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Acute Myocardial Infarction or Pulmonary Embolism

Activase therapy in patients with acute myocardial infarction or pulmonary embolism is contraindicated in the following situations because of an increased risk of bleeding:

•    Active internal bleeding
•     History of cerebrovascular accident
•     Recent intracranial or intraspinal surgery or trauma (see WARNINGS)
•     Intracranial neoplasm, arteriovenous malformation, or aneurysm
•     Known bleeding diathesis
•     Severe uncontrolled hypertension

Acute Ischemic Stroke

Activase therapy in patients with acute ischemic stroke is contraindicated in the following situations because of an increased risk of bleeding, which could result in significant disability or death:

•     Evidence of intracranial hemorrhage on pretreatment evaluation
•     Suspicion of subarachnoid hemorrhage on pretreatment evaluation
•     Recent (within 3 months) intracranial or intraspinal surgery, serious head trauma, or previous stroke
•     History of intracranial hemorrhage
•     Uncontrolled hypertension at time of treatment (e.g., > 185 mm Hg systolic or > 110 mm Hg diastolic)
•     Seizure at the onset of stroke
•     Active internal bleeding
•     Intracranial neoplasm, arteriovenous malformation, or aneurysm
•     Known bleeding diathesis including but not limited to:

—  Current use of oral anticoagulants (e.g., warfarin sodium) or an International Normalized Ratio (INR) > 1.7 or a prothrombin time (PT) > 15 seconds
— Administration of heparin within 48 hours preceding the onset of stroke and have an elevated activated partial thromboplastin time (aPTT) at presentation
—  Platelet count < 100,000/mm³

REFERENCES

14. Aylward P, Wilcox R, Horgan J, White H, Granger C, Califf R, et al. for the GUSTO-I Investigators. Relation of increased arterial blood pressure to mortality and stroke in the context of contemporary thrombolytic therapy for acute myocardial infarction: a randomized trial. Ann Int Med. 1996;125:891-900.

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