FrancophonIA/ELRC3.0 huggingface dataset:
English: Change in PANSS Score Mean baseline (SD) Mean change (SD) P-value (vs Placebo) Diff. of LS Means (SE) Responder Analysis Responder, n (%) Non-responder, n (%) P value (vs Placebo)
Maltese: Bidla fil-Punteġġ PANSS Linja Bażi Medja (SD) Tibdil Medju (SD) Valur P (vs Plaċebo) Diff. ta' Medji LS (SE) Analiżi ta' Responsuri Irrispondew, n (%) Ma rrispondewx, n (%) Valur P (vs Plaċebo)
English: Population pharmacokinetics analyses indicated no discernible difference on the apparent clearance of paliperidone after administration of INVEGA between extensive metabolisers and poor metabolisers of CYP2D6 substrates.
Maltese: Analiżi tal-karatteristiċi farmakokinetiċi fil-popolazzjoni ma wrew l-ebda differenza fit-tneħħija apparenti ta' paliperidone wara l-għoti ta' INVEGA bejn metabolizzaturi estensivi u metabolizzaturi dgħajfa ta' substrati ta' CYP2D6.
English: In schizophrenia clinical trials, there was no difference observed between placebo and the 3 and 6 mg doses of INVEGA.
Maltese: Fi provi kliniċi dwar skiżofrenja, ma ġietx osservata differenza bejn il-plaċebo u dożi ta' 3 mg u 6 mg ta' INVEGA.
English: Currently available data are described in section 4.8 and 5.1 but no recommendation on a posology can be made.
Maltese: Data disponibbli hija deskritta fis-sezzjoni 4.8 u 5.1, iżda ma tista' ssir l-ebda rakkomandazzjoni dwar pożoloġija.
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, and glabellar reflex abnormal, 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: L-EPS kienu jinkludu analiżi miġbura tat-termini li ġejjin: parkinsoniżmu (li jinkludi produzzjoni eċċessiva ta' bżieq, ebusija muskuloskeletrika, parkinsoniżmu, tliegħeb, riġidità b'movimenti qishom ta' rota tal-ingranaġġ, bradikinesija, ipokinesija, wiċċ mingħajr espressjoni bħal f'maskra, ebusija tal-muskoli, akinesija, riġidità tal-muskoli tal-għonq, riġidità tal-muskoli, mixja parkinsonjana, u rifless glabellari anormali, rogħda ta' parkinson ta' waqt il-mistrieħ), akatisija (li tinkludi akatisija, irrekwitezza, iperkinesija, u sindrome ta' sieq b'irrekwitezza), diskineżija (diskineżija, ġbid talmuskoli, koreoatetożi, atetożi u mijoklonus), distonija (li tinkludi distonija, spażmi tal-muskoli, ipertonija, tortikollis, kontrazzjonijiet involontarji tal-muskoli, kontrazzjonijiet tal-muskoli, blefarospażmi, okuloġirazzjonii, paraliżi tal-ilsien, spażmi tal-wiċċ, laringospażmi, mijotonija, opistotonus, spażmu orofarinġeali, plewrototonus, spażmi tal-ilsien, u triżmu), u rogħda.
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-Sindrome Malinn Newrolettiku (NMS), li hu kkaratterizzat minn ipertermija, ebusija tal-muskoli, instabilità awtonomika, perċezzjoni mibdula, u livelli elevati ta' creatine phosphokinase fis-serum, ġie rrappurtat li jseħħ b'paliperidone.
English: All tested doses of INVEGA separated from placebo on day 4 (p < 0.05).
Maltese: Id-dożi kollha ttestjati ta' INVEGA infirdu mill-plaċebo f'jum 4 (p < 0.05).
English: Paliperidone systemic exposure in adolescent subjects (15 years and older) was comparable to that in adults.
Maltese: L-esponiment sistemiku għal paliperidone f'individwi adolexxenti (15-il sena u fuqhom) kien komparabbli għal dak ta' adulti.
English: INVEGA contains the active substance paliperidone which belongs to the class of antipsychotic medicines.
Maltese: INVEGA fih is-sustanza attiva paliperidone li tappartjieni għal klassi ta' mediċini antipsikotiċi.
English: Pharmacologic group: Psycholeptics, other antipsychotics ATC code: N05AX13
Maltese: Psikolettiċi, antipsikotiċi oħra Kodiċi ATC:
English: Excipient with known effect Each 3 mg tablet contains 13.2 mg lactose.
Maltese: Kull pillola ta' 3 mg fiha 13.2 mg ta' lactose.
English: Refer to ‘Extrapyramidal symptoms' below.
Maltese: Ara ‘Sintomi ekstrapiramidali' hawn taħt.
English: Adverse reactions that may suggest increase in prolactin levels (e.g., amenorrhoea, galactorrhoea, menstrual disturbances, gynaecomastia) were reported overall in 9.3% of subjects.
Maltese: Reazzjonijiet avversi li jistgħu jissuġerixxu din iż-żieda fil-livelli ta' prolaktin (eż. amenorrea, galaktorrea, disturbi menstruwali, ginekomastja) kienu rapportati b'mod globali f'9.3% ta' individwi.
English: In the pooled adolescent schizophrenia population (12 years and older, N = 545) exposed to INVEGA, the frequency and type of undesirable effects were similar to those in adults except for the following ADRs that were reported more frequently in adolescents receiving INVEGA than adults receiving INVEGA (and more frequently than placebo): sedation/somnolence, parkinsonism, weight increase, upper respiratory tract infection, akathisia, and tremor were reported very commonly (≥ 1/10) in adolescents; abdominal pain, galactorrhoea, gynaecomastia, acne, dysarthria, gastroenteritis, epistaxis, ear infection, blood triglyceride increased, and vertigo were reported commonly (≥ 1/100, < 1/10) in adolescents.
Maltese: Fil-popolazzjoni miġbura ta' adolexxenti bi skiżofrenija (12-il sena u akbar, N = 545) esposti għal INVEGA, il-frekwenza u t-tip ta' effetti mhux mixtieqa kienu simili għal dawk f'adulti ħlief għall-ADRs li ġejjin li kienu rapportati fi frekwenza ogħla f'adolexxenti li kienu qed jirċievu INVEGA milli f'adulti li kienu qed jirċievu INVEGA (u bi frekwenza akbar mill-plaċebo): sedazzjoni/ħedla, parkinsoniżmu, żieda fil-piż, infezzjoni fil-passaġġ respiratorju ta' fuq, akatisja, u rogħda ġew rapportati aktar ta' spiss (≥ 1/10) f'adolexxenti; uġigħ addominali, gallatorea, ġinekomastja, akne, disartrija, gastroenterite, epistassi, infezzjoni tal-widnejn, żieda ta' trigliċeridi fid-demm, u vertiġni kienu rapportati b'mod komuni (>1/100, < 1/10) f'adolexxenti.
English: • lung congestion
Maltese: • konġestjoni tal-pulmun
English: CARTON FOR PVC-PCTFE/ALUMINIUM BLISTER (for white and clear blister)
Maltese: KARTUNA GĦALL-FOLJA PVC-PCTFE/ALUMINJU (għall-folja bajda u trasparenti)
English: INVEGA Lower Dose (3-6 mg)
Maltese: INVEGA Doża Anqas (3-6 mg)
English: The absolute oral bioavailability of paliperidone following INVEGA administration is 28% (90% CI of 23%-33%).
Maltese: Il-bijodisponibiltà orali assoluta ta' paliperidone wara l-għoti ta' INVEGA hija ta' 28% (90% CI ta'
English: Pack sizes of 14, 28, 30, 49, 56, and 98 prolonged-release tablets.
Maltese: Daqsijiet tal-pakketti ta' 14, 28, 30, 49, 56, u 98 pillola li jerħu l-mediċina bil-mod.
English: 30 prolonged-release tablets 350 prolonged-release tablets
Maltese: Kull flixkun fih 30 pillola jew 350 pillola.
English: • loss of menstrual periods
Maltese: • assenza tal-pirjid menstruwali
English: Adolescent Schizophrenia Study: R076477-PSZ-3003: 26-week, flexible-dose, active-controlled Intent-to-Treat Analysis Set.
Maltese: Studju ta' Skiżofrenija fl-Adolexxenti: R076477-PSZ-3003: 26 ġimgħa, doża flessibbli, ikkontrollati b'mod attiv Sett ta' Analiżi Intenzjonati biex Tikkura.
English: Elimination of paliperidone decreased with decreasing renal function.
Maltese: L-eliminazzjoni ta' paliperidone naqset bit-tnaqqis tal-funzjoni renali.
English: Adverse reactions that may suggest increase in prolactin levels (e.g., amenorrhoea, galactorrhoea, menstrual disturbances, gynaecomastia) were reported overall in 2% of subjects.
Maltese: Ġew irrappurtati reazzjonijiet avversi globalment li jistgħu jissuġġerixxu żieda fil-prolactin (eż. amenorrea, galactorrea, disturbi menstrwali, ġinekomastija) fi 2% tal-individwi.
English: Enrolled subjects 1) met DSM-IV criteria for schizoaffective disorder, as confirmed by the Structured Clinical Interview for DSM-IV Disorders, 2) had a Positive and Negative Syndrome Scale (PANSS) total score of at least 60, and 3) had prominent mood symptoms as confirmed by a score of at least 16 on the Young Mania Rating Scale (YMRS) and/or Hamilton Rating Scale 21 for Depression (HAM-D 21).
Maltese: Individwi rreġistrati 1) kienu konformi mal-kriterji tad-DSM-IV għal disturb skiżoaffettiv, kif ikkonfermat mill-Intervista Klinika Strutturata għad-Disturbi tad-DSM-IV, 2) kellhom punteġġ totali ta' mill-anqas 60 fuq l-Iskala tas-Sindromi Pożittivi u Negattivi (PANSS), u 3) kellhom sintomi talburdata prominenti kif ikkonfermat minn punteġġ ta' mill-anqas 16 fuq l-Iskala ta' Klassifikazzjoni ta' Manija fiż-Żgħażagħ (YMRS) u/jew l-Iskala ta' Klassifikazzjoni ta' Hamilton 21 għad-Dipressjoni (HAM-D 21).
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'metaanaliżi ta' 17-il prova klinika kkontrollata, pazjenti anzjani bid-dimenzja kkurati b'antipsikotiċi atipiċi oħrajn, inkluż risperidone, aripiprazole, olanzapine, u quetiapine kellhom żieda fir-riskju ta' mortalità meta mqabbla ma' dawk li ħadu plaċebo.
English: The efficacy of INVEGA in adolescent subjects with schizophrenia (INVEGA N = 149, placebo N = 51) was studied in a randomised, double-blind, placebo-controlled, 6-week study using a fixed-dose weight-based treatment group design over the dose range of 1.5 mg/day to 12 mg/day.
Maltese: L-effikaċja ta' INVEGA f'individwi adolexxenti bi skiżofrenija (INVEGA N = 149, plaċebo N= 51) kienet studjata fi studju każwali ta' 6 ġimgħat li kien ukoll double-blind u bil-plaċebo bħala kontroll, li uża doża ta' trattament fissa bażata fuq il-piż fil-meded ta' dożi ta' bejn 1.5 mg/jum sa 12-il mg/jum.
English: Efficacy of INVEGA over a flexible dose range of 3 mg/day to 9 mg/day in adolescent subjects (12 years and older) with schizophrenia (INVEGA N = 112, aripiprazole N = 114) was also evaluated in a randomised, double-blind, active-controlled study that included an 8-week, double-blind acute phase and an 18-week, double-blind maintenance phase.
Maltese: L-effikaċja ta' INVEGA fuq medda ta' dożi flessibbli ta' 3 mg/jum sa 9 mg/jum f'individwi adolexxenti (12-il sena u akbar) bi skiżofrenija (INVEGA N-112, aripiprazole N = 114) kienet ukoll evalwata fi studju każwali, double-blind u b'kontroll attiv li kien jinkludi fażi akuta double-blind ta' 8 ġimgħat u fażi ta' manteniment double-blind ta'18-il ġimgħa.
English: In a study 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 f'persuni b'indeboliment epatiku moderat (Child-Pugh Klassi B), il-konċentrazzjonijiet fil-plażma ta' paliperidone ħieles kienu simili għal dawk ta' persuni f'saħħithom.
English: Based on pooled data from the three, placebo-controlled, 6-week, fixed-dose trials with INVEGA (3, 6, 9, and 12 mg), orthostatic hypotension was reported by 2.5% of subjects treated with INVEGA 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' INVEGA (3,6,9, u 12-il mg), ġiet irrappurtata ipotensjoni ortostatika f'2.5% tal-individwi kkurati b'INVEGA meta mqabbel ma' 0.8% tal-individwi kkurati bi plaċebo.
English: dry mouth, toothache
Maltese: Mhux magħrufa
English: • neuroleptic malignant syndrome (confusion, reduced or loss of consciousness, high fever, and severe muscle stiffness)
Maltese: • sindrome newrolettiku malinn (konfużjoni, koxjenza mnaqqsa jew telf mis-sensi, deni għoli, u ebusija severa fil-muskoli)
English: Hypersensitivity to the active substance, risperidone, or to any of the excipients listed in section 6.1.
Maltese: Sensittività eċċessiva għas-sustanza attiva, risperidone, jew għal kwalunkwe sustanza mhux attiva elenkata fis-sezzjoni 6.1.
English: In clinical trials with some other atypical antipsychotics, increased risks of death and cerebrovascular accidents have been reported (see section 4.4).
Maltese: Fi provi kliniċi b'xi antipsikotiċi atipiċi oħrajn, ġew irrappurtati riskji miżjuda ta' mewt u inċidenti ċerebrovaskulari (ara sezzjoni 4.4)
English: • tremor (shaking)
Maltese: • rogħda (tertir)
English: Menstrual disorder includes: menstruation irregular, oligomenorrhoea
Maltese: Disturb fil-menstrwazzjoni jinkludi: menstrwazzjoni irregolari, oligomenorrea
English: • breakdown of muscle fibers and pain in muscles (rhabdomyolysis), abnormal posture
Maltese: • kollass tal-fibri muskolari u uġigħ fil-muskoli (rabdomajlosi), qagħda mhix normali
English: • hives (or “nettle rash”), hair loss, eczema, acne
Maltese: • ħorrieqija (raxx),telf ta' xagħar, ekżema, akne
English: Schizophrenia Studies: Proportion of Subjects with Responder Status at LOCF End Point Studies R076477-SCH-303, R076477-SCH-304, and R076477-SCH-305: Intent-to-Treat Analysis Set
Maltese: Proporzjon ta' Individwi bi Status ta' Li Rrispondew f'Punt Aħħari ta' LOCF Studji R076477-SCH-303, R076477-SCH-304, u R076477-SCH-305: Sett ta' Analiżi tal-Intenzjoni-biexTikkura
English: The mean terminal elimination half-life of paliperidone was 24, 40, and 51 hours in subjects with mild, moderate, and severe renal impairment, respectively, compared with 23 hours in subjects with normal renal function (CrCl ≥ 80 mL/min).
Maltese: Il-half-life medja tal-eliminazzjoni terminali ta' paliperidone kienet ta' 24, 40 u 51 siegħa għal persuni b'indeboliment renali ħafif, moderat u qawwi rispettivament, meta mqabbel ma' 23 siegħa f'persuni b'funzjoni renali normali (CrCl ≥ 80 mL/min).
English: 7 & 10 TABLET PVC-PTFE/ALU BLISTER (for white and clear blister)
Maltese: FOLJA TAL-PVC-PTFE/ALU B'7 U 10 PILLOLI (għall-folji bojod u trasparenti)
English: The changes in PANSS total scores from baseline to week 8 and week 26 were numerically similar between the INVEGA and aripiprazole treatment groups.
Maltese: Il-bidliet fil-punteġġi totali ta' PANSS mil-linja bażi f'ġimgħa 8 u ġimgħa 26 kienu numerikament simili bejn il-gruppi ta' trattament ta' INVEGA u aripiprazole.
English: Hyperprolactinaemia
Maltese: iperinsulinemija
English: Subjects were 12-17 years of age and met DSM-IV criteria for schizophrenia.
Maltese: L-individwi kellhom bejn 12 sa 17-il sena u ssodidaw il-kriterji DSM-IV għal skiżofrenija.
English: An examination of population subgroups did not reveal any evidence of differential responsiveness on the basis of gender, age, or geographic region.
Maltese: Eżami ta' sottogruppi tal-popolazzjoni ma weriex evidenza ta' rispons differenzjali fuq il-bażi ta' sess, età, jew reġjun ġeografiku.
English: There were insufficient data to explore differential effects based on race.
Maltese: Ma kienx hemm biżżejjed dejta biex ikunu esplorati effetti differenzjali ibbażati fuq razza.
English: Pack sizes of 14, 28, 49, 56, and 98 prolonged-release tablets.
Maltese: Daqsijiet tal-pakketti ta' 14, 28, 49, 56, u 98 pillola li jerħu l-mediċina bil-mod.
English: • irregular heartbeat, abnormal electrical tracing of the heart (electrocardiogram or ECG), a fluttering or pounding feeling in your chest (palpitations)
Maltese: • taħbit tal-qalb irregolari, intraċċar elettriku mhux normali tal-qalb (elettrokardjogramma jew ECG), tferfir jew taħbit qawwi f'sidrek (palpitazzjonijiet)
English: Adolescents weighing < 51 kg: the maximum recommended daily dose of INVEGA is 6 mg.
Maltese: Adolexxenti li jiżnu < 51 kg: id-doża massima rakkomandata ta' kuljum ta' INVEGA hi ta' 6 mg.
English: This medicinal product contains less than 1 mmol sodium (23 mg) per tablet, 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: Immune system disorders anaphylactic reaction,
Maltese: Disturbi fis-sistema immuni reazzjoni anafilattika, sensittività eċċessiva
English: Co-administration of INVEGA 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 flimkien ta' INVEGA 12-il mg darba kuljum ma' pilloli ta' divalproex sodium li jerħu lmediċina bil-mod (500 mg sa 2,000 mg darba kuljum) ma affettwax il-farmakokinetika ta' valproate fl-istat fiss.
English: • infection of the chest (bronchitis), common cold symptoms, sinus infection, urinary tract infection, feeling like you have the flu
Maltese: • infezzjoni fis-sider (bronkite), sintomi ta' riħ komuni, infezzjoni fis-sinus, infezzjoni fl-apparat tal-awrina, tħossok qisek għandek l-influwenza
English: EU/1/07/395/011 - 015 EU/1/07/395/031 - 035 EU/1/07/395/049 - 052 EU/1/07/395/061 - 062 EU/1/07/395/071 - 073
Maltese: EU/1/07/395/049 - 052 EU/1/07/395/061 - 062 EU/1/07/395/071 - 073
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 lġrieden, ġew osservati żidiet fl-adenomi tal-glandoli pitwitarji (fil-ġrieden), adenomi endokrinali filfrixa (fil-firien) u adenomi tal-glandoli mammarji (fiż-żewġ speċi).
English: Torsade de pointes and ventricular fibrillation have been reported in association with overdose.
Maltese: Torsade de pointes u fibrillazzjoni tal-ventrikulu ġew irrappurtati b'konnessjoni ma' doża eċċessiva.
English: The adverse drug reactions (ADRs) most frequently reported in clinical trials with adults were headache, insomnia, sedation/somnolence, parkinsonism, akathisia, tachycardia, tremor, dystonia, upper respiratory tract infection, anxiety, dizziness, weight increased, nausea, agitation, constipation, vomiting, fatigue, depression, dyspepsia, diarrhoea, dry mouth, toothache, musculoskeletal pain, hypertension, asthenia, back pain, electrocardiogram QT prolonged, and cough.
Maltese: L-iktar reazzjonijiet avversi għall-mediċina (ADRs) li ġew irrappurtati b'mod frekwenti fl-adulti kienu wġigħ ta' ras, nuqqas ta' rqad, sedazzjoni/ngħas, parkinsoniżmu, akatisija, takikardija, rogħda, distonja, infezzjoni fuq in-naħa ta' fuq tal-apparat respiratorju, ansjetà, sturdament, żieda fil-piż, dardir, aġitazzjoni, stitikezza, remettar, għeja, dipressjoni, dispepsja, dijarea, ħalq xott, uġigħ fis-snien, uġigħ muskoluskeletriku, pressjoni għolja, astenja, uġigħ fid-dahar, elettrokardjogramma ta' QT imtawwal u sogħla.
English: Schizophrenia Studies: Positive and Negative Syndrome Scale for Schizophrenia (PANSS) Total Score - Change From Baseline to End Point - LOCF for Studies R076477-SCH-303, R076477-SCH-304, and R076477-SCH-305: Intent-to-Treat Analysis Set
Maltese: Skala ta' Sindromi Pożittivi u Negattivi għal Skiżofrenja (PANSS) Punteġġ TotaliBidla mil-Linja Bażi sal-Punt Aħħari-LOCF għal Studji R076477-SCH-303, R076477-SCH-304, u R076477SCH-305:
English: Oriented polyamide (OPA)-aluminium-polyvinyl chloride (PVC)/aluminium push-through child-resistant blister.
Maltese: Oriented polyamide (OPA)-aluminium-polyvinyl chloride (PVC)/ aluminju li timbotta b'subgħajk minn ġo folja li ma tinfetaħx faċilment mit-tfal.
English: Psychiatric disorders: sleep-related eating disorder Nervous system disorders: cerebrovascular disorder Eye disorders: floppy iris syndrome (intraoperative) Respiratory, thoracic and mediastinal disorders: rales
Maltese: Disturbi psikjatriċi: disturb fil-kwantità ta' ikel li wieħed jiekol, marbut mal-irqad Disturbi tas-sistema nervuża: disturb ċerebrovaskulari Disturbi fl-għajnejn: sindromu tal-ħabba li titħarrek (intraoperattiv)
English: Adolescent Schizophrenia Study: R076477-PSZ-3001: 6-week, fixed-dose, placebo-controlled Intent-to-Treat Analysis Set.
Maltese: Studu ta' Skiżofrenija fl-Adolexxenti: R076477-PSZ-3001: 6 ġimgħat, doża fissa, bil-plaċebo bħala kontroll Sett ta' Analiżi Intenzjonati biex Tikkura.
English: An approximately 3-fold increased risk of cerebrovascular adverse reactions have been seen in randomised placebo-controlled clinical trials in the dementia population with some atypical antipsychotics, including risperidone, aripiprazole, and olanzapine.
Maltese: Ġiet innutata żieda fir-riskju ta' reazzjonijiet ċerebrovaskulari avversi ta' madwar 3 darbiet aktar fi provi kliniċi li fihom il-pazjenti ntagħżlu b'mod każwali kkontrollati bi plaċebo fil-popolazzjoni biddimenzja b'xi antipsikotiċi atipiċi, inkluż risperidone, aripiprazole, u olanzapine.
English: White polyvinyl chloride (PVC) laminated with polychloro-trifluoroethylene (PCTFE)/aluminium push-through layer.
Maltese: Polyvinyl chloride abjad (PVC) laminat b'saff ta' polychloro-trifluoroethylene (PCTFE)/aluminju li timbotta b'subgħajk.
English: Polyvinyl chloride (PVC) laminated with polychloro-trifluoroethylene (PCTFE)/aluminium push-through layer.
Maltese: Polyvinyl chloride (PVC) laminat b'saff ta' polychloro-trifluoroethylene (PCTFE)/aluminju li timbotta b'subgħajk.
English: Other medicinal products or herbals which are inducers, e.g., rifampicin and St John´s wort (Hypericum perforatum) may have similar effects on paliperidone.
Maltese: John's Wort (Hypericum perforatum) jista' jkollhom effetti simili fuq paliperidone.
English: How to store INVEGA
Maltese: X'fih INVEGA
English: Mean baseline (SD) Mean change (SD) P-value (vs, Placebo) Diff. of LS Means (SE)
Maltese: Linja bażi medja (SD) Bidla medja (SD) Valur P (vs. Placebo) Diff. ta' Medji LS (SE)
English: electrocardiogram abnormal, palpitations atrial fibrillation, postural orthostatic tachycardia syndrome
Maltese: arritmija tas-sinus, elettrokardijogram ma mhux normali, palpitazzjonijiet fibrilazzjoni atrijali, sindromu ta' takikardija minħabba l-qagħda pożizzjonali
English: Iron oxide (Black) (E172) Propylene glycol Hypromellose
Maltese: Linka tal-istampar Iron oxide (iswed) (E172) Propylene glycol Hypromellose
English: The efficacy of INVEGA in the treatment of schizophrenia in adolescents between 12 and 14 years old has not been established.
Maltese: L-effikaċja ta' INVEGA fi trattament ta' skiżofrenija f' adolexxenti ta' bejn it-12 u 14-il sena ma ġiex stabbilit.
English: Predefined secondary endpoints included the Personal and Social Performance (PSP) scale and the Clinical Global Impression - Severity (CGI-S) scale.
Maltese: Punti aħħarin sekondarji li kienu definiti minn qabel kienu jinkludu l-iskala tal-Imġiba Personali u Soċjali (PSP) u l-iskala talImpressjoni Klinika Globali - Severità (CGI-S).
English: In a study conducted in elderly subjects with schizophrenia, the safety profile was similar to that seen in non-elderly subjects.
Maltese: Fi studju li sar f'persuni anzjani bi skiżofrenja, il-profil ta' sigurtà kien simili għal persuni mhux anzjani.
English: 14 prolonged-release tablets 28 prolonged-release tablets 30 prolonged-release tablets 49 prolonged-release tablets 56 prolonged-release tablets 98 prolonged-release tablets
Maltese: 14-il pillola li jerħu l-mediċina bil-mod 28 pillola li jerħu l-mediċina bil-mod 30 pillola li jerħu l-mediċina bil-mod 49 pillola li jerħu l-mediċina bil-mod 56 pillola li jerħu l-mediċina bil-mod 98 pillola li jerħu l-mediċina bil-mod
English: INVEGA should be used with caution with medicines that increase the activity of the central nervous system (psychostimulants such as methylphenidate).
Maltese: INVEGA għandu jintuża b'kawtela ma' mediċini li jżidu l-attività tas-sistema nervuża ċentrali (psikostimulanti bħal methylphenidate).
English: Response defined as decrease from baseline in PANSS Total Score ≥ 20% Note: Negative change in score indicates improvement.
Maltese: Ir-rispons huwa definit bħala tnaqqis mil-linja bażi fil-Punteġġ Totali ta' PANSS ≥ 20% Nota: Bidla negattiva fil-punteġġ tindika titjib.