FrancophonIA/ELRC3.0 huggingface dataset:
English: The effect of renal impairment on the pharmacokinetics of ribociclib was also assessed in a renal impairment study that included 7 healthy subjects with normal renal function (absolute GFR [aGFR] ≥90 ml/min), 7 non-cancer subjects with severe renal impairment (aGFR 15 to <30 ml/min) and 3 noncancer subjects with end-stage renal disease (ESRD) (aGFR <15 ml/min) at a single ribociclib dose of 400 mg.
Maltese: L-effett tal-indeboliment tal-kliewi fuq il-farmakokinetiċi ta' ribociclib kien ukoll evalwat waqt studju dwar l-indeboliment tal-kliewi li kien jinkludi 7 suġġetti b'saħħithom b'funzjoni normali tal-kliewi (GFR assolut [aGFR] ta' ≥90 ml/min), 7 suġġetti mingħajr kanċer b'indeboliment sever tal-kliewi (aGFR ta' 15 sa <30 ml/min) u 3 suġġetti mingħajr kanċer b'mard tal-kliewi fl-aħħar stadju (ESRD) (aGFR ta' <15 ml/min) meta mogħtija doża waħda ta' ribociclib ta' 400 mg.
English: • Abdominal pain, nausea, vomiting and diarrhoea (signs of gastroenteritis, which is an infection of the gastrointestinal tract)
Maltese: • Uġigħ fl-addome, dardir, rimettar u dijarea (sinjali ta' gastroenterite, li hija infezzjoni tal passaġġ gastrointestinali)
English: Treatment of pre- and perimenopausal women with the approved Kisqali combinations should also include an LHRH agonist in accordance with local clinical practice.
Maltese: It-trattament tan-nisa qabel u waqt il-menopawsa bil-kombinazzjonijiet approvati ta' Kisqali għandu jinkludi wkoll agonista LHRH skont il-prattika klinika lokali.
English: Ribociclib is a moderate to strong CYP3A4 inhibitor and may interact with medicinal substrates that are metabolised via CYP3A4, which can lead to increased serum concentrations of the concomitantly used medicinal product.
Maltese: Ribociclib huwa inibitur moderat sa qawwi ta' CYP3A4 u jista' jinteraġixxi ma' sottostrati mediċinali li huma metabolizzati permezz ta' CYP3A4, u dan jista' jwassal għal żieda fil-konċentrazzjonijiet fisserum tal-prodott mediċinali użat fl-istess waqt.
English: The efficacy results demonstrated a statistically significant improvement in PFS in patients receiving Kisqali plus letrozole compared to patients receiving placebo plus letrozole in the full analysis set (hazard ratio of 0.556, 95% CI: 0.429, 0.720, one sided stratified log-rank test p-value 0.00000329) with clinically meaningful treatment effect.
Maltese: Ir-riżultati tal-effikaċja wrew titjib statistikament sinifikanti fil-PFS f'pazjenti li kienu qed jirċievu Kisqali flimkien ma' letrozole meta mqabbla ma' pazjenti li kienu qed jirċievu plaċebo flimkien ma' letrozole fis-sett ta' analiżi sħiħa (proporzjon ta' periklu ta' 0.556, CI ta' 95%: 0.429, 0.720, valur p ta' test log-rank stratifikat ta' naħa waħda 0.00000329) b'effett tat-trattament klinikament sinifikanti.
English: The overall safety evaluation of Kisqali is based on the pooled dataset from 1,065 patients who received Kisqali in combination with endocrine therapy (N=582 in combination with an aromatase inhibitor and N=483 in combination with fulvestrant) and who were included in the randomised, double-blind, placebo-controlled phase III clinical studies (MONALEESA-2, MONALEESA-7 NSAI subgroup and MONALEESA-3) in HR-positive, HER2-negative advanced or metastatic breast cancer.
Maltese: L-evalwazzjoni globali tas-sigurtà ta' Kisqali hija bbażata fuq ġabra tas-sett tad-data minn 1,065 pazjent li rċevew Kisqali flimkien ma' terapija endokrinali (N=582 f'kombinazzjoni ma' inibitur ta' aromatase u N=483 flimkien ma' fulvestrant) u li ġew inklużi fi studji kliniċi randomizzati, double-blind, ikkontrollati bi plaċebo, ta' fażi
English: These findings included reduced/small lung lobes and additional vessel on the aortic arch and diaphragmatic hernia, absent accessory lobe or (partly) fused lung lobes and reduced/small accessory lung lobe (30 and 60 mg/kg), extra/rudimentary thirteenth ribs and misshapen hyoid bone and reduced number of phalanges in the pollex.
Maltese: Dawn is-sejbiet kienu jinkludu lobi tal-pulmun ta' daqs iżgħar/żgħar u kanali tad-demm addizzjonali fuq l-ark tal-aorta u ftuq fid-dijaframma, lobu aċċessorju nieqes jew lobi tal-pulmun (parzjalment) imwaħħla u lobu aċċessorju tal-pulmun ta' daqs iżgħar/żgħir (30 u 60 mg/kg), kustilji numru tlettax żejda/rudimentali u għadma tal-hyoid iffurmata ħażin u numru inqas ta' falanġi fil-pollex.
English: The median PFS2 was 32.3 months (95% CI: 27.6, 38.3) in the placebo arm and was not reached (95% CI: 39.4, NE) for the ribociclib arm.
Maltese: IlPFS2 medjan kien ta' 32.3 xhur (95% CI: 27.6, 38.3) fil-grupp mogħti l-plaċebo u ma ntlaħqx (95% CI: 39.4, NE) fil-grupp mogħti ribociclib.
English: Ribociclib is a strong CYP3A4 inhibitor at the 600 mg dose and a moderate CYP3A4 inhibitor at the 400 mg dose.
Maltese: Ribociclib hu inibitur qawwi ta' CYP3A4 f'doża ta' 600 mg u inibitur moderat ta' CYP3A4 f'doża ta' 400 mg.
English: A total of 726 female patients were randomised in a 2:1 ratio to receive either Kisqali 600 mg and fulvestrant (n=484) or placebo and fulvestrant (n=242), stratified according to the presence of liver and/or lung metastases (Yes [n= 351 (48.3%)] versus No [n=375 (51.7%)]) and according to prior endocrine therapy (A [n=354 (48.8%)] versus B [n=372 (51.2%)]).
Maltese: Total ta' 726 pazjent nisa kienu randomizzati fi proporzjon ta' 2:1 biex jirċievu jew Kisqali 600 mg u fulvestrant (n=484) jew plaċebo u fulvestrant (n=242), stratifikati skont il-preżenza ta' metastasi talfwied u/jew il-pulmun (Iva [n= 351 (48.3%)] meta mqabbel ma' Le [n=375 (51.7%)]) u skont terapija endokrinali minn qabel (A [n=354 (48.8%)] meta mqabbel ma' B [n=372 (51.2%)]).
English: The analysis of ECG data showed 52 patients (4.9%) and 11 patients (1.4%) with at least one >480 msec post-baseline QTcF for the Kisqali plus aromatase inhibitor or fulvestrant arms and the placebo plus aromatase inhibitor or fulvestrant arms, respectively.
Maltese: L-analiżi tad-data tal-ECG uriet 52 pazjent (4.9%) u 11-il pazjent (1.4%) b'mill-inqas QTcF wieħed wara l-linja bażi ta' >480 msec għall-gruppi ta' Kisqali flimkien mal-inibitur ta' aromatase jew fulvestrant u l-gruppi tal-plaċebo flimkien mal-inibitur ta' aromatase jew fulvestrant rispettivament.
English: This was evident for patients with liver and/or lung metastases (HR of 0.561 [95% CI: 0.424, 0.743], median progression-free survival [mPFS] 24.8 months for Kisqali plus letrozole versus 13.4 months for letrozole alone), or without liver and/or lung metastases (HR of 0.597 [95% CI: 0.426, 0.837], mPFS 27.6 months versus 18.2 months).
Maltese: Dan kien evidenti għall-pazjenti b'metastażi fil-fwied u/jew filpulmun (HR ta' 0.561 [CI ta' 95%: 0.424, 0.743], sopravivenza mingħajr progressjoni medjana [mPFS - median progression-free survival] ta' 24.8 xhur għal Kisqali flimkien ma' letrozole kontra 13.4 xhur għal letrozole waħdu), jew mingħajr metastażi fil-fwied u/jew fil-pulmun (HR ta' 0.597 [CI ta' 95%: 0.426, 0.837], mPFS ta' 27.6 xhur kontra 18.2 xhur).
English: Hepatotoxicity: hepatocellular injury, drug-induced liver injury (<1%), hepatotoxicity, hepatic failure, autoimmune hepatitis (single case).
Maltese: Tossiċità fil-fwied: ħsara epatoċellulari, ħsara fil-fwied ikkawżata mill-mediċina (<1%), tossiċità fil-fwied, insuffiċjenza tal-fwied, epatite awtoimmuni (każ wieħed).
English: Kaplan-Meier median Ribociclib: 20.5 months Placebo: 12.8 months
Maltese: Il-medjana skont Kaplan-Meier Ribociclib: 20.5 xhur Plaċebo: 12.8 xhur
English: Hypersensitivity to the active substance or to peanut, soya or any of the excipients listed in section 6.1.
Maltese: Sensittività eċċessiva għas-sustanza attiva jew għall-karawett, soja jew kwalunkwe sustanza mhux attiva elenkata fis-sezzjoni 6.1.
English: In study E2301 40.2% of patients had de novo metastatic disease, 23.7% had bone-only disease, and 56.7% had visceral disease.
Maltese: Fl-istudju E2301 40.2% tal-pazjenti kellhom mard metastatiku de novo, 23.7% kellhom marda tal-għadam biss, u 56.7% kellhom mard vixxerali.
English: It is used in combination with an aromatase inhibitor or fulvestrant, which are used as hormonal anticancer therapies.
Maltese: Jintuża flimkien ma' inibitur ta' aromatase jew fulvestrant, li jintużaw f'terapiji ormonali kontra l-kanċer.
English: Kisqali plus NSAI plus goserelin (%, 95% CI)
Maltese: Kisqali flimkien ma' NSAI flimkien ma' goserelin (%, 95% CI)
English: Nervous system disorders Headache, dizziness
Maltese: Disturbi fis-sistema nervuża Uġigħ ta' ras, sturdament
English: Table 10 MONALEESA-7 - Efficacy results (ORR, CBR) based on investigator assessment in patients who received NSAI
Maltese: Tabella 10 MONALEESA-7 - Riżultati tal-effikaċja (ORR, CBR) ibbażati fuq valutazzjoni tal investigatur f'pazjenti li rċevew NSAI
English: Target organs associated with the pharmacological action of ribociclib in repeat-dose studies include bone marrow (hypocellularity), lymphoid system (lymphoid depletion), intestinal mucosa (atrophy), skin (atrophy), bone (decreased bone formation), kidney (concurrent degeneration and regeneration of tubular epithelial cells) and testes (atrophy).
Maltese: Organi filmira marbuta mal-azzjoni farmakoloġika ta' ribociclib fi studji dwar dożi ripetuti jinkludu l-mudullun (ipoċellularità), is-sistema limfatika (tnaqqis limfojde), il-mukuża intestinali (atrofija), il-ġilda (atrofija), l-għadam (tnaqqis fil-formazzjoni tal-għadam), il-kliewi (deġenerazzjoni u riġenerazzjoni flistess waqt ta' ċelluli tal-epitelju tat-tubi ż-żgħar) u t-testikoli (atrofija).
English: Prior to study entry 42.7% of patients had received chemotherapy in the adjuvant and 13.1% in the neoadjuvant setting, while 58.5% had received endocrine therapy in the adjuvant and 1.4% in the neoadjuvant setting and 21% had received prior endocrine therapy in the advanced breast cancer setting.
Maltese: Qabel irreġistrazzjoni għall-istudju, 42.7% tal-pazjenti kienu rċevew kimoterapija fl-ambjent awżiljarju u 13.1% fl-ambjent neoawżiljarju, filwaqt li 58.5% irċevew terapija endokrinali fl-ambjent awżiljarju u 1.4% fl-ambjent neoawżiljarju u 21% kienu rċevew terapija endokrinali minn qabel fl-ambjent talkanċer tas-sider avvanzat.
English: Co-administration of midazolam (CYP3A4 substrate) with multiple doses of Kisqali (400 mg) increased the midazolam exposure by 280% (3.80-fold) in healthy subjects, compared with administration of midazolam alone.
Maltese: L-għoti ta' midazolam (sottostrat ta' CYP3A4) flimkien ma' dożi multipli ta' Kisqali (400 mg) żied lesponiment għal midazolam b'280% (3.80 darba) f'individwi f'saħħithom, meta mqabbel mal-għoti ta' midazolam waħdu.
English: • Abdominal (belly) pain
Maltese: • Uġigħ addominali (fiż-żaqq)
English: After initiating treatment, ECG should be repeated at approximately day 14 of the first cycle and at the beginning of the second cycle, then as clinically indicated.
Maltese: Wara li jinbeda t-trattament, ECG għandu jiġi ripetut f'madwar jum 14 tal-ewwel ċiklu u fil-bidu tat-tieni ċiklu, imbagħad kif indikat klinikament.
English: Grade 3* febrile neutropenia**
Maltese: Newtropenija bid-deni** ta' Grade 3*
English: In study E2301 (MONALEESA-7), the observed mean QTcF increase from baseline was approximately 10 msec higher in the tamoxifen plus placebo subgroup compared with the NSAI plus placebo subgroup, suggesting that tamoxifen alone had a QTcF prolongation effect which can contribute to the QTcF values observed in the Kisqali plus tamoxifen group.
Maltese: Fl-istudju E2301 (MONALEESA-7), iż-żieda fil-medja osservata ta' QTcF mil-linja bażi kienet bejn wieħed u ieħor 10 msec aktar fis-sottogrupp ta' tamoxifen flimkien ma' plaċebo meta mqabbel massottogrupp NSAI flimkien ma' plaċebo, li jissuġġerixxi li tamoxifen waħdu kellu effett ta' titwil QTcF li jista' jikkontribwixxi għall-valuri QTcF osservati fil-grupp ta' Kisqali flimkien ma' tamoxifen.
English: In the overall study population, the efficacy results demonstrated a statistically significant improvement in PFS in patients receiving Kisqali plus NSAI/tamoxifen plus goserelin compared to patients receiving placebo plus NSAI/tamoxifen plus goserelin (hazard ratio of 0.553, 95% CI: 0.441, 0.694, one-sided stratified log-rank test p-value 9.83x10
Maltese: Fil-popolazzjoni ġenerali tal-istudju, ir-riżultati tal-effikaċja wrew titjib statistikament sinifikanti filPFS f'pazjenti li kienu qed jirċievu Kisqali flimkien ma' NSAI/tamoxifen flimkien ma' goserelin meta mqabbla ma' pazjenti li kienu qed jirċievu plaċebo flimkien ma' NSAI/tamoxifen flimkien ma' goserelin (proporzjon ta' periklu ta' 0.553, 95% CI: 0.441, 0.694, valur-p tat-test ta' log-rank stratifikat ta' naħa waħda 9.83x10
English: Censoring times Ribociclib (N=248) Placebo (N=247)
Maltese: Żminijiet ta' ċensura Ribociclib (N=248) Plaċebo (N=247)
English: Kisqali plus fulvestrant (%, 95% CI)
Maltese: Kisqali flimkien ma' fulvestrant (%, CI ta' 95%)
English: Censoring times Ribociclib (N=334) Placebo (N=334)
Maltese: Żminijiet ta' ċensura Ribociclib (N=334) Plaċebo (N=334)
English: Discontinuation of treatment with Kisqali plus any combination due to abnormal liver function tests or hepatotoxicity occurred in 2.3% and 0.4% of patients respectively (see sections 4.2 and 4.4).
Maltese: Twaqqif tattrattament b'Kisqali flimkien ma' kwalunkwe kombinazzjoni minħabba testijiet tal-funzjoni tal-fwied mhux normali jew tossiċità fil-fwied u fil-marrara seħħ fi 2.3% u 0.4% tal-pazjenti rispettivament (ara sezzjonijiet 4.2 u 4.4).
English: If QTcF interval prolongation to greater than 500 msec or greater than 60 msec change from baseline occurs in combination with torsade de pointes or polymorphic ventricular tachycardia or signs/symptoms of serious arrhythmia, permanently discontinue Kisqali.
Maltese: Jekk iseħħ titwil tal-intervall QTcF ta' aktar minn 500 msec jew bidla ta' aktar minn 60 msec mil-linja bażi flimkien ma' torsade de pointes jew takikardija ventrikulari polimorfika jew sinjali/sintomi ta' arritmija serja, waqqaf Kisqali b'mod permanenti.
English: Similar results were observed for the NSAI subgroup, with an HR of 0.660 (95% CI: 0.503, 0.868) and a median PFS2 of 32.3 months (95% CI: 26.9, 38.3) in the placebo arm versus not reached (95% CI: 39.4, NE) in the ribociclib arm.
Maltese: Riżultati simili kienu osservati fis-sottogrupp NSAI, b'HR ta' 0.660 (95% CI: 0.503, 0.868) u b'PFS2 medjan ta' 32.3 xhur (95% CI: 26.
English: Co-administration of caffeine (CYP1A2 substrate) with multiple doses of Kisqali (400 mg) increased the caffeine exposure by 20% (1.20-fold) in healthy subjects, compared with administration of caffeine alone.
Maltese: L-għoti ta' kaffeina (sottostrat ta' CYP1A2) flimkien ma' dożi multipli ta' Kisqali (400 mg) żied lesponiment għall-kaffeina b'20% (1.20 darba) f'individwi f'saħħithom, meta mqabbel ma' għoti ta' kaffeina waħedha.
English: Neutropenia was the most frequently reported adverse drug reaction (73.7%) and a grade 3 or 4 decrease in neutrophil counts (based on laboratory findings) was reported in 58.6% of patients receiving Kisqali plus any combination in the phase III studies.
Maltese: Newtropenija kienet l-aktar reazzjoni avversa tal-mediċina rrappurtata b'mod frekwenti (73.7%) u tnaqqis fl-għadd ta' newtrofili ta' grad 3 jew 4 (ibbażat fuq sejbiet tal-laboratorju) kien irrappurtat f'58.6% tal-pazjenti li kienu qed jirċievu Kisqali flimkien ma' kwalunkwe kombinazzjoni fl-istudji ta' fażi
English: Co-administration of the strong CYP3A4 inducer rifampicin (600 mg daily for 14 days) with a single 600 mg dose of ribociclib decreased the ribociclib AUCinf and Cmax by 89% and 81%, respectively, relative to a single 600 mg ribociclib dose given alone in healthy subjects.
Maltese: L-għoti tal-induttur qawwi ta' CYP3A4 rifampicin (600 mg kuljum għal 14-il ġurnata) flimkien ma' doża waħda ta' 600 mg ta' ribociclib naqqas l-AUCinf u Cmax ta' ribociclib b'89% u 81%, rispettivament, meta mqabbel ma' doża waħda ta' 600 mg ribociclib mogħtija waħedha f'individwi f'saħħithom.
English: • with uncontrolled or significant cardiac disease, including recent myocardial infarction,
Maltese: • b'mard tal-qalb mhux ikkontrollat jew sinifikanti, inkluż infart mijokardijaku reċenti,
English: Within this subgroup, the hazard ratio for the second line patients who had received prior endocrine therapy in the advanced breast cancer setting was 0.539 (95% CI: 0.333, 0.873), with a median PFS of 18.8 months (95% CI: 12.5, NE) and 11.4 months (95% CI: 3.7, 16.3) in the Kisqali and placebo arms, respectively.
Maltese: F'dan is-sottogrupp, il-proporzjon ta' periklu għall-pazjenti tat-tieni linja li kienu rċevew terapija endokrinali minn qabel fl-ambjent tal-kanċer tas-sider avvanzat kien ta'0.539 (95% CI: 0.333, 0.873), b'PFS medjana ta' 18.8 xhur (95% CI: 12.5, NE) u 11.4 xhur (95% CI: 3.7, 16.3) fil-gruppi ta' Kisqali u plaċebo, rispettivament.
English: Kisqali packs containing 63 tablets are intended for use by patients taking the full ribociclib daily dose of 600 mg (3 tablets once daily).
Maltese: Il-pakketti ta' Kisqali fihom 63 pillola maħsuba sabiex jintużaw minn pazjenti li qed jieħdu d-doża sħiħa ta' ribociclib kuljum ta' 600 mg (3 pilloli darba kuljum).
English: Distribution of PFS is summarised in the Kaplan-Meier curve for PFS in Figure 2.
Maltese: Id-distribuzzjoni tal-PFS hija miġbura fil-qosor fil-kurva Kaplan-Meier għall-PFS fil-Figura 2.
English: Table 7 MONALEESA-2 - Efficacy results (PFS) based on investigator radiological assessment (02 January 2017 cut-off)
Maltese: Tabella 7 MONALEESA-2 - Riżultati tal-effikaċja (PFS)ibbażati fuq valutazzjoni radjuloġika tal-investigatur (data meta waqfet tinġabar id-data 02 ta' Jannar 2017)
English: Binding of ribociclib to human plasma proteins in vitro was approximately 70% and was independent of concentration (10 to 10000 ng/ml).
Maltese: L-irbit ta' ribociclib mal-proteini tal-plażma tal-bniedem in vitro kien ta' madwar 70% u kien indipendenti mill-konċentrazzjoni (10 sa 10,000 ng/ml).
English: Median PFS was 23.8 months (95% CI: 19.2, NE) for Kisqali plus NSAI/tamoxifen plus goserelin treated patients and 13.0 months (95% CI: 11.0, 16.4) for patients receiving placebo plus NSAI/tamoxifen plus goserelin.
Maltese: Il-PFS medjana kienet ta' 23.8 xhur (95% CI: 19.2, NE) għal pazjenti ttrattati b'Kisqali flimkien ma' NSAI/tamoxifen flimkien ma' goserelin u 13.0 xhur (95% CI: 11.0, 16.4) għal pazjenti li kienu qed jirċievu plaċebo flimkien ma' NSAI/tamoxifen flimkien ma' goserelin.
English: <90 ml/min/1.73 m2) and 35 patients with moderate renal impairment (eGFR 30 to <60 ml/min/1.73 m2), mild and moderate renal impairment had no effect on the exposure of ribociclib (see section 4.2).
Maltese: <60 ml/min/1.73 m2), indeboliment ħafif u moderat tal-kliewi ma kellu l-ebda effett fuq l-esponiment għal ribociclib (ara sezzjoni 4.2).
English: Based on the observed QT prolongation during treatment, treatment with Kisqali may have to be interrupted, reduced or discontinued as described in Table 4 (see sections 4.2, 4.8 and 5.2).
Maltese: Abbażi ta' titwil ta' QT osservat waqt it-trattament, it-trattament b'Kisqali jista' jkollu jiġi nterrott, imnaqqas jew imwaqqaf kif deskritt fit-Tabella 4 (ara sezzjonijiet 4.2, 4.8 u 5.2).
English: Caution and monitoring for toxicity are advised during concomitant treatment with sensitive substrates of these transporters which exhibit a narrow therapeutic index, including but not limited to digoxin, pitavastatin, pravastatin, rosuvastatin and metformin.
Maltese: Hu avżat li jkun hemm kawtela u monitoraġġ dwar tossiċità matul it-trattament flimkien ma' sottostrati sensittivi ta' dawn ittrasportaturi li jesebixxu indiċi terapewtiku dejjaq, inkluż imma mhux limitat biss għal digoxin, pitavastatin, pravastatin, rosuvastatin u metformin.
English: Censoring times Ribociclib (N=335) Placebo (N=337)
Maltese: Ribociclib (N=335) Plaċebo (N=337)
English: * Grading according to CTCAE Version 4.03 (CTCAE = Common Terminology Criteria for Adverse Events) ** Baseline = prior to treatment initiation
Maltese: [Common Terminology Criteria for Adverse Events]) ** Linja bażi = qabel il-bidu tat-trattament
English: The estimated QTcF mean change from baseline for 600 mg Kisqali in combination with NSAI or fulvestrant was 22.0 msec (90% CI: 20.56, 23.44) and 23.7 msec (90% CI: 22.31, 25.08), respectively at the geometric mean Cmax at steady-state compared to 34.7 msec (90% CI: 31.64, 37.78) in combination with tamoxifen (see section 4.4).
Maltese: Il-bidla medja mil-linja bażi fi QTcF stmata għal 600 mg Kisqali flimkien ma' NSAI jew fulvestrant kienet ta' 22.0 msec (90% CI: 20.56, 23.44) u 23.7 msec (90% CI: 22.31, 25.
English: The results for PFS based on the blinded independent central radiological assessment of a randomly selected subset of approximately 40% of randomised patients were supportive of the primary efficacy results based on the investigator's assessment (hazard ratio of 0.492; 95% CI: 0.345, 0.703).
Maltese: Ir-riżultati għall-PFS ibbażati fuq valutazzjoni radjoloġika ċentrali indipendenti u blinded ta' sottosett magħżul b'mod randomizzat ta' madwar 40% ta' pazjenti randomizzati kienu ta' appoġġ għar-riżultati tal-effikaċja primarja bbażati fuq il-valutazzjoni tal-investigatur (proporzjon ta' periklu ta' 0.492; 95% CI: 0.345, 0.703).
English: You should not take Kisqali on days 22 to 28 of the cycle.
Maltese: M'għandekx tieħu Kisqali fil-ġranet 22 u 28 taċ-ċiklu.
English: • Medicines used to treat pulmonary arterial hypertension and erectile dysfunction such as sildenafil.
Maltese: • Mediċini użati biex jittrattaw pressjoni għolja fl-arterji tal-pulmun u disfunzjoni erettili bħal sildenafil.
English: 189 (3 x 63) film-coated tablets (in PCTFE/PVC blisters)
Maltese: 189 (3 x 63) pillola miksija b'rita (f'folji PCTFE/PVC)
English: • St. John's Wort (also known as Hypericum perforatum) - a herbal product used to treat depression and other conditions.
Maltese: John's Wort (magħruf ukoll bħala Hypericum perforatum)- prodott mill-ħxejjex użat biex jittratta d-depressjoni u kondizzjonijiet oħra.
English: Microcrystalline cellulose Crospovidone type A Low-substituted hydroxypropylcellulose Magnesium stearate
Maltese: Microcrystalline cellulose Crospovidone tip A
English: The geometric mean plasma effective half-life (based on accumulation ratio) was 32.0 hours (63% CV) and the geometric mean apparent oral clearance (CL/F) was 25.5 l/hr (66% CV) at steady state at 600 mg in patients with advanced cancer.
Maltese: Il-half-life ġeometrika medja effettiva fil-plażma (ibbażata fuq proporzjon ta' akkumulazzjoni) kienet ta' 32.0 siegħa (63% CV) u t-tneħħija (CL/F - clearance) orali ġeometrika medja apparenti kienet ta' 25.5 l/siegħa (66% CV) fi stat fiss b'600 mg f'pazjenti b'kanċer avanzat.
English: Ribociclib: 131, Placebo: 187 Hazard Ratio = 0.553
Maltese: Nru ta' episodji Ribociclib: 131, Plaċebo: 187 Proporzjon ta' periklu = 0.553 95% CI [0.441, 0.694]
English: 189 (3 x 63) film-coated tablets (in PA/alu/PVC blisters)
Maltese: 189 (3 x 63) pillola miksija b'rita (f'folji PA/alu/PVC)
English: Repeated-dose toxicity studies (treatment schedule of 3 weeks on/1 week off) of up to 27 weeks' duration in rats and up to 39 weeks' duration in dogs, revealed the hepatobiliary system (proliferative changes, cholestasis, sand-like gallbladder calculi, and inspissated bile) as the primary target organ of toxicity of ribociclib.
Maltese: Studji dwar l-effett tossiku minn dożi ripetuti (skeda ta' trattament ta' 3 ġimgħat fuq ittrattament/ġimgħa bla trattament) li damu sa 27 ġimgħa fil-firien u sa 39 ġimgħa fil-klieb, urew issistema tal-fwied u tal-marrara (bidliet proliferattivi, kolestasi, ġebel qishom ramel fil-marrara, u fluwidu biljari aktar magħqud) bħala l-organu primarju fil-mira ta' tossiċità ta' ribociclib.
English: • Medicines used to treat cardiac disorders such as digoxin
Maltese: • Mediċini użati biex jittrattaw disturbi kardijaċi bħal digoxin.
English: At the time of the primary PFS analysis overall survival data were not mature with 89 (13%) of deaths (HR 0.
Maltese: Fiż-żmien tal-analiżi primarja tal-PFS, id-data dwar is-sopravivenza globali ma kinitx matura b'89 (13%) ta' mwiet (HR 0.