USA - engelsk - NLM (National Library of Medicine)

bioverativ therapeutics inc. - eftrenonacog alfa (unii: 02e00t2qde) (eftrenonacog alfa - unii:02e00t2qde) - eftrenonacog alfa 500 [iu] in 5 ml - alprolix, coagulation factor ix (recombinant), fc fusion protein, is a recombinant dna derived coagulation factor ix concentrate indicated in adults and children with hemophilia b (congenital factor ix deficiency) for: - on-demand treatment and control of bleeding episodes, - perioperative management of bleeding, - routine prophylaxis to reduce the frequency of bleeding episodes. limitation of use: alprolix is not indicated for induction of immune tolerance in patients with hemophilia b. alprolix is contraindicated in individuals who have a known history of hypersensitivity reactions, including anaphylaxis, to the product or its excipients (sucrose, mannitol, sodium chloride, l-histidine and polysorbate 20). risk summary there are no studies of alprolix use in pregnant women to inform a drug-associated risk. the background risk of major birth defects and miscarriage for the indicated population is unknown; however, the background risk in the u.s. general population of major birth defects is 2%–4% and of misca

Australia - engelsk - 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 - engelsk - 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 - engelsk - 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 - engelsk - 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.

USA - engelsk - 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.

Israel - engelsk - Ministry of Health

pfizer pharmaceuticals israel ltd - coagulation factor ix recombinant-rfix - lyophilized powder for injection - coagulation factor ix recombinant-rfix 250 iu/vial - coagulation factor ix - coagulation factor ix - benefix is indicated for the control and prevention of hemorrhagic episodes in patients with hemophilia b (congenital factor ix deficiency or christmas disease), including control and prevention of bleeding in surgical settings, in previously treated patients (ptp) and previously untreated patients (pup). benefix is not indicated for the treatment of other factor deficiencies (e.g. factors ii,vii, and x)' nor for the treatment of hemophilia a patients with inhibitors to factor viii, nor for the reversal of coumarin-induced anticoagulation, nor for the treatment of bleeding due to low levels of liver-dependent coagulation factors.

Israel - engelsk - Ministry of Health

pfizer pharmaceuticals israel ltd - coagulation factor ix recombinant-rfix - lyophilized powder for injection - coagulation factor ix recombinant-rfix 500 iu/vial - coagulation factor ix - coagulation factor ix - benefix is indicated for the control and prevention of hemorrhagic episodes in patients with hemophilia b (congenital factor ix deficiency or christmas disease), including control and prevention of bleeding in surgical settings, in previously treated patients (ptp) and previously untreated patients (pup).benefix is not indicated for the treatment of other factor deficiencies (e.g. factors ii,vii, and x)' nor for the treatment of hemophilia a patients with inhibitors to factor viii, nor for the reversal of coumarin-induced anticoagulation, nor for the treatment of bleeding due to low levels of liver-dependent coagulation factors.

Israel - engelsk - Ministry of Health

pfizer pharmaceuticals israel ltd - coagulation factor ix recombinant-rfix - lyophilized powder for injection - coagulation factor ix recombinant-rfix 1000 iu/vial - coagulation factor ix - coagulation factor ix - benefix is indicated for the control and prevention of hemorrhagic episodes in patients with hemophilia b (congenital factor ix deficiency or christmas disease), including control and prevention of bleeding in surgical settings, in previously treated patients (ptp) and previously untreated patients (pup). benefix is not indicated for the treatment of other factor deficiencies (e.g. factors ii,vii, and x)' nor for the treatment of hemophilia a patients with inhibitors to factor viii, nor for the reversal of coumarin-induced anticoagulation, nor for the treatment of bleeding due to low levels of liver-dependent coagulation factors.

Israel - engelsk - Ministry of Health

pfizer pharmaceuticals israel ltd - coagulation factor ix recombinant-rfix - lyophilized powder for injection - coagulation factor ix recombinant-rfix 2000 iu - coagulation factor ix - coagulation factor ix - benefix is indicated for the control and prevention of hemorrhagic episodes in patients with hemophilia b (congenital factor ix deficiency or christmas disease), including control and prevention of bleeding in surgical settings, in previously treated patients (ptp) and previously untreated patients (pup). benefix is not indicated for the treatment of other factor deficiencies (e.g. factors ii,vii, and x)' nor for the treatment of hemophilia a patients with inhibitors to factor viii, nor for the reversal of coumarin-induced anticoagulation, nor for the treatment of bleeding due to low levels of liver-dependent coagulation factors.