Nebenwirkungen · Vimpat
Vimpat 10 mg/ml solution for infusion · Abschnitt 4.8 · PDF-Seite 74
HOS-119567 · Präparat HOS-094947
The safety profile of lacosamide in placebo-controlled (255 patients from 1 month to less than 4 years of age and 343 patients from 4 years to less than 17 years of age) and in open-label clinical studies (847 patients from 1 month to less than or equal to 18 years of age) in adjunctive therapy in paediatric patients with partial-onset seizures was consistent with the safety profile observed in adults. As data available in paediatric patients younger than 2 years of age is limited, lacosamide is not indicated in this age range. The additional adverse reactions observed in the paediatric population were pyrexia, nasopharyngitis, pharyngitis, decreased appetite, abnormal behaviour and lethargy. Somnolence was reported more frequently in the paediatric population (≥ 1/10) compared to the adult population (≥ 1/100 to < 1/10).
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