Wirkstoffe & Arzneimittelsicherheit

Nebenwirkungen · Halaven

HALAVEN 0.44 mg/ml solution for injection · Abschnitt 4.8 · PDF-Seite 6–7

HOS-124170 · Präparat HOS-095809

6 System Organ Adverse Reactions – all Grades Class Very Common Common Uncommon Rare or not (Frequency %) (Frequency %) (Frequency %) known Metabolism and Decreased appetite Hypokalaemia (6.8%) nutrition (22.5%) (G3/4: 0.7%)d (G3/4: 2.0%) disorders Hypomagnesaemia (2.8%) (G3/4: 0.3%) Dehydration (2.8 %) (G3/4: 0.5%)d Hyperglycaemia Hypophosphataemia Hypocalcaemia Psychiatric Insomnia disorders Depression Nervous system Peripheral neuropathyc Dysgeusia disorders (35.9%) (G3/4: 7.3%) Dizziness (9.0%) Headache (17.5%) (G3/4: 0.4%)d (G3/4: 0.7%) Hypoaesthesia Lethargy Neurotoxicity Eye disorders Lacrimation increased (5.8%) (G3/4: 0.1%)d Conjunctivitis Ear and labyrinth Vertigo disorders Tinnitus Cardiac disorders Tachycardia Vascular Hot flush Deep vein thrombosis disorders Pulmonary embolism (1.3%) (G3/4: 1.1%)a Respiratory, Dyspnoea (15.2%)a Oropharyngeal pain Interstitial lung thoracic and (G3/4: 3.5%)a Epistaxis disease (0.2%) (G3/4: mediastinal Cough (15.0%) (G3/4: Rhinorrhoea 0.1%) disorders 0.5%)d Gastrointestinal Nausea (35.7%) (G3/4: Abdominal pain Mouth ulceration disorders 1.1%)d Stomatitis (11.1%) Pancreatitis Constipation (22.3%) (G3/4: 1.0%)d (G3/4: 0.7%)d Dry mouth Diarrhoea (18.7%) Dyspepsia (6.5%) (G3/4: 0.8%) (G3/4: 0.3%)d Vomiting (18.1%) Gastrooesophageal (G3/4: 1.0%) reflux disease Abdominal distension Hepatobiliary Aspartate Hepatotoxicity disorders aminotransferase (0.8%) (G3/4: 0.6%) increased (7.7%) (G3/4: 1.4%)d Alanine aminotransferase increased (7.6%) (G3/4: 1.9%)d Gamma glutamyl transferase increased (1.7%) (G3/4: 0.9%)d Hyperbilirubinaemia (1.4%) (G3/4: 0.4%)

Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.