Wirkstoffe & Arzneimittelsicherheit

Nebenwirkungen · Reagila

Reagila 1.5 mg orodispersible tablets Reagila 3 mg orodispersible tablets Reagila 4.5 mg orodispersible tablets Reagila 6 mg orodispersible tablets · Abschnitt 4.8 · PDF-Seite 29

HOS-129609 · Präparat HOS-096751

QT- prolongation With cariprazine no QT interval prolongation was detected compared to placebo in a clinical study designed to assess QT prolongation (see section 5.1). In other clinical studies, only a few, non-serious, QT-prolongations have been reported with cariprazine. During the long-term, open-label treatment period in, 3 patients (0.4%) had QTcB > 500 msec, one of whom also had QTcF > 500 msec. A > 60 msec increase from baseline was observed in 7 patients (1%) for QTcB and in 2 patients (0.3%) for QTcF. In the long-term, maintenance of effect study, during the open-label phase, > 60 msec increase of from baseline was observed in 12 patients (1.6%) for QTcB and in 4 patients (0.5%) for QTcF. During the double-blind treatment period, > 60 msec increases from baseline in QTcB were observed in 3 cariprazine-treated patients (3.1%) and 2 placebo-treated patients (2%).

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