FrancophonIA/ELRC3.0 huggingface dataset:
English: A total of 666 postmenopausal women were randomised 2:1 to the palbociclib plus letrozole arm or placebo plus letrozole arm and were stratified by site of disease (visceral versus nonvisceral), disease-free interval from the end of (neo)adjuvant treatment to disease recurrence (de novo metastatic versus 12 months versus >12 months), and by the type of prior (neo)adjuvant anticancer therapies (prior hormonal therapy versus no prior hormonal therapy).
Maltese: Total ta' 666 mara li għaddew mill-menopawsa ntgħażlu b'mod każwali fi proporzjon ta' 2:1 għallparti tal-istudju dwar palbociclib flimkien ma' letrozole, jew għall-parti tal-istudju dwar il-plaċebo flimkien ma' letrozole, u kienu stratifikati permezz tal-post tal-marda (vixxerali kontra mhux vixxerali), intervall ħieles mill-marda mit-tmiem tat-trattament (neo) awżiljarja għal meta reġgħet qabdithom il-marda (metastatiku de novo kontra 12-il xahar kontra >12-il xahar), u mit-tip ta' terapiji kontra l-kanċer (neo) awżiljarji minn qabel (terapija ormonali minn qabel kontra l-ebda terapija ormonali minn qabel).
English: There was no obvious trend in the mean palbociclib fu in human plasma in vivo with worsening renal function.
Maltese: Ma kien hemm ebda tendenza ovvja fil-fu ta' palbociclib medja fi plasma umana in vivo hekk kif il-funzjoni tal-kliewi bdiet tiggrava.
English: Dose modification of IBRANCE is recommended based on individual safety and tolerability.
Maltese: Il-modifikazzjoni tad-doża ta' IBRANCE hija rakkomandata abbażi tas-sigurtà u t-tollerabbiltà talindividwu.
English: NAME OF THE MEDICINAL PRODUCT IBRANCE 100 mg hard capsules palbociclib
Maltese: IBRANCE 100 mg kapsuli ibsin palbociclib
English: - IBRANCE 125 mg is supplied as opaque, hard capsules, with a caramel body (printed “PBC 125” in white) and a caramel cap (printed “Pfizer” in white).
Maltese: - IBRANCE 125 mg huwa fornut bħala kapsuli opaki, ibsin, b'korp kulur il-karamell (“PBC 125” ipprintjata bl-abjad) u għatu kulur il-karamell (“Pfizer” ipprintjata bl-abjad).
English: Tabulated list of adverse reactions
Maltese: Lista tabulata ta' reazzjonijiet avversi tal-mediċina
English: More than half (62%) had an ECOG PS of 0, 60% had visceral metastases, and 60% had received more than 1 prior hormonal regimen for their primary diagnosis.
Maltese: Aktar min nofs (62%) kellhom ECOG PS ta' 0, 60% kellhom metastasi vixxerali, u 60% kienu rċivew aktar minn skeda ormonali waħda minn qabel għad-dijanjosi primarja tagħhom.
English: In addition, based on a population pharmacokinetic analysis that included 183 patients with advanced cancer, where 73 patients had mild renal impairment and 29 patients had moderate renal impairment, mild and moderate renal 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 73 pazjent kellhom indeboliment ħafif tal-kliewi u 29 pazjent kellhom indeboliment moderat tal-kliewi, l-indeboliment ħafif u moderat tal-kliewi ma kellu l-ebda effett fuq il-farmakokinetika ta' palbociclib.
English: Palbociclib-related findings in the testis, epididymis, prostate, and seminal vesicle included decreased organ weight, atrophy or degeneration, hypospermia, intratubular cellular debris, lower sperm motility and density, and decreased secretion.
Maltese: Sejbiet relatati ma' palbociclib fit-testikoli, fl-epididimu, fil-prostata, u fil-bużżieqa seminali, inkludew tnaqqis fil-piż talorgani, atrofija jew diġenerazzjoni, ipospermija, frak taċ-ċelluli intratubulari, tnaqqis fil-motilità jew fid-densità tal-isperma, u tnaqqis tat-tnixxija.
English: Management of some adverse reactions may require temporary dose interruptions/delays, and/or dose reductions, or permanent discontinuation as per dose reduction schedules provided in Tables 1, 2, and 3 (see sections 4.4 and 4.8).
Maltese: L-immaniġġjar ta' reazzjonijiet avversi jista' jeħtieġ interruzzjonijiet/dewmien, u/jew tnaqqis fid-doża, jew twaqqif permanenti skont l-iskedi tat-tnaqqis tad-doża pprovduti f'Tabelli 1, 2, u 3 (ara sezzjonijiet 4.4 u 4.8).
English: Palbociclib is a highly selective, reversible inhibitor of cyclin-dependent kinases (CDK) 4 and 6.
Maltese: Palbociclib huwa inibitur riversibbli selettiv ħafna, ta' kinases dipendenti fuq is-cyclin (CDK) 4 u 6. Cyclin D1 u CDK4/6 huma 'l isfel mill-passaġġi ta' senjalar li jwasslu għal proliferazzjoni ċellulari.
English: It is given together with aromatase inhibitors or fulvestrant, which are used as hormonal anticancer therapies.
Maltese: Dan jingħata flimkien ma' inibituri ta' aromatase jew fulvestrant, li jintużaw bħala terapiji ormonali ta' kontra l-kanċer.
English: The median time to first episode of any grade neutropenia was 15 days (12-700 days) and the median duration of Grade ≥3 neutropenia was 7 days across 3 randomised clinical studies.
Maltese: Iż-żmien medju għall-ewwel episodju ta' newtropenija ta' kwalunkwe grad kien ta' 15-il jum (12700 jum) u d-dewmien medjan tan-newtropenija ta' Grad ≥3 kien ta' 7 ijiem fit-3 studji kliniċi fejn ilpazjenti ntgħażlu b'mod każwali.
English: In the placebo plus fulvestrant arm, 15.5% of randomised patients received palbociclib and other CDK inhibitors as post progression subsequent treatments.
Maltese: 5% tal-pazjenti li ntgħażlu b'mod każwali rċivew palbociclib u inibituri ta' CDK oħra bħala trattamenti sussegwenti ta' wara l-progressjoni.
English: The mean Cmax of palbociclib is generally observed between 6 to 12 hours following oral administration.
Maltese: Is-Cmax medju ta' palbociclib huwa ġeneralment osservat bejn 6 sa 12-il siegħa wara l-għoti orali.
English: After a median follow-up time of 45 months, the final OS analysis was performed based on 310 events (60% of randomised patients).
Maltese: Wara żmien ta' segwitu medjan ta' 45 xahar, l-analiżi tal-OS finali ġiet imwettqa abbażi ta' 310 avvenimenti (60% tal-pazjenti li ntgħażlu b'mod każwali).
English: In vitro and in vivo studies indicate that palbociclib undergoes extensive hepatic metabolism in humans.
Maltese: Studji in vitro u in vivo jindikaw li palbociclib jgħaddi minn metaboliżmu estensiv fil-fwied filbnedmin.
English: At the time of the updated analyses, the median time from randomisation to second subsequent therapy was 38.8 months in the palbociclib + letrozole arm and 28.8 months in the placebo + letrozole arm, HR 0.73 (95% CI: 0.58, 0.91).
Maltese: Fiż-żmien tal-analiżi aġġornatiiż-żmien medjan minn randomization għat-tieni terapija sussegwenti kien ta' 38.8 xhar fil- palbociclib + letrozole u 28.8 xhur fil-plaċebo + letrozole HR 0.73 (95% CI:
English: Under fasting conditions, the coadministration of multiple doses of the proton pump inhibitor (PPI) rabeprazole with a single dose of 125 mg IBRANCE decreased palbociclib AUCinf and Cmax by 62% and 80%, respectively.
Maltese: Taħt kundizzjonijiet meta l-individwu jkun sajjem, l-għoti flimkien ta' diversi dożi ta' l-inibitur talpompa tal-protoni (PPI) rabeprazole ma' doża waħda ta' 125 mg ta' palbociclib, naqqas l-AUCinf u sCmax ta' palbociclib bi 62% u 80%, rispettivament.
English: Reduced foetal body weights were observed at a maternally toxic dose of 300 mg/kg/day in rats (3 times human clinical exposure based on AUC), and an increased incidence of skeletal variations, including small phalanges in the forelimb was observed at a maternally toxic dose of 20 mg/kg/day in rabbits (4 times human clinical exposure based on AUC).
Maltese: Kien osservat tnaqqis fil-piżijiet tal-ġisem tal-fetu f'doża tossika għall-omm ta' 300 mg/kg/jum fil-firien (3 darbiet l-esponiment kliniku tal-bniedem abbażi tal-AUC), u kienet osservata żieda fl-inċidenza ta' varjazzjonijiet skeletriċi, inkluż falanġi żgħar fis-saqajn ta' quddiem, f'doża tossika għall-omm ta' 20 mg/kg/jum fil-fniek (4 darbiet lesponiment kliniku tal-bniedem abbażi tal-AUC).
English: NAME OF THE MEDICINAL PRODUCT IBRANCE 75 mg hard capsules palbociclib
Maltese: IBRANCE 75 mg kapsuli ibsin palbociclib
English: This was evident for pre/perimenopausal women (HR of 0.46 [95% CI: 0.28, 0.75]) and postmenopausal women (HR of 0.52 [95% CI: 0.40, 0.66]) and patients with visceral site of metastatic disease (HR of 0.50 [95% CI: 0.38, 0.65]) and non-visceral site of metastatic disease (HR of 0.48 [95% CI: 0.33, 0.71]).
Maltese: Dan kien evidenti għal nisa qabel ma kellhom ilmenopawsa/waqt il-perimenopawsa (HR ta' 0.46 [95% CI: 0.28-0.75]) u nisa li jkunu għaddew millmenopawsa (HR ta' 0.52 [95% CI: 0.40-0.66]) u pazjenti b'sit vixxerali tal-marda metastatika (HR ta' 0.50
English: Based on in vitro data, palbociclib may inhibit the uptake transporter organic cationic transporter OCT1 and then may increase the exposure of medical product substrates of this transporter (e.g., metformin).
Maltese: Abbażi ta' data in vitro, palbociclib jista' jinibixxi t-trasportatur tal-assorbiment tat-trasportatur organiku katajoniku OCT1 u mbagħad jista' jżid l-esponiment tas-sottostrati tal-mediċini ta' dan ittrasportatur (eż. metformin).
English: intent-to-treat population) - PALOMA-2 study (31-May-2017)
Maltese: Dijagramma ta' Kaplan-Meier ta' sopravivenza bla progressjoni (evalwazzjoni talinvestigatur, popolazzjoni bl-intenzjoni li tiġi ttrattata) - studju PALOMA-2 (31 ta' Mejju 2017)
English: Propylene glycol
Maltese: Il-Gradi Kollha
English: Coadministration of CYP3A inducers may lead to decreased palbociclib exposure and consequently a risk for lack of efficacy.
Maltese: L-għoti flimkien ta' indutturi ta' CYP3A jista' jwassal għal tnaqqis fl-esponiment ta' palbociclib u konsegwentement riskju ta' nuqqas ta' effikaċja.
English: In 6 healthy male subjects given a single oral dose of [14C]palbociclib, a median of 92% of the total administered radioactive dose was recovered in 15 days; faeces (74% of dose) was the major route of excretion, with 17% of the dose recovered in urine.
Maltese: C]palbociclib, medjan ta' 92% taddoża radjuattiva totali mogħtija ġie rkuprat fi 15-il jum; l-ippurgar (74% tad-doża) kien ir-rotta maġġuri tal-eliminazzjoni, bi 17% tad-doża rkuprata fl-awrina.
English: Opaque, hard capsule, with a light orange body (printed “PBC 75” in white) and a light orange cap (printed “Pfizer” in white).
Maltese: Kapsula opaka, iebsa, b'korp oranġjo ċar (“PBC 75” ipprintjata bl-abjad) u għatu oranġjo ċar (“Pfizer” ipprintjata bl-abjad).
English: Under fed conditions (intake of a moderate-fat meal), coadministration of multiple doses of the proton pump inhibitor (PPI) rabeprazole with a single dose of 125 mg IBRANCE decreased palbociclib Cmax by 41%, but had limited impact on AUCinf (13% decrease) compared with a single dose of 125 mg IBRANCE administered alone.
Maltese: Taħt kundizzjonijiet meta l-individwu jkun kiel (it-teħid ta' ikla b'kontenut moderat ta' xaħam), lgħoti flimkien ta' diversi dożi tal-inibitur tal-pompa tal-protoni (PPI, proton pump inhibitor) rabeprazole ma' doża waħda ta' 125 mg ta' palbociclib, naqqas is-Cmax ta' palbociclib b'41%, iżda kellu impatt limitat fuq l-AUCinf (tnaqqis ta' 13%) meta mqabbel ma' doża waħda ta' 125 mg ta' palbociclib mogħti waħdu.
English: The geometric mean apparent oral clearance (CL/F) of palbociclib was 63 L/h, and the mean plasma elimination half-life was 28.8 hours in patients with advanced breast cancer.
Maltese: L-eliminazzjoni orali apparenti medja ġeometrika (CL/F) ta' palbociclib kienet ta' 63 L/h, u n-nofs ħajja medja tal-eliminazzjoni fil-plażma kienet ta' 28.8 siegħa f'pazjenti b'kanċer avvanzat tas-sider.
English: OR (measurable disease) [% (95% CI)] CBR [% (95% CI)]
Maltese: CBR [%] (95% CI)
English: What IBRANCE looks like and contents of the pack - IBRANCE 75 mg is supplied as opaque, hard capsules, with a light orange body (printed “PBC 75” in white) and a light orange cap (printed “Pfizer” in white).
Maltese: Kif jidher IBRANCE u l-kontenut tal-pakkett - IBRANCE 75 mg huwa fornut bħala kapsuli opaki, ibsin, b'korp oranġjo ċar (“PBC 75” ipprintjata bl-abjad) u għatu oranġjo ċar (“Pfizer” ipprintjata bl-abjad).
English: ALT=alanine aminotransferase; AST=aspartate aminotransferase; ILD=interstitial lung disease; N/n=number of patients; N/A=not applicable.
Maltese: ILD=marda interstizjali tal-pulmun; n=numru ta' pazjenti; N/A=mhux applikabli .
English: Grade ≥3 non-haematological toxicity (if persisting despite medical treatment)
Maltese: Tossiċità mhux ematoloġika ta' Grad ≥3 (jekk tippersisti minkejja trattament mediku)
English: Age, gender, and body weight
Maltese: Età, sess u piż tal-ġisem
English: i ILD/pneumonitis includes any reported PTs that are part of the Standardised MedDRA Query
Maltese: ILD/pulmonite tinkludi kwalunkwe PTs irrappurtati li huma parti mid-Domanda ta' MedDRA Standardizzata Marda Interstizjali tal-Pulmun (dejqa).
English: NAME OF THE MEDICINAL PRODUCT IBRANCE 125 mg hard capsules palbociclib
Maltese: IBRANCE 125 mg kapsuli ibsin palbociclib
English: The recommended dose is 125 mg of palbociclib once daily for 21 consecutive days followed by 7 days off treatment (Schedule 3/1) to comprise a complete cycle of 28 days.
Maltese: Id-doża rakkomandata hija ta' 125 mg ta' palbociclib darba kuljum għal 21 jum konsekuttiv segwiti minn 7 ijiem mingħajr trattament (Skeda 3/1) li jinkludu ċiklu komplut ta' 28 jum.
English: Based on a population pharmacokinetic analysis in 183 patients with cancer (50 male and 133 female patients, age ranging from 22 to 89 years, and body weight ranging from 38 to 123 kg), gender had no effect on the exposure of palbociclib, and age and body weight had no clinically important effect on the exposure of palbociclib.
Maltese: Abbażi ta' analiżi farmakokinetika tal-popolazzjoni f'183 pazjent b'kanċer (50 pazjent raġel u 133 pazjenti nisa, bl-età tvarja minn 22 sa 89 sena, u l-piż tal-ġisem li jvarja minn 38 sa 123 kg), issess ma kellux effett fuq l-esponiment ta' palbociclib, u l-età u l-piż tal-ġisem ma kellhom l-ebda effett klinikament importanti fuq l-esponiment ta' palbociclib.
English: The effect of palbociclib on the QT interval corrected for heart rate (QTc) interval was evaluated using time matched electrocardiogram (ECG) evaluating the change from baseline and corresponding pharmacokinetic data in 77 patients with advanced breast cancer.
Maltese: L-effett ta' palbociclib fuq l-intervall QT ikkoreġut għall-intervall tar-rata tal-qalb (QTc) kien evalwat bl-użu ta' elettrokardjogramma mqabbla mall-ħin (ECG) li tevalwa l-bidla mid-data ta' linja bażi u li tikkorrispondi ma' data farmakokinetika f'77 pazjenti b'kanċer tas-sider avvanzat.
English: The overall safety profile of IBRANCE is based on pooled data from 872 patients who received palbociclib in combination with endocrine therapy (N=527 in combination with letrozole and N=345 in combination with fulvestrant) in randomised clinical studies in HR-positive, HER2-negative advanced or metastatic breast cancer.
Maltese: Il-profil ġenerali dwar is-sigurtà ta' IBRANCE huwa bbażat fuq data miġbura minn 872 pazjent li rċivew palbociclib flimkien mat-terapija tal-endokrina (N=527 flimkien ma' letrozole u N=345 flimkien ma' fulvestrant) fi studji kliniċi li fihom il-parteċipanti ntgħażlu b'mod każwali, dwar kanċer tas-sider pożittiv għal HR, negattiv għal HER2, avvanzat jew metastatiku.
English: Therefore, administration of palbociclib with medicinal products that are substrates of P-gp (e.g., digoxin, dabigatran, colchicine) or BCRP (e.g., pravastatin, rosuvastatin, sulfasalazine) may increase their therapeutic effect and adverse reactions.
Maltese: Għaldaqstant, l-għoti ta' palbociclib ma' prodotti mediċinali oħrajn li huma sottostrati ta' P-gp (eż., digoxin, dabigatran, colchicine) jew ta' BCRP (eż., pravastatin, rosuvastatin, sulfasalazine) jista' jżid l-effett terapewtiku tagħhom u r-reazzjonijiet avversi.
English: Permanently discontinue IBRANCE in patients with severe ILD or pneumonitis (see section 4.2).
Maltese: Waqqaf IBRANCE b'mod permanenti f'pazjenti b'ILD jew pulmonite severa (ara sezzjoni 4.2).
English: Table 6 shows the efficacy results based on the primary and the updated analyses from the PALOMA-2 study, as assessed by the investigator and by the independent review.
Maltese: Tabella 6 turi r-riżultati tal-effikaċja bbażati fuq l-analiżi primarja u aġġornata mill-istudju PALOMA2, kif evalwat mill-investigatur u mir-reviżjoni indipendenti.
English: The majority of the material was excreted as metabolites.
Maltese: Il-maġġoranza tal-materjal kienet eliminata bħala metaboliti.
English: However, in a follow-up study with fresh tumour samples, no relation between RB1 expression and tumour response was observed.
Maltese: Madankollu, fi studju sussegwenti b'kampjuni ta' tumur frisk, ma ġietx osservata relazzjoni bejn l-espressjoni RB1 u rrispons tat-tumur.
English: • chest pain
Maltese: AST miżjud
English: The concomitant use of strong CYP3A inducers including, but not limited to: carbamazepine, enzalutamide, phenytoin, rifampin, and St. John's Wort should be avoided (see sections 4.3 and 4.4).
Maltese: L-użu fl-istess ħin ta' indutturi qawwija ta' CYP3A li jinkludu, iżda li mhumiex limitati għal: carbamazepine, enzalutamide, phenytoin, rifampin, u St.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON - 75 MG CAPSULES
Maltese: TIKKETTA TAL-FLIXKUN - 75 MG KAPSULI
English: Patients with advanced symptomatic, visceral spread, that were at risk of life-threatening complications in the short term (including patients with massive uncontrolled effusions [pleural, pericardial, peritoneal], pulmonary lymphangitis, and over 50% liver involvement), were not eligible for enrolment into the study.
Maltese: Pazjenti b'firxa vixxerali, sintomatika avvanzata li kienu f'riskju ta ' kumplikazzjonijiet ta' periklu għall-ħajja fit-terminu qasir (li jinkludu pazjenti bi effużjonijiet massiva mhux kontrollat [plewra, perikardjali, peritonali], lymphangitis pulmonari, u l-involviment tal-fwied aktar minn 50 %) , ma kinux eliġibbli għar-reġistrazzjoni fl-istudju
English: † 1-sided p-value from the log-rank test stratified by the presence of visceral metastases and sensitivity to prior endocrine therapy per randomisation.
Maltese: Mhux statistikament sinifikanti. valur-p ta' naħa waħda mit-test log-rank stratifikat bil-preżenza ta' metastasi vixxerali u s-sensittività għal terapija tal-endokrina preċedenti skont l-għażla każwali.
English: Other side effects with IBRANCE may include: Very common side effects (may affect more than 1 in 10 people): Infections Reduction in white blood cells, red blood cells, and blood platelets Feeling of tiredness Decreased appetite Inflammation of the mouth and lips (stomatitis), nausea, vomiting, diarrhoea Rash Hair loss Weakness Fever Abnormalities in liver blood tests Dry skin Common side effects (may affect up to 1 in 10 people): Fever with a drop in the white blood cell count (febrile neutropenia) Blurred vision, increased tearing, dry eye Alteration in taste (dysgeusia) Nosebleed Reporting of side effects If you get any side effects, talk to your doctor, pharmacist, or nurse.
Maltese: Infezzjonijiet u infestazzjonijiet Komuni ħafna Infezzjonijiet Disturbi tad-demm u tas-sistema limfatika Komuni ħafna Newtropenija Lewkopenija Anemija Tromboċitopenija Mhux komuni Newtropenija bid-deni Disturbi fil-metaboliżmu u n-nutrizzjoni Komuni ħafna Tnaqqis fl-aptit Disturbi fis-sistema nervuża Komuni Tibdil fis-sens tat-togħma Disturbi fl-għajnejn Komuni Vista mċajpra Żieda fid-dmugħ Għajn xotta Disturbi respiratorji, toraċiċi u medjastinali Komuni Epistassi
English: Cardiac electrophysiology
Maltese: Tagħrif farmakokinetiku
English: Opaque, hard capsule, with a light orange body (printed “PBC 100” in white) and a caramel cap (printed “Pfizer” in white).
Maltese: Kapsula opaka, iebsa, b'korp oranġjo ċar (“PBC 100” ipprintjata bl-abjad) u għatu kulur il-karamell (“Pfizer” ipprintjata bl-abjad).
English: Opaque, hard capsule, with a caramel body (printed “PBC 125” in white) and a caramel cap (printed “Pfizer” in white).
Maltese: Kapsula opaka, iebsa, b'korp kulur il-karamell (“PBC 125” ipprintjata bl-abjad) u għatu kulur ilkaramell (“Pfizer” ipprintjata bl-abjad).
English: Effect of tamoxifen on palbociclib exposure
Maltese: Effett ta' tamoxifen fuq l-esponiment ta' palbociclib
English: IBRANCE is for oral use.
Maltese: IBRANCE huwa għal użu orali.
English: ILD/pneumonitis*,i Gastrointestinal disorders
Maltese: Disturbi gastro-intestinali
English: It should be taken with food, preferably a meal to ensure consistent palbociclib exposure (see section 5.2).
Maltese: Għandu jittieħed mal-ikel, preferibbilment ma' ikla sabiex jiġi żgurat esponiment konsistenti ta' palbociclib (ara sezzjoni 5.2).
English: Table 4 reports the adverse reactions from the pooled dataset of 3 randomised studies.
Maltese: Tabella 4 tirrapporta l-ADRs mis-sett tad-data miġbur ta' 3 studji li fihom il-parteċipanti ntgħażlu b'mod każwali.
English: Administer IBRANCE with caution to patients with moderate or severe renal impairment, with close monitoring of signs of toxicity (see sections 4.2 and 5.2).
Maltese: Agħti IBRANCE b'kawtela lil pazjenti b'indeboliment moderat jew sever tal-kliewi b'monitoraġġ mill-qrib ta' sinjali ta' tossiċità (ara sezzjonijiet 4.2 u 5.2)
English: IBRANCE 75 mg hard capsules Each hard capsule contains 75 mg of palbociclib.
Maltese: IBRANCE 75 mg kapsuli ibsin Kull kapsula iebsa fiha 75 mg ta' palbociclib.
English: In vivo, palbociclib is a weak, time-dependent inhibitor of CYP3A.
Maltese: Palbociclib in vivo, huwa inibitur dgħajjef ta' CYP3A dipendenti fuq iż-żmien .
English: Excretion of unchanged palbociclib in faeces and urine was 2% and 7% of the administered dose, respectively.
Maltese: L-eliminazzjoni ta' palbociclib mhux mibdul fl-ippurgar u fl-awrina kien ta' 2% u ta' 7% tad-doża mogħtija, rispettivament.
English: Palbociclib was the major circulating drug-derived entity in plasma.
Maltese: Palbociclib kien l-entità maġġuri derivata mill-mediċina li tiċċirkola fil-plażma.
English: IBRANCE 125 mg hard capsules Each hard capsule contains 125 mg of palbociclib.
Maltese: IBRANCE 125 mg kapsuli ibsin Kull kapsula iebsa fiha 125 mg ta' palbociclib.
English: Pregnancy and breast-feeding and fertility
Maltese: Tqala u treddigħ u fertilità
English: The efficacy of palbociclib in combination with fulvestrant versus fulvestrant plus placebo was evaluated in an international, randomised, double-blind, parallel-group, multicentre study conducted in women with HR-positive, HER2-negative locally advanced breast cancer not amenable to resection or radiation therapy with curative intent or metastatic breast cancer, regardless of their menopausal status, whose disease progressed after prior endocrine therapy in the (neo)adjuvant or metastatic setting.
Maltese: L-effikaċja ta' palbociclib flimkien ma' fulvestrant meta mqabbla ma' fulvestrant flimkien ma' plaċebo, kienet evalwata fi studju internazzjonali, li fih il-parteċipanti ntgħażlu b'mod każwali, double-blind, ta' grupp parallel, b'aktar minn ċentru wieħed, imwettaq f'nisa b'kanċer avvanzat tassider, pożittiv għal HR, negattiv għal HER2, li ma jistax jiġi risezzjonat jew jirċievi terapija ta' radjazzjoni b'intenzjoni kurattivi jew kanċer tas-sider metastatiku irrispettivament mill-istatus talmenopawsa tagħhom, fejn il-marda tagħhom avvanzat wara terapija endokrinali minn qabel fl-isfond (neo)awżiljarju jew metastatiku.
English: Treatment of pre/perimenopausal women with the combination of palbociclib plus an aromatase inhibitor should always be combined with an LHRH agonist (see section 4.4).
Maltese: It-trattament ta' nisa qabel ma jkollhom ilmenopawsa/waqt il-perimenopausal b'palbociclib flimkien ma' inibitur ta' aromatase għandu dejjem jiġi ikkombinat ma' agonista ta' LHRH (ara sezzjoni 4.4).
English: Through inhibition of CDK4/6, palbociclib reduced cellular proliferation by blocking progression of the cell from G1 into S phase of the cell cycle.
Maltese: Permezz tal-inibizzjoni ta' CDK4/6, palbociclib naqqas il-proliferazzjoni ċellulari billi mblokka lprogress taċ-ċellula minn G1 fil-fażi S taċ-ċiklu taċ-ċelluli.