Metalyse Dosage/Direction for Use

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 early as possible after onset of symptoms.
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: See Table 4.

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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 Precautions and on the STREAM study in Pharmacology: Pharmacodynamics under Actions).
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 Precautions.
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 Special precautions for disposal and other handling under Cautions for Usage.