Nebenwirkungen · Ecalta
ECALTA 100 mg powder for concentrate for solution for infusion · Abschnitt 4.8 · PDF-Seite 7
HOS-208914 · Präparat HOS-154205
The safety of anidulafungin was investigated in 68 paediatric patients (1 month to < 18 years) with invasive candidiasis including candidaemia (ICC) in a prospective, open-label, non-comparative paediatric study (see section 5.1). The frequencies of certain hepatobiliary adverse events, including alanine aminotransferase (ALT) increased and aspartate aminotransferase (AST) increased appeared at a higher frequency (7-10%) in these paediatric patients than has been observed in adults (2%). Although chance or differences in underlying disease severity may have contributed, it cannot be excluded that hepatobiliary adverse reactions occur more frequently in paediatric patients compared to adults.
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Vollständigen Kontext in der EMA-Fachinformation lesen →Quellennachweis
Version 2025-09-09T11:03:00Z · SHA-256 097242f9762e0489f279b42d9538ddfb4f0c8bed589c1b1580de18accd48be17 · Passage 1c9be5ece15fdb17274dd4f6e1cef2eced0af898c966ca175c92e0b4b3e36c1b · Zeichen 3669–4369 im Abschnitt