FrancophonIA/ELRC3.0 huggingface dataset:
English: - The other ingredients are: - Tablet core: lactose, microcrystalline cellulose, hypromellose, croscarmellose sodium,
Maltese: - Qalba tal-pillola: lactose, microcrystalline cellulose, hypromellose, croscarmellose sodium,
English: In vitro human plasma studies have determined that capecitabine, 5'-DFCR, 5'-DFUR and 5-FU are 54%, 10%, 62% and 10% protein bound, mainly to albumin.
Maltese: Studji in vitro dwar il-plażma umana wrew li capecitabine, 5'-DFCR, 5'-DFUR u 5-FU huma 54%, 10%, 62% u 10% mwaħħla mal-proteini, prinċipalment mal-albumina.
English: Date of latest renewal: 09 January 2017
Maltese: Data tal-ewwel awtorizzazzjoni: 20 ta' April 2012 Data tal-aħħar tiġdid: 09 ta' Jannar 2017
English: Faecal excretion is minimal (2.6%).
Maltese: Ittneħħija fil-ħmieġ hija minima (2.6%).
English: Hepatic failure (rare), Cholestatic hepatitis (rare)
Maltese: Insuffiċjenza talfwied (rari), Epatite kolestatika (rari)
English: Oedema, Chills,
Maltese: Rimettar, Tqalligħ,
English: Cardiotoxicity (see section 4.4)
Maltese: Kardjotossiċità (ara sezzjoni 4.4)
English: • inflammation of the veins (thrombophlebitis)
Maltese: • infjammazzjoni fil-vini (tromboflebite)
English: 400 mg/m2 intravenous bolus, followed by 600 mg/m2 intravenous 22 hr
Maltese: 400 mg/m2 fil-vini bolus, segwit minn 600 mg/ m2 fil-vini 22 hr
English: Grade 4
Maltese: • Grad 4
English: For hand-foot syndrome and hyperbilirubinemia, see section 4.4.
Maltese: Għas-sindrome tal-idejnsaqajn u iperbilirubinimja, ara sezzjoni 4.4.
English: Capecitabine Teva 500 mg film-coated tablets EU/1/12/761/002
Maltese: Capecitabine Teva 500 mg pilloli miksija b'rita EU/1/12/761/002
English: For terms marked with a “+”, the frequency count was based on grade 3-4 ADRs.
Maltese: Għal termini mmarkati b'“+”, lgħadd tal-frekwenza kien ibbażat fuq ADRs ta' grad 3-4.
English: If you have an unrecognised DPD deficiency and take capecitabine, you are at an increased risk of acute early-onset of severe forms of the side effects listed under section 4 Possible side effects.
Maltese: Jekk għandek defiċjenza ta' DPD mhux magħrufa u tieħu capecitabine, għandek riskju ogħla ta' bidu akut bikri ta' forom qawwija tal-effetti sekondarji elenkati taħt sezzjoni 4 Effetti sekondarji possibbli.
English: 5 mg/kg intravenous 30-90 mins
Maltese: 5 mg/kg fil-vini 3090 mins
English: Hypertension,
Maltese: Ipertensjoni,
English: Table 6 Treatment regimens in study NO16966 (mCRC) Treatment
Maltese: Tabella 6 Korsijiet ta' trattament fl-istudju NO16966 (mCRC)
English: Atrial fibrillation, Cardiac ischaemia/infarction
Maltese: Iskemija/infart kardijaku
English: Pharmacotherapeutic group: antineoplastic agents, antimetabolites, ATC code: L01BC06
Maltese: Kategorija farmakoterapewtika: sustanzi antineoplastiċi, anti-metabolita, Kodiċi ATC:
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), very rare (< 1/10,000).
Maltese: Il-kategoriji li ġejjin huma wżati biex jikklassifikaw l-ADRs skont 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: At the dose of 1250 mg/m2 on day 14 with administration after food intake, the peak plasma concentrations (Cmax in μg/ml) for capecitabine, 5'-DFCR, 5'-DFUR, 5-FU and FBAL were 4.67, 3.05, 12.1, 0.95 and 5.46 respectively.
Maltese: B'doża ta' 1250 mg/m2 fl-14-il jum bl-għoti wara t-teħid tal-ikel, il konċentrazzjonijiet massimi fil-plażma (Cmax f'µg/ml) ta' capecitabine, 5'-DFCR, 5'-DFUR, 5-FU u FBAL kienu ta' 4.67, 3.05, 12.1, 0.95 u 5.46 rispettivament.
English: Pulmonary embolism, Pneumothorax, Haemoptysis, Asthma, Dyspnoea exertional
Maltese: Emboliżmu pulmonari, Pnewmotorax, Emoptisi,
English: Dose limiting toxicities
Maltese: Gradi ta' tossiċità
English: Body System
Maltese: Sistema talĠisem
English: The effect of an aluminium hydroxide and magnesium hydroxide-containing antacid on the pharmacokinetics of capecitabine was investigated.
Maltese: L-effett ta' antaċidi li fihom aluminium hydroxide u magnesium hydroxide fuq il-farmakokinetika ta' capecitabine kien investigat.
English: Τel: +353 19630330
Maltese: L-Irlanda Τel: +353 19630330
English: • History of severe and unexpected reactions to fluoropyrimidine therapy,
Maltese: • Passat mediku ta' reazzjonijiet serji u mhux mistennija għat-terapija bi fluoropyrimidine,
English: The most commonly reported and/or clinically relevant treatment-related adverse drug reactions (ADRs) were gastrointestinal disorders (especially diarrhoea, nausea, vomiting, abdominal pain, stomatitis), hand-foot syndrome (palmar-plantar erythrodysesthesia), fatigue, asthenia, anorexia, cardiotoxicity, increased renal dysfunction on those with preexisting compromised renal function, and thrombosis/embolism.
Maltese: L-aktar reazzjonijiet avversi tal-mediċina (ADRs) relatati mat-trattament irrappurtati b'mod frekwenti u/jew ta' rilevanza klinika kienu disturbi gastrointestinali (speċjalment dijarea, tqalligħ, rimettar, uġigħ addominali, stomatite), s-sindrome tal-idejn u s-saqajn (eritrodisasteżija palmari-plantari), għeja, astenja, anoreksja, kardjotossiċità, disfunzjoni renali miżjuda f'dawk b'funzjoni renali kompromessa minn qabel, u trombożi/emboliżmu.
English: 2031 GA Haarlem The Netherlands
Maltese: 2031 GA Haarlem Il-Pajjiżi l-Baxxi
English: Hiccups,
Maltese: Sinkope,
English: In this treatment subgroup comparison, XELOX plus bevacizumab was similar compared to FOLFOX-4 plus bevacizumab in terms of progression-free survival (hazard ratio 1.01; 97.5% CI 0.84-1.22).
Maltese: F'dan il-paragun ta' sottogrupp ta' trattament, XELOX u bevacizumab kien simili meta mqabbel ma' FOLFOX-4 u bevacizumab f'termini ta' sopravivenza mingħajr progressjoni (hazard ratio 1.01; 97.5% CI 0.84-1.22).
English: • Hypersensitivity to the active substance or to any of the excipients listed in section 6.1 or fluorouracil,
Maltese: • Sensittività eċċessiva għas-sustanza attiva jew għal kwalunkwe sustanza mhux attiva elenkata fis-sezzjoni 6.1, jew għal fluorouracil,
English: 120 Patients were randomised to a modified XELIRI regimen with capecitabine 800 mg/m2 twice daily for two weeks followed by a 7-day rest period), irinotecan (200 mg/m2 as a 30 minute infusion on day 1 every 3 weeks), and bevacizumab (7.5 mg/kg as a 30 to 90 minute infusion on day 1 every 3 weeks) ; 127 patients were randomised to treatment with capecitabine (1000 mg/m2 twice daily for two weeks followed by a 7-day rest period), oxaliplatin (130 mg/m2 as a 2 hour infusion on day 1 every 3 weeks), and bevacizumab (7.5 mg/kg as a 30 to 90 minute infusion on day 1 every 3 weeks).
Maltese: II, b'aktar minn ċentru wieħed, randomised u kkontrollat (AIO KRK 0604) issostni l-użu ta' capecitabine b'doża tal-bidu ta' 800 mg/m2 għal ġimagħtejn kull 3 ġimgħat flimkien ma' irinotecan u bevacizumab għat-trattament primarju ta' pazjenti b'kanċer metastatiku talkolorektum. 120 pazjent kienu randomised għall-kors modifikat ta' XELIRI b'capecitabine (800 mg/m2 darbtejn kuljum għal ġimagħtejn segwit minn perjodu mingħajr trattament ta' 7 ijiem), irinotecan (200 mg/m2 bħala infużjoni ta' 30 minuta f'jum 1 kull 3 ġimgħat), u bevacizumab (7.5 mg/kg bħala infużjoni ta' 30 sa 90 minuta f'jum 1 kull 3 ġimgħat); 127 pazjent kienu randomised għat-trattament b'capecitabine (1000 mg/m2 darbtejn kuljum għal ġimagħtejn segwit minn perjodu mingħajr trattament ta' 7 ijiem), oxaliplatin (130 mg/m2 bħala infużjoni ta' sagħtejn f'jum 1 kull 3 ġimgħat), u bevacizumab (7.5 mg/kg bħala infużjoni ta' 30 sa 90 minuta f'jum 1 kull 3 ġimgħat).
English: Acute renal failure secondary to dehydration (rare)
Maltese: Insuffiċjenza akuta talkliewi sekondarja għal deidratazzjoni (rari)
English: DPD deficiency: DPD deficiency is a rare condition present at birth that is not usually associated with health problems unless you receive certain medicines.
Maltese: Defiċjenza ta' DPD: Defiċjenza ta' DPD hija kondizzjoni rari preżenti mit-twelid li normalment ma tkunx assoċjata ma' problemi ta' saħħa jekk ma tiħux ċertu mediċini.
English: Gender, presence or absence of liver metastasis at baseline, Karnofsky Performance Status, total bilirubin, serum albumin, ASAT and ALAT had no statistically significant effect on the pharmacokinetics of 5'-DFUR, 5-FU and FBAL.
Maltese: bilirubin totali, albumina fis-serum, ASAT u ALAT ma kellhom l-ebda effett statistikament sinifikattiv fuq il-farmakokinetika ta' 5'-DFUR, 5-FU u FBAL.
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 Teva (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 Capecitabine Teva (eż. stomatite, infjammazzjoni tal-mukuża, dijarea, newtropenija, u newrotossiċità).
English: Ventricular fibrillation (rare), QT prolongation (rare), Torsade de pointes (rare), Bradycardia (rare), Vasospasm (rare)
Maltese: Torsade de pointes (rari), Bradikardija (rari), Vażospażmu (rari)
English: Capecitabine is contraindicated in patients with severe renal impairment (creatinine clearance below 30 ml/min [Cockcroft and Gault] at baseline).
Maltese: Capecitabine huwa kontra-indikat f'pazjenti b'indeboliment serju tal-kliewi (tneħħija tal-krejatinina taħt it-30 ml/min [Cockcroft u Gault] fil-linja bażi).
English: Diarrhoea (see section 4.4)
Maltese: Dijarea (ara sezzjoni 4.4)
English: • Recent or concomitant treatment with brivudine (see section 4.4 and 4.5 for drug-drug interaction),
Maltese: • Trattament reċenti jew fl-istess waqt bi brivudine (ara sezzjoni 4.4 u 4.5 għall-interazzjoni bejn mediċina u oħra),
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: 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: Filpopolazzjoni 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: 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: MARKETING AUTHORISATION NUMBER(S) Capecitabine Teva 150 mg film-coated tablets EU/1/12/761/001
Maltese: Capecitabine Teva 150 mg pilloli miksija b'rita EU/1/12/761/001
English: CLINICAL PARTICULARS 4.1 Therapeutic indications Capecitabine Teva 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: - għat-trattament awżiljarju ta' pazjenti wara kirurġija ta' kanċer tal-kolon ta' stadju III (stadu ta' Dukes' C) (ara sezzjoni 5.1).
English: Toxic leukoencephalopa thy (very rare)
Maltese: Lewkoenċefalopatija tossika (rari ħafna)
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 0.77-1.01; p = 0.068) u 0.86 (95% CI 0.74-1.01; p = 0.060), rispettivament.
English: Not applicable *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: *Skont 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 Avversi (CTCAE)
English: • In patients with severe renal impairment (creatinine clearance below 30 ml/min),
Maltese: • F'pazjenti b'indeboliment sever tal-kliewi (tneħħija tal-krejatinina taħt 30 ml/min),
English: Oxaliplatin 85 mg/m2 intravenous 2 hr
Maltese: 85 mg/m2 fil-vini 2 hr
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: Defiċjenza ta' dihydropyrimidine dehydrogenase (DPD) B'mod rari, tossiċità severa, mhux mistennija, (eż. stomatite, dijarea, infjammazzjoni tal-mukuża, newtropenija u newrotossiċità) assoċjati ma' 5-FU kienet attribwita għal nuqqas ta' attività ta' DPD.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/12/761/002
Maltese: EU/1/12/761/002
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]; p=0.0045).
English: Capecitabine Teva 500 mg film-coated tablets PVC/PE/PVDC - Aluminium blister containing 10 film-coated tablets.
Maltese: Capecitabine Teva 500 mg pilloli miksija b'rita PVC/PE/PVDC - Folja tal-aluminju li fiha 10 pilloli miksijn b'rita.
English: plus bevacizumab (Arm-B, n-166).
Maltese: bevacizumab, cisplatin, irinotecan),
English: Capecitabine Teva 150 mg film-coated tablets PVC/PE/PVDC - Aluminium blister containing 10 film-coated tablets.
Maltese: Capecitabine Teva 150 mg pilloli miksija b'rita PVC/PE/PVDC - Folja tal-aluminju li fiha 10 pilloli miksijn b'rita.
English: Capecitabine is activated via several enzymatic steps (see section 5.2).
Maltese: capecitabine (ara sezzjoni 5.2).
English: Danmark Teva Denmark A/S Tlf: +45 44985511
Maltese: Tlf: +45 44985511
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 fis-sopravvivenza bla marda fil-protokoll għal kull popolazzjoni (hazard ratio 0.92; 95% CI 0.80-1.06).
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 mal 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: • confusional state, panic attacks, depressed mood, decreased libido
Maltese: • stat ta' konfużjoni, attakki ta' paniku, burdata depressa, tnaqqis fil-libido
English: Table 7 Key efficacy results for the non-inferiority analysis of Study NO16966 PRIMARY ANALYSIS
Maltese: Tabella 7 Riżultati importanti tal-effikaċja għall-analiżi ta' nuqqas ta' inferjorità ta' Studju NO16966
English: Capecitabine Monotherapy
Maltese: Monoterapija b'Capecitabine
English: Ophthalmologic complications
Maltese: Komplikazzjonijiet oftalmoloġiċi
English: Hypo- or hypercalcaemia
Maltese: Ipo- jew iperkalċimja
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 tal-kliewi (tneħħija talkrejatinina 30-50 ml/min) iseħħu aktar ta' spiss meta mqabbla mal-popolazzjoni totali (ara sezzjonijiet 4.2 u 4.3).
English: MARKETING AUTHORISATION NUMBER(S) EU/1/12/761/001
Maltese: EU/1/12/761/001
English: Paediatric population
Maltese: Fatturi etniċi
English: Monotherapy with capecitabine in adjuvant colon cancer 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, randomised u kkontrollata f'pazjenti b'kanċer filkolon ta' stadju III (Dukes' C) jissapportja l-użu ta' capecitabine għat-trattament awżiljarju ta' pazjenti b'kanċer tal-kolon (Studju XACT; M66001).
English: 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 Teva (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 tal ġene 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'Capecitabine Teva (ara sezzjoni 4.3).
English: A clinically significant interaction between brivudine and fluoropyrimidines (e.g. capecitabine, 5-fluorouracil, tegafur), resulting from the inhibition of dihydropyrimidine dehydrogenase by sorivudine, 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 sorivudine.
English: Parameter: Progression-free Survival EPP ITT Parameter: Overall Survival EPP ITT
Maltese: EPP ITT Parametru:
English: Capecitabine Teva can induce severe skin reactions such as Stevens-Johnson syndrome and Toxic Epidermal Necrolysis.
Maltese: Capecitabine Teva jista' jikkawża reazzjonijiet severi fil-ġilda bħas-sindrome ta' Stevens-Johnson u nekrolisi tossika tal-epidermide.
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
English: Discontinue permanently
Maltese: Burdata depressa,
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 noninferior 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: 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: Pazjenti b'għadd ta' newtrofili fil-linja bażi ta' <1.5 x 109/L u/jew b'għadd ta' tromboċiti ta'
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 żieda 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: Lacrimal duct stenosis (rare), Corneal disorders(rare), keratitis (rare), punctate keratitis (rare)
Maltese: Disturbi fil-kornea (rari), Keratite (rari), Keratite ttikkjata
English: Thrombophlebitis Deep vein thrombosis,
Maltese: Tromboflebite Trombożi fil-vini lkbar,
English: Other than warfarin, no formal interaction studies between capecitabine and other CYP2C9 substrates have been conducted.
Maltese: Minbarra b'warfarin, ma saru l-ebda studji formali ta' interazzjoni bejn capecitabine u sottostrati oħra ta' CYP2C9.
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 tal-istonku: meta-analiżi Meta-analiżi ta' sitt provi kliniċi (studji SO14695, SO14796, M66001, NO16966, NO16967, M17032)
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: 646; 715) in patients treated with 5-FU-containing regimens.
Maltese: Iż-żmien Medjan ta' sopravivenza globali kien 703 ijiem (95% CI: 671; 745) f'pazjenti ttrattati b'korsijiet li fihom capecitabine u 683 jum (95% CI:
English: Caution must be exercised in patients with history of significant cardiac disease, arrhythmias and angina pectoris (see section 4.8).
Maltese: Trid tingħata attenzjoni lill-pazjenti li għandhom passat ta' mard kardijaku sinifikanti, arritmija u anġina pectoris (ara sezzjoni 4.8).
English: Capecitabine Teva dose calculations
Maltese: DATA TA' SKADENZA
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) għattrattament awżiljarju ta' pazjenti b'kanċer tal-kolon (studju NO16968).
English: • nerve pain
Maltese: • uġigħ fin-nervaturi
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: This medicine contains less than 1 mmol sodium (23 mg) per film-coated tablet, that is to say essentially “sodium-free”.
Maltese: Din il-mediċina fiha anqas minn 1 mmol sodium (23 mg) f'kull pillola miksija b'rita, jiġifieri essenzjalment “ħieles mis-sodium”.
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 tal-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: Leucovorin 200 mg/m2 intravenous 2 hr
Maltese: 200 mg/m2 fil-vini 2 hr
English: Each film-coated tablet contains 150 mg capecitabine.
Maltese: Kull pillola miksija b'rita fiha 150 mg capecitabine.
English: Coumarin-derivative anticoagulants
Maltese: Antikoagulazzjoni b'derivattiv ta' coumarin