FrancophonIA/ELRC3.0 huggingface dataset:
English: Hungary/ Magyarország Angelini Pharma Magyarország Kft Dayka Gábor u. 3., 214-215. számú iroda
Maltese: Hungary/ Magyarország Angelini Pharma Magyarország Kft Dayka Gábor u.
English: • rufinamide (to treat seizures).
Maltese: • rufinamide (għall-kura ta' aċċessjonijiet).
English: • armodafinil, modafinil (to treat sleepiness)
Maltese: • armodafinil, modafinil (għall-kura ta' ngħas)
English: (present in 74 mg tablets), indigotine (E132) (present in 74 mg tablets) and carnauba wax
Maltese: (E172) (preżenti fil-pilloli ta' 74 mg), indigotine (E132) (preżenti fil-pilloli ta' 74 mg) u carnauba wax (E903).
English: (a) Olanzapine 15 mg in Study D1050231, quetiapine extended-release (XR) 600 mg in Study D1050233.
Maltese: (a) Olanzapine 15 mg fi Studju D1050231, quetiapine b'rilaxx estiż (XR - extended-release) 600 mg fi Studju D1050233. N huwa stima tan-numru ta' individwi għal kull mudell.
English: Pharmacotherapeutic group: Psycholeptics, antipsychotics.
Maltese: Psikolettiċi, antipsikotiċi.
English: Eosinophilia Leukopenia**** Neutropenia****
Maltese: Eosinofilja Lewkopenija****
English: Angelini Pharmaceuticals România SRL Str. Carol Davila, Nr. 9, Sector 5
Maltese: Carol Davila, Nr. 9, Sector 5
English: Lurasidone is metabolised into two active metabolites (ID-14283 and ID-14326) and two non-active metabolites (ID-20219 and ID-20220).
Maltese: Lurasidone huwa metabolizzat f'żewġ metaboliti attivi (ID-14283 u ID-14326) u żewġ metaboliti mhux attivi (ID-20219 u ID-20220).
English: Lurasidone was administered as lurasidone hydrochloride at daily doses of either 20, 40, 80, 120 mg (6-17 years) or 160 mg (10-17 years only) for
Maltese: Lurasidone ingħata bħala lurasidone hydrochloride f'dożi ta' kuljum ta' jew 20, 40, 80, 120 mg (6-17-il sena) jew 160 mg (10-17 snin biss) għal 7 t'ijiem.
English: D1050233.
Maltese: Studju D1050233
English: Lurasidone and its metabolites ID-14283, ID-14326, ID-20219 and ID-20220 correspond to approximately 11.4, 4.1, 0.4, 24 and 11% respectively, of serum radioactivity respectively.
Maltese: Lurasidone u l-metaboliti tiegħu ID-14283, ID-14326, ID-20219 u ID-20220 jikkorrispondu għal madwar 11.4, 4.1, 0.4, 24, 11% rispettivament, tar-radjuattività fis-serum rispettivament.
English: Lurasidone is an in vitro substrate of the efflux transporters P-gp and BCRP.
Maltese: In vitro Lurasidone huwa sottostrat tat-trasportaturi tal-effluss P-gp u BCRP.
English: -0.44 (0.112; -0.66 to -0.22)
Maltese: -0.44 (0.112; -0.66 sa valur-p N huwa n-numru ta' individwi.
English: In a long-term safety study clinically stable patients were treated using 37 - 111 mg lurasidone or risperidone 2 - 6 mg.
Maltese: Fi studju ta' sigurtà fit-tul pazjenti klinikament stabbli kienu kkurati bl-użu ta' 37 - 111 mg lurasidone jew risperidone 2 - 6 mg.
English: Latuda 74 mg
Maltese: 74 mg
English: ΠΑΡΑΓΩΓΗΣ & ΕΜΠΟΡΙΑΣ ΦΑΡΜΑΚΩΝ Aχαίας 4 & Τροιζηνίας GR-14564 Νέα Κηφισιά Τηλ: + 30 210 626 9200
Maltese: ΕΜΠΟΡΙΑΣ ΦΑΡΜΑΚΩΝ Aχαίας 4 & Τροιζηνίας GR-14564
English: Schizophrenia Studies: Positive and Negative Syndrome Scale for Schizophrenia (PANSS) Total Score - Change From Baseline to Week 6- MMRM for Studies D1050229, D1050231, and D1050233: Intent-to-Treat Analysis Set
Maltese: Punteġġ Totali tal-Iskala ta' Sindrome Pożittivi u Negattivi għall-Iskiżofrenja (PANSS - Positive and Negative Syndrome Scale) - Bidla mil-Linja Bażi sa Ġimgħa 6 - MMRM għall-Istudji D1050229, D1050231, u D1050233: Sett ta' Analiżi b'Intenzjoni ta' Kura
English: EU/1/14/913/014 98 x 1 film-coated tablets
Maltese: EU/1/14/913/014 98 x 1 pillola miksija b'rita
English: Hyperprolactinaemia Lurasidone elevates prolactin levels due to antagonism of dopamine D2 receptors.
Maltese: Lurasidone jgħolli l-livelli ta' prolactin minħabba antagoniżmu tar-riċetturi D2 ta' dopamine.
English: Study Statistic Placebo Lurasidone dose (b)
Maltese: Doża ta' Lurasidone (b)
English: Limited data have been collected in healthy subjects ≥ 65 years.
Maltese: Inġabret dejta limitata f'individwi f'saħħithom ta' ≥ 65sena.
English: Lurasidone is an inhibitor of P-gp, BCRP and OCT1 in vitro (see section 4.5).
Maltese: In vitro Lurasidone huwa inibitur ta' P-gp, BCRP u OCT1 (ara sezzjoni 4.5).
English: • speech problems, unusual muscle movements; a collection of symptoms known as extrapyramidal symptoms (EPS) which typically will involve unusual purposeless involuntary muscle movements.
Maltese: • problemi biex titkellem, movimenti mhux tas-soltu tal-muskoli; kollezzjoni ta' sintomi magħrufa bħala sintomi ekstrapiramidali (EPS - extrapyramidal symptoms) li tipikament jinvolvu movimenti mhux tas-soltu, bla skop, involontarji tal-muskoli.
English: Anemia****
Maltese: Anemija****
English: Lurasidone had a small increase from baseline to Month 12 in body weight and body mass index (Mean (SD): 0.73 (3.36) kg and 0.28 (1.17) kg/m2, respectively) compared to quetiapine extended release (1.23 (4.56) kg and 0.45 (1.63) kg/m2, respectively).
Maltese: Lurasidone kellu żieda żgħira mil-linja bażi sa Xahar 12 fil-piż tal-ġisem u fl-indiċi tal-massa tal-ġisem (medja (SD): 0.73 (3.36) kg u 0.28 (1.17) kg/m2, rispettivament) meta mqabbel ma' quetiapine b'rilaxx estiż (1.23 (4.56) kg u 0.45 (1.63) kg/m2, rispettivament).
English: CYP3A4 is the major enzyme responsible for metabolism of the active metabolite ID-14283.
Maltese: CYP3A4 hija l-enzima prinċipali responsabbli għall-metaboliżmu tal-metabolit attiv ID-14283.
English: Kaplan-Meier estimates of the probability of relapse at Week 28 were 42.2% for lurasidone and 51.2% for placebo.
Maltese: L-istimi Kaplan-Meier tal-probabbiltà ta' rikaduta fil-Ġimgħa 28 kienu 42.2% għall lurasidone u 51.2% għall-plaċebo.
English: • nafcillin (to treat infections)
Maltese: • nafcillin (għall-kura ta' infezzjonijiet)
English: Brigittenauer Lände 50-54 1200 Wien
Maltese: Angelini Pharma Österreich GmbH Brigittenauer Lände 50-54 1200
English: Treatment Difference vs. placebo
Maltese: Differenza fil-Kura vs plaċebo
English: Other medicines and Latuda
Maltese: Mediċini oħra u Latuda
English: The serum concentrations of lurasidone are increased in healthy subjects with Child-Pugh Class A, B and C hepatic impairment with an increased exposure of 1.5-, 1.7- and 3-fold respectively.
Maltese: Il-konċentrazzjonijiet ta' lurasidone fis-serum jiżdiedu f'individwi f'saħħithom b'indeboliment epatiku ta' Child-Pugh Klassi A, B u Ċ b'żieda fl-esponiment ta' 1.5, 1.7 u 3 darbiet rispettivament.
English: • erythromycin (to treat infections)
Maltese: • erythromycin (għall-kura ta' infezzjonijiet)
English: Latuda 18.5 mg tablets lurasidone
Maltese: Latuda 18.5 mg pilloli lurasidone
English: Table 2.1 Bipolar Depression Paediatric Study: Children's Depression Rating Scale, Revised (CDRS-R) Total Score and Clinical Global Impression-Bipolar Version, Severity of Illness (CGI-BP-S) Depression Score (Depression) - Change From Baseline to Week 6 - MMRM for Study D1050326: Intent-to-Treat Analysis Set
Maltese: Punteġġ Totali tal-Iskala tal-Klassifikazzjoni tad-Depressjoni fit-Tfal, Riveduta (CDRS-R) u Punteġġ tad-Depressjoni (Depressjoni) tal-Impressjoni Globali Klinika - Verżjoni Bipolari, Severità tal-Marda (CGI-BP-S) - Bidla mil-Linja Bażi sa Ġimgħa 6 - MMRM għal Studju D1050326:
English: Aziende Chimiche Riunite Angelini Francesco ACRAF SPA
Maltese: Aziende Chimiche Riunite Angelini Francesco
English: HR3 5PG
Maltese: HR3 5PG Ir-Renju Unit
English: The key secondary endpoint was Clinical Global Impression - Bipolar Version, Severity of Illness (CGI-BP-S) Depression Score.
Maltese: Il-punt finali sekondarju ewlieni kien il-Punteġġ tad-Depressjoni tal-Impressjoni Globali Klinika - Verżjoni Bipolari, Severità tal-Marda (CGI-BP-S, Clinical Global Impression - Bipolar Version, Severity of Illness).
English: Potential for lurasidone to affect other medicinal products
Maltese: Potenzjal li lurasidone jaffettwa prodotti mediċinali oħra
English: 14 x 1 film-coated tablets 28 x 1 film-coated tablets 30 x 1 film-coated tablets 56 x 1 film-coated tablets 60 x 1 film-coated tablets 90 x 1 film-coated tablets 98 x 1 film-coated tablets
Maltese: 14 x 1 pillola miksija b'rita 28 x 1 pillola miksija b'rita 30 x 1 pillola miksija b'rita 56 x 1 pillola miksija b'rita 60 x 1 pillola miksija b'rita 90 x 1 pillola miksija b'rita 98 x 1 pillola miksija b'rita
English: • lack of energy (lethargy)
Maltese: • nuqqas ta' enerġija (letarġija)
English: Lurasidone doses ranging from 9 to 74 mg administered to healthy subjects produced a dose-dependent reduction in the binding of 11C-raclopride, a D2/D3 receptor ligand, in the caudate, putamen and ventral striatum detected by positron emission tomography.
Maltese: Dożi ta' lurasidone li jvarjaw minn 9 sa 74 mg mogħtija lill-individwi f'saħħithom wasslu għal tnaqqis dipendenti mid-doża fl-irbit ta' 11C-raclopride, ligand tar-riċettur lD2/D3, fl-istrijatum caudate, putamen u ventrali osservat permezz ta' tomografija ta' emissjoni ta' pożitroni.
English: Overall, lurasidone had a negligible effect on weight and other metabolic parameters including total cholesterol, triglycerides, and glucose levels.
Maltese: B'mod ġenerali, lurasidone kellu effett negliġibbli fuq il-piż u fuq parametri metaboliċi oħra inkluż il-kolesterol totali, trigliċeridi, u livelli ta' glucose.
English: Lurasidone is a selective blocking agent of dopamine and monoamine effects.
Maltese: Lurasidone huwa sustanza li timblokka b'mod selettiv l-effetti ta' dopamine u ta' monoamine.
English: ****ADRs noted in Phase 2 and 3 controlled and uncontrolled studies; however, the incidence of occurrence for these are too low to estimate frequencies.
Maltese: ****ADRs innutati fi studji kkontrollati u mhux ikkontrollati ta' Fażi 2 u 3; madankollu, l-inċidenza tal-okkorrenza ta' dawn hija baxxa wisq biex jiġu stmati l-frekwenzi.
English: Renal failure****
Maltese: Insuffiċjenza renali****
English: • diltiazem (to treat high blood pressure)
Maltese: • diltiazem (għall-kura ta' pressjoni għolja)
English: Parkinson's disease
Maltese: • Parkinsoniżmu:
English: Lurasidone and its active metabolite ID-14283 are primarily metabolised by CYP3A4.
Maltese: Lurasidone u l-metabolit attiv tiegħu ID-14283 huma metabolizzat primarjament minn CYP3A4.
English: The following terms and frequencies are applied: very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100), rare (≥ 1/10,000 to < 1/1,000), very rare (<1 /10,000) and not known (cannot be estimated from the available data).
Maltese: Huma applikati t-termini u l-frekwenzi li ġejjin: komuni ħafna (≥ 1/10), komuni (≥ 1/100 sa < 1/10), mhux komuni (≥ 1/1,000 sa < 1/100), rari (≥ 1/10,000 sa < 1/1,000), rari ħafna (<1 /10,000) u mhux magħruf (ma tistax tittieħed stima mid-data disponibbli).
English: Lethargy Dysarthria Tardive dyskinesia
Maltese: Diskajneżja tardiva
English: You can also report side effects directly via the following website: www.mhra.gov.uk/yellowcard.
Maltese: Tista 'tirrapporta wkoll effetti sekondarji direttament permezz tal-websajt li ġejja: www.medicinesauthority.gov.mt/adrportal.
English: Dose adjustment is recommended in moderate (Child-Pugh Class B) and severe hepatic impairment (Child-Pugh Class C) patients.
Maltese: Aġġustament fid-doża huwa rrakkomandat f'pazjenti b'indeboliment epatiku moderat (Child Pugh Klassi B) u indeboliment epatiku sever (Child Pugh Klassi Ċ).
English: Patients should be counseled on signs and symptoms of elevated prolactin, such as gynecomastia, galactorrhea, amenorrhea and erectile dysfunction.
Maltese: Ilpazjenti għandhom jingħataw pariri dwar sinjali u sintomi ta' żieda fi prolactin, bħal ginekomastija, galattorea, amenorrea u disfunzjoni erettili.
English: Sleepiness, dizziness and vision problems may occur during treatment with this medicine (see section 4, Possible side effects).
Maltese: Ngħas, sturdament u problemi fil-vista jistgħu jseħħu waqt kura b'din il-mediċina (ara sezzjoni 4, Effetti sekondarji possibli).
English: Interaction with grapefruit juice Grapefruit juice should be avoided during treatment with lurasidone (see section 4.5).
Maltese: Interazzjoni ma' meraq tal-grejpfrut Meraq tal-grejpfrut għandu jiġi evitat waqt kura b'lurasidone (ara sezzjoni 4.5).
English: Cartons contain 14 x 1, 28 x 1, 30 x 1, 56 x 1, 60 x 1, 90 x 1 or 98 x 1 tablets in aluminium/aluminium perforated unit dose blisters.
Maltese: In-natura tal-kontenitur u ta' dak li hemm ġo fih Kaxxi li fihom 14 x 1, 28 x 1, 30 x 1, 56 x 1, 60 x 1, 90 x 1 jew 98 x 1 pillola miksija b'rita f'folji magħmulin minn aluminju/aluminju mtaqqab biex tkun tista' tinqata' doża waħda.
English: Lurasidone reaches peak serum concentrations in approximately 1-3 hours.
Maltese: Lurasidone jilħaq konċentrazzjonijiet massimi fis-serum wara madwar 1-3 sigħat.
English: Latuda 37 mg tablets lurasidone
Maltese: Latuda 37 mg pilloli lurasidone
English: Lurasidone also exhibits partial agonism at the 5HT-1A receptor with a binding affinity of 6.38 nM. Lurasidone does not bind to histaminergic or muscarinic receptors.
Maltese: Lurasidone juri wkoll agoniżmu parzjali għar-riċettur 5HT-1A b'affinità ta' rbit ta' 6.38 nM. Lurasidone ma jintrabatx ma' riċetturi istaminerġiċi jew muskariniċi.
English: EU/1/14/913/002 28 x 1 film-coated tablets EU/1/14/913/003 30 x 1 film-coated tablets EU/1/14/913/004 56 x 1 film-coated tablets EU/1/14/913/005 60 x 1 film-coated tablets EU/1/14/913/006 90 x 1 film-coated tablets EU/1/14/913/007 98 x 1 film-coated tablets
Maltese: EU/1/14/913/001 14 x 1 pillola miksija b'rita EU/1/14/913/002 28 x 1 pillola miksija b'rita EU/1/14/913/003 30 x 1 pillola miksija b'rita EU/1/14/913/004 56 x 1 pillola miksija b'rita EU/1/14/913/005 60 x 1 pillola miksija b'rita EU/1/14/913/006 90 x 1 pillola miksija b'rita EU/1/14/913/007 98 x 1 pillola miksija b'rita
English: In patients with moderate (Creatinine Clearance (CrCl) ≥ 30 and < 50 ml/min), severe renal impairment (CrCL >15 and < 30 ml/min) and End Stage Renal Disease (ESRD) patients (CrCl < 15 ml/min), the recommended starting dose is 18.5 mg and the maximum dose should not exceed 74 mg once daily.
Maltese: F'pazjenti b'indeboliment renali moderat (Tneħħija tal-Krejatinina (CrCl - Creatinine Clearance) ≥ 30 u < 50 ml/min), indeboliment renali sever (CrCL > 15 u < 30 ml/min) u pazjenti b'Marda tal-Kliewi tal-Aħħar Stadju (ESRD - End Stage Renal Disease) (CrCl <15 ml/min), id-doża tal-bidu rrakkomandata hija ta' 18.5 mg u d-doża massima m'għandhiex taqbeż 74 mg darba kuljum.
English: EU/1/14/913/016 28 x 1 film-coated tablets EU/1/14/913/017 30 x 1 film-coated tablets EU/1/14/913/018 56 x 1 film-coated tablets EU/1/14/913/019 60 x 1 film-coated tablets EU/1/14/913/020 90 x 1 film-coated tablets EU/1/14/913/021 98 x 1 film-coated tablets
Maltese: EU/1/14/913/015 14 x 1 pillola miksija b'rita EU/1/14/913/016 28 x 1 pillola miksija b'rita EU/1/14/913/017 30 x 1 pillola miksija b'rita EU/1/14/913/018 56 x 1 pillola miksija b'rita EU/1/14/913/019 60 x 1 pillola miksija b'rita EU/1/14/913/020 90 x 1 pillola miksija b'rita EU/1/14/913/021 98 x 1 pillola miksija b'rita
English: LS Mean Change (SE)
Maltese: Bidla Medja LS (SE)
English: Each 18.5 mg tablet contains lurasidone hydrochloride equivalent to 18.6 mg lurasidone.
Maltese: Kull 18.5 mg pillola fiha lurasidone hydrochloride ekwivalenti għal 18.6 mg lurasidone.
English: Latuda 74 mg tablets lurasidone
Maltese: Latuda 74 mg pilloli lurasidone
English: Pharmacokinetics in special patient groups:
Maltese: Farmakokinetika fi gruppi speċjali ta' pazjenti:
English: The following terms and frequencies are applied: very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1000 to < 1/100), rare (≥ 1/10,000 to < 1/1000), very rare (<1 /10,000) and not known (cannot be estimated from the available data).
Maltese: Huma applikati t-termini u l-frekwenzi li ġejjin: komuni ħafna (≥ 1/10), komuni (≥ 1/100 sa < 1/10), mhux komuni (≥ 1/1000 sa < 1/100), rari (≥ 1/10,000 sa < 1/1000), rari ħafna (<1 /10,000) u mhux magħruf (ma tistax tittieħed stima mid-dejta disponibbli).
English: Placebo-adjusted LS mean change (95% CI) from Baseline to Week 6 LOCF in CDRS-R total score for the lurasidone group was -1.8 (-5.6, 2.0) for subjects in the 10- to 14year-old age patients and was -8.6 (-12.4, -4.8) for subjects in the 15- to 17-year-old age patients.
Maltese: Il-bidla medja LS aġġustata bil-plaċebo (95% CI) mil-Linja Bazi sa LOCF (Last Observation Carried Forward) ta' Ġimgħa 6 fil-punteġġ totali ta' CDRS-R għall-grupp ta' lurasidone kienet ta' -1.8 (-5.6, 2.0) għal individwi fil-grupp ta' pazjenti ta' bejn l-10-14-il sena u kienet ta' 8.6 (12.4, -4.8) għal invidiwi fil-grupp ta' pazjenti ta' bejn il-15 sa 17-il sena.
English: 05-552 Łazy Tel.: + 48 22 70 28 200
Maltese: Tel.: + 48 22 70 28 200
English: Package leaflet: Information for the patient Latuda 18.5 mg film-coated tablets Latuda 37 mg film-coated tablets Latuda 74 mg film-coated tablets lurasidone
Maltese: Informazzjoni għall-pazjent Latuda 18.5 mg pilloli miksija b'rita Latuda 37 mg pilloli miksija b'rita Latuda 74 mg pilloli miksija b'rita lurasidone
English: Renal impairment The serum concentrations of lurasidone are increased in healthy subjects with mild, moderate and severe renal impairment with an increased exposure of 1.5, 1.9 and 2.0-fold respectively.
Maltese: Il-konċentrazzjonijiet ta' lurasidone fis-serum jiżdiedu f'individwi f'saħħithom b'indeboliment renali ħafif, moderat u sever b'żieda fl-esponiment ta' 1.5, 1.9 u 2.0 darbiet rispettivament.
English: Lurasidone is not expected to have a clinically relevant inhibitory potential on transporters OATP1B1, OATP1B3, OCT2, OAT1, OAT3, MATE1, MATE2K or BSEP based on in vitro data.
Maltese: Ibbażat fuq dejta in vitro, Lurasidone mhux mistenni li jkollu potenzjal inibitorju ta' rilevanza klinika fuq it-trasportaturi OATP1B1, OATP1B3, OCT2, OAT1, OAT3, MATE1, MATE2K jew BSEP.
English: Serum creatinine increased
Maltese: krejatinina fis-serum
English: Based on this data, lurasidone is not expected to affect the pharmacokinetics of medicinal products that are substrates of CYP1A2, CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP2D6, and CYP2E1.
Maltese: Ibbażat fuq din id-dejta, lurasidone mhux mistenni li jkollu effett fuq il-farmakokinetika ta' prodotti mediċinali li huma sottostrati ta' CYP1A2, CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP2D6, u CYP2E1.
English: Angelini Farmacéutica S.A. C. Osi, 7
Maltese: Spain/ España Angelini Farmacéutica S.A. C.
English: Mannitol (E 421) Starch, pregelatinised Croscarmellose sodium (E468)
Maltese: Croscarmellose sodium (E468)
English: Lurasidone is contraindicated with strong CYP3A4 inducers (e.g. carbamazepine, phenobarbital, phenytoin, rifampicin, St John's wort (Hypericum perforatum)) (see section 4.3).
Maltese: phenobarbital, phenytoin, rifampicin, St John's wort (Hypericum perforatum)) (ara sezzjoni 4.3).
English: If signs and symptoms of tardive dyskinesia appear, the discontinuation of all antipsychotics, including lurasidone, should be considered.
Maltese: Jekk jiġu osservati sinjali u sintomi ta' diskajneżja ttardjata, għandu jiġi kkunsidrat twaqqif tal-antipsikotiċi kollha, inkluż lurasidone.
English: • Latuda 74 mg film-coated tablets are pale green, film-coated oval tablets debossed with “LD”.
Maltese: • Latuda 74 mg pilloli miksija b'rita huma ta' lewn aħdar ċar, pilloli ovali miksija b'rita, imnaqqxa b'"LD".
English: Current available data are described in section 5.1 and 5.2, but no recommendation on a posology can be made.
Maltese: Data disponibbli hija deskritta fis- sezzjoni 5.1 u 5.2, iżda ma tista' ssir l-ebda rakkomandazzjoni dwar pożoloġija.
English: Following administration of lurasidone, the elimination half-life was 20-40 hours.
Maltese: Wara l-għoti ta' lurasidone, il-half-life tal-eliminazzjoni kienet ta' 20-40 siegħa.
English: Convulsion****
Maltese: Konvulżjoni****
English: The short-term efficacy of lurasidone was studied in a 6-week multicentre, randomized, double-blind, placebo-controlled, study of children and adolescent patients (10-17 years of age) who met Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-V) criteria for a major depressive episode associated with bipolar I disorder, with or without rapid cycling, and without psychotic features (N=350).
Maltese: L-effikaċja fuq perjodu qasir ta' żmien ta' lurasidone kienet studjata fi studju ta' 6 ġimgħat, multiċentriku, randomised, double-blind, ikkontrollat bil-plaċebo, f'pazjenti tfal u adolexxenti (età ta' bejn 10-17-il sena) li laħqu l-kriterji tal-Manwali Dijanjostiku u Statistiku ta' Disturbi Mentali, il-Ħames Edizzjoni (DSM-V, Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition) għal episodju dipressiv maġġuri assoċjat mad-disturb bipolari I, bi jew mingħajr ċiklu rapidu, u mingħajr karatteristiċi psikotiċi (N=350).
English: Lurasidone is contraindicated with strong CYP3A4 inhibitors (e.g. boceprevir, clarithromycin, cobicistat, indinavir, itraconazole, ketoconazole, nefazodone, nelfinavir, posaconazole, ritonavir, saquinavir, telaprevir, telithromycin, voriconazole) (see section 4.3).
Maltese: clarithromycin, cobicistat, indinavir, itraconazole, ketoconazole, nefazodone, nelfinavir, posaconazole, ritonavir, saquinavir, telaprevir, telithromycin, voriconazole) (ara sezzjoni 4.3).
English: Lurasidone is an in vitro inhibitor of the efflux transporter BCRP and the clinical relevance of intestinal BCRP inhibition cannot be excluded.
Maltese: Lurasidone huwa inibitur in vitro ta' trasportatur tal-effluss BCRP u r-relevanza klinika tal- inibizzjoni intestinali ta' BCRP ma jistax jiġi eskluż.
English: A clinical drug interaction study investigating the effect of coadministration of lurasidone on patients taking oral combination contraceptives including norgestimate and ethinyl estradiol, indicated that lurasidone had no clinically or statistically meaningful effects on the pharmacokinetics of the contraceptive or sex hormone binding globulin (SHBG) levels.
Maltese: Studju kliniku dwar l-interazzjoni tal-mediċina li nvestiga l-effett ta' għoti fl-istess waqt ta' lurasidone fuq pazjenti li jieħdu kontraċettivi orali kkombinati inkluż norgestimate u ethinyl estradiol, indika li lurasidone ma kellux effetti klinikament jew statistikament sinifikanti fuq il-farmakokinetika tal-livelli tal-kontraċettiv jew tal-globulina li teħel mal-ormon tas-sess (SHBG - sex hormone binding globulin).
English: Based on in vitro studies lurasidone is not a substrate of CYP1A1, CYP1A2, CYP2A6, CYP4A11, CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP2D6 or CYP2E1 enzymes.
Maltese: Ibbażat fuq studji in vitro lurasidone mhux sottostrat tal-enzimi CYP1A1, CYP1A2, CYP2A6, CYP4A11, CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP2D6 jew CYP2E1.
English: • joint pains
Maltese: • riħ komuni
English: • increase in creatine phosphokinase (an enzyme in muscles) seen in blood tests
Maltese: • żieda ta' creatine phosphokinase (enzima fil-muskoli) osservata f'testijiet tad-demm
English: • Fever, sweating, muscle stiffness, and reduced consciousness.
Maltese: • Deni, għaraq, ebusija fil-muskoli, u koxjenza mnaqqsa.
English: The mechanism of action of the minor active metabolite of lurasidone ID-14283 is similar to that of lurasidone.
Maltese: Il-mekkaniżmu ta' azzjoni tal-metabolit attiv minuri ta' lurasidone ID-14283, huwa simili għal dak ta'
English: Lurasidone showed significant separation from placebo from as early as Day 4.
Maltese: Lurasidone wera separazzjoni sinifikanti mill-plaċebo anka minn Jum 4.
English: Potential for other medicinal products to affect lurasidone
Maltese: Potenzjal li prodotti mediċinali oħra jaffettwaw lurasidone
English: Via Vecchia del Pinocchio, 22 60100
Maltese: Aziende Chimiche Riunite Angelini Francesco ACRAF SPA Via Vecchia del Pinocchio, 22 60100
English: An elevated risk of acute dystonia is observed in males and younger age groups.
Maltese: Riskju ogħla ta' distonija akuta huwa osservat f'irġiel u fi gruppi ta'età iżgħar.
English: Moderate CYP3A4 inhibitors are estimated to result in a 2-5 fold increase in exposure of CYP3A4 substrates.
Maltese: Inibituri moderati ta' CYP3A4 huma stmati li jwasslu għal żieda ta' 2-5 darbiet fl-esponiment għal sottostrati ta' CYP3A4.
English: Parkinsonism** Dizziness Dystonia*** Dyskinesia
Maltese: Parkinsoniżmu** Sturdament