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1. Ensure that the appropriate vial size is chosen according to the body weight of the patient. (See Table 6.)
Click on icon to see table/diagram/image2. Check that the cap of the vial is still intact.
3. Remove the flip-off cap from the vial.
4. Open the top of the vial adapter. Remove the tip-cap from the pre-filled syringe with the solvent. Then immediately screw the pre-filled syringe on the vial adapter tightly and penetrate the vial stopper in the middle with the spike of the vial adapter.
5. Add the solvent into the vial by pushing the syringe plunger down slowly to avoid foaming.
6. Keep the syringe attached to the vial adapter and reconstitute by swirling gently.
7. The reconstituted solution for injection results in a colourless to pale yellow, clear solution. Only clear solution without particles should be used.
8. Directly before the solution will be administered, invert the vial with the syringe still attached, so that the syringe is below the vial.
9. Transfer the appropriate volume of Metalyse reconstituted solution into the syringe, based on the patient's weight.
10. Unscrew the syringe from the vial adapter.
11. A pre-existing intravenous line may be used for administration of Metalyse in sodium chloride 9 mg/ml (0.9%) solution only. No other medicinal product should be added to the injection solution.
12. Metalyse is to be administered to the patient, intravenously in about 10 seconds. It should not be administered in a line containing glucose as Metalyse is incompatible with glucose solution.
13. The line should be flushed after Metalyse injection for a proper delivery.
14. Any unused reconstituted solution should be discarded.
Alternatively, the reconstitution can be performed with a needle instead of the included vial adapter.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
Incompatibilities: Metalyse is incompatible with glucose infusion solutions.
