Wirkstoffe & Arzneimittelsicherheit

Nebenwirkungen · Vimpat

Treatment initiation pack (in adolescents and children weighing 50 kg or more and adults only) Vimpat 50 mg film-coated tablets Vimpat 100 mg film-coated tablets Vimpat 150 mg film-coated tablets Vimpat 200 mg film-coated tablets · Abschnitt 4.8 · PDF-Seite 32

HOS-119499 · 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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