ACTILYSE

Actilyse should be prescribed by physicians experienced in the use of thrombolytic treatment and with the facilities to monitor that 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. 25 ml/kg bw 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.

75 ml/kg bw 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. 6.

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. 75 ml/kg bw 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.

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. 6. 3 and

The most frequent adverse reaction associated with Actilyse is bleeding in different forms resulting in a fall in haematocrit and/or haemoglobin values. Adverse reactions listed below are classified according to frequency and system organ class.

Frequency groupings are defined according to the following convention:

Very common (≥1/10), Common (≥1/100 to <1/10), Uncommon (≥1/1 000 to <1/100), Rare (≥1/10 000 to <1/1 000), Very rare (<1/10 000), Not known (cannot be estimated from the available data). Except for intracerebral/intracranial haemorrhage as adverse reaction in the indication stroke as well as for reperfusion arrhythmias in the indication acute myocardial infarction, there is no medical reason to assume that the qualitative and quantitative adverse reaction profile of Actilyse in the indications acute massive pulmonary embolism and acute ischaemic stroke is different from the profile in the indication acute myocardial infarction.

g. g. g. 5 **Cardiac disorders As with other thrombolytic agents, the events described above under the respective section have been reported as sequelae of myocardial infarction and / or thrombolytic administration. These cardiac events can be life-threatening and may lead to death.

***Frequency calculation This adverse reaction has been observed in post-marketing experience. With 95 % certainty, the frequency category is not greater than “rare” but might be lower. Precise frequency estimation is not possible as the adverse drug reaction did not occur in a clinical trial database of 8299 patients.

Death and permanent disability are reported in patients who have experienced stroke (including intracranial bleeding) and other serious bleeding episodes. Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important.

It allows continued monitoring of the benefit/risk balance of the medicinal product. uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

4. 5 hours after last known well and after exclusion of intracranial haemorrhage by appropriate imaging techniques. The treatment effect is time-dependent; therefore, earlier treatment increases the probability of a favourable outcome.

1). 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. 0 *given in a concentration of 1mg/mL over 60 min as a constant rate infusion.

Adjunctive therapy Drugs affecting coagulation/platelet function 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 after treatment with Actilyse 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. 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. 6. Paediatric population There is limited experience with the use of Actilyse in children and adolescents.

3). 4 for recommendations on prior imaging techniques to be used). 1. e. g. 4) • bacterial endocarditis, pericarditis • acute pancreatitis • active ulcerative gastrointestinal disease, oesophageal varices, known arterial- aneurysm and/or arterial/venous malformation • neoplasm with increased bleeding risk • severe liver disease, including hepatic failure, cirrhosis, portal hypertension (oesophageal varices) and active hepatitis • major surgery or significant trauma in past 3 months.

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1. e. g. 4) • bacterial endocarditis, pericarditis • acute pancreatitis • active ulcerative gastrointestinal disease, oesophageal varices, known arterial- aneurysm and/or arterial/venous malformation • neoplasm with increased bleeding risk • severe liver disease, including hepatic failure, cirrhosis, portal hypertension (oesophageal varices) and active hepatitis • major surgery or significant trauma in past 3 months.

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