Alteplase

Alteplase is indicated for the 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.

Alteplase is indicated for the 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.

Alteplase is indicated for thrombolytic treatment in acute myocardial infarction.

90 minutes (accelerated) dose regimen: for patients in whom treatment can be started within 6 h after symptom onset.

3 h dose regimen: for patients in whom treatment can be started between 6-12 h after symptom onset provided that the diagnosis has been clearly confirmed.

Alteplase is contraindicated in cases where there is a high risk of haemorrhage such as:

• significant bleeding disorder at present or within the past 6 months
• known haemorrhagic diathesis
• patients receiving effective oral anticoagulant treatment, e.g. warfarin sodium (see section 4.4)
• manifest or recent severe or dangerous bleeding
• known history of or suspected intracranial haemorrhage
• suspected subarachnoid haemorrhage or condition after subarachnoid haemorrhage from aneurysm
• any history of central nervous system damage (i.e. neoplasm, aneurysm, intracranial or spinal surgery)
• recent (less than 10 days) traumatic external heart massage, obstetrical delivery, recent puncture of a noncompressible blood-vessel (e.g. subclavian or jugular vein puncture)

Alteplase is contraindicated in cases of severe uncontrolled arterial hypertension.

Alteplase is contraindicated in cases of documented ulcerative gastrointestinal disease during the last 3 months, oesophageal varices, arterial-aneurysm, arterial/venous malformations.

Alteplase is contraindicated in cases of severe liver disease, including hepatic failure, cirrhosis, portal hypertension (oesophageal varices) and active hepatitis.

Alteplase is contraindicated in cases of neoplasm with increased bleeding risk.

Alteplase is contraindicated in cases of acute pancreatitis.

Alteplase is contraindicated in cases of bacterial endocarditis, pericarditis.