FrancophonIA/ELRC3.0 huggingface dataset:
English: Eli Lilly and Company Limited Tel: + 44-(0) 1256 315000
Maltese: United Kingdom Eli Lilly and Company Limited Tel: + 44-(0) 1256 315000
English: Oy Eli Lilly Finland Ab Puh/Tel: + 358-(0) 9 85 45 250
Maltese: Suomi/Finland Oy Eli Lilly Finland Ab Puh/Tel: + 358-(0) 9 85 45 250
English: Febrile neutropenia was reported in 0.9% patients.
Maltese: Newtropenija bid-deni ġiet irrappurtata f'0.9% tal-pazjenti.
English: Creatinine
Maltese: Kreatinina
English: The geometric mean systemic volume of distribution is approximately 750 L (69% CV), indicating distribution of abemaciclib into tissues.
Maltese: Il-medja ġeometrika tal-volum ta' distribuzzjoni sistemiku hija madwar 750 L (69% CV), li tindika distribuzzjoni ta' abemaciclib fit-tessuti.
English: Verzenios is available in calendar blister packs of 14, 28, 42, 56, 70 and 168 film-coated tablets and perforated unit dose blisters of 28 x 1 film-coated tablets.
Maltese: Verzenios huwa disponibbli f'pakketti ta' folji b'kalendarju ta' 14, 28, 42, 56, 70 u 168 pillola miksija b'rita u folji ta' doża waħda mtaqqbin ta' 28 x 1 pilloli miksijin b'rita.
English: PCTFE/PE/PVC blisters sealed with an aluminium foil in a calendar blister card, in packs of 14, 28, 42, 56, 70 or 168 film-coated tablets.
Maltese: Folji tal-PCTFE/PE/PVC issiġillati bil-fojl tal-aluminju f'kard ta' folji b'kalendarju f'pakketti ta' 14, 28, 42, 56, 70 jew 168 pillola miksija b'rita.
English: The most commonly occurring adverse reactions are diarrhoea, infections, neutropenia, anaemia, fatigue, nausea, vomiting and decreased appetite.
Maltese: L-aktar reazzjonijiet avversi li seħħew b'mod komuni huma dijarea, infezzjonijiet, newtropenija, anemija, għeja, nawsja, rimettar u tnaqqis fl-aptit.
English: Abemaciclib is highly bound to plasma proteins in humans (mean bound fraction approximately 96% to 98%).
Maltese: Abemaciclib jintrabat ħafna mal-proteini tal-plażma fil-bnedmin (medja tal-proporzjon marbut hija madwar 96% sa 98%).
English: Abemaciclib blocks the effects of proteins called cyclin-dependent kinase 4 and 6.
Maltese: Abemaciclib jibblokka l-effetti ta' proteini msejħa kinase 4 u 6 dipendenti fuq cyclin.
English: a NCI Common Terminology Criteria for Adverse Events (CTCAE) b ANC: Grade 1: ANC < LLN - 1500/mm3; Grade 2: ANC 1000 - <1500/mm3; Grade 3: ANC 500 - <1000/mm3; Grade 4: ANC <500/mm3
Maltese: Grad 1: ANC < LLN - 1500/mm3; Grad 2: ANC 1000 - <1500/mm3; Grad 3: ANC 500 - <1000/mm3; Grad 4: ANC <500/mm3 LLN = il-limitu l-baxx tan-normal
English: Abemaciclib is primarily metabolised by CYP3A4.
Maltese: Abemaciclib jiġi metabolizzat primarjament minn CYP3A4.
English: • medicines that may increase the concentration of Verzenios in the blood:
Maltese: • mediċini li jistgħu jnaqsu l-effikaċja ta' Verzenios:
English: Fatal events occurred in <1% of patients.
Maltese: Avvenimenti fatali seħħew f'<1% tal-pazjenti.
English: Icepharma hf. Sími + 354 540 8000
Maltese: Sími + 354 540 8000
English: Avoid grapefruit or grapefruit juice.
Maltese: Evita l-grejpfrut jew il-meraq tal-grejpfrut.
English: The median age of patients enrolled was 63 years (range 32-88).
Maltese: Il-medjan tal-età tal-pazjenti rreġistrati kien ta' 63 sena (tvarja minn 32-88).
English: The half-life of abemaciclib increased from 24 to 55 hours (see section 4.2).
Maltese: Il-half-life ta' abemaciclib żdiedet minn 24 sa 55 siegħa (ara sezzjoni 4.2).
English: Pharmacotherapeutic group: Antineoplastic agents, protein kinases inhibitors, ATC code: L01XE50
Maltese: Sustanzi antineoplastiċi, inibituri ta' protein kinases, Kodiċi ATC:
English: Grade 1
Maltese: Grad 1
English: Abemaciclib is metabolised to several metabolites primarily by cytochrome P450 (CYP) 3A4.
Maltese: Abemaciclib jiġi mmetaboliżzat f'diversi metaboliti l-aktar miċ-ċitokrom P450 (CYP) 3A4.
English: Beige, oval tablet of 5.2 x 9.5 mm, debossed with “Lilly” on one side and “50” on the other.
Maltese: Pillola beġ, ovali ta' 5.2 x 9.5 mm, imnaqqxa b'“Lilly” fuq naħa waħda u “50” fuq in-naħa l-oħra.
English: Yellow, oval tablet of 7.5 x 13.7 mm, debossed with “Lilly” on one side and “150” on the other.
Maltese: Pillola safra, ovali ta' 7.5 x 13.7 mm, imnaqqxa b'“Lilly” fuq naħa waħda u “150” fuq in-naħa l-oħra.
English: White, oval tablet of 6.6 x 12.0 mm, debossed with “Lilly” on one side and “100” on the other.
Maltese: Pillola bajda, ovali ta' 6.6 x 12.0 mm, imnaqqxa b'“Lilly” fuq naħa waħda u “100” fuq in-naħa l-oħra.
English: Randomised Phase 3 Study MONARCH 2: Verzenios in combination with fulvestrant
Maltese: Studju Arbitrarju ta' Fażi 3 MONARCH 2: Verzenios flimkien ma' fulvestrant
English: Grade 3
Maltese: Grad 3
English: Frequency gradings are: very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000), very rare (<1/10,000), and not known (cannot be estimated from the available data).
Maltese: Il-gradi tal-frekwenza huma: komuni ħafna (≥1/10), komuni (≥1/100 sa <1/10), mhux komuni (≥1/1,000 sa <1/100), rari (≥1/10,000 sa <1/1,000), rari ħafna (<1/10,000), u mhux magħrufa (ma tistax tittieħed stima mid-dejta disponibbli).
English: Approximately 56% patients had visceral metastases.
Maltese: AUC0-∞ u 35% abbażi tas-Cmax.
English: Abemaciclib plus endocrine therapya All Grades Toxicity
Maltese: Abemaciclib flimkien ma' terapija endokrinalia
English: Before treatment initiation, absolute neutrophil counts (ANC) ≥1500/mm3, platelets ≥100,000/mm3, and haemoglobin ≥8 g/dL are recommended.
Maltese: Qabel il-bidu tattrattament, huwa rrakkomandat għadd assolut tan-newtrofili (ANC, absolute neutrophil counts) ≥1500/mm3, plejtlits ≥100,000/mm3, u emoglobina ≥8 g/dL.
English: In addition, Ndesethyl and N-desethylhydroxy metabolites circulate at AUCs that are 39% and 15% of parent drug.
Maltese: N-desethyl u N-desethylhydroxy jiċċirkulaw b'AUCs li huma 39% u 15% tas-sustanza oriġinali.
English: Grade 2
Maltese: Grad 2
English: Steady state was achieved within 5 days following repeated twice daily dosing, and abemaciclib accumulated with a geometric mean accumulation ratio of 3.7 (58% CV) and 5.8 (65% CV) based on Cmax and AUC, respectively.
Maltese: L-istat fiss inkiseb fi żmien 5 ijiem wara għoti ripetut tad-doża darbtejn kuljum, u abemaciclib akkumula bi proporzjon ta' akkumulazzjoni ġeometrika medja ta' 3.7 (58% CV) u 5.8 (65% CV) abbażi tas-Cmax u tal-AUC, rispettivament.
English: Grade 3, recurrent; or Grade 4
Maltese: Grad 3, rikurrenti; jew Grad 4
English: Verzenios in combination with endocrine therapy
Maltese: Verzenios flimkien ma' terapija endokrinali
English: Musculoskeletal and connective tissue disorders
Maltese: Disturbi muskoluskelettriċi u tat-tessuti konnettivi Komuni
English: Eli Lilly Slovakia s.r.o.
Maltese: Slovenská republika Eli Lilly Slovakia s.r.o.
English: 14 film-coated tablets 168 film-coated tablets 28 x 1 film-coated tablets 28 film-coated tablets 56 film-coated tablets 42 film-coated tablets 70 film-coated tablets
Maltese: 14-il pillola miksijin b'rita 168 pillola miksijin b'rita 28 x 1 pilloli miksijin b'rita 28 pillola miksijin b'rita 56 pillola miksijin b'rita 42 pillola miksijin b'rita 70 pillola miksijin b'rita
English: The median age of patients enrolled was 60 years (range, 32-91 years).
Maltese: Il-medjan tal-età tal-pazjenti rreġistrati kien ta' 60 sena (tvarja minn, 32-91 sena).
English: MONARCH 2: Kaplan-Meier plot of progression-free survival (Investigator assessment, intent-to-treat population)
Maltese: MONARCH 2: Plot Kaplan-Meier ta' sopravivenza mingħajr progressjoni (Stima tal investigatur, popolazzjoni bl-intenzjoni li tiġi ttratata)
English: Other medicines and Verzenios
Maltese: Mediċini oħra u Verzenios
English: Concomitant use of CYP3A4 inducers should be avoided due to the risk of decreased efficacy of abemaciclib (see section 4.5).
Maltese: L-użu fl-istess waqt ta' indutturi ta' CYP3A4 għandhom jiġu evitati minħabba riskju ta' tnaqqis fleffikaċja ta' abemaciclib (ara sezzjoni 4.5).
English: MONARCH 3: Kaplan-Meier plot of progression-free survival (Investigator assessment, intent-to-treat population)
Maltese: MONARCH 3: Plot Kaplan-Meier ta' sopravivenza mingħajr progressjoni (Stima tal investigatur, popolazzjoni bl-intenzjoni li tiġi ttrattata)
English: • Film-coating: titanium dioxide (E171), talc (E553b), polyvinyl alcohol (E1203), macrogol 3350 (E1521), iron oxide yellow (E172) [50 mg and 150 mg tablets only], iron oxide red (E172) [50 mg tablets only].
Maltese: • Il-kisi b'rita: titanium dioxide (E171), talc (E553b), polyvinyl alcohol (E1203), macrogol 3350 (E1521), iron oxide isfar (E172) [il-pilloli ta' 50 mg u 150 mg biss], iron oxide aħmar (E172) [il-pilloli ta' 50 mg biss].
English: Mild (Child Pugh A) and moderate (Child Pugh B) hepatic impairment had no effect on the exposure of abemaciclib.
Maltese: Indeboliment ħafif (Child Pugh A) u moderat (Child Pugh B) tal fwied ma kellu l-ebda effett fuq l-esponiment ta' abemaciclib.
English: The study met its primary endpoint of improving PFS. Primary efficacy results are summarised in Table 7 and Figure 1.
Maltese: Ir-riżultati ta' effikaċja primarja huma mqassra f'Tabella 7 u Figura 1.
English: Persistent or Recurrent Grade 2, or Grade 3 (>5.0-20.0 x ULN)
Maltese: Grad 2, jew Grad 3 Persistenti jew Rikurrenti (>5.0-20.0 x ULN)
English: It is currently unknown whether abemaciclib may reduce the effectiveness of systemically acting hormonal contraceptives.
Maltese: Bħalissa mhuwiex magħruf jekk abemaciclib inaqqasx l-effettività ta' kontraċettivi ormonali li jaħdmu b'mod sistemiku.
English: Objective response rateb [%] (95% CI)
Maltese: Rata oġġettiva ta' risponsb [%] (95% CI)
English: EXPIRY DATE
Maltese: DATA TA' SKADENZA EXP
English: • Tiredness
Maltese: • Sturdament
English: Grade 3 or 4 ALT or AST elevations (based on laboratory findings) were reported in 6.1% and 4.2% patients.
Maltese: Żidiet ta' Grad 3 jew 4 fl-ALT jew fl-AST (abbażi ta' sejbiet tal-laboratorju) ġew irrappurtati f'6.1% u 4.2% tal-pazjenti.
English: Eli Lilly (Suisse) S.A Pārstāvniecība Latvijā
Maltese: Eli Lilly (Suisse)
English: In vitro, Rb-negative and Rb-depleted cancer cell lines are generally less sensitive to abemaciclib.
Maltese: In vitro, linji ta' ċelluli tal-kanċer negattivi għal Rb u nieqsa minn Rb jkunu ġeneralment inqas sensittivi għal abemaciclib.
English: The primary endpoint was investigator-assessed progression-free survival (PFS) evaluated according to RECIST 1.1; key secondary efficacy endpoints included objective response rate (ORR), clinical benefit rate (CBR) and overall survival (OS).
Maltese: L-iskop finali primarju kien is-sopravivenza mingħajr progressjoni (PFS, progression-free survival) evalwata skont RECIST 1.1 stmata mill-investigatur; skopijiet finali sekondarji l-aktar importanti ta' effikaċja kienu jinkludu r-rata oġġettiva ta' rispons (ORR, objective response rate), r-rata ta' benefiċċju kliniku (CBR, clinical benefit rate) u s-sopravivenza globali (OS, overall survival).
English: A high-fat meal increased combined AUC of abemaciclib and its active metabolites by 9% and increased Cmax by 26%.
Maltese: Ikla b'ammont għoli ta' xaħam żiedet l-AUC kombinat ta' abemaciclib u l-metaboliti attivi tiegħu b'9% u żiedet is-Cmax b'26%.
English: Medical treatment may be necessary.
Maltese: Jista' jkun hemm bżonn ta' trattament mediku.
English: Lilly S.A. Tel: + 34-91 663 50 00
Maltese: Tel: + 34-91 663 50 00
English: EU/1/18/1307/016 EU/1/18/1307/017 EU/1/18/1307/018 EU/1/18/1307/019 EU/1/18/1307/020 EU/1/18/1307/021
Maltese: EU/1/18/1307/016 EU/1/18/1307/017 EU/1/18/1307/018 EU/1/18/1307/019 EU/1/18/1307/020
English: Aluminium/aluminium perforated unit dose blisters of 28 x 1 film-coated tablets.
Maltese: Folji tal-aluminium/aluminium imtaqqbin biex jinqatgħu dożi waħdiet ta' 28 x pillola 1 miksija b'rita.
English: Concomitant use of inducers of CYP3A4
Maltese: Indutturi ta' CYP3A4
English: The study met its primary endpoint of improving PFS. Primary efficacy results are summarised in Table 8 and Figure 2.
Maltese: Ir-riżultati ta' effikaċja primarja huma mqassra f'Tabella 8 u Figura 2.
English: Clinical benefit ratec (measurable disease)
Maltese: Rata ta' benefiċċju klinikuc (marda li tista'
English: Abemaciclib is metabolised in the liver.
Maltese: Abemaciclib jiġi metabolizzat fil-fwied.
English: See section 4 “Possible side effects”, and talk to your doctor if you have any symptoms.
Maltese: Ara sezzjoni 4 “Effetti sekondarji possibbli”, u kellem lit-tabib tiegħek jekk għandek xi sintomi.
English: Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucosegalactose malabsorption should not take this medicine.
Maltese: Pazjenti bi problemi ereditarji rari ta' intolleranza għall-galactose, defiċjenza totali tal-lactase jew assorbiment ħażin tal-glucose-galactose m'għandhomx jieħdu din il-mediċina.
English: In subjects with severe hepatic impairment (Child Pugh C), the AUC0-∞ of abemaciclib and potency adjusted unbound abemaciclib plus its active metabolites increased 2.1-fold and 2.4-fold, respectively.
Maltese: (Child Pugh C), l-AUC0-∞ ta' abemaciclib u l-qawwa aġġustata ta' abemaciclib mhux marbut flimkien mal-metaboliti attivi żdiedet 2.1 drabi u 2.4 drabi, rispettivament.
English: Verzenios is used to treat women with certain types of breast cancer (hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-)) which have spread beyond the original tumour and/or to other organs.
Maltese: -hormone receptor-positive (HR+), negattiv għar-riċettur 2 tal-fattur ta' tkabbir epidermali uman -human epidermal growth factor receptor 2-negative (HER2-)) li nfirxu lil hinn mit-tumur oriġinali u/jew għal organi oħra.
English: Medicinal products that are substrates of transporters Abemaciclib and its major active metabolites inhibit the renal transporters organic cation transporter 2 (OCT2), multidrug and extrusion toxin protein (MATE1), and MATE2-K.
Maltese: Abemaciclib u l-metaboliti attivi prinċipali tiegħu jinibixxu t-trasportaturi tal-kliewi t-trasportatur 2 tal katjoni organiċi (OCT2, organic cation transporter 2), il-proteina ta' estrużjoni ta' ħafna mediċini u tossini
English: Co-administration of abemaciclib with the strong CYP3A4 inducer rifampicin decreased the plasma concentration of abemaciclib by 95% and unbound potency adjusted plasma concentration of abemaciclib plus its active metabolites by 77% based on AUC0-∞.
Maltese: L-għoti ta' abemaciclib flimkien mal-induttuur qawwi ta' CYP3A4 rifampicin naqqas il-konċentrazzjoni ta' abemaciclib fil-plażma b'95% u l-konċentrazzjoni ta' abemaciclib mhux marbut flimkien malmetaboliti attivi tiegħu aġġustati għall-qawwa fil-plażma b'77% abbażi tal-AUC0-∞.
English: Hazard ratio (95% CI) and p-value
Maltese: Proporzjon ta' periklu (95% CI) u valur p
English: Examples of strong CYP3A4 inhibitors include, but not limited to: clarithromycin, itraconazole, ketoconazole, lopinavir/ritonavir, posaconazole or voriconazole.
Maltese: o Clarithromycin (antibijotiku użat fit-trattament ta' infezzjonijiet minn batterji) o Itraconazole, ketoconazole, posaconazole, voriconazole (użati fit-trattament ta'
English: Approximately 39% of patients had received chemotherapy and 44% had received antihormonal therapy in the (neo)adjuvant setting.
Maltese: Madwar 39% tal-pazjenti kienu rċivew kimoterapija u 44% kienu rċivew terapija kontra l-ormoni fl-isfond ta' terapija
English: In cancer patients, abemaciclib inhibits CDK4 and CDK6 as indicated by inhibition of phosphorylation of Rb and topoisomerase II alpha, which results in cell cycle inhibition upstream of the G1 restriction point.
Maltese: F'pazjenti bil-kanċer, abemaciclib jinibixxi CDK4 u CDK6 kif huwa indikat permezz tal-inibizzjoni talfosforilazzjoni ta' Rb u ta' topoisomerase II alpha, li jwassal għal inibizzjoni taċ-ċiklu taċ-ċellula iktar 'il fuq mill-punt ta' restrizzjoni G1.
English: Effects of other medicinal products on the pharmacokinetics of abemaciclib
Maltese: Effetti ta' abemaciclib fuq il-farmakokinetika ta' prodotti mediċinali oħra
English: A reduction in the risk of disease progression or death was observed in patients with visceral disease, (HR of 0.481 [95% CI: 0.369, 0.627]), median PFS 14.7 months versus 6.5 months; in patients with bone-only disease (HR of 0.543 [95% CI: 0.355, 0.833]); patients with measurable disease (HR of 0.523 [95% CI: 0.412, 0.644]).
Maltese: Kien osservat tnaqqis fir-riskju tal-progressjoni tal-marda jew mewt f'pazjenti bil-marda fil-vixxri, (HR ta' 0.481 [95% CI: 0.369, 0.627]), medjan ta' PFS ta' 14.7 xhur versus 6.5 xhur; f'pazjenti bil-marda fl-għadam biss (HR ta' 0.543 [95% CI: 0.355, 0.833]); u f'pazjenti b'marda li setgħet titkejjel (HR ta' 0.523 [95% CI: 0.412, 0.644]).
English: o Itraconazole, ketoconazole, posaconazole, voriconazole (used to treat fungal infections) o Lopinavir/ritonavir (used to treat HIV/AIDS) o Digoxin (used to treat heart disorders) o Dabigatran etexilate (used to reduce the risk of stroke and blood clots)
Maltese: infezzjonijiet minn fungi) o Lopinavir/ritonavir (użati fil-kura tal-HIV/AIDS) o Digoxin (użat fit-trattament ta' disturbi fil-qalb) o Dabigatran etexilate (użat biex inaqqas ir-riskju ta' puplesija u l-formazzjoni ta' ċapep tad-demm)
English: Elderly No dose adjustment is required based on age (see section 5.2).
Maltese: Ma huwa meħtieġ l-ebda aġġustmentt fid-doża abbażi tal-età (ara sezzjoni 5.2).
English: Sun.
Maltese: Tne.
English: A series of prespecified subgroup PFS analyses showed consistent results across patient subgroups including age (<65 or ≥65 years), race, geographic region, disease site, endocrine therapy resistance, presence of measurable disease, progesterone receptor status, and menopausal status.
Maltese: Serje ta' analiżi ta' PFS f'sottogrupp speċifikat minn qabel urew riżultati konsistenti fis-sottogruppi kollha tal-pazjenti inklużi l-età (<65 jew ≥65 sena), ir-razza, ir-reġjun ġeografiku, is-sit tal-marda, ir reżistenza għat-terapija endokrinali, il-preżenza ta' marda li tista' titkejjel, l-istat tar-riċettur tal proġesteron, u l-istat tal-menopawsa.
English: In vivo interactions of abemaciclib with clinically relevant substrates of these transporters, such as dofetilide or creatinine, may occur (see section 4.8).
Maltese: Jistgħu jseħħu interazzjonijiet in vivo ta' abemaciclib ma' sustrati rilevanti b'mod kliniku ta' dawn it-trasportaturi, bħal dofetilide jew kreatinina (ara sezzjoni 4.8).
English: Investigator assessment, number of events Median [months] (95% CI)
Maltese: Stima tal-investigatur, numru ta' avvenimenti (%) Medjan [xhur] (95% CI)
English: Venous thromboembolic events include DVT, pulmonary embolism, cerebral venous sinus thrombosis, subclavian, axillary vein thrombosis,DVT inferior vena cava and pelvic venous thrombosis
Maltese: Avvenimenti tromboemboliċi jinkludu DVT, emboliżmu fil-pulmuni, trombożi fis-sinus tal-vini ċerebrali,
English: Verzenios 100 mg film-coated tablets polyvinyl alcohol (E1203) titanium dioxide (E171) macrogol (E1521) talc (E553b)
Maltese: Verzenios 100 mg pilloli miksijin b'rita polyvinyl alcohol (E1203) titanium dioxide (E171) macrogol (E1521) talc (E553b)
English: Verzenios plus fulvestrant prolonged progression-free survival with neither a clinically meaningful or significant detriment to health-related quality of life.
Maltese: Verzenios flimkien ma' fulvestrant tawwal is-sopravivenza mingħajr progressjoni mingħajr detriment ta' sinifikat kliniku u lanqas sinifkanti fil-kwalità ta' ħajja marbuta massaħħa.
English: Drink plenty of fluids.
Maltese: Ixrob ħafna fluwidi.
English: Venous thromboembolic events were reported in 5.3% of patients treated with abemaciclib plus fulvestrant or aromatase inhibitors, compared to 0.8% of patients treated with placebo plus fulvestrant or aromatase inhibitors.
Maltese: Avvenimenti tromboemboliċi fil-vini ġew irrappurtati f'5.3% tal-pazjenti ttrattati b'abemaciclib flimkien ma' fulvestrant jew inibituri ta' aromatase, meta mqabbla ma' 0.8% tal-pazjenti ttrattati bi plaċebo flimkien ma' fulvestrant jew inibituri ta' aromatase.
English: The safety and efficacy of abemaciclib in children and adolescents aged less than 18 years has not been established.
Maltese: Is-sigurtà u l-effikaċja ta' abemaciclib fit-tfal u adolexxenti b'età anqas minn 18-il sena ma ġewx determinati s'issa.
English: In patients with severe (Child Pugh C) hepatic impairment, a decrease in dosing frequency to once daily is recommended (see section 5.2).
Maltese: F'pazjenti b'indeboliment sever (Child Pugh C) tal-fwied, huwa rrakkomandat tnaqqis fil-frekwenza tal-għoti tad-doża għal darba kuljum (ara sezzjoni 5.2).
English: Age, gender, and body weight had no effect on the exposure of abemaciclib in a population pharmacokinetic analysis in patients with cancer (135 males and 859 females; age range 24-91 years; and body weight range 36-175 kg).
Maltese: L-età, is-sess tal-persuna, u l-piż tal-ġisem ma kellhom l-ebda effett fuq l-esponiment ta' abemaciclib f'analiżi farmakokinetika ta' popolazzjoni f'pazjenti bil-kanċer (135 raġel u 859 mara; b'età li tvarja minn 24-91 sena; u piż tal-ġisem li jvarja minn 36-175 kg).
English: Diarrhoea was the most commonly reported adverse reaction (see Table 6).
Maltese: Id-dijarea kienet l-aktar reazzjoni avversa rrappurtata b'mod komuni (ara Tabella 6).
English: Verzenios plus aromatase inhibitor
Maltese: inibitur ta' aromatase
English: These results correspond to a clinically meaningful reduction in the risk of disease progression or death of 44.7% and a 7.2 month improvement in median PFS for patients treated with Verzenios plus fulvestrant.
Maltese: Dawn ir-riżultati jaqblu ma' tnaqqis b'sinifikat kliniku fir-riskju ta' progressjoni talmarda jew mewt ta' 44.7% u titjib ta' 7.2 xhur fil-PFS medjan għall-pazjenti ttrattati b'Verzenios flimkien ma' fulvestrant.
English: Median PFS was significantly prolonged in the Verzenios plus fulvestrant arm (HR of 0.553 [95% CI 0.449, 0.681]); median PFS was 16.4 months versus 9.3 months in the placebo plus fulvestrant arm.
Maltese: Il-PFS medjan twal b'mod sinifikanti fil-fergħa ta' Verzenios flimkien ma' fulvestrant (HR ta' 0.553 [95% CI 0.449, 0.681]); il-PFS medjan kien ta' 16.4 xhur versus 9.3 xhur fil-fergħa tal-plaċebo flimkien ma' fulvestrant.
English: It is given together with hormonal therapies, such as aromatase inhibitors or fulvestrant.
Maltese: Jingħata flimkien ma' terapiji ormonali , bħal inibituri ta' aromatase jew fulvestrant.
English: If strong CYP3A4 inhibitors need to be co-administered, the dose of abemaciclib should be reduced (see section 4.2), followed by careful monitoring of toxicity.
Maltese: Jekk jeħtieġ li jingħataw inibituri qawwija ta' CYP3A4 flimkien miegħu, id-doża ta' abemaciclib għandha titnaqqas (ara sezzjoni 4.2), u tiġi segwita b'monitoraġġ b'attenzjoni tat-tossiċità.
English: This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodiumfree'.
Maltese: Dan il-prodott mediċinali fih inqas minn 1 mmol ta' sodium (23 mg) f'kull pillola, jiġifieri tista' tgħid li huwa essenzjalment “mingħajr sodium”.
English: Lilly France Tél: +33-(0) 1 55 49 34 34
Maltese: Tél: +33-(0) 1 55
English: • Abnormalities in liver blood tests
Maltese: • Raxx • Testijiet tad-demm tal-fwied li mhumiex normali
English: Overall survival was not mature at the final PFS analysis (93 events observed across the two arms).
Maltese: Is-sopravivenza mingħajr progressjoni ma kinitx matura fl-analiżi finali ta' PFS (93 avveniment osservat fiż-żewġ fergħat).
English: In pre- or perimenopausal women, the endocrine therapy should be combined with a luteinising hormone-releasing hormone (LHRH) agonist.
Maltese: F'nisa qabel jew qrib il-menopawsa, it-terapija endokrinali għandha tingħata flimkien ma' agonist talormon li jerħi l-ormon luteinising (LHRH, luteinising hormone-releasing hormone).