FrancophonIA/ELRC3.0 huggingface dataset:
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: The pooled analysis includes 3,097 patients treated with capecitabine-containing regimens and 3,074 patients treated with 5-FU-containing regimens.
Maltese: L-analiżi globali tinkludi 3,097 pazjent ittrattati b'korsijiet li fihom capecitabine u 3,074 pazjent ittrattati b'korsijiet li fihom 5-FU.
English: Paraesthesia, Dysaesthesia, Peripheral neuropathy, Peripheral sensory neuropathy, Dysgeusia, Headache
Maltese: Newropatija periferali, Newropatija sensorjali periferali, Disgewżja,
English: In patients with moderate renal impairment at baseline, a dose reduction to 75 % for a starting dose of 1,250 mg/m² is recommended.
Maltese: F'pazjenti b'indeboliment moderat tal-kliewi fil-linja bażi, tnaqqis fid-doża ta' 75 % għal doża tal-bidu ta' 1,250 mg/m² huwa rakkomandat.
English: Constipation, Dyspepsia Upper gastrointestinal haemorrhage, Mouth ulceration, Gastritis,
Maltese: fuq, Ulċerazzjoni filħalq, Gastrite,
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, +Infezzjoni, Herpes orali
English: Dihydropyrimidinase cleaves the pyrimidine ring to yield 5-fluoro-ureidopropionic acid (FUPA).
Maltese: 5-fluoro-ureidopropionic acid (FUPA).
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 mal-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: 127 patients were randomised to treatment with capecitabine (1,000 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: 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 (1,000 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: 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-kreatinina instabet li tinfluwenza l-espożizzjoni sistematika għal 5'-DFUR (żieda ta' 35 % fl-AUC meta t-tneħħija tal-kreatinina tonqos b'50 %) u għal FBAL (żieda ta' 114 % fl-AUC meta t-tneħħija tal-kreatinina tonqos b'50 %).
English: SPECIAL STORAGE CONDITIONS For 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: Pharyngitis, Oral candidiasis, Influenza, Gastroenteritis, Fungal infection, Infection, Tooth abscess
Maltese: Kandidajasi orali, Influwenza, Gastroenterite, Infezzjoni millmoffa, Infezzjoni, Axxess f'sinna
English: In all studies combined, the following covariates were statistically significantly associated with an increased risk of developing HFS: increasing capecitabine starting dose (gram), decreasing cumulative capecitabine dose (0.1*kg), increasing relative dose intensity in the first six weeks, increasing duration of study treatment (weeks), increasing age (by 10 year increments), female gender, and good Eastern Cooperative Oncology Group (ECOG) performance status at baseline (0
Maltese: 1*kg), żieda fl-intensità tad-doża relattiva fl-ewwel sitt ġimgħat, żieda fit-tul ta' trattament taħt studju (ġimgħat), żjieda fl-età (b'żjidiet ta' 10 snin), sess femminili, u Grupp tal-Onkoloġija tal-Kooperattiva tal-Lvant (ECOG - Eastern Cooperative Oncology Group) performance status fil-linja bażi tajjeb (0 kontra ≥ 1).
English: 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 hija kondizzjoni rari preżenti mit-twelid li normalment ma tkunx assoċjata ma' problemi ta' saħħa jekk ma tiħux ċertu mediċini.
English: Each 150 mg film-coated tablet contains 150 mg capecitabine Each 300 mg film-coated tablet contains 300 mg capecitabine Each 500 mg film-coated tablet contains 500 mg capecitabine
Maltese: Kull pillola miksija b'rita ta' 150 mg fiha 150 mg ta' capecitabine Kull pillola miksija b'rita ta' 300 mg fiha 300 mg ta' capecitabine Kull pillola miksija b'rita ta' 500 mg fiha 500 mg ta' capecitabine
English: INFORMATION IN BRAILLE Capecitabine medac 500 mg
Maltese: Capecitabine medac 500 mg
English: Rare/Very rare (Post-marketing experience)
Maltese: Rari/Rari ħafna (Esperjenza ta' wara t-tqegħid fissuq)
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: In combination treatment, the recommended starting dose of capecitabine should be reduced to 800-1,000 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: 1,000 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: • radiotherapy and certain medicines used to treat cancer (folinic acid, oxaliplatin, bevacizumab,
Maltese: • radjuterapija u ċerti mediċini użati għat-trattament tal-kanċer (aċidu foliniku, oxaliplatin,
English: +Infection, Oral herpes
Maltese: Infezzjoni virali tal-Herpes,
English: MARKETING AUTHORISATION NUMBER(S) EU/1/12/802/029-042
Maltese: TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/12/802/029-042
English: In this trial, 1,987 patients were randomised to treatment with capecitabine (1,250 mg/m² twice daily for 2 weeks followed by a 1-week rest period and given as 3-week cycles for 24 weeks) or 5-FU and leucovorin (Mayo Clinic regimen: 20 mg/m² leucovorin intravenous followed by 425 mg/m² intravenous bolus 5-FU, on days 1 to 5, every 28 days for 24 weeks).
Maltese: F'din il-prova, 1,987 pazjent kienu magħżula b'mod każwali għat-trattament b'capecitabine (1,250 mg/m² darbtejn kuljum għal ġimagħtejn segwit minn perjodu ta' waqfien ta' ġimgħa u mogħti bħala ċikli ta' 3 ġimgħat għal 24 ġimgħa) jew 5-FU u leucovorin (program ta' Mayo Clinic: 20 mg/m² leucovorin fil-vini segwit minn 425 mg/m² 5-FU bolus fil-vini, mill-ewwel sal-ħames jum, kull 28 jum għal 24 ġimgħa).
English: The results indicate that XELOX is equivalent to FOLFOX-4 in terms of overall survival (see table 7).
Maltese: Irriżultati jindikaw li XELOX huwa ekwivalenti għal FOLFOX-4 f'termini ta' sopravivenza globali (ara tabella 7).
English: Jaundice
Maltese: Wara
English: If unscheduled laboratory assessments during a treatment cycle show that the neutrophil count drops below 1.0 x 109/L or that the platelet count drops below 75 x 109/L treatment with capecitabine should be interrupted.
Maltese: Jekk valutazzjonijiet tal-laboratorju mhux ipprogrammati waqt ċiklu ta' trattament juru li l-għadd tan-newtrofili waqa' taħt 1.0 x 109/L jew jekk l-għadd tal-plejtlits jaqa' taħt 75 x 109/L, it-trattament b'capecitabine għandu jitwaqqaf.
English: White to off-white, oblong shaped, biconvex tablet, debossed with ‘300' on the one side and plain on the other side.
Maltese: Pillola bojod għal offwajt, ta' forma oblunga, bikonvessi, imnaqqxa bin-numru ‘300' fuq naħa u lixxi fuq in-naħa l-oħra.
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 pereżempju phenprocoumon), il-waqfien ta' capecitabine jista' jirrekjiedi li t-tabib tiegħek ibiddel id-doża tal-antikoagulanti tiegħek.
English: Capecitabine medac 300 mg film-coated tablets Hypromellose (E464)
Maltese: Capecitabine medac 300 mg pilloli miksija b'rita Hypromellose (E464)
English: • tiredness
Maltese: Rinorreja
English: • irregular heartbeat and palpitations (arrhythmias), chest pain and heart attack (infarction)
Maltese: • taħbita tal-qalb irregolari u palpitazzjonijiet (arritmiji), uġigħ fis-sider u attakk tal-qalb (infart)
English: Tablet core
Maltese: Indikazzjonijet kollha
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: Two examples are provided here: A person whose body weight is 64 kg and height is 1.64 m has a body surface area of 1.7 m² and should take 4 tablets of 500 mg and 1 tablet of 150 mg two times daily.
Maltese: Żewġ eżempji huma pprovuti hawnhekk: persuna li għandha piż tal-ġisem ta' 64 kg u tul ta' 1.64 m għandha erja tas-superfiċje tal-ġisem ta' 1.7 m² u għandha tieħu 4 pilloli ta' 500 mg u pillola ta' 150 mg darbtejn kuljum.
English: Capecitabine medac 150 mg film-coated tablets Hypromellose (E464)
Maltese: Capecitabine medac 150 mg pilloli miksija b'rita Hypromellose (E464)
English: This 21 day period is one treatment cycle.
Maltese: Dan il-perjodu ta' 21 ġurnata huwa ċiklu wieħed ta'
English: Cutaneous lupus erythematosus (rare), Severe skin reactions such as
Maltese: Lupus erythematosus tal-ġilda (rari),
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 1,401 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: 1,401 pazjent kienu magħżula b'mod każwali għal erba' gruppi ta' trattament differenti, inkluż XELOX flimkien ma' plaċebo, FOLFOX-4 flimkien ma' plaċebo, XELOX flimkien ma' bevacizumab,
English: Neurotoxicity, Tremor, Neuralgia,
Maltese: Ipokalimja, Iponatrimja, Ipomagnesimja,
English: Headache, Lethargy, Dizziness, Paraesthesia, Dysgeusia
Maltese: Sturdament, Parasteżija, Disgewsja
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: L-inċidenza ta' reazzjonijiet avversi ta' grad 3 jew 4 f'pazjenti b'indeboliment moderat tal-kliewi (tneħħija tal-kreatinina ta' 30 - 50 ml/min fil-linja bażi) hija ikbar meta mqabba mal-populazzjoni totali.
English: Do not take Capecitabine medac
Maltese: Tiħux Capecitabine medac
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, b'pazjenti magħżula b'mod każwali b'kanċer fil kolon fi stadju III (Dukes Ċ) u b'kontrolli jissapportja l-użu ta' capecitabine għat-trattament awżiljarju ta' pazjenti b'kanċer tal-kolon (Studju XACT; M66001).
English: How to store Capecitabine medac
Maltese: Mediċini oħra u Capecitabine medac
English: NAME OF THE MEDICINAL PRODUCT Capecitabine medac 150 mg tablets capecitabine
Maltese: Capecitabine medac 150 mg pilloli capecitabine
English: Capecitabine medac 500 mg film-coated tablets Hypromellose (E464)
Maltese: Capecitabine medac 500 mg pilloli miksija b'rita Hypromellose (E464)
English: Central or peripheral nervous system disease
Maltese: Disturbi fis-sistema nervuża
English: Capecitabine medac 500 mg film-coated tablets Each film-coated tablet contains 25 mg anhydrous lactose.
Maltese: Capecitabine medac 500 mg pilloli miksijin b'rita Kull pillola miksija b'rita fiha 25 mg anhydrous lactose.
English: HFS also known as hand-foot skin reaction or palmar-plantar erythrodysesthesia or chemotherapy induced acral erythema.
Maltese: HFS magħruf ukoll bħala reazzjoni tal-ġilda tal-idejn u s-saqajn jew eritrodisasteżija palmari-plantari jew eritema akrali kkaġunata mill-kemjoterapija.
English: The film-coated 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: 15.9 mm u wisgħa ta' 8.4 mm, imnaqqxa bin-numru ‘500' fuq naħa u lixxi fuq in-naħa l-oħra.
English: In combination with docetaxel, the recommended starting dose of capecitabine in the treatment of metastatic breast cancer is 1,250 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' 1,250 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: Do not give Capecitabine medac to children and adolescents.
Maltese: Tagħtix Capecitabine medac lil tfal u adolexxenti.
English: For combination with irinotecan, the recommended starting dose is 800 mg/m² when administered twice daily for 14 days followed by a 7-day rest period combined with irinotecan 200 mg/m² on day 1.
Maltese: Għall-kombinazzjoni ma' irinotecan, id-doża tal-bidu rakkomandata hija ta' 800 mg/ m² meta jingħata darbtejn kuljum għal 14-il ġurnata segwit minn perjodu ta' waqfien ta' sebat ijiem ikkombinat ma' irinotecan 200 mg/m² f'jum 1.
English: Haematuria, Proteinuria, Creatinine renal clearance decreased, Dysuria
Maltese: Ematurja, Proteina flawrina, Tnaqqis fit tneħħija tal-kreatinina mill-kliewi, Disurja
English: The MTD of capecitabine alone using the intermittent regimen is 3,000 mg/m² per day, whereas, when combined with radiotherapy for rectal cancer, the MTD of capecitabine is 2,000 mg/m² per day using either a continuous schedule or given daily Monday through Friday during a 6-week course of radiotherapy.
Maltese: L-MTD ta' capecitabine waħdu bl-użu ta' kors intermittenti hija ta' 3,000 mg/m² kuljum, filwaqt, meta kkombinat ma' radjuterapija għall-kanċer fir-rektum, l-MTD ta' capecitabine hija 2,000 mg/m² kuljum bl-użu ta' programm kontinwu jew mogħti kuljum mit-Tnejn sal-Ġimgħa waqt kors ta' sitt ġimgħat ta'
English: Japanese patients had also about 25 % lower Cmax and 34 % lower AUC for FBAL than Caucasian patients.
Maltese: Pazjenti Ġappuniżi kellhom ukoll Cmax għal FBAL 25 % inqas u AUC 34 % inqas minn pazjenti Kawkasi.
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 1,900 patients (studies M66001, SO14695, and SO14796).
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: Standard and reduced dose calculations according to body surface area for starting doses of Capecitabine medac of 1,250 mg/m² and 1,000 mg/m² are provided in tables 1 and 2, respectively.
Maltese: Kalkulazzjonijiet tad-doża stàndard jew doża mnaqqsa skont l-erja tas-superfiċje tal-ġisem għad-dożi tal-bidu ta' Capecitabine medac ta' 1,250 mg/m² u 1,000 mg/m² huma pprovduti f'tabelli 1 u 2 rispettivament.
English: Capecitabine medac 300 mg film-coated tablets
Maltese: Capecitabine medac 300 mg pilloli capecitabine
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: MARKETING AUTHORISATION NUMBER(S) EU/1/12/802/015-028
Maltese: TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/12/802/015-028
English: Capecitabine medac 300 mg film-coated tablets Each film-coated tablet contains 15 mg anhydrous lactose.
Maltese: Capecitabine medac 300 mg pilloli miksijin b'rita Kull pillola miksija b'rita fiha 15 mg anhydrous lactose.
English: Treatment with capecitabine monotherapy may be resumed when bilirubin decreases to ≤ 3.0 x ULN or hepatic aminotransferases decrease to ≤ 2.5 x ULN.
Maltese: It-trattament b'capecitabine li jittieħed waħdu jista' jitkompla meta l-bilirubin jonqos għal ≤ 3.0 x ULN jew l-aminotransferases epatiċi jitnaqqsu għal ≤ 2.5 x ULN.
English: Severe skin reactions
Maltese: tossiċità severa.
English: Non-inferiority of the XELOX-containing arms compared with the FOLFOX-4-containing arms in the overall comparison was demonstrated in terms of progression-free survival (PFS) in the eligible patient population and the intent-to-treat population (see table 7).
Maltese: Injezzjoni bolus fil-vini immedjatament wara leucovorin F'paragun globali ntwera li l-gruppi li fihom XELOX ma kienux inferjuri meta mqabbla ma' gruppi li fihom FOLFOX-4 f'termini ta' sopravivenza mingħajr progressjoni (PFS - progression-free survival) fil-popolazzjoni ta' pazjenti eliġibbli u tal-popolazzjoni b'intenzjoni li jiġu ttrattati (ara tabella 7).
English: The results of a meta-analysis of 14 clinical trials with data from over 4,700 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 4,700 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: Capecitabine medac 150 mg film-coated tablets Each film-coated tablet contains 7 mg anhydrous lactose.
Maltese: Capecitabine medac 150 mg pilloli miksijin b'rita Kull pillola miksija b'rita fiha 7 mg anhydrous lactose.
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 (ADRs), 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 (ADRs - adverse drug reactions), ta' grad 3 u grad 4, inkluż dawk li wasslu għat-twaqqif, meta mqabbel ma' pazjenti iżgħar.
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'
English: Dyspnoea, Epistaxis, Cough, Rhinorrhoea
Maltese: (rari), Bradikardija (rari), Vażospażmu
English: Given as monotherapy, the recommended starting dose for capecitabine in the adjuvant treatment of colon cancer, in the treatment of metastatic colorectal cancer or of locally advanced or metastatic breast cancer is 1,250 mg/m² administered twice daily (morning and evening; equivalent to 2,500 mg/m² total daily dose) for 14 days followed by a 7-day rest period.
Maltese: Mogħti bħala monoterapija, d-doża rakkomandata tal-bidu ta' capecitabine fit-trattament awżiljarju tal-kanċer tal-kolon, fit-trattament ta' kanċer tal-kolorektum li mmetastatizza jew ta' kanċer tas-sider lokalment avvanzat jew li mmetastatizza hija ta' 1,250 mg/m² mogħtija darbtejn kuljum (fil-għodu u fil-għaxija; ekwivalenti għal doża totali ta' kuljum ta' 2,500 mg/m²) għal 14-il ġurnata segwit minn perjodu ta' waqfien ta' sebat ijiem.
English: Film-coated tablets
Maltese: IL-PRODOTT MEDIĊINALI
English: Table 2 Standard and reduced dose calculations according to body surface area for a starting dose of capecitabine of 1,000 mg/m²
Maltese: Tabella 2 Kalkulazzjonijiet għad-doża standard u mnaqqsa skont l-erja tas-superfiċje tal-ġisem għad-doża tal-bidu ta' capecitabine ta' 1,000 mg/m² Livell ta' doża ta' 1,000 mg/m² (darbtejn kuljum)
English: Capecitabine medac 500 mg film-coated tablets
Maltese: Capecitabine medac 500 mg pilloli capecitabine
English: DPD activity is the rate limiting step.
Maltese: L-attività ta' DPD hija l-pass li jillimita r-rata.
English: For the capecitabine dose of 1,250 mg/m² twice daily on days 1 to 14 every 3 weeks, a frequency of 53 % to 60 % of all-grades HFS was observed in capecitabine monotherapy trials (comprising studies in adjuvant therapy in colon cancer, treatment of metastatic colorectal cancer, and treatment of breast cancer) and a frequency of 63 % was observed in the capecitabine/docetaxel arm for the treatment of metastatic breast cancer.
Maltese: Għad-doża ta' 1,250 mg/m² capecitabine darbtejn kuljum fi ġranet 1 sa 14 kull 3 ġimgħat, kienet osservata frekwenza ta' HFS ta' kull grad ta' 53 % sa 60 % fil-provi ta' monoterapija b'capecitabine
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: A total of 156 patients were randomised to treatment with 5-FU (800 mg/m² per day, continuous infusion on days 1 to 5 every 3 weeks) and cisplatin (80 mg/m² as a 2-hour infusion on day 1, every 3 weeks).
Maltese: Total ta' 156 pazjent kienu randomised għat-trattament b'5-FU (800 mg/m² kuljum, infużjoni kontinwa fl-ewwel sal-ħames jum kull 3 ġimgħat) u cisplatin (80 mg/m² bħala infużjoni fuq medda ta' sagħtejn fl-ewwel jum, kull 3 ġimgħat).
English: Capecitabine medac is not indicated in children and adolescents.
Maltese: Tfal u adolexxenti Capecitabine medac mhux indikat fit-tfal u l-adolexxenti.
English: Libido decreased
Maltese: Tnaqqis fil-libido
English: Deep vein thrombosis, Hypertension, Petechiae,
Maltese: Anġina instabbli, Anġina pectoris,
English: • if you know that you have a partial deficiency in the activity of the enzyme dihydropyrimidine dehydrogenase (DPD),
Maltese: • jekk taf li għandek defiċjenza parzjali tal-attività tal-enzima dihydropyrimidine dehydrogenase
English: Hand--foot syndrome
Maltese: Sindromu ta'