FrancophonIA/ELRC3.0 huggingface dataset:
English: The following headings are used to rank the ADRs by frequency: very common (≥ 1/10), common (≥ 1/100 to < 1/10) uncommon (≥ 1/1,000 to < 1/100), rare (≥ 1/10,000 to < 1/1,000) and very rare (< 1/10,000).
Maltese: Il-kategoriji li ġejjin huma wżati biex jikklassifikaw l-ADRs skond il-frekwenza: komuni ħafna (≥ 1/10), komuni (≥ 1/100 sa < 1/10), mhux komuni (≥ 1/1,000 sa <1/100), rari (≥ 1/10,000 sa <
English: Oxaliplatin 130 mg/m2 intravenous 2 hr
Maltese: Oxaliplatin 130 mg/m2 ġol-vini 2 hr
English: 30 film-coated tablets 60 film-coated tablets 120 film-coated tablets 30 x 1 film-coated tablets 60 x 1 film-coated tablets 120 x 1 film-coated tablets
Maltese: 30 pillola miksija b'rita 60 pillola miksija b'rita 120 pillola miksija b'rita 30 x 1 pillola miksija b'rita 60 x 1 pillola miksija b'rita 120 x 1 pillola miksija b'rita
English: Dihydropyrimidinase cleaves the pyrimidine ring to yield 5fluoro-ureidopropionic acid (FUPA).
Maltese: pyrimidine biex jipproduċi 5-fluoro-ureidopropionic acid (FUPA).
English: Capecitabine monotherapy
Maltese: Monoterapija b'Capecitabine
English: - metastatic colorectal cancer (see section 5.1).
Maltese: (ara sezzjoni 5.1). - kanċer metastatiku tal-kolorektum (ara sezzjoni 5.1).
English: The MTD of capecitabine was 2000 mg/m2 per day when combined with interferon alpha-2a (3 MIU/m2 per day) compared to 3000 mg/m2 per day when capecitabine was used alone.
Maltese: L-MTD ta' capecitabine kienet ta' 2000 mg/m2 kuljum meta meħud flimkien ma' interferon alfa-2a (3 MIU/m2 kuljum) imqabbla ma' 3000 mg/m2 kuljum meta capecitabine jintuża waħdu.
English: In the all-randomised population, tests for difference of capecitabine vs 5-FU/LV in disease-free and overall survival showed hazard ratios of 0.88 (95% CI 0.77 - 1.01; p = 0.068) and 0.86 (95% CI 0.74 - 1.01; p = 0.060), respectively.
Maltese: Fil-popolazzjonijiet randomised kollha, testijiet għad-differenza ta' capecitabine vs 5-FU/LV fis-sopravivenza bla marda u fis-sopravivenza globali wrew hazard ratios ta' 0.88 (95% CI 0.771.01; p = 0.068) u 0.86 (95% CI 0.74 - 1.01; p = 0.060), rispettivament.
English: In the allrandomised population, capecitabine was shown to be superior to 5-FU/LV for disease-free survival (hazard ratio 0.849; 95% CI 0.739 - 0.976; p = 0.0212), as well as for overall survival (hazard ratio 0.828; 95% CI 0.705 - 0.971; p = 0.0203).
Maltese: Fil popolazzjoni randomised kompletament, capecitabine ntwera li huwa superjuri għal 5-FU/LV għal sopravivenza mingħajr il-marda (hazard ratio 0.849; 95% CI 0.739 - 0.976; p = 0.0212), kif ukoll għal sopravivenza totali (hazard ratio 0.828; 95% CI 0.705 - 0.971; p = 0.0203).
English: • certain types of arrhythmias (including ventricular fibrillation, torsade de pointes, and bradycardia)
Maltese: • bidliet speċifiċi fl-elettrokardjogramma ( titwil ta' QT) • ċertu tipi ta' arritmija (inkluż fibrillazzjoni tal-ventrikolu, torsade de pointes, u bradikardija)
English: Acute renal failure secondary to dehydration might be potentially fatal.
Maltese: Insuffiċjenza akuta tal kliewi sekondarja għal deidratazzjoni tista' tkun potenzjalment fatali.
English: Survival was superior in the capecitabine + docetaxel combination arm (p=0.0126).
Maltese: Is sopravivenza kienet ogħla fil-grupp ta' kura kombinata b'capecitabine u docetaxel (p=0.0126).
English: Patients treated with XELIRI experienced excessive gastrointestinal toxicity compared with FOLFIRI (diarrhoea 48% and 14% for XELIRI and FOLFIRI respectively).
Maltese: Pazjenti kkurati b'XELIRI kellhom tossiċità gastro-intestinali eċċessiva meta mqabbla ma' FOLFIRI (dijarea 48% u 14% għal XELIRI u FOLFIRI rispettivament.
English: In the largest study (BICC-C), patients were randomised to receive either open label FOLFIRI (n=144), bolus 5-FU (mIFL) (n=145) or XELIRI (n=141) and were additionally randomised to receive either double-blind treatment with celecoxib or placebo.
Maltese: Fl-akbar studju (BICC-C), il-pazjenti kienu randomised biex jirċievu open label FOLFIRI (n=144), 5-FU bħala bolus (mIFL) (n=145) jew XELIRI (n=141) u barra dan kienu randomised biex jirċievu kura doubleblind b'celecoxib jew plaċebo.
English: *According to the National Cancer Institute of Canada Clinical Trial Group (NCIC CTG) Common Toxicity Criteria (version 1) or the Common Terminology Criteria for Adverse Events (CTCAE) of the Cancer Therapy Evaluation Program, US National Cancer Institute, version 4.0.
Maltese: *Skond il-Kriterji Komuni tat-Tossiċità (verżjoni 1) tal-Grupp ta' Provi Kliniċi tal-Istitut Nazzjonali tal-Kanċer tal-Kanada (NCIC CTG), jew il-Kriterji ta' Terminoloġija Komuni għall-Avvenimenti
English: The pharmacokinetics of capecitabine have been evaluated over a dose range of 502-3514 mg/m2/day.
Maltese: .2 Tagħrif farmakokinetiku Il-farmakokinetika ta' capecitabine ġiet ikkalkulata fuq firxa ta' doża ta' 502-3514 mg/m2/kuljum.
English: • DPD Deficiency: if you have a known DPD deficiency, you are at an increased risk of acute early-onset of toxicity and severe, life-threatening, or fatal adverse reactions caused by Capecitabine Accord (e.g. stomatitis, mucosal inflammation, diarrhoea, neutropenia, and neurotoxicity).
Maltese: • Defiċjenza ta' DPD: jekk għandek defiċjenza magħrufa ta' DPD, tinsab f'riskju akbar ta' feġġa akuta bikrija ta' tossiċità u reazzjonijiet severi, ta' theddida għall-ħajja, jew avversi fatali kkawżati minn Capecitabine Accord (eż stomatite, infjammazzjoni mukożali, dijarea, newtropenija, u newrotossiċità).
English: /FOLFOX-4+BV (EPP*: N = 937; ITT**: N=
Maltese: FOLFOX-4/ FOLFOX4+P /FOLFOX-4+BV (EPP*: N = 937;
English: However this was associated with an increased incidence of gastrointestinal toxicity and neutropenia during first-line treatment with XELIRI (26% and 11% for XELIRI and first line capecitabine respectively).
Maltese: Madankollu dan kien assoċjat ma' inċidenza akbar ta' tossiċità gastro intestinali u newtropenija waqt kura primarja b'XELIRI (26% u 11% għall XELIRI u capecitabine bħala kura primarja rispettivament).
English: • In patients with known complete absence of dihydropyrimidine dehydrogenase (DPD)
Maltese: Defiċjenza ta' Dihydropyrimidine dehydrogenase (DPD)
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: XELOX intwera li huwa superjuri b'mod sinifikanti għal 5-FU/LV (HR=0.80, 95% CI=[0.69; 0.93];
English: • blood-thinning medicines (coumarin, warfarin),
Maltese: • mediċini għall-gotta (allopurinol), • mediċini biex traqqaq id-demm (coumarin, warfarin),
English: 150 mg 300 mg 500 mg Dose per administration (mg)
Maltese: 150 mg 300 mg 500 mg Doża kull għotja
English: (neuropathy)
Maltese: (newropatija)
English: Herpes zoster, Urinary tract infection, Oral candidiasis, Upper respiratory tract infection , Rhinitis, Influenza, +Infection, Oral herpes
Maltese: Kandidajasi orali, Infezzjoni flapparat repiratorju ta' fuq, Rinite, Influwenza, +Infezzjoni, Herpes orali
English: Although DPD deficiency cannot be precisely defined, it is known that patients with certain homozygous or certain compound heterozygous mutations in the DPYD gene locus(e.g. DPYD*2A, c.1679T>G, c.2846A>T and c.1236G>A/HapB3 variants), which can cause complete or near complete absence of DPD enzymatic activity (as determined from laboratory assays), have the highest risk of lifethreatening or fatal toxicity and should not be treated with Capecitabine Accord (see section 4.3).
Maltese: Għalkemm id-defiċjenza ta' DPD ma tistax tiġi definita b'mod preċiż, huwa magħruf li l-pazjenti b'ċerti mutazzjonijiet omożigoti jew ċerti eterożigotiċi komposti fil-ġene locus DPYD (eż. varjanti DPYD*2A, c.1679T>G, c.2846A>T u c.1236G>A/HapB3), li jistgħu jikkawżaw assenza totali jew kważi totali ta' attività enżimatika DPD (kif determinat mill-assaġġi tallaboratorju), għandhom l-ogħla riskju ta' theddida għall-ħajja jew tossiċità fatali u m'għandhomx jiġu kkurati b' Capecitabine Accord (ara sezzjoni 4.3).
English: Capecitabine Accord is available in blister packs containing 30, 60 or 120 film-coated tablets or in perforated unit dose blister packs containing 30 x 1, 60 x 1 or 120 x 1 film-coated tablets.
Maltese: Capecitabine Accord jiġi f'pakketti bil-folji li fihom 30, 60 jew 120 pillola miksija b'rita jew f'pakketti bil-folji ta' doża waħda perforati li fihom 30 x 1, 60 x 1 jew 120 x 1 pillola miksija b'rita.
English: The primary efficacy analyses in the per protocol population demonstrated non-inferiority in overall survival for capecitabine- vs 5-FU-based regimens (hazard ratio 0.86; 95% CI 0.8 - 0.99) and for oxaliplatin- vs cisplatin-based regimens (hazard ratio 0.92; 95% CI 0.80 - 1.1).
Maltese: L-analiżi ta' effikaċja primarja f'popolazzjoni skond il-protokoll wriet nuqqas ta' inferjorità fissopravivenza globali għal capecitabine vs korsijiet ibbażati fuq 5-FU (hazard ratio 0.86; 95% CI 0.80.99) u għal oxaliplatin vs korsijiet ibbażati fuq cisplatin (hazard ratio 0.92; 95% CI 0.80 - 1.1).
English: Colon, colorectal and advanced gastric cancer: meta-analysis A meta-analysis of six clinical trials (studies SO14695, SO14796, M66001, NO16966, NO16967, M17032) supports capecitabine replacing 5-FU in mono- and combination treatment in gastrointestinal cancer.
Maltese: Kanċer tal-kolon, tal-kolorektum u kanċer avvanzat ta' l-istonku: meta-analiżi Meta-analiżi ta' sitt provi kliniċi (studji SO14695, SO14796, M66001, NO16966, NO16967, M17032)
English: Dose limiting toxicities
Maltese: Gradi ta' tossiċità*
English: Pyrexia, Weakness, +Lethargy, Temperature intolerance
Maltese: +Letarġija, Intolleranza għat temperatura
English: capecitabine 1000 mg/m2 oral twice daily
Maltese: capecitabine 1000 mg/m2 mill ħalq darbtejn kuljum
English: Median overall survival time was 703 days (95% CI: 671; 745) in patients treated with capecitabine -containing regimens and 683 days (95% CI:
Maltese: Iż-żmien medjan ta' sopravivenza globali kien 703 ijiem (95% CI: 671; 745) f'pazjenti kkurati b'korsijiet li fihom capecitabine u 683 jum (95% CI: 646; 715) f'pazjenti kkurati b'korsijiet li fihom 5-FU.
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/m2 darbtejn kuljum)
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 HFS (all grades) occurred in 2066 (43%) patients after a median time of 239 [95% CI 201, 288] days after starting treatment with capecitabine.
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 HFS (kull grad) seħħet f'2066 (43%) pazjent wara ħin medjan ta' 239 [95% CI 201, 288] ġurnata wara l-bidu tal-kura b'capecitabine.
English: activity (see section 4.4),
Maltese: (ara sezzjoni 4.4),
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=0.0489) u jindika li korsijiet li fihom capecitabine mhumiex inferjuri għall-korsijiet li fihom 5-FU.
English: • difficulty speaking, impaired memory, loss of movement coordination, balance disorder, fainting, nerve damage (neuropathy) and problems with sensation
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: Deficiency of DPD may lead to increased toxicity of capecitabine (see section 4.3 and
Maltese: Defiċjenza ta' DPD tista' twassal għal żjieda fit tossicità ta' capacitabine (ara sezzjoni 4.3 u 4.4).
English: - In combination with docetaxel: an increased incidence of grade 3 or 4 treatment-related adverse reactions and treatment-related serious adverse reactions were observed in patients 60 years of age or more (see section 5.1).
Maltese: - Flimkien ma' docetaxel: inċidenza ogħla ta' reazzjonijiet avversi ta' grad 3 jew 4 li huma relatati mal-kura u ta' reazzjonijiet avversi serji li huma relatati mal-kura ġew osservati f'pazjenti li għandhom 60 sena jew aktar (ara sezzjoni 5.1).
English: Standard antidiarrhoeal treatments (e.g. loperamide) may be used.
Maltese: Tista' tintuża kura stàndard kontra d-dijarea (eż. loperamide).
English: However, folinic acid has an effect on the pharmacodynamics of capecitabine and its toxicity may be enhanced by folinic acid: the maximum tolerated dose (MTD) of capecitabine alone using the intermittent regimen is 3000 mg/m2 per day whereas it is only 2000 mg/m2 per day when capecitabine was combined with folinic acid (30 mg orally bid).
Maltese: Madankollu, folinic acid għandu effett fuq ilfarmakodinamika ta' capecitabine u t-tossiċità tiegħu tista' tiġi msaħħa minn folinic acid: id-doża massima tollerata (MTD) ta' capecitabine waħdu bl-użu ta' kors intermittenti huwa ta' 3000 mg/m2 kuljum filwaqt li l-MTD hija biss ta' 2000 mg/ m2 kuljum meta capecitabine jittieħed flimkien ma'
English: A significant reduction in the risk of progression was associated with FOLFIRI (HR, 0.76; 95%CI, 0.62-0.95; P <0.01), a result partly due to poor tolerance to the XELIRI regimens used.
Maltese: Tnaqqis sinifikanti fir-riskju ta' progressjoni kien assoċjat ma' FOLFIRI (HR, 0.76; CI ta' 95%, 0.62-0.95; P <0.01),
English: Data from a randomised clinical study (Souglakos et al, 2012) comparing FOLFIRI + bevacizumab with XELIRI + bevacizumab showed no significant differences in PFS or OS between treatments.
Maltese: Data minn studju kliniku randomised (Souglakos et al, 2012) li qabbel FOLFIRI + bevacizumab ma' XELIRI + bevacizumab ma wriet l-ebda differenzi sinifikanti fil-PFS jew OS bejn il-kuri.
English: Data from one multicentre, randomised, controlled phase III clinical trial in patients with stage III (Dukes' C) colon cancer supports the use of capecitabine for the adjuvant treatment of patients with colon cancer (XACT Study; M66001).
Maltese: III multicentre, randomized u kkontrollata f'pazjenti b'kanċer fil kolon ta' stadju III (Dukes' C) jissapportja l-użu ta' capecitabine għall-kura awżiljarja ta' pazjenti b'kanċer tal-kolon (Studju XACT; M66001).
English: In the event of grade 2-4 acute toxicity, treatment must be discontinued immediately.
Maltese: F'każ ta' tossiċità akuta ta' grad 2-4, ilkura għandha titwaqqaf immedjatament.
English: In human cancer xenograft models capecitabine demonstrated a synergistic effect in combination with docetaxel, which may be related to the upregulation of thymidine phosphorylase by docetaxel.
Maltese: F'mudelli tax-xenograft ta' kanċer uman, capecitabine wera effett sinerġistiku meta jittieħed flimkien ma' docetaxel, li jista' jkun relatat maż-żjieda ta' thymidine phosphorylase minn docetaxel.
English: Altered coagulation parameters and/or bleeding have been reported in patients taking capecitabine concomitantly with coumarin-derivative anticoagulants such as warfarin and phenprocoumon.
Maltese: Bdil fil-parametri tal-koagulazzjoni u/jew fil-fsada ġew irrapportati f'pazjenti li kienu qed jieħdu capecitabine waqt kura b'antikoagulanti derivattivi ta' coumarin, bħal warfarin u phenprocoumon.
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: Terapija ta' taħlita f'kanċer awżiljarju tal-kolon Tagħrif minn prova klinika multicentre, randomised u kkontrollata ta' fażi 3 f'pazjenti b'kanċer tal kolon ta' stadju III (Dukes' C) jsostni l-użu ta' capecitabine flimkien ma' oxaliplatin (XELOX) għallkura awżiljarja ta' pazjenti b'kanċer tal-kolon (studju NO16968).
English: Patients with baseline neutrophil counts of <1.5 x 109/L and/or thrombocyte counts of <100 x 109/L should not be treated with capecitabine.
Maltese: Ematoloġija Pazjenti b'għadd ta' newtrofili fil-linja bażi ta' <1.5 x 109/L u/jew b'għadd ta' tromboċiti ta' <100 x
English: Do not give Capecitabine Accord to children and adolescent.
Maltese: Tagħtix Capecitabine Accord lil tfal u adolexxenti.
English: Dihydropyrimidine dehydrogenase (DPD) deficiency Rarely, unexpected, severe toxicity (e.g. stomatitis, diarrhoea, mucosal inflammation, neutropenia and neurotoxicity) associated with 5-FU has been attributed to a deficiency of DPD activity.
Maltese: B'mod rari, tossiċità severa, mhux mistennija, (eż. stomatite, dijarea, infjammazzjoni mukożali, newtropenija u newrotossiċità) assoċjati ma' 5-FU kienet attribwita għal nuqqas ta' attività ta' DPD.
English: See also interaction with coumarin-derivative anticoagulants below, and section 4.4.
Maltese: Ara wkoll interazzjoni ma' sustanzi kontra ilkoagulazzjoni tad-demm derivati minn coumarin taħt, u sezzjoni 4.4.
English: Median survival was 442 days (capecitabine + docetaxel) vs. 352 days (docetaxel alone).
Maltese: Issopravivenza medja kienet ta' 442 jum (capecitabine + docetaxel) vs.
English: The study contained two parts: an initial 2-arm part in which 634 patients were randomised to two different treatment groups, including XELOX or FOLFOX-4, and a subsequent 2x2 factorial part in which 1401 patients were randomised to four different treatment groups, including XELOX plus placebo, FOLFOX-4 plus placebo, XELOX plus bevacizumab, and FOLFOX-4 plus bevacizumab.
Maltese: L-istudju kien fih żewġ partijiet: il-parti tal-bidu b'żewġ gruppi fejn 634 pazjent kienu randomised għal żewġ gruppi ta' kura differenti, inkluż XELOX jew FOLFOX-4, u l-parti ta' 2x2 fatturi ta' wara fejn 1401 pazjent kienu randomised għal erba' gruppi ta' kura differenti, inkluż XELOX flimkien ma' plaċebo, FOLFOX-4 flimkien ma' plaċebo, XELOX
English: Ethnic factors: 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 Kawkasi (n=22).
English: The following covariates were statistically significantly associated with a decreased risk of developing diarrhoea: increasing cumulative capecitabine dose (0.1*kg) and increasing relative dose intensity in the first six weeks.
Maltese: Il-kovarjanti li ġejjin kienu assoċjati b'mod statistikament sinifikanti ma' tnaqqis fir-riskju ta' żvilupp ta' dijarea: żjieda fid-doża kumulattiva ta' capecitabine (0.1*) u żjieda fl-intensità tad-doża relattiva fl-ewwel sitt ġimgħat.
English: Capecitabine Accord is not indicated in children and adolescent.
Maltese: Capecitabine Accord mhux indikat fit-tfal u l-adolexxenti.
English: Pain in jaw , Muscle spasms, Trismus, Muscular weakness
Maltese: Uġigħ fix-xedaq, Spażmi fil muskoli, Trismus, Indebboliment muskolari
English: Other medicines and Capecitabine Accord
Maltese: Mediċini oħra u Capecitabine Accord
English: FOLFOX-4 or
Maltese: FOLFOX-4 jew
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: 1000 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: NCIC CTC grade 2 diarrhoea is defined as an increase of 4 to 6 stools/day or nocturnal stools, grade 3 diarrhoea as an increase of 7 to 9 stools/day or incontinence and malabsorption.
Maltese: CTC 2 hija definita bħala żjieda ta' 4 sa 6 ħmieġ/kuljum jew ħmieġ bil-lejl, dijarea ta' grad 3 bħala żjieda ta' 7 sa 9 ħmieġ/kuljum jew inkontinenza u assorbiment imnaqqas.
English: However, the on-treatment PFS analysis did not confirm the results of the general PFS and OS analysis: the hazard ratio of XELOX versus FOLFOX-4 was 1.24 with 97.5% CI 1.07 - 1.44.
Maltese: Madankollu, l-analiżi tal-PFS wara l-kura ma kkonfermax ir-riżultati ta' l-analiżi ġenerali tal-PFS u tal-OS: il-hazard ratio ta' XELOX kontra FOLFOX-4 kien ta' 1.24 b'97.5% CI 1.07 - 1.44.
English: Table 5 Summary of related ADRs reported in patients treated with capecitabine monotherapy
Maltese: Sommarju ta' l-ADRs relatati rrapportati f'pazjenti kkurati b'monoterapija ta' capecitabine
English: For PVC/PVdC-aluminium blisters (perforated unit dose) Do not store above 30°C.
Maltese: Għall-folji tal-PVC/PVdC-aluminju (doża ta' unità perforata)
English: Sequential treatment consisted of first-line capecitabine (1250 mg/m2 twice daily for 14 days), second-line irinotecan (350 mg/m2 on day 1), and third-line combination of capecitabine (1000 mg/m2 twice daily for 14 days) with oxaliplatin (130 mg/m2 on day 1).
Maltese: Kura sekwenzjali ikkonsistiet minn capecitabine (1250 mg/m2 darbtejn kuljum għal 14-il ġurnata) bħala kura primarja, irinotecan (350 mg/m2 fl-ewwel ġurnata) bħala kura sekondarja, u taħlita ta' capecitabine (1000 mg/m2 darbtejn kuljum għal 14-il ġurnata) ma' oxaliplatin (130 mg/m2 fl-ewwel ġurnata) bħala kura terzjarja.
English: • if you know that you do not have any activity of the enzyme dihydropyrimidine dehydrogenase (DPD)
Maltese: • F'pazjenti b'assenza sħiħa magħrufa ta' attività ta' dihydropyrimidine dehydrogenase (DPD)
English: Patients were randomised to receive either FOLFIRI plus bevacizumab (Arm-A, n=167) or XELIRI plus bevacizumab (Arm-B, n-166).
Maltese: flimkien ma' bevacizumab (Grupp-B , n=166).
English: XELOX was demonstrated to be non-inferior to FOLFOX-4 in terms of progression-free survival in the perprotocol population and intent-to-treat population (see Table 10).
Maltese: Intwera li XELOX ma kienx inferjuri għal FOLFOX-4 f'termini ta' sopravivenza mingħajr progressjoni fil-popolazzjoni skond protokoll u fil-popolazzjoni b'intenzjoni li jiġu kkurati (ara Tabella 10).
English: You should take Capecitabine Accord no later than 30 minutes after meals.
Maltese: Għandek tieħu Capecitabine Accord mhux aktar tard minn 30 minuta wara l-ikel.
English: Visual acuity reduced, Diplopia
Maltese: Tnaqqis flakutezza tal-vista, Diplopja
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 li għandhom attività baxxa jew nieqsa ta' DPD, enzima involuta fid-degradazzjoni talfluorouracil, huma f'riskju akbar għal reazzjonijiet avversi severi, ta' theddida għall-ħajja, jew fatali kkawżati minn fluorouracil.
English: EU/1/12/762/013 EU/1/12/762/014 EU/1/12/762/015 EU/1/12/762/016 EU/1/12/762/017 EU/1/12/762/018 EU/1/12/762/025 EU/1/12/762/026 EU/1/12/762/027
Maltese: EU/1/12/762/016 EU/1/12/762/017 EU/1/12/762/018 EU/1/12/762/025 EU/1/12/762/026 EU/1/12/762/027
English: 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: 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.