Prothromplex Caution For Usage

Incompatibilities: This medicinal product must not be mixed with other medicinal products except those mentioned in Special precautions for disposal and other handling as follows. For reconstitution only the enclosed reconstitution set should be used and for injection/infusion only the provided injection/infusion set, should be used because treatment failure can occur as a consequence of coagulation factor adsorption to the internal surface of some injection/infusion equipment.
As with all coagulation factor preparations, the efficacy and tolerance of the medicinal product may be impaired by mixing with other medicinal products. It is advisable to rinse a common venous access with isotonic saline solution before and after the administration of Prothromplex TOTAL 600 IU.
Special precautions for disposal and other handling: Only the enclosed reconstitution set is to be used for reconstitution.
Prothromplex TOTAL 600 IU is only to be reconstituted immediately before administration. The solution is clear or slightly opalescent. Cloudy solutions or those with deposits are to be disposed of.
Reconstitution of the powder for solution for injection: Use aseptic technique.
1. Warm the unopened vial containing the solvent (sterilized water for injections) to room or body temperature (maximum 37°C).
2. Remove protective caps from the powder vial and the solvent vial and clean the rubber stoppers of both vials.
3. Remove protective covering from one end of the enclosed transfer needle by twisting, remove and insert the needle through the rubber stopper of the solvent vial.
4. Remove protective covering from the other end of the transfer needle taking care not to touch the exposed end.
5. Invert the solvent vial over the powder vial and insert the end of the transfer needle through the rubber stopper of the powder vial. The solvent will be sucked in by the vacuum in the powder vial.
6. Disconnect the two vials by removing the transfer needle together with the solvent vial from the powder vial. Gently agitate the powder vial to accelerate dissolution.
7. Upon complete dissolution of the powder, insert the enclosed aeration needle and any foam will collapse. Remove the aeration needle.
Injection/infusion: Use aseptic technique.
Before administration, the reconstituted solution should always be checked visually for floating particles or discoloration.
1. Remove protective covering from one end of the enclosed filter needle by twisting and fit the needle onto a sterile disposable syringe. Draw the solution into the syringe.
2. Disconnect the filter needle from the syringe and slowly administer the solution intravenously (maximum infusion/injection rate: 2 ml per minute).
After administration, discard all needles unsealed, together with the syringe and/or the infusion set in the product box, to avoid putting other persons at risk.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.