FrancophonIA/ELRC3.0 huggingface dataset:
English: Overall, neutropenia of any grade was reported in 716 (82.1%) patients receiving IBRANCE regardless of the combination, with Grade 3 neutropenia being reported in 500 (57.3%) patients, and Grade 4 neutropenia being reported in 97 (11.1 %) patients (see Table 4).
Maltese: B'mod ġenerali, in-newtropenija ta' kwalunkwe grad kienet irrappurtata f'716 (82.1%) -il pazjent li rċivew IBRANCE irrispettivament mill-kombinazzjoni, bin-newtropenija ta' Grad 3 li ġiet irrappurtata f'500 (57.3%) pazjent, u n-newtropenija ta' Grad 4 li ġiet irrappurtata f'97 (11.1 %) pazjent (ara Tabella 4).
English: In addition, based on a population pharmacokinetic analysis that included 183 patients with advanced cancer, where 40 patients had mild hepatic impairment based on National Cancer Institute (NCI) classification (total bilirubin ≤ Upper Limit of Normal (ULN) and Aspartate Aminotransferase (AST) > ULN, or total bilirubin >1.0 to 1.5 × ULN and any AST), mild hepatic impairment had no effect on the pharmacokinetics of palbociclib.
Maltese: Barra minn hekk, abbażi ta' analiżi farmakokinetika tal-popolazzjoni li inkludiet 183 pazjent b'kanċer avvanzat, fejn 40 pazjent kellhom indeboliment ħafif tal-fwied abbażi ta' klassifikazzjoni tan-National Cancer Institute (NCI) (bilirubina totali ≤ Limitu ta' Fuq tan-Normal (ULN,) u Aspartate Aminotransferase (AST) > ULN, jew bilirubina totali >1.0 sa 1.5 × ULN u kwalunkwe AST), lindeboliment ħafif tal-fwied ma kellu l-ebda effett fuq il-farmakokinetika ta' palbociclib.
English: The observed hazard ratio (HR) was 0.576 (95% confidence interval [CI]: 0.46, 0.72) in favour of palbociclib plus letrozole, with a stratified log-rank test 1-sided p-value of <0.000001.
Maltese: Ilproporzjon ta' periklu (HR, hazard ratio) osservat kien ta' 0.576 (95% CI: 0.46-0.72) favur palbociclib flimkien ma' letrozole, permezz ta' test log-rank stratifikat b'valur-p ta' naħa waħda ta' <0.
English: IBRANCE 100 mg hard capsules
Maltese: IBRANCE 100 mg kapsuli ibsin
English: Each hard capsule contains 93 mg of lactose (as monohydrate).
Maltese: Eċċipjenti b'effett magħruf Kull kapsula iebsa fiha 93 mg ta' lactose (bħala monohydrate).
English: • Dihydroergotamine and ergotamine used to treat migraine.
Maltese: • Dihydroergotamine u ergotamine użati sabiex jittrattaw il-migranja.
English: Absolute neutrophil counts (ANC) of ≥1000/mm3 and platelet counts of ≥50,000/mm3 are recommended to receive IBRANCE.
Maltese: Għadd ta' newtrofili assolut (ANC, absolute neutrophil counts) ta' ≥ 1000/mm u għadd tal-plejtlits ta'
English: EU/1/16/1147/005 (21 hard capsules) EU/1/16/1147/009 (63 hard capsules)
Maltese: EU/1/16/1147/005 (21 kapsula iebsa) EU/1/16/1147/009 (63 kapsula iebsa)
English: Effect of CYP3A inducers
Maltese: Effett ta' indutturi ta' CYP3A
English: The Kaplan-Meier curves for PFS based on the updated cutoff date of 31 May 2017 are displayed in Figure 1 below.
Maltese: Il-kurvi Kaplan-Meier għall-PFS ibbażati fuq id-data tal-għeluq aġġornata tal-31 ta' Mejju 2017 huma murija f'Figura 1 hawn taħt.
English: For patients with severe hepatic impairment (Child-Pugh class C), the recommended dose of IBRANCE is 75 mg once daily on Schedule 3/1 (see sections 4.4 and 5.2).
Maltese: Għal pazjenti b'indeboliment sever tal-fwied (klassi Ċ ta' Child-Pugh), id-doża rakkomandata ta' IBRANCE hija 75 mg darba kuljum fuq Skeda 3/1 (ara sezzjonijiet 4.4 u 5.2).
English: Updated analysis (23 October 2015 cutoff) IBRANCE plus fulvestrant (N=347)
Maltese: Analiżi Aġġornata (23 ta' Ottubru 2015, Data tal-Għeluq) IBRANCE flimkien ma' Fulvestrant
English: N=number of patients; CI=confidence interval; OR=objective response based on confirmed and unconfirmed responses according to RECIST 1.1; TTR=time to first tumour response.
Maltese: N=numru ta' pazjenti; CI =intervall ta' kunfidenza; OR =rispons oġġettiv ibbażat fuq risponsi kkonfermati u mhux ikkonfermati skont RECIST 1.1; TTR = żmien sal-ewwel rispons tat-tumur.
English: Effect of CYP3A inhibitors
Maltese: Effett ta' inibituri ta' CYP3A
English: Placebo plus letrozole (N=110)
Maltese: Plaċebo flimkien ma' letrozole (N=110)
English: IBRANCE 75 mg hard capsules IBRANCE 100 mg hard capsules IBRANCE 125 mg hard capsules palbociclib
Maltese: IBRANCE 75 mg kapsula iebsa IBRANCE 100 mg kapsula iebsa IBRANCE 125 mg kapsula iebsa palbociclib
English: Each hard capsule contains 74 mg of lactose (as monohydrate).
Maltese: Eċċipjenti b'effett magħruf Kull kapsula iebsa fiha 74 mg ta' lactose (bħala monohydrate).
English: Laboratory abnormalities observed in pooled dataset from 3 randomised studies (N=872)
Maltese: Anormalitajiet tal-laboratorju osservati f'sett tad-data miġbur minn 3 studji li fihom il-parteċipanti ntgħażlu b'mod każwali (N=872)
English: EU/1/16/1147/003 (21 hard capsules) EU/1/16/1147/008 (63 hard capsules)
Maltese: EU/1/16/1147/003 (21 kapsula iebsa) EU/1/16/1147/008 (63 kapsula iebsa)
English: Infections have been reported at a higher rate in patients treated with IBRANCE in randomised clinical studies compared to patients treated in the respective comparator arm. Grade 3 and Grade 4 infections occurred respectively in 4.5% and 0.7% of patients treated with IBRANCE in any combination (see section 4.8).
Maltese: Infezzjonijiet ta' Grad 3 u Grad 4 seħħew rispettivament f'4.5 % u 0.7% ta' pazjenti ttrattati b'IBRANCE fi kwalunke kombinazzjoni (ara sezzjoniji 4.8).
English: The primary endpoint of the study was progression-free survival (PFS) evaluated according to Response Evaluation Criteria in Solid Tumours (RECIST) v1.1, as assessed by investigator.
Maltese: Il-punt aħħari primarju tal-istudju kien is-sopravivenza bla progressjoni (PFS) evalwata skont ilKriterji ta' Evalwazzjoni tar-Reazzjoni f'Tumuri Solidi (RECIST, Response Evaluation Criteria in Solid Tumours) v1.1. kif evalwata mill-investigatur.
English: Kaplan-Meier plot of progression-free survival (investigator assessment, intent-to-treat population) - PALOMA-3 study (23 October 2015 cutoff)
Maltese: Dijagramma Kaplan-Meier ta' sopravivenza bla progressjoni (evalwazzjoni tal-investigatur, popolazzjoni bl-intenzjoni li tiġi ttrattata) - minn studju PALOMA-3 (23 ta' Ottubru 2015 data tal-għeluq tad-data)
English: 63 hard capsules
Maltese: 21 kapsula iebsa 63 kapsula iebsa
English: Capsule shell
Maltese: MG KAPSULI
English: IBRANCE 75 mg hard capsules
Maltese: IBRANCE 75 mg kapsuli ibsin
English: Monitor patients for pulmonary symptoms indicative of ILD/pneumonitis (e.g. hypoxia, cough, dyspnoea).
Maltese: Immonitorja l-pazjenti għal sintomi pulmonari indikattivi ta' ILD/pulmonite (eż. nuqqas ta' ossiġenu fit-tessuti, sogħla, qtugħ ta' nifs).
English: An updated analysis of the primary and secondary endpoints was performed after an additional 15 months of follow up (data cutoff date: 31-May-2017).
Maltese: Analiżi aġġornata tal-punti aħħarin primarji u sekondarji saret wara 15-il xahar addizzjonali ta' segwitu (id-data tal-għeluq tad-data: 31 ta' Mejju 2017).
English: All Grades n (%)
Maltese: Terminu Ppreferut n (%)
English: Table 5 reports the laboratory abnormalities observed in pooled datasets from 3 randomised studies.
Maltese: Tabella 5 tirrapporta l-anormalitajiet tal-laboratorju osservati f'settijiet tad-data miġbura minn 3 studji li fihom il-parteċipanti ntgħażlu b'mod każwali.
English: Drug-drug interaction between palbociclib and letrozole
Maltese: Interazzjoni bejn palbociclib u letrozole
English: Primary Analysis (26 February 2016 Cutoff)
Maltese: Analiżi Primarja (Data ta' għeluq 26 ta' Frar 2016)
English: Placebo plus letrozole (N=112)
Maltese: Plaċebo flimkien ma' letrozole (N=112)
English: IBRANCE 125 mg hard capsules
Maltese: IBRANCE 125 mg kapsuli ibsin
English: The pharmacokinetics of palbociclib were characterised in patients with solid tumours including advanced breast cancer and in healthy volunteers.
Maltese: Il-farmakokinetika ta' palbociclib kienet ikkaratterizati f'pazjenti b'tumuri solidi inkluż kanċer avvanzat tas-sider u f'voluntiera f'saħħithom.
English: Each carton contains 21 hard capsules (3 blister strips per pack) or 63 hard capsules (9 blister strips per pack).
Maltese: Kull kartuna fiha 21 kapsula iebsa (3 strixxi bil-folji għal kull pakkett) jew 63 kapsula iebsa (9 strixxi bil-folji għal kull pakkett).
English: Vision blurred
Maltese: Marda Vixxerali
English: How to store IBRANCE 6.
Maltese: Kif taħżen IBRANCE 6.
English: Febrile neutropenia has been reported in 0.9% of patients receiving IBRANCE in combination with fulvestrant and in 1.7% of patients receiving palbociclib in combination with letrozole.
Maltese: In-newtropenija bid-deni ġiet irrappurtata f'0.9% tal-pazjenti li jirċievu IBRANCE flimkien ma' fulvestrant, u f'1.7% tal-pazjenti li jirċievu palbociclib flimkien ma' letrozole.
English: The most common (≥20%) adverse reactions of any grade reported in patients receiving palbociclib in randomised clinical studies were neutropenia, infections, leukopenia, fatigue, nausea, stomatitis, anaemia, diarrhoea, alopecia and thrombocytopenia.
Maltese: L-aktar reazzjonijiet avversi tal-mediċina (ADRs, adverse drug reactions) komuni (≥20%) ta' kwalunkwe grad irrappurtati f'pazjenti li kienu qed jirċievu palbociclib fi studji kliniċi li fihom ilparteċipanti ntgħażlu b'mod każwali kienu n-newtropenija, l-infezzjonijiet, il-lewkopenija, l-għeja, iddardir, l-istomatite, l-anemija, id-dijarea, l-alopeċja u t-tromboċitopenija.
English: If Grade 4 on Day 22, see Grade 4 dose modification guidelines below.
Maltese: Jekk Grad 4 f'Jum 22, ara l-linji gwidi għall-modifikazzjoni tad-doża ta' Grad 4 hawn taħt.
English: What IBRANCE contains - The active substance is palbociclib.
Maltese: X'fih IBRANCE - Is-sustanza attiva hija palbociclib.
English: Based on male reproductive organ findings (seminiferous tubule degeneration in testis, epididymal hypospermia, lower sperm motility and density, and decreased prostate secretion) in nonclinical safety studies, male fertility may be compromised by treatment with palbociclib (see section 5.3).
Maltese: Abbażi ta' sejbiet dwar l-organu riproduttiv tal-irġiel (deġenerazzjoni tat-tubi seminiferi fit-testikoli, ipospermija epididimali, motilità u densità aktar baxxa tal-isperma, u tnaqqis fit-tnixxija tal-isperma) fi studji mhux kliniċi dwar is-sigurtà, il-fertilità tal-irġiel tista' tkun kompromessa mit-trattament b'palbociclib (ara sezzjoni 5.3).
English: Hazard ratio [(95% CI) and p-value]
Maltese: Proporzjon ta' periklu [(95% CI) u valur p]
English: - IBRANCE 100 mg hard capsule: each capsule contains 100 mg palbociclib.
Maltese: - IBRANCE 100 mg kapsula iebsa: kull kapsula fiha 100 mg palbociclib.
English: The median age of patients enrolled in this study was 62 years (range 28-89), 48.3% of patients had received chemotherapy and 56.3% had received antihormonal therapy in the (neo)adjuvant setting prior to their diagnosis of advanced breast cancer while 37.2% of patients had received no prior systemic therapy in the (neo)adjuvant setting.
Maltese: L-età medjana tal-pazjenti rreġistrati f'dan l-istudju kienet ta' 62 sena (medda 28-89), 48.3% tal-pazjenti kienu rċivew il-kimoterapija u 56.3% kienu rċivew terapija kontra l-ormoni fl-isfond (neo) awżiljarju qabel id-dijanjosi tagħhom ta' kanċer avvanzat tas-sider filwaqt li 37.2% tal-pazjenti ma kienu rċivew l-ebda terapija sistemika minn qabel fl-isfond (neo) awżiljarju.
English: Comparator arms*
Maltese: Fergħat tal-komparatur*
English: Each hard capsule contains 56 mg of lactose (as monohydrate).
Maltese: Eċċipjenti b'effett magħruf Kull kapsula iebsa fiha 56 mg ta' lactose (bħala monohydrate).
English: Palbociclib did not affect mating or fertility in female rats at any dose tested up to 300 mg/kg/day (approximately 3 times human clinical exposure based on AUC), and no adverse effects were observed in female reproductive tissues in repeat-dose toxicity studies up to 300 mg/kg/day in the rat and 3 mg/kg/day in the dog (approximately 5 and 3 times human clinical exposure based on AUC, respectively).
Maltese: Palbociclib ma affettwax it-tgħammir jew il-fertilità fil-firien nisa fi kwalunkwe doża ttestjata sa 300 mg/kg/jum (bejn wieħed u ieħor 3 darbiet l-esponiment kliniku tal-bniedem abbażi tal-AUC) u lebda effett avvers ma kien osservat fit-tessuti riproduttivi tan-nisa fi studji dwar l-effett tossiku b'dożi ripetuti sa 300 mg/kg/jum fil-firien u 3 mg/kg/jum fil-klieb (bejn wieħed u ieħor 5 u 3 darbiet lesponiment kliniku tal-bniedem abbażi tal-AUC, rispettivament).
English: Secondary efficacy endpoints
Maltese: Rappurtar tal-effetti sekondarji
English: Peak palbociclib unbound exposure (unbound Cmax) was increased by 7%, 38% and 72% for mild, moderate and severe hepatic impairment, respectively, relative to subjects with normal hepatic function.
Maltese: L-esponiment massimu mhux marbut ta' palbociclib (Cmax mhux marbut) żdied b'7%, bi 38% u bi 72% għal indeboliment tal-fwied ħafif, moderat u sever, rispettivament, fir-rigward ta' individwi b'funzjoni normali tal-fwied.
English: PC: SN: NN:
Maltese: Fi kwalunkwe ħin:
English: Palbociclib-related neoplastic finding in rats included an increased incidence of microglial cell tumours in the central nervous system of males at 30 mg/kg/day; there were no neoplastic findings in female rats at any dose up to 200 mg/kg/day.
Maltese: Is-sejba neoplastika relatata ma' palbociclib fil-firien inkludiet żieda fl-inċidenza ta' tumuri fiċ-ċelluli mikroglijali fissistema nervuża ċentrali tal-irġiel f'doża ta' 30 mg/kg/jum; ma kien hemm l-ebda sejba neoplastika filfirien nisa fi kwalunkwe doża sa 200 mg/kg/jum.
English: Effects of palbociclib on the pharmacokinetics of other medicinal products
Maltese: L-effetti ta' palbociclib fuq il-farmakokinetika ta' prodotti mediċinali oħrajn
English: Critical visceral disease
Maltese: Mard vixxerali kritiku
English: In vitro studies with human hepatocytes, liver cytosolic and S9 fractions, and recombinant sulphotransferase (SULT) enzymes indicated that CYP3A and SULT2A1 are mainly involved in the metabolism of palbociclib.
Maltese: L-istudji in vitro bl-epatoċiti tal-bnedmin, ċitostoliku tal-bnedmin u frazzjonijiet S9, u enzimi ta' sulfotransferase (SULT) rikombinanti indikaw li CYP3A u ULT2A1 prinċiparjament huma involuti fil-metaboliżmu ta' palbociclib.
English: Contains lactose.
Maltese: Użu orali.
English: Palbociclib did not prolong the QTc to any clinically relevant extent at the recommended dose of 125 mg daily (Schedule 3/1).
Maltese: Palbociclib ma tawwalx il-QTc sa xi punt klinikament rilevanti bid-doża rakkomandata ta' 125 mg kuljum (Skeda
English: Palbociclib was not mutagenic in a bacterial reverse mutation (Ames) assay and did not induce structural chromosomal aberrations in the in vitro human lymphocyte chromosome aberration assay.
Maltese: Palbociclib ma kienx mutaġeniku f'assaġġ (Ames) tal-mutazzjoni batterjali inversa u ma induċiex aberazzjonijiet kromożomali strutturali fl-assaġġ tal-aberazzjonijiet kromożomali tal-limfoċiti talbnedmin in vitro.
English: Palbociclib is a reversible inhibitor of cyclin-dependent kinases 4 and 6, which are both involved in regulating the cell cycle.
Maltese: Palbociclib huwa inibitur riversibbli ta' kinase 4 u 6 dipendenti fuq is-cyclin, li huma t-tnejn involuti fir-regolamentazzjoni taċ-ċiklu taċ-ċelluli.
English: Effects of other medicinal products on the pharmacokinetics of palbociclib
Maltese: L-effetti ta' prodotti mediċinali oħrajn fuq il-farmakokinetika ta' palbociclib
English: The median duration of palbociclib treatment across the pooled dataset at the time of the final overall survival (OS) analysis was 14.8 months.
Maltese: It-tul medjan tat-trattament b'palbociclib madwar d-dataset miġbura fiż-żmien talanaliżi finali tas-sopravivenza globali (OS - overall survival) kien 14.8 xhur.
English: Coadministration of multiple 600 mg doses of rifampin with a single 125 mg palbociclib dose decreased palbociclib AUCinf and Cmax by 85% and 70%, respectively, relative to a single 125 mg palbociclib dose given alone.
Maltese: L-għoti flimkien ta' diversi dożi ta' 600 mg ta' rifampin ma' doża waħda ta' 125 mg ta' palbociclib, naqqas l-AUCinf u s-Cmax ta' palbociclib bi 85% u 70%, rispettivament, meta mqabbel ma' doża waħda ta' 125 mg ta' palbociclib mogħtija waħidha.
English: - IBRANCE 75 mg hard capsule: each capsule contains 75 mg palbociclib.
Maltese: - IBRANCE 75 mg kapsula iebsa: kull kapsula fiha 75 mg palbociclib.
English: When coadministered with palbociclib, the recommended dose of fulvestrant is 500 mg administered intramuscularly on Days 1, 15, 29, and once monthly thereafter.
Maltese: Meta mogħtija flimkien ma' palbociclib, id-doża rakkomandata ta' fulvestrant hija ta' 500 mg mogħtija ġol-muskolu f'Jiem 1, 15, 29, u darba fix-xahar wara dan.
English: - IBRANCE 125 mg hard capsule: each capsule contains 125 mg palbociclib.
Maltese: - IBRANCE 125 mg kapsula iebsa: kull kapsula fiha 125 mg palbociclib.
English: The adverse reactions are listed by system organ class and frequency category.
Maltese: Ir-reazzjonijiet avversi huma elenkati skont is-sistema tal-klassifika tal-organi u l-kategorija talfrekwenza.
English: The median age of patients enrolled in this study was 57 years (range 29, 88).
Maltese: L-età medjana tal-pazjenti rreġistrati f'dan l-istudju kienet ta' 57 sena (medda 29, 88).
English: The study met its primary endpoint of prolonging investigator-assessed PFS at the interim analysis conducted on 82% of the planned PFS events; the results crossed the prespecified Haybittle-Peto efficacy boundary (α=0.00135), demonstrating a statistically significant prolongation in PFS and a clinically meaningful treatment effect.
Maltese: L-istudju ssodisfa l-punt aħħari primarju tiegħu li jtawwal il-PFS evalwata mill-investigatur fl-analiżi interim imwettqa fi 82% tal-avvenimenti ppjanati tal-PFS; ir-riżultati qasmu l-livell ta' effikaċja Haybittle-Peto speċifikat minn qabel (α=0.00135), u dan juri titwil statstikament sinifikanti fil-PFS u effett tat-trattament b'rilevanza klinika sinifikanti.
English: Palbociclib induced micronuclei via an aneugenic mechanism in Chinese Hamster Ovary cells in vitro and in the bone marrow of male rats at doses ≥100 mg/kg/day.
Maltese: Palbociclib induċa mononukleji permezz ta' mekkaniżmu anewġeniku f'ċelluli tal-Ovarju tal-Ħamster Ċiniż in vitro u fil-mudullun ta' firien irġiel f'dożi ta' ≥100 mg/kg/jum.
English: Coadministration of multiple 200 mg doses of itraconazole with a single 125 mg palbociclib dose increased palbociclib total exposure (AUCinf) and the peak concentration (Cmax) by approximately 87% and 34%, respectively, relative to a single 125 mg palbociclib dose given alone.
Maltese: L-għoti flimkien ta' diversi dożi ta' 200 mg ta' itraconazole ma' doża waħda ta' 125 mg ta' palbociclib żied l-esponiment totali ta' palbociclib (AUCinf) u l-konċentrazzjoni massima (Cmax) b'bejn wieħed u ieħor 87% u 34%, rispettivament, meta mqabbel ma' doża waħda ta' 125 mg ta' palbociclib mogħtija waħidha.
English: The majority of patients (97.4%) had metastatic disease at baseline, 23.6% of patients had bone-only disease, and 49.2% of patients had visceral disease.
Maltese: Il-maġġoranza talpazjenti (97.4%) kellhom marda metastatika fil-linja bażi, 23.6% tal-pazjenti kellhom marda talgħadam biss u 49.2% tal-pazjenti kellhom marda vixxerali.
English: Final overall survival (OS) (13 April 2018 cutoff) Number of events (%) Median [months (95% CI)] Hazard ratio (95% CI) and p-value†
Maltese: Sopravivenza globali (OS) finali (13 ta' April 2018 data tal-għeluq tad-data) Numru ta' avvenimenti (%) Medjan [xhur (95% CI)] Proporzjon ta' periklu (95% CI) u valur-p p=0.0429 CBR=rispons ta' benefiċċju kliniku; CI=intervall ta' kunfidenza; N=numru ta' pazjenti; OR=rispons oġġettiv.
English: Pharmacokinetics of palbociclib has not been evaluated in patients <18 years of age.
Maltese: Il-farmakokinetika ta' palbociclib ma ġewx evalwati f'pazjenti l-età ta' <18-il sena.
English: - IBRANCE 100 mg is supplied as opaque, hard capsules, with a light orange body (printed “PBC 100” in white) and a caramel cap (printed “Pfizer” in white).
Maltese: - IBRANCE 100 mg huwa fornut bħala kapsuli opaki, ibsin, b'korp oranġjo ċar (“PBC 100” ipprintjata bl-abjad) u għatu kulur il-karamell (“Pfizer” ipprintjata bl-abjad).
English: Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency, or glucose-galactose malabsorption should not take this medicine.
Maltese: Pazjenti li għandhom problemi ereditarji rari ta' intolleranza għall-galactose, nuqqas ta' Lapp lactase jew malassorbiment tal-glucose-galactose m'għandhomx jieħdu din il-mediċina.
English: The efficacy and safety of palbociclib have not been studied in patients with critical visceral disease (see section 5.1).
Maltese: L-effikaċja u s-sigurtà ta' palbociclib ma ġewx studjati f'pazjenti b'mard vixxerali kritiku (ara Sezzjoni 5.1 ).
English: Approximately 20% of patients were pre/perimenopausal.
Maltese: Bejn wieħed u ieħor, 20% tal-pazjenti kienu nisa qabel ma jkollhom il-menopawsa/waqt il-perimenopawsa.
English: In a pharmacokinetic study in healthy volunteers, palbociclib AUCinf and Cmax values were 30% and 35% higher, respectively, in Japanese subjects compared with non-Asian subjects after a single oral dose.
Maltese: Fi studju farmakokinetiku fuq voluntiera b'saħħithom, il-valuri tal-AUCinf u s-Cmax ta' palbociclib kienu 30% u 35% ogħla, rispettivament, f'individwi Ġappuniżi meta mqabbla ma' individwi mhux Asjatiċi wara doża orali waħda.
English: * letrozole or fulvestrant
Maltese: FUL=fulvestrant;
English: • Carbamazepine and phenytoin, used to stop seizures or fits.
Maltese: • Carbamazepine, u phenytoin, użati sabiex iwaqqfu l-aċċessjonijiet.
English: Coadministration of multiple doses of palbociclib with midazolam increased the midazolam AUCinf and Cmax values by 61% and 37%, respectively, as compared with administration of midazolam alone.
Maltese: L-għoti flimkien ta' diversi dożi ta' palbociclib ma' midazolam żied il-valuri talAUCinf u tas-Cmax ta' midazolam b'61% u 37%, rispettivament, meta mqabbel mal-għoti ta' midazolam waħdu.
English: No dose adjustments are required for coadministration of palbociclib with moderate CYP3A inducers (see section 4.5).
Maltese: L-ebda aġġustament fid-doża mhu meħtieġ għal indutturi moderati ta' CYP3A (ara sezzjoni 4.4).
English: Coadministration of multiple 400 mg daily doses of modafinil, a moderate CYP3A inducer, with a single 125 mg IBRANCE dose decreased palbociclib AUCinf and Cmax by 32% and 11%, respectively, relative to a single 125 mg IBRANCE dose given alone.
Maltese: L-għoti flimkien ta' diversi dożi ta' kuljum ta' 400 mg ta' modafinil, induttur moderat ta' CYP3A, ma' doża waħda ta' 125 mg ta' IBRANCE, naqqas l-AUCinf u s-Cmax ta' palbociclib bi 32% u 11%, rispettivament, meta mqabbel għal doża waħda ta' 125 mg ta' IBRANCE mogħtija waħidha.
English: GENERAL CLASSIFICATION FOR SUPPLY 15.
Maltese: Effetti sekondarji possibbli 5.
English: Compared to palbociclib given under overnight fasted conditions, the AUCinf and Cmax of palbociclib increased by 21% and 38% when given with high-fat food, by 12% and 27% when given with low-fat food, and by 13% and 24% when moderate-fat food was given 1 hour before and 2 hours after palbociclib dosing.
Maltese: Meta mqabbel ma' palbociclib mogħti taħt kundizzjonijiet ta' sawm tul lejl, l-AUCinf u s-Cmax ta' palbociclib żdiedu b'21% u bi 38% meta mogħti ma' ikel b'kontenut għoli ta' xaħam, bi 12% u b'27% meta mogħti ma' ikel b'kontenut baxx ta' xaħam, u bi 13% u b'24% meta ngħata ikel b'kontenut moderat ta' xaħam siegħa qabel u sagħtejn wara d-doża ta' palbociclib.