Nebenwirkungen · Evoltra
Evoltra 1 mg/ml concentrate for solution for infusion · Abschnitt 4.8 · PDF-Seite 8
HOS-114448 · Präparat HOS-094089
Adverse reactions considered to be related to clofarabine reported at frequencies ≥ 1/1,000 (i.e. in > 1/115 patients) in clinical trials and post-marketing Infections and infestations Common: Septic shock*, sepsis, bacteraemia, pneumonia, herpes zoster, herpes simplex, oral candidiasis Frequency not known: C. difficile colitis Neoplasms benign and malignant Common: Tumour lysis syndrome* (including cysts and polyps) Blood and lymphatic system disorders Very common: Febrile neutropaenia Common: Neutropaenia Immune system disorders Common: Hypersensitivity Metabolism and nutrition disorders Common: Anorexia, decreased appetite, dehydration Frequency not known: hyponatremia Psychiatric disorders Very common: Anxiety Common: Agitation, restlessness, mental status change Nervous system disorders Very common: Headache Common: Somnolence, peripheral neuropathy, paraesthesia, dizziness, tremor Ear and labyrinth disorders Common: Hypoacusis Cardiac disorders Common: Pericardial effusion*, tachycardia* Vascular disorders Very common: Flushing*
Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.
Vollständigen Kontext in der EMA-Fachinformation lesen →Quellennachweis
Version 2024-07-19T13:13:00Z · SHA-256 b6c4c8e2a08241633a344425bddf0c7c67b8e36cf88774f3228bedc236be1d69 · Passage 1c8a0df5b3730ee65f94a46f14dcc360a9ecb708cf995af194dac9be9295d9a8 · Zeichen 2157–3807 im Abschnitt