Tenecteplase Recombinant Tissue Plasminogen Activator
Composition Indications How Supplied
Recombinant Tissue Plasminogen Activator (TNK-t-PA) 50 mg, as lyophilized powder to be reconstituted with 10 ml of sterile water for injection.
Elaxim (Tenecteplase) is indicated for use in the reduction of mortality associated with acute myocardial infarction (AMI).
Elaxim TNK-t-PA therapy in patients with acute myocardial infarction is contraindicated in the following situations because of an increased risk of bleeding:
• Active internal bleeding
• History of cerebrovascular accident
• Intracranial or intraspinal surgery or trauma within 2 months
• Intracranial neoplasm, arteriovenous malformation, or aneurysm
• Known bleeding diathesis
• Severe uncontrolled hypertension
• Prior hypersensitivity to TNK-t-PA
Elaxim TNK-t-PA is supplied as a sterile lyophilized powder in a vial under partial vacuum.
Each Elaxim TNK-t-PA vial is packaged with one 10 ml vial of sterile water for injection for reconstitution.
Store lyophilized Elaxim TNK-t-PA at 2-8 C°.