FrancophonIA/ELRC3.0 huggingface dataset:
English: The pharmacokinetic parameters for vemurafenib were determined using non-compartmental analysis in a phase I and phase III studies (20 patients after 15 days of dosing at 960 mg twice daily, and 204 patients in steady state day 22) as well as by population PK analysis using pooled data from 458 patients.
Maltese: III (20 pazjent wara 15-il ġurnata ta' dożaġġ b'960 mg darbtejn kuljum, u 204 pazjenti fi stat fiss f'ġurnata 22) kif ukoll permezz ta' analiżi tal-PK tal-popolazzjoni bl-użu ta' data miġbura minn 458 pazjent.
English: Headache, dysgeusia, dizziness
Maltese: Dijarea, rimettar, tqalligħ, stitikezza
English: Vemurafenib exhibits high inter-patient variability.
Maltese: Rakkomandazzjoni ta' modifikazzjoni fiddoża
English: In this section, ADRs are based on results in 468 patients from a phase III randomised open label study in adult patients with BRAF V600 mutation-positive unresectable or stage IV melanoma, as well as a phase II single-arm study in patients with BRAF V600 mutation-positive stage IV melanoma who had previously failed at least one prior systemic therapy (see section 5.1).
Maltese: II bi grupp wieħed f'pazjenti b'melanoma ta' stadju IV pożittiva għall-mutazzjoni BRAF V600 li ma ħadmitx fuqhom mill-inqas terapija sistemika waħda mogħtija qabel (ara sezzjoni 5.1).
English: Focal bone marrow necrosis was noted in one dog in a prematurely terminated 39-week BID dog study at exposures similar to the anticipated clinical exposure (based on AUC comparisons).
Maltese: Nekrosi fokali fil-mudullun kienet innutata f'kelb wieħed fi studju ta' 39 ġimgħa b'għoti BID fuq il-klieb li kien imwaqqaf b'mod prematur b'esponimenti simili għall-esponimenti kliniċi antiċipati (ibbażat fuq paraguni tal-AUC).
English: - Cohort 1 with previously untreated patients (N = 90): Patients who had not received previous treatment for brain metastases; prior systemic therapy for metastatic melanoma was allowed, excluding BRAF inhibitors and MEK inhibitors.
Maltese: Pazjenti li ma kinux irċevew trattament qabel għal metastasi fil-moħħ; kienet permessa terapija sistemika minn qabel għall-melanoma metastatika, minbarra inibituri ta' BRAF u inibituri ta' MEK.
English: Non-clinical and clinical studies with retrospective sequencing analyses have shown that the test also detects the less common BRAF V600D mutations and V600K mutations with lower sensitivity.
Maltese: Studji mhux kliniċi u kliniċi b'analiżi ta' sekwenzjar retrospettiv urew li t-test jiskopri wkoll il-mutazzjonijiet inqas komuni BRAF V600D u V600K b'sensittività aktar baxxa.
English: Of the specimens available from the non-clinical and clinical studies (n=920), that were mutation-positive by the cobas test and additionally analyzed by sequencing, no specimen was identified as being wild type by both Sanger and 454 sequencing.
Maltese: Mill-kampjuni disponibbli mill-istudji mhux kliniċi u kliniċi (n=920), li kienu pożittivi għall-mutazzjoni b'test cobas u barra dan kienu analizzati permezz ta' sekwenzjar, l-ebda kampjun ma kien identifikat bħala tat-tip selvaġġ kemm minn sekwenzjar Sanger kif ukoll minn dak 454.
English: ● A type of skin cancer (cutaneous squamous cell carcinoma)
Maltese: • Tip ta' kanċer (karċinoma taċ-ċellula skwamuża mhux fil-ġilda)
English: 3rd occurrence of QTc>500 ms during treatment and change from pre-treatment value remains <60 ms
Maltese: It-tieni okkorrenza ta' QTc>500 ms waqt it trattament u bidla mill-valur ta' qabel ittrattament tibqa <60 ms
English: Surveillance for non-cuSCC should occur as outlined in section 4.4.
Maltese: Għandha ssir sorveljanza għal SCC mhux fil-ġilda kif deskritt f'sezzjoni 4.4.
English: ● Change in liver tests results (ALT, alkaline phosphatase and bilirubin increase)
Maltese: • Bidla fir-riżultati ta' testijiet tal-fwied (żieda f'ALT, alkaline phosphatase u bilirubin)
English: All patients were required to have advanced melanoma with BRAF V600 mutations according to the cobas 4800 BRAF V600 Mutation Test.
Maltese: Il-pazjenti kollha kienu meħtieġa li jkollhom melanoma avanzata b'mutazzjonijiet BRAF V600 skont it-Test ta' Mutazzjoni cobas 4800 BRAF V600.
English: Tablet core
Maltese: Magnesium stearate
English: alkaline phosphatase increased (c), AST increased (c),bilirubin increased (c) GGT increased (c, weight decreased, electrocardiogram QT prolonged, blood creatinine increased(1)(2) (h)
Maltese: titwil flelettrokardjogramm a ta' QT, żieda tal kreatinina fid demm(1)(2) (h)
English: Vomiting
Maltese: Artrite
English: (z) As of February 01, 2012, a total of 675 patients were evaluable for the post-hoc analysis update of PFS.
Maltese: Sal-1 ta' Frar 2012, total ta' 675 pazjent setgħu jiġu evalwati għall-aġġornament tal-analiżi post-hoc tal-PFS.
English: No data are available in patients with melanoma harbouring rare BRAF V600 mutations other than V600E and V600K.
Maltese: M'hemmx data disponibbli f'pazjenti b'melanoma li għandha mutazzjonijiet BRAF V600 rari minbarra dawk V600E u V600K.
English: No teratogenicity was observed in embryofoetal development studies in rats and rabbits at doses up to respectively 250 mg/kg/day and 450 mg/kg/day leading to exposures below the anticipated clinical exposure (based on AUC comparison).
Maltese: Ma kinetx osservata teratoġeniċità fl-istudji dwar l-iżvilupp tal-embriju/fetu fuq il-firien u l-fniek b'dożi sa 250 mg/kg/jum u 450 mg/kg/jum rispettivament li wasslu għall-esponimenti inqas mill-esponiment kliniku mistenni (ibbażat fuq paragun tal-AUC).
English: Dose adjustments for CYP3A4 substrates with narrow therapeutic window may be considered, if clinically indicated (see sections 4.4 and 4.6).
Maltese: Jistgħu jiġu kkunsidrati aġġustamenti fid-doża għal substrati ta' CYP3A4 b'indiċi terapewtiku dejjaq, jekk dan ikun klinikament indikat (ara sezzjonijiet 4.4 u 4.6).
English: December 30, 2010 data cut-off date (y) Overall Response Rate (95% CI)
Maltese: Data ta' waqfien tad-data, 30 ta' Diċembru 2010
English: For patients treated with stereotactic radiotherapy (SRT) or surgery, a new RECIST-assessable brain lesion must have developed following this prior therapy.
Maltese: Għall-pazjenti ttrattati b'radjuterapija stereotattika (SRT - stereotactic radiotherapy) jew kirurġija, trid tkun żviluppata leżjoni ġdida fil-moħħ li tista' tiġi evalwata permezz ta' RECIST wara din it-terapija preċedenti.
English: Vasculitis
Maltese: sturdament
English: Treatment with vemurafenib should continue until disease progression or the development of unacceptable toxicity (see tables 1 and 2 below).
Maltese: Tul tat-trattament Trattament b'vemurafenib għandu jitkompla sal-progressjoni tal-marda jew sa meta tiżviluppa tossiċità mhux aċċettabbli (ara tabelli 1 u 2 hawn taħt).
English: If you get any side effects, talk to your doctor.
Maltese: jaggrava l-effetti sekondarji ta' trattament ta' radjazzjoni.
English: Table 9 shows the overall response rate and progression-free survival in previously untreated patients with BRAF V600 mutation-positive melanoma.
Maltese: It-Tabella 9 turi r-rata ta' rispons globali u s-sopravivenza mingħajr progressjoni f'pazjenti b'melanoma pożittiva għall-mutazzjoni BRAF V600 li ma kinux ittrattati qabel.
English: Liver enzymes (transaminases and alkaline phosphatase) and bilirubin should be measured before initiation of treatment and monitored monthly during treatment, or as clinically indicated.
Maltese: Enzimi tal-fwied (transaminases u alkaline phosphatase) u bilirubin għandhom jiġu mkejla qabel jinbeda t-trattament u mmonitorjati kull xahar waqt it-trattament, jew kif indikat klinikament.
English: * Includes acute kidney injury, renal impairment, and laboratory changes consistent with acute kidney injury.
Maltese: * Jinkludu ħsara akuta fil-kliewi, indeboliment renali, u bidliet tal-laboratorju konsistenti ma' ħsara akuta fil kliewi.
English: See monitoring measures in section 4.4.
Maltese: Ara l-miżuri ta' sorveljanza f'sezzjoni 4.4.
English: In vitro studies have demonstrated that vemurafenib is a substrate of the efflux transporters P-gp and BCRP.
Maltese: Studji in vitro wrew li vemurafenib huwa substrat tat-trasportaturi tal-effluss P-gp u
English: However, in repeat-dose toxicity studies, no histopathological findings were noted on reproductive organs in males and females in rats and dogs at doses up to 450 mg/kg/day (at exposures below the anticipated clinical exposure based on AUC comparison).
Maltese: Madankollu, fi studji dwar leffett tossiku minn dożi ripetuti, ma kinux osservati sejbiet istopatoloġiċi fl-organi riproduttivi f'firien u klieb maskili u femminili b'dożi sa 450 mg/kg/jum (f'esponimenti inqas mill-esponiment kliniku mistenni bbażat fuq paragun tal-AUC).
English: There are only very limited data available in patients with moderate to severe hepatic impairment.
Maltese: Hemm biss data limitata ħafna disponibbli f'pazjenti b'indeboliment moderat sa sever tal-fwied.
English: Please tell your doctor if you are taking an oral contraceptive.
Maltese: Zelboraf jista' jnaqqas l-effikaċja ta' xi kontraċettivi orali.
English: ● Change in liver tests results (GGT increase)
Maltese: • Tħossok għajjien (għeja)
English: Number of crossover patients (%)
Maltese: mwiet (%)
English: Cases of cuSCC (which include those classified as keratoacanthoma or mixed keratoacanthoma subtype) have been reported in patients treated with vemurafenib (see section 4.8).
Maltese: Kreatinina fis-serum għandha titkejjel qabel jinbeda t-trattament u għandha tiġi ssorveljata matul it-trattament kif indikat klinikament (ara sezzjonijiet 4.2 u 4.8).
English: After cessation of vemurafenib treatment, a washout of 8 days might be necessary to avoid an interaction with a subsequent treatment.
Maltese: Wara waqfien ta' trattament b'vemurafenib, perjodu mingħajr mediċina ta' 8 ijiem jista' jkun neċessarju biex tiġi evitata interazzjoni ma' trattament sussegwenti.
English: The effects of vemurafenib on medicinal products that are substrates of BCRP are unknown.
Maltese: L-effetti ta' vemurafenib fuq prodotti mediċinali li huma substrati ta' BCRP mhumiex magħrufa.
English: Pregnancy and breast-feeding
Maltese: • Infjammazzjoni tal-frixa
English: Following oral dosing, the absorption rate constant for the population of metastatic melanoma patients is estimated to be 0.19 hr-1 (with 101% between patient variability).
Maltese: Wara dożaġġ orali, il-kostanti tar-rata ta' assorbiment għallpopolazzjoni ta' pazjenti b'melanoma metastatika huwa stmat bħala 0.19 sigħat-1 (b'101% varjabilità bejn il-pazjenti).
English: ● Blockage of blood flow to part of the eye (retinal vein occlusion)
Maltese: • Imblokk tal-fluss tad-demm għal parti mill-għajn (okklużjoni tal-vina tar-retina)
English: This change may have led to the development of melanoma.
Maltese: Din ilbidla setgħet wasslet għall-iżvilupp ta' melanoma.
English: Most lesions classified as “other” (43%) were benign skin lesions (e.g. verruca vulgaris, actinic keratosis, benign keratosis, cyst/benign cyst).
Maltese: Ħafna mil leżjonijiet ikklassifikati bħala “oħrajn” (43%) kienu leżjonijiet beninni fil-ġilda (eż. verruca vulgaris,keratosi aktinika, keratosi beninna, ċesti/ċesti beninni). CuSCC ġeneralment seħħet kmieni fil-kors ta' trattament bi żmien medjan għall-ewwel dehra ta' 7 sa 8 ġimgħat.
English: Serious hypersensitivity reactions, including anaphylaxis have been reported in association with vemurafenib.
Maltese: Reazzjonijiet serji ta' sensittività eċċessiva, inkluż anafilassi kienu rrappurtati f'assoċjazzjoni ma' vemurafenib.
English: Based on mechanism of action, vemurafenib may cause progression of cancers associated with RAS mutations (see section 4.8).
Maltese: Ibbażat fuq il-mekkaniżmu ta' azzjoni, vemurafenib jista' jikkawża progressjoni ta' kanċers assoċjati ma' mutazzjonijiet RAS (ara sezzjoni 4.8).
English: ● medicines for nausea and vomiting (e.g. ondansetron, domperidone).
Maltese: • mediċini għal tqalligħ u rimettar (eż. ondansetron, domperidone).
English: February 1,
Maltese: Tabella 10:
English: Folliculitis
Maltese: Follikulite
English: If co-administration cannot be avoided, exercise caution, as vemurafenib may increase plasma exposure of CYP1A2 substrate drugs.
Maltese: Jekk l-għoti fl-istess ħin ma jkunx jista' jiġi evitat, uża kawtela, għax vemurafenib jista' jżid l-esponiment fil-plażma ta' mediċini substrati ta' CYP1A2.
English: pruritus, vomiting, skin papilloma and hyperkeratosis.
Maltese: keratosi seborroeika, papilloma fil-ġilda
English: Effects of vemurafenib on other medicinal products Vemurafenib may increase the plasma exposure of medicinal products predominantly metabolised by CYP1A2 and decrease the plasma exposure of medicines predominantly metabolised by CYP3A4.
Maltese: Effetti ta' vemurafenib fuq prodotti mediċinali oħra Vemurafenib jista' jżid l-esponiment fil-plażma ta' prodotti mediċinali li fil-biċċa l-kbira huma mmetabolizzati minn CYP1A2 u jnaqqas l-esponiment fil-plażma ta' mediċini li fil-biċċa l-kbira huma mmetabolizzati minn CYP3A4.
English: Preclinical data generated in biochemical assays demonstrated that vemurafenib can potently inhibit BRAF kinases with activating codon 600 mutations (table 6).
Maltese: Data ta' qabel l-użu kliniku ġġenerata f'analiżi bijokimiċi wriet li vemurafenib jista' jinibixxi b'mod qawwi lil BRAF kinases b'mutazzjonijiet li jattivaw kodon 600 (tabella 6).
English: Renal elimination does not appear to be of importance for vemurafenib elimiation, whereas biliary excretion of unchanged compound may be an important route of elimination.. Vemurafenib is a substrate and inhibitor of P-gp in vitro.
Maltese: L-eliminazzjoni mill-kliewi ma tidhirx li hija ta' importanza għall-eliminazzjoni ta' vemurafenib, filwaqt li t-tneħħija mill-marrara tas-sustanza mhux mibdula tista' tkun rotta importanti ta' eliminazzjoni.
English: Ophthalmologic reactions
Maltese: Reazzjonijiet allerġiċi
English: Unstratified log-rank test for PFS and Chi-squared test for Overall Response Rate.
Maltese: PFS medjana (xhur) (CI ta' 95%) (x) Test log-rank mhux stratifikat ta' PFS u test Chi-squared għar-Rata ta' Rispons Globali.
English: Hazard Ratio (95% CI)
Maltese: Progressjoni (CI ta' 95%)
English: In the population pharmacokinetic analysis using data from clinical trials in patients with metastatic melanoma, increases in AST and ALT up to three times the upper limit of normal did not influence the apparent clearance of vemurafenib.
Maltese: Fl-analiżi tal-farmakokinetika tal-popolazzjoni bl-użu ta' data minn provi kliniċi f'pazjenti b'melanoma metastaika, żidiet f'AST u ALT sa tliet darbiet illimitu ta' fuq tan-normal ma influwenzawx it-tneħħija evidenti ta' vemurafenib.
English: QTc increase meets values of both >500 ms and >60 ms change from pre-treatment values
Maltese: Żieda f'QTc tilħaq il-valuri ta' bidla ta' >500 ms kif ukoll ta' >60 ms mill-valuri ta' qabel it-trattament
English: Liver enzyme abnormalities reported in the phase III clinical study are expressed below as the proportion of patients who experienced a shift from baseline to a grade 3 or 4 liver enzyme abnormalities:
Maltese: III huma elenkati hawn taħt bħala l-proporzjon ta' pazjenti li kellhom esperjenza ta' bidla mil-linja bażi għal anormalitajiet ta' grad 3 jew 4 fl-enzimi tal-fwied:
English: Dose adjustments for medicinal products predominantly metabolised via CYP1A2 or CYP3A4 should be considered based on their therapeutic windows before concomitantly treating with vemurafenib (see sections 4.5 and 4.6).
Maltese: Aġġustamenti fid-doża għallprodotti mediċinali li fil-biċċa l-kbira huma mmetabolizzati permezz ta' CYP1A2 jew CYP3A4 għandhom jiġu kkunsidrati abbażi tal-firxa terapewtika tagħhom qabel jingħataw flimkien ma' vemurafenib (ara sezzjonijiet 4.5 u 4.6).
English: At steady state, the mean vemurafenib exposure in plasma is stable during the 24-hour interval as indicated by the mean ratio of 1.13 between the plasma concentrations before and 2-4 hours after the morning dose.
Maltese: Fi stat fiss, l-esponiment medju għal vemurafenib fil-plażma huwa stabbli matul l-intervall ta' 24 siegħa kif indikat mill-proporzjon medju ta' 1.13 bejn il-konċentrazzjonijiet fil-plażma qabel u 24 sigħat wara d-doża ta' filgħodu.
English: In the phase III study, ninety-four (28%) of 336 patients with unresectable or metastatic melanoma treated with vemurafenib were ≥ 65 years.
Maltese: III, erbgħa u disgħin (28%) minn 336 pazjent b'melanoma li ma setgħetx titneħħa jew metastatika ttrattati b'vemurafenib kellhom ≥ 65 sena.
English: Table 5: Acute kidney injury cases in the phase III study Vemurafenib (%) Dacarbazine (%)
Maltese: III Vemurafenib (%) Dacarbazine (%)
English: Exposure-dependent QT prolongation was observed in an uncontrolled, open-label phase II study in previously treated patients with metastatic melanoma.
Maltese: Melanoma primarja ġdida kienet irrappurtata fi provi kliniċi.
English: Patients should be carefully monitored for safety and dose modifications applied if clinically indicated (see Table 1 in section 4.2).
Maltese: Il-pazjenti għandhom jiġu mmonitorjati b'attenzjoni għas-sigurtà u jekk klinikament indikat għandhom jiġu applikati modifiki fid-doża (ara t-Tabella 1 fis-sezzjoni 4.2).
English: ● In case of vomiting, continue to take Zelboraf as usual and do not take an additional dose.
Maltese: • Fil-każ ta' rimettar, kompli ħu Zelboraf bħas-soltu u tiħux doża addizzjonali.
English: During treatment, avoid exposing your skin to direct sunlight.
Maltese: Waqt it-trattament, evita li tesponi l-ġilda tiegħek għal xemx diretta.
English: Electrocardiogram (ECG) and electrolytes (including magnesium) must be monitored in all patients before treatment with vemurafenib, after one month of treatment and after dose modification.
Maltese: L-elettrokardjogramm (ECG) u l-elettroliti (inkluż magnesium) iridu jiġu ssorveljati fil-pazjenti kollha qabel trattament b'vemurafenib, wara xahar ta' trattament u wara modifikazzjoni tad-doża.
English: 2nd occurrence of any grade 4 AE or persistence of any grade 4 AE after 1st dose reduction
Maltese: It-tieni okkorrenza ta' kwalunkwe AE ta' grad 4 jew persistenza ta' kwalunkwe AE ta' grad 4 wara tnaqqis fid-doża għall-ewwel darba
English: Progression of pre-existing chronic myelomonocytic leukaemia with NRAS mutation.
Maltese: Progressjoni ta' lewkimja mijelomonoċitika kronika eżistenti minn qabel b'mutazzjoni NRAS.
English: The recommended dose of vemurafenib is 960 mg (4 tablets of 240 mg) twice daily (equivalent to a total daily dose of 1,920 mg).
Maltese: (ekwivalenti għal doża totali ta' kuljum ta' 1,920 mg).
English: ● Types of kidney injury characterized by inflammation (acute interstitial nephritis) or damage to the tubules of the kidney (acute tubular necrosis).
Maltese: • Tipi ta' ħsara fil-kliewi kkaratterizzata minn infjammazzjoni (nefrite akuta tal-interstizju) jew ħsara fit-tubi ż-żgħar tal-kliewi (nekrosi akuta tat-tubi ż-żgħar).
English: Occasional intake of vemurafenib on an empty stomach is expected to have limited influence on steady state exposure due to the high accumulation of vemurafenib at steady state.
Maltese: Konsum okkażjonali ta' vemurafenib fuq stonku vojt huwa mistenni li jkollu influwenza limitata fuq l-esponiment fi stat fiss minħabba l-akkumulazzjoni għolja ta' vemurafenib fi stat fiss.
English: February 01, 2012 data cut-off date (z) Progression-free survival Hazard Ratio (95% CI)
Maltese: Data ta' waqfien tad-data, 1 ta' Frar 2012 (ż)
English: In the human mass balance study with vemurafenib administered orally, on average 95% of the dose was recovered within 18 days.
Maltese: Fl-istudju tal-bilanċ tal-massa tal-bniedem b'vemurafenib mogħti b'mod orali, bħala medja 95% taddoża kienet irkuprata fi żmien 18-il jum.
English: LDH normal
Maltese: X'fih Zelboraf
English: Estimate (SE; 95% CI)
Maltese: Stima (SE; 95% CI)
English: Overall mortality
Maltese: Mortalità globali
English: Wye Valley Business Park Brecon Road
Maltese: Wye Valley Business Park
English: -5.7 (1.39; -8.4 to -3.0)
Maltese: -5.7 (1.39; -8.4 sa -3.0)
English: Primary Endpoint:
Maltese: Punt Finali Primarju:
English: Date of latest renewal: 14 November 2018
Maltese: Data tal-aħħar tiġdid: 14 ta 'Novembru 2018
English: Stamullen, Co. Meath, K32 YD60,
Maltese: Meath, K32 YD60,
English: Block-7, City North Business Campus,
Maltese: Block-7, City North Business Campus, Stamullen, Co.
English: • gas (flatulence)
Maltese: • gass (flatulenza)
English: • The active substance is lurasidone.
Maltese: • Is-sustanza attiva hi lurasidone.
English: Анджелини Фарма България ЕООД бул.
Maltese: Bulgaria/ България Анджелини Фарма България ЕООД бул.
English: Hay-on-Wye
Maltese: Hay-on-Wye Hereford
English: Active Control (a)
Maltese: Kontroll Attiv (a)
English: Bipolar Depression
Maltese: Depressjoni Bipolari
English: Prins Bernhardplein 200 1097 JB Amsterdam, Netherlands med.infoeu@sunovion.com
Maltese: 1097 JB Amsterdam, Netherlands med.infoeu@sunovion.com
English: • amprenavir, efavirenz, etravirine (to treat HIV infection)
Maltese: • amprenavir, efavirenz, etravirine (għall-kura tal-infezzjoni HIV)
English: Neuroleptic malignant syndrome (NMS)
Maltese: - neuroleptic malignant syndrome)
English: Angelini Pharma Polska Sp. z o.o.
Maltese: Angelini Pharma Polska Sp. z o.o. ul.
English: Subjects with ESRD (CrCl<15 ml/min) have not been investigated.
Maltese: Individwi b'ESRD (CrCl<15 ml/min) ma ġewx investigati.
English: Placebo Lurasidone dose 18.5-74 mg (a) (b)
Maltese: Statistika tal-Istudju Plaċebo Doża ta' Lurasidone 18.5-74 mg (a) (b)
English: ATC code: N05AE05
Maltese: N05AE05
English: Extrapyramidal symptoms (EPS)
Maltese: Sintomi ekstrapiramidali (EPS - Extrapyramidal symptoms)
English: AndersonBrecon (UK) Ltd. Units 2-7
Maltese: AndersonBrecon (UK) Ltd.
English: The pharmacokinetics of lurasidone in paediatric patients was investigated in 49 children aged 6-12 years and 56 adolescents aged 13-17 years.
Maltese: Il-farmakokinetika ta' lurasidone f'pazjenti pedjatriċi kienet investigata f'49 tfal ta' bejn 6-12 snin u 56 adolexxenti ta' età bejn 13-17-il sena.
English: Hyperhidrosis Angioedema Stevens-Johnson syndrome
Maltese: Għaraq eċċessiv Anġjoedima Sindrome ta' Stevens-Johnson
English: Key Secondary Endpoint: CGI-BP-S Depression Score
Maltese: Punt Finali Sekondarju Ewlieni: Punteġġ tad-Depressjoni CGI-BP-S
English: Ancona (AN), Italy Millmount Healthcare Ltd.
Maltese: Millmount Healthcare Ltd.
English: Carnauba wax (E 903)
Maltese: Carnauba wax (E 903) 6.2 Inkompatibbiltajiet
English: 37 mg 74 mg 111 mg 148 mg
Maltese: 111 mg 148 mg
English: Angelini S.p.A
Maltese: Italy/ Italia Angelini S.p.A
English: Iron oxide, Yellow (E 172) Indigotine (E 132)
Maltese: Iron oxide, Isfar (E 172) Indigotine (E 132) Carnauba wax (E 903)
English: The probability of all-cause discontinuation at Week 28 were 58.2% for lurasidone and 69.9% for placebo (p=0.072).
Maltese: Il-probabbiltà ta' waqfien mill-kawżi kollha f'Ġimgħa 28 kienu 58.2% għall lurasidone u 69.9% għall-plaċebo (p = 0.072).
English: 7 days.
Maltese: 5 snin.
English: Date of first authorisation: 21 March 2014
Maltese: DATA TAL-EWWEL AWTORIZZAZZJONI/TIĠDID TAL-AWTORIZZAZZJONI Data tal-ewwel awtorizzazzjoni: 21 Marzu 2014
English: Orthostatic hypotension/syncope
Maltese: Pressjoni ortostatika baxxa/sinkope
English: Lurasidone binds strongly to dopaminergic D2- and to serotonergic 5-HT2A and 5-HT7- receptors with high binding affinity of 0.994, 0.47 and 0.495 nM, respectively.
Maltese: Lurasidone jintrabat b'mod qawwi mar-riċetturi dopaminerġiċi D2 u serotonerġiċi 5-HT2A u 5-HT7 b'affinità ta' rbit għolja ta' 0.994, 0.47 u 0.495 nM, rispettivament.
English: CDRS-R Total Score
Maltese: Punteġġ Totali CDRS-R
English: Following administration of 37 mg of lurasidone, the mean approximate apparent volume of distribution was 6000 L. Lurasidone is highly bound (~99%) to serum proteins.
Maltese: Wara għoti ta' 37 mg ta' lurasidone, il-volum ta' distribuzzjoni apparenti approssimattiv medju kien ta' 6000 L. Lurasidone huwa marbut ħafna (~99%) mal-proteini tas-serum.
English: Treatment Difference vs. placebo Estimate (SE)
Maltese: Differenza fil-Kura kontra plaċebo Stima (SE)
English: (b) Lurasidone doses of 18.5, 37, 55.5, 74 mg are equivalent to 20, 40, 60 and 80 amounts of lurasidone hydrochloride.
Maltese: (b) Dożi ta' Lurasidone ta' 18.5, 37, 55.5, 74 mg huma ekwivalenti għal 20, 40, 60 u 80 ammonti ta'