Armenia - English - Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

baxter ag - factor viii inhibitor bypassing activity - powder and solvent for solution for infusion - 1000u (50u/ml)

New Zealand - English - Medsafe (Medicines Safety Authority)

takeda new zealand limited - factor viii inhibitor bypassing fraction 1000 u;  ;   - powder for injection with diluent - 1000 u - active: factor viii inhibitor bypassing fraction 1000 u     excipient: sodium chloride sodium citrate dihydrate water for injection - feiba nf is indicated for treatment of haemorrhage and to cover surgical interventions in: · haemophilia a patients with factor viii inhibitors · haemophilia b patients with factor ix inhibitors. feiba nf is indicated for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in haemophilia a subjects with inhibitors experiencing >/= 12 bleeding episodes per year. prophylaxis with feiba nf is recommended for patients with high titer (>5bu) inhibitor or low titer (<5 bu) inhibitor, refractory to increased dosing with fviii or fix.

New Zealand - English - Medsafe (Medicines Safety Authority)

takeda new zealand limited - factor viii inhibitor bypassing fraction 2500 u;  ;   - powder for injection with diluent - 2500 u - active: factor viii inhibitor bypassing fraction 2500 u     excipient: sodium chloride sodium citrate dihydrate water for injection - feiba nf is indicated for treatment of haemorrhage and to cover surgical interventions in: · haemophilia a patients with factor viii inhibitors · haemophilia b patients with factor ix inhibitors. feiba nf is indicated for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in haemophilia a subjects with inhibitors experiencing >/= 12 bleeding episodes per year. prophylaxis with feiba nf is recommended for patients with high titer (>5bu) inhibitor or low titer (<5 bu) inhibitor, refractory to increased dosing with fviii or fix.

New Zealand - English - Medsafe (Medicines Safety Authority)

takeda new zealand limited - factor viii inhibitor bypassing fraction 500 u;  ;   - powder for injection with diluent - 500 u - active: factor viii inhibitor bypassing fraction 500 u     excipient: sodium chloride sodium citrate dihydrate water for injection - feiba nf is indicated for treatment of haemorrhage and to cover surgical interventions in: · haemophilia a patients with factor viii inhibitors · haemophilia b patients with factor ix inhibitors. feiba nf is indicated for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in haemophilia a subjects with inhibitors experiencing >/= 12 bleeding episodes per year. prophylaxis with feiba nf is recommended for patients with high titer (>5bu) inhibitor or low titer (<5 bu) inhibitor, refractory to increased dosing with fviii or fix.

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

takeda pharmaceuticals australia pty ltd - factor viii inhibitor bypassing fraction, quantity: 1000 mg - injection, powder for - excipient ingredients: sodium citrate dihydrate; sodium chloride - feiba-nf is indicated for routine prophylaxis, control of spontaneous bleeding episodes and use in surgery in haemophilia a or b patients with inhibitors.

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

takeda pharmaceuticals australia pty ltd - factor viii inhibitor bypassing fraction, quantity: 1000 u - injection, powder for - excipient ingredients: sodium citrate dihydrate; sodium chloride - feiba-nf is indicated for routine prophylaxis, control of spontaneous bleeding episodes and use in surgery in haemophilia a or b patients with inhibitors.

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

takeda pharmaceuticals australia pty ltd - factor viii inhibitor bypassing fraction, quantity: 500 u - injection, powder for - excipient ingredients: sodium citrate dihydrate; sodium chloride - feiba-nf is indicated for routine prophylaxis, control of spontaneous bleeding episodes and use in surgery in haemophilia a or b patients with inhibitors.

Ireland - English - HPRA (Health Products Regulatory Authority)

baxter healthcare limited - feiba - pdr+solv for soln for inf - 50 units/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

Ireland - English - 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