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Actilyse should be given as soon as possible after symptom onset.
Myocardial Infarction: 90-minutes (accelerated) dose regimen in whom treatment can be started within 6 hours after symptom onset: 15 mg as an intravenous bolus, 50 mg as an infusion over the first 30 minutes, followed by an infusion of 35 mg over 60 minutes, until the maximal dose of 100 mg. In patients with a body weight below 65 kg, the total dose should be weight-adjusted with 15 mg as an intravenous bolus and 0.75 mg/kg body weight over 30 minutes (maximum of 50 mg), followed by an infusion of 0.5 mg/kg over 60 minutes (maximum of 35 mg).
3-hour dose regimen in whom treatment can be started between 6 and 12 hours after symptom onset: 10 mg as an intravenous bolus, 50 mg as an intravenous infusion over the first hour, followed by infusions of 10 mg over 30 minutes, until the maximal dose of 100 mg over 3 hours, in patients with a body weight below 65 kg the total dose should not exceed 1.5 mg/kg.
The accepted maximum dose in acute myocardial infarction is 100 mg alteplase.
Adjunctive Therapy: Antithrombotic adjunctive therapy is recommended according to the current international guidelines for the management of patients with ST-elevation myocardial infarction.
Pulmonary Embolism: A total dose of 100 mg should be administered in 2 hours. The most experience available is with the following dose regimen: 10 mg as an intravenous bolus over 1 - 2 minutes, 90 mg as an intravenous infusion over two hours, The total dose should not exceed 1.5 mg/kg in patients with a body weight below 65 kg
Adjunctive Therapy: After treatment with Actilyse, heparin therapy should be initiated (or resumed) when aPTT values are less than twice the upper limit of normal. The infusion should be adjusted to maintain aPTT between 50 - 70 seconds (1.5 to 2.5 fold of the reference value).
Acute Ischaemic Stroke: The recommended dose is 0.9 mg/kg (maximum of 90 mg) infused over 60 minutes with 10% of the total dose administered as an initial intravenous bolus. Treatment should be initiated as early as possible within 4.5 hours of symptom onset. The treatment effect is time-dependent; therefore earlier treatment increases the probability of a favourable outcome.
Adjunctive Therapy: The safety and efficacy of this regimen with concomitant administration of heparin and acetylsalicylic acid during the first 24 hrs after the symptom onset has not been investigated sufficiently. Therefore, administration of acetylsalicylic acid or IV heparin should be avoided in the first 24 hrs after treatment with Actilyse. If heparin is required for other indications (eg, prevention of deep vein thrombosis) the dose should not exceed 10,000 IU/day administered SC.
Administration: Instructions for Use/Handling: Under aseptic conditions, the contents of an injection vial of Actilyse (50 mg) dry substance is dissolved with sterilised water for injection to obtain a final concentration of 1 mg alteplase per mL.
The 1 mg/mL reconstituted solution may be diluted further with sterile sodium chloride 9 mg/mL (0.9%) solution for injection up to a minimal concentration of 0.2 mg/mL.
A further dilution of the 1 mg/mL reconstituted solution with sterilised water for injections or in general, the use of carbohydrate infusion solutions, e.g. dextrose is not recommended. Actilyse must not be mixed with other drugs, neither in the same infusion-vial nor via the same venous line (not even with heparin).
