FrancophonIA/ELRC3.0 huggingface dataset:
English: Patients with low white blood cell counts should be monitored carefully for infection and risk of other complications of neutropaenia and treated as medically indicated (e.g., with antibiotics, granulocyte-colony stimulating factor [G-CSF]).
Slovenian: Bolnike z majhnim številom belih krvnih celic je treba skrbno spremljati zaradi možnosti infekcije in nevarnosti drugih zapletov nevtropenije ter zdraviti, kot je indicirano (npr. z antibiotiki, granulocitne kolonije spodbujajočim faktorjem (G-CSF)).
English: In a study performed in patients with renal impairment, the most common adverse reactions reported over all cycles across all cohorts were diarrhoea (57.6%), nausea (42.4%), vomiting (36.4%), fatigue (33.3%) and anaemia (24.2%).
Slovenian: V študiji, izvedeni med bolniki z ledvično okvaro, so bili najpogostejši neželeni učinki, o katerih so poročali v vseh ciklih in vseh kohortah, diareja (57,6 %), navzea (42,4 %), bruhanje (36,4 %), utrujenost (33,3 %) in anemija (24,2 %).
English: The following headings are used to rank the adverse reactions by frequency: very common (≥1/10), common (≥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), and not known (cannot be estimated from the available data).
Slovenian: Za razvrstitev neželenih učinkov po njihovi pogostnosti se uporabljajo naslednje oznake: 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) in neznana (ni mogoče oceniti iz razpoložljivih podatkov).
English: Treatment with Teysuno in combination with cisplatin may be associated with a transient decline of glomerular filtration rate caused primarily by pre-renal factors (e.g., dehydration, electrolyte imbalance, etc).
Slovenian: Zdravljenje z zdravilom Teysuno v kombinaciji s cisplatinom je lahko povezano z začasnim zmanjšanjem hitrosti glomerularne filtracije, ki ga primarno povzročijo prerenalni dejavniki (npr. dehidracija, neravnovesje elektrolitov itd.).
English: The patient's BSA must be recalculated and the Teysuno dose adjusted accordingly if a patient's weight increases or decreases by ≥10% from the one used for the previous calculation of BSA and the change is clearly not related to fluid retention.
Slovenian: BSA bolnika se mora preračunati, odmerek zdravila Teysuno pa ustrezno prilagoditi, če se bolnikova masa poveča ali zmanjša za ≥10 % glede na maso, ki se je uporabila za predhodni izračun BSA, in če sprememba zagotovo ni povezana z zastajanjem tekočine.
English: At the initiation of subsequent cycles of treatment
Slovenian: Ob uvedbi naknadnih ciklov zdravljenja
English: Treatment-related toxicities can be expected to increase as 5-FU exposure increases (see section 5.2).
Slovenian: Pričakuje se, da se poveča z zdravljenjem povezana toksičnost, saj se poveča izpostavljenost za 5-FU (glejte poglavje 5.2).
English: Most ocular reactions will resolve or improve with suspension of medicinal product and proper treatment (instillation of artificial tears, antibiotic eye drops, implantation of glass or silicone tubes in lacrimal punctas or canaliculi, and/or use of spectacles rather than contact lenses).
Slovenian: Večinoma očesne reakcije izzvenijo ali se zmanjšajo z ukinitvijo zdravila in z ustreznim zdravljenjem (vkapavanje umetnih solz, antibiotične kapljice za oko, vsaditev steklenih ali silikonskih cevk v lakrimalne luknjice ali kanalčke in/ali uporaba očal namesto kontaktnih leč).
English: ANNEX III LABELLING AND PAGKAGE LEAFLET
Slovenian: PRILOGA III OZNAČEVANJE IN NAVODILO ZA UPORABO
English: Table 1: Standard dose and dose reductions allowed for Teysuno and/or for cisplatin
Slovenian: Preglednica 1: Standardni odmerek in zmanjšana odmerka, dopustna za zdravilo Teysuno in/ali cisplatin
English: If a treatment delay is indicated for either Teysuno or cisplatin, then administration of both medicinal products should be delayed until the requirements for restarting both are met unless one of the medicinal products has been permanently discontinued.
Slovenian: Če je odlog zdravljenja indiciran za zdravilo Teysuno ali cisplatin, se odloži uporaba obeh zdravil, dokler niso izpolnjeni pogoji za ponovno uvedbo obeh zdravil, razen če je bilo zdravljenje z enim izmed zdravil trajno prekinjeno.
English: Prophylactic treatment for diarrhoea should be administered as indicated.
Slovenian: Profilaktično zdravljenje za drisko se uvede, kot je indicirano.
English: Post-marketing surveillance experience in gastric cancer patients
Slovenian: Izkušnje s postmarketinškim nadzorom pri bolnikih, ki imajo rak želodca
English: • End stage renal disease patients requiring dialysis.
Slovenian: • Bolniki z ledvično boleznijo v končnem stadiju, ki zahteva dializo.
English: a Treatment for patients with CrCl <30 ml/min is not recommended unless the benefits of Teysuno treatment clearly outweigh the risks.
Slovenian: a Zdravljenje bolnikov z očistkom kreatinina < 30 ml/min ni priporočljivo, razen če je jasno, da so koristi zdravljenja Teysuno večje od tveganja.
English: If a DPD inducer were to be concomitantly administered with Teysuno, the exposure of 5-FU might not reach the efficacious level.
Slovenian: Če bi se induktor DPD uporabljal sočasno z zdravilom Teysuno, izpostavljenost za 5-FU morda ne bi dosegla ravni učinkovitosti.
English: PCTFE/PVC/Al opaque blisters containing 14 capsules each.
Slovenian: Neprosojni pretisni omoti (PCTFE/PVC/aluminij), ki vsebujejo vsak po 14 kapsul.
English: However, limited data available on CYP2A6*4/*4 genotype in Japanese patients treated with Teysuno suggest significantly decreased 5-FU levels in this subpopulation.
Slovenian: Iz omejenih podatkov, ki so na voljo za genotip CYP2A6*4/*4 pri japonskih bolnikih, zdravljenih z zdravilom Teysuno, je razvidno izrazito znižanje ravni 5-FU pri tej subpopulaciji.
English: Median (Range) ≥65, n (%)
Slovenian: Mediana (razpon) ≥ 65, n (%)
English: Dose limiting toxicities include diarrhoea and dehydration.
Slovenian: Toksični učinki, ki omejujejo odmerek, vključujejo drisko in dehidracijo.
English: Most adverse reactions are reversible and can be managed by symptomatic therapy, dose interruptions and dose reductions.
Slovenian: Večina neželenih učinkov je reverzibilnih in jih je mogoče obvladovati s simptomatskim zdravljenjem, prekinitvijo zdravljenja in zmanjšanjem odmerka.
English: Folinate/folinic acid
Slovenian: Folinat/folinska kislina
English: Treatment with brivudine can be started 24 hours after the last dose of Teysuno (see section 4.3 and 4.5).
Slovenian: Zdravljenje z brivudinom lahko začnemo 24 ur po zadnjem odmerku zdravila Teysuno (glejte poglavji 4.3 in 4.5).
English: 5-FU is activated within cells by phosphorylation to its active metabolite, 5-fluoro-deoxyuridine-monophosphate (FdUMP).
Slovenian: 5-FU se aktivira v celicah s fosforilacijo v aktivni presnovek, 5-fluoro-deoksiuridin-monofosfat (FdUMP).
English: This analysis also demonstrated that the trend in changes in Teysuno pharmacokinetics observed with increasing age was related to change in renal function as measured by creatinine clearance.
Slovenian: Ta analiza je tudi pokazala, da je trend pri spreminjanju farmakokinetičnih lastnosti zdravila Teysuno, ki so ga opazili ob povečanju starosti, povezan s spremembami v ledvični funkciji, izmerjenimi z očistkom kreatinina.
English: Administration of Teysuno in hepatitis B virus carriers, HBc antigen negative and HBc antibody positive patients, or HBs antigen negative and HBs antibody positive patients may result in reactivation of hepatitis B.
Slovenian: Uporaba zdravila Teysuno pri nosilcih virusa hepatitis B, pri bolnikih, ki so antigen HBc negativni in antigen HBc pozitivni ali pri bolnikih, ki so antigen HBs negativni in antigen HBs pozitivni lahko povzroči reaktivacijo hepatitisa B.
English: c At the discretion of the treating physician, patients may continue with treatment without reduction or interruption for adverse reactions (irrespective of grade) considered unlikely to become serious or lifethreatening (e.g., alopecia, changes in sexual function, and dry skin).
Slovenian: c Po presoji lečečega zdravnika lahko bolniki nadaljujejo zdravljenje, ne da bi zmanjšali odmerke ali prekinili zdravljenje, saj je malo verjetno, da bi neželeni učinki (ne glede na stopnjo) postali resni ali življenjsko nevarni (npr. alopecija, spremembe pri spolni funkciji ali suha koža).
English: Location of primary lesion, n (%) Stomach
Slovenian: Mesto primarne lezije, n (%) Želodec
English: If you have taken brivudine you must wait for at least 4 weeks after stopping brivudine before starting to take Teysuno.
Slovenian: Če ste jemali brivudin, morate po končanem jemanju brivudina počakati najmanj 4 tedne, preden začnete jemati zdravilo Teysuno.
English: A Phase I study investigated the pharmacokinetics of Teysuno monotherapy in Asian (Chinese/Malay) and Caucasian (US) patients.
Slovenian: V študiji faze I so proučevali farmakokinetiko pri samostojnem zdravljenju z zdravilom Teysuno pri azijskih (kitajskih/malezijskih) in kavkaških (ZDA) bolnikih.
English: Data from a multicentre, multinational (excluding Asia), randomised, controlled, open-label Phase III clinical study (FLAGS) support the use of Teysuno in combination with cisplatin for the treatment of patients with advanced gastric cancer.
Slovenian: Podatki, pridobljeni iz multicentrične, multinacionalne (izvzemši Azijo), randomizirane, nadzorovane, odprte klinične študije faze III (FLAGS), podpirajo uporabo zdravila Teysuno v kombinaciji s cisplatinom za zdravljenje bolnikov z napredovalim rakom želodca.
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 this medicinal product.
Slovenian: Ženske v rodni dobi/Kontracepcija pri moških in ženskah Ženskam v rodni dobi je treba svetovati, da naj med zdravljenjem s tem zdravilom ustrezno poskrbijo za preprečevanje zanositve.
English: If you take more Teysuno than you should If you take more capsules than you should, contact your doctor immediately.
Slovenian: Če ste vzeli večji odmerek zdravila Teysuno, kot bi smeli Če ste vzeli več kapsul, kot vam je bilo naročeno, se takoj posvetujte s svojim zdravnikom.
English: What you need to know before you take Teysuno
Slovenian: Kaj morate vedeti, preden boste vzeli zdravilo Teysuno
English: The safety profile of Teysuno in a post-marketing safety surveillance study in Japan of 4,177 patients treated with Teysuno for advanced gastric cancer was generally similar to that seen with this regimen and in the Japanese registration studies (i.e., major toxicities were leukocytopaenia, anorexia, and nausea/vomiting).
Slovenian: Varnostni profil zdravila Teysuno v študijah o postmarketinškem nadzoru varnosti na Japonskem pri 4.177 bolnikih z napredovalim rakom želodca, zdravljenih z zdravilom Teysuno, je bil v glavnem podoben profilu, ki je bil opažen pri tej shemi in v japonskih študijah o registraciji (glavni toksični učinki so bili levkocitopenija, anoreksija in navzea/bruhanje).
English: Median [95% CI], months
Slovenian: Mediana (95-% IZ), meseci
English: Patients with anorexia, asthenia, nausea, vomiting, diarrhoea, stomatitis, and gastrointestinal obstruction should be monitored closely for signs of dehydration.
Slovenian: Bolnike, ki imajo težave z anoreksijo, astenijo, navzeo, bruhanjem, drisko, stomatitisom ali gastrointestinalno obstrukcijo, je treba pozorno spremljati glede znakov dehidracije.
English: o If you feel tired and have fever together with loss of appetite, contact your doctor immediately.
Slovenian: o Če ste utrujeni in imate povišano telesno temperaturo, hkrati pa ste izgubili apetit, se takoj posvetujte s svojim zdravnikom.
English: Tabulated list of adverse reactions
Slovenian: Tabularičen seznam neželenih učinkov
English: The safety and efficacy of Teysuno in children and adolescents under 18 years old have not been established.
Slovenian: Varnost in učinkovitost zdravila Teysuno pri otrocih in mladostnikih, starih pod 18 let, še nista bili dokazani.
English: Teysuno capsules should be swallowed with water at least 1 hour before or 1 hour after a meal.
Slovenian: Teysuno kapsule je treba pogoltniti z vodo vsaj eno uro pred obrokom ali eno uro po obroku.
English: The gimeracil component did not affect the pharmacokinetic profile of tegafur.
Slovenian: Sestavina gimeracil ni vplivala na farmakokinetični profil za tegafur.
English: 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.
Slovenian: 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.
English: Gimeracil and uracil AUC0-12 values were comparable between the two groups, suggesting that DPD inhibition was similar for the Asian and Caucasian groups.
Slovenian: 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.
English: • Co-administration of other fluoropyrimidines with Teysuno.
Slovenian: • Sočasna uporaba drugih fluoropirimidinov z zdravilom Teysuno.
English: Teysuno with food and drink Teysuno should be taken at least one hour before or one hour after a meal.
Slovenian: Zdravilo Teysuno skupaj s hrano in pijačo Zdravilo Teysuno se jemlje vsaj eno uro pred obrokom ali eno uro po obroku.
English: 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).
Slovenian: 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).
English: Teysuno dose adjustment for next dose / next cycle
Slovenian: Prilagoditev odmerka zdravila Teysuno za naslednji odmerek/cikel
English: Patients taking Teysuno should be informed of the risks and instructed to contact their physician immediately if moderate or severe toxicity occurs.
Slovenian: 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.
English: Therefore, Teysuno cannot be used as a substitute for other oral 5-FU products.
Slovenian: Zato zdravila Teysuno ni mogoče uporabiti kot nadomestka za druga peroralna zdravila 5-FU.
English: 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.
Slovenian: 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.
English: If you experience any of the side effects or if you notice any side effects not listed in this leaflet, please tell your doctor.
Slovenian: 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.
English: Renal function, as reflected by creatinine clearance, was the primary factor that influenced gimeracil exposure and 5-FU exposure.
Slovenian: Ledvična funkcija, izražena z očistkom kreatinina, predstavlja primarni dejavnik, ki vpliva na izpostavljenost za gimeracil in 5-FU.
English: Treatment with Teysuno produced various skin effects in rat (keratosis of footpad and tail) and dog (skin crusts and erosions).
Slovenian: Zdravljenje z zdravilom Teysuno je povzročilo različne kožne reakcije pri podganah (keratoza podplatnih blazinic in repa) in psih (kraste in erozije).
English: 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.
Slovenian: 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.
English: A maximum of two consecutive dose reductions for each medicinal product, as described in Table 1, can be applied in case of toxicity.
Slovenian: V primeru toksičnosti se lahko uporabita največ dva zaporedno zmanjšana odmerka za posamezno zdravilo, kot je opisano v Preglednici 1.
English: Levels of tegafur, gimeracil, oteracil and 5-FU were quantifiable through 10 hours postdose.
Slovenian: Vrednosti za tegafur, gimeracil, oteracil in 5-FU so bile izmerljive 10 ur po odmerku.
English: Capsule contents Lactose monohydrate Magnesium stearate
Slovenian: Vsebina kapsule laktoza monohidrat magnezijev stearat
English: Different MedDRA preferred terms that were considered clinically similar have been grouped into a single term.
Slovenian: Različni izrazi, ki jih priporoča MedDRA in ki označujejo podobno klinično stanje, so bili združeni v en sam izraz.
English: Baseline or Grade 1
Slovenian: Izhodiščna stopnja ali stopnja 1
English: 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.
Slovenian: 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.
English: o If you have fever of 38.5o C or higher, stop taking Teysuno and contact your doctor immediately.
Slovenian: o Če imate telesno temperature povišano na 38,5 °C ali več, prenehajte jemati zdravilo Teysuno in se takoj posvetujte s svojim zdravnikom.
English: There is no known antidote available in case of overdose.
Slovenian: Ni znanega antidota za preveliko odmerjanje.
English: Treatment with brivudine can be started 24 hours after the last dose of Teysuno.
Slovenian: Zdravljenje z brivudinom lahko začnemo 24 ur po zadnjem odmerku kapecitabina.
English: Patients with rare hereditory problems of galactose intolerance, the Lapp lactase deficiency or glucose/galactose malabasorption should not take this medicinal product.
Slovenian: Bolniki z redko dedno intoleranco za galaktozo, laponsko obliko zmanjšane aktivnosti laktaze ali malabsorpcijo glukoze/galaktoze ne smejo jemati tega zdravila.
English: 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.
Slovenian: 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.
English: Children and adolescents Teysuno is not recommended for children under 18 years of age.
Slovenian: Otroci in mladostniki Zdravila Teysuno ne priporočajo za otroke, mlajše od 18 let.
English: Terms for treatment-related ocular toxicities have been combined as follows.
Slovenian: Izrazi za očesno toksičnost, povezano z zdravljenjem, so bili razvrščeni, kot sledi.
English: 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).
Slovenian: 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).
English: 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.
Slovenian: 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.
English: 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.
Slovenian: 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.
English: Leukoencephalopathy, anosmia
Slovenian: levkoencefalopatija, anozmija
English: However, due to possible additive pharmacodynamic effects (myelotoxicity), caution is advised as coadministration may increase the risk and severity of haematologic toxicity of Teysuno.
Slovenian: Zaradi morebitnih aditivnih farmakodinamskih učinkov (mielotoksičnost) se priporoča previdnost, saj se zaradi sočasne uporabe lahko povečata nevarnost in stopnja resnosti hematološke toksičnosti zdravila Teysuno.
English: The recommended dose of cisplatin with this regimen is 75 mg/m2 by intravenous infusion administered once every 4 weeks.
Slovenian: Priporočeni odmerek zdravila s cisplatinom pri tej shemi je 75 mg/m2 z intravenskim infundiranjem, ki se opravi enkrat na 4 tedne.
English: • Severe bone marrow suppression (severe leukopaenia, neutropaenia, or thrombocytopaenia; see section 4.2, Table 5).
Slovenian: • Huda supresija kostnega mozga (huda levkopenija, nevtropenija ali trombocitopenija; glejte poglavje 4.2, Preglednico 5).
English: Other clinical studies with Teysuno in combination with cisplatin
Slovenian: Druge klinične študije z zdravilom Teysuno v kombinaciji s cisplatinom
English: Teysuno dose changes within a 21-day treatment cycle
Slovenian: Odmerek zdravila Teysuno se spremeni znotraj 21-dnevnega cikla zdravljenja
English: Dehydration and diarrhoea may increase the risk of renal toxicity for cisplatin.
Slovenian: Z dehidracijo in drisko se lahko poveča nevarnost ledvične toksičnosti zaradi cisplatina.
English: Your dose of Teysuno will be determined by your doctor based on your height and weight.
Slovenian: Zdravnik bo določil odmerek zdravila Teysuno glede na vašo višino in telesno maso.
English: 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).
Slovenian: 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).
English: Toxic epidermal necrolysis, Stevens-Johnson syndrome, photosensitivity reaction, nail disorder
Slovenian: toksična epidermalna nekroliza, StevensJohnsonov sindrom, občutljivostne reakcije na svetlobo, spremembe nohtov
English: There have been some case reports of foetal abnormalities.
Slovenian: Poročali so o nekaj kliničnih primerih nenormalnosti ploda.
English: The oteracil component of Teysuno did not affect the pharmacokinetic profiles of 5-FU, tegafur, gimeracil, FBAL, or uracil.
Slovenian: Zdravilna učinkovina zdravila Teysuno oteracil ni vplivala na farmakokinetični profil za 5-FU, tegafur, gimeracil, FBAL ali uracil.
English: If cisplatin is discontinued before 6 cycles, Teysuno treatment alone can be resumed when the criteria for restarting it are met.
Slovenian: 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.
English: Glucose/galactose intolerance/malabsorption
Slovenian: Intoleranca za glukozo/galaktozo oziroma malabsorpcija glukoze/galaktoze