Country: New Zealand
Language: English
Source: Medsafe (Medicines Safety Authority)
Damoctocog alfa pegol 3000 [iU]
Bayer New Zealand Limited
3000 IU
Powder for injection with diluent
Active: Damoctocog alfa pegol 3000 [iU] Excipient: Calcium chloride dihydrate Glacial acetic acid Glycine Histidine Polysorbate 80 Sodium chloride Sucrose Water for injection
General sale
Treatment and prophylaxis of bleeding in previously treated patients (PTPs) not less than 12 years of age with haemophilia A (congenital factor VIII deficiency).
Package - Contents - Shelf Life: Combination pack, Powder packaged in a glass vial and sWFI diluent packaged in a glass pre-filled syringe - 3000 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 - 3000 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
2021-12-16