METALYSE is contraindicated in: patients with known hypersensitivity to the active substance tenecteplase, gentamicin (a trace residue from the manufacturing process) or to any of the excipients.
Situations associated with a risk of bleeding such as: Significant bleeding disorder at present or within the past 6 months, known haemorrhagic diathesis, any history of central nervous system damage (i.e. neoplasm, aneurysm, intracranial or spinal surgery).
Severe uncontrolled arterial hypertension (see Precautions).
Severe hepatic dysfunction, including hepatic failure, cirrhosis, portal hypertension (oesophageal varices) and active hepatitis.
Active ulcerative gastro-intestinal disease.
Known arterial aneurysm and/or arterial/venous malformation.
Neoplasm with increased bleeding risk.
Bacterial endocarditis, pericarditis.
Acute pancreatitis.
Haemorrhagic stroke or stroke of unknown origin at any time.
Patients receiving effective oral anticoagulant treatment (e.g. vitamin K antagonists with INR >1.3) (see Bleeding under Precautions).
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.