natgillin/translations-raw huggingface dataset:
If you are being treated for GIST: The starting dose is 400 mg, to be taken as one tablet once a day. 
Ako se liječite zbog GIST-a: Početna doza je 400 mg, koja se uzima kao jedna tableta jednom na dan.
Glivec 100 mg film-coated tablets 
Glivec 100 mg filmom obložene tablete
Ara-C 2x 2 g/m i.v. 
Ara-C 2x 2 g/m i.v. (3 h, svakih 12 h), dan 5
If you are being treated for GIST: The starting dose is 400 mg, to be taken as 4 capsules once a day. 
Ako se liječite zbog GIST-a: Početna doza je 400 mg, koja se uzima kao 4 kapsula jednom na dan.
Each capsule of Glivec contains 50 mg imatinib (as mesilate). 
Svaka kapsula Gliveca sadrži 50 mg imatiniba (u obliku imatinibmesilata).
Glivec 400 mg film-coated tablets 
Glivec 400 mg filmom obložene tablete
What Glivec looks like and contents of the pack Glivec 400 mg film-coated tablets are very dark yellow to brownish-orange oval tablets. 
Glivec 400 mg filmom obložene tablete su jako tamnožute do smećkastonarančaste ovalne tablete.
Each film-coated tablet contains 100 mg imatinib (as mesilate). 
Svaka filmom obložena tableta sadrži 100 mg imatiniba (u obliku imatinibmesilata).
Iron oxide, red (E172) Iron oxide, yellow (E172) Macrogol 
Ovojnica tablete: željezov oksid, crveni (E172) željezov oksid, žuti (E172) makrogol talk hipromeloza
Each tablet of Glivec contains 400 mg imatinib (as mesilate). 
Svaka tableta Gliveca sadrži 400 mg imatiniba (u obliku imatinibmesilata).
9/l and/or platelets < 50 x10 
9/l i/ili trombociti <50 x10
If you are being treated for MDS/MPD: The starting dose is 400 mg, to be taken as 4 capsules once a day. 
Ako se liječite zbog MDS/MPD-a: Početna doza je 400 mg, koja se uzima kao 4 kapsule jednom na dan.
Prednisolone 200 mg oral, 5 days per month for 13 months All treatment regimens include administration of steroids for CNS prophylaxis. 
Svi režimi liječenja uključuju primjenu steroida radi CNS profilakse.
Liver dysfunction 
Zatajenje jetre
- If you are being treated for MDS/MPD: The starting dose is 400 mg to be taken as one tablet once a day. 
Ako se liječite zbog MDS/MPD-a: Početna doza je 400 mg, koja se uzima kao jedna tableta jednom na dan.
Your doctor may decide to increase the dose to 400 mg, to be taken as 8 capsules once a day, depending on how you respond to treatment. 
Ovisno o tome kako reagirate na liječenje, liječnik može odlučiti povećati dozu do 400 mg, koja se uzima kao 8 kapsula jednom na dan.
Each capsule contains 50 mg of imatinib (as mesilate). 
Svaka kapsula sadrži 50 mg imatiniba (u obliku imatinibmesilata).
Each capsule contains 100 mg of imatinib (as mesilate). 
Svaka kapsula sadrži 100 mg imatiniba (u obliku imatinibmesilata).
The recommended dose of Glivec is 400 mg/day for the adjuvant treatment of adult patients following resection of GIST. 
Za adjuvantno liječenje odraslih bolesnika nakon resekcije GIST-a preporučena doza Gliveca iznosi 400 mg/dan.
(3 h), days 1-4; Mitoxantrone 10 mg/m i.v. 
Ara-C 1000 mg/m2/12 h i.v.(3 h), dani 1-4; Mitoksantron 10 mg/m i.v. dani 3-5;
The recommended dosage of Glivec is 600 mg/day for adult patients in accelerated phase. 
Za odrasle bolesnike u ubrzanoj fazi preporučena doza Gliveca iznosi 600 mg/dan.
Each capsule of Glivec contains 100 mg imatinib (as mesilate). 
Svaka kapsula Gliveca sadrži 100 mg imatiniba (u obliku imatinibmesilata).
MTX 15 mg intrathecal, day 1; 
MTX 15 mg intratekalno, dan 1; metilprednizolon 40 mg intratekalno, dan 1
- If you are being treated for GIST: The starting dose is 400 mg, to be taken as 4 tablets once a day. 
Ako se liječite zbog GIST-a: Početna doza je 400 mg, koja se uzima kao 4 tablete jednom na dan.
DEX (6 mg/m2/day PO): days 1-5; 29-33 6-MP (75 mg/m2/day, PO): days 8-28 Methotrexate (20 mg/m2/week, PO): days 8, 15, 22 
DEX (6 mg/m2/dan, p.o.): dani 1-5; 29-33 6-MP (75 mg/m2/dan, p.o.): dani 8-28 Metotreksat (20 mg/m2/tjedan, p.o.): dani 8, 15, 22 VP-16 (100 mg/m2, i.v.): dani 29-33 CPM (300 mg/m2, i.v.): dani 29-33
- If you are being treated for MDS/MPD: The starting dose is 400 mg to be taken as 4 tablets once a day. 
Ako se liječite zbog MDS/MPD-a: Početna doza je 400 mg, koja se uzima kao 4 tablete jednom na dan.
9/l and platelets  75 x 109/l. 
9/l i/ili trombociti <50 x 109/l
Your doctor may decide to increase the dose to 400 mg, to be taken as 4 tablets once a day, depending on how you respond to treatment. 
Ovisno o tome kako reagirate na liječenje, liječnik može odlučiti povećati dozu do 400 mg, koja se uzima kao 4 tablete jednom na dan.
(24 h), day 1, and Ara-C 2 g/m i.v. 
(24 h), dan 1, Ara-C 1 g/m i.v. (2 h, svakih 12 h), dani 2-3 (ukupno
Each tablet of Glivec contains 100 mg imatinib (as mesilate). 
Svaka tableta Gliveca sadrži 100 mg imatiniba (u obliku imatinibmesilata).
G-CSF (5 μg/kg, SC): days 5-14 or until ANC > 1500 post nadir Triple IT therapy (age-adjusted): days 1 and 15 DEX (6 mg/m2/day, PO): days 1-7 and 15-21 
Trostruka i.t. terapija (prilagođena dobi): dani 1 i 15 DEX (6 mg/m2/dan, p.o.): dani 1-7 i 15-21
Your doctor may decide to increase the dose to 400 mg, to be taken as 4 capsules once a day, depending on how you respond to treatment. 
Ovisno o tome kako reagirate na liječenje, liječnik može odlučiti povećati dozu do 400 mg, koja se uzima kao 4 kapsule jednom na dan.
Glivec 100 mg film-coated tablets imatinib 
Glivec 100 mg filmom obložene tablete imatinib
(24 h), days 1, 15; 6-MP 25 mg/m2 oral, days 1-20 
MTX 500 mg/m2 i.v. (24 h), dani 1, 15; 6-MP 25 mg/m peroralno, dani 1-20
Headache2 
Nuspojave
The recommended dosage of Glivec is 400 mg/day for adult patients in chronic phase CML. 
Za odrasle bolesnike u kroničnoj fazi KML-a preporučena doza Gliveca iznosi 400 mg/dan.
IV or PO q6h x 6 doses)iii: 
6 doza)iii: Dani 2 i 3
Pharmacokinetics in GIST patients 
Farmakokinetika u bolesnika s GIST-om
Study AUS01 
Studija AUS01 Indukcijskokonsolidacijska terapija
Vitreous haemorrhage* Ear and labyrinth disorders Uncommon: 
Krvarenje u staklasto tijelo* Poremećaji uha i labirinta Manje često:
 20 x 10 
9/i trombociti 20 x 10
The recommended dose of Glivec is 600 mg/day for adult patients with Ph+ ALL. 
Za odrasle bolesnike s Ph+ ALL-om preporučena doza Gliveca iznosi 600 mg/dan.
One large, open-label, multicentre, international randomised phase III study has been conducted in patients with newly diagnosed Ph+ CML. 
U bolesnika s novodijagnosticiranim Ph+ KML-om provedeno je jedno veliko, otvoreno, multicentrično, internacionalno, randomizirano ispitivanje faze III.
Glivec 50 mg hard capsules Packs containing 30 capsules. 
Glivec 50 mg tvrde kapsule Sadržaj kapsule:
Glivec 400 mg film-coated tablets imatinib 
Glivec 400 mg filmom obložene tablete imatinib
29.7 16/84 vs. 39/81 0.27 (0.15; 0.48) 98.7 vs. 56.1 79.9 vs. 41.5 * Full follow-up period; NE - Not estimable 
(0,15; 0,48) 98,7 vs. 56,1 79,9 vs. 41,5
Alternating chemotherapy course: high dose chemotherapy with MTX 1 g/m i.v. 
Izmjenični tijek kemoterapije: visoka doza kemoterapije s MTX 1 g/m i.v. (24 h), dan 1, i Ara-C 2 g/m i.v. (svakih 12 h), dani 2-3, kroz
Triple IT therapy (age-adjusted): day 1 ARA-C (3 g/m2/dose q 12 h x 4, IV): days 2 and 3 G-CSF (5 μg/kg, SC): days 4-13 or until ANC > 1500 post nadir 
Trostruka i.t. terapija (prilagođena dobi): dan 1 ARA-C (3 g/m2/doza svakih 12 sati x 4, i.v.): dani 2 i 3
The recommended dose of Glivec is 600 mg/day for adult patients in blast crisis. 
Za odrasle bolesnike u blastičnoj krizi preporučena doza Gliveca iznosi 600 mg/dan.
(24 h), day 1; Etoposide 250 mg/m i.v. 
MTX 1,5 g/m i.v. (24 h), dan 1; Etopozid 250 mg/m i.v. (1 h) dani 4-5;
Study AJP01 Induction therapy CP 1.2 g/m i.v. 
Studija AJP01 Indukcijska terapija CP 1,2 g/m i.v. (3 h), dan 1; Daunorubicin 60 mg/m i.v. (1 h), dani 1-3;
9/l) and thrombocytopenias (platelet count 
9/l) i trombocitopenija (broj trombocita <50 x 10
Hepatic failure 
Anafilaktički šok*
CPM (300 mg/m 2/day, IV): days 22-26 MESNA (150 mg/m 2/day, IV): days 22-26 G-CSF (5 μg/kg, SC): days 27-36 or until ANC > 1500 post nadir ARA-C (3 g/m 2, q12h, IV): days 43, 44 L-ASP (6000 IUnits/m 2, IM): day 44 
CPM (300 mg/m2/dan, i.v.): dani 22-26 MESNA (150 mg/m2/dan, i.v.): dani 22-26
Haemorrhagic corpus luteum/haemorrhagic ovarian cyst 
Hemoragična cista žutog tijela/hemoragična cista jajnika
(1 h), days 28-31, 35-38, 42-45; 
CP 1 g/m i.v. (1 h), dani 26, 46; Ara-C 75 mg/m i.v. (1 h), dani 28-31, 35-38, 42-45;
Your doctor will tell you what dose you need to take, when to take it and for how long you need to take it. 
Liječnik će Vam propisati koju dozu morate uzimati, kada je uzeti i koliko dugo je morate uzimati.
- Take the tablets in the morning and evening as prescribed by your doctor. 
- Tablete uzimajte ujutro i navečer, kako Vam je propisao liječnik.
Body Surface Area (m2) 
Tjelesna površina (m2)
Do not take the missed dose at all and do not double the next one. 
Nemojte uzeti propuštenu dozu i nemojte udvostručiti sljedeću dozu.
administration to be given morning and evening) 
(ujutro i navečer).
DPD deficiency: DPD deficiency is a rare condition present at birth that is not usually associated with health problems unless you receive certain medicines. 
Nedostatak DPD-a: nedostatak DPD-a je rijetko stanje prisutno od rođenja, koje obično nije povezano sa zdravstvenim problemima, osim ako ne primate određene lijekove.
What Capecitabine SUN is and what it is used for 
Što je Kapecitabin SUN i za što se koristi
- Take the tablets within 30 minutes after the end of a meal (breakfast and dinner). 
- Tablete uzimajte najkasnije 30 minuta nakon što završite s jelom (doručkom i večerom).
These side effects can become severe; therefore, it is important that you always contact your doctor immediately when you start to experience a side effect. 
Ove nuspojave mogu postati ozbiljne, stoga je važno da se uvijek obratite svom liječniku odmah čim uočite nuspojave.
Central or peripheral nervous system disease. 
Bolest središnjeg ili perifernog živčanog sustava.
Ophthalmologic complications. 
Oftalmološke komplikacije.
Table 6 Treatment regimens in study NO16966 (mCRC) 
Tablica 6 Protokoli liječenja u ispitivanju NO16966 (mCRC)
You must not take Capecitabine SUN if you are pregnant or think you might be. 
Ne smijete uzimati lijek Kapecitabin SUN ako ste trudni ili mislite da biste mogli biti trudni.
Do not give Capecitabine SUN to children and adolescents. 
Nemojte davati lijek Kapecitabin SUN djeci i adolescentima.
Capecitabine SUN may be used either alone or in combination with other medicines. 
Kapecitabin SUN se može primijeniti samostalno ili u kombinaciji s drugim lijekovima.
Finally, β-ureido-propionase cleaves FUPA to α-fluoro-βalanine (FBAL) which is cleared in the urine. 
Na kraju, β-ureido-propionaza cijepa FUPA do α-fluoro-βalanina (FBAL) koji se izlučuje urinom.
How to store Capecitabine SUN Contents of the pack and other information 
Kako čuvati lijek Kapecitabin SUN Sadržaj pakiranja i druge informacije
Only after being absorbed by the body is it changed into an active anti-cancer agent (more in tumour tissue than in normal tissue). 
Tek nakon što se apsorbira u organizmu, mijenja se u djelatni lijek protiv raka (više u tumorskom tkivu nego u zdravom tkivu).
Do not take Capecitabine SUN - if you are allergic to capecitabine or any of the other ingredients of this medicine (listed in section 6). 
Nemojte uzimati lijek Kapecitabin SUN - ako ste alergični na kapecitabin ili neki drugi sastojak ovog lijeka (naveden u dijelu 6.).
Alu/Alu blister containing 10 film-coated tablets. 
Alu/Alu blister sadrži 10 filmom obloženih tableta.
Your doctor may instruct you to decrease the dose and/or temporarily discontinue treatment with Capecitabine SUN. 
Liječnik Vam može savjetovati da smanjite dozu i/ili privremeno prestanete uzimati lijek Kapecitabin SUN.
About 3% of the administered dose is excreted in urine as unchanged capecitabine. 
Oko 3% primijenjene doze izluči urinom u nepromijenjenom obliku.
Table 3 Capecitabine dose reduction schedule (3-weekly cycle or continuous treatment) Toxicity grades* 
Tablica 3 Raspored smanjivanja doze kapecitabina (ciklusi od 3 tjedna ili kontinuirano liječenje) Stupnjevi toksičnosti*
A link between decreased levels of DPD and increased, potentially fatal toxic effects of 5-FU therefore cannot be excluded. 
Stoga se ne može isključiti povezanost između smanjenih razina DPD-a i pojačanih, potencijalno smrtonosnih toksičnih učinaka 5-FU.
- If contraindications exist to any of the medicinal products in the combination regimen, that medicinal product should not be used. 
- Ako postoje kontraindikacije za bilo koji od lijekova koji se primjenjuju u kombiniranom liječenju, taj se lijek ne smije primjenjivati.
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 21 June 2013 
Datum prvog odobrenja: 21 lipanj 2013
The AUC of FBAL increased with age (20% increase in age results in a 15% increase in the AUC of FBAL). 
AUC FBAL porasla je s dobi (20% veća dob imala je 15-%tno povećanje AUC FBAL).
Furthermore, Capecitabine SUN is used to prevent new occurrence of colon cancer after complete removal of the tumour by surgery. 
Nadalje, Kapecitabin SUN se koristi za spriječavanje pojave novog karcinoma debelog crijeva nakon što je tumor u potpunosti kirurški uklonjen.
Dehydration. 
Dehidracija.
Do not drive if you feel dizzy, nauseous or tired after taking this medicine. 
Nemojte upravljati vozilima ili strojevima ako osjećate omaglicu, mučninu ili umor nakon uzimanja ovog lijeka.
- History of severe and unexpected reactions to fluoropyrimidine therapy. 
- Prethodne teške i neočekivane nuspojave na fluoropirimidinsku terapiju.
Capecitabine SUN tablets are usually taken for 14 days followed by a 7 day rest period (when no tablets are taken). 
Kapecitabin SUN tablete se preporučuje uzimati 14 dana, nakon čega slijedi 7 dana pauze (bez uzimanja tableta).
Allopurinol: interactions with allopurinol have been observed for 5-FU; with possible decreased efficacy of 5-FU. 
Alopurinol: interakcije s alopurinolom primijećene su za 5-FU, s mogućom smanjenom djelotvornošću 5-FU.
STOP taking Capecitabine SUN immediately and contact your doctor if any of these symptoms occur: - Diarrhoea: if you have an increase of 4 or more bowel movements compared to your normal bowel movements each day or any diarrhoea at night. 
PRESTANITE odmah uzimati lijek Kapecitabin SUN i obratite se liječniku ako se pojave neki od ovih simptoma: - proljev: ako se pražnjenje crijeva poveća za 4 ili više pražnjenja u usporedbi s normalnim svakodnevnim pražnjenjem crijeva ili ako imate proljev noću.
Contents of the pack and other information 
Sadržaj pakiranjai druge informacije
In the event of grade 2-4 acute toxicity, treatment must be discontinued immediately until observed toxicity resolves. 
U slučaju akutne toksičnosti 2.-4. stupnja liječenje se mora odmah prekinuti dok se uočena toksičnost ne povuče.
Dose changes within a treatment cycle 
Promjene doze tijekom ciklusa liječenja
Other side effects seen in this setting are the following: 
Ostale nuspojave primijećene u takvim okolnostima su:
Capecitabine should be permanently discontinued in patients who experience a severe skin reaction during treatment. 
Primjenu kapecitabina potrebno je trajno obustaviti u bolesnika koji razviju tešku kožnu reakciju tijekom liječenja.
- Hypersensitivity to the active substance or to any of the excipients listed in section 6.1 or fluorouracil. 
- Preosjetljivost na kapecitabin, ili neku od pomoćnih tvari navedenih u dijelu 6.1 ili na fluorouracil.
- It is important that you take all your medicines as prescribed by your doctor. 
- Od iznimne je važnosti da lijek uzimate na način koji Vam je propisao liječnik.
Creatinine clearance was found to influence the systemic exposure to 5'-DFUR (35% increase in AUC when creatinine clearance decreases by 50%) and to FBAL (114% increase in AUC when creatinine clearance decreases by 50%). 
Uočeno je da klirens kreatinina utječe na sistemsku izloženost 5'-DFUR (35-%tno povećanje AUC kad se klirens kreatinina smanji za 50%) i FBAL (114-%tno povećanje AUC kad se klirens kreatinina smanji za 50%).
The parameters of capecitabine, 5'-deoxy-5-fluorocytidine (5'-DFCR) and 5'-deoxy-5-fluorouridine (5'-DFUR) measured on days 1 and 14 were similar. 
Pokazatelji aktivnosti kapecitabina, 5'-deoksi-5-fluorocitidin (5'-DFCR) i 5'-deoksi-5-fluorouridin (5'DFUR) izmjereni 1. i 14. dan bili su slični.
Diabetes mellitus or electrolyte disturbances. 
Šećerna bolest ili poremećaji elektrolita.
However, the marketing authorisation holder shall submit periodic safety update reports for this medicinal product if the product is included in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC 
Nositelj odobrenja će periodička izvješća o neškodljivosti podnositi ako je lijek uvršten u referentni popis datuma EU (EURD popis) predviđenim člankom 107(c) stavkom 7 Direktive 2001/83/EZ i objavljenim na europskom internetskom portalu za lijekove.
If you take more Capecitabine SUN than you should Contact your doctor as soon as possible before taking the next dose. 
Ako uzmete više Kapecitabin SUN-a nego što ste trebali, što prije se obratite svom liječniku, prije uzimanja sljedeće doze.
Before starting treatment, tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including medicines obtained without a prescription. 
Prije početka liječenja obavijestite svog liječnika ili ljekarnika ako uzimate ili ste nedavno uzimali ili biste mogli uzeti bilo koje druge lijekove.
This may also be relevant with folic acid supplementation for folate deficiency due to the similarity between folinic acid and folic acid. 
To može biti važno i kod primjene nadomjestaka folne kiseline zbog deficijencije folata, s obzirom na sličnost između folinatne i folne kiseline.
Day 1, prior to XELOX, every 3 weeks 
prvoga dana, prije XELOX protokola, svaka 3 tjedna
Discontinue permanently or If physician deems it to be in the patient's best interest to continue, interrupt until resolved to grade 0-1 
Trajno obustaviti ili ako liječnik smatra da je nastavak liječenja u interesu bolesnika, prekinuti dok se ne svede na stupanj 0-1
Careful monitoring of patients ≥60 years of age is advisable. 
Savjetuje se pažljivo praćenje bolesnika u dobi od 60 godina.
What Capecitabine SUN is and what it is used for What you need to know before you take Capecitabine SUN How to take Capecitabine SUN Possible side effects 
Što je Kapecitabin SUN i za što se koristi Što morate znati prije nego počnete uzimati lijek Kapecitabin SUN Kako uzimati lijek Kapecitabin SUN Moguće nuspojave
The following headings are used to rank the ADRs by frequency: very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100), rare (≥ 1/10,000 to < 1/1,000), very rare (< 1/10,000). 
Za klasifikaciju nuspojava prema učestalosti koriste se sljedeće oznake: vrlo često (≥ 1/10), često (≥ 1/100 do < 1/10), manje često (≥ 1/1,000, do < 1/100), rijetko (≥ 1/10 000 i < 1/1000), vrlo rijetko (< 1/10 000).
Cytochrome P-450 2C9 substrates: Other than warfarin, no formal drug-drug interaction studies between capecitabine and other CYP2C9 substrates have been conducted. 
Supstrati izoenzima 2C9 citokroma P-450: Osim s varfarinom, nisu provedena formalna ispitivanja interakcije lijekova izmedju kapecitabina i drugih supstrata CYP2C9.
Care should be exercised when capecitabine is co-administered with 2C9 substrates (e.g., phenytoin). 
Potreban je oprez kada se kapecitabin primjenjuje istodobno sa supstratima 2C9 (npr. s fenitoinom).
Your doctor may want you to take a combination of 150 mg and 500 mg tablets for each dose. 
Liječnik će Vam možda propisati da za svaku dozu uzimate kombinaciju tableta od 150 mg i 500 mg.
- In patients with severe hepatic impairment. 
- Bolesnici s teškim oštećenjem jetre.
Rarely, unexpected, severe toxicity (e.g. stomatitis, diarrhoea, neutropenia and neurotoxicity) associated with 5-FU has been attributed to a deficiency of DPD activity. 
U rijetkim je slučajevima neočekivana jaka toksičnost (npr. stomatitis, proljev, neutropenija i neurotoksičnost) povezana s primjenom 5-FU pripisana nedostatnoj aktivnosti DPD-a.
+ For each term, the frequency count was based on ADRs of all grades. 
+za svaki pojam učestalost se temeljila na nuspojavama na lijek svih stupnjeva.
It is therefore possible that Capecitabine SUN could affect your ability to drive a car or operate machines. 
Stoga postoji mogućnost da Kapecitabin SUN utječe na sposobnost upravljanja vozilima i strojevima.
Other medicines and Capecitabine SUN 
Drugi lijekovi i Kapecitabin SUN
- During pregnancy and lactation. 
- Trudnoća i dojenje.
Capecitabine SUN belongs to the group of medicines called "cytostatic agents", which stop the growth of cancer cells. 
Kapecitabin SUN pripada skupini lijekova pod nazivom "citostatici", koji zaustavljaju rast stanica karcinoma.
What Capecitabine SUN contains - The active substance is capecitabine. 
Što Kapecitabin SUN sadrži - Djelatna tvar je kapecitabin.
Sorivudine and analogues: a clinically significant drug-drug interaction between sorivudine and 5-FU, resulting from the inhibition of dihydropyrimidine dehydrogenase by sorivudine, has been described. 
Sorivudin i analozi: u literaturi je opisana klinički značajna interakcija između sorivudina i 5-FU, koja proizlazi iz inhibicije dihidropirimidin dehidrogenaze sorivudinom.
Pharmacotherapeutic group: antineoplastic agents, antimetabolites, pyrimidine analogues, ATC code: L01BC06 
Farmakoterapijska skupina: antineoplastici, antimetaboliti, pirimidinski analozi, ATK oznaka: L01BC06
5 mg/kg IV 30-90 mins Day 1, prior to FOLFOX-4, every 2 weeks 
5 mg/kg i.v./30 - 90 min prvog dana, prije FOLFOX-4 protokola, svaka 2 tjedna
What you need to know before you take Capecitabine SUN 
Što morate znati prije nego počnete uzimati lijek Kapecitabin SUN
Hypo- or hypercalcaemia. 
Hipokalcijemija ili hiperkalcijemija.
The dose of Capecitabine SUN is based on your body surface area. 
Doza lijeka Kapecitabin SUN-a ovisi o Vašoj tjelesnoj površini, a ona se izračunava na temelju
In addition to the above, when Capecitabine SUN is used alone, very common side effects which may affect more than 1 person in 10 are: - abdominal pain - rash, dry or itchy skin - tiredness - loss of appetite (anorexia). 
Uz prethodno navedene, kada se Kapecitabin SUN primjenjuje samostalno, vrlo česte nuspojave koje se mogu javiti u više od 1 na 10 osoba su: - bol u trbuhu - osip, suha koža ili svrbež - umor - gubitak apetita (anoreksija).
The AUC0-∞ values in μg•h/ml were 7.75, 7.24, 24.6, 2.03 and 36.3. 
Vrijednosti AUC0- u g•sat/ml iznosile su 7,75; 7,24; 24,6; 2,03 i 36,3.
Table 9 Key efficacy results for the non-inferiority analysis of study NO16967 
Tablica 9 Ključni rezultati djelotvornosti iz analize neinferiornosti u ispitivanju NO 16967
If caught early, these side effects usually improve within 2 to 3 days after stopping treatment. 
Ako se zamijete u ranoj fazi, te se nuspojave povlače unutar 2 do 3 dana nakon prestanka liječenja.
- In patients with severe leukopenia, neutropenia, or thrombocytopenia. 
- Bolesnici s teškom leukopenijom, neutropenijom ili trombocitopenijom.
5-Fluorouracil: IV bolus injection immediately after leucovorin 
intravenska bolus injekcija odmah nakon leukovorina
- In patients with known dihydropyrimidine dehydrogenase (DPD) deficiency (see section 4.4). 
- Bolesnici s poznatim deficitom dihidropirimidin dehidrogenaze (DPD) (vidjeti dio 4.4).
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. 
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.
Capecitabine SUN is not indicated in children and adolescents. 
Kapecitabin SUN nije namijenjen za primjenu u djece i adolescenata.