Profilnine Caution For Usage

factor ix complex




Grifols Asia Pacific
Full Prescribing Info
Caution For Usage
Instructions for use and handling: Do not use after the expiry date shown on the vial label.
Check assay value on label carefully before use.
Use aseptic technique during reconstitution and administration.
Left-over product must never be stored for later use, nor stored in a refrigerator.
Solution preparation: 1. Warm the vial and syringe but not above 30°C.
2. Attach the plastic plunger to the syringe containing diluent.
3. Remove the filter from its packaging. Remove the grey rubber cap from the syringe tip and then attach the syringe to the filter.
4. Remove the vial adaptor from its packaging. Attach the vial adaptor to the syringe-filter assembly.
5. Remove the plastic flip-top cap from the concentrate vial and wipe the exposed rubber with the antiseptic wipe provided.
6. Place the syringe/filter/adaptor assembly over the top of the concentrate vial and pierce the stopper with the adaptor needle.
7. Transfer all the Water for Injections into the concentrate vial by depressing the syringe plunger.
8. Gently swirl the vial until all the concentrate has dissolved. As with other parenteral solutions, do not use the solution if it is not properly dissolved or particles are visible.
9. Briefly separate the syringe/filter and vial/adaptor assemblies to release any vacuum.
10. Invert the concentrate vial and draw-up the solution through the filter into the syringe.
11. Prepare the injection site, separate the filter/vial adaptor from the syringe. Inject the solution intravenously using the butterfly needle provided or a sterile needle.
Administer slowly at a rate not exceeding 10 ml/minute.
After reconstitution with the Water for Injections solvent provided, the product should be used immediately.
Do not re-use the administration sets.
Any unused product or waste material should be disposed of in accordance with local requirements.
The solution should be clear or slightly opalescent. Do not use solutions that are cloudy or have deposits.
Reconstituted product should be inspected visually for particulate matter and discoloration prior to administration.
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