FrancophonIA/ELRC3.0 huggingface dataset:
English: Severe skin reactions: Ecansya can induce severe skin reactions such as Stevens-Johnson syndrome and Toxic Epidermal Necrolysis.
Slovenian: Hude kožne reakcije: Zdravilo Ecansya lahko izzove hude kožne reakcije, kot sta Stevens-Johnsonov sindrom in toksična epidermalna nekroliza.
English: Since DNA and RNA are essential for cell division and growth, the effect of 5-FU may be to create a thymidine deficiency that provokes unbalanced growth and death of a cell.
Slovenian: Ker sta RNA in DNA bistveni za rast in delitev celice, povzroči 5-FU pomanjkanje timidina, kar izzove neuravnoteženo rast in smrt celice.
English: 5-Fluorouracil: intravenous bolus injection immediately after leucovorin
Slovenian: 5- fluorouracil: intravenska injekcija v bolusu neposredno po levkovorinu
English: ( 1/100 to < 1/10), uncommon ( 1/1,000 to < 1/100), rare (≥1/10,000 to <1/1,000), very rare (<1/10,000).
Slovenian: Neželeni učinki so razvrščeni po njihovi pogostnosti: zelo pogosti ( 1/10), pogosti ( 1/100 do < 1/10), občasni ( 1/1.000 do < 1/100), redki ( 1/10.000 do < 1/1.000), zelo redki (< 1/10.000).
English: Medical management of overdose should include customary therapeutic and supportive medical interventions aimed at correcting the presenting clinical manifestations and preventing their possible complications.
Slovenian: Zdravljenje prevelikega odmerjanja mora vključevati standardne terapevtske in podporne medicinske postopke, ki so namenjeni zdravljenju trenutnih kliničnih simptomov in preprečevanju nadaljnjih zapletov.
English: Treatment of eye disorders should be initiated as clinically appropriate.
Slovenian: Z njihovim zdravljenjem je treba pričeti, kot je klinično ustrezno.
English: Exposure to crushed or cut capecitabine tablets:
Slovenian: Izpostavljenost zdrobljenim ali razrezanim tabletam kapecitabina:
English: DPD deficiency: DPD deficiency is a rare condition present at birth that is not usually associated with health problems unless you receive certain medicines.
Slovenian: Pomanjkanje encima dihidropirimidin dehidrogenaze (DPD): Pomanjkanje encima DPD je redko prirojeno stanje, ki navadno ne povzroča težav z zdravjem, razen če prejmete določena zdravila.
English: Some of these side effects are more common when capecitabine is used with other medicines for the treatment of cancer.
Slovenian: Nekateri od teh neželenih učinkov so bolj pogosti, če kapecitabin uporabljamo z drugimi zdravili za zdravljenje raka.
English: The parameters of capecitabine, 5'-deoxy-5-fluorocytidine (5'-DFCR) and 5'-deoxy-5-fluorouridine (5'-DFUR) measured on days 1 and 14 were similar.
Slovenian: Parametri kapecitabina, 5'-deoksi-5-fluorocitidina (5'-DFCR) in 5'-deoksi-5-fluorouridina (5'-DFUR), ki so jih izmerili prvi in štirinajsti dan, so bili podobni.
English: The incorporation of 5-FU also leads to inhibition of RNA and protein synthesis.
Slovenian: Vgraditev 5-FU zavira tudi sintezo RNA in proteinov.
English: This may also be relevant with folic acid supplementation for folate deficiency due to the similarity between folinic acid and folic acid.
Slovenian: To je lahko pomembno tudi pri jemanju dodatkov s folno kislino pri pomanjkanju folatov zaradi podobnosti med folinsko in folno kislino.
English: If caught early, these side effects usually improve within 2 to 3 days after treatment discontinuation.
Slovenian: Če ukrepamo takoj, neželeni učinki ponavadi minejo v 2 do 3 dneh po prekinitvi zdravljenja.
English: All indications:
Slovenian: Vse indikacije
English: Do not give Ecansya to children and adolescents.
Slovenian: Otrokom in mladostnikom ne dajajte zdravila Ecansya.
English: Furthermore, Ecansya is used to prevent new occurrence of colon cancer after complete removal of the tumour by surgery.
Slovenian: Zdravilo Ecansya se uporablja tudi za preprečevanje novega pojava raka debelega črevesa po kompletni odstranitvi tumorja z operacijo.
English: 9/L should not be treated with capecitabine.
Slovenian: 9/l, ne zdravimo s kapecitabinom.
English: Ecansya tablets should be swallowed whole with water within 30 minutes after a meal.
Slovenian: Tablete zdravila Ecansya je treba pogoltniti cele z vodo v 30 minutah po obroku.
English: Care should be exercised when capecitabine is co-administered with 2C9 substrates (e.g., phenytoin).
Slovenian: Previdnost je potrebna, kadar kapecitabin dajemo skupaj s substrati 2C9 (npr. fenitoinom).
English: Creatinine clearance was found to influence the systemic exposure to 5'-DFUR (35% increase in AUC when creatinine clearance decreases by 50%) and to FBAL (114% increase in AUC when creatinine clearance decreases by 50%).
Slovenian: Kreatininski očistek je vplival na sistemsko izpostavljenost 5'-DFUR (35-% povečanje AUC, kreatininski očistek zmanjšan za 50 %) in FBAL (114- % povečanje AUC in padec kreatinskega očistka za 50 %).
English: Treatment with brivudine can be started 24 hours after the last dose of capecitabine.
Slovenian: Zdravljenje z brivudinom lahko začnemo 24 ur po zadnjem odmerku kapecitabina.
English: What Ecansya is and what it is used for
Slovenian: Kaj je zdravilo Ecansya in za kaj ga uporabljamo
English: The AUC0- values in g•h/ml were 7.75, 7.24, 24.6, 2.03 and 36.3.
Slovenian: Vrednosti AUC0-∞ v μg•h/ml so znašale 7,75; 7,24; 24,6; 2,03 in 36,3.
English: Deficiency of DPD may lead to increased toxicity of capecitabine (see section 4.3 and 4.4).
Slovenian: Pomanjkanje DPD lahko vodi do povečane toksičnosti kapecitabina (glejte poglavji 4.3 in 4.4).
English: Dehydration should be prevented or corrected at the onset.
Slovenian: Dehidracija: Dehidracijo moramo preprečiti ali popraviti takoj na začetku.
English: D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND
Slovenian: D. POGOJI ALI OMEJITVE V ZVEZI Z VARNO IN UČINKOVITO UPORABO ZDRAVILA
English: A. MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE
Slovenian: A. PROIZVAJALEC (PROIZVAJALCI), ODGOVOREN (ODGOVORNI) ZA SPROŠČANJE SERIJ
English: In the event of accidental administration of brivudine to patients being treated with capecitabine, effective measures should be taken to reduce the toxicity of capecitabine.
Slovenian: V primeru nenamernega dajanja brivudina bolnikom, ki se zdravijo s kapecitabinom, je treba uvesti učinkovite ukrepe za zmanjšanje toksičnosti kapecitabina.
English: See also interaction with coumarin-derivative anticoagulants below, and section 4.4.
Slovenian: Glejte tudi spodnji odstavek o medsebojnem delovanju s kumarinskimi antikoagulanti in poglavje 4.4.
English: Accord Healthcare Limited, Sage house, 319 Pinner Road, Harrow HA1 4HF, United Kingdom Pharmacare Premium Limited, HHF 003, Hal Far Industrial Estate Birzebbugia, BBG 3000, Malta KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia
Slovenian: Accord Healthcare Limited, Sage house, 319 Pinner Road, Harrow HA1 4HF, Velika Britanija Pharmacare Premium Limited, HHF 003, Hal Far Industrial Estate Birzebbugia, BBG 3000, Malta KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenija
English: See section 2 "Ecansya contains lactose".
Slovenian: Glejte poglavje 2 "Zdravilo Ecansya vsebuje laktozo".
English: In a preplanned multivariate Cox analysis, superiority of capecitabine compared with bolus 5-FU/LV was demonstrated.
Slovenian: V vnaprej načrtovani multivariantni Coxovi analizi so dokazali superiornost kapecitabina v primerjavi s 5-FU/LV v obliki bolusa.
English: For those toxicities considered by the treating physician to be unlikely to become serious or life-threatening, e.g. alopecia, altered taste, nail changes, treatment can be continued at the same dose without reduction or interruption.
Slovenian: Pri toksičnosti, za katero lečeči zdravnik meni, da ne bo postala resnejša ali življenjsko ogrožajoča, kot npr. alopecija, sprememba okusa, spremembe na nohtih, lahko zdravljenje nadaljujemo z enakim odmerkom brez zmanjšanja ali prekinitve.
English: If the calculated creatinine clearance decreases during treatment to a value below 30 ml/min, Ecansya should be discontinued.
Slovenian: Če se izračunani kreatininski očistek med zdravljenjem zmanjša pod 30 ml/min, je treba zdravljenje z zdravilom Ecansya ukiniti.
English: - The other ingredients (excipients) are:
Slovenian: - Druge sestavine zdravila (pomožne snovi) so:
English: Japanese patients had also about 25% lower Cmax and 34% lower AUC for FBAL than Caucasian patients.
Slovenian: Japonski bolniki so imeli v primerjavi s kavkaškimi bolniki prav tako približno 25 % nižjo Cmax in 34 % nižjo AUC za FBAL.
English: In all clinical trials, patients were instructed to administer capecitabine within 30 minutes after a meal.
Slovenian: V vseh kliničnih preskušanjih so bolniki jemali kapecitabin v 30 minutah po obroku.
English: 5-FU is further catabolised by the enzyme dihydropyrimidine dehydrogenase (DPD) to the much less toxic dihydro-5-fluorouracil (FUH2).
Slovenian: 5-FU se nadalje presnovi z encimom dihidropirimidin dehidrogenazo (DPD) v precej manj toksični dihidro-5-fluorouracil (FUH2).
English: Pharmacotherapeutic group: antineoplastic agents, antimetabolites, ATC code: L01BC06.
Slovenian: Farmakoterapevtska skupina: zdravila z delovanjem na novotvorbe (citostatiki), zaviralci celične presnove (antimetaboliti), oznaka ATC: L01BC06.
English: At the end of treatment, 37% of patients in the XELIRI and 26% of patients in the FOLFIRI arm were without evidence of the disease (p=0.56).
Slovenian: Na koncu zdravljenja je bilo 37 % bolnikov v skupini s XELIRI in 26 % bolnikov v skupini s FOLFIRI brez znakov bolezni (p = 0,56).
English: Doses of capecitabine omitted for toxicity are not replaced.
Slovenian: Opuščenih odmerkov kapecitabina zaradi toksičnosti ne nadomeščamo.
English: Table 9 Key efficacy results for the non-inferiority analysis of Study NO16967 PRIMARY ANALYSIS
Slovenian: Glavni rezultati o učinkovitosti za analizo ne-inferiornosti v študiji NO16967 OSNOVNA ANALIZA
English: Concomitant use of allopurinol with capecitabine should be avoided.
Slovenian: Sočasnemu jemanju alopurinola in kapecitabina se je treba izogibati.
English: However this was associated with an increased incidence of gastrointestinal toxicity and neutropenia during first-line treatment with XELIRI (26% and 11% for XELIRI and first line capecitabine respectively).
Slovenian: To pa je bilo povezano s povečano incidenco gastrointestinalnih toksičnosti in nevtropenije med zdravljenjem s shemo XELIRI v prvi liniji (26 % za XELIRI in 11 % za kapecitabin v prvi liniji).
English: Renal impairment (see section 4.2, 4.4, and 5.2):
Slovenian: Ledvična okvara (glejte poglavja 4.2, 4.4 in 5.2)
English: It has been reported that the DPYD*2A, c.1679T>G variants lead to a greater reduction in enzymatic activity than the other variants with a higher risk of side effects.
Slovenian: Poročali so, da različici DPYD*2A in c.1679T>G povzročita večje zmanjšanje encimske aktivnosti kot druge različice in predstavljata večje tveganje za neželene učinke.
English: Ecansya with food and drink You should take Ecansya no later than 30 minutes after meals.
Slovenian: Zdravilo Ecansya skupaj s hrano in pijačo Zdravilo Ecansya morate vzeti najpozneje 30 minut po obroku.
English: 10.4 months
Slovenian: 10,4 meseca
English: Other side-effects seen in this setting are the following:
Slovenian: Drugi neželeni učinki, ki so jih opazili pri tovrstnem zdravljenju, so bili naslednji:
English: No studies have been conducted to assess the impact of capecitabine on milk production or its presence in human breast milk.
Slovenian: Študije o oceni vpliva kapecitabina na nastajanje mleka ali prisotnosti kapecitabina v materinem mleku pri ljudeh niso bile izvedene.
English: There is evidence that the metabolism of 5-FU in the anabolic pathway blocks the methylation reaction of deoxyuridylic acid to thymidylic acid, thereby interfering with the synthesis of deoxyribonucleic acid (DNA).
Slovenian: Obstajajo dokazi, da presnova 5-FU v anabolični poti zavira reakcijo metiliranja deoksiuridinske kisline v timidinsko kislino, s čimer ovira sintezo deoksiribonukleinske kisline (DNA).
English: The efficacy data is based on a median observation time of 59 months for OS and 57 months for DFS.
Slovenian: Podatki o učinkovitosti temeljijo na mediani časa opazovanja 59 mesecev za celokupno preživetje ter 57 mesecev za preživetje brez bolezni.
English: See section 4.
Slovenian: Preglednica 4.
English: A two-year mouse carcinogenicity study produced no evidence of carcinogenicity by capecitabine.
Slovenian: Dveletna študija pri miših ni pokazala kancerogenega delovanja kapecitabina.
English: 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).
Slovenian: Po peroralnem dajanju 825 mg/m2 kapecitabina dvakrat na dan 14 dni so japonski bolniki (n = 18) imeli približno 36 % nižjo Cmax in 24 % nižjo AUC kapecitabina kakor kavkaški bolniki (n = 22).
English: In this trial, 1002 patients were randomised in a 2x2 factorial design to one of the following 4 arms:
Slovenian: V tem preskušanju sta bila 1.002 bolnika randomizirana v eno od naslednjih štirih skupin po 2x2 faktorskem načrtu:
English: Brivudine must not be administered concomitantly with capecitabine.
Slovenian: Brivudin: Brivudina ne smemo dajati sočasno s kapecitabinom.
English: 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.
Slovenian: 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.
English: Table 3 Capecitabine dose reduction schedule (3 weekly cycle or continuous treatment)
Slovenian: Shema za zmanjšanje odmerka pri zdravljenju s kapecitabinom (3-tedenski cikli ali neprekinjeno zdravljenje)
English: There is some evidence that dexpanthenol is effective for hand-foot syndrome prophylaxis in patients treated with Ecansya.
Slovenian: Obstajajo dokazi, da je dekspantenol učinkovit pri preprečevanju sindroma roka-noga pri bolnikih, zdravljenih z zdravilom Ecansya.
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: Za bolnike, stare 60 let ali več, je priporočljivo začetni odmerek kapecitabina zmanjšati na 75 % (950 mg/m2 dvakrat na dan).
English: Hazard ratio 95% CI P value
Slovenian: razmerje ogroženosti 95-% CI p vrednost
English: Adjuvant treatment in patients with stage III colon cancer is recommended for a duration of 6 months.
Slovenian: Adjuvantno zdravljenje bolnikov z rakom kolona stadija III se priporoča 6 mesecev.
English: Capecitabine may cause dizziness, fatigue and nausea.
Slovenian: Kapecitabin lahko povzroči omotico, utrujenost in slabost.
English: The enhanced toxicity may be relevant when switching from 5-FU/LV to a capecitabine regimen.
Slovenian: Povečana toksičnost je lahko pomembna, ko shemo 5-FU/LV zamenjamo s kapecitabinom.
English: If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
Slovenian: Če vam je zdravnik povedal, da ne prenašate nekaterih sladkorjev, se pred uporabo tega zdravila posvetujte z zdravnikom.
English: Patients with anorexia, asthenia, nausea, vomiting or diarrhoea may rapidly become dehydrated.
Slovenian: Bolniki, ki imajo anoreksijo, astenijo, navzejo, drisko ali bruhajo, lahko hitro dehidrirajo.
English: 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.
Slovenian: Ker možnost za škodo dojenemu otroku ni znana, je treba med zdravljenjem s kapecitabinom in še 2 tedna po zadnjem odmerku dojenje prekiniti.
English: 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.
Slovenian: 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.
English: No information is available on hepatic impairment due to cirrhosis or hepatitis.
Slovenian: O okvari zaradi ciroze ali hepatitisa ni podatkov.
English: 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.
Slovenian: 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.
English: These results suggest an interaction, probably due to an inhibition of the cytochrome P450 2C9 isoenzyme system by capecitabine.
Slovenian: Rezultati kažejo na interakcijo, ki je verjetno posledica zaviranja izoencimskega sistema citokroma P450 2C9 s kapecitabinom.
English: The usual dose for adults is 1250 mg/m2 of body surface area taken two times daily (morning and evening).
Slovenian: Običajni odmerek za odrasle je 1250 mg/m2 telesne površine dvakrat na dan (zjutraj in zvečer).
English: What you need to know before you take Ecansya
Slovenian: Kaj morate vedeti, preden boste vzeli zdravilo Ecansya
English: 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.
Slovenian: 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.
English: Interaction with other medicinal products
Slovenian: Medsebojno delovanje z drugimi zdravili
English: 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.
Slovenian: 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.
English: 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%.
Slovenian: 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 %.
English: 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.
Slovenian: 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.
English: 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.
Slovenian: Dehidracija lahko povzroči akutno ledvično odpoved, še posebno pri bolnikih z že obstoječim okrnjenim delovanjem ledvic ali kadar kapecitabin dajemo sočasno z nefrotoksičnimi zdravili.
English: Overall response rate was 49% in the XELIRI and 48% in the FOLFIRI arm (p=0.76).
Slovenian: Celokupni odgovor je bil 49 % v skupini s XELIRI in 48 % v skupini s FOLFIRI (p = 0,76).
English: Toxicity due to capecitabine administration may be managed by symptomatic treatment and/or modification of the dose (treatment interruption or dose reduction).
Slovenian: Toksičnost zaradi jemanja kapecitabina lahko obravnavamo s simptomatičnim zdravljenjem ali spremembo odmerka (prekinitev zdravljenja ali zmanjšanje odmerka) ali z obema ukrepoma.
English: 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.
Slovenian: Učinki pomanjkanja DNA in RNA so najopaznejši v celicah, ki se hitreje delijo in hitreje presnavljajo 5-FU.
English: Patients taking phenytoin concomitantly with capecitabine should be regularly monitored for increased phenytoin plasma concentrations.
Slovenian: Pri bolnikih, ki jemljejo fenitoin sočasno s kapecitabinom, je treba redno nadzirati povečane koncentracije fenitoina v plazmi.
English: The pharmacokinetics of capecitabine have been evaluated over a dose range of 502-3514 mg/m2/day.
Slovenian: Farmakokinetiko kapecitabina so ocenjevali v odmerkih od 502 do 3.514 mg/m2/dan.
English: See section 5.1 for details of major studies, including study designs and major efficacy results.
Slovenian: Za podrobnosti o glavnih študijah, vključno z njihovimi načrti in glavnimi izsledki o učinkovitosti, glejte poglavje 5.1.
English: 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.
Slovenian: 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.
English: Treatment with brivudine can be started 24 hours after the last dose of capecitabine (see section 4.3 and 4.5).
Slovenian: Zdravljenje z brivudinom lahko začnemo 24 ur po zadnjem odmerku kapecitabina (glejte poglavji 4.3 in 4.5).
English: 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.
Slovenian: 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.
English: Other medicines and Ecansya
Slovenian: Druga zdravila in zdravilo Ecansya
English: 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.
Slovenian: Pomanjkanje dihidropirimidin dehidrogenaze (DPD): Redko, nepričakovano, hudo toksičnost (npr. stomatitis, drisko, vnetje sluznic, nevtropenijo in nevrotoksičnost), povezano s 5-FU, pripisujemo pomanjkanju aktivnosti DPD.
English: 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).
Slovenian: 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.