FrancophonIA/ELRC3.0 huggingface dataset:
English: Combination therapy with capecitabine and docetaxel in locally advanced or metastatic breast cancer Data from one multicentre, randomised, controlled phase III clinical trial support the use of capecitabine in combination with docetaxel for treatment of patients with locally advanced or metastatic breast cancer after failure of cytotoxic chemotherapy, including an anthracycline.
Maltese: Terapija kombinata b'capecitabine u docetaxel f'kanċer avvanzat lokalment jew metastatiku tas-sider Tagħrif minn prova klinika waħda kkontrollata, multiċentrali u b'għażliet każwali ta' fażi
English: The following factors were pre-specified in the statistical analysis plan for inclusion in the model: age, time from surgery to randomisation, gender, carcinoembryonic antigen (CEA) levels at baseline, lymph nodes at baseline, and country.
Maltese: Il-fatturi li ġejjin kienu speċifikati minn qabel fil-pjan ta' analiżi statistika għallinklużjoni fil-mudell: età, ħin mill-kirurġija sal-għażla każwali, sess, livelli ta' antiġen karċinoembrijoniku (CEA - carcinoembryonic antigen) fil-linja bażi, glandoli limfatiċi fil-linja bażi, u pajjiż.
English: The XELIRI regimens included capecitabine 1,000 mg/m² twice daily on days 1 to 14 of a 3-week cycle combined with irinotecan 250 mg/m² on day 1.
Maltese: Il-korsijiet ta' XELIRI kienu jinkludu capecitabine 1,000 mg/m² darbtejn kuljum fi ġranet 1 sa 14 ta' ċiklu ta' 3 ġimgħat flimkien ma' irinotecan 250 mg/m² f'jum 1.
English: Bone marrow depression, +Febrile neutropenia
Maltese: Depressjoni talmudullun, +Newtropenija biddeni
English: A clinically significant interaction between brivudine and fluoropyrimidines (e.g. capecitabine, 5-fluorouracil, tegafur), resulting from the inhibition of dihydropyrimidine dehydrogenase by brivudine, has been described.
Maltese: Ġiet deskritta interazzjoni ta' sinifikanza klinika bejn brivudine u fluoropyrimidines (eż. capecitabine,
English: Median progression free survival ITT
Maltese: Sopravivenza mingħajr progressjoni
English: - ECX: epirubicin (50 mg/m² as a bolus on day 1 every 3 weeks), cisplatin (60 mg/m² as a two hour infusion on day 1 every 3 weeks), and capecitabine (625 mg/m² twice daily continuously).
Maltese: - ECX: epirubicin (50 mg/m² bħala bolus fl-ewwel jum kull 3 ġimgħat), cisplatin (60 mg/m²
English: Following oral administration of 825 mg/m² capecitabine twice daily for 14 days, Japanese patients (n = 18) had about 36 % lower Cmax and 24 % lower AUC for capecitabine than Caucasian patients (n = 22).
Maltese: Wara l-għoti mill-ħalq ta' 825 mg/m² capecitabine darbtejn kuljum għal 14-il jum, pazjenti Ġappuniżi (n = 18) kellhom Cmax għal capecitabine madwar 36 % inqas u AUC 24 % inqas minn pazjenti
English: Light peach coloured, oblong shaped, biconvex tablet, debossed with ‘150' on the one side and plain on the other side.
Maltese: Pillola ta' lewn isfar fl-aħmar ċar, ta' forma oblunga, bikonvessi, imnaqqxa bin-numru ‘150' fuq naħa u lixxi fuq in-naħa l-oħra.
English: • medicines for seizures or tremors (phenytoin)
Maltese: • suffejra (sfura fil-ġilda u fl-għajnejn)
English: Placebo or Bevacizumab
Maltese: Prothrombin imtawwal
English: In this trial, 944 patients were randomised to 3-week cycles for 24 weeks with capecitabine (1,000 mg/m² twice daily for 2 weeks followed by a 1-week rest period) in combination with oxaliplatin (130 mg/m² intravenous infusion over 2 hours on day 1 every 3 weeks); 942 patients were randomised to bolus 5-FU and leucovorin.
Maltese: darbtejn kuljum għall-ġimagħtejn segwit b'perijodu ta' mistrieħ ta' ġimgħa) flimkien ma' oxaliplatin (130 mg/m² infużjoni fil-vini fuq medda ta' sagħtejn fl-ewwel ġurnata kull 3 ġimgħat); 942 pazjent kienu magħżula b'mod każwali għall-bolus 5-FU u leucovorin.
English: The results of a meta-analysis of 14 clinical trials with data from over 4,700 patients treated with capecitabine showed that in all studies combined, increasing age (by 10 year increments) was statistically significantly associated with an increased risk of developing HFS and diarrhoea and with a decreased risk of developing neutropenia.
Maltese: Ir-riżultati ta' meta-analiżi ta' 14-il prova klinika b'tagħrif minn aktar minn 4,700 pazjent ittrattati b'capecitabine wrew li fl-istudji kollha kombinati, żieda fl-età (b'żjidiet ta' 10 snin) kienet assoċjati b'mod statistikament sinifikanti ma' żieda fir-riskju ta' żvilupp ta' HFS u dijarea u ma' riskju mnaqqas ta' żvilupp ta' newtropenija.
English: Following grade 3 HFS, subsequent doses of capecitabine should be decreased.
Maltese: HFS ta' grad 3, id-dożi ta' capecitabine li jmissu għandhom jiġu mnaqqsa.
English: Hypomagnesaemia,
Maltese: Lewkopenija, Anemija emolitika,
English: Median PFS was 10.0 and 8.9 months; p = 0.64, overall survival 25.7 and 27.5 months; p = 0.55 and response rates 45.5 and 39.8 %; p = 0.32 for FOLFIRI-Bev and XELIRI-Bev, respectively.
Maltese: 27.5 xhur; p = 0.55 u r-rati ta' rispons kienu ta' 45.5 u 39.8 %; p = 0.
English: Since metabolism of R-warfarin was not affected, these results indicate that capecitabine down-regulates isozyme 2C9, but has no effect on isozymes 1A2 and 3A4.
Maltese: Billi l metaboliżmu ta' R-warfarin ma kienx affettwat, dawn ir-riżultati jindikaw li capecitabine jnaqqas l-attività ta' isoenżima 2C9, iżda m'għandu l-ebda effect fuq l-isoenżimi 1A2 u 3A4.
English: An analysis of safety data in patients ≥ 60 years of age treated with capecitabine monotherapy and an analysis of patients treated with capecitabine plus docetaxel combination therapy showed an increase in the incidence of treatment-related grade 3 and 4 adverse reactions and treatment-related serious adverse reactions compared to patients < 60 years of age.
Maltese: Analiżi ta' tagħrif dwar is-sigurtà f'pazjenti b'età ta' ≥ 60 sena ttrattati b'monoterapija ta' capecitabine u analiżi ta' pazjenti ttrattati b'terapija mħalta ta' capecitabine flimkien ma' docetaxel uriet żieda flinċidenza ta' reazzjonijiet avversi ta' grad 3 u 4 u ta' reazzjonijiet avversi serji relatati mat-trattament meta mqabbla ma' pazjenti b'età ta' < 60 sena.
English: • gout medicines (allopurinol)
Maltese: • għoqiedi taħt il-ġilda (lipoma)
English: Data from one multicentre, randomised, controlled phase 3 clinical trial in patients with stage III (Dukes' C) colon cancer supports the use of capecitabine in combination with oxaliplatin (XELOX) for the adjuvant treatment of patients with colon cancer (NO16968 study).
Maltese: Tagħrif minn prova klinika multiċentrali, ta' fażi 3 f'pazjenti b'kanċer tal-kolon ta' stadju III (Dukes Ċ) li ntgħażlu b'mod każwali u b'kontrolli jsostni l-użu ta' capecitabine flimkien ma' oxaliplatin
English: - EOX: epirubicin (50 mg/m² as a bolus on day 1 every 3 weeks), oxaliplatin (130 mg/m² given as a 2 hour infusion on day 1 every three weeks), and capecitabine (625 mg/m² twice daily continuously).
Maltese: - EOX: epirubicin (50 mg/m² bħala bolus fl-ewwel jum kull 3 ġimgħat), oxaliplatin (130 mg/m²
English: Hyperglycaemia
Maltese: Enċefalopatija
English: Gastrointestinal haemorrhage, Constipation, Upper abdominal pain, Dyspepsia, Flatulence, Dry mouth
Maltese: Fwawar, Pressjoni baxxa, Kriżi ipertensiva, Fwawar, Infjammazzjoni filvini
English: Tablet coating
Maltese: Doża kollha
English: - ECF: epirubicin (50 mg/ m² as a bolus on day 1 every 3 weeks), cisplatin (60 mg/m² as a two hour infusion on day 1 every 3 weeks) and 5-FU (200 mg/m² daily given by continuous infusion via a central line).
Maltese: - ECF: epirubicin (50 mg/ m² bħala bolus fl-ewwel jum kull 3 ġimgħat), cisplatin (60 mg/m²
English: - EOF: epirubicin (50 mg/m² as a bolus on day 1 every 3 weeks), oxaliplatin (130 mg/m² given as a 2 hour infusion on day 1 every three weeks), and 5-FU (200 mg/m² daily given by continuous infusion via a central line).
Maltese: - EOF: epirubicin (50 mg/m² bħala bolus fl-ewwel jum kull 3 ġimgħat), oxaliplatin (130 mg/m²
English: Hydronephrosis, Urinary incontinence, Haematuria, Nocturia, Blood creatinine increased
Maltese: Inkontinenza talawrina, Ematurja, Nokturja,
English: The parameters of capecitabine, 5'-DFCR and 5'-DFUR measured on days 1 and 14 were similar.
Maltese: Il parametri ta' capecitabine, 5'-DFCR) u 5-DFUR) mkejla fl-ewwel u fl-14-il jum kienu jixxiebħu.
English: Sepsis, Urinary tract infection, Cellulitis, Tonsillitis,
Maltese: Sadd intestinali, Axxite, Enterite,
English: Colon, colorectal and gastric cancer
Maltese: Purpura, Sindrome ta' tifkira tarradjazzjoni
English: Patients receiving concomitant capecitabine and oral coumarin-derivative anticoagulant therapy should have their anticoagulant response (International Normalised Ratio [INR] or prothrombin time) monitored closely and the anticoagulant dose adjusted accordingly (see section 4.5).
Maltese: [INR - International Normalised Ratio] jew ħin protrombin) osservat b'attenzjoni kbira u d-doża antikoagulanti mibdula skont ir-riżultat (ara sezzjoni 4.5).
English: Data from a multicentre, randomised, controlled phase III clinical trial in patients with advanced gastric cancer supports the use of capecitabine for the first-line treatment of advanced gastric cancer (ML17032).
Maltese: III multiċentrali,f'pazjenti b'kanċer avvanzat tal-istonku li ntgħażlu b'mod każwali u b'kontrolli jissapportja l-użu ta' capecitabine għat-trattament primarju ta' kanċer avvanzat tal-istonku (ML 17,032).
English: Febrile neutropenia, Pancytopenia, Granulocytopenia, Thrombocytopenia, Leukopenia, Haemolytic anaemia, INR increased/Prothrombin time prolonged
Maltese: • emboli fil-vini fil-pulmun (emboliżmu pulmonari), kollass tal-pulmun, sogħla bid-demm, ażżma, qtugħ ta' nifs mal-eżerċizzju
English: Back pain, Arthralgia pain, Facial pain, Musculoskeletal stiffness, Muscular weakness
Maltese: Uġigħ fix-xedaq, Spażmi fil-muskoli,
English: The ratio of 5-FU concentration in tumour to plasma was 21.4 (ranged from 3.9 to 59.9, n = 8) whereas the ratio in healthy tissues to plasma was 8.9 (ranged from 3.0 to 25.8, n = 8).
Maltese: (li kienet tvarja minn 3.9 għal 59.9, n = 8) filwaqt li l-proporzjon f'tessuti f'saħħithom għal plażma kienet ta' 8.9 (li kienet tvarja minn 3.0 għal 25.
English: • Stevens-Johnson syndrome: if you experience painful red or purplish rash that spreads and blisters and/or other lesions begin to appear in the mucous membrane (e.g. mouth and lips), in particular if you had before light sensitivity, infections of the respiratory system (e.g. bronchitis) and/or fever.
Maltese: - Sindrome ta' Stevens-Johnson: jekk ikollok raxx juġgħa ta' lewn aħmar jew jagħti fil-vjola li jinfirex u nfafet u/jew leżjonijiet oħra jibdew jidhru fil-membrani mukużi (eż. ħalq u xufftejn), b'mod partikolari jekk qabel kellek sensittività għad-dawl, infezzjonijiet tas-sistema respiratorju (eż. bronkite) u/jew deni.
English: Vascular disorders Lower limb oedema, Hypertension, +Embolism and thrombosis
Maltese: Pressjoni għolja, +Emboliżmu u trombożi
English: Finally, β-ureido-propionase cleaves FUPA to FBAL which is cleared in the urine.
Maltese: Finalment, β-ureido-propionase jkisser FUPA għal FBAL li jitneħħa fl-awrina.
English: Discontinue permanently or If physician deems it to be in the patient's best interest to continue, interrupt until resolved to grade 0-1
Maltese: Jekk it-tabib huwa tal-fehma li huwa fl-aħjar interess tal-pazjent li jkompli, interrompi sakemm riżolta għal grad 0 - 1
English: Sequential treatment consisted of first-line capecitabine (1,250 mg/m² twice daily for 14 days), second-line irinotecan (350 mg/m² on day 1), and third-line combination of capecitabine (1,000 mg/m² twice daily for 14 days) with oxaliplatin (130 mg/m² on day 1).
Maltese: Trattament sekwenzjali ikkonsista minn capecitabine (1,250 mg/m² darbtejn kuljum għal 14-il ġurnata) bħala trattament primarju, irinotecan (350 mg/m² fl-ewwel ġurnata) bħala trattament sekondarju, u taħlita ta'
English: Joint swelling, Bone
Maltese: Oxaliplatin fl-Ewwel Ġurnata, kull
English: • if you have a history of eye problems as you may need extra monitoring of your eyes,
Maltese: • jekk għandek storja ta' problemi fl-għajnejn għandu mnejn ikollok bżonn aktar monitoraġġ ta'
English: • narrowing or blockage of tear duct (lacrimal duct stenosis)
Maltese: • huma tidjiq jew imblokk tal-kanal tad-dmugħ (stenosi tal-kanal tad-dmugħ)
English: There is some evidence that dexpanthenol is effective for HFS prophylaxis in patients treated with capecitabine.
Maltese: Hemm xi evidenza li dexpanthenol huwa effettiv għall-profilassi ta' HFS f'pazjenti ttrattati b'capecitabine.
English: At the dose of 1,250 mg/m² on day 14 with administration after food intake, the peak plasma concentrations (Cmax in µg/ml) for capecitabine, 5'-DFCR, 5'-DFUR, 5-FU and FBAL were 4.67, 3.05, 12.1, 0.95 and 5.46 respectively.
Maltese: B'doża ta' 1,250 mg/m² fl-14-il jum bl-għoti wara t-teħid tal-ikel, ilkonċentrazzjonijiet massimi fil-plażma (Cmax f'µg/ml) ta' capecitabine, 5'-DFCR, 5'-DFUR, 5-FU u
English: • infections of the lungs or respiratory system (e.g. pneumonia or bronchitis)
Maltese: • infezzjonijiet fil-pulmun jew fis-sistema tal-apparat respiratorju (eż. pulmonite jew bronkite)
English: For patients with partial DPD deficiency (such as those with heterozygous mutations in the DPYD gene) and where the benefits of capecitabine are considered to outweigh the risks (taking into account the suitability of an alternative non-fluoropyrimidine chemotherapeutic regimen), these patients must be treated with extreme caution and frequent monitoring with dose adjustment according to toxicity.
Maltese: Għal pazjenti b'defiċjenza parzjali ta' DPD (bħal dawk b'mutazzjonijiet eterozigotiċi fil-ġene DPYD) u fejn il-benefiċċji ta' capecitabine huma meqjusa li jiżbqu r-riskji (b'konsiderazzjoni tal-adegwatezza ta' kors kimoterapewtiku alternattiv li ma fihx fluoropyrimidine), dawn il-pazjenti għandhom jiġu ttrattati b'attenzjoni kbira ħafna u monitoraġġ frekwenti b'aġġustament tad-doża skont it-tossiċità.
English: Dysphagia, Rectal haemorrhage, Abdominal pain lower, Oral dysaesthesia, Paraesthesia oral, Hypoaesthesia oral,
Maltese: Distensjoni addominali, marda tarrifluss gastro osofagali, Uġigħ filħalq, Disfaġija, Emorraġija mirrektum, Uġigħ fil-parti t'isfel tal-addome, Disestesija orali, parestesija orali, Ipoestesija, Skomdu addominali
English: • swelling (oedema), chills and rigors
Maltese: • Is-sustanzi mhux attivi l-oħra huma:
English: Capecitabine is first metabolised by hepatic carboxylesterase to 5'-DFCR, which is then converted to 5'-DFUR by cytidine deaminase, principally located in the liver and tumour tissues.
Maltese: Bijotrasformazzjoni Capecitabine huwa immetabolizzat l-ewwel minn carboxylesterase epatika għal 5'-DFCR, li wara huwa mibdul fi 5'-DFUR minn cytidine deaminase, li jinsab prinċipalment fil-fwied u fit-tessuti bittumur.
English: 5-Fluorouracil 400 mg/m² intravenous bolus, followed by
Maltese: 5-Fluorouracil 400 mg/m² fil-vini bolus, segwit minn 600 mg/ m² fil-vini 22 hr
English: Based on a pharmacokinetic study in cancer patients with mild to severe renal impairment, there is no evidence for an effect of creatinine clearance on the pharmacokinetics of intact drug and 5-FU.
Maltese: m'hemm l-ebda evidenza ta' effett tat-tneħħija tal-kreatinina fuq il-farmakokinetika tal-mediċina intatta u ta' 5-FU.
English: XELOX showed a trend towards superior OS with a HR of 0.87 (95 % CI = [0.72; 1.05]; p = 0.1486) which translates into a 13 % reduction in risk of death.
Maltese: 72; 1.05]; p = 0.1486) li tirriżulta fi tnaqqis ta' 13 % fir-riskju ta' mewt.
English: Capecitabine is a non-cytotoxic fluoropyrimidine carbamate, which functions as an orally administered precursor of the cytotoxic moiety 5-FU.
Maltese: Capecitabine huwa fluoropyrimidine carbamate mhux ċitotossiku, li jiffunzjona bħala prekursur mogħti mill-ħalq tal-parti tal-molekola ċitotossika 5-FU).
English: Parameter: Overall survival PPP
Maltese: 6.4 Prekawzjonijiet speċjali għall-ħażna
English: In the primary analysis for DFS in the ITT population, XELOX was shown to be significantly superior to 5-FU/LV (HR = 0.80, 95 % CI = [0.69; 0.93]; p = 0.0045).
Maltese: 95 % CI=[0.69; 0.93]; p = 0.0045).
English: • vertigo, ear pain
Maltese: • deidratazzjoni, telf tal-piż
English: ThyPase activity was measured and found to be 4 times greater in primary colorectal tumour than in adjacent normal tissue.
Maltese: L-attività ta' ThyPase kienet imkejla u nstabet li kienet 4 darbiet iżjed f'tumur primarju tal-kolon u tar-rektum milli f'tessut normali fil-qrib.
English: In addition to the ADRs described in tables 4 and 5, the following ADRs with an incidence of less than 0.1 % were associated with the use of capecitabine monotherapy based on a pooled analysis from clinical safety data from 7 clinical trials including 949 patients (2 phase III and 5 phase II clinical trials in metastatic colorectal cancer and metastatic breast cancer): cardiomyopathy, cardiac failure, sudden death, and ventricular extrasystoles.
Maltese: Barra mill-ADRs deskritti f'Tabelli 4 u 5, ibbażat fuq analiżi globali minn tagħrif dwar is-sigurtà klinika minn 7 provi kliniċi li kienu jinkludu 949 pazjent (2 provi kliniċi ta' fażi
English: Blister, Skin ulcer, Rash, Urticaria, Photosensitivity reaction, Palmar erythema, Swelling face, Purpura, Radiation recall syndrome
Maltese: • diffikultà biex titkellem, indeboliment tal-memorja, telf tal-koordinazzjoni tal-moviment, disturb fil-bilanċ, ħass ħażin, ħsara fin-nervi (newropatija) u problemi bis-sensazzjoni
English: Combination treatment consisted of first-line capecitabine (1,000 mg/m² twice daily for 14 days) combined with irinotecan (250 mg/m² on day 1) (XELIRI) and second-line capecitabine (1,000 mg/m² twice daily for 14 days) plus oxaliplatin
Maltese: bħala trattament primarju u capecitabine (1,000 mg/m² darbtejn kuljum għal 14-il ġurnata) u oxaliplatin (130 mg/m² fl-ewwel ġurnata) bħala trattament sekondarju.
English: Brivudine must not be administered concomitantly with capecitabine.
Maltese: Brivudine Brivudine m'għandux jingħata fl-istess waqt ma' capecitabine.
English: Biotransformation
Maltese: Sistema talġisem
English: Pharyngolaryngeal pain, Dysphonia
Maltese: Uġigħ fid-dahar, Artralġja
English: The hazard ratio for overall survival was 0.94 (95 % CI: 0.89; 1.00, p = 0.0489) indicating that capecitabine-containing regimens are non-inferior to 5-FU-containing regimens.
Maltese: Il-hazard ratio għas-sopravivenza globali kien 0.94 (95 % CI: 0.89; 1.00, p = 0.
English: There was no clinically significant effect of bevacizumab on the pharmacokinetic parameters of capecitabine or its metabolites in the presence of oxaliplatin.
Maltese: Ma kien hemm l-ebda effett ta' sinifikanza klinika ta' bevacizumab fuq il-parametri farmakokinetiċi ta' capecitabine jew tal-metaboliti tiegħu fil-preżenza ta' oxaliplatin.
English: Data from a randomised multicentre, phase III study comparing capecitabine to 5-FU and oxaliplatin to cisplatin in patients with advanced gastric cancer supports the use of capecitabine for the first-line treatment of advanced gastric cancer (REAL-2).
Maltese: Tagħrif minn studju ta' fazi III b'pazjenti li ntgħażlu b'mod każwali u multiċentrali li qabbel capecitabine ma' 5-FU u oxaliplatin ma' cisplatin f'pazjenti b'kanċer avvanzat tal-istonku jissapportja l-użu ta' capecitabine bħala trattament primarju ta' kanċer avvanzat tal-istonku (REAL-2).
English: Peach coloured, oblong shaped, biconvex tablet, debossed with ‘500' on the one side and plain on the other side.
Maltese: Pillola ta' lewn aħmar fl-isfar, ta' forma oblunga, bikonvessi, imnaqqxa bin-numru ‘500' fuq naħa u lixxi fuq in-naħa l-oħra.
English: As this medicinal product contains anhydrous lactose as an excipient, patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.
Maltese: Peress li dan il-prodott mediċinali fih lactose anidru bħala eċċipjent, pazjenti bi problemi ereditarji rari ta' intolleranza għal galactose, nuqqas talapp lactase jew assorbiment ħażin ta' glucose-galactose m'għandhomx jieħdu din il-mediċina.
English: • specific changes in the electrocardiogram (QT prolongation)
Maltese: • bidliet speċifiċi fl-elettrokardjogramma (titwil tal-QT)
English: Hiccups,
Maltese: Vertigo,
English: • skin rash, hair loss (alopecia), skin reddening, dry skin, itching (pruritus), skin discolouration,
Maltese: • raxx tal-ġilda, twaqqigħ ħafif tax-xagħar (alopeċja), ħmura fil-ġilda, ġilda xotta, ħakk (pruritus),
English: A population pharmacokinetic analysis was carried out after capecitabine treatment of 505 patients with colorectal cancer dosed at 1,250 mg/m² twice daily.
Maltese: Farmakokinetiċi f'popolazzjonijiet speċjali Analiżi farmakokinetika fuq il-popolazzjoni kienet magħmula wara t-trattament b'capecitabine f'505 pazjenti b'kanċer tal-kolon u tar-rektum li ngħataw doża ta' 1,250 mg/m² darbtejn kuljum.
English: Some of the ADRs are reactions commonly seen with the combination medicinal product (e.g. peripheral sensory neuropathy with docetaxel or oxaliplatin, hypertension seen with bevacizumab); however an exacerbation by capecitabine therapy can not be excluded.
Maltese: newropatija periferali tas-sensi ma' docetaxel jew oxaliplatin, pressjoni għolja osservata ma' bevacizumab); iżda rkadar ikkawżat minn terapija ta' capecitabine ma jistax jiġi eskluż.
English: Table 9 Key efficacy results for the non-inferiority analysis of study NO16967 PRIMARY ANALYSIS
Maltese: Tabella 9 Riżultati importanti tal-effikaċja għall-analiżi ta' nuqqas ta' inferjorità ta' studju
English: The analysis for the secondary endpoint of RFS
Maltese: Mard tas-sistema nervuża ċentrali jew periferali
English: In this trial, 627 patients with metastatic colorectal carcinoma who have received prior treatment with irinotecan in combination with a fluoropyrimidine regimen as first line therapy were randomised to treatment with XELOX or FOLFOX-4.
Maltese: F'din il-prova, 627 pazjent b'karċinoma metastatika talkolorektum li rċevew trattament minn qabel b'irinotecan flimkien ma' kors ta' fluoropyrimidine bħala trattament primarju kienu magħżula każwalment għat-trattament b'XELOX jew FOLFOX-4.
English: No clinically significant differences in exposure to capecitabine or its metabolites, free platinum or total platinum occurred when capecitabine was administered in combination with oxaliplatin or in combination with oxaliplatin and bevacizumab.
Maltese: L-ebda differenzi ta' sinifikanza klinika fl-espożizzjoni għal capecitabine jew għall-metaboliti tiegħu, platinum ħieles jew platinum totali ma dehru meta capecitabine ingħata f'taħlita ma' oxaliplatin jew f'taħlita ma' oxaliplatin u bevacizumab.
English: Patients with hepatic impairment due to liver metastases According to a pharmacokinetic study in cancer patients with mild to moderate liver impairment due to liver metastases, the bioavailability of capecitabine and exposure to 5-FU may increase compared to patients with no liver impairment.
Maltese: Pazjenti b'indeboliment tal-fwied minħabba metastasi fil-fwied Skont studju farmakokinetiku f'pazjenti bil-kanċer, b'indeboliment tal-fwied ħafif għal moderat minħabba metastasi fil-fwied, il-biodisponibiltà ta' capecitabine u l-espożizzjoni għal 5-FU jistgħu jiżdiedu meta mqabbla ma' pazjenti bl-ebda indeboliment tal-fwied.
English: Permanent discontinuation should be considered based on clinical assessment of the onset, duration and severity of the observed toxicities.
Maltese: Twaqqif permanenti għandu jiġi kkunsidrat ibbażat fuq valutazzjoni klinika tal-bidu, tul u severità tattossiċitajiet osservati.
English: In addition to the ADRs described in tables 4 and 5, and based on the above pooled analysis from clinical safety data from 7 clinical trials, encephalopathy was also associated with the use of capecitabine monotherapy with an incidence of less than 0.1 %.
Maltese: Barra mill-ADRs deskritti fit-Tabelli 4 u 5, u bbażat fuq analiżi globali minn tagħrif kliniku dwar issigurtà minn 7 provi kliniċi, enċefalopatija wkoll kienet assoċjata mal-użu ta' capecitabine bħala monoterapija b'inċidenza ta' inqas minn 0.1 %.