FrancophonIA/ELRC3.0 huggingface dataset:
English: Thymidine phosphorylase activity was measured and found to be 4 times greater in primary colorectal tumour than in adjacent normal tissue.
Maltese: L-attività ta' thymidine phosphorylase kienet imkejla u nstabet li kienet 4 darbiet iżjed f'tumur primarju tal-kolon u tar-rektum milli f'tessut normali fil-qrib.
English: Do not use this medicine after the expiry date which is stated on the carton and blister after EXP.
Maltese: Tużax din il-mediċina wara d-data ta' meta tiskadi li tidher fuq il-kartuna u l-folja wara EXP.
English: Interaction with other medicinal products
Maltese: Interazzjoni ma' prodotti mediċinali oħra
English: For the capecitabine dose of 1000 mg/m2 twice daily on days 1 to 14 every 3 weeks, a frequency of 22% to 30% of all-grade HFS was observed in capecitabine combination therapy.
Maltese: Għad-doża ta' 1000 mg/m capecitabine darbtejn kuljum fi ġranet 1 sa 14 kull 3 ġimgħat, kienet osservata frekwenza ta' HFS ta' kull grad ta' 22% sa 30% f'terapija kombinata ta' capecitabine.
English: Each film-coated tablet contains 7 mg anhydrous lactose.
Maltese: Eċċipjent b'effett magħruf Kull pillola miksija b'rita fiha 7 mg anhydrous lactose.
English: Monotherapy with capecitabine in metastatic colorectal cancer Data from two identically-designed, multicentre, randomised, controlled phase III clinical trials (SO14695; SO14796) support the use of capecitabine for first line treatment of metastatic colorectal cancer.
Maltese: Monoterapija b'capecitabine f'kanċer metastatiku tal-kolon u tar-rektum Informazzjoni minn żewġ provi kliniċi kkontrollati ta' fażi 3 iddisinjati b'mod identiku, multicentre u randomised (SO14695; SO14796), jissapportjaw l-użu ta' capecitabine għat-trattament primarju ta' kanċer metastatiku tal-kolon u tar-rektum.
English: - sleeplessness (insomnia), depression - headache, sleepiness, dizziness, abnormal sensation in the skin (numbness or tingling sensation), taste changes - eye irritation, increased tears, eye redness (conjunctivitis) - inflammation of the veins (thrombophlebitis) - shortness of breath, nose bleeds, cough, runny nose - cold sores or other herpes infections - infections of the lungs or respiratory system (e.g. pneumonia or bronchitis) - bleeding from the gut, constipation, pain in upper abdomen, indigestion, excess wind, dry mouth - skin rash, hair loss (alopecia), skin reddening, dry skin, itching (pruritus), skin discolouration,
Maltese: tnemnim jew tingiż), bidliet fit-togħma - irritazzjoni fl-għajnejn, żieda fid-dmugħ, ħmura fl-għajnejn (konġuntivite) - infjammazzjoni fil-vini (tromboflebite) - qtugħ ta' nifs, fsada mill-imnieħer, sogħla, imnieħer inixxi - ponot tad-deni jew infezzjonijiet oħra kkawżati minn herpes - infezzjonijiet fil-pulmun jew fis-sistema respiratorja (eż. pnewmonja jew bronkite) - fsada mill-musrana, stitikezza, uġigħ fl-addome ta' fuq, indiġestjoni, gass żejjed, ħalq xott - raxx tal-ġilda, telf ta' xagħar (alopeċja), ħmura tal-ġilda, ġilda xotta, ħakk (pruritus), tibdil fil kulur tal-ġilda, telf tal-ġilda, infjammazzjoni tal-ġilda, disturb fid-dwiefer - uġigħ fil-ġogi, jew fir-riġlejn jew dirgħajn (estremitajiet), sider jew dahar - deni, nefħa fir-riġlejn jew dirgħajn, tħossok ma tiflaħx - problemi bil-funzjoni tal-fwied (osservati fit-testijiet tad-demm) u żieda ta' bilirubin fid-demm
English: Median survival was 392 days (capecitabine) vs. 391 days (Mayo regimen).
Maltese: Is-sopravivenza medja kienet ta' 392 jum (capecitabine) vs.
English: Ecansya tablets should be swallowed whole with water within 30 minutes after a meal.
Maltese: Pilloli Ecansya għandhom jinbelgħu sħaħ mal-ilma fi żmien 30 minuta wara ikla.
English: What Ecansya looks like and contents of the pack Ecansya 150 mg film-coated tablets (tablets) are light peach coloured, oblong shaped, biconvex tablets of 11.4 mm in length and 5.3 mm in width, debossed with "150" on one side and plain on other side.
Maltese: Ecansya 150 mg pilloli miksija b'rita (pilloli) huma pilloli ta' lewn il-ħawħ ċari, f'għamla oblong, imżaqqin fuq żewġ naħat ta' tul ta' 11.4 mm u wisa' ta' 5.3 mm, imnaqqxa b'”150” fuq naħa waħda u mingħajr kitba fuq in-naħa l-oħra.
English: An analysis of safety data in patients treated with capecitabine monotherapy (colorectal cancer) with baseline renal impairment showed an increase in the incidence of treatment-related grade 3 and 4 adverse reactions compared to patients with normal renal function (36% in patients without renal impairment n=268, vs. 41% in mild n=257 and 54% in moderate n=59, respectively) (see section 5.2).
Maltese: Analiżi ta' tagħrif dwar is-sigurtà f'pazjenti ttrattati b'monoterapija ta' capecitabine (kanċer tal-kolon u tar-rektum) u b'indeboliment tal-kliewi fil-linja bażi, uriet żieda fl-inċidenza ta' reazzjonijiet avversi ta' grad 3 u 4 relatati mat-trattament meta mqabbla ma' pazjenti b'funzjoni renali normali (36% f'pazjenti mingħajr indeboliment tal-kliewi n=268, vs. 41% f'indeboliment ħafif n=257 u 54% f'indeboliment moderat n=59, rispettivament) (ara sezzjoni 5.2).
English: In a preplanned multivariate Cox analysis, superiority of capecitabine compared with bolus 5-FU/LV was demonstrated.
Maltese: F'analiżi Cox multivarjat, ippjanat minn qabel, kienet dimostrata is-superjorità ta' capecitabine meta mqabbel ma' 5-FU/LV bħala bolus.
English: In first-line treatment the median progression-free survival in the intent-to-treat population was 5.8 months (95%CI 5.1 - 6.2 months) for capecitabine monotherapy and 7.8 months (95%CI 7.0 - 8.3 months; p=0.0002) for XELIRI.
Maltese: Fit-trattament primarju l-medjan tas-sopravivenza mingħajr progessjoni fil-popolazzjoni b'intenzjoni li jiġu trattati kien ta' 5.8 xhur (CI ta' 95% 5.1 - 6.2 xhur) għall-monoterapija b'capecitabine u 7.8 xhur (CI ta' 95% 7.0 - 8.3 xhur; p=0.0002) għal XELIRI.
English: In patients with moderate renal impairment at baseline, a dose reduction to 75% for a starting dose of 1250 mg/m2 is recommended.
Maltese: F'pazjenti b'indeboliment moderat tal-kliewi fil-linja bażi, tnaqqis fid-doża ta' 75% għal doża tal-bidu ta' 1250 mg/m2 huwa rakkomandat.
English: - Ecansya 500 mg film-coated tablets Hypromellose (6cps)
Maltese: - Ecansya 500 mg pilloli miksijin b'rita Hypromellose (6cps)
English: Pain in jaw, Muscle spasms, Trismus, Muscular weakness
Maltese: Uġigħ fix-xedaq, Spażmi fil-muskoli, Trismus, Indebboliment muskolari
English: - EOX: epirubicin (50 mg/m 2 as a bolus on day 1 every 3 weeks), oxaliplatin (130 mg/m 2 given as a 2 hour infusion on day 1 every three weeks), and capecitabine (625 mg/m 2 twice daily continuously).
Maltese: - EOX: epirubicin (50 mg/m 2 bħala bolus fl-ewwel jum kull 3 ġimgħat), oxaliplatin (130 mg/m mogħti bħala infużjoni fuq medda ta' sagħtejn fl-ewwel jum kull 3 ġimgħat), u capecitabine (625 mg/m 2 darbtejn kuljum b'mod kontinwu).
English: Caution must be exercised in patients with central or peripheral nervous system disease, e.g. brain metastasis or neuropathy (see section 4.8).
Maltese: Trid tingħata attenzjoni lill-pazjenti b'mard fis-sistema nervuża ċentrali jew periferali eż. metastasi filmoħħ jew newropatija (ara sezzjoni 4.8).
English: For patients 60 years of age or more, a starting dose reduction of capecitabine to 75% (950 mg/m2 twice daily) is recommended.
Maltese: Għall-pazjenti li għandhom 60 sena jew aktar, tnaqqis fid-doża tal-bidu ta' capecitabine għal 75% (950 mg/m darbtejn kuljum) huwa rakkomandat.
English: The results indicate that XELOX is equivalent to FOLFOX-4 in terms of overall survival (see table 7).
Maltese: Ir-riżultati jindikaw li XELOX huwa ekwivalenti għal FOLFOX-4 f'termini ta' sopravivenza globali (ara tabella 7).
English: DPD deficiency: DPD deficiency is a rare condition present at birth that is not usually associated with health problems unless you receive certain medicines.
Maltese: Defiċjenza ta' DPD hija kondizzjoni rari preżenti mit-twelid li normalment ma tkunx assoċjata ma' problemi ta' saħħa jekk ma tiħux ċertu mediċini.
English: In combination treatment, the recommended starting dose of capecitabine should be reduced to 800 - 1000 mg/m2 when administered twice daily for 14 days followed by a 7-day rest period, or to 625 mg/m2 twice daily when administered continuously (see section 5.1).
Maltese: F'terapija kombinata, id-doża rakkomandata tal-bidu ta' capecitabine għandha titnaqqas għal 8001000 mg/m2 meta mogħti darbtejn kuljum għal 14-il ġurnata segwit minn perjodu ta' waqfien ta' sebat ijiem, jew għal 625 mg/m2 darbtejn kuljum meta mogħti b'mod kontinwu (ara sezzjoni 5.1).
English: Rare/Very Rare (Post-Marketing Experience)
Maltese: Rari/Rari Ħafna (Esperjenza ta' wara t-Tqegħid fis-Suq)
English: 5-Fluorouracil 400 mg/m intravenous bolus, followed by 600 mg/ 2 intravenous 22 hr
Maltese: 400 mg/m2 fil-vini bolus, segwit minn
English: In all studies combined, the following covariates were statistically significantly associated with an increased risk of developing HFS: increasing capecitabine starting dose (gram), decreasing cumulative capecitabine dose (0.1*kg), increasing relative dose intensity in the first six weeks, increasing duration of study treatment (weeks), increasing age (by 10 year increments), female gender, and good ECOG performance status at baseline (0 versus ≥1).
Maltese: 1*kg), żieda fl-intensità tad-doża relattiva fl-ewwel sitt ġimgħat, żjieda fit-tul ta' trattament taħt studju (ġimgħat), żieda fl-età (b'żjidiet ta' 10 snin), sess femminili, u ECOG performance status fil-linja bażi tajjeb (0 kontra ≥1).
English: Dose limiting toxicities include diarrhoea, abdominal pain, nausea, stomatitis and hand-foot syndrome (hand-foot skin reaction, palmar-plantar erythrodysesthesia).
Maltese: Tossiċitajiet li jillimitaw id-doża jinkludu dijarea, uġigħ addominali, tqalligħ, stomatite u s-sindrome tal-idejn u s-saqajn (reazzjoni tal-ġilda fl-idejn u fis-saqajn, eritrodisasteżija palmari-plantari).
English: Myalgia, Arthralgia, Pain in extremity
Maltese: Mijalġja, Artralġja, Uġigħ fl-estremitajiet
English: Constipation, Dyspepsia Upper gastrointestinal haemorrhage, Mouth ulceration, Gastritis, Abdominal distension, Gastroesophageal reflux disease, Oral pain, Dysphagia, Rectal haemorrhage, Abdominal pain lower, Oral dysaesthesia, Paraesthesia oral, Hypoaesthesia oral, Abdominal discomfort
Maltese: Ulċerazzjoni fil-ħalq, Gastrite, Distensjoni addominali, marda tar-rifluss gastro-osofagali, Uġigħ fil-ħalq, Disfaġija, Emorraġija mir-rektum, Uġigħ fil-parti t'isfel tal-addome, Disestesija orali, parestesija orali, Ipoestesija, Skomdu addominali
English: Sepsis, Urinary tract infection, Cellulitis, Tonsillitis,
Maltese: Sepsis, Infezzjoni fl-apparat tal-awrina, Ċellulite, Tonsillite, Farinġite,
English: During standard fertility studies, impairment of fertility was observed in female mice receiving capecitabine; however, this effect was reversible after a drug-free period.
Maltese: Waqt studji standard dwar il-fertilità, indeboliment fil-fertilità ġiet osservata fi ġrieden femminili li kienu qed jingħataw capecitabine; madankollu, dan l-effett kien riversibbli wara perjodu mingħajr mediċina.
English: The XELIRI has been compared with 5-FU + irinotecan (FOLFIRI) in three randomised studies in patients with metastatic colorectal cancer.
Maltese: XELIRI ġie mqabbel ma' 5-FU + irinotecan (FOLFIRI) fi tliet studji randomised f'pazjenti b'kanċer metastatiku tal-kolorektum.
English: The analysis for the secondary endpoint of RFS supports these results with a HR of 0.78 (95% CI=[0.67; 0.92]; p=0.0024) for XELOX vs. 5-FU/LV.
Maltese: 67; 0.92]; p=0.0024) għal XELOX kontra 5-FU/LV.
English: - ECX: epirubicin (50 mg/m 2 as a bolus on day 1 every 3 weeks), cisplatin (60 mg/m 2 as a two hour infusion on day 1 every 3 weeks), and capecitabine (625 mg/m 2 twice daily continuously).
Maltese: - ECX: epirubicin (50 mg/m2 bħala bolus fl-ewwel jum kull 3 ġimgħat), cisplatin (60 mg/m mogħti bħala infużjoni fuq sagħtejn fl-ewwel jum kull 3 ġimgħat), u capecitabine (625 mg/m darbtejn kuljum b'mod kontinwu).
English: Japanese patients had also about 25% lower Cmax and 34% lower AUC for FBAL than Caucasian patients.
Maltese: Pazjenti Ġappuniżi kellhom ukoll Cmax għal FBAL 25% inqas u AUC 34% inqas minn pazjenti Kawkasi.
English: How to store Ecansya
Maltese: Kalkulazzjonijiet tad-doża ta' Ecansya
English: Dyspnoea, Epistaxis, Cough, Rhinorrhoea
Maltese: Qtugħ ta' nifs, Epistassi, Sogħla, Rinorreja
English: United Kingdom Consilient Health (UK) Ltd. Tel: + 44 (0)203 751 1888
Maltese: Tel: + 44 (0)203 751 1888
English: The rate of withdrawal due to adverse events was higher in the XELOX combination therapy arm (21%) as compared with that of the 5-FU/LV monotherapy arm (9%) in the ITT population.
Maltese: Fil-popolazzjoni ITT, ir-rata ta' rtirar minħabba avvenimenti avversi kienet ogħla fil-grupp ta' terapija kombinata XELOX (21 %) meta mqabbla ma' dik tal-grupp ta' 5-FU/LV bħala monoterapija (9 %).
English: 5-Fluorouracil: intravenous bolus injection immediately after leucovorin
Maltese: Injezzjoni bolus fil-vini immedjatament wara leucovorin
English: There is some evidence that dexpanthenol is effective for hand-foot syndrome prophylaxis in patients treated with Ecansya.
Maltese: Hemm xi evidenza li dexpanthenol huwa effettiv għall-profilassi tas-sindrome tal-idejn u s-saqajn f'pazjenti ttrattati b'Ecansya.
English: See leaflet for further information.
Maltese: Ara l-fuljett ta' tagħrif għal aktar informazzjoni.
English: In this trial, 1987 patients were randomised to treatment with capecitabine (1250 mg/m2 twice daily for 2 weeks followed by a 1-week rest period and given as 3week cycles for 24 weeks) or 5-FU and leucovorin (Mayo Clinic regimen: 20 mg/m2 leucovorin intravenous followed by 425 mg/m2 intravenous bolus 5-FU, on days 1 to 5, every 28 days for 24 weeks).
Maltese: F'din il-prova, 1987 pazjent kienu randomised għat-trattament b'capecitabine (1250 mg/m2 darbtejn kuljum għal ġimagħtejn segwit minn perjodu ta' waqfien ta' ġimgħa u mogħti bħala ċikli ta' 3 ġimgħat għal 24 ġimgħa) jew 5-FU u leucovorin (program ta' Mayo Clinic: 20 mg/m2 leucovorin fil-vini segwit minn 425 mg/m2 5-FU bolus fil-vini, mill-ewwel sal-ħames jum, kull 28 jum għal 24 ġimgħa).
English: For PVC/PVdC-aluminium blisters
Maltese: - Folji tal-PVC/PVdC/aluminju 30 pillola miksija b'rita:
English: Parameter: Progression-free Survival EPP ITT Parameter: Overall Survival EPP ITT
Maltese: Sopravivenza mingħajr Progressjoni EPP
English: The results indicate that XELOX is equivalent to FOLFOX-4 in terms of overall survival (see table 9).
Maltese: Ir-riżultati jindikaw li XELOX huwa ekwivalenti għal FOLFOX-4 f'termini ta' sopravivenza globali (ara tabella 9).
English: For PVC/PVdC/aluminium blisters Do not store above 30°C.
Maltese: Għall-folji tal-PVC/PVdC/aluminju Taħżinx f'temperatura 'l fuq minn 30°C.
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 randomised u multicentre 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: The major metabolite excreted in urine is FBAL, which represents 57% of the administered dose.
Maltese: FBAL, li jirrappreżenta 57% tad-doża mogħtija.
English: Film-coated tablet (tablet).
Maltese: Pillola miksija b'rita (pillola).
English: Hypotension, Hot flush, Peripheral coldness
Maltese: Parasteżija, Disasteżija, Newropatija periferali,
English: Two examples are provided here: A person whose body weight is 64 kg and height is 1.64 m has a body surface area of 1.7 m2 and should take 4 tablets of 500 mg and 1 tablet of 150 mg two times daily.
Maltese: Żewġ eżempji huma pprovuti hawnhekk: persuna li għandha piż talġisem ta' 64 kg u tul ta' 1.64 m għandha erja tas-superfiċje tal-ġisem ta' 1.7 m2 u għandha tieħu 4 pilloli ta' 500 mg u pillola ta' 150 mg darbtejn kuljum.
English: The following factors were pre-specified in the statistical analysis plan for inclusion in the model: age, time from surgery to randomization, gender, CEA levels at baseline, lymph nodes at baseline, and country.
Maltese: Il-fatturi li ġejjin kienu speċifikati minn qabel fil-pjan ta' analiżi statistika għall-inklużjoni fil-mudell: età, ħin mill-kirurġija sar-randomisation, sess, livelli ta' CEA fil-linja bażi, glandoli limfatiċi fil-linja bażi, u pajjiż.
English: Brivudine must not be administered concomitantly with capecitabine.
Maltese: Brivudine m'għandux jingħata fl-istess waqt ma' capecitabine.
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 25.8, n=8).
English: Reduced dose
Maltese: U KWANTITATTIVA
English: Treatment with capecitabine monotherapy may be resumed when bilirubin decreases to ≤3.0 x ULN or hepatic aminotransferases decrease to ≤ 2.5 x ULN.
Maltese: It-trattament b'capecitabine li jittieħed waħdu jista' jitkompla meta l-bilirubin jonqos għal ≤3.0 x ULN jew l-aminotransferases epatiċi jitnaqqsu għal ≤ 2.5 x ULN.
English: The tablets are white to off white, oblong shaped, biconvex tablets of 14.6 mm in length and 6.7 mm in width, debossed with "300" on one side and plain on other side.
Maltese: Il-pilloli huma ta' lewn bajdani għal ofwajt, f'għamla oblong, imżaqqin fuq żewġ naħat ta' tul ta' 14.6 mm u wisa' ta' 6.7 mm, imnaqqxa bi ”300” fuq naħa waħda u mingħajr kitba fuq in-naħa l-oħra.
English: Coumarin-derivative anticoagulants: altered coagulation parameters and/or bleeding have been reported in patients taking capecitabine concomitantly with coumarin-derivative anticoagulants such as warfarin and phenprocoumon.
Maltese: Sustanzi kontra l-koagulazzjoni tad-demm derivati minn coumarin Bdil fil-parametri tal-koagulazzjoni u/jew fil-fsada ġew irrapportati f'pazjenti li kienu qed jieħdu capecitabine waqt trattament b'sustanzi kontra l-koagulazzjoni tad-demm derivati minn coumarin, bħal warfarin u phenprocoumon.
English: Angina unstable, Angina pectoris, Myocardial ischaemia/infarction, Atrial fibrillation, Arrhythmia, Tachycardia, Sinus tachycardia, Palpitations
Maltese: Anġina instabbli, Anġina pectoris, Iskemija/infart mijokardjali, Fibrillazzjoni atrijali, Arritmija, Takikardija, Takikardija tas-sinus, Palpitazzjonijiet
English: Patients with low or absent DPD activity, an enzyme involved in fluorouracil degradation, are at increased risk for severe, life-threatening, or fatal adverse reactions caused by fluorouracil.
Maltese: Pazjenti b'attività baxxa jew assenti ta' DPD, enzima involuta fid-degradazzjoni ta' fluorouracil, għandhom riskju akbar ta' reazzjonijiet avversi severi, ta' periklu għall-ħajja, jew fatali kkawżati minn fluorouracil.
English: The pooled analysis includes 3097 patients treated with capecitabine-containing regimens and 3074 patients treated with 5-FU-containing regimens.
Maltese: L-analiżi globali tinkludi 3097 pazjent ittrattat b'korsijiet li fihom capecitabine u 3074 pazjent ittrattat b'korsijiet li fihom 5-FU.
English: The median overall survival was 10.0 months in cisplatin-based regimens and 10.4 months in oxaliplatin-based regimens.
Maltese: 0 xhur f'korsijiet bbażati fuq cisplatin u 10.4 xhur f'korsijiet bbażati fuq oxaliplatin.
English: PVC/PVdC/aluminium blisters EU/1/12/763/016 30 film-coated tablets EU/1/12/763/017 60 film-coated tablets EU/1/12/763/018 120 film-coated tablets
Maltese: Folji tal-PVC/PVdC/aluminju EU/1/12/763/016 30 pillola miksija b'rita EU/1/12/763/017 60 pillola miksija b'rita EU/1/12/763/018 120 pillola miksija b'rita
English: Hypokalaemia, Appetite disorder, Malnutrition, Hypertriglyceridaemia
Maltese: Ipokalimja, Disturbi fl-aptit, Nutrizzjoni ħażina, Ipertrigliċeridemija.
English: Non-inferiority of the XELOX-containing arms compared with the FOLFOX-4-containing arms in the overall comparison was demonstrated in terms of progression-free survival in the eligible patient population and the intent-to-treat population (see table 7).
Maltese: F'paragun globali ntwera li l-gruppi li fihom XELOX ma kienux inferjuri meta mqabbla ma' gruppi li fihom FOLFOX-4 f'termini ta' sopravivenza mingħajr progressjoni fil-popolazzjoni ta' pazjenti eliġibbli u tal-popolazzjoni b'intenzjoni li jiġu ttrattati (ara tabella 7).
English: In this trial, 944 patients were randomised to 3-week cycles for 24 weeks with capecitabine (1000 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: F'din il-prova, 944 pazjent kienu randomised għal ċikli ta' 3 ġimgħat għal 24 ġimgħa b'capecitabine (1000 mg/m 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 randomised għall-bolus 5-FU u leucovorin.
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/m mogħti bħala infużjoni fuq medda ta' sagħtejn fl-ewwel jum kull 3 ġimgħat) u 5-FU (200 mg/m mogħti kuljum bħala infużjoni kontinwa permezz ta' linja ċentrali).
English: Capecitabine in combination therapy
Maltese: Capecitabine f'terapija ta' taħlita
English: Dose per administration (mg)
Maltese: Doża kull għotja (mg)
English: PVC/PVdC/aluminium blisters EU/1/12/763/004 30 film-coated tablets EU/1/12/763/005 60 film-coated tablets EU/1/12/763/006 120 film-coated tablets
Maltese: Folji tal-PVC/PVdC/aluminju EU/1/12/763/004 30 pillola miksija b'rita EU/1/12/763/005 60 pillola miksija b'rita EU/1/12/763/006 120 pillola miksija b'rita
English: General
Maltese: hr
English: Elderly.
Maltese: Anzjani.
English: Hydronephrosis, Urinary incontinence, Haematuria, Nocturia, Blood creatinine increased
Maltese: Idronefrożi, Inkontinenza tal-awrina, Ematurja, Nokturja, Żieda tal-krejatinina fid-demm
English: Monotherapy with capecitabine after failure of taxanes, anthracycline containing chemotherapy, and for whom anthracycline therapy is not indicated
Maltese: Monoterapija b'capecitabine wara falliment ta' taxanes, kemjoterapija li fiha anthracycline, u għal dawk li terapija b'anthracycline mhix indikata
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: 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 bit-tumur.
English: Since metabolism of R-warfarin was not affected, these results indicate that capecitabine downregulates 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: The tablets are peach colored, oblong shaped, biconvex tablets of 15.9 mm in length and 8.4 mm in width, debossed with "500" on one side and plain on other side.
Maltese: 9 mm u wisa' ta' 8.4 mm, imnaqqxa b'”500” fuq naħa waħda u mingħajr kitba fuq in-naħa l-oħra.
English: Administration with food decreases the rate of capecitabine absorption, but only results in a minor effect on the AUC of 5'-DFUR, and on the AUC of the subsequent metabolite 5-FU.
Maltese: L-għoti ma' l-ikel inaqqas ir-rata tal-assorbiment ta' capecitabine iżda jirriżulta biss f'effett minuri fuq l-AUC ta' 5'-DFUR, u fuq l-AUC tal-metabolit sussegwenti 5-FU.