FrancophonIA/ELRC3.0 huggingface dataset:
English: Creatinine clearance was found to influence the systemic exposure to 5'-DFUR (35% increase in AUC when creatinine clearance decreases by 50%) and to FBAL (114% increase in AUC when creatinine clearance decreases by 50%).
Maltese: It-tneħħija tal-krejatinina instabet li tinfluwenza l-espożizzjoni sistematika għal 5'-DFUR (żjieda ta' 35% fl-AUC meta t-tneħħija talkrejatinina tonqos b'50%) u għal FBAL (żjieda ta' 114% fl-AUC meta t-tneħħija tal-krejatinina tonqos b'50%).
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: Informazzjoni minn żewġ provi kliniċi kkontrollati ta' fażi 3 iddisinjati b'mod identiku, multicentre u randomised (SO14695; SO14796), jissapportjaw l-użu ta' capecitabine għall-kura primarja ta' kanċer metastatiku tal-kolon u tar-rektum.
English: The most commonly reported and/or clinically relevant treatment-related adverse drug reactions (ADRs) were gastrointestinal disorders (especially diarrhoea, nausea, vomiting, abdominal pain, stomatitis), hand-foot syndrome (palmar-plantar erythrodysesthesia), fatigue, asthenia, anorexia, cardiotoxicity, increased renal dysfunction on those with preexisting compromised renal function, and thrombosis/embolism.
Maltese: L-aktar reazzjonijiet avversi tal-mediċina (ADRs) relatati mal-kura rrapportati b'mod frekwenti u/jew ta' rilevanza klinika kienu disturbi gastro-intestinali (speċjalment dijarea, tqalligħ, rimettar, uġigħ addominali, stomatite), s-sindrome ta' l-idejn u s-saqajn (eritrodisasteżija palmari-plantari), għeja,
English: Capecitabine in combination therapy
Maltese: f'terapija kombinata ta' capecitabine.
English: • 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: Interrupt until resolved to grade 0-1 100%
Maltese: Għal-lista sħiħa ta' eċċipjenti, ara sezzjoni 6.1.
English: ITT *PPP=per-protocol population; **ITT=intent-to-treat population.
Maltese: *PPP=popolazzjoni skond il-protokoll; **ITT= popolazzjoni b'intenzjoni li jiġu kkurati.
English: Abdominal distension,
Maltese: Parasteżija, Disasteżija,
English: Capecitabine Accord 150 mg film-coated tablets The film-coated tablets are light peach colored, oblong shaped, biconvex, 11.4 mm in length and 5.3 mm in width, debossed with ‘150' on one side and plain on other side.
Maltese: Capecitabine Accord 150 mg pilloli miksijin b'rita Il-pilloli miksija b'rita huma pilloli miksijin b'rita ta' lewn aħmar fl-isfar ċar, ta' forma oblunga, bikonvessi, b'tul ta' 11.4 mm u wisa' ta' 5.3 mm, imnaqqxa bin-numru ‘150' fuq naħa waħda u lixxi fuq in-naħa l-oħra.
English: In a interaction study with single-dose warfarin administration, there was a significant increase in the mean AUC (+57%) of S-warfarin.
Maltese: Fi studju dwar l-interazzjoni tal-mediċina waqt l-għoti ta' doża waħda ta' warfarin, kien hemm żjieda sinifikattiva fil-medja ta' l-AUC (+57%) ta' S-warfarin.
English: The manifestations of acute overdose include nausea, vomiting, diarrhoea, mucositis, gastrointestinal irritation and bleeding, and bone marrow depression.
Maltese: Is-sintomi ta' doża eċċessiva akuta jinkludu tqalligħ, rimettar, dijarea, mukożite, irritazzjoni gastro intestinali u fsada, u depressjoni tal-mudullun.
English: Angina unstable, Angina pectoris, Myocardial ischaemia/infarction, Atrial fibrillation, Arrhythmia, Tachycardia, Sinus tachycardia, Palpitations
Maltese: Iskemija/infart mijokardjali, Fibrillazzjoni atrijali, Arritmija, Takikardija, Takikardija tassinus,
English: There is some evidence that dexpanthenol is effective for hand-foot syndrome prophylaxis in patients treated with Capecitabine Accord.
Maltese: Hemm xi evidenza li dexpanthenol huwa effettiv għall-profilassi tas-sindrome tal-idejn u s-saqajn f'pazjenti kkurati b'Capecitabine Accord.
English: Other than warfarin, no formal interaction studies between capecitabine and other CYP2C9 substrates have been conducted.
Maltese: Minbarra b'warfarin, ma saru l-ebda studji formali ta' interazzjoni bejn mediċina u oħra bejn capecitabine u sottostrati oħra ta' CYP2C9.
English: Capecitabine Accord 300 mg film-coated tablets The film-coated tablets are white to off white, oblong shaped, biconvex, 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 miksija b'rita huma pilloli miksijin b'rita ta' lewn abjad għal abjad fl-isfar, ta' forma oblunga, bikonvessi, b'tul ta' 14.6 mm u wisa' ta' 6.7 mm, imnaqqxa bin-numru ‘300' fuq naħa waħda u lixxi fuq in-naħa l-oħra.
English: Capecitabine Accord 150 mg film-coated tablets Capecitabine Accord 300 mg film-coated tablets Capecitabine Accord 500 mg film-coated tablets capecitabine
Maltese: Capecitabine Accord 150 mg pilloli miksijin b'rita Capecitabine Accord 300 mg pilloli miksijin b'rita Capecitabine Accord 500 mg pilloli miksijin b'rita
English: 604 patients were randomised to treatment with 5-FU and leucovorin (Mayo regimen: 20 mg/m2 leucovorin intravenous followed by 425 mg/m2 intravenous bolus 5-FU, on days 1 to 5, every 28 days).
Maltese: FU u leucovorin (kors ta' Mayo: 20 mg/m2 leucovorin ġol-vini segwit minn 425 mg/m2 5-FU bolus ġol-vini, mill-ewwel sal-ħames jum, kull 28 jum).
English: Dose level 1250 mg/m2 (twice daily)
Maltese: Livell tad-doża 1250 mg/m2 (darbtejn kuljum)
English: A comparison of XELOX plus bevacizumab versus FOLFOX-4 plus bevacizumab was a pre-specified exploratory analysis.
Maltese: XELOX u bevacizumab kontra FOLFOX-4 u bevacizumab kien analiżi esploratorju speċifikat minn qabel.
English: Capecitabine is contraindicated in patients with severe renal impairment (creatinine clearance below 30 ml/min [Cockcroft and Gault] at baseline).
Maltese: Indeboliment tal-kliewi: Capecitabine huwa kontra-indikat f'pazjenti b'indeboliment serju tal-kliewi (tneħħija tal-krejatinina taħt it-30 ml/min [Cockcroft u Gault] fil-linja bażi).
English: These reactions occurred within several days and up to several months after initiating capecitabine therapy and, in a few cases, within one month after stopping capecitabine.In a clinical pharmacokinetic interaction study, after a single 20 mg dose of warfarin, capecitabine treatment increased the AUC of S-warfarin by 57% with a 91% increase in INR value.
Maltese: Fi studju kliniku farmakokinetiku dwar l-interazzjonijiet, wara doża waħda ta' 20 mg ta' warfarin, il-kura b'capecitabine żiedet l-AUC ta' S-warfarin b'57% b'żjieda ta' 91% fil-valur ta' l-INR.
English: Recommended posology (see section 5.1)
Maltese: Pożoloġija Pożoloġija rakkomandata (ara sezzjoni 5.1)
English: • radiotherapy and certain medicines used to treat cancer (folinic acid, oxaliplatin, bevacizumab,
Maltese: • radjuterapija u ċerti mediċini użati għall-kura tal-kanċer (aċidu foliniku, oxaliplatin,
English: No significant differences occurred in the exposure to other metabolites (5'-DFCR, 5'-DFUR, and 5-FU).
Maltese: L-ebda differenzi sinifikanti ma seħħew fl-espożizzjoni għal metaboliti oħra (5'-DFCR, 5'-DFUR, u 5-FU). 5.3 Tagħrif ta' qabel l-użu kliniku dwar is-sigurtà
English: Eye pain, Visual impairment, Vision blurred
Maltese: Indeboliment filvista, Vista mċajpra
English: Median progression free survival
Maltese: Sopravivenza mingħajr Progressjoni
English: • Recent or concomitant treatment with brivudine (see section 4.4 and 4.5 for drug-drug interaction),If contraindications exist to any of the medicinal products in the combination regimen, that medicinal product should not be used.
Maltese: • Trattament reċenti jew fl-istess waqt bi brivudine (ara sezzjonijiet 4.4 u 4.5 għall-interazzjoni bejn mediċina u oħra),
English: A meta-analysis of 14 clinical trials with data from over 4700 patients treated with capecitabine monotherapy or capecitabine in combination with different chemotherapy regimens in multiple indications (colon, colorectal, gastric and breast cancer) showed that patients on capecitabine who developed hand-foot syndrome (HFS) had a longer overall survival compared to patients who did not develop HFS: median overall survival 1100 days (95% CI 1007;1200) vs 691 days (95% CI 638;754) with a hazard ratio of 0.61 (95% CI 0.56; 0.66).
Maltese: Meta-analiżi ta' 14-il prova klinika b'tagħrif minn aktar minn 4700 pazjent kkurati b'capecitabine bħala monoterapija jew capecitabine flimkien ma' korsijiet ta' kimoterapiji differenti f'indikazzjonijiet multipli (kanċer tal-kolon, tal-kolorektum, ta' l-istonku u tas-sider) wriet li pazjenti fuq capecitabine li żviluppaw is-sindrome ta' l-idejn u s-saqajn (HFS) kellhom sopravivenża totali itwal meta mqabbel ma' pazjenti li ma żviluppawx HFS: sopravivenza totali medjana 1100 ġurnata (95% CI 1007;1200) vs
English: Administration of capecitabine should be interrupted if treatmentrelated elevations in bilirubin of >3.0 x ULN or treatment-related elevations in hepatic aminotransferases (ALT, AST) of >2.5 x ULN occur.
Maltese: ULN relatata mal-kura jew żjieda fil-livell ta' aminotransferases tal-fwied (ALT, AST) ta' > 2.5 x ULN relatata mal-kura.
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 Tossiċitajiet li jillimitaw id-doża jinkludu dijarea, uġigħ addominali, tqalligħ, stomatite u s-sindrome ta' l-idejn u s-saqajn (reazzjoni tal-ġilda fl-idejn u fis-saqajn, eritrodisasteżija palmari-plantari).
English: How to take Capecitabine Accord
Maltese: Tiħux Capecitabine Accord
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 mogħti bħala infużjoni fuq sagħtejn fl-ewwel jum kull 3 ġimgħat), u capecitabine (625 mg/m2
English: Fatigue, Asthenia Pyrexia, Oedema peripheral, Malaise, Chest pain
Maltese: Ipertensjoni, Petekje, Fwawar, Kesħa fil-periferi
English: When capecitabine and cisplatin are used in combination, the use of vitamin B6 (pyridoxine) is not advised for symptomatic or secondary prophylactic treatment of hand-foot syndrome, because of published reports that it may decrease the efficacy of cisplatin.
Maltese: Meta capecitabine u cisplatin jintużaw flimkien, l-użu ta' vitamina B6 (pyridoxine) mhux rakkomandat għall-kura profilattika sintomatika jew sekondarja ts-sindrome ta' l-idejn u s-saqajn,
English: • blood infection, urinary tract infection, infection of the skin, infections in the nose and throat, fungal infections (including those of the mouth), influenza, gastroenteritis, tooth abscess,
Maltese: • infezzjoni tad-demm, infezzjoni tal-apparat urinarju, infezzjoni tal-ġilda, infezzjonijiet fl imnieħer u l-gerżuma, infezzjonijiet fungali (inklużi dawk tal-ħalq), influwenza, gastroenterite,
English: EU/1/12/762/001-003 EU/1/12/762/004-006 EU/1/12/762/019-021 EU/1/12/762/007-009 EU/1/12/762/010-012 EU/1/12/762/022-024 EU/1/12/762/013-015 EU/1/12/762/016-018 EU/1/12/762/025-027
Maltese: EU/1/12/762/001-003 EU/1/12/762/004-006 EU/1/12/762/019-021 EU/1/12/762/007-009 EU/1/12/762/010-012 EU/1/12/762/022-024
English: If unscheduled laboratory assessments during a treatment cycle show that the neutrophil count drops below 1.0 x 109/L or that the platelet count drops below 75 x 109/L, treatment with capecitabine should be interrupted.
Maltese: Jekk valutazzjonijiet tal-laboratorju mhux ipprogrammati waqt ċiklu ta' kura juru li l-għadd tan-newtrofili waqa' taħt 1.0 x 109/L jew jekk lgħadd tal-plejtlits jaqa' taħt 75 x 109/l, kura b'capecitabine għandha titwaqqaf.
English: The following factors were pre-specified in the statistical analysis plan for inclusion in the model: age, time from surgery to randomisation, 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: - 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 mogħti bħala infużjoni fuq medda ta' sagħtejn fl-ewwel jum kull 3 ġimgħat) u 5-FU (200 mg/m2 mogħti kuljum bħala infużjoni kontinwa permezz ta' linja ċentrali).
English: Combination treatment consisted of first-line capecitabine (1000 mg/m2 twice daily for 14 days) combined with irinotecan (250 mg /m2 on day 1) (XELIRI) and second-line capecitabine (1000 mg/m2 twice daily for 14 days) plus oxaliplatin (130 mg/m2 on day 1).
Maltese: Kura kombinata ikkonsistiet minn capecitabine (1000 mg/m2 darbtejn kuljum għal 14-il ġurnata) flimkien ma' irinotecan (250 mg/m2 fl-ewwel ġurnata) (XELIRI) bħala kura primarja u capecitabine
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 lattività ta' isoenżima 2C9, iżda m'għandu l-ebda effect fuq l-isoenżimi 1A2 u 3A4.
English: The median progression-free survival was 5.6 months (capecitabine + cisplatin) versus 5.0 months (5-FU + cisplatin).
Maltese: Il-medjan tas-sopravivenza mingħajr progressjoni kien ta' 5.6 xhur (capecitabine + cisplatin) versus
English: Each film-coated tablet contains 150 mg capecitabine
Maltese: Kull pillola miksija b'rita fiha 150 mg capecitabine
English: Progression-free Survival after 6 months
Maltese: Sopravivenza mingħajr progressjoni wara 6 xhur
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 mogħti bħala infużjoni fuq medda ta' sagħtejn fl-ewwel jum kull 3 ġimgħat), u 5-FU (200 mg/m2 mogħti kuljum bħala infużjoni kontinwa permezz ta' linja ċentrali).
English: Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu
Maltese: Informazzjoni ddettaljata dwar dan il-prodott mediċinali tinsab fuq is-sit elettroniku tal-Aġenzija Ewropea għall-Mediċini http://www.ema.europa.eu/.
English: combined with docetaxel at 75 mg/m2 as a 1 hour intravenous infusion every 3 weeks.
Maltese: sebat ijiem, flimkien ma' 75 mg/m2 docetaxel mogħti bħala infużjoni fil-vini fuq perjodu ta' siegħa kull 3 ġimgħat.
English: 600 mg/ m2 intravenous 22 hr
Maltese: 400 mg/m2 ġol-vini bolus, segwit minn 600 mg/ m2 ġol-vini 22 hr
English: Capecitabine Accord 150 mg and 500 mg film-coated tablets
Maltese: Capecitabine Accord 150 mg u 500 mg pilloli miksijin b'rita
English: Number of 150 mg tablets, 300 mg tablets and/or 500 mg tablets per administration (each administration to be given morning and evening)
Maltese: Numru ta' pilloli ta' 150 mg, 300 mg pilloli u/jew 500 mg pilloli għal kull għotja (kull għotja għandha tingħata filgħodu u filgħaxija)
English: Capecitabine was at least equivalent to intravenous 5-FU/LV in disease-free survival in per protocol population (hazard ratio 0.92; 95% CI 0.80-1.06).
Maltese: Capecitabine kien mill-inqas ekwivalenti għal 5-FU/LV filvini fis-sopravvivenza bla marda fil-protokoll għal kull popolazzjoni (hazard ratio 0.92; 95% CI 0.80
English: This 21 day period is one treatment cycle.
Maltese: Dan il-perjodu ta' 21 ġurnata huwa ċiklu wieħed ta' kura.
English: Capecitabine Accord 150 mg film-coated tablets Each film-coated tablet contains 7 mg anhydrous lactose.
Maltese: Capecitabine Accord 150 mg pilloli miksijin b'rita Kull pillola miksija b'rita fiha 7 mg anhydrous lactose
English: Patients with moderately impaired renal function show an increased rate of dose reduction (44%) vs. 33% and 32% in patients with no or mild renal impairment and an increase in early withdrawals from treatment (21% withdrawals during the first two cycles) vs. 5% and 8% in patients with no or mild renal impairment.
Maltese: 33% u 32% f'pazjenti bl-ebda indeboliment jew indeboliment ħafif tal-kliewi, u żjieda ta' rtirar kmieni mill-kura (rtirar ta' 21% waqt l-ewwel żewġ ċikli) vs. 5% u 8% f'pazjenti bl-ebda indeboliment jew indeboliment moderat tal-kliewi.
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), żjieda fl-intensità tad-doża relattiva fl-ewwel sitt ġimgħat, żjieda fit-tul ta' kura taħt studju (ġimgħat), żjieda fl-età (b'żjidiet ta' 10 snin), sess femminili, u ECOG performance status fil-linja bażi tajjeb (0 kontra ≥1). Dijarea (ara sezzjoni 4.4)
English: Uncommon ADRs reported for capecitabine in combination therapy are consistent with the ADRs reported for capecitabine monotherapy or reported for monotherapy with the combination medicinal product (in literature and/or respective summary of product characteristics).
Maltese: ADRs mhux komuni rrapportati għal capecitabine f'terapija kombinata huma konsistenti ma' l-ADRs irrapportati għall-monterapija b'capecitabine jew irrapportati għall-monoterapija bil-prodott mediċinali kombinat (fil-letteratura u/jew sommarju tal-karatterisitiċi tal-prodott rispettiv). Xi ADRs huma reazzjonijiet osservati b'mod komuni bil-prodott mediċinali kombinat (e.ż.
English: Each pack contains 30, 60 or 120 film-coated tablets.
Maltese: Kull pakkett fih 30, 60 jew 120 pillola miksijin b'rita.
English: In the EORTC study patients were randomised to receive either open label FOLFIRI (n=41) or XELIRI (n=44) with additional randomisation to either double-blind treatment with celecoxib or placebo.
Maltese: (n=44) b'randomisation addizzjonali għal kura double-blind b'celecoxib jew plaċebo.
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: xhur (CI ta' 95% 5.1 - 6.2 xhur) għall-monoterapija b'capecitabine u 7.8 xhur (CI ta' 95% 7.0 - 8.3
English: Sore throat, Dysaesthesia pharynx
Maltese: Żjieda tal krejatinina fiddemm
English: in combination with docetaxel (see section 5.1) for the treatment of patients with locally advanced or metastatic breast cancer after failure of cytotoxic chemotherapy.
Maltese: (ara sezzjoni 5.1). - flimkien ma' docetaxel (ara sezzjoni 5.1) huwa indikat għall-kura ta' pazjenti b'kanċer tas-sider lokalment avvanzat jew metastatiku wara l-falliment ta' kemjoterapija ċitotossika.
English: The results indicate that XELOX is equivalent to FOLFOX-4 in terms of overall survival (see Table 10).
Maltese: Ir-riżultati jindikaw li XELOX huwa ekwivalenti għal FOLFOX-4 f'termini ta' sopravivenza globali (ara Tabella 10).
English: Capecitabine Accord 300 mg film-coated tablets are white to off white, oblong shaped, biconvex, film-coated 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: bikonvessi, miksijin b'rita, b'tul ta' 14.6 mm u wisa' ta' 6.7 mm, imnaqqxa bin-numru ‘300' fuq naħa u lixxi fuq in-naħa l-oħra.
English: For Arm B, the XELIRI regimen used capecitabine 1000 mg/m2 twice daily for 14 days +irinotecan 250 mg/m2 on day 1.
Maltese: 1000 mg/m2 darbtejn kuljum għal 14-il ġurnata + irinotecan 250 mg/m2 fl-ewwel ġurnata.
English: Given as monotherapy, the recommended starting dose for capecitabine in the adjuvant treatment of colon cancer, in the treatment of metastatic colorectal cancer or of locally advanced or metastatic breast cancer is 1250 mg/m2 administered twice daily (morning and evening; equivalent to 2500 mg/m2 total daily dose) for 14 days followed by a 7-day rest period.
Maltese: Mogħtija bħala monoterapija, id-doża rakkomandata tal-bidu ta' capecitabine fil-kura awżiljarja tal kanċer tal-kolon, fil-kura ta' kanċer tal-kolorektum li mmetastatizza jew ta' kanċer tas-sider lokalment avvanzat jew li mmetastatizza hija ta' 1250 mg/m2 mogħtija darbtejn kuljum (fil-għodu u fil-għaxija; ekwivalenti għal doża totali ta' kuljum ta' 2500 mg/m2) għal 14-il ġurnata segwit minn perjodu ta' waqfien ta' sebat ijiem.
English: EU/1/12/762/001 EU/1/12/762/002 EU/1/12/762/003 EU/1/12/762/004 EU/1/12/762/005 EU/1/12/762/006 EU/1/12/762/019 EU/1/12/762/020 EU/1/12/762/021
Maltese: EU/1/12/762/005 EU/1/12/762/006 EU/1/12/762/019 EU/1/12/762/020
English: Cutaneous lupus erythematosus (rare), Severe skin reactions such as StevensJohnson Syndrome and toxic Epidermal Necrolysis (very rare) (see section 4.4.)
Maltese: Sindrome ta' Stevens-Johnson u Nekrolisi tossika talEpidermide (rari ħafna) (ara sezzjoni
English: Rare/Very Rare (Post-Marketing Experience)
Maltese: Rari/Rari Ħafna
English: How to store Capecitabine Accord
Maltese: X'fih Capecitabine Accord
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 ta' l-assorbiment ta' capecitabine iżda jirriżulta biss f'effett minuri fuq l-AUC ta' 5'-DFUR, u fuq l-AUC tal-metabolit sussegwenti 5-FU.
English: Headache, Lethargy Dizziness, Parasthesia, Dysgeusia
Maltese: Dijabete, Ipokalimja, Disturbi fl-aptit,
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 multicentre, randomised u kkontrollata f'pazjenti b'kanċer avvanzat ta' l-istonku jissapportja l-użu ta' capecitabine għall-kura primarja ta' kanċer avvanzat ta' l istonku (ML 17032).
English: Each film-coated tablet contains 500 mg capecitabine
Maltese: Kull pillola miksija b'rita fiha 500 mg capecitabine
English: Standard and reduced dose calculations according to body surface area for starting doses of Capecitabine Accord of 1250 mg/m2 and 1000 mg/m2 are provided in Tables 1 and 2, respectively.
Maltese: Kalkulazzjonijiet tad-doża stàndard jew doża mnaqqsa skond l-erja tas-superfiċje tal-ġisem għad-dożi tal-bidu ta' Capecitabine Accord ta' 1250 mg/m2 u 1000 mg/m2 hma pprovduti f'Tabelli 1 u 2 rispettivament.
English: Each film-coated tablet contains 300 mg capecitabine
Maltese: Kull pillola miksija b'rita fiha 300 mg capecitabine
English: Lower limb oedema, Hypertension, +Embolism and thrombosis
Maltese: Pressjoni għolja, +Emboliżmu u trombożi
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%
English: Hyperbilirubinemia, Liver function test abnormalities
Maltese: Lewkopenija, Anemija emolitika, Proporzjon normalizzat Internazzjonali
English: Monotherapy with capecitabine in adjuvant colon cancer
Maltese: Monoterapija b'capecitabine f'kanċer awżiljarju tal-kolon