Actilyse Dosage/Direction for Use

Actilyse should be given as early as possible after symptom onset. The following dose guidelines apply.
Acute myocardial infarction: Posology: a) 90 minutes (accelerated) dose regimen for patients with acute myocardial infarction, in whom treatment can be started within 6 hours after symptom onset.
In patients with a body weight ≥ 65 kg: See Table 1.

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In patients with a body weight < 65 kg the total dose should be weight adjusted according to the following table: See Table 2.

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b) 3 h dose regimen for patients with acute myocardial infarction, in whom treatment can be started between 6 and 12 hours after symptom onset.
In patients with a body weight ≥ 65 kg: See Table 3.

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In patients with a body weight < 65 kg: See Table 4.

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Adjunctive therapy: Antithrombotic adjunctive therapy is recommended according to the current international guidelines for the management of patients with ST-elevation myocardial infarction.
Method of administration: The reconstituted solution should be administered intravenously and is for immediate use.
2 mg vials of alteplase are not indicated for use in this indication. For instructions prior to reconstitution / administration, see Special precautions for disposal and other handling under Cautions for Usage.
Acute massive pulmonary embolism: Posology: In patients with a body weight ≥ 65 kg: A total dose of 100 mg of alteplase should be administered in 2 hours. Most experience is available with the following dose regimen: See Table 5.

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In patients with a body weight < 65 kg: See Table 6.

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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).
Method of administration: The reconstituted solution should be administered intravenously and is for immediate use.
2 mg vials of alteplase are not indicated for use in this indication. For instructions prior to reconstitution / administration, see Special precautions for disposal and other handling under Cautions for Usage.
Acute ischaemic stroke: Treatment must only be performed under the responsibility and follow-up of a physician trained and experienced in neurovascular care, see Contraindications and Precautions.
Posology: The recommended dose is 0.9 mg alteplase/kg body weight (maximum of 90 mg) starting with 10% of the total dose as an initial intravenous bolus, immediately followed by the remainder of the total dose infused intravenously over 60 minutes. (See Table 7.)

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Adjunctive therapy: The safety and efficacy of this regimen with concomitant administration of heparin or platelet aggregation inhibitors such as acetylsalicylic acid within the first 24 hours of onset of the symptoms have not been sufficiently investigated. Therefore, administration of intravenous heparin or platelet aggregation inhibitors such as acetylsalicylic acid should be avoided in the first 24 hours after treatment with Actilyse due to an increased haemorrhagic risk. If heparin is required for other indications (e.g. prevention of deep vein thrombosis) 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.
2 mg vials of alteplase are not indicated for use in this indication. For instructions prior to reconstitution / administration, see Special precautions for disposal and other handling under Cautions for Usage.
Paediatric population: There is limited experience with the use of Actilyse in children and adolescents. Actilyse is contraindicated for the treatment of acute ischaemic stroke in children and adolescents under 16 years of age (see Contraindications). The dose for adolescents 16-17 years old is the same as for adults (see Precautions for recommendations on prior imaging techniques to be used).