Idelvion

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Albutrepenonacog alfa 1000 [iU];  ;  

Available from:

CSL Behring (NZ) Ltd

INN (International Name):

Albutrepenonacog alfa 1000 IU

Dosage:

1000 IU

Pharmaceutical form:

Powder for injection

Composition:

Active: Albutrepenonacog alfa 1000 [iU]     Excipient: Hydrochloric acid Mannitol Polysorbate 80 Sodium citrate dihydrate Sucrose Water for injection

Prescription type:

General sale

Manufactured by:

AbbVie Bioresearch Centre

Therapeutic indications:

Idelvion is indicated in all patients with haemophilia B for: - Routine prophylaxis to prevent or reduce the frequency of bleeding episodes - Control and prevention of bleeding episodes - Control and prevention of bleeding in the perioperative setting.

Product summary:

Package - Contents - Shelf Life: Combination pack, includes administration pack (filter transfer device, syringe, venipuncture set, swabs and plaster) - 1000 IU - 36 months from date of manufacture stored at or below 25°C protect from light. do not freeze 4 hours reconstituted stored at or below 25°C - Vial, glass, diluent - 2.5 mL - 60 months from date of manufacture stored at or below 25°C - Vial, glass, active component - 1000 IU - 36 months from date of manufacture stored at or below 25°C protect from light

Authorization date:

2016-09-29