Wirkstoffe & Arzneimittelsicherheit

Nebenwirkungen · Evoltra

Evoltra 1 mg/ml concentrate for solution for infusion · Abschnitt 4.8 · PDF-Seite 10

HOS-114456 · Präparat HOS-094089

Pericardial effusion and pericarditis were reported as an adverse event in 9% (10/115) of patients. Three of these events were subsequently assessed as being related to clofarabine: pericardial effusion (2 events; 1 of which was serious) and pericarditis (1 event; not serious). In the majority of patients (8/10), the pericardial effusion and pericarditis were deemed to be asymptomatic and of little or no clinical significance on echocardiographic assessment. However, the pericardial effusion was clinically significant in 2 patients with some associated haemodynamic compromise.

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