FrancophonIA/ELRC3.0 huggingface dataset:
English: When Azacitidine Celgene is reconstituted using refrigerated (2 °C to 8 °C) water for injections, the chemical and physical in-use stability of the reconstituted medicinal product has been demonstrated at 2 °C to 8 °C for 22 hours.
Croatian: Kada se Azacitidin Celgene rekonstituira rashlađenom vodom za injekcije (2 °C do 8 °C), kemijska i fizikalna stabilnost rekonstituiranog lijeka u primjeni dokazana je pri 2 °C do 8 °C tijekom 22 sata.
English: 9/l.
Croatian: 9/L ili
English: In patients who were RBC transfusion dependent at baseline and achieved transfusion independence on treatment, the median duration of RBC transfusion independence was 13.9 months in the azacitidine group and was not reached in the CCR group.
Croatian: U bolesnika koji su ovisili o transfuzijama eritrocita na početku i postigli neovisnost o transfuzijama uz liječenje, medijan trajanja neovisnosti o transfuzijama eritrocita iznosio je 13,9 mjeseci u skupini koja je primala azacitidin i nije bio postignut u skupini koja je primala CCR.
English: In all pre- specified subgroups age [(< 75 years & ≥ 75 years), gender, race, ECOG performance status (0 or 1 & 2) , baseline cytogenetic risk (intermediate & poor) , geographic region, WHO classification of AML (including AML with myelodysplasia-related changes), baseline WBC count (≤ 5 x10
Croatian: Trend koristi za ukupno preživljenje išao je u prilog azacitidinu u svim unaprijed određenim podskupinama po dobi [(< 75 godina i ≥ 75 godina), spolu, rasi, ECOG funkcionalnom statusu (0 ili 1 i 2) , početnom citogenetskom riziku (srednji i visoki), geografskoj regiji, klasifikaciji AML-a prema SZO-u (uključujući AML s promjenama povezanim s mijelodisplazijom), početnom broju bijelih krvnih stanica (≤ 5 x 10
English: In patients who were platelet transfusion dependent at baseline and achieved transfusion independence on treatment, the median duration of platelet transfusion independence was 10.8 months in the azacitidine group and 19.2 months in the CCR group.
Croatian: U bolesnika koji su na početku bili ovisni o transfuzijama trombocita i postigli neovisnost o transfuzijama uz liječenje, medijan trajanja neovisnosti o transfuzijama trombocita bio je 10,8 mjeseci u skupini liječenoj azacitidinom i 19,2 mjeseca u skupini liječenoj CCR-om.
English: Each vial contains 100 mg azacitidine.
Croatian: Svaka bočica sadrži 100 mg azacitidina.
English: In patients who achieved CR or CRi, the median duration of remission was 10.4 months (95% CI = 7.2, 15.2) for the azacitidine subjects and 12.3 months (95% CI = 9.0, 17.0) for the CCR subjects.
Croatian: U bolesnika koji su postigli potpunu remisiju ili potpunu remisjiju s nepotpunim oporavkom krvne slike, medijan trajanja remisije iznosio je 10,4 mjeseca (95 % CI = 7,2; 15,2) u ispitanika liječenih azacitidinom i 12,3 mjeseca (95 % CI = 9,0; 17,0) u ispitanika liječenih CCR-om.
English: Do not use Azacitidine Celgene
Croatian: Nemojte primjenjivati Azacitidin Celgene:
English: The survival benefits of azacitidine were consistent regardless of the CCR treatment option (BSC alone, low-dose cytarabine plus BSC or standard induction chemotherapy plus BSC) utilised in the control arm.
Croatian: Dobrobit od azacitidina za vrijeme preživljenja bila je konzistentna bez obzira na vrstu liječenja primijenjenu u kontrolnoj skupini tijekom liječenja CCR-om (samo BSC-om, niske doze citarabina s BSC-om ili standardna indukcijska kemoterapija s BSC-om).
English: Of the patients in the azacitidine group who were RBC transfusion dependent at baseline, 38.5% (95% CI = 31.1, 46.2) of these patients became RBC transfusion independent during the treatment period, compared with 27.6% of (95% CI = 20.9, 35.1) patients in the combined CCR groups.
Croatian: Od bolesnika u skupini liječenoj azacitidinom koji su na početku bili ovisni o transfuziji eritrocita, 38,5 % (95 % CI = 31,1; 46,2) postalo je neovisno o transfuzijama eritrocita tijekom razdoblja liječenja u usporedbi s 27,6 % (95 % CI = 20,9; 35,1) bolesnika u kombiniranim skupinama liječenima CCR-om.
English: Of the patients in the azacitidine group who were platelet transfusion dependent at baseline, 40.6% (95% CI = 30.9, 50.8) of these patients became platelet transfusion independent during the treatment period, compared with 29.3% of (95% CI = 19.7, 40.4) patients in the combined CCR groups.
Croatian: Od bolesnika u skupini liječenoj azacitidinom koji su na početku bili ovisni o transfuziji trombocita, 40,6 % (95 % CI = 30,9; 50,8) postalo je neovisno o transfuziji trombocita tijekom razdoblja liječenja u usporedbi s 29,3 % (95 % CI = 19,7, 40,4) bolesnika u kombiniranim skupinama liječenima CCR-om.
English: You should not breast-feed when using Azacitidine Celgene.
Croatian: Ne smijete dojiti za vrijeme primjene Azacitidina Celgene.
English: How to use Azacitidine Celgene
Croatian: Kako primjenjivati Azacitidin Celgene
English: What Azacitidine Celgene is
Croatian: Što je Azacitidin Celgene
English: *Recovery = counts ≥ nadir count + (0.5 x [baseline count - nadir count]) Patients with reduced baseline blood counts (i.e. WBC < 3.0 x 10
Croatian: ≥ najniža vrijednost + (0,5 x [početna vrijednost - najniža vrijednost]) Bolesnici sa smanjenim vrijednostima početne krvne slike (tj. bijele krvne stanice < 3,0 x 10
English: 9/l and
Croatian: 9/L i
English: 9/l or ANC < 1.5 x 10
Croatian: 9/L i >5 x 10
English: Adult population aged 65 years or older with AML with > 30% marrow blasts The results presented below represent the intent-to-treat population studied in AZA-AML-001 (see section 4.1 for the approved indication).
Croatian: Niže prikazani podaci odnose se na populaciju koju se namjeravalo liječiti u ispitivanju AZA-AML-001 (vidjeti dio 4.1 za odobrene indikacije).
English: Platelets (x 10
Croatian: Trombociti (x 10 9/L)
English: How to store Azacitidine Celgene
Croatian: Kako čuvati Azacitidin Celgene
English: If the Azacitidine Celgene suspension is prepared using water for injections that has not been refrigerated, the suspension must be placed in the refrigerator (2 °C - 8 °C) immediately after it is prepared and kept refrigerated for up to a maximum of 8 hours.
Croatian: Ako je suspenzija Azacitidina Celgene pripremljena s vodom za injekcije koja nije bila rashlađena, suspenziju se mora staviti u hladnjak (2 °C do 8 °C) odmah nakon pripreme te čuvati u hladnjaku najviše 8 sati.
English: Elderly patients
Croatian: Starije osobe
English: Following Azacitidine Celgene treatment, if the decrease in WBC or ANC or platelets from that prior to treatment is ≤ 50 %, or greater than 50 % but with an improvement in any cell line differentiation, the next cycle should not be delayed and no dose adjustment made.
Croatian: Sljedeći ciklus ne treba odgađati te dozu ne treba prilagođavati ako je nakon liječenja Azacitidinom Celgene smanjenje vrijednosti bijelih krvnih stanica ili apsolutnog broja neutrofila ili trombocita u odnosu na vrijednosti prije početka liječenja ≤ 50 % ili veće od 50 %, ali uz poboljšanje diferencijacije bilo koje stanične linije.
English: If the Azacitidine Celgene suspension is prepared using water for injections that has been stored in the refrigerator (2 °C - 8 °C), the suspension must be placed in the refrigerator (2 °C - 8 °C) immediately after it is prepared and kept refrigerated for up to a maximum of 22 hours.
Croatian: Ako je suspenzija Azacitidina Celgene pripremljena rashlađenom vodom za injekcije (2 °C do 8 °C), suspenziju se mora staviti u hladnjak (2 °C do 8 °C) odmah nakon pripreme te držati u hladnjaku najviše 22 sata.
English: A patient experienced diarrhoea, nausea, and vomiting after receiving a single intravenous dose of approximately 290 mg/m almost 4 times the recommended starting dose.
Croatian: Nakon primjene jedne intravenske doze od približno 290 mg/m2, gotovo 4 puta veće od preporučene početne doze, kod bolesnika su se pojavili proljev, mučnina i povraćanje.
English: A patient was considered RBC or platelet transfusion independent during the treatment period if the subject had no RBC or platelet transfusions during any consecutive 56 days during the reporting period, respectively.
Croatian: Smatralo se da bolesnik nije ovisan o transfuziji eritrocita ili trombocita tijekom razdoblja liječenja ako taj ispitanik nije primio
English: Cytotoxic
Croatian: • tjeskoba
English: How Azacitidine Celgene works
Croatian: Kako Azacitidin Celgene djeluje
English: CLINICAL PARTICULARS
Croatian: Izračun pojedinačne doze
English: What Azacitidine Celgene is used for
Croatian: Za što se Azacitidin Celgene koristi
English: < 75.0 x 10
Croatian: 9/L ili trombociti < 75,0 x 10
English: Method of administration Reconstituted Azacitidine Celgene should be injected subcutaneously (insert the needle at a 45-90
Croatian: Rekonstituirani Azacitidin Celgene treba injicirati supkutano (iglu uvesti pod kutom od 45-90°) koristeći se iglom od 25 G u nadlakticu, bedro ili abdomen.
English: These proteins encourage the growth of new cells.
Croatian: Ti proteini potiču rast novih stanica.
English: What is Balimek?
Croatian: Što je Balimek?
English: It was to be available as tablets to be taken by mouth.
Croatian: Trebao je biti dostupan u obliku tableta koje se uzimaju kroz usta.
English: The main measure of effectiveness was how long patients lived without their disease getting worse.
Croatian: Glavna mjera djelotvornosti bilo je razdoblje tijekom kojega su bolesnici živjeli bez pogoršanja bolesti.
English: EMEA/H/C/004052
Croatian: EMA/41972/2018 EMEA/H/C/004052
English: The active substance in Balimek, binimetinib, blocks proteins called MEK1 and MEK2.
Croatian: Djelatna tvar u lijeku Balimek, binimetinib, blokira proteine naziva MEK1 i MEK2.
English: The evidence provided was insufficient to show that Balimek fulfils an unmet medical need.
Croatian: Dostavljeni dokazi nisu bili dostatni za dokazivanje da lijek Balimek ispunjava nezadovoljenu medicinsku potrebu.
English: It was to be used in patients who had a specific genetic mutation (change) called NRAS Q61 mutation.
Croatian: Trebao se primjenjivati u bolesnika koji imaju posebnu genetsku mutaciju (promjena) nazvanu mutacija NRAS Q61.
English: Considering this, along with data on the time patients lived overall and their quality of life, the CHMP considered that Balimek's effectiveness was questionable.
Croatian: S obzirom na navedeno, uzimajući u obzir i podatke o ukupnom životnom vijeku bolesnika i njihovoj kvaliteti života, CHMP je zaključio da je djelotvornost lijeka Balimek upitna.
English: The company had not responded to the last round of questions at the time of the withdrawal.
Croatian: U trenutku povlačenja tvrtka još nije bila dostavila svoje odgovore na posljednji niz pitanja.
English: Balimek is a medicine that contains the active substance binimetinib.
Croatian: Balimek je lijek koji sadrži djelatnu tvar binimetinib.
English: The Committee also considered that although no medicine is approved specifically to treat patients with the NRAS Q61 mutation, there are effective treatments for melanoma in general.
Croatian: Odbor također smatra da, iako ne postoji lijek odobren posebno za liječenje bolesnika s mutacijom NRAS Q61, općenito postoje djelotvorni lijekovi za liječenje melanoma.
English: Balimek was expected to be used for treating melanoma (a type of skin cancer) that had spread or could not be removed by surgery.
Croatian: Balimek se trebao primjenjivati za liječenje melanoma (vrsta raka kože) koji se proširio ili se nije mogao kirurški odstraniti.
English: The company informed the CHMP that there are no consequences for patients currently included in clinical trials using Balimek.
Croatian: Tvrtka je obavijestila CHMP da nema posljedica za bolesnike koji su u ovom trenutku uključeni u klinička ispitivanja u kojima se koristi lijek Balimek.
English: The company presented data from one main study comparing Balimek with dacarbazine (a cancer medicine used for treating melanoma).
Croatian: Tvrtka je dostavila podatke iz jednog glavnog ispitivanja u okviru kojeg je lijek Balimek uspoređen s dakarbazinom (lijek protiv raka koji se primjenjuje za liječenje melanoma).
English: On 4 January 2018, Pierre Fabre Médicament officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wished to withdraw its application for a marketing authorisation for Balimek, for the treatment of melanoma.
Croatian: Pierre Fabre Médicament službeno je obavijestio Odbor za lijekove za humanu uporabu (CHMP) kako želi povući svoj zahtjev za odobrenje za stavljanje u promet lijeka Balimek za liječenje melanoma.
English: In its letter notifying the Agency of the withdrawal of the application, the company stated that the withdrawal is based on CHMP's opinion that the data supplied did not provide sufficient evidence to conclude that the medicine's benefits outweigh its risks.
Croatian: U svojem dopisu kojim obavještava Agenciju o povlačenju zahtjeva tvrtka je navela da povlači zahtjev zbog mišljenja CHMP-a da dostavljeni podatci ne pružaju dostatne dokaze za donošenje zaključka da koristi lijeka nadmašuju s njim povezane rizike.
English: The CHMP noted that patients treated with Balimek lived slightly longer without their disease getting worse compared with those receiving dacarbazine.
Croatian: CHMP je uočio da su bolesnici liječeni lijekom Balimek živjeli neznatno dulje bez pogoršanja bolesti u usporedbi s bolesnicima koji su primali dakarbazin.
English: Withdrawal of the marketing authorisation application for Balimek (binimetinib)
Croatian: Povlačenje zahtjeva za izdavanje odobrenja za stavljanje u promet lijeka Balimek (binimetinib)
English: By blocking the MEK proteins, Balimek is expected to slow down the growth of melanoma cells.
Croatian: Blokiranjem MEK proteina lijek Balimek trebao je usporiti rast stanica melanoma.
English: What was Balimek expected to be used for?
Croatian: Za što se Balimek trebao koristiti?
English: Based on the data reviewed, at the time of the withdrawal, the CHMP had some concerns and was of the provisional opinion that Balimek could not have been approved for the treatment of advanced melanoma in patients with the NRAS Q61 mutation.
Croatian: Na temelju pregleda podataka u trenutku povlačenja CHMP je smatrao da postoje razlozi za zabrinutost te je njegovo privremeno mišljenje bilo da nije moguće dati odobrenje za lijek Balimek za liječenje naprednog stadija melanoma u bolesnika s mutacijom NRAS Q61.
English: The study involved 402 patients with advanced melanoma with the NRAS Q61 mutation that had spread or could not be removed by surgery.
Croatian: Ispitivanje je obuhvatilo 402 bolesnika s mutacijom NRAS Q61 i s naprednim stadijem melanoma koji se proširio ili se nije mogao kirurški odstraniti.
English: How does Balimek work?
Croatian: Kako djeluje Balimek?
English: EMA/41972/2018
Croatian: (binimetinib) EMA/41972/2018
English: Moreover, the CHMP was concerned that Balimek was linked to worse side effects than dacarbazine.
Croatian: Nadalje, CHMP je izrazio zabrinutost zbog nuspojava povezanih s lijekom Balimek, koje su ozbiljnije nego nuspojave povezane s dakarbazinom.
English: Therefore, at the time of the withdrawal, the CHMP was of the opinion that the benefits of Balimek did not outweigh its risks.
Croatian: Sukladno navedenome, CHMP je u vrijeme povlačenja smatrao kako koristi od lijeka Balimek ne nadmašuju s njim povezane rizike.
English: 1 ml (100 mg/ml) 1 pre-filled syringe
Croatian: 1 napunjena štrcaljka
English: 1 ml (100 mg/ml) 2 pre-filled syringes
Croatian: 2 napunjene štrcaljke
English: 1 bottle
Croatian: 2 boce
English: MA (EU) number (Invented) name Strength Pharmaceutical form
Croatian: Broj (EU) odobrenja (Zaštićeno) ime
English: The full EPAR for Capecitabine SUN can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Croatian: Cjelovito Europsko javno izvješće o ocjeni dokumentacije o lijeku (EPAR) može se naći na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: The full EPAR for the reference medicine can also be found on the Agency's website.
Croatian: Cjeloviti EPAR za referentni lijek također možete naći na internetskim stranicama Agencije.
English: For other types of cancer, treatment is stopped if the disease gets worse or the patient cannot tolerate the treatment.
Croatian: U slučaju ostalih tipova karcinoma, liječenje se prekida ako se bolest pogorša ili ako bolesnik ne podnosi liječenje.
English: It is taken as tablets, while 5-FU normally needs to be injected.
Croatian: Uzima se u obliku tableta, dok 5-FU obično mora biti ubrizgan.
English: A risk management plan has been developed to ensure that Capecitabine SUN is used as safely as possible.
Croatian: Pripremljen je plan upravljanja rizikom kako bi se osiguralo da se Kapecitabin SUN koristi što je sigurnije moguće.
English: capecitabine
Croatian: kapecitabin
English: This is a summary of the European public assessment report (EPAR) for Capecitabine SUN.
Croatian: Ovo je sažetak Europskoga javnog izvješća o ocjeni dokumentacije (EPAR) za Kapecitabin SUN.
English: Two medicines are bioequivalent when they produce the same levels of the active substance in the body.
Croatian: Dva lijeka su bioekvivalentna kada u tijelu postižu iste razine djelatne tvari.
English: Capecitabine SUN tablets should be swallowed with water within the 30 minutes after a meal.
Croatian: Kapecitabin SUN tablete uzimaju se s vodom u roku od 30 minuta nakon obroka.
English: The doctor will calculate the number of 150- and 500-mg tablets the patient needs to take.
Croatian: Liječnik mora izračunati koliko tableta od 150 i 500 mg bolesnik mora uzeti.
English: 5-FU is an analogue of pyrimidine.
Croatian: 5-FU je analog pirimidina.
English: It is not intended to provide practical advice on how to use Capecitabine SUN.
Croatian: Svrha sažetka nije davati praktične savjete o načinu korištenja Kapecitabina SUN.
English: Capecitabine SUN is taken twice a day at doses between 625 and 1,250 mg per square metre body surface area (calculated using the patient's height and weight).
Croatian: Kapecitabin SUN uzima se dva puta dnevno u dozama između 625 i 1.250 mg po metru kvadratnom tjelesne površine (izračunato pomoću visine i mase bolesnika).
English: In the body, 5-FU takes the place of pyrimidine and interferes with the enzymes involved in making new DNA.
Croatian: U tijelu, 5-FU preuzima ulogu pirimidina i interferira s enzimima uključenima u izradu nove DNK.
English: Capecitabine SUN is available as tablets (150 and 500 mg).
Croatian: Kapecitabin SUN dostupan je u tabletama (150 i 500 mg).
English: It explains how the Agency assessed the medicine to recommend its authorisation in the EU and its conditions of use.
Croatian: Objašnjava kako je Agencija ocijenila lijek radi njegovog odobrenja u Europskoj uniji te uvjeta za njegovu primjenu.
English: The dose depends on the type of cancer being treated.
Croatian: Doza ovisi o tipu karcinoma koji se liječi.
English: Treatment is continued for six months after colon surgery.
Croatian: Liječenje se nastavlja tijekom šest mjeseci nakon kirurškog zahvata na debelom crijevu.
English: It can only be obtained with a prescription and must be prescribed by a doctor who is experienced in the use of anticancer medicines.
Croatian: Ovaj se lijek izdaje samo na liječnički recept, a terapiju mora propisati liječnik s iskustvom u liječenju antikancerogenim lijekovima.
English: This means that Capecitabine SUN is similar to a ‘reference medicine' already authorised in the European Union (EU) called Xeloda.
Croatian: To znači da je Kapecitabin SUN sličan „referentnom lijeku” pod nazivom Xeloda koji je već odobren u Europskoj uniji (EU).
English: Pyrimidine is part of the genetic material of cells (DNA and RNA).
Croatian: Pirimidin je genetski materijal stanica (DNK ili RNK).
English: Doses need to be adjusted for patients with liver or kidney disease and for patients who develop certain side effects.
Croatian: Doza se mora prilagoditi bolesnicima s oboljenjima jetre ili bubrega i u slučaju bolesnika kod kojih se manifestiraju određene nuspojave.
English: What are the benefits and risks of Capecitabine SUN?
Croatian: Koje su koristi i rizici Kapecitabina SUN?
English: The Committee recommended that Capecitabine SUN be approved for use in the EU.
Croatian: Povjerenstvo preporučuje odobrenje Kapecitabina SUN za korištenje u Europskoj uniji.
English: What measures are being taken to ensure the safe and effective use of Capecitabine SUN?
Croatian: Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena Kapecitabina SUN?
English: Capecitabine is a ‘prodrug' that is converted to 5-fluorouracil (5-FU) in the body, mainly in tumour cells.
Croatian: Kapecitabin je predlijek koji se u tijelu pretvara u 5-fluorouracil (5-FU), i to uglavnom u stanicama tumora.
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Capecitabine SUN, including the appropriate precautions to be followed by healthcare professionals and patients.
Croatian: Na temelju tog plana sigurnosne informacije uključene su u sažetak opisa svojstava lijeka kao i u uputu o Kapecitabinu SUN, uključujući odgovarajuće mjere opreza kojih se zdravstveni djelatnici i bolesnici trebaju pridržavati.
English: Other information about Capecitabine SUN
Croatian: Druge informacije o Kapecitabinu SUN
English: Therefore, the CHMP's view was that, as for Xeloda, the benefit outweighs the identified risk.
Croatian: Stoga je stav CHMP-a da, kao i kod lijeka Xeloda, koristi nadmašuju utvrđene rizike.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Capecitabine SUN on 21 June 2013.
Croatian: Europska komisija izdaje odobrenje za stavljanje u promet koje za lijek Kapecitabin SUN vrijedi na prostoru Europske unije od 21 lipnja 2013. godine.
English: Capecitabine SUN is a ‘generic medicine'.
Croatian: Kapecitabin SUN je „generički lijek”.
English: • advanced gastric (stomach) cancer.
Croatian: • uznapredovanog gastritičnog karcinoma (karcinoma želuca).
English: It is used to treat:
Croatian: Ovaj se lijek koristi za liječenje sljedećih bolesti:
English: What is Capecitabine SUN and what is it used for?
Croatian: Što je Kapecitabin SUN i za što se koristi?
English: Because Capecitabine SUN is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine's.
Croatian: Budući da je Kapecitabin SUN generički lijek te je bioekvivalentan referentnom lijeku, smatra se da su njegovi koristi i rizici isti kao i oni referentnog lijeka.
English: For practical information about using Capecitabine SUN, patients should read the package leaflet or contact their doctor or pharmacist.
Croatian: Praktične informacije o korištenju Kapecitabina SUN bolesnici trebaju pročitati u uputi o lijeku ili se obratiti svom liječniku ili ljekarniku.
English: • locally advanced or metastatic breast cancer (breast cancer that has begun to spread to other parts of the body).
Croatian: • lokalno uznapredovanog ili metastatskog karcinoma dojke (karcinoma dojke koji se počeo širiti u druge dijelove tijela).
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with EU requirements, Capecitabine SUN has been shown to have comparable quality and to be bioequivalent to Xeloda.
Croatian: Povjerenstvo za lijekove za primjenu kod ljudi (CHMP) pri Agenciji zaključilo je kako je, u skladu sa zahtjevima EU-a, potvrđeno kako Kapecitabin SUN posjeduje usporedivu kakvoću te je bioekvivalentan s lijekom Xeloda.
English: • metastatic colorectal cancer (cancer of the large bowel that has spread to other parts of the body).
Croatian: • metastaziranog kolorektalnog karcinoma (karcinoma debelog crijeva koji se proširio u ostale dijelove tijela).
English: For more information about treatment with Capecitabine SUN, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Croatian: Više informacija o liječenju Kapecitabinom SUN pročitajte u uputi o lijeku (također dio EPAR-a) ili se obratite svom liječniku ili ljekarniku.