Nebenwirkungen · Xeplion
Xeplion 150 mg and Xeplion 100 mg prolonged release suspension for injection · Abschnitt 4.8 · PDF-Seite 32–33
HOS-124294 · Präparat HOS-095825
32 Injury, poisoning fall and procedural complications a The frequency of adverse reactions is qualified as “not known” because they were not observed in paliperidone palmitate clinical trials. They were either derived from spontaneous post-marketing reports and frequency cannot be determined, or they were derived from risperidone (any formulation) or oral paliperidone clinical trials data and/or post-marketing reports. b Refer to ‘Hyperprolactinaemia’ below. c Refer to ‘Extrapyramidal symptoms’ below. d In placebo-controlled trials, diabetes mellitus was reported in 0.32% in Xeplion-treated subjects compared to a rate of 0.39% in placebo group. Overall incidence from all clinical trials was 0.65% in all Xeplion treated subjects. e Insomnia includes: initial insomnia, middle insomnia; Convulsion includes: grand mal convulsion; Oedema includes: generalised oedema, oedema peripheral, pitting oedema. Menstrual disorder includes: menstruation delayed, menstruation irregular, oligomenorrhoea.
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Version 2026-06-03T17:43:00Z · SHA-256 2d38bdc767adb9ede103df61263cd780b613b64f4605afd38720f25f2e234f90 · Passage 028248fe5ab3f0899bca9c566ca8fcf5ed0e15d98211e60f7ee1ce28570813b4 · Zeichen 12764–13854 im Abschnitt