Metalyse 25 mg Dosage/Direction for Use

Metalyse should be administered as early as possible and no later than 4.5 hours after last known well and after exclusion of intracranial haemorrhage by appropriate imaging techniques, see Precautions. The treatment effect is time-dependent; therefore, earlier treatment increases the probability of a favourable outcome.
Metalyse should be administered on the basis of body weight, with a maximum single dose of 5,000 units (25 mg) tenecteplase.
Benefit-risk of tenecteplase treatment should be carefully evaluated in patients weighing 50 kg or less due to limited availability of data.
The volume required to administer the correct total dose can be calculated from the following scheme (table 2): see Table 2.

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Adjunctive therapy: The safety and efficacy of this regimen with concomitant treatment with heparin or platelet aggregation inhibitors such as acetylsalicylic acid during the first 24 hours after treatment with Metalyse have not been investigated sufficiently. Therefore, administration of intravenous heparin or platelet aggregation inhibitors such as acetylsalicylic acid should be avoided in the first 24 hours after treatment with Metalyse due to an increased haemorrhagic risk.
If heparin is required for other indications the dose should not exceed 10,000 IU per day, administered subcutaneously.
Method of administration: The reconstituted solution should be administered intravenously and is for immediate use.
The required dose should be administered as a single intravenous bolus over 5 to 10 seconds.
Instructions for use/handling: Metalyse should be reconstituted by adding the appropriate volume of sterile water for injection to the vial containing the powder for solution for injection using a needle and a syringe (not provided in the package).
1. Remove the flip-off cap from the vial.
2. Fill a syringe with 5 ml of sterile water for injection and penetrate the vial stopper in the middle with the needle.
3. Add all the sterile water for injection into the vial by pushing the syringe plunger down slowly to avoid foaming.
4. Keep the syringe attached to the vial and reconstitute by swirling gently.
5. The reconstituted preparation is a colourless to pale yellow, clear solution. Only clear solution without particles should be used.
6. Directly before the solution is administered, invert the vial with the syringe still attached, so that the syringe is below the vial.
7. Transfer the appropriate volume of reconstituted solution of Metalyse into the syringe, based on the patient's weight (see Table 2).
8. A pre-existing intravenous line, which has been used for administration of 0.9% sodium chloride solution only, may be used for administration of Metalyse. Metalyse should not be mixed with other drugs, neither in the same vial nor the same venous line (not even with heparin).
9. Metalyse should be administered as a single dose to the patient, intravenously over 5 to 10 seconds. It should not be administered into a line containing dextrose as Metalyse is incompatible with dextrose solution.
10. The line should be flushed after Metalyse injection for proper delivery.
11. Any unused solution should be discarded.