natgillin/translations-raw huggingface dataset:
The efficacy data is based on a median observation time of 59 months for OS and 57 months for DFS.
Podatki o učinkovitosti temeljijo na mediani časa opazovanja 59 mesecev za celokupno preživetje ter 57 mesecev za preživetje brez bolezni.
See section 4.
Preglednica 4.
A two-year mouse carcinogenicity study produced no evidence of carcinogenicity by capecitabine.
Dveletna študija pri miših ni pokazala kancerogenega delovanja kapecitabina.
Following oral administration of 825 mg/m2 capecitabine twice daily for 14 days, Japanese patients (n=18) had about 36% lower Cmax and 24% lower AUC for capecitabine than Caucasian patients (n=22).
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).
In this trial, 1002 patients were randomised in a 2x2 factorial design to one of the following 4 arms:
V tem preskušanju sta bila 1.002 bolnika randomizirana v eno od naslednjih štirih skupin po 2x2 faktorskem načrtu:
Brivudine must not be administered concomitantly with capecitabine.
Brivudin: Brivudina ne smemo dajati sočasno s kapecitabinom.
Patients with low or absent DPD activity, an enzyme involved in fluorouracil degradation, are at increased risk for severe, life-threatening, or fatal adverse reactions caused by fluorouracil.
Bolniki z zmanjšano ali odsotno aktivnostjo DPD, encima, ki je vpleten v razgradnjo fluorouracila, imajo večje tveganje za hud, življensko ogrožujoč ali smrten neželeni učinek zaradi fluorouracila.
Table 3 Capecitabine dose reduction schedule (3 weekly cycle or continuous treatment)
Shema za zmanjšanje odmerka pri zdravljenju s kapecitabinom (3-tedenski cikli ali neprekinjeno zdravljenje)
There is some evidence that dexpanthenol is effective for hand-foot syndrome prophylaxis in patients treated with Ecansya.
Obstajajo dokazi, da je dekspantenol učinkovit pri preprečevanju sindroma roka-noga pri bolnikih, zdravljenih z zdravilom Ecansya.
For patients 60 years of age or more, a starting dose reduction of capecitabine to 75% (950 mg/m2 twice daily) is recommended.
Za bolnike, stare 60 let ali več, je priporočljivo začetni odmerek kapecitabina zmanjšati na 75 % (950 mg/m2 dvakrat na dan).
Hazard ratio 95% CI P value
razmerje ogroženosti 95-% CI p vrednost
Adjuvant treatment in patients with stage III colon cancer is recommended for a duration of 6 months.
Adjuvantno zdravljenje bolnikov z rakom kolona stadija III se priporoča 6 mesecev.
Capecitabine may cause dizziness, fatigue and nausea.
Kapecitabin lahko povzroči omotico, utrujenost in slabost.
The enhanced toxicity may be relevant when switching from 5-FU/LV to a capecitabine regimen.
Povečana toksičnost je lahko pomembna, ko shemo 5-FU/LV zamenjamo s kapecitabinom.
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
Če vam je zdravnik povedal, da ne prenašate nekaterih sladkorjev, se pred uporabo tega zdravila posvetujte z zdravnikom.
Patients with anorexia, asthenia, nausea, vomiting or diarrhoea may rapidly become dehydrated.
Bolniki, ki imajo anoreksijo, astenijo, navzejo, drisko ali bruhajo, lahko hitro dehidrirajo.
As the potential for harm to the nursing infant is unknown, breast-feeding should be discontinued while receiving treatment with capecitabine and for 2 weeks after the final dose.
Ker možnost za škodo dojenemu otroku ni znana, je treba med zdravljenjem s kapecitabinom in še 2 tedna po zadnjem odmerku dojenje prekiniti.
Women of childbearing potential/Contraception in males and females Women of childbearing potential should be advised to avoid becoming pregnant while receiving treatment with capecitabine.
Ženske v rodni dobi/kontracepcija pri moških in ženskah Ženskam v rodni dobi je treba svetovati naj ne zanosijo, medtem ko se zdravijo s kapecitabinom.
No information is available on hepatic impairment due to cirrhosis or hepatitis.
O okvari zaradi ciroze ali hepatitisa ni podatkov.
Although sensitivity analyses show that differences in regimen schedules and timing of tumor assessments impact the on-treatment PFS analysis, a full explanation for this result has not been found.
Čeprav je analiza občutljivosti pokazala, da na preživetje brez napredovanja bolezni ob zdravljenju vplivajo razlike med odmerjanji v shemah zdravljenja in čas ocene tumorja, popolne razlage tega rezultata niso našli.
These results suggest an interaction, probably due to an inhibition of the cytochrome P450 2C9 isoenzyme system by capecitabine.
Rezultati kažejo na interakcijo, ki je verjetno posledica zaviranja izoencimskega sistema citokroma P450 2C9 s kapecitabinom.
The usual dose for adults is 1250 mg/m2 of body surface area taken two times daily (morning and evening).
Običajni odmerek za odrasle je 1250 mg/m2 telesne površine dvakrat na dan (zjutraj in zvečer).
What you need to know before you take Ecansya
Kaj morate vedeti, preden boste vzeli zdravilo Ecansya
Not applicable *According to the National Cancer Institute of Canada Clinical Trial Group (NCIC CTG) Common Toxicity Criteria (version 1) or the Common Terminology Criteria for Adverse Events (CTCAE) of the Cancer Therapy Evaluation Program, US National Cancer Institute, version 4.0.
2. pojav dokončna prekinitev zdravljenja * 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.
Interaction with other medicinal products
Medsebojno delovanje z drugimi zdravili
The Ecansya pivotal studies included females of childbearing potential and males only if they agreed to use an acceptable method of birth control to avoid pregnancy for the duration of the study and for a reasonable period thereafter.
V ključnih študijah s kapecitabinom so sodelovale ženske v rodni dobi in moški, če so se strinjali, da bodo uporabljali sprejemljivo metodo kontracepcije, da bi preprečili nosečnost v času študije in primernem obdobju po njej.
In addition to the ADRs described in tables 4 and 5, and based on the above pooled analysis from clinical safety data from 7 clinical trials, encephalopathy was also associated with the use of capecitabine monotherapy with an incidence of less than 0.1%.
Poleg neželenih učinkov, opisanih v preglednicah 4 in 5, in na podlagi zgoraj omenjene skupne analize iz kliničnih podatkov o varnosti iz sedmih kliničnih preskušanj, je bila tudi encefalopatija povezana z samostojno uporabo kapecitabina, in sicer z incidenco, manjšo kot 0,1 %.
For patients with partial DPD deficiency (such as those with heterozygous mutations in the DPYD gene) and where the benefits of Ecansya are considered to outweigh the risks (taking into account the suitability of an alternative non-fluoropyrimidine chemotherapeutic regimen), these patients must be treated with extreme caution and frequent monitoring with dose adjustment according to toxicity.
Bolnike z delnim pomanjkanjem DPD (kot so tisti s heterozigotnimi mutacijami v genu DPYD), za katere smatramo, da koristi zdravila Ecansya odtehtajo tveganja (upoštevaje primernost druge ne-fluoropirimidinske sheme kemoterapije), je treba zdraviti izredno previdno in jih pogosto spremljati ter prilagoditi odmerek glede na toksičnost.
Dehydration may cause acute renal failure, especially in patients with pre-existing compromised renal function or when capecitabine is given concomitantly with known nephrotoxic medicinal products.
Dehidracija lahko povzroči akutno ledvično odpoved, še posebno pri bolnikih z že obstoječim okrnjenim delovanjem ledvic ali kadar kapecitabin dajemo sočasno z nefrotoksičnimi zdravili.
Overall response rate was 49% in the XELIRI and 48% in the FOLFIRI arm (p=0.76).
Celokupni odgovor je bil 49 % v skupini s XELIRI in 48 % v skupini s FOLFIRI (p = 0,76).
Toxicity due to capecitabine administration may be managed by symptomatic treatment and/or modification of the dose (treatment interruption or dose reduction).
Toksičnost zaradi jemanja kapecitabina lahko obravnavamo s simptomatičnim zdravljenjem ali spremembo odmerka (prekinitev zdravljenja ali zmanjšanje odmerka) ali z obema ukrepoma.
The effects of DNA and RNA deprivation are most marked on those cells which proliferate more rapidly and which metabolise 5-FU at a more rapid rate.
Učinki pomanjkanja DNA in RNA so najopaznejši v celicah, ki se hitreje delijo in hitreje presnavljajo 5-FU.
Patients taking phenytoin concomitantly with capecitabine should be regularly monitored for increased phenytoin plasma concentrations.
Pri bolnikih, ki jemljejo fenitoin sočasno s kapecitabinom, je treba redno nadzirati povečane koncentracije fenitoina v plazmi.
The pharmacokinetics of capecitabine have been evaluated over a dose range of 502-3514 mg/m2/day.
Farmakokinetiko kapecitabina so ocenjevali v odmerkih od 502 do 3.514 mg/m2/dan.
See section 5.1 for details of major studies, including study designs and major efficacy results.
Za podrobnosti o glavnih študijah, vključno z njihovimi načrti in glavnimi izsledki o učinkovitosti, glejte poglavje 5.1.
In repeat-dose toxicity studies, daily oral administration of capecitabine to cynomolgus monkeys and mice produced toxic effects on the gastrointestinal, lymphoid and haemopoietic systems, typical for fluoropyrimidines.
V študijah toksičnosti pri ponavljajočih se odmerkih je dnevno jemanje kapecitabina pri opicah cynomolgus in miših povzročilo toksične učinke na gastrointestinalni, limfni in krvni sistem, ki so sicer tipični za fluoropirimidine.
Treatment with brivudine can be started 24 hours after the last dose of capecitabine (see section 4.3 and 4.5).
Zdravljenje z brivudinom lahko začnemo 24 ur po zadnjem odmerku kapecitabina (glejte poglavji 4.3 in 4.5).
The median follow up at the time of the primary analyses in the intent-to-treat population was 1.5 years; data from analyses following an additional 1 year of follow up are also included in table 7.
Mediana spremljanja v času primarne analize v populaciji, ki so jo nameravali zdraviti, je bila 1,5 leta; podatki iz analize po dodatnem enoletnem spremljanju so prav tako vključeni v preglednico 7.
Other medicines and Ecansya
Druga zdravila in zdravilo Ecansya
Dihydropyrimidine dehydrogenase (DPD) deficiency: Rarely, unexpected, severe toxicity (e.g. stomatitis, diarrhoea, mucosal inflammation, neutropenia and neurotoxicity) associated with 5-FU has been attributed to a deficiency of DPD activity.
Pomanjkanje dihidropirimidin dehidrogenaze (DPD): Redko, nepričakovano, hudo toksičnost (npr. stomatitis, drisko, vnetje sluznic, nevtropenijo in nevrotoksičnost), povezano s 5-FU, pripisujemo pomanjkanju aktivnosti DPD.
There was a small increase in plasma concentrations of capecitabine and one metabolite (5'-DFCR); there was no effect on the 3 major metabolites (5'-DFUR, 5-FU and FBAL).
V plazmi so opazili majhno povečanje koncentracij kapecitabina in enega presnovka (5'-DFCR); na preostale tri glavne presnovke (5'-DFUR, 5-FU in FBAL) pa ni vplival.
The median follow up at the time of the primary analyses in the intent-to-treat population was 2.1 years; data from analyses following an additional 6 months of follow up are also included in table 9.
Mediana spremljanja v času primarne analize v populaciji, ki so jo nameravali zdraviti, je bila 2,1 leta; podatki iz analize po dodatnih 6 mesecih spremljanja so prav tako vključeni v preglednico 9.
Although 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 life-threatening or fatal toxicity and should not be treated with Ecansya (see section 4.3).
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 Ecansya (glejte poglavje 4.3).
Cardiotoxicity (see section 4.4):
Kardiotoksičnost (glejte poglavje 4.4)
Toxcity was similar between treatments with the exception of neutropenia reported more commonly in patients treated with FOLFIRI.
Toksičnost je bila med obema zdravljenjema primerljiva z izjemo nevtropenije, o kateri so pri bolnikih zdravljenih s FOLFIRI poročali pogosteje.
Modified XELIRI+ bevacizumab (ITT: N= 120)
spremenjena shema XELIRI + bevacizumab (ITT: n = 120)
In a clinical pharmacokinetic interaction study, after a single 20 mg dose of warfarin, capecitabine treatment increased the AUC of S-warfarin by 57% with a 91% increase in INR value.
V klinični raziskavi farmakokinetičnih interakcij je po odmerku 20 mg varfarina zdravljenje s kapecitabinom povečalo AUC S-varfarina za 57 %, vrednost INR pa je narasla za 91 %.
No significant differences occurred in the exposure to other metabolites (5'-DFCR, 5'-DFUR, and 5-FU).
Značilnih razlik v izpostavljenosti drugim presnovkom (5'-DFCR, 5'-DFUR in 5-FU) ni bilo.
The overall safety profile of capecitabine is based on data from over 3000 patients treated with capecitabine as monotherapy or capecitabine in combination with different chemotherapy regimens in multiple indications.
Celokupni varnostni profil kapecitabina temelji na podatkih, zbranih od več kot 3.000 bolnikov pri samostojnem zdravljenju s kapecitabinom ali pri zdravljenju s kapecitabinom v kombinaciji z različnimi kemoterapijami pri več indikacijah.
Patients were randomised to receive either FOLFIRI plus bevacizumab (Arm-A, n=167) or XELIRI plus bevacizumab (Arm-B, n-166).
Bolnike so randomizirali, da so prejeli FOLFIRI in bevacizumab (skupina A, n = 167) ali XELIRI in bevacizumab (skupina B, n = 166).
Your doctor may want you to take a combination of 150 mg, 300 mg and 500 mg tablets for each dose.
Zdravnik vam bo morda predpisal jemanje kombinacije 150-mg, 300-mg in 500-mg tablet pri vsakem odmerku.
- first-line treatment of advanced gastric cancer in combination with a platinum based regimen (see section 5.1).
- za prvo linijo zdravljenja napredovalega raka želodca v kombinaciji s shemo na osnovi platine (glejte poglavje 5.1).
However, similar to other nucleoside analogues (ie, 5-FU), capecitabine was clastogenic in human lymphocytes (in vitro) and a positive trend occurred in mouse bone marrow micronucleus tests (in vivo).
Podobno kakor drugi nukleozidni analogi, kot je 5-FU, je bil kapecitabin v človeških limfocitih klastogen (in vitro), mikronukleozni test (in vivo) v celicah kostnega mozga miši pa je imel pozitivno tendenco.
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.
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, FOLFOX-4 in placebo, XELOX in bevacizumab ter FOLFOX-4 in bevacizumab.
Two examples are provided here: A person whose body weight is 64 kg and height is 1.64 m has a body surface area of 1.7 m2 and should take 4 tablets of 500 mg and 1 tablet of 150 mg two times daily.
Navedena sta dva primera: oseba, ki tehta 64 kg in je visoka 1,64 m, ima telesno površino 1,7 m2 in jemlje 4 tablete po 500 mg in 1 tableto po 150 mg dvakrat na dan.
These dose adjustment recommendations for renal impairment apply both to monotherapy and combination use (see also section "Elderly" below).
Priporočila za prilagajanje odmerkov pri ledvični okvari veljajo za samostojno in kombinirano zdravljenje (glejte tudi spodnji odstavek Starejši bolniki).
Film-coating
Filmska obloga
The overall objective response rates (investigator assessment) were 20% (first trial) and 25% (second trial).
Celotni objektivni odziv po oceni raziskovalca je bil v prvem preskušanju 20-%, v drugem pa 25-%.
Advanced gastric cancer:
Napredovali rak želodca:
Number of 150 mg tablets, 300 mg tablets and/or 500 mg tablets per administration (each administration to be given morning and evening)
Število 150-mg tablet, 300-mg tablet in/ali 500-mg tablet za posamezno dajanje (zdravilo se daje zjutraj in zvečer)
Grade 4 diarrhoea is an increase of ≥10 stools/day or grossly bloody diarrhoea or the need for parenteral support.
Driska stopnje 4 pomeni 10 ali več izpraznitev črevesa na dan ali močne krvave driske ali potrebo po parenteralni hidraciji.
Administration with food decreases the rate of capecitabine absorption, but only results in a minor effect on the AUC of 5'-DFUR, and on the AUC of the subsequent metabolite 5-FU.
Jemanje s hrano zmanjša hitrost absorpcije kapecitabina, kar pa ima le neznaten vpliv na AUC 5'-DFUR in na AUC presnovka 5-FU.
All grades
Vse stopnje
Following grade 3 hand-foot syndrome, subsequent doses of capecitabine should be decreased.
Po pojavu 3. stopnje moramo nadaljnje odmerke kapecitabina zmanjšati.
If you have an unrecognised DPD deficiency and take Ecansya, you are at an increased risk of acute early-onset of severe forms of the side effects listed under section 4 Possible side effects.
Če ne veste, da imate pomanjkanje DPD in vzamete zdravilo Ecansya, imate večje tveganje za nenaden, zgodnji pojav hudih oblik neželenih učinkov, navedenih v poglavju 4, Možni neželeni učinki.
In this trial, 627 patients with metastatic colorectal carcinoma who have received prior treatment with irinotecan in combination with a fluoropyrimidine regimen as first line therapy were randomised to treatment with XELOX or FOLFOX-4.
V tem preskušanju je bilo 627 bolnikov z metastatskim kolorektalnim rakom, ki so prej prejeli zdravljenje z irinotekanom v kombinaciji s fluoropirimidini v prvi liniji zdravljenja, randomiziranih v zdravljenje po shemi XELOX ali FOLFOX-4.
Median survival was 392 days (capecitabine) vs. 391 days (Mayo regimen).
Mediana preživetja je bila 392 dni (kapecitabin) v primerjavi s 391 dnevi (shema Mayo).
There is no data on Ecansya and impact on fertility.
Podatkov o vplivu zdravila Ecansya na plodnost ni.
Rigors, Body temperature increased ** Based on the post-marketing experience, persistent or severe palmar-plantar erythrodysaesthesia syndrome can eventually lead to loss of fingerprints (see section 4.4.)
** Na podlagi izkušenj po prihodu zdravila na trg lahko vztrajen ali hud sindrom palmarno-plantarne eritrodisestezije sčasoma privede do izgube prstnih odtisov (glejte poglavje 4.4).
Brivudine: a clinically significant interaction between brivudine and fluoropyrimidines (e.g. capecitabine, 5-fluorouracil, tegafur), resulting from the inhibition of dihydropyrimidine dehydrogenase by brivudine, has been described.
Brivudin: Opisali so klinično pomembno medsebojno delovanje med brivudinom in fluoropirimidini (npr. kapecitabinom, 5-fluorouracilom in tegafurjem), ki je rezultat brivudinovega zaviranja dihidropirimidin dehidrogenaze.
According to immunohistochemical studies, thymidine phosphorylase appears to be in large part localised in tumour stromal cells.
Imunohistokemične študije kažejo, da se timidin fosforilaza večinoma nahaja v tumorskih stromalnih celicah.
If the other medicinal product(s) have to be discontinued permanently, capecitabine treatment can be resumed when the requirements for restarting capecitabine are met.
Če je treba zdravljenje z drugim zdravilom oz. drugimi zdravili dokončno prekiniti, se lahko zdravljenje s kapecitabinom nadaljuje, ko so izpolnjeni pogoji za nadaljevanje zdravljenja s kapecitabinom.
Dose modifications for toxicity when capecitabine is used continuously in combination with other medicinal products
Prilagajanje odmerkov zaradi toksičnosti, kadar se kapecitabin uporablja neprekinjeno v kombinaciji z drugimi zdravili
Therefore, brivudine must not be administered concomitantly with capecitabine (see section 4.3 and 4.4).
Brivudina zato ne smemo dajati sočasno s kapecitabinom (glejte poglavji 4.3 in 4.4).
Acute renal failure secondary to dehydration might be potentially fatal.
Akutna ledvična odpoved, ki nastopi zaradi dehidracije, je lahko smrtna.
Based on the population pharmacokinetic analysis, which included patients with a wide range of ages (27 to 86 years) and included 234 (46%) patients greater or equal to 65, age has no influence on the pharmacokinetics of 5'-DFUR and 5-FU.
Na osnovi podatkov populacijske farmakokinetične študije, ki je zajela bolnike z velikim razponom v letih (27 do 86 let) in 234 bolnikov (46 %), starih 65 let ali starejših, so ugotovili, da starost ne vpliva na farmakokinetiko 5'- DFUR in 5- FU.
The median time to progression was 140 days (capecitabine) vs. 144 days (Mayo regimen).
Mediana časa do napredovanja bolezni je bila 140 dni (kapecitabin) v primerjavi s 144 dnevi (shema Mayo).
In lactating mice, considerable amounts of capecitabine and its metabolites were found in milk.
Pri miših v laktaciji so v mleku našli precej kapecitabina in njegovih presnovkov.
The time to peak plasma concentrations (Tmax in hours) were 1.50, 2.00, 2.00, 2.00 and 3.34.
Časi do dosega največje plazemske koncentracije (Tmax v urah) so bili 1,50; 2,00; 2,00; 2,00 in 3,34.
The ratio of 5-FU concentration in tumour to plasma was 21.4 (ranged from 3.9 to 59.9, n=8) whereas the ratio in healthy tissues to plasma was 8.9 (ranged from 3.0 to 25.8, n=8).
Razmerje koncentracij 5-FU v tumorjih v primerjavi s plazmo je bilo 21,4 (območje 3,9 do 59,9, n = 8), razmerje med zdravimi tkivi in plazmo pa 8,9 (območje 3,0 do 25,8, n = 8).
If you forget to take Ecansya
Če ste pozabili vzeti zdravilo Ecansya
Oxaliplatin: no clinically significant differences in exposure to capecitabine or its metabolites, free platinum or total platinum occurred when capecitabine was administered in combination with oxaliplatin or in combination with oxaliplatin and bevacizumab.
Oksaliplatin: Klinično pomembnih razlik v izpostavljenosti kapecitabinu ali njegovim presnovkom, prosti platini ali celokupni platini, ni bilo, ko so kapecitabin dajali v kombinaciji z oksaliplatinom ali v kombinaciji z oksaliplatinom in bevacizumabom.
The 5 year OS rate was 78% for XELOX versus 74% for 5-FU/LV.
Delež celokupnega petletnega preživetja je bil 78 % za shemo XELOX v primerjavi s 74 % za 5-FU/LV.
When capecitabine was used in combination with other medicinal products, elderly patients (≥65 years) experienced more grade 3 and grade 4 adverse drug reactions, including those leading to discontinuation, compared to younger patients.
Kadar so kapecitabin uporabljali z drugimi zdravili, so imeli starejši bolniki (stari 65 let ali več) v primerjavi z mlajšimi več neželenih učinkov stopnje 3 in 4, vključno s tistimi, ki so povzročili ukinitev zdravila.
Injury, poisoning and procedural complications
Poškodbe in zastrupitve ter zapleti pri posegih kontuzija
Based on genetic toxicity findings, male patients with female partners of reproductive potential should use effective contraception during treatment and for 3 months following the last dose of capecitabine.
Na podlagi ugotovitev o genetski toksičnosti morajo bolniki, ki imajo partnerko v rodni dobi, med zdravljenjem in še 3 mesece po zadnjem odmerku kapecitabina uporabljati učinkovito kontracepcijo.
The sequential enzymatic biotransformation of capecitabine to 5-FU leads to higher concentrations within tumour tissues.
Postopna encimska biotransformacija kapecitabina v 5-FU daje večje koncentracije v tumorskih tkivih.