FrancophonIA/ELRC3.0 huggingface dataset:
English: It should be taken with water at least 1 hour before or 1 hour after a meal (see section 4.2).
Slovenian: Zdravilo se jemlje z vodo in najmanj 1 uro pred obrokom ali 1 uro po obroku (glejte poglavje 4.2).
English: FdUMP and reduced folate are bound to thymidylate synthase leading to formation of a ternary complex which inhibits DNA synthesis.
Slovenian: FdUMP in reducirani folat sta vezana na timidilatno sintazo, iz česar nastane trikomponentni kompleks, ki zavira sintezo DNA.
English: Doses omitted for toxicity are not replaced; and, if a patient vomits after taking a dose, this dose should not be replaced.
Slovenian: Odmerki, ki so bili izpuščeni zaradi toksičnosti, se ne nadomestijo; prav tako se odmerek ne nadomesti, če bolnik po prejemu odmerka bruha.
English: Tegafur is a prodrug of 5-FU with good oral bioavailability.
Slovenian: Tegafur je predzdravilo snovi 5-FU z dobro peroralno biološko uporabnostjo.
English: For minimum criteria for resumption of Teysuno treatment, see Table 6.
Slovenian: Glede minimalnih meril za nadaljevanje zdravljenja z zdravilom Teysuno si oglejte Preglednico 6.
English: Patients with diarrhoea should be carefully monitored and given fluid and electrolyte replacement if they become dehydrated.
Slovenian: Bolnike, pri katerih se pojavi driska, je treba skrbno opazovati in jim v primeru dehidracije nadomeščati tekočino in elektrolite.
English: • Pregnancy and breast-feeding.
Slovenian: • Nosečnost in dojenje.
English: Cisplatin will be stopped after 6 treatment cycles.
Slovenian: Zdravilo cisplatin se ukine po šestih ciklih zdravljenja.
English: However, the increase in 5-FU exposure tended to be greater than proportional to the increasing tegafur dose.
Slovenian: Vendar je bilo povečanje izpostavljenosti za 5-FU nadsorazmerno glede na povečanje odmerka tegafurja.
English: What Teysuno is and what it is used for What you need to know before you take Teysuno How to take Teysuno
Slovenian: Kaj je zdravilo Teysuno in za kaj ga uporabljamo Kaj morate vedeti, preden boste vzeli zdravilo Teysuno Kako jemati zdravilo Teysuno Možni neželeni učinki
English: Repeat-dose toxicity studies in rats, dogs and monkeys produced changes typically associated with administration of an anti-cancer medicinal product eliciting cytotoxic effects on populations of rapidly dividing cells, such as anaemia, decrease in the immune and digestive system function, disruption of spermatogenesis, and atrophy in male and female reproductive organs.
Slovenian: V študijah toksičnosti pri ponavljajočih se odmerkih pri podganah, psih in opicah so ugotovili spremembe, tipično povezane z uporabo zdravila proti raku, ki ima citotoksične učinke na populacije hitro delečih se celic, kot so anemija, zmanjšano delovanje imunskega in prebavnega sistema, zastoj spermatogeneze ter atrofija v moških in ženskih reproduktivnih organih.
English: Available pharmacodynamic/toxicological data in animals have shown excretion of Teysuno or its metabolites in milk (for details see section 5.3).
Slovenian: Razpoložljivi farmakodinamski/toksikološki podatki pri živalih kažejo na izločanje zdravila Teysuno/presnovkov v mleko (za podrobnosti glejte poglavje 5.3).
English: Gimeracil is primarily cleared by the kidney (see section 5.2); so, in patients with renal insufficiency gimeracil renal clearance is decreased and 5-FU exposure thus increased.
Slovenian: Gimeracil se primarno izloča prek ledvic (glejte poglavje 5.2); tako se pri bolnikih z insuficienco ledvic zmanjša ledvični očistek gimeracila, izpostavljenost za 5-FU pa se poveča.
English: Each hard capsule contains 70.2 mg lactose monohydrate.
Slovenian: Ena trda kapsula vsebuje 70,2 mg laktoze monohidrata.
English: Co-administration of other fluoropyrimidines such as capecitabine, 5-FU, tegafur, or flucytosine can lead to additive toxicities, and is contraindicated.
Slovenian: Sočasna uporaba drugih fluoropirimidinov, kot so kapecitabin, 5-FU, tegafur in flucitozin, lahko povzroči aditivne toksične učinke, poleg tega pa je kontraindicirana.
English: Female
Slovenian: Ženske
English: The single and multiple dose pharmacokinetics (PK) of Teysuno in combination with cisplatin were evaluated in three studies.
Slovenian: Farmakokinetika (PK) enkratnega in večkratnega odmerjanja zdravila Teysuno v kombinaciji s cisplatinom je bila ovrednotena v treh študijah.
English: • Recent or concomitant treatment with brivudine (see section 4.4 and 4.5 for drug-drug interaction).
Slovenian: • Nedavno ali sočasno zdravljenje z brivudinom (glede medsebojnega delovanja med zdravili glejte poglavji 4.4 in 4.5).
English: Patients treated with Teysuno in combination with cisplatin should be closely monitored and laboratory tests, including haematology, liver function, renal function, and serum electrolytes, should be performed frequently.
Slovenian: Bolnike, zdravljene z zdravilom Teysuno v kombinaciji s cisplatinom, je treba skrbno spremljati, pogosto in redno pa je treba opravljati tudi laboratorijske preiskave, vključno s preiskavo krvi, jetrne funkcije, ledvične funkcije in serumskih elektrolitov.
English: In a Japanese Phase I study that utilized 5 dose groups with doses ranging from 25 to 200 mg/body, there was a dose-proportional increase in exposure for tegafur, gimeracil and oteracil.
Slovenian: V japonski študiji faze I, pri kateri so uporabili 5 skupin z odmerki med 25 in 200 mg/telesno maso, so ugotovili povečano izpostavljenost, sorazmerno z odmerkom, za tegafur, gimeracil in oteracil.
English: Like all medicines, Teysuno can cause side effects, although not everybody gets them.
Slovenian: Kot vsa zdravila ima lahko tudi zdravilo Teysuno neželene učinke, ki pa se ne pojavijo pri vseh bolnikih.
English: However, since no DPD inducers are currently known, the interaction between a DPD inducer and Teysuno can not be evaluated.
Slovenian: Ker trenutno ni na voljo nobenega induktorja DPD, ni mogoče ovrednotiti medsebojnega delovanja induktorja DPD in zdravila Teysuno.
English: Following a single dose of Teysuno, T1/2 values ranged from 6.7 to 11.3 hours for tegafur, from 3.1 to 4.1 hours for gimeracil, and from 1.8 to 9.5 hours for oteracil.
Slovenian: Po enkratnem odmerku zdravila Teysuno so vrednosti T1/2 znašale od 6,7 do 11,3 ure za tegafur, od 3,1 do 4,1 ure za gimeracil in od 1,8 do 9,5 ure za oteracil.
English: The frequencies of very common, common, and uncommon adverse reactions are from 593 patients treated with Teysuno in combination with cisplatin in clinical trials.
Slovenian: Oznake za zelo pogoste, pogoste in občasne neželene učinke se nanašajo na 593 bolnikov, ki so prejemali zdravilo Teysuno v kombinaciji s cisplatinom v kliničnih študijah.
English: Each hard capsule contains 93.6 mg lactose monohydrate.
Slovenian: Ena trda kapsula vsebuje 93,6 mg laktoze monohidrata.
English: As CYP2A6 is the major enzyme responsible for the conversion of tegafur to 5-FU, co-administration of a known CYP2A6 inhibitor and Teysuno should be avoided as effectiveness of Teysuno could be decreased (see section 5.2).
Slovenian: Ker je CYP2A6 glavni encim, odgovoren za pretvorbo tegafurja v 5-FU, je treba preprečiti sočasno uporabo znanega inhibitorja CYP2A6 in zdravila Teysuno, saj bi to lahko zmanjšalo učinkovitost zdravila Teysuno (glejte poglavje 5.2).
English: In the Phase III FLAGS study, there was no apparent relationship between 5-FU AUC (Teysuno/cisplatin arm) and 5-FU concentration (5-FU/cisplatin arm) during Cycle 1 and efficacy outcomes of overall survival (OS) or progression-free survival (PFS).
Slovenian: V študiji FLAGS faze III niso ugotovili očitne povezave med 5-FU AUC (kombinacija Teysuno/cisplatin) oziroma koncentracijo 5-FU (kombinacija 5-FU/cisplatin) znotraj 1. cikla in rezultati učinkovitosti glede celokupnega preživetja (OS) ali preživetja brez napredovanja bolezni (PFS).
English: During a treatment cycle, dose adjustment should be performed for each individual medicinal product that is considered to be causally related to the toxicity, if such a distinction can be made.
Slovenian: Med ciklom zdravljenja se mora odmerek prilagoditi za vsako posamezno zdravilo, za katero se ugotovi vzročna povezava s toksičnostjo.
English: The main metabolic pathway for tegafur is through conversion to 5-FU via CYP2A6 in the liver, whereas gimeracil was stable in human liver homogenate (S9 fraction) with adenosine 3'-phosphate 5'-phosphosulfphate lithium salt (PAPS; a co-factor for sulfotransferase) or nicotinamide adenine dinucleotide phosphate (NADPH).
Slovenian: Glavna presnovna pot za tegafur poteka prek pretvorbe v 5-FU z encimom CYP2A6 v jetrih, medtem ko je gimeracil stabilen v homogenatu človeških jeter (frakcija S9) z adenozin 3'-fosfat 5'-fosfosulfat litijevo soljo (PAPS; kofaktor za sulfotransferazo) ali nikotinamid adenin dinukleotid fosfatom (NADPH).
English: The standard and reduced Teysuno and cisplatin doses and calculations according to body surface area (BSA) for doses of Teysuno given in combination with cisplatin are provided in Table 1 and Table 2, respectively.
Slovenian: Standardni in zmanjšani odmerki zdravila Teysuno in cisplatina ter izračuni glede na telesno površino (BSA - »body surface area«) za odmerke zdravila Teysuno, ki se predpiše v kombinaciji s cisplatinom, so navedeni v Preglednici 1 in Preglednici 2, in sicer v tem zaporedju.
English: - Diarrhoea, nausea, vomiting, constipation o If you experience diarrhoea more than 4 times a day or in the middle of the night, or if you experience sore mouth accompanied by diarrhoea, stop taking Teysuno and contact your doctor immediately.
Slovenian: - Driska, navzea, bruhanje, zaprtost o Če imate drisko več kot 4-krat na dan ali sredi noči ali če imate vnetje ustne sluznice skupaj z drisko, prenehajte jemati zdravilo Teysuno in se takoj posvetujte s svojim zdravnikom.
English: Oteracil, gimeracil, 5-FU, and tegafur were 8.4%, 32.2%, 18.4%, and 52.3% protein bound, respectively.
Slovenian: Oteracil, gimeracil, 5-FU in tegafur so bili 8,4-, 32,2-, 18,4- in 52,3-odstotno vezani na proteine, in sicer v tem zaporedju.
English: If you become pregnant during this time, you must tell your doctor.
Slovenian: Če v tem času zanosite, morate o tem obvestiti svojega zdravnika.
English: Use caution when driving or operating a machine, as Teysuno may make you tired, nauseous or have blurred vision.
Slovenian: Pri upravljanju vozil ali strojev bodite previdni, kajti zaradi zdravila Teysuno lahko postanete utrujeni, občutite slabost ali imate zamegljen vid.
English: In the event of accidental administration of brivudine to patients being treated with Teysuno, effective measures should be taken to reduce the toxicity of Teysuno.
Slovenian: V primeru nenamernega dajanja brivudina bolnikom, ki se zdravijo z zdravilom Teysunon, je treba uvesti učinkovite ukrepe za zmanjšanje toksičnosti zdravila Teysuno.
English: • Contraindications for cisplatin; refer to the cisplatin SmPC.
Slovenian: • Kontraindikacije za cisplatin; oglejte si povzetek glavnih značilnosti za cisplatin.
English: The protein binding in human serum was not concentration-dependent over a range of 0.1 to 1.0 µg/ml for oteracil, gimeracil, and 5-FU and 1.2 to 11.8 µg/ml for tegafur.
Slovenian: Vezava na proteine v človeškem serumu ni bila odvisna od koncentracije v mejah med 0,1 in 1,0 µg/ml za oteracil, gimeracil in 5-FU ter med 1,2 in 11,8 µg/ml za tegafur.
English: Table 4: Teysuno and cisplatin dose modification according to creatinine clearance values at the start of a cycle of treatment
Slovenian: Preglednica 4: Spremembe odmerkov zdravila Teysuno in cisplatina glede na vrednosti očistka kreatinina na začetku cikla zdravljenja
English: The combination of tegafur, gimeracil, and oteracil was set at 1:0.4:1 molar ratio as optimum in order to maintain 5-FU exposure and thus sustain anti-tumour activity while reducing toxicity associated with 5-FU alone.
Slovenian: Kombinacija tegafurja, gimeracila in oteracila je določena z optimalnim molarnim razmerjem 1 : 0,4 : 1, s katerim se zagotavlja izpostavljenost za 5-FU in tako ohranja protitumorsko delovanje ob zmanjšani toksičnosti, povezani s samo snovjo 5-FU.
English: First dose reductiona: to 20 mg/m2 BSA ≥ 2.13 m2
Slovenian: Prvi zmanjšani odmereka: na 20 mg/m2 BSA ≥ 2,13 m2
English: Studies in Japanese patients have suggested an effect of CYP2A6*4 polymorphism on Teysuno pharmacokinetics.
Slovenian: Iz študij z japonskimi bolniki izhaja, da polimorfizem CYP2A6*4 vpliva na farmakokinetične lastnosti zdravila Teysuno.
English: Despite the lack of DLTs in the last cohort, the dose of cisplatin was not elevated beyond 75 mg/m2.
Slovenian: V zadnji kohorti niso opazili toksičnih učinkov, ki omejujejo odmerek, vendar odmerka cisplatina vseeno niso povečali nad 75 mg/m2.
English: o If you vomit more than two times in 24 hours, stop taking Teysuno and contact your doctor immediately.
Slovenian: o Če ste v 24-ih urah bruhali več kot dvakrat, prenehajte jemati zdravilo Teysuno in se takoj posvetujte s svojim zdravnikom.
English: Administration of Teysuno with a meal reduced exposure to oteracil and gimeracil, with a more pronounced effect for oteracil than for gimeracil (see section 5.2).
Slovenian: Pri uporabi zdravila Teysuno ob obroku se je zmanjšala izpostavljenost za oteracil in gimeracil, in sicer z izrazitejšim učinkom pri oteracilu kot pri gimeracilu (glejte poglavje 5.2).
English: As with other fluoropyrimidines, Teysuno administration caused embryolethality and teratogenicity in animals (see section 5.3).
Slovenian: Tako kot pri drugih fluoropirimidinih je tudi uporaba zdravila Teysuno povzročila smrtnost zarodkov in teratogenost pri živalih (glejte poglavje 5.3).
English: Rare side effects (may affect 1 to 10 in 10,000 people) and very rare side effects (may affect less than 1 in 10,000 people) include:
Slovenian: Med redke (pojavijo se lahko pri 1 do 10 od 10.000 bolnikov) in zelo redke neželene učinke (pojavijo se pri manj kot 1 od 10.000 bolnikov) so vključeni:
English: Comparison of safety between 71 patients ≥70 years old (elderly) and 450 patients <70 years old treated with Teysuno in combination with cisplatin in the FLAGS study demonstrated that the incidence of all Grade 3 or higher adverse reactions (62% vs 52%), all serious adverse reactions (30% vs 19%), and the rate of premature withdrawal due to adverse reactions from both Teysuno and cisplatin (21% vs 12%) appeared to be higher among patients ≥70 years old.
Slovenian: Primerjava varnosti, izvedena med 71 bolniki, starimi 70 let ali več (starejši), in 450 bolniki, starimi manj kot 70 let, ki so bili zdravljeni z zdravilom Teysuno v kombinaciji s cisplatinom, v študiji FLAGS je pokazala, da so pogostnost vseh neželenih učinkov stopnje 3 ali višje stopnje (62 % proti 52 %), pogostnost vseh resnih neželenih učinkov (30 % proti 19 %) in količnik predčasnega umika tako zdravila Teysuno kot cisplatina zaradi neželenih učinkov (21 % proti 12 %) višji pri bolnikih, starih 70 let ali več.
English: In vitro evaluation using human liver microsomes indicated that neither tegafur, gimeracil nor oteracil showed any relevant inhibitory effects on enzyme activities of the cytochrome P450 isoforms tested (i.e., CYP1A1/2, CYP2A6, CYP2C8/9, CYP2C19, CYP2D6, CYP2E1 and CYP3A4).
Slovenian: In vitro ovrednotenje je ob uporabi človeških jetrnih mikrosomov pokazalo, da niti tegafur niti gimeracil niti oteracil niso izkazali pomembnih zaviralnih učinkov na aktivnost encimov za citokrom P450, testirane izooblike (npr. CYP1A1/2, CYP2A6, CYP2C8/9, CYP2C19, CYP2D6, CYP2E1 in CYP3A4).
English: A minimum washout period of 7 days is recommended between administration of Teysuno and other fluoropyrimidines.
Slovenian: Minimalna doba izpiranja, ki se priporoča med uporabo zdravila Teysuno in uporabo drugih fluoropirimidinov, je 7 dni.
English: Teysuno dose modifications for toxicity when used in combination with cisplatin can be made in two ways.
Slovenian: Odmerek zdravila Teysuno zaradi toksičnosti se lahko, če se to zdravilo uporablja v kombinaciji s cisplatinom, spreminja na dva načina.
English: Creatinine clearance (CrCl) must be determined for every cycle before the start of treatment on Day 1.
Slovenian: Spremembe odmerkov zaradi ledvične toksičnosti Očistek kreatinina (CrCl) je treba določiti za vsak cikel na 1. dan pred začetkom zdravljenja.
English: If any of the side effects get serious, stop taking Teysuno and tell your doctor immediately.
Slovenian: Če kateri koli neželeni učinek postane resen, prenehajte jemati zdravilo Teysuno in se takoj posvetujte s svojim zdravnikom.
English: Although studies of Teysuno in combination with cisplatin that were conducted in Japan utilised doses and dosing schedules that differed from this regimen, the safety profile from these studies was similar, with the most common toxicities being haematologic, gastrointestinal, fatigue, and anorexia.
Slovenian: Čeprav so bili odmerki in sheme odmerjanja, ki so se uporabljali v študijah zdravila Teysuno v kombinaciji s cisplatinom, opravljenih na Japonskem, drugačni od te sheme, je bil varnostni profil pri teh študijah podoben, saj so med najpogostejše toksične učinke spadali hematološka in gastrointestinalna toksičnost ter utrujenost in anoreksija.
English: Among the metabolites, 9.5% to 9.7% of the administered tegafur was excreted in the urine as 5-FU and approximately 70% to 77% as FBAL, accounting for approximately 83% to 91% of the administered Teysuno dose (total tegafur + 5-FU + FBAL).
Slovenian: Med presnovki se je 9,5-9,7 % prejetega tegafurja izločilo z urinom kot 5-FU in približno 70-77 % kot FBAL, kar ustreza približno 83-91 % prejetega odmerka zdravila Teysuno (skupno tegafur + 5-FU + FBAL).
English: If deterioration of glomerular filtration rate is observed, Teysuno and/or cisplatin dose should be adjusted according to Table 4, and appropriate supportive measures taken (see section 4.2).
Slovenian: je treba prilagoditi odmerek zdravila Teysuno in/ali cisplatin v skladu s Preglednico 4 in ustreznimi podpornimi ukrepi (glejte poglavje 4.2).
English: Following a single dose of Teysuno, approximately 3.8% to 4.2% of administered tegafur, 65% to 72% of administered gimeracil, and 3.5% to 3.9% of administered oteracil were excreted unchanged in the urine.
Slovenian: Po enkratnem odmerku zdravila Teysuno se je približno 3,8-4,2 % prejetega tegafurja, 65-72 % prejetega gimeracila in 3,5-3,9 % prejetega oteracila v nespremenjeni obliki izločilo z urinom.
English: The capsules should be taken by mouth with water at least 1 hour before or 1 hour after a meal (see section 5.2).
Slovenian: Kapsule se jemljejo peroralno in z vodo ter najmanj 1 uro pred obrokom ali 1 uro po obroku (glejte poglavje 5.2).
English: The term peripheral neuropathy includes the following reported adverse reactions: peripheral sensory neuropathy, paraesthesia, hypoaesthesia, peripheral neuropathy, polyneuropathy, neurotoxicity, and dysaesthesia.
Slovenian: Izraz periferna nevropatija vključuje naslednje neželene učinke, o katerih so poročali: periferno senzorično nevropatijo, parestezijo, hipestezijo, periferno nevropatijo, polinevropatijo, nevrotoksičnost in disestezijo.
English: Coumarin-derivative anticoagulant
Slovenian: Kumarinski antikoagulant
English: If you forget to take Teysuno
Slovenian: Če ste pozabili vzeti zdravilo Teysuno
English: - Low platelet count leading to an increased chance of bleeding o If you have bleeding of the skin, mouth (caused by brushing teeth), nose, respiratory tract, stomach, gut, etc., stop taking Teysuno and contact your doctor immediately.
Slovenian: - Majhno število trombocitov, kar poveča možnost krvavitve: o Če krvavite na koži, v ustih (zaradi umivanja zob), nosu, na respiratornem traktu, v želodcu, črevesju itd., prenehajte jemati zdravilo Teysuno in se takoj posvetujte s svojim zdravnikom.
English: Standard dosea: 25 mg/m2
Slovenian: Standardni odmereka: 25 mg/m2
English: The recommended standard dose of Teysuno when administered in combination with cisplatin is 25 mg/m2 (expressed as tegafur content) twice daily, morning and evening, for 21 consecutive days followed by 7 days rest (1 treatment cycle).
Slovenian: Če se zdravilo Teysuno uporablja v kombinaciji s cisplatinom, se priporoča standardni odmerek 25 mg/m2 (izraženo z vsebnostjo tegafurja) dvakrat dnevno, zjutraj in zvečer, in sicer 21 zaporednih dni, ki jim sledi 7 dni premora (1 cikel zdravljenja).
English: Dose modifications should be applied for the precipitating adverse reaction as necessary (see section 4.2).
Slovenian: Po potrebi je treba spremeniti odmerke zaradi sprožitvenih neželenih učinkov (glejte poglavje 4.2).
English: It is not known whether Teysuno or its metabolites are excreted in human milk.
Slovenian: Ni znano, ali se Teysuno/presnovki izločajo v materino mleko.
English: Following oral administration, tegafur is gradually converted to 5-FU in vivo, mainly by CYP2A6 enzyme activity in the liver.
Slovenian: Tegafur se po peroralni uporabi postopno pretvori v 5-FU in vivo, v glavnem z delovanjem encima CYP2A6 v jetrih.
English: Second dose reductiona: to 15 mg/m2 BSA ≥ 2.17 m2
Slovenian: Drugi zmanjšani odmereka: na 15 mg/m2 BSA ≥ 2,17 m2
English: Ethnicity
Slovenian: Narodnost
English: It is a fixed dose combination of three active substances, tegafur, which after absorption is converted into the anti-cancer substance 5-FU; gimeracil, a dihydropyrimidine dehydrogenase (DPD) inhibitor to prevent degradation of 5-FU by the body; and, oteracil, an orotate phosphoribosyltransferase (OPRT) inhibitor that decreases the activity of 5-FU in normal gastrointestinal mucosa.
Slovenian: Gre za fiksno kombinacijo odmerkov treh zdravilnih učinkovin: tegafurja, ki se po absorpciji pretvori v antikancerogeno snov 5-FU; gimeracila, inhibitorja dihidropirimidin dehidrogenaze (DPD), ki preprečuje razgradnjo snovi 5-FU v telesu, in oteracila, inhibitorja orotat fosforiboziltransferaze (OPRT), ki zmanjšuje aktivnost snovi 5-FU pri normalni gastrointestinalni sluznici.
English: Comparison of 218 patients with mild renal impairment at baseline (CrCl 51 to 80 ml/min) to 297 patients with normal renal function at baseline (CrCl >80 ml/min) treated with Teysuno in combination with cisplatin in the FLAGS study indicated that there were no clinically significant differences in safety between patients with mild renal impairment and patients with normal renal function.
Slovenian: Primerjava 218 bolnikov z blago izhodiščno ledvično okvaro (CrCl 51-80 ml/min) in 297 bolnikov z normalno izhodiščno ledvično funkcijo (CrCl > 80 ml/min), zdravljenih z zdravilom Teysuno v kombinaciji s cisplatinom, v študiji FLAGS je pokazala, da med bolniki z blago ledvično okvaro in bolniki z normalno ledvično funkcijo ni bilo klinično pomembnih razlik glede varnosti.
English: There are no clinical data on the distribution of radiolabeled components of Teysuno.
Slovenian: Kliničnih podatkov o porazdelitvi radioaktivno označenih sestavin zdravila Teysuno ni.
English: A Phase I study established the current regimen by evaluating cohorts of Teysuno and cisplatin of 30 mg/m2 and 60 mg/m2 (dose-limiting toxicities [DLTs] seen were fatigue, and diarrhoea and dehydration); 25 mg/m2 and 60 mg/m2; and 25 mg/m2 and 75 mg/m2.
Slovenian: Na podlagi študije faze I je bila oblikovana trenutna shema odmerjanja, in sicer z ovrednotenjem kohort za zdravilo Teysuno in cisplatin v odmerkih 30 mg/m2 in 60 mg/m2 (opaženi toksični učinki, ki omejujejo odmerek (DLT), so bili utrujenost, driska in dehidracija); 25 mg/m2 in 60 mg/m2, ter 25 mg/m2 in 75 mg/m2.
English: a Expressed as tegafur content.
Slovenian: a Izraženo z vsebnostjo tegafurja.
English: Administration of Teysuno under fed conditions resulted in decreased AUC0-inf for oteracil of approximately 71% and gimeracil of approximately 25% relative to fasting administration.
Slovenian: Pri uporabi zdravila Teysuno na poln želodec se je AUC0-inf za oteracil zmanjšal za približno 71 % in za gimeracil za približno 25 % v primerjavi z uporabo na tešče.
English: Therefore, Teysuno should not be administered to children or adolescents under 18 years of age.
Slovenian: Zdravila Teysuno se ne sme uporabljati pri otrocih ali mladostnikih, starih pod 18 let.