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(Approval lapsed) ACTIVASE alteplase 50mg for intravenous use (USA)

Section 19A approved medicine
(Approval lapsed) ACTIVASE alteplase 50mg for intravenous use (USA)
Section 19A approval holder
Pro Pharmaceuticals Group Pty Ltd ABN: 20605457430
Phone
1300 077 674
Approved until
Status
Expired
Medicines in short supply/unavailable
ACTILYSE alteplase (rch) 50 mg powder for injection vial with diluent vial AUST R: 17905
Indication(s)

Myocardial Infarction

ACTILYSE is indicated for intravenous use in adults for the lysis of suspected occlusive coronary artery thrombi associated with evolving transmural myocardial infarction. Treatment should be initiated as soon as possible after the onset of symptoms. The treatment can be initiated within 12 hours of symptom onset.

Pulmonary Embolism

ACTILYSE is also indicated in patients with acute massive pulmonary embolism in whom thrombolytic therapy is considered appropriate.

Acute Ischaemic Stroke

ACTILYSE is indicated for thrombolytic 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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