FrancophonIA/ELRC3.0 huggingface dataset:
English: A total of 672 patients were randomised in a 1:1 ratio to receive either Kisqali 600 mg plus NSAI/tamoxifen plus goserelin (n=335) or placebo plus NSAI/tamoxifen plus goserelin (n=337), stratified according to: the presence of liver and/or lung metastases (Yes [n=344 (51.2%)] versus No [n=328 (48.8%)]), prior chemotherapy for advanced disease (Yes [n=120 (17.9%)] versus No [n=552 (82.1%)]), and endocrine combination partner (NSAI and goserelin [n=493 (73.4%)] versus tamoxifen and goserelin [n=179 (26.6%)]).
Maltese: Total ta' 672 pazjent kienu randomizzati fi proporzjon ta' 1:1 biex jirċievu Kisqali 600 mg flimkien ma' NSAI/tamoxifen flimkien ma' goserelin (n=335) jew plaċebo flimkien ma' NSAI/tamoxifen flimkien ma' goserelin (n=337), stratifikati skont il-preżenza ta' metastasi fil-fwied u/jew fil-pulmun (Iva [n=344 (51.2%)]) versus Le [n=328 (48.8%)]). kimoterapija minn qabel għal mard avvanzat (Iva [n=120 (17.9%)] versus Le [n=552 (82.1%)]), u msieħeb tal-kombinazzjoni endokrinali (NSAI u goserelin [n=493 (73.4%)] versus tamoxifen u goserelin [n=179 (26.6%)]).
English: • Medicines used to treat symptoms of benign prostatic hyperplasia such as alfuzosin.
Maltese: • Mediċini użati biex jittrattaw sintomi ta' iperplasija beninna tal-prostata bħal alfuzosin.
English: • Everolimus, used for several types of cancer and tuberous sclerosis (also used to prevent the rejection of an organ transplant).
Maltese: • Everolimus, użat għal diversi tipi ta' kanċer u sklerożi tuberuża (użati wkoll biex jipprevjeni r riġettar ta' trapjant tal-organi).
English: Following repeated once-daily dosing, steady state was generally achieved after 8 days and ribociclib accumulated with a geometric mean accumulation ratio of 2.51 (range: 0.97 to 6.40).
Maltese: Wara dożaġġ ripetut ta' darba kuljum, stat fiss ġeneralment intlaħaq wara 8 ijiem u ribociclib akkumula bi proporzjon ġeometriku medju ta' akkumulazzjoni ta' 2.51 (firxa: 0.97 sa 6.40).
English: The geometric mean apparent plasma terminal half-life (T1/2) of ribociclib ranged from 29.7 to 54.7 hours and the geometric mean CL/F of ribociclib ranged from 39.9 to 77.5 l/hr at 600 mg across studies in healthy subjects.
Maltese: Il-half-life (T1/2) terminali ġeometrika medja apparenti fil-plażma ta' ribociclib varjat minn 29.7 sa 54.7 sigħat u CL/F ġeometrika medja ta' ribociclib varjat minn 39.9 sa 77.5 l/siegħa b'600 mg matul l-istudji f'individwi f'saħħithom.
English: A more mature update of overall survival data (30 November 2018 cut-off) is provided in Table 11 and Figures 4 and 5.
Maltese: Aġġornament aktar matur tad-data dwar is-sopravivenza sħiħa (data meta waqfet tinġabar id-data 30 ta' Novembru 2018) jinsab f'Tabella 11 u f'Figuri 4 u 5.
English: Table 2 Dose modification and management - Neutropenia
Maltese: Tabella 2 Modifikazzjoni fid-doża u immaniġġjar - Newtropenija
English: Placebo plus fulvestrant N=242
Maltese: Plaċebo flimkien ma' fulvestrant N=242
English: Dysgeusia, dyspepsia
Maltese: Disgewżja, dispepsja
English: The observed clinical benefit rate (CBR) was higher in Kisqali arm (79.1%; 95% CI: 74.8:83.5) compared to placebo arm (69.7%; 95% CI: 64.8:74.6, p=0.002).
Maltese: Ir-rata ta' benefiċċju kliniku (CBR) osservat kienet ogħla filgrupp ta' Kisqali (79.1%; 95% CI: 74.8:83.5) meta mqabbla mal-grupp ta' plaċebo (69.7%; 95% CI: 64.8:74.6, p=0.002).
English: Lymphopenia, thrombocytopenia, febrile neutropenia
Maltese: Limfopenija, tromboċitopenija, newtropenija bid-deni
English: • Some medicines used to treat seizures or fits (anti-epileptics) such as carbamazepine and phenytoin.
Maltese: • Xi mediċini użati biex jittrattaw aċċessjonijiet (anti-epilettiċi) bħal carbamazepine u phenytoin.
English: In the phase III clinical studies, hepatobiliary toxicity events occurred in a higher proportion of patients in the Kisqali plus any combination arms compared with the placebo plus any combination arms (23.2% versus 16.5%, respectively), with more grade 3/4 adverse events reported in the patients treated with Kisqali plus any combination (11.4% versus 5.4%, respectively).
Maltese: III, avvenimenti ta' tossiċi fil-fwied u fil-marrara seħħew fi proporzjon ogħla ta' pazjenti fil-gruppi ta' Kisqali flimkien ma' kwalunkwe kombinazzjoni meta mqabbel mal-gruppi tal-plaċebo flimkien ma' kwalunkwe kombinazzjoni (23.2% versus 16.5%, rispettivament), b'aktar avvenimenti avversi ta' grad 3/4 irrappurtati fil-pazjenti ttrattati b'Kisqali flimkien ma' kwalunkwe kombinazzjoni (11.4% versus 5.4%, rispettivament).
English: • Reduced appetite
Maltese: • Aptit imnaqqas
English: The pharmacokinetics of ribociclib were investigated in patients with advanced cancer following oral daily doses of 50 mg to 1200 mg.
Maltese: Il-farmakokinetika ta' ribociclib kienet investigata f'pazjenti b'kanċer avanzat wara dożi orali ta' kuljum ta' 50 mg sa 1,200 mg.
English: Patients with moderate (Child-Pugh class B) and severe hepatic impairment (Child-Pugh class C) can have increased (less than 2-fold) exposure to ribociclib and the starting dose of 400 mg Kisqali once daily is recommended (see section 5.2).
Maltese: Pazjenti b'indeboliment moderat (Child-Pugh klassi B) u sever (Child-Pugh klassi Ċ) tal-fwied jista' jkollhom żieda (inqas minn darbtejn) fl-esponiment għal ribociclib u hija rakkomandata d-doża talbidu ta' 400 mg Kisqali darba kuljum (ara sezzjoni 5.2).
English: Simulations using physiologically-based pharmacokinetic models suggested that Kisqali given at the clinically relevant dose of 600 mg is expected to increase the midazolam AUC by 5.2-fold.
Maltese: Simulazzjonijiet bl-użu ta' mudelli farmakokinetiċi abbażi fiżjoloġika ssuġġerew li Kisqali mogħti bid-doża klinikament rilevanti ta' 600 mg huwa mistenni li jżid l-AUC ta' midazolam b'5.2 darbiet.
English: Elderly No dose adjustment is required in patients over 65 years of age (see section 5.2).
Maltese: Anzjani Mhux meħtieġ aġġustament fid-doża f'pazjenti ta' età 'l fuq minn 65 sena (ara sezzjoni 5.2).
English: The primary endpoint for the study was met at the planned interim analysis conducted after observing 80% of targeted progression-free survival (PFS) events using Response Evaluation Criteria in Solid Tumours (RECIST v1.1), based on the investigator assessment in the full population (all randomised patients), and confirmed by a blinded independent central radiological assessment.
Maltese: Il-punt finali primarju tal-istudju intlaħaq fl-analiżi interim ippjanata mwettqa wara li kienu osservati 80% tal-avvenimenti ta' sopravivenza mingħajr progressjoni (PFS - progression-free survival) immirati bl-użu ta' Kriterji ta' Evalwazzjoni tar-Rispons f'Tumuri Solidi (RECIST v1.1), ibbażat fuq valutazzjoni mill-investigatur fil-popolazzjoni sħiħa (il-pazjenti randomised kollha), u kkonfermat minn valutazzjoni radjuloġiku ċentrali indipendenti blinded.
English: In study F2301 21.2% had bone-only disease and 60.5% had visceral disease.
Maltese: Fl-istudju F2301, 21.2% kellhom mard tal-għadam biss u 60.5% kellhom mard vixxerali.
English: Effect of ribociclib on cytochrome P450 enzymes
Maltese: L-effetti ta' ribociclib fuq l-enżimi taċ-ċitokromu P450
English: • Some medicines used to treat heart rhythm problems or high blood pressure such as amiodarone, disopyramide, procainamide, quinidine, sotalol and verapamil.
Maltese: • Xi mediċini użati biex jittrattaw problemi fir-ritmu tal-qalb jew il-pressjoni għolja fid-demm bħal amiodarone, disopyramide, procainamide, quinidine, sotalol u verapamil.
English: At the clinically relevant dose of 600 mg, simulations using PBPK models predicted only weak inhibitory effects of ribociclib on CYP1A2 substrates (<2-fold increase in AUC).
Maltese: Bid-doża klinikament rilevanti ta' 600 mg, simulazzjonijiet bl-użu ta' mudelli PBPK bassru effetti inibitorji dgħajfa biss ta' ribociclib fuq sottostrati ta' CYP1A2 (żieda fl-AUC ta' < darbtejn).
English: • Medicines used to prevent the rejection of an organ transplant such as tacrolimus, sirolimus and ciclosporin (also used to treat inflammation in rheumatoid arthritis and psoriasis).
Maltese: • Mediċini użati biex jipprevjenu r-rifjut ta' trapjant ta' organu bħal tacrolimus, sirolimus u ciclosporin (użati wkoll għat-trattament ta' infjammazzjoni f'artrite rewmatika u psorjasi).
English: Each film-coated tablet contains ribociclib succinate equivalent to 200 mg ribociclib.
Maltese: Kull pillola miksija b'rita fiha fibociclib succinate ekwivalenti għal 200 mg ribociclib.
English: At the time of the primary PFS analysis, overall survival data were not mature with 120 (16.5%) deaths (HR 0.670; [95%CI: 0.465, 0.964)].
Maltese: Fiż-żmien tal-analiżi PFS primarja, id-data dwar is-sopravivenza globali ma kinitx matura b'120 (16.5%) mwiet (HR 0.670; [95%CI: 0.465, 0.964)].
English: Healthy subjects received single oral doses ranging from 400 mg to 600 mg or repeated daily doses (8 days) at 400 mg.
Maltese: Individwi f'saħħithom irċevew dożi orali singoli li varjaw minn 400 mg sa 600 mg jew dożi ripetuti ta' kuljum (8 ijiem) ta' 400 mg.
English: Ribociclib exhibited slightly over-proportional increases in exposure (Cmax and AUC) across the dose range tested (50 to 1200 mg).
Maltese: Ribociclib wera żidiet ftit aktar minn proporzjonali fl-esponiment (Cmax u AUC) matul il-firxa taddoża ttestjata (50 sa 1,200 mg).
English: Each film-coated tablet contains ribociclib succinate, equivalent to 200 mg ribociclib.
Maltese: Kull pillola miksija b'rita fiha ribociclib succinate, ekwivalenti għal 200 mg ribociclib.
English: Clinical activity (pharmacological and safety) of ribociclib was due primarily to parent drug, with negligible contribution from circulating metabolites.
Maltese: L-attività klinika (farmakoloġika u s-sigurtà) ta' ribociclib kienet dovuta primarjament għall-mediċina oriġinali, b'kontribut negliġibbli mill-metaboliti fiċ-ċirkolazzjoni.
English: Ribociclib was extensively metabolised, with unchanged drug accounting for 17.3% and 12.1% of the dose in faeces and urine, respectively.
Maltese: Ribociclib kien metabolizzat b'mod estensiv, bil-mediċina mhux mibdula responsabbli għal 17.3% u 12.1% tad-doża fl-ippurgar u fl-awrina, rispettivament.
English: Kisqali Dose
Maltese: Jekk tieqaf tieħu Kisqali
English: Overall response rate (ORR) per investigator assessment based on RECIST v1.1 was higher in the Kisqali arm (40.9%; 95% CI: 35.6, 46.2) compared to the placebo arm (29.7%; 95% CI: 24.8, 34.6, p=0.00098).
Maltese: Ir-rata ta' rispons globali (ORR) għal kull valutazzjoni tal-investigatur ibbażata fuq RECIST v1.1 kienet ogħla fil-grupp ta' Kisqali (40.9%; 95% CI: 35.6, 46.2) meta mqabbla mal-grupp ta' plaċebo (29.7%; 95% CI: 24.8, 34.6, p=0.00098).
English: Medical treatment may be necessary.
Maltese: Jista' jkun meħtieġ trattament mediku.
English: The median follow-up time at the time of primary PFS analysis was 20.4 months.
Maltese: Iż-żmien medjan ta' segwitu fiż-żmien tal-analiżi PFS primarja kien ta' 20.4 xhur.
English: Based on a population pharmacokinetic analysis that included 77 patients with normal renal function (eGFR ≥90 ml/min/1.73 m2), 76 patients with mild renal impairment (eGFR 60 to
Maltese: Ibbażat fuq analiżi tal-farmakokinetika tal-popolazzjoni li kienet tinkludi 77 pazjent b'funzjoni normali tal-kliewi (eGFR ≥90 ml/min/1.73 m2), 76 pazjent b'indeboliment ħafif tal-kliewi (eGFR 60
English: Table 8 MONALEESA-2 - Efficacy results (ORR, CBR) based on investigator assessment(02 January 2017 cut-off)
Maltese: Tabella 8 MONALEESA-2 riżultati tal-effikaċja (ORR, CBR) ibbażati fuq valutazzjoni talinvestigatur (data meta waqfet tinġabar id-data 02 ta' Jannar 2017)
English: The primary efficacy results were supported by PFS results based on blinded independent central radiological assessment.
Maltese: PFS ibbażati fuq valutazzjoni radjoloġika ċentrali indipendenti u blinded.
English: There is only limited experience with reported cases of overdosage with Kisqali.
Maltese: Hemm biss esperjenza limitata b'każijiet irrappurtati ta' doża eċċessiva b'Kisqali.
English: Kisqali 600 mg or placebo were given orally daily for 21 consecutive days followed by 7 days off treatment in combination with fulvestrant 500 mg intramuscularly once daily on Days 1 and 15 in Cycle 1 and Day 1 of each subsequent 28-day cycle.
Maltese: Kisqali 600 mg jew plaċebo ngħataw mill-ħalq kuljum għal 21 jum konsekuttiv segwit minn 7 ijiem mingħajr trattament flimkien ma' fulvestrant 500 mg mogħti ġol-muskolu darba kuljum fil-Jiem 1 u 15 fiċĊiklu 1 u l-Jum 1 ta' kull ċiklu ta' 28 jum sussegwenti.
English: A total of 668 patients were randomised in a 1:1 ratio to receive either Kisqali 600 mg and letrozole (n=334) or placebo and letrozole (n=334), stratified according to the presence of liver and/or lung metastases (Yes [n=292 (44%)]) versus No [n=376 (56%)]).
Maltese: Total ta' 668 pazjent kienu randomised fi proporzjon ta' 1:1 biex jirċievu Kisqali 600 mg u letrozole (n=334) jew plaċebo u letrozole (n=334), stratifikati skont il-preżenza ta' metastasi fil-fwied u/jew filpulmun (Iva [n=292 (44%)]) versus Le [n=376 (56%)]).
English: ), with an estimated 41% reduction in relative risk of progression or death in favour of the Kisqali plus fulvestrant arm.
Maltese: ), b'tnaqqis stmat ta' 41% firriskju relattiv ta' progressjoni jew mewt favur il-grupp ta' Kisqali flimkien ma' fulvestrant.
English: Grade 2* (>3 to 5 x ULN)
Maltese: Grad 2* (>3 sa 5 x ULN)
English: OUTER CARTON OF MULTIPACK (INCLUDING BLUE BOX)
Maltese: TAGĦRIF LI GĦANDU JIDHER FUQ IL-PAKKETT TA' BARRA KARTUNA TA' BARRA TA' PAKKETT MULTIPLU (INKLUŻ KAXXA BLU)
English: Light greyish violet, unscored, round, curved with bevelled edges (approximate diameter: 11.1 mm), debossed with “RIC” on one side and “NVR” on the other side.
Maltese: Vjola ċara fil-griż, mingħajr sinjal imnaqqax, tonda, ibbuzzata bi xfar imċanfrin (dijametru ta' madwar: 11.1 mm), imnaqqxa b'“RIC” fuq naħa u “NVR” fuq in-naħa l-oħra.
English: Ribociclib has no potential for time-dependent inhibition of CYP1A2, CYP2C9, and CYP2D6.
Maltese: Ribociclib m'għandux il-potenzjal ta' inibizzjoni dipendenti miż-żmien għal CYP1A2, CYP2C9, u CYP2D6.
English: Hazard ratio (95% CI) CI=confidence interval; N=number of patients; NE = Not estimable.
Maltese: Proporzjon ta' periklu (95% CI) CI=intervall ta' kunfidenza; N=numru ta' pazjenti; NE = Ma jistax jiġi stmat.
English: Kaplan-Meier median Ribociclib: 27.5 months Placebo: 13.8 months
Maltese: Il-medja skont Kaplan-Meier Ribociclib: 27.5 xhur Plaċebo: 13.8 xhur
English: Hazard Ratio = 0.569 95% CI [0.436, 0.743]
Maltese: Proporzjon ta' Periklu = 0.569 95% CI [0.436, 0.743]
English: Median PFS was 20.5 months (95% CI: 18.5, 23.5) for Kisqali plus fulvestrant treated patients and 12.8 months (95% CI: 10.9, 16.3) for patients receiving placebo plus fulvestrant.
Maltese: Il-PFS medjana kienet ta' 20.5 xhur (95% CI: 18.5, 23.5) għal pazjenti ttrattati b'Kisqali flimkien ma' fulvestrant u 12.8 xhur (95% CI: 10.9, 16.3) għal pazjenti li kienu qed jirċievu plaċebo flimkien ma' fulvestrant.
English: • Medicines used for the treatment of gastrointestinal disorders such as cisapride.
Maltese: • Mediċini użati biex jittrattaw disturbi gastrointestinali bħal cisapride.
English: Your heart activity will also be monitored before and during treatment with Kisqali with a test called an electrocardiogram (ECG).
Maltese: L-attività tal-qalb tiegħek se tiġi mmonitorjata wkoll qabel u waqt it-trattament b'Kisqali b'test li jissejjaħ elettrokardjogramm (ECG - electrocardiogram).
English: Infections and infestations Infections
Maltese: Infezzjonijiet u infestazzjonijiet Infezzjonijiet
English: There was no statistically significant difference in overall survival (OS) between the Kisqali plus letrozole arm and the placebo plus letrozole arm (HR 0.746 [95% CI: 0.517, 1.078]).
Maltese: Ma kien hemm l-ebda differenza statistikament sinifikanti fis-sopravivenza globali (OS - overall survival) bejn il-grupp ta' Kisqali flimkien ma' letrozole u l-grupp tal-plaċebo flimkien ma' letrozole (HR 0.746 [CI ta' 95%: 0.517, 1.078]).
English: Kisqali plus NSAI plus goserelin N=248
Maltese: Kisqali flimkien ma' NSAI flimkien ma' goserelin N=248
English: Efficacy results for overall response rate (ORR) and clinical benefit rate (CBR) per investigator assessment based on RECIST v1.1 are provided in Table 10.
Maltese: Ir-riżultati tal-effikaċja għar-rata ta' rispons globali (ORR) u r-rata ta' benefiċċju kliniku (CBR) għal kull valutazzjoni tal-investigatur ibbażata fuq RECIST v1.1 huma pprovduti fit-Tabella 10.
English: Kaplan-Meier median Ribociclib: 23.8 months Placebo: 13.0 months
Maltese: Il-medja skont Kaplan-MeierRibociclib: 23.8 xhur Plaċebo: 13.0 xhur
English: ORR: Overall response rate = proportion of patients with complete response + partial response b
Maltese: ORR: Rata ta' rispons globali = proporzjon ta' pazjenti b'rispons sħiħ + rispons parzjali b
English: Grade 3* (>5 to 20 x ULN)
Maltese: Grad 3* (>5 sa 20 x ULN)
English: Rash: rash, rash maculopapular, rash pruritic.
Maltese: Raxx: raxx, raxx makulopapulari, raxx bi prurite.
English: Substances that are substrates of transporters
Maltese: Sustanzi li huma sottostrati ta' trasportaturi
English: Kisqali packs containing 42 tablets are intended for use by patients taking the reduced ribociclib daily dose of 400 mg (2 tablets once daily).
Maltese: Il-pakketti ta' Kisqali fihom 42 pillola maħsuba sabiex jintużaw minn pazjenti li qed jieħdu d-doża mnaqqsa ta' ribociclib kuljum ta' 400 mg (2 pilloli darba kuljum).
English: In vitro data are not sufficient to exclude a potential of ribociclib to induce CYP2B6 via CAR.
Maltese: Data in vitro mhijiex suffiċjenti biex tkun eskluża l-possibbiltà li ribociclib jinduċi CYP2B6 permezz ta' CAR.
English: If grade ≥2 abnormalities are noted, more frequent monitoring is recommended.
Maltese: Jekk ikunu nnottati anormalitajiet ta' grad ≥2, huwa rakkomandat monitoraġġ aktar frekwenti.
English: The effect at the 200 mg once-daily dose was predicted to be a 1.7- and 2.8-fold increase, respectively.
Maltese: L-effett tad-doża ta' 200 mg darba kuljum kien imbassar li se jkun ta' żieda ta' 1.7 u 2.8 drabi, rispettivament.
English: Kisqali is indicated for the treatment of women with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative locally advanced or metastatic breast cancer in combination with an aromatase inhibitor or fulvestrant as initial endocrine-based therapy, or in women who have received prior endocrine therapy.
Maltese: Kisqali huwa indikat għat-trattament ta' nisa b'kanċer tas-sider avanzat lokalment jew metastatiku, pożittiv għar-riċettur tal-ormoni (HR - hormone receptor), negattiv għar-riċettur tal-fattur tat-tkabbir epidermali uman 2 (HER2 - human epidermal growth factor receptor 2) flimkien ma' inibitur ta' aromatase jew fulvestrant bħala terapija inizjali abbażi endokrinali, jew f'nisa li rċevew terapija endokrinali minn qabel.
English: Concurrent elevations in ALT or AST greater than three times the upper limit of normal and total bilirubin greater than two times the upper limit of normal, with normal alkaline phosphatase, in the absence of cholestasis occurred in 6 patients (4 patients in Study A2301 [MONALEESA-2], whose levels recovered to normal within 154 days and 2 patients in Study F2301 [MONALEESA-3], whose levels recovered to normal in 121 and 532 days, respectively, after discontinuation of Kisqali).
Maltese: [MONALEESA-2], li l-livelli tagħhom reġgħu għan-normal fi żmien 154 jum u żewġ pazjenti flIstudju F2301 [MONALEESA-3], li l-livelli tagħhom reġgħu għan-normal f'121 u 532 jum, rispettivament, wara li twaqqaf Kisqali).
English: Children and adolescents Kisqali is not to be used in children and adolescents under 18 years of age.
Maltese: Tfal u adolexxenti Kisqali m'għandux jintuża fi tfal u adolexxenti ta' età inqas minn 18-il sena.
English: Placebo plus NSAI plus goserelin (%, 95% CI)
Maltese: Plaċebo flimkien ma' NSAI flimkien ma' goserelin (%, 95% CI)
English: Blood and lymphatic system disorders Neutropenia, leukopenia, anaemia
Maltese: Disturbi tad-demm u tas-sistema limfatika Newtropenija, lewkopenija, anemija
English: Table 12 MONALEESA-3 - Efficacy results (PFS) based on investigator radiological assessment
Maltese: Tabella 12 MONALEESA-3 - Riżultati tal-effikaċja (PFS) ibbażati fuq valutazzjoni radjoloġika tal-investigatur
English: Kisqali is also not recommended to be used in combination with tamoxifen (see sections 4.1, 4.4 and 5.1).
Maltese: Kisqali mhuwiex irrakkomandat ukoll li jintuża flimkien ma' tamoxifen (ara sezzjonijiet 4.1, 4.4 u 5.1).
English: The use of Kisqali with medicinal products known to prolong QTc interval and/or strong CYP3A4 inhibitors should be avoided as this may lead to clinically meaningful prolongation of the QTcF interval (see sections 4.2, 4.5 and 5.1).
Maltese: L-użu ta' Kisqali flimkien ma' prodotti mediċinali magħrufa li jtawlu l-intervall QTc u/jew inibituri qawwija ta' CYP3A4 għandu jiġi evitat għax dan jista' jwassal għal titwil klinikament sinifikanti talintervall QTcF (ara sezzjonijiet 4.2, 4.5 u 5.1).
English: Ribociclib has not been evaluated in male fertility studies.
Maltese: Ribociclib ma ġiex evalwat fi studji dwar il-fertilità tal-irġiel.
English: In the subgroup of patients who had received up to one line of treatment for metastatic/advanced disease, the hazard ratio was of 0.565 (95% CI: 0.428, 0.744), with a median PFS of 14.6 months (95% CI: 12.5, 18.5) and 9.1 months (95% CI: 6.1, 11.1) in the Kisqali and placebo arms, respectively.
Maltese: Fis-sottogrupp ta' pazjenti li kienu rċevew sa linja waħda ta' trattament għal mard metastatiku/avvanzat, il-proporzjon tal-periklu kien ta' 0.565 (95% CI: 0.428, 0.744), b'PFS medjana ta' 14.6 xhur (95% CI: 12.5, 18.5) u 9.1 xhur (95% CI: 6.1, 11.1) fil-gruppi ta' Kisqali u plaċebo, rispettivament.
English: Table 6 Adverse drug reactions observed in the three phase III clinical studies
Maltese: Tabella 6 Reazzjonijiet avversi tal-mediċina osservati fit-tliet studji kliniċi ta' fażi
English: Efficacy results for overall response rate (ORR) and clinical benefit rate (CBR) per investigator assessment based on RECIST v1.1 are provided in Table 13.
Maltese: Ir-riżultati tal-effikaċja għal rata ta' rispons globali (ORR) u r-rata ta' benefiċċju kliniku (CBR) għal kull valutazzjoni tal-investigatur ibbażata fuq RECIST v1.1 huma pprovduti fit-Tabella 13.
English: Baseline grade = 2: No dose interruption.
Maltese: Linja bażi grad = 2: L-ebda interruzzjoni tad-doża.
English: Figure 4 MONALEESA-7: Kaplan Meier plot of final OS analysis (30-Nov-2018 cut-off)
Maltese: Plott Kaplan Meier tal-analiżi tal-OS finali (data meta waqfet tinġabar id-data 30-Nov-2018)
English: Table 5 Dose modification and management - Other toxicities*
Maltese: Tabella 5 Modifikazzjoni fid-doża u immaniġġjar - Tossiċitajiet oħra*
English: C] ribociclib to humans, the primary metabolic pathways for ribociclib involved oxidation (dealkylation, C and/or N-oxygenation, oxidation (-2H)) and combinations thereof.
Maltese: C] ribociclib lill-bnedmin, ir-rotot metaboliċi primarji ta' ribociclib involvew ossidazzjoni (tneħħija ta' gruppi alkyl, ossiġinazzjoni ta' C u/jew ta' N, ossidazzjoni (-2H)) u taħlita ta' dawn.
English: Adverse drug reactions from the phase III clinical studies (Table 6) are listed by MedDRA system organ class.
Maltese: III (Tabella 6) huma elenkati skont ilklassi tas-sistemi u tal-organi MedDRA.
English: Of all patients who received Kisqali in studies MONALEESA-2 and MONALEESA-3, representative proportions of patients were ≥65 years and ≥75 years of age (see section 5.1).
Maltese: Mill-pazjenti kollha li rċevew Kisqali fl-istudji MONALEESA-2 u MONALEESA-3, proporzjonijiet rappreżentattivi ta' pazjenti kienu ≥65 sena u ≥75 sena (ara sezzjoni 5.1).