FrancophonIA/ELRC3.0 huggingface dataset:
English: DPD deficiency cannot be precisely defined, it is known that patients with certain homozygous or certain compound heterozygous mutations in the DPYD gene locus (e.g. DPYD*2A, c.1679T>G, c.2846A>T and c.1236G>A/HapB3 variants), which can cause complete or near complete absence of DPD enzymatic activity (as determined from laboratory assays), have the highest risk of lifethreatening or fatal toxicity and should not be treated with Capecitabine Teva (see section 4.3).
Slovenian: Čeprav pomanjkanja DPD ne moremo natančno določiti, je znano, da imajo bolniki z določenimi homozigotnimi ali določenimi sestavljenimi heterozigotnimi mutacijami v lokaciji gena DPYD (npr. z različicami DPYD*2A, c.1679T>G, c.2846A>T in c.1236G>A/HapB3), ki lahko povzročijo popolno ali skoraj popolno pomanjkanje encimske aktivnosti DPD (določene z laboratorijskim testom), največje tveganje za življensko ogrožujočo ali smrtno toksičnost in jih ne smemo zdraviti z zdravilom Kapecitabin Teva (glejte poglavje 4.3).
English: Capecitabine Teva 500 mg film-coated tablets EU/1/12/761/002
Slovenian: Kapecitabin Teva 500 mg filmsko obložene tablete EU/1/12/761/002
English: • decreases in the number of white blood cells or red blood cells (seen in tests),
Slovenian: • zmanjšanje števila belih ali rdečih krvnih celic (vidno v testih)
English: In addition, during a 13-week study, atrophic and degenerative changes occurred in reproductive organs of male mice; however these effects were reversible after a drug-free period (see section 4.6).
Slovenian: Med 13-tedensko študijo so se pri mišjih samcih pojavile atrofične in degenerative spremembe na reproduktivnih organih, ki so po prenehanju jemanja kapecitabina izginile (glejte poglavje 4.6).
English: Based on a pharmacokinetic study in cancer patients with mild to severe renal impairment, there is no evidence for an effect of creatinine clearance on the pharmacokinetics of intact drug and 5-FU.
Slovenian: Glede na farmakokinetično študijo pri bolnikih, ki imajo blago do hudo ledvično okvaro, ni dokazov za vpliv kreatininskega očistka na farmakokinetiko zdravila in 5-FU.
English: • Recent or concomitant treatment with brivudine (see section 4.4 and 4.5 for drug-drug interaction),
Slovenian: • Nedavno ali sočasno zdravljenje z brivudinom (glede medsebojnega delovanja med zdravili glejte poglavji 4.4 in 4.5).
English: Capecitabine Teva with food and drink You should take Capecitabine Teva no later than 30 minutes after meals.
Slovenian: Zdravilo Kapecitabin Teva skupaj s hrano in pijačo Zdravilo Kapecitabin Teva morate vzeti najpozneje v 30 minutah po obroku.
English: Other medicines and Capecitabine Teva
Slovenian: Druga zdravila in zdravilo Kapecitabin Teva
English: If caught early, these side effects usually improve within 2 to 3 days after treatment discontinuation.
Slovenian: Če ukrepamo takoj, neželeni učinki minejo v 2 do 3 dneh po prekinitvi zdravljenja.
English: In patients with moderate renal impairment at baseline, a dose reduction to 75% for a starting dose of 1250 mg/m2 is recommended.
Slovenian: Pri bolnikih z zmerno okvaro ledvic v izhodišču, je priporočeno zmanjšanje odmerka na 75 % začetnega odmerka 1250 mg/m2.
English: Hypo- or hypercalcaemia
Slovenian: Hipokalciemija ali hiperkalciemija
English: Mogilska 80, 31-546 Krakow
Slovenian: Krakow 31-546 Poljska
English: diarrhoea is an increase of ≥10 stools/day or grossly bloody diarrhoea or the need for parenteral support.
Slovenian: Driska stopnje 4 pomeni 10 ali več izpraznitev črevesa na dan ali močne krvave driske ali potrebo po parenteralni hidraciji.
English: • eye irritation, increased tears, eye redness (conjunctivitis)
Slovenian: • razdraženost oči, povečano solzenje, rdeče oči (konjunktivitis)
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: Če pri bolnikih, starejših od 60 let, ki se zdravijo z zmanjšanim odmerkom kapecitabina v kombinaciji z docetakselom, ni opaziti toksičnosti, se lahko odmerek postopno zveča do 1250 mg/m2 dvakrat dnevno.
English: Tablet coating Macrogol (400) Hypromellose Titanium dioxide (E171) Yellow iron oxide (E172) Red iron oxide (E172)
Slovenian: Filmska obloga makrogol (400) hipromeloza titanov dioksid (E171) rumeni železov oksid (E172) rdeči železov oksid (E172)
English: Patients treated with XELIRI experienced excessive gastrointestinal toxicity compared with FOLFIRI (diarrhoea 48% and 14% for XELIRI and FOLFIRI respectively).
Slovenian: Bolniki, zdravljeni s XELIRI, so imeli več gastrointestinalnih toksičnosti v primerjavi z bolniki, zdravljenimi s FOLFIRI (driska 48 % za XELIRI in 14 % za FOLFIRI).
English: The elimination half-life (t1/2 in hours) of capecitabine, 5'-DFCR, 5'-DFUR, 5-FU and FBAL were 0.85, 1.11, 0.66, 0.76 and 3.23 respectively.
Slovenian: Razpolovne dobe izločanja (t1/2 v urah) kapecitabina, 5´-DFCR, 5´-DFUR, 5-FU in FBAL so bile 0,85; 1,11; 0,66; 0,76 in 3,23.
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 Capecitabine Teva (e.g. stomatitis, mucosal inflammation, diarrhoea, neutropenia, and neurotoxicity).
Slovenian: • Pomanjkanje DPD: če je znano, da imate pomanjkanje DPD, imate večje tveganje za nenaden, zgodnji pojav toksičnosti in hude, življenjsko ogrožujoče ali smrtne neželene učinke, povzročene z zdravilom Kapecitabin Teva (npr. stomatitis, vnetje sluznic, drisko, nevtropenijo in nevrotoksičnost).
English: • dehydration, weight loss
Slovenian: • dehidracija, izguba telesne mase
English: Common All grades
Slovenian: Vse stopnje
English: Following a mean duration of follow-up for the study population of 26.2 months, treatment responses were as shown below:
Slovenian: Odgovori na zdravljenje so po povprečnem trajanju spremljanja študijske populacije 26,2 meseca prikazani spodaj.
English: • headache, sleepiness, dizziness, abnormal sensation in the skin (numbness or tingling sensation),
Slovenian: • glavobol, zaspanost, omotičnost, nenormalni občutki na koži (otrplost ali občutek ščemenja),
English: Capecitabine Teva belongs to the group of medicines called "cytostatic medicines", which stop the growth of cancer cells.
Slovenian: Zdravilo Kapecitabin Teva spada v skupino zdravil, ki jih imenujemo »citostatične učinkovine«, ki zavirajo rast rakavih celic.
English: Folinic acid/folic acid
Slovenian: Folinska kislina/folna kislina
English: Dose modifications for toxicity when capecitabine is used continuously in combination with other medicinal products
Slovenian: Prilagoditev odmerka za toksičnost, ko se kapecitabin uporablja neprekinjeno v kombinaciji z drugimi zdravili
English: The tablets are available in blisters containing 10 film-coated tablets.
Slovenian: Tablete so pakirane v pretisne omote z 10 filmsko obloženimi tabletami.
English: Capecitabine should only be prescribed by a doctor experienced in the use of anticancer medicines.
Slovenian: Kapecitabin vam lahko predpiše samo zdravnik, ki ima izkušnje z uporabo zdravil proti raku.
English: Patients should be carefully monitored for ophthalmological complications such as keratitis and corneal disorders, especially if they have a prior history of eye disorders.
Slovenian: Bolnike je treba skrbno spremljati zaradi oftalmoloških neželenih učinkov, kot sta keratitis in okvare roženice, še posebej, če so v preteklosti že imeli bolezni oči.
English: In vitro human plasma studies have determined that capecitabine, 5'-DFCR, 5'-DFUR and 5-FU are 54%, 10%, 62% and 10% protein bound, mainly to albumin.
Slovenian: Študije in vitro na človeški plazmi so pokazale, da se na proteine (v glavnem na albumin) veže 54 % kapecitabina, 10 % 5´-DFCR, 62 % 5´-DFUR in 10 % 5-FU.
English: Careful monitoring of patients ≥60 years of age is advisable.
Slovenian: Bolnike, starejše od 65 let, je priporočljivo pazljivo nadzorovati.
English: Table 4 lists ADRs associated with the use of capecitabine monotherapy based on a pooled analysis of safety data from three major studies including over 1900 patients (studies M66001, SO14695, and SO14796).
Slovenian: Preglednica 4 našteva neželene učinke, povezane s samostojnim zdravljenjem s kapecitabinom, ki so jih zbrali z analizo podatkov o varnosti v treh glavnih kliničnih študijah pri več kot 1.900 bolnikih (študije M66001, SO14695 in SO14796).
English: • narrowing or blockage of tear duct (lacrimal duct stenosis)
Slovenian: • zožanje ali zaprtje solznega kanala (stenoza solznega kanala)
English: Cardiotoxicity (see section 4.4)
Slovenian: Kardiotoksičnost (glejte poglavje 4.4)
English: • decreases in blood cells including platelets, thinning of blood (seen in tests)
Slovenian: • zmanjšanje krvnih celic, vključno krvnih ploščic, razredčitev krvi (vidno v testih)
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 črevesja ali ust, bolečine ali krvavitev iz črevesja ali želodca, depresija kostnega mozga (znižanje določenih vrst krvnih celic).
English: Cardiotoxicity has been associated with fluoropyrimidine therapy, including myocardial infarction, angina, dysrhythmias, cardiogenic shock, sudden death and electrocardiographic changes (including very rare cases of QT prolongation).
Slovenian: Kardiotoksičnost, povezana z zdravljenjem s fluoropirimidinom, vključuje miokardni infarkt, angino pektoris, motnje ritma, kardiogeni šok, nenadno smrt in elektrokardiografske spremembe (vključno z zelo redkimi primeri podaljšanja intervala QT).
English: Hand and foot syndrome also known as hand-foot skin reaction or palmar-plantar erythrodysesthesia or chemotherapy induced acral erythema.
Slovenian: Sindrom roka-noga je znan tudi kot kožna reakcija na roki in nogi, palmarno-plantarna eritrodisestezija ali s kemoterapijo povzročena rdečina okončin.
English: A reduction of the starting dose in these patients may be considered to avoid serious toxicity.
Slovenian: Pri teh bolnikih se lahko resni toksičnosti izognemo z zmanjšanim začetnim odmerkom.
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.
Slovenian: Rak kolona, kolorektalni rak in napredovali rak želodca: meta-analiza Meta-analiza šestih kliničnih preskušanj (študije SO14695, SO14796, M66001, NO16966, NO16967, M17032) podpira zamenjavo 5-FU s kapecitabinom pri zdravljenju raka prebavil, samostojno ali v kombinaciji z drugimi zdravili.
English: A clinically significant interaction between brivudine and fluoropyrimidines (e.g. capecitabine, 5-fluorouracil, tegafur), resulting from the inhibition of dihydropyrimidine dehydrogenase by sorivudine, has been described.
Slovenian: Opisali so klinično pomembno medsebojno delovanje med brivudinom in fluoropirimidini (npr. kapecitabinom, 5-fluorouracilom in tegafurjem), ki je rezultat sorivudinovega zaviranja dihidropirimidin dehidrogenaze.
English: Elderly patients (see section 4.2)
Slovenian: Posebne skupine bolnikov Starejši bolniki (glejte poglavje 4.2)
English: Dose modifications for toxicity when capecitabine is used as a 3 weekly cycle in combination with other medicinal products
Slovenian: Prilagoditev odmerkov za toksičnosti, ko je kapecitabin uporabljen v 3 tedenskem ciklu v kombinaciji z drugimi zdravili
English: Some of the ADRs are reactions commonly seen with the combination medicinal product (e.g. peripheral sensory neuropathy with docetaxel or oxaliplatin, hypertension seen with bevacizumab); however an exacerbation by capecitabine therapy can not be excluded.
Slovenian: Nekatere neželene učinke pogosto opazijo pri zdravljenju z zdravilom iz kombinacije (npr. periferno senzorično nevropatijo pri docetakselu ali oksaliplatinu, hipertenzijo pri bevacizumabu); vseeno pa njihovega poslabšanja pri zdravljenju s kapecitabinom ne moremo izključiti.
English: For patients 60 years of age or more, a starting dose reduction of capecitabine to 75% (950 mg/m2 twice daily) is recommended.
Slovenian: 60 let, je priporočeno znižanje začetnega odmerka na 75 % (950 mg/m dvakrat dnevno).
English: After oral administration, capecitabine is rapidly and extensively absorbed, followed by extensive conversion to the metabolites, 5'-DFCR and 5'-DFUR.
Slovenian: Po peroralnem zaužitju se kapecitabin absorbira hitro in v velikem obsegu, nato pa se v velikem obsegu pretvori v presnovka 5´-DFCR in 5´-DFUR.
English: cisplatin, irinotecan), - medicines used to treat folic acid deficiency.
Slovenian: bevacizumab, cisplatin, irinotekan), - zdravil za zdravljenje pomanjkanja folne kisline.
English: Parameter: Progression-free Survival PPP
Slovenian: Parameter: Preživetje brez napredovanja bolezni
English: There is no data on capecitabine and impact on fertility.
Slovenian: Podatkov o vplivu kapecitabina na plodnost ni.
English: - Tablet coating: macrogol 400, hypromellose, titanium dioxide (E171), yellow iron oxide (E172),
Slovenian: - Filmska obloga: makrogol 400, hipromeloza, titanov dioksid (E171), rumeni železov oksid
English: • blood clots in the deep veins, high or low blood pressure, hot flushes, cold limbs (extremities),
Slovenian: • krvni strdek globoko v veni, visok ali nizek tlak, vročični oblivi, hladne okončine (ekstremitete), vijolične lise na koži
English: Grade 4
Slovenian: • Stopnja 4
English: Capecitabine is first metabolised by hepatic carboxylesterase to 5'-DFCR, which is then converted to 5'-DFUR by cytidine deaminase, principally located in the liver and tumour tissues.
Slovenian: Kapecitabin se najprej pretvori z jetrno karboksilesterazo v 5´-DFCR, ta pa se prek citidin deaminaze, ki se nahaja v jetrih in tumorskih tkivih, naprej pretvori v 5´-DFUR.
English: In all studies combined, the following covariates were statistically significantly associated with an increased risk of developing HFS: increasing capecitabine starting dose (gram), decreasing cumulative capecitabine dose (0.1*kg), increasing relative dose intensity in the first six weeks, increasing duration of study treatment (weeks), increasing age (by 10 year increments), female gender, and good ECOG performance status at baseline (0 versus ≥1).
Slovenian: Z večjim tveganjem za razvoj sindroma roka-noga so bile statistično značilno povezane naslednje sospremenljivke, povzete iz vseh študij: večji začetni odmerek kapecitabina (grami), manjši kumulativni odmerek kapecitabina (0,1*kg), večji odmerek v prvih šestih tednih, daljše zdravljenje (tedni), višja starost (v korakih po 10 let), ženski spol, dobro stanje zmogljivosti po ECOG ob vključitvi (0 v primerjavi z ≥ 1).
English: Further catalytic activation of 5'-DFUR then occurs by thymidine phosphorylase (ThyPase).
Slovenian: Nadaljnja katalitska aktivacija 5´DFUR poteka s timidin fosforilazo.
English: The incidence of grade 3 or 4 adverse reactions in patients with moderate renal impairment (creatinine clearance 30-50 ml/min) is increased compared to the overall population (see sections 4.2 and 4.3).
Slovenian: Pogostnost pojavov neželenih učinkov stopnje 3 ali 4 pri bolnikih z zmerno ledvično okvaro (očistek kreatinina 30 do 50 ml/min) je v primerjavi s preostalo populacijo povečana (glejte poglavji 4.2 in
English: Coumarin-derivative anticoagulants
Slovenian: Kumarinski antikoagulanti
English: Method of administration Capecitabine Teva film-coated tablets should be swallowed with water within 30 minutes after a meal.
Slovenian: Zdravilo Kapecitabin Teva je treba pogoltniti z vodo v 30 minutah po obroku.
English: • diabetes, decrease in blood potassium, malnutrition, increased blood triglycerides
Slovenian: • sladkorna bolezen, znižanje kalija v krvi, podhranjenost, povišanje trigliceridov v krvi
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 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 in 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: Excipient(s)
Slovenian: Pomožna(e) snov(i)
English: The study contained two parts: an initial 2-arm part in which 634 patients were randomised to two different treatment groups, including XELOX or FOLFOX-4, and a subsequent 2x2 factorial part in which 1401 patients were randomised to four different treatment groups, including XELOX plus placebo, FOLFOX-4 plus placebo, XELOX plus bevacizumab, and FOLFOX-4 plus bevacizumab.
Slovenian: Študija je bila sestavljena iz dveh delov: začetnega dela iz dveh skupin, v katerem so 634 bolnikov randomizirali v dve različni skupini zdravljenja, po shemi XELOX ali shemi FOLFOX-4, in poznejšega dela s faktorskim načrtom 2x2 v katerem so 1.401 bolnika randomizirali v štiri različne skupine zdravljenja, XELOX in placebo,
English: Parameter: Progression-free Survival PPP ITT Parameter: Overall Survival PPP ITT *PPP=per-protocol population; **ITT=intent-to-treat population
Slovenian: ITT *PPP = populacija po protokolu (per-protocol population); **ITT = populacija, ki so jo nameravali zdraviti (intent-to-treat population)
English: Capecitabine Teva contains capecitabine, which itself is not a cytostatic medicine.
Slovenian: Zdravilo Kapecitabin Teva vsebuje kapecitabin, ki sam nima citostatičnega učinka.
English: Microcrystalline cellulose Hypromellose Croscarmellose sodium Magnesium stearate
Slovenian: Jedro tablete laktoza mikrokristalna celuloza hipromeloza natrijev karmelozat magnezijev stearat
English: At the beginning of a treatment cycle, if a treatment delay is indicated for either capecitabine or the other medicinal product(s), then administration of all therapy should be delayed until the requirements for restarting all medicinal products are met.
Slovenian: Če je zamik zdravljenja s kapecitabinom ali drugimi zdravili indiciran na začetku cikla zdravljenja, potem je treba z dajanjem vseh zdravil počakati, dokler niso izpolnjeni pogoji za začetek dajanja vseh zdravil.
English: P=0.45
Slovenian: 25,5 meseca p = 0,45
English: If you are a male patient and your female partner could become pregnant, you should use effective contraception during treatment with Capecitabine Teva and for 3 months after the last dose.
Slovenian: Če ste bolnik in bi vaša partnerka lahko zanosila, morate med zdravljenjem z zdravilom Kapecitabin Teva in še 3 mesece po zadnjem odmerku zdravila uporabljati učinkovito kontracepcijo.
English: Parameter: Overall Survival PPP
Slovenian: ITT Parameter: Celokupno preživetje
English: The incidence of grade 3 or 4 adverse reactions in patients with moderate renal impairment (creatinine clearance 30-50 ml/min at baseline) is increased compared to the overall population.
Slovenian: Povečanje neželenih učinkov stopnje 3 ali 4 pri bolnikih z zmerno okvaro ledvic (kreatinski očistek pod 30-50 ml/min v izhodišču) je povečan v primerjavi z celotno populacijo.
English: In the study published by Skof et al, patients were randomised to receive either FOLFIRI or XELIRI.
Slovenian: V študiji, ki jo je objavil Skof s sodelavci, so bolnike randomizirali v FOLFIRI ali XELIRI.
English: Dihydropyrimidinase cleaves the pyrimidine ring to yield 5
Slovenian: Dihidropirimidinaza cepi pirimidinski obroč, pri čemer nastane 5
English: Careful monitoring and prompt treatment interruption is recommended if the patient develops a grade 2, 3 or 4 adverse event during treatment and subsequent dose adjustment as outlined in table 3 above.
Slovenian: V primeru, da se pri bolniku med zdravljenjem pojavijo neželeni učinki stopnje 2, 3 ali 4, je priporočeno pazljivo opazovanje, takojšnja prekinitev zdravljenja in posledična prilagoditev odmerka kot je prikazano v preglednici 3 zgoraj.
English: • Stomatitis: if you have pain, redness, swelling or sores in your mouth and/or throat.
Slovenian: • Stomatitis: če imate bolečino, rdečino, otekanje ali rane v ustih in/ali žrelu.
English: Parameter: Progression-free Survival EPP ITT Parameter: Overall Survival EPP ITT *EPP=eligible patient population; **ITT=intent-to-treat population.
Slovenian: ITT *EPP = primerna populacija bolnikov (eligible patient population); **ITT = populacija bolnikov, ki so jih nameravali zdraviti (intent-to-treat population)
English: What Capecitabine Teva looks like and contents of the pack
Slovenian: Izgled zdravila Kapecitabin Teva in vsebina pakiranja
English: At the dose of 1250 mg/m2 on day 14 with administration after food intake, the peak plasma concentrations (Cmax in μg/ml) for capecitabine, 5'-DFCR, 5'-DFUR, 5-FU and FBAL were 4.67, 3.05, 12.1, 0.95 and 5.46 respectively.
Slovenian: Pri odmerku 1.250 mg/m2 ob jemanju po obroku so bile na 14. dan največje plazemske koncentracije (Cmax v μg/ml) za kapecitabin, 5´-DFCR, 5´-DFUR, 5-FU in FBAL 4,67; 3,05; 12,1; 0,95 in 5,46.
English: The following factors were prespecified in the statistical analysis plan for inclusion in the model: age, time from surgery to randomization, gender, CEA levels at baseline, lymph nodes at baseline, and country.
Slovenian: V načrtu statistične analize so bili za vključitev v model vnaprej določeni naslednji dejavniki: starost, čas od operacije do randomizacije, spol, izhodiščna vrednost karcinoembrionalnega antigena (CEA), izhodiščno stanje bezgavk, država.
English: If unscheduled laboratory assessments during a treatment cycle show that the neutrophil count drops below 1.0 x 109/L or that the platelet count drops below 75 x 10
Slovenian: Če nenačrtovani laboratorijski pregled med ciklom zdravljenja pokaže, da je število neutrofilcev padlo pod 1.0 x 109/L ali število trombocitov pod 75 x 109/L, je treba zdravljenje s kapecitabinom prekiniti.
English: Patients with hepatic impairment due to liver metastases According to a pharmacokinetic study in cancer patients with mild to moderate liver impairment due to liver metastases, the bioavailability of capecitabine and exposure to 5-FU may increase compared to patients with no liver impairment.
Slovenian: Glede na farmakokinetično študijo pri bolnikih z rakom, ki imajo blago ali zmerno jetrno okvaro zaradi zasevkov v jetrih, je biološka uporabnost kapecitabina in izpostavljenost 5-FU lahko povečana v primerjavi z bolniki brez okvare.
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: Bolezni centralnega ali perifernega živčnega sistema Pri bolnikih, ki imajo bolezen centralnega ali perifernega živčevja, npr. metastaze v možganih ali nevropatijo, je potrebna previdnost (glejte poglavje 4.8).