FrancophonIA/ELRC3.0 huggingface dataset:
English: Kisqali was evaluated in a randomised, double-blind, placebo-controlled, multicentre phase III clinical study in the treatment of postmenopausal women with hormone receptor-positive, HER2-negative, advanced breast cancer who received no prior therapy for advanced disease in combination with letrozole versus letrozole alone.
Maltese: Kisqali kien evalwat fi studju kliniku, randomised, double-blind, ikkontrollat bil-plaċebo, b'aktar minn ċentru wieħed fit-trattament ta' nisa wara l-menopawsa b'kanċer tas-sider avanzat, pożittiv għarriċettur tal-ormon, negattiv għal HER2, li ma rċevew l-ebda terapija minn qabel għall-marda avanzata flimkien ma' letrozole kontra letrozole waħdu.
English: Median PFS [months] (95% CI) 20.5 (18.5 - 23.5) Hazard ratio (95% CI)
Maltese: (18.5 - 23.5) Proporzjon ta' periklu (95% CI)
English: These effects can be linked to a direct anti-proliferative effects on the testicular germ cells resulting in atrophy of the seminiferous tubules.
Maltese: Dawn l-effetti jistgħu jkunu marbuta ma' effetti diretti kontra l-proliferazzjoni fuq iċ-ċelluli ġerminali tat-testikoli b'riżultat ta' atrofija tat-tubi seminiferi.
English: • Painful and frequent urination (signs of a urinary tract infection)
Maltese: • Uġigħ waqt li tgħaddi l-awrina u awrina frekwenti (sinjali ta' infezzjoni fl-apparat tal-awrina)
English: Respiratory, thoracic and mediastinal disorders Dyspnoea, cough
Maltese: Disturbi respiratorji, toraċiċi u medjastinali Qtugħ ta' nifs, sogħla
English: Table 9 MONALEESA-7 - Efficacy results (PFS) in patients who received NSAI
Maltese: Tabella 9 MONALEESA-7 - Riżultati tal-effikaċja (PFS) f'pazjenti li rċevew NSAI
English: 126 (3 x 42) film-coated tablets (in PA/alu/PVC blisters)
Maltese: 126 (3 x 42) pillola miksija b'rita (f'folji PA/alu/PVC)
English: • Some medicines used for sedation or anaesthesia such as midazolam.
Maltese: • Xi mediċini użati għal sedazzjoni jew anestesija bħal midazolam.
English: The safety and efficacy of Kisqali in children and adolescents aged below 18 years have not been established.
Maltese: Is-sigurtà u l-effikaċja ta' Kisqali fit-tfal u l-adolexxenti ta' età inqas minn 18-il sena ma ġewx determinati s'issa.
English: 4, pruritus
Maltese: 4, ħakk
English: 126 (3 x 42) film-coated tablets (in PCTFE/PVC blisters)
Maltese: 126 (3 x 42) pillola miksija b'rita (f'folji PCTFE/PVC)
English: Investigations Abnormal liver function tests
Maltese: Investigazzjonijiet Testijiet tal-funzjoni tal-fwied mhux normali
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 0.427; 95% CI: 0.288, 0.633).
Maltese: Ir-riżultati għal PFS ibbażata fuq il-valutazzjoni radjoloġika ċentrali indipendenti u blinded ta' sottosett magħżul b'mod randomizzat ta' madwar 40% ta' pazjenti randomizzati kienu ta' appoġġ għar-riżultati primarji tal-effikaċja bbażati fuq il-valutazzjoni tal-investigatur (proporzjon ta' periklu ta' 0.427; 95% CI: 0.288, 0.633).
English: • Sore throat, runny nose, fever (signs of a respiratory tract infection)
Maltese: • Uġigħ fil-griżmejn, imnieħer inixxi, deni (sinjali ta' infezzjoni tal-passaġġ respiratorju)
English: Take Kisqali once a day on days 1 to 21 of a 28-day cycle.
Maltese: Ħu Kisqali darba kuljum fi ġranet 1 sa 21 ta' ċiklu ta' 28 ġurnata.
English: There are no clinical data available regarding effects of ribociclib on fertility.
Maltese: M'hemmx tagħrif kliniku disponibbli dwar l-effetti ta' ribociclib fuq il-fertilità.
English: Kisqali is not recommended to be used in combination with tamoxifen (see sections 4.8 and 5.1).
Maltese: Kisqali mhux irrakkomandat li jintuża flimkien ma' tamoxifen (ara s-sezzjonijiet 4.8 u 5.1).
English: Dose modification for use of Kisqali with strong CYP3A4 inhibitors Concomitant use of strong CYP3A4 inhibitors should be avoided and an alternative concomitant medicinal product with less potential to inhibit CYP3A4 inhibition should be considered.
Maltese: L-użu fl-istess waqt ta' inibituri qawwija ta' CYP3A4 għandu jiġi evitat u għandu jiġi kkunsidrat prodott mediċinali alternattiv fl-istess waqt b'potenzjal inqas ta' inibizzjoni ta' CYP3A4.
English: 21 film-coated tablets.
Maltese: 21 pillola miksija b'rita.
English: Data in subjects with ESRD are limited (n=3) but indicate a similar or somewhat larger increase in ribociclib exposure compared to subjects with severe renal impairment.
Maltese: Data f'individwi b'ESRD hija limitata (n=3) iżda tindika żieda simili jew kemxejn akbar fl-esponiment għal ribociclib meta mqabbla ma' individwi b'indeboliment sever tal-kliewi.
English: Kisqali was given orally at a dose of 600 mg daily for 21 consecutive days followed by 7 days off treatment in combination with NSAI (letrozole 2.5 mg or anastrozole 1 mg) or tamoxifen (20 mg) orally once daily for 28 days, and goserelin (3.6 mg) subcutaneously every 28 days, until disease progression or unacceptable toxicity.
Maltese: Kisqali ngħata mill-ħalq b'doża ta' 600 mg kuljum għal 21 jum konsekuttiv segwit minn 7 ijiem mingħajr trattament flimkien ma' NSAI (letrozole 2.5 mg jew anastrozole 1 mg) jew tamoxifen (20 mg) mogħti mill-ħalq darba kuljum għal 28 jum, u goserelin (3.6 mg) mogħti taħt il-ġilda kull 28 jum, sakemm ikun hemm progressjoni tal-marda jew tossiċità mhux aċċettabbli.
English: The majority of patients included were Caucasian (57.7%), Asian (29.5%) or Black (2.8%) and nearly all patients (99.0%) had a baseline ECOG performance status of 0 or 1.
Maltese: Il-maġġoranza tal-pazjenti inklużi kienu Kawkasi (57.7%), Asjatiċi (29.5%) jew Suwed (2.8%) u kważi l-pazjenti kollha (99.0%) kellhom status ta' prestazzjoni ECOG fil-linja bażi ta' 0 jew 1.
English: Infections: urinary tract infections, respiratory tract infections, gastroenteritis, sepsis (<1%).
Maltese: Komuni ħafna Żieda ta' krejatinina fid-demm, titwil ta' QT fuq l-elettrokardjogramm Komuni Infezzjonijiet: infezzjonijiet fl-apparat urinarju, infezzjonijiet fl-apparat respiratorju, gastroenterite, sepsis (<1%).
English: Ribociclib is a substrate for P-gp in vitro, but based on mass balance data inhibition of P-gp or BCRP is unlikely to affect ribociclib exposure at therapeutic doses.
Maltese: Ribociclib hu sottostrat ta' P-gp in vitro, imma abbażi ta' data dwar il-bilanċ tal-massa tal-inibizzjoni ta' P-gp jew BCRP x'aktarx mhux se jaffettwa l-espożizzjoni ta' ribociclib f'dożi terapewtiċi.
English: Figure 5 MONALEESA-7: Kaplan Meier plot of final OS analysis in patients who received NSAI (30-Nov-18 cut-off)
Maltese: Plott Kaplan Meier tal-analiżi tal-OS finali f'pazjenti mogħtija NSAI (data ta' meta waqfet tinġabar id-data 30-Nov-18)
English: Ribociclib exhibited slightly over-proportional increases in exposure (Cmax and AUC) across the dose range of 50 mg to 1200 mg following both single dose and repeated doses.
Maltese: Ribociclib wera żidiet ftit aktar minn proporzjonali fl-esponiment (Cmax u AUC) matul il-firxa taddoża ta' 50 mg sa 1,200 mg kemm wara doża waħda kif ukoll wara dożi ripetuti.
English: Other medicines and Kisqali
Maltese: Kif jaħdem Kisqali
English: • Fever (pyrexia)
Maltese: • Dgħjufija (astenja)
English: If treatment with a strong CYP3A4 inhibitor cannot be avoided, the dose should be reduced to 400 mg once daily (see sections 4.2 and 4.5).
Maltese: Jekk it-trattament b'inibitur qawwi ta' CYP3A4 ma jistax jiġi evitat, id-doża għandha titnaqqas għal 400 mg darba kuljum (ara sezzjonijiet 4.2 u 4.5).
English: Based on the severity of the neutropenia, treatment with Kisqali may have to be interrupted, reduced or discontinued as described in Table 2 (see sections 4.2 and 4.8).
Maltese: Abbażi tas-severità tan-newtropenija, it-trattament b'Kisqali jista' jkollu jiġi interrott, imnaqqas jew imwaqqaf kif deskritt fit-Tabella 2 (ara sezzjonijiet 4.2 u 4.8).
English: Unit packs containing 21, 42 or 63 film-coated tablets and multipacks containing 63 (3 packs of 21), 126 (3 packs of 42) or 189 (3 packs of 63) film-coated tablets.
Maltese: Pakketti li fihom 21, 42 jew 63 pillola miksija b'rita u pakketti multipli li fihom 63 (3 pakketti ta' 21), 126 (3 pakketti ta' 42) jew 189 (3 pakketti ta' 63) pillola miksija b'rita.
English: In the pre-specified subgroup analysis of 495 patients who had received Kisqali or placebo in combination with NSAI plus goserelin, the median PFS was 27.5 months (95% CI: 19.1, NE) in the Kisqali plus NSAI subgroup and 13.8 months (95% CI: 12.6, 17.4) in the placebo plus NSAI subgroup [HR: 0.569; 95% CI: 0.436, 0.743].
Maltese: Fl-analiżi tas-sottogrupp speċifikat minn qabel ta' 495 pazjent li kienu rċevew Kisqali jew plaċebo flimkien ma' NSAI flimkien ma' goserelin, il-PFS medjana kienet ta' 27.5 xhur (95% CI: 19.1, NE) fis-sottogrupp ta' Kisqali flimkien ma' NSAI u 13.8 xhur (95% CI: 12.6, 17.4) fis-sottogrupp ta' plaċebo flimkien ma' NSAI
English: Drug-drug interaction studies between ribociclib and oral contraceptives have not been conducted (see section 4.6)
Maltese: Interazzjoni bejn mediċina u oħra bejn ribociclib u kontraċettivi orali Ma sarux studji dwar l-interazzjoni bejn mediċina u oħra bejn ribociclib u l-kontraċettivi orali (ara sezzjoni 4.6).
English: Day
Maltese: Doża
English: What Kisqali is
Maltese: X'inhu Kisqali is
English: Log-rank test and Cox model are stratified by lung and/or liver metastasis, prior chemotherapy for advanced disease, and endocrine combination partner per IRT
Maltese: It-test log-rank u l-mudell Cox huma stratifikati b'metastazi tal-pulmun u/jew tal-fwied, mill-kimoterapija mogħtija għal mard avvanzat, u minn imsieħeb ikkombinat endokrinali għall-IRT
English: Placebo plus fulvestrant (%, 95% CI)
Maltese: Plaċebo flimkien ma' fulvestrant (%,CI ta' 95%)
English: Additionally, in vivo antitumour activity of ribociclib in combination with fulvestrant was assessed in immune-deficient mice bearing the ZR751 ER+ human breast cancer xenografts and the combination with fulvestrant resulted in complete tumour growth inhibition.
Maltese: Barra minn hekk, l-attività in vivo kontra t-tumuri ta' ribociclib flimkien ma' fulvestrant kienet evalwata fi ġrieden b'defiċjenza fis-sistema immunitarja li kellhom xenografi tal-kanċer tas-sider tal-bniedem ZR751 ER+ u l-kombinazzjoni ma' fulvestrant irriżultat f'inibizzjoni kompluta tat-tkabbir tat-tumur.
English: • with long QT syndrome;
Maltese: • bis-sindrome ta' QT twil;
English: The primary efficacy results demonstrated a statistically significant improvement in PFS in patients receiving Kisqali plus fulvestrant compared to patients receiving placebo plus fulvestrant in the full analysis set (hazard ratio of 0.593, 95% CI: 0.480, 0.732, one-sided stratified log-rank test p-value 4.1x10
Maltese: Ir-riżultati tal-effikaċja primarja wrew titjib statistikament sinifikanti fil-PFS f'pazjenti li kienu qed jirċievu Kisqali flimkien ma' fulvestrant meta mqabbla ma' pazjenti li kienu qed jirċievu plaċebo flimkien ma' fulvestrant fis-sett ta' analiżi sħiħa (proporzjon ta' periklu ta' 0.593, 95% CI: 0.480, 0.732, valur-p tat-test ta' log-rank stratifikat minn naħa waħda 4.1x10
English: • Spinning sensation (vertigo)
Maltese: • Tħoss kollox idur bik (vertigo)
English: Ribociclib was the major circulating drug-derived entity in plasma.
Maltese: Ribociclib kien l-entità prinċipali derivata mill-mediċina li tiċċirkola fil-plażma.
English: CI=confidence interval; N=number of patients; p-value is obtained from the one-sided stratified log-rank test.
Maltese: CI=intervall ta' kunfidenza; N=numru ta' pazjenti; avalur p jinkiseb mit-test log-rank stratifikat ta' naħa waħda.
English: 63 (3 x 21) film-coated tablets (in PA/alu/PVC blisters)
Maltese: 63 (3 x 21) pillola miksija b'rita (f'folji PA/alu/PVC)
English: The analysis suggested that ribociclib causes concentration-dependent increases in the QTc interval.
Maltese: L-analiżi ssuġġeriet li ribociclib jikkawża żidiet dipendenti millkonċentrazzjoni fl-intervall QTc.
English: Dose interruptions and/or adjustments due to hepatobiliary toxicity events were reported in 10.4% of Kisqali plus any combination treated patients, primarily due to ALT increased (6.9%) and/or AST increased (6.1%).
Maltese: Interruzzjonijiet u/jew aġġustamenti fid-doża minħabba avvenimenti ta' tossiċità fil-fwied u filmarrara ġew irrappurtati f'10.4% tal-pazjenti ttrattati b'Kisqali flimkien ma' kwalunkwe kombinazzjoni, primarjament minħabba żieda fl-ALT (6.9%) u/jew fl-AST (6.1%).
English: • Tamoxifen, another medicine for the treatment of breast cancer.
Maltese: • Tamoxifen, mediċina oħra għat-trattament tal-kanċer tas-sider.
English: 42 film-coated tablets (in PA/alu/PVC blisters)
Maltese: 42 pillola miksija b'rita (f'folji PA/alu/PVC)
English: How to store Kisqali
Maltese: Gћalxiex jintuża Kisqali
English: Caution is recommended in case of concomitant use with sensitive CYP3A4 substrates with a narrow therapeutic index (see section 4.4).
Maltese: Hija rakkomandata kawtela meta jintuża flimkien ma' sottostrati sensittivi ta' CYP3A4 b'indiċi terapewtiku dejjaq (ara sezzjoni 4.4).
English: Results in the Kisqali plus NSAI subgroup were consistent across subgroups of age, race, prior adjuvant/ neoadjuvant chemotherapy or hormonal therapies, liver and/or lung involvement and bone-only metastatic disease.
Maltese: Ir-riżultati fis-sottogrupp ta' Kisqali flimkien ma' NSAI kienu konsistenti fis-sottogruppi kollha ta' età, razza, kimoterapija awżiljarja/neoawżiljarja jew terapiji ormonali minn qabel, involviment talfwied u/jew tal-pulmuni u mard metastatiku tal-għadam biss.
English: Gastrointestinal disorders Nausea, diarrhoea, vomiting, constipation, stomatitis, abdominal pain
Maltese: Dardir, dijarrea, rimettar, stitikezza, stomatite, uġigħ addominali
English: 63 (3 x 21) film-coated tablets (in PCTFE/PVC blisters)
Maltese: 63 (3 x 21) pillola miksija b'rita (f'folji PCTFE/PVC)
English: Alternative concomitant medicinal products with less potential to inhibit CYP3A4 should be considered and patients should be monitored for ribociclib-related AEs (see sections 4.2, 4.4 and
Maltese: Għandhom jiġu kkunsidrati prodotti mediċinali mogħtija fl-istess waqt alternattivi b'potenzjal inqas li jinibixxu CYP3A4 u l-pazjenti għandhom jiġu mmonitorjati għall-episodji avversi b'rabta ma' ribociclib (ara sezzjonijiet 4.2, 4.4 u 5.2).
English: C] ribociclib, 91.7% of the total administered radioactive dose was recovered within 22 days; faeces was the major route of excretion (69.1%), with 22.6% of the dose recovered in urine.
Maltese: 91.7% tad-doża radjuattiva totali mogħtija kienet irkuprata fi żmien 22 ġurnata; l-ippurgar kien ir-rotta ewlenija għat-tneħħija (69.1%), bi 22.6% tad-doża rkuprata fl-awrina.
English: Kisqali was given orally at a dose of 600 mg daily for 21 consecutive days followed by 7 days off treatment in combination with letrozole 2.5 mg once daily for 28 days.
Maltese: Kisqali ingħata mill-ħalq b'doża ta' 600 mg kuljum għal 21 ġurnata konsekuttiva segwit minn 7 ijiem mingħajr it-trattament flimkien ma' letrozole 2.5 mg darba kuljum għal 28 ġurnata.
English: Censoring Times Ribociclib (N=248) Placebo (N=247)
Maltese: Żminijiet ta' Ċensura Ribociclib (N=248) Plaċebo (N=245)
English: Patients in MONALEESA-7 had not received prior endocrine treatment in the advanced breast cancer setting.
Maltese: Il-pazjenti fil-MONALEESA-7 ma kinux irċevew trattament endokrinali minn qabel filkanċer tas-sider avvanzat.
English: In the placebo arm, a QTcF interval increase of >60 msec from baseline occurred in 6/90 (6.7%) patients receiving tamoxifen and in no patients receiving a NSAI (see section 5.2).
Maltese: Filgrupp tal-plaċebo, żieda ta' >60 msec mil-linja bażi tal-intervall QTcF seħħet f'6/90 (6.7%) talpazjenti li kienu qed jirċievu tamoxifen u f'ebda pazjent li kien qed jirċievi NSAI (ara sezzjoni 5.2).
English: Progression-free survival Median PFS [months] (95% CI) 25.3 (23.0-30.3) Hazard ratio (95% CI) p-value a
Maltese: Sopravivenza mingħajr progressjoni PFS medjana [xhur] (95% CI) 20.5
English: Kisqali works by blocking proteins called cyclin-dependent kinases 4 and 6, which are important for the growth and division of cells.
Maltese: Kisqali jaħdem billi jimblokka proteini li jissejħu kinases 4 u 6 dipendenti fuq cyclin, li huma importanti għat-tkabbir u d-diviżjoni taċ-ċelluli.
English: 42 film-coated tablets (in PCTFE/PVC blisters)
Maltese: 42 pillola miksija b'rita (f'folji PCTFE/PVC)
English: Kisqali is not recommended to be used in combination with tamoxifen (see section 5.1).
Maltese: Kisqali mhux irrakkomandat li jintuża flimkien ma' tamoxifen (ara sezzjoni 5.1).
English: Dose reduction due to adverse events, regardless of causality, occurred in 37.3% of patients receiving Kisqali in the phase III clinical studies regardless of the combination and permanent discontinuation was reported in 7.0% of patients receiving Kisqali and any combination in the phase III clinical studies.
Maltese: III irrispettivament mill-kombinazzjoni u twaqqif permanenti kien irrappurtat f'7.0% tal-pazjenti li rċevew Kisqali u kwalunkwe kombinazzjoni flistudji kliniċi ta' fażi
English: In addition, haematological (e.g. neutropenia, thrombocytopenia) toxicity and possible QTc prolongation may occur.
Maltese: Barra dan, tista' sseħħ tossiċità ematoloġika (eż. newtropenija, tromboċitopenija) u possibbilment titwil ta' QTc.
English: CI=confidence interval, NE=not estimable, N=number of patients; p-value is obtained from the one-sided log-rank test stratified by lung and/or liver metastases, prior chemotherapy for advanced disease, and endocrine partner per IRT (interactive response technology).
Maltese: CI=intervall ta' kunfidenza, NE=ma tistax tingħata stima, N=għadd ta' pazjenti; il-valur-p jinkiseb mit-test ta' log-rank stratifikat minn naħa waħda b'metastażi tal-pulmun u/jew tal-fwied, mill-kimoterapija mogħtija qabel għal mard avvanzat, u minn imsieħeb endokrinali għall-IRT (teknoloġija b'rispons interattiv).
English: 21 film-coated tablets (in PA/alu/PVC blisters)
Maltese: 21 pillola miksija b'rita (f'folji PA/alu/PVC)
English: Based on the severity of the transaminase elevations, treatment with Kisqali may have to be interrupted, reduced or discontinued as described in Table 3 (see sections 4.2 and 4.8).
Maltese: Abbażi tas-severità ta' żidiet ta' transaminase, it-trattament b'Kisqali jista' jkollu jiġi interrott, imnaqqas jew imwaqqaf kif deskritt fit-Tabella 3 (ara sezzjonijiet 4.2 u 4.8).
English: Your doctor will tell you exactly how many tablets of Kisqali to take; in certain situations your doctor may instruct you to take a lower dose of Kisqali, e.g. 400 mg (2 tablets of 200 mg) once daily or 200 mg (1 tablet of 200 mg) once daily.
Maltese: Ittabib tiegħek se jgħidlek eżattament kemm għandek tieħu pilloli ta' Kisqali; f'ċerti sitwazzjonijiet it-tabib tiegħek jista' jgħidlek sabiex tieħu doża mnaqqsa ta' Kisqali, eż. 400 mg (2 pilloli ta' 200 mg) darba kuljum jew 200 mg (pillola waħda ta' 200 mg) darba kuljum.
English: Figure 3 MONALEESA-7 - Kaplan-Meier plot of PFS based on investigator assessment in patients who received NSAI
Maltese: Figure 3 MONALEESA-7 - Kurva ta' Kaplan-Meier ta' PFS ibbażata fuq valutazzjoni talinvestigatur f'pazjenti li rċevew NSAI
English: Table 3 Dose modification and management - Hepatobiliary toxicity
Maltese: Tabella 3 Modifikazzjoni fid-doża u immaniġġjar - Tossiċità fil-fwied u fil-marrara
English: Figure 1 MONALEESA-2 - Kaplan-Meier plot of PFS based on investigator assessment02 January 2017 cut-off)
Maltese: Kaplan-Meier ta' PFS ibbażata fuq valutazzjoni talinvestigatur (data meta waqfet tinġabar id-data 02 ta' Jannar 2017)
English: Table 4 Dose modification and management - QT prolongation
Maltese: Tabella 4 Modifikazzjoni fid-doża u immaniġġjar - titwil ta' QT
English: Kisqali packs containing 21 tablets are intended for use by patients taking the lowest ribociclib daily dose of 200 mg (1 tablet once daily).
Maltese: Il-pakketti ta' Kisqali fihom 21 pillola maħsuba sabiex jintużaw minn pazjenti li qed jieħdu l-anqas doża ta' ribociclib kuljum ta' 200 mg (pillola 1 darba kuljum).
English: In the phase III clinical studies, 83.2% (89/107) of grade 3 or 4 ALT or AST elevation events occurred within the first 6 months of treatment.
Maltese: III, 83.2% (89/107) tal-avvenimenti ta' żieda fl-ALT jew AST ta' grad 3 jew 4 seħħew fl-ewwel 6 xhur tat-trattament.
English: • Hair loss or hair thinning (alopecia)
Maltese: • Telf tal-kulur tal-ġilda fi rqajja (vitiligo)
English: 21 film-coated tablets (in PCTFE/PVC blisters)
Maltese: 21 pillola miksija b'rita (f'folji PCTFE/PVC)
English: In pre- or perimenopausal women, the endocrine therapy should be combined with a luteinising hormone-releasing hormone (LHRH) agonist.
Maltese: Fin-nisa qabel jew waqt il-menopawsa, it-terapija endokrinali għandha tkun ikkombinata ma' agonista tal-ormon li jistimula l-produzzjoni tal-ormon ta' lutejinazzjoni (LHRH).
English: Data from a clinical study in patients with breast cancer indicated no clinically relevant effects of fulvestrant on ribociclib exposure following co-administration of these medicinal products.
Maltese: Id-data minn studju kliniku f'pazjenti b'kanċer tas-sider ma indikat l-ebda effett klinikament rilevanti ta' fulvestrant fuq l-esponiment għal ribociclib wara l-għoti flimkien ta' dawn il-prodotti mediċinali.
English: Kisqali 200 mg film-coated tablets
Maltese: Kisqali 200 mg pilloli miksija b'rita
English: Ribociclib did not inhibit OAT1, OAT3 or MRP2 at clinically relevant concentrations in vitro.
Maltese: Ribociclib ma inibixxiex OAT1, OAT3 jew MRP2 f'konċentrazzjonijiet relevanti klinikament in vitro.
English: Increases in transaminases were observed.
Maltese: Kienu osservati żidiet fit-transaminases.
English: Prior to study entry, of these 672 patients, 14% of patients had received prior chemotherapy for metastatic disease, 32.6% of patients had received chemotherapy in the adjuvant and 18.0% in the neoadjuvant setting; 39.6% had received endocrine therapy in the adjuvant setting and 0.7% in the neoadjuvant setting.
Maltese: Qabel ir-reġistrazzjoni għall-istudju, minn dawn is672 pazjent, 14% tal-pazjenti kienu rċevew kimoterapija minn qabel għal mard metastatiku, 32.6% talpazjenti kienu rċevew kimoterapija fl-ambjent awżiljarju u 18.0% fl-ambjent neoawżiljarju; 39.6% kienu rċevew terapija endokrinali fl-ambjent awżiljarju u 0.7% fl-ambjent neoawżiljarju.
English: Additionally, the probability of progression on next-line therapy or death (PFS2) in patients who received prior ribociclib in the study was lower compared to patients in the placebo arm with an HR of 0.692 (95% CI: 0.548, 0.875) in the overall study population.
Maltese: Barra minn hekk, il-probabbiltà ta' progressjoni għat-terapija li jmiss jew għall-mewt (PFS2) f'pazjenti li qabel kienu ngħataw ribociclib fl-istudju kienet aktar baxxa imqabbel mal-pazjenti filgrupp mogħti l-plaċebo b'HR ta' 0.692 (95% CI: 0.548, 0.875) fl-istudju tal-popolazzjoni sħiħa.
English: Hazard ratios based on pre-specified subgroup analysis of the patients treated with Kisqali plus fulvestrant showed consistent benefit across different subgroups including age, prior treatment (early or advanced), prior adjuvant/neoadjuvant chemotherapy or hormonal therapies, liver and/or lung involvement and bone-only metastatic disease.
Maltese: Proporzjonijiet tal-periklu bbażati fuq analiżi ta' sottogruppi speċifikati minn qabel tal-pazjenti ttrattati b'Kisqali flimkien ma' fulvestrant urew benefiċċju konsistenti f'sottogruppi differenti inklużi l-età, ittrattament minn qabel (bikri jew avvanzat), kimoterapija awżiljarja/neoawżiljarja jew terapiji ormonali minn qabel, involviment tal-fwied u/jew il-pulmun u mard metastatiku tal-għadam biss.
English: In vitro data indicate that ribociclib has no potential to induce UGT enzymes or the CYP enzymes CYP2C9, CYP2C19 and CYP3A4 via PXR.
Maltese: Data in vitro tindika li Kisqali m'għandu l-ebda potenzjal li jinduċu enzimi UGT jew l-enzimi CYP CYP2C9, CYP2C19 u CYP3A4 permezz ta' PXR. Għalhekk, Kisqali mhux mistenni li jkollu effett fuq sottostrati ta' dawn l-enzimi.
English: 21 film-coated tablets 42 film-coated tablets 63 film-coated tablets
Maltese: Pillola miksija b'rita 21 pillola miksija b'rita 42 pillola miksija b'rita 63 pillola miksija b'rita