FrancophonIA/ELRC3.0 huggingface dataset:
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: • DPD Deficiency: if you have a known DPD deficiency, you are at an increased risk of acute early-onset of toxicity and severe, life-threatening, or fatal adverse reactions caused by XELODA (e.g. stomatitis, mucosal inflammation, diarrhoea, neutropenia, and neurotoxicity).
Croatian: • nedostatak DPD-a: ako imate nedostatak DPD-a, imate povećan rizik od akutnog ranog nastupa toksičnosti i teških, po život opasnih ili smrtonosnih nuspojava koje uzrokuje lijek
English: Cutaneous lupus erythematosus (rare), Severe skin reactions such as StevensJohnson Syndrome and toxic Epidermal Necrolysis (very rare) (see section 4.4.)
Croatian: StevensJohnsonova sindroma i toksične epidermalne nekrolize (vrlo rijetko) (vidjeti dio
English: Rash, Alopecia, Erythema, Dry skin, Pruritus, Skin hyperpigmentation, Rash macular, Skin desquamation, Dermatitis, Pigmentation disorder, Nail disorder
Croatian: osip, alopecija eritem, suha koža, svrbež, hiperpigmentacija kože, makularni osip, ljuštenje kože, dermatitis,
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 potrebno je savjetovati da tijekom liječenja kapecitabinom izbjegavaju trudnoću.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/00/163/002
Croatian: 12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/00/163/002
English: -2nd appearance -3rd appearance
Croatian: -2. pojavljivanje -3. pojavljivanje
English: The results of a meta-analysis of 14 clinical trials with data from over 4700 patients treated with capecitabine showed that in all studies combined, female gender was statistically significantly associated with an increased risk of developing HFS and diarrhoea and with a decreased risk of developing neutropenia.
Croatian: Rezultati metaanalize 14 kliničkih ispitivanja sa više od 4700 bolesnika liječenih kapecitabinom pokazali su da je u svim ispitivanjima zajedno ženski spol statistički značajno povezan s povećanim rizikom razvoja sindroma šaka-stopalo i proljeva te sa smanjenim rizikom razvoja neutropenije.
English: LIST OF EXCIPIENTS Also contains anhydrous lactose See package leaflet for further information.
Croatian: Također sadrži bezvodnu laktozu.Vidjeti uputu o lijeku za dodatne informacije.
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 intravenous bolus 5-FU, on days 1 to 5, every 28 days for 24 weeks).
Croatian: 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 (Mayo protokol: 20 mg/m2 leukovorina i.v. i 425 mg/m2 5-FU intravenski u bolusu od prvog do petog dana, svakih 28 dana u razdoblju od 24 tjedna).
English: Data from one multicentre, randomised, controlled phase 3 clinical trial in patients with stage III (Dukes' C) colon cancer supports the use of capecitabine in combination with oxaliplatin (XELOX) for the adjuvant treatment of patients with colon cancer (NO16968 study).
Croatian: Podaci iz multicentričnog, randomiziranog kontroliranog kliničkog ispitivanja faze III u bolesnika s karcinomom kolona stadija III (Dukes C) podržavaju primjenu kapecitabina u kombinaciji s oksaliplatinom (XELOX) u adjuvantnom liječenju bolesnika s karcinomom kolona (ispitivanje NO16968).
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 HFS (all grades) occurred in 2066 (43%) patients after a median time of 239 [95% CI 201, 288] days after starting treatment with capecitabine.
Croatian: Metaanaliza 14 kliničkih ispitivanja na više od 4700 bolesnika liječenih monoterapijom kapecitabinom ili kapecitabinom u različitim kemoterapijskim protokolima, u različitim indikacijama (karcinom kolona, kolorektalni karcinom, karcinom želuca i karcinom dojke) pokazala je da se sindrom šakastopalo (svi stupnjevi) razvio u 2066 (43%) bolesnika nakon medijana vremena od
English: Capecitabine 1000 mg/m oral twice daily
Croatian: kapecitabin 1000 mg/m oralno dvaput dnevno placebo ili bevacizumab
English: 4.5 Interaction with other medicinal products and other forms of interaction
Croatian: 4.5 Interakcije s drugim lijekovima i drugi oblici interakcija Ispitivanja interakcija provedena su samo u odraslih osoba.
English: In combination with docetaxel, the recommended starting dose of capecitabine in the treatment of metastatic breast cancer is 1250 mg/m2 twice daily for 14 days followed by a 7- day rest period, combined with docetaxel at 75 mg/m2 as a 1 hour intravenous infusion every 3 weeks.
Croatian: U kombinaciji s docetakselom preporučena početna doza kapecitabina u liječenju metastatskog karcinoma dojke je 1250 mg/m² i uzima se dvaput dnevno tijekom 14 dana nakon čega slijedi 7 dana pauze, dok je doza docetaksela 75 mg/m² i primjenjuje se svaka 3 tjedna u jednosatnoj intravenskoj infuziji.
English: • Grade 3 -1st appearance
Croatian: · Stupanj 3 -1. pojavljivanje
English: Pulmonary embolism, Pneumothorax, Haemoptysis, Asthma, Dyspnoea exertional
Croatian: pneumotoraks, hemoptiza, astma, zaduha pri naporu
English: For patients with partial DPD deficiency (such as those with heterozygous mutations in the DPYD gene) and where the benefits of Xeloda are considered to outweigh the risks (taking into account the suitability of an alternative non-fluoropyrimidine chemotherapeutic regimen), these patients must be treated with extreme caution and frequent monitoring with dose adjusment according to toxicity.
Croatian: i za koje se smatra da koristi liječenja lijekom Xeloda nadmašuju rizike (uzimajući u obzir prikladnost nekog drugog kemoterapijskog protokola koji ne uključuje fluoropirimidin), liječenje treba provoditi uz izniman oprez i sa čestim praćenjem uz prilagodbu doze sukladno toksičnosti.
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 (kombinacijski lijek)
English: In patients with severe leukopenia, neutropenia, or thrombocytopenia, In patients with severe hepatic impairment,
Croatian: • Bolesnici s teškom leukopenijom, neutropenijom ili trombocitopenijom,
English: • if you have or had heart problems (for example an irregular heartbeat or pains to the chest, jaw and back brought on by physical effort and due to problems with the blood flow to the heart)
Croatian: čeljusti i leđima uzrokovane fizičkim naporom ili otežanim dotokom krvi u srce)
English: Xeloda with food and drink You should take Xeloda no later than 30 minutes after meals.
Croatian: Lijek Xeloda uzmite najkasnije 30 minuta nakon jela.
English: • bowel obstruction, collection of fluid in the abdomen, inflammation of the small or large intestine, the stomach or the oesophagus, pain in the lower abdomen, abdominal discomfort, heartburn (reflux of food from the stomach), blood in the stool jaundice (yellowing of skin and eyes)
Croatian: • opstrukcija crijeva, nakupljanje tekućine u trbuhu, upala tankog ili debelog crijeva, želuca ili jednjaka, bol u donjem dijelu trbuha, nelagoda u trbuhu, žgaravica (povrat hrane iz želuca), krv u stolici
English: For combination with irinotecan, the recommended starting dose is 800 mg/m2 when administered twice daily for 14 days followed by a 7-day rest period combined with irinotecan 200 mg/m2 on day 1.
Croatian: Kada se primjenjuje u kombinaciji s irinotekanom, preporučena početna doza je 800 mg/m² dvaput dnevno tijekom 14 dana, nakon čega slijedi 7 dana pauze uz primjenu irinotekana u dozi od
English: The results of a meta-analysis of 14 clinical trials with data from over 4700 patients treated with capecitabine showed that in all studies combined, increasing age (by 10 year increments) was statistically significantly associated with an increased risk of developing HFS and diarrhoea and with a decreased risk of developing neutropenia.
Croatian: Rezultati metaanalize 14 kliničkih ispitivanja sa više od 4700 bolesnika liječenih kapecitabinom pokazali su da je u svim ispitivanjima starija životna dob (u intervalima od 10 godina) statistički značajno povezana s povećanim rizikom razvoja sindroma šaka-stopalo i proljeva i smanjenim rizikom razvoja neutropenije.
English: Brivudine: a clinically significant interaction between brivudine and fluoropyrimidines (e.g. capecitabine, 5-Fluorouracil, tegafur), resulting from the inhibition of dihydropyrimidine dehydrogenase by brivudine, has been described.
Croatian: kapecitabina, 5-fluorouracila, tegafura), koja proizlazi iz inhibicije dihidropirimidin dehidrogenaze brivudinom.
English: Upper gastrointestinal haemorrhage, Mouth ulceration, Gastritis, Abdominal distension, Gastroesophageal reflux disease, Oral pain, Dysphagia, Rectal haemorrhage, Abdominal pain lower, Oral dysaesthesia, Paraesthesia oral, Hypoaesthesia oral, Abdominal discomfort
Croatian: Poremećaji probavnog sustava zatvor, dispepsija krvarenje u gornjem dijelu probavnog sustava, ulceracije usne šupljine, gastritis, distenzija abdomena, gastroezofagealna refluksna bolest, bol u usnoj šupljini, disfagija, rektalno krvarenje, bol u donjem dijelu abdomena, oralna dizestezija, oralna parestezija, oralna hipoestezija, nelagoda u abdomenu
English: In this trial, 160 patients were randomised to treatment with capecitabine (1000 mg/m2 twice daily for 2 weeks followed by a 7-day rest period) and cisplatin (80 mg/m2 as a 2-hour infusion every 3 weeks).
Croatian: U tom je ispitivanju 160 bolesnika slučajnim odabirom liječeno kapecitabinom (1000 mg/m2 dvaput dnevno u trajanju od 2 tjedna, nakon čega slijedi pauza od 7 dana) i cisplatinom (80 mg/m2 u obliku dvosatne infuzije svaka 3 tjedna).
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: Metaanaliza šest kliničkih ispitivanja (SO14695, SO14796, M66001, NO16966, NO16967, M17032)
English: Lipoma
Croatian: Bevacizumab
English: Angina unstable, Angina pectoris, Myocardial ischaemia/infarction, Atrial fibrillation, Arrhythmia, Tachycardia, Sinus tachycardia, Palpitations
Croatian: Srčani poremećaji nestabilna angina, angina pektoris, ishemija miokarda/infarkt, fibrilacija atrija, aritmija, tahikardija, sinusna tahikardija, palpitacije fibrilacija ventrikula (rijetko), produljenje QT- intervala (rijetko), Torsade de pointes (rijetko), bradikardija, vazospazam (rijetko)
English: In this trial, 255 patients were randomised to treatment with capecitabine (1250 mg/m2 twice daily for 2 weeks followed by 1-week rest period and docetaxel 75 mg/m2 as a 1 hour intravenous infusion every 3 weeks).
Croatian: U tom je ispitivanju slučajnim odabirom 255 bolesnica liječeno kapecitabinom (1250 mg/m2 dvaput dnevno tijekom 2 tjedna, nakon čega je slijedila jednotjedna pauza i 75 mg/m2 docetaksela u jednosatnoj intravenskoj infuziji svaka 3 tjedna).
English: The primary efficacy analyses in the per protocol population demonstrated non-inferiority in overall survival for capecitabine- vs 5-FU-based regimens (hazard ratio 0.86; 95% CI 0.8 - 0.99) and for oxaliplatin- vs cisplatin-based regimens (hazard ratio 0.92; 95% CI 0.80 - 1.1).
Croatian: Analize osnovnih parametara djelotvornosti u populaciji prema protokolu pokazale su da liječenje kapecitabinom u usporedbi s protokolima koji sadrže 5-FU (omjer hazarda 0,86; 95% CI 0,8 do 0,99) i liječenje oksaliplatinom u usporedbi s protokolima koji sadrže cisplatin (omjer hazarda 0,92; 95% CI 0,80 do 1,1) nije lošije.
English: The XELIRI regimens included capecitabine 1000 mg/m2 twice daily on days 1 to 14 of a three-week cycle combined with irinotecan 250 mg/m2 on day1.
Croatian: XELIRI protokol obuhvaćao je primjenu kapecitabina u dozi od 1000 mg/m2 dvaput dnevno od 1. do 14. dana trotjednog ciklusa u kombinaciji s irinotekanom u dozi od 250 mg/m2 1. dana.
English: All indications:
Croatian: u različitim indikacijama.
English: Advanced gastric cancer:
Croatian: Uznapredovali karcinom želuca
English: PRIMARY ANALYSI S XELOX/XELOX+P/ XELOX+BV (EPP*: N=967; ITT**: N=1017)
Croatian: Tablica 7 Ključni rezultati djelotvornosti iz analize o neinferiornosti u ispitivanju NO16966 PRIMARNA ANALIZA XELOX / XELOX + P / XELOX + BV (EPP*: N = 967; ITT**: N = 1017)
English: Diarrhoea (see section 4.4):
Croatian: Proljev (vidjeti dio 4.4)
English: • Xeloda 500 mg film-coatedtablets: Each tablet contains 500 mg capecitabine
Croatian: • Xeloda 500 mg filmom obložene tablete Svaka tableta sadrži 500 mg kapecitabina
English: 2 hr
Croatian: m2
English: • difficulty speaking, impaired memory, loss of movement coordination, balance disorder, 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)
Croatian: • poteškoće pri govoru, poremećaj pamćenja, gubitak koordinacije pokreta, poremećaj ravnoteže, nesvjestica, oštećenje živaca (neuropatija) i tegobe s osjetima
English: Table 1 Standard and reduced dose calculations according to body surface area for a starting dose of capecitabine of 1250 mg/m2
Croatian: Izračuni doze lijeka Xeloda Tablica 1 Izračuni standardnih i smanjenih doza prema tjelesnoj površini za početnu dozu kapecitabina od 1250 mg/ m2
English: History of severe and unexpected reactions to fluoropyrimidine therapy, Hypersensitivity to capecitabine or to any of the excipients listed in section 6.1 or fluorouracil, In patients with known complete absence of dihydropyrimidine dehydrogenase (DPD) activity (see section 4.4),
Croatian: • Prethodne teške i neočekivane nuspojave na fluoropirimidinsku terapiju, • Preosjetljivost na kapecitabin ili neku od pomoćnih tvari navedenih u dijelu 6.1 ili na fluorouracil,
English: Xeloda 150 mg film-coated tablets Each 150 mg film-coated tablet contains 15.6 mg anhydrous lactose.
Croatian: Xeloda 150 mg filmom obložene tablete Jedna 150 mg filmom obložena tableta sadrži 15,6 mg bezvodne laktoze.
English: Combination treatment consisted of first-line capecitabine (1000 mg/m2 twice daily for 14 days) combined with irinotecan (250 mg /m2 on day 1) (XELIRI) and second-line capecitabine (1000 mg/m2 twice daily for 14 days) plus oxaliplatin (130 mg/m2 on day 1).
Croatian: Kombinirana terapija sastojala se od primjene kapecitabina (1000 mg/m2 dvaput dnevno tijekom 14 dana) u kombinaciji s irinotekanom (250 mg/m2 1. dana) (XELIRI protokol) u prvoj liniji liječenja, a zatim od primjene kapecitabina (1000 mg/m2 dvaput dnevno tijekom 14 dana) i oksaliplatina (130 mg/m2 1. dana) u drugoj liniji liječenja.
English: • Tablet core: anhydrous lactose, croscarmellose sodium, hypromellose (3 mPa.s), microcrystalline cellulose, magnesium stearate.
Croatian: • Jezgra tablete: bezvodna laktoza, umrežena karmelozanatrij, hipromeloza (3 mPa.s),
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: • 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: For Arm B, the XELIRI regimen used capecitabine 1000 mg/m2 twice daily for 14 days + irinotecan 250 mg/m2 on day 1.
Croatian: U skupini B je XELIRI protokol obuhvaćao primjenu kapecitabina u dozi od 1000 mg/m2 dvaput dnevno tijekom 14 dana uz primjenu irinotekana u dozi od 250 mg/m2 1. dana.
English: Sequential treatment consisted of first-line capecitabine (1250 mg/m2 twice daily for 14 days), second-line irinotecan (350 mg/m2 on day 1), and third-line combination of capecitabine (1000 mg/m2 twice daily for 14 days) with oxaliplatin (130 mg/m2 on day 1).
Croatian: Sekvencijska terapija sastojala se od primjene kapecitabina (1250 mg/m2 dvaput dnevno tijekom 14 dana) u prvoj liniji liječenja, primjene irinotekana (350 mg/m2 1. dana) u drugoj liniji te, na kraju, liječenja kombinacijom kapecitabina (1000 mg/m2 dvaput dnevno tijekom 14 dana) i oksaliplatina (130 mg/m2 1. dana) u trećoj liniji liječenja.
English: 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: (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: 4.6 Fertility, pregnancy and lactation
Croatian: 4.6 Plodnost, trudnoća i dojenje Žene reproduktivne dobi/Kontracepcija u muškaraca i žena
English: Reduced dose 950 mg/m2
Croatian: Smanjena doza 950 mg/m2
English: 10.0 and 8.9 months; p=0.64, overall survival 25.7 and 27.5 months; p=0.55 and response rates 45.5 and 39.8%; p=0.32 for FOLFIRI-Bev and XELIRI-Bev, respectively.
Croatian: Medijan preživljenja bez progresije bolesti (PFS) iznosio je 10,0 mjeseci za FOLFIRI-Bev i 8,9 mjeseci za XELIRI-Bev (p=0,64), medijan ukupnog preživljenja 25,7 odnosno 27,5 mjeseci (p=0,55), a stope odgovora 45,5% odnosno 39,8% (p=0,32).
English: Reduced dose 625 mg/m2
Croatian: Smanjena doza 625 mg/m2
English: In the EORTC study patients were randomised to receive either open label FOLFIRI (n=41) or XELIRI (n=44) with additional randomisation to either double-blind treatment with celecoxib or placebo.
Croatian: XELIRI (n=44) te dodatno randomizirani na dvostruko slijepo liječenje celekoksibom ili placebom.
English: Appetite decreased Hypokalaemia, Hyponatraemia, Hypomagnesaemia,
Croatian: Poremećaji metabolizma i prehrane smanjen apetit hipokalijemija, hiponatrijemija, hipomagnezijemija, hipokalcijemija, hiperglikemija
English: Dehydration, Weight decreased
Croatian: • dehidracija, gubitak težine • nesanica, depresija
English: Reduced dose 500 mg/m2
Croatian: Smanjena doza 500 mg/m2
English: Posology adjustments for special populations:
Croatian: Prilagodba doze u posebnim skupinama bolesnika
English: Xeloda may make you feel dizzy, nauseous or tired.
Croatian: Dok uzimate lijek Xeloda, možete osjećati omaglicu, mučninu ili umor.
English: Blister, Skin ulcer, Rash, Urticaria, Photosensitivity reaction, Palmar erythema, Swelling face, Purpura, Radiation recall syndrome
Croatian: urtikarija, fotosenzibilna reakcija, palmarni eritem, oticanje lica, purpura, sindrom radijacijskog dermatitisa (“radiation recall”)
English: 3 weeks), and bevacizumab (7.5 mg/kg as a 30 to 90 minute infusion on day 1 every 3 weeks ; 127 patients were randomised to treatment with capecitabine (1000 mg/m2 twice daily for two weeks followed by a 7-day rest period), oxaliplatin (130 mg/m as a 2 hour infusion on day 1 every 3 weeks), and bevacizumab (7.5 mg/kg as a 30 to 90 minute infusion on day 1 every 3 weeks).
Croatian: 127 bolesnika je randomizirano za liječenje kapecitabinom (1000 mg/m2 dvaput dnevno tijekom dva tjedna, nakon čega slijedi pauza od 7 dana), oksaliplatinom (130 mg/m2 kao 2-satna infuzija 1. dana svaka 3 tjedna) i bevacizumabom (7,5 mg/kg kao infuzija u trajanju od 30 do 90 minuta 1. dana svaka
English: Name and address of the manufacturer responsible for batch release Roche Pharma AG
Croatian: 11. NAZIV I ADRESA NOSITELJA ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET Roche Registration GmbH
English: Colon and colorectal cancer:
Croatian: Karcinom kolona i kolorektalni karcinom
English: Pharyngitis, Oral candidiasis, Influenza, Gastroenteritis, Fungal infection, Infection, Tooth abscess
Croatian: gastroenteritis, gljivična infekcija, infekcija, apsces zuba
English: Xeloda 500 mg film-coated tablets Each 500 mg film-coated tablet contains 52 mg anhydrous lactose.
Croatian: Xeloda 500 mg filmom obložene tablete Jedna 500 mg filmom obložena tableta sadrži 52 mg bezvodne laktoze.
English: Capecitabine was at least equivalent to IV 5-FU/LV in disease-free survival in per protocol population (hazard ratio 0.92; 95% CI 0.80-1.06).
Croatian: Kapecitabin je bio najmanje jednako učinkovit kao 5-FU/LV i.v. prema analizi preživljenja bez znakova bolesti u populaciji bolesnika liječenih po protokolu (omjer hazarda 0,92; 95% interval pouzdanosti (CI)
English: 150 mg 500 mg
Croatian: Doza po jednoj primjeni (mg) 150 mg 500 mg
English: Reduced dose 750 mg/m2
Croatian: Smanjena doza 750 mg/m2
English: Table 8
Croatian: Tablicu 4).
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% FOLFIRI).
Croatian: 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: Xeloda 150 mg film-coated tablets Each film-coated tablet contains 150 mg capecitabine.
Croatian: Xeloda 150 mg filmom obložene tablete Jedna filmom obložena tableta sadrži 150 mg kapecitabina.
English: Contents of the pack and other information What Xeloda contains
Croatian: Kako čuvati lijek Xeloda Sadržaj pakiranja i druge informacije
English: Day 1, prior to XELOX, every 3 weeks
Croatian: 7,5 mg/kg intravenski 30 - 90 min prvoga dana, prije XELOX protokola, svaka 3 tjedna
English: • skin ulcer and blister, reaction of the skin with sunlight, reddening of palms, swelling or pain of the face joint swelling or stiffness, bone pain, muscle weakness or stiffness
Croatian: • vrijedovi i mjehurići po koži, reakcija kože na sunčevo svjetlo, crvenilo dlanova, oticanje ili bol u licu
English: • blood clots in the veins in the lung (pulmonary embolism), collapsed lung, coughing up blood, asthma, shortness of breath on exertion
Croatian: (ekstremiteti), ljubičaste mrlje po koži • krvni ugrušci u venama u plućima (plućna embolija), kolaps pluća, iskašljavanje krvi, astma,
English: In patients with severe renal impairment (creatinine clearance below 30 ml/min), Recent or concomitant treatment with brivudine (see section 4.4 and 4.5 for drug-drug interaction),
Croatian: • Nedavno ili istodobno liječenje brivudinom (za informacije o interakciji između lijekova vidjeti dijelove 4.4 i 4.5),
English: Fatigue, Asthenia
Croatian: povraćanje, mučnina,
English: For the capecitabine dose of 1000 mg/m2 twice daily on days 1 to 14 every 3
Croatian: Doza od 1000 mg/m2 (dvaput dnevno)
English: Xeloda 500 mg film-coated tablets.
Croatian: Xeloda 500 mg filmom obložene tablete.