Metalyse 25 mg Adverse Reactions

As with other thrombolytic agents, haemorrhage is the most common adverse reaction 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.
Except for the occurrence of ADR reperfusion arrhythmias in the indication acute myocardial infarction and the frequency of ADR intracranial haemorrhage in the indication acute ischaemic stroke, the safety profile of Metalyse in the indication acute ischaemic stroke and acute myocardial infarction is regarded similar based on the outcome demonstrated by published academic clinical randomised trials and Real World Evidence (RWE) data.
List of adverse reactions: Immune system disorders: anaphylactoid reaction including rash, urticaria, bronchospasm, laryngeal oedema.
Nervous system disorders: intracranial haemorrhage such as cerebral haemorrhage, cerebral haematoma, haemorrhagic stroke, haemorrhagic transformation stroke, intracranial haematoma, subarachnoid haemorrhage.
Eye disorders: eye haemorrhage.
Cardiac disorders: pericardial haemorrhage.
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.