FrancophonIA/ELRC3.0 huggingface dataset:
English: Hepatobiliary disorders transaminases increased gamma-glutamyltr ansferase increased, hepatic enzyme increased jaundice
Maltese: Disturbi fis-sistema endokrinarja iperprolaktinimja tnixxija mhux xierqa tal-ormon antidijuretiku, glukows preżenti fl-awrina
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: Dehret żieda ta' madwar 3 darbiet fir-riskju ta' reazzjonijiet ċerebrovaskulari avversi fi provi kliniċi fejn il-pazjenti ntgħażlu b'mod arbitrarju, ikkontrollati bi plaċebo fil-popolazzjoni bid-dimenzja b'xi antipsikotiċi atipiċi, inkluż risperidone, aripiprazole, u olanzapine.
English: During the double-blind phase of the long-term randomised withdrawal study, elevations of prolactin to above the reference range (> 13.13 ng/mL in males and > 26.72 ng/mL in females) were noted in a higher percentage of males and females in the TREVICTA group than in the placebo group (9% vs. 3% and 5% vs. 1%, respectively).
Maltese: Matul il-fażi fejn la l-investigaturi u lanqas l-individwi li ntagħżlu b'mod każwali ma kienu jafu liema sustanza qed tintuża tal-istudju fit-tul ta' twaqqif tal-mediċina, ġew innutati żidiet fil-livelli talprolaktin aktar mill-firxa ta' riferenza (> 13.13 ng/mL fl-irġiel u > 26.72 ng/mL fin-nisa) fi proporzjon ikbar fl-irġiel u n-nisa fil-grupp ta' TREVICTA milli fil-grupp tal-plaċebo (9% vs. 3% u 5% vs. 1%, rispettivament).
English: Dose pack contents
Maltese: Kontenut tal-Pakkett tad-Doża
English: Each TREVICTA 175 mg pre-filled syringe contains 273 mg paliperidone palmitate.
Maltese: Kull siringa mimlija għal-lest ta' TREVICTA 175 mg fiha 273 mg paliperidone palmitate.
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 jitqies it-twaqqif talantipsikotiċi kollha, inkluż ta' paliperidone.
English: > 9 months
Maltese: > 9 xhur
English: • pneumonia, infection of the chest (bronchitis), infection of the breathing passages, sinus infection, bladder infection, ear infection, tonsillitis, fungal infection of the nails, 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, tonsillite, infezzjoni bil-fungu fiddwiefer, infezzjoni fil-ġilda
English: TREVICTA should be used with caution with medicines that increase the activity of the central nervous system (psychostimulants such as methylphenidate).
Maltese: TREVICTA għandu jintuża b'kawtela ma' mediċini li jżidu l-attività tas-sistema nervuża ċentrali (psikostimulanti bħal methylphenidate).
English: Prolonged release suspension for injection.
Maltese: TAQSAMX id-doża f'ħafna injezzjonijiet.
English: Deltoid muscle administration
Maltese: Għoti ġol-muskolu deltojd
English: Because of its potential for inducing orthostatic hypotension (see section 4.4), an additive effect may be observed when TREVICTA is administered with other medicinal products that have this potential, e.g., other antipsychotics, tricyclics.
Maltese: Minħabba l-potenzjal li għandu li jikkaġuna ipotensjoni ortostatika (ara sezzjoni 4.4), jista' jiġi osservat effett kumulattiv meta TREVICTA jingħata ma' prodotti mediċinali oħra li għandhom dan ilpotenzjal eż. antipsikotiċi oħrajn, triċikliċi.
English: Each TREVICTA 263 mg pre-filled syringe contains 410 mg paliperidone palmitate.
Maltese: Kull siringa mimlija għal-lest ta' TREVICTA 263 mg fiha 410 mg paliperidone palmitate.
English: In the long-term randomised withdrawal study, 506 adult subjects who met DSM-IV criteria for schizophrenia were enrolled into the open-label transition phase and treated with flexible doses of 1-monthly paliperidone palmitate injectable administered into the deltoid or gluteal muscle (50-150 mg) for 17 weeks (dose adjustments occurred at weeks 5 and 9).
Maltese: Fl-istudju fit-tul ta' waqfien tal-mediċina fejn l-individwi ntgħażlu b'mod arbitrarju, 506 individwi adulti li ssodisfaw il-kriterji DSM-IV għall-iskizofrenja ġew irreġistrati ġo fażi ta' bidla fejn kemm linvestigaturi kif ukoll l-individwi kienu jafu li qed jiġu ttrattati b'dożi flessibbli ta' paliperidone palmitate ta' kull xahar li jista' jiġi injettat mogħti fil-muskolu deltojd jew gluteali (50-150 mg) għal 17-il ġimgħa (aġġustamenti fid-doża seħħew fil-ġimgħat 5 u 9).
English: Each pack contains 1 pre-filled syringe and 2 needles.
Maltese: Kull pakkett fih siringa 1 mimlija għal-lest u 2 labriet.
English: • For those < 90 kg, the thin wall 1 inch, 22 gauge (0.72 mm x 25.4 mm) needle should be used.
Maltese: • Għal dawk < 90 kg, għandha tintuża l-labra magħmula minn materjal irqiq ta' pulzier, 22 gejġ (0.
English: Conversely, abnormal decreases in body weight (≥ 7%) from double-blind baseline to double-blind end point were reported for 1% subjects in the TREVICTA group and 8% subjects in the placebo group.
Maltese: Kontra ta' dan, tnaqqis mhux normali fil-piż tal-ġisem (≥ 7%) mill-linja bażi sal-iskop finali fejn la l-investigaturi u lanqas l-individwi ma kienu jafu liema sustanza qed tintuża kienu rrappurtati għal 1% tal-individwi fil-grupp ta' TREVICTA u 8% talindividwi fil-grupp tal-plaċebo.
English: Infections and infestations upper respiratory tract infection, urinary tract infection, influenza pneumonia, bronchitis, respiratory tract infection, sinusitis, cystitis, ear infection, tonsillitis, onychomycosis, cellulitis eye infection, acarodermatitis, subcutaneous abscess
Maltese: Infezzjonijiet u infestazzjonijiet infezzjoni fil-parti ta' fuq tal-apparat tan-nifs, infezzjoni fl-apprat tal-awrina, influwenza pulmonite, bronkite, infezzjoni fl-apprat tannifs, sinusite, ċistite, infezzjoni fil-widna, tonsillite, onikkomikożi, ċellulite infezzjoni fl-għajn, akarodermatite, axxess taħt il-ġilda
English: In the non-inferiority study, 1,429 acutely ill subjects (baseline mean PANSS total score: 85.7) who met DSM-IV criteria for schizophrenia were enrolled into the open-label phase and treated with 1-monthly paliperidone palmitate injectable for 17 weeks.
Maltese: Fl-istudju ta' non-inferjorità, 1,429 indivdwi morda b'mod akut (medja tal-punteġġ totali PANSS fillinja bażi: 85.7) li ssodisfaw il-kriterji DSM-IV għall-iskizofrenja ġew irreġistrati fil-fażi fejn kemm linvestigaturi kif ukoll l-individwi kienu jafu li qed jiġu ttrattati b'paliperidone palmitate ta' kull xahar li jista' jiġi injettat għal 17-il ġimgħa.
English: Recommended re-initiation regimen after missing 4 months to 9 months of TREVICTA
Maltese: Skeda rrakkomandata għal bidu mill-ġdid wara li jinqabżu minn 4 xhur sa 9 xhur ta' TREVICTA
English: Gluteal injections should be alternated between the two gluteal muscles.
Maltese: Injezzjonijiet gluteali għandhom jiġu alternati bejn iż-żewġ muskoli gluteali.
English: TREVICTA is not recommended to treat elderly patients with dementia due to increased risk of overall mortality and cerebrovascular adverse reactions.
Maltese: TREVICTA mhuwiex irrakkomandat għat-trattament ta' pazjenti anzjani bid-dimenzja minħabba ż-żieda fir-riskju ta' mortalità totali u reazzjonijiet ċerebrovaskulari avversi.
English: Pre-filled syringe (cyclic-olefin-copolymer) with a plunger stopper, backstop, and tip cap (bromobutyl rubber) with a thin wall 22G 1½ inch (0.72 mm x 38.1 mm) safety needle and a thin wall 22G 1 inch (0.72 mm x 25.4 mm) safety needle.
Maltese: Siringa mimlija għal-lest (cyclic-olefin-copolymer) b'waqfien għall-planġer, protezzjoni fuq wara li twaqqaf, u għatu fit-tarf (lastku bromobutyl) b'labra ta' sigurtà magħmula minn materjal irqiq ta' 22G u pulzier u nofs (0.
English: Skin and subcutaneous tissue disorders urticaria, pruritus, rash, alopecia, eczema, dry skin, erythema, acne drug eruption, hyperkeratosis, dandruff angioedema, skin discolouration, seborrhoeic dermatitis
Maltese: Disturbi fil-ġilda u fit-tessuti ta' taħt il-ġilda urtikarja, prurite, raxx, alopeċja, ġilda xotta, eritema, akne reazzjoni fil-ġilda mill-mediċina, iperkeratożi, brija anġjoedima, telf ta' kulur fil-ġilda, dermatite tassabborea
English: • an interruption in conduction between the upper and lower parts of the heart, abnormal electrical conduction of the heart, prolongation of the QT interval from your heart, rapid heartbeat upon standing, slow heart rate, abnormal electrical tracing of the heart (electrocardiogram or ECG), a fluttering or pounding feeling in your chest (palpitations)
Maltese: • interruzzjoni fit-trasmissjoni ta' impulsi bejn il-partijiet ta' fuq u t'isfel tal-qalb, trasmissjoni ta' impulsi elettriċi mhux normali fil-qalb, titwil tal-intervall QT mill-qalb tiegħek, taħbit tal-qalb li jiżdied hekk kif tqum bilwieqfa, rata baxxa ta' taħbit tal-qalb, intraċċar elettriku mhux normali tal-qalb (elettrokardjogramma jew ECG), tħoss tferfir jew taħbit qawwi f'sidrek (palpitazzjonijiet)
English: Events of leucopenia, neutropenia, and agranulocytosis have been reported with paliperidone.
Maltese: Każijiet ta' lewkopenija, newtropenija, u agranuloċitożi ġew irrappurtati b'paliperidone.
English: Insomnia includes: initial insomnia, middle insomnia; Convulsion includes: grand mal convulsion; Oedema includes: generalised oedema, oedema peripheral, pitting oedema Menstrual disorder includes: menstruation delayed, menstruation irregular, oligomenorrhoea.
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: Overall incidence from all clinical trials was 0.65% in all subjects treated 1-monthly paliperidone palmitate injectable.
Maltese: L-inċidenza globali mill-provi kliniċi kollha kienet ta' 0.65% fl-individwi kollha ttrattati b'paliperidone palmitate ta' kull xahar li jista' jiġi injettat.
English: Each pre-filled syringe contains paliperidone palmitate equivalent to 350 mg paliperidone.
Maltese: Kull siringa mimlija għal-lest fiha paliperidone palmitate ekwivalenti għal 350 mg paliperidone.
English: Even though paliperidone is a strong D2-antagonist, which is believed to relieve the symptoms of schizophrenia, it causes less catalepsy and decreases motor functions less than traditional neuroleptics.
Maltese: Minkejja li paliperidone huwa antagonist qawwi ta' D2, li hu maħsub li jtaffi s-sintomi tal-iskizofrenija, huwa jikkawża inqas katalessi u jnaqqas ilfunzjonijiet motorji inqas minn newtrolettiċi tradizzjonali.
English: No embryotoxicity or malformations were observed following intramuscular administration of paliperidone palmitate to pregnant rats up to the highest dose (160 mg/kg/day) corresponding to 2.2 times the exposure level in humans at the maximum recommended dose of 525 mg. Other dopamine antagonists, when administered to pregnant animals, have caused negative effects on learning and motor development in the offspring.
Maltese: Ma ġewx osservati tossiċitajiet fl-embriju jew formazzjonijiet ħżiena wara l-għoti ta' paliperidone palmitate filmuskolu lill-firien tqal sal-ogħla doża (160 mg/kg/kuljum) li tikkorrispondi għal 2.2 drabi l-livell ta' esponiment fil-bnedmin bid-doża massima rakkomandata ta' 525 mg.
English: The time to relapse of the placebo group (median 395 days) was significantly shorter than for the TREVICTA group (the median could not be estimated due to the low percentage of subjects with relapse [8.8%]).
Maltese: Iż-żmien għar-rikaduta tal-grupp ta' plaċebo (medjan ta' 395 jum) kien iqsar b'mod sinifikanti minn dak għall-grupp ta' TREVICTA (il-medjan ma setax jiġi stmat minħabba l-perċentwal baxx ta' individwi li kellhom rikaduta [8.8%]).
English: Patients with a history of a clinically significant low white blood cell count (WBC) or a drug-induced leucopenia/neutropenia should be monitored during the first few months of therapy and discontinuation of TREVICTA should be considered at the first sign of a clinically significant decline in WBC in the absence of other causative factors.
Maltese: Pazjenti bi storja ta' għadd baxx ta' ċelluli bojod fid-demm (WBC - white blood cell) sinifikanti b'mod kliniku jew lewkopenija/newtropenija kkaġunata minn mediċina għandhom jiġu mmonitorjati waqt l-ewwel ftit xhur tat-terapija u għandu jiġi kkunsidrat it-twaqqif ta' TREVICTA mal-ewwel sinjal ta' tnaqqis fil-WBC sinifikanti b'mod kliniku fin-nuqqas ta' fatturi oħra li jistgħu jikkawżaw dan.
English: TREVICTA 263 mg prolonged release suspension for injection paliperidone
Maltese: TREVICTA 263 mg suspensjoni li terħi l-mediċina bil-mod għall-injezzjoni paliperidone
English: Caution is advised if paliperidone is combined with other medicinal products known to lower the seizure threshold (i.e., phenothiazines or butyrophenones, tricyclics or SSRIs, tramadol, mefloquine, etc.).
Maltese: Hija rrakkomandata l-kawtela jekk paliperidone jingħata flimkien ma' prodotti mediċinali oħra magħrufa li jnaqqsu l-limitu li fih isseħħ aċċessjoni (i.e., phenothiazines jew butyrophenones, triċikliċi jew SSRIs, tramadol, mefloquine eċċ).
English: Attach needle
Maltese: Ż-ŻGĦAR EWLENIN
English: tremor, headache tardive dyskinesia, syncope, psychomotor hyperactivity, dizziness postural, disturbance in attention, dysarthria, dysgeusia, hypoaesthesia, paraesthesia neuroleptic malignant syndrome, cerebral ischaemia, unresponsive to stimuli, loss of consciousness, depressed level of consciousness, convulsion e, balance disorder, coordination abnormal,
Maltese: sturdament, diskajneżja c, rogħda, uġigħ ta' ras diskajneżja tardiva, sinkope, attivita psikomotorja eċċessiva, sturdament skont ilqagħda, disturb flattenzjoni, disartrija, disgewżja, ipoestesija, parestesija sindrom newrolettiku malinn, iskemija fil-moħħ, mingħajr rispons għall-istimuli, telf mis-sensi, livelli depressi ta' koxjenza, konvulżjoni e, disturb fil-bilanċ, koordinazzjoni mhux normali koma taddiajbete, ras tirtogħod
English: Cardiac disorders tachycardia atrioventricular block, conduction disorder, electrocardiogram QT prolonged, postural orthostatic tachycardia syndrome, bradycardia, electrocardiogram abnormal, palpitations atrial fibrillation, sinus arrhythmia
Maltese: Disturbi fil-qalb takikardija imblokk atrijoventrikulari, disturb ta' konduzzjoni tal-impulsi elettriċi talqalb, intervall QT talelettrokardjogramma mtawwal, sindrom ta' takikardija ortostatika tal-qagħda, bradikardija, elettrokardjogramma mhux normali, palpitazzjonijiet fibrillazzjoni talatriju, arritmija tassinus
English: TREVICTA 525 mg prolonged release suspension for injection paliperidone
Maltese: TREVICTA 525 mg suspensjoni li terħi l-mediċina bil-mod għall-injezzjoni paliperidone
English: IFIS may increase the risk of eye complications during and after the operation.
Maltese: IFIS jista' jżid ir-riskju ta' kumplikazzjonijiet fl-għajn waqt u wara l-operazzjoni.
English: TREVICTA should not be used while breast-feeding.
Maltese: TREVICTA huwa maħsub għal użu ġol-muskolu biss.
English: Renal and urinary disorders urinary incontinence, pollakiuria, dysuria urinary retention
Maltese: Disturbi fil-kliewi u fis-sistema urinarja inkontinenza tal-awrina, pollakijurja, disurja żamma tal-awrina
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 jekk risperidone mogħti mill-ħalq jikkawżax kanċer fil-firien u l-ġrieden, dehru żidiet fl-adenomi fil-glandoli pitwitarji (fil-ġurdien), adenomi endokrinarji fil-frixa (fil-far) u adenomi fil-glandoli mammarji (fiż-żewġ speċi).
English: C-paliperidone, 59% of the dose was excreted unchanged into urine, indicating that paliperidone is not extensively metabolised in the liver.
Maltese: C-paliperidone li jerħi l-mediċina b'mod immedjat, 59% taddoża tneħħiet mhux mibdula fl-awrina, li jindika li paliperidone ma jiġix metabolizzat b'mod estensiv fil-fwied.
English: This medicine contains less than 1 mmol sodium (23 mg) per dose, 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 ‘ħieles mis-sodium'.
English: The total exposure of paliperidone following TREVICTA administration was dose-proportional over a 175-525 mg dose range, and approximately dose-proportional for Cmax.
Maltese: L-esponiment totali għal paliperidone wara għoti ta' TREVICTA kien fi proporzjon maddoża fuq il-medda ta' doża minn 175-525 mg, u bejn wiehed u ieħor fi proporzjon mad-doża għasCmax.
English: Last TREVICTA dose (Week 0)
Maltese: L-aħħar doża ta' TREVICTA (Ġimgħa 0)
English: No interaction study between TREVICTA and lithium has been performed, however, a pharmacokinetic interaction is not likely to occur.
Maltese: Ma sar l-ebda studju dwar interazzjoni bejn TREVICTA u lithium, madankollu, mhuwiex probabbli li sseħħ interazzjoni farmakokinetika.
English: Each pre-filled syringe contains paliperidone palmitate equivalent to 525 mg paliperidone.
Maltese: Kull siringa mimlija għal-lest fiha paliperidone palmitate ekwivalenti għal 525 mg paliperidone.
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: Population pharmacokinetics analysis showed no evidence of age related pharmacokinetics differences.
Maltese: Analiżi farmakokinetiċi tal-popolazzjoni ma wrew l-ebda xhieda ta' differenzi farmakokinetiċi marbuta mal-età.
English: Among those treated with risperidone, the mortality was 4% compared with 3.1% for placebo.
Maltese: Fost dawk ittrattati b'risperidone, ilmortalità kienet 4% meta mqabbla ma' 3.1% għall-plaċebo.
English: Switching from other antipsychotic medicinal products Patients should not be switched directly from other antipsychotics as 3-monthly paliperidone palmitate injectable should only be initiated after the patient is stabilised on the 1-monthly paliperidone palmitate injectable.
Maltese: Bidla minn prodotti mediċinali antipsikotiċi oħra Il-pazjenti m'għandhomx jinqalbu direttament minn antipsikotiċi oħra minħabba li paliperidone palmitate li jiġi injettat kull 3 xhur għandu jinbeda biss wara li l-pazjent jiġi stabilizzat fuq paliperidone palmitate li jiġi injettat kull xahar.
English: TREVICTA, when administered at doses that are 3.5-fold higher than the corresponding dose of 1-monthly paliperidone palmitate injection (see section 4.2), results in paliperidone exposures similar to those obtained with corresponding monthly doses of 1-monthly paliperidone palmitate injection and corresponding once daily doses of paliperidone prolonged release tablets.
Maltese: TREVICTA, meta jingħata b'dożi li huma 3.5 darbiet ogħla mid-doża korrispondenti tal-injezzjoni ta' paliperidone palmitate ta' kull xahar (ara sezzjoni 4.2), twassal għal esponimenti ta' paliperidone simili għal dawk li nkisbu bid-dożi korrispondenti ta' injezzjoni ta' paliperidone palmitate ta' kull xahar mogħtija darba fix-xahar u dożi korrispondenti ta' pilloli paliperidone li jittieħdu mill-ħalq li jerħu l-mediċina fit-tul mogħtija darba kuljum.
English: 12 mg * All doses of once daily paliperidone prolonged release tablets should be individualised to the specific patient, taking into consideration variables such as reasons for switching, response to previous paliperidone treatment, severity of psychotic symptoms, and/or propensity for side effects.
Maltese: 12 mg * Id-dożi kollha tal-pilloli paliperidone li jerħu l-mediċina bil-mod u jittieħdu kuljum għandhom jiġu indivdiwalizzati għall-pazjent speċifiku, filwaqt li jitqiesu affarijiet li jvarjaw bħal raġunijiet għall-bidla, rispons għat-trattament preċedenti b'paliperidone, severità tas-sintomi psikotiċi, u/jew it-tendenza għal effetti sekondarji.
English: - if you have Parkinson's disease - if you have ever been diagnosed with a condition whose symptoms include high temperature and muscle stiffness (also known as Neuroleptic Malignant Syndrome) - if you have ever experienced twitching or jerking movements that you cannot control in your face, tongue, or other parts of your body (Tardive Dyskinesia) - if you know that you have had low levels of white blood cells in the past (which may or may not have been caused by other medicines) - if you are diabetic or prone to diabetes - if you have had breast cancer or a tumour in the pituitary gland in your brain - if you have a heart disease or heart disease treatment that makes you prone to low blood pressure - if you have low blood pressure when you stand up or sit up suddenly - if you have a history of seizures - if you have kidney problems - if you have liver problems - if you have prolonged and/or painful erection - if you have problems with controlling body temperature or overheating - if you have an abnormally high level of the hormone prolactin in your blood or if you have a possible prolactin-dependent tumour - if you or someone else in your family has a history of blood clots, as antipsychotics have been associated with formation of blood clots.
Maltese: L-effikaċja ta' TREVICTA fil-manteniment tat-trattament tal-iskizofrenja f'individwi li ġew ittrattati b'mod sodisfaċenti għal mill-inqas erba' xhur b'paliperidone palmitate ta' kull xahar li jista' jiġi injettat u bl-aħħar żewġ dożi jkunu b'doża tal-istess qawwa ġiet ivvalutata fi studju wieħed fit-tul ta' waqfien mill-mediċina, ikkontrollat bi plaċebo fejn la l-individwi li ntgħażlu b'mod arbitrarju u lanqas l-investigaturi ma kienu jafu liema mediċina kienet qed tintuża u studju wieħed ta' non-inferjorità fittul, ikkontrollat b'mod attiv, fejn la l-investigaturi u lanqas l-individwi ma kienu jafu liema mediċina qed tintuża.
English: QT prolongation, ventricular arrhythmias (ventricular fibrillation, ventricular tachycardia), sudden unexplained death, cardiac arrest, and Torsade de pointes may occur with antipsychotics.
Maltese: Titwil tal-intervall QT, arritmiji tal-ventrikulu (fibrillazzjoni tal-ventrikulu, takikardija tal-ventrikulu), mewt zoptu mingħajr spjegazzjoni, waqfien kardijaku, u Torsade de pointes jistgħu jseħħu blantipsikotiċi.
English: Each pre-filled syringe contains paliperidone palmitate equivalent to 175 mg paliperidone.
Maltese: Kull siringa mimlija għal-lest fiha paliperidone palmitate ekwivalenti għal 175 mg paliperidone.
English: Venous thromboembolism
Maltese: Tromboemboliżmu fil-vini
English: Repeat-dose toxicity studies of intramuscularly injected paliperidone palmitate (the 1-monthly formulation) and orally administered paliperidone in rat and dog showed mainly pharmacological effects, such as sedation and prolactin-mediated effects on mammary glands and genitals.
Maltese: Studji dwar tossiċità minn dożi ripetuti ta' paliperidone palmitate injettat fil-muskolu (il-formulazzjoni ta' kull xahar) u paliperidone mogħti mill-ħalq fil-far u l-kelb urew fil-biċċa l-kbira effetti farmakoloġiċi, bħal sedazzjoni u effetti medjati mill-prolactin fuq il-glandoli mammarji u l-ġenitali.
English: Shake syringe vigorously for at least 15 seconds
Maltese: Ħawwad is-siringa bis-saħħa għal mill-inqas 15-il sekonda
English: The data presented in this paragraph are based on a population pharmacokinetic analysis.
Maltese: Id-dejta ppreżentata f'dan il-paragrafu hija bbażata fuq analiżi farmakokinetika tal-popolazzjoni.
English: Pregnancy, puerperium and perinatal conditions drug withdrawal syndrome neonatal (see section 4.6)
Maltese: Kondizzjonijiet ta' waqt it-tqala, ilħlas u wara l-ħlas sidrom ta' twaqqif ta' mediċina li tivvizzja fi trabi tat-twelid (ara sezzjoni 4.6)
English: Torsade de pointes and ventricular fibrillation have been reported in a patient in the setting of overdose with oral paliperidone.
Maltese: Torsade de pointes u fibrillazzjoni tal-ventrikulu ġew irrappurtati f'pazjent li ngħata doża eċċessiva ta' paliperidone orali.
English: Dispose properly
Maltese: MANIFATTUR RESPONSABBLI
English: Hyperprolactinaemia
Maltese: Aqbad il-pakkett tas-siringa