FrancophonIA/ELRC3.0 huggingface dataset:
English: A fertility study in female rats resulted in prolonged oestrous cycle and delayed copulation at ≥1.5 mg/kg/day lurasidone hydrochloride, whilst the copulation and fertility indices, and the numbers of corpora lutea, implantations and live foetuses were decreased at 150 mg/kg/day lurasidone hydrochloride.
Maltese: Studju dwar il-fertilità f'firien femminili irriżulta f'ċiklu estrus imtawwal u kopulazzjoni ttardjata b'≥1.5 mg/kg/kuljum ta' lurasidone hydrochloride, filwaqt li l-indiċi tal-kopulazzjoni u tal-fertilità, u n-numri ta' korpora lutea, impjantazzjonijiet u feti ħajjin naqsu b'150 mg/kg/kuljum ta' lurasidone hydrochloride.
English: No data are available in elderly people treated with 148 mg of lurasidone.
Maltese: M'hemmx dejta disponibbli dwar persuni anzjani kkurati b'148 mg ta' lurasidone.
English: Diarrhoea**** Dysphagia**** Gastritis****
Maltese: Disfunzjoni erettili**** Amenorea**** Dismenorea****
English: Urine comprised mostly of a number of metabolites with minimal renal excretion of parent compound.
Maltese: L-awrina kienet magħmula l-aktar minn numru ta' metaboliti bi tneħħija renali minima tal-komponent prinċipali.
English: Angina**** AV block first degree**** Bradycardia****
Maltese: Imblokk AV tal-ewwel grad**** Bradikardija****
English: Coadministration of lurasidone with medicinal products that moderately inhibit CYP3A4 (e.g. diltiazem, erythromycin, fluconazole verapamil) may increase exposure to lurasidone.
Maltese: L-għoti ta' lurasidone flimkien ma' prodotti mediċinali li jinibixxu b'mod moderat lil CYP3A4 (eż. diltiazem, erythromycin, fluconazole, verapamil) jista' jżid l-esponiment għal lurasidone.
English: Tablet coating
Maltese: Żieda fil-piż
English: magnesium stearate (E470b), titanium dioxide (E171), macrogol, yellow iron oxide (E172)
Maltese: • Is-sustanzi mhux attivi l-oħra huma mannitol, starch magħmul ġelatina, croscarmellose sodium, hypromellose, magnesium stearate (E 470b), titanium dioxide (E171), macrogol, iron oxide isfar
English: The incidence of ADRs reported in clinical trials is tabulated by frequency category.
Maltese: L-inċidenza ta' ADRs irrappurtati fi provi kliniċi hija tabulata skont il- frekwenza.
English: Dosing recommendations for elderly patients with normal renal function (CrCl ≥ 80 ml/min) are the same as for adults with normal renal function.
Maltese: Ir-rakkomandazzjonijiet tad-dożaġġ għall-pazjenti anzjani b'funzjoni renali normali (CrCl ≥ 80 ml/min) huma l-istess bħal dawk għall-adulti b'funzjoni renali normali.
English: Lurasidone is an in vitro inhibitor of the efflux transporter P-gp and the clinical relevance of intestinal P-gp inhibition cannot be excluded.
Maltese: Lurasidone huwa inibitur in vitro ta' trasportatur tal-effluss P-gp u r-relevanza klinika tal- inibizzjoni intestinali ta' P-gp ma tistax tiġi eskluża.
English: Sudden death attributable to underlying cardiovascular disease observed during the clinical development programme**** *Somnolence includes adverse reaction terms: hypersomnia, hypersomnolence, sedation, and somnolence **Parkinsonism includes adverse reaction terms: bradykinesia, cogwheel rigidity, drooling, extrapyramidal disorder, hypokinesia, muscle rigidity, parkinsonism, psychomotor retardation, and tremor ***Dystonia includes adverse reaction terms: dystonia, oculogyric crisis, oromandibular dystonia, tongue spasm, torticollis, and trismus.
Maltese: *Ngħas jinkludi t-termini ta' reazzjonijiet avversi: ipersomnja, ngħas eċċessiv, sedazzjoni u ngħas **Parkinsoniżmu jinkludi t-termini ta' reazzjonijiet avversi: bradikajneżja, riġidità cogwheel, tnixxja ta' bżieq mill-ħalq, disturb ekstrapiramidali, ipokajneżja, ebusija tal-muskoli, parkinsoniżmu, ittardjar psikomotorju, u rogħda ***Distonija tinkludi t-termini ta' reazzjonijiet avversi: distonija, kriżi okuloġirika, distonja oromandibulari, spażmu fl-ilsien, tortikollis, u trismus.
English: The safety profile of lurasidone in children included in this short-term study is in general consistent with that observed when treated within the approved indication in adults, however, differences in frequency of the most commonly occurred adverse reactions have been observed in paediatric patients for nausea (very common), diarrhea (common) and decreased appetite (common), compared with adults (common, unknown, and uncommon, respectively).
Maltese: Il-profil tas-sigurtà ta' lurasidone fi tfal inkluż f'dan l-istudju li sar fuq pejodu qasir huwa ġeneralment konsistenti ma' dak osservat meta kkurati fi ħdan l-indikazzjoni approvata fl-adulti, madankollu, kienu osservati differenzi fil-frekwenza tal-aktar reazzjonijiet avversi li seħħew b'mod komuni f'pazjenti pedjatriċi għal dardir (komuni ħafna), dijarea (komuni) u nuqqas ta' aptit (komuni), meta mqabbla mal-adulti (komuni, mhux magħruf, u mhux komuni, rispettivament).
English: (a) p-values for lurasidone vs. placebo were adjusted for multiple comparisons.
Maltese: (a) valuri-p għal lurasidone vs. plaċebo kienu aġġustati għal paraguni multipli.
English: High serum prolactin levels in long-term repeat-dose studies in female rats were associated with effects on bones, adrenal glands, and reproductive tissues.
Maltese: Livelli għolja ta' prolactin fis-serum fi studji fit-tul dwar doża ripetuta f'firien femminili kienu assoċjati ma' effetti fuq l-għadam, glandoli adrenali, u tessuti riproduttivi.
English: The safety of lurasidone has been evaluated at doses of 18.5 -148 mg in clinical studies in patients with schizophrenia treated for up to 52 weeks and in the post-marketing setting.
Maltese: Is-sigurtà ta' lurasidone kienet evalwata f'dożi ta' 18.5 -148 mg fi studji kliniċi f'pazjenti bi skiżofrenja kkurati sa 52 ġimgħa u f'ambejnt ta' wara t-tqegħid fis-suq.
English: The efficacy of lurasidone in the treatment of schizophrenia was demonstrated in five multi-centre, placebo-controlled, double-blind, 6-week trials in subjects who met Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) criteria for schizophrenia.
Maltese: L-effikaċja ta' lurasidone fil-kura ta' skiżofrenja intweriet f'ħames provi b'aktar minn ċentru wieħed, ikkontrollati bil-plaċebo, double-blind, ta' 6 ġimgħat f'individwi li laħqu l-kriterji tal-Manwali Dijanjostiku u Statistiku ta' Disturbi Mentali, ir-Raba' Edizzjoni (DSM-IV - Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition) għall-iskiżofrenja.
English: EU/1/14/913/008-014
Maltese: TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/14/913/008-014
English: Coadministration of lurasidone with diltiazem (slow-release formulation), a moderate CYP3A4 inhibitor, resulted in a 2.2 and 2.4-fold increase in exposure of lurasidone and ID-14283 respectively (see section 4.2).
Maltese: L-għoti ta' lurasidone flimkien ma' diltiazem (formulazzjoni ta' rilaxx bil-mod), inibitur moderat ta' CYP3A4, wassal għal żieda ta' 2.2 u 2.4 darbiet fl-esponiment għal lurasidone u ID-14283,
English: Each 37 mg tablet contains lurasidone hydrochloride equivalent to 37.2 mg lurasidone.
Maltese: Kull 37 mg pillola fiha lurasidone hydrochloride ekwivalenti għal 37.2 mg lurasidone.
English: Co-administration of lurasidone and posaconazole (strong CYP3A4 inhibitor) resulted in an approximate 4-5 fold increase in lurasidone exposure.
Maltese: L-għoti flimkien ta' lurasidone u posaconazole (inibitur qawwi ta' CYP3A4) irriżulta f'żieda ta' madwar 4-5 darbiet fl-esponiment għal lurasidone.
English: Concomitant administration of the P-gp substrate dabigatran etexilate may result in increased dabigatran plasma concentrations.
Maltese: Amministrazzjoni konkomitanti tas-sottostrat-P-gp dabigatran etexilate jista' jirriżulta f'żieda fil-konċentrazzjonijiet ta' dabigatran fil-plażma.
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: Kienet osservata żieda ta' madwar 3 darbiet fir-riskju ta' reazzjonijiet avversi ċerebrovaskulari fi provi kliniċi randomised ikkontrollati bil-plaċebo fil-popolazzjoni bid-dimenzja b'xi antipsikotiċi atipiċi, inkluż risperidone, aripiprazole u olanzapine.
English: Additionally, lurasidone was superior to placebo on the predefined secondary endpoint Clinical Global Impression - Severity (CGI-S) scale.
Maltese: Barra dan, lurasidone kien superjuri għall-plaċebo fuq l-iskala tal-punt finali sekondarju definit minn qabel ta' Severità tal-Impressjoni Klinika Globali (CGI-S - Clinical Global Impression - Severity).
English: Neuroleptic Malignant Syndrome, characterised by hyperthermia, muscle rigidity, autonomic instability, altered consciousness and elevated serum creatine phosphokinase levels, has been reported to occur with lurasidone.
Maltese: Sindrome newrolettiku malinn (NMS - Neuroleptic malignant syndrome) Sindrome Newrolettiku Malinn, ikkaratterizzat minn ipertermija, ebusija tal-muskoli, instabilità awtonomika, koxjenza mibdula u livelli elevati ta' creatine phosphokinase fis-serum, kien irrappurtat li jseħħ b'lurasidone.
English: • muscle spasms and stiffness
Maltese: Ebusija muskolu-skeletrika
English: In a meta-analysis of 17 controlled clinical trials, elderly patients with dementia treated with other atypical antipsychotics, including risperidone, aripiprazole, olanzapine, and quetiapine had an increased risk of mortality compared to placebo.
Maltese: F'meta-analiżi ta' 17-il prova klinika kkontrollata, pazjenti anzjani bid-dimenzja kkurati b'antipsikotiċi atipiċi oħrajn, inkluż risperidone, aripiprazole, olanzapine, u quetiapine kellhom riskju ogħla ta' mortalità meta mqabbel mal-plaċebo.
English: Latuda is indicated for the treatment of schizophrenia in adults aged 18 years and over.
Maltese: Latuda huwa indikat f'adulti minn 18 il-sena u aktar għall-kura ta' skiżofrenja.
English: Cardiovascular monitoring should commence immediately, including continuous electrocardiographic monitoring for possible arrhythmias.
Maltese: Monitoraġġ kardjovaskulari għandu jinbeda immedjatament, inkluż monitoraġġ elettrokardjografiku kontinwu għall-possibilità ta' arritmija.
English: In a long-term dog repeat-dose study, high serum prolactin levels were associated with effects on male and female reproductive tissues.
Maltese: Fi studju fit-tul dwar doża ripetuta fil-klieb, livelli għolja ta' prolactin fis-serum kienu assoċjati ma' effetti fuq it-tessuti riproduttivi maskili u femminili.
English: Baseline Mean (SD)
Maltese: Medja fil-Linja Bażi (SD)
English: Events of interest to the class Extrapyramidal symptoms (EPS): In the short-term placebo controlled studies, the incidence of reported events related to EPS, excluding akathisia and restlessness, was 13.5% for lurasidone-treated subjects versus 5.8% for placebo-treated subjects.
Maltese: Fl-istudji kkontrollati bil-plaċebo ta' żmien qasir, l-inċidenza ta' avvenimenti relatati ma' EPS irrappurtati, minbarra akatisja u aġitazzjoni, kienet ta' 13.5% għall-individwi kkurati b'lurasidone kontra 5.8% għall-individwi kkurati bil-plaċebo.
English: (b) p-values for lurasidone vs. placebo were adjusted for multiple comparisons.
Maltese: (b) valuri p għal lurasidone kontra plaċebo kienu aġġustati għal paraguni multipli.
English: Drug withdrawal syndrome neonatal (see 4.6)
Maltese: Sindrome ta' waqfien tal-mediċina fi trabi tat-twelid (ara 4.6)
English: There have been reports of agitation, hypertonia, hypotonia, tremor, somnolence, respiratory distress, or feeding disorder.
Maltese: Kien hemm rapporti ta' aġitazzjoni, ipertonija, ipotonija, rogħda, ngħas, distress respiratorju, jew disturb biex jieklu.
English: Lurasidone is metabolised mainly via CYP3A4.
Maltese: Fil-biċċa l-kbira Lurasidone huwa metabolizzat permezz ta' CYP3A4.
English: Coadministration of lurasidone with mild (e.g. armodafinil, amprenavir, aprepitant, prednisone, rufinamide) or moderate (e.g. bosentan, efavirenz, etravirine, modafinil, nafcillin) inducers of CYP3A4 would be expected to give a <2-fold reduction in lurasidone exposure during co-administration and for up to 2 weeks after discontinuation of mild or moderate CYP3A4 inducers.
Maltese: L-għoti ta' lurasidone flimkien ma' indutturi ħfief (eż. armodafinil, amprenavir, aprepitant, prednisone, rufinamide) jew moderati (eż. bosentan, efavirenz, etravirine, modafinil, nafcillin) ta' CYP3A4 huwa mistenni li jwassal għal tnaqqis ta' <darbtejn fl-esponiment għal lurasidone waqt l-għoti flimkien u sa ġimagħtejn wara t-twaqqif ta' indutturi ħfief jew moderati ta' CYP3A4.
English: Latuda contains the active substance lurasidone and belongs to a group of medicines called antipsychotics.
Maltese: Latuda fih is-sustanza attiva lurasidone u jappartjeni għall-grupp ta' mediċini msejħa antipsikotiċi.
English: In the short-term trials, the primary efficacy endpoint was defined as the mean change from baseline to Week 6 in Positive and Negative Syndrome Scale (PANSS) total scores, a validated multi-item inventory composed of five factors to evaluate positive symptoms, negative symptoms, disorganised thoughts, uncontrolled hostility/excitement, and anxiety/depression.
Maltese: Fil-provi ta' żmien qasir, il-punt finali primarju tal-effikaċja kien definit bħala l-bidla medja mil-linja bażi sa Ġimgħa 6 fil-punteġġi totali tal-Iskala ta' Sindrome Pożittivi u Negattivi (PANSS - Positive and Negative Syndrome Scale), inventarju validat ta' diversi termini magħmul minn ħames fatturi sabiex jevalwa sintomi pożittivi, sintomi negattivi, ħsibijiet disorganizzati, ostilità/eċitament mhux ikkontrollat, u ansjetà/depressjoni.
English: Caution is advised when prescribing lurasidone with medicinal products known to prolong the QT interval, e.g. class IA antiarrhythmics (e.g. quinidine, disopyramide) and class III antiarrhythmics (e.g. amiodarone, sotalol), some antihistaminics, some other antipsychotics and some antimalarials (e.g. mefloquine).
Maltese: Kawtela hija rrakkomandata meta lurasidone jiġi preskritt ma' prodotti mediċinali magħrufa li jtawwlu l-intervall QT, eż. antiarritmiċi ta' klassi IA (eż. quinidine, disopyramide) u antiarritmiċi ta' klassi III (eż. amiodarone, sotalol), xi antistamini, xi antipsikotiċi oħra, u xi mediċini kontra l-malarja (eż.
English: • if you are taking some other medicines (see section 2, Other medicines and Latuda)
Maltese: • jekk qed tieħu xi mediċini oħra (ara sezzjoni 2, Mediċini oħra u Latuda)
English: Adrenaline and dopamine should not be used, or other sympathomimetics with beta agonist activity, since beta stimulation may worsen hypotension in the setting of lurasidone-induced alpha blockade.
Maltese: Adrenaline u dopamine m'għandhomx jintużaw, lanqas simpatomimetiċi oħra b'attività agonista għar-riċetturi beta, peress li stimulazzjoni beta tista' taggrava l-pressjoni baxxa f'sitwazzjoni ta' imblokk alpha ikkawżat minn lurasidone.
English: If antiarrhythmic therapy is administered, disopyramide, procainamide, and quinidine carry a theoretical hazard of QT-prolonging effects when administered in patients with an acute overdose of lurasidone.
Maltese: Jekk tingħata terapija kontra l-arritmija, disopyramide, procainamide, u quinidine għandhom periklu teoretiku ta' effetti li jtawwlu QT meta jingħataw lill-pazjenti b'doża eċċessiva akuta ta' lurasidone.
English: Following oral administration of a radiolabelled dose, approximately 67% dose was recovered in faeces and 19% in urine.
Maltese: Wara għoti orali ta' doża radjutikkettata, madwar 67% tad-doża kienet irkuprata fl-ippurgar u 19% fl-awrina.
English: • medicines containing ergot alkaloid derivatives (used for treating migraines), and other medicines including terfenadine and astemizole (used for treating hay fever and other allergic conditions), cisapride (used for treating digestive problems), pimozide (used to treating psychiatric illnesses), quinidine (used for treating heart conditions), bepridil (used for treating chest pain).
Maltese: • mediċini li fihom derivattivi ta' ergot alkaloid (użati għall-kura tal-emigranja), u mediċini oħra inkluż terfenadine u astemizole (użati għall-kura tar-riħ tal-ħuxlief (hay fever) u kondizzjonijiet allerġiċi oħra), cisapride (użat għall-kura ta' problemi fid-diġestjoni), pimozide (użat għall-kura ta' mard psikjatriku), quinidine (użat għall-kura ta' kondizzjonijiet tal-qalb), bepridil (użat għall-kura ta' uġigħ fis-sider).
English: Post marketing reports of clinically serious cases of skin and other hypersensitivity reactions have been reported in association with lurasidone treatment, including some reports of Stevens-Johnson syndrome.
Maltese: Rapporti ta' wara t-tqegħid fis-suq dwar każijiet klinikament serji ta' reazzjonijiet fuq il-ġilda u reazzjonijiet ta' sensittività eċċessiva ġew rapportati flimkien mat-trattament b'lurasidone, li jinkludu xi rapporti tas-sindrome ta' Stevens-Johnson.
English: It is effective in a dose range of 37 to 148 mg once daily.
Maltese: Huwa effettiv f'firxa ta' dożi minn 37 sa 148 mg darba kuljum.
English: The incidence of akathisia for lurasidone-treated subjects was 12.9% versus 3.0% for placebo-treated subjects.
Maltese: L-inċidenza ta' akatisja għall-individwi kkurati b'lurasidone kienet ta' 12.9% kontra 3.0%
English: • decreased liver function
Maltese: • funzjoni tal-kliewi mnaqqsa • funzjoni tal-fwied mnaqqsa
English: In the main clinical efficacy studies, lurasidone was administered at doses of 37-148 mg lurasidone.
Maltese: Fl-istudji ewlenin dwar l-effikaċja klinika, lurasidone ingħata b'dożi ta' 37-148 mg lurasidone.
English: Musculoskeletal stiffness Blood creatine phosphokinase increase
Maltese: Żieda ta' creatine phosphokinase fid-demm
English: • Latuda 18.5 mg film-coated tablets are white to off-white, film-coated round tablets debossed with “LA”
Maltese: • Latuda 18.5 mg pilloli miksija b'rita huma ta' lewn abjad sa abjad maħmuġ, pilloli tondi miksija b'rita, imnaqqxa b'"LA"
English: Each 74 mg tablet contains lurasidone hydrochloride equivalent to 74.5 mg lurasidone.
Maltese: Kull 74 mg pillola fiha lurasidone hydrochloride ekwivalenti għal 74.5 mg lurasidone
English: The mechanism for this increased risk is not known.
Maltese: Il-mekkaniżmu ta' din iż-żieda fir-riskju mhux magħruf.
English: • bosentan (to treat high blood pressure or ulcers of the fingers)
Maltese: • bosentan (għall-kura ta' pressjoni għolja jew ulċeri fis-swaba)
English: • abnormal nerve impulses in the heart
Maltese: • impulsi mhux normali tan-nervaturi fil-qalb
English: Lurasidone may cause orthostatic hypotension, perhaps due to its α1-adrenergic receptor antagonism.
Maltese: Lurasidone jista' jikkawża pressjoni ortostatika baxxa, forsi minħabba l-antagoniżmu tiegħu għar-riċettur α1-adrenerġiku.
English: P-values for olanzapine and quetiapine XR vs. placebo were unadjusted.
Maltese: Valuri p għal olanzapine u quetiapine XR kontra plaċebo ma kinux aġġustati.
English: Coadministration of lurasidone with midazolam, a sensitive CYP3A4 substrate, resulted in a < 1.5-fold increase in midazolam exposure.
Maltese: L-għoti ta' lurasidone flimkien ma' midazolam, sottostrat sensittiv ta' CYP3A4, wassal għal żieda ta' < 1.5 darbiet fl-esponiment għal midazolam.
English: Clinical monitoring of weight is recommended.
Maltese: Huwa rrakkomandat monitoraġġ kliniku tal-piż.
English: A persistent effect of posaconazole on lurasidone exposure was observed up to 2-3 weeks after stop of posaconazole co-administration.
Maltese: Ġie osservat effett persistenti ta' posaconazole fuq l esponiment għal lurasidone sa 2-3 ġimgħat wara t-twaqqif tal-għoti flimkien ma' posaconazole.
English: Pale green, film-coated oval tablets of 12 mm x 7 mm debossed with ‘LD'
Maltese: Pilloli ovali miksija b'rita, ta' lewn aħdar ċar, ta' 12 mm x 7 mm imnaqqxa b'‘LD'
English: RO-București 050451 Tel: + 40 21 331 6767
Maltese: RO-București 050451
English: - Concomitant administration of strong CYP3A4 inhibitors (e.g. boceprevir, clarithromycin, cobicistat, indinavir, itraconazole, ketoconazole, nefazodone, nelfinavir, posaconazole, ritonavir, saquinavir, telaprevir, telithromycin, voriconazole) and strong CYP3A4 inducers (e.g. carbamazepine, phenobarbital, phenytoin, rifampicin, St John's wort (Hypericum perforatum) (see section 4.5).
Maltese: (eż. boceprevir, clarithromycin, cobicistat, indinavir, itraconazole, ketoconazole, nefazodone, nelfinavir, posaconazole, ritonavir, saquinavir, telaprevir, telithromycin, voriconazole) (ara sezzjoni 4.3).
English: In case of severe extrapyramidal symptoms, anticholinergic medicinal products should be administered.
Maltese: F'każ ta' sintomi extrapiramidali severi, għandhom jingħataw prodotti mediċinali antikolinerġiċi.
English: • dizziness
Maltese: • qagħda riġida
English: This is because alcohol will have an additive negative effect.
Maltese: Dan huwa għax l-alkoħol ikollu effett addittiv negattiv .
English: • deliberate injury to oneself
Maltese: • korriment intenzjonat lill-persuna nnifisha
English: Monitoring is recommended when lurasidone and CYP3A4 substrates known to have a narrow therapeutic index (e.g. astemizole, terfenadine, cisapride, pimozide, quinidine, bepridil or ergot alkaloids [ergotamine, dihydroergotamine]) are coadministered.
Maltese: Huwa rrakkomandat monitoraġġ meta lurasidone u sottostrati ta' CYP3A4 magħrufa li għandhom indiċi terapewtiku dejjaq (eż. astemizole, terfenadine, cisapride, pimozide, quinidine, bepridil jew ergot alkaloids [ergotamine, dihydroergotamine]) jingħataw flimkien.
English: Long-term maintenance efficacy of lurasidone (37 to 148 mg lurasidone once daily) was demonstrated in a 12 month non-inferiority trial with quetiapine extended release (200 to 800 mg once daily).
Maltese: L-effikaċja ta' manteniment fit-tul ta' lurasidone (37 sa 148 mg lurasidone darba kuljum) intweriet fi prova ta' nuqqas ta' inferjorità ta' 12-il xahar b'quetiapine b'rilaxx estiż (200 sa 800 mg darba kuljum).
English: Long-term maintenance efficacy of lurasidone (37 to 148 mg lurasidone once daily ) was demonstrated in a 12 month non-inferiority trial with quetiapine extended release (200 to 800 mg once daily).
Maltese: L-effikaċja ta' manteniment fit-tul ta' lurasidone (37 sa 148 mg lurasidone darba kuljum ) intweriet fi prova ta' nuqqas ta' inferjorità ta' 12-il xahar b'quetiapine b'rilaxx estiż (200 sa 800 mg darba kuljum).
English: • prednisone (to treat inflammatory disease)
Maltese: • prednisone (għall-kura ta' mard infjammatorju)
English: Lurasidone was not teratogenic in rats or rabbits at an exposure similar to or below the maximum recommended human dose (148 mg lurasidone ).
Maltese: Lurasidone ma kienx teratoġeniku fil-firien jew fil-fniek f'esponimenti simili għal jew inqas mid-doża massima rrakkomandata fil-bniedem (148 mg lurasidone).
English: Rhabdomyolysis
Maltese: Plaċebo
English: • spinning sensation
Maltese: • sensazzjonijiet ta' ansjetà f'daqqa waħda
English: These prolactin-related effects are not considered to be relevant to human reproduction.
Maltese: Dawn l-effetti relatati ma' prolactin mhumiex meqjusa bħala rilevanti għar-riproduzzjoni umana.
English: People with this disorder may also feel depressed, anxious, guilty, or tense.
Maltese: Nies b'dan id-disturb għandhom mnejn iħossuhom wkoll depressi, anzjużi, ħatja, jew taħt tensjoni.
English: EU/1/14/913/001-007
Maltese: TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/14/913/001-007
English: For administration of medicinal products that are substrates of CYP3A4 with a narrow therapeutic range, see section 4.5.
Maltese: Għall-għoti ta' prodotti mediċinali li huma sottostrati ta' CYP3A4 li għandhom firxa terapewtika dejqa, ara sezzjoni 4.5.
English: Breast enlargement**** Breast pain**** Galactorrhoea**** Erectile dysfunction**** Amenorrhoea**** Dysmenorrhoea****
Maltese: Tkabbir tas-sider**** Uġigħ fis-sider**** Galaktorea****
English: Estimate (SE)
Maltese: NUMRU(I)
English: Coadministration of lurasidone with the strong CYP3A4 inhibitor ketoconazole resulted in a 9- and 6-fold increase in exposure of lurasidone and its active metabolite ID-14283 respectively.
Maltese: L-għoti ta' lurasidone flimkien mal-inibitur qawwi ta' CYP3A4 ketoconazole wassal għal żieda ta' 9 u 6 darbiet fl-esponiment għal lurasidone u għal metabolit attiv tiegħu, ID-14283, rispettivament.