FrancophonIA/ELRC3.0 huggingface dataset:
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 medac (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 medac (eż. stomatite, infjammazzjoni tal-mukuża, dijarea, newtropenija, u newrotossiċità).
English: supports these results with a HR of 0.78 (95 % CI = [0.67; 0.92]; p = 0.0024) for XELOX vs. 5-FU/LV.
Maltese: 67; 0.92]; p = 0.0024) għal XELOX kontra 5-FU/LV.
English: Gender, presence or absence of liver metastasis at baseline, Karnofsky Performance Status, total bilirubin, serum albumin, aspartate-aminotransferase (ASAT) and alanine-aminotransferase (ALAT) had no statistically significant effect on the pharmacokinetics of 5'-DFUR, 5-FU and FBAL.
Maltese: bilirubin totali, albumina fis-serum, aspartate-aminotransferase (ASAT) u alanine-aminotransferase (ALAT) ma kellhom l-ebda effett statistikament sinifikattiv fuq il-farmakokinetika ta' 5'-DFUR, 5-FU
English: Deficiency of DPD may lead to increased toxicity of capecitabine (see section 4.3 and 4.4).
Maltese: Defiċjenza ta' DPD tista' twassal għal żieda fit-tossicità ta' capacitabine (ara sezzjonijiet 4.3 u 4.4).
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: 646; 715) f'pazjenti ttrattati b'korsijiet li fihom 5-FU.
English: The overall objective response rates in the all-randomised population (investigator assessment) were 25.7 % (capecitabine) vs. 16.7 % (Mayo regimen); p < 0.0002.
Maltese: 7 % (capecitabine) vs. 16.7 % (kors ta' Mayo); p < 0.0002.
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: 5.9 xhur għal mIFL (p = 0.004 għall-paragun ma' FOLFIRI), u 5.8 xhur għal XELIRI (p = 0.015).
English: Titanium dioxide (E171) Iron oxide red (E172)
Maltese: Titanium dioxide (E 171) Iron oxide aħmar (E172) Iron oxide isfar (E172)
English: • in combination with docetaxel (see section 5.1) for the treatment of patients with locally advanced or metastatic breast cancer after failure of cytotoxic chemotherapy.
Maltese: • flimkien ma' docetaxel (ara sezzjoni 5.1) għat-trattament ta' pazjenti b'kanċer tas-sider lokalment avvanzat jew metastatiku wara l-falliment ta' kemjoterapija ċitotossika.
English: Dihydropyrimidine dehydrogenase (DPD) deficiency Rarely, unexpected, severe toxicity (e.g. stomatitis, diarrhoea, mucosal inflammation, neutropenia and neurotoxicity) associated with 5-fluorouracil (5-FU) has been attributed to a deficiency of DPD activity.
Maltese: B'mod rari, tossiċità severa, mhux mistennija, (eż. stomatite, dijarea, infjammazzjoni tal-mukuża, newtropenija u newrotossiċità) assoċjati ma' 5-fluorouracil (5-FU) kienet attribwita għal nuqqas ta' attività ta' DPD.
English: The hazard ratio for duration of survival (overall survival) was similar to the hazard ratio for PFS (hazard ratio 0.85; 95 % CI 0.64 - 1.13).
Maltese: Il-hazard ratio għat-tul tas-sopravivenza (sopravivenza totali) kien simili għall hazard ratio tal-PFS (hazard ratio 0.85; 95 % CI 0.64 - 1.13).
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 magħżula b'mod każwali 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: XELOX (PPP*: N = 251; ITT**: N = 313)
Maltese: (PPP*: N = 251;
English: Aphasia, Memory impairment, Ataxia, Syncope, Balance disorder, Sensory disorder, Neuropathy peripheral
Maltese: Afasja, Nuqqas talmemorja, Ataxja, Sinkope, Disturbi fil-bilanċ, Disturbi fis-sensi, Newropatija periferali
English: In the all-randomised 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: Fil-popolazzjoni li ntgħażlet kollha b'mod każwali, 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: When capecitabine and cisplatin are used in combination, the use of vitamin B6 (pyridoxine) is not advised for symptomatic or secondary prophylactic treatment of HFS, because of published reports that it may decrease the efficacy of cisplatin.
Maltese: Meta capecitabine u cisplatin jintużaw flimkien, l-użu ta' vitamina B6 (pyridoxine) mhux rakkomandat għat-trattament profilattiku sintomatiku jew sekondarju ta' HFS, minħabba rapporti ppublikati li hija tista' tnaqqas l-effikaċja ta' cisplatin.
English: • In patients with known complete absence of dihydropyrimidine dehydrogenase (DPD) activity
Maltese: Defiċjenza ta' Dihydropyrimidine dehydrogenase (DPD)
English: A meta-analysis of 14 clinical trials with data from over 4,700 patients treated with capecitabine monotherapy or capecitabine in combination with different chemotherapy regimens in multiple indications (colon, colorectal, gastric and breast cancer) showed that HFS (all grades) occurred in 2,066 (43 %) patients after a median time of 239 [95 % CI 201, 288] days after starting treatment with capecitabine.
Maltese: Meta-analiżi ta' 14-il prova klinika b'tagħrif minn aktar minn 4,700 pazjent ittrattati b'capecitabine bħala monoterapija jew capecitabine flimkien ma' korsijiet ta' kimoterapiji differenti f'indikazzjonijiet multipli (kanċer tal-kolon, tal-kolorektum, tal-istonku u tas-sider) wriet li HFS (kull grad) seħħet f'2,066 (43 %) pazjent wara ħin medjan ta' 239 [95 % CI 201, 288] ġurnata wara l-bidu tat-trattament b'capecitabine.
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: Angina unstable, Angina pectoris, Myocardial ischaemia, Atrial fibrillation, Arrhythmia, Tachycardia, Sinus tachycardia, Palpitations
Maltese: Iskemija mijokardjali, Fibrillazzjoni atrijali, Arritmija, Takikardija, Takikardija tassinus,
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: If grade 2 or 3 HFS occurs, administration of capecitabine should be interrupted until the event resolves or decreases in intensity to grade 1.
Maltese: HFS ta' grad 2 jew 3, l-għoti ta' capecitabine għandu jiġi interrott sakemm ir-reazzjoni tieqaf jew tnaqqas fl-intensità għal grad 1.
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: • confusional state, panic attacks, depressed mood, decreased libido
Maltese: • stat konfużjonali, attakki ta' paniku, burdata depressa, tnaqqis fil-libido
English: 28 film-coated tablets 30 film-coated tablets 56 film-coated tablets 60 film-coated tablets 84 film-coated tablets 112 film-coated tablets 120 film-coated tablets
Maltese: 28 pillola miksija b'rita 30 pillola miksija b'rita 56 pillola miksija b'rita 60 pillola miksija b'rita 84 pillola miksija b'rita 112-il pillola miksija b'rita 120 pillola miksija b'rita
English: Capecitabine monotherapy
Maltese: Monoterapija b'capecitabine
English: Patients with moderately impaired renal function show an increased rate of dose reduction (44 %) vs. 33 % and 32 % in patients with no or mild renal impairment and an increase in early withdrawals from treatment (21 % withdrawals during the first two cycles) vs. 5 % and 8 % in patients with no or mild renal impairment.
Maltese: Pazjenti b'indeboliment moderat filfunzjoni renali wrew żieda fir-rata ta' tnaqqis fid-doża (44 %) vs. 33 % u 32 % f'pazjenti bl-ebda indeboliment jew indeboliment ħafif tal-kliewi, u żieda ta' rtirar kmieni mit-trattament (rtirar ta' 21 % waqt l-ewwel żewġ ċikli) vs. 5 % u 8 % f'pazjenti bl-ebda indeboliment jew indeboliment moderat talkliewi.
English: Hypocalcaemia,
Maltese: Idronefrożi,
English: Hypokalaemia, Appetite disorder, Malnutrition, Hypertriglyceridaemia
Maltese: Ipokalimja, Disturbi fl-aptit, Nutrizzjoni ħażina, Ipertrigliċeridemija
English: • In patients with severe renal impairment (creatinine clearance below 30 ml/min),
Maltese: • F'pazjenti b'indeboliment sever tal-kliewi (tneħħija tal-kreatinina taħt 30 ml/min),
English: Capecitabine 1,000 mg/m² oral twice daily
Maltese: capecitabine 1,000 mg/m² mill ħalq darbtejn kuljum
English: 5-FU is further catabolised by the enzyme DPD to the much less toxic dihydro-5-fluorouracil (FUH2).
Maltese: 5-FU jkompli jiġi kkatabolizzat mill-enżima DPD għal dihydro-5-fluorouracil (FUH2) li huwa ħafna inqas tossiku.
English: In first-line treatment the median PFS in the intent-to-treat population was 5.8 months (95 %CI 5.1 - 6.2 months) for capecitabine monotherapy and 7.8 months (95 %CI 7.0-8.3 months; p = 0.0002) for XELIRI.
Maltese: Fit-trattament primarju l-medjan tal-PFS fil-popolazzjoni b'intenzjoni li jiġu ttrattati kien ta' 5.8 xhur (CI ta' 95 % 5.1 -- 6.2 xhur) għall-monoterapija b'capecitabine u 7.8 xhur (CI ta' 95 % 7.0 - 8.3 xhur; p = 0.0002) għal XELIRI.
English: Capecitabine dose reduction decreases systemic exposure to 5-FU more than dose-proportionally, due to non--linear pharmacokinetics for the active metabolite.
Maltese: Tnaqqis fid-doża ta' capecitabine tnaqqas l espożizzjoni sistematika għal 5-FU aktar minn proporzjonali mad-doża, minħabba farmakokinetika mhux linejari għall-metabolit attiv.
English: 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: 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 3,000 mg/m² per day whereas it is only 2,000 mg/m² per day when capecitabine was combined with folinic acid (30 mg orally bid).
Maltese: Madankollu, folinic acid għandu effett fuq ilfarmakodinamika 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' 3,000 mg/m² kuljum filwaqt li l-MTD hija biss ta' 2,000 mg/ m² kuljum meta capecitabine jittieħed flimkien ma'
English: Administration of capecitabine should be interrupted if treatment-related elevations in bilirubin of > 3.0 x ULN or treatment-related elevations in hepatic aminotransferases (ALT, AST) of > 2.5 x ULN occur.
Maltese: L-għoti ta' capecitabine għandu jiġi interrott f'każ li sseħħ żieda fil-livelli ta' bilirubin ta' > 3.0 x ULN relatata mat-trattament jew żieda fil-livell ta' aminotransferases tal-fwied (ALT, AST) ta' > 2.5 x ULN relatata mat-trattament.
English: 6.5 Nature and contents of container Aluminium/aluminium or PVC/PVdC/Aluminium blisters.
Maltese: Folji tal-Aluminju/aluminju jew tal-PVC/PVdC/Aluminju.
English: Although DPD deficiency cannot be precisely defined, it is known that patients with certain homozygous or certain compound heterozygous mutations in the DPYD gene locus (e.g. DPYD*2A, c.1679T>G, c.2846A>T and c.1236G>A/HapB3 variants), which can cause complete or near complete absence of DPD enzymatic activity (as determined from laboratory assays), have the highest risk of life-threatening or fatal toxicity and should not be treated with capecitabine (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 tal laboratorju), għandhom l-ogħla riskju ta' tossiċità ta' periklu għall-ħajja jew fatali u m'għandhomx jiġu ttrattati b'capecitabine (ara sezzjoni 4.3).
English: XELOX was demonstrated to be non-inferior to FOLFOX-4 in terms of PFS 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' PFS fil popolazzjoni skont protokoll u fil-popolazzjoni b'intenzjoni li jiġu ttrattati (ara tabella 9).
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 (1,379 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 (1,379 mg/m²/kuljum).
English: Based on the population pharmacokinetic analysis, which included patients with a wide range of ages (27 to 86 years) and included 234 (46 %) patients greater or equal to 65, age has no influence on the pharmacokinetics of 5'-DFUR and 5-FU.
Maltese: etajiet (minn 27 sa 86 sena) u li kienet tinkludi 234 (46 %) pazjent li kellhom iżjed minn 65 sena jew kellhom 65 sena, l-età m'għandha l-ebda influwenza fuq il-farmakokinetika ta' 5'-DFUR u 5-FU. L
English: Pyrexia, Weakness, +Lethargy, Temperature intolerance
Maltese: +Letarġija, Intolleranza għat-temperatura
English: versus ≥ 1).
Maltese: NUMRU(I)
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'
English: Ventricular fibrillation (rare), QT prolongation (rare), Torsade de pointes (rare), Bradycardia (rare), Vasospasm (rare)
Maltese: Fibrillazzjoni talventrikolu (rari), Titwil ta' QT (rari), Torsade de pointes
English: Dose limiting toxicities include diarrhoea, abdominal pain, nausea, stomatitis and hand-foot syndrome (HFS, hand-foot skin reaction, palmar-plantar erythrodysesthesia).
Maltese: Tossiċitajiet li jillimitaw id-doża jinkludu dijarea, uġigħ addominali, tqalligħ, stomatite u s-sindromu tal-idejn u s-saqajn (HFS, reazzjoni tal-ġilda fl-idejn u fis-saqajn, eritrodisasteżija palmari-plantari).
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 ttrattati b'monoterapija ta' capecitabine
English: Table 3 Capecitabine dose reduction schedule (3-weekly cycle or continuous treatment) Toxicity grades*
Maltese: Tabella 3 Skeda tat-tnaqqis fid-doża ta' capecitabine (ċiklu ta' 3 ġimgħat jew trattament kontinwu)
English: Altered coagulation parameters and/or bleeding have been reported in patients taking capecitabine concomitantly with coumarin-derivative anticoagulants such as warfarin and phenprocoumon.
Maltese: Bdil fil-parametri tal-koagulazzjoni u/jew fil-fsada ġew irrapportati f'pazjenti li kienu qed jieħdu capecitabine waqt trattament b'antikoagulanti derivattivi ta' coumarin, bħal warfarin u phenprocoumon.
English: Capecitabine and its metabolites are predominantly excreted in urine; 95.5 % of administered capecitabine dose is recovered in urine.
Maltese: Capecitabine u l-metaboliti tiegħu huma mneħħijin mill-ġisem l-aktar fl-awrina; 95.5 % tad-doża ta' capecitabine mogħtija huwa rkuprat fl-awrina.
English: The primary efficacy analyses in the per protocol population demonstrated non-inferiority in overall survival for capecitabine- vs 5-FU-based regimens (hazard ratio 0.86; 95 % CI 0.8 - 0.99) and for oxaliplatin- vs cisplatin-based regimens (hazard ratio 0.92; 95 % CI 0.80 - 1.1).
Maltese: L-analiżi ta' effikaċja primarja f'popolazzjoni skont il-protokoll wriet nuqqas ta' inferjorità fissopravivenza globali għal capecitabine vs korsijiet ibbażati fuq 5-FU (hazard ratio 0.86; 95 % CI 0.8 - 0.99) u għal oxaliplatin vs korsijiet ibbażati fuq cisplatin (hazard ratio 0.92; 95 % CI 0.80 - 1.1).
English: MARKETING AUTHORISATION NUMBER(S) EU/1/12/802/001-014
Maltese: TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/12/802/001-014
English: The median PFS was 5.6 months (capecitabine + cisplatin) versus 5.0 months (5-FU + cisplatin).
Maltese: Il-medjan tal-PFS kien ta' 5.6 xhur (capecitabine + cisplatin) versus 5.0 xhur
English: The incorporation of 5-FU also leads to inhibition of ribonucleic acid (RNA) and protein synthesis.
Maltese: L-inkorporazzjoni ta' 5-FU twassal wkoll għall-inibizzjoni tas-sintesi ta' ribonucleic acid (RNA) u tal-proteini.
English: For Arm B, the XELIRI regimen used capecitabine 1,000 mg/m² twice daily for 14 days + irinotecan 250 mg/m² on day 1.
Maltese: Għall-Grupp B, il-kors ta' XELIRI uża capecitabine 1,000 mg/m² darbtejn kuljum għal 14-il ġurnata + irinotecan 250 mg/m² fl-ewwel ġurnata.
English: However, similar to other nucleoside analogues (i.e., 5-FU), capecitabine was clastogenic in human lymphocytes (in vitro) and a positive trend occurred in mouse bone marrow micronucleus tests (in vivo).
Maltese: Madankollu, bħall-analogi ta' nucleoside oħra (i.e., 5-FU), capecitabine kien klastoġeniku f'limfoċiti umani (in vitro) u seħħet xejra pożittiva f'testijiet fuq il-mikronukleu tal-mudullun tal-ġrieden (in vivo).
English: For PVC/PVdC-aluminium blisters:
Maltese: Għall-folji tal-PVC/PVdC-aluminju:
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: Overall response rate was 49 % in the XELIRI and 48 % in the FOLFIRI arm (p = 0.76).
Maltese: Ir-rata ta' rispons globali kienet ta' 49 % fil-grupp ta' XELIRI u ta' 48 % fil-grupp ta' FOLFIRI (p = 0.76).
English: The pharmacokinetics of capecitabine have been evaluated over a dose range of 5023,514 mg/m²/day.
Maltese: .2 Tagħrif farmakokinetiku Il-farmakokinetika ta' capecitabine ġiet ikkalkulata fuq firxa ta' doża ta' 502 - 3,514 mg/m²/kuljum.
English: • blood-thinning medicines (coumarin, warfarin)
Maltese: • mediċini għall-gotta (allopurinol), • mediċini biex traqqaq id-demm (coumarin, warfarin),
English: Capecitabine medac 150 mg film-coated tablets Capecitabine medac 300 mg film-coated tablets Capecitabine medac 500 mg film-coated tablets capecitabine
Maltese: Capecitabine medac 150 mg pilloli miksijin b'rita Capecitabine medac 300 mg pilloli miksijin b'rita Capecitabine medac 500 mg pilloli miksijin b'rita
English: Capecitabine medac contains capecitabine, which itself is not a cytostatic medicine.
Maltese: Capecitabine medac fih capecitabine, li huwa nnifsu mhuwiex mediċina ċitostatika.
English: The film-coated tablets are white to off white, oblong shaped, biconvex tablets of 14.6 mm in length and 6.7 mm in width, debossed with ‘300' on one side and plain on other side.
Maltese: Il-pilloli miksijin b'rita huma pilloli bojod għal offwajt, ta' forma oblunga, bikonvessi, b'tul ta' 14.6 mm u wisgħa ta' 6.7 mm, imnaqqxa bin-numru ‘300' fuq naħa u lixxi fuq in-naħa l-oħra.
English: Pulmonary embolism, Pneumothorax, Haemoptysis, Asthma, Dyspnoea exertional
Maltese: Emboliżmu pulmonari, Pnewmotorax,
English: BATCH NUMBER Lot:
Maltese: NUMRU TAL-LOTT LOTT
English: Aluminium/aluminium blisters
Maltese: Aluminju/folji tal-aluminju
English: NAME OF THE MARKETING AUTHORISATION HOLDER medac GmbH
Maltese: medac GmbH
English: Monotherapy with capecitabine in metastatic colorectal cancer Data from two identically designed, multi centre, randomised, controlled phase III clinical trials (SO14695; SO14796) support the use of capecitabine for first line treatment of metastatic colorectal cancer.
Maltese: Informazzjoni minn żewġ provi kliniċi kkontrollati ta' fażi 3 iddisinjati b'mod identiku, multicentrali u b'għażla każwali (SO14695; SO14796), jissapportjaw l-użu ta' capecitabine għat-trattament primarju ta' kanċer metastatiku tal-kolon u tar-rektum.
English: Median PFS and overall survival (OS) times were shorter for XELIRI versus FOLFIRI (PFS 5.9 versus 9.6 months and OS 14.8 versus 19.9 months), in addition to which excessive rates of diarrhoea were reported in patients receiving the XELIRI regimen (41 % XELIRI, 5.1 % FOLFIRI).
Maltese: Iż-żmien medjan ta' PFS u ta' sopravivenza globali (OS - overall survival) kienu iqsar għal XELIRI kontra FOLFIRI (PFS ta' 5.9 kontra 9.6 xhur u OS ta' 14.8 kontra 19.9 xhur), u barra dan kienu rrappurtati rati eċċessivi ta' dijarea f'pazjenti li kienu qed jirċievu l-kors ta' XELIRI (41 % XELIRI, 5.1 %
English: Time to progressive disease was superior in the capecitabine + docetaxel combination arm (p < 0.0001).
Maltese: Iż-żmien għall-progressjoni talmarda kien superjuri fil-grupp ta' trattament kombinat b'capecitabine u docetaxel (p < 0.0001).
English: Capecitabine is contraindicated in patients with severe renal impairment (creatinine clearance below 30 ml/min [Cockcroft and Gault] at baseline).
Maltese: Capecitabine huwa kontraindikat f'pazjenti b'indeboliment serju tal-kliewi (tneħħija tal-kreatinina taħt it-30 ml/min [Cockcroft u Gault] fil-linja bażi).
English: Abdominal distension,
Maltese: sensittività eċċessiva,
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: Indeboliment tal-kliewi Reazzjonijiet avversi ta' grad 3 jew 4 f'pazjenti b'indeboliment moderat tal-kliewi (tneħħija tal kreatinina 30 - 50 ml/min) iseħħu aktar ta' spiss meta mqabbla mal-popolazzjoni totali (ara sezzjonijiet 4.2 u 4.3).
English: INFORMATION IN BRAILLE Capecitabine medac 150 mg
Maltese: Capecitabine medac 150 mg
English: INFORMATION IN BRAILLE Capecitabine medac 300 mg
Maltese: Capecitabine medac 300 mg
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: Ematoloġija Pazjenti b'għadd ta' newtrofili fil-linja bażi ta' < 1.5 x 109/L u/jew b'għadd ta' tromboċiti ta'
English: Capecitabine medac is indicated:
Maltese: Capecitabine medac huwa indikat għat-trattament ta':