As with other thrombolytic agents, haemorrhage is the most common undesirable effect associated with the use of METALYSE. Haemorrhage at any site or body cavity can occur and may result in life-threatening situations, permanent disability or death.
The type of haemorrhage associated with thrombolytic therapy can be divided into two broad categories: Superficial bleeding, normally from injection sites; internal bleeding at any site or body cavity.
With intracranial haemorrhage neurological symptoms such as somnolence, aphasia, hemiparesis, convulsion may be associated.
Immune System Disorders: Anaphylactoid reaction including rash, urticaria,bronchospasm,laryngeal oedema.
Nervous System Disorders: Intracranial haemorrhage such as cerebral haemorrhage, cerebral haematoma, haemorrhagic stroke, intracranial haematoma, subarachnoid haemorrhage.
Eye Disorders: Eye haemorrhage.
Cardiac Disorders: Reprefusion arrhyhmia such as asystole, accelerated idioventricular arrhythmia, arrhythmia, extrasystoles, atrial fibrillation, atrioventricular block first degree-atrioventricular block complete, bradycardia, tachycardia, ventricular arrhythmia, ventricular fibrillation, ventricular tachycardia occur in close temporal relationship to treatment with METALYSE.
Reperfusion arrhythmias may lead to cardiac arrest, can be life threatening and may require the use of conventional arrhythmic therapies.
Vascular Disorders: Haemorrhage, embolism.
Respiratory, Thoracic and Mediastinal Disorders: Epistaxis, pulmonary haemorrhage.
Gastrointestinal Disorders: Gastrointestinal haemorrhage such as gastric haemorrhage, gastric ulcer haemorrhage, rectal haemorrhage, haematemesis, melaena, mouth haemorrhage. Nausea, vomiting, retroperitoneal haemorrhage such as retroperitoneal haematoma.
Skin and Subcutaneous Tissue Disorders: Ecchymosis.
Renal and Urinary Disorders: Urogenital haemorrhage such as haematuria, haemorrhage urinary tract.
General Disorders and Administration Site Conditions: Injection site haemorrhage, puncture site haemorrhage.
Investigations: Blood pressure decreased, body temperature increased.
Injury, Poisoning and Procedural Complications: Fat embolism, which may lead to corresponding consequences in the organs concerned.
Surgical and Medical Procedures: Transfusion.