FrancophonIA/ELRC3.0 huggingface dataset:
English: Patients were randomised to receive either FOLFIRI plus bevacizumab (Arm-A, n=167) or XELIRI plus bevacizumab (Arm-B, n-166).
Maltese: FOLFIRI flimkien ma' bevacizumab (Grupp-A, n= 167) jew XELIRI flimkien ma' bevacizumab (Grupp-B , n=166).
English: Faecal excretion is minimal (2.6%).
Maltese: It-tneħħija fil-ħmieġ hija minima (2.6%).
English: Cardiac arrhythmias (including ventricular fibrillation, torsade de pointes, and bradycardia), angina pectoris, myocardial infarction, heart failure and cardiomyopathy have been reported in patients receiving capecitabine.
Maltese: Arritmija kardijaka (inkluż fibrillazzjoni ventrikolari, torsade de pointes u bradikardija), anġina pectoris, infart mijokardijaku, insuffiċjenza talqalb u kardjomijopatija ġew irrapportati f'pazjenti li qed jieħdu capecitabine.
English: Data from a randomised clinical study (Souglakos et al, 2012) comparing FOLFIRI + bevacizumab with XELIRI + bevacizumab showed no significant differences in PFS or OS between treatments.
Maltese: Data minn studju kliniku randomised (Souglakos et al, 2012) li qabbel FOLFIRI + bevacizumab ma' XELIRI + bevacizumab ma wriet l-ebda differenzi sinifikanti fil-PFS jew OS bejn it-trattamenti.
English: However this was associated with an increased incidence of gastrointestinal toxicity and neutropenia during first-line treatment with XELIRI (26% and 11% for XELIRI and first line capecitabine respectively).
Maltese: Madankollu dan kien assoċjat ma' inċidenza akbar ta' tossiċità gastrointestinali u newtropenija waqt trattament primarju b'XELIRI (26% u 11% għal XELIRI u capecitabine bħala trattament primarju rispettivament).
English: In the event of grade 2-4 acute toxicity, treatment must be discontinued immediately.
Maltese: F'każ ta' tossiċità akuta ta' grad 2-4, ittrattament għandu jitwaqqaf immedjatament.
English: Median OS was 23.1 months for FOLFIRI, 17.6 months for mIFL (p=0.09), and 18.9 months for XELIRI (p=0.27).
Maltese: OS medjana kienet ta' 23.1 xhur għal FOLFIRI, 17.6 xhur għal mIFL (p=0.09), u 18.9 xhur għal XELIRI (p=0.27).
English: Muskuloskeletal and connective tissue disorders
Maltese: Disturbi muskolu-skeletriċii u tat-tessuti konnettivi
English: QT prolongation (rare), Torsade de pointes (rare), Bradycardia (rare), Vasospasm (rare)
Maltese: Fibrillazzjoni tal-ventrikolu (rari), Titwil ta' QT (rari), Torsade de pointes (rari), Bradikardija (rari), Vażospażmu (rari)
English: What Ecansya contains - The active substance is capecitabine.
Maltese: - Is-sustanza attiva hi capecitabine.
English: Antacid: 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: Patients treated with XELIRI experienced excessive gastrointestinal toxicity compared with FOLFIRI (diarrhoea 48% and 14% for XELIRI and FOLFIRI respectively).
Maltese: Pazjenti ttrattati b'XELIRI kellhom tossiċità gastrointestinali eċċessiva meta mqabbla ma' FOLFIRI (dijarea 48% u 14% għal XELIRI u FOLFIRI rispettivament.
English: Name and address of the manufacturers responsible for batch release Accord Healthcare Ltd.
Maltese: Isem u indirizz tal-manifatturi responsabbli għall-ħruġ tal-lott Accord Healthcare Ltd.
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: Patients with certain heterozygous DPYD variants (including DPYD*2A, c.1679T>G, c.2846A>T and c.1236G>A/HapB3 variants) have been shown to have increased risk of severe toxicity when treated with capecitabine.
Maltese: Pazjenti b'ċerti varjanti eterozigotiċi ta' DPYD (inklużi varjanti DPYD*2A, c.1679T>G, c.2846A>T u c.1236G>A/HapB3) intwera li għandhom riskju akbar ta' tossiċità severa meta ttrattati b'capecitabine.
English: Table 4 Summary of related ADRs reported in patients treated with capecitabine monotherapy Body System Very Common
Maltese: Tabella 4 Sommarju tal-ADRs relatati rrapportati f'pazjenti trattati b'monoterapija ta' capecitabine
English: Posology Recommended posology (see section 5.1):
Maltese: Pożoloġija Pożoloġija rakkomandata (ara sezzjoni 5.1):
English: Aphasia, Memory impairment, Ataxia, Syncope, Balance disorder, Sensory disorder, Neuropathy peripheral
Maltese: Afasja, Nuqqas tal-memorja, Ataxja, Sinkope, Disturbi fil-bilanċ, Disturbi fis-sensi, Newropatija periferali
English: Oxaliplatin 130 mg/m intravenous 2 hr
Maltese: Oxaliplatin 130 mg/m 2 fil-vini 2
English: A significant reduction in the risk of progression was associated with FOLFIRI (HR, 0.76; 95%CI, 0.62-0.95; P <0.01), a result partly due to poor tolerance to the XELIRI regimens used.
Maltese: Tnaqqis sinifikanti fir-riskju ta' progressjoni kien assoċjat ma' FOLFIRI (HR, 0.76; CI ta' 95%, 0.62-0.95; P <0.01), riżultat parzjalment ikkawżat minn tolleranza baxxa għall-korsijiet ta' XELIRI użati.
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 tal-kolorektum. 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: Headache, Lethargy Dizziness, Paraesthesia, Dysgeusia
Maltese: Uġigħ ta' ras, Letarġija, Sturdament, Parasteżija, Disgewsja
English: The requirements for submission of PSURs for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal.
Maltese: PSURs għal dan il-prodott mediċinali huma mniżżla fil-lista tad-dati ta' referenza tal-Unjoni (lista EURD) prevista skont l-Artikolu 107c(7) tad-Direttiva 2001/83/KE u kwalunkwe aġġornament sussegwenti ppubblikat fuq il-portal elettroniku Ewropew tal-mediċini.
English: Jaundice
Maltese: Ġenerali
English: There is evidence that the metabolism of 5-FU in the anabolic pathway blocks the methylation reaction of deoxyuridylic acid to thymidylic acid, thereby interfering with the synthesis of deoxyribonucleic acid (DNA).
Maltese: Hemm evidenza li l-metaboliżmu ta' 5-FU fis-sensiela ta' reazzjonijiet anaboliċi jwaqqaf ir-reazzjoni tal-methylation ta' deoxyuridylic acid għal thymidylic acid, u b'hekk jinterferixxi mas-sintesi ta' deoxyribonucleic acid (DNA).
English: Median progression free survival ITT
Maltese: Sopravivenza mingħajr progressjoni medjana ITT
English: Marketing Authorisation Holder KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia
Maltese: KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Is-Slovenja
English: Ecansya is available in blisters (Aluminium-aluminium or PVC/PVdC-aluminium) containing 30, 60 or 120 film-coated tablets.
Maltese: Ecansya jiġi f'folji (Aluminju-aluminju jew PVC/PVdC-aluminju) li fihom 30, 60 jew 120 pillola miksijin b'rita.
English: For terms marked with a “+”, the frequency count was based on grade 3-4 ADRs.
Maltese: Għal termini mmarkati b'“+”, l-għadd tal-frekwenza kien ibbażat fuq ADRs ta' grad 3-4.
English: In an interaction study with single-dose warfarin administration, there was a significant increase in the mean AUC (+57%) of S-warfarin.
Maltese: Fi studju dwar l-interazzjoni waqt l-għoti ta' doża waħda ta' warfarin, kien hemm żieda sinifikattiva fil-medja tal-AUC (+57%) ta' S-warfarin.
English: Previous therapy should have included an anthracycline.
Maltese: It-terapija preċedenti kellha tinkludi anthracycline.
English: A meta-analysis of 14 clinical trials with data from over 4700 patients treated with capecitabine monotherapy or capecitabine in combination with different chemotherapy regimens in multiple indications (colon, colorectal, gastric and breast cancer) showed that patients on capecitabine who developed hand-foot syndrome (HFS) had a longer overall survival compared to patients who did not develop HFS: median overall survival 1100 days (95% CI 1007;1200) vs 691 days (95% CI 638;754) with a hazard ratio of 0.61 (95% CI 0.56; 0.66).
Maltese: Meta-analiżi ta' 14-il prova klinika b'tagħrif minn aktar minn 4700 pazjent ttrattati 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 pazjenti fuq capecitabine li żviluppaw is-sindrome tal-idejn u s-saqajn (HFS) kellhom sopravivenża totali itwal meta mqabbel ma' pazjenti li ma żviluppawx HFS: sopravivenza totali medjana 1100 ġurnata (95% CI 1007;1200) vs 691 ġurnata (95% CI 638; 754) b'proporzjon ta' periklu ta' 0.61 (95% CI 0.56; 0.66).
English: Acute renal failure secondary to dehydration might be potentially fatal.
Maltese: Insuffiċjenza akuta tal-kliewi sekondarja għal deidratazzjoni tista' tkun potenzjalment fatali.
English: If you have an unrecognised DPD deficiency and take Ecansya, 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 Ecansya, għandek riskju ogħla ta' bidu akut bikri ta' forom qawwija tal-effetti sekondarji elenkati taħt sezzjoni 4 Effetti sekondarji possibbli.
English: No significant differences occurred in the exposure to other metabolites (5'-DFCR, 5'-DFUR, and 5-FU).
Maltese: L-ebda differenzi sinifikanti ma seħħew fl-espożizzjoni għal metaboliti oħra (5'-DFCR, 5'-DFUR, u 5-FU).
English: - In combination with docetaxel: an increased incidence of grade 3 or 4 treatment-related adverse reactions and treatment-related serious adverse reactions were observed in patients 60 years of age or more (see section 5.1).
Maltese: - Flimkien ma' docetaxel: inċidenza ogħla ta' reazzjonijiet avversi ta' grad 3 jew 4 li huma relatati mat-trattament u ta' reazzjonijiet avversi serji li huma relatati mat-trattament ġew osservati f'pazjenti li għandhom 60 sena jew aktar (ara sezzjoni 5.1).
English: Capecitabine 1000 mg/m 2 oral twice daily
Maltese: Capecitabine 1000 mg/m mill-ħalq darbtejn kuljum
English: Ecansya contains capecitabine, which itself is not a cytostatic medicine.
Maltese: Ecansya fih capecitabine, li huwa nnifsu mhuwiex mediċina ċitostatika.
English: Cardiotoxicity.
Maltese: Kardjotossiċità
English: Acute renal failure secondary to dehydration (rare)
Maltese: Insuffiċjenza akuta tal-kliewi sekondarja għal deidratazzjoni (rari)
English: Neutropenia
Maltese: Disturbi
English: Pyrexia, Weakness, Lethargy, Temperature intolerance
Maltese: Deni, Debbulizza, Letarġija, Intolleranza għat-temperatura
English: In the EORTC study patients were randomised to receive either open label FOLFIRI (n=41) or XELIRI (n=44) with additional randomisation to either double-blind treatment with celecoxib or placebo.
Maltese: Fl-istudju EORTC il-pazjent kienu randomised biex jirċievu open label FOLFIRI (n=41) jew XELIRI (n=44) b'randomisation addizzjonali għal trattament double-blind b'celecoxib jew plaċebo.
English: Diarrhoea.
Maltese: Deidratazzjoni
English: Visual acuity reduced, Diplopia
Maltese: Tnaqqis fl-akutezza tal-vista, Diplopja
English: Aluminium/aluminium or PVC/PVdC/aluminium blister containing 10 film-coated tablets.
Maltese: Folja tal-aluminju/aluminju jew PVC/PVdC/aluminju li fiha 10 pilloli miksija b'rita.
English: Table 9 Key efficacy results for the non-inferiority analysis of Study NO16967 PRIMARY ANALYSIS
Maltese: Tabella 9 Riżultati importanti tal-effikaċja għall-analiżi ta' nuqqas ta' inferjorità ta' Studju NO16967
English: Febrile neutropenia, Pancytopenia, Granulocytopenia, Thrombocytopenia, Leukopenia, Haemolytic anaemia, International Normalised Ratio (INR) increased/ Prothrombin time prolonged
Maltese: Panċitopenija, Granuloċitopenija, Tromboċitopenija, Lewkopenija, Anemija emolitika, Proporzjon Normalizzat Internazzjonali (INR) miżjud/Ħin ta' Prothrombin imtawwal
English: Confusional state, Panic attack, Depressed mood, Libido decreased
Maltese: Stat ta' konfużjoni, Attakk ta' paniku, Burdata depressa, Tnaqqis fil-libido
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: KRKA Magyarország Kereskedelmi Kft. Tel.: + 36 (1) 355 8490
Maltese: Tel.: + 36 (1) 355 8490
English: 5-FU is further catabolised by the enzyme dihydropyrimidine dehydrogenase (DPD) to the much less toxic dihydro-5-fluorouracil (FUH2).
Maltese: 5-FU jkompli jiġi kkatabolizzat mill-enżima dihydropyrimidine dehydrogenase (DPD) għal dihydro-5-fluorouracil (FUH2) li huwa ħafna inqas tossiku.
English: Survival was superior in the capecitabine + docetaxel combination arm (p=0.0126).
Maltese: Is-sopravivenza kienet ogħla fil-grupp ta' trattament kombinat b'capecitabine u docetaxel (p=0.0126).
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 talmukuża ,newtropenija u newrotossiċità) assoċjati ma' 5-FU kienet attribwita għal nuqqas ta' attività ta' DPD.
English: Dihydropyrimidine dehydrogenase (DPD) activity is the rate limiting step.
Maltese: L-attività ta' dihydropyrimidine dehydrogenase (DPD) hija l-pass li jillimita r-rata.
English: Median PFS was 7.6 months for FOLFIRI, 5.9 months for mIFL (p=0.004) for the comparison with FOLFIRI), and 5.8 months for XELIRI (p=0.015).
Maltese: PFS medjana kienet ta' 7.6 xhur għal FOLFIRI, 5.9 xhur għal mIFL (p=0.004 għall-paragun ma' FOLFIRI), u 5.8 xhur għal XELIRI (p=0.015).
English: Rare side effects (may affect up to 1 in 1,000 people) include: - narrowing or blockage of tear duct (lacrimal duct stenosis) - liver failure - inflammation leading to dysfunction or obstruction in bile secretion (cholestatic hepatitis) - specific changes in the electrocardiogram (QT prolongation) - certain types of arrhythmia (including ventricular fibrillation, torsade de pointes, and bradycardia) - eye inflammation causing eye pain and possibly eyesight problems - inflammation of the skin causing red scaly patches due to an immune system illness
Maltese: Effetti sekondarji rari (jistgħu jaffettwaw sa persuna waħda minn kull 1,000) jinkludu: - djuq jew sadd tal-kanal tad-dmugħ (stenosi tal-kanal tad-dmugħ) - insuffiċjenza tal-fwied - infjammazzjoni li twassal għal disfunzjoni jew sadd fis-sekrezzjoni tal-bili (epatite kolestatika) - bidliet speċifiċi fl-elettrokardjogramma ( titwil ta' QT) - ċertu tipi ta' arritmija (inkluż fibrillazzjoni tal-ventrikolu, torsade de pointes, u bradikardija) - infjammazzjoni fl-għajnejn li tikkawża uġigħ fl-għajnejn u possibilment problemi fil-vista - infjammazzjoni tal-ġilda li tikkawża rqajja ħomor bil-qoxra kkawżata minn marda fis-sistema immuni
English: The overall objective response rates (investigator assessment) were 20% (first trial) and 25% (second trial).
Maltese: Ir-rati oġġettivi tar-respons totali (valutazzjoni investigattiva) kienu ta' 20% (l-ewwel prova) u ta' 25% (it-tieni prova).
English: Allopurinol: interactions with allopurinol have been observed for 5-FU; with possible decreased efficacy of 5-FU.
Maltese: Interazzjonijiet ma' allopurinol ġew osservati għal 5-FU; bi tnaqqis possibbli tal-effikaċja ta' 5-FU.
English: In the largest study (BICC-C), patients were randomised to receive either open label FOLFIRI (n=144), bolus 5-FU (mIFL) (n=145) or XELIRI (n=141) and were additionally randomised to receive either double-blind treatment with celecoxib or placebo.
Maltese: Fl-akbar studju (BICC-C), il-pazjenti kienu randomised biex jirċievu open label FOLFIRI (n=144), 5-FU bħala bolus (mIFL) (n=145) jew XELIRI (n=141) u barra dan kienu randomised biex jirċievu trattament double-blind b'celecoxib jew plaċebo.
English: However, folinic acid has an effect on the pharmacodynamics of capecitabine and its toxicity may be enhanced by folinic acid: the maximum tolerated dose (MTD) of capecitabine alone using the intermittent regimen is 3000 mg/m2 per day whereas it is only 2000 mg/m2 per day when capecitabine was combined with folinic acid (30 mg orally bid).
Maltese: Madankollu, folinic acid għandu effett fuq il-farmakodinamika ta' capecitabine u t-tossiċità tiegħu tista' tiġi msaħħa minn folinic acid: id-doża massima tollerata (MTD) ta' capecitabine waħdu bl-użu ta' kors intermittenti huwa ta' 3000 mg/m kuljum filwaqt li l-MTD hija biss ta' 2000 mg/ m2 kuljum meta capecitabine jittieħed flimkien ma' folinic acid (30 mg meħud mill-ħalq darbtejn kuljum).
English: In the allrandomised population, capecitabine was shown to be superior to 5FU/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: Fil-popolazzjoni 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: ( 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 < 1/1,000) rari ħafna (< 1/10,000).
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), is-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: OTHER
Maltese: I
English: Severe skin reactions: Ecansya can induce severe skin reactions such as Stevens-Johnson syndrome and Toxic Epidermal Necrolysis.
Maltese: Ecansya jista' jikkawża reazzjonijiet severi fil-ġilda bħas-sindrome ta' Stevens-Johnson u nekrolisi tossika tal-epidermide.
English: +Anaemia, Neutropenic fever, Thrombocytopenia
Maltese: +Deni newtropeniku, Tromboċitopenija
English: The hazard ratio for duration of survival (overall survival) was similar to the hazard ratio for progression-free survival (hazard ratio 0.85; 95% CI 0.641.13).
Maltese: Il-hazard ratio għat-tul tas-sopravivenza (sopravivenza totali) kien simili għall-hazard ratio tas-sopravivenza mingħajr progressjoni (hazard ratio 0.85; 95% CI 0.64 - 1.13).
English: INFORMATION IN BRAILLE Ecansya 300 mg
Maltese: Ecansya 300 mg
English: Hand-foot syndrome (see section 4.4): For the capecitabine dose of 1250 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: Sindrome tal-idejn u s-saqajn (HFS) (ara sezzjoni 4.4): 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, trattament ta' kanċer metastatiku tal-kolorektum, u trattament tal-kanċer tas-sider) u kienet osservata frekwenza ta' 63% fil-grupp ta' capecitabine/docetaxel għat-trattament ta' kanċer metastatiku tas-sider.
English: Hypocalcaemia, Hyperglycaemia
Maltese: Ipo- jew iperkalċimja
English: Median survival was 384 and 373 days.
Maltese: Is-sopravivenza medjana kienet ta' 384 u 373 jum.
English: Capecitabine was not mutagenic in vitro to bacteria (Ames test) or mammalian cells (Chinese hamster V79/HPRT gene mutation assay).
Maltese: Capecitabine ma kienx mutaġeniku in vitro għall-batterji (test ta' Ames) jew għal ċelluli mammiferi (analiżi ta' tibdil fil-ġeni tal-ħamster Ċiniż V79/HPRT).
English: 12.1 months
Maltese: 12.1 xhur
English: Cardiotoxicity has been associated with fluoropyrimidine therapy, including myocardial infarction, angina, dysrhythmias, cardiogenic shock, sudden death and electrocardiographic changes (including very rare cases of QT prolongation).
Maltese: Il-kardjotossiċità ġiet assoċjata mat-terapija b'fluoropyrimidine, inkluż infart mijokardijaku, anġina, disritmija, xokk kardjoġeniku, mewt għal għarrieda u bidliet elettrokardjografiċi (inkluż każijiet rari ħafna ta' titwil ta' QT).
English: Combination treatment consisted of first-line capecitabine (1000 mg/m 2 twice daily for 14 days) combined with irinotecan (250 mg /m 2 on day 1) (XELIRI) and second-line capecitabine (1000 mg/m2 twice daily for 14 days) plus oxaliplatin (130 mg/m2 on day 1).
Maltese: It-trattament kombinat ikkonsista minn capecitabine (1000 mg/m 2 darbtejn kuljum għal 14-il ġurnata) flimkien ma' irinotecan (250 mg/m fl-ewwel ġurnata) (XELIRI) bħala trattament primarju u capecitabine (1000 mg/m 2 darbtejn kuljum għal 14-il ġurnata) u oxaliplatin (130 mg/m2 fl-ewwel ġurnata) bħala trattament sekondarju.