Ireland - English - HPRA (Health Products Regulatory Authority)

baxter healthcare limited - feiba - pdr+solv for soln for inf - 25 units/ml

Singapore - English - HSA (Health Sciences Authority)

takeda pharmaceuticals (asia pacific) pte. ltd. - anti inhibitor coagulant complex - injection, powder, for solution - 50 u/ml - anti inhibitor coagulant complex 50 u/ml

Singapore - English - HSA (Health Sciences Authority)

takeda pharmaceuticals (asia pacific) pte. ltd. - anti inhibitor coagulant complex - injection, powder, for solution - 25 u/ml - anti inhibitor coagulant complex 25 u/ml

Ireland - English - 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

Malta - English - Medicines Authority

baxter healthcare limited - factor viii inhibitor bypassing fraction 500 u - powder and solvent for solution for injection

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

takeda pharmaceuticals australia pty ltd - water for injections, quantity: 5.4 ml - injection, solution - excipient ingredients: - adynovate is a long-acting antihaemophilic factor (recombinant) indicated in haemophilia a (congenital factor viii deficiency) patients for:,? control and prevention of bleeding episodes,? routine prophylaxis to prevent or reduce the frequency of bleeding episodes,? perioperative management (surgical prophylaxis),adynovate is not indicated for the treatment of von willebrand disease.

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

takeda pharmaceuticals australia pty ltd - water for injections, quantity: 5.4 ml - injection, solution - excipient ingredients: - adynovate is a long-acting antihaemophilic factor (recombinant) indicated in haemophilia a (congenital factor viii deficiency) patients for:,? control and prevention of bleeding episodes,? routine prophylaxis to prevent or reduce the frequency of bleeding episodes,? perioperative management (surgical prophylaxis),adynovate is not indicated for the treatment of von willebrand disease.

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

takeda pharmaceuticals australia pty ltd - water for injections, quantity: 5.4 ml - injection, solution - excipient ingredients: - adynovate is a long-acting antihaemophilic factor (recombinant) indicated in haemophilia a (congenital factor viii deficiency) patients for:,? control and prevention of bleeding episodes,? routine prophylaxis to prevent or reduce the frequency of bleeding episodes,? perioperative management (surgical prophylaxis),adynovate is not indicated for the treatment of von willebrand disease.

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

takeda pharmaceuticals australia pty ltd - water for injections, quantity: 5.4 ml - injection, solution - excipient ingredients: - adynovate is a long-acting antihaemophilic factor (recombinant) indicated in haemophilia a (congenital factor viii deficiency) patients for:,? control and prevention of bleeding episodes,? routine prophylaxis to prevent or reduce the frequency of bleeding episodes,? perioperative management (surgical prophylaxis),adynovate is not indicated for the treatment of von willebrand disease.

United States - English - NLM (National Library of Medicine)

baxalta us inc. - antihemophilic factor, human recombinant (unii: p89dr4ny54) (antihemophilic factor, human recombinant - unii:p89dr4ny54) - antihemophilic factor, human recombinant 250 [iu] in 5 ml - adynovate, antihemophilic factor (recombinant), pegylated, is a human antihemophilic factor indicated in children and adults with hemophilia a (congenital factor viii deficiency) for: - on-demand treatment and control of bleeding episodes - perioperative management - routine prophylaxis to reduce the frequency of bleeding episodes limitation of use adynovate is not indicated for the treatment of von willebrand disease. adynovate is contraindicated in patients who have had prior anaphylactic reaction to adynovate, to the parent molecule (advate), mouse or hamster protein, or excipients of adynovate (e.g. tris, mannitol, trehalose, glutathione, and/or polysorbate 80). risk summary there are no data with adynovate use in pregnant women to inform a drug-associated risk. animal reproduction studies have not been conducted with adynovate. it is unknown whether adynovate can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. adynovate should be given to a pregnant woman only