FrancophonIA/ELRC3.0 huggingface dataset:
English: If grade 2 or 3 hand-foot syndrome occurs, administration of capecitabine should be interrupted until the event resolves or decreases in intensity to grade 1.
Slovenian: Če se pojavi sindrom 2. ali 3. stopnje, je treba jemanje kapecitabina prekiniti, dokler simptomi ne ponehajo oziroma se ne zmanjšajo na 1. stopnjo.
English: Caution must be exercised in patients with diabetes mellitus or electrolyte disturbances, as these may be aggravated during capecitabine treatment.
Slovenian: Sladkorna bolezen ali elektrolitske motnje: Pri bolnikih s sladkorno boleznijo ali elektrolitskimi motnjami je potrebna previdnost, ker se njihovo stanje med zdravljenjem s kapecitabinom lahko poslabša.
English: Patients with certain heterozygous DPYD variants (including DPYD*2A, c.1679T>G, c.2846A>T and c.1236G>A/HapB3 variants) have been shown to have increased risk of severe toxicity when treated with capecitabine.
Slovenian: Izkazalo se je, da imajo bolniki z določenimi heterozigotnimi različicami DPYD (vključno z različicami DPYD*2A, c.1679T>G, c.2846A>T in c.1236G>A/HapB3) pri zdravljenju s kapecitabinom večje tveganje za hudo toksičnost.
English: Capecitabine was not mutagenic in vitro to bacteria (Ames test) or mammalian cells (Chinese hamster V79/HPRT gene mutation assay).
Slovenian: Kapecitabin in vitro pri bakterijah (Amesov test) ali celicah sesalcev (kitajski hrček V79/HPRT, metoda genske mutacije) ni bil mutagen.
English: The median duration of survival was 10.5 months (capecitabine + cisplatin) versus 9.3 months (5-FU + cisplatin).
Slovenian: Mediana trajanja preživetja je bila 10,5 meseca (kapecitabin + cisplatin) v primerjavi z 9,3 meseca (5-FU + cisplatin).
English: Posology Recommended posology (see section 5.1):
Slovenian: Odmerjanje Priporočeno odmerjanje (glejte poglavje 5.1):
English: Patients receiving concomitant capecitabine and oral coumarin-derivative anticoagulant therapy should have their anticoagulant response (INR or prothrombin time) monitored closely and the anticoagulant dose adjusted accordingly (see section 4.5).
Slovenian: Bolnikom, ki sočasno prejemajo kapecitabin in peroralni kumarinski antikoagulant, je treba skrbno spremljati antikoagulantni odziv (INR ali protrombinski čas) ter ustrezno prilagajati odmerek antikoagulanta (glejte poglavje 4.5).
English: Currently, no comparative data are available on capecitabine monotherapy in colorectal cancer in comparison with first line combination regimens.
Slovenian: Trenutno še nimamo podatkov o primerjavi samostojnega zdravljenja s kapecitabinom s kombiniranim zdravljenjem v okviru prvega zdravljenja.
English: In the case of colorectal tumours, 5-FU generation appears to be in large part localised in tumour stromal cells.
Slovenian: Pri kolorektalnih tumorjih je generacija 5-FU močno lokalizirana v tumorskih stromalnih celicah.
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 cannot 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: XELOX or XELOX+ Bevacizumab
Slovenian: shema XELOX + bevacizumab
English: Radiotherapy: the MTD of capecitabine alone using the intermittent regimen is 3000 mg/m2 per day, whereas, when combined with radiotherapy for rectal cancer, the MTD of capecitabine is 2000 mg/m per day using either a continuous schedule or given daily Monday through Friday during a 6-week course of radiotherapy.
Slovenian: Radioterapija: Največji prenosljivi odmerek kapecitabina samega pri intermitentnem dajanju je 3.000 mg/m2 na dan, v kombinaciji z radioterapijo za rak danke pa je največji prenosljivi odmerek kapecitabina 2.000 mg/m2 na dan z uporabo neprekinjene sheme ali dnevnim dajanjem od ponedeljka do petka med 6-tedensko radioterapijo.
English: Thymidine phosphorylase activity was measured and found to be 4 times greater in primary colorectal tumour than in adjacent normal tissue.
Slovenian: Aktivnost timidin fosforilaze je štirikrat večja v primarnih kolorektalnih tumorjih kot v sosednjih zdravih tkivih.
English: Aluminium/aluminium or PVC/PVdC/aluminium blister containing 10 film-coated tablets.
Slovenian: Al/Al ali PVC/PVdC/Al pretisni omoti vsebujejo 10 filmsko obloženih tablet.
English: 7.5 mg/kg intravenous 30-90 mins
Slovenian: 7,5 mg/kg intravensko 30-90 min
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.
Slovenian: V študiji EORTC so bolnike randomizirali, da so kot odprto zdravljenje prejeli FOLFIRI (n = 41) ali XELIRI (n = 44) in jih dodatno randomizirali v dvojno slepo zdravljenje s celekoksibom ali placebom.
English: Ecansya contains lactose
Slovenian: Zdravilo Ecansya vsebuje laktozo
English: Patients with severe diarrhoea should be carefully monitored and given fluid and electrolyte replacement if they become dehydrated.
Slovenian: Driska: Bolnike, pri katerih se pojavi huda driska, je treba skrbno opazovati in jim v primeru dehidracije nadomeščati tekočino in elektrolite.
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: Capecitabine dose reduction decreases systemic exposure to 5-FU more than dose-proportionally, due to non-linear pharmacokinetics for the active metabolite.
Slovenian: Če zmanjšamo odmerek kapecitabina, se sistemska izpostavljenost 5-FU zaradi nelinearne farmakokinetike aktivnega presnovka zmanjša bolj kot sorazmerno z odmerkom.
English: If grade 2 (or higher) dehydration occurs, capecitabine treatment should be immediately interrupted and the dehydration corrected.
Slovenian: Če se pojavi dehidracija stopnje 2 ali več, je treba zdravljenje s kapecitabinom takoj prekiniti in bolnika hidrirati.
English: MARKETING AUTHORISATION NUMBER (S)
Slovenian: ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET
English: Non-inferiority of the XELOX-containing arms compared with the FOLFOX-4-containing arms in the overall comparison was demonstrated in terms of progression-free survival in the eligible patient population and the intent-to-treat population (see table 7).
Slovenian: Ne-inferiornost zdravljenja, ki vsebuje XELOX v primerjavi z zdravljenjem, ki vsebuje FOLFOX-4 v celokupni primerjavi, je bila dokazana glede na preživetje brez napredovanja bolezni v primerni populaciji bolnikov in populaciji bolnikov, ki so jo nameravali zdraviti (glejte preglednico 7).
English: In addition to the above, when Ecansya is used alone, very common side effects, which may affect more than 1 in 10 people are: - abdominal pain - rash, dry or itchy skin - tiredness - loss of appetite (anorexia)
Slovenian: Poleg zgoraj omenjenih neželenih učinkov se lahko pri samostojni uporabi zdravila Ecansya zelo pogosto (pri več kot 1od 10 bolnikov) pojavijo naslednji neželeni učinki: - bolečina v trebuhu, - izpuščaj, suha ali srbeča koža, - utrujenost, - izguba apetita (anoreksija).
English: What Ecansya contains - The active substance is capecitabine.
Slovenian: Kaj vsebuje zdravilo Ecansya - Učinkovina je kapecitabin.
English: STOP taking Ecansya 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 kateri koli od navedenih simptomov, takoj PRENEHAJTE z jemanjem zdravila Ecansya in pokličite zdravnika: - Driska: če pogostnost dnevnih iztrebljanj preseže število, ki je za vas običajno, za štiri ali več, ali če imate ponoči drisko.
English: These adverse reactions may be more common in patients with a prior history of coronary artery disease.
Slovenian: Ti neželeni učinki so pogostejši pri bolnikih, ki so že imeli koronarno srčno bolezen.
English: Elderly.
Slovenian: Starejši
English: Median OS was 23.1 months for FOLFIRI, 17.6 months for mIFL (p=0.09), and 18.9 months for XELIRI (p=0.27).
Slovenian: Mediana celokupnega preživetja je bila 23,1 meseca za FOLFIRI, 17,6 meseca za mIFL (p = 0,09) in 18,9 meseca za XELIRI (p = 0,27).
English: Time to progressive disease was superior in the capecitabine + docetaxel combination arm (p<0.0001).
Slovenian: Čas do napredovanja bolezni je bil v skupini, ki je jemala kapecitabin in docetaksel, daljši (p < 0,0001).
English: In patients with mild renal impairment (creatinine clearance 51-80 ml/min at baseline) no adjustment of the starting dose is recommended.
Slovenian: Bolnikom z blago ledvično okvaro (očistek kreatinina 51 do 80 ml/min na začetku zdravljenja) začetnega odmerka ni treba prilagajati.
English: Following oral administration of capecitabine to patients with colorectal cancer, the ratio of 5-FU concentration in colorectal tumours to adjacent tissues was 3.2 (ranged from 0.9 to 8.0).
Slovenian: Po peroralnem zaužitju kapecitabina je pri bolnikih s kolorektalnim rakom razmerje koncentracij 5-FU v kolorektalnih tumorjih znašalo v primerjavi s sosednjimi tkivi 3,2 (območje 0,9 do 8,0).
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: 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 Ecansya (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 Ecansya (npr. stomatitis, vnetje sluznic, drisko, nevtropenijo in nevrotoksičnost).
English: Capecitabine is a non-cytotoxic fluoropyrimidine carbamate, which functions as an orally administered precursor of the cytotoxic moiety 5-fluorouracil (5-FU).
Slovenian: Kapecitabin je necitotoksičen fluoropirimidinski karbamat v obliki prekurzorja citotoksične učinkovine 5-fluorouracila (5-FU).
English: Insufficient safety and efficacy data are available in patients with hepatic impairment to provide a dose adjustment recommendation.
Slovenian: Za bolnike z jetrno okvaro ni na razpolago dovolj podatkov o varnosti in učinkovitosti za navodila o prilagajanju odmerka.
English: ADRs considered by the investigator to be possibly, probably, or remotely related to the administration of capecitabine are listed in table 4 for capecitabine given as monotherapy and in table 5 for capecitabine given in combination with different chemotherapy regimens in multiple indications.
Slovenian: Neželeni učinki, ki so po mnenju raziskovalca morda, verjetno ali nejasno povezani z jemanjem kapecitabina, so navedeni v preglednici 4 za samostojno zdravljenje s kapecitabinom in v preglednici 5 za dajanje kapecitabina v kombinaciji z različnimi kemoterapijami pri več indikacijah.
English: The frequency of the heterozygous DPYD*2A genotype in the DPYD gene in Caucasian patients is around 1%, 1.1% for c.2846A>T, 2.6-6.3% for c.1236G>A/HapB3 variants and 0.07 to 0.1% for c.1679T>G.
Slovenian: Pri belcih je pogostnost heterozigotnega genotipa DPYD*2A v genu DPYD okoli 1 %, pogostnost različice c.2846A>T 1,1 %, različice c.1236G>A/HapB3 2,6-6,3 % in različice c.1679T>G 0,07-0,1 %.
English: Dose limiting toxicities
Slovenian: Toksičnosti, ki lahko omejijo odmerjanje
English: (neuropathy) - if you have calcium imbalances (seen in blood tests) - if you have diabetes - if you cannot keep food or water in your body because of severe nausea and vomiting - if you have diarrhoea - if you are or become dehydrated - if you have imbalances of ions in your blood (electrolyte imbalances, seen in tests) - if you have a history of eye problems as you may need extra monitoring of your eyes - if you have a severe skin reaction.
Slovenian: (nevropatijo)), - imate porušeno ravnovesje kalcija (opaženo pri krvni preiskavi), - imate sladkorno bolezen, - ne morete v sebi zadržati hrane ali tekočine zaradi hude slabosti in bruhanja, - imate drisko, - ste ali postanete dehidrirani, - imate porušeno ravnotežje ionov v vaši krvi (elektrolitsko neravnovesje, opaženo v preiskavah), - ste v preteklosti imeli bolezni oči, ker boste morda potrebovali dodatne kontrole oči, - imate hudo kožno reakcijo.
English: An effective method of contraception should be used during treatment and for 6 months after the last dose of capecitabine.
Slovenian: Med zdravljenjem in še 6 mesecev po zadnjem odmerku kapecitabina je treba uporabljati učinkovito metodo kontracepcije.
English: Maintain dose level
Slovenian: vzdrževanje odmerka vzdrževanje odmerka
English: Ophthalmologic complications: 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: Oftalmološki neželeni učinki: 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: For the dosing schedule of XELOX and FOLFOX-4 (without addition of placebo or bevacizumab), refer to table 6.
Slovenian: Odmerjanje zdravljenja po shemah XELOX in FOLFOX-4 (brez dodatka placeba ali bevacizumaba) je opisano v preglednici 6.
English: You must inform your doctor if you know that you have an allergy or over-reaction to this medicine, - if you previously have had severe reactions to fluoropyrimidine therapy (a group of anticancer medicines, such as fluorouracil), - if you are pregnant or breast-feeding, - if you have severely low levels of white cells or platelets in the blood (leucopenia, neutropenia or thrombocytopenia), - if you have severe liver or kidney problems, - if you know that you do not have any activity of the enzyme dihydropyrimidine dehydrogenase (DPD) - if you are being treated now or have been treated in the last 4 weeks with brivudine as part of herpes zoster (chickenpox or shingles) therapy.
Slovenian: Če imate preobčutljivostno reakcijo na to zdravilo, obvestite zdravnika, - če ste v preteklosti imeli hudo reakcijo na zdravljenje s fluoropirimidini (skupina zdravil za zdravljenje raka, kamor spada fluorouracil), - če ste noseči ali dojite, - če imate zelo nizko raven belih krvnih celic ali trombocitov v krvi (levkopenija, nevtropenija ali trombocitopenija), - če imate hude težave z jetri ali ledvicami, - če veste, da nimate nobene aktivnosti encima dihidropirimidin dehidrogenaze (DPD), - če se trenutno zdravite ali ste se v preteklih 4 tednih zdravili z brivudinom, ki se uporablja kot del zdravljenja herpes zostra (norice ali pasovec).
English: 150 mg 300 mg 500 mg Dose per administration (mg)
Slovenian: 150 mg 300 mg 500 mg Enkratni odmerek (mg)
English: Further catalytic activation of 5'-DFUR then occurs by thymidine phosphorylase (ThyPase).
Slovenian: Nadaljnja katalitska aktivacija 5'-DFUR poteka s timidin fosforilazo.
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: Do not take the missed dose at all.
Slovenian: Ne zaužijte izpuščenega odmerka.
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: Kadar je na začetku cikla zdravljenja indicirano odloženo zdravljenje s kapecitabinom ali drugim zdravilom oz. drugimi zdravili, je treba odložiti zdravljenje z obema oz. vsemi, dokler niso vzpostavljeni pogoji za ponovno zdravljenje z obema zdraviloma oz. vsemi zdravili.
English: Each film-coated tablet contains 150 mg, 300 mg or 500 mg capecitabine.
Slovenian: Ena filmsko obložena tableta vsebuje 150 mg, 300 mg ali 500 mg kapecitabina.
English: Patients treated with XELIRI + bevacizumab reported a significantly higher incidence of diarrhoea, febrile neutropenia and hand-foot skin reactions than patients treated with FOLFIRI + bevacizumab with significantly increased treatment delays, dose reductions and treatment discontinuations.
Slovenian: Pri bolnikih, zdravljenih s XELIRI + bevacizumabom, so poročali o signifikantno večji incidenci driske, febrilne nevtropenije in kožnih reakcij roka-noga kot pri bolnikih, zdravljenih s FOLFIRI + bevacizumabom.
English: Within each frequency grouping, ADRs are presented in order of decreasing seriousness.
Slovenian: V razvrstitvah pogostnosti so neželeni učinki navedeni po padajoči resnosti.
English: The safety profiles of capecitabine monotherapy for the metastatic breast cancer, metastatic colorectal cancer and adjuvant colon cancer populations are comparable.
Slovenian: Varnostni profil samostojnega zdravljenja s kapecitabinom je podoben pri populaciji z metastatskim rakom dojk, metastatskim kolorektalnim rakom in pri bolnikih na adjuvantnem zdravljenju raka kolona.
English: There is no relevant use of capecitabine in the paediatric population in the indications colon, colorectal, gastric and breast cancer.
Slovenian: Smotrne uporabe kapecitabina pri pediatrični populaciji za indikacije raka kolona, kolorektalnega raka, raka želodca ali dojk, ni.
English: In a randomised, controlled phase III study (CAIRO), the effect of using capecitabine at a starting dose of 1000 mg/m2 for 2 weeks every 3 weeks in combination with irinotecan for the first-line treatment of patients with metastatic colorectal cancer was studied.
Slovenian: V randomizirani, kontrolirani študiji faze III (CAIRO) so proučevali učinek uporabe kapecitabina v začetnem odmerku 1.000 mg/m2 2 tedna vsake 3 tedne v kombinaciji z irinotekanom v prvi liniji zdravljenja bolnikov z metastatskim kolorektalnim rakom.
English: The median overall survival was 10.9 months in capecitabine-based regimens and 9.6 months in 5-FU based regimens.
Slovenian: Mediana celokupnega preživetja je bila 10,9 meseca pri shemah osnovanih na kapecitabinu in 9,6 meseca pri shemah, osnovanih na 5-FU.
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: 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: Toxicity grades* Dose changes within a treatment cycle Dose adjustment for next cycle/dose (% of starting dose)
Slovenian: Prilagoditev odmerka za naslednji cikel/odmerek (% začetnega odmerka)
English: Confusional state, Panic attack, Depressed mood, Libido decreased
Slovenian: Psihiatrične motnje nespečnost, depresija stanje zmedenosti, panični napad, depresivno razpoloženje, zmanjšan libido
English: Full dose
Slovenian: Polni odmerek
English: The 3 year DFS rate was 71% for XELOX versus 67% for 5-FU/LV.
Slovenian: Delež triletnega preživetja brez bolezni je bil 71 % za shemo XELOX v primerjavi s 67 % za 5-FU/LV.
English: The following factors were pre-specified 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: Capecitabine should only be prescribed by a doctor experienced in the use of anticancer medicines.
Slovenian: Zdravilo Ecansya lahko predpiše le zdravnik z izkušnjami pri zdravljenju raka.
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).
Slovenian: 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: 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: Ledvična okvara: 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 4.3).
English: The median overall survival was 10.0 months in cisplatin-based regimens and 10.4 months in oxaliplatin-based regimens.
Slovenian: Mediana celokupnega preživetja je bila 10,0 meseca pri shemah osnovanih na cisplatinu in 10,4 meseca pri shemah, osnovanih na oksaliplatinu.
English: If you are a woman who could become pregnant you should use effective contraception during treatment with Ecansya and for 6 months after the last dose.
Slovenian: Če ste ženska v rodni dobi, morate med zdravljenjem z zdravilom Ecansya in še 6 mesecev po zadnjem odmerku zdravila uporabljati učinkovito kontracepcijo.
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)
Slovenian: Zelo redki neželeni učinki (pojavijo se lahko pri največ 1 od 10.000 bolnikov) vključujejo: - hude kožne reakcije, kot so kožni izpuščaj, razjede in mehurji, ki lahko vključujejo razjede v ustih, nosu, na spolovilih, rokah, nogah in v očeh (rdeče in zatekle oči).
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.