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alteplase (Actilyse)


following a full submission:

alteplase (Actilyse®) is accepted for use within NHS Scotland.

Indication under review: the fibrinolytic treatment of acute ischaemic stroke. Treatment must be started as early as possible within 4.5 hours after onset of the 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).

Evidence for the extension of the time window in which alteplase can be administered is from  a placebo-controlled study.  Alteplase treatment resulted in significantly more patients having no symptoms or no significant disabling symptoms at three months compared to placebo.

Drug Details

Drug Name: alteplase (Actilyse)
SMC Drug ID: 714/11
Manufacturer: Boehringer Ingelheim Ltd
Indication: For the fibrinolytic treatment of acute ischaemic stroke, commenced within 3 to 4.5 hours of stroke symptom onset and after prior exclusion of intracranial haemorrhage by means of appropriate imaging techniques (extension licence of 3 hour time limit).
BNF Category:
Sub Category: 2.10 Myocardial infarction and fibrinolysis
Submission Type: Full submission
Status: Accepted
Date Advice Published: 11 June 2012