FrancophonIA/ELRC3.0 huggingface dataset:
English: - In patients with known dihydropyrimidine dehydrogenase (DPD) deficiency (see section 4.4).
Croatian: - Bolesnici s poznatim deficitom dihidropirimidin dehidrogenaze (DPD) (vidjeti dio 4.4).
English: Folinic acid/folic acid: 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: Folinatna kiselina/folna kiselina: ispitivanje kombinirane primjene kapecitabina i folinatne kiseline pokazalo je da folinatna kiselina nema većeg utjecaja na farmakokinetiku kapecitabina i njezinih metabolita.
English: Capecitabine SUN is not indicated in children and adolescents.
Croatian: Kapecitabin SUN nije namijenjen za primjenu u djece i adolescenata.
English: Coumarin-derivative anticoagulants: altered coagulation parameters and/or bleeding have been reported in patients taking capecitabine concomitantly with coumarin-derivative anticoagulants such as warfarin and phenprocoumon.
Croatian: Kumarinski antikoagulansi: promijenjeni koagulacijski parametri i/ili krvarenje zabilježeni su u bolesnika koji su kapecitabin uzimali istodobno s kumarinskim antikoagulansima, kao što su varfarin i fenprokumon.
English: See also interaction with coumarin-derivative anticoagulants below, and section 4.4.
Croatian: Vidjeti interakcije s kumarinskim antikoagulansima u nastavku te dio 4.4.
English: • Grade 4 -1st appearance
Croatian: • Stupanj 4 -1. pojavljivanje
English: Interrupt until resolved to grade 0-1
Croatian: -1. pojavljivanje Prekinuti dok se ne svede na stupanj 0-2. pojavljivanje
English: Women of childbearing potential/Contraception in males and females Women of childbearing potential should be advised to avoid becoming pregnant while receiving treatment with capecitabine.
Croatian: Žene reproduktivne dobi / Kontracepcija u muškaraca i žena Žene reproduktivne dobi potrebno je savjetovati da tijekom liječenja kapecitabinom izbjegavaju trudnoću.
English: If the calculated creatinine clearance decreases during treatment to a value below 30 ml/min, capecitabine should be discontinued.
Croatian: Ako se izračunati klirens kreatinina smanji tijekom liječenja ispod 30 ml/min liječenje kapecitabinom treba prekinuti.
English: After oral administration, capecitabine is rapidly and extensively absorbed, followed by extensive conversion to the metabolites, 5'-DFCR and 5'-DFUR.
Croatian: Nakon peroralne primjene kapecitabin se brzo i ekstenzivno apsorbira, nakon čega slijedi ekstenzivna konverzija u metabolite 5'-DFCR i 5'-DFUR.
English: Coumarin-derivative anticoagulation.
Croatian: Antikoagulacijska terapija derivatima kumarina.
English: An effective method of contraception should be used during treatment.
Croatian: Tijekom liječenja se mora primjenjivati u činkovita metoda kontracepcije.
English: Oxaliplatin Leucovorin 5-Fluorouracil
Croatian: 5-fluorouracil:
English: 1) or the Common Terminology Criteria for Adverse Events (CTCAE) of the Cancer Therapy Evaluation Program, US National Cancer Institute, version 4.0.
Croatian: *prema općim kriterijima toksičnosti skupine za klinička ispitivanja Kanadskoga nacionalnog instituta za rak (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, US National Cancer Institute), verzija 4.0.
English: - Treatment with sorivudine or its chemically related analogues, such as brivudine (see section 4.5).
Croatian: - Liječenje sorivudinom ili njegovim kemijskim analozima, poput brivudina (vidjeti dio 4.5).
English: Capecitabine SUN with food and drink You should take Capecitabine SUN no later than 30 minutes after meals.
Croatian: Kapecitabin SUN s hranom i pićem Lijek Kapecitabin SUN uzmite najkasnije 30 minuta nakon jela.
English: Uncommon Severe and/or Lifethreatening (grade 3-4) or considered medically relevant
Croatian: Teške i/ili po život opasne (stupanj 3 do 4) ili one koje se smatraju medicinski značajnima
English: There is some evidence that dexpanthenol is effective for hand-foot syndrome prophylaxis in patients treated with capecitabine.
Croatian: Postoje dokazi o tome da je deksapantenol djelotvoran za profilaksu sindroma šaka-stopalo u bolesnika liječenih kapecitabinom.
English: Hand-foot syndrome (also known as hand-foot skin reaction or palmar-plantar erythrodysesthesia or chemotherapy induced acral erythema).
Croatian: Sindrom šaka-stopalo (poznat i kao kožna reakcija na šakama i stopalima ili palmarno-plantarna eritrodizestezija ili akralni eritem izazvan kemoterapijom).
English: Sun Pharmaceutical Industries Europe B.V. Polarisavenue 87
Croatian: Sun Pharmaceutical Industries Europe BV Polarisavenue 87
English: If grade 2 or 3 hand- foot syndrome occurs, administration of capecitabine should be interrupted until the event resolves or decreases in intensity to grade 1.
Croatian: Ako se razvije sindrom šaka-stopalo 2. ili 3. stupnja liječenje kapecitabinom mora se prekinuti do povlačenja tegoba ili smanjenja njihovog intenziteta na 1. stupanj.
English: Phenytoin: increased phenytoin plasma concentrations resulting in symptoms of phenytoin intoxication in single cases have been reported during concomitant use of capecitabine with phenytoin.
Croatian: Fenitoin: povećana koncentracija fenitoina u plazmi, koja je u pojedinačnim slučajevima dovela do pojave simptoma intoksikacije fenitoinom, zabilježena je tijekom istodobnog uzimanja kapecitabina i fenitoina.
English: PRIMARY ANALYSIS XELOX/XELOX+P/ XELOX+BV (EPP*: N=967; ITT**: N=1017)
Croatian: PRIMARNA ANALIZA XELOX / XELOX + P / XELOX + BV (EPP*: N = 967; ITT**: N = 1017)
English: Capecitabine SUN contains capecitabine, which itself is not a cytostatic agent.
Croatian: Kapecitabin SUN sadrži kapecitabina, koji sam po sebi nije citostatik.
English: The European Medicines Agency has waived the obligation to conduct studies with the reference medicinal product containing 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 je izuzela obvezu podnošenja rezultata ispitivanja referentnog lijeka koji sadrži kapecitabin u svim podskupinama pedijatrijske populacije u indikacijama adenokarcinoma kolona i rektuma, adenokarcinoma želuca i karcinoma dojke (vidjeti dio 4.2 za informacije o pedijatrijskoj primjeni).
English: Patients with known DPD deficiency should not be treated with capecitabine (see section 4.3).
Croatian: Bolesnici s poznatim deficitom DPD-a ne smiju se liječiti kapecitabinom (vidjeti dio 4.3).
English: In a drug 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: Very rare side effects (may affect up to 1 in 10,000 people) include: - severe skin reaction such as skin rash, ulceration and blistering which may involve ulcers of the mouth, nose, genitalia, hands, feet and eyes (red and swollen eyes).
Croatian: Vrlo rijetke nuspojave (mogu se javiti u do 1 na 10 000 osoba): - teške kožne reakcije poput osipa kože, vrijedova i mjehurića koji mogu obuhvaćati vrijedove u ustima, nosu, spolnim organima, šakama, stopalima i očima (crvene i otečene oči).
English: Patients with hepatic impairment due to liver metastases: According to a pharmacokinetic study in cancer patients with mild to moderate liver impairment due to liver metastases, the bioavailability of capecitabine and exposure to 5-FU may increase compared to patients with no liver impairment.
Croatian: Bolesnici s oštećenjem jetre zbog jetrenih metastaza: Prema ispitivanjima farmakokinetike u bolesnika s karcinomom koji su imali blago do umjereno narušenu funkciju jetre zbog jetrenih metastaza, bioraspoloživost kapecitabina i izloženost 5-FU mogu biti veći u usporedbi s bolesnicima koji nemaju narušenu funkciju jetre.
English: Caution must be exercised in patients with pre-existing hypo- or hypercalcaemia (see section 4.8).
Croatian: Pozornost se mora obratiti na bolesnike s već postojećom hipokalcijemijom ili hiperkalcijemijom (vidjeti dio 4.8).
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.
Croatian: Ako ne znate da imate nedostatak DPD-a, a uzimate lijek Kapecitabin SUN, možete dobiti teške oblike nuspojava navedenih u dijelu 4. Moguće nuspojave.
English: Permanent discontinuation should be considered bases on clinical assessment of the onset, duration and severity of the observed toxicities.
Croatian: Treba razmotriti trajnu obustavu lijeka na temelju kliničke procjene nastupa, trajanja i težine toksičnosti.
English: Capecitabine has minor or moderate influence on the ability to drive and use machines.
Croatian: Kapecitabin malo do umjereno utječe na sposobnost upravljanja vozilima i rada sa strojevima.
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).
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 ECOG status na početku liječenja (0 nasuprot ≥ 1).
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.
Croatian: Interferon alfa: MTD kapecitabina iznosila je 2000 mg/m2 dnevno u kombinaciji s interferonom alfa2a (3 MIU/m2 dnevno), u usporedbi s 3000 mg/m2 dnevno kad se kapecitabin primjenjivao sam.
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.
Croatian: Karcinom debelog crijeva, kolorektalni karcinom i uznapredovali karcinom želuca: metaanaliza Metaanaliza šest kliničkih ispitivanja (SO14695, SO14796, M66001, NO16966, NO16967, M17032) podržava zamjenu 5-FU kapecitabinom u monoterapiji i kombiniranoj terapiji karcinoma probavnog sustava.
English: When capecitabine was used in combination with other medicinal products, elderly patients (≥65 years) experienced more grade 3 and grade 4 adverse drug reactions, including those leading to discontinuation, compared to younger patients.
Croatian: Pri primjeni kapecitabina u kombinaciji s drugim lijekovima stariji bolesnici (65 godina) su imali više nuspojava 3. i 4. stupnja nego mlađi, uključujući i one zbog kojih je trebalo prekinuti liječenje.
English: Currently, no comparative data are available on capecitabine monotherapy in colorectal cancer in comparison with first line combination regimens.
Croatian: Za sada nema podataka o usporedbi monoterapije kapecitabinom i kombinirane terapije u prvoj liniji liječenja kolorektalnoga karcinoma
English: Bevacizumab: there was no clinically significant effect of bevacizumab on the pharmacokinetic parameters of capecitabine or its metabolites in the presence of oxaliplatin.
Croatian: Bevacizumab: nisu uočeni klinički značajni učinci bevacizumaba na farmakokinetičke parametre kapecitabina ili njegovih metabolita u prisutnosti oksaliplatina.
English: blood in the urine, increase in blood creatinine (sign of kidney dysfunction) - unusual bleeding from the vagina - swelling (oedema), chills and rigors.
Croatian: krv u mokraći, povišene razine kreatinina u krvi (znak poremećaja bubrežne funkcije) - neuobičajeno krvarenje iz rodnice - oticanje (edemi), zimica i tresavica.
English: Antacid: the effect of an aluminium hydroxide and magnesium hydroxide-containing antacid on the pharmacokinetics of capecitabine was investigated.
Croatian: Antacidi: ispitivan je učinak antacida koji sadrže aluminij hidroksid i magnezij hidroksid na farmakokinetiku kapecitabina.
English: There is no relevant use of capecitabine in the paediatric population in the indications colon, colorectal, gastric and breast cancer.
Croatian: Nema relevantne primjene kapecitabina u pedijatrijskoj populaciji u indikaciji karcinoma debelog crijeva, kolorektalnog karcinoma, karcinoma želuca i karcinoma dojke.
English: Therefore, capecitabine must not be administered concomitantly with sorivudine or its chemically related analogues, such as brivudine (see section 4.3).
Croatian: Stoga se kapecitabin ne smije primjenjivati sa sorivudinom ili njemu kemijski srodnim analozima, kao što je brivudin (vidjeti dio 4.3).
English: Capecitabine is indicated for the treatment of metastatic colorectal cancer (see section 5.1).
Croatian: Kapecitabin je indiciran za liječenje metastatskog kolorektalnog karcinoma (vidjeti dio 5.1).
English: Capecitabine SUN tablets should be swallowed whole with water, and within 30 minutes of a meal.
Croatian: Kapecitabin SUN tablete potrebno je progutati cijele, s vodom, u roku od 30 minuta nakon obroka.
English: You need to be particularly careful if you are taking any of the following: - gout medicines (allopurinol) - blood-thinning medicines (coumarin, warfarin) - certain anti-viral medicines (sorivudine and brivudine) - medicines for seizures or tremors (phenytoin) - a medicine to treat cancer (interferon alpha) - radiotherapy and certain medicines used to treat cancer (folinic acid, oxaliplatin, bevacizumab,
Croatian: Osobito budite oprezni ako uzimate neki od ovih lijekova: - lijekove za giht (alopurinol) - lijekove protiv zgrušavanja krvi (kumarin, varfarin) - određene antivirusne lijekove (sorivudin i brivudin) - lijekove protiv epilepsije ili tremora (fenitoin) - lijekove za liječenje karcinoma (interferon alfa) - ako primate terapiju zračenjem ili uzimate neke lijekove za liječenje raka (folinatna kiselina,
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.
Croatian: Nuspojave na lijek koje je naveo ispitivač kao 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 pri različitim indikacijama.
English: Cardiotoxicity.
Croatian: Kardiotoksičnost.
English: Capecitabine in combination with docetaxel (see section 5.1) is indicated for the treatment of patients with locally advanced or metastatic breast cancer after failure of cytotoxic chemotherapy.
Croatian: Kapecitabin je u kombinaciji s docetakselom (vidjeti dio 5.1) indiciran u liječenju bolesnika s lokalno uznapredovalim ili metastatskim karcinomom dojke nakon neuspjeha citotoksične kemoterapije antraciklinima.
English: Parameter: Progression-free Survival PPP ITT Parameter: Overall Survival PPP ITT
Croatian: Parametar: preživljenje bez progresije bolesti PPP ITT Parametar: ukupno preživljenje PPP ITT
English: In case you are using coumarin anticoagulants (containing e.g. phenprocoumon), stopping Capecitabine SUN might require that your doctor adjusts your anticoagulant dose.
Croatian: Ako uzimate antikoagulanse kumarinskog tipa (koji sadrže npr. fenprokumon) nakon prestanaka uzimanja kapecitabina možda će Vam liječnik morati prilagoditi dozu antikoagulansa.
English: During a treatment cycle for those toxicities considered by the treating physician not to be related to capecitabine, capecitabine should be continued and the dose of the other medicinal product should be adjusted according to the appropriate Prescribing Information.
Croatian: Ako se tijekom liječenja razviju toksične reakcije koje prema mišljenju liječnika koji provodi liječenje nisu povezane s primjenom kapecitabina, liječenje kapecitabinom treba nastaviti, a dozu drugog lijeka treba prilagoditi prema Sažetku opisa svojstava tog lijeka.
English: In monkeys, abortion and embryolethality were observed at high doses, but there was no evidence of teratogenicity.
Croatian: U majmuna su, visoke doze izazvale pobačaj i smrt ploda, ali nije bilo dokaza teratogenosti.
English: In patients with unrecognised DPD deficiency treated with capecitabine, life-threatening toxicities manifesting as acute overdose may occur (see section 4.9).
Croatian: U bolesnika s neprepoznatim deficitom DPD-a liječenih kapecitabinom, može doći do po život opasne toksičnosti koja se manifestira kao akutno predoziranje (vidjeti dio 4.9).
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).
Croatian: Međutim folinatna kiselina djeluje na farmakodinamiku kapecitabina te njezina toksičnost može biti povećana folinatnom kiselinom: najveća podnošljiva doza (MTD - Maximum tolerated dose) kapecitabina u monoterapiji i intermitentnom liječenju iznosi 3000 mg/m2 dnevno, a 2000 mg/m2 dnevno kad se kapecitabin daje u kombinaciji s folinatnom kiselinom (30 mg oralno dvaput dnevno).
English: Capecitabine SUN is used in the treatment of colon, rectal, gastric, or breast cancers.
Croatian: Kapecitabin SUN se koristi za liječenje karcinoma debelog crijeva, rektuma, želuca ili dojke.
English: Capecitabine can induce severe skin reactions such as Stevens-Johnson syndrome and Toxic Epidermal Necrolysis.
Croatian: Kapecitabin može potaknuti razvoj teških kožnih reakcija poput StevensJohnosonova sindroma i toksične epidermalne nekrolize.
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./
Croatian: 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./
English: There are no side-effects caused by stopping treatment with Capecitabine SUN.
Croatian: Nema nuspojava uzrokovanih prestankom liječenja kapecitabinom.
English: Breast-feeding should be discontinued while receiving treatment with capecitabine.
Croatian: Dojenje treba prekinuti dok traje liječenje kapecitabinom.
English: If you forget to take Capecitabine SUN
Croatian: Ako ste zaboravili uzeti lijek Kapecitabin SUN
English: Patients with renal impairment (see section 4.2, 4.4, and 5.2) An analysis of safety data in patients treated with capecitabine monotherapy (colorectal cancer) with baseline renal impairment showed an increase in the incidence of treatment-related grade 3 and 4 adverse reactions compared to patients with normal renal function (36% in patients without renal impairment n=268, vs. 41% in mild n=257 and 54% in moderate n=59, respectively) (see section 5.2).
Croatian: Bolesnici s oštećenjem bubrežne funkcije (vidjeti dijelove 4.2, 4.4, i 5.2) Analiza sigurnosnih podataka kod bolesnika liječenih monoterapijom kapecitabinom (kolorektalni karcinom) s postojećim oštećenjem bubrežne funkcije pokazala je višu incidenciju s terapijom povezanih nuspojava 3. i 4. stupnja u usporedbi s bolesnicima s normalnom bubrežnom funkcijom (36% kod bolesnika bez oštećenja bubrežne funkcije n=268 nasuprot 41% kod blagog oštećenja bubrežne funkcije n=257 i 54% kod umjerenog oštećenja bubrežne funkcije n=59) (vidjeti dio 5.2).
English: cisplatin, irinotecan) - medicines used to treat folic acid deficiency.
Croatian: oksilaplatin, bevacizumab, cisplatin, irinotekan) - lijekove za liječenje nedostatka folne kiseline.
English: You might get the following side effects if you take a lot more capecitabine than you should: feeling or being sick, diarrhoea, inflammation or ulceration of the gut or mouth, pain or bleeding from the intestine or stomach, or bone marrow depression (reduction in certain kinds of blood cells).
Croatian: Ako uzmete puno više kapecitabina nego što ste trebali, mogle bi se javiti sljedeće nuspojave: mučnina ili povraćanje, proljev, upala ili vrijedovi u crijevima ili ustima, bol ili krvarenje iz crijeva ili želuca, ili depresija koštane srži (smanjenje broja nekih vrsta krvnih stanica).
English: The hazard ratio for overall survival was 0.94 (95% CI: 0.89; 1.00, p=0.0489) indicating that capecitabine-containing regimens are non-inferior to 5-FU-containing regimens.
Croatian: Omjer hazarda za ukupno preživljenje bio je 0,94 (95% CI: 0,89; 1,00, p=0,0489), što pokazuje da terapijski protokoli koji sadrže kapecitabin nisu inferiorni u odnosu na terapijske protokole koji sadrže 5-FU.
English: Capecitabine is indicated for first-line treatment of advanced gastric cancer in combination with a platinum-based regimen (see section 5.1).
Croatian: Kapecitabin je indiciran u prvoj liniji liječenja uznapredovalog karcinoma želuca u kombinaciji s platinskim spojem (vidjeti dio 5.1).
English: Dose limiting toxicities include diarrhoea, abdominal pain, nausea, stomatitis and hand-foot syndrome (hand-foot skin reaction, palmar-plantar erythrodysesthesia).
Croatian: Toksičnost koja ograničava dozu uključuje proljev, bol u abdomenu, mučninu, stomatitis i sindrom šaka-stopalo (kožna reakcija na šakama i stopalima, palmarno-plantarna eritrodizestezija).
English: The usual dose for adults is 1250 mg/m2 of body surface area taken two times daily (morning and evening).
Croatian: Uobičajena doza za odrasle iznosi 1250 mg/m2 tjelesne površine i uzima se dvaput dnevno
English: and bevacizumab (7.5 mg/kg as a 30 to 90 minute infusion on day 1 every 3 weeks).
Croatian: 3 tjedna) i bevacizumab (7,5 mg/kg kao infuzija u trajanju od 30 do 90 minuta 1. dana svaka 3 tjedna).
English: Capecitabine should only be prescribed by a doctor experienced in the use of anticancer medicines.
Croatian: Kapecitabin SUN smije propisati samo liječnik s iskustvom u primjeni lijekova protiv karcinoma.
English: If you stop taking Capecitabine SUN
Croatian: Ako prestanete uzimati lijek Kapecitabin SUN
English: Effective contraceptive precautions must be taken by patients who are taking Capecitabine SUN. You must not breast-feed if you are taking Capecitabine SUN.
Croatian: Učinkovite mjere kontracepcije moraju se primjenjivati kod pacijenata koji uzimaju Kapecitabin SUN.
English: Parameter: Overall Survival EPP ITT *EPP=eligible patient population; **ITT=intent-to-treat population
Croatian: *EPP = populacija pogodnih bolesnika; **ITT = populacija bolesnika predviđenih za liječenje
English: Tablet coating: hypromellose (E464) titanium dioxide (E171) lactose monohydrate macrogol yellow iron oxide (E172) and red iron oxide (E172).
Croatian: Ovojnica tablete: hipromeloza (E464) titanijev dioksid (E171) laktoza hidrat makrogol željezov oksid, žuti (E172) i željezov oksid, crveni (E172).