Actilyse Contraindications

Generally, in all indications ACTILYSE should not be administered to patients with known hypersensitivity to the active substance alteplase gentamicin (a trace residue from the manufacturing process) or to any of the excipients.
As with all thrombolytic agents, Actilyse should not be used in cases where there is a high risk of haemorrhage eg, significant bleeding disorder at present or within the past 6 months, known haemorrhagic diathesis; patients receiving oral anticoagulants eg, warfarin sodium (INR >1.3); any history of central nervous system damage (ie, neoplasm, aneurysm, intracranial or spinal surgery); history, evidence or suspicion of intracranial haemorrhage including sub-arachnoid haemorrhage; severe uncontrolled arterial hypertension; major surgery or significant trauma in the past 3 months (this includes any trauma associated with the current acute myocardial infarction), recent trauma of the head or cranium; prolonged or traumatic cardiopulmonary resuscitation (>2 min), obstetrical delivery within the past 10 days, recent puncture of a noncompressible blood vessel (eg, subclavian or jugular vein puncture); severe hepatic dysfunction, including hepatic failure, cirrhosis, portal hypertension (oesophageal varices) and active hepatitis; haemorrhagic retinopathy eg, in diabetes (vision disturbances may indicate haemorrhagic retinopathy) or other haemorrhagic ophthalmic conditions; bacterial endocarditis and pericarditis; acute pancreatitis; documented ulcerative gastrointestinal disease during the last 3 months; arterial aneurysms, arterial/venous malformations; neoplasm with increased bleeding risk.
The following contraindications apply where Actilyse is indicated: Acute Myocardial Infarction and Pulmonary Embolism: 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.
Acute Ischaemic Stroke: Symptoms of ischaemic attack which began >4.5 hrs prior to infusion or when the onset of symptom is unknown; symptoms of acute ischaemic stroke which were either rapidly improving or only minor prior to start of infusion; severe stroke assessed clinically (eg, 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; combination of previous stroke, 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 or diastolic blood pressure > 110 mmHg, or aggressive management (IV medication) necessary to reduce blood pressure to these limits; blood glucose < 50 or > 400 mg/dL.
Actilyse is not indicated for the therapy of acute stroke in children and adolescents under 18 years. For use in patients above 80 years of age, see Precautions.