Jivi

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Damoctocog alfa pegol 250 [iU]

Available from:

Bayer New Zealand Limited

Dosage:

250 IU

Pharmaceutical form:

Powder for injection with diluent

Composition:

Active: Damoctocog alfa pegol 250 [iU] Excipient: Calcium chloride dihydrate Glacial acetic acid Glycine Histidine Polysorbate 80 Sodium chloride Sucrose Water for injection

Prescription type:

General sale

Therapeutic indications:

Treatment and prophylaxis of bleeding in previously treated patients (PTPs) not less than 12 years of age with haemophilia A (congenital factor VIII deficiency).

Product summary:

Package - Contents - Shelf Life: Combination pack, Powder packaged in a glass vial and sWFI diluent packaged in a glass pre-filled syringe - 250 IU - 24 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) protect from light. Within the two years the product may be stored at 25°C for up to 6 months 3 hours reconstituted stored at or below 30°C protect from light - Syringe, glass, Sterile WFI diluent packaged in a syringe closed with rubber stopper and tip cap - 2.5 mL - 48 months from date of manufacture stored at or below 25°C - Vial, glass, Drug product powder packaged in a vial closed with a rubber stopper - 250 IU - 24 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) protect from light. Within the two years the product may be stored at 25°C for up to 6 months

Authorization date:

2021-12-16