Nebenwirkungen · Briviact (in Italy: Nubriveo)
Briviact 10 mg film-coated tablets Briviact 25 mg film-coated tablets Briviact 50 mg film-coated tablets Briviact 75 mg film-coated tablets Briviact 100 mg film-coated tablets · Abschnitt 4.8 · PDF-Seite 10–11
HOS-132751 · 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 10 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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Vollständigen Kontext in der EMA-Fachinformation lesen →Quellennachweis
Version 2025-05-19T16:24:00Z · SHA-256 8b43e201402e087df36cd28aad896b8b68dd1973b788cdf0991029210330f8cc · Passage 4da48aac648cfe72943e21e80a506578ad9eed28946bec5945ba98cb71e462b7 · Zeichen 3611–4327 im Abschnitt