METALYSE Powder and solvent for solution for injection Ref.[9393] Active ingredients: Tenecteplase

Posology

Metalyse should be prescribed by physicians experienced in the use of thrombolytic treatment and with the facilities to monitor that use.

Treatment with Metalyse should be initiated as soon as possible after onset of symptoms.

The appropriate presentation of tenecteplase product should be chosen carefully and in line with the indication. The 40 mg and 50 mg presentations are only intended for use in acute myocardial infarction.

Metalyse should be administered on the basis of body weight, with a maximum dose of 10,000 units (50 mg tenecteplase). The volume required to administer the correct dose can be calculated from the following scheme:

For details see section 6.6: Special precautions for disposal and other handling

Elderly (≥75 years)

Metalyse should be administered with caution in the elderly (≥75 years) due to a higher bleeding risk (see information on bleeding in section 4.4 and on the STREAM study in section 5.1).

Paediatric population

The safety and efficacy of Metalyse in children (below 18 years) have not been established. No data are available.

Adjunctive therapy

Antithrombotic adjunctive therapy with platelet inhibitors and anticoagulants should be administered according to the current relevant treatment guidelines for the management of patients with ST-elevation myocardial infarction.

For coronary intervention see section 4.4.

Unfractionated heparin and enoxaparin have been used as antithrombotic adjunctive therapy in clinical studies with Metalyse.

Acetylsalicylic acid should be initiated as soon as possible after symptom onset and continued with lifelong treatment unless it is contraindicated.

Method of administration

The reconstituted solution should be administered intravenously and is for immediate use. The reconstituted solution is a clear and colourless to slightly yellow solution.

The required dose should be administered as a single intravenous bolus over approximately 10 seconds.

For instructions on reconstitution of the medicinal product before administration, see section 6.6.

Symptoms

In the event of overdose there may be an increased risk of bleeding.

Therapy

In case of severe prolonged bleeding substitution therapy may be considered (plasma, platelets), see also section 4.4.

Shelf life as packaged for sale: 2 years.

Reconstituted solution: Chemical and physical in-use stability has been demonstrated for 24 hours at 2-8°C and 8 hours at 30°C.

From a microbiological point of view, the reconstituted solution should be used immediately. If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2-8°C.

Do not store above 30°C. Keep the container in the outer carton in order to protect from light. For storage conditions of the reconstituted medicinal product, see section 6.3.

Metalyse 8 000 units (40 mg) powder and solvent for solution for injection

20 mL glass vial type I, with a coated (B2-42) grey rubber stopper and a flip-off cap filled with powder for solution for injection. Each vial contains 40 mg tenecteplase. 10 mL plastic pre-filled syringe with 8 mL of solvent. Sterile vial adapter.

Metalyse 10 000 units (50 mg) powder and solvent for solution for injection

20 mL glass vial type I, with a coated (B2-42) grey rubber stopper and a flip-off cap filled with powder for solution for injection. Each vial contains 50 mg tenecteplase. 10 mL plastic pre-filled syringe with 10 mL of solvent. Sterile vial adapter.

Metalyse should be reconstituted by adding the complete volume of water for injections from the prefilled syringe to the vial containing the powder for injection.

1. Ensure that the appropriate vial size is chosen according to the body weight of the patient.

2. 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 the included needle.

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.