Wirkstoffe & Arzneimittelsicherheit

Nebenwirkungen · Metalyse

Metalyse 8 000 units (40 mg) powder and solvent for solution for injection Metalyse 10 000 units (50 mg) powder and solvent for solution for injection · Abschnitt 4.8 · PDF-Seite 6–7

HOS-091185 · Präparat HOS-084225

6 Table 1 displays the frequency of adverse reactions. System organ class Adverse reaction Immune system disorders Rare Anaphylactoid reaction (including rash, urticaria, bronchospasm, laryngeal oedema) Nervous system disorders Uncommon Intracranial haemorrhage (such as cerebral haemorrhage, cerebral haematoma, haemorrhagic stroke, haemorrhagic transformation stroke, intracranial haematoma, subarachnoid haemorrhage) including associated symptoms as somnolence, aphasia, hemiparesis, convulsion Eye disorders Uncommon Eye haemorrhage Cardiac disorders Uncommon Reperfusion arrhythmias (such as asystole, accelerated idioventricular arrhythmia, arrhythmia, extrasystoles, atrial fibrillation, atrioventricular first degree to atrioventricular block complete, bradycardia, tachycardia, ventricular arrhythmia, ventricular fibrillation, ventricular tachycardia) occur in close temporal relationship to treatment with tenecteplase. Rare Pericardial haemorrhage Vascular disorders Very common Haemorrhage Rare Embolism (thrombotic embolisation) Respiratory, thoracic and mediastinal disorders Common Epistaxis Rare Pulmonary haemorrhage Gastrointestinal disorders Common Gastrointestinal haemorrhage (such as gastric haemorrhage, gastric ulcer haemorrhage, rectal haemorrhage, haematemesis, melaena, mouth haemorrhage) Uncommon Retroperitoneal haemorrhage (such as retroperitoneal haematoma) Not known Nausea, vomiting Skin and subcutaneous tissue disorders Common Ecchymosis Renal and urinary disorders Common Urogenital haemorrhage (such as haematuria, haemorrhage urinary tract) General disorders and administration site conditions Common Injection site haemorrhage, puncture site haemorrhage Investigations Rare Blood pressure decreased Not known Body temperature increased Injury, poisoning and procedural complications Not known Fat embolism, which may lead to corresponding consequences in the organs concerned

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