FrancophonIA/ELRC3.0 huggingface dataset:
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 tal-kolon ta' stadju III (Dukes' C) jsostni l-użu ta' capecitabine flimkien ma' oxaliplatin (XELOX) għat-trattament awżiljarju ta' pazjenti b'kanċer tal-kolon (studju NO16968).
English: Tablet core
Maltese: ANALIŻI PRIMARJA
English: Tabulated list of adverse reactions
Maltese: Lista f'tabella tar-reazzjonijiet avversi
English: However, similar to other nucleoside analogues (ie, 5-FU), capecitabine was clastogenic in human lymphocytes (in vitro) and a positive trend occurred in mouse bone marrow micronucleus tests (in vivo).
Maltese: Madankollu, bħall-analogi ta' nucleoside oħra (i.e., 5-FU), capecitabine kien klastoġeniku f'limfoċiti umani (in vitro) u seħħet xejra pożittiva f'testijiet fuq il-mikronukleu tal-mudullun tal-ġrieden (in vivo).
English: Cytochrome P-450 2C9 substrates: 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 capecitabine u sottostrati oħra ta' CYP2C9.
English: ADRs considered by the investigator to be possibly, probably, or remotely related to the administration of capecitabine are listed in table 4 for capecitabine given as monotherapy and in table 5 for capecitabine given in combination with different chemotherapy regimens in multiple indications.
Maltese: ADRs ikkunsidrati mill-investigatur bħala possibbilment, probabbilment jew remotament relatati ma' l-għoti ta' capecitabine huma mniżżla f'tabella 4 għal capecitabine mogħti bħala monoterapija u f'tabella 5 għal capecitabine mogħti flimkien ma' korsijiet ta' kimoterapija differenti f'indikazzjonijiet multipli.
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 fil-popolazzjoni b'intenzjoni li jiġu ttrattati (ara tabella 9).
English: See also interaction with coumarin-derivative anticoagulants below, and section 4.4.
Maltese: Ara wkoll interazzjoni ma' sustanzi kontra il-koagulazzjoni tad-demm derivati minn coumarin taħt, u sezzjoni 4.4.
English: • Periodic safety update reports (PSURs)
Maltese: • Rapporti perjodiċi aġġornati dwar is-sigurtà (PSURs)
English: Median survival was 442 days (capecitabine + docetaxel) vs. 352 days (docetaxel alone).
Maltese: Is-sopravivenza medja kienet ta' 442 jum (capecitabine + docetaxel) vs.
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 żieda fil-livelli ta' bilirubin ta' >3.0 x ULN relatata mat-trattament jew żieda fil-livell ta' aminotransferases tal-fwied (ALT, AST) ta' > 2.5 x ULN relatata mat-trattament.
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 life-threatening or fatal toxicity and should not be treated with Ecansya (see section 4.3).
Maltese: Għalkemm defiċjenza ta' DPD ma tistax tiġi definita b'mod preċiż, huwa magħruf li pazjenti b'ċerti mutazzjonijiet omozigotiċi jew ċerti mutazzjonijiet eterozigotiċi komposti fil-lok talġene DPYD (eż. varjanti DPYD*2A, c.1679T>G, c.2846A>T u c.1236G>A/HapB3), li jistgħu jikkawżaw nuqqas totali jew kważi totali tal-attività tal-enzima' DPD (kif determinat minn analiżi tallaboratorju), għandhom l-ogħla riskju ta' tossiċità ta' periklu għall-ħajja jew fatali u m'għandhomx jiġu ttrattati b'Ecansya (ara sezzjoni 4.3).
English: Each film-coated tablet contains 150 mg, 300 mg or 500 mg capecitabine.
Maltese: Kull pillola miksija b'rita fiha 150 mg, 300 mg jew 500 mg ta' capecitabine.
English: Capecitabine dose reduction decreases systemic exposure to 5-FU more than dose-proportionally, due to non-linear pharmacokinetics for the active metabolite.
Maltese: Tnaqqis fid-doża ta' capecitabine tnaqqas l-espożizzjoni sistematika għal 5-FU aktar minn proporzjonali mad-doża, minħabba farmakokinetika mhux linejari għall-metabolit attiv.
English: Capecitabine is contraindicated in patients with severe renal impairment (creatinine clearance below 30 ml/min [Cockcroft and Gault] at baseline).
Maltese: Capecitabine huwa kontraindikat f'pazjenti b'indeboliment serju tal-kliewi (tneħħija tal-krejatinina taħt it-30 ml/min [Cockcroft u Gault] fil-linja bażi).
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 għat-trattament profilattiku sintomatiku jew sekondarju tas-sindrome tal-idejn u s-saqajn, minħabba rapporti ppublikati li hija tista' tnaqqas l-effikaċja ta' cisplatin.
English: INFORMATION IN BRAILLE Ecansya 150 mg
Maltese: Ecansya 150 mg
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: KRKA Sverige AB Tlf: + 46 (0)8 643 67 66 (SE)
Maltese: Tlf: + 46 (0)8 643 67 66 (SE)
English: INFORMATION IN BRAILLE Ecansya 500 mg
Maltese: Ecansya 500 mg
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-żieda ta' thymidine phosphorylase minn docetaxel.
English: Cardiovascular toxicity (e.g. PR- and QT-interval prolongation) was detectable in cynomolgus monkeys after intravenous administration (100 mg/kg) but not after repeated oral dosing (1379 mg/m2/day).
Maltese: Tossiċità kardjovaskulari (eż. titwil ta' l-intervall tal-QT u PR) setgħet tiġi osservata f'xadini cynomolgus wara l-għoti fil-vini (100 mg/kg) iżda mhux wara dożi ripetuti mill-ħalq (1379 mg/m2/kuljum).
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% FOLFIRI).
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: Brivudine: a clinically significant interaction between brivudine and fluoropyrimidines (e.g. capecitabine, 5-fluorouracil, tegafur), resulting from the inhibition of dihydropyrimidine dehydrogenase by brivudine, has been described.
Maltese: Ġiet deskritta interazzjoni ta' sinifikanza klinika bejn brivudine u fluoropyrimidines (eż. capecitabine, 5-Fluorouracil, tegafur), li rriżultat mill-impedizzjoni ta' dihydropyrimidine dehydrogenase minn brivudine.
English: Pulmonary embolism, Pneumothorax, Haemoptysis, Asthma, Dyspnoea exertional
Maltese: Emboliżmu pulmonari, Pnewmotorax, Emoptisi, Ażżma, Qtugħ ta' nifs ma' l-eżerċizzju
English: PHARMACEUTICAL FORM AND CONTENTS Film-coated tablet
Maltese: GĦAMLA FARMAĊEWTIKA U KONTENUT
English: FOLFOX-4+BV (EPP*: N=937; ITT**: N=1017)
Maltese: FOLFOX-4/ FOLFOX-4+P/ FOLFOX-4+BV (EPP*: N = 937;
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, pilloli ta' 300 mg u/jew pilloli ta' 500 mg kull għotja (kull għotja għandha tingħata filgħodu u filgħaxija)
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: - Infection: if you experience signs of infection caused by bacteria or virus, or other organisms.
Maltese: - Infezzjoni: jekk ikollok sinjali ta' infezzjoni kkawżati minn batterja jew virus, jew organiżmi oħra.
English: Some of the ADRs are reactions commonly seen with the combination medicinal product (e.g. peripheral sensory neuropathy with docetaxel or oxaliplatin, hypertension seen with bevacizumab); however an exacerbation by capecitabine therapy cannot be excluded.
Maltese: Xi ADRs huma reazzjonijiet osservati b'mod komuni bil-prodott mediċinali kkombinat (eż. newropatija periferali tas-sensi ma' docetaxel jew oxaliplatin, pressjoni għolja osservata ma' bevacizumab); iżda rkadar ikkawżat minn terapija ta' capecitabine ma jistax jiġi eskluż.
English: Toxic leukoencephalopathy (very rare)
Maltese: Lewkoenċefalopatija tossika (rari ħafna)
English: Table 8 Key efficacy results for AIO KRK study XELOX + bevacizumab
Maltese: Tabella 8 Riżultati ewlenin tal-effikaċja għall-istudju AIO KRK XELOX + bevacizumab
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 Ecansya (e.g. stomatitis, mucosal inflammation, diarrhoea, neutropenia, and neurotoxicity).
Maltese: - Defiċjenza ta' DPD: jekk għandek defiċjenza magħrufa ta' DPD, għandek riskju ogħla ta' bidu akut bikri ta' tossiċità u reazzjonijiet avversi severi, ta' periklu għall-ħajja jew fatali kkawżati minn Ecansya (eż. stomatite, infjammazzjoni tal-mukuża, dijarea, newtropenija, u newrotossiċità).
English: Overall response rate was 49% in the XELIRI and 48% in the FOLFIRI arm (p=0.76).
Maltese: Ir-rata ta' rispons globali kienet ta' 49% fil-grupp ta' XELIRI u ta' 48% fil-grupp ta' FOLFIRI (p=0.76).
English: A person whose body weight is 80 kg and height is 1.80 m has a body surface area of 2.00 m2 and should take 5 tablets of 500 mg two times daily.
Maltese: Persuna li għandha piż tal-ġisem ta' 80 kg u tul ta' 1.80 m għandha erja tas-superfiċje tal-ġisem ta' 2.00 m2 u għandha tieħu 5 pilloli ta' 500 mg darbtejn kuljum.
English: Herpes zoster, Urinary tract infection, Oral candidiasis, Upper respiratory tract infection, Rhinitis, Influenza,
Maltese: Herpes zoster, Infezzjoni fl-apparat tal-awrina, Kandidajasi orali, Infezzjoni fl-apparat repiratorju ta' fuq, Rinite, Influwenza,
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 ittrattati b'capecitabine bħala monoterapija jew capecitabine flimkien ma' korsijiet ta' kimoterapiji differenti f'indikazzjonijiet multipli (kanċer tal-kolon, tal-kolorektum, tal-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 tat-trattament b'capecitabine.
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 żieda ta' 4 sa 6 ħmieġ/kuljum jew ħmieġ bil-lejl, dijarea ta' grad 3 bħala żieda ta' 7 sa 9 ħmieġ/kuljum jew inkontinenza u assorbiment imnaqqas.
English: See also section "Do not take Ecansya".
Maltese: Ara wkoll is-sezzjoni “Tiħux Ecansya”.
English: Tel.: + 48 (0)22 573 7500
Maltese: KRKA-POLSKA Sp. z o.o. Tel.: + 48 (0)22 573 7500
English: Median progression-free survival (PFS) was 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=0.32 għal FOLFIRI-Bev u XELIRI-Bev, rispettivament.
English: Capecitabine and its metabolites are predominantly excreted in urine; 95.5% of administered capecitabine dose is recovered in urine.
Maltese: Capecitabine u l-metaboliti tiegħu huma mneħħijin mill-ġisem l-aktar fl-awrina; 95.5% tad-doża ta' capecitabine mogħtija huwa rkuprat fl-awrina.
English: Hepatic function abnormal
Maltese: Funzjoni epatika mhux normali
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: - flimkien ma' docetaxel (ara sezzjoni 5.1) għat-trattament ta' pazjenti b'kanċer tas-sider lokalment avvanzat jew metastatiku wara l-falliment ta' kemjoterapija ċitotossika.
English: In case you are using coumarin anticoagulants (containing e.g. phenprocoumon), stopping capecitabine might require that your doctor adjusts your anticoagulant dose.
Maltese: F'każ li inti qed tuża antikoagulanti coumarin (li fihom eż. phenprocoumon), il-waqfien ta' capecitabine jista' jirrekjiedi li t-tabib tiegħek ibiddel id-doża tal-antikoagulanti tiegħek.
English: Ecansya 150 mg film-coated tablets Ecansya 300 mg film-coated tablets Ecansya 500 mg film-coated tablets capecitabine
Maltese: Ecansya 150 mg pilloli miksijin b'rita Ecansya 300 mg pilloli miksijin b'rita Ecansya 500 mg pilloli miksijin b'rita
English: 25.5 months
Maltese: 25.5 xhur
English: Bone marrow depression,
Maltese: Depressjoni tal-mudullun,
English: Ecansya 500 mg tablets capecitabine
Maltese: Ecansya 500 mg pilloli capecitabine
English: Blister, Skin ulcer, Rash, Urticaria, Photosensitivity reaction, Palmar erythema, Swelling face, Purpura, Radiation recall syndrome
Maltese: Nuffata, Ulċeri fil-ġilda, Raxx, Urtikarja, Reazzjoni ta' fotosensittività, Eritema tal-idejn, Nefħa fil-wiċċ, Purpura, Sindrome ta' tifkira tar-radjazzjoni
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 tat-trattament, 37% tal-pazjenti fil-grupp ta' XELIRI u 26% tal-pazjenti fil-grupp ta' FOLFIRI kienu mingħajr evidenza tal-marda (p=0.56).
English: Ecansya 150 mg tablets capecitabine
Maltese: Ecansya 150 mg pilloli capecitabine
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: żieda fid-doża kumulattiva ta' capecitabine (0.1*kg) u żieda fl-intensità tad-doża relattiva fl-ewwel sitt ġimgħat.
English: B. PACKAGE LEAFLET
Maltese: Tabella 5
English: Ecansya 300 mg film-coated tablets (tablets) are white to off white, oblong shaped, biconvex tablets of 14.6 mm in length and 6.7 mm in width, debossed with "300" on one side and plain on other side.
Maltese: Ecansya 300 mg pilloli miksija b'rita (pilloli) huma pilloli ta' lewn bajdani għal ofwajt, f'għamla oblong, imżaqqin fuq żewġ naħat ta' tul ta' 14.6 mm u wisa' ta' 6.7 mm, imnaqqxa bi ”300” fuq naħa waħda u mingħajr kitba fuq in-naħa l-oħra.
English: Petechiae,
Maltese: Dijabete,
English: Dose modifications for toxicity when capecitabine is used continuously in combination with other medicinal products
Maltese: Modifikazzjonijiet fid-doża għal tossiċitajiet meta capecitabine jintuża kontinwament f'taħlita ma' prodotti mediċinali oħra
English: NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia
Maltese: Detentur tal-Awtorizzazzjoni għat-Tqegħid fis-Suq KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Is-Slovenja
English: For Arm B, the XELIRI regimen used capecitabine 1000 mg/m twice daily for 14 days + irinotecan 250 mg/m2 on day 1.
Maltese: Għall-Grupp B, il-kors ta' XELIRI uża capecitabine 1000 mg/m2 darbtejn kuljum għal 14-il ġurnata + irinotecan 250 mg/m2 fl-ewwel ġurnata.
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' trattament differenti, inkluż XELOX jew FOLFOX-4, u l-parti ta' 2x2 fatturi ta' wara fejn 1401 pazjent kienu randomised għal erba' gruppi ta' trattament differenti, inkluż XELOX flimkien ma' plaċebo, FOLFOX-4 flimkien ma'
English: Ecansya 300 mg tablets capecitabine
Maltese: Ecansya 300 mg pilloli capecitabine
English: Capecitabine Monotherapy 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: Schedule
Maltese: TIKKETTAR
English: - Ecansya 300 mg film-coated tablets Hypromellose (6cps)
Maltese: - Ecansya 300 mg pilloli miksijin b'rita Hypromellose (6cps)
English: Parameter: Progression-free Survival PPP ITT Parameter: Overall Survival PPP ITT *PPP=per-protocol population; **ITT=intent-to-treat population
Maltese: *PPP=popolazzjoni skont il-protokoll; **ITT= popolazzjoni b'intenzjoni li jiġu ttrattati.
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 (żieda ta' 35% fl-AUC meta t-tneħħija tal-krejatinina tonqos b'50%) u għal FBAL (żieda ta' 114% fl-AUC meta t-tneħħija tal-krejatinina tonqos b'50%).
English: Care should be exercised when capecitabine is co-administered with 2C9 substrates (e.g., phenytoin).
Maltese: Għandu jkun hemm attenzjoni meta capecitabine jingħata flimkien ma' sottostrati ta' 2C9 (eż., phenytoin).
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 fil-vini fis-sopravvivenza bla marda fil-protokoll għal kull popolazzjoni (hazard ratio 0.92; 95% CI 0.80-1.06).
English: Vaginal haemorrhage
Maltese: Disturbi vaskulari
English: This interaction, which leads to increased fluoropyrimidine toxicity, is potentially fatal.
Maltese: Din l-interazzjoni, li twassal għal żieda fit-tossiċità ta' fluoropyrimidine, hija potenzjalment fatali.
English: Tablet coating - Ecansya 150 mg film-coated tablets Hypromellose (6cps)
Maltese: Il-kisja tal-pillola - Ecansya 150 mg pilloli miksijin b'rita Hypromellose (6cps)
English: 10.4 months
Maltese: 10.4 xhur
English: There was a small increase in plasma concentrations of capecitabine and one metabolite (5'-DFCR); there was no effect on the 3 major metabolites (5'-DFUR, 5-FU and FBAL).
Maltese: Kien hemma żjieda żgħira fil-konċentrazzjonijiet fil-plażma ta' capecitabine u metabolit wieħed (5'-DFCR); ma kien hemm l-ebda effett fuq il-3 metaboliti maġġuri (5'-DFUR, 5-FU u FBAL).
English: See table 6 for treatment regimens.
Maltese: Ara tabella 6 għall-korsijiet ta' trattament.
English: 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: Pharyngitis, Oral candidiasis, Influenza, Gastroenteritis, Fungal infection, Infection, Tooth abscess
Maltese: Kandidajasi orali, Influwenza, Gastroenterite, Infezzjoni mill-moffa, Infezzjoni, Axxess f'sinna
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 fis-sopravivenza 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: 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 gastrointestinali u fsada, u depressjoni tal-mudullun.
English: Treatment with brivudine can be started 24 hours after the last dose of capecitabine (see section 4.3 and 4.5).
Maltese: It-trattament bi brivudine jista' jibda 24 siegħa wara l-aħħar doża ta' capecitabine (ara sezzjonijiet 4.3 u 4.5).
English: The incidence of grade 3 or 4 adverse reactions in patients with moderate renal impairment (creatinine clearance 30-50 ml/min at baseline) is increased compared to the overall population.
Maltese: Reazzjonijiet avversi ta' grad 3 jew 4 f'pazjenti b'indeboliment moderat tal-kliewi (tneħħija talkrejatinina 30-50 ml/min) iseħħu aktar ta' spiss meta mqabbla mal-popolazzjoni totali (ara sezzjonijiet
English: Contusion
Maltese: Antaċidi
English: Intestinal obstruction, Ascites, Enteritis, Gastritis, Dysphagia, Abdominal pain lower, Oesophagitis, Abdominal discomfort, Gastrooesophageal reflux disease, Colitis, Blood in stool
Maltese: Sadd intestinali, Axxite, Enterite, Gastrite, Disfaġija, Uġigħ fil-parti t'isfel tal-addome, Osofaġite, Skumdità addominali, Marda ta' rifluss gastro-osofaġali, Kolite, Demm fl-ippurgar