FrancophonIA/ELRC3.0 huggingface dataset:
English: After multiple dose administration (30 mg/m2, expressed as tegafur content, twice daily for 14 days; N=10), the median Tmax of tegafur, gimeracil, and oteracil was 0.8, 1.0, and 2.0 hours, respectively, and the corresponding mean ± SD AUC(0-12h) and Cmax was 19967 ± 6027 ng.hr/ml and 2970 ± 852 ng/ml for tegafur, 1483 ± 527 ng.hr/ml and 305 ± 116 ng/ml for gimeracil, and 692 ± 529 ng.hr/ml and 122 ± 82 ng/ml for oteracil.
Slovenian: Po večkratnem odmerjanju (30 mg/m2, izraženo z vsebnostjo tegafurja, dvakrat dnevno v obdobju 14 dni; N = 10) je mediana Tmax za tegafur, gimeracil in oteracil znašala 0,8, 1,0 in 2,0 ure, in sicer v tem zaporedju, ustrezno povprečje ± SD AUC(0-12h) in Cmax pa 19967 ± 6027 ng.hr/ml in 2970 ± 852 ng/ml za tegafur, 1483 ± 527 ng.hr/ml in 305 ± 116 ng/ml za gimeracil ter 692 ± 529 ng.hr/ml in 122 ± 82 ng/ml za oteracil.
English: No consistent relationship was seen between absolute QTcF interval values or change from Baseline values and maximum plasma concentration of Teysuno components.
Slovenian: Med absolutnimi vrednostmi intervala QTcF oziroma spremembo od izhodiščnih vrednosti in največjo koncentracijo sestavin zdravila Teysuno v plazmi niso opazili stalne povezave.
English: - inhibitors of the enzyme CYP2A6 which activates Teysuno such as tranylcypromine and methoxsalen - folinic acid (often used in chemotherapy with methotrexate) - blood-thinning medicines: coumarin-derivative anticoagulants such as warfarin - medicines for the treatment of seizures or tremors such as phenytoin - medicines that treat gout such as allopurinol
Slovenian: Zdravila Teysuno ne smete uporabiti kot nadomestek za druga peroralna zdravila s fluoropirimidinom; - inhibitorje encima CYP2A6, ki aktivira zdravilo Teysuno, kot sta tranilcipromin in metoksalen; - folno kislino (pogosto se uporablja pri kemoterapiji z metotreksatom); - zdravila proti strjevanju krvi: kumarinske antikoagulante, kot je varfarin; - zdravila za zdravljenje epileptičnih napadov ali tremorjev, kot je fenitoin, ali - zdravila, s katerimi se zdravi protin, kot je alopurinol.
English: Maximum plasma uracil concentration was observed at 4 hours, with a return to baseline levels within approximately 48 hours after dosing, indicating the reversibility of the DPD inhibition by gimeracil.
Slovenian: Največjo koncentracijo uracila v plazmi so opazili po 4 urah, v približno 48 urah po odmerjanju pa se je vrnila na izhodiščno raven, kar je pokazalo, da je zaviranje DPD-ja prek gimeracila reverzibilno.
English: Cisplatin a Expressed as tegafur content.
Slovenian: Cisplatin a Izraženo z vsebnostjo tegafurja.
English: o If you become dehydrated you may have symptoms such as dry mouth, weakness, dry skin, dizziness, cramping o Try to eat frequent small meals.
Slovenian: o Če postanete dehidrirani, imate lahko simptome, kot so suha usta, oslabelost, suha koža, omotica in krči.
English: Other
Slovenian: Drugi
English: Fatal cases have been reported following capecitabine interaction.
Slovenian: V povezavi z medsebojnim delovanjem s kapecetabinom so poročali o smrtnih primerih.
English: The median Tmax for 5-FU was 2.0 hours and the mean AUC0-inf and Cmax was 842 ± 252 ng.hr/ml and 174 ± 58 ng/ml.
Slovenian: Mediana Tmax za 5-FU je znašala 2,0 ure, povprečje AUC0-inf in Cmax pa 842 ± 252 ng.hr/ml in 174 ± 58 ng/ml.
English: How to take Teysuno
Slovenian: Kako jemati zdravilo Teysuno
English: System Organ Classa
Slovenian: Organski sistema
English: 4.7 Effects on ability to drive and use machines Teysuno has a moderate influence on the ability to drive and use machines as fatigue, dizziness, blurred vision, and nausea are common adverse reactions of Teysuno in combination with cisplatin.
Slovenian: 4.7 Vpliv na sposobnost vožnje in upravljanja s stroji Zdravilo Teysuno ima zmeren vpliv na sposobnost vožnje in upravljanja s stroji, kajti pogosti neželeni učinki zdravila Teysuno v kombinaciji s cisplatinom so utrujenost, omotica, zamegljen vid in navzea.
English: Caution is advised as co-administration of Teysuno and coumarin anticoagulation therapy may increase the risk of bleeding (see section 4.4).
Slovenian: S sočasno uporabo zdravila Teysuno in kumarinskega antikoagulanta se lahko poveča nevarnost krvavitve, zato se priporoča previdnost (glejte poglavje 4.4).
English: Other oral fluorpyrimidines
Slovenian: Drugi peroralni fluorpirimidini
English: Marketing Authorisation Holder Nordic Group B.V.
Slovenian: Imetnik dovoljenja za promet z zdravilom Nordic Group B.V.
English: If indicated, the dose of phenytoin should be adjusted according to the phenytoin SmPC.
Slovenian: Če je indicirano, prilagodite odmerek fenitoina v skladu s povzetkom glavnih značilnosti za fenitoin.
English: Teysuno dose modification at the start of the cycle of treatment
Slovenian: Sprememba odmerka zdravila Teysuno na začetku cikla zdravljenja
English: However, polyglutamated methotrexate inhibits thymidylate synthase and dihydrofolate reductase, potentially increasing cytotoxicity of 5-FU.
Slovenian: Metotreksat poliglutamat zavira timidilatno sintazo in dihidrofolat reduktazo, kar lahko poveča citotoksičnost 5-FU.
English: Other medicines and Teysuno Tell your doctor if you are taking , have recently taken or might take any other medicines.
Slovenian: Obvestite zdravnika ali farmacevta, če jemljete, ste pred kratkim jemali ali pa boste morda začeli jemati katero koli drugo zdravilo.
English: Cardiac failure, acute myocardial infarction, pericardial effusion, atrial fibrillation, angina pectoris, cardiac fibrillation, tachycardia, palpitations
Slovenian: Srčne bolezni srčno popuščanje, akutni miokardni infarkt, infarkt, perikardialni izliv, atrijska fibrilacija, angina pektoris, fibrilacija srca, tahikardija, palpitacije
English: However, co-administration may decrease clearance and, thus increase plasma levels of 5-FU.
Slovenian: S sočasno uporabo se lahko zmanjša očistek in zato poviša raven 5-FU v plazmi.
English: Each pack contains either 42 capsules, 84 capsules or 126 capsules.
Slovenian: Vsako pakiranje vsebuje 42 kapsul, 84 kapsul ali 126 kapsul.
English: No dose limiting toxicities were observed in the first cycle of treatment.
Slovenian: V prvem ciklu zdravljenja niso opazili toksičnosti, zaradi katere bi bilo treba omejiti odmerek.
English: Teysuno is indicated in adults for the treatment of advanced gastric cancer when given in combination with cisplatin (see section 5.1).
Slovenian: Zdravilo Teysuno je v kombinaciji s cisplatinom indicirano pri odraslih za zdravljenje napredovalega raka želodca (glejte poglavje 5.1).
English: The plasma concentrations of uracil returned to baseline levels approximately 48 hours after dosing indicating reversibility of DPD inhibition by gimeracil.
Slovenian: Koncentracija uracila v plazmi se je na izhodiščno raven vrnila približno 48 ur po odmerjanju, kar je pokazalo, da je zaviranje DPD-ja prek gimeracila reverzibilno.
English: Confusional state, restlessness, personality disorder, hallucination, depression, anxiety, libido decreased, sexual inhibition
Slovenian: Psihiatrične motnje nespečnost zmedenost, nemir, osebnostna motnja, halucinacije, depresija, tesnoba, zmanjšan libido, motnje spolne funkcije
English: Nordic Pharma
Slovenian: Italia Nordic Pharma
English: Platelet count ≥100 x 109/l
Slovenian: Število trombocitov ≥ 100 x 109/l
English: Teysuno is contraindicated during breast-feeding (see section 4.3).
Slovenian: Zdravilo Teysuno je kontraindicirano med dojenjem (glejte poglavje 4.3).
English: Teysuno was clastogenic in vitro using Chinese hamster lung cells and was weakly clastogenic in vivo in mouse bone marrow.
Slovenian: Zdravilo Teysuno je imelo klastogene učinke in vitro ob uporabi pljučnih celic kitajskega hrčka in blage klastogene učinke in vivo pri kostnem mozgu miši.
English: They are provided in blisters containing 14 capsules each.
Slovenian: Zapakirane so v pretisnih omotih po 14 kapsul.
English: Standard dose (mg/m2)
Slovenian: Standardni odmerek (mg/m2)
English: The dose for one patient in the severe cohort was reduced to 13.2 mg/m2 once daily at the start of Cycle 12 due to an adverse reaction (Grade 2 diarrhoea) in Cycle 11.
Slovenian: Na začetku 12. cikla so pri enem bolniku s hudo ledvično odpovedjo zaradi neželenega učinka (diareje 2. stopnje) v 11. ciklu odmerek zmanjšali na 13,2 mg/m2 enkrat na dan.
English: No adjustment of the standard dose is recommended for patients of Asian ethnicity (see section 5.2).
Slovenian: Pri bolnikih azijske narodnosti se ne priporočajo nobene spremembe standardnega odmerka (glejte poglavje 5.2).
English: In a Phase I Teysuno monotherapy study that investigated the pharmacokinetics of components and metabolites in patients with normal and impaired renal function, patients with mild renal impairment (CrCl 51 to 80 ml/min) receiving the same monotherapy dose of 30 mg/m2 twice daily (the maximum tolerated dose for monotherapy) as patients with normal renal function (CrCl >80 ml/min) had an increase in mean 5-FU AUC0-inf relative to that of the normal patients.
Slovenian: V študiji faze I o samostojnem zdravljenju z zdravilom Teysuno, v kateri so proučevali farmakokinetične lastnosti učinkovin in presnovkov pri bolnikih z normalno ledvično funkcijo in bolnikih z okvarjeno ledvično funkcijo, se je pri bolnikih z blago ledvično okvaro (CrCl 51-80 ml/min), ki v okviru samostojnega zdravljenja dvakrat dnevno prejemajo enak odmerek (30 mg/m2; največji tolerančni odmerek pri samostojnem zdravljenju) kot bolniki z normalno ledvično funkcijo (CrCl > 80 ml/min), povečalo povprečje AUC0-inf za 5-FU v primerjavi s povprečjem pri bolnikih z normalno ledvično funkcijo.
English: o If you experience diarrhoea, avoid high-fibre, fatty and spicy foods.
Slovenian: o Če imate drisko, ne uživajte vlakninsko bogate, mastne in začinjene hrane.
English: Frequent monitoring of phenytoin blood/plasma levels is advised when Teysuno and phenytoin are administered concomitantly.
Slovenian: Če se zdravilo Teysuno in fenitoin uporabljata sočasno, se priporoča redno spremljanje ravni fenitoina v krvi/plazmi.
English: No adjustment of the standard dose is recommended in patients >70 years old (see section 4.8).
Slovenian: Pri bolnikih, ki so stari 70 let ali več, se ne priporočajo nobene spremembe standardnega odmerka (glejte poglavje 4.8).
English: Toxicity gradesa
Slovenian: Stopnje toksičnostia
English: No data are available on the effect of Teysuno in combination with cisplatin on human fertility.
Slovenian: Podatkov o učinku zdravila Teysuno v kombinaciji s cisplatinom na plodnost pri človeku ni na voljo.
English: - Do not use this medicine after the expiry date which is stated on the outer carton and blister after EXP.
Slovenian: - Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na pretisnem omotu in škatli poleg oznake EXP ali Uporabno do. Rok uporabnosti zdravila se izteče na zadnji dan navedenega meseca.
English: The median Tmax for 5-FU was 2.0 hours and the mean AUC(0-12h) and Cmax was 870 ± 405 ng.hr/ml and 165 ± 62 ng/ml, respectively.
Slovenian: Mediana Tmax za 5-FU je znašala 2,0 ure, povprečje AUC(0-12h) in Cmax pa 870 ± 405 ng.hr/ml in 165 ± 62 ng/ml, in sicer v tem zaporedju.
English: Each pack contains 42 capsules or 84 capsules.
Slovenian: Vsako pakiranje vsebuje 42 kapsul ali 84 kapsul.
English: Dose reduction 1 (mg/m2)
Slovenian: Zmanjšani odmerek 1 (mg/m2)
English: • Eye disorder includes adverse reactions of eye pruritus, ocular hyperaemia, eye irritation, eye disorder, and foreign body sensation in eyes.
Slovenian: • Očesna obolenja vključujejo neželene učinke, ki se nanašajo na očesni pruritus, očesno hiperemijo, draženje oči, druge očesne motnje in občutek tujka v očesu.
English: Therefore, the daily exposure to 5-FU would be expected to be comparable in these groups, since the daily exposure in patients in the severe renal impairment group is based on the administration of Teysuno once a day, while the daily exposure to 5-FU in the patients with normal renal function is based on the administration of Teysuno twice daily.
Slovenian: Zato se pričakuje, da bo izpostavljenost 5-FU v teh dveh skupinah primerljiva, saj dnevna izpostavljenost pri bolnikih s hudo ledvično okvaro temelji na odmerjanju zdravila Teysuno enkrat na dan, dnevna izpostavljenost 5-FU pri bolnikih z normalnim ledvičnim delovanjem pa na odmerjanju zdravila Teysuno dvakrat na dan. Treba pa je poudariti, da lahko pri bolnikih s hudo ledvično okvaro izpostavljenost 5-FU niha in je lahko nepričakovano večja zaradi vpliva nihanja ledvičnega delovanja pri teh bolnikih.
English: Patients should be tested for HBV infection before initiating treatment with Teysuno.
Slovenian: Pred pričetkom zdravljenja z zdravilom Teysuno je potrebno bolnike testirati za okužbo z HBV.
English: LIST OF EXCIPIENTS Also contains lactose.
Slovenian: SEZNAM POMOŽNIH SNOVI Teysuno trde kapsule vsebujejo tudi laktozo.
English: Manifestations of acute overdose reported include nausea, vomiting, diarrhoea, mucositis, gastrointestinal irritation, bleeding, bone marrow depression, and respiratory failure.
Slovenian: Pojavne oblike akutnega prevelikega odmerjanja, o katerih so poročali, vključujejo navzeo, bruhanje, drisko, mukozitis, gastrointestinalno draženje, krvavitev, depresijo kostnega mozga in okvaro respiratorne funkcije.
English: Warnings and precautionsTalk to your doctor before taking teysuno if you have: blood disorders kidney disease stomach and/or bowel problems such as pain, diarrhoea, vomiting and dehydration eye disorders, such as “dry eye” or increased tearing a current or previous infection of the liver with the hepatitis B virus, since your doctor may want to monitor you more closely
Slovenian: Opozorila in previdnostni ukrepi Pred začetkom jemanja zdravila Teysuno se posvetujte z zdravnikom: - če imate bolezni krvi; - če imate obolenje ledvic; če imate želodčne in/ali črevesne težave, kot so bolečine, driska, bruhanje in dehidracija; - če imate očesne motnje, kot so "suhe oči" ali močnejše solzenje; če imate ali ste preboleli okužbo jeter z virusom hepatitisa B. Vaš zdravnik vas bo morda želel natančno spremljati.
English: - are taking other fluoropyrimidine anti-cancer medicine such as fluorouracil and capecitabine, or have had severe and unexpected reactions to fluoropyrimidines - have known genetic deficiency of the enzyme dihydropyrimidine dehydrogenase (DPD) - are pregnant or breast-feeding - have severe blood disorders - have kidney disease requiring dialysis - are being treated now or have been treated in the last 4 weeks with brivudine as part of herpes zoster (chickenpox or shingles) therapy.
Slovenian: Ne jemljite zdravila Teysuno: - če ste alergični na tegafur, gimeracil, oteracil ali katero koli sestavino tega zdravila (navedeno v poglavju 6); - če jemljete drugo zdravilo proti raku s fluoropirimidinom, kot sta fluorouracil in kapecitabin, ali če ste imeli hude in nepričakovane reakcije na fluoropirimidine; - če imate znano genetsko pomanjkanje encima dihidropirimidin dehidrogenaza (DPD); - če ste noseči ali dojite; - če imate hude bolezni krvi; - če imate ledvično bolezen, ki zahteva dializo; - če se zdaj zdravite ali ste se v zadnjih 4 tednih zdravili z brivudinom, ki se uporablja kot del zdravljenja herpes zostra (norice ali pasovec).
English: If you have any doubts talk to your doctor.
Slovenian: V primeru dvomov se posvetujte s svojim zdravnikom.
English: Standard anti-diarrhoeal therapy (e.g., loperamide) and intravenous fluids/electrolytes should be initiated early when diarrhoea develops.
Slovenian: Če se pojavi driska, je treba zgodaj uvesti standardno zdravljenje (npr. z loperamidom) in intravenske tekočine/elektrolite.
English: Teysuno is an oral fluoropyrimidine anti-cancer medicinal product.
Slovenian: Teysuno je zdravilo proti raku iz skupine fluoropirimidinov za peroralno uporabo.
English: In this study, 521 patients were randomised to treatment with Teysuno (25 mg/m2 orally twice daily for 21 days followed by a 7-day rest period) and cisplatin (75 mg/m2 intravenous infusion once every 4 weeks); and 508 patients were randomised to treatment with 5-FU (1000 mg/m2/24 hours as a continuous intravenous infusion on Days 1 through 5 repeated every 4 weeks) and cisplatin (100 mg/m2 as an intravenous infusion on Day 1 repeated every 4 weeks).
Slovenian: 4 tedne), 508 bolnikov pa so naključno izbrali za zdravljenje s snovjo 5-FU (1000 mg/m2/24 ur s stalno intravensko infuzijo od 1. do 5. dneva, pri čemer se zdravljenje ponovi vsake 4 tedne) in cisplatinom (100 mg/m2 z intravensko infuzijo na 1. dan, pri čemer se zdravljenje ponovi vsake
English: Discontinue treatment a According to the Common Terminology Criteria for Adverse Events (CTCAE) of the Cancer Therapy Evaluation Program, US National Cancer Institute, version 3.0. b For Grade 2 nausea and/or vomiting, the anti-emetic therapy should be optimized prior to a suspension of Teysuno.
Slovenian: (US National Cancer Institute), verzija 3.0. b Pri drugostopenjski navzei in/ali bruhanju se antiemetično zdravljenje prilagodi pred ukinitvijo zdravila
English: As renal function decreased, there was an increase in 5-FU steady state exposure.
Slovenian: Ob zmanjšanem delovanju ledvic se je uravnotežena izpostavljenost za 5-FU povečala.
English: Mean AUC0-inf and Cmax for 5-FU were approximately 3-fold greater following administration of Teysuno (50 mg expressed as tegafur content) than following administration of tegafur alone (800 mg), while AUC0-inf and Cmax values for the 5-FU metabolite α-fluoro-β-alanine (FBAL) were approximately 15- to 22-fold lower following administration of Teysuno than following administration of tegafur.
Slovenian: Povprečje AUC0-inf in Cmax za 5-FU je znašalo približno 3-krat več pri uporabi zdravila Teysuno (50 mg, izraženo z vsebnostjo tegafurja) kot pri samostojni uporabi tegafurja (800 mg), medtem ko sta bili vrednosti AUC0-inf in Cmax za 5-FU presnovek α-fluoro-β-alanine (FBAL) približno 15- do 22--krat nižji pri uporabi zdravila Teysuno kot pri uporabi tegafurja.
English: INFORMATION IN BRAILLE Teysuno 20 mg/5.8 mg/15.8 mg 17.
Slovenian: PODATKI V BRAILLOVI PISAVI Teysuno 20 mg/5,8 mg/15,8 mg
English: 30 to 49 ml/min Start treatment at one reduced dose level
Slovenian: 30 do 49 ml/min zdravljenje se začne z za eno stopnjo zmanjšano velikostjo odmerka zdravljenje z zdravilom cisplatin se začne z odmerkom, ki je za 50 % zmanjšan glede na prejšnji cikel
English: No dose limiting toxicities were observed in Cycle 1 in patients with moderate or severe renal impairment.
Slovenian: V prvem ciklu pri bolnikih z zmerno ali hudo ledvično okvaro niso opazili toksičnosti, zaradi katere bi bilo treba omejiti odmerek.
English: Mean 5-FU maximum plasma concentration (Cmax) and area under the concentration-time curve (AUC) values were approximately 3-fold higher after Teysuno administration than after administration of tegafur alone, despite a 16-fold lower Teysuno dose (50 mg of tegafur) compared to tegafur alone (800 mg), and are attributed to inhibition of DPD by gimeracil.
Slovenian: Povprečna vrednost največje koncentracije snovi 5-FU v plazmi (Cmax) in površina pod krivuljo koncentracije v odvisnosti od časa (AUC) sta bili približno 3-krat večji po uporabi zdravila Teysuno kot po uporabi zgolj tegafurja, čeprav je odmerek zdravila Teysuno 16-krat manjši (50 mg tegafurja) v primerjavi s samostojnim odmerkom tegafurja (800 mg), kar se pripisuje gimeracilu, ki zavira DPD.
English: You must not take brivudine (an anti-viral medicine for the treatment of shingles or chickenpox) at the same time as Teysuno treatment (including during any rest periods when you are not taking any Teysuno capsules).
Slovenian: Med zdravljenjem z zdravilom Teysuno (vključno z obdobji premora, ko kapsul zdravila Teysuno ne jemljete), ne smete jemati brivudina (protivirusnega zdravila za zdravljenje pasovca ali noric).
English: Table 6: Minimum criteria to resume Teysuno treatment following its suspension due to a toxicity Non-haematologic
Slovenian: Merila za nadaljevanje zdravljenja z zdravilom Teysuno Preglednica 6: Minimalna merila za nadaljevanje zdravljenja z zdravilom Teysuno, ki sledi ukinitvi zdravila zaradi toksičnosti
English: • Severe renal impairment (CrCl below 30 ml/min) Although roughly similar daily exposure to 5-FU would be expected in patients with severe renal impairment at a dose of 20 mg/m2 once daily compared to 30 mg/m2 twice daily in patients with normal renal function (see section 5.2), administration of Teysuno is not recommended due to possibly higher incidence of adverse events of the blood and lymphatic system disorders unless the benefits clearly outweigh the risks (see sections 4.4 and 4.8).
Slovenian: Čeprav se pri bolnikih s hudo ledvično okvaro, ki prejemajo 20 mg/m2 na dan, pričakuje, da bo dnevna izpostavljenost 5-fluorouracilu, približno enaka kot pri bolnikih z normalnim delovanjem ledvic, ki prejemajo 30 mg/m2 dvakrat na dan, (glejte poglavje 5.2), se dajanje zdravila Teysuno ne priporoča, saj obstaja možnost večje incidence neželenih dogodkov bolezni krvi in limfatičnega sistema, razen če je jasno, da so koristi večje od tveganja (glejte poglavji 4.4 in 4.8).
English: doses, steady-state conditions are reached for tegafur, gimeracil, and oteracil at the latest by Day 8.
Slovenian: Po uporabi odmerkov 30 mg/m2 se vzpostavi stanje dinamičnega ravnovesja za tegafur, gimeracil in oteracil, in sicer najpozneje na 8. dan.
English: INFORMATION IN BRAILLE Teysuno 15 mg/4.35 mg/11.8 mg 17.
Slovenian: PODATKI V BRAILLOVI PISAVI Teysuno 15 mg/4,35 mg/11,8 mg
English: Uncommon side effects (may affect 1 to 10 in 1,000 people) include:
Slovenian: Med občasne neželene učinke (pojavijo se lahko pri 1 do 10 od 1.000 bolnikov) so vključeni:
English: The only Grade 3 or higher adverse reaction was reduced visual acuity.
Slovenian: Zmanjšanje ostrine vida je bil edini neželeni učinek stopnje 3 ali višje stopnje.
English: No clinical trials are available comparing Teysuno versus other oral 5-FU compounds.
Slovenian: Za primerjavo zdravila Teysuno z drugimi peroralnimi 5-FU učinkovinami niso bila opravljena klinična preskušanja.
English: Contents of the pack and other information What Teysuno contains - The active substances are tegafur, gimeracil and oteracil.
Slovenian: Kaj je zdravilo Teysuno in za kaj ga uporabljamo Zdravilo Teysuno vsebuje zdravilne učinkovine tegafur, gimeracil in oteracil.
English: Capsule contents: lactose monohydrate, magnesium stearate Capsule shell: gelatin, red iron oxide (E172), titanium dioxide (E171), sodium lauryl sulphate, talc
Slovenian: Vsebina kapsule: laktoza monohidrat, magnezijev stearat Ovojnica kapsule: želatina, rdeč železov oksid (E172), titanov dioksid (E171), natrijev lavrilsulfat, smukec
English: Dose reduction 2 (mg/m2)
Slovenian: Zmanjšani odmerek 2 (mg/m2)
English: See Table 2 for the details of the number of Teysuno capsules to be administered for each dose level.
Slovenian: Glede podrobnosti o številu kapsul zdravila Teysuno, ki se uporabijo za posamezno velikost odmerka, si oglejte Preglednico 2.
English: Only a small amount of oteracil is metabolised in the liver because of its low permeability.
Slovenian: V jetrih se zaradi majhne prepustnosti presnavlja samo majhna količina oteracila.
English: Caution is advised as folinic acid is known to enhance the activity of 5-FU.
Slovenian: Za folinsko kislino je znano, da povečuje aktivnost snovi 5-FU, zato se priporoča previdnost.
English: Teysuno contains the active substances tegafur gimeracil and oteracil.
Slovenian: - Zdravilne učinkovine so tegafur, gimeracil in oteracil.
English: You must not take Teysuno if you are pregnant or think you might be.
Slovenian: Če ste noseči ali mislite, da ste noseči, ne smete jemati zdravila Teysuno.
English: NAME OF THE MEDICINAL PRODUCT Teysuno 15 mg/4.35 mg/11.8 mg hard capsules
Slovenian: IME ZDRAVILA Teysuno 15 mg/4,35 mg/11,8 mg trde kapsule