United States - English - 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

United States - English - 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

Israel - English - Ministry of Health

takeda israel ltd - factor viii inhibitor bypassing fraction - powder and solvent for solution for injection/infusion - factor viii inhibitor bypassing fraction 1000 u/vial - factor viii inhibitor bypassing activity - factor viii inhibitor bypassing activity - control of bleeding episodes in haemophilia a patients with factor viii inhibitors and also in patients with acquired factor viii inhibitors .control of bleeding in hemophilia b patients with inhibitors, if no other specific treatment is available.

Israel - English - Ministry of Health

takeda israel ltd - factor viii inhibitor bypassing fraction - powder and solvent for solution for injection/infusion - factor viii inhibitor bypassing fraction 500 u/vial - factor viii inhibitor bypassing activity - factor viii inhibitor bypassing activity - control of bleeding episodes in haemophilia a patients with factor viii inhibitors and also in patients with acquired factor viii inhibitors.control of bleeding in hemophilia b patients with inhibitors, if no other specific treatment is available.

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

centrale afdeling voor fractionering - departement central de fractionnement s.p.r.l.-b.v.b.a. - human coagulation factor viii 100 iu/ml - powder and solvent for solution for injection - 1000 iu/10 ml - human coagulation factor viii 100 iu/ml - coagulation factor viii

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

centrale afdeling voor fractionering - departement central de fractionnement s.p.r.l.-b.v.b.a. - human coagulation factor viii 100 iu/ml - powder and solvent for solution for injection - 500 iu/5 ml - human coagulation factor viii 100 iu/ml - coagulation factor viii

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

centrale afdeling voor fractionering - departement central de fractionnement s.p.r.l.-b.v.b.a. - human coagulation factor viii 1000 iu/5 ml - powder and solvent for solution for injection - 200 iu/ml - human coagulation factor viii 200 iu/ml - coagulation factor viii

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

centrale afdeling voor fractionering - departement central de fractionnement s.p.r.l.-b.v.b.a. - human coagulation factor viii 1000 iu/5 ml - powder and solvent for solution for injection - 200 iu/ml - human coagulation factor viii 200 iu/ml - coagulation factor viii

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

octapharma benelux sa-nv - human coagulation factor viii 100 iu/ml - powder and solvent for solution for injection - 100 iu/ml - human coagulation factor viii 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 viii 50 iu/ml - powder and solvent for solution for injection - 50 iu/ml - human coagulation factor viii 50 iu/ml - coagulation factor viii