Nebenwirkungen · Briviact (in Italy: Nubriveo)
Briviact 10 mg/ml oral solution · Abschnitt 4.8 · PDF-Seite 30
HOS-132787 · Präparat HOS-097290
The safety profile of brivaracetam observed in children from 1 month of age was consistent with the safety profile observed in adults. In the open label, uncontrolled, long-term studies suicidal ideation was reported in 4.7 % of paediatric patients (assessed from 6 years onwards, more common in adolescents) compared with 2.4 % of adults and behavioural disorders were reported in 24.8 % of paediatric patients compared with 15.1 % of adults. The majority of events were mild or moderate in intensity, were non-serious, and did not lead to discontinuation of study drug. An additional adverse reaction reported in children was psychomotor hyperactivity (4.7 %).
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Version 2025-05-19T16:24:00Z · SHA-256 8b43e201402e087df36cd28aad896b8b68dd1973b788cdf0991029210330f8cc · Passage f844534bc94070ac7f846ba5a651bcb6cf4bc4d7cfb107feeaa7089872809397 · Zeichen 3705–4367 im Abschnitt