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Learn more about Activase® (Alteplase) for Acute Ischemic Stroke Treatment. Indications Activase (alteplase) is indicated for the treatment of acute ischemic stroke. Exclude intracranial hemorrhage as the primary cause of stroke signs and symptoms prior to initiation of treatment. Initiate treatment as soon as possible but within 3 hours after symptom onset. Activase is indicated for use in acute myocardial infarction (AMI) for the reduction of mortality and reduction of the incidence of heart failure. Limitation of Use: The risk of stroke may outweigh the benefit produced by thrombolytic therapy in patients whose AMI puts them at low risk for death or heart failure. Activase is indicated for the lysis of acute massive pulmonary embolism (PE), defined as: • Acute pulmonary emboli obstructing blood flow to a lobe or multiple lung segments. • Acute pulmonary emboli accompanied by unstable hemodynamics, e.g.,failure to maintain blood pressure without supportive measures. Important Safety Information Contraindications Do not administer Activase to treat acute ischemic stroke in the following situations in which the risk of bleeding is greater than the potential benefit: current intracranial hemorrhage (ICH); subarachnoid hemorrhage; active internal bleeding; recent (within 3months) intracranial or intraspinal surgery or serious head trauma; presence of intracranial conditions that may increase the risk of bleeding; bleeding diathesis; and current severe uncontrolled hypertension. Do not administer Activase to treat acute myocardial infarction or pulmonary embolism in the following situations in which the risk of bleeding is greater than the potential benefit: active internal bleeding; history of recent stroke; recent (within 3months) intracranial or intraspinal surgery or serious head trauma; presence of intracranial conditions that may increase the risk of bleeding; bleeding diathesis; and current severe uncontrolled hypertension. Warnings and Precautions Bleeding Activase can cause significant, sometimes fatal, internal or external bleeding, especially at arterial and venous puncture sites.Avoid intramuscular injections and trauma to the patient. Fatal cases of hemorrhage associated with traumatic intubation in patients administered Activase have been reported. Heparin, aspirin, or Activase may cause bleeding complications; therefore carefully monitor for bleeding. If serious bleeding occurs, terminate the Activase infusion. Orolingual Angioedema Monitor patients during and for several hours after infusion for orolingual angioedema. If angioedema develops, discontinue the Activase infusion and promptly institute appropriate therapy. Cholesterol Embolization Cholesterol embolism, sometimes fatal, has been reported rarely in patients treated with thrombolytic agents. Reembolization of Deep Venous Thrombi during Treatment for Acute Massive Pulmonary Embolism Consider the possible risk of reembolization due to the lysis of underlying deep venous thrombi patients with acute massive PE Coagulation Tests May be Unreliable during Activase Therapy Coagulation tests and/or measures of fibrinolytic activity may be unreliable during Activase therapy. Adverse Reactions The most frequent adverse reaction associated with Activase therapy is bleeding. Allergic‑type reactions, e.g.,anaphylactoid reaction, laryngeal edema, orolingual angioedema, rash, and urticaria have been reported.

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