FrancophonIA/ELRC3.0 huggingface dataset:
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.
Croatian: • u kombinaciji s docetakselom (vidjeti dio 5.1) za liječenje bolesnika s lokalno uznapredovalim ili metastatskim karcinomom dojke nakon neuspjeha citotoksične kemoterapije.
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
Croatian: 28 filmom obloženih tableta 30 filmom obloženih tableta 56 filmom obloženih tableta 60 filmom obloženih tableta 84 filmom obložene tablete 112 filmom obloženih tableta 120 filmom obloženih tableta
English: ThyPase activity was measured and found to be 4 times greater in primary colorectal tumour than in adjacent normal tissue.
Croatian: Izmjerena je aktivnost ThyPase i nađeno je da je ona 4 puta veća u primarnom kolorektalnom karcinomu nego u okolnom zdravom tkivu.
English: Capecitabine has minor or moderate influence on the ability to drive and use machines.
Croatian: Kapecitabin malo ili umjereno utječe na sposobnost upravljanja vozilima i rada na strojevima.
English: Day 1, prior to FOLFOX-4, every 2 weeks
Croatian: 30 - 90 min prvog dana, prije FOLFOX-4 protokola, svaka 2 tjedna
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).
Croatian: Međutim, ovo je bilo povezano s povećanom incidencijom gastrointestinalne toksičnosti i neutropenije tijekom prvolinijskog liječenja XELIRI protokolom (26 % uz XELIRI protokol i 11 % kod prvolinijskog liječenja kapecitabinom).
English: It is therefore possible that Capecitabine medac could affect your ability to drive a car or operate machines.
Croatian: Stoga postoji mogućnost da Kapecitabin medaca utječe na sposobnost upravljanja vozilima i strojevima.
English: The overall safety profile of capecitabine is based on data from over 3,000 patients treated with capecitabine as monotherapy or capecitabine in combination with different chemotherapy regimens in multiple indications.
Croatian: Ukupni sigurnosni profil kapecitabina temelji se na podacima od preko 3000 bolesnika koji su liječeni kapecitabinom kao monoterapijom ili kapecitabinom kao dijelom različitih kemoterapijskih protokola u različitim indikacijama.
English: The European Medicines Agency has waived the obligation to conduct studies with capecitabine in all subsets of the paediatric population in adenocarcinoma of the colon and rectum, gastric adenocarcinoma and breast carcinoma (see section 4.2 for information on paediatric use).
Croatian: Europska agencija za lijekove izuzela je obvezu provođenja ispitivanja kapecitabina u svim podskupinama pedijatrijske populacije za indikacije adenokarcinoma kolona i rektuma, adenokarcinoma želuca i karcinoma dojke (vidjeti dio 4.2 za informacije o pedijatrijskoj primjeni).
English: • cold sores or other herpes infections
Croatian: • različite vrste herpes infekcija
English: Table 7 Key efficacy results for the non-inferiority analysis of study NO16966
Croatian: Tablica 7 Ključni rezultati djelotvornosti iz analize o neinferiornosti u ispitivanju NO 16966
English: In this trial, 1,002 patients were randomised in a 2x2 factorial design to one of the following 4 arms:
Croatian: U to je ispitivanje slučajnim odabirom uključeno 1002 bolesnika u faktorijalnom dizajnu 2 x 2 u jednu od sljedeće 4 skupine:
English: HR (97.5 % CI)
Croatian: omjer hazarda (97,5 % CI)
English: An effective method of contraception should be used during treatment and for 6 months after the last dose of capecitabine.
Croatian: Potrebno je primjenjivati učinkovitu metodu kontracepcije tijekom liječenja i još 6 mjeseci nakon posljednje doze kapecitabina
English: Parameter: Overall survival
Croatian: Parametar: ukupno preživljenje
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.
Croatian: U jednom kliničkom ispitivanju farmakokinetičkih interakcija, nakon jednokratne doze varfarina od 20 mg, uzimanje kapecitabina povećalo je AUC S-varfarina za 57 % te vrijednosti INR za 91 %.
English: • medicines used to treat folic acid deficiency
Croatian: • lijekove za liječenje nedostatka folatne kiseline.
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 1,900 patients (studies M66001, SO14695, and SO14796).
Croatian: U tablici 4 nalazi se popis nuspojava povezanih s primjenom kapecitabina u monoterapiji koji se temelji na združenoj analizi sigurnosnih podataka iz tri glavna ispitivanja na više od 1900 bolesnika (M66001, SO14695, SO14796).
English: Pack sizes: 28, 30, 56, 60, 84, 112 or 120 film-coated tablets.
Croatian: Veličine pakiranja: 28, 30, 56, 60, 84, 112 ili 120 filmom obloženih tableta.
English: The 5 year OS rate was 78 % for XELOX versus 74 % for 5-FU/LV.
Croatian: Petogodišnja stopa ukupnog preživljenja bila je 78 % za XELOX nasuprot 74 % za 5-FU/LV.
English: The dose of Capecitabine medac is based on your body surface area.
Croatian: Doza Kapecitabin medaca ovisi o Vašoj tjelesnoj površini, a ona se izračunava na temelju
English: • blood-thinning medicines (coumarin, warfarin)
Croatian: • lijekove protiv zgrušavanja krvi (kumarin, varfarin),
English: • decrease in blood sodium, magnesium or calcium, increase in blood sugar
Croatian: • smanjenje natrija, magnezija ili kalcija u krvi, porast razine šećera u krvi
English: Patients were randomised to receive either FOLFIRI plus bevacizumab (Arm-A, n = 167) or XELIRI plus bevacizumab (Arm-B, n-166).
Croatian: Bolesnici su randomizirani da primaju ili FOLFIRI + bevacizumab (skupina A, n = 167) ili XELIRI + bevacizumab (skupina B, n = 166).
English: There is some evidence that dexpanthenol is effective for HFS prophylaxis in patients treated with capecitabine.
Croatian: Postoje dokazi o tome da je dekspantenol djelotvoran za profilaksu HFS u bolesnika liječenih lijekom kapecitabin.
English: LABORATORI FUNDACIÓ DAU C/ C, 12-14 Pol. Ind. Zona Franca, Barcelona 08040 Barcelona
Croatian: Ind. Zona Franca, Barcelona 08040 Barcelona
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.
Croatian: Ovdje su navedena dva primjera: osoba čija tjelesna težina iznosi 64 kg, a visina 1,64 m, ima tjelesnu površinu od 1,7 m² te mora uzimati 4 tablete od 500 mg i 1 tabletu od 150 mg dvaput dnevno.
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.
Croatian: Ako se razvije HFS 2. ili 3. stupnja liječenje kapecitabinom mora se prekinuti do povlačenja tegoba ili smanjenja njihovog intenziteta na 1. stupanj.
English: A combination study with capecitabine and folinic acid indicated that folinic acid has no major effect on the pharmacokinetics of capecitabine and its metabolites.
Croatian: Ispitivanje kombinirane primjene kapecitabina i folinatna kiseline pokazalo je da folinatna kiselina nema većeg utjecaja na farmakokinetiku kapecitabina i njegovih metabolita.
English: According to immunohistochemical studies, ThyPase appears to be in large part localised in tumour stromal cells.
Croatian: Prema imunohistokemijskim istraživanjima izgleda da je ThyPase većinom lokalizirana u tumorskim stromalnim stanicama.
English: In addition to the ADRs described in tables 4 and 5, and based on the above pooled analysis from clinical safety data from 7 clinical trials, encephalopathy was also associated with the use of capecitabine monotherapy with an incidence of less than 0.1 %.
Croatian: Uz nuspojave opisane u tablicama 4 i 5 te temeljeno na gore navedenoj analizi združenih podataka o kliničkoj sigurnosti primjene iz 7 kliničkih ispitivanja, encefalopatija je također bila povezana s uzimanjem kapecitabina kao monoterapije, s incidencijom manjom od 0,1 %.
English: Some of these side effects are more common when capecitabine is used with other medicines for the treatment of cancer.
Croatian: Neke od ovih nuspojava češće su kad se kapecitabin koristi u kombinaciju s drugim lijekovima za liječenje karcinoma.
English: In patients with mild renal impairment (creatinine clearance 51 - 80 ml/min at baseline) no adjustment of the starting dose is recommended.
Croatian: U bolesnika s blagim oštećenjem bubrežne funkcije (početnim klirensom kreatinina 51 - 80 ml/min) nije potrebna prilagodba početne doze.
English: cisplatin, irinotecan)
Croatian: bevacizumab, cisplatin, irinotekan),
English: Table 5 lists ADRs associated with the use of capecitabine in combination with different chemotherapy regimens in multiple indications based on safety data from over 3,000 patients.
Croatian: U tablici 5 nalazi se popis nuspojava povezanih s primjenom kapecitabina u različitim kemoterapijskim protokolima, u različitim indikacijama, koji se temelji na sigurnosnim podacima dobivenim od više od 3000 bolesnika.
English: In an interaction study with single-dose warfarin administration, there was a significant increase in the mean AUC (+57 %) of S-warfarin.
Croatian: Tijekom ispitivanja interakcije s jednokratnom dozom varfarina uočeno je znatno povećanje površine ispod krivulje (AUC) (+57 %) S-varfarina.
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.
Croatian: Medijan ukupnog vremena preživljenja iznosio je 703 dana (95 % CI: 671; 745) u bolesnika liječenih protokolima koji su sadržavali kapecitabin i 683 dana (95 % CI: 646; 715) u bolesnika liječenih protokolima koji su sadržavali 5-FU.
English: Dose per administration (mg)
Croatian: Doza po primjeni (mg)
English: Hand--foot syndrome
Croatian: Sindrom šaka-stopalo
English: Capecitabine is first metabolised by hepatic carboxylesterase to 5'-DFCR, which is then converted to 5'-DFUR by cytidine deaminase, principally located in the liver and tumour tissues.
Croatian: Kapecitabin se najprije metabolizira jetrenom karboksilesterazom u 5'-DFCR koji se pomoću citidin deaminaze pretvara u 5'-DFUR koji se uglavnom nalazi u jetri i tumorskim tkivima.
English: HFS also known as hand-foot skin reaction or palmar-plantar erythrodysesthesia or chemotherapy induced acral erythema.
Croatian: HFS poznat i kao kožna reakcija na šakama i stopalima ili palmarno-plantarna eritrodizestezija ili akralni eritem izazvan kemoterapijom.
English: • decreases in the number of white blood cells or red blood cells (seen in tests)
Croatian: • smanjenje broja bijelih ili crvenih krvnih stanica (u krvnim pretragama)
English: In addition to the ADRs described in tables 4 and 5, the following ADRs with an incidence of less than 0.1 % were associated with the use of capecitabine monotherapy based on a pooled analysis from clinical safety data from 7 clinical trials including 949 patients (2 phase III and 5 phase II clinical trials in metastatic colorectal cancer and metastatic breast cancer): cardiomyopathy, cardiac failure, sudden death, and ventricular extrasystoles.
Croatian: Uz nuspojave opisane u tablicama 4 i 5, sljedeće nuspojave s incidencijom manjom od 0,1 % su bile povezane s uporabom kapecitabina kao monoterapije, temeljeno na analizi združenih podataka o kliničkoj sigurnosti primjene iz 7 kliničkih ispitivanja na 949 bolesnika (2 faze III i 5 faza II kliničkih ispitivanja u bolesnika s metastatskim kolorektalnim karcinomom i metastatskim karcinomom dojke): kardiomiopatija, zatajenje srca, iznenadna smrt i ventrikularne ekstrasistole.
English: blood in the urine, increase in blood creatinine (sign of kidney dysfunction)
Croatian: porast kreatinina u krvi (znak poremećene funkcije bubrega)
English: 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.
Croatian: Metaanaliza šest kliničkih ispitivanja (SO14695, SO14796, M66001, NO16966, NO16967, M17032) podržava zamjenu 5-FU kapecitabinom u monoterapiji i kombiniranoj terapiji karcinoma probavnog sustava.
English: Following oral administration of 825 mg/m² capecitabine twice daily for 14 days, Japanese patients (n = 18) had about 36 % lower Cmax and 24 % lower AUC for capecitabine than Caucasian patients (n = 22).
Croatian: Nakon peroralne primjene 825 mg/m² kapecitabina dvaput dnevno tijekom 14 dana, Japanci (n = 18) su imali 36 % niži Cmax i 24 % niži AUC kapecitabina nego bijelci (n = 22).
English: • if you are being treated now or have been treated in the last 4 weeks with brivudine as part of herpes zoster (chickenpox or shingles) therapy.
Croatian: • ako se liječite ili ste se u zadnja 4 tjedna liječili brivudinom u klopu liječenja herpes zostera
English: PVC/PVdC/Aluminium blisters
Croatian: PVC/PVdC/aluminij blisteri
English: Not applicable *According to the National Cancer Institute of Canada Clinical Trial Group (NCIC CTG) Common Toxicity Criteria (version 1) or the Common Terminology Criteria for Adverse Events (CTCAE) of the Cancer Therapy Evaluation Program, US National Cancer Institute, version 4.0.
Croatian: (National Cancer Institute of Canada Clinical Trial Group - NCIC CTG), verzija 1 ili uobičajenom nazivlju kriterija za štetne događaje prema programu evaluacije terapije karcinoma Američkog nacionalnog instituta za rak (Common Terminology Criteria for Adverse Events (CTCAE) of the Cancer Therapy Evaluation Program,
English: ITT *PPP = per-protocol population; **ITT = intent-to-treat population.
Croatian: *PPP = populacija po protokolu; **ITT = populacija bolesnika predviđenih za liječenje
English: Each pack contains 28, 30, 56, 60, 84, 112, or 120 film-coated tablets.
Croatian: Jedno pakiranje sadrži 28, 30, 56, 60, 84, 112 ili 120 filmom obloženih tableta.
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS Blister
Croatian: PODACI KOJE MORA NAJMANJE SADRŽAVATI BLISTER ILI STRIP BLISTER
English: SPECIAL STORAGE CONDITIONS For PVC/PVdC/Aluminium blisters: Do not store above 30 °C
Croatian: Za PVC/PVdC-aluminij blistere: Ne čuvati na temperaturi iznad 30 °C.
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).
Croatian: Iako deficit DPD-a nije precizno definiran, poznato je da bolesnici s određenim homozigotnim ili određenim višestrukim heterozigotnim mutacijama u lokusu gena DPYD (npr. varijantama DPYD*2A, c.1679T>G, c.2846A>T i c.1236G>A/HapB3), koje mogu uzrokovati potpun ili gotovo potpun izostanak enzimske aktivnosti DPD-a (određuje se laboratorijskim testovima), imaju najveći rizik od po život opasne ili smrtonosne toksičnosti te se ne smiju liječiti kapecitabinom (vidjeti dio 4.3).
English: Capecitabine is a non-cytotoxic fluoropyrimidine carbamate, which functions as an orally administered precursor of the cytotoxic moiety 5-FU.
Croatian: Kapecitabin je necitotoksični fluoropirimidin karbamat koji djeluje kao oralno primijenjeni prethodnik citotoksične čestice 5-FU.
English: Capecitabine and its metabolites are predominantly excreted in urine; 95.5 % of administered capecitabine dose is recovered in urine.
Croatian: Kapecitabin i njegovi metaboliti većinom se izlučuju urinom; 95,5 %
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.
Croatian: Osoba čija tjelesna težina iznosi 80 kg, a visina 1,80 m ima tjelesnu površinu od 2,00 m² te mora uzimati 5 tableta od 500 mg dvaput dnevno.
English: • pain in the joints or in the limbs (extremities), chest or back
Croatian: • bol u zglobovima ili udovima (ekstremitetima), prsnom košu ili leđima
English: • interferon alpha
Croatian: • interferon alfa,
English: • irregular heartbeat and palpitations (arrhythmias), chest pain and heart attack (infarction)
Croatian: • nepravilni srčani otkucaji i palpitacije (aritimije), bol u prsima i srčani udar (infarkt)
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 Eastern Cooperative Oncology Group (ECOG) performance status at baseline (0
Croatian: U svim ispitivanjima sljedeći nezavisni čimbenici su bili statistički značajno povezani s povećanim rizikom razvoja sindroma šaka-stopalo: povećana početna doza kapecitabina (u gramima), smanjena kumulativna doza kapecitabina (0,1*kg), povećanje intenziteta relativne doze u prvih šest tjedana, produženje liječenja u ispitivanju (tjedni), starija životna dob (u intervalima od 10 godina), ženski spol i dobar status prema ljestvici Istočne kooperativne skupine za onkologiju (ECOG) na početku liječenja (0 nasuprot ≥ 1).
English: Dihydropyrimidinase cleaves the pyrimidine ring to yield 5-fluoro-ureidopropionic acid (FUPA).
Croatian: Dihidropiriminidaza cijepa pirimidinski prsten i nastaje 5-fluoro-ureidopropionska kiselina (FUPA).
English: • blood clots in the deep veins, high or low blood pressure, hot flushes, cold limbs (extremities),
Croatian: • krvni ugrušci u dubokim venama, visok ili nizak tlak, navale vrućine, hladni udovi
English: Capecitabine medac contains capecitabine, which itself is not a cytostatic medicine.
Croatian: Kapecitabin medac sadrži kapecitabin, koji sam po sebi nije citostatik.
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).
Croatian: Kardiovaskularna toksičnost (npr. produljenje PR i QT intervala) utvrđena je u cinomolgus majmuna nakon intravenske primjene (100 mg/kg), ali ne i nakon ponovljene peroralne doze (1379 mg/m² na dan).
English: Table 9 Key efficacy results for the non-inferiority analysis of study NO16967 PRIMARY ANALYSIS
Croatian: Tablica 9 Ključni rezultati djelotvornosti iz analize neinferiornosti u ispitivanju NO 16967
English: • for first-line treatment of advanced gastric cancer in combination with a platinum based regimen (see section 5.1).
Croatian: • u prvoj liniji liječenja uznapredovalog karcinoma želuca u kombinaciji s protokolom temeljenim na platini (vidjeti dio 5.1).
English: In repeat-dose toxicity studies, daily oral administration of capecitabine to cynomolgus monkeys and mice produced toxic effects on the gastrointestinal, lymphoid and haemopoietic systems, typical for fluoropyrimidines.
Croatian: U ispitivanju toksičnosti ponovljene doze, peroralna dnevna primjena kapecitabina izazvala je u cinomolgus majmuna i miševa toksične učinke na gastointestinalnom, limfnom i hematopoteskom sustavu, što je tipično za fluoropirimidine.
English: Ventricular fibrillation (rare), QT prolongation (rare), Torsade de pointes (rare), Bradycardia (rare), Vasospasm (rare)
Croatian: palpitacije fibrilacija ventrikula (rijetko), produljenje QTintervala (rijetko), Torsade de pointes (rijetko), bradikardija, vazospazam (rijetko)
English: If no toxicity is observed in patients ≥ 60 years of age treated with a reduced capecitabine starting dose in combination with docetaxel, the dose of capecitabine may be cautiously escalated to 1,250 mg/m² twice daily.
Croatian: Ako se u tih bolesnika ne uoče znakovi toksičnosti pri primjeni smanjene početne doze kapecitabina u kombinaciji s docetakselom, doza kapecitabina može se oprezno povećavati do 1250 mg/m² dvaput dnevno.
English: Table 8 Key efficacy results for AIO KRK study
Croatian: Tablica 8 Ključni podaci o djelotvornosti ispitivanja AIO KRK
English: A population pharmacokinetic analysis was carried out after capecitabine treatment of 505 patients with colorectal cancer dosed at 1,250 mg/m² twice daily.
Croatian: Populacijska farmakokinetska analiza provedena je u skupini od 505 bolesnika s kolorektalnim karcinomom nakon liječenja kapecitabinom u dozi od 1250 mg/m² dvaput dnevno.
English: EPP ITT *EPP = eligible patient population; **ITT = intent-to-treat population.
Croatian: *EPP = populacija pogodnih bolesnika; **ITT = populacija bolesnika predviđenih za liječenje
English: Time to progressive disease was superior in the capecitabine + docetaxel combination arm (p < 0.0001).
Croatian: Vrijeme do progresije bolesti bilo je duže u skupini koja je liječena kombinacijom kapecitabina i docetaksela (p < 0,0001).
English: These dose adjustment recommendations for renal impairment apply both to monotherapy and combination use (see also section “Elderly” below).
Croatian: Preporuke o prilagodbi doziranja u slučaju oštećenja bubrežne funkcije odnose se i na monoterapiju i na kombiniranu primjenu (vidjeti ispod odjeljak „Starije osobe“).
English: In human cancer xenograft models capecitabine demonstrated a synergistic effect in combination with docetaxel, which may be related to the upregulation of ThyPase by docetaxel.
Croatian: Na ksenografskim modelima humanog karcinoma kapecitabin je pokazao sinergističko djelovanje u kombinaciji s docetakselom, što se može dovesti u vezu s povećanjem aktivnosti ThyPase uzrokovane docetakselom.
English: The ratio of 5-FU concentration in tumour to plasma was 21.4 (ranged from 3.9 to 59.9, n = 8) whereas the ratio in healthy tissues to plasma was 8.9 (ranged from 3.0 to 25.8, n = 8).
Croatian: Omjer koncentracije 5-FU u tumoru u odnosu na plazmu iznosio je 21,4 (raspon od 3,9 do 5,9; n = 8), pri čemu je omjer u zdravim tkivima u odnosu na plazmu iznosio 8,9 (raspon od 3,0 do 25,8; n = 8).
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 monotherapy and in table 5 for capecitabine given in combination with different chemotherapy regimens in multiple indications.
Croatian: Nuspojave za koje ispitivač smatra da su moguće, vjerojatno ili slabo povezane s primjenom kapecitabina, navedene su u tablici 4 za kapecitabin u monoterapiji i u tablici 5 za kapecitabin u različitim kemoterapijskim protokolima u različitim indikacijama.
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 1,401 patients were randomised to four different treatment groups, including XELOX plus placebo, FOLFOX-4 plus placebo, XELOX plus bevacizumab, and FOLFOX-4 plus bevacizumab.
Croatian: Ispitivanje se sastojalo od dva dijela: prvog (inicijalnog) dijela u kojem je 634 bolesnika bilo randomizirano u dvije terapijske skupine: jedna skupina primala je XELOX protokol, a druga FOLFOX-4 protokol, i naknadnog 2 x 2 faktorijalnog dijela u kojem je 1401 bolesnik randomiziran u jednu od četiri različite terapijske skupine: XELOX i placebo, FOLFOX-4 i placebo, XELOX i bevacizumab te FOLFOX-4 i bevacizumab.
English: The pharmacokinetics of capecitabine have been evaluated over a dose range of 5023,514 mg/m²/day.
Croatian: Farmakokinetika kapecitabina procjenjivana je u rasponu dnevne doze od 502 do 3514 mg/m².