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)

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.

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)

baxalta incorporated - coagulation factor ix human (unii: 6u90y1795t) (coagulation factor ix human - unii:6u90y1795t) - coagulation factor ix human 30 [iu] in 1 ml

Malta - English - Medicines Authority

baxalta innovations gmbh industriestrasse 67, 1221, vienna, austria - factor ii, prothrombin, factor ix, human, factor x, factor vii - powder and solvent for solution for injection - factor ii (prothrombin) 24-45 iu/mg factor ix, human 30 iu/mg factor x, human 30 iu/mg factor vii, human 25 iu/mg - antihemorrhagics

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

baxter healthcare corporation - coagulation factor ix human (unii: 6u90y1795t) (coagulation factor ix human - unii:6u90y1795t) - coagulation factor ix human 300 [iu] in 1 ml

Ireland - English - HPRA (Health Products Regulatory Authority)

octapharma (ip) sprl - human coagulation factor ii; human coagulation factor vii; human coagulation factor ix; human coagulation factor x; protein c; protein s - powder and solvent for solution for infusion - 1000 international unit(s) - blood coagulation factors; coagulation factor ix, ii, vii and x in combination

Ireland - English - HPRA (Health Products Regulatory Authority)

octapharma (ip) sprl - human plasma coagulation factor ii; human plasma coagulation factor vii; human plasma coagulation factor ix; human plasma coagulation factor x; protein c; protein s - powder and solvent for solution for infusion - 500 international unit(s) - blood coagulation factors; coagulation factor ix, ii, vii and x in combination

Ireland - English - HPRA (Health Products Regulatory Authority)

baxalta innovations gmbh - human coagulation factor ii; human coagulation factor vii; human coagulation factor ix; human coagulation factor x; protein c - powder and solvent for solution for injection - 600 international unit(s) - blood coagulation factors; coagulation factor ix, ii, vii and x in combination - antihemorrhagics, coagulation factors ix, ii, vii and x in combination - treatment of bleeding and perioperative prophylaxis of bleeding in acquired deficiency of prothrombin complex coagulation factors, such as a deficiency caused by treatment with vitamin k antagonists or in case of overdose with vitamin k antagonists, when rapid correction of the deficiency is required. treatment and perioperative prophylaxis of hemorrhages in congenital deficiency of vitamin k-dependent coagulation factors, when purified specific coagulation factor concentrate is not available.

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