FrancophonIA/ELRC3.0 huggingface dataset:
English: Population pharmacokinetics analyses indicated no discernible difference on the apparent clearance of paliperidone after administration of oral paliperidone between extensive metabolisers and poor metabolisers of CYP2D6 substrates.
Maltese: Diversi analiżijiet talkaratteristiċi farmakokinetiċi fil-popolazzjoni ma wrew l-ebda differenza fit-tneħħija apparenti ta' paliperidone wara l-amministrrazzjoni ta' paliperidone orali bejn metabolizzaturi estensivi u metabolizzaturi dgħajfa ta' sustrati ta' CYP2D6.
English: Paliperidone is not expected to cause clinically important pharmacokinetic interactions with medicinal products that are metabolised by cytochrome P-450 isozymes.
Maltese: Paliperidone mhuwiex mistenni li jikkawża interazzjonijiet farmakokinetiċi klinikament importanti ma' mediċini li huma metabolizzati bl-isozimi taċ-ċitokroma P-450.
English: Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu
Maltese: Informazzjoni dettaljata dwar din il-mediċina tinsab fuq is-sit web tal-Aġenzija Ewropea għallMediċini: http://www.ema.europa.eu.
English: Male rats showed a statistically significant increase in mammary gland adenomas and carcinomas at 30 and 60 mg/kg/month which is 1.2 and 2.2 times the exposure level at the maximum recommended human 150 mg dose.
Maltese: Il-firien maskili urew żieda statistikament rilevanti fl-adenomi u l-karċinomi talglandoli mammarji bi 30 u 60 mg/kg/xahar li huwa 1.2 u 2.2 darbiet il-livell ta' esponiment bid-doża massima ta' 150 mg rakkomandata fil-bnedmin.
English: Based on pooled data from the three placebo-controlled, 6-week, fixed-dose trials with oral paliperidone prolonged release tablets (3, 6, 9, and 12 mg), orthostatic hypotension was reported by 2.5% of subjects treated with oral paliperidone compared with 0.8% of subjects treated with placebo.
Maltese: Skont tagħrif miġbur minn tliet provi kkontrollati bi plaċebo, ta' sitt ġimgħat, b'doża fissa ta' paliperidone orali f'pilloli li jerħu l-mediċina bil-mod (3, 6, 9, u 12 mg), ġiet irrapportata ipotensjoni ortostatika fi 2.5% tal-individwi trattati b'paliperidone orali meta mqabbel ma' 0.8% tal-individwi ttrattati bi plaċebo.
English: Treatment initiation pack: Each pack contains 1 pack of Xeplion 150 mg and 1 pack of Xeplion 100 mg.
Maltese: Kull pakkett fih pakkett 1 ta' Xeplion 150 mg u pakkett 1 ta' Xeplion 100 mg.
English: Mean baseline (SD) Mean change (SD) P-value (vs.
Maltese: Linja bażi medja (SD) Bidla medja (SD) Valur-P (vs. Plaċebo)
English: An approximately 3-fold increased risk of cerebrovascular adverse reactions has been seen in randomised placebo-controlled clinical trials in the dementia population with some atypical antipsychotics, including risperidone, aripiprazole, and olanzapine.
Maltese: Ġiet innotata żieda fir-riskju ta' madwar 3 darbiet aktar ta' reazzjonijiet ċerebrovaskulari avversi fi provi kliniċi randomised, ikkontrollati bi plaċebo fil-popolazzjoni bid-dimenzja b'xi antipsikotiċi atipiċi, inkluż risperidone, aripiprazole, u olanzapine.
English: 12 mg daily
Maltese: 12-il mg kuljum
English: • symptoms of drug withdrawal
Maltese: • sintomi ta' twaqqif ta' mediċina li tivvizzja
English: Shake the syringe vigorously for a minimum of 10 seconds to ensure a homogeneous suspension.
Maltese: Ħawwad is-siringa sew għal mill-inqas 10 sekondi sabiex ikollok suspensjoni omoġenja.
English: The primary efficacy endpoint was defined as a decrease in Positive and Negative Syndrome Scale (PANSS) total scores as shown in the table below.
Maltese: Il-kejl aħħari primarju ta' effiċjenza kien iddefinit bħala t-tnaqqis fil-punteġġi totali tal-Iskala tas-Sindromi Pożittivi u Negattivi (PANSS) kif muri fit-tabella li ġejja.
English: Manufacturer Janssen Pharmaceutica NV Turnhoutseweg 30
Maltese: Il-Manifattur Janssen Pharmaceutica NV Turnhoutseweg 30
English: Parkinson's disease and dementia with Lewy bodies
Maltese: Marda ta' Parkinson u dimenzja b'korpi Lewy
English: Xeplion 150 mg injection Paliperidone
Maltese: Xeplion 150 mg injezzjoni Paliperidone
English: 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.
Maltese: Sintomi ekstrapiramidali (EPS - Extrapyramidal symptoms) EPS kienet tinkludi analiżi miġbura tal-frażijiet li ġejjin: parkinsoniżmu (jinkludi ħruġ ta' bżieq eċċessiv, ebusija muskuloskeletrika, parkinsoniżmu, bżieq li jnixxi mill-ħalq, riġidità b'movimenti qishom ta' rota tal-ingranaġġ, bradikinesja, ipokinesja, uċuħ qishom b'maskra, ebusija fil-muskoli, askinesja, riġidità fl-għonq, riġidità fil-muskoli, mixja parkinsonjana, u rifless glabellari anormali, rogħda ta' parkinson ta' waqt il-mistrieħ), akatisja (tinkludi akatisja, irrikwitezza, iperkinesja, u sindrome ta' sieq b'irrikwitezza), diskajnesja (diskajnesja, ġbid tal-muskoli, korejoatetożi, atetożi, u mijoklonus), distonja (tinkludi distonja, ipertonja, torċikollis, kontrazzjonijiet involontarji tal-muskoli, ġbid tal-muskoli, blefarospażmu, tidwir tal-għajnejn, paraliżi tal-ilsien, spażmu fil-wiċċ, spażmu fillarinġi, mijotonja, opistotonus, spażmu orofarinġeali, plewrototonus, spażmu tal-ilsien, u trismus), u rogħda.
English: Hypersensitivity to the active substance, to risperidone or to any of the excipients listed in section 6.1.
Maltese: Ipersensittività għas-sustanza attiva, għal risperidone jew għal kwalunkwe eċċipjent elenkat fissezzjoni 6.1.
English: Xeplion 75 mg injection Paliperidone IM
Maltese: Xeplion 75 mg injezzjoni Paliperidone
English: Population pharmacokinetics analysis showed no evidence of age related pharmacokinetics differences.
Maltese: Analiżi farmakokinetika ta' popolazzjoni ma wriet l-ebda evidenza ta' differenzi farmakokinetiċi marbuta mal-età.
English: AM MANGION LTD. Tel: +356 2397 6000
Maltese: Tel: +356 2397 6000
English: Caution is advised when prescribing Xeplion with medicinal products known to prolong the QT interval, e.g. class IA antiarrhythmics (e.g., quinidine, disopyramide) and class III antiarrhythmics (e.g. amiodarone, sotalol), some antihistaminics, some other antipsychotics and some antimalarials (e.g. mefloquine).
Maltese: Għandha tintuża kawtela meta Xeplion jingħata ma' mediċini li huma magħrufa li jtawlu l-intervall QT, eż. antiarritmiċi tal-klassi IA, (eż. quinidine, disopyramide) u antiarritmiċi tal-klassi III (eż. amiodarone, sotalol), xi antistaminiċi, xi antipsikotiċi oħrajn, u xi mediċini kontra l-malarja (eż. mefloquine).
English: Xeplion 100 mg injection Paliperidone
Maltese: Xeplion 100 mg injezzjoni Paliperidone
English: 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 + 0.7 (4.79) kg.
Maltese: Waqt il-perijodu ta' 33 ġimgħa ta' transizzjoni/manteniment open-label tal-prova ta' prevenzjoni ta' rikorrenza fit-tul, 12% tal-individwi ttrattati b'Xeplion laħqu dan il-kriterju (żieda fil-piż ta'  7% mill-fażi double-blind sa tmiem il-prova); il-bidla medja (SD) fil-piż mil-linja bażi open-label kienet ta' +0.7 (4.79) kg.
English: Co-administration of oral paliperidone prolonged release tablets at steady-state (12 mg once daily) with divalproex sodium prolonged release tablets (500 mg to 2,000 mg once daily) did not affect the steady-state pharmacokinetics of valproate.
Maltese: L-għoti ta' pilloli b'rilaxx fit-tul ta' paliperidone orali fi stadju fiss (12-il mg darba kuljum) flimkien mal-pilloli ta' rilaxx fit-tul ta' divalproex sodium (500 mg sa 2,000 mg darba kuljum) ma affettwax ilfarmakokinetika tal-istat fiss ta' valproate.
English: The difference is unlikely to be of clinical relevance.
Maltese: Id-differenza aktarx li ma jkollhiex rilevanza klinika.
English: • dizziness
Maltese: • distonja:
English: d.o.o.
Maltese: • waqgħa.
English: Cases of venous thromboembolism, including cases of pulmonary embolism and cases of deep vein thrombosis, have been reported with antipsychotic medicinal products (frequency unknown).
Maltese: Każijiet ta' tromboemboliżmu fil-vini, inklużi każijiet ta' emboliżmu fil-pulmun u każijiet ta' trombożi fil-vini fondi kienu rrapportati bi prodotti mediċinali antipsikotiċi (frekwenza mhux magħrufa).
English: Schizophrenia is a disease with “positive” and “negative” symptoms.
Maltese: L-iskizofrenija hija marda b'sintomi “pożittivi” u “negattivi”.
English: Additional clinical signs may include myoglobinuria (rhabdomyolysis) and acute renal failure.
Maltese: Sinjali kliniċi oħrajn jistgħu jinkludu mijoglubinurja (rabdomajoliżi) u insuffiċjenza renali akuta.
English: Insomnia includes: initial insomnia, middle insomnia; Convulsion includes: grand mal convulsion; Oedema includes: generalised oedema, oedema peripheral, pitting oedema.
Maltese: Insomnja tinkludi: insomnja fil-bidu tal-irqad, insomnja f'nofs l-irqad; Konvulżjoni tinkludi: konvulżjoni grand mal; Edima tinkludi: edima mifruxa, edima periferali, edima bl-iffossar.
English: In vitro studies indicate that CYP2D6 and CYP3A4 may be minimally involved in paliperidone metabolism, but there are no indications in vitro nor in vivo that these isozymes play a significant role in the metabolism of paliperidone.
Maltese: Studji in vitro jindikaw li CYP2D6 u CYP3A4 jistgħu jkunu involuti b'mod minimu fil-metaboliżmu ta' paliperidone, iżda ma hemm l-ebda indikazzjonijiet in vitro jew in vivo li dawn l-isozimi għandhom sehem sinifikanti fil-metaboliżmu ta' paliperidone.
English: Anaphylactic reaction
Maltese: • reazzjoni allerġika
English: Adverse reactions that may suggest increase in prolactin levels (e.g., amenorrhoea, galactorrhoea, menstrual disturbances, gynaecomastia) were reported overall in < 1% of subjects.
Maltese: Ġew irrapportati reazzjonijiet avversi li potenzjalment huma marbuta ma' żieda fil-prolactin (eż., amenorrea, galaktorrea, disturbi tal-menstrwazzjoni, ġinekomastija) b'mod ġenerali f'< 1% tal-individwi.
English: In a meta-analysis of 17 controlled clinical trials, elderly patients with dementia treated with other atypical antipsychotics, including risperidone, aripiprazole, olanzapine, and quetiapine had an increased risk of mortality compared to placebo.
Maltese: F'meta-analiżi ta' 17-il prova klinika kkontrollata, pazjenti anzjani bid-dimenzja kkurati b'antipsikotiċi atipiċi oħrajn, inkluż risperidone, aripiprazole, olanzapine, u quetiapine kellhom riskju ogħla ta' mortalità meta mqabbla ma' dawk li ħadu plaċebo.
English: If signs and symptoms of tardive dyskinesia appear, the discontinuation of all antipsychotics, including paliperidone, should be considered.
Maltese: Jekk jidhru s-sinjali u s-sintomi ta' diskajneżja tardiva, għandu jiġi kkunsidrat ittwaqqif tal-antipsikotiċi kollha, inkluż ta' paliperidone.
English: In general, overall initiation plasma levels with Xeplion were within the exposure range observed with 6-12 mg prolonged release oral paliperidone.
Maltese: B'mod ġenerali, il-livelli globali tal-plażma fil-bidu b'Xeplion kienu jaqgħu fil-medda ta' esponiment osservata b'paliperidone orali ta' 6-12 mg b'rilaxx fit-tul.
English: How to store Xeplion
Maltese: X'fih Xeplion
English: This medicinal product contains less than 1 mmol sodium (23 mg) per dose, i.e., essentially sodium-free.
Maltese: Dan il-prodott mediċinali fih anqas minn 1 mmol sodium (23 mg) f'kull doża, i.e., huwa essenzjalment mingħajr sodium.
English: Refer to ‘Hyperprolactinaemia' below.
Maltese: Irreferi għal ‘Iperprolaktinimja' taħt.
English: 25-50 mg monthly
Maltese: 3 mg kuljum25-50 mg kull xahar
English: 1 pre-filled syringe of paliperidone 150 mg and 2 needles 1 pre-filled syringe of paliperidone 100 mg and 2 needles
Maltese: Siringa 1 mimlija għal-lest ta' paliperidone 150 mg u 2 labriet Siringa1 mimlija għal-lest ta' paliperidone 100 mg u 2 labriet
English: Paliperidone also blocks alpha 1-adrenergic receptors and slightly less, H1-histaminergic and alpha 2-adrenergic receptors.
Maltese: Paliperidone jimblokka wkoll riċetturi alfa 1-adrenerġiċi u jimblokka inqas riċetturi istaminerġiċi H1 u adrenerġiċi alfa 2.
English: CARDBOARD CARTON (100 mg PRE-FILLED SYRINGE, COMPONENT OF TREATMENT INITIATION PACK - WITHOUT BLUE BOX)
Maltese: KARTUNA (100 mg SIRINGA MIMLIJA GĦAL-LEST, KOMPONENT TAL-PAKKETT TAL-BIDU TAL-KURA - MINGĦAJR IL-KAXXA L-BLU)
English: The trial was stopped early for efficacy reasons as a significantly longer time to relapse (p < 0.0001, Figure 1) was seen in patients treated with Xeplion compared to placebo (hazard ratio = 4.32; 95% CI: 2.4-7.7).
Maltese: Il-prova twaqqfet kmieni għal raġunijiet ta' effikaċja minħabba li kien osservat żmien itwal b'mod sinifikanti għar-rikaduta (p < 0.0001, Figura 1) f'pazjenti kkurati b'Xeplion meta mqabbel mal-plaċebo (proporzjon ta' periklu = 4.32; 95% CI: 2.4-7.7).
English: Xeplion 150 mg: Each pre-filled syringe contains paliperidone palmitate equivalent to 150 mg paliperidone.
Maltese: Xeplion 150 mg: Kull siringa mimlija għal-lest fiha paliperidone palmitate ekwivalenti għal 150 mg paliperidone.
English: Each Xeplion 75 mg pre-filled syringe contains 117 mg paliperidone palmitate.
Maltese: Kull siringa mimlija għal-lest ta' Xeplion 75 mg fiha 117 mg ta' paliperidone palmitate.
English: PRE-FILLED SYRINGE
Maltese: • konġestjoni fil-pulmuni
English: In a 13-week study (n = 636) comparing three fixed doses of Xeplion (initial deltoid injection of 150 mg followed by 3 gluteal or deltoid doses of either 25 mg/4 weeks, 100 mg/4 weeks or 150 mg/4 weeks) to placebo, all three doses of Xeplion were superior to placebo in improving the PANSS total score.
Maltese: Fi studju ta' 13-il ġimgħa (n = 636) li kien iqabbel tliet dożi fissi ta' Xeplion (injezzjoni fid-deltojd ta' doża inizjali ta' 150 mg segwita minn tliet dożi fil-warrani jew fid-deltojd ta' 25 mg/4 ġimgħat, 100 mg/4 ġimgħat jew 150 mg/4 ġimgħat) mal-plaċebo, it-tliet dożi kollha ta' Xeplion kienu aqwa mill-plaċebo fit-titjib tal-punteġġ totali tal-PANSS.
English: The potential benefit of stopping alpha 1 blocking therapy prior to cataract surgery has not been established and must be weighed against the risk of stopping the antipsychotic therapy.
Maltese: Il-benefiċċju potenzjali li titwaqqaf it-terapija li timblokka ta' alfa 1 qabel il-kirurġija tal-kataretti ma ġietx stabbilita u għandha tiġi ppiżata kontra r-riskju li titwaqqaf it-terapija antipsikotika.
English: Xeplion 25 mg injection Paliperidone IM
Maltese: Xeplion 25 mg injezzjoni Paliperidone
English: Gluteal muscle administration
Maltese: • xofftejn maqsuma
English: R092670-PSY-3004 Mean baseline (SD) Mean change (SD) P-value (vs.
Maltese: R092670-PSY-3004 Linja bażi medja (SD) Bidla medja (SD) Valur-P (vs. Plaċebo)
English: The initiation regimen for Xeplion (150 mg/100 mg in the deltoid muscle on day 1/day 8) was designed to rapidly attain steady-state paliperidone concentrations when initiating therapy without the use of oral supplementation.
Maltese: Il-kors inizjali għal Xeplion (150 mg/100 mg fil-muskolu taddeltojd f'jum 1/jum 8) kien maħsub sabiex jinkisbu malajr il-konċentrazzjonijiet ta' paliperidone fi stat fiss meta tinbeda l-kura mingħajr l-użu ta' supplimenti orali.
English: • inflammation of the pancreas, swollen tongue, stool incontinence, very hard stool
Maltese: • infjammazzjoni tal-frixa, ilsien minfuħ, inkontinenza tal-ippurgar, ippurgar iebes ħafna
English: R092670-PSY-3007* Mean baseline (SD) Mean change (SD) P-value (vs.
Maltese: R092670-PSY-3007* Linja bażi medja (SD) Bidla medja (SD) Valur-P (vs. Plaċebo)
English: Following intramuscular injection of single doses (25-150 mg) in the deltoid muscle, on average, a 28% higher Cmax was observed compared with injection in the gluteal muscle.
Maltese: Wara injezzjoni ta' dożi singoli (25-150 mg) fil-muskolu, fl-ispalla ġie osservat Cmax b'medja ta' 28% ogħla meta mqabbel ma' injezzjoni fil-muskolu tal-warrani.
English: R092670-PSY-3003 Mean baseline (SD) Mean change (SD) P-value (vs.
Maltese: R092670-PSY-3003 Linja bażi medja (SD) Bidla medja (SD) Valur-P (vs. Plaċebo)
English: CARDBOARD CARTON (150 mg PRE-FILLED SYRINGE, COMPONENT OF TREATMENT INITIATION PACK - WITHOUT BLUE BOX)
Maltese: KARTUNA (150 mg SIRINGA MIMLIJA GĦAL-LEST, KOMPONENT TAL-PAKKETT TAL-BIDU TAL-KURA - MINGĦAJR IL-KAXXA L-BLU)
English: Patients with severe neutropenia (absolute neutrophil count < 1 x 10
Maltese: Pazjenti b'newtropenija qawwija (għadd assolut ta' newtrofili < 1 x 10
English: Patients with kidney problems
Maltese: Pazjenti bi problemi fil-kliewi
English: QT prolongation, ventricular arrhythmias (ventricular fibrillation, ventricular tachycardia), sudden unexplained death, cardiac arrest, and Torsade de pointes may occur with antipsychotics.
Maltese: Bl-antipsikotiċi jista' jkun hemm prolongazzjoni tal-QT, arritmiji ventrikulari (fibrillazzjoni ventrikulari, takikardja ventrikulari), mewt f'daqqa bla spjegazzjoni, attakk tal-qalb u Torsade de pointes.
English: In a study with oral paliperidone in subjects with moderate hepatic impairment (Child-Pugh class B), the plasma concentrations of free paliperidone were similar to those of healthy subjects.
Maltese: Fi studju b'paliperidone orali f'individwi b'indeboliment epatiku moderat (Child-Pugh Klassi B), il-konċentrazzjonijiet fil-plażma ta' paliperidone ħieles kienu simili għal dawk ta' individwi f'saħħithom.
English: Xeplion contains the active substance paliperidone which belongs to the class of antipsychotic medicines and is used as a maintenance treatment for the symptoms of schizophrenia in adult patients stabilised on paliperidone or risperidone.
Maltese: Xeplion fih is-sustanza attiva paliperidone li tappartjenti għall-klassi ta' mediċini antipsikotiċi u jintuża bħala kura ta' manteniment għas-sintomi tal-iskizofrenija f'pazjenti adulti stabbiliti fuq paliperidone jew risperidone.
English: The recommended monthly maintenance dose is 50 mg with a range of 25 to 100 mg based on patient tolerability and/or efficacy.
Maltese: Id-doża ta' manteniment ta' kull xahar rakkomandata hija ta' 50 mg b'medda ta' 25 sa 100 mg skont it-tollerabbiltà tal-pazjent u/jew l-effikaċja.
English: • pneumonia, infection of the chest (bronchitis), infection of the breathing passages, sinus infection, bladder infection, ear infection, fungal infection of the nails, tonsillitis, infection of the skin
Maltese: • pulmonite, infezzjoni fis-sider (bronkite), infezzjoni tal-passaġġi tan-nifs, infezzjoni fis-sinus, infezzjoni fil-bużżieqa tal-awrina, infezzjoni fil-widnejn, infezzjoni bil-fungu fid-dwiefer, tonsillite, infezzjoni fil-ġilda
English: Xeplion 50 mg injection Paliperidone IM
Maltese: Xeplion 50 mg injezzjoni Paliperidone
English: Hyperglycaemia and diabetes mellitus
Maltese: Ipergliċemija u dijabete mellitus
English: Paliperidone can have minor or moderate influence on the ability to drive and use machines due to potential nervous system and visual effects, such as sedation, somnolence, syncope, vision blurred (see section 4.8).
Maltese: Paliperidone jista' jkollu influwenza żgħira jew moderata fuq il-kapaċità ta' sewqan u tħaddim ta' magni minħabba l-effetti potenzjali fuq is-sistema nervuża u l-vista, bħal sedazzjoni, ngħas, sinkope, vista mċajpra (ara sezzjoni 4.8).
English: Xeplion 100 mg: Each pre-filled syringe contains paliperidone palmitate equivalent to 100 mg paliperidone.
Maltese: Xeplion 100 mg: Kull siringa mimlija għal-lest fiha paliperidone palmitate ekwivalenti għal 100 mg paliperidone.
English: Approximately 80% of the administered radioactivity was recovered in urine and 11% in the faeces.
Maltese: Bejn wieħed u ieħor 80% tar-radjuattività li ġiet amministrata nġabret mill-awrina u 11% fl-ippurgar.
English: An antiemetic effect was observed in preclinical studies with paliperidone.
Maltese: Ġie osservat effett antiemetiku fi studji pre-kliniċi b'paliperidone.
English: Psychiatric disorders insomnia e agitation, depression, anxiety sleep disorder, mania, libido decreased, nervousness, nightmare catatonia, confusional state, somnambulism, blunted affect, anorgasmia sleep-related eating disorder
Maltese: Disturbi psikjatriċi nuqqas ta' rqad aġitazzjoni, depressjoni, ansjetà disturb fl-irqad, manija, tnaqqis fil-libido, nervożismu, ħmar illejl katatonja, stat ta' konfużjoni, somnambuliżmu, tnaqqis kbir flespressjoni talemozzjonijiet, ma jinkisibx orgażmu
English: In this study, doses of Xeplion included 25, 50, 75, and 100 mg administered monthly; the 75 mg dose was allowed only in the 52-week open-label extension.
Maltese: F'dan l-istudju, id-dożi ta' Xeplion kienu jinkludu 25, 50, 75, u 100 mg mogħtija kull xahar; id-doża ta' 75 mg kienet permessa biss fl-estensjoni open-label ta' 52 ġimgħa.
English: • sleep disorder, elated mood (mania), decreased sexual drive, nervousness, nightmares
Maltese: • disturb fl-irqad, burdata ta' ferħ kbir (manija), tnaqqis fl-aptit sesswali, nervi, ħmar il-lejl
English: Seizures
Maltese: Prijapiżmu
English: Events of leucopenia, neutropenia, and agranulocytosis have been reported with Xeplion.
Maltese: Każijiet ta' lewkopenija, newtropenija, u agranuloċitożi ġew irrappurtati bi Xeplion.
English: Use in patients with prolactin-dependent tumours
Maltese: Użu f'pazjenti b'tumuri dipendenti fuq il-prolaktin
English: Overall incidence from all clinical trials was 0.65% in all paliperidone palmitate -treated subjects
Maltese: L-inċidenza globali mill-provi kliniċi kollha kienet ta' 0.65% flindividwi kollha kkurati b'paliperidone palmitate.
English: In oral carcinogenicity studies of risperidone in rats and mice, increases in pituitary gland adenomas (mouse), endocrine pancreas adenomas (rat), and mammary gland adenomas (both species) were seen.
Maltese: Fi studji dwar il-karċinoġeniċità orali ta' risperidone fil-firien u l-ġrieden, dehru żidiet fl-adenomi tal-glandoli pitwitarji (fil-ġurdien), adenomi endokrinali fil-frixa (fil-far) u adenomi tal-glandoli mammarji (fiż-żewġ speċi).
English: The efficacy of Xeplion in the acute treatment of schizophrenia was established in four short-term (one 9-week and three 13-week) double-blind, randomised, placebo-controlled, fixed-dose studies of acutely relapsed adult inpatients who met DSM-IV criteria for schizophrenia.
Maltese: L-effikaċja ta' Xeplion fit-trattament akut tal-iskizofrenija kienet stabbilita f'erba' provi fuq żmien qasir (wieħed ta' 9 ġimgħat u tlieta ta' 13-il ġimgħa) double-blind, randomised, ikkontrollati bi plaċebo, b'doża fissa fuq pazjenti adulti ġo sptar b'rikaduta akuta li ssodisfaw il-kriterji DSM-IV għall-iskizofrenja.
English: Xeplion is not recommended in patients with moderate or severe renal impairment (creatinine clearance < 50 mL/min) (see section 4.4).
Maltese: Xeplion mhuwiex irrakkomandat f'pazjenti b'indeboliment renali moderat jew sever (tneħħija talkreatinina < 50 mL/min) (ara sezzjoni 4.4).
English: The safety and efficacy of Xeplion in children and adolescents < 18 years of age have not been established.
Maltese: Is-sigurtà u l-effikaċja ta' Xeplion fit-tfal u l-adolexxenti tal-età ta' < 18-il sena għadhom ma ġewx stabbiliti.
English: Gradual withdrawal of stimulant treatment is recommended (see section 4.5).
Maltese: Huwa rrakkomandat li t-twaqqif tat-trattament bl-istimulant isir bil-mod (ara sezzjoni 4.5).
English: The pack contains a pre-filled syringe and 2 safety needles (a 1½-inch 22 gauge needle [38.1 mm x 0.72 mm] and a 1-inch 23 gauge needle [25.4 mm x 0.64 mm]) for intramuscular injection.
Maltese: 72 mm] u labra ta' pulzier (1 pulzier) ta' ħxuna 23 [25.4 mm x 0.64 mm]) għallinjezzjoni ġol-muskolu.