Nebenwirkungen · Sovaldi
Sovaldi 400 mg film-coated tablets Sovaldi 200 mg film-coated tablets · Abschnitt 4.8 · PDF-Seite 16
HOS-129830 · Präparat HOS-096803
Paediatric population The safety and efficacy of Sovaldi in paediatric patients aged 3 years and above are based on data from 106 patients who were treated with Sovaldi and ribavirin for 12 weeks (genotype 2 patients) and for 24 weeks (genotype 3 patients) in a Phase 2, open-label clinical trial. No adverse drug reactions specific to Sovaldi have been identified. The adverse reactions observed were generally consistent with those observed in clinical studies of Sovaldi plus ribavirin in adults (see Table 6). Decreased appetite was observed as a very common adverse drug reaction to Sovaldi when given in combination with ribavirin oral solution in paediatric patients aged 3 to < 12 years.
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