Nebenwirkungen · Entresto
Entresto 6 mg/6 mg granules in capsules for opening Entresto 15 mg/16 mg granules in capsules for opening · Abschnitt 4.8 · PDF-Seite 32
HOS-134432 · Präparat HOS-097566
In the PANORAMA-HF study, the safety of sacubitril/valsartan was assessed in a randomised, active-controlled, 52-week study of 375 paediatric heart failure (HF) patients aged 1 month to <18 years compared to enalapril. The 215 patients who rolled over into the long-term open-label extension study (PANORAMA-HF OLE) were treated for a median of 2.5 years, for up to 4.5 years. The safety profile observed in both studies was similar to that observed in adult patients. Safety data in patients aged 1 month to <1 year was limited.
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Vollständigen Kontext in der EMA-Fachinformation lesen →Quellennachweis
Version 2026-01-13T10:33:00Z · SHA-256 63effd0dd78bf1b11f8cfe5ae77efc68b2653de13ba467bbf4e48289e340b97e · Passage a32fd0b26945cde6ca11b7b0152e2387913e307e008c884c17d35804b74ce8d9 · Zeichen 4866–5395 im Abschnitt