הממלכה המאוחדת - אנגלית - MHRA (Medicines & Healthcare Products Regulatory Agency)

2,500unit) powder and 50ml solvent for solution for infusion vials (takeda uk ltd - factor viii inhibitor bypassing fraction - powder and solvent for solution for infusion - 2500unit

הממלכה המאוחדת - אנגלית - MHRA (Medicines & Healthcare Products Regulatory Agency)

bio products laboratory ltd - von willebrand factor; factor viii - powder and solvent for solution for injection - 500unit ; 250unit

בלגיה - אנגלית - AFMPS (Agence Fédérale des Médicaments et des Produits de Santé)

baxalta innovations gmbh - anti-inhibitor coagulant complex 500 u - powder and solvent for solution for injection - 500 u - factor viii inhibitor bypassing activity 500 iu - factor viii inhibitor bypassing activity

בלגיה - אנגלית - AFMPS (Agence Fédérale des Médicaments et des Produits de Santé)

baxalta innovations gmbh - anti-inhibitor coagulant complex 1000 u - powder and solvent for solution for injection - 1000 u - factor viii inhibitor bypassing activity 1000 iu - factor viii inhibitor bypassing activity

אירלנד - אנגלית - HPRA (Health Products Regulatory Authority)

baxalta innovations gmbh - feiba - powder and solvent for solution for infusion - 25 unit(s)/millilitre - blood coagulation factors; factor viii inhibitor bypassing activity - coagulation factors - it is used for: treatment of bleeding in hemophilia a patients with inhibitors; treatment of bleeding in hemophilia b patients with inhibitors, if no other specific treatment is available (see section 5.1); treatment of bleeding in non-hemophiliacs with acquired inhibitors to factor viii; prophylaxis of bleeding in hemophilia a patients with inhibitors who have experienced a significant bleed or are at high risk of significant bleeding

אירלנד - אנגלית - HPRA (Health Products Regulatory Authority)

baxalta innovations gmbh - feiba - powder and solvent for solution for infusion - 50 unit(s)/millilitre - blood coagulation factors; factor viii inhibitor bypassing activity - blood coagulation factors - it is used for: treatment of bleeding in hemophilia a patients with inhibitors; treatment of bleeding in hemophilia b patients with inhibitors, if no other specific treatment is available (see section 5.1); treatment of bleeding in non-hemophiliacs with acquired inhibitors to factor viii; prophylaxis of bleeding in hemophilia a patients with inhibitors who have experienced a significant bleed or are at high risk of significant bleeding

נמיביה - אנגלית - Namibia Medicines Regulatory Council

adcock ingram critical care (pty) ltd - factor viii inhibitor - injection - each 1 ml solution contains: factor viii inhibitor bypassing activity 50 u

נמיביה - אנגלית - Namibia Medicines Regulatory Council

adcock ingram critical care (pty) ltd - factor viii inhibitor - injection - each 1 ml solution contains: factor viii inhibitor bypassing activity 50 iu

ארצות הברית - אנגלית - NLM (National Library of Medicine)

takeda pharmaceuticals america, inc. - anti-inhibitor coagulant complex (unii: cs849dun3m) (anti-inhibitor coagulant complex - unii:cs849dun3m) - anti-inhibitor coagulant complex 500 [usp'u] in 20 ml - feiba is an anti-inhibitor coagulant complex indicated for use in hemophilia a and b patients with inhibitors for: - control and prevention of bleeding episodes - perioperative management - routine prophylaxis to prevent or reduce the frequency of bleeding episodes. feiba is not indicated for the treatment of bleeding episodes resulting from coagulation factor deficiencies in the absence of inhibitors to coagulation factor viii or coagulation factor ix. - known anaphylactic or severe hypersensitivity reactions to feiba or any of its components, including factors of the kinin generating system. - disseminated intravascular coagulation (dic). - acute thrombosis or embolism (including myocardial infarction). risk summary there are no data with feiba use in pregnant women to inform a drug-associated risk. there are no adequate and well-controlled studies in pregnant women. animal reproduction studies have not been conducted with feiba. it is also not known whether feiba can cause fetal harm when administered to a pregnant woman or can affect reproductive capacity. in the u.s. general population, the estimated background risk for major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. there is no information available on the effect of feiba on labor and delivery. risk summary there is no information regarding the presence of feiba in human milk, the effect on the breastfed child, or the effects on milk production. the developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for feiba and any potential adverse effects on the breastfed child from feiba or from the underlying condition. safety and efficacy of feiba have been evaluated in nine pediatric subjects treated in the routine prophylaxis trial including 4 subjects ≥7 to <12 years of age and 5 subjects ≥12 to <16 years of age. the dosing for all pediatric subjects was based on body weight. a total of 576 infusions were given for the treatment of 223 bleeding episodes (504 infusions for joint bleeding episodes, 72 infusions for muscle and soft tissue bleeding episodes). in 223 (100%) of the episodes, hemostasis was achieved with one or more infusions. hemostatic efficacy was rated as excellent or good in a majority (96.9%) of the bleeding episodes in both regimens at 24 hours post infusion. the median annualized bleeding episode rate (abr) for children ≥7 to <12 years of age was 7.7 bleeds per patient per year, as compared to 39 for subjects treated with on-demand therapy [see clinical studies (14)] . the safety and efficacy of feiba has not been evaluated in neonates. the safety and efficacy of feiba has not been evaluated in subjects ≥65 years of age.

מלזיה - אנגלית - NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

dksh malaysia sdn. bhd. - human coagulation factor viii; von willebrand factor -