Israel - English - Ministry of Health

kamada ltd, israel - factor ix - powder for solution for injection - factor ix 1000 iu/vial - coagulation factor ix, ii, vii and x in combination - coagulation factor ix, ii, vii and x in combination - treatment and prophylaxis of bleeding in patients with haemophilia b ( congenital factor ix deficiency).

United States - English - NLM (National Library of Medicine)

csl behring llc - coagulation factor ix human (unii: 6u90y1795t) (coagulation factor ix human - unii:6u90y1795t) - coagulation factor ix human 500 [iu] in 5 ml - mononine is indicated for the prevention and control of bleeding in factor ix deficiency, also known as hemophilia b or christmas disease. mononine is not indicated in the treatment or prophylaxis of hemophilia a patients with inhibitors to factor viii. mononine contains non-detectable levels of factors ii, vii and x (<0.0025 iu per factor ix unit using standard coagulation assays) and is, therefore, not indicated for replacement therapy of these clotting factors. mononine is also not indicated in the treatment or reversal of coumarin-induced anticoagulation or in a hemorrhagic state caused by hepatitis-induced lack of production of liver dependent coagulation factors. known hypersensitivity to mouse protein is a contraindication to mononine.

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

csl behring australia pty ltd - factor ix, quantity: 500 iu - injection, diluent for - excipient ingredients: water for injections - monofix-vf is indicated for the treatment of haemorrhages, for use in minor surgery, and as a prophylaxis in patients with haemophilia b. it has not been evaluated in major surgery. monofix-vf is not indicated for the treatment of factor ii, vii or x deficiencies because it does not contain therapeutic levels fo these coagulation factors. monofix-vf is not indicated for the treatment of haemophilia a patients with factor viii inhibitors. indications as at 14 may 1999: 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 is 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.

Malta - English - Medicines Authority

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

United States - English - NLM (National Library of Medicine)

novo nordisk - coagulation factor ix recombinant human (unii: 382l14738l) (coagulation factor ix recombinant human - unii:382l14738l) - coagulation factor ix recombinant human 500 [iu] in 1 ml - rebinyn, coagulation factor ix (recombinant), glycopegylated, is a recombinant dna-derived coagulation factor ix concentrate indicated for use in adults and children with hemophilia b (congenital factor ix deficiency) for: limitations of use : rebinyn is not indicated for immune tolerance induction in patients with hemophilia b. rebinyn is contraindicated in patients who have known hypersensitivity to rebinyn or its components (including hamster proteins) [see warnings and precautions (5.1) and description (11) ] risk summary there are no data with rebinyn use in pregnant women to determine whether there is a drug-associated risk. animal reproduction studies have not been conducted with rebinyn. it is unknown whether rebinyn can cause fetal harm when administered to a pregnant woman or can affect fertility. in the u.s. general population, the estimated background risk of major birth defect and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. risk summary there is no informati

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

csl behring australia pty ltd - factor ix, quantity: 50 iu/ml - injection, diluent for - excipient ingredients: water for injections - "tbsf" high purity factor ix concentrate is indicated for the treatment of haemorrhages, for use in surgery, and as prophylaxis in patients with haemophilia b. "tbsf" high purity factor ix concentrate is not indicated for the treatment of factor ii, vii or x deficiencies because it does not contain therapeutic levels of these coagulation factors. "tbsf" high purity factor ix concentrate is not indicated for the treatment of haemophilia a patients with factor viii inhibitors.

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.