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Read time: 30 mins
Last updated: 06 May 2020
Published: 24 Jul 2020

4.1 Therapeutic indications

Thrombolytic treatment in acute myocardial infarction

- 90 minutes (accelerated) dose regimen (see section 4.2): for patients in whom treatment can be started within 6 hours after symptom onset

- 3 hour dose regimen (see section 4.2): for patients in whom treatment can be started between 6 - 12 hours after symptom onset provided that the diagnosis has been clearly confirmed.

Actilyse has proven to reduce 30-day-mortality in patients with acute myocardial infarction.

Thrombolytic treatment in acute massive pulmonary embolism with haemodynamic instability

The diagnosis should be confirmed whenever possible by objective means such as pulmonary angiography or non-invasive procedures such as lung scanning. There is no evidence for positive effects on mortality and late morbidity related to pulmonary embolism.

Fibrinolytic treatment of acute ischaemic stroke

Treatment must be started as early as possible within 4.5 hours after onset of stroke symptoms and after exclusion of intracranial haemorrhage by appropriate imaging techniques (e.g. cranial computerised tomography or other diagnostic imaging method sensitive for the presence of haemorrhage). The treatment effect is time-dependent; therefore earlier treatment increases the probability of a favourable outcome.

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Drug Licencing

Drugs appearing in this section are approved by UK Medicines & Healthcare Products Regulatory Agency (MHRA), & the European Medicines Agency (EMA).