Malta - angļu - Medicines Authority

takeda manufacturing austria ag industriestrasse 67, a-1221, vienna, austria - factor viii, human, von willebrand - powder and solvent for solution for injection - factor viii, human 1000 iu von willebrand factor, human 750 iu - antihemorrhagics

Kanāda - angļu - Health Canada

wyeth canada - coagulation factor ix (recombinant); water - kit - 1000unit; 10ml - coagulation factor ix (recombinant) 1000unit; water 10ml - hemostatics

Amerikas Savienotās Valstis - angļu - 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 - angļu - Medicines Authority

octapharma (ip) sprl alle de la recherche 65, 1070 (anderlecht), belgium - factor viii, human - powder and solvent for solution for injection - factor viii, human 50 iu/ml - antihemorrhagics

Malta - angļu - Medicines Authority

octapharma (ip) sprl alle de la recherche 65, 1070 (anderlecht), belgium - factor viii, human - powder and solvent for solution for injection - factor viii, human 50 iu - antihemorrhagics

Izraēla - angļu - Ministry of Health

bayer israel ltd - recombinant human coagulation factor viii - powder and solvent for solution for injection - recombinant human coagulation factor viii 2000 iu - coagulation factor viii - treatment and prophylaxis of bleeding in patients with haemophilia a (congenital factor viii deficiency). kovaltry can be used for all age groups.

Izraēla - angļu - Ministry of Health

bayer israel ltd - recombinant human coagulation factor viii - powder and solvent for solution for injection - recombinant human coagulation factor viii 250 iu - coagulation factor viii - treatment and prophylaxis of bleeding in patients with haemophilia a (congenital factor viii deficiency). kovaltry can be used for all age groups.

Izraēla - angļu - Ministry of Health

bayer israel ltd - recombinant human coagulation factor viii - powder and solvent for solution for injection - recombinant human coagulation factor viii 500 iu - coagulation factor viii - treatment and prophylaxis of bleeding in patients with haemophilia a (congenital factor viii deficiency). kovaltry can be used for all age groups.

Amerikas Savienotās Valstis - angļu - NLM (National Library of Medicine)

novo nordisk - antihemophilic factor, human recombinant (unii: p89dr4ny54) (antihemophilic factor, human recombinant - unii:p89dr4ny54) - esperoct [antihemophilic factor (recombinant), glycopegylated-exei] is a recombinant dna-derived coagulation factor viii concentrate indicated for use in adults and children with hemophilia a for: limitation of use: esperoct is not indicated for the treatment of von willebrand disease. (1) esperoct is contraindicated in patients who have known hypersensitivity to esperoct or its components (including hamster proteins) [see warnings and precautions (5.1) and description (11) ]. there are no data with esperoct use in pregnant women to determine whether there is a drug-associated risk. animal reproduction studies have not been conducted with esperoct. it is unknown whether esperoct 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 information regarding the presence of esperoct in human

Amerikas Savienotās Valstis - angļu - NLM (National Library of Medicine)

laboratoire français du fractionnement et des biotechnologies société anonyme (lfb s.a.) - coagulation factor viia recombinant human (unii: ac71r787ov) (coagulation factor viia recombinant human - unii:ac71r787ov) - sevenfact  [coagulation factor viia (recombinant)-jncw] is indicated for the treatment and control of bleeding episodes occurring in adults and adolescents (12 years of age and older) with hemophilia a or b with inhibitors.  limitation of use: sevenfact is not indicated for the treatment of patients with congenital factor vii deficiency. sevenfact is contraindicated in - known allergy to rabbits or rabbit proteins. exposure to sevenfact in these patients can result in severe hypersensitivity reaction.  - patients with severe hypersensitivity reaction to sevenfact or any of its components. exposure to sevenfact in these patients can result in severe hypersensitivity reaction.  risk summary there are no adequate and well-controlled studies using sevenfact in pregnant women to determine whether there is a drug-associated risk. animal studies evaluating the embryo-fetal teratogenic potential of sevenfact have not been conducted. it is unknown whether sevenfact can cause fetal harm when administered to a pregnant