment and prophylaxis of bleeding including surgical bleeding in patients with haemophilia a (congenital fviii deficiency). there are insuffcient data to recommend the use of wilate in children less than 12 years of age.

Australia - English - 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.

Australia - English - 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.

Australia - English - 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.

Australia - English - Department of Health (Therapeutic Goods Administration)

csl behring australia pty ltd - factor viii,von willebrand factor -

Malta - English - Medicines Authority

takeda manufacturing austria ag industriestrasse 67, a-1221, vienna, austria - factor viii, human, von willebrand - powder and solvent for solution for injection - factor viii, human 250 iu von willebrand factor, human 190 iu - antihemorrhagics

Malta - English - Medicines Authority

takeda manufacturing austria ag industriestrasse 67, a-1221, vienna, austria - factor viii, human, von willebrand - powder and solvent for solution for injection - factor viii, human 500 iu von willebrand factor, human 375 iu - antihemorrhagics