ACTILYSE is contraindicated in: patients with known hypersensitivity to the active substance alteplase, gentamicin (a trace residue from the manufacturing process) or to any of the excipients; cases where there is a high risk of haemorrhage such as: significant bleeding disorder at present or within the past 6 months, known haemorrhagic diathesis; patients receiving effective oral anticoagulants treatment, e.g. warfarin sodium (INR> 1.3) (please see Bleeding under Precautions); any history of central nervous system damage (i.e. neoplasm, aneurysm, intracranial or spinal surgery); history or evidence or suspicion of intracranial haemorrhage including sub-arachnoid haemorrhage; severe uncontrolled arterial hypertension; major surgery or significant trauma in the past 10 days (this includes any trauma associated with the current acute myocardial infarction), recent trauma to head or cranium; prolonged or traumatic cardiopulmonary resuscitation (> 2 minutes), obstetrical delivery, within the past 10 days, recent puncture of a non-compressible blood-vessel (e.g. subclavian or jugular vein puncture); severe hepatic dysfunction, including hepatic failure, cirrhosis, portal hypertension (oesophageal varices) and active hepatitis; bacterial endocarditis, pericarditis; acute pancreatitis; documented ulcerative gastro-intestinal disease during the last 3 months; arterial aneurysms, arterial/venous malformations; neoplasm with increased bleeding risk.
In the indication of acute myocardial the following contraindications apply in addition: Haemorrhagic stroke or stroke of unknown origin at any time; Ischaemic stroke or transient ischaemic attack (TIA) in the preceding 6 months, except current acute ischaemic stroke within 4.5 hours.
In the indication of acute massive pulmonary embolism the following contraindications apply in addition: Haemorrhagic stroke or stroke of unknown origin at any time; Ischaemic stroke or transient ischaemic attack (TIA) in the preceding 6 months, except current acute ischaemic stroke within 4.5 hours.
In the indication acute ischaemic stroke the following contraindications apply in addition: symptoms of ischaemic attack began more than 4.5 hours prior to infusion start or when time of symptom onset is unknown; symptoms of acute ischaemic stroke that were either rapidly improving or only minor before start of infusion; severe stroke as assessed clinically (e.g. NIHSS > 25) and/or by appropriate imaging techniques; seizure at the onset of stroke; history of previous stroke or serious head-trauma within three months; a combination of previous stroke and diabetes mellitus; administration of heparin within 48 hours preceding the onset of stroke with an elevated activated partial thromboplastin time (aPTT) at presentation; platelet count of less than 100,000/mm3; systolic blood pressure > 185 mmHg or diastolic blood pressure > 110 mmHg, or aggressive management (IV medication) necessary to reduce blood pressure to these limits; blood glucose < 50 mg/dL or > 400 mg/dL; children under 16 years of age (for children ≥ 16 years of age see Precautions).