FrancophonIA/ELRC3.0 huggingface dataset:
English: Method of administration Capecitabine SUN tablets should be swallowed with water within 30 minutes after a meal.
Slovenian: Način uporabe Tablete zdravila Kapecitabin SUN je treba pogoltniti z vodo v 30 minutah po obroku.
English: Capecitabine SUN is not indicated in children and adolescents.
Slovenian: Zdravilo Kapecitabin SUN ni namenjeno otrokom in mladostnikom.
English: Capecitabine is indicated for the treatment of metastatic colorectal cancer (see section 5.1).
Slovenian: Kapecitabin je indiciran za zdravljenje metastatske oblike kolorektalnega raka (glejte poglavje 5.1).
English: In case you are using coumarin anticoagulants (containing e.g. phenprocoumon), stopping Capecitabine SUN might require that your doctor adjusts your anticoagulant dose.
Slovenian: Če sočasno jemljete kumarinske antikoagulante (ki vsebujejo na primer fenprokumon) vam bo zdravnik v primeru prekinitve zdravljenja z zdravilom Kapecitabin SUN morda moral prilagoditi odmerek antikoagulanta.
English: If no toxicity is observed in patients ≥60 years of age treated with a reduced capecitabine starting dose in combination with docetaxel, the dose of capecitabine may be cautiously escalated to 1250 mg/m2 twice daily.
Slovenian: 60 let ali več, med zdravljenjem z zmanjšanim odmerkom kapecitabina v kombinaciji z docetakselom toksičnost ne pojavi, lahko odmerek kapecitabina previdno zvečamo na 1.250 mg/m2 dvakrat na dan.
English: Capecitabine is indicated for first-line treatment of advanced gastric cancer in combination with a platinum-based regimen (see section 5.1).
Slovenian: Kapecitabin je indiciran za prvo linijo zdravljenja napredovalega raka želodca v kombinaciji s shemo na osnovi platine (glejte poglavje 5.1).
English: Oxaliplatin Capecitabine
Slovenian: Odmerek kapecitabina
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).
Slovenian: Bolniki z ledvično okvaro (glejte poglavja 4.2, 4.4 in 5.2) Analiza varnostnih podatkov pri bolnikih z ledvično okvaro, ki so jih zdravili samo s kapecitabinom (zaradi kolorektalnega raka) je pokazala, da je incidenca z zdravljenjem povezanih neželenih učinkov stopnje 3 in 4 pri teh bolnikih večja, kot pri bolnikih z normalnim delovanjem ledvic (36 % pri bolnikih brez ledvične okvare, n = 268, v primerjavi z 41 % pri bolnikih z blago ledvično okvaro, n = 257, in 54 % pri bolnikih z zmerno ledvično okvaro, n = 59) (glejte poglavje 5.2).
English: - In patients with known dihydropyrimidine dehydrogenase (DPD) deficiency (see section 4.4).
Slovenian: - Znano pomanjkanje dihidropirimidin dehidrogenaze (DPD) (glejte poglavje 4.4).
English: Capecitabine is indicated for the adjuvant treatment of patients following surgery of stage III (Dukes' stage C) colon cancer (see section 5.1).
Slovenian: Kapecitabin je indiciran za adjuvantno zdravljenje bolnikov po operaciji raka kolona stadija III (Dukes C) (glejte poglavje 5.1).
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).
Slovenian: Evropska agencija za zdravila je opustila zahtevo za predložitev rezultatov študij z referenčno zdravilo, ki vsebuje kapecitabinom v vseh podskupinah pediatrične populacije z adenokarcinomom kolona in rektuma, želodčnim adenokarcinomom in rakom dojk (glejte poglavje 4.2 za podatke o pediatrični uporabi).
English: Capecitabine SUN contains anhydrous lactose This medicine contains anhydrous lactose.
Slovenian: Kapecitabin SUN vsebuje brezvodno laktozo Zdravilo vsebuje brezvodno laktozo.
English: Each film-coated tablet contains 20.69 mg anhydrous lactose.
Slovenian: Ena filmsko obložena tableta vsebuje 20.69 mg brezvodne laktoze.
English: Parameter: Overall Survival EPP ITT *EPP=eligible patient population; **ITT=intent-to-treat population
Slovenian: Parameter: Celokupno preživetje EPP ITT *EPP = primerna populacija bolnikov (eligible patient population); **ITT = populacija bolnikov, ki so jih nameravali zdraviti (intent-to-treat population); CI = interval zaupanja (confidence interval); P = placebo
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.
Slovenian: bevacizumab 10,0 in za XELIRI-bevacizumab 8,9 meseca; p = 0,64, celokupno preživetje za FOLFIRI-bevacizumab je bilo 25,7 in za XELIRI-bevacizumab 27,5 meseca; p = 0,55, odgovor je bil 45,5 % za FOLFIRI-bevacizumab in 39,8 % za XELIRI-bevacizumab; p = 0,32.
English: Further catalytic activation of 5'-DFUR then occurs by thymidine phosphorylase (ThyPase).
Slovenian: Nadaljnja katalitska aktivacija 5´-DFUR poteka s timidin fosforilazo.
English: XELOX or XELOX+ Bevacizumab
Slovenian: XELOX ali XELOX + bevacizumab oksaliplatin kapecitabin
English: Capecitabine is also indicated as monotherapy for the treatment of patients with locally advanced or metastatic breast cancer after failure of taxanes and an anthracycline-containing chemotherapy regimen or for whom further anthracycline therapy is not indicated.
Slovenian: Kapecitabin je indiciran tudi kot monoterapija za zdravljenje bolnikov z lokalno napredovalo ali metastatsko obliko raka dojk po neuspešnem zdravljenju s taksani in antraciklinsko kemoterapijo ali za zdravljenje bolnikov, pri katerih nadaljnje zdravljenje z antraciklini ni indicirano.
English: Capecitabine SUN contains capecitabine, which itself is not a cytostatic agent.
Slovenian: Zdravilo Kapecitabin SUN vsebuje kapecitabin, ki sam nima citostatičnega učinka.
English: Bevacizumab: there was no clinically significant effect of bevacizumab on the pharmacokinetic parameters of capecitabine or its metabolites in the presence of oxaliplatin.
Slovenian: Bevacizumab: klinično pomembnega vpliva bevacizumaba na farmakakokinetične parametre kapecitabina ali njegovih presnovkov v prisotnosti oksaliplatina ni bilo.
English: Caution must be exercised in patients with central or peripheral nervous system disease, e.g. brain metastasis or neuropathy (see section 4.8).
Slovenian: Pri bolnikih, ki imajo bolezen centralnega ali perifernega živčevja, npr. metastaze v možganih ali nevropatijo, je potrebna previdnost (glejte poglavje 4.8).
English: LIST OF EXCIPIENTS Also contains anhydrous lactose.
Slovenian: SEZNAM POMOŽNIH SNOVI Vsebuje tudi brezvodno laktozo.
English: XELOX showed a trend towards superior OS with a HR of 0.87 (95% CI=[0.72; 1.05]; p=0.1486) which translates into a 13% reduction in risk of death.
Slovenian: Shema XELOX je pokazala trend k večjemu celokupnemu preživetju z razmerjem ogroženosti 0,87 (95-% interval zaupanja 0,72-1,05; P = 0,1486), kar pomeni 13 % zmanjšanje tveganja za smrt.
English: 1) or the Common Terminology Criteria for Adverse Events (CTCAE) of the Cancer Therapy Evaluation Program, US National Cancer Institute, version 4.0.
Slovenian: * Glede na skupne kriterije toksičnosti skupine za klinična preskušanja Kanadskega državnega inštituta za raka (NCIC CTG - National Cancer Institute of Canada Clinical Trial Group) (verzija 1) ali skupne kriterije za terminologijo neželenih dogodkov (CTCAE - Common Terminology Criteria for Adverse Events) programa za vrednotenje zdravljenja raka državnega inštituta za raka ZDA, verzija 4.
English: Patients taking coumarinderivative anticoagulants concomitantly with capecitabine should be monitored regularly for alterations in their coagulation parameters (PT or INR) and the anti-coagulant dose adjusted accordingly.
Slovenian: Bolnike, ki jemljejo antikoagulante kumarinskega tipa sočasno s kapecitabinom, moramo pazljivo spremljati in meriti njihove koagulacijske parametre (protrombinski čas ali INR) ter odmerek antikoagulanta ustrezno prilagajati.
English: What Capecitabine SUN contains - The active substance is capecitabine.
Slovenian: Kaj vsebuje zdravilo Kapecitabin SUN - Zdravilna učinkovina je kapecitabin.
English: The rate of withdrawal due to adverse events was higher in the XELOX combination therapy arm (21%) as compared with that of the 5-FU/LV monotherapy arm (9%) in the ITT population.
Slovenian: Delež prekinitev zdravljenja zaradi neželenih učinkov je bil v populaciji, ki so jo nameravali zdraviti (ITT), v skupini s shemo kombiniranega zdravljenja XELOX višji (21 %) v primerjavi s skupino z monoterapijo s 5FU/LV (9 %).
English: Capecitabine SUN tablets should be swallowed whole with water, and within 30 minutes of a meal.
Slovenian: Tablete zdravila Kapecitabin SUN je treba pogoltniti cele z vodo v roku 30 minut od obroka.
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.
Slovenian: Folinska/folna kislina: kombinacijska študija kapecitabina in folinske kisline je pokazala, da ta nima velikega vpliva na farmakokinetične lastnosti kapecitabina in njegovih presnovkov, pač pa vpliva na njegove farmakodinamične lastnosti.
English: Interrupt until resolved to grade 0-1
Slovenian: • Stopnja 2 1. pojav prekinitev, dokler ni dosežena stopnja
English: Discontinue treatment permanently
Slovenian: 2. pojav dokončna prekinitev zdravljenja
English: Do not take the missed dose at all and do not double the next one.
Slovenian: Če ste pozabili vzeti zdravilo Kapecitabin SUN Ne zaužijte izpuščenega odmerka in naslednjič ne vzemite dvojnega odmerka.
English: FOLFOX-4 or FOLFOX-4 + Bevacizumab
Slovenian: FOLFOX-4 ali FOLFOX-4 + bevacizumab oksaliplatin levkovorin 5-fluorouracil
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).
Slovenian: Če boste vzeli veliko več kapecitabina, kot bi ga smeli, se lahko pri vas pojavijo naslednji neželeni učinki: slabost ali bruhanje, driska, vnetje ali razjede črevesu ali ustih, bolečine ali krvavitev iz črevesja ali želodca, depresija kostnega mozga (znižanje določenih vrst krvnih celic).
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.
Slovenian: Fenitoin: med sočasnim jemanjem kapecitabina in fenitoina so v posameznih primerih opazili povečanje koncentracij fenitoina v plazmi, ki so povzročile simptome zastrupitve s fenitoinom.
English: FOLFOX-4/FOLFOX-4+P/ FOLFOX-4+BV (EPP*: N = 937; ITT**: N= 1017)
Slovenian: FOLFOX-4/FOLFOX-4 + P/ FOLFOX-4 + BEVACIZUMAB (EPP*: n = 937; ITT**: n = 1.017)
English: Do not give Capecitabine SUN to children and adolescents.
Slovenian: Otrokom in mladostnikom ne dajajte zdravila Kapecitabin SUN.
English: PHARMACEUTICAL FORM Film-coated tablet.
Slovenian: Filmsko obložena tableta.
English: + For each term, the frequency count was based on ADRs of all grades.
Slovenian: +Pri vsakem terminu so pri določitvi pogostnosti upoštevali neželene učinke vseh stopenj.
English: Hand-foot syndrome (also known as hand-foot skin reaction or palmar-plantar erythrodysesthesia or chemotherapy induced acral erythema).
Slovenian: Sindrom je znan tudi pod imenom kožna reakcija na roki in nogi, palmarnoplantarna eritrodisestezija ali s kemoterapijo povzročena rdečina okončin.
English: involved in the metabolism of uracil and thymine, or - if you are being treated now or have been treated in the last 4 weeks with brivudine, sorivudine or similar classes of substance as part of herpes zoster (chickenpox or shingles) therapy.
Slovenian: - če se trenutno zdravite ali ste se v preteklih 4 tednih zdravili z brivudinom, sorivudinom ali podobnimi učinkovinami, ki se uporabljajo kot del zdravljenja herpes zostra (norice ali pasovec).
English: -2nd appearance -3rd appearance -4th appearance
Slovenian: 2. pojav 3. pojav -4. pojav dokončna prekinitev zdravljenja
English: Oxaliplatin Leucovorin 5-Fluorouracil
Slovenian: 5-fluorouracil i.v.
English: Eye disorders Lacrimation increased Visual disorders, Dry eye, Eye pain, Visual impairment, Vision blurred
Slovenian: Očesne bolezni povečano solzenje motnje vida, suho oko, bolečina v očeh, poslabšan vid, zamegljen vid
English: Dose level 1000 mg/m2 (twice daily)
Slovenian: Odmerek 1.000 mg/m2 (dvakrat na dan)
English: Excipients.
Slovenian: Driska.
English: There must be at least a 4-week waiting period between end of treatment with sorivudine or its chemically related analogues such as brivudine and start of capecitabine therapy.
Slovenian: Med zaključkom zdravljenja s sorivudinom ali kemično podobnimi analogi, kot je brivudin, in začetkom zdravljenja s kapecitabinom mora biti vsaj 4-tedenski premor.
English: Japanese patients (n=18) had about 36% lower Cmax and 24% lower AUC for capecitabine than Caucasian patients (n=22).
Slovenian: Etnični dejavniki: po peroralnem dajanju 825 mg/m2 kapecitabina dvakrat na dan 14 dni so japonski bolniki (n = 18) imeli približno 36 % nižjo Cmax in 24 % nižjo AUC kapecitabina kakor kavkaški bolniki (n = 22).
English: fainting, nerve damage (neuropathy) and problems with sensation - blurred or double vision - vertigo, ear pain - irregular heartbeat and palpitations (arrhythmias), chest pain and heart attack (infarction) - blood clots in the deep veins, high or low blood pressure, hot flushes, cold limbs (extremities),
Slovenian: omedlevanje, okvaro živcev (nevropatijo) in težave z občutenjem, - zamegljen ali dvojen vid, - vrtoglavico, bolečine v ušesu, - nereden srčni utrip in palpitacije (aritmije), bolečino v prsnem košu in srčni napad (infarkt), - trdke krvi v globokih venah, visok ali nizek krvni tlak, vročinske valove, mrzle okončine,
English: Grade 1 hand- foot syndrome is defined as numbness, dysesthesia/paresthesia, tingling, painless swelling or erythema of the hands and/or feet and/or discomfort which does not disrupt the patient's normal activities.
Slovenian: Sindrom 1. stopnje se kaže kot otrplost, disestezija ali parestezija, mravljinčenje, neboleče otekanje ali rdečina rok in nog ali obojih okončin oziroma kot neugodje, ki ne vpliva na bolnikove normalne dejavnosti.
English: Capecitabine SUN is used in the treatment of colon, rectal, gastric, or breast cancers.
Slovenian: Zdravilo Kapecitabin SUN se uporablja za zdravljenje raka debelega črevesa, danke, želodca in raka dojk.
English: Leucovorin on Days 1 and 2, every 2 weeks
Slovenian: 22 h oksaliplatin 1. dan, vsake 2 tedna levkovorin 1. in 2. dan, vsake 2 tedna
English: Ophthalmologic complications.
Slovenian: Oftalmološki neželeni učinki.
English: Parameter: Progression-free Survival PPP ITT Parameter: Overall Survival PPP ITT
Slovenian: Parameter: Preživetje brez napredovanja bolezni PPP ITT Parameter: Celokupno preživetje PPP ITT
English: - The other ingredients are: - Tablet core: talc (E553b), anhydrous lactose, croscarmellose sodium (E468), hypromellose (E464), cellulose microcrystalline (E460), magnesium stearate (E572).
Slovenian: - Druge sestavine zdravila so: - Jedro tablete: smukec (E553b), brezvodna laktoza, premrežen natrijev karmelozat (E468), hipromeloza (E464), mikrokristalna celuloza(E460), magnezijev stearat (E572).
English: Key efficacy results for AIO KRK study
Slovenian: Glavni rezultati o učinkovitosti za študijo AIO KRK.
English: 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.
Slovenian: Če se pojavi katerikoli od navedenih simptomov, takoj PRENEHAJTE z jemanjem zdravila Kapecitabin SUN in pokličite svojega zdravnika: - Driska: če pogostnost dnevnih iztrebljanj preseže število, ki je za vas običajno, za štiri ali več,
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.
Slovenian: Kumarinski antikoagulanti: pri bolnikih, ki so kapecitabin jemali sočasno s kumarinskimi antikoagulanti, kot sta varfarin in fenprokomon, so se pojavili spremenjeni testi koagulacije ali krvavitve ali oboje.
English: Hand-foot syndrome (see section 4.4) For the capecitabine dose of 1250 mg/m2 twice daily on days 1 to 14 every 3 weeks, a frequency of
Slovenian: Sindrom roka-noga (glejte poglavje 4.4) Če so bolniki kapecitabin prejemali v odmerku 1.250 mg/m2 dvakrat na dan od 1. do 14. dneva vsake
English: Each film-coated tablet contains 68.95 mg anhydrous lactose.
Slovenian: Ena filmisko obložena tableta vsebuje 68.95 mg brezvodne laktoze.
English: Grade 3 hand- foot syndrome is moist desquamation, ulceration, blistering and severe pain of the hands and/or feet and/or severe discomfort that causes the patient to be unable to work or perform activities of daily living.
Slovenian: Za 3. stopnjo so značilni vlažno luščenje kože, nastajanje razjed in mehurjev na koži in huda bolečina v rokah ali nogah ali obojih okončinah ali pa hudo neugodje, ki bolniku onemogoča opravljanje njegovih vsakodnevnih dejavnosti.
English: Given as monotherapy, the recommended starting dose for capecitabine in the adjuvant treatment of colon cancer, in the treatment of metastatic colorectal cancer or of locally advanced or metastatic breast cancer is 1250 mg/m2 administered twice daily (morning and evening; equivalent to 2500 mg/m2 total daily dose) for 14 days followed by a 7-day rest period.
Slovenian: Priporočeni začetni odmerek kapecitabina za samostojno adjuvantno zdravljenje raka kolona, metastatskega kolorektalnega raka ali lokalno napredovalega ali metastatskega raka dojk je 1.250 mg/m2 dvakrat na dan (zjutraj in zvečer; celokupni dnevni odmerek znaša 2.500 mg/m2) 14 dni,
English: In the all-randomised population, capecitabine was shown to be superior to 5FU/LV for disease-free survival (hazard ratio 0.849; 95% CI 0.739 - 0.976; p = 0.0212), as well as for overall survival (hazard ratio 0.828; 95% CI 0.705 - 0.971; p = 0.0203).
Slovenian: V celotni randomizirani populaciji je bil kapecitabin superioren v primerjavi s 5-FU/LV v preživetju brez bolezni (razmerje ogroženosti 0,849; 95-% interval zaupanja 0,739-0,976; p = 0,0212), kot tudi v celokupnem preživetju (razmerje ogroženosti 0,828; 95-% interval zaupanja 0,705-0,971; p = 0,0203).
English: A meta-analysis of 14 clinical trials with data from over 4700 patients treated with capecitabine monotherapy or capecitabine in combination with different chemotherapy regimens in multiple indications (colon, colorectal, gastric and breast cancer), showed that patients on capecitabine who developed hand-foot syndrome (HFS) had a longer overall survival compared to patients who did not develop HFS: median overall survival 1100 days (95% CI 1007; 1200) vs. 691 days (95% CI 638; 754) with a hazard ratio of 0.61 (95% CI 0.56; 0.66).
Slovenian: Meta-analiza 14 kliničnih preskušanj s podatki od več kot 4.700 bolnikov, zdravljenih s kapecitabinom samim ali kapecitabinom v kombinaciji z različnimi shemami kemoterapije pri več indikacijah (rak kolona, kolorektalni rak, rak želodca in rak dojk) je pokazala, da so imeli bolniki, ki so Se zdravili s kapecitabinom pri katerih se je razvil sindrom roka-noga, daljše celokupno preživetje v primerjavi z bolniki, ki niso imeli tega sindroma; mediana celokupnega preživetja je bila 1.100 dni (95-% interval zaupanja; 1.007; 1.200) v primerjavi s 691 dnevi (95-% interval zaupanja 638; 754) z razmerjem ogroženosti 0,61 (95-% interval zaupanja; 0,56; 0,66).
English: Capecitabine SUN 500 mg film-coated tablets are peach coloured, oval, biconvex, 17.5 mm x 8.7 mm tablets, with inscription ‘500'on one side and plain on other side.
Slovenian: Kapecitabin SUN 150 mg filmsko obložene tablete so breskove barve, ovalne, bikonveksne oblike, velikost 17.5 mm x 8.7 mm, z oznako “500” na eni strani in brez oznake na drugi strani.
English: In this treatment subgroup comparison, XELOX plus bevacizumab was similar compared to FOLFOX-4 plus bevacizumab in terms of progression-free survival (hazard ratio 1.01; 97.5% CI 0.84 - 1.22).
Slovenian: V tej primerjavi podskupin je bilo preživetje brez napredovanja bolezni v skupini, ki se je zdravila po shemi XELOX v kombinaciji z bevacizumabom, podobno kot v skupini, ki se je zdravila po shemi FOLFOX-4 v kombinaciji z bevacizumabom (razmerje ogroženosti 1,01; 97,5-% interval zaupanja 0,84-1,22).
English: Each pack contains 120 film-coated tablets (12 blisters of 10 tablets).
Slovenian: Vsaka škatla vsebuje 120 filmsko obloženih tablet (12 pretisnih omotov po 10 tablet).
English: - certain types of arrhythmia (including ventricular fibrillation, torsade de pointes, and bradycardia) - eye inflammation causing eye pain and possibly eyesight problems - inflammation of the skin causing red scaly patches due to an immune system illness.
Slovenian: - vnetje oči, ki povzroči boleče oči in morda težave z vidom, - vnetje kože, ki povzroči rdeče srbeče zaplate zaradi bolezni imunskega sistema.
English: - Tablet coating: hypromellose (E464), titanium dioxide (E171), lactose monohydrate, macrogol and ferric oxide yellow and red (E172).
Slovenian: - Filmska obloga: hipromeloza (E464), titanov dioksid (E171), laktoza monohidrat, makrogol, rumeni in rdeči železov oksid (E172).
English: 5-fluorouracil IV bolus/infusion, each on Days 1 and 2, every 2 weeks
Slovenian: bolus/infuzija, oboje 1. in 2. dan, vsake 2 tedna placebo ali bevacizumab
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.
Slovenian: Interferon alfa: pri sočasnem jemanju kapecitabina z interferonom alfa (3 mio i. e./m2 na dan) je bil največji prenosljivi odmerek kapecitabina 2.000 mg/m2 na dan, pri jemanju samega kapecitabina pa 3.000 mg/m2 na dan.
English: Tablet core: talc (E553b) anhydrous lactose croscarmellose sodium (E468) hypromellose (E464) microcrystalline cellulose (E460) magnesium stearate (E572)
Slovenian: Jedro tablete: smukec (E553b), brezvodna laktoza, premrežen natrijev karmelozat (E468), hipromeloza (E464), mikrokristalna celuloza (E460), magnezijev stearat (E572)
English: However, the on-treatment PFS analysis did not confirm the results of the general PFS and OS analysis: the hazard ratio of XELOX versus FOLFOX-4 was 1.24 with 97.5% CI 1.07 - 1.44.
Slovenian: Analiza preživetja brez napredovanja bolezni ob zdravljenju (ontreatment progression-free survival) ni potrdila rezultata celotne analize preživetja brez napredovanja bolezni in celokupnega preživetja: razmerje ogroženosti za zdravljenje po shemi XELOX v primerjavi s FOLFOX-4 je bilo 1,24 (97,5-% interval zaupanja 1,07-1,44).
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).
Slovenian: Analiza primarne učinkovitosti pri populaciji po protokolu je za celokupno preživetje dokazala, da so sheme osnovane na kapecitabinu neinferiorne shemam osnovanim na 5-FU (razmerje ogroženosti 0,86; 95-% interval zaupanja 0,80-0,99), sheme osnovane na oksaliplatinu pa neinferiorne shemam osnovanim na cisplatinu (razmerje ogroženosti 0,92; 95-% interval zaupanja 0,80-1,10).
English: How to take Capecitabine SUN
Slovenian: Kako jemati zdravilo Kapecitabin SUN