Alteplase

ACTIVASE rt-PA (alteplase for injection) is indicated for intravenous use in adults for: 1) the lysis of suspected occlusive coronary artery thrombi associated with evolving transmural myocardial infarction; and 2) the reduction of mortality associated with acute myocardial infarction (AMI), the improvement of ventricular function following AMI and the reduction in the incidence of congestive heart failure.

Treatment should be initiated as soon as possible after the onset of acute myocardial symptoms. Greater benefit appears to be associated with earlier treatment of ACTIVASE rt-PA, following the onset of symptoms. ACTIVASE rt-PA is effective in patients in whom therapy is initiated within six (6) hours of onset of symptoms for the accelerated infusion regimen or up to twelve (12) hours after onset of symptoms for the 3-hour infusion regimen.

The GUSTO study was designed to enrol patients within a 6-hour period following the onset of myocardial infarct symptoms. The data available from this trial are insufficient to support a recommendation for use of the accelerated infusion regimen in patients presenting more than six (6) hours after the onset of symptoms.

Thrombolytic treatment of occluded central venous access devices including those used for haemodialysis The 2 mg vial is the only recommended presentation of alteplase for use in this indication.