FrancophonIA/ELRC3.0 huggingface dataset:
English: Common side effects (may affect up to 1 in 10 people) include: - decreases in the number of white blood cells or red blood cells (seen in tests) - dehydration, weight loss - sleeplessness (insomnia), depression - headache, sleepiness, dizziness, abnormal sensation in the skin (numbness or tingling sensation), taste changes - eye irritation, increased tears, eye redness (conjunctivitis) - inflammation of the veins (thrombophlebitis) - shortness of breath, nose bleeds, cough, runny nose - cold sores or other herpes infections - infections of the lungs or respiratory system (e.g. pneumonia or bronchitis) - bleeding from the gut, constipation, pain in upper abdomen, indigestion, excess wind, dry mouth - skin rash, hair loss (alopecia), skin reddening, dry skin, itching (pruritus), skin discolouration,
Maltese: - irritazzjoni fl-għajnejn, żieda fid-dmugħ, ħmura fl-għajnejn (konġuntivite) - infjammazzjoni fil-vini (tromboflebite) - qtugħ ta' nifs, fsada mill-imnieħer, sogħla, imnieħer inixxi - ponot tad-deni jew infezzjonijiet oħra kkawżati minn herpes - infezzjonijiet fil-pulmun jew fis-sistema respiratorja (eż. pnewmonja jew bronkite) - fsada mill-musrana, stitikezza, uġigħ fl-addome ta' fuq, indiġestjoni, gass żejjed, ħalq xott - raxx tal-ġilda, telf ta' xagħar (alopeċja), ħmura tal-ġilda, ġilda xotta, ħakk (pruritus), tibdil filkulur tal-ġilda, telf tal-ġilda, infjammazzjoni tal-ġilda, disturb fid-dwiefer - uġigħ fil-ġogi, jew fir-riġlejn jew dirgħajn (estremitajiet), sider jew dahar - deni, nefħa fir-riġlejn jew dirgħajn, tħossok ma tiflaħx - problemi bil-funzjoni tal-fwied (osservati fit-testijiet tad-demm) u żieda ta' bilirubin fid-demm
English: Capecitabine in combination with cisplatin was non-inferior to 5-FU in combination with cisplatin in terms of progression-free survival in the per protocol analysis (hazard ratio 0.81; 95% CI 0.63 - 1.04).
Maltese: Capecitabine f'taħlita ma' cisplatin ma' kienx inferjuri għal 5-FU f'taħlita ma' cisplatin f'termini ta' sopravivenza mingħajr progressjoni f'analiżi skont il-protokoll (hazard ratio 0.81; 95% CI 0.63 - 1.04).
English: PHARMACEUTICAL FORM AND CONTENTS 60 film-coated tablets
Maltese: GĦAMLA FARMAĊEWTIKA U KONTENUT 60 pillola miksija b'rita
English: 750 mg/m2
Maltese: Doża mnaqqsa 750 mg/m2
English: Parameter: Progression-free Survival PPP ITT Parameter: Overall Survival PPP ITT
Maltese: Sopravivenza globali PPP ITT
English: Oxaliplatin: no clinically significant differences in exposure to capecitabine or its metabolites, free platinum or total platinum occurred when capecitabine was administered in combination with oxaliplatin or in combination with oxaliplatin and bevacizumab.
Maltese: Oxaliplatin: l-ebda differenzi ta' sinifikanza klinika fl-espożizzjoni għal capecitabine jew għallmetaboliti tiegħu, platinum ħieles jew platinum totali ma dehru meta capecitabine ingħata f'taħlita ma' oxaliplatin jew f'taħlita ma' oxaliplatin u bevacizumab.
English: 950 mg/m2
Maltese: Doża mnaqqsa 950 mg/m2
English: Dose limiting toxicities include diarrhoea, abdominal pain, nausea, stomatitis and hand-foot syndrome (hand-foot skin reaction, palmar-plantar erythrodysesthesia).
Maltese: Tossiċitajiet li jillimitaw id-doża jinkludu dijarea, uġigħ addominali, tqalligħ, stomatite u s-sindrome ta' l-idejn u s-saqajn (reazzjoni tal-ġilda fl-idejn u fis-saqajn, eritrodisasteżija palmari-plantari).
English: There is some evidence that dexpanthenol is effective for hand-foot syndrome prophylaxis in patients treated with capecitabine.
Maltese: Hemm xi evidenza li dexpanthenol huwa effettiv għall-profilassi tas-sindrome tal-idejn u s-saqajn f'pazjenti kkurati b' capecitabine.
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 filplażma 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: 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 in the eligible patient population and the intent-to-treat population (see table 7).
Maltese: 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 fil-popolazzjoni ta' pazjenti eliġibbli u tal-popolazzjoni b'intenzjoni li jiġu kkurati (ara tabella 7).
English: 625 mg/m2
Maltese: Doża mnaqqsa 625 mg/m2
English: In the event of grade 2-4 acute toxicity, treatment must be discontinued immediately until observed toxicity resolves.
Maltese: F'każ ta' tossiċità akuta ta' grad 2-4, il-kura għandha titwaqqaf immedjatament sakemm it-tossiċità osservata tgħaddi.
English: Renal and urinary disorder
Maltese: Disturbi filkliewi u fissistema urinarja
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: FOLFOX-4 u bevacizumab f'termini ta' sopravivenza mingħajr progressjoni (hazard ratio 1.01; 97.5% CI 0.84 - 1.22).
English: Capecitabine SUN contains anhydrous lactose This medicine contains anhydrous lactose.
Maltese: Capecitabine SUN fih anhydrous lactose
English: Eye disorders Lacrimation increased Visual disorders, Dry eye, Eye pain, Visual impairment, Vision blurred
Maltese: Disturbi fil-vista, Għajn tinħass xotta, Uġigħ fl-għajn, Indeboliment fil-vista, Vista mċajpra
English: Alu/Alu blister containing 10 film-coated tablets.
Maltese: Folja tal-Alu/Alu li fiha 10 pilloli miksijin b'rita.
English: 1, every 3 weeks).
Maltese: 3 ġimgħat).
English: Each carton contains 60 film-coated tablets (6 blisters of 10 tablets).
Maltese: Kull kaxxa tal-kartun fiha 60 pillola miksija b'rita (6 folji ta' 10 pilloli)
English: Each film-coated tablet contains 20.69 mg anhydrous lactose.
Maltese: 69 mg anhydrous lactose.
English: Capecitabine is indicated for the treatment of metastatic colorectal cancer (see section 5.1).
Maltese: Capecitabine huwa indikat għall-kura ta' kanċer metastatiku tal-kolorektum (ara sezzjoni 5.1).
English: Caution must be exercised in patients with central or peripheral nervous system disease, e.g. brain metastasis or neuropathy (see section 4.8).
Maltese: Trid tingħata attenzjoni lill-pazjenti b'mard fissistema nervuża ċentrali jew periferali eż. metastasi fil-moħħ jew newropatija (ara sezzjoni 4.8).
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' kura juru li l-għadd tan-newtrofili waqa' taħt 1.0 x 109/L jew jekk lgħadd tal-plejtlits jaqa' taħt 75 x 109/L, kura b'capecitabine għandha titwaqqaf.
English: - ECF: epirubicin (50 mg/m2 as a bolus on day 1 every 3 weeks), cisplatin (60 mg/m2 as a two hour infusion on day 1 every 3 weeks) and 5-FU (200 mg/m2 daily given by continuous infusion via a central line).
Maltese: - ECF: epirubicin (50 mg/ m2 bħala bolus fl-ewwel jum kull 3 ġimgħat), cisplatin (60 mg/m2 mogħti bħala infużjoni fuq medda ta' sagħtejn fl-ewwel jum kull 3 ġimgħat) u 5-FU (200 mg/m2
English: Diabetes,
Maltese: Disfaġija,
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 ECOG performance status at baseline (0 versus ≥1).
Maltese: 1*kg), żjieda fl-intensità tad-doża relattiva fl-ewwel sitt ġimgħat, żjieda fit-tul ta' kura taħt studju (ġimgħat), żjieda fl-età (b'żjidiet ta' 10 snin), sess femminili, u ECOG performance status fil-linja bażi tajjeb (0 kontra ≥1).
English: Angina unstable, Angina pectoris, Myocardial ischaemia, Atrial fibrillation, Arrhythmia, Tachycardia, Sinus tachycardia, Palpitations
Maltese: Capecitabine SUN jintuża għall-kura ta' kanċer tal-kolon, tar-rektum, fl-istonku, jew tas-sider.
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 rrakkomandata 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: Method of administration Capecitabine SUN tablets should be swallowed with water within 30 minutes after a meal.
Maltese: Metodu ta' kif għandu jingħata Il-pilloli Capecitabine SUN għandhom jinbelgħu mal-ilma fi żmien 30 minuta wara ikla.
English: 500 mg/m2
Maltese: Doża mnaqqsa 500 mg/m2
English: Median progression-free survival (PFS) was
Maltese: Is sopravivenza mingħajr progressjoni (PFS - progression-free survival) medjana kienet ta' 10.0
English: 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 ta' l-Istitut Nazzjonali tal-Kanċer tal-Kanada (NCIC CTG), jew Il-Kriterji ta' Terminoloġija Komuni għall-Avvenimenti Avversi (CTCAE) versjoni 3.0 tal-Programm ta' Valutazzjoni tat-Terapija tal-Kanċer, Istitut Nazzjonali tal-Kanċer ta' l-Istati Uniti, verżjoni 4.0.
English: 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' 1250 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 (inkluż studji b'terapija awżiljarja f'kanċer tal-kolon, kura ta' kanċer metastatiku tal-kolorektum, u kura tal-kanċer tas-sider) u kienet osservata frekwenza ta' 63% fil-grupp ta' capecitabine/docetaxel għall-kura ta' kanċer metastatiku tas-sider.
English: Permanent discontinuation should be considered bases on clinical assessment of the onset, duration and severity of the observed toxicities.
Maltese: Twaqqif permanenti għandu jiġi kkunsidrat ibbażat fuq valutazzjoni klinika tal-bidu, tul u severità tat-tossiċitajiet osservati.
English: Coumarin-derivative anticoagulants: altered coagulation parameters and/or bleeding have been reported in patients taking capecitabine concomitantly with coumarin-derivative anticoagulants such as warfarin and phenprocoumon.
Maltese: Sustanzi kontra il-koagulazzjoni tad-demm derivati minn coumarin: bdil fil-parametri talkoagulazzjoni u/jew fil-fsada ġew irrapportati f'pazjenti li kienu qed jieħdu capecitabine waqt kura b'sustanzi kontra il-koagulazzjoni tad-demm derivati minn coumarin, bħal warfarin u phenprocoumon.
English: Parameter: Overall Survival EPP ITT *EPP=eligible patient population; **ITT=intent-to-treat population
Maltese: Sopravivenza Globali EPP ITT *EPP=popolazzjoni ta' pazjenti eliġibbli; **ITT=popolazzjoni b'intenzjoni li jiġu kkurati
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: Capecitabine dose calculations
Maltese: Indikazzjonijet kollha
English: Breastfeeding
Maltese: psikjatriċi
English: Data from a randomised multicentre, phase III study comparing capecitabine to 5-FU and oxaliplatin to cisplatin in patients with advanced gastric cancer supports the use of capecitabine for the first-line treatment of advanced gastric cancer (REAL-2).
Maltese: Tagħrif minn studju ta' fazi III randomised u multicentre li qabbel capecitabine ma' 5-FU u oxaliplatin ma' cisplatin f'pazjenti b'kanċer avvanzat ta' l-istonku jissapportja l-użu ta' capecitabine bħala kura primarja ta' kanċer avvanzat ta' l-istonku (REAL-2).
English: What Capecitabine SUN looks like and contents of the pack Capecitabine SUN 150 mg are light peach coloured, oval, biconvex, film-coated tablet debossed with ‘150' on one side and plain on other side.
Maltese: Kif jidher Capecitabine SUN u l-kontenut tal-pakkett Capecitabine SUN 150 mg huma pilloli miksijin b'rita f'għamla ovali mżaqqin fuq żewġ naħat ta' lewn ħawħi ċar b'iskrizzjoni fuqhom ta' 150" fuq naħa u lixxi fuq in-naħa l-oħra.
English: Since metabolism of R-warfarin was not affected, these results indicate that capecitabine downregulates isozyme 2C9, but has no effect on isozymes 1A2 and 3A4.
Maltese: Billi lmetaboliżmu ta' R-warfarin ma kienx affettwat, dawn ir-riżultati jindikaw li capecitabine jnaqqas lattività ta' isoenżima 2C9, iżda m'għandu l-ebda effect fuq l-isoenżimi 1A2 u 3A4.
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 għall-kura awżiljarja ta' pazjenti b'kanċer tal-kolon (Studju XACT;
English: Data from a multicentre, randomised, controlled phase III clinical trial in patients with advanced gastric cancer supports the use of capecitabine for the first-line treatment of advanced gastric cancer (ML17032).
Maltese: III multicentre, randomised u kkontrollata f'pazjenti b'kanċer avvanzat ta' l-istonku jissapportja l-użu ta' capecitabine għall-kura primarja ta' kanċer avvanzat ta' listonku (ML 17032).
English: During standard fertility studies, impairment of fertility was observed in female mice receiving capecitabine; however, this effect was reversible after a drug-free period.
Maltese: Waqt studji stàndard dwar il-fertilità, indeboliment fil-fertilità ġiet osservata fi ġrieden femminili li kienu qed jingħataw capecitabine; madankollu, dan l-effett kien riversibbli wara perjodu mingħajr mediċina.
English: NAME OF THE MEDICINAL PRODUCT Capecitabine SUN 150 mg film-coated tablets capecitabine
Maltese: TAL-PRODOTT MEDIĊINALI Capecitabine SUN 150 mg pilloli miksijin b'rita 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 kkurati 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 kkurati b'FOLFIRI + bevacizumab b'żieda sinifikanti fid-dewmien tal-kura, tnaqqis fid-doża u twaqqif tal-kura.
English: NAME OF THE MEDICINAL PRODUCT Capecitabine SUN 500 mg film-coated tablets.
Maltese: IL-PRODOTT MEDIĊINALI Capecitabine SUN pilloli 500 mg miksija b'rita.
English: Your doctor may want you to take a combination of 150 mg and 500 mg tablets for each dose.
Maltese: It-tabib tiegħek għandu mnejn ikun jixtieq li inti tieħu kombinazzjoni ta' pilloli ta' 150 mg u 500 mg għal kull doża.
English: Blister, Skin ulcer, Rash, Urticaria, Photosensitivity reaction, Palmar erythema, Swelling face, Purpura, Radiation recall syndrome
Maltese: Reazzjoni ta' fotosensittività, Eritema ta' l-idejn, Nefħa fil-wiċċ, Purpura, Sindrome ta' tifkira tar-radjazzjoni
English: Hand-foot syndrome (also known as hand-foot skin reaction or palmar-plantar erythrodysesthesia or chemotherapy induced acral erythema).
Maltese: Sindrome ta' l-idejn u s-saqajn (magħruf ukoll bħala reazzjoni tal-ġilda ta' l-idejn u s-saqajn jew eritrodisasteżija palmari-plantari jew eritema akrali kkaġunata mill-kemjoterapija).
English: Sepsis, Urinary tract infection, Cellulitis, Tonsillitis, Pharyngitis, Oral candidiasis, Influenza,
Maltese: Kandidajasi orali, Influwenza, Gastroenterite, Infezzjoni mill-moffa, Infezzjoni,
English: Excipients.
Maltese: Dijarea.
English: Elderly patients (see section 4.2)
Maltese: Pazjenti anzjan (ara sezzjoni 4.2)
English: Each film-coated tablet contains 150 mg of capecitabine.
Maltese: Kull pillola miksija b'rita fiha 150 mg capecitabine.
English: Each film-coated tablet contains 500 mg of capecitabine.
Maltese: Kull pillola miksija b'rita fiha 500 mg capecitabine.
English: NAME OF THE MEDICINAL PRODUCT Capecitabine SUN 500 mg film-coated tablets capecitabine
Maltese: TAL-PRODOTT MEDIĊINALI Capecitabine SUN 500 mg pilloli miksijin b'rita capecitabine
English: Common side effects (may affect up to 1 in 10 people) include: - decrease in blood sodium, magnesium or calcium, increase in blood sugar - nerve pain - ringing or buzzing in the ears (tinnitus), loss of hearing - vein inflammation - hiccups, change in voice - pain or altered/abnormal sensation in the mouth, pain in the jaw - sweating, night sweats - muscle spasm - difficulty in urination, blood or protein in the urine - bruising or reaction at the injection site (caused by medicines given by injection at the same time).
Maltese: Effetti sekondarji komuni (jistgħu jaffettwaw sa persuna waħda minn kull 10) jinkludu: - livell imnaqqas ta' sodium, magnesium jew calcium fid-demm, żieda ta' zokkor fid-demm - uġigħ fin-nervaturi - tisfir jew żarżir fil-widnejn (tinnitus), telf tas-smigħ - infjammazzjoni tal-vini - sulluzzu, bidla fil-vuċi - uġigħ jew sensazzjoni mibdula/mhux normali fil-ħalq, uġigħ fix-xedaq - għaraq, għaraq matul il-lejl - spażmi fil-muskoli - diffikultà biex tgħaddi l-awrina, demm jew proteina fl-awrina
English: The results of a meta-analysis of 14 clinical trials with data from over 4700 patients treated with capecitabine showed that in all studies combined, female gender was statistically significantly associated with an increased risk of developing HFS and diarrhoea and with a decreased risk of developing neutropenia.
Maltese: Ir-riżultati ta' meta-analiżi ta' 14-il prova klinika b'tagħrif minn aktar minn 4700 pazjent kkurati b'capecitabine wrew li fl-istudji kollha kombinati, sess femminili kien assoċjati b'mod statistikament sinifikanti ma' żjieda fir-riskju ta' żvilupp ta' HFS u dijarea u ma' riskju mnaqqas ta' żvilupp ta' newtropenija.
English: In combination with docetaxel, the recommended starting dose of capecitabine in the treatment of metastatic breast cancer is 1250 mg/m2 twice daily for 14 days followed by a 7-day rest period, combined with docetaxel at 75 mg/m2 as a 1 hour intravenous infusion every 3 weeks.
Maltese: F'taħlita ma' docetaxel, id-doża tal-bidu rakkomandata ta' capecitabine fil-kura ta' kanċer metastatiku tas-sider hija ta' 1250 mg/m2 darbtejn kuljum għal 14-il jum segwita minn perjodu ta' waqfien ta' sebat ijiem, flimkien ma' 75 mg/m2 docetaxel mogħti bħala infużjoni fil-vini fuq perjodu ta' siegħa kull 3 ġimgħat.
English: Standard and reduced dose calculations according to body surface area for starting doses of capecitabine of 1250 mg/m2 and 1000 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 ta' 1250 mg/m2 u 1000 mg/m2 hma pprovduti f'tabelli 1 u 2 rispettivament.
English: Sore throat, Dysaesthesia pharynx
Maltese: Żjieda tal-krejatinina fiddemm
English: An analysis of safety data in patients ≥60 years of age treated with capecitabine monotherapy and an analysis of patients treated with capecitabine plus docetaxel combination therapy showed an increase in the incidence of treatment-related grade 3 and 4 adverse reactions and treatment-related serious adverse reactions compared to patients <60 years of age.
Maltese: Analiżi ta' tagħrif dwar is-sigurtà f'pazjenti b'età ta' ≥ 60 sena kkurati b'monoterapija ta' capecitabine u analiżi ta' pazjenti kkurati b'terapija mħalta ta' capecitabine flimkien ma' docetaxel uriet żjieda flinċidenza ta' reazzjonijiet avversi ta' grad 3 u 4 u ta' reazzjonijiet avversi serji relatati mal-kura meta mqabbla ma' pazjenti b'età ta' < 60 sena.
English: 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),
Maltese: darbtejn kuljum għal ġimagħtejn segwit minn perjodu mingħajr kura 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: Each carton contains 120 film-coated tablets (12 blisters of 10 tablets).
Maltese: Kull kaxxa tal-kartun fiha 120 pillola miksija b'rita (12-il folja ta' 10 pilloli)
English: Tablet coating: hypromellose (E464) titanium dioxide (E171) lactose monohydrate macrogol
Maltese: Kisja tal-pillola: hypromellose (E464), titanium dioxide (E171), lactose monohydrate, macrogol u iron oxide isfar u aħmar (E172).
English: - EOX: epirubicin (50 mg/m2 as a bolus on day 1 every 3 weeks), oxaliplatin (130 mg/m2 given as a 2 hour infusion on day 1 every three weeks), and capecitabine (625 mg/m2 twice daily continuously).
Maltese: - EOX: epirubicin (50 mg/m2 bħala bolus fl-ewwel jum kull 3 ġimgħat), oxaliplatin (130 mg/m2
English: NAME OF THE MEDICINAL PRODUCT Capecitabine SUN 150 mg film-coated tablets.
Maltese: IL-PRODOTT MEDIĊINALI Capecitabine SUN pilloli 150 mg miksija b'rita.
English: What Capecitabine SUN looks like and contents of the pack Capecitabine SUN 500 mg are peach coloured, oval, biconvex, film-coated tablet debossed with '500' on one side and plain on other side.
Maltese: Kif jidher Capecitabine SUN u l-kontenut tal-pakkett Capecitabine SUN 500 mg huma pilloli miksijin b'rita, f'għamla ovali mżaqqin fuq żewġ naħat ta' lewn ħawħi ċar, bi skrizzjoni ta' "500" fuq naħa waħda u lixxi fuq in-naħa l-oħra.
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: Il-kura b'capecitabine li tittieħed waħidha tista' titkompla meta l-bilirubin jonqos għal ≤ 3.0 x ULN jew l-aminotransferases epatiċi jitnaqqsu għal ≤ 2.5 x ULN.
English: Excipient(s) with known effect:
Maltese: Effetti sekondarji oħra huma:
English: However, grade 3 or 4 treatment-related adverse reactions were more frequent in patients ≥60 years of age compared to younger patients.
Maltese: Madankollu, reazzjonijiet avversi ta' grad 3 jew 4 li huma relatati mal-kura kienu aktar frekwenti f'pazjenti li għandhom ≥ 60 sena meta mqabbla ma' pazjenti iżgħar.
English: - EOF: epirubicin (50 mg/m2 as a bolus on day 1 every 3 weeks), oxaliplatin (130 mg/m2 given as a 2 hour infusion on day 1 every three weeks), and 5-FU (200 mg/m2 daily given by continuous infusion via a central line).
Maltese: - EOF: epirubicin (50 mg/m2 bħala bolus fl-ewwel jum kull 3 ġimgħat), oxaliplatin (130 mg/m2
English: Phenytoin: increased phenytoin plasma concentrations resulting in symptoms of phenytoin intoxication in single cases have been reported during concomitant use of capecitabine with phenytoin.
Maltese: Phenytoin: żjieda fil-konċentrazzjonijiet ta' phenytoin fil-plażma li tirriżulta f'sintomi ta' intossikazzjoni ta' phenytoin f'każijiet individwali, ġew irrapportati waqt l-użu ta' capecitabine flimkien ma' phenytoin.
English: Other side effects are:
Maltese: Parameter: