General: Hemorrhagic cerebral infarction may occur in patients receiving this product. Therefore, the patient should be thoroughly examined by means of computed tomography and clinical assessments be made with regard to the status of onset of the symptoms and clinical manifestations, and the use of this product should be avoided in patients with a possibility of cerebral embolism or with a risk of bleeding.
Since the use of this product is accompanied by an increased risk of hemorrhage, it must be ascertained beforehand whether hemorrhage is present or not, and patients receiving this product should be carefully monitored frequently by hematologic examinations such as blood coagulability (bleeding time, prothrombin time, and the like) and observed for clinical signs. If intracerebral hemorrhage is suspected, urokinase therapy should be withdrawn immediately. Intracerebral hemorrhage is ascertained by means of computed tomography as a rule. If CT is not available, this product should be administered only when findings from a cerebrospinal fluid examination and observation of clinical signs and symptoms indicate absence of any hemorrhagic lesion.
Administration to elderly patients: Carefully administer this drug to elderly patients as a risk of hemorrhage may be enhanced.
Pediatric Use: Safety in children has not been established. (Adequate well-controlled clinical studies in children have not been performed.)