FrancophonIA/ELRC3.0 huggingface dataset:
English: Verzenios 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: hormone receptor), negattiv għar-riċettur 2 tal-fattur ta' tkabbir tal-epidermide tal-bniedem (HER2, human epidermal growth factor receptor 2) avvanzat b'mod lokali jew metastatiku flimkien ma' inibitur ta' aromatase jew fulvestrant bħala terapija inizjali b'bażi endokrinali, jew f'nisa li jkunu rċivew terapija endokrinali qabel.
English: CYP3A4 inhibitors
Maltese: Inibituri ta' CYP3A4
English: What you need to know before you take Verzenios Do not take Verzenios:
Maltese: Twissijiet u prekawzjonijiet Verzenios jista':
English: • Verzenios 150 mg film-coated tablet: each tablet contains 150 mg abemaciclib.
Maltese: • Verzenios 150 mg pillola miksija b'rita: kull pillola fiha 150 mg abemaciclib.
English: There should, however, be close monitoring for signs of toxicity.
Maltese: Madankollu, għandu jkun hemm monitoraġġ mill-qrib għal sinjali ta' tossiċità.
English: Abemaciclib in combination with letrozole, anastrozole, or fulvestrant.
Maltese: Abemaciclib flimkien ma' letrozole, anastrozole, jew fulvestrant.
English: Although not an adverse reaction, abemaciclib has been shown to increase serum creatinine in 98.3% of patients (based on laboratory findings), 1.9% Grade 3 or 4 (based on laboratory findings).
Maltese: Għalkemm mhijiex reazzjoni avversa, abemaciclib intwera li jżid il-kreatinina fis-serum f'98.3% talpazjenti (abbażi ta' sejbiet tal-laboratorju), b'1.9% ta' Grad 3 jew 4 (abbażi ta' sejbiet tal-laboratorju).
English: In patients receiving an aromatase inhibitor or fulvestrant alone, 78.4% reported an increase in serum creatinine (all laboratory grades).
Maltese: F'pazjenti li jkunu qed jirċievu inibitur ta' aromatase jew fulvestrant waħdu, 78.4% irrappurtaw żieda fil kreatinina fis-serum (tal-gradi kollha tal-laboratorju).
English: Verzenios 50 mg film-coated tablets Verzenios 100 mg film-coated tablets Verzenios 150 mg film-coated tablets
Maltese: Verzenios 50 mg pilloli miksija b'rita Verzenios 100 mg pilloli miksija b'rita Verzenios 150 mg pilloli miksija b'rita
English: Toxicitya
Maltese: Tossiċità tal
English: Film coating
Maltese: Gradi kollha
English: Verzenios contains sodium
Maltese: Verzenios fih is-sodium
English: • Muscular weakness
Maltese: • Debbulizza fil-muskoli
English: Nervous system disorders
Maltese: Disturbi fis-sistema nervuża Komuni ħafna Disgewżja
English: Eli Lilly Sweden AB Tel: + 46-(0) 8 7378800
Maltese: Tel: + 46-(0) 8 7378800
English: - Verzenios 150 mg film-coated tablets are yellow, oval tablets debossed with “Lilly” on one side and “150” on the other.
Maltese: - Verzenios 150 mg pilloli miksijin b'rita huma pilloli ovali, sofor, imnaqqxa b'“Lilly” fuq naħa waħda u “150” fuq in-naħa l-oħra.
English: In a clinical study in patients with breast cancer, there was no clinically-relevant pharmacokinetic drug interaction between abemaciclib and anastrozole, fulvestrant, exemestane, letrozole or tamoxifen.
Maltese: Fi studju kliniku f'pazjenti b'kanċer tas-sider, ma kien hemm l-ebda interazzjoni farmakokinetika bejn il mediċini li kienet rilevanti b'mod kliniku bejn abemaciclib u anastrozole, fulvestrant, exemestane,
English: The requirements for submission of periodic safety update reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal.
Maltese: Artikolu 107c(7) tad-Direttiva 2001/83/KE u kwalunkwe aġġornament sussegwenti ppubblikat fuq il-portal web Ewropew tal-mediċini.
English: No dose adjustments are necessary in patients with mild (Child Pugh A) or moderate (Child Pugh B) hepatic impairment.
Maltese: Mhumiex meħtieġa aġġustamenti fid-doża f'pazjenti b'indeboliment ħafif (Child Pugh A) jew moderat
English: However, based on the in vitro inhibition of P-gp and breast cancer resistance protein (BCRP) observed with abemaciclib, in vivo interactions of abemaciclib with narrow therapeutic index substrates of these transporters, such as digoxin or dabigatran etexilate, may occur.
Maltese: Madankollu, abbażi tal-inibizzjoni in vitro ta' P-gp u tal-proteina ta' reżistenza tal-kanċer tas-sider (BCRP, breast cancer resistance protein) osservata b'abemaciclib, in vivo jistgħu jseħħu interazzjonijiet ta' abemaciclib ma' sustrati b'indiċi terapewtiċi stretti ta' dawn it-traportaturi, bħal digoxin jew dabigatran etexilate.
English: In a clinical drug interaction study with metformin (substrate of OCT2, MATE1 and 2) co-administered with 400 mg abemaciclib, a small but not clinically relevant increase (37%) in metformin plasma exposure was observed.
Maltese: MATE1 u 2) mogħti flimkien ma' 400 mg abemaciclib, ġiet osservata żieda żgħira iżda mhux rilevanti b'mod kliniku (37%) fl-esponiment għal metformin fil-plażma.
English: Median [months] (95% CI) Hazard ratio (95% CI) and p-value
Maltese: Stima tal-investigatur, numru ta' avvenimenti (%) Medjan [xhur] (95% CI) Proporzjon ta' periklu (95% CI) u valur p
English: Across clinical studies, median time to onset of the first diarrhoea event was approximately 6 to 8 days, and median duration of diarrhoea was 9 to 12 days (Grade 2) and 6 to 8 days (Grade 3).
Maltese: Tul l-istudji kliniċi, il-medjan taż-żmien għall-bidu talewwel avveniment ta' dijarea kien madwar 6 sa 8 ijiem, u l-medjan tat-tul ta' żmien tad-dijarea kien minn 9 ijiem sa 12-il jum (Grad 2) u minn 6 sa 8 ijiem (Grad 3).
English: A series of prespecified subgroup PFS analyses showed consistent results across patient subgroups including age (<65 or ≥65 years), disease site, disease setting (de novo metastatic vs recurrent metastatic vs locally advanced recurrent), presence of measurable disease, progesterone receptor status, and baseline ECOG performance status.
Maltese: Serje ta' analiżi ta' PFS ta' sottogrupp speċifikat minn qabel urew riżultati konsistenti fis-sottogruppi kollha tal-pazjenti inklużi l-età (<65 jew ≥65 sena), is-sit tal-marda, l-ambjent tal-marda (metastatika de novo vs metastatika rikorrenti vs rikorrenti avvanzata b'mod lokali), il-preżenza ta' marda li tista'
English: Verzenios film-coated tablets come in different strengths:
Maltese: Il-pilloli miksijin b'rita Verzenios jiġu f'qawwijiet differenti:
English: - Verzenios 50 mg film-coated tablets are beige, oval tablets debossed with “Lilly” on one side and “50” on the other.
Maltese: - Verzenios 50 mg pilloli miksijin b'rita huma pilloli ovali, beġ, imnaqqxa b'“Lilly” fuq naħa waħda u “50” fuq in-naħa l-oħra.
English: • Verzenios 100 mg film-coated tablet: each tablet contains 100 mg abemaciclib.
Maltese: • Verzenios 100 mg pillola miksija b'rita: kull pillola fiha 100 mg abemaciclib.
English: In patients with advanced and/or metastatic cancer, co-administration of the CYP3A4 inhibitor clarithromycin resulted in a 3.4-fold increase in the plasma exposure of abemaciclib and a 2.5-fold increase in the combined unbound potency adjusted plasma exposure of abemaciclib and its active metabolites.
Maltese: F'pazjenti b'kanċer avvanzat u/jew metastatiku, l-għoti flimkien mal-inibitur ta' CYP3A4 clarithromycin wassal għal żieda ta' 3.4 darbiet aktar fl-esponiment għal abemaciclib fil-plażma u żieda ta' 2.5 drabi aktar fl-esponiment kombinat ta' abemaciclib mhux marbut u l-metaboliti attivi tiegħu aġġustati għall-qawwa fil-plażma.
English: • Dizziness
Maltese: Doża rrakkomandata
English: Eli Lilly Polska Sp. z o.o.
Maltese: Eli Lilly Italia S.p.A.
English: Verzenios 150 mg film-coated tablets polyvinyl alcohol (E1203) titanium dioxide (E171) macrogol (E1521) talc (E553b) iron oxide yellow (E172)
Maltese: Verzenios 150 mg pilloli miksijin b'rita polyvinyl alcohol (E1203) titanium dioxide (E171) macrogol (E1521) talc (E553b) iron oxide isfar (E172)
English: Verzenios contains lactose
Maltese: Kif gћandek tieћu Verzenios
English: These results correspond to a clinically meaningful reduction in the risk of disease progression or death of 46% for patients treated with abemaciclib plus an aromatase inhibitor.
Maltese: Dawn ir-riżultati jaqblu ma' tnaqqis li għandhom sinifikat b'mod kliniku fir-riskju ta' progressjoni tal-marda jew mewt ta' 46% tal-pazjenti ttrattati b'abemaciclib flimkien ma' inibitur ta' aromatase.
English: General supportive care should be provided.
Maltese: Għandha tiġi pprovduta kura ġenerali ta' sostenn.
English: • Verzenios 50 mg film-coated tablet: each tablet contains 50 mg abemaciclib.
Maltese: • Verzenios 50 mg pillola miksija b'rita: kull pillola fiha 50 mg abemaciclib.
English: Abemaciclib absorption is slow, with a Tmax of 8 hours and a mean absolute bioavailability of approximately 45 %.
Maltese: L-assorbiment ta' abemaciclib isir bil-mod, b'Tmax ta' 8 sigħat u bijodisponibiltà medja assoluta ta' madwar 45 %.
English: 100 mg twice daily
Maltese: 100 mg darbtejn kuljum
English: Verzenios 50 mg film-coated tablets polyvinyl alcohol (E1203) titanium dioxide (E171) macrogol (E1521) talc (E553b) iron oxide yellow (E172) iron oxide red (E172)
Maltese: Verzenios 50 mg pilloli miksijin b'rita polyvinyl alcohol (E1203) titanium dioxide (E171) macrogol (E1521) talc (E553b) iron oxide isfar (E172)
English: In patients who have had their dose reduced to 50 mg abemaciclib twice daily and in whom co-administration of a strong CYP3A4 inhibitor cannot be avoided, the abemaciclib dose may be continued with close monitoring of signs of toxicity.
Maltese: F'pazjenti li tnaqqisitilhom id-doża għal 50 mg abemaciclib darbtejn kuljum u li għalihom ma jistax jiġi evitat l-għoti fl-istess waqt ta' inibitur qawwi ta' CYP3A4, id-doża ta' abemaciclib tista' titkompla b'monitoraġġ mill-qrib tas-sinjali ta' tossiċità.
English: Dose adjustment recommendations for adverse reactions Verzenios dose combination therapy
Maltese: Doża ta' Verzenios terapija kombinata
English: Patients were randomised in a 2:1 ratio to receive Verzenios 150 mg twice daily plus fulvestrant 500 mg at intervals of one month, with an additional 500 mg dose given two weeks after the initial dose, versus placebo plus fulvestrant according to the same schedule.
Maltese: Il-pazjenti ntagħżlu b'mod arbitrarju fi proporzjon ta' 2:1 biex jirċievu Verzenios 150 mg darbtejn kuljum flimkien ma' fulvestrant 500 mg f'intervalli ta' xahar, b'doża addizzjonali ta' 500 mg mogħtija ġimagħtejn wara d-doża tal-bidu, versus plaċebo flimkien ma' fulvestrant skont l-istess skeda.
English: The geometric mean hepatic clearance (CL) of abemaciclib was 21.8 L/h (39.8% CV), and the mean plasma elimination half-life for abemaciclib in patients was 24.8 hours (52.1% CV).
Maltese: L/siegħa (39.8% CV), u l-medja tal-half-life tal-eliminazzjoni mill-plażma għal abemaciclib fil-pazjenti kienet ta' 24.8 siegħa
English: Abemaciclib was not mutagenic in a bacterial reverse mutation (Ames) assay, was not clastogenic in an in vitro chromosomal aberration assay in human peripheral blood lymphocytes, and was not clastogenic in an in vivo rat bone marrow micronucleus assay.
Maltese: Tossiċità fuq il-ġeni Abemaciclib ma kienx mutaġeniku f'analiżi ta' mutazzjoni kkoreġuta tal-batterji (Ames), ma kienx klastoġeniku f'assaġġ in vitro ta' abberrazzjoni tal-kromosomi f'limfoċiti tad-demm periferali tal bniedem, u ma kienx klastoġeniku f'assaġġ in vivo tal-mikronukleju tal-mudullun tal-għadam tal-far.
English: Fri.
Maltese: Ġim.
English: The efficacy and safety of Verzenios in combination with an aromatase inhibitor (anastrozole or letrozole) was evaluated in MONARCH 3, a randomised, double-blind, placebo-controlled phase 3 study in women with HR positive, HER2 negative locally advanced or metastatic breast cancer who had not received prior systemic therapy in this disease setting.
Maltese: Studju Arbitrarju ta' Fażi 3 MONARCH 3: Verzenios flimkien ma' inibituri ta' aromatase L-effikaċja u s-sigurtà ta' Verzenios flimkien ma' inibitur ta' aromatase (anastrozole jew letrozole) ġew evalwati f'MONARCH 3, studju ta' fażi 3, ikkontrollat bil-plaċebo fejn la l-investigaturi u lanqas l individwi li ntagħżlu b'mod arbitrarju ma kienu jafu liema sustanza qed tintuża f'nisa b'kanċer tas-sider avvanzat b'mod lokali jew metastatiku pożittiv għal HR, negattiv għal HER2 li ma kinux irċivew terapija sistemika qabel f'dan l-isfond tal-marda.
English: Verzenios is a cancer medicine containing the active substance abemaciclib.
Maltese: Verzenios huwa mediċina għall-kanċer u fih is-sustanza attiva abemaciclib.
English: Venous thromboembolism
Maltese: Tromboemboliżmu fil-vinic
English: Charles de Giorgio Ltd. Tel: + 356 25600 500
Maltese: Tel: + 356 25600 500
English: Verzenios 100 mg
Maltese: INFORMAZZJONI BIL-BRAILLE Verzenios 100 mg
English: Verzenios 150 mg tablets abemaciclib
Maltese: Verzenios 150 mg pilloli abemaciclib
English: EU/1/18/1307/001 EU/1/18/1307/002 EU/1/18/1307/003 EU/1/18/1307/004 EU/1/18/1307/005 EU/1/18/1307/006 EU/1/18/1307/007 EU/1/18/1307/008 EU/1/18/1307/009 EU/1/18/1307/010 EU/1/18/1307/011 EU/1/18/1307/012 EU/1/18/1307/013 EU/1/18/1307/014 EU/1/18/1307/015
Maltese: EU/1/18/1307/006 EU/1/18/1307/007 EU/1/18/1307/008 EU/1/18/1307/009 EU/1/18/1307/010
English: Objective response rateb [%] (95% CI) Complete response, (%) Partial response, (%)
Maltese: Rata oġġettiva ta' risponsb [%] (95% CI) Rispons sħiħ, (%)
English: The primary biotransformation is hydroxylation to a metabolite that circulates with an AUC that is 77% of parent drug.
Maltese: Il-bijotrasformazzjoni primarja hija l-idroksilazzjoni għal metabolit li jiċċirkola b'AUC li hija 77% tas-sustanza oriġinali.
English: The recommended dose of abemaciclib is 150 mg twice daily when used in combination with endocrine therapy.
Maltese: Id-doża rrakkomandata ta' abemaciclib hija 150 mg darbtejn kuljum meta jintuża flimkien ma' terapija endokrinali.
English: Each film-coated tablet contains 28 mg of lactose (as monohydrate).
Maltese: Eċċipjenti b'effett magħruf Kull pillola miksija b'rita fiha 28 mg ta' lactose (bħala monohydrate).
English: Verzenios 100 mg tablets abemaciclib
Maltese: Verzenios 100 mg pilloli abemaciclib
English: Verzenios 50 mg tablets abemaciclib
Maltese: Verzenios 50 mg pilloli abemaciclib
English: Elevation in AST and/or ALT >3 x ULN WITH total bilirubin >2 x ULN, in the absence of cholestasis
Maltese: BIT-total ta' bilirubin >2 x
English: Belgique/België/Belgien
Maltese: Belgique/België/Belgien Eli Lilly Benelux S.A./N.V. Tél/Tel:
English: Objective response rateb [%] (95% CI) Duration of response [months] (95% CI)
Maltese: Rata oġġettiva ta' risponsb [%] (95% CI) Tul ta' żmien tar-rispons [xhur] (95% CI)
English: MONARCH 3: Summary of efficacy data (Investigator assessment, intent-to-treat population)
Maltese: MONARCH 3: Sommarju tad-dejta ta' effikaċja (Stima tal-investigatur, popolazzjoni bl intenzjoni li tiġi ttrattata)
English: Abemaciclib has been shown to increase serum creatinine due to inhibition of renal tubular secretion transporters without affecting glomerular function (as measured by iohexol clearance) (see section 4.5).
Maltese: Abemaciclib intwera li jżid il-kreatinina fis-serumminħabba inibizzjoni tat-trasportaturi tas-sekrezzjoni mit-tubuli tal-kliewi mingħajr ma jaffettwa l-funzjoni tal-glomeruli (kif imkejla mit-tneħħija ta' iohexol) (ara sezzjoni 4.5).
English: EU/1/18/1307/007 (14 film-coated tablets) EU/1/18/1307/008 (168 film-coated tablets) EU/1/18/1307/009 (28 x 1 film-coated tablets) EU/1/18/1307/014 (28 film-coated tablets) EU/1/18/1307/015 (56 film-coated tablets) EU/1/18/1307/020 (42 film-coated tablets) EU/1/18/1307/021 (70 film-coated tablets)
Maltese: EU/1/18/1307/007(14-il pillola miksijin b'rita) EU/1/18/1307/008 (168 pillola miksijin b'rita) EU/1/18/1307/009 (28 x 1 pilloli miksijin b'rita) EU/1/18/1307/014 (28 pillola miksijin b'rita) EU/1/18/1307/015 (56 pillola miksijin b'rita) EU/1/18/1307/020 (42 pillola miksijin b'rita) EU/1/18/1307/021 (70 pillola miksijin b'rita)
English: Discontinue abemaciclib.
Maltese: Mhux applikabbli.
English: EU/1/18/1307/004 (14 film-coated tablets) EU/1/18/1307/005 (168 film-coated tablets) EU/1/18/1307/006 (28 x 1 film-coated tablets) EU/1/18/1307/012 (28 film-coated tablets) EU/1/18/1307/013 (56 film-coated tablets) EU/1/18/1307/018 (42 film-coated tablets) EU/1/18/1307/019 (70 film-coated tablets)
Maltese: EU/1/18/1307/004 (14-il pillola miksijin b'rita) EU/1/18/1307/005 (168 pillola miksijin b'rita) EU/1/18/1307/006 (28 x 1 pilloli miksijin b'rita) EU/1/18/1307/012 (28 pillola miksijin b'rita) EU/1/18/1307/013 (56 pillola miksijin b'rita) EU/1/18/1307/018 (42 pillola miksijin b'rita) EU/1/18/1307/019 (70 pillola miksijin b'rita)
English: In an exposure-response analysis in healthy subjects at exposures comparable to a 200 mg twice-daily dose, abemaciclib did not prolong the QTcF interval to any clinically relevant extent.
Maltese: F'analiżi ta' esponiment u rispons f'individwi f'saħħithom b'esponimenti kumparabbli ma' dawk ta' doża ta' 200 mg darbtejn kuljum, abemaciclib ma tawwalx l-intervall QTcF sa xi punt rilevanti b'mod kliniku.
English: EU/1/18/1307/001 (14 film-coated tablets) EU/1/18/1307/002 (168 film-coated tablets) EU/1/18/1307/003 (28 x 1 film-coated tablets) EU/1/18/1307/010 (28 film-coated tablets) EU/1/18/1307/011 (56 film-coated tablets) EU/1/18/1307/016 (42 film-coated tablets) EU/1/18/1307/017 (70 film-coated tablets)
Maltese: EU/1/18/1307/001 (14-il pillola miksijin b'rita) EU/1/18/1307/002 (168 pillola miksijin b'rita) EU/1/18/1307/003 (28 x 1 pilloli miksijin b'rita) EU/1/18/1307/010 (28 pillola miksijin b'rita) EU/1/18/1307/011 (56 pillola miksijin b'rita) EU/1/18/1307/016 (42 pillola miksijin b'rita) EU/1/18/1307/017 (70 pillola miksijin b'rita)
English: Dose modification is recommended for patients who develop ≥ Grade 2 diarrhoea (see section 4.2).
Maltese: Hija rrakkomandata modifikazzjoni fid-doża għall-pazjenti li jiżviluppaw dijarea ≥ Grad 2 (ara sezzjoni 4.2).
English: Each film-coated tablet contains 42 mg of lactose (as monohydrate).
Maltese: Eċċipjenti b'effett magħruf Kull pillola miksija b'rita fiha 42 mg ta' lactose (bħala monohydrate).
English: • Infections
Maltese: • Infezzjonijiet
English: How to store Verzenios
Maltese: X'fih Verzenios
English: Each film-coated tablet contains 14 mg of lactose (as monohydrate).
Maltese: Eċċipjenti b'effett magħruf Kull pillola miksija b'rita fiha 14 mg ta' lactose (bħala monohydrate).
English: MONARCH 2: Summary of efficacy data (Investigator assessment, intent-to-treat population)
Maltese: MONARCH 2: Sommarju tad-dejta ta' effikaċja (Stima tal-investigatur, popolazzjoni bl intenzjoni li tiġi ttrattata)
English: Cardiac electrophysiology
Maltese: Newtropenija Lewkopenija Anemija
English: Verzenios 150 mg
Maltese: INFORMAZZJONI BIL-BRAILLE Verzenios 150 mg
English: A reduction in the risk of disease progression or death was observed in patients with visceral disease, (HR of 0.567 [95% CI: 0.407, 0.789]), median PFS 21.6 months versus 14.0 months; in patients with bone-only disease (HR 0.565, [95% CI: 0.306, 1.044]); and in patients with measurable disease (HR 0.517, [95% CI: 0.392, 0.681]).
Maltese: F'pazjenti li kienu qabel/qrib ilmenopawsa, il-proporzjon ta' periklu kien 0.415 (95% CI: 0.246, 0.698); f'pazjenti li kienu negattivi għar-riċettur tal-proġesteron, l-HR kien 0.509 (95% CI: 0.325, 0.797).
English: Overall survival was not mature at the final PFS analysis (133 events observed across the two arms).
Maltese: Is-sopravivenza globali ma kinitx matura fl-analiżi finali ta' PFS (133 avveniment osservati fiż-żewġ fergħat).
English: Diarrhoea
Maltese: Dijarea
English: • medicines that may reduce the effectiveness of Verzenios: o Carbamazepine (anti-epileptic used to treat seizures or fits) o Rifampicin, used to treat tuberculosis (TB) o Phenytoin (used to treat seizures) o St. John's wort (a herbal product used to treat mild depression and anxiety)
Maltese: o Carbamazepine (anti-epilettiku użat fil-kura tal-konvulżjonijiet jew l-aċċessjonijiet) o Rifampicin, użat fit-trattament tat-tuberkulożi (TB)
English: Approximately 25% of patients had primary endocrine resistance (progression on endocrine therapy within the first 2 years of adjuvant endocrine therapy or within the first 6 months of first line endocrine therapy for metastatic breast cancer) and for the majority, endocrine resistance developed later.
Maltese: Madwar 25% tal-pazjenti kellhom reżistenza endokrinali primarja (progressjoni fuq terapija endokrinali fi żmien l-ewwel sentejn ta' terapija endokrinali addizzjonali jew fi żmien l-ewwel 6 xhur ta' terapija endokrinali bħala l-ewwel għażla għal kanċer metastatiku tas-sider) u għall-biċċa l-kbira, ir-reżistenza endokrinali żviluppat wara. 59% tal pazjenti kellhom terapija endokrinali l-aktar riċenti fl-ambjent (neo)addizzjonali, u 38% fl-ambjent metastatiku.
English: and a Grade 3 or 4 decrease in neutrophil counts (based on laboratory findings) was reported in 28.2% of patients receiving abemaciclib in combination with aromatase inhibitors or fulvestrant.
Maltese: Newtropenija ġiet irrappurtata b'mod frekwenti (45.1%) u tnaqqis ta' Grad 3 jew 4 fl-għadd tan-newtrofili (abbażi ta' sejbiet tal-laboratorju) ġie rrappurtat fi 28.2% tal-pazjenti li kienu qed jirċievu abemaciclib flimkien ma' inibituri ta' aromatase jew fulvestrant.
English: Common Venous thromboembolismc
Maltese: Dijarea Rimettar Nawsja
English: Pyrexia
Maltese: Anzjani
English: Carcinogenicity
Maltese: Tromboċitopenija
English: - Verzenios 100 mg film-coated tablets are white, oval tablets debossed with “Lilly” on one side and “100” on the other.
Maltese: - Verzenios 100 mg pilloli miksijin b'rita huma pilloli ovali, bojod, imnaqqxa b'“Lilly” fuq naħa waħda u “100” fuq in-naħa l-oħra.
English: Neutropenia was reported frequently (45.1%).
Maltese: (52.1% CV).
English: 150 mg twice daily
Maltese: 150 mg darbtejn kuljum
English: In clinical studies, increases in serum creatinine occurred within the first month of abemaciclib dosing, remained elevated but stable through the treatment period, were reversible upon treatment discontinuation, and were not accompanied by changes in markers of renal function, such as blood urea nitrogen (BUN), cystatin C, or calculated glomerular filtration rate based on cystatin C.
Maltese: Fi studji kliniċi żidiet fil-kreatinina fis-serum seħħew fi żmien l-ewwel xahar ta' għoti tad-dożi ta' abemaciclib, baqgħu għoljin iżda stabbli matul il-perjodu ta' trattament, kienu riversibbli meta twaqqaf it-trattament, u ma kinux akkumpanjati minn bidliet fil-markaturi tal-funzjoni tal-kliewi, bħall-urea nitrogen fid-demm (BUN, blood urea nitrogen), cystatin C, jew ir-rata kklkulata ta' filtrazzjoni mill-glomeruli bbżata fuq cystatin C.
English: Concomitant use of strong CYP3A4 inducers (including, but not limited to: carbamazepine, phenytoin, rifampicin and St. John's wort) should be avoided due to the risk of decreased efficacy of abemaciclib.
Maltese: (li jinkludu, iżda mhux limitati għal: carbamazepine, phenytoin, rifampicin u St.
English: This will allow quick identification of new safety information.
Maltese: Ara l-fuljett għal aktar informazzjoni.
English: Patients were randomised in a 2:1 ratio to receive Verzenios 150 mg twice daily plus a non-steroidal aromatase inhibitor given daily at the recommended dose versus placebo plus a non-steroidal aromatase inhibitor according to the same schedule.
Maltese: Il-pazjenti ntagħżlu b'mod arbitrarju fi proporzjon ta' 2:1 biex jirċievu Verzenios 150 mg darbtejn kuljum flimkien ma' inibitur ta' aromatase li mhux sterojd mogħti kuljum bid-doża rrakkomandata versus plaċebo flimkien ma' inibitur ta' aromatase li mhux sterojd skont l-istess skeda.
English: After a single oral dose of [14C] -abemaciclib, approximately 81% of the dose was excreted in faeces and 3.4% excreted in urine.
Maltese: Wara doża waħda mill-ħalq ta' [14C] -abemaciclib, madwar 81% tad-doża tneħħiet fl ippurgar u 3.4% tneħħiet fl-awrina.
English: 50 mg twice daily
Maltese: 50 mg darbtejn kuljum