New Zealand - English - Medsafe (Medicines Safety Authority)

takeda new zealand limited - octocog alfa 500 [iu];   - injection with diluent - 500 iu - active: octocog alfa 500 [iu]   excipient: calcium chloride dihydrate glutathione histidine mannitol polysorbate 80 sodium chloride trehalose dihydrate trometamol water for injection - advate is indicated for use in haemophilia a for prevention and control of haemorrhagic episodes. patients with haemophilia a may be treated with advate as perioperative management. advate is not indicated in von willebrand's disease.

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.

New Zealand - English - Medsafe (Medicines Safety Authority)

takeda new zealand limited - octocog alfa 4000 [iu];   - injection with diluent - 4000 iu - active: octocog alfa 4000 [iu]   excipient: calcium chloride dihydrate glutathione histidine mannitol polysorbate 80 sodium chloride trehalose dihydrate trometamol water for injection - advate is indicated for use in haemophilia a for prevention and control of haemorrhagic episodes. patients with haemophilia a may be treated with advate as perioperative management. advate is not indicated in von willebrand's disease.

New Zealand - English - Medsafe (Medicines Safety Authority)

takeda new zealand limited - icatibant 10 mg/ml ((as icatibant acetate)) - solution for injection - 10 mg/ml - active: icatibant 10 mg/ml ((as icatibant acetate)) excipient: glacial acetic acid sodium chloride sodium hydroxide water for injection - firazyr is indicated for symptomatic treatment of acute attacks of hereditary angiooedema (hae) in adults (with c1-esterase-inhibitor deficiency).

New Zealand - English - Medsafe (Medicines Safety Authority)

takeda new zealand limited - anagrelide hydrochloride 0.61mg equivalent to 0.5 mg anagrelide - capsule - 0.5 mg - active: anagrelide hydrochloride 0.61mg equivalent to 0.5 mg anagrelide excipient: crospovidone gelatin lactose lactose monohydrate magnesium stearate microcrystalline cellulose povidone tekprint black sw-9008 titanium dioxide - agrylin capsules are indicated for the treatment of essential thrombocythaemia (et).

New Zealand - English - Medsafe (Medicines Safety Authority)

takeda new zealand limited - teduglutide 5mg; water for injection 0.5 ml - powder for injection with diluent - 5 mg - active: teduglutide 5mg excipient: dibasic sodium phosphate heptahydrate histidine hydrochloric acid mannitol monobasic sodium phosphate monohydrate sodium hydroxide water for injection active: water for injection 0.5 ml - revestive is indicated for the treatment of adult patients with short bowel syndrome (sbs) who are dependent on parenteral support. patients should be stable at least to 4 weeks on their parenteral support regimen before initiating teduglutide therapy

New Zealand - English - Medsafe (Medicines Safety Authority)

takeda new zealand limited - nonacog gamma 100 iu/ml equivalent to 500 iu/vial;   - powder for injection - 100 iu/ml - active: nonacog gamma 100 iu/ml equivalent to 500 iu/vial   excipient: calcium chloride dihydrate histidine mannitol polysorbate 80 sodium chloride sucrose water for injection - · routine prophylaxis of bleeding episodes in patients with haemophilia b · treatment & prevention of bleeding episodes in patients with haemophilia b (congenital factor ix deficiency) · peri-operative management in patients with haemophilia b

New Zealand - English - Medsafe (Medicines Safety Authority)

takeda new zealand limited - nonacog gamma 200 iu/ml equivalent to 1000 iu/vial;   - powder for injection - 200 iu/ml - active: nonacog gamma 200 iu/ml equivalent to 1000 iu/vial   excipient: calcium chloride dihydrate histidine mannitol polysorbate 80 sodium chloride sucrose water for injection - · routine prophylaxis of bleeding episodes in patients with haemophilia b · treatment & prevention of bleeding episodes in patients with haemophilia b (congenital factor ix deficiency) · peri-operative management in patients with haemophilia b