FrancophonIA/ELRC3.0 huggingface dataset:
English: Total clearance of paliperidone was reduced in subjects with impaired renal function by 32% on average in mild (CrCl = 50 to < 80 mL/min), 64% in moderate (CrCl = 30 to < 50 mL/min), and 71% in severe (CrCl = 10 to < 30 mL/min) renal impairment, corresponding to an average increase in exposure (AUCinf) of 1.5, 2.6, and 4.8-fold, respectively, compared to healthy subjects.
Maltese: It-tneħħija totali ta' paliperidone naqset b'medja ta' 32% f'individwi b'indeboliment ħafif (CrCl = 50 sa < 80 mL/min), 64% f'indeboliment moderat (CrCl = 30 sa < 50 mL/min), u 71% f'indeboliment sever (CrCl = 10 sa < 30 mL/min) fil-funzjoni talkliewi, li jaqbel ma' żieda medja fl-esponiment (AUCinf) ta' 1.5, 2.6, u 4.8 darbiet, rispettivament, meta mqabbel ma' individwi f'saħħithom.
English: Following administration of TREVICTA, the (+) and (-) enantiomers of paliperidone interconvert, reaching an AUC (+) to (-) ratio of approximately 1.7-1.8.
Maltese: Wara għoti ta' TREVICTA, l-enantijomeri (+) u (-) ta' paliperidone jikkonvertu wieħed fl-ieħor, u jilħqu AUC bi proporzjon ta' (+) u (-) ta' madwar 1.7-1.8.
English: Gradual withdrawal of stimulant treatment is recommended (see section 4.5).
Maltese: Huwa rrakkomandat li t-twaqqif tat-trattament blistimulant isir bil-mod (ara sezzjoni 4.5).
English: Antipsychotic medicinal products (including paliperidone) with alpha-adrenergic blocking effects have been reported to induce priapism.
Maltese: Prodotti mediċinali antipsikotiċi (inkluż paliperidone) li għandhom effetti ta' mblukkar alfa adrenerġiku ġew irrappurtati li jikkawżaw prijapiżmu.
English: The difference (95% CI) between the treatment groups was 1.2% (-2.7%, 5.1%), meeting non-inferiority criterion based on a margin of -10%.
Maltese: Id-differenza bejn (95% CI) il-gruppi ta' trattament kienet 1.2% (-2.7%, 5.1%), li tissodisfa l-kriterju tan-nuqqas ta' inferjorità abbażi ta' marġini ta' -10%.
English: TREVICTA contains a racemic mixture of (+)- and (-)-paliperidone.
Maltese: TREVICTA fih taħlita raċemika ta' paliperidone (+) u (-).
English: Extrapyramidal symptoms (EPS) included a pooled analysis of the following terms: parkinsonism (includes extrapyramidal disorder, extrapyramidal symptoms, on and off phenomenon, Parkinson's disease, parkinsonian crisis, 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, chorea, movement disorder, muscle twitching, choreoathetosis, athetosis, and myoclonus), dystonia (includes dystonia, cervical spasm, emprosthotonus, oculogyric crisis, oromandibular dystonia, risus sardonicus, tetany, 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) kienu jinkludu ġabra ta' analiżi t-termini li ġejjin: parkinsonism (jinkludi disturb ekstrapiramidali, sintomi ekstrapiramidali, fenomenu ta' fażijiet ta' immobbiltà jinbidlu f'fażijiet ta' mobilità, marda ta' Parkinson, kriżi parkinsonjana, ħruġ eċċessiv ta' bżieq, ebusija muskoluskeletrika, parkinsoniżmu, tlegħib, riġidità b'movimenti qishom ta' rota tal-ingranaġġ, bradikinesja, ipokinesja, wiċċ qisu b'maskra, ebusija fil-muskoli, akinesija, riġidità fl-għonq, riġidità fil-muskoli, mixja parkinsonjana, rifless glabellari mhux normali, rogħda ta' parkinson ta' waqt ilmistrieħ), akatisja (tinkludi akatisja, nuqqas ta' kwiet, iperkinesja, u sindrom ta' riġel b'nuqqas ta' kwiet), diskajneżja (diskajneżja, korea, disturb fiċ-ċaqliq, ġbid tal-muskoli għall-għarrieda, koreoatatożi, atetożi,u mijoklonus), distonja (tinkludi distonja, spażmu tal-għonq tal-utru, emprostotonus, kriżi ta' qlib tal-għajnejn, distonja oromandibulari, risus sardonicus, tetanja, ipertonja, tortikollis, ġbid involontarju tal-muskoli, kontrattura tal-muskoli, blefarospażmu, qlib tal-għajnejn o, paraliżi tal-ilsien, spażmu fil-wiċċ, spażmu fil-larinġi, mijotonja, opistotonus, spażmu orofarinġali, plewrototonus, spażmu fl-ilsien u trismus), u rogħda.
English: TREVICTA with alcohol Alcohol should be avoided.
Maltese: TREVICTA mal-alkoħol L-alkoħol għandu jiġi evitat.
English: Cases of venous thromboembolism (VTE) have been reported with antipsychotic medicinal products.
Maltese: Każijiet ta' tromboemboliżmu fil-vini (VTE - venous thromboembolism) kienu rrapportati bi prodotti mediċinali antipsikotiċi.
English: TREVICTA, a 3-monthly injection, is indicated for the maintenance treatment of schizophrenia in adult patients who are clinically stable on 1-monthly paliperidone palmitate injectable product (see section 5.1).
Maltese: TREVICTA, injezzjoni ta' kull 3 xhur, huwa indikat għat-trattament ta' manteniment tal-iskizofrenija f'pazjenti adulti li jkunu stabbli b'mod kliniku fuq paliperidone palmitate ta' kull xahar li jista' jiġi injettat (ara sezzjoni 5.1).
English: akathisia c, sedation/ somnolence, dystonia c,
Maltese: akatisja c, sedazzjoni/ ħedla tan-ngħa, distonja c,
English: • symptoms of drug withdrawal
Maltese: • sintomi ta' waqfien ta' mediċina li tivvizzja
English: In the clinical trials of TREVICTA, 0.3% of subjects reported orthostatic hypotension related adverse reaction.
Maltese: Fil-provi kliniċi ta' TREVICTA, 0.3% tal-individwi rrappurtaw reazzjoni avversa marbuta ma' ipotensjoni ortostatika.
English: In the TREVICTA group, the mean change from double-blind baseline to double-blind end point was +2.90 ng/mL for males (vs. -10.26 ng/mL in the placebo group) and +7.48 ng/mL for females (vs. -32.93 ng/mL in the placebo group).
Maltese: 26 ng/mL fil-grupp ta' plaċebo) u +7.48 ng/mL għan-nisa (vs. -32.93 ng/mL fil-grupp tal-plaċebo).
English: Immediate medical treatment may be needed.
Maltese: Jista' jkun hemm bżonn trattament mediku immedjat.
English: Paliperidone is not expected to cause clinically important pharmacokinetic interactions with medicinal products that are metabolised by cytochrome P450 isozymes.
Maltese: Paliperidone mhuwiex mistenni li jikkawża interazzjonijiet farmakokinetiċi importanti b'mod kliniku ma' prodotti mediċinali li huma metabolizzati bl-isozimi taċ-ċitokrom P450.
English: The dose could be adjusted (i.e., 50 mg, 75 mg, 100 mg, or 150 mg) at the week 5 and 9 injections and the injection site could be deltoid or gluteal.
Maltese: Id-doża setgħet tiġi aġġustata (i.e., 50 mg, 75 mg, 100 mg, jew 150 mg) fl-injezzjonijiet tal-ġimgħat 5 u 9 u s-sit tal-injezzjoni setgħet tkun tad-deltojd jew gluteali.
English: Based on population pharmacokinetic analysis, the median apparent half-life of paliperidone following TREVICTA administration over the dose range of 175-525 mg ranged from 84-95 days following deltoid injections and 118-139 days following gluteal injections.
Maltese: Abbażi ta' analiżi farmakokinetika tal-popolazzjoni, il-medjan tal-half-life apparenti ta' paliperidone wara għoti ta' TREVICTA fuq medda ta' doża ta' 175-525 mg kien ivarja minn 84-95 jum wara injezzjonijiet fil-muskolu deltoid u minn 118-139 jum wara injezzjonijiet gluteali.
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 possibbli li titwaqqaf it-terapija li timblokka alfa 1 qabel l-operazzjoni tal-kataretti ma ġiex stabbilit u għandu jitqies kontra r-riskju li titwaqqaf it-terapija antipsikotika.
English: Then administer TREVICTA (into deltoid a or gluteal muscle)
Maltese: Imbagħad agħti TREVICTA (ġolmuskolu deltojd a jew gluteali)
English: TREVICTA 175 mg prolonged release suspension for injection TREVICTA 263 mg prolonged release suspension for injection TREVICTA 350 mg prolonged release suspension for injection TREVICTA 525 mg prolonged release suspension for injection paliperidone
Maltese: TREVICTA 175 mg suspensjoni li terħi l-mediċina bil-mod għall-injezzjoni TREVICTA 263 mg suspensjoni li terħi l-mediċina bil-mod għall-injezzjoni TREVICTA 350 mg suspensjoni li terħi l-mediċina bil-mod għall-injezzjoni TREVICTA 525 mg suspensjoni li terħi l-mediċina bil-mod għall-injezzjoni paliperidone
English: There was a statistically significant increase in mammary gland adenocarcinomas in female rats at 10, 30 and 60 mg/kg/month.
Maltese: Kien hemm żieda sinifikanti b'mod statistiku fl-adenokarċinomi fil-glandoli mammarji tal-firien nisa b'10, 30 u 60 mg/kg/xahar.
English: There was a significant difference (p < 0.0001) between the two treatment groups in the time to relapse in favour of TREVICTA.
Maltese: Kien hemm differenza sinifikanti (p < 0.0001) fiż-żmien għar-rikaduta bejn iżżewġ gruppi ta' kura li kienet favur TREVICTA.
English: Vascular disorders hypertension hypotension, orthostatic hypotension venous thrombosis, flushing pulmonary embolism, ischaemia
Maltese: Disturbi vaskulari ipertensjoni ipotensjoni, ipotensjoni ortostatika trombożi fil-vini, fwawar emboliżmu filpulmuni, iskemija
English: TREVICTA 525 mg injection paliperidone
Maltese: TREVICTA 525 mg injezzjoni paliperidone
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 għal kwalunkwe eċċipjent elenkat fissezzjoni 6.1.
English: TREVICTA 175 mg prolonged release suspension for injection TREVICTA 263 mg prolonged release suspension for injection TREVICTA 350 mg prolonged release suspension for injection TREVICTA 525 mg prolonged release suspension for injection
Maltese: TREVICTA 175 mg suspensjoni li terħi l-mediċina bil-mod għall-injezzjoni TREVICTA 263 mg suspensjoni li terħi l-mediċina bil-mod għall-injezzjoni TREVICTA 350 mg suspensjoni li terħi l-mediċina bil-mod għall-injezzjoni TREVICTA 525 mg suspensjoni li terħi l-mediċina bil-mod għall-injezzjoni
English: TREVICTA 263 mg injection paliperidone
Maltese: TREVICTA 263 mg injezzjoni paliperidone
English: Based on the final analysis (N = 305), 42 subjects (29.0%) in the placebo group and 14 subjects (8.8%) in the TREVICTA group had experienced a relapse event during the double blind phase.
Maltese: Abbażi tal-analiżi finali (N = 305), 42 individwu (29.0%) fil-grupp tal-plaċebo u 14-il individwu (8.8%) fil-grupp ta' TREVICTA kellhom każ ta' rikaduta waqt il-fażi tal-istudju fejn la l-investigaturi u lanqas l-individwi ma kienu jafu liema sustanza qed tintuża.
English: Intraoperative Floppy Iris Syndrome (IFIS) has been observed during cataract surgery in patients treated with medicinal products with alpha 1a-adrenergic antagonist effect, such as TREVICTA (see section 4.8).
Maltese: Is-sindrom intraoperattiv tal-ħabba li titħarrek (IFIS - Intraoperative Floppy Iris Syndrome) ġie osservat waqt operazzjonijiet tal-kataretti f'pazjenti ttrattati b'mediċini b'effett antagonist għar-riċettur adrenerġiku alfa 1a, bħal ma huwa TREVICTA (ara sezzjoni 4.8).
English: Neuroleptic Malignant Syndrome (NMS), characterised by hyperthermia, muscle rigidity, autonomic instability, altered consciousness, and elevated serum creatine phosphokinase levels has been reported to occur with paliperidone.
Maltese: Is-Sindrom Newrolettiku Malinn (NMS), ikkaratterizzat minn ipertermija, riġidità fil-muskoli, nuqqas ta' stabilità awtonomika, koxjenza mibdula, u livelli għoljin ta' creatine phosphokinase fis-serum ġie rrappurtat li jseħħ b'paliperidone.
English: Undesirable effects noted with risperidone formulations
Maltese: Effetti mhux mixtieqa nnutati bil-formulazzjonijiet ta' risperidone
English: Pharmacotherapeutic group: Psycholeptics, other antipsychotics.
Maltese: Psikolettiċi, antipsikotiċi oħra.
English: 4 months to 9 months
Maltese: 4 xhur sa 9 xhur
English: TREVICTA has not been studied in patients with renal impairment (see section 5.2).
Maltese: TREVICTA ma ġiex studjat f'pazjenti b'indeboliment tal-kliewi (ara sezzjoni 5.2).
English: Following intramuscular injection of TREVICTA at doses of 175-525 mg in the deltoid muscle, on average, an 11-12% higher Cmax was observed compared with injection in the gluteal muscle.
Maltese: Wara injezzjoni ta' TREVICTA ġol-muskolu bid-dożi ta' 175-525 mg fil-muskolu deltojd, kienet osservata, bħala medja, Cmax minn 11-12% ogħla meta mqabbla ma' injezzjoni fil-muskolu gluteali.
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 ttrattati b'antipsikotiċi atipiċi oħrajn, inkluż risperidone, aripiprazole, olanzapine, u quetiapine kellhom żieda fir-riskju ta' mortalità meta mqabbla ma' dawk li ħadu plaċebo.
English: Male rats showed a statistically significant increase in mammary gland adenomas and carcinomas at 30 and 60 mg/kg/month which is 0.6 and 1.2 times the exposure level at the maximum recommended human 525 mg dose.
Maltese: Il-firien irġiel urew żieda sinifikanti b'mod statistiku f'adenomi u karċinomi tal-glandoli mammarji bi 30 u 60 mg/kg/xahar li huwa 0.6 u 1.2 darbiet il-livell ta' esponiment tad-doża massima ta'525 mg rakkomandata fil-bnedmin.
English: TREVICTA 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.
Maltese: TREVICTA fih is-sustanza attiva paliperidone li tappartjenti għall-klassi ta' mediċini antipsikotiċi u jintuża bħala trattament ta' manteniment għas-sintomi tal-iskizofrenija f'pazjenti adulti.
English: TREVICTA 350 mg injection paliperidone
Maltese: TREVICTA 350 mg injezzjoni paliperidone
English: The difference is not likely to be of clinical relevance.
Maltese: Id-differenza aktarx li ma jkollhiex rilevanza klinika.
English: The following terms and frequencies are applied: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100); rare (≥ 1/10,000 to < 1/1,000); very rare (< 1/10,000); and not known (cannot be estimated from the available data).
Maltese: Intużaw dawn it-termini u l-frekwenzi: komuni ħafna (≥ 1/10); komuni (≥ 1/100 sa < 1/10); mhux komuni (≥ 1/1000 sa < 1/100); rari
English: Caution is advised when prescribing TREVICTA 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 antibiotics (e.g., fluoroquinolones), some other antipsychotics and some antimalarials (e.g., mefloquine).
Maltese: Hija rrakkomkandata l-kawtela meta TREVICTA jiġi ordnat ma' prodotti mediċinali magħrufa li jtawlu l-intervall QT, eż. antiarritmiċi tal-klassi IA, (eż., quinidine, disopyramide) u antiarritmiċi talklassi III (eż., amiodarone, sotalol), xi antistaminiċi, xi antibijotiċi (eż., fluoroquinolones), xi antipsikotiċi oħrajn, u xi mediċini kontra l-malarja (eż., mefloquine).
English: 90 kg or more yellow hub
Maltese: Inqas minn 90 kg l-aċċessorju r-roża
English: No data are available in patients with severe hepatic impairment (Child-Pugh class C).
Maltese: M'hemm l-ebda dejta disponibbli f'pazjenti b'indeboliment sever tal-fwied (klassi C ta' Child-Pugh).
English: TREVICTA 175 mg injection paliperidone
Maltese: TREVICTA 175 mg injezzjoni paliperidone
English: How to store TREVICTA
Maltese: X'fih TREVICTA
English: After shaking the syringe for at least 15 seconds, check the appearance of the suspension in the viewing window.
Maltese: Wara li tħawwad is-siringa għal mill-anqas 15-il sekonda, iċċekkja d-dehra tas-suspensjoni mit-tieqa li tara minnha.
English: 1 month after day 8
Maltese: Xahar wara jum 8
English: The safety and efficacy of TREVICTA in children and adolescents < 18 years of age have not been established.
Maltese: Is-sigurtà u l-effikaċja ta' TREVICTA fit-tfal u l-adolexxenti tal-età ta' < 18-il sena ma ġewx stabbiliti.
English: TREVICTA is not recommended in patients with moderate or severe renal impairment (creatinine clearance < 50 mL/min).
Maltese: TREVICTA mhuwiex irrakkomandat f'pazjenti b'indeboliment moderat jew sever tal-kliewi (tneħħija tal-kreatinina < 50 mL/min).
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: Analiżi farmakokinetika tal-popolazzjoni ma wrew l-ebda differenza fit-tneħħija apparenti ta' paliperidone wara l-għoti ta' paliperidone mill-ħalq bejn metabolizzaturi estensivi u metabolizzaturi dgħajfa ta' sustrati ta' CYP2D6.
English: PRE-FILLED SYRINGE
Maltese: Sess tal-persuna
English: One female (2.4%) in the TREVICTA group experienced an adverse reaction of amenorrhea, while no potentially prolactin related adverse reactions were noted among females in the placebo group.
Maltese: Mara waħda (2.4%) fil-grupp ta' TREVICTA kellha reazzjoni avversa ta' amenorrea, filwaqt li ma ġew innnutati l-ebda reazzjonijiet avversi possibbilment marbuta mal-prolaktin fost nisa fil-grupp tal-plaċebo.
English: Safety data involving concomitant use of TREVICTA with other antipsychotics is limited.
Maltese: Dejta ta' sigurtà li tinvolvi l-użu ta' TREVICTA flimkien ma' antipsikotiċi oħra hija limitata.
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 influwenza moderata fuq il-kapaċità ta' sewqan u tħaddim ta' magni minħabba l-effetti possibbli fuq is-sistema nervuża u l-vista, bħal sedazzjoni, ngħas, sinkope, vista mċajpra (ara sezzjoni 4.8).
English: Date of first authorisation: 05 December 2014 Date of latest renewal:
Maltese: Data tal-ewwel awtorizzazzjoni: 05 ta' Diċembru 2014
English: For subjects that met randomisation criteria at weeks 14 and 17, 1,016 were randomised in a 1:1 ratio to continue on monthly injections of 1-monthly paliperidone palmitate injectable or to switch to TREVICTA with a 3.5 multiple of the week 9 and 13 dose of 1-monthly paliperidone palmitate injectable for 48 weeks.
Maltese: Għal individiwi li ssodisfaw kriterji għal għażla arbitrarja fil-ġimgħat 14 u 17, 1,016 intgħażlu b'mod arbitrarju fi proporzjon ta' 1:1 biex jew ikomplu fuq injezzjonijiet kull xahar ta' paliperidone palmitate ta' kull xahar li jista' jiġi injettat jew jaqilbu għal TREVICTA b'multiplu ta' 3.5 tad-doża tal-ġimgħa 9 u 13 ta' paliperidone palmitate ta' kull xahar li jista' jiġi injettat għal 48 ġimgħa.
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, inkluż każijiet ta' emboliżmu fil-pulmuni u każijiet ta' trombożi fil-vini fil-fond, ġew irrappurtati bi prodotti mediċinali antipsikotiċi (frekwenza mhux magħrufa).
English: In clinical trials of TREVICTA, 5.3% of subjects reported injection site related adverse reaction.
Maltese: Fi provi kliniċi ta' TREVICTA, 5.3% tal-individwi rrappurtaw reazzjoni avversa marbuta mal-post talinjezzjoni.
English: Each pre-filled syringe contains 819 mg paliperidone palmitate equivalent to 525 mg paliperidone.
Maltese: Kull siringa mimlija għal-lest fiha 819 mg paliperidone palmitate ekwivalenti għal 525 mg paliperidone.
English: Weight should be monitored regularly.
Maltese: Il-piż għandu jiġi mmonitorjat b'mod regolari.
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 insomnja e aġitazzjoni, depressjoni, ansjetà disturb fl-irqad, manija, tnaqqis fil-libido, nervożità, ħmar il-lejl katatonja, stat ta' konfużjoni, somnambuliżmu, tnaqqis kbir flespressjoni talemozzjonijiet, ma jinkisibx orgażmu
English: Each TREVICTA 525 mg pre-filled syringe contains 819 mg paliperidone palmitate.
Maltese: Kull siringa mimlija għal-lest ta' TREVICTA 525 mg fiha 819 mg paliperidone palmitate.
English: Each TREVICTA 350 mg pre-filled syringe contains 546 mg paliperidone palmitate.
Maltese: Kull siringa mimlija għal-lest ta' TREVICTA 350 mg fiha 546 mg paliperidone palmitate.
English: • TREVICTA can raise your levels of a hormone called "prolactin" found on a blood test (which may or may not cause symptoms).
Maltese: • TREVICTA jista' jżid il-livelli ta' ormon imsejjaħ "prolactin" li jinstab b'test tad-demm (li jista' jikkawża jew ma jikkawżax sintomi).
English: Each pre-filled syringe contains 410 mg paliperidone palmitate equivalent to 263 mg paliperidone.
Maltese: Kull siringa mimlija għal-lest fiha 410 mg paliperidone palmitate ekwivalenti għal 263 mg paliperidone.
English: Each pre-filled syringe contains 546 mg paliperidone palmitate equivalent to 350 mg paliperidone.
Maltese: Kull siringa mimlija għal-lest fiha 546 mg paliperidone palmitate ekwivalenti għal 350 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 mogħtija nġabret lura mill-awrina u 11% flippurgar.
English: It is important to only use the needles provided in the TREVICTA pack.
Maltese: Huwa importanti li tuża biss il-labar provduti fil-pakkett ta' TREVICTA.
English: SHAKE VIGOROUSLY for at least 15 seconds
Maltese: ĦAWWAD BIS-SAĦĦA għal millinqas 15-il sekonda
English: Gluteal muscle administration
Maltese: Użu għal ġol-muskoli
English: A switch from gluteal to deltoid (and vice versa) should be considered for future injection in the event of injection site discomfort (see section 4.8).
Maltese: Bidla minn gluteali għal deltoid (u viċe versa) għandha titqies għal injezzjonijiet futuri f'każ ta' skumdità fis-sit tal-injezzjoni (ara sezzjoni 4.8).
English: Dosing window
Maltese: Injetta d-doża
English: Gastrointestinal disorders abdominal pain, vomiting, nausea, constipation, diarrhoea, dyspepsia, toothache abdominal discomfort, gastroenteritis, dysphagia, dry mouth, flatulence pancreatitis, swollen tongue, faecal incontinence, faecaloma, cheilitis intestinal obstruction, ileus
Maltese: Disturbi gastrointestinali uġigħ fl-addome, rimettar, nawsja, stitikezza, dijarea, dispepsja, uġigħ fis-snien skumdità fl-addome, gastroenterite, disfaġja, ħalq xott, gass pankreatite, ilsien minfuħ, inkontinenza talippurgar, fikaloma, kejlite imblokk filmusrana, ileus
English: Grasp needle pouch
Maltese: Doża maqbuża
English: Each pre-filled syringe contains 273 mg paliperidone palmitate equivalent to 175 mg paliperidone.
Maltese: Kull siringa mimlija għal-lest fiha 273 mg paliperidone palmitate ekwivalenti għal 175 mg paliperidone.
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 mill-ħalq ta' pilloli ta' paliperidone li jerħu l-mediċina fit-tul fl-istat fiss (12-il mg darba kuljum) flimkien mal-pilloli ta' divalproex sodium li jerħu l-mediċina fit-tul (500 mg sa 2000 mg darba kuljum) ma affettwax il-farmakokinetika ta' valproate fl-istat fiss.
English: Since this medicine may reduce your urge to vomit, there is a chance that it may mask the body's normal response to ingestion of toxic substances or other medical conditions.
Maltese: Minħabba li din il-mediċina tista' tnaqqaslek l-impuls li tirremetti, hemm possibbiltà li tista' tostor irreazzjoni normali tal-ġisem għall-inġestjoni ta' sustanzi tossiċi jew kundizzjonijiet mediċi oħrajn.