FrancophonIA/ELRC3.0 huggingface dataset:
English: Each film-coated tablet contains 25 mg anhydrous lactose.
Maltese: Eċċipjent b'effett magħruf Kull pillola miksija b'rita fiha 25 mg anhydrous lactose.
English: The incorporation of 5-FU also leads to inhibition of RNA and protein synthesis.
Maltese: L-inkorporazzjoni ta' 5-FU twassal wkoll għall-inibizzjoni tas-sintesi tal-RNA u tal-proteini.
English: The results of a meta-analysis of 14 clinical trials with data from over 4700 patients treated with capecitabine showed that in all studies combined, the following covariates were statistically significantly associated with an increased risk of developing diarrhoea: increasing capecitabine starting dose (gram), increasing duration of study treatment (weeks), increasing age (by 10 year increments), and female gender.
Maltese: Ir-riżultati ta' meta-analiżi ta' 14-il prova klinika b'tagħrif minn aktar minn 4700 pazjent ittrattati b'capecitabine wrew li fl-istudji kollha kombinati, l-kovarjanti li ġejjin kienu assoċjati b'mod statistikament sinifikanti ma' żieda fir-riskju ta' żvilupp ta' dijarea: żieda fid-doża (grammi) tal-bidu ta' capecitabine, żieda fit-tul ta' trattament taħt studju (ġimgħat), żieda fl-età (b'żjidiet ta' 10 snin), u sess femminili.
English: Patients treated with XELIRI + bevacizumab reported a significantly higher incidence of diarrhoea, febrile neutropenia and hand-foot skin reactions than patients treated with FOLFIRI + bevacizumab with significantly increased treatment delays, dose reductions and treatment discontinuations.
Maltese: Pazjenti ttrattati b'XELIRI + bevacizumab irrappurtaw inċidenza ogħla b'mod sinifikanti ta' dijarea, newtropenija bid-deni u reazzjonijiet tal-ġilda tal-idejn u tas-saqajn minn pazjenti ttrattati b'FOLFIRI + bevacizumab b'żieda sinifikanti fid-dewmien tat-trattament, tnaqqis fid-doża u twaqqif tat-trattament.
English: PVC/PVdC/aluminium blisters EU/1/12/763/010 30 film-coated tablets EU/1/12/763/011 60 film-coated tablets EU/1/12/763/012 120 film-coated tablets
Maltese: Folji tal-PVC/PVdC/aluminju EU/1/12/763/010 30 pillola miksija b'rita EU/1/12/763/011 60 pillola miksija b'rita EU/1/12/763/012 120 pillola miksija b'rita
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 żieda ta' rtirar kmieni mit-trattament (rtirar ta' 21% waqt l-ewwel żewġ ċikli) vs. 5% u 8% f'pazjenti bl-ebda indeboliment jew indeboliment moderat tal-kliewi.
English: Stevens-Johnson Syndrome and toxic Epidermal Necrolysis (very rare) (see section 4.4.)
Maltese: Għandu jsir tnaqqis fid-doża skont il-bżonn (ara sezzjoni 4.2).
English: Neurotoxicity, Tremor, Neuralgia, Hypersensitivity reaction, Hypoaesthesia
Maltese: Newrotossiċità, Tregħid, Nevralġija, Reazzjoni ta' sensittività eċċessiva, Ipoestesija
English: As this medicinal product contains anhydrous lactose as an excipient, patients with rare hereditary problems of galactose intolerance, total 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 għall-galactose, nuqqas totali ta' lactase jew malassorbiment tal-glucose-galactose m'għandhomx jieħdu din il-mediċina.
English: Montagnani et al used the results from the above three studies to provide an overall analysis of randomised studies comparing FOLFIRI and XELIRI treatment regimens in the treatment of mCRC.
Maltese: Montagnani et al użaw ir-riżultati mit-tliet studji ta' fuq biex jipprovdu analiżi globali tal-istudji randomised li qabblu korsijiet ta' trattament ta' FOLFIRI u XELIRI fit-trattament ta' mCRC.
English: The tablets are light peach colored, 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: Il-pilloli huma ta' lewn il-ħawħ ċar, 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: This may also be relevant with folic acid supplementation for folate deficiency due to the similarity between folinic acid and folic acid.
Maltese: Dan jista' jkun rilevanti wkoll b'supplimentazzjoni ta' folic acid għal defiċjenza ta' folate minħabba x-xebħ bejn folinic acid u folic acid.
English: Based on the population pharmacokinetic analysis, which included patients with a wide range of ages (27 to 86 years) and included 234 (46%) patients greater or equal to 65, age has no influence on the pharmacokinetics of 5'-DFUR and 5-FU.
Maltese: Ibbażat fuq analiżi tal-farmakokinetika tal-popolazzjoni, li kienet tinkludi pazjenti b'firxa wiesa' ta' etajiet (minn 27 sa 86 sena) u li kienet tinkludi 234 (46%) pazjent li kellhom iżjed minn 65 sena jew kellhom 65 sena, l-età m'għandha l-ebda influwenza fuq il-farmakokinetika ta' 5'-DFUR u 5-FU. L-AUC ta' FBAL żdiedet ma' l-età (20% żieda fl-età tirriżulta f'żieda ta' 15% fl-AUC ta' FBAL).
English: NAME OF THE MARKETING AUTHORISATION HOLDER KRKA
Maltese: KRKA Magyarország Kereskedelmi
English: Neutropenia, Anaemia
Maltese: Newtropenija, Anemija
English: Hand-foot syndrome (also known as hand-foot skin reaction or palmar-plantar erythrodysesthesia or chemotherapy induced acral erythema).
Maltese: Sindrome tal-idejn u s-saqajn magħruf ukoll bħala reazzjoni tal-ġilda tal-idejn u s-saqajn jew eritrodisasteżija palmari-plantari jew eritema akrali kkaġunata mill-kemjoterapija.
English: Aluminium/aluminium blisters EU/1/12/763/007 30 film-coated tablets EU/1/12/763/008 60 film-coated tablets EU/1/12/763/009 120 film-coated tablets
Maltese: Aluminju/folji tal-aluminju EU/1/12/763/007 30 pillola miksija b'rita EU/1/12/763/008 60 pillola miksija b'rita EU/1/12/763/009 120 pillola miksija b'rita
English: Radiotherapy: the MTD of capecitabine alone using the intermittent regimen is 3000 mg/m2 per day, whereas, when combined with radiotherapy for rectal cancer, the MTD of capecitabine is 2000 mg/m per day using either a continuous schedule or given daily Monday through Friday during a 6-week course of radiotherapy.
Maltese: Radjuterapija L-MTD ta' capecitabine waħdu bl-użu ta' kors intermittenti hija ta' 3000 mg/m2 kuljum, filwaqt, meta kkombinat ma' radjuterapija għall-kanċer fir-rektum, l-MTD ta' capecitabine hija 2000 mg/m2 kuljum bl-użu ta' programm kontinwu jew mogħti kuljum mit-Tnejn sal-Ġimgħa waqt kors ta' sitt ġimgħat ta' radjuterapija.
English: Oxaliplatin: 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: These results suggest an interaction, probably due to an inhibition of the cytochrome P450 2C9 isoenzyme system by capecitabine.
Maltese: Dawn ir-riżultati jissuġġerixxu interazzjoni, x'aktarx minħabba l-impedizzjoni minn capecitabine tas-sistema tal-isoenżimi taċ-ċitokromju P450 2C9.
English: In combination with docetaxel, the recommended starting dose of capecitabine in the treatment of metastatic breast cancer is 1250 mg/m2 twice daily for 14 days followed by a 7-day rest period, combined with docetaxel at 75 mg/m2 as a 1 hour intravenous infusion every 3 weeks.
Maltese: F'taħlita ma' docetaxel, id-doża tal-bidu rakkomandata ta' capecitabine fit-trattament ta' kanċer metastatiku tas-sider hija ta' 1250 mg/m2 darbtejn kuljum għal 14-il jum segwita minn perjodu ta' waqfien ta' sebat ijiem, flimkien ma' 75 mg/m2 docetaxel mogħti bħala infużjoni fil-vini fuq perjodu ta' siegħa kull 3 ġimgħat.
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 tat-tossiċitajiet osservati.
English: It has been reported that the DPYD*2A, c.1679T>G variants lead to a greater reduction in enzymatic activity than the other variants with a higher risk of side effects.
Maltese: Ġie rrappurtat li l-varjanti DPYD*2A, c.1679T>G wasslu għal tnaqqis akbar fl-attività tal-enzima mill-varjanti l-oħra b'riskju ogħla ta' effetti sekondarji.
English: Each film-coated tablet contains 15 mg anhydrous lactose.
Maltese: Eċċipjent b'effett magħruf Kull pillola miksija b'rita fiha 15 mg anhydrous lactose.
English: Haematuria, Proteinuria, Creatinine renal clearance decreased, Dysuria
Maltese: Ematurja, Proteina fl-awrina, Tnaqqis fit-tneħħija tal-krejatinina mill-kliewi, Disurja
English: MARKETING AUTHORISATION NUMBER (S)
Maltese: NUMRU(I)
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, multicentre u randomised ta' fażi
English: When capecitabine was used in combination with other medicinal products, elderly patients (≥65 years) experienced more grade 3 and grade 4 adverse drug reactions, including those leading to discontinuation, compared to younger patients.
Maltese: Meta capecitabine ntuża flimkien ma' prodotti mediċinali oħra, pazjenti anzjani (≥65 sena) kellhom esperjenza akbar ta' reazzjonijiet avversi għall-mediċina ta' grad 3 u grad 4, inkluż dawk li wasslu għat-twaqqif, meta mqabbel ma' pazjenti iżgħar.
English: In reproductive toxicity studies in animals, capecitabine administration caused embryolethality and teratogenicity.
Maltese: Fi studji dwar it-tossiċità riproduttiva fl-annimali, l-għoti ta' capecitabine kkawża mewt tal-embriju u teratoġeniċità.
English: Aluminium/aluminium blisters EU/1/12/763/013 30 film-coated tablets EU/1/12/763/014 60 film-coated tablets EU/1/12/763/015 120 film-coated tablets
Maltese: Aluminju/folji tal-aluminju EU/1/12/763/013 30 pillola miksija b'rita EU/1/12/763/014 60 pillola miksija b'rita EU/1/12/763/015 120 pillola miksija b'rita
English: Sequential treatment consisted of first-line capecitabine (1250 mg/m2 twice daily for 14 days), second-line irinotecan (350 mg/m2 on day
Maltese: Trattament sekwenzjali jikkonsistiet minn capecitabine (1250 mg/m2 darbtejn kuljum għal 14-il ġurnata) bħala trattament primarju, irinotecan (350 mg/m 2 fl-ewwel ġurnata) bħala trattament sekondarju, u taħlita ta' capecitabine (1000 mg/m 2 darbtejn kuljum għal 14-il ġurnata) ma' oxaliplatin
English: Uncommon
Maltese: Mhux Komuni
English: KRKA Pharma Dublin, Ltd. Tel: + 353 1 293 91 80
Maltese: KRKA Farmacéutica, S.L. Tel: + 34 911 61 03 81
English: After oral administration, capecitabine is rapidly and extensively absorbed, followed by extensive conversion to the metabolites, 5'-DFCR and 5'-DFUR.
Maltese: Wara l-għoti orali, capecitabine jiġi assorbit malajr u b'mod estensiv, segwit minn bidla estensiva għall-metaboliti, 5'-DFCR u 5'-DFUR.
English: In repeat-dose toxicity studies, daily oral administration of capecitabine to cynomolgus monkeys and mice produced toxic effects on the gastrointestinal, lymphoid and haemopoietic systems, typical for fluoropyrimidines.
Maltese: Fi studji dwar l-effett tossiku minn dożi ripetuti, l-għoti kuljum ta' capecitabine mill-ħalq lil xadini cynomolgus u ġrieden, ipproduċew effetti tossiċi fuq is-sistema gastrointestinali, limfatika u emopoetika, tipika għal fluoropyrimidines.
English: Table 3 Capecitabine dose reduction schedule (3 weekly cycle or continuous treatment)
Maltese: Tabella 3 Skeda tat-tnaqqis fid-doża ta' capecitabine (ciklu ta' 3 ġimgħat jew trattament kontinwu) Gradi ta' tossiċità*
English: How to take Ecansya
Maltese: X'fih Ecansya
English: Finally, -ureido-propionase cleaves FUPA to
Maltese: Dan il-fuljett kien rivedut l-aħħar f'
English: Diabetes mellitus or electrolyte disturbances.
Maltese: Dijabete mellitus jew disturbi fl-elettroliti
English: A comparison of XELOX plus bevacizumab versus FOLFOX-4 plus bevacizumab was a pre-specified exploratory analysis.
Maltese: Paragun ta' XELOX u bevacizumab kontra FOLFOX-4 u bevacizumab kien analiżi esploratorju speċifikat minn qabel.
English: PVC/PVdC/aluminium blisters Do not store above 30°C.
Maltese: Folji tal-PVC/PVdC/aluminju Taħżinx f'temperatura 'l fuq minn 30C.
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: 80, 95% CI=[0.69; 0.93]; p=0.0045).
English: KRKA Farmacéutica, S.L.
Maltese: Kipa Pharmacal Ltd.
English: Hypokalaemia, Hyponatraemia, Hypomagnesaemia,
Maltese: Ipokalimja, Iponatrimja, Ipomagnesimja, Ipokalċimja, Ipergliċemija
English: The results of a meta-analysis of 14 clinical trials with data from over 4700 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 4700 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: Children and adolescents Ecansya is not indicated in children and adolescents.
Maltese: Tagħtix Ecansya lil tfal u adolexxenti.
English: Aluminium/aluminium blisters EU/1/12/763/001 30 film-coated tablets EU/1/12/763/002 60 film-coated tablets EU/1/12/763/003 120 Film-coated tablets
Maltese: Aluminju/folji tal-aluminju EU/1/12/763/001 30 pillola miksija b'rita EU/1/12/763/002 60 pillola miksija b'rita EU/1/12/763/003 120 pillola miksija b'rita
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 tal-kolorektum li rċevew trattament minn qabel b'irinotecan flimkien ma' kors ta' fluoropyrimidine bħala trattament primarju kienu randomised għat-trattament b'XELOX jew FOLFOX-4.
English: Posology adjustments during treatment
Maltese: Sopravivenza mingħajr Progressjoni
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: Colon, colorectal and gastric cancer
Maltese: Folinic acid/folic acid
English: Sore throat, Dysaesthesia pharynx
Maltese: Uġigħ fil-griżmejn, Disasteżija tal-farinġi
English: Hepatobiliary disorders
Maltese: Mhux applikabbli
English: Only after being absorbed by the body is it changed into an active anti-cancer medicine (more in tumour tissue than in normal tissue).
Maltese: Huwa biss wara li jiġi assorbit mill-ġisem li jinbidel f'mediċina attiva kontra l-kanċer (aktar f'tessut tat-tumur milli f'tessut normali).
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: Caution must be exercised in patients with pre-existing hypo- or hypercalcaemia (see section 4.8).
Maltese: Trid tingħata attenzjoni lillpazjenti li diġa għandhom ipo- jew iperkalċimja (ara sezzjoni 4.8).
English: The results of a meta-analysis of 14 clinical trials with data from over 4700 patients treated with capecitabine showed that in all studies combined, female gender 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 4700 pazjent ittrattat b'capecitabine wrew li fl-istudji kollha kombinati, sess femminili kien assoċjati b'mod statistikament sinifikanti ma' żieda fir-riskju ta' żvilupp ta' HFS u dijarea u ma' riskju mnaqqas ta' żvilupp ta' newtropenija.
English: Ecansya belongs to the group of medicines called "cytostatic medicines", which stop the growth of cancer cells.
Maltese: Ecansya jappartieni għall-grupp ta' mediċini msejħa "mediċini ċitostatiċi", li jwaqqfu l-iżvilupp taċċelluli tal-kanċer.
English: In addition, during a 13-week study, atrophic and degenerative changes occurred in reproductive organs of male mice; however these effects were reversible after a drug-free period (see section 4.6).
Maltese: Barra minn hekk, waqt studju ta' 13-il ġimgħa, tibdil atrofiku u deġenerattiv seħħ f'organi riproduttivi ta' ġrieden maskili; madankollu dawn l-effetti kienu riversibbli wara perjodu mingħajr mediċina (ara sezzjoni 4.6).
English: Flushing, Hypotension, Hypertensive crisis, Hot flush, Phlebitis
Maltese: Fwawar, Pressjoni baxxa, Kriżi ipertensiva, Fwawar, Infjammazzjoni fil-vini
English: The median overall survival was 10.9 months in capecitabine-based regimens and 9.6 months in 5-FU based regimens.
Maltese: 9 xhur f'korsijiet bbażati fuq capecitabine u 9.6 xhur f'korsijiet bbażati fuq 5-FU.
English: 1, every 3 weeks).
Maltese: 4.2 u 4.3).
English: Elderly
Maltese: Dijarea
English: Film-coating
Maltese: Bijotrasformazzjoni
English: Table 7 Key efficacy results for the non-inferiority analysis of Study NO16966 PRIMARY ANALYSIS XELOX/XELOX+P/
Maltese: Tabella 7 Riżultati importanti tal-effikaċja għall-analiżi ta' nuqqas ta' inferjorità ta' Studju NO16966
English: Other medicines and Ecansya
Maltese: Kif taħżen Ecansya
English: Ecansya 500 mg film-coated tablets (tablets) are peach coloured, 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: Ecansya 500 mg pilloli miksija b'rita (pilloli) huma pilloli ta' lewn il-ħawħ, f'għamla oblong, imżaqqin fuq żewġ naħat ta' tul ta' 15.
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 fl-inċidenza ta' reazzjonijiet avversi ta' grad 3 u 4 u ta' reazzjonijiet avversi serji relatati mattrattament meta mqabbla ma' pazjenti b'età ta' < 60 sena.
English: Common side-effects (may affect up to 1 in 10 people) include: - decrease in blood sodium, magnesium or calcium, increase in blood sugar - nerve pain - ringing or buzzing in the ears (tinnitus), loss of hearing - vein inflammation - hiccups, change in voice - pain or altered/abnormal sensation in the mouth, pain in the jaw - sweating, night sweats - muscle spasm
Maltese: Effetti sekondarji komuni (jistgħu jaffettwaw sa persuna waħda minn kull 10) jinkludu: - livell imnaqqas ta' sodium, magnesium jew calcium fid-demm, żieda ta' zokkor fid-demm - uġigħ fin-nervaturi - tisfir jew żarżir fil-widnejn (tinnitus), telf tas-smigħ - infjammazzjoni tal-vini - sulluzzu, bidla fil-vuċi - uġigħ jew sensazzjoni mibdula/mhux normali fil-ħalq, uġigħ fix-xedaq - għaraq, għaraq matul il-lejl - spażmi fil-muskoli - diffikultà biex tgħaddi l-awrina, demm jew proteina fl-awrina - tbenġil jew reazzjoni fis-sit tal-injezzjoni (ikkawżati minn mediċini mogħtija permezz ta'
English: Parameter: Progression-free Survival EPP ITT Parameter: Overall Survival EPP ITT *EPP=eligible patient population; **ITT=intent-to-treat population
Maltese: *EPP=popolazzjoni ta' pazjenti eliġibbli; **ITT=popolazzjoni b'intenzjoni li jiġu ttrattati
English: In the instance of exposure to crushed or cut capecitabine tablets, the following adverse drug reactions have been reported: eye irritation, eye swelling, skin rash, headache, paresthesia, diarrhea, nausea, gastric irritation, and vomiting.
Maltese: F'każ ta' esponiment għal pilloli mfarrka jew maqsuma ta' capecitabine, ġew irrappurtati rreazzjonijiet avversi tal-mediċina li ġejjin: irritazzjoni fl-għajnejn, nefħa fl-għajnejn, raxx tal-ġilda, uġigħ ta' ras, parestesija, dijarea, tqalligħ, irritazzjoni gastrika, u rimettar.
English: Interferon alpha: 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
English: Diarrhoea, Vomiting, Nausea, Stomatitis, Abdominal pain
Maltese: Dijarea, Rimettar, Tqalligħ, Stomatite, Uġigħ addominali
English: Vascular disorders
Maltese: Tromboflebite
English: There are no side-effects caused by stopping treatment with capecitabine.
Maltese: M'hemm l-ebda effetti sekondarji kkawżati minn waqfien tat-trattament b'capecitabine.
English: A population pharmacokinetic analysis was carried out after capecitabine treatment of 505 patients with colorectal cancer dosed at 1250 mg/m2 twice daily.
Maltese: 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' 1250 mg/m2 darbtejn kuljum.
English: Ecansya is indicated for the treatment of: - for the adjuvant treatment of patients following surgery of stage III (Dukes' stage C) colon cancer (see section 5.1).
Maltese: Ecansya huwa indikat għat-trattament ta': - għat-trattament awżiljarju ta' pazjenti wara kirurġija ta' kanċer tal-kolon ta' stadju III (stadju ta'
English: The enzyme involved in the final conversion to 5-FU, thymidine phosphorylase (ThyPase), is found in tumour tissues, but also in normal tissues, albeit usually at lower levels.
Maltese: L-enżima involuta fil-bidla finali għal 5-FU, thymidine phosphorylase (ThyPase), tinstab f'tessuti bit-tumur, iżda wkoll f'tessuti normali, għalkemm is-soltu fl-livell aktar baxx.
English: • Grade 2 -1st appearance
Maltese: • Grad 2
English: Hiccups, Pharyngolaryngeal pain, Dysphonia
Maltese: Sulluzzu, Uġigħ faringolarinġali, Disfonija
English: The overall objective response rates in the all-randomised population (investigator assessment) were 25.7% (capecitabine) vs. 16.7% (Mayo regimen); p <0.0002.
Maltese: 7% (kors ta' Mayo); p < 0.0002.
English: Standard and reduced dose calculations according to body surface area for starting doses of Ecansya 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' Ecansya ta' 1250 mg/m2 u 1000 mg/m2 hma pprovduti f'tabelli 1 u 2