Australija - engleski - Department of Health (Therapeutic Goods Administration)

csl behring australia pty ltd - factor viii, quantity: 500 iu - injection, solution - excipient ingredients: water for injections - human coagulation factor viii is indicated for the treatment and prophylaxis of bleeding associated with factor viii deficiency due to haemophilia a.

Malta - engleski - Medicines Authority

bio products laboratory limited dagger lane, elstree hertfordshire, wd6 3bx, united kingdom - factor viii, human - powder and solvent for solution for injection - factor viii, human 25 iu/ml - antihemorrhagics

Malta - engleski - Medicines Authority

octapharma (ip) sprl alle de la recherche 65, 1070 (anderlecht), belgium - human von, willebrand factor, human coagulation, factor xiii - powder and solvent for solution for injection - human von willebrand factor 1000 iu human coagulation factor viii 1000 iu - antihemorrhagics

Malta - engleski - Medicines Authority

bio products laboratory limited - factor viii, human; von willebrand factor, human - powder and solvent for solution for injection - factor viii, human 250 iu; von willebrand factor, human 430 iu - antihemorrhagics

Malta - engleski - Medicines Authority

bio products laboratory limited - factor viii, human; von willebrand factor, human - powder and solvent for solution for injection - factor viii, human 500 iu; von willebrand factor, human 860 iu - antihemorrhagics

Malta - engleski - Medicines Authority

bio products laboratory limited - factor viii, human; von willebrand factor, human - powder and solvent for solution for injection - factor viii, human 1000 iu; von willebrand factor, human 1720 iu - antihemorrhagics

Sjedinjene Američke Države - engleski - NLM (National Library of Medicine)

csl behring gmbh - human coagulation factor viii/von willebrand factor complex (unii: 5t6b772r4q) (human coagulation factor viii/von willebrand factor complex - unii:5t6b772r4q) - human coagulation factor viii/von willebrand factor complex 80 [iu] in 1 ml - humate-p, antihemophilic factor/von willebrand factor complex (human), is indicated for treatment and prevention of bleeding in adults with hemophilia a (classical hemophilia). humate-p is also indicated in adult and pediatric patients with von willebrand disease (vwd) for: controlled clinical trials to evaluate the safety and efficacy of prophylactic dosing with humate-p to prevent spontaneous bleeding have not been conducted in vwd subjects [see clinical studies (14)]. humate-p is contraindicated in individuals who have had an anaphylactic or severe systemic reaction to antihemophilic factor or von willebrand factor preparations. animal reproduction studies have not been conducted with humate-p. it is also not known whether humate-p can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. humate-p should be given to a pregnant woman only if clearly needed. it is not known whether humate-p can cause harm to the mother or the fetus when administered during labor and deli

Malta - engleski - Medicines Authority

octapharma (ip) limited - human von willebrand factor; human coagulation factor viii - powder and solvent for solution for injection - human von willebrand factor 500 iu; human coagulation factor viii 500 iu - antihemorrhagics

Sjedinjene Američke Države - engleski - NLM (National Library of Medicine)

biogen inc. - (1-743)-(1638-2332)-blood-coagulation factor viii (synthetic human) fusion protein with immunoglobulin g1 (synthetic human fc domain fragment), (1444-6'),(1447-9')-bis(disulfide) with immunoglobulin g1 (synthetic human fc domain fragment) (unii: 7pcm518ylr) ((1-743)-(1638-2332)-blood-coagulation factor viii (synthetic human) fusion protein with immunoglobulin g1 (synthetic human fc domain fragment), (1444-6'),(1447-9')-bis(disulfide) with immunoglobulin g1 (synthetic human fc domain fragment) - unii:7pcm51 - (1-743)-(1638-2332)-blood-coagulation factor viii (synthetic human) fusion protein with immunoglobulin g1 (synthetic human fc domain fragment), (1444-6'),(1447-9')-bis(disulfide) with immunoglobulin g1 (synthetic human fc domain fragment) 250 [iu] in 3 ml - eloctate, antihemophilic factor (recombinant), fc fusion protein, is a recombinant dna derived, antihemophilic factor indicated in adults and children with hemophilia a (congenital factor viii 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 eloctate is not indicated for the treatment of von willebrand disease. eloctate is contraindicated in patients who have had life-threatening hypersensitivity reactions to eloctate or other constituents of the product. [see description (11 )] risk summary there are no studies of eloctate use in pregnant women to inform a drug-associated risk. the background risk of major birth defects and miscarriage in the indicated population is unknown; however, the background risk of major birth defects in the u.s. general population is 2-4% and of miscarriage is 15-20% of clinically recognized pregnancies. animal reproductive and devel

Irska - engleski - HPRA (Health Products Regulatory Authority)

baxalta innovations gmbh - factor viii, human recombinant - powder and solvent for solution for injection - 1000 iu international unit(s) - blood coagulation factors; coagulation factor viii - antihaemorrhagics: blood coagulation factor viii - treatment and prophylaxis of bleeding in patients with haemophilia a (congenital factor viii deficiency). this product does not contain von willebrand factor and is therefore not indicated in von willebrand’s disease