Israel - English - Ministry of Health

dover medical & scientific equipment ltd, israel - factor ix - powder and solvent for solution for injection - factor ix 100 iu/ml - coagulation factor ix - coagulation factor ix - treatment and prophylaxis of bleeding in patients with haemophilia b (congenital factor ix deficiency).

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).

Belgium - English - AFMPS (Agence Fédérale des Médicaments et des Produits de Santé)

octapharma benelux sa-nv - human coagulation factor ix 100 iu/ml - powder and solvent for solution for injection - 100 iu/ml - human coagulation factor ix 100 iu/ml - coagulation factor viii

Belgium - English - AFMPS (Agence Fédérale des Médicaments et des Produits de Santé)

octapharma benelux sa-nv - human coagulation factor ix 100 iu/ml - powder and solvent for solution for injection - 100 iu/ml - human coagulation factor ix 100 iu/ml - coagulation factor viii

United States - English - 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

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 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.

Australia - English - Department of Health (Therapeutic Goods Administration)

csl behring australia pty ltd - factor viii, quantity: 250 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.

Australia - English - Department of Health (Therapeutic Goods Administration)

csl behring australia pty ltd - factor viii, quantity: 250 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.

Australia - English - Department of Health (Therapeutic Goods Administration)

csl behring australia pty ltd - factor viii, quantity: 250 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.