Nebenwirkungen · Baraclude
Baraclude 0.05 mg/ml oral solution · Abschnitt 4.8 · PDF-Seite 29
HOS-114643 · Präparat HOS-094121
The safety of entecavir in paediatric patients from 2 to < 18 years of age is based on two clinical trials in subjects with chronic HBV infection; one Phase 2 pharmacokinetic trial (study 028) and one Phase 3 trial (study 189). These trials provide experience in 195 HBeAg-positive nucleoside- treatment-naïve subjects treated with entecavir for a median duration of 99 weeks. The adverse reactions observed in paediatric subjects who received treatment with entecavir were consistent with those observed in clinical trials of entecavir in adults (see a. Summary of the safety profile and section 5.1) with the following exception in the paediatric patients: ▪ very common adverse reactions: neutropenia.
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