New Zealand - English - Medsafe (Medicines Safety Authority)

csl behring (nz) ltd - albutrepenonacog alfa 500 [iu];  ;   - powder for injection - 500 iu - active: albutrepenonacog alfa 500 [iu]     excipient: hydrochloric acid mannitol polysorbate 80 sodium citrate dihydrate sucrose water for injection - idelvion is indicated in all patients with haemophilia b for: - routine prophylaxis to prevent or reduce the frequency of bleeding episodes - control and prevention of bleeding episodes - control and prevention of bleeding in the perioperative setting.

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: 1000 iu - injection, powder for - excipient ingredients: polysorbate 80; histidine; sucrose; 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: 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)

pfizer australia pty ltd - factor ix (recombinant); nonacog alfa -

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

csl behring australia pty ltd - factor ix, quantity: 3500 iu - solution - excipient ingredients: - idelvion is indicated in all patients with haemophilia b for:,? routine prophylaxis to prevent or reduce the frequency of bleeding episodes,? control and prevention of bleeding episodes,? control and prevention of bleeding in the perioperative setting.

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

csl behring australia pty ltd - factor ix, quantity: 2000 iu - solution - excipient ingredients: - idelvion is indicated in all patients with haemophilia b for:,? routine prophylaxis to prevent or reduce the frequency of bleeding episodes,? control and prevention of bleeding episodes,? control and prevention of bleeding in the perioperative setting.

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

csl behring australia pty ltd - factor ix, quantity: 1000 iu - solution - excipient ingredients: - idelvion is indicated in all patients with haemophilia b for:,? routine prophylaxis to prevent or reduce the frequency of bleeding episodes,? control and prevention of bleeding episodes,? control and prevention of bleeding in the perioperative setting.

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

csl behring australia pty ltd - factor ix, quantity: 500 iu - solution - excipient ingredients: - idelvion is indicated in all patients with haemophilia b for:,? routine prophylaxis to prevent or reduce the frequency of bleeding episodes,? control and prevention of bleeding episodes,? control and prevention of bleeding in the perioperative setting.