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

grifols usa, llc - coagulation factor ix human (unii: 6u90y1795t) (coagulation factor ix human - unii:6u90y1795t) - coagulation factor ix human 500 [iu] in 10 ml - alphanine sd is indicated for the prevention and control of bleeding in patients with factor ix deficiency due to hemophilia b. alphanine sd contains low, non-therapeutic levels of factors ii, vii, and x, and, therefore, is not indicated for the treatment of factor ii, vii or x deficiencies. this product is also not indicated for the reversal of coumarin anticoagulant-induced hemorrhage, nor in the treatment of hemophilia a patients with inhibitors to factor viii. none known.

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

wyeth biopharma division of wyeth pharmaceuticals llc - coagulation factor ix recombinant human (unii: 382l14738l) (coagulation factor ix recombinant human - unii:382l14738l) - coagulation factor ix recombinant human 1000 [iu] in 5 ml - benefix® , coagulation factor ix (recombinant), is a human blood coagulation factor indicated in adults and children with hemophilia b (congenital factor ix deficiency or christmas disease) for: limitation of use benefix is not indicated for induction of immune tolerance in patients with hemophilia b [see warnings and precautions (5.3)] . benefix is contraindicated in patients who have manifested life-threatening, immediate hypersensitivity reactions, including anaphylaxis, to the product or its components, including hamster protein. risk summary there are no data with benefix use in pregnant women to inform a drug-associated risk. animal reproduction studies have not been conducted with benefix. it is not known whether benefix can affect reproductive capacity or cause fetal harm when given to pregnant women. 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 informa

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

aptevo biotherapeutics llc - coagulation factor ix recombinant human (unii: 382l14738l) (coagulation factor ix recombinant human - unii:382l14738l) - coagulation factor ix recombinant human 250 [iu] in 5 ml - ixinity, coagulation factor ix (recombinant), is a human blood coagulation factor indicated for the treatment of: - adults and children ≥ 12 years of age with hemophilia b for: on-demand treatment and control of bleeding episodes perioperative management - on-demand treatment and control of bleeding episodes - perioperative management - adults with hemophilia b for: routine prophylaxis to reduce the frequency of bleeding episodes - routine prophylaxis to reduce the frequency of bleeding episodes ixinity is not indicated for induction of immune tolerance in patients with hemophilia b [see warnings and precautions (5.3) ]. ixinity is contraindicated in patients who have known hypersensitivity to ixinity or its excipients, including hamster protein [see warnings and precautions (5.1) ]. risk summary there are no data with ixinity use in pregnant women to inform a drug-associated risk. animal reproduction studies have not been conducted with ixinity. in the u.s. general population, the estimated b

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

takeda pharmaceuticals america, inc. - coagulation factor ix recombinant human (unii: 382l14738l) (coagulation factor ix recombinant human - unii:382l14738l) - coagulation factor ix recombinant human 250 [iu] in 5 ml - rixubis (coagulation factor ix [recombinant]) is an antihemophilic factor indicated in adults and children with hemophilia b for: - on-demand treatment and control of bleeding episodes - perioperative management of bleeding - routine prophylaxis to reduce the frequency of bleeding episodes. rixubis is not indicated for induction of immune tolerance in patients with hemophilia b [see warnings and precautions (5.3)] . rixubis is contraindicated in patients who have: - known hypersensitivity to rixubis or its excipients including hamster protein - disseminated intravascular coagulation (dic) [see warnings and precautions (5.4)] - signs of fibrinolysis [see warnings and precautions (5.4)] risk summary there are no data with rixubis use in pregnant women to inform a drug-associated risk. animal reproduction studies have not been conducted with rixubis. it is also not known whether rixubis can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. in the u.s. general population,

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.

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

grifols usa, llc - factor ix complex (unii: fw411qxd5m) (factor ix complex - unii:fw411qxd5m) - factor ix complex 500 [iu] in 5 ml - profilnine, factor ix complex, is indicated for the prevention and control of bleeding in patients with factor ix deficiency (hemophilia b). profilnine contains non-therapeutic levels of factor vii and is not indicated for use in the treatment of factor vii deficiency. none known.

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.

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: 500 iu; factor x, quantity: 500 iu; factor ii, quantity: 500 iu - injection, diluent for - excipient ingredients: water for injections - prothrombinex-vf is indicated in - treatment and perioperative prophylaxis of bleeding in acquired deficiency of prothrombin complex factors, such as deficiency caused by treatment with vitamin k antagonists, or in case of overdose of vitamin k antagonists, when rapid correction of the deficiency is required. - treatment and prophylaxis of bleeding in patients with single or multiple congenital deficiency of factor ix, ii or x when purified specific coagulation factor product is not available (see precautions).