FrancophonIA/ELRC3.0 huggingface dataset:
English: Posology adjustments during treatment
Slovenian: Prilagajanje odmerjanja med zdravljenjem
English: Dose limiting toxicities include diarrhoea, abdominal pain, nausea, stomatitis and hand-foot syndrome (hand-foot skin reaction, palmar-plantar erythrodysesthesia).
Slovenian: Med toksičnosti, ki lahko omejijo odmerjanje, uvrščajo drisko, bolečino v trebuhu, slabost, stomatitis in sindrom roka-noga (reakcija na dlaneh in podplatih, palmarno-plantarna eritrodisestezija).
English: Immune system disorders
Slovenian: Bolezni imunskega sistema preobčutljivost
English: Treatment with capecitabine monotherapy may be resumed when bilirubin decreases to ≤3.0 x ULN or hepatic aminotransferases decrease to ≤ 2.5 x ULN.
Slovenian: Samostojno zdravljenje s kapecitabinom lahko nadaljujemo, ko se vrednosti bilirubina znižajo pod 3,0-kratno zgornjo referenčno vrednost oziroma ko je aktivnost jetrnih aminotransferaz zmanjšana na manj kot 2,5-kratno zgornjo referenčno vrednost.
English: - Hand-and-foot skin-reaction: if you have pain, swelling, redness or tingling of hands and/or feet.
Slovenian: - Kožna reakcija na rokah in nogah: če imate boleče, otekle, rdeče ali skeleče roke ali noge ali oboje okončine.
English: Phase I studies evaluating the effect of capecitabine on the pharmacokinetics of either docetaxel or paclitaxel and vice versa showed no effect by capecitabine on the pharmacokinetics of docetaxel or paclitaxel (Cmax and AUC) and no effect by docetaxel or paclitaxel on the pharmacokinetics of 5'-DFUR.
Slovenian: Raziskave faze I, ki so ocenjevale učinek kapecitabina na farmakokinetiko docetaksela ali paklitaksela in obratno, niso pokazale vplivov kapecitabina na farmakokinetiko docetaksela ali paklitaksela (Cmax in AUC).
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.
Slovenian: Za kombinacijo z irinotekanom je priporočeni začetni odmerek 800 mg/m2, kadar ga dajemo dvakrat na dan 14 dni, čemur sledi 7-dnevni premor, irinotekan pa damo 1. dan v odmerku 200 mg/m2.
English: In the largest study (BICC-C), patients were randomised to receive either open label FOLFIRI (n=144), bolus 5-FU (mIFL) (n=145) or XELIRI (n=141) and were additionally randomised to receive either double-blind treatment with celecoxib or placebo.
Slovenian: V največji študiji (BICC-C) so bolnike randomizirali, da so kot odprto zdravljenje prejeli FOLFIRI (n = 144), 5-FU v bolusu (mIFL) (n = 145) ali XELIRI (n = 141).
English: Ecansya is used in the treatment of colon, rectal, gastric, or breast cancers.
Slovenian: Zdravilo Ecansya se uporablja za zdravljenje raka debelega črevesa, danke, želodca in raka dojk.
English: Anhydrous lactose Microcrystalline cellulose (E460) Croscarmellose sodium Hypromellose (E-5) Magnesium stearate
Slovenian: Jedro tablete brezvodna laktoza mikrokristalna celuloza (E460) premreženi natrijev karmelozat hipromeloza (E-5) magnezijev stearat
English: Data from a multicentre, randomised, controlled phase II study (AIO KRK 0604) supports the use of capecitabine at a starting dose of 800 mg/m2 for 2 weeks every 3 weeks in combination with irinotecan and bevacizumab for the first-line treatment of patients with metastatic colorectal cancer.
Slovenian: Podatki multicentrične, randomizirane, kontrolirane študije faze II (AIO KRK 0604) podpirajo uporabo kapecitabina v začetnem odmerku 800 mg/m2 2 tedna vsake 3 tedne v kombinaciji z irinotekanom in bevacizumabom v prvi liniji zdravljenja bolnikov z metastatskim kolorektalnim rakom.
English: Neoplasm benign, malignant and unspecified
Slovenian: Benigne, maligne in neopredeljene novotvorbe lipom
English: Blood and lymphatic system disorders
Slovenian: Bolezni krvi in limfatičnega sistema nevtropenija,
English: - In combination with docetaxel: an increased incidence of grade 3 or 4 treatment-related adverse reactions and treatment-related serious adverse reactions were observed in patients 60 years of age or more (see section 5.1).
Slovenian: - V kombinaciji z docetakselom: pri bolnikih, starih 60 let ali več, so opazili večjo pogostnost z zdravljenjem povezanih neželenih učinkov stopnje 3 ali 4 ter z zdravljenjem povezanih resnih neželenih učinkov (glejte poglavje 5.1).
English: Hydronephrosis, Urinary incontinence, Haematuria, Nocturia, Blood creatinine increased
Slovenian: Bolezni sečil hidronefroza, urinarna inkontinenca, hematurija, nikturija, zvišan kreatinin v krvi
English: However, grade 3 or 4 treatment-related adverse reactions were more frequent in patients 60 years of age compared to younger patients.
Slovenian: Pri bolnikih, starih 60 let ali več, so bili z zdravljenjem povezani neželeni učinki stopnje 3 ali 4 bolj pogosti kot pri mlajših bolnikih.
English: How to take Ecansya
Slovenian: Kako jemati zdravilo Ecansya
English: - Steven-Johnson syndrome: if you experience painful red or purplish rash that spreads and blisters and/or other lesions begin to appear in the mucous membrane (e.g. mouth and lips), in particular if you had before light sensitivity, infections of the respiratory system (e.g. bronchitis) and/or fever.
Slovenian: - Bolečina v prsnem košu: če občutite bolečino, omejeno na sredino prsnega koša, še posebno, če se pojavi med naporom - Stevens-Johnsonov sindrom: če dobite boleč, rdeč ali škrlaten izpuščaj, ki se širi ali se začnejo pojavljati mehurji in/ali druge poškodbe na sluznici (npr. v ustih in na ustnicah), še posebno, če ste bili občutljivi na svetlobo ali imeli okužbe dihal (npr. bronhitis) in/ali zvišano telesno temperaturo.
English: Talk to your doctor or pharmacist before taking Ecansya - if you know that you have a partial deficiency in the activity of the enzyme dihydropyrimidine dehydrogenase (DPD) - if you have liver or kidney diseases - 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) - if you have brain diseases (for example, cancer that has spread to the brain) or nerve damage
Slovenian: - veste, da imate delno pomanjkanje aktivnosti encima dihidropirimidin dehidrogenaze (DPD), - imate jetrno ali ledvično bolezen, - imate ali ste imeli težave s srcem (npr. neredno bitje srca ali bolečine v prsnici in za njo, ki se pojavijo pri fizičnem naporu zaradi težav s pretokom krvi v srce), - imate možgansko bolezen (npr. raka, ki se je razširil v možgane ali okvaro živcev
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: 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: Hypromellose (6cps), titanium dioxide (E171), yellow iron oxide, red iron oxide (E172), talc.
Slovenian: Hipromeloza (6cps), titanov dioksid (E171), rumeni železov oksid, rdeči železov oksid (E172), smukec.
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: 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: Če se pri bolniku med zdravljenjem pojavijo neželeni dogodki stopnje 2, 3 ali 4, ga je priporočljivo skrbno nadzorovati in takoj prekiniti zdravljenje, nadaljnje odmerke pa prilagoditi v skladu z zgornjo preglednico 3.
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 dvojni vid, - vrtoglavico, bolečine v ušesu, - nereden srčni utrip in palpitacije (aritmije), bolečino v prsnem košu in srčni napad (infarkt), - strdke krvi v globokih venah, visok ali nizek krvni tlak, vročinske valove, mrzle okončine,
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: The enzyme involved in the final conversion to 5-FU, thymidine phosphorylase (ThyPase), is found in tumour tissues, but also in normal tissues, albeit usually at lower levels.
Slovenian: Encim timidin fosforilaza, ki v zadnjem postopku pretvori kapecitabin v 5-FU, se nahaja v tumorskih tkivih, v manjših količinah ga najdemo tudi v normalnih tkivih.
English: 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: 5-fluorouracil intravenous bolus/infusion, each on Days 1 and 2, every 2 weeks
Slovenian: 5 fluorouracil intravensko bolus/infuzija, oboje 1. in 2. dan, vsake 2 tedna levkovorin 200 mg/m intravensko 2 h
English: Dose modifications for toxicity when capecitabine is used as a 3 weekly cycle in combination with other medicinal products
Slovenian: Prilagajanje odmerkov zaradi toksičnosti, kadar se kapecitabin uporablja z drugimi zdravili v 3-tedenskih ciklih
English: In an interaction study with single-dose warfarin administration, there was a significant increase in the mean AUC (+57%) of S-warfarin.
Slovenian: Antikoagulantno zdravljenje s kumarinskimi derivati: V raziskavi interakcij so pri jemanju enkratnega odmerka varfarina ugotovili pomembno povečanje povprečne AUC S-varfarina (+ 57 %).
English: 9/L and/or thrombocyte counts of <100 x 10
Slovenian: 9/l in/ali število trombocitov
English: Parameter: Progression-free Survival EPP ITT Parameter: Overall Survival EPP ITT *EPP=eligible patient population; **ITT=intent-to-treat population
Slovenian: Parameter: Preživetje brez napredovanja bolezni EPP ITT 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: UNIQUE IDENTIFIER - 2D BARCODE 2D barcode carrying the unique identifier included.
Slovenian: Vsebuje dvodimenzionalno črtno kodo z edinstveno oznako.
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, the following covariates were statistically significantly associated with an increased risk of developing diarrhoea: increasing capecitabine starting dose (gram), increasing duration of study treatment (weeks), increasing age (by 10 year increments), and female gender.
Slovenian: Meta-analiza 14 kliničnih preskušanj s podatki od več kot 4.700 bolnikov, zdravljenih s kapecitabinom, je pokazala, da so bile z večjim tveganjem za razvoj driske statistično značilno povezane naslednje sospremenljivke, povzete iz vseh študij: večji začetni odmerek kapecitabina (grami), daljše zdravljenje (tedni), višja starost (v korakih po 10 let) in ženski spol.
English: Allopurinol: interactions with allopurinol have been observed for 5-FU; with possible decreased efficacy of 5-FU.
Slovenian: Alopurinol: Medsebojna delovanja so opazili med 5-FU in alupurinolom.
English: Table 6 Treatment regimens in study NO16966 (mCRC) Treatment
Slovenian: Sheme zdravljenja v študiji NO16966 (metastatski kolorektalni rak) Zdravljenje Začetni odmerek
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 v preglednici 8.
English: NCIC CTC grade 2 diarrhoea is defined as an increase of 4 to 6 stools/day or nocturnal stools, grade 3 diarrhoea as an increase of 7 to 9 stools/day or incontinence and malabsorption.
Slovenian: Driska stopnje 2 je po NCIC CTC opredeljena kot povečana potreba po izpraznitvi črevesa 4- do 6-krat na dan ali kot nočne povečane potrebe po izpraznitvi črevesa.
English: Infusion related reaction, Injection site reaction, Infusion site pain, Injection site pain
Slovenian: +zvišana telesna temperatura, z infuzijo povezana reakcija, reakcija na mestu injiciranja, bolečina na mestu infundiranja, bolečina na mestu injiciranja
English: The hazard ratio for duration of survival (overall survival) was similar to the hazard ratio for progression-free survival (hazard ratio 0.85; 95% CI 0.641.13).
Slovenian: Razmerje ogroženosti za trajanje preživetja (celokupnega) je bilo podobno razmerju ogroženosti za preživetje brez napredovanja bolezni (razmerje ogroženosti 0,85; 95-% interval zaupanja 0,64-1,13).
English: Administration with food decreases the rate of capecitabine absorption (see section 5.2).
Slovenian: Trenutni podatki o varnosti in učinkovitosti zdravila priporočajo jemanje kapecitabina s hrano, ki zmanjša hitrost absorpcije kapecitabina (glejte poglavje 5.2).
English: In first-line treatment the median progression-free survival in the intent-to-treat population was 5.8 months (95%CI 5.1 - 6.2 months) for capecitabine monotherapy and 7.8 months (95%CI 7.0 - 8.3 months; p=0.0002) for XELIRI.
Slovenian: V prvi liniji zdravljenja je bila mediana preživetja brez napredovanja bolezni v populaciji, ki so jo nameravali zdraviti, 5,8 meseca (95-% interval zaupanja 5,1−6,2 meseca) za samostojno zdravljenje s kapecitabinom in 7,8 meseca (95-% interval zaupanja 7,0−8,3 meseca; p = 0,0002) za zdravljenje s shemo XELIRI.
English: Genotyping for these alleles is recommended to identify patients at increased risk for severe toxicity.
Slovenian: Za prepoznavanje bolnikov z visokim tveganjem za hudo toksičnost je priporočljiva genotipizacija teh alelov.
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: In the allrandomised 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: Ecansya is indicated for the treatment of: - for the adjuvant treatment of patients following surgery of stage III (Dukes' stage C) colon cancer (see section 5.1).
Slovenian: - za adjuvantno zdravljenje bolnikov po operaciji raka kolona stadija III (Dukes C) (glejte poglavje 5.1).
English: For the capecitabine dose of 1000 mg/m2 twice daily on days 1 to 14 every 3 weeks, a frequency of 22% to 30% of all-grade HFS was observed in capecitabine combination therapy.
Slovenian: Če so bolniki kapecitabin prejemali v odmerku 1.000 mg/m2 dvakrat na dan 1. do 14. dan vsake 3 tedne v kombinaciji z drugimi zdravili, je bila pogostnost vseh stopenj sindroma roka-noga 22- do 30-%.
English: However, folinic acid has an effect on the pharmacodynamics of capecitabine and its toxicity may be enhanced by folinic acid: the maximum tolerated dose (MTD) of capecitabine alone using the intermittent regimen is 3000 mg/m2 per day whereas it is only 2000 mg/m2 per day when capecitabine was combined with folinic acid (30 mg orally bid).
Slovenian: Zaradi folinske kisline se lahko poveča toksičnost kapecitabina: največji prenosljivi odmerek kapecitabina samega med intermitentnim dajanjem je 3.000 mg/m2 na dan, skupaj s folinsko kislino 30 mg peroralno dvakrat na dan pa 2.000 mg/m2.
English: Median progression free survival ITT
Slovenian: Mediana preživetja brez napredovanja bolezni ITT
English: In this trial, 255 patients were randomised to treatment with capecitabine (1250 mg/m2 twice daily for 2
Slovenian: 255 bolnikov, randomizirano vključenih v preskušanje, je prejemalo zdravljenje s kapecitabinom (1.250 mg/m2 dvakrat na dan 2
English: 9/L, treatment with capecitabine should be interrupted.
Slovenian: je treba zdravljenje s kapecitabinom prekiniti.
English: Anorexia
Slovenian: Encefalopatija
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: Bolnikom z zmerno ledvično okvaro in začetnim odmerkom 1.250 mg/m2 je priporočljivo zmanjšati odmerek na 75 %.
English: There is insufficient data to recommend a specific dose in patients with partial DPD activity as measured by specific test.
Slovenian: Pri teh bolnikih se lahko resni toksičnosti izognemo z zmanjšanim začetnim odmerkom.Na voljo ni dovolj podatkov, da bi pri bolnikih z delnim pomanjkanjem aktivnosti DPD, določenim s posebnim testom, lahko priporočili specifičen odmerek.
English: purple spots on the skin - blood clots in the veins in the lung (pulmonary embolism), collapsed lung, coughing up blood,
Slovenian: škrlatne pike na koži, - strdke krvi v venah in pljučih (pulmonalni embolizem), kolaps pljuč, izkašljevanje krvi, astmo,
English: The XELIRI regimens included capecitabine 1000 mg/m twice daily on days 1 to 14 of a three-week cycle combined with irinotecan 250 mg/m2 on day1.
Slovenian: Shema XELIRI je vključevala zdravljenje s kapecitabinom 1.000 mg/m2 dvakrat na dan od 1. do 14. dne v tritedenskih ciklih v kombinaciji z irinotekanom250 mg/m2 1. dan.
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: There must be at least a 4-week waiting period between end of treatment with brivudine and start of capecitabine therapy.
Slovenian: Med zaključkom zdravljenja z brivudinom in začetkom zdravljenja s kapecitabinom mora biti vsaj 4-tedenski premor.
English: Marketing Authorisation Holder KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia
Slovenian: Imetnik dovoljenja za promet z zdravilom KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenija
English: In patients with moderate renal impairment at baseline, no dose reduction is required for a starting dose of 1000 mg/m2.
Slovenian: Odmerka ni treba prilagajati za bolnike z zmerno ledvično okvaro in začetnim odmerkom 1.000 mg/m2.
English: Capecitabine is contraindicated during pregnancy.
Slovenian: Kapecitabina med nosečnostjo ni dovoljeno jemati.
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 (on-treatment 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: HR (95% CI)
Slovenian: Razmerje ogroženosti (95 % CI)
English: Cardiac arrhythmias (including ventricular fibrillation, torsade de pointes, and bradycardia), angina pectoris, myocardial infarction, heart failure and cardiomyopathy have been reported in patients receiving capecitabine.
Slovenian: Pri bolnikih, ki so jemali kapecitabin, so se pojavile srčne aritmije (vključno z ventrikularno fibrilacijo, torsade de pointes in bradikardijo), angina pektoris, miokardni infarkt, srčno popuščanje in kardiomiopatija.
English: Symptoms
Slovenian: Znaki
English: In the instance of exposure to crushed or cut capecitabine tablets, the following adverse drug reactions have been reported: eye irritation, eye swelling, skin rash, headache, paresthesia, diarrhea, nausea, gastric irritation, and vomiting.
Slovenian: V primeru izpostavljenosti zdrobljenim ali razrezanim tabletam kapecitabina so poročali o naslednjih neželenih učinkih: draženje oči, otekanje oči, kožni izpuščaj, glavobol, parestezija, driska, slabost, draženje želodca in bruhanje.
English: OTHER
Slovenian: I
English: The median time to progression was 186 days (capecitabine + docetaxel) vs. 128 days (docetaxel alone).
Slovenian: Mediana časa do napredovanja bolezni v skupini, ki je jemala kapecitabin in docetaksel, je bila 186 dni, v skupini, ki je jemala le docetaksel, pa 128 dni.
English: In these trials, a total of 236 patients were treated with capecitabine (1250 mg/m2 twice daily for 2 weeks followed by 1-week rest period).
Slovenian: V preskušanjih je bilo 236 bolnikov zdravljenih s kapecitabinom (odmerek 1.250 mg/m2 dvakrat na dan 2 tedna, sledi en teden premora).
English: Common side-effects (may affect up to 1 in 10 people) include: - decrease in blood sodium, magnesium or calcium, increase in blood sugar - nerve pain - ringing or buzzing in the ears (tinnitus), loss of hearing - vein inflammation - hiccups, change in voice - pain or altered/abnormal sensation in the mouth, pain in the jaw - sweating, night sweats - muscle spasm
Slovenian: Pogosti neželeni učinki (pojavijo se lahko pri največ 1 od 10 bolnikov) vključujejo: - znižanje ravni natrija, magnezija in kalcija v krvi, povišanje krvnega sladkorja, - bolečino v živcih, - zvonjenje ali brnenje v ušesih (tinitus), izgubo sluha, - vnetje ven, - kolcanje, spremembo glasu, - bolečino ali spremenjen/nenormalen občutek v ustih, bolečino v čeljustnicah, - potenje, nočno potenje, - mišične krče,
English: Dihydropyrimidine dehydrogenase (DPD) activity is the rate limiting step.
Slovenian: Na hitrost pretvorbe ključno vpliva dihidropirimidin dehidrogenaza (DPD).
English: Dose modifications for toxicity when capecitabine is used continuously in combination with other medicinal products should be made according to table 3 above for capecitabine and according to the appropriate summary of product characteristics for the other medicinal product(s).
Slovenian: Kadar se kapecitabin uporablja neprekinjeno v kombinaciji z drugimi zdravili, je treba odmerke zaradi toksičnosti prilagajati v skladu z zgornjo preglednico 3 za kapecitabin in v skladu s primernim povzetkom glavnih značilnosti za drugo oz. druga zdravila.