What is Nuwiq®?
Nuwiq® is an injectable medicine that contains the active substance human recombinant coagulation factor VIII (simoctocog alfa).
What are the therapeutic indications of Nuwiq®?
Nuwiq® is licensed for the treatment and prophylaxis of bleeding in patients with haemophilia A (congenital factor VIII deficiency). Nuwiq® can be used for all age groups.
What vial sizes does Nuwiq® come in, and what is the reconstituted volume?
Nuwiq® is supplied in packs containing single-use vials of 250, 500, 1000 or 2000 International Units (IU). Packs can be distinguished by colour-coded printing on the label and the box. The reconstituted volume is 2.5 ml for all vial sizes.
How is Nuwiq® produced?
Nuwiq® is produced by recombinant DNA technology in genetically modified human embryonic kidney (HEK) cells. No animal or human derived materials are added during the manufacturing process or to the final medicinal product. The process also includes a solvent-detergent viral inactivation step and a 20 nm filtration step. A short film of the manufacturing process for Nuwiq® is available here.
What is the content of a single Nuwiq® pack?
Nuwiq® is available in vials containing 250, 500, 1000 or 2000 International Units (IU) of human coagulaton factor VIII (rDNA), simoctocog alfa. Each pack of Nuwiq® contains:
• Powder in a glass vial, closed with a stopper and sealed with a flip-off cap
• Water for Injections in a pre-filled syringe
• A sterile vial adapter for reconstitution with one butterfly needle and two alcohol swabs
• A package leaflet with information for the user
What is the shelf life of Nuwiq® and how should it be stored?
The shelf-life is 2 years when stored in a refrigerator (2°C – 8°C).
During the shelf-life, the product may be kept at room temperature (up to 25°C) for a single period not exceeding 1 month. Once the product has been taken out of the refrigerator the product must not be returned to the refrigerator. Please record the beginning of storage at room temperature on the product carton.
Do not freeze.
Keep the vial in the outer carton in order to protect from light.
After reconstitution, chemical and physical in-use stability has been demonstrated for 24 hours when stored at room temperature. Do not refrigerate after reconstitution. From a microbiological point of view, the product should be used immediately after reconstitution. If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user.