Wirkstoffe & Arzneimittelsicherheit

Nebenwirkungen · Methylthioninium chloride Proveblue

Methylthioninium chloride Proveblue 5 mg/ml solution for injection · Abschnitt 4.8 · PDF-Seite 6–7

HOS-213668 · Präparat HOS-155158

6  System organ class Adverse reactions Frequency Blood and lymphatic system Methaemoglobinaemia, Not known disorders Hyperbilirubinaemia1 Not known Haemolytic anaemia Not known Immune system disorders Anaphylactic reactions Not known Psychiatric disorders Confusional state Not known Agitation Not known Nervous system disorders Dizziness Very common Headache Common Anxiety Common Tremor Not known Fever Not known Aphasia Not known Paraesthesia Very common Dysgeusia Very common Serotonin Syndrome with concomitant Not known use of serotonergic drugs (see section 4.4 and section 4.5). Eye disorders Mydriasis Not known Cardiac disorders Cardiac arrhythmia Not known Tachycardia Not known Vascular disorders Hypertension Not known Hypotension Not known Respiratory, thoracic and Dyspnoea Not known mediastinal disorders Tachypnoea Not known Hypoxia Not known Gastrointestinal disorders Nausea Very common Vomiting Common Abdominal pain Common Faeces discoloration (blue-green) Not known Skin and subcutaneous tissue Skin discoloration (blue) Very common disorders Sweating Very common Urticaria Not known Phototoxicity / Photosensitivity Not known Renal and urinary disorders Chromaturia (blue-green) Very common General disorders and Chest pain Common administration site conditions Local tissue necrosis at the injection site Not known Injection site pain Common Investigations Haemoglobin decreased Not known Musculoskeletal and connective Pain in extremity Very common tissue disorder 1 Reported in infants only

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