FrancophonIA/ELRC3.0 huggingface dataset:
English: Table 2 Standard and reduced dose calculations according to body surface area for a starting dose of capecitabine of 1000 mg/m2
Croatian: Tablica 2 Izračuni standardnih i smanjenih doza prema tjelesnoj površini za početnu dozu kapecitabina od 1000 mg/m2
English: Capecitabine is indicated for the adjuvant treatment of patients following surgery of stage III (Dukes' stage C) colon cancer (see section 5.1).
Croatian: Kapecitabin je indiciran za adjuvantno liječenje bolesnika nakon operacije karcinoma debelog crijeva stadija III (stadij C prema Dukesovoj klasifikaciji) (vidjeti dio 5.1).
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.
Croatian: Izračuni standardnih i smanjenih doza prema površini ljudskog tijela za početne doze kapecitabina od 1250 mg/m2 i 1000 mg/m2 navedeni su u Tablici 1, odnosno Tablici 2.
English: ADRs are added to the appropriate frequency grouping (Very common or Common) according to the highest incidence seen in any of the major clinical trials and are only added when they were seen in addition to those seen with capecitabine monotherapy or seen at a higher frequency grouping compared to capecitabine monotherapy (see Table 4).
Croatian: Nuspojave su svrstane u odgovarajuće kategorije ukupne učestalosti (vrlo često ili često) prema najvećoj incidenciji primijećenoj u bilo kojem od glavnih ispitivanja i navode se samo ako su dodatno primijećene uz one već zabilježene kod monoterapije kapecitabinom ili ako je njihova učestalost veća u usporedbi s monoterapijom kapecitabinom (vidjeti Tablicu 4).
English: Each film-coated tablet contains 20.69 mg anhydrous lactose.
Croatian: Jedna filmom obložena tableta sadrži 20,69 mg laktoze, bezvodne.
English: Tablet core: talc (E553b) anhydrous lactose croscarmellose sodium (E468) hypromellose (E464) microcrystalline cellulose (E460) magnesium stearate (E572)
Croatian: Jezgra tablete: talk (E553b) laktoza, bezvodna karmelozanatrij, umrežena (E468) hipromeloza (E464) celuloza, mikrokristalična (E460) magnezijev stearat (E572)
English: However, grade 3 or 4 treatment-related adverse reactions were more frequent in patients ≥60 years of age compared to younger patients.
Croatian: Međutim, u bolesnika u dobi od  60 godina češće se razvijaju nuspojave 3. ili 4. stupnja nego u mlađih bolesnika.
English: LIST OF EXCIPIENTS Also contains anhydrous lactose.
Croatian: POPIS POMOĆNIH TVARI Također sadrži bezvodnu laktozu.
English: The hazard ratio for duration of survival (overall survival) was similar to the hazard ratio for progression-free survival (hazard ratio 0.85; 95% CI 0.64 - 1.13).
Croatian: Omjer hazarda za trajanje preživljenja (ukupno preživljenje) bio je sličan omjeru hazarda preživljenja bez progresije bolesti (omjer hazarda 0,85; 95% CI 0,64 do 1,13).
English: Patients taking coumarinderivative anticoagulants concomitantly with capecitabine should be monitored regularly for alterations in their coagulation parameters (PT or INR) and the anti-coagulant dose adjusted accordingly.
Croatian: U bolesnika koji kapecitabin uzimaju istodobno s kumarinskim antikoagulansima treba redovito pratiti promjene koagulacijskih parametara (PV ili INR) i u skladu s time prilagoditi dozu antikoagulansa.
English: Before starting treatment, you must tell your doctor if you are pregnant, if you think you may be pregnant or if you intend to become pregnant.
Croatian: Ako ste trudni, mislite da ste trudni ili planirate zatrudnjeti, o tome morate obavijestiti svog liječnika prije početka liječenja.
English: Capecitabine is also indicated as monotherapy for the treatment of patients with locally advanced or metastatic breast cancer after failure of taxanes and an anthracycline-containing chemotherapy regimen or for whom further anthracycline therapy is not indicated.
Croatian: Kapecitabin je također indiciran kao monoterapija u liječenju bolesnika s lokalno uznapredovalim ili metastatskim karcinomom dojke nakon neuspjeha kemoterapijskog liječenja kombinacijom taksana i antraciklina ili u slučajevima u kojima daljnje liječenje antraciklinima nije indicirano.
English: Grade 2 hand- foot syndrome is painful erythema and swelling of the hands and/or feet and/or discomfort affecting the patient's activities of daily living.
Croatian: Sindrom šaka-stopalo 2. stupnja očituje se bolnim eritemom i oticanjem šaka i/ili stopala i/ili nelagodom koja utječe na svakodnevnu aktivnost bolesnika.
English: - In patients with severe renal impairment (creatinine clearance below 30 ml/min).
Croatian: - Bolesnici s teškim oštećenjem bubrežne funkcije (klirens kreatinina manji od 30 ml/min).
English: Method of administration Capecitabine SUN tablets should be swallowed with water within 30 minutes after a meal.
Croatian: Način primjene Kapecitabin SUN tablete moraju se progutati s vodom najkasnije 30 minuta nakon obroka.
English: Pre-medication with an oral corticosteroid such as dexamethasone according to the docetaxel summary of product characteristics should be started prior to docetaxel administration for patients receiving the capecitabine plus docetaxel combination.
Croatian: Premedikacija oralnim kortikosteroidom, kao što je deksametazon, mora započeti prije primjene docetaksela u bolesnika liječenih kombinacijom kapecitabina i docetaksela, prema Sažetku opisa svojstava za docetaksel.
English: Each pack contains 120 film-coated tablets (12 blisters of 10 tablets).
Croatian: Svaka kutija sadrži 120 filmom obloženih tableta (12 blistera s 10 tableta).
English: The results indicate that XELOX is equivalent to FOLFOX-4 in terms of overall survival (see table 9).
Croatian: Rezultati također pokazuju da je XELOX protokol jednako učinkovit kao FOLFOX-4 protokolu u pogledu ukupnog preživljenja (vidjeti Tablicu 9).
English: In combination treatment, the recommended starting dose of capecitabine should be reduced to 800 - 1000 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).
Croatian: U kombiniranoj terapiji preporučenu početnu dozu kapecitabina potrebno je smanjiti na 8001000 mg/m² i uzimati dvaput dnevno tijekom 14 dana, nakon čega slijedi 7 dana pauze ili na 625 mg/m² dvaput dnevno pri kontinuiranoj (svakodnevnoj) primjeni (vidjeti dio 5.1).
English: Each pack contains 60 film-coated tablets (6 blisters of 10 tablets).
Croatian: Svaka kutija sadrži 60 filmom obloženih tableta (6 blistera s 10 tableta).
English: Capecitabine is contraindicated in patients with severe renal impairment (creatinine clearance below 30 ml/min [Cockcroft and Gault] at baseline).
Croatian: Primjena kapecitabina je kontraindicirana u bolesnika s teškim oštećenjem bubrežne funkcije (početni klirens kreatinina manji od 30 ml/min, [prema Cockroft Gault-ovoj formuli]).
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% FOFIRI).
Croatian: Medijani preživljenja bez progresije bolesti (PFS) i ukupnog preživljenja (OS) bili su kraći kod primjene XELIRI protokola u odnosu na FOLFIRI (PFS 5,9 naspram 9,6 mjeseci, a OS 14,8 naspram 19,9 mjeseci), a uz to su prijavljene znatno veće stope proljeva u bolesnika koji su primali XELIRI protokol (41% XELIRI, 5.1% FOLFIRI).
English: Table 1 Standard and reduced dose calculations according to body surface area for a starting dose of capecitabine of 1250 mg/m2
Croatian: Tablica 1 Izračuni standardnih i smanjenih doza prema tjelesnoj površini za početnu dozu kapecitabina od 1250 mg/m2
English: fainting, nerve damage (neuropathy) and problems with sensation - blurred or double vision - vertigo, ear pain - irregular heartbeat and palpitations (arrhythmias), chest pain and heart attack (infarction) - blood clots in the deep veins, high or low blood pressure, hot flushes, cold limbs (extremities),
Croatian: nesvjestica, oštećenje živaca (neuropatija) i tegobe s osjetima - zamagljen vid ili dvostruke slike - vrtoglavica, bol u uhu - nepravilan srčani ritam i osjećaj lupanja srca (aritmije), bol u prsima i srčani udar (infarkt) - krvni ugrušci u dubokim venama, visok ili nizak krvni tlak, navale vrućine, hladni udovi
English: Cutaneous lupus erythematosus (rare), Severe skin reactions such as Steven-Johnson Syndrome and toxic Epidermal Necrolysis (very rare) (see section
Croatian: kožni lupus eritematozus (rijetko), teške kožne reakcije poput StevensJohnsonova sindroma i toksične epidermalne nekrolize (vrlo rijetko) (vidjeti dio 4.4)
English: Capecitabine SUN 500 mg film-coated tablets are peach coloured, oval, biconvex, 17.5 mm x 8.7 mm tablets, with inscription ‘500'on one side and plain on other side.
Croatian: Kapecitabin SUN 500 mg filmom obložene tablette su ovalne, bikonveksne tablete, boje breskve, veličine 17,5 mm x 8,7 mm s oznakom ´500´ s jedne strane i bez oznake s druge strane.
English: Key efficacy results for AIO KRK study
Croatian: Ključni podaci o djelotvornosti ispitivanja AIO KRK
English: Dose modifications for toxicity when capecitabine is used continuously in combination with other medicinal products should be made according to table 3 above for capecitabine and according to the appropriate summary of product characteristics for the other medicinal product(s).
Croatian: Prilagodbe doze zbog toksičnosti kada se kapecitabin primjenjuje kontinuirano u kombinaciji s drugim lijekovima moraju se provoditi u skladu s gore navedenom Tablicom 3 za kapecitabin te u skladu s odgovarajućim Sažetkom opisa svojstava za drugi lijek (lijekove).
English: Oxaliplatin: no clinically significant differences in exposure to capecitabine or its metabolites, free platinum or total platinum occurred when capecitabine was administered in combination with oxaliplatin or in combination with oxaliplatin and bevacizumab.
Croatian: Oksaliplatin: kod primjene kapecitabina u kombinaciji s oksaliplatinom ili u kombinaciji s oksaliplatinom i bevacizumabom nisu uočene klinički značajne razlike u izloženosti kapecitabinu ili njegovim metabolitima, slobodnom platinu ili ukupnom platinu.
English: Grade 1 hand- foot syndrome is defined as numbness, dysesthesia/paresthesia, tingling, painless swelling or erythema of the hands and/or feet and/or discomfort which does not disrupt the patient's normal activities.
Croatian: Sindrom šaka-stopalo 1. stupnja definiran je utrnulošću, dizestezijom/ parestezijama, trncima, bezbolnim otokom ili eritemom šaka i/ili stopala i/ili nelagodom koja ne ometa bolesnika u svakodnevnim aktivnostima.
English: Given as monotherapy, the recommended starting dose for capecitabine in the adjuvant treatment of colon cancer, in the treatment of metastatic colorectal cancer or of locally advanced or metastatic breast cancer is 1250 mg/m2 administered twice daily (morning and evening; equivalent to 2500 mg/m2 total daily dose) for 14 days followed by a 7-day rest period.
Croatian: Karcinom debelog crijeva, kolorektalni karcinom i karcinom dojke Preporučena početna doza kapecitabina primijenjenog kao monoterapija u adjuvantnom liječenju karcinoma debelog crijeva, liječenju metastatskog kolorektalnog karcinoma ili u liječenju lokalno uznapredovalog ili metastatskog karcinoma dojke iznosi 1250 mg/m² i uzima se dvaput dnevno (ujutro i navečer; što odgovara ukupnoj dnevnoj dozi od 2500 mg/m²) tijekom 14 dana, nakon čega slijedi 7 dana pauze, tj. neuzimanja lijeka.
English: Grade 3 hand- foot syndrome is moist desquamation, ulceration, blistering and severe pain of the hands and/or feet and/or severe discomfort that causes the patient to be unable to work or perform activities of daily living.
Croatian: Sindrom šaka-stopalo 3. stupnja očituje se vlažnim ljuštenjem, ulceriranjem, pojavom mjehurića i jakom boli u šakama i/ili stopalima i/ili izraženim tegobama koje uzrokuju radnu nesposobnost bolesnika i onemogućavaju njegove svakodnevne aktivnosti.
English: Dose modifications for toxicity when capecitabine is used as a 3 weekly cycle in combination with other medicinal products should be made according to table 3 above for capecitabine and according to the appropriate summary of product characteristics for the other medicinal product(s).
Croatian: Prilagodbe doze zbog toksičnosti kada se kapecitabin primjenjuje u ciklusima od 3 tjedna u kombinaciji s drugim lijekovima moraju se provoditi u skladu s gore navedenom Tablicom 3 za kapecitabin te u skladu s odgovarajućim Sažetkom opisa svojstava drugog lijeka (lijekova).
English: Each film-coated tablet contains 68.95 mg anhydrous lactose.
Croatian: Jedna filmom obložena tableta sadrži 68,95 mg laktoze, bezvodne.
English: Do not use this medicine after the expiry date which is stated on the carton and blister after EXP. Do not store above 25°C.
Croatian: Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na kutiji i blisteru iza oznaka „Rok valjanosti“ ili „EXP:“.
English: Herpes zoster, Urinary tract infection, Oral candidiasis, Upper respiratory tract infection, Rhinitis, Influenza, +Infection, Oral herpes
Croatian: Herpes zoster, infekcija mokraćnog sustava, oralna kandidijaza, infekcija gornjeg dišnog sustava rinitis, gripa, +infekcija, oralni herpes
English: - Steven-Johnson syndrome: if you experience painful red or purplish rash that spreads and blisters and/or other lesions begin to appear in the mucous membrane (e.g. mouth and lips), in particular if you had before light sensitivity, infections of the respiratory system (e.g. bronchitis) and/or fever.
Croatian: - Stevens-Johnsonov sindrom: ako dobijete bolan crveni ili ljubičasto-crveni osip koji se širi i počnu se javljati mjehurići i/ili druga oštećenja na sluznici (npr. u ustima i na usnicama),
English: 604 patients were randomised to treatment with 5-FU and leucovorin (Mayo regimen: 20 mg/m2 leucovorin IV followed by 425 mg/m2 IV bolus 5-FU, on days 1 to 5, every 28 days).
Croatian: Skupina od 604 bolesnika randomizirana je za liječenje 5-FU i leukovorinom (Mayo protokol: 20 mg/m² leukovorina i.v. i zatim 425 mg/ m2 5-FU i.v. u bolusu od prvog do petog dana, svakih 28 dana).
English: Table 4 Summary of related ADRs reported in patients treated with capecitabine monotherapy Body System Very Common
Croatian: Tablica 4 Sažetak povezanih nuspojava na lijek prijavljenih u bolesnika koji su liječeni kapecitabinom kao monoterapijom
English: Colon and colorectal cancer
Croatian: Karcinom debelog crijeva i kolorektalni karcinom
English: 120 Patients were randomised to a modified XELIRI regimen with capecitabine 800 mg/m2 twice daily for two weeks followed by a 7-day rest period), irinotecan (200 mg/m2 as a 30 minute infusion on day 1 every
Croatian: 120 bolesnika randomizirano je za liječenje modificiranim XELIRI protokolom, koji je obuhvaćao kapecitabin (u dozi od 800 mg/m2 dvaput dnevno tijekom dva tjedna, nakon čega slijedi pauza od 7 dana), irinotekan (200 mg/m2 kao 30-minutna infuzija 1. dana svaka
English: Non-inferiority of the XELOX-containing arms compared with the FOLFOX-4-containing arms in the overall comparison was demonstrated in terms of progression-free survival in the eligible patient population and the intent-to-treat population (see table 7).
Croatian: Utvrđeno je da liječenje XELOX protokolom nije inferiorno u odnosu na liječenje FOLFOX-4 protokolom kad se uspoređuje preživljenje bez progresije bolesti u populaciji pogodnih bolesnika i populaciji bolesnika predviđenih za liječenje (vidjeti Tablicu 7).
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.
Croatian: U cjelokupnoj randomiziranoj populaciji testovi za utvrđivanje razlike između kapecitabina i 5-FU/LV u preživljenju bez znakova bolesti i ukupnom preživljenju pokazali su omjere hazarda od 0,88 (95% CI 0,77 - 1,01; p = 0,068), odnosno 0,86 (95% CI 0,74 - 1,01; p = 0,060).
English: Uncommon ADRs reported for capecitabine in combination therapy are consistent with the ADRs reported for capecitabine monotherapy or reported for monotherapy with the combination medicinal product (in literature and/or respective summary of product characteristics).
Croatian: Manje česte nuspojave koje su prijavljene kod kapecitabina u kombiniranoj terapiji su u skladu s nuspojavama prijavljenima kod monoterapije kapecitabinom ili prijavljenima kod monoterapije lijekom koji se može primjenjivati u kombinaciji s kapecitabinom (u literaturi i/ili odgovarajućim Sažecima opisa svojstava lijeka).
English: Excipients.
Croatian: Proljev.
English: Table 5 Summary of related ADRs reported in patients treated with capecitabine in combination treatment in addition to those seen with capecitabine monotherapy or seen at a higher frequency grouping compared to capecitabine monotherapy Body System Very common
Croatian: Tablica 5 Sažetak povezanih nuspojava prijavljenih u bolesnika liječenih kapecitabinom u kombiniranom liječenju, a koje su dodatno primijećene uz one već zabilježene kod monoterapije kapecitabinom ili su se javljale s većom učestalošću od onih kod monoterapije kapecitabinom
English: A meta-analysis of 14 clinical trials with data from over 4700 patients treated with capecitabine monotherapy or capecitabine in combination with different chemotherapy regimens in multiple indications (colon, colorectal, gastric and breast cancer), showed that patients on capecitabine who developed hand-foot syndrome (HFS) had a longer overall survival compared to patients who did not develop HFS: median overall survival 1100 days (95% CI 1007; 1200) vs. 691 days (95% CI 638; 754) with a hazard ratio of 0.61 (95% CI 0.56; 0.66).
Croatian: Metaanaliza 14 kliničkih ispitivanja sa više od 4700 bolesnika liječenih monoterapijom kapecitabinom ili kapecitabinom u kombinaciji s različitim kemoterapijskim protokolima, u različitim indikacijama (karcinom debelog crijeva, kolorektalni karcinom, uznapredovali karcinom želuca i karcinom dojke) je pokazala da bolesnice koje su liječene kapecitabinom, a koje su razvile sindrom šaka-stopalo (HFS), imaju duži period ukupnog preživljenja u usporedbi s bolesnicama koje nisu razvile HFS: medijan ukupnog preživljenja iznosio je 1100 dana (95% CI 1007; 1200) u usporedbi s 691 dan (95% CI 15,0; 17,0) s omjerom hazarda od 0,61 (95% CI 0,56; 0,66).
English: MARKETING AUTHORISATION NUMBER(S) EU/1/13/831/001
Croatian: BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/13/831/001
English: CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2) .
Croatian: Lijek se izdaje na ograničeni recept (Vidjeti Dodatak I: Sažetak opisa svojstava lijeka, dio 4.2).
English: Bone marrow depression, +Febrile Neutropenia
Croatian: neutropenija, trombocitopenija depresija koštane srži, +febrilna neutropenija
English: Eye disorders Lacrimation increased Visual disorders, Dry eye, Eye pain, Visual impairment, Vision blurred
Croatian: Poremećaji oka pojačano suzenje poremećaji vida, suhoća oka, bol u oku, oštećenje vida, zamagljen vid
English: België/Belgique/Belgien/България/Česká republika/ Danmark/Eesti/Ελλάδα/Hrvatska/Ireland/Ísland/Κύπρος/ Latvija/Lietuva/Luxembourg/Luxemburg/Magyarország/
Croatian: 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
English: Capecitabine SUN may make you feel dizzy, nauseous or tired.
Croatian: Dok uzimate lijek Kapecitabin SUN možete osjećati omaglicu, mučninu ili umor.
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).
Croatian: U cjelokupnoj randomiziranoj populaciji kapecitabina se pokazala superiornijom u odnosu na 5-FU/LV u preživljenju bez znakova bolesti (omjer hazarda 0,849; 95% CI: 0,739 - 0,976; p = 0,0212) kao i u sveukupnom preživljenju (omjer hazarda 0,828; 95% CI: 0,705 - 0,971; p = 0,0203).
English: There must be at least a 4-week waiting period between end of treatment with sorivudine or its chemically related analogues such as brivudine and start of capecitabine therapy.
Croatian: Nakon terapije sorivudinom ili njegovim kemijskim analozima, kao što je brivudin, mora proći najmanje 4 tjedna prije početka liječenja kapecitabinom.
English: What Capecitabine SUN looks like and contents of the pack Capecitabine SUN 500 mg are peach coloured, oval, biconvex, film-coated tablet debossed with '500' on one side and plain on other side.
Croatian: Kako Kapecitabin SUN izgleda i sadržaj pakovanja Kapecitabin SUN 500 mg su ovalne, bikonveksne, filmom obložene tablete svijetle boje breskve s utisnutom oznakom ´500´ s jedne strane i bez oznake s druge strane.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/13/831/002
Croatian: 12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/13/831/002
English: In the primary analysis for DFS in the ITT population, XELOX was shown to be significantly superior to 5-FU/LV (HR=0.80, 95% CI=[0.69; 0.93]; p=0.0045).
Croatian: Primarnom analizom preživljenje bez znakova bolesti u populaciji bolesnika predviđenih za liječenje XELOX se pokazao značajno superiornijim u odnosu na 5-FU/LV (omjer hazarda =0,80; 95% CI=[0,69; 0,93]; p=0,0045).
English: Paraesthesia, Dysaesthesia, Peripheral neuropathy, Peripheral sensory neuropathy, Dysgeusia, Headache
Croatian: Poremećaji živčanog sustava parestezija, disestezija, periferna neuropatija, periferna senzorna neuropatija, disgeuzija, glavobolja neurotoksičnost, tremor, neuralgija, reakcija preosjetljivosti, hipoestezija
English: In this trial, 1987 patients were randomised to treatment with capecitabine (1250 mg/m2 twice daily for 2 weeks followed by a 1-week rest period and given as 3-week cycles for 24 weeks) or 5-FU and leucovorin (Mayo Clinic regimen: 20 mg/m2 leucovorin IV followed by 425 mg/m2 IV bolus 5-FU, on days 1 to 5, every 28 days for 24 weeks).
Croatian: U tom ispitivanju slučajnim odabirom 1987 bolesnika liječeno je kapecitabinom (1250 mg/m2 dvaput dnevno kroz 2 tjedna nakon čega slijedi jednotjedna pauza, ciklusi u 3-tjednim intervalima u razdoblju od 24 tjedna) ili 5-FU i leukovorinom (protokol Mayo klinike: 20 mg/m2 leukovorina i.v. i 425 mg/m2 5-FU i.v. u bolusu od prvog do petog dana, svakih 28 dana u razdoblju od 24 tjedna).
English: Common side effects (may affect up to 1 in 10 people) include: - decrease in blood sodium, magnesium or calcium, increase in blood sugar - nerve pain - ringing or buzzing in the ears (tinnitus), loss of hearing - vein inflammation - hiccups, change in voice - pain or altered/abnormal sensation in the mouth, pain in the jaw - sweating, night sweats - muscle spasm - difficulty in urination, blood or protein in the urine - bruising or reaction at the injection site (caused by medicines given by injection at the same time).
Croatian: Česte nuspojave (mogu se javiti u do 1 na 10 osoba): - snižene razine natrija, magnezija ili kalcija u krvi, povišene razine šećera u krvi - živčana bol - zvonjenje ili zujanje u ušima (tinitus), gubitak sluha - upala vena - štucanje, promjena boje glasa - bol ili promijenjen/abnormalan osjet u ustima, bol u čeljusti - znojenje, noćno znojenje - grčevi mišića - otežano mokrenje, krv ili bjelančevine u mokraći - modrice ili reakcija na mjestu injekcije (posljedica primjene lijekova injekcijom u isto vrijeme).
English: Marketing Authorisation Holder and Manufacturer Sun Pharmaceutical Industries Europe B.V. Polarisavenue 87
Croatian: Nositelj odobrenja za stavljanje gotovog lijeka u promet i proizvođač Sun Pharmaceutical Industries Europe BV Polarisavenue 87