If serious bleeding occurs, terminate the Activase infusion, and treat appropriately. Hemorrhage can occur 1 or more days after administration of Activase, while patients are still receiving anticoagulant therapy. Because heparin, aspirin, or Activase may cause bleeding complications, carefully monitor for bleeding, especially at arterial puncture sites. The concomitant administration of heparin and aspirin with and following infusions of Activase for the treatment of acute ischemic stroke during the first 24 hours after symptom onset has not been investigated. Aspirin and heparin have been administered concomitantly with and following infusion with Activase in the management of acute myocardial infarction and pulmonary embolism. Fatal cases of hemorrhage associated with traumatic intubation in patients administered Activase have been reported. Perform venipunctures carefully and only as required. Avoid intramuscular injections and trauma to the patient. Important Safety Information Contraindicationsĭo 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 3 months) intracranial or intraspinal surgery or serious head trauma presence of intracranial conditions that may increase the risk of bleeding (e.g., some neoplasms, arteriovenous malformations, or aneurysms) bleeding diathesis and current severe uncontrolled hypertension.ĭo 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 3 months) 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.Īctivase can cause significant, sometimes fatal internal or external bleeding, especially at arterial and venous puncture sites. IV, intravenous SK, streptokinase SQ, subcutaneous. All patients also received chewable aspirin and heparin.īTwo-tailed P value is for comparison of Accelerated Activase to the respective SK control arm.
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