Wirkstoffe & Arzneimittelsicherheit

Nebenwirkungen · Xeplion

Xeplion 25 mg prolonged release suspension for injection Xeplion 50 mg prolonged release suspension for injection Xeplion 75 mg prolonged release suspension for injection Xeplion 100 mg prolonged release suspension for injection Xeplion 150 mg prolonged release suspension for injection · Abschnitt 4.8 · PDF-Seite 12–13

HOS-124253 · Präparat HOS-095825

12 Renal and urinary incontinence, urinary retention urinary disorders pollakiuria, dysuria Pregnancy, drug withdrawal puerperium and syndrome perinatal neonatal (see conditions section 4.6) Reproductive amenorrhoea erectile dysfunction, priapism, breast system and breast ejaculation disorder, discomfort, breast disorders menstrual disordere, engorgement, gynaecomastia, breast galactorrhoea, sexual enlargement, dysfunction, breast vaginal discharge pain General disorders pyrexia, asthenia, face oedema, oedemae, hypothermia, body temperature and fatigue, injection site body temperature chills, thirst, drug decreased, administration reaction increased, gait withdrawal injection site site conditions abnormal, chest pain, syndrome, necrosis, chest discomfort, injection site injection site malaise, induration abscess, injection ulcer site cellulitis, injection site cyst, injection site haematoma 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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