Prothrombinex-VF is a freeze dried powder containing purified human coagulation factors II, IX and X and low levels of factors V and VII. It is prepared from pooled human plasma. It is used (in combination with other agents) for the reversal of warfarin toxicity.

To outline the correct reconstitution and administration technique for Prothrombinex-VF to ensure that it is administered to the patient in a safe, timely manner and wastage is minimised.

Mix2Vial - needle-free reconstitution & filter transfer system is supplied with all freeze-dried products in CSL Biotherapies’ range of plasma-derived therapies.

Prothrombinex-VF requires consent and should be prescribed on the Blood and blood product administration form. All product batch numbers and expiry must be documented in the patient's medical record. This is a legal requirement.

Alaris PC with LVP and syringe adaptor or Alaris PC with syringe attachment.

Each single pack contains one vial of Prothrombinex-VF 500 international units, one 20mL vial of Water for Injection and one Mix2Vial filter transfer set.

See CPG0120 Management Of Warfarin Toxicity or the Product Information for Prothrombinex-VF Dosing Information.

Reconstitution:

*Follow the reconstitution instructions in Appendix 1*

Additional reconstitution tips:
Before reconstitution, allow the vials of Prothrombinex-VF and Water for Injections to reach room temperature.
The Mix2Vial is intended to filter the contents of one vial of Prothrombinex-VF only. Use a new one for each vial.
As Prothrombinex-VF does not contain an antimicrobial preservative, it should be used as soon as practicable after reconstitution. Store reconstituted solution at ROOM TEMPERATURE only. The infusion should be completed within three hours of reconstitution. Any unused portion remaining in the vial or syringe must be discarded appropriately.

Avoid excessive frothing when dissolving the Prothrombinex-VF. A clear or slightly opalescent solution is usually obtained in 10 minutes or less.

DO NOT administer if the product appears cloudy or sediment is present in the bottle. A slight green tinge is acceptable.

If the vial of Prothrombinex-VF does not contain a vacuum and draw the Water for Injection into it, do not use the product. Notify pharmacy who will return it to the Australian Red Cross Blood Service.

Administration:

• Remove the blue end of the Mix2Vial from the product vial by gently rotating the blue attachment. Discard the Water for Injections and blue end of the Mix2Vial.

• Attach syringe to the clear end of the Mix2Vial . Draw reconstituted product into the syringe. One large syringe may be used to pool several vials of reconstituted product.

• Flush IV cannula with sodium chloride 0.9%.

• Administer the reconstituted solution intravenously at a rate not exceeding 3 mL/min (180 mL/hr) using the Alaris PC with LVP and syringe adaptor, or via Alaris PC with syringe attachment. Doses above 60 mL (3 vials) must be drawn up into multiple syringes and given sequentially.

• Maintain visual observation of the patient during the administration.

• On completion, flush the IV line with 50 mL of sodium chloride 0.9% at the same rate as the infusion.