FrancophonIA/ELRC3.0 huggingface dataset:
English: The enhancement of imaging starts 15 to 20 minutes after the start of the infusion, and lasts for about 4 hours.
Maltese: L-immaġni jibdew jissaħħu bejn 15 u 20 minuta wara li tinbeda l-infużjoni, u l-effett idum xi 4 sigħat.
English: Manganese interacts with the water molecules.
Maltese: Il-manganiż jirreaġixxi mal-molekoli ta' l-ilma.
English: Overall, during the studies, 33% of patients had more lesions detected after TESLASCAN but 20% of patients had fewer lesions.
Maltese: TESLASCAN iżda f'20% tal-pazjenti nstabu inqas leżjonijiet.
English: They underwent a TESLASCAN-enhanced MRI scan.
Maltese: TESLASCAN waqt l-MRI.
English: EUROPEAN PUBLIC ASSESSMENT REPORT (EPAR)
Maltese: RAPPORT TA' VALUTAZZJONI PUBBLIKA EWROPEW (EPAR) TESLASCAN Sommarju ta' l-EPAR għall-pubbliku
English: TESLASCAN is used as a single intravenous infusion at a dose of 0.5 ml per kilogram body weight.
Maltese: TESLASCAN jintuża bħala infużjoni fil-vina ta' darba b'doża ta' 0.5ml għal kull kilogramma li jiżen il-pazjent.
English: This allows the difference between normal and abnormal tissue to
Maltese: B'hekk tidher id-differenza bejn it-tessut normali u t-tessut anormali.
English: The most common side effects with TESLASCAN (seen in between 1 and 10 patients in 100) are headache, nausea (feeling sick), flushing and feeling hot. For the full list of all side effects reported with TESLASCAN, see the Package Leaflet.
Maltese: L-iktar effetti sekondarji komuni b'TESLASCAN (li dehru f'bejn 1 u 10 pazjenti minn 100) huma luġigħ ta' ras, id-dardir (tħossok ma tiflaħx), fwawar u sensazzjoni ta' sħana.
English: The rate of infusion is 2 to 3 ml/min for liver imaging and 4 to 6 ml/min for imaging the pancreas.
Maltese: Ir-rata ta' infużjoni hi bejn 2 u 3 ml kull minuta għall-ħruġ ta' immaġni tal-fwied u bejn 4 u 6 ml kull minuta għall-ħruġ ta' immaġni tal-frixa.
English: TESLASCAN is a solution for infusion (drip into a vein) containing the active substance mangafodipir
Maltese: TESLASCAN hu sustanza għall-infużjoni (drip fil-vina) li jkun fiha s-sustanza attiva mangafodipir trisodium.
English: The patients had between one and five liver lesions that had already been detected using MRI, ultrasound, or computerised tomography (CT).
Maltese: Il-pazjenti kellhom bejn waħda u ħames leżjonijiet fil-fwied li diġà kienu nstabu bl-MRI, bl-ultrasound, jew bittomografija kompjuterizzata (CT).
English: In the detection of pancreatic lesions, TESLASCAN-enhanced MRI was as effective as spiral CT.
Maltese: Fis-sejbien ta' leżjonijiet fil-frixa, MRI msaħħaħ bitTESLASCAN kien effettiv daqs CT spirali.
English: The Committee for Medicinal products for Human Use (CHMP) decided that TESLASCAN's benefits are greater than its risks as a contrast medium for diagnostic MRI, for the detection of lesions of the liver suspected to be due to metastatic disease or hepatocellular carcinomas, and as an adjunct to MRI to aid in the investigation of focal pancreatic lesions.
Maltese: Il-Kumitat għall-Prodotti Mediċinali għall-Użu mill-Bniedem (CHMP) iddeċieda li l-benefiċċji ta' TESLASCAN huma ikbar mir-riskji tiegħu meta jintuża għal MRI dijanjostika, għat-tiftix ta' leżjonijiet tal-fwied li jkun hemm suspett li seħħew minħabba metastasi jew kankrijiet fiċ-ċelloli talfwied, u bħala għajnuna għall-MRI biex jiġu investigati leżjonijiet fokali fil-frixa.
English: The full EPAR for TESLASCAN is available here.
Maltese: Informazzjoni oħra dwar TESLASCAN:
English: What is the risk associated with TESLASCAN?
Maltese: Għalxiex jintuża TESLASCAN?
English: The European Commission granted a marketing authorisation valid throughout the European Union, for TESLASCAN to GE Healthcare AS on 22 May 1997.
Maltese: L-awtorizzazzjoni għat-tqegħid fis-suq ġiet imġedda fit-22 ta' Mejju 2002 u t-22 ta' Mejju 2007.
English: What benefit has TESLASCAN shown during the studies?
Maltese: Kif ġie studjat TESLASCAN?
English: Water molecules in the body are affected by the magnetic fields, and produce a signal when the radio waves are applied.
Maltese: Il-kampijiet manjetiċi jaffettwaw il-molekuli ta' l-ilma fil-ġisem, u dawn jipproduċu sinjal meta jkunu applikati rradio waves.
English: In TESLASCAN, the manganese is bound to another chemical in a ‘chelate'.
Maltese: F'TESLASCAN, il-manganiż ikun magħqud f'‘chelate' ma' kimika oħra.
English: TESLASCAN is used in patients who are undergoing magnetic resonance imaging (MRI) to detect lesions (damaged tissue) in the liver that might be caused by liver cancer or cancer that has spread to the liver from other parts of the body.
Maltese: TESLASCAN m'għandux jintuża f'pazjenti li jkollhom sensittività eċċessiva (allerġija) għallmangafodipir trisodium jew għal xi sostanza oħra tiegħu.
English: The studies of TESLASCAN in MRI for liver lesions involved 617 patients.
Maltese: Fl-istudji ta' TESLASCAN fl-MRI għal leżjonijiet tal-fwied ħadu sehem 617-il pazjent.
English: DPD deficiency.
Maltese: Defiċjenza ta' DPD.
English: PRIMARY ANALYSIS XELOX/XELOX+P/ XELOX+BV (EPP*: N=967; ITT**: N=1017)
Maltese: ANALIŻI PRIMARJA XELOX/XELOX+P/ XELOX+BV (EPP*: N=967; ITT**: N=1017)
English: Body Surface Area (m2)
Maltese: Erja tasSuperfiċje talĠisem (m2)
English: The AUC0-∞ values in μg•h/ml were 7.75, 7.24, 24.6, 2.03 and 36.3.
Maltese: Il-valuri ta' AUC0-∞ f'μg•h/ml kienu ta' 7.75, 7.24, 24.6, 2.03 u 36.3.
English: Coumarin-derivative anticoagulation.
Maltese: Antikoagulazzjoni b'derivattiv ta' coumarin.
English: Recommended posology (see section 5.1):
Maltese: Pożoloġija rakkomandata (ara sezzjoni 5.1):
English: 85 mg/m2 IV 2 hr 200 mg/m2 IV 2 hr 400 mg/m2 IV bolus, followed by 600 mg/m2 IV 22 hr
Maltese: 85 mg/m2 IV 2 hr 200 mg/m2 IV 2 hr 400 mg/m2 IV bolus, segwit minn 600 mg/ m2 IV 22 hr
English: FOLFOX-4/FOLFOX-4+P/ FOLFOX-4+BV (EPP*: N = 937; ITT**: N= 1017)
Maltese: FOLFOX-4/FOLFOX-4+P/ FOLFOX-4+BV (EPP*: N = 937;
English: What Capecitabine SUN contains - The active substance is capecitabine.
Maltese: X'fih Capecitabine SUN - Is-sustanza attiva hi capecitabine.
English: Nederland/Pays-Bas/Niederlande/Нидерландия/Nizozemsko/ Nederlandene/Holland/Ολλανδία/Nizozemska/The Netherlands/Holland/Ολλανδία/ Nīderlande/Nyderlandai/Pays-Bas/Niederlande/Hollandia/ L-Olanda/Nederland/Nederland/Niederlande/Holandia/Países Baixos/ Olanda/Nizozemska/Holandsko/Alankomaat/Nederländerna/Nederländerna Tel./тел./tlf./τηλ./Sími/τηλ./Tlf./Puh./
Maltese: Nederland/Pays-Bas/Niederlande/Нидерландия/Nizozemsko/ Nederlandene/Holland/Ολλανδία/Nizozemska/The Netherlands/Holland/Ολλανδία/ Nīderlande/Nyderlandai/Pays-Bas/Niederlande/Hollandia/
English: MARKETING AUTHORISATION NUMBER(S) EU/1/13/831/001
Maltese: FIS-SUQ EU/1/13/831/001
English: Ophthalmologic complications.
Maltese: Komplikazzjonijiet oftalmoloġiċi.
English: Oxaliplatin Leucovorin 5-Fluorouracil
Maltese: 5-Fluorouracil:
English: Pyrexia,
Maltese: Raxx,
English: - In patients with known dihydropyrimidine dehydrogenase (DPD) deficiency (see section 4.4).
Maltese: - F'pazjenti b'defiċjenza magħrufa ta' dihydropyrimidine dehydrogenase (DPD) (ara sezzjoni 4.4).
English: 1000 mg/m2
Maltese: Doża kollha 1000 mg/m2
English: Cardiotoxicity.
Maltese: Kardjotossiċità.
English: Each film-coated tablet contains 68.95 mg anhydrous lactose.
Maltese: Kull pillola miksija b'rita fiha 68.95 mg anhydrous lactose.
English: Finally, β-ureido-propionase cleaves FUPA to α-fluoro-βalanine (FBAL) which is cleared in the urine.
Maltese: Finalment, β-ureido-propionase jkisser FUPA għal α-fluoro-β-alanine (FBAL) li jitneħħa fl-awrina.
English: The following headings are used to rank the ADRs by frequency: very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100), rare (≥ 1/10,000 to < 1/1,000), very rare (< 1/10,000).
Maltese: Il-kategoriji li ġejjin huma wżati biex jikklassifikaw l-ADRs skont il-frekwenza: komuni ħafna (≥1/10), komuni (≥1/100 sa <1/10), mhux komuni (≥1/1,000 sa <1/100), rari (≥1/10,000 sa <1/1,000), rari ħafna (<1/10,000).
English: +Neutropenia, +Leucopenia, +Anaemia, +Neutropenic fever, Thrombocytopenia
Maltese: +Newtropenija, +Lewkopenija, +Anemija, +Deni newtropeniku, Tromboċitopenija
English: Toxicity grades*
Maltese: Gradi ta' tossiċità
English: Diarrhoea.
Maltese: Deidratazzjoni.
English: 130 mg/m2 IV 2 hr 1000 mg/m2 oral twice
Maltese: 130 mg/m2 IV 2 hr 1000 mg/m2 mill-ħalq darbtejn kuljum
English: The parameters of capecitabine, 5'-deoxy-5-fluorocytidine (5'-DFCR) and 5'-deoxy-5-fluorouridine (5'-DFUR) measured on days 1 and 14 were similar.
Maltese: Ilparametri ta' capecitabine, 5'-deoxy-5-fluorocytidine (5'-DFCR) u 5'-deoxy-5-fluorouridine (5'-DFUR) mkejla fl-ewwel u fl-14-il jum kienu jixxiebħu.
English: Discontinue permanently
Maltese: Inkontinenza ta' l
English: Tablet core: talc (E553b) anhydrous lactose croscarmellose sodium (E468) hypromellose (E464) microcrystalline cellulose (E460) magnesium stearate (E572)
Maltese: Il-qalba tal-pillola: talc (E553b) anhydrous lactose croscarmellose sodium (E468) hypromellose (E464) microcrystalline cellulose (E460) magnesium stearate (E572)
English: cisplatin, irinotecan) - medicines used to treat folic acid deficiency.
Maltese: bevacizumab, cisplatin, irinotecan) - mediċini użati biex jikkuraw defiċjenza ta' folic acid.
English: Pharmacotherapeutic group: antineoplastic agents, antimetabolites, pyrimidine analogues, ATC code: L01BC06
Maltese: Kategorija farmakoterapewtika: sustanzi antineoplastiċi, anti-metaboliti, analogi ta' pyrimidine, Kodiċi ATC:
English: België/Belgique/Belgien/България/Česká republika/ Danmark/Eesti/Ελλάδα/Hrvatska/Ireland/Ísland/Κύπρος/ Latvija/Lietuva/Luxembourg/Luxemburg/Magyarország/
Maltese: België/Belgique/Belgien/България/Česká republika/ Danmark/Eesti/Ελλάδα/Hrvatska/Ireland/Ísland/Κύπρος/ Latvija/Lietuva/Luxembourg/Luxemburg/Magyarország/ Malta/Nederland/Norge/Österreich/Polska/Portugal/ România/Slovenija/Slovenská republika/Suomi/Finland/Sverige Sun Pharmaceutical Industries Europe B.V.
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 (rari), Bradikardija (rari), Vażospażmu (rari)
English: Colon, colorectal and advanced gastric cancer: meta-analysis A meta-analysis of six clinical trials (studies SO14695, SO14796, M66001, NO16966, NO16967, M17032) supports capecitabine replacing 5-FU in mono- and combination treatment in gastrointestinal cancer.
Maltese: Kanċer tal-kolon, tal-kolorektum u kanċer avvanzat ta' l-istonku: meta-analiżi Meta-analiżi ta' sitt provi kliniċi (studji SO14695, SO14796, M66001, NO16966, NO16967, M17032) isostnu is-sostituzzjoni ta' 5-FU minn capecitabine f'kura waħedha u ta' taħlita f'kanċer gastrointestinali.
English: Antacid: the effect of an aluminium hydroxide and magnesium hydroxide-containing antacid on the pharmacokinetics of capecitabine was investigated.
Maltese: Antaċidi: l-effett ta' antaċidi li fihom aluminium hydroxide u magnesium hydroxide fuq ilfarmakokinetika ta' capecitabine kien investigat.
English: Sorivudine and analogues: a clinically significant drug-drug interaction between sorivudine and 5-FU, resulting from the inhibition of dihydropyrimidine dehydrogenase by sorivudine, has been described.
Maltese: Sorivudine u analogi: ġiet deskritta interazzjoni ta' sinifikanza klinika bejn sorivudine u 5-FU, li rriżultat mill-impedizzjoni ta' dihydropyrimidine dehydrogenase minn sorivudine.
English: The overall objective response rates in the all-randomised population (investigator assessment) were 41.6% (capecitabine + docetaxel) vs. 29.7% (docetaxel alone); p = 0.0058.
Maltese: Ir-rati oġġettivi tarrespons totali fil-popolazzjoni li ġiet randomised (valutazzjoni investigattiva) kienu ta' 41.6% (capecitabine + docetaxel) vs. 29.7% (docetaxel waħdu); p = 0.0058.
English: Interferon alpha: the MTD of capecitabine was 2000 mg/m2 per day when combined with interferon alpha-2a (3 MIU/m2 per day) compared to 3000 mg/m2 per day when capecitabine was used alone.
Maltese: Interferon alfa: l-MTD ta' capecitabine kienet ta' 2000 mg/m2 kuljum meta meħud flimkien ma' interferon alfa-2a (3 MIU/m2 kuljum) imqabbla ma' 3000 mg/m2 kuljum meta capecitabine jintuża waħdu.
English: Gender, presence or absence of liver metastasis at baseline, Karnofsky Performance Status, total bilirubin, serum albumin, ASAT and ALAT had no statistically significant effect on the pharmacokinetics of 5'-DFUR, 5-FU and FBAL.
Maltese: Is sess, il-preżenza jew in-nuqqas ta' metastasi fil-fwied fil-linja bażi, Karnofsky Performance Status, bilirubin totali, albumina fis-serum, ASAT u ALAT ma kellhom l-ebda effett statistikament sinifikattiv fuq il-farmakokinetika ta' 5'-DFUR, 5-FU u FBAL.
English: At the dose of 1250 mg/m2 on day 14 with administration after food intake, the peak plasma concentrations (Cmax in μg/ml) for capecitabine, 5'-DFCR, 5'-DFUR, 5-FU and FBAL were 4.67, 3.05, 12.1, 0.95 and 5.46 respectively.
Maltese: B'doża ta' 1250 mg/m2 fl-14-il jum bl-għoti wara t-teħid ta' l-ikel, il konċentrazzjonijiet massimi fil-plażma (Cmax f'μg/ml) ta' capecitabine, 5'-DFCR, 5'-DFUR, 5-FU u FBAL kienu ta' 4.67, 3.05, 12.1, 0.95 u 5.46 rispettivament.
English: Capecitabine is indicated for the adjuvant treatment of patients following surgery of stage III (Dukes' stage C) colon cancer (see section 5.1).
Maltese: Capecitabine huwa indikat għall-kura awżiljarja ta' pazjenti wara kirurġija ta' kanċer tal-kolon ta' stadju III (stadu ta' Dukes' C) (ara sezzjoni 5.1).
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 tal-qalb u kardjomijopatija ġew irrapportati f'pazjenti li qed jieħdu capecitabine.
English: LIST OF EXCIPIENTS Also contains anhydrous lactose.
Maltese: Din il-mediċina fiha anhydrous lactose.
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 kkurati b'korsijiet li fihom capecitabine u 683 jum (95% CI: 646; 715) f'pazjenti kkurati b'korsijiet li fihom 5-FU.
English: 5 mg/kg IV 30-90 mins Day 1, prior to FOLFOX-4, every 2 weeks
Maltese: 5 mg/kg IV 30-90 mins Fl-Ewwel Ġurnata, qabel FOLFOX-4, kull ġimagħtejn
English: If you have an unrecognised DPD deficiency and take Capecitabine SUN, you may experience severe forms of the side effects listed under section 4 Possible side effects.
Maltese: Jekk għandek defiċjenza ta' DPD mhux magħrufa u tieħu Capecitabine SUN, jista' jkollok forom qawwija tal-effetti sekondarji elenkati taħt sezzjoni 4 Effetti sekondarji possibbli.
English: - The other ingredients are: - Tablet core: talc (E553b), anhydrous lactose, croscarmellose sodium (E468), hypromellose (E464), cellulose microcrystalline (E460), magnesium stearate (E572).
Maltese: - Qalba tal-pillola: talc (E553b), anhydrous lactose, croscarmellose sodium (E468), hypromellose (E464), microcrystalline cellulose (E460), magnesium stearate(E572).
English: The AUC of FBAL increased with age (20% increase in age results in a 15% increase in the AUC of FBAL).
Maltese: u 5-FU. L-AUC ta' FBAL żdiedet ma' l-età (20% żjieda fl-età tirriżulta f'żjieda ta' 15% fl-AUC ta' FBAL).
English: Allopurinol: interactions with allopurinol have been observed for 5-FU; with possible decreased efficacy of 5-FU.
Maltese: Allopurinol: interazzjonijiet ma' allopurinol ġew osservati għal 5-FU; bi tnaqqis possibbli ta' leffikaċja ta' 5-FU.
English: Deep vein thrombosis, Hypertension, Petechiae,
Maltese: Trombożi fil-vini l-kbar, Ipertensjoni, Petekje,
English: Biotransformation
Maltese: Bijotransformazzioni
English: See table 6 for treatment regimens.
Maltese: Ara tabella 6, għall korsijiet ta' kura.
English: Dihydropyrimidinase cleaves the pyrimidine ring to yield 5-fluoro-ureidopropionic acid (FUPA).
Maltese: Dihydropyrimidinase jkisser iċ-ċirku ta' pyrimidine biex jipproduċi 5-fluoro-ureidopropionic acid (FUPA).
English: Febrile neutropenia, Pancytopenia, Granulocytopenia, Thrombocytopenia, Leukopenia, Haemolytic anaemia, International Normalised Ratio (INR) increased/Prothrombin time prolonged
Maltese: Newtropenija bid-deni, Panċitopenija, Granuloċitopenija, Tromboċitopenija, Lewkopenija, Anemija emolitika, Proporzjon Normalizzat Internazzjonali (INR) miżjud/Ħin ta' Prothrombin imtawwal
English: Table 7 Key efficacy results for the non-inferiority analysis of study NO16966
Maltese: Tabella 7 Riżultati importanti ta' l-effikaċja għall-analiżi ta' nuqqas ta' inferjorità ta' studju NO16966
English: Cutaneous lupus erythematosus (rare), Severe skin reactions such as Steven-Johnson Syndrome and toxic Epidermal Necrolysis (very rare) (see section
Maltese: Lupus erythematosus tal-ġilda (rari), Reazzjonijiet severi filġilda bħas-Sindrome ta' Stevens-Johnson u Nekrolisi tossika talEpidermide (rari ħafna) (ara sezzjoni 4.4.)
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 kura primarja b'XELIRI (26% u 11% għall XELIRI u capecitabine bħala kura primarja rispettivament).
English: - Treatment with sorivudine or its chemically related analogues, such as brivudine (see section 4.5).
Maltese: - Kura b'sorivudine jew u bl-analogi relatati kimikament miegħu, bħal brivudine (ara sezzjoni 4.5).
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 (ciklu ta' 3 ġimgħat jew kura kontinwa) Gradi ta' tossiċità
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 fissopravivenza 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: In a clinical pharmacokinetic interaction study, after a single 20 mg dose of warfarin, capecitabine treatment increased the AUC of S-warfarin by 57% with a 91% increase in INR value.
Maltese: Fi studju kliniku farmakokinetiku dwar l-interazzjonijiet, wara doża waħda ta' 20 mg ta' warfarin, il-kura b'capecitabine żiedet l-AUC ta' Swarfarin b'57% b'żjieda ta' 91% fil-valur ta' l-INR.
English: 5-Fluorouracil: IV bolus injection immediately after leucovorin
Maltese: Injezzjoni bolus IV immedjatament wara leucovorin
English: Capecitabine SUN is not indicated in children and adolescents.
Maltese: Capecitabine SUN mhux indikat fit-tfal u l-adolexxenti.
English: No significant differences occurred in the exposure to other metabolites (5'-DFCR, 5'-DFUR, and 5-FU).
Maltese: Lebda differenzi sinifikanti ma seħħew fl-espożizzjoni għal metaboliti oħra (5'-DFCR, 5'-DFUR, u 5-FU).
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/m2 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: Diabetes mellitus or electrolyte disturbances.
Maltese: Dijabete mellitus jew disturbi fl-elettroliti.
English: Table 9 Key efficacy results for the non-inferiority analysis of study NO16967
Maltese: Tabella 9 Riżultati importanti ta' l-effikaċja għall-analiżi ta' nuqqas ta' inferjorità ta' studju NO16967
English: Pyrexia, Weakness, +Lethargy, Temperature intolerance
Maltese: Deni, Debbulizza, +Letarġija, Intolleranza għat-temperatura
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 mal-kura rrapportati b'mod frekwenti u/jew ta' rilevanza klinika kienu disturbi gastro-intestinali (speċjalment dijarea, tqalligħ, rimettar, uġigħ addominali, stomatite), s-sindrome ta' l-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: Lacrimal duct stenosis (rare), Corneal disorders (rare), keratitis (rare), punctate keratitis (rare)
Maltese: Stenożi tal-kanal taddmugħ (rari), Disturbi fil-kornea (rari), Keratite (rari), Keratite ttikkjata (rari)
English: Survival was superior in the capecitabine + docetaxel combination arm (p=0.0126).
Maltese: Is-sopravivenza kienet ogħla fil-grupp ta' kura kombinata b'capecitabine u docetaxel (p=0.0126).
English: Uncommon Severe and/or Lifethreatening (grade 3-4) or considered medically relevant
Maltese: Mhux Komuni Severi u/jew ta' periklu għall-ħajja (grad 3-4) rilevanti medikament
English: In the all-randomised 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: ADRs considered by the investigator to be possibly, probably, or remotely related to the administration of capecitabine are listed in table 4 for capecitabine given as a monotherapy and in table 5 for capecitabine given in combination with different chemotherapy regimens in multiple indications.
Maltese: ADRs ikkunsidrati mill-investigatur bħala possibbilment, probabbilment jew remotament relatati ma' l-għoti ta' capecitabine huma mniżżla f'tabella 4 għal capecitabine mogħti bħala monoterapija u f'tabella 5 għal capecitabine mogħti flimkien ma' korsijiet ta' kimoterapija differenti f'indikazzjonijiet multipli.
English: - History of severe and unexpected reactions to fluoropyrimidine therapy.
Maltese: - Passat mediku ta' reazzjonijiet serji u mhux mistennija għat-terapija bi fluoropyrimidine.
English: Parameter: Progression-free Survival EPP ITT
Maltese: Sopravivenza mingħajr Progressjoni EPP ITT
English: Patients with baseline neutrophil counts of <1.5 x 109/L and/or thrombocyte counts of <100 x 109/L should not be treated with capecitabine.
Maltese: Pazjenti b'għadd ta' newtrofili fil-linja bażi ta' <1.5 x 109/L u/jew b'għadd ta' tromboċiti ta' <100 x 109/L m'għandhomx jiġu kkurati b'capecitabine.
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 żjieda fittossicità ta' capacitabine (ara sezzjoni 4.3 u 4.4).