ACTILYSE TREATMENT-SET 50 mg/vial

BOEHRINGER INGELHEIM SINGAPORE PTE. LTD.

BOEHRINGER INGELHEIM SINGAPORE PTE. LTD.

Therapeutic

Prescription Only

INJECTION, POWDER, FOR SOLUTION

**4.2 Posology and method of administration** ACTILYSE should be given as early as possible after symptom onset. _Posology_ **1\. Acute myocardial infarction** 1. 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: - 15 mg as an intravenous bolus, immediately followed by - 50 mg as an intravenous infusion over the first 30 minutes, immediately followed by an intravenous infusion of - 35 mg over 60 minutes, until the maximum total dose of 100 mg. In patients with a body weight < 65 kg the total dose should be weight adjusted with - 15 mg as an intravenous bolus, immediately followed by - 0.75 mg/kg body weight as an intravenous infusion over the first 30 minutes (maximum 50 mg), immediately followed by an intravenous infusion of - 0.5 mg/kg over 60 minutes (up to a maximum of 35 mg). 2. 3 hours 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: - 10 mg as an intravenous bolus, immediately followed by - 50 mg as an intravenous infusion over the first hour, immediately followed by an intravenous infusion of - 40 mg over two hours, until the maximum total dose of 100 mg. In patients with a body weight < 65 kg: - 10 mg as an intravenous bolus, immediately followed by - an intravenous infusion over three hours up to a maximum total dose of 1.5 mg/kg body weight. Adjunctive therapy: Antithrombotic adjunctive therapy is recommended according to the current international guidelines for the management of patients with ST-elevation myocardial infarction. 2\. **Acute massive pulmonary embolism** In patients with a body weight ≥ 65 kg: 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, immediately followed by - 90 mg as an intravenous infusion over two hours until the total dose of 100mg In patients with a body weight < 65 kg: - 10 mg as an intravenous bolus over 1 – 2 minutes, immediately followed by - an intravenous infusion up to a maximum total dose of 1.5 mg/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). 3\. **Acute ischaemic stroke** The recommended total dose is 0.9 mg/kg body weight (maximum of 90 mg) infused 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. Treatment should be initiated as early as possible within 4.5 hours of symptom onset, see section 4.4 Special warnings and precautions – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_. The treatment effect is time-dependent; therefore earlier treatment increases the probability of a favourable outcome. Beyond 4.5 hours after onset of stroke symptoms there is a negative benefit risk ratio associated with Actilyse administration and so it should not be administered (see 5.1 Pharmacological properties – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_).  Adjunctive therapy: The safety and efficacy of this regimen with concomitant administration of heparin or platelet aggregation inhibitors such as acetylsalicylic acid during the first 24 hours after the symptom-onset has not been investigated sufficiently. 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 international units per day, administered subcutaneously. _Method of_ administration The reconstituted solution should be administered intravenously and is for immediate use. Handling Instructions Under aseptic conditions the contents of an injection vial of ACTILYSE (50 mg) dry substance is dissolved with sterilised water for injection according to the following table to obtain a final concentration of 1 mg alteplase per ml.  For this purpose a transfer cannula is included with the pack-sizes of 50 mg. Instructions for reconstituting Actilyse  The 1mg/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 since the occurrence of turbidity of the reconstituted solution cannot be excluded. A further dilution of the 1mg/mL reconstituted solution with sterilised water for injections or in general, the use of carbohydrate infusion solutions, e.g. dextrose is not recommended due to increasing formation of turbidity of the reconstituted solution. ACTILYSE should not be mixed with other drugs, neither in the same infusion-vial nor the same venous line (not even with heparin). Traceability In order to improve traceability of biological medicinal products, the trade name and the batch number of the administered product should be clearly recorded in the patient file.