FrancophonIA/ELRC3.0 huggingface dataset:
English: The incidence of grade 3 or 4 adverse reactions in patients with moderate renal impairment (creatinine clearance 30-50 ml/min) is increased compared to the overall population (see sections 4.2 and 4.3).
Maltese: Reazzjonijiet avversi ta' grad 3 jew 4 f'pazjenti b'indeboliment moderat talkliewi (tneħħija tal-krejatinina 30-50 ml/min) iseħħu aktar ta' spiss meta mqabbla mal-popolazzjoni totali (ara sezzjonijiet 4.2 u 4.3).
English: The hazard ratio for duration of survival (overall survival) was similar to the hazard ratio for progression-free survival (hazard ratio 0.85; 95% CI 0.64 - 1.13).
Maltese: Il-hazard ratio għat-tul tas-sopravivenza (sopravivenza totali) kien simili għall-hazard ratio tas-sopravivenza mingħajr progressjoni (hazard ratio 0.85; 95% CI 0.64 - 1.13).
English: Japanese patients (n=18) had about 36% lower Cmax and 24% lower AUC for capecitabine than Caucasian patients (n=22).
Maltese: pazjenti Ġappuniżi (n=18) kellhom Cmax għal capecitabine madwar 36% inqas u AUC 24% inqas minn pazjenti Kawkasi (n=22).
English: Herpes zoster, Urinary tract infection, Oral candidiasis, Upper respiratory tract infection, Rhinitis, Influenza, +Infection, Oral herpes
Maltese: Herpes zoster, Infezzjoni flapparat ta' l-awrina, Kandidajasi orali, Infezzjoni fl-apparat repiratorju ta' fuq, Rinite, Influwenza, +Infezzjoni, Herpes orali
English: 150 mg 500 mg
Maltese: 150 mg 500 mg Doża kull għotja (mg)
English: Data from one multicentre, randomised, controlled phase 3 clinical trial in patients with stage III (Dukes' C) colon cancer supports the use of capecitabine in combination with oxaliplatin (XELOX) for the adjuvant treatment of patients with colon cancer (NO16968 study).
Maltese: Tagħrif minn prova klinika multicentre, randomised u kkontrollata ta' fażi 3 f'pazjenti b'kanċer talkolon 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: Hypo- or hypercalcaemia.
Maltese: Ipo- jew iperkalċimja.
English: Hypokalaemia, Hyponatraemia, Hypomagnesaemia, Hypocalcaemia, Hyperglycaemia
Maltese: Ipokalimja, Iponatrimja, Ipomagnesimja, Ipokalċimja, Ipergliċemija
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: Fl-istudju EORTC il-pazjent kienu randomised biex jirċievu open label FOLFIRI (n=41) jew XELIRI (n=44) b'randomisation addizzjonali għal kura double-blind b'celecoxib jew plaċebo.
English: Table 6 Treatment regimens in study NO16966 (mCRC)
Maltese: Tabella 6 Korsijiet ta' kura fl-istudju NO16966 (mCRC) Doża tal-Bidu
English: Parameter: Progression-free Survival EPP ITT Parameter: Overall Survival EPP ITT
Maltese: Sopravivenza mingħajr Progressjoni EPP ITT Parametru:
English: Folinic acid/folic acid: a combination study with capecitabine and folinic acid indicated that folinic acid has no major effect on the pharmacokinetics of capecitabine and its metabolites.
Maltese: Folinic acid/folic acid: studju ta' taħlita b'capecitabine u folinic acid indika li folinic acid m'għandu lebda effett maġġuri fuq il-farmakokinetika ta' capecitabine u l-metaboliti tiegħu.
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: Tablet coating: hypromellose (E464) titanium dioxide (E171) lactose monohydrate macrogol yellow iron oxide (E172) and red iron oxide (E172).
Maltese: Il-kisja tal-pillola: hypromellose (E464) titanium dioxide (E171) lactose monohydrate macrogol iron oxide isfar (E172) u iron oxide aħmar (E172).
English: Cytochrome P-450 2C9 substrates: Other than warfarin, no formal drug-drug 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: Other medicines and Capecitabine SUN
Maltese: Mediċini oħra u Capecitabine SUN
English: Parameter: Progression-free Survival PPP ITT Parameter: Overall Survival PPP ITT *PPP=per-protocol population; **ITT=intent-to-treat population
Maltese: Sopravivenza Globali PPP ITT *PPP=popolazzjoni skont il-protokoll; **ITT= popolazzjoni b'intenzjoni li jiġu kkurati
English: Table 4 Summary of related ADRs reported in patients treated with capecitabine monotherapy Body System Very Common
Maltese: Tabella 4 Sommarju ta' l-ADRs relatati rrapportati f'pazjenti kkurati b'monoterapija ta' capecitabine
English: MARKETING AUTHORISATION NUMBER(S) EU/1/13/831/002
Maltese: TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/13/831/002
English: Administration of capecitabine should be interrupted if treatment-related elevations in bilirubin of >3.0 x ULN or treatment-related elevations in hepatic aminotransferases (ALT, AST) of >2.5 x ULN occur.
Maltese: L-għoti ta' capecitabine għandu jiġi interrott f'każ li sseħħ żjieda fillivelli ta' bilirubin ta' >3.0 x ULN relatata mal-kura jew żjieda fil-livell ta' aminotransferases talfwied (ALT, AST) ta' > 2.5 x ULN relatata mal-kura.
English: At the end of treatment, 37% of patients in the XELIRI and 26% of patients in the FOLFIRI arm were without evidence of the disease (p=0.56).
Maltese: Fl-aħħar tal-kura, 37% tal-pazjenti fil-grupp ta' XELIRI u 26% tal-pazjenti filgrupp ta' FOLFIRI kienu mingħajr evidenza tal-marda (p=0.56).
English: Paraesthesia, Dysaesthesia, Peripheral neuropathy, Peripheral sensory neuropathy, Dysgeusia, Headache
Maltese: Parasteżija, Disasteżija, Newropatija periferali, Newropatija sensorjali periferali, Disgewżja, Uġigħ ta' ras
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 (1000 mg/m2 darbtejn kuljum għal 14-il ġurnata) u oxaliplatin (130 mg/m2 fl-ewwel ġurnata) bħala kura sekondarja.
English: - Hypersensitivity to the active substance or to any of the excipients listed in section 6.1 or fluorouracil.
Maltese: - Sensitività eċċessiva għas-sustanza attiva jew għal kwalunkwe wieћed mill-eċċipjenti elenkati fissezzjoni 6.1, jew għal fluorouracil.
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 skont il-protokoll wriet nuqqas ta' inferjorità fissopravivenza globali għal capecitabine vs korsijiet ibbażati fuq 5-FU (hazard ratio 0.86; 95% CI 0.8 - 0.99) u għal oxaliplatin vs korsijiet ibbażati fuq cisplatin (hazard ratio 0.92; 95% CI 0.80 - 1.1).
English: - Tablet coating: hypromellose (E464), titanium dioxide (E171), lactose monohydrate, macrogol and ferric oxide yellow and red (E172).
Maltese: - Kisja tal-pillola: hypromellose (E464), titanium dioxide (E171), lactose monohydrate, macrogol u iron oxide isfar u aħmar (E172).
English: Capecitabine was at least equivalent to IV 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 IV fissopravvivenza bla marda fil-protokoll għal kull popolazzjoni (hazard ratio 0.92; 95% CI 0.80-1.06).
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: Dejta 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: Median PFS and overall survival (OS) times were shorter for XELIRI versus FOLFIRI (PFS 5.9 versus 9.6 months and OS 14.8 versus 19.9 months), in addition to which excessive rates of diarrhoea were reported in patients receiving the XELIRI regimen (41% XELIRI, 5.1% FOFIRI).
Maltese: Iż-żmien medjan ta' PFS u ta' sopravivenza globali (OS - overall survival) kienu iqsar għal XELIRI kontra FOLFIRI (PFS ta' 5.9 kontra 9.6 xhur u OS ta' 14.8 kontra 19.9 xhur), u barra dan kienu rrappurtati rati eċċessivi ta' dijarea f'pazjenti li kienu qed jirċievu l-kors ta' XELIRI (41% XELIRI, 5.1% FOLFIRI).
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 kkombinat (fil-letteratura u/jew sommarju tal-karatterisitiċi tal-prodott rispettiv).
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 flimkien ma' bevacizumab, u FOLFOX-4 flimkien ma' bevacizumab.
English: Headache, Lethargy Dizziness, Parasthesia Dysgeusia
Maltese: Uġigħ ta' ras, Letarġija, Sturdament, Parasteżija, Disgewsja
English: XELOX was demonstrated to be non-inferior to FOLFOX-4 in terms of progression-free survival in the per-protocol population and intent-to-treat population (see table 9).
Maltese: Intwera li XELOX ma kienx inferjuri għal FOLFOX-4 f'termini ta' sopravivenza mingħajr progressjoni fil-popolazzjoni skont protokoll u filpopolazzjoni b'intenzjoni li jiġu kkurati (ara tabella 9).
English: In a drug 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: 604 patients were randomised to treatment with 5-FU and leucovorin (Mayo regimen: 20 mg/m2 leucovorin IV followed by 425 mg/m2 IV bolus 5-FU, on days 1 to 5, every 28 days).
Maltese: waqfien tal-kura u mogħtija bħala ċikli ta' 3 ġimgħat). 604 pazjenti ġew randomised għall-kura b'5-FU u leucovorin (kors ta' Mayo: 20 mg/m2 leucovorin IV segwit minn 425 mg/m2 5-FU IV bolus,
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 691 ġurnata (95% CI 638; 754) b'proporzjon ta' periklu ta' 0.61 (95% CI 0.56; 0.66).
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' lidejn u s-saqajn, minħabba rapporti ppublikati li hija tista' tnaqqas l-effikaċja ta' cisplatin.
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 691 ġurnata (95% CI 638; 754) b'proporzjon ta' periklu ta' 0.61 (95% CI 0.56; 0.66).
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 rrakkomandata tal-bidu ta' capecitabine għandha titnaqqas għal 800 - 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: Hypokalaemia, Appetite disorder, Malnutrition, Hypertriglyceridaemia,
Maltese: Ipokalimja, Disturbi fl-aptit, Nutrizzjoni ħażina, Ipertrigliċeridemija
English: Hiccups, Pharyngolaryngeal pain,
Maltese: IL-PRODOTTI MEDIĊINALI, JEKK HEMM BŻONN.
English: Each pack contains 120 film-coated tablets (12 blisters of 10 tablets).
Maltese: Kull pakkett fih 120 pillola miksija b'rita (12 folji ta' 10 pilloli).
English: This interaction, which leads to increased fluoropyrimidine toxicity, is potentially fatal.
Maltese: Din l-interazzjoni, li twassal għal żjieda fit-tossiċità ta' fluoropyrimidine, hija potenzjalment fatali.
English: Ethnic factors: Following oral administration of 825 mg/m2 capecitabine twice daily for 14 days,
Maltese: Wara l-għoti mill-ħalq ta' 825 mg/m2 capecitabine darbtejn kuljum għal 14-il jum,
English: 10.0 and 8.9 months; p=0.64, overall survival 25.7 and 27.5 months; p=0.55 and response rates 45.5 and 39.8%; p=0.32 for FOLFIRI-Bev and XELIRI-Bev, respectively.
Maltese: 7 u 27.5 xhur; p=0.55 u r-rati ta' rispons kienu ta' 45.5 u 39.8%; p=0.
English: Capecitabine in combination with docetaxel (see section 5.1) is indicated for the treatment of patients with locally advanced or metastatic breast cancer after failure of cytotoxic chemotherapy.
Maltese: Capecitabine 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: PHARMACEUTICAL FORM AND CONTENTS 120 film-coated tablets
Maltese: GĦAMLA FARMAĊEWTIKA U KONTENUT 120 pillola miksija b'rita
English: Capecitabine SUN 150 mg film-coated tablets are light peach coloured, oval, biconvex, 11.5 mm x
Maltese: Capecitabine SUN 150 mg pillola miksija b'rita hija pillola ta' lewn aħmar fl-isfar ċar, ibbużżata fuq iż-żewġ naħat, ta' forma ovali,11.5 mm x 5.7 mm, bil-marka ‘150' fuq naħa waħda u lixxi fuq in-naħa l-oħra.
English: Table 4 lists ADRs associated with the use of capecitabine monotherapy based on a pooled analysis of safety data from three major studies including over 1900 patients (studies M66001, SO14695, and SO14796).
Maltese: Tabella 4 telenka l-ADRs assoċjati ma' l-użu ta' capecitabine bħala monoterapija ibbażati fuq analiżi globali ta' tagħrif dwar is-sigurtà minn tliet studji maġġuri li kienu jinkludu aktar minn 1900 pazjent (studji M66001, SO14695, u SO14796).
English: For hand-foot syndrome and hyperbilirubinemia, see section 4.4.
Maltese: Għas-sindrome ta' lidejnsaqajn u iperbilirubinimja, ara sezzjoni 4.4.
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 għall-kura primarja ta' kanċer metastatiku tal-kolon u tar-rektum.
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 issuperjorità ta' capecitabine meta mqabbel ma' 5-FU/LV bħala bolus.
English: Film-coated tablet
Maltese: Emorraġija fil-vaġina
English: Dysgeusia, Headache
Maltese: Stitikezza, Dispepsja
English: Patients with renal impairment (see section 4.2, 4.4, and 5.2) 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: .2) Analiżi ta' tagħrif dwar is-sigurtà f'pazjenti kkurati b'monoterapija ta' capecitabine (kanċer tal-kolon u tar-rektum) u b'indeboliment tal-kliewi fil-linja bażi, uriet żjieda fl-inċidenza ta' reazzjonijiet avversi ta' grad 3 u 4 relatati mal-kura 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: INFORMATION IN BRAILLE Capecitabine SUN 150 mg film-coated tablets
Maltese: INFORMAZZJONI BIL-BRAILLE Capecitabine SUN 150 mg pilloli miksija b'rita
English: INFORMATION IN BRAILLE Capecitabine SUN 500 mg film-coated tablets
Maltese: INFORMAZZJONI BIL-BRAILLE Capecitabine SUN 500 mg pilloli miksija b'rita
English: However, the marketing authorisation holder shall submit periodic safety update reports for this medicinal product if the product is included in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC
Maltese: Madankollu, id-detentur talawtorizzazzjoni għat-tqegħid fis-suq għandu jippreżenta rapporti perjodiċi aġġornati dwar is-sigurtà għal dan il-prodott jekk il-prodott huwa inkluż fil-lista tad-dati ta' referenza tal-Unjoni (lista EURD) prevista skont l-Artikolu 107c(7) tad-Direttiva 2001/83/KE u ppubblikati fuq il-portal elettroniku Ewropew tal-mediċini.
English: Each pack contains 60 film-coated tablets (6 blisters of 10 tablets).
Maltese: Kull pakkett fih 60 pillola miksija b'rita (6 folji ta' 10 pilloli).
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: Fil-kura primarja ilmedjan tas-sopravivenza mingħajr progessjoni fil-popolazzjoni b'intenzjoni li jiġu kkurati 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: You need to be particularly careful if you are taking any of the following: - gout medicines (allopurinol) - blood-thinning medicines (coumarin, warfarin) - certain anti-viral medicines (sorivudine and brivudine) - medicines for seizures or tremors (phenytoin) - a medicine to treat cancer (interferon alpha) - radiotherapy and certain medicines used to treat cancer (folinic acid, oxaliplatin, bevacizumab,
Maltese: Hemm bżonn li toqgħod attent b'mod speċjali jekk inti qed tieħu xi wieħed minn dawn li ġejjin: - mediċini għall-gotta (allopurinol) - mediċini li jraqqu d-demm (kumarin, warfarina) - ċerti mediċini antivirali (sorivudine u brivudine) - mediċini għall-aċċessjonijiet jew għar-rogħda (phenytoin) - mediċina għall-kura tal-kanċer (interferon alpha) - radjuterapija u ċerti mediċini użati għall-kura tal-kanċer (aċidu foliniku, oxaliplatin,
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 it-tossiċità ta' 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: 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
Maltese: Emorraġija fl-apparat gastrointestinali ta' fuq, Ulċerazzjoni fil-ħalq, Gastrite, Distensjoni addominali, marda tar-rifluss gastro-osofagali, Uġigħ fil-ħalq, Disfaġija, Emorraġija mir-rektum, Uġigħ fil-parti t'isfel ta' l-addome, Disestesija orali, parestesija orali, Ipoestesija, Skomdu addominali
English: Do not give Capecitabine SUN to children and adolescents.
Maltese: Tagħtix Capecitabine SUN lil tfal u adolexxenti.