FrancophonIA/ELRC3.0 huggingface dataset:
English: In a 40-week juvenile toxicity study in dogs with oral doses of risperidone (which is extensively converted to paliperidone) up to 5 mg/kg/day, effects on sexual maturation, long bone growth and femur mineral density were observed from 3 times the clinical exposure based on AUC.
Maltese: Fi studju ta' 40 ġimgħa dwar tossiċità ġovanili fil-klieb b'dożi orali sa 5 mg/kg/jum ta' risperidone (li jiġi konvertit b'mod estensiv għal paliperidone), effetti fuq il-maturazzjoni sesswali, żvilupp bl-għadam il-kbir u densità minerali fil-wirk kienu osservati sa minn 3 darbiet l-esponiment kliniku bbażat fuq AUC.
English: Events of leucopenia, neutropenia, and agranulocytosis have been reported with antipsychotic agents, including INVEGA.
Maltese: Każijiet ta' lewkopenija, newtropenija u agranuloċitosi ġew rapportati b'sustanzi antipsikotiċi, li jinkludu INVEGA.
English: Paliperidone also blocks alfa1-adrenergic receptors and blocks, to a lesser extent, H1-histaminergic and alfa2-adrenergic receptors.
Maltese: Paliperidone jimblokka wkoll riċetturi alfa1-adrenerġiċi u jimblokka, b'mod inqas qawwi, riċetturi istaminerġiċi H1 u adrenerġiċi alfa2.
English: In schizophrenia clinical trials, the proportions of subjects meeting a weight gain criterion of ≥ 7% of body weight were compared, revealing a similar incidence of weight gain for INVEGA 3 mg and 6 mg compared with placebo, and a higher incidence of weight gain for INVEGA 9 mg and 12 mg compared with placebo.
Maltese: Fi provi kliniċi dwar skiżofrenja, tqabblu l-proporzjonijiet ta' persuni li laħqu l-kriterju ta' żieda fil-piż ta'  7% tal-piż tal-ġisem, u dan wera inċidenza simili ta' żieda fil-piż għal INVEGA 3 mg u 6 mg meta mqabbla mal-plaċebo, u inċidenza ogħla ta' żieda fil-piż għal INVEGA 9 mg u 12-il mg meta mqabbla mal-plaċebo.
English: This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium-free'.
Maltese: Din il-mediċina fiha inqas minn 1 mmol ta' sodium (23 mg) f'kull doża, li tista' tgħid huwa essenzjalment ‘bla sodium'.
English: 14 prolonged-release tablets 28 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 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: Caution is advised when prescribing INVEGA with medicines 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 jingħata INVEGA ma' mediċini li huma magħrufa li jtawlu l-intervall tal-QT, eż. antiarritmijaċi tal-klassi IA, (eż. quinidine, disopyramide) u antiarritmijaċi tal-klassi III (eż. amiodarone, sotalol), xi antistaminiċi, xi antipsikotiċi oħrajn, u xi mediċini kontra l-malarja (eż. mefloquine).
English: In schizophrenia clinical trials, increases in serum prolactin were observed with INVEGA in 67% of subjects.
Maltese: Fi provi kliniċi dwar skiżofrenja kienu osservati żidiet fis-serum prolactin b'INVEGA f'67% talpersuni.
English: Not observed in INVEGA clinical studies but observed in post-marketing environment with paliperidone In placebo-controlled pivotal trials, diabetes mellitus was reported in 0.05% in INVEGA-treated subjects compared to a rate of 0% in placebo group.
Maltese: Mhux osservat fl-istudji kliniċi b' INVEGA imma osservati fl-ambjent ta' wara t-tqegħid fis-suq b'paliperidone Fi provi ewlenien ikontrollati bi plaċebo, id-dijabete mellitus ġiet rapportata f'0.05% f'individwi trattati b'INVEGA meta mqabbel ma' rata ta' 0% fil-grupp tal-plaċebo.
English: Dizziness and vision problems may occur during treatment with this medicine (see section 4, possible side effects).
Maltese: Meta tieħu din il-mediċina jista' jkun li jkollok problemi ta' sturdament u vista (ara sezzjoni 4, effetti sekondarji li jista' jkollu).
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, imma m'hemm l-ebda indikazzjonijiet in vitro jew in vivo li dawn l-isożimi għandhom sehem sinifikanti fil-metaboliżmu ta' paliperidone.
English: Dosing recommendations for elderly patients with normal renal function (≥ 80 mL/min) are the same as for adults with normal renal function.
Maltese: Ir-rakkomandazzjoni għad-dożaġġ għal pazjenti anzjani li għandhom funzjoni renali normali (≥ 80 mL/min) hija l-istess għall-adulti b'funzjoni renali normali.
English: Refer to ‘Hyperprolactinaemia' below.
Maltese: Ara ‘Iperprolaktinemija' hawn taħt.
English: A 15 mg dose was also included in Study R076477-SCH-305, but results are not presented since this is above the maximum recommended daily dose of 12 mg.
Maltese: Doża ta' 15 mg kienet inkluża wkoll fi Studju R076477-SCH-305, imma r-riżultati mhumiex ippreżentati billi dan kien ogħla mill-massimu rakkomandat b'doża ta' kuljum ta' 12-il mg.
English: Venous thromboembolism
Maltese: Tromboemboliżmu fil-Vini
English: Additionally, in study SCA-3001 in the ITT population the effect on psychotic symptoms measured by PANSS was clearly less pronounced and not reaching statistical significance for patients receiving concomitantly mood stabilisers and/or antidepressants.
Maltese: Flimkien ma' dan, flistudju SCA-3001 fil-popolazzjoni ITT l-effett fuq is-sintomi psikotiċi mkejla bil-PANSS kien inqas notevoli b'mod ċar u ma laħaqx sinifikat statistiku għal pazjenti li kienu qed jirċievu stabilizzaturi talburdata u/jew antidipressanti mogħtija fl-istess ħin.
English: Dominating central serotonin antagonism may reduce the tendency of paliperidone to cause extrapyramidal side effects.
Maltese: Il-ħila li jiddomina l-antagoniżmu tas-serotonin ċentrali jista' jnaqqas it-tendenza ta' paliperidone li jikkawża effetti ekstrapiramidali.
English: Ear and labyrinth disorders vertigo, tinnitus, ear pain
Maltese: Disturbi fil-widnejn u fis-sistema labirintika vertiġini, tinnite, uġigħ fil-widnejn
English: Medicinal products affecting gastrointestinal transit time may affect the absorption of paliperidone, e.g., metoclopramide.
Maltese: Prodotti mediċinali li jaffettwaw iż-żmien ta' tranżitu gastrointestinali jistgħu jaffettwaw l-assorbiment ta' paliperidone, eż. metoclopramide.
English: Vascular disorders orthostatic hypotension, hypertension hypotension pulmonary embolism, venous thrombosis,
Maltese: Disturbi vaskulari ipotensjoni ortostatika, pressjoni għolja pressjoni baxxa emboliżmu filpulmun, trombożi fil-vini, iskemija, fwawar
English: If signs and symptoms of tardive dyskinesia appear, the discontinuation of all antipsychotics, including INVEGA, should be considered.
Maltese: Jekk jitfaċċaw is-sinjali u s-sintomi ta' diskineżija tardiva, għandu jitqies it-twaqqif tal-antipsikotiċi kollha, inkluż INVEGA.
English: For specific posology recommendations in the paediatric population see section 4.2.
Maltese: Għal rakkomandazzjonijiet speċifiċi dwar il-pożoloġija fil-popolazzjoni pedjatrika ara sezzjoni 4.2.
English: • erectile dysfunction, ejaculation disorder
Maltese: • disfunzjoni erettili, disturb ta' eġakulazzjoni
English: psychomotor hyperactivity,
Maltese: konġestjoni pulmonari
English: • a blockage in the bowels, stool incontinence, very hard stool, lack of bowel muscle movement that causes blockage
Maltese: • sadd fl-imsaren, inkontinenza tal-ippurgar, ippurgar iebes ħafna, nuqqas ta' moviment filmuskolu tal-musrana li jikkawża sadda
English: In adolescents weighing < 51 kg, a 23% higher exposure was observed than in adolescents weighing ≥ 51 kg. Age alone did not influence the paliperidone exposure.
Maltese: F'adolexxenti li jiżnu < 51 kg, kienet osservata żieda ta' 23% fl-esponiment milli f'adolexxenti li jiżnu ≥ 51 kg.
English: INVEGA 12 mg
Maltese: INVEGA 12-il mg
English: Co-administration of INVEGA once daily with carbamazepine 200 mg twice daily caused a decrease of approximately 37% in the mean steady-state Cmax and AUC of paliperidone.
Maltese: Meta INVEGA ingħata flimkien darba kuljum flimkien ma' 200 mg ta' carbamazepine darbtejn kuljum, dan wassal għal tnaqqis ta' madwar 37% fil-medja tal-istat fiss tas-Cmax u l-AUC ta' paliperidone.
English: Fertility There were no relevant effects observed in the non-clinical studies.
Maltese: Fertilità Ma kien hemm ebda effetti osservati fi studji mhux kliniċi
English: Dose dependence for EPS was seen with the two higher doses of INVEGA (9 and 12 mg).
Maltese: Dipendenza fuq id-doża għall-EPS dehret bl-ogħla żewġ dożi ta' INVEGA (9 u 12-il mg).
English: Schizoaffective Disorder Studies: Primary Efficacy Parameter, PANSS Total Score Change from Baseline from Studies R076477-SCA-3001 and R076477-SCA-3002: Intent-to-Treat Analysis Set
Maltese: Parametru Primarju tal-Effikaċja, Tibdil fil-Punteġġ Totali talPANSS mil-Linja Bażi mill-Istudji R076477-SCA-3001 u R076477-SCA-3002: Sett ta' Analiżi talIntenzjoni-biex-Tikkura
English: • common cold symptoms
Maltese: • sintomi ta' riħ komuni
English: Infections and infestations bronchitis, upper respiratory tract infection, sinusitis, urinary tract infection, influenza pneumonia, respiratory tract infection, cystitis, ear infection, tonsillitis eye infection, onychomycosis, cellulitis, acarodermatitis
Maltese: Infezzjonijiet u infestazzjonijiet bronkite, infezzjoni fil-parti ta' fuq talpassaġġ respiratorju, sinusite, infezzjoni fl-apparat awrinarju, influwenza pnewmonja, infezzjoni fl-apparat respiratorju, ċistite, infezzjoni filwidnejn, tonsillite infezzjoni fl-għajnejn, onikomiċosi, ċellulite, akarodermatite
English: Nervous system disorders parkinsonism , akathisia b,
Maltese: Disturbi fis-sistema nervuża parkinsoniżmu, akaisija, sedazzjoni/ngħas, uġigħ ta' ras distonija b, sturdament, diskineżija b,
English: For patients with moderate to severe renal impairment (creatinine clearance  10 to < 50 mL/min), the recommended initial dose of INVEGA is 3 mg every other day, which may be increased to 3 mg once daily after clinical reassessment.
Maltese: Għal pazjenti b'indeboliment renali moderat sa qawwi (tneħħija tal-krejatinina  10 sa < 50 mL/min), id-doża rakkomandata ta' INVEGA hija 3 mg ġurnata iva u oħra le, li tista' tiżdied sa 3 mg darba kuljum wara evalwazzjoni klinika mill-ġdid.
English: • pneumonia, infection of the breathing passages, bladder infection, ear infection, tonsillitis
Maltese: • pnewmonja, infezzjoni tal-passaġġi tan-nifs, infezzjoni fl-apparat tal-awrina, infezzjoni filwidnejn, tonsillite
English: Mon, Tue, Wed, Thu, Fri, Sat, Sun
Maltese: • żieda fil-piż, żieda fl-aptit, telf ta' piż, nuqqas t'aptit
English: Adolescents generally experienced side effects that were similar to those seen in adults except the following side effects were seen more commonly:
Maltese: Adolexxenti ġeneralment jesperjenzaw effetti sekondarji simili għal dawk li jidhru f'adulti ħlief li leffetti sekondarji li ġejjin kienu aktar komuni:
English: These tumours can be related to prolonged dopamine D2 antagonism and hyperprolactinemia.
Maltese: Dawn it-tumuri jistgħu jiġu relatati ma' antagoniżmu tad-dopamina D2 fit-tul u iperprolaktinemija.
English: QT prolongation, ventricular arrythmias (ventricular fibrillation, ventricular tachycardia), sudden unexplained death, cardiac arrest and Torsade de pointes may occur with antipsychotics.
Maltese: B'antipsikotiċi jista' jkun hemm titwil tal-QT, arritmiji ventrikulari (fibrillazzjoni ventrikulari, takikardija ventrikulari), mewt f'daqqa bla spjegazzjoni, waqfien kardijaku u Torsade de pointes.
English: In schizoaffective disorder clinical trials, a higher percentage of INVEGA-treated subjects (5%) had an increase in body weight of ≥ 7% compared with placebo-treated subjects (1%).
Maltese: Fi provi kliniċi dwar disturb skiżoaffettiv, perċentwal ogħla ta' individwi kkurati b'INVEGA (5%) kellhom żieda fil-piż tal-ġisem ta' ≥ 7% meta mqabbla ma' individwi kkurati bi plaċebo (1%).
English: • chills, an increase in body temperature
Maltese: • sirdat, żieda fit-temperatura tal-ġisem
English: Other medicines and INVEGA
Maltese: Mediċini oħra u INVEGA
English: Cases of venous thromboembolism, including cases of pulmonary embolism and cases of deep vein thrombosis have been reported with antipsychotic drugs - Frequency unknown.
Maltese: Każijiet ta' tromboemboliżmi fil-vini, inklużi każijiet ta' emboliżmu fil-pulmun u każijiet ta' trombożi fil-vini fondi kienu rrappurtati b'mediċini antipsikotiċi - Frekwenza mhux magħrufa.
English: confusional state, libido decreased, anorgasmia, nervousness, nightmare catatonia, somnambulism, blunted affect
Maltese: Disturbi psikjatriċi insomnija manija, aġitazzjoni, depressjoni, ansjetà disturb fl-irqad, stat konfużjonali, tnaqqis fil-libido, anorgasmija, nervożità, ħmar illejl katatonja, somnambuliżmu, tnaqqis fil-kapaċità li turi emozzjonijiet
English: Paliperidone is a selective blocking agent of monoamine effects, whose pharmacological properties are different from that of traditional neuroleptics.
Maltese: Paliperidone huwa aġent li jimblokka b'mod selettiv l-effetti monoamini, li l-propjetajiet farmakoloġiċi tiegħu huma differenti minn dawk ta' newrolettiċi tradizzjonali.
English: Respiratory, thoracic and mediastinal disorders pharyngolarynge al pain, cough, nasal congestion dyspnoea, wheezing, epistaxis sleep apnoea syndrome, hyperventilation, pneumonia aspiration, respiratory tract congestion, dysphonia pulmonary congestion
Maltese: Disturbi respiratorji toraċiċi u medjastinali uġigħ farinġolarinġeali, sogħla, konġestjoni fl-imnieħer dispnea, tħarħir, epistassi sindromu ta' apnea fl-irqad, iperventilazzjoni, aspirazzjoni pnewmonali, konġestjoni flapparat respiratorju, disfonja,
English: Hepatobiliary disorders transaminases increased gamma-glutamyltran sferase increased, hepatic enzyme increased jaundice
Maltese: Disturbi fis-sistema endokrinarja iperprolaktinemija a tnixxija mhux xierqa fl-ormon antidijuretiku, preżenza ta' glukosju fl-awrina
English: • parkinsonism: This condition may include slow or impaired movement, sensation of stiffness or tightness of the muscles (making your movements jerky), and sometimes even a sensation of movement "freezing up" and then restarting.
Maltese: • parkinsoniżmu: din il-kundizzjoni tista' tinkludi moviment indebolit jew bil-mod, sensazzjoni ta' ebusijatal-muskoli (il-movimenti tiegħek jidhru bl-iskossi), u xi kultant anke sensazzjoni li l moviment qed ‘jiffriża' u mbagħad terġa' tibda.
English: Butyl hydroxytoluene (E321) Ferric Oxide (Yellow) (E172) (3, 12 mg tablet only) Polyethylene Oxide 7000K Ferric Oxide (Red) (E172)
Maltese: Butyl hydroxytoluene (E321) Ferric Oxide (Isfar) (E172) (pilloli ta' 3, 12-il mg biss) Polyethylene Oxide 7000K
English: The INVEGA group in the flexible-dose study (dosed between 3 and 12 mg/day, mean modal dose of 8.6 mg/day) and the higher dose group of INVEGA in the 2 dose-level study (12 mg/day with option to reduce to 9 mg/day) were each superior to placebo in the PANSS at 6 weeks.
Maltese: Il-grupp ta' INVEGA fl-istudju tad-doża flessibbli (doża bejn 3 u 12-il mg/kuljum, doża medja modali ta' 8.6 mg/kuljum) u l-grupp tad-doża ogħla ta' INVEGA fl-istudju taż-żewġ livelli ta' doża (12-il mg/kuljum bl-għażla li titnaqqas għal 9 mg/kuljum) kienu t-tnejn superjuri għall-plaċebo filPANSS fis-6 ġimgħa.
English: Current or past use of medicines with alpha 1a-adrenergic antagonist effect should be made known to the ophthalmic surgeon in advance of surgery.
Maltese: L-użu attwali jew passat ta' mediċini b'effett antagonista adrenerġiku alfa 1a għandu jkun mgħarref bih il-kirurgu oftalmiku qabel l-operazzjoni.
English: Statistically superior improvements in manic symptoms as measured by YMRS (secondary efficacy scale) were observed in patients from the flexible-dose study and the INVEGA higher dose in the second study.
Maltese: Ġie osservat titjib statistikament superjuri fis-sintomi manijaċi kif imkejjel mill-YMRS (skala ta' effikaċja sekondarja) f'pazjenti mill-istudju ta' doża flessibbli u l-ogħla doża ta' INVEGA fit-tieni studju.
English: Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucosegalactose malabsorption should not take this medicine.
Maltese: Kontenut ta' lactose (japplika biss għall-pilloli ta' 3 mg) Pazjenti li għandhom problemi ereditarji rari ta' intolleranza għal galactose, id-defiċjenza ta' Lapp lactase jew problemi fl-assorbiment għal glucose-galactose m'għandhomx jieħdu din il-mediċina.
English: Concomitant use of INVEGA with psychostimulants The combined use of psychostimulants (e.g., methylphenidate) with paliperidone can lead to extrapyramidal symptoms upon change of either or both treatments (see section 4.4).
Maltese: L-użu konkomitanti ta' INVEGA ma' psikostimulanti L-użu ta' psikostimulanti (eż., methylphenidate) flimkien ma' paliperidone jista' jwassal għal sintomi ekstrapiramidali meta jkun hemm bidla fi trattament wieħed jew fit-tnejn li huma (ara sezzjoni 4.4).
English: Overcoat
Maltese: FLIXKUN
English: Tabulated list of adverse reactions
Maltese: Deskrizzjoni ta' reazzjonijiet avversi partikolari
English: Store in the original package in order to protect from moisture.
Maltese: Aħżen fil-pakkett oriġinali biex tipproteġi mill-umdità.
English: Since patients treated with antipsychotics often present with acquired risk factors for VTE, all possible risk factors for VTE should be identified before and during treatment with INVEGA and preventive measures undertaken.
Maltese: Minħabba li pazjenti kkurati b'antipsikotiċi ta' spiss ikollhom fatturi ta' riskju għal VTE li jkunu ħadu, il-fatturi kollha possibbli ta' riskju għal VTE għandhom jiġu identifikati qabel u waqt il-kura b'INVEGA u jittieħdu miżuri ta' prevenzjoni.
English: • inflammation of the pancreas
Maltese: • żieda fil-piż
English: In a 7-week juvenile toxicity study in rats administered oral doses of paliperidone up to 2.5 mg/kg/day, corresponding to an exposure approximately equal to the clinical exposure based on AUC, no effects on growth, sexual maturation and reproductive performance were observed.
Maltese: Fi studju ta' 7 ġimgħat dwar it-tossiċità ġovanili f'firien li ngħataw dożi orali ta' paliperidone sa 2.5 mg mg/kg/jum, li jikkorispondi għal esponiment li hu kważi ugwali għall-esponiment kliniku abbażi ta' AUC, ma ġew osservati l-ebda effetti fuq żvilupp, maturazzjoni sesswali u prestazzjoni riprodutttiva.
English: dandruff
Maltese: • sturdament
English: 30 prolonged-release tablets - EU/1/07/395/057 350 prolonged-release tablets - EU/1/07/395/058
Maltese: 30 pillola li jerħu l-mediċina bil-mod - EU/1/07/395/057 350 pillola li jerħu l-mediċina bil-mod - EU/1/07/395/058
English: In the up to 2-year, open-label treatment study of INVEGA in adolescents with schizophrenia, incidence of elevated serum prolactin levels occurred in 48% of females and 60% of males.
Maltese: Fl-istudju bit-tikketta tingħaraf li dam sejjer għal sentejn ta' INVEGA f'adolexxenti bi skiżofrenija, l-inċidenza ta' livelli ogħla ta' prolaktin fis-serum seħħ fi 48% ta' nisa u 60% ta' rġiel.
English: Bottles:
Maltese: - Fliexken:
English: 30 prolonged-release tablets - EU/1/07/395/063 350 prolonged-release tablets - EU/1/07/395/064
Maltese: 30 pillola li jerħu l-mediċina bil-mod - EU/1/07/395/063 350 pillola li jerħu l-mediċina bil-mod - EU/1/07/395/064
English: waist circumference increased, anorexia, blood triglycerides increased water intoxication, diabetic ketoacidosis c, hypoglycaemia, polydipsia, blood cholesterol increased hyperinsulinaemi
Maltese: Intossikazzjoni blilma, ketoaċidosi dijabetika c, ipogliċemija, polidipsija, żieda tal-kolesterol fiddemm.
English: LOCF = last observation carried forward.
Maltese: LOCF=l-aħħar osservazzjoni miġjuba 'l quddiem.
English: Change in PANSS Score 26 week endpoint Mean baseline (SD) Mean change (SD) P-value (vs aripiprazole) Diff. of LS Means (SE) Responder Analysis 26 week endpoint Responder, n (%) Non-responder, n (%) P value (vs aripiprazole)
Maltese: Bidla fil-Punteġġ PANSS 8 ġimgħat, punt aħħari akut Linja Bażi Medja (SD) Tibdil medju (SD) Valur P (vs aripiprazole) Diff. ta' LS Means (SE) Bidla ta' Punteġġ PANSS 26 ġimgħa punt aħħari Linja Bażi Medja (SD) Tibdil medju (SD) Valur P (vs aripiprazole) Diff. ta' LS Means (SE) Analiżi ta' Responsuri 26 ġimgħa punt aħħari
English: 30 prolonged-release tablets - EU/1/07/395/061 350 prolonged-release tablets - EU/1/07/395/062
Maltese: 30 pillola li jerħu l-mediċina bil-mod - EU/1/07/395/061 350 pillola li jerħu l-mediċina bil-mod - EU/1/07/395/062
English: ischaemia, flushing
Maltese: Is-sustanzi l-oħra huma:
English: General disorders pyrexia, asthenia, fatigue face oedema, oedema e, chills, body temperature increased, gait abnormal, thirst, chest pain, chest discomfort, malaise hypothermia c, body temperature decreased c, drug withdrawal syndrome induration
Maltese: Disturbi ġenerali deni, astenja, għeja edema tal-wiċċ, edema e, sirdat, żieda fittemperatura talġisem, pass mhux normali, għatx, uġigħ fis-sider, dwejjaq fis-sider, tħossok mhux f'sikktek ipotermija c, temperatura talġisem aktar baxxa c, sindromu ta' tiżmin tal-mediċina c, indurazzjoni
English: Butyl hydroxytoluene (E321) Ferric oxide (yellow) (E172) Polyethylene oxide 7000K Ferric oxide (red) (E172) Hydroxyethyl cellulose Polyethylene glycol 3350 Cellulose acetate
Maltese: Butyl hydroxytoluene (E321) Ferric oxide (isfar) (E172) Polyethylene oxide 7000K Ferric oxide (aħmar) (E172) Hydroxyethyl cellulose Polyethylene glycol 3350 Cellulose acetate
English: INVEGA 3 mg prolonged-release tablets INVEGA 6 mg prolonged-release tablets INVEGA 9 mg prolonged-release tablets INVEGA 12 mg prolonged-release tablets paliperidone
Maltese: INVEGA pilloli ta' 3 mg li jerħu l-mediċina bil-mod INVEGA pilloli ta' 6 mg li jerħu l-mediċina bil-mod INVEGA pilloli ta' 9 mg li jerħu l-mediċina bil-mod INVEGA pilloli ta' 12-il mg li jerħu l-mediċina bil-mod paliperidone
English: EU/1/07/395/006 - 010 EU/1/07/395/026 - 030 EU/1/07/395/045 - 048 EU/1/07/395/059 - 060 EU/1/07/395/068 - 070
Maltese: EU/1/07/395/045 - 048 EU/1/07/395/059 - 060
English: Butyl hydroxytoluene (E321) Polyethylene oxide 7000K Ferric oxide (red) (E172) Hydroxyethyl cellulose Polyethylene glycol 3350 Cellulose acetate
Maltese: Butyl hydroxytoluene (E321) Polyethylene oxide 7000K Ferric oxide (aħmar) (E172) Hydroxyethyl cellulose Polyethylene glycol 3350 Cellulose acetate
English: Overall incidence from all clinical trials was 0.14% in all INVEGA-treated subjects 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: The PANSS is a validated multi-item inventory composed of five factors to evaluate positive symptoms, negative symptoms, disorganised thoughts, uncontrolled hostility/excitement, and anxiety/depression.
Maltese: Il-PANSS huwa inventarju b'bosta entrati vvalidat magħmul minn ħames fatturi sabiex jevalwa s-sintomi pożittivi, is-sintomi negattivi, ħsibijiet diżorganizzati, ostilità/eċċitament mhux ikkontrollati, u ansjetà/dipressjoni.
English: Prolactin
Maltese: Prolaktin
English: In the lower dose group of the 2 dose-level study (6 mg/day with option to reduce to 3 mg/day), INVEGA was not significantly different from placebo as measured by the PANSS.
Maltese: Fil-grupp bid-doża l-baxxa tal-istudju taż-2 livelli ta' doża (6 mg/kuljum blgħażla li titnaqqas għal 3 mg/kuljum), INVEGA ma kienx differenti b'mod sinifikanti mill-plaċebo kif imkejjel mill-PANSS.
English: 30 prolonged-release tablets - EU/1/07/395/059 350 prolonged-release tablets - EU/1/07/395/060
Maltese: 30 pillola li jerħu l-mediċina bil-mod - EU/1/07/395/059 350 pillola li jerħu l-mediċina bil-mod - EU/1/07/395/060