Urokinase-Green Cross Special Precautions

General precautions: 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 If intracerebral hemorrhage is suspected, urokinase therapy should be withdrawn immediately.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.
Careful Administration: Patients with hemorrhage: under surgical treatments such as operations (including hepatic, renal biopsies), hemorrhagic oculopathy such as diabetic hemorrhagic retinopathy, hemorrhage of the digestive tract, hemorrhage of the urinary tract, abortion or premature delivery, immediately after child delivery, during menstruation, and the like.
Patients with possible hemorrhage: ulcers of the digestive tract, diverticulitis of the digestive tract, colitis, serious hypertension, active tuberculosis, a history of intracranial hemorrhage and the like.
Patients receiving treatment with anticoagulants.
Patients with serious hepatic or renal disturbances.
Patients with intractable hypocoagulability: coagulation factor deficiency, thrombocytopenia, and the like.
Patients with a history of hypersensitivity to this product or tissue culture urokinase.
Use in Pregnancy: In view of the fibrinolytic properties intrinsic in urokinase, it seems possible that premature separation of the placenta may occur. Therefore, the product should only be used in pregnant women or women suspected of being pregnant, provided that the expected therapeutic benefits are evaluated to outweigh the possible risks associated with treatment.
Use in Children: Safety in children has not been established. (Adequate well-controlled clinical studies in children have not been performed.)
Use in Elderly: Carefully administer this drug to elderly patients as a risk of hemorrhage may be enhanced.