Thrombolytic therapy is associated with a risk of bleeding. METALYSE is contraindicated in the following situations: Significant bleeding disorder at present or within the past 6 months, known haemorrhagic diathesis.
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).
Severe uncontrolled arterial 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 or traumatic cardiopulmonary resuscitation (>2 minutes) within the past 2 weeks.
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.
Acute pericarditis and/or subacute bacterial endocarditis.
Hypersensitivity to the active substance tenecteplase, gentamicin (a trace residue from the manufacturing process) or to any of the excipients.
Haemorrhagic stroke or stroke of unknown origin at any time.
Ischaemic stroke or transient ischaemic attack (TIA) in the preceding 6 months.