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Metabolism and nutrition disorders. Respiratory, thoracic and mediastinal disorders. Skin and subcutaneous tissue disorders. Musculoskeletal and connective tissue disorders. Renal and urinary disorders. Pregnancy, puerperium and perinatal conditions. General disorders and administration site conditions. Injury, poisoning and procedural complications. 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. Overall incidence from all clinical trials was 0. Menstrual disorder includes: menstruation delayed, menstruation irregular, oligomenorrhoea. Undesirable effects noted with risperidone formulations. Paliperidone is the active metabolite of risperidone, therefore, the adverse reaction profiles of these compounds (including both the oral and injectable formulations) are relevant to one another, buy test-r 200 mg injectable steroids $45.00 sustanon (testosterone blend). Description of selected adverse reactions. Rarely, cases of anaphylactic reaction after injection with Xeplion have been reported during post-marketing experience in patients who have previously tolerated oral risperidone or oral paliperidone (see section 4. The most commonly reported injection site related adverse reaction was pain. The majority of these reactions were reported to be of mild to moderate severity. Subject evaluations of injection site pain based on a visual analogue scale tended to lessen in frequency and intensity over time in all Phase 2 and 3 studies with Xeplion. Injections into the deltoid were perceived as slightly more painful than corresponding gluteal injections. Other injection site reactions were mostly mild in intensity and included induration (common), pruritus (uncommon) and nodules (rare). Extrapyramidal symptoms (EPS) EPS included a pooled analysis of the following terms: parkinsonism (includes salivary hypersecretion, musculoskeletal stiffness, parkinsonism, drooling, cogwheel rigidity, bradykinesia, hypokinesia, masked facies, muscle tightness, akinesia, nuchal rigidity, muscle rigidity, parkinsonian gait, glabellar reflex abnormal, and parkinsonian rest tremor), akathisia (includes akathisia, restlessness, hyperkinesia, and restless leg syndrome), dyskinesia (dyskinesia, muscle twitching, choreoathetosis, athetosis, and myoclonus), dystonia (includes dystonia, hypertonia, torticollis, muscle contractions involuntary, muscle contracture, blepharospasm, oculogyration, tongue paralysis, facial spasm, laryngospasm, myotonia, opisthotonus, oropharyngeal spasm, pleurothotonus, tongue spasm, and trismus), and tremor. It should be noted that a broader spectrum of symptoms are included that do not necessarily have an extrapyramidal origin. In the 13-week study involving the 150 mg initiation dosing, the proportion of subjects with an abnormal weight increase ? 7% showed a dose-related trend, with a 5% incidence rate in the placebo group compared with rates of 6%, 8% and 13% in the Xeplion 25 mg, 100 mg, and 150 mg groups, respectively. During the 33-week open-label transition/maintenance period of the long-term recurrence prevention trial, 12% of Xeplion-treated subjects met this criterion (weight gain of ? 7% from double-blind phase to endpoint); the mean (SD) weight change from open-label baseline was + 0. In clinical trials, median increases in serum prolactin were observed in subjects of both genders who received Xeplion.
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