FrancophonIA/ELRC3.0 huggingface dataset:
English: Some of the ADRs are reactions commonly seen with the combination medicinal product (e.g. peripheral sensory neuropathy with docetaxel or oxaliplatin, hypertension seen with bevacizumab); however an exacerbation by capecitabine therapy can not be excluded.
Maltese: Xi ADRs huma reazzjonijiet osservati b'mod komuni bil-prodott mediċinali kkombinat (eż. newropatija periferali tas-sensi ma' docetaxel jew oxaliplatin, pressjoni għolja osservata ma' bevacizumab); iżda rkadar ikkawżat minn terapija ta' capecitabine ma jistax jiġi eskluż.
English: A person whose body weight is 80 kg and height is 1.80 m has a body surface area of 2.00 m2 and should take 5 tablets of 500 mg two times daily.
Maltese: Persuna li għandha piż talġisem ta' 80 kg u tul ta' 1.80 m għandha erja tas-superfiċje tal-ġisem ta' 2.00 m2 u għandha tieħu 5 pilloli ta' 500 mg darbtejn kuljum.
English: Constipation, Dyspepsia
Maltese: Parasteżija, Disasteżija,
English: intravenous bolus injection immediately after leucovorin
Maltese: Injezzjoni bolus fil-vini immedjatament wara leucovorin
English: • inflammation leading to dysfunction or obstruction in bile secretion (cholestatic hepatitis)
Maltese: • infjammazzjoni li twassal għal disfunzjoni jew sadd fis-sekrezzjoni tal-bili (epatite kolestatika)
English: Deficiency of DPD may lead to increased toxicity of capecitabine (see section 4.3 and
Maltese: Defiċjenza ta' DPD tista' twassal għal żieda fittossicità ta' capacitabine (ara sezzjoni 4.3 u 4.4).
English: The median duration of survival was 10.5 months (capecitabine + cisplatin) versus 9.3 months (5-FU + cisplatin).
Maltese: 9.3 xhur (5-FU + cisplatin).
English: Very rare side effects (may affect up to 1 in 10,000 people) include:
Maltese: Effetti sekondarji rari ħafna (jistgħu jaffettwaw sa persuna waħda minn kull 10,000) jinkludu:
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: Dyspnoea, Epistaxis, Cough, Rhinorrhoea
Maltese: Axxite, Enterite, Gastrite,
English: Headache, Lethargy, Dizziness, Paraesthesia, Dysgeusia
Maltese: Uġigħ ta' ras, Letarġija, Sturdament, Parasteżija,
English: FOLFOX-4 (PPP*: N=252; ITT**: N=314)
Maltese: (PPP*: N = 252;
English: • infections of the lungs or respiratory system (e.g. pneumonia or bronchitis)
Maltese: • infezzjonijiet fil-pulmun jew fis-sistema respiratorja (eż. pnewmonja jew bronkite)
English: Other medicines and Capecitabine Teva
Maltese: Mediċini oħra u Capecitabine Teva
English: Median progression free survival ITT
Maltese: Sopravivenza mingħajr Progressjoni
English: Capecitabine Teva 500 mg film-coated tablets Each film-coated tablet contains 52.0 mg lactose.
Maltese: Capecitabine Teva 500 mg pilloli miksija b'rita Kull pillola miksija b'rita fiha 52.0 mg lactose.
English: For Arm B, the XELIRI regimen used capecitabine 1000 mg/m2 twice daily for 14 days +irinotecan 250 mg/m2 on day 1.
Maltese: Għall-Grupp B, il-kors ta' XELIRI uża capecitabine 1000 mg/m2 darbtejn kuljum għal 14-il ġurnata + irinotecan 250 mg/m2 fl-ewwel ġurnata.
English: Administration of capecitabine should be interrupted if treatmentrelated elevations in bilirubin of >3.0 x ULN or treatment-related elevations in hepatic aminotransferases (ALT, AST) of >2.5 x ULN occur.
Maltese: relatata mat-trattament jew żieda fil-livell ta' aminotransferases tal-fwied (ALT, AST) ta' >2.5 x ULN relatata mat-trattament.
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), żieda fl-intensità tad-doża relattiva fl-ewwel sitt ġimgħat, żieda fit-tul ta' trattament taħt studju (ġimgħat), żieda fl-età (b'żjidiet ta' 10 snin), sess femminili, u ECOG performance status fil-linja bażi tajjeb (0 kontra ≥1).
English: Monotherapy with capecitabine in metastatic colorectal cancer Data from two identically-designed, multicentre, 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, multicentre u randomised (SO14695; SO14796), jissapportjaw l-użu ta' capecitabine għat-trattament primarju ta' kanċer metastatiku tal-kolon u tar-rektum.
English: • problems with liver function (seen in blood tests) and increased blood bilirubin (excreted by the liver)
Maltese: • problemi bil-funzjoni tal-fwied (osservati fit-testijiet tad-demm) u żieda ta' bilirubin fid-demm
English: Capecitabine Teva 150 mg film-coated tablets Each film-coated tablet contains 15.6 mg lactose.
Maltese: Capecitabine Teva 150 mg pilloli miksija b'rita Kull pillola miksija b'rita fiha 15.6 mg lactose.
English: Diabetes mellitus or electrolyte disturbances
Maltese: Dijabete mellitus jew disturbi fl-elettroliti
English: Creatinine clearance was found to influence the systemic exposure to 5'-DFUR (35% increase in AUC when creatinine clearance decreases by 50%) and to FBAL (114% increase in AUC when creatinine clearance decreases by 50%).
Maltese: DFUR (żieda ta' 35% fl-AUC meta t-tneħħija tal-krejatinina tonqos b'50%) u għal FBAL (żieda ta' 114% fl-AUC meta t-tneħħija tal-krejatinina tonqos b'50%).
English: Sequential treatment consisted of first-line capecitabine (1250 mg/m2 twice daily for 14 days), second-line irinotecan (350 mg/m2 on day 1), and third-line combination of capecitabine (1000 mg/m2 twice daily for 14 days) with oxaliplatin (130 mg/m2 on day 1).
Maltese: Trattament sekwenzjali ikkonsista minn capecitabine (1250 mg/m2 darbtejn kuljum għal 14-il ġurnata) bħala trattament primarju, irinotecan (350 mg/m2 fl-ewwel ġurnata) bħala trattament sekondarju, u taħlita ta' capecitabine (1000 mg/m2 darbtejn kuljum għal 14-il ġurnata) ma' oxaliplatin (130 mg/m2 fl-ewwel ġurnata) bħala trattament terzjarju.
English: Pain in jaw , Muscle spasms, Trismus, Muscular weakness
Maltese: Uġigħ fix-xedaq, Spażmi filmuskoli, Trismus, Indebboliment muskolari
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 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' 3000 mg/m2
English: Administration with food decreases the rate of capecitabine absorption, but only results in a minor effect on the AUC of 5'-DFUR, and on the AUC of the subsequent metabolite 5-FU.
Maltese: capecitabine iżda jirriżulta biss f'effett minuri fuq l-AUC ta' 5'-DFUR, u fuq l-AUC tal-metabolit sussegwenti 5-FU.
English: Body surface area (m2)
Maltese: Erja tas superfiċje talġisem (m
English: The study contained two parts: an initial 2-arm part in which 634 patients were randomised to two different treatment groups, including XELOX or FOLFOX-4, and a subsequent 2x2 factorial part in which 1401 patients were randomised to four different treatment groups, including XELOX plus placebo, FOLFOX-4 plus placebo, XELOX plus bevacizumab, and FOLFOX-4 plus bevacizumab.
Maltese: XELOX jew FOLFOX-4, u l-parti ta' 2x2 fatturi ta' wara fejn 1401 pazjent kienu randomised għal erba' gruppi ta' trattament differenti, inkluż XELOX flimkien ma' plaċebo, FOLFOX-4 flimkien ma' plaċebo, XELOX flimkien ma' bevacizumab, u FOLFOX-4 flimkien ma' bevacizumab.
English: Combination treatment consisted of first-line capecitabine (1000 mg/m2 twice daily for 14 days) combined with irinotecan (250 mg /m2 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: darbtejn kuljum għal 14-il ġurnata) flimkien ma' irinotecan (250 mg/m2 fl-ewwel ġurnata) (XELIRI) bħala trattament primarju u capecitabine (1000 mg/m2 darbtejn kuljum għal 14-il ġurnata) u oxaliplatin (130 mg/m2 fl-ewwel ġurnata) bħala trattament sekondarju.
English: Visual acuity reduced, Diplopia
Maltese: Indeboliment fil-vista, Vista mċajpra
English: The film-coated tablets are oval biconvex light peach, 11.5 mm x 5.4 mm with inscription “C” on one side and “150”on the other side.
Maltese: Il-pilloli miksija b'rita huma lewn il-ġilda, ibbuzzati fuq iż-żewġ naħat ovali, 11.5 mm x 5.4 mm b'iskrizzjoni “C” fuq naħa waħda u “150” fuq in-naħa l-oħra.
English: Pharyngolaryngeal pain, Dysphonia
Maltese: Nutrizzjoni ħażina, Ipertrigliċeridemija
English: Patients were randomised to receive either FOLFIRI plus bevacizumab (Arm-A, n=167) or XELIRI
Maltese: FOLFIRI flimkien ma' bevacizumab (Grupp-A, n= 167) jew XELIRI flimkien ma' bevacizumab (Grupp-B, n=166).
English: Herpes zoster, Urinary tract infection, Oral candidiasis, Upper respiratory tract infection, Rhinitis, Influenza, +Infection, Oral herpes
Maltese: Herpes zoster, Infezzjoni fl apparat tal-awrina, Kandidajasi orali, Infezzjoni fl-apparat repiratorju ta' fuq, Rinite,
English: In first-line treatment the median progression-free survival 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 tas-sopravivenza mingħajr progessjoni filpopolazzjoni 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: The AUC of 5-FU was 30%-35% higher on day 14.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: In combination treatment, the recommended starting dose of capecitabine should be reduced to 8001000 mg/m2 when administered twice daily for 14 days followed by a 7-day rest period, or to 625 mg/m2 twice daily when administered continuously (see section 5.1).
Maltese: F'terapija kombinata, id-doża rakkomandata tal-bidu ta' capecitabine għandha titnaqqas għal 800-1000 mg/m2 meta mogħti darbtejn kuljum għal 14-il ġurnata segwit minn perjodu ta' waqfien ta' sebat ijiem, jew għal 625 mg/m2 darbtejn kuljum meta mogħti b'mod kontinwu (ara sezzjoni 5.1).
English: However, the on-treatment PFS analysis did not confirm the results of the general PFS and OS analysis: the hazard ratio of XELOX versus FOLFOX-4 was 1.24 with 97.5% CI 1.07-1.44.
Maltese: Madankollu, l-analiżi tal-PFS wara t-trattament ma kkonfermatx ir-riżultati tal-analiżi ġenerali tal-PFS u tal-OS: il-hazard ratio ta' XELOX kontra FOLFOX-4 kien ta' 1.24 b'97.5% CI 1.07-1.44.
English: Hand and foot syndrome also known as hand-foot skin reaction or palmar-plantar erythrodysesthesia or chemotherapy induced acral erythema.
Maltese: Sindrome tal-idejn u s-saqajn magħruf ukoll bħala reazzjoni tal-ġilda tal-idejn u s-saqajn jew eritrodisasteżija palmari-plantari jew eritema akrali kkaġunata mill-kemjoterapija.
English: Rare/Very Rare (Post-Marketing Experience)
Maltese: Rari/Rari Ħafna (Esperjenza ta' wara t-Tqegħid fisSuq)
English: Table 3 Capecitabine dose reduction schedule (3 weekly cycle or continuous treatment) Toxicity grades* Dose changes within a treatment cycle
Maltese: Tabella 3 Skeda tat-tnaqqis fid-doża ta' capecitabine (ċiklu ta' 3 ġimgħat jew trattament kontinwu)
English: Median overall survival ITT
Maltese: Sopravivenza Globali EPP ITT
English: • vertigo, ear pain
Maltese: • vertigo, uġigħ fil-widnejn
English: Upper gastrointestinal haemorrhage, Mouth ulceration, Gastritis, Abdominal distension, Gastroesophageal reflux disease, Oral pain, Dysphagia, Rectal haemorrhage, Abdominal pain lower, Oral dysaesthesia, Paraesthesia oral, Hypoaesthesia oral, Abdominal discomfort
Maltese: Ulċerazzjoni fil-ħalq, Gastrite, Distensjoni addominali, marda tar-rifluss gastro-osofagali, Uġigħ fil-ħalq, Disfaġija, Emorraġija mir-rektum, Uġigħ fil-parti t'isfel tal-addome, Disestesija orali,
English: Do not give capecitabine to children and adolescents.
Maltese: Tagħtix capecitabine lil tfal u adolexxenti.
English: The incidence of grade 3 or 4 adverse reactions in patients with moderate renal impairment (creatinine clearance 30-50 ml/min at baseline) is increased compared to the overall population.
Maltese: L-inċidenza ta' reazzjonijiet avversi ta' grad 3 jew 4 f'pazjenti b'indeboliment moderat tal-kliewi (tneħħija tal-krejatinina ta' 30-50 ml/min fil-linja bażi) hija ikbar meta mqabba mal-populazzjoni totali.
English: Since metabolism of R-warfarin was not affected, these results indicate that capecitabine down-regulates isozyme 2C9, but has no effect on isozymes 1A2 and 3A4.
Maltese: Billi l-metaboliżmu ta' R-warfarin ma kienx affettwat, dawn ir-riżultati jindikaw li capecitabine jnaqqas l-attività ta' isoenżima 2C9, iżda m'għandu l-ebda effect fuq l-isoenżimi 1A2 u 3A4.
English: • irregular heartbeat and palpitations (arrhythmias), chest pain and heart attack (infarction)
Maltese: • taħbit tal-qalb irregolari u palpitazzjonijiet (arritmija), uġigħ fis-sider u attakk ta' qalb (infart)
English: Hypocalcaemia,
Maltese: Letarġija,
English: The rate of withdrawal due to adverse events was higher in the XELOX combination therapy arm (21%) as compared with that of the 5-FU/LV monotherapy arm (9%) in the ITT population.
Maltese: Fil-popolazzjoni ITT, ir-rata ta' rtirar minħabba avvenimenti avversi kienet ogħla fil-grupp ta' terapija kombinata XELOX (21%) meta mqabbla ma' dik tal-grupp ta' 5-FU/LV bħala monoterapija (9%).
English: • cold sores or other herpes infections
Maltese: +Infezzjoni, Herpes orali
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 hand-foot syndrome, 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 tas-sindrome tal-idejn u s-saqajn,
English: cisplatin, irinotecan), - medicines used to treat folic acid deficiency.
Maltese: - mediċini użati biex jittrattaw defiċjenza ta' folic acid.
English: • specific changes in the electrocardiogram (QT prolongation)
Maltese: • bidliet speċifiċi fl-elettrokardjogramma ( titwil ta' QT)
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 ttrattati b'Capecitabine.
English: Two examples are provided here: A person whose body weight is 64 kg and height is 1.64 m has a body surface area of 1.7 m2 and should take 4 tablets of 500 mg and 1 tablet of 150 mg two times daily.
Maltese: Żewġ eżempji huma pprovuti hawnhekk: persuna li għandha piż tal-ġisem ta' 64 kg u tul ta' 1.64 m għandha erja tas-superfiċje tal-ġisem ta' 1.7 m2 u għandha tieħu 4 pilloli ta' 500 mg u pillola ta' 150 mg darbtejn kuljum.
English: Rare side effects (may affect up to 1 in 1,000 people) include:
Maltese: Effetti sekondarji rari (jistgħu jaffettwaw sa persuna waħda minn kull 1,000) jinkludu:
English: Oxaliplatin 130 mg/m2 intravenous 2 hr
Maltese: 130 mg/m2 fil-vini 2 hr
English: Cutaneous lupus erythematosus (rare), Severe skin reactions such as Stevens-Johnson Syndrome and toxic Epidermal Necrolysis (very rare) (see section 4.4.)
Maltese: Fi studji fuq l-annimali kienu osservati effetti fuq il-fertilità (ara sezzjoni 5.3).
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 standard 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: LIST OF EXCIPIENTS Also contains lactose.
Maltese: TA' EĊĊIPJENTI Fih ukoll lactose.
English: The following factors were prespecified in the statistical analysis plan for inclusion in the model: age, time from surgery to randomization, gender, CEA levels at baseline, lymph nodes at baseline, and country.
Maltese: Il-fatturi li ġejjin kienu speċifikati minn qabel fil-pjan ta' analiżi statistika għall-inklużjoni fil-mudell: età, ħin mill-kirurġija sar-randomisation, sess, livelli ta' CEA fil-linja bażi, glandoli limfatiċi fil-linja bażi, u pajjiż.
English: +Neutropenia, +Leucopenia, +Anaemia, +Neutropenic fever, Thrombocytopenia
Maltese: Newtropenija, +Lewkopenija, Anemija,
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: 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 tal kliewi.
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 mogħti bħala infużjoni fuq medda ta' sagħtejn fl-ewwel jum kull 3 ġimgħat), u capecitabine (625 mg/m2 darbtejn kuljum b'mod kontinwu).
English: - ECX: 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 capecitabine (625 mg/m2 twice daily continuously).
Maltese: - ECX: epirubicin (50 mg/m2 bħala bolus fl-ewwel jum kull 3 ġimgħat), cisplatin (60 mg/m2 mogħti bħala infużjoni fuq sagħtejn fl-ewwel jum kull 3 ġimgħat), u capecitabine (625 mg/m2 darbtejn kuljum b'mod kontinwu).
English: • swelling (oedema), chills and rigors
Maltese: • suffejra (il-ġilda u l-għajnejn jisfaru)
English: • narrowing or blockage of tear duct (lacrimal duct stenosis)
Maltese: • djuq jew sadd tal-kanal tad-dmugħ (stenosi tal-kanal tad-dmugħ)
English: The following covariates were statistically significantly associated with a decreased risk of developing diarrhoea: increasing cumulative capecitabine dose (0.1*kg) and increasing relative dose intensity in the first six weeks.
Maltese: Il-kovarjanti li ġejjin kienu assoċjati b'mod statistikament sinifikanti ma' tnaqqis firriskju ta' żvilupp ta' dijarea: żieda fid-doża kumulattiva ta' capecitabine (0.1*kg) u żieda fl-intensità tad-doża relattiva fl-ewwel sitt ġimgħat.
English: Package leaflet: Information for the user Capecitabine Teva 150 mg film-coated tablets Capecitabine Teva 500 mg film-coated tablets capecitabine
Maltese: Informazzjoni għall-utent Capecitabine Teva 150 mg pilloli miksija b'rita Capecitabine Teva 500 mg pilloli miksija b'rita capecitabine
English: • decreases in blood cells including platelets, thinning of blood (seen in tests)
Maltese: • tnaqqis fiċ-ċelluli tad-demm inkluż plejtlits, demm debboli (osservat fit-testijiet)
English: Hyperglycaemia
Maltese: Merckle GmbH
English: Hypomagnesaemia,
Maltese: Fibrillazzjoni atrijali,
English: Table 4 lists ADRs associated with the use of capecitabine monotherapy based on a pooled analysis of safety data from three major studies including over 1900 patients (studies M66001, SO14695, and SO14796).
Maltese: Tabella 4 telenka l-ADRs assoċjati mal-użu ta' capecitabine bħala monoterapija ibbażati fuq analiżi globali ta' tagħrif dwar is-sigurtà minn tliet studji maġġuri li kienu jinkludu aktar minn 1900 pazjent (studji M66001, SO14695, u SO14796).
English: General
Maltese: HR
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: warfarin, it-trattament b'capecitabine żied l-AUC ta' S-warfarin b'57% b'żieda ta' 91% fil-valur tal
English: How to store Capecitabine Teva 6.
Maltese: 7% (capecitabine) vs. 16.
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, the following covariates were statistically significantly associated with an increased risk of developing diarrhoea: increasing capecitabine starting dose (gram), increasing duration of study treatment (weeks), increasing age (by 10 year increments), and female gender.
Maltese: Ir-riżultati ta' meta-analiżi ta' 14-il prova klinika b'tagħrif minn aktar minn 4700 pazjent ittrattat b'capecitabine wrew li fl-istudji kollha kombinati, l-kovarjanti li ġejjin kienu assoċjati b'mod statistikament sinifikanti ma' żieda fir-riskju ta' żvilupp ta' dijarea: żieda fid-doża (grammi) tal-bidu ta' capecitabine, żieda fit-tul ta' trattament taħt studju (ġimgħat), żieda fl-età (b'żjidiet ta' 10 snin), u sess femminili.
English: Radiotherapy
Maltese: Radjuterapija
English: Table 8 Key efficacy results for AIO KRK study XELOX + bevacizumab
Maltese: .7 Effetti fuq il-ħila biex issuq u tħaddem magni
English: Table 4 Summary of related ADRs reported in patients treated with capecitabine monotherapy Body System Very Common All grades
Maltese: Tabella 4 Sommarju tal-ADRs relatati rrapportati f'pazjenti ttrattati b'monoterapija ta' capecitabine
English: Treatment with capecitabine monotherapy may be resumed when bilirubin decreases to ≤3.0 x ULN or hepatic aminotransferases decrease to ≤2.5 x ULN.
Maltese: It-trattament b'capecitabine li jittieħed waħdu jista' jitkompla meta l-bilirubin jonqos għal ≤ 3.0 x ULN jew l-aminotransferases epatiċi jitnaqqsu għal ≤ 2.5 x ULN.
English: Bevacizumab
Maltese: Plaċebo jew Bevacizumab
English: NAME OF THE MEDICINAL PRODUCT Capecitabine Teva 150 mg film-coated tablets Capecitabine Teva 500 mg film-coated tablets
Maltese: Capecitabine Teva 150 mg pilloli miksija b'rita Capecitabine Teva 500 mg pilloli miksija b'rita
English: • Vomiting: if you vomit more than once in a 24-hour time period.
Maltese: • Rimettar: jekk tirremetti aktar minn darba f'perijodu ta' 24 siegħa.
English: Patients with low or absent DPD activity, an enzyme involved in fluorouracil degradation, are at increased risk for severe, life-threatening, or fatal adverse reactions caused by fluorouracil.
Maltese: Pazjenti b'attività baxxa jew assenti ta' DPD, enzima involuta fid-degradazzjoni ta' fluorouracil,
English: Number of 150 mg tablets and/or 500 mg
Maltese: Doża kull għotja (mg) 150 mg 500 mg
English: - Keep this leaflet.
Maltese: Stat ta' konfużjoni,
English: Full dose 1000 mg/m2
Maltese: 1000 mg/m2
English: Capecitabine can induce the occurrence of diarrhoea, which has been observed in up to 50% of patients.
Maltese: Capecitabine jista' jinduċi l-okkorrenza ta' dijarea, li kienet osservata f'sa 50% tal-pazjenti.