natgillin/translations-raw huggingface dataset:
Patients with anorexia, asthenia, nausea, vomiting, diarrhoea, stomatitis, and gastrointestinal obstruction should be monitored closely for signs of dehydration.
Bolnike, ki imajo težave z anoreksijo, astenijo, navzeo, bruhanjem, drisko, stomatitisom ali gastrointestinalno obstrukcijo, je treba pozorno spremljati glede znakov dehidracije.
o If you feel tired and have fever together with loss of appetite, contact your doctor immediately.
o Če ste utrujeni in imate povišano telesno temperaturo, hkrati pa ste izgubili apetit, se takoj posvetujte s svojim zdravnikom.
Tabulated list of adverse reactions
Tabularičen seznam neželenih učinkov
The safety and efficacy of Teysuno in children and adolescents under 18 years old have not been established.
Varnost in učinkovitost zdravila Teysuno pri otrocih in mladostnikih, starih pod 18 let, še nista bili dokazani.
Teysuno capsules should be swallowed with water at least 1 hour before or 1 hour after a meal.
Teysuno kapsule je treba pogoltniti z vodo vsaj eno uro pred obrokom ali eno uro po obroku.
The gimeracil component did not affect the pharmacokinetic profile of tegafur.
Sestavina gimeracil ni vplivala na farmakokinetični profil za tegafur.
Among 593 patients treated with Teysuno in combination with cisplatin, the most common severe adverse reactions (Grade 3 or higher with frequency of at least 10%) were neutropaenia, anaemia, and fatigue.
Pri 593 bolnikih, ki so prejemali zdravilo Teysuno v kombinaciji s cisplatinom, so bili najpogostejši hudi neželeni učinki (stopnja 3 ali višja stopnja, s pogostnostjo najmanj 10 %) nevtropenija, anemija in utrujenost.
Gimeracil and uracil AUC0-12 values were comparable between the two groups, suggesting that DPD inhibition was similar for the Asian and Caucasian groups.
Vrednosti AUC0-12 za gimeracil in uracil so bile primerljive med skupinama, kar pomeni, da je bilo zaviranje DPD-ja v azijski in kavkaški skupini podobno.
• Co-administration of other fluoropyrimidines with Teysuno.
• Sočasna uporaba drugih fluoropirimidinov z zdravilom Teysuno.
Teysuno with food and drink Teysuno should be taken at least one hour before or one hour after a meal.
Zdravilo Teysuno skupaj s hrano in pijačo Zdravilo Teysuno se jemlje vsaj eno uro pred obrokom ali eno uro po obroku.
Patients receiving oral coumarin-derivative anticoagulant therapy must have their anticoagulant response (International Normalized Ratio for prothrombin time [INR] or prothrombin time [PT]) monitored closely and the anticoagulant dose adjusted accordingly (see section 4.5).
Bolnikom, ki prejemajo peroralni kumarinski antikoagulant, je treba skrbno spremljati antikoagulantni odziv (mednarodno normalizirano razmerje za protrombinski čas (INR) ali protrombinski čas (PT)) ter ustrezno prilagajati odmerek antikoagulanta (glejte poglavje 4.5).
Teysuno dose adjustment for next dose / next cycle
Prilagoditev odmerka zdravila Teysuno za naslednji odmerek/cikel
Patients taking Teysuno should be informed of the risks and instructed to contact their physician immediately if moderate or severe toxicity occurs.
Bolniki, ki jemljejo zdravilo Teysuno, morajo biti obveščeni o nevarnostih in poučeni, da se ob pojavu zmerne ali hude toksičnosti takoj obrnejo na svojega zdravnika.
Therefore, Teysuno cannot be used as a substitute for other oral 5-FU products.
Zato zdravila Teysuno ni mogoče uporabiti kot nadomestka za druga peroralna zdravila 5-FU.
A population PK analysis of Teysuno components and metabolites assessed the influence of various factors, including gender, age, food, ethnicity (Caucasian vs Asian), renal function, and hepatic function in 315 patients.
S populacijsko farmakokinetično analizo sestavin zdravila Teysuno in presnovkov so ocenili vpliv različnih dejavnikov, vključno s spolom, starostjo, hrano, narodnostjo (kavkaška v primerjavi z azijsko) ter ledvično in jetrno funkcijo, pri 315 bolnikih.
If you experience any of the side effects or if you notice any side effects not listed in this leaflet, please tell your doctor.
Če se pri vas pojavi kateri koli neželeni učinek ali če opazite kateri koli neželeni učinek, ki ni omenjen v tem navodilu, obvestite svojega zdravnika.
Renal function, as reflected by creatinine clearance, was the primary factor that influenced gimeracil exposure and 5-FU exposure.
Ledvična funkcija, izražena z očistkom kreatinina, predstavlja primarni dejavnik, ki vpliva na izpostavljenost za gimeracil in 5-FU.
Treatment with Teysuno produced various skin effects in rat (keratosis of footpad and tail) and dog (skin crusts and erosions).
Zdravljenje z zdravilom Teysuno je povzročilo različne kožne reakcije pri podganah (keratoza podplatnih blazinic in repa) in psih (kraste in erozije).
In the Phase III (FLAGS) study, tegafur AUC was significantly higher in patients with the CYP2A6*4 allele, however, no significant difference was found for 5-FU AUC and for the incidence of adverse reactions.
V študiji (FLAGS) faze III je bila vrednost AUC za tegafur izrazito višja pri bolnikih z alelom CYP2A6*4, nobene pomembne razlike pa niso našli pri vrednosti AUC za 5-FU in pri pojavnosti neželenih učinkov.
A maximum of two consecutive dose reductions for each medicinal product, as described in Table 1, can be applied in case of toxicity.
V primeru toksičnosti se lahko uporabita največ dva zaporedno zmanjšana odmerka za posamezno zdravilo, kot je opisano v Preglednici 1.
Levels of tegafur, gimeracil, oteracil and 5-FU were quantifiable through 10 hours postdose.
Vrednosti za tegafur, gimeracil, oteracil in 5-FU so bile izmerljive 10 ur po odmerku.
Capsule contents Lactose monohydrate Magnesium stearate
Vsebina kapsule laktoza monohidrat magnezijev stearat
Different MedDRA preferred terms that were considered clinically similar have been grouped into a single term.
Različni izrazi, ki jih priporoča MedDRA in ki označujejo podobno klinično stanje, so bili združeni v en sam izraz.
Baseline or Grade 1
Izhodiščna stopnja ali stopnja 1
The frequencies of medically relevant rare and very rare adverse reactions are estimated from post-marketing surveillance of 866,000 patients in Asia (mostly Japanese) treated with Teysuno-based therapy.
Oznake za klinično pomembne redke in zelo redke neželene učinke se nanašajo na postmarketinški nadzor pri 866.000 bolnikih v Aziji (večinoma Japoncih), ki so bili deležni zdravljenja na osnovi zdravila Teysuno.
o If you have fever of 38.5o C or higher, stop taking Teysuno and contact your doctor immediately.
o Če imate telesno temperature povišano na 38,5 °C ali več, prenehajte jemati zdravilo Teysuno in se takoj posvetujte s svojim zdravnikom.
There is no known antidote available in case of overdose.
Ni znanega antidota za preveliko odmerjanje.
Treatment with brivudine can be started 24 hours after the last dose of Teysuno.
Zdravljenje z brivudinom lahko začnemo 24 ur po zadnjem odmerku kapecitabina.
Patients with rare hereditory problems of galactose intolerance, the Lapp lactase deficiency or glucose/galactose malabasorption should not take this medicinal product.
Bolniki z redko dedno intoleranco za galaktozo, laponsko obliko zmanjšane aktivnosti laktaze ali malabsorpcijo glukoze/galaktoze ne smejo jemati tega zdravila.
Efforts should be made to ensure early detection of ocular reactions, including an early ophthalmologic consultation in the event of any persistent or vision-reducing ocular symptoms such as lacrimation or corneal symptoms.
Prizadevati si je treba za zgodnje odkrivanje očesnih reakcij, vključno z zgodnjim posvetovanjem z oftalmologom v primeru dolgotrajnih očesnih simptomov ali simptomov, ki poslabšujejo vid, kot so solzenje in kornealni simptomi.
Children and adolescents Teysuno is not recommended for children under 18 years of age.
Otroci in mladostniki Zdravila Teysuno ne priporočajo za otroke, mlajše od 18 let.
Terms for treatment-related ocular toxicities have been combined as follows.
Izrazi za očesno toksičnost, povezano z zdravljenjem, so bili razvrščeni, kot sledi.
For the primary endpoint of overall survival, Teysuno in combination with cisplatin was non-inferior to 5-FU in combination with cisplatin (see Table 9).
Primarni končni rezultat glede celokupnega preživetja pri zdravilu Teysuno v kombinaciji s cisplatinom ni bil slabši kot pri 5-FU v kombinaciji s cisplatinom (glejte Preglednico 9).
After oral administration, oteracil was distributed at high concentrations in normal gastrointestinal tract tissues while considerably lower concentrations were seen in blood and tumour tissue in animal studies.
Po peroralni uporabi se je oteracil z visokimi koncentracijami porazdelil v normalno tkivo gastrointestinalnega trakta, medtem ko je bilo v krvnem in tumorskem tkivu opaziti znatno nižje koncentracije pri študijah na živalih.
Although CYP2A6 variants are associated with pharmacokinetic variability of tegafur, the AUC of gimeracil, which is affected by renal function, is the key determinant in the pharmacokinetic variability of 5-FU.
Čeprav so različice encima CYP2A6 povezane s farmakokinetično variabilnostjo tegafurja, je vrednost AUC za gimeracil, ki je odvisna od ledvične funkcije, glavni dejavnik pri farmakokinetični variabilnosti snovi 5-FU.
Leukoencephalopathy, anosmia
levkoencefalopatija, anozmija
However, due to possible additive pharmacodynamic effects (myelotoxicity), caution is advised as coadministration may increase the risk and severity of haematologic toxicity of Teysuno.
Zaradi morebitnih aditivnih farmakodinamskih učinkov (mielotoksičnost) se priporoča previdnost, saj se zaradi sočasne uporabe lahko povečata nevarnost in stopnja resnosti hematološke toksičnosti zdravila Teysuno.
The recommended dose of cisplatin with this regimen is 75 mg/m2 by intravenous infusion administered once every 4 weeks.
Priporočeni odmerek zdravila s cisplatinom pri tej shemi je 75 mg/m2 z intravenskim infundiranjem, ki se opravi enkrat na 4 tedne.
• Severe bone marrow suppression (severe leukopaenia, neutropaenia, or thrombocytopaenia; see section 4.2, Table 5).
• Huda supresija kostnega mozga (huda levkopenija, nevtropenija ali trombocitopenija; glejte poglavje 4.2, Preglednico 5).
Other clinical studies with Teysuno in combination with cisplatin
Druge klinične študije z zdravilom Teysuno v kombinaciji s cisplatinom
Teysuno dose changes within a 21-day treatment cycle
Odmerek zdravila Teysuno se spremeni znotraj 21-dnevnega cikla zdravljenja
Dehydration and diarrhoea may increase the risk of renal toxicity for cisplatin.
Z dehidracijo in drisko se lahko poveča nevarnost ledvične toksičnosti zaradi cisplatina.
Your dose of Teysuno will be determined by your doctor based on your height and weight.
Zdravnik bo določil odmerek zdravila Teysuno glede na vašo višino in telesno maso.
There was a 15% decrease in AUC0-inf for 5-FU under fed versus fasting conditions, and tegafur exposure was not altered by food (thus demonstrating absence of a food effect).
Opazili so 15-odstotno zmanjšanje vrednosti AUC0-inf za 5-FU pri uporabi na poln želodec v primerjavi z uporabo na tešče, izpostavljenost za tegafur pa se s hrano ni spremenila (to dokazuje odsotnost vpliva hrane).
Toxic epidermal necrolysis, Stevens-Johnson syndrome, photosensitivity reaction, nail disorder
toksična epidermalna nekroliza, StevensJohnsonov sindrom, občutljivostne reakcije na svetlobo, spremembe nohtov
There have been some case reports of foetal abnormalities.
Poročali so o nekaj kliničnih primerih nenormalnosti ploda.
The oteracil component of Teysuno did not affect the pharmacokinetic profiles of 5-FU, tegafur, gimeracil, FBAL, or uracil.
Zdravilna učinkovina zdravila Teysuno oteracil ni vplivala na farmakokinetični profil za 5-FU, tegafur, gimeracil, FBAL ali uracil.
If cisplatin is discontinued before 6 cycles, Teysuno treatment alone can be resumed when the criteria for restarting it are met.
Če se zdravljenje s cisplatinom prekine pred zaključkom 6 ciklov, se zdravljenje zgolj z zdravilom Teysuno lahko nadaljuje, ko so izpolnjena merila za ponovno uvedbo zdravljenja.
Glucose/galactose intolerance/malabsorption
Intoleranca za glukozo/galaktozo oziroma malabsorpcija glukoze/galaktoze
It should be taken with water at least 1 hour before or 1 hour after a meal (see section 4.2).
Zdravilo se jemlje z vodo in najmanj 1 uro pred obrokom ali 1 uro po obroku (glejte poglavje 4.2).
FdUMP and reduced folate are bound to thymidylate synthase leading to formation of a ternary complex which inhibits DNA synthesis.
FdUMP in reducirani folat sta vezana na timidilatno sintazo, iz česar nastane trikomponentni kompleks, ki zavira sintezo DNA.
Doses omitted for toxicity are not replaced; and, if a patient vomits after taking a dose, this dose should not be replaced.
Odmerki, ki so bili izpuščeni zaradi toksičnosti, se ne nadomestijo; prav tako se odmerek ne nadomesti, če bolnik po prejemu odmerka bruha.
Tegafur is a prodrug of 5-FU with good oral bioavailability.
Tegafur je predzdravilo snovi 5-FU z dobro peroralno biološko uporabnostjo.
For minimum criteria for resumption of Teysuno treatment, see Table 6.
Glede minimalnih meril za nadaljevanje zdravljenja z zdravilom Teysuno si oglejte Preglednico 6.
Patients with diarrhoea should be carefully monitored and given fluid and electrolyte replacement if they become dehydrated.
Bolnike, pri katerih se pojavi driska, je treba skrbno opazovati in jim v primeru dehidracije nadomeščati tekočino in elektrolite.
• Pregnancy and breast-feeding.
• Nosečnost in dojenje.
Cisplatin will be stopped after 6 treatment cycles.
Zdravilo cisplatin se ukine po šestih ciklih zdravljenja.
However, the increase in 5-FU exposure tended to be greater than proportional to the increasing tegafur dose.
Vendar je bilo povečanje izpostavljenosti za 5-FU nadsorazmerno glede na povečanje odmerka tegafurja.
What Teysuno is and what it is used for What you need to know before you take Teysuno How to take Teysuno
Kaj je zdravilo Teysuno in za kaj ga uporabljamo Kaj morate vedeti, preden boste vzeli zdravilo Teysuno Kako jemati zdravilo Teysuno Možni neželeni učinki
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.
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.
Available pharmacodynamic/toxicological data in animals have shown excretion of Teysuno or its metabolites in milk (for details see section 5.3).
Razpoložljivi farmakodinamski/toksikološki podatki pri živalih kažejo na izločanje zdravila Teysuno/presnovkov v mleko (za podrobnosti glejte poglavje 5.3).
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.
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.
Each hard capsule contains 70.2 mg lactose monohydrate.
Ena trda kapsula vsebuje 70,2 mg laktoze monohidrata.
Co-administration of other fluoropyrimidines such as capecitabine, 5-FU, tegafur, or flucytosine can lead to additive toxicities, and is contraindicated.
Sočasna uporaba drugih fluoropirimidinov, kot so kapecitabin, 5-FU, tegafur in flucitozin, lahko povzroči aditivne toksične učinke, poleg tega pa je kontraindicirana.
The single and multiple dose pharmacokinetics (PK) of Teysuno in combination with cisplatin were evaluated in three studies.
Farmakokinetika (PK) enkratnega in večkratnega odmerjanja zdravila Teysuno v kombinaciji s cisplatinom je bila ovrednotena v treh študijah.
• Recent or concomitant treatment with brivudine (see section 4.4 and 4.5 for drug-drug interaction).
• Nedavno ali sočasno zdravljenje z brivudinom (glede medsebojnega delovanja med zdravili glejte poglavji 4.4 in 4.5).
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.
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.
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.
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.
Like all medicines, Teysuno can cause side effects, although not everybody gets them.
Kot vsa zdravila ima lahko tudi zdravilo Teysuno neželene učinke, ki pa se ne pojavijo pri vseh bolnikih.
However, since no DPD inducers are currently known, the interaction between a DPD inducer and Teysuno can not be evaluated.
Ker trenutno ni na voljo nobenega induktorja DPD, ni mogoče ovrednotiti medsebojnega delovanja induktorja DPD in zdravila Teysuno.
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.
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.
The frequencies of very common, common, and uncommon adverse reactions are from 593 patients treated with Teysuno in combination with cisplatin in clinical trials.
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.
Each hard capsule contains 93.6 mg lactose monohydrate.
Ena trda kapsula vsebuje 93,6 mg laktoze monohidrata.
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).
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).
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).
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).
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.
Med ciklom zdravljenja se mora odmerek prilagoditi za vsako posamezno zdravilo, za katero se ugotovi vzročna povezava s toksičnostjo.
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).
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).
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.
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.
- 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.
- 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.
Oteracil, gimeracil, 5-FU, and tegafur were 8.4%, 32.2%, 18.4%, and 52.3% protein bound, respectively.
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.
If you become pregnant during this time, you must tell your doctor.
Če v tem času zanosite, morate o tem obvestiti svojega zdravnika.
Use caution when driving or operating a machine, as Teysuno may make you tired, nauseous or have blurred vision.
Pri upravljanju vozil ali strojev bodite previdni, kajti zaradi zdravila Teysuno lahko postanete utrujeni, občutite slabost ali imate zamegljen vid.
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.
V primeru nenamernega dajanja brivudina bolnikom, ki se zdravijo z zdravilom Teysunon, je treba uvesti učinkovite ukrepe za zmanjšanje toksičnosti zdravila Teysuno.
• Contraindications for cisplatin; refer to the cisplatin SmPC.
• Kontraindikacije za cisplatin; oglejte si povzetek glavnih značilnosti za cisplatin.
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.
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.
Table 4: Teysuno and cisplatin dose modification according to creatinine clearance values at the start of a cycle of treatment
Preglednica 4: Spremembe odmerkov zdravila Teysuno in cisplatina glede na vrednosti očistka kreatinina na začetku cikla zdravljenja
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.
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.
First dose reductiona: to 20 mg/m2 BSA ≥ 2.13 m2
Prvi zmanjšani odmereka: na 20 mg/m2 BSA ≥ 2,13 m2
Studies in Japanese patients have suggested an effect of CYP2A6*4 polymorphism on Teysuno pharmacokinetics.
Iz študij z japonskimi bolniki izhaja, da polimorfizem CYP2A6*4 vpliva na farmakokinetične lastnosti zdravila Teysuno.
Despite the lack of DLTs in the last cohort, the dose of cisplatin was not elevated beyond 75 mg/m2.
V zadnji kohorti niso opazili toksičnih učinkov, ki omejujejo odmerek, vendar odmerka cisplatina vseeno niso povečali nad 75 mg/m2.
o If you vomit more than two times in 24 hours, stop taking Teysuno and contact your doctor immediately.
o Če ste v 24-ih urah bruhali več kot dvakrat, prenehajte jemati zdravilo Teysuno in se takoj posvetujte s svojim zdravnikom.