Metalyse Contraindications

Hypersensitivity to the active substance or to any of the excipients listed in Description or to gentamicin (a trace residue from the manufacturing process). If treatment with Metalyse is nevertheless considered to be necessary, facilities for resuscitation should be immediately available in case of need.
Furthermore, Metalyse is contraindicated in the following situations because thrombolytic therapy is associated with a higher risk of bleeding: Significant bleeding disorder either at present or within the past 6 months; Patients receiving effective oral anticoagulant treatment, e.g. warfarin sodium (INR >1.3) (see Bleeding under Precautions); Any history of central nervous system damage (i.e. neoplasm, aneurysm, intracranial or spinal surgery); Known haemorrhagic diathesis; Severe uncontrolled hypertension; Major surgery, biopsy of a parenchymal organ, or significant trauma within the past 2 months (this includes any trauma associated with the current AMI); Recent trauma to the head or cranium; Prolonged cardiopulmonary resuscitation (>2 minutes) within the past 2 weeks; Acute pericarditis and/or subacute bacterial endocarditis; Acute pancreatitis; Severe hepatic dysfunction, including hepatic failure, cirrhosis, portal hypertension (oesophageal varices) and active hepatitis; Active peptic ulceration; Arterial aneurysm and known arterial/venous malformation; Neoplasm with increased bleeding risk; Any known history of haemorrhagic stroke or stroke of unknown origin; Known history of ischaemic stroke or transient ischaemic attack in the preceding 6 months; Dementia.