Recomlyse Dosage/Direction for Use

Method of administration: Acute myocardial infarction: Recomlyse should be prescribed by physicians experienced in the use of thrombolytic treatment and with the facilities to monitor that use.
Treatment with Recomlyse with a single dose of 16 mg should be initiated as early as possible after onset of symptoms.
Elderly (≥75 years): Recomlyse should be administered with caution in the elderly (≥75 years) due to a higher bleeding risk.
Paediatric population: The safety and efficacy of Recomlyse 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.
Method of administration: The reconstituted solution should be administered intravenously and is for immediate use.
For instructions on reconstitution of the medicinal product before administration, see Reconstitution and handling as follows.
Acute ischemic stroke: Treatment with Recomlyse should be initiated as soon as possible within 4.5 hours of onset at the recommended dose of 0.25 mg/kg body weight (maximum dose is 25 mg). The required dose should be administered as a single intravenous bolus over approximately 5-10 seconds. The volume required to administer the correct total dose can be calculated from the following scheme. (See Table 3.)

Click on icon to see table/diagram/image

Elderly patients (≥80 years): Recomlyse should be administered with caution in elderly patients (≥80 years) due to a higher bleeding risk.
Adjuvant therapy: The safety and effectiveness of this treatment regimen when combined with heparin or platelet aggregation inhibitors (e.g., aspirin) during the first 24 hours of symptom onset have not been adequately studied. Due to an increased risk of bleeding, intravenous heparin or the use of platelet aggregation inhibitors (e.g., aspirin) should be avoided within 24 hours of treatment with this product. If heparin is given to treat other symptoms (eg, to prevent deep vein thrombosis), the dose should not exceed 10,000 IU and should be given by subcutaneous injection.
If a patient undergoes intravascular thrombectomy after intravenous thrombolysis, the clinician should decide whether to use antiplatelet aggregation or anticoagulation therapy after assessing the benefits and risks.
Reconstitution and handling: Recomlyse should be reconstituted by adding 3 mL of Water for Injections (WFI), shake gently until completely dissolved, do not shake vigorously or foaming may occur. If foaming occurs, let the solution stand until the foam disappears. It should not be mixed with 0.9% Sodium Chloride solution or dextrose. Recomlyse is to be administered as a single intravenous bolus in about 5-10 seconds. Any unused solution should be discarded. If the reconstituted solution is not administered immediately, preserve from light, store at 2-8°C and use in 24 hours.
Recomlyse should not be mixed with other medication, neither in the same injection-vial nor the same intravenous line (not even with heparin).