Nuwiq Caution For Usage

Incompatibilities: In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.
Only the provided injection sets should be used because treatment failure can occur as a consequence of human coagulation factor VIII adsorption to the internal surfaces of some injection equipment.
Special precautions for disposal and other handling: The powder should only be reconstituted with the supplied solvent (2.5 ml water for injections) using the supplied injection set. The vial should be gently rotated until all powder is dissolved. After reconstitution, the solution should be drawn back into the syringe.
The reconstituted medicinal product should be inspected visually for particulate matter and discoloration prior to administration. The reconstituted medicinal product is a clear, colourless solution, free from foreign particles and has a pH of 6.5 to 7.5. Do not use solutions that are cloudy or have deposits.
Instructions for preparation and administration: 1. Allow the solvent syringe (water for injections) and the powder in the closed vial to reach room temperature. The patient can do this by holding it in his hands until they feel as warm as his hands. Do not use any other way to heat the vial and pre-filled syringe. This temperature should be maintained during reconstitution.
2. Remove the plastic flip-off cap from the powder vial to expose the central portions of the rubber stopper. Do not remove the gray stopper or metal ring around the top of the vial.
3. Wipe the top of the vial with an alcohol swab. Allow the alcohol to dry.
4. Peel back the paper cover from the vial adapter package. Do not remove the adapter from the package.
5. Place the powder vial on an even surface and hold it. Take the adapter package and place the vial adapter over the centre of the rubber stopper of the powder vial. Press down firmly the adapter package until the adapter spike penetrates the rubber stopper. The adapter snaps to the vial when done.
6. Peel back the paper cover from the pre-filled syringe package. Hold the plunger rod at the end and do not touch the shaft. Attach the threaded end of the plunger rod to the solvent syringe plunger. Turn the plunger rod clockwise until a slight resistance is felt.
7. Break off the tamper-proof plastic tip from the solvent syringe by snapping the perforation of the cap. Do not touch the inside of the cap or the syringe tip. In case the solution is not used immediately close the filled syringe with the tamper-proof plastic tip for storage.
8. Remove the adapter packaging and discard.
9. Firmly connect the solvent syringe to the vial adapter by turning clockwise until resistance is felt.
10. Slowly inject all solvent into the powder vial by pressing down the plunger rod.
11. Without removing the syringe, gently move or swirl the vial in circles a few times to dissolve the powder. Do not shake. Wait until all the powder dissolves completely.
12. Visually inspect the final solution for particles before administration. The solution should be clear and colourless, practically free from visible particles. Do not use solutions that are cloudy or have deposits.
13. Turn the vial attached to the syringe upside down, and slowly draw the final solution into the syringe. Make sure that the entire content of the vial is transferred to the syringe.
14. Detach the filled syringe from the vial adapter by turning counter clockwise and discard the empty vial.
15. The solution is now prepared for immediate use. Do not refrigerate.
16. Clean the chosen injection site with one of the provided alcohol swabs.
17. Attach the provided infusion set to the syringe. Insert the needle of the infusion set into the chosen vein. If the patient have used a tourniquet to make the vein easier to see, the tourniquet should be released before the patient start injecting the solution. No blood must flow into the syringe due to the risk of formation of fibrin clots.
18. Inject the solution into the vein at a slow speed, not faster than 4 ml per minute.
If the patient use more than one vial of powder for one treatment, they may use the same injection needle again. The vial adapter and the syringe are for single use only.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.