Dosage: 10% ml of the XY mg as IV Bolus, Remainder ml as IV infusion over 1 hour.

Therapeutic indications®:

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 favorable outcome.

Contraindications®:

Generally, in all indications Actilyse should not be administered to patients with known hypersensitivity to the active substance alteplase, gentamicin (a trace residue from the manufacturing process) or to any of the excipients listed in section 6.1.

Major Contraindications®

1. Paediatric patients <18 years and more than 80.
2. Symptoms of Ischemic attack beginning >4.5 hours prior to infusion start or time of symptom onset is unknown.
3. Very mild Strokes, as the risks outweigh the benefit
4. Minor neurological deficit or symptoms rapidly improving before start of infusion
5. Severe Stroke as assessed clinically (e.g. NIHSS >25) and/or by appropriate imaging techniques.
6. Seizure at onset of Stroke
7. Evidence of intracranial hemorrhage (ICH) on the CT-scan
8. Symptoms suggestive of subarachnoid hemorrhage, even if CT-scan is normal
9. Administration of heparin within the previous 48 hours and a thromboplastin time exceeding the upper limit of normal for laboratory
10. Any history of prior Stroke and concomitant diabetes
11. Prior Stroke within the last 3 months
12. A platelet count of below 100,000/mm³
13. Systolic blood pressure >185 or diastolic BP > 110 mmHg, or aggressive management necessary to reduce BP to these limits
14. Blood glucose 400 mg/dl Recent major surgery in the past 3 months.

Please refer to the local SMPC for the full list of contraindications.

Actilys® (alteplase) Summary of product Characteristics March 2019.

Document ID: PC-AE-101771