FrancophonIA/ELRC3.0 huggingface dataset:
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 mal-waqqaf, rata baxxa ta' taħbit tal-qalb, intraċċar elettriku mhux normali tal-qalb (elettrokardjogramma jew ECG), tħoss tferfir jew taħbit qawwi f'sidrek (palpitazzjonijiet)
English: Xeplion should be used with caution with medicines that increase the activity of the central nervous system (psychostimulants such as methylphenidate).
Maltese: Xeplion għandu jintuża b'kawtela ma' mediċini li jżidu l-attività tas-sistema nervuża ċentrali (psikostimulanti bħal methylphenidate).
English: Xeplion is not recommended in patients with moderate or severe renal impairment (creatinine clearance < 50 mL/min) (see sections 4.2 and 5.2).
Maltese: Xeplion mhuwiex irrakkomandat għal pazjenti b'indeboliment renali moderat jew sever (tneħħija tal-kreatinina < 50 mL/min) (ara sezzjonijiet 4.2 u 5.2).
English: Pharmacotherapeutic group: Psycholeptics, other antipsychotics.
Maltese: Psikolettiċi, antipsikotiċi oħrajn. kodiċi ATC:
English: Among those treated with risperidone, the mortality was 4% compared with 3.1% for placebo.
Maltese: Fost dawk ikkurati b'risperidone, ilmortalità kienet 4% meta mqabbel ma' 3.1% bil-plaċebo.
English: In general, recommended dosing of Xeplion for elderly patients with normal renal function is the same as for younger adult patients with normal renal function.
Maltese: Ġeneralment, id-dożaġġ rakkomandat ta' Xeplion għal pazjenti anzjani b'funzjoni renali normali huwa l-istess bħal dak ta' pazjenti adulti iżgħar b'funzjoni renali normali.
English: Weight should be monitored regularly.
Maltese: Il-piż għandu jiġi mmonitorjat regolarment.
English: Each Xeplion 150 mg pre-filled syringe contains 234 mg paliperidone palmitate.
Maltese: Kull siringa mimlija għal-lest ta' Xeplion 150 mg fiha 234 mg ta' paliperidone palmitate.
English: Acute treatment of schizophrenia
Maltese: Trattament akut tal-iskizofrenija
English: Subjects initially received flexible doses (25-100 mg) of Xeplion during a 9-week transition period, followed by a 24-week maintenance period, where subjects were required to have a PANSS score of ≤ 75.
Maltese: Fil-bidu l-individwi ngħataw dożi flessibbli (25-100 mg) ta' Xeplion matul perijodu ta' transizzjoni ta' 9 ġimgħat, segwit minn perijodu ta' manteniment ta' 24 ġimgħa, fejn lindividwi kienu meħtieġa li jkollhom punteġġ tal-PANSS ta' ≤ 75.
English: • abdominal pain, vomiting, nausea, constipation, diarrhoea, indigestion, toothache
Maltese: • uġigħ fl-addome, rimettar, nawsja, stitikezza, dijarea, indiġestjoni, uġigħ tas-snien
English: A total of 410 stabilised patients were randomised to either Xeplion (median duration 171 days [range 1 day to 407 days]) or to placebo (median duration 105 days [range 8 days to 441 days]) until they experienced a relapse of schizophrenia symptoms in the variable length double-blind phase.
Maltese: Total ta' 410 pazjenti stabbilizzati ntgħażlu b'mod randomised għal Xeplion (tul medjan ta' 171 jum [medda jum 1 sa 407 ijiem]) jew għal plaċebo (tul medjan ta' 105 jum [medda 8 ijiem sa 441 jum]) sakemm kellhom rikaduta tassintomi tal-iskizofrenija fil-fażi double-blind ta' tul varjabbli.
English: This study included a 33-week open-label acute treatment and stabilisation phase, a randomised, double-blind placebo-controlled phase to observe for relapse, and a 52-week open-label extension period.
Maltese: Dan l-istudju kien jinkludi trattament akut open-label ta' 33 ġimgħa u fażi ta' stabbilizzazzjoni, fażi randomised, double-blind u kkontrollata bil-plaċebo għall-osservazzjoni ta' rikaduti, u perijodu ta' estensjoni ta' 52 ġimgħa open-label.
English: Body temperature regulation
Maltese: Regolazzjoni tat-temperatura tal-ġisem
English: No data are available in patients with severe hepatic impairment (Child-Pugh class C).
Maltese: M'hemmx tagħrif dwar pazjenti b'indeboliment epatiku qawwi (Child-Pugh Klassi C).
English: Renal and urinary disorders urinary incontinence, pollakiuria, dysuria urinary retention
Maltese: Disturbi fil-kliewi u fis-sistema urinarja inkontinenza talawrina, pollakijurja, disurja żamma tal-awrina
English: Venous thromboembolism
Maltese: Dożi maqbuża
English: After the injection is complete, use either thumb or finger of one hand (8a, 8b) or a flat surface (8c) to activate the needle protection system.
Maltese: Wara li tlesti l-injezzjoni, uża jew il-behem jew saba' ta' id waħda (8a, 8b) jew wiċċ ċatt (8ċ) biex tħaddem is-sistema ta' protezzjoni tal-labra.
English: Xeplion 75 mg prolonged release suspension for injection Paliperidone
Maltese: Xeplion 75 mg suspensjoni li terħi l-mediċina bil-mod għall-injezzjoni Paliperidone
English: Each Xeplion 25 mg pre-filled syringe contains 39 mg paliperidone palmitate.
Maltese: Kull siringa mimlija għal-lest ta' Xeplion 25 mg fiha 39 mg ta' paliperidone palmitate.
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 jista' jostor irreazzjoni normali tal-ġisem għall-inġestjoni ta' sustanzi tossiċi jew kundizzjonijiet mediċi oħrajn.
English: Each pre-filled syringe contains 117 mg paliperidone palmitate equivalent to 75 mg paliperidone.
Maltese: Kull siringa mimlija għal-lest fiha 117 mg ta' paliperidone palmitate ekwivalenti għal 75 mg paliperidone.
English: This decrease is caused, to a substantial degree, by a 35% increase in renal clearance of paliperidone likely as a result of induction of renal P-gp by carbamazepine.
Maltese: Dan ittnaqqis huwa kkawżat fil-parti l-kbira, minn żieda ta' 35% tat-tneħħija renali ta' paliperidone aktarx minħabba l-induzzjoni ta' P-gp renali b'carbamazepine.
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 ‘bla sodium'.
English: Each Xeplion 100 mg pre-filled syringe contains 156 mg paliperidone palmitate.
Maltese: Kull siringa mimlija għal-lest fiha 156 mg ta' paliperidone palmitate ekwivalenti għal 100 mg paliperidone.
English: Endocrine disorders hyperprolactinaemia inappropriate antidiuretic hormone secretion, glucose urine present
Maltese: Disturbi fissistema endokrinarja iperprolaktinemja tnixxija mhux f'lokha tal-ormon antidijuretiku, glukożju preżenti fl-awrina
English: Each pre-filled syringe contains paliperidone palmitate equivalent to 25 mg paliperidone.
Maltese: Kull siringa mimlija għal-lest fiha paliperidone palmitate ekwivalenti għal 25 mg paliperidone.
English: • a decrease in body temperature
Maltese: • żieda fit-temperatura tal-ġisem
English: • not moving or responding while awake (catatonia)
Maltese: • ma tiċċaqqlaqx jew ma tirrispondix waqt li tkun imqajjem/ma (katatonja)
English: Pharmacokinetic studies with paliperidone palmitate have shown somewhat lower (10-20%) plasma concentrations of paliperidone in patients who are overweight or obese in comparison with normal weight patients (see section 4.2).
Maltese: Studji farmakokinetiċi b'paliperidone palmitate urew konċentrazzjonijiet kemmxejn aktar baxxi ta' paliperidone fil-plażma f'pazjenti li għandhom piż żejjed jew obeżità meta mqabbla ma' pazjenti b'piż normali (ara sezzjoni 4.2).
English: 9 mg daily
Maltese: 9 mg kuljum
English: Xeplion is also available in a Treatment initiation pack which contains two pre-filled syringes (150 mg + 100 mg) and 2 additional safety needles.
Maltese: Xeplion huwa disponibbli wkoll bħala Pakkett għall-bidu tal-kura li fih żewġ siringi mimlija għal-lest (150 mg + 100 mg) u żewġ labriet addizzjonali ta' sigurtà.
English: Missed second initiation dose (4-7 weeks from first injection) If 4 to 7 weeks have elapsed since the first injection of Xeplion, resume dosing with two injections of 100 mg in the following manner: a deltoid injection as soon as possible another deltoid injection one week later resumption of the normal monthly cycle of injections in either the deltoid or gluteal muscle of 25 mg to 150 mg based on individual patient tolerability and/or efficacy.
Maltese: It-tieni doża inizjali maqbuża (4-7 ġimgħat mill-ewwel injezzjoni) Jekk ikunu għaddew minn 4 sa 7 ġimgħat mill-ewwel injezzjoni ta' Xeplion, erġa' ibda d-dożar b'żewġ injezzjonijiet ta' 100 mg kif ġej: injezzjoni fid-deltojde mill-aktar fis possibbli injezzjoni oħra fid-deltojde ġimgħa wara kompli ċ-ċiklu normali ta' kull xahar tal-injezzjonijiet fil-muskolu tad-deltojde jew fil-warrani ta' 25 mg sa 150 mg fuq il-bażi tat-tollerabbiltà individwali tal-pazjent u/jew l-effikaċja.
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 fissnien skumdità fl-addome, gastroenterite, disfaġja, nixfa fil-ħalq, gass pankreatite, ilsien minfuħ, inkontinenza talippurgar, fikaloma, kejlite sadda filmusrana, iljus
English: Elderly Efficacy and safety in elderly > 65 years have not been established.
Maltese: Anzjani Ma ġietx stabbilita l-effikaċja u s-sigurtà fl-anzjani ta' aktar minn 65 sena.
English: Current or past use of medicinal products 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' prodotti mediċinali b'effett antagonista adrenerġiku alfa 1a għandu jkun mgħarraf bih ilkirurgu oftalmiku qabel l-operazzjoni.
English: Xeplion 150 mg and Xeplion 100 mg prolonged release suspension for injection
Maltese: Xeplion 150 mg u Xeplion 100 mg suspensjoni għall-injezzjoni li terħi l-mediċina bil-mod
English: Each pre-filled syringe contains 234 mg paliperidone palmitate equivalent to 150 mg paliperidone.
Maltese: Kull siringa mimlija għal-lest fiha 234 mg ta' paliperidone palmitate ekwivalenti għal 150 mg paliperidone.
English: During monthly maintenance treatment with Xeplion, patients previously stabilised on different doses of paliperidone prolonged release tablets can attain similar paliperdone steady-state exposure by injection.
Maltese: Matul it-trattament ta' manteniment ta' kull xahar bi Xeplion, il-pazjenti li qabel ikunu ġew stabilizzati fuq dożi differenti ta' pilloli ta' paliperidone li jerħu l-mediċina bil-mod jistgħu jiksbu esponiment simili ta' paliperdone fl-istat fiss permezz ta' injezzjoni.
English: One week following administration of a single oral dose of 1 mg immediate-release
Maltese: Ġimgħa wara l-amministrazzjoni ta' doża waħda orali ta' 1 mg,
English: in your blood
Maltese: U LUŻU
English: • muscle spasms, joint stiffness, muscle weakness, neck pain
Maltese: • spażmi fil-muskoli, ebusija fil-ġogi, dgħufija fil-muskoli, uġigħ fl-għonq
English: • Xeplion can raise your levels of a hormone called "prolactin" found on a blood test (which may or may not cause symptoms).
Maltese: • Xeplion jista' jżid il-livelli ta' ormon imsejjaħ "prolactin" li jinstab b'test tad-demm (li jista' jikkawża jew ma jikkawżax sintomi).
English: The disposition of a single oral dose paliperidone 3 mg prolonged release tablet was studied in subjects with varying degrees of renal function.
Maltese: Id-dispożizzjoni ta' doża waħda orali ta' pillola paliperidone 3 mg b'rilaxx fit-tul ġiet studjata f'individwi bi gradi differenti ta' funzjoni renali.
English: The recommended needle size for maintenance administration of Xeplion into the gluteal muscle is the 1½-inch, 22 gauge needle (38.1 mm x 0.72 mm).
Maltese: Il-pakkett fih siringa mimlija għal-lest u 2 labriet (labra ta' pulzier u nofs (1 ½ pulzier) ta' ħxuna 22 [38.1 mm x 0.
English: Functioning was evaluated using the Personal and Social Performance (PSP) scale.
Maltese: Il-funzjonament kien evalwat permezz taliskala tal-Imġiba Personali u Soċjali (PSP).
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, ħakk, raxx alopeċja, ekżema, ġilda xotta, eritema, akne reazzjoni fil-ġilda mill-mediċina, iperkeratożi, brija anġjoedima, telf ta' kulur tal-ġilda, dermatite tassabborea
English: Undesirable effects noted with risperidone formulations
Maltese: Effetti mhux mixtieqa osservati bil-formulazzjonijiet ta' risperidone
English: Administration
Maltese: LISTA
English: Janssen-Cilag Polska Sp. z o.o.
Maltese: Janssen-Cilag SpA
English: For DELTOID injection, if the patient weighs < 90 kg, use the 1-inch, 23 gauge needle (25.4 mm x 0.64 mm) (needle with blue coloured hub); if the patient weighs ≥ 90 kg, use the 1½-inch, 22 gauge needle (38.1 mm x 0.72 mm) (needle with grey coloured hub).
Maltese: 4 mm x 0.64 mm) (il-labra bil-buttun blu); jekk il-pazjent jiżen  90 kg, uża s-siringa ta' pulzier u nofs, ta' ħxuna 22 (38.1 mm x 0.
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 4.1 times the exposure level in humans at the maximum recommended dose of 150 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 embrijotossiċità jew malformazzjonijiet wara l-għoti ta' paliperidone palmitate fil-muskolu lil firien tqal sal-ogħla doża (160 mg/kg/kuljum) li tikkorrispondi għal 4.1 drabi l-livell ta' espożizzjoni fil-bnedmin bid-doża massima rakkomandata ta' 150 mg.
English: Intraoperative Floppy Iris Syndrome
Maltese: Reazzjoni Avversa għall-Mediċina Frekwenza
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 tannifs, infezzjoni flapparat tal-awrina, influwenza pulmonite, bronkite, infezzjoni fl-apparat tan-nifs, sinożite, ċistite, infezzjoni filwidnejn, tonsillite, infezzjoni fid-dwiefer bil-fungu, ċellulite infezzjoni flgħajnejn, akarodermatite, axxess taħt il-ġilda
English: The PSP is a validated clinician rated scale that measures personal and social functioning in four domains: socially useful activities (work and study), personal and social relationships, self-care and disturbing and aggressive behaviours.
Maltese: Il-PSP hija skala nominali validata minn tobba li tkejjel ilfunzjonament personali u soċjali f'erba' oqsma: attivitajiet soċjali utli (xogħol u studju), relazzjonijiet personali u soċjali, kura personali u mġiba inkwjetanti u aggressiva.
English: Even though paliperidone is a strong D2-antagonist, which is believed to relieve the positive symptoms of schizophrenia, it causes less catalepsy and decreases motor functions less than traditional neuroleptics.
Maltese: D2 qawwi, li hu maħsub li jtaffi s-sintomi pożittivi tal-iskizofrenija, jikkawża inqas katalessi u jnaqqas il-funzjonijiet motorji inqas meta mqabbel ma' newtrolettiċi tradizzjonali.
English: The total exposure of paliperidone following Xeplion administration was dose-proportional over a 25-150 mg dose range, and less than dose-proportional for Cmax for doses exceeding 50 mg.
Maltese: L-esponiment totali ta' paliperidone wara l-għoti ta' Xeplion kien proporzjonali mad-doża fuq firxa ta' dożi bejn il-25 u l-150 mg, u inqas minn proporzjonali mad-doża għas-Cmax filkaż ta' dożi li jaqbżu l-50 mg.
English: Not known: frequency cannot be estimated from the available data
Maltese: Mhux magħruf: ma tistax tittieħed stima tal-frekwenza mid-data disponibbli
English: Repeat-dose toxicity studies of intramuscularly injected paliperidone palmitate (the 1-month 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 tossikoloġiċi b'doża ripetuta ta' paliperidone palmitate injettat fil-muskolu (il-formulazzjoni ta' xahar) u paliperidone mogħti mill-ħalq fuq il-far u l-kelb wrew b'mod ewlieni effetti farmakoloġiċi, bħal sedazzjoni u effetti medjati mill-prolactin fuq il-glandoli mammarji u l-ġenitali.
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 irrapportati f'pazjent li ngħata doża eċċessiva ta' paliperidone orali.
English: Xeplion 100 mg prolonged release suspension for injection Paliperidone
Maltese: Xeplion 100 mg suspensjoni li terħi l-mediċina bil-mod għall-injezzjoni Paliperidone
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 Xeplion 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 medika ta' għadd baxx sinifikanti b'mod kliniku ta' ċelluli bojod fid-demm (WBC) jew lewkopenija/newtropenija kkaġunata minn mediċina għandhom jiġu mmonitorjati waqt l-ewwel ftit xhur tat-terapija u għandu jiġi kkunsidrat it-twaqqif ta' Xeplion mal-ewwel sinjal ta' tnaqqis sinifikanti b'mod kliniku fil-WBC fin-nuqqas ta' fatturi oħra li jistgħu jikkawżaw dan.
English: Each pre-filled syringe contains paliperidone palmitate equivalent to 75 mg paliperidone.
Maltese: Kull siringa mimlija għal-lest fiha paliperidone palmitate ekwivalenti għal 75 mg paliperidone.
English: Paliperidone is not extensively metabolised in the liver.
Maltese: Paliperidone mhuwiex metabolizzat b'mod estensiv fil-fwied.
English: 6 mg daily
Maltese: 6 mg kuljum
English: Xeplion 25 mg prolonged release suspension for injection Paliperidone
Maltese: Xeplion 25 mg suspensjoni li terħi l-mediċina bil-mod għall-injezzjoni Paliperidone
English: Each pre-filled syringe contains 78 mg paliperidone palmitate equivalent to 50 mg paliperidone.
Maltese: Kull siringa mimlija għal-lest fiha 78 mg ta' paliperidone palmitate ekwivalenti għal 50 mg paliperidone.
English: For those ≥ 90 kg, the 1½ inch, 22 gauge needle (38.1 mm x 0.72 mm) is recommended.
Maltese: Għal dawk  90 kg, hija rrakkomandata l-labra ta' pulzier u nofs (1½ pulzier), ta' ħxuna 22 (38.1 mm x 0.
English: The adverse drug reactions (ADRs) most frequently reported in clinical trials were insomnia, headache, anxiety, upper respiratory tract infection, injection site reaction, parkinsonism, weight increased, akathisia, agitation, sedation/somnolence, nausea, constipation, dizziness, musculoskeletal pain, tachycardia, tremor, abdominal pain, vomiting, diarrhoea, fatigue, and dystonia.
Maltese: Fi provi kliniċi l-iktar reazzjonijiet avversi għall-mediċina (ADRs) li ġew irrapportati b'mod frekwenti kienu nuqqas ta' rqad, uġigħ ta' ras, ansjetà, infezzjoni fil-parti ta' fuq tal-apparat tan-nifs, reazzjoni fis-sit tal-injezzjoni, parkinsoniżmu, żieda fil-piż, akatisja, aġitazzjoni, ħedla tan-ngħas, nawsja, stitikezza, sturdament, uġigħ muskoluskeletriku, takikardija, rogħda, skumdità fl-addome, rimettar, dijarea, għeja, u distonja.
English: Co-administration of oral paliperidone prolonged release 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: L-għoti ta' paliperidone b'rilaxx fit-tul darba kuljum ma' 200 mg ta' carbamazepine darbtejn kuljum wassal għal tnaqqis ta' madwar 37% fil-medja ta' stat fiss ta' Cmax u l-AUC ta' paliperidone.
English: In general, expected signs and symptoms are those resulting from an exaggeration of paliperidone's known pharmacological effects, i.e., drowsiness and sedation, tachycardia and hypotension, QT prolongation, and extrapyramidal symptoms.
Maltese: B'mod ġenerali, is-sinjali u s-sintomi li wieħed jistenna huma dawk li jiġu minn esaġerazzjoni taleffetti farmakoloġiċi magħrufa ta' paliperidone, jiġifieri ħedla u sedazzjoni, takikardja u ipotensjoni, prolongazzjoni tal-QT, u sintomi ekstrapiramidali.
English: Xeplion 150 mg prolonged release suspension for injection Paliperidone
Maltese: Xeplion 150 mg suspensjoni li terħi l-mediċina bil-mod għall-injezzjoni Paliperidone
English: For patients stabilised with 150 mg a deltoid injection as soon as possible at the 100 mg dose another deltoid injection one week later (day 8) at the 100 mg dose resumption of the normal monthly cycle of injections in either the deltoid or gluteal muscle of 25 mg to 150 mg based on individual patient tolerability and/or efficacy.
Maltese: Fil-każ ta' pazjenti stabbilizzati b'150 mg injezzjoni fid-deltojde mill-aktar fis possibbli b'doża ta' 100 mg injezzjoni oħra fid-deltojde ġimgħa wara (it-8 jum) b'doża ta' 100 mg kompli ċ-ċiklu normali ta' kull xahar tal-injezzjonijiet fil-muskoli tad-deltojde jew tal-warrani ta' 25 mg sa 150 mg fuq il-bażi tat-tollerabbiltà individwali tal-pazjent u/jew l-effikaċja.
English: 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 diabetic coma, head titubation
Maltese: sturdament, diskajneżja c, rogħda, uġigħ ta' ras diskajneżja tardiva, sinkope attività eċċessiva psikomotorja, sturdament skont ilqagħda, disturb flattenzjoni, disartrija, disgewżja, ipoestesija, parestesija sindrome newrolettiku malinn, iskemija ċerebrovaskulari, ma jirrispondix għall-istimuli, tintilef minn sensik, livell dipress ta' koxjenza, konvulżjoni e, disturb fil-bilanċ, koordinazzjoni mhux normali koma dijabetika, ras tirtogħod
English: Menstrual disorder includes: menstruation delayed, menstruation irregular, oligomenorrhoea
Maltese: Disturb fil-menstrwazzjoni jinkludi: dewmien biex isseħħ menstrwazzjoni, menstrwazzjoni irregolari, oligomenorrea
English: Four metabolic pathways have been identified in vivo, none of which accounted for more than 6.5% of the dose: dealkylation, hydroxylation, dehydrogenation, and benzisoxazole scission.
Maltese: Ġew identifikati erba' mogħdijiet metaboliċi in vivo, li l-ebda waħda minnhom ma kienet twassal għal iktar minn 6.5% tad-doża: dealkilazzjoni, idroksilazzjoni, deidroġenazzjoni, u xizzjoni tal-benzisoxazole.
English: Pre-filled syringe (cyclic-olefin-copolymer) with a plunger stopper, backstop, and tip cap (bromobutyl rubber) with a 22G 1½-inch safety needle (0.72 mm x 38.1 mm) and a 23G 1-inch safety needle (0.64 mm x 25.4 mm).
Maltese: 72 mm x 38.1 mm) u b'labra ta' pulzier (1 pulzier), ta' ħxuna 23G (0.64 mm x 25.4 mm).
English: This medicine may cause an electrocardiogram (ECG) abnormality demonstrating a long time for an electrical impulse to travel through a certain part of the heart (known as “QT prolongation”).
Maltese: Din il-mediċina tista' tikkawża anormalità fl-elettrokardjogramma (ECG) li turi tul ta' ħin għal impuls elettriku sabiex jivvjaġġa matul ċerta parti tal-qalb (magħrufa bħala “titwil tal-QT”).
English: Prolonged release suspension for injection Day 8
Maltese: Suspensjoni li terħi l-mediċina bil-mod għall-injezzjoni Jum 8