FrancophonIA/ELRC3.0 huggingface dataset:
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).
Danish: Blandt metabolitterne blev 9,5 % til 9,7 % af indgivet tegafur udskilt i urinen som 5-FU og ca. 70 % til 77 % som FBAL, hvilket udgør ca. 83 % til 91 % af den indgivne dosis Teysuno (total tegafur + 5-FU + FBAL).
English: ANNEX III LABELLING AND PAGKAGE LEAFLET
Danish: BILAG III ETIKETTERING OG INDLÆGSSEDDEL
English: Treatment-related toxicities can be expected to increase as 5-FU exposure increases (see section 5.2).
Danish: Der kan forventes en stigning af behandlingsrelaterede toksiciteter med øget eksponering for 5FU (se pkt.
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).
Danish: I fase III FLAGS forsøget var der intet åbenbart forhold mellem AUC for 5-FU (Teysuno/cisplatinarmen) og koncentrationen af 5-FU (5-FU/cisplatin-armen) under behandlingsforløb 1 og effektresultaterne af den samlede overlevelse eller progressionsfri overlevelse.
English: Following oral administration, tegafur is gradually converted to 5-FU in vivo, mainly by CYP2A6 enzyme activity in the liver.
Danish: Efter peroral indgivelse konverteres tegafur gradvist til 5-FU in vivo, hovedsageligt af CYP2A6-enzymaktivitet i leveren.
English: American Indian or Alaska Native Other
Danish: Indianere og inuitter fra Alaska Andre
English: The European Medicines Agency has waived the obligation to submit the results of studies with Teysuno in all subsets of the paediatric population in gastric adenocarcinoma (see section 4.2 for information on paediatric use).
Danish: Det Europæiske Lægemiddelagentur har frafaldet kravet om at indsende resultaterne af forsøget med Teysuno hos alle undergrupper af den pædiatriske population ved gastrisk adenocarcinom (se pkt.
English: Table 4: Teysuno and cisplatin dose modification according to creatinine clearance values at the start of a cycle of treatment
Danish: Tabel 4: Dosisændring af Teysuno og cisplatin i henhold til creatinin-clearance ved starten på et behandlingsforløb
English: Dehydration and diarrhoea may increase the risk of renal toxicity for cisplatin.
Danish: Dehydrering og diarré kan øge risikoen for nyretoksicitet på grund af cisplatin.
English: o If you experience nausea and vomit a dose of medication, make sure you tell your doctor.
Danish: o Hvis du får kvalme og kaster en dosis medicin op, skal du fortælle det til lægen.
English: Patients with renal impairment (see sections 4.2, 4.3, 4.4, and 5.2)
Danish: 4.2, 4.3, 4.4 og 5.2)
English: - This medicine does not require any special storage conditions.
Danish: - Dette lægemiddel kræver ingen særlige forholdsregler vedrørende opbevaringen.
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.
Danish: - Diarré, kvalme, opkastning, forstoppelse o Hvis du har diarré flere end 4 gange på en dag eller midt om natten, eller hvis du har ondt i munden samtidig med, at du har diarré, skal du stoppe med at tage Teysuno og kontakte lægen med det samme.
English: A maximum of two consecutive dose reductions for each medicinal product, as described in Table 1, can be applied in case of toxicity.
Danish: Der kan i tilfælde af toksicitet maksimalt anvendes to konsekutive dosisreduktioner af hvert lægemiddel, som beskrevet i tabel 1.
English: Fluoropyrimidines may increase phenytoin plasma concentration when administered concomitantly with phenytoin causing phenytoin toxicity.
Danish: Fluoropyrimidiner kan øge plasmakoncentrationen af phenytoin ved samtidig indgift med phenytoin, hvilket forårsager phenytointoksicitet.
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.
Danish: Efter peroral indgift blev oteracil distribueret ved høje koncentrationer i normalt væv i gastrointestinalkanalen, mens betydeligt lavere koncentrationer sås i blod og tumorvæv under dyreforsøg.
English: The cycles are repeated.
Danish: Behandlingsforløbene gentages.
English: Patients with diarrhoea should be carefully monitored and given fluid and electrolyte replacement if they become dehydrated.
Danish: Patienter med diarré bør kontrolleres nøje og gives væske og elektrolyterstatning ved dehydrering.
English: PHARMACEUTICAL FORM AND CONTENTS Hard capsules
Danish: LÆGEMIDDELFORM OG INDHOLDSMÆNGDE (PAKNINGSSTØRRELSE) Hårde kapsler.
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.
Danish: Indgift af Teysuno efter indtagelse af mad resulterede i reduceret AUC0-inf for oteracil på ca. 71 % og gimeracil på ca. 25 % i forhold til fastende indgift.
English: o To prevent bleeding, avoid hard work or strenuous sports so as to prevent injuries and bruises.
Danish: o Blødning kan forebygges ved at undgå hårdt arbejde eller anstrengende sport, så du undgår skader og blå mærker.
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.
Danish: Selvom forsøg med Teysuno i kombination med cisplatin, der blev udført i Japan, anvendte andre doser og behandlingsregimer end i dette regime, var sikkerhedsprofilen fra disse forsøg den samme, hvor de mest almindelige toksiciteter var hæmatologiske, gastrointestinale, træthed og anoreksi.
English: 15 mg capsulea (brown/white)
Danish: 15 mg kapsela (brun/hvid)
English: After single dose administration, there was a statistically significant decrease in 5-FU and gimeracil Cmax for the severe hepatic impairment group relative to that of the normal group, but this difference was not observed after multiple dose administration.
Danish: Efter indgift af enkeltdosis var der et statistisk signifikant fald i 5-FU og gimeracil Cmaks for gruppen med svært nedsat leverfunktion i forhold til den normale gruppe, men denne forskel kunne ikke observeres efter indgift af multiple doser.
English: Febrile neutropenia, lymphopenia
Danish: Febril neutropeni, lymfopeni
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.
Danish: Hvis det er nødvendigt at udsætte behandling med enten Teysuno eller cisplatin, bør behandling udsættes for begge lægemidler, indtil kravene for at genindlede behandling af begge stoffer er opfyldt, medmindre et af lægemidlerne er blevet permanent seponeret.
English: Liver function test abnormal, gamma glutamyltransferase increased
Danish: Unormal leverfunktionstest, øget gamma-glutamyltransferase
English: Your doctor will tell you what dose you need to take, when to take it and for how long you need to take it.
Danish: Din læge vil fortælle dig, hvilken dosis du skal tage, hvornår du skal tage den, og hvor længe du skal tage den. Din dosis Teysuno vil blive fastsat af din læge på grundlag af din højde og vægt.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 14 March 2011
Danish: DATO FOR FØRSTE MARKEDSFØRINGSTILLADELSE/FORNYELSE AF TILLADELSEN Dato for første tilladelse: 14 marts, 2011 Dato for seneste fornyelse: 19 november, 2015
English: Dizziness, headache, dysgeusia
Danish: Svimmelhed, hovedpine, dysgeusi
English: Overall Survival Intent-to-treat Full analysis set Progression-free Survival Full analysis set CI = confidence interval; Full analysis set = all randomised, treated patients analysed as allocated (primary analysis population)
Danish: KI = konfidensinterval, fuldt analysesæt = alle randomiserede, behandlede patienter analyseret som efter tildelt behandling (primær analysepopulation)
English: There must be at least a 4-week waiting period between end of treatment with brivudine and start of Teysuno therapy.
Danish: Der skal være en periode på mindst 4 uger mellem endt behandling med brivudin og initiering af behandling med Teysuno.
English: Total daily dose in mga
Danish: Samlet dagsdosis i mga
English: In this study, 7 patients with moderate renal impairment were treated with 20 mg/m2 Teysuno twice daily, while 7 patients with severe renal impairment received Teysuno 20 mg/m2 once daily.
Danish: I dette forsøg blev 7 patienter med moderat nedsat nyrefunktion behandlet med 20 mg/m2 Teysuno to gange dagligt, mens 7 patienter med svært nedsat nyrefunktion fik Teysuno 20 mg/m2 én gang dagligt.
English: First dose reductiona: to 20 mg/m2 BSA ≥ 2.13 m2
Danish: Første dosisreduktiona: til 20 mg/m2 BSA ≥ 2,13 m2
English: If any of the side effects get serious, stop taking Teysuno and tell your doctor immediately.
Danish: Hvis en eller flere af bivirkningerne bliver alvorlige, skal du holde op med at tage Teysuno og fortælle det til lægen med det samme.
English: Teysuno dose modifications for toxicity when used in combination with cisplatin can be made in two ways.
Danish: Dosisændring af Teysuno på grund af toksicitet, når lægemidlet anvendes i kombination med cisplatin, kan udføres på to måder.
English: For minimum criteria for resumption of Teysuno treatment, see Table 6.
Danish: Minimumskriterierne for genoptagelse af Teysuno-behandlingen er anført i tabel 6.
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.
Danish: En sammenligning af sikkerheden mellem 71 patienter ≥70 år (ældre) og 450 patienter <70 år, der blev behandlet med Teysuno i kombination med cisplatin i FLAGS forsøget, påviste, at forekomsten af alle bivirkninger af grad 3 eller værre (62 % vs. 52 %), alle alvorlige bivirkninger (30 % vs. 19 %) og frekvensen af udtrædelse før tid på grund af bivirkninger af både Teysuno og cisplatin (21 % vs. 12 %) lod til at være højere blandt patienter ≥70 år.
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.
Danish: Efter en enkeltdosis Teysuno varierede T1/2-værdier fra 6,7 til 11,3 timer for tegafur, fra 3,1 til 4,1 timer for gimeracil og fra 1,8 til 9,5 timer for oteracil.
English: The 5-FU pharmacokinetic profile was similar in the presence and absence of oteracil.
Danish: Den farmakokinetiske profil af 5-FU var den samme både med og uden oteracil.
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).
Danish: Eftersom CYP2A6 er det enzym, der er ansvarligt for omdannelse af tegafur til 5-FU, bør samtidig indgift af en kendt CYP2A6-hæmmer og Teysuno undgås, da Teysunos virkning kan blive nedsat (se pkt.
English: Table 1: Standard dose and dose reductions allowed for Teysuno and/or for cisplatin
Danish: Tabel 1: Tilladte standard doser og dosisreduktioner for Teysuno og/eller cisplatin
English: DPD inducers
Danish: DPD-inducere
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).
Danish: Den anbefalede sædvanlige dosis Teysuno givet i kombination med cisplatin er 25 mg/m2 (udtrykt som tegafurindhold) to gange dagligt, morgen og aften, i 21 konsekutive dage efterfulgt af 7 dages pause (1 behandlingsforløb).
English: No studies have been performed with Teysuno alone or in combination with cisplatin in paediatric patients.
Danish: Der er ikke udført forsøg med Teysuno alene eller i kombination med cisplatin hos pædiatriske patienter.
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.
Danish: Proteinbinding i humant serum var ikke afhængigt af koncentration over et interval på 0,1 til 1,0 µg/ml for oteracil, gimeracil og 5-FU og 1,2 til 11,8 µg/ml for tegafur.
English: Teysuno dose adjustment for next dose / next cycle
Danish: Dosisjustering af Teysuno for næste dosis/i næste behandlingsforløb
English: If you stop taking Teysuno
Danish: Hvis du holder op med at tage Teysuno
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).
Danish: In-vitro-evaluering med humane levermikrosomer tydede på, at hverken tegafur, gimeracil eller oteracil viste nogen relevant hæmmende virkning på enzymaktiviteten af de cytokrom P450 isoformer, der blev testet (dvs. CYP1A1/2, CYP2A6, CYP2C8/9, CYP2C19, CYP2D6, CYP2E1 og CYP3A4).
English: Levels of tegafur, gimeracil, oteracil and 5-FU were quantifiable through 10 hours postdose.
Danish: Niveauer af tegafur, gimeracil, oteracil og 5-FU var kvantificerbare i 10 timer efter dosis.
English: Hypotension, deep vein thrombosis, hypertension
Danish: Hypotension, dyb venetrombose, hypertension
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).
Danish: Den vigtigste metaboliske vej for tegafur er gennem konvertering til 5-FU via CYP2A6 i leveren, hvor gimeracil var stabil i humant leverhomogenat (S9 fraktion) med adenosin 3'-phosphat 5'-phosphosulphate lithiumsalt (PAPS, en kofaktor for sulfotransferase) eller nicotinamid adenin dinucleotid phosphat (NADPH).
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.
Danish: Efter en enkeltdosis Teysuno blev ca. 3,8 % til 4,2 % af indgivet tegafur, 65 % til 72 % af indgivet gimeracil og 3,5 % til 3,9 % af indgivet oteracil udskilt uændret i urinen.
English: There was no effect of gimeracil on renal clearance of tegafur, FBAL, and 5-FU following administration of Teysuno as compared to their clearance following administration of tegafur alone.
Danish: Gimeracil påvirkede ikke renal clearance af tegafur, FBAL og 5-FU efter indgift af Teysuno i sammenligning med clearance efter indgift af tegafur alene.
English: Third occurrence
Danish: Tredje forekomst
English: The term peripheral neuropathy includes the following reported adverse reactions: peripheral sensory neuropathy, paraesthesia, hypoaesthesia, peripheral neuropathy, polyneuropathy, neurotoxicity, and dysaesthesia.
Danish: Termen perifer neuropati omfatter følgende indberettede bivirkninger: perifer sensorisk neuropati, paræstesi, hypæstesi, perifer neuropati, polyneuropati, neurotoksicitet og dysæstesi.
English: Table 2: Standard and reduced dose calculations by body surface area (m2)
Danish: Tabel 2: Beregning af standard og reducerede doser efter legemsoverflade (m2)
English: Co-administration of other fluoropyrimidines such as capecitabine, 5-FU, tegafur, or flucytosine can lead to additive toxicities, and is contraindicated.
Danish: Samtidig indgift af andre fluoropyrimidiner såsom capecitabin, 5-FU, tegafur eller flucytosin kan medføre additiv toksicitet, og er derfor kontraindiceret.
English: Teysuno is prescribed by doctors for the treatment of adults with advanced stomach (gastric) cancer and is taken with cisplatin, another anti-cancer medicine.
Danish: Teysuno ordineres af læger til behandling af voksne med fremskreden mavekræft (ventrikelcancer) og tages sammen med cisplatin, et andet lægemiddel mod cancer.
English: Second dose reductiona: to 15 mg/m2 BSA ≥ 2.17 m2
Danish: Anden dosisreduktiona: til 15 mg/m2 BSA ≥ 2,17 m2
English: Teysuno contains the active substances tegafur gimeracil and oteracil.
Danish: Teysuno indeholder de aktive stoffer tegafur, gimeracil og oteracil.
English: Teysuno has not been studied in gastric cancer patients with MSI.
Danish: Teysuno er ikke blevet undersøgt hos patienter med ventrikelcancer og MSI.
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.
Danish: Toksicitetsforsøg med gentagen dosering hos rotter, hunde og aber producerede ændringer, der typisk associeres med indgift af et anti-cancer lægemiddel, der fremkalder cytotoksiske virkninger på populationer med hurtigt delende celler, såsom anæmi, reduktion i immun- og fordøjelsessystemets funktion, afbrydelse af spermatogenese og atrofi af forplantningsorganerne hos hanner og hunner.
English: The incidence of blood and lymphatic systems disorders adverse reactions observed across all cycles in the moderate and severe renal impairment patients were 28.6% and 44.4%, respectively.
Danish: Hyppigheden af bivirkninger i blod- og lymfesystem på tværs af alle cykler var 28,6 % og 44,4 % hos patienter med hhv. moderat og svær nyreinsufficiens.
English: Folinate/folinic acid
Danish: Folinat/folinsyre
English: If you forget to take Teysuno
Danish: Hvis du har glemt at tage Teysuno
English: No clinical trials are available comparing Teysuno versus other oral 5-FU compounds.
Danish: Der er ikke udført kliniske forsøg, der sammenligner Teysuno med andre orale 5-FU-forbindelser.
English: Therefore, Teysuno should not be administered to children or adolescents under 18 years of age.
Danish: Derfor bør Teysuno ikke indgives til børn eller unge under 18 år.
English: Central and peripheral neuropathy has been reported in patients treated with Teysuno in combination with cisplatin.
Danish: Der er indberettet central og perifer neuropati hos patienter i behandling med Teysuno i kombination med cisplatin.
English: Available pharmacodynamic/toxicological data in animals have shown excretion of Teysuno or its metabolites in milk (for details see section 5.3).
Danish: Der foreligger farmakodynamiske/toksikologiske data om dyr, der viser, at Teysuno eller dets metabolitter udskilles i mælk (der er yderligere oplysninger under pkt.
English: The association between 5-FU sensitivity and MSI in patients with gastric cancer is unclear and the association between Teysuno and MSI in gastric cancer is unknown.
Danish: Sammenhængen mellem følsomhed for 5-FU og MSI hos patienter med ventrikelcancer er uklar, og sammenhængen mellem Teysuno og MSI ved ventrikelcancer kendes ikke.
English: Brivudine must not be administered concomitantly with Teysuno.
Danish: Brivudin må ikke administreres samtidig med Teysuno.
English: Standard dosea: 25 mg/m2
Danish: Sædvanlig dosisa: 25 mg/m2
English: Gimeracil increases 5-fluorouracil (5-FU) exposure by inhibiting DPD, the primary enzyme for metabolizing 5-FU.
Danish: Gimeracil øger eksponeringen af 5-fluorouracil (5-FU) ved at hæmme DPD, det primære enzym ved metabolisering af 5-FU.
English: Gimeracil inhibits the metabolism of 5-FU by reversibly and selectively inhibiting DPD, the primary metabolic enzyme for 5-FU, so that higher plasma concentrations of 5-FU are achieved with the administration of a lower dose of tegafur.
Danish: Gimeracil hæmmer metabolismen af 5-FU ved reversibelt og selektivt at hæmme DPD, det primære metaboliske enzym for 5-FU, så højere plasmakoncentrationer af 5-FU kan opnås med indgift af en lavere dosis tegafur.
English: Patients should be provided with outpatient prescriptions for anti-emetic and anti-diarrhoeal medicinal products.
Danish: Patienter i ambulant behandling bør få udleveret recept på både antiemetika og lægemidler mod diarré.
English: Treatment-related bone marrow suppression, including neutropaenia, leukopaenia, thrombocytopaenia, anaemia, and pancytopaenia, has been reported among patients treated with Teysuno in combination with cisplatin.
Danish: Behandlingsrelateret knoglemarvssuppression, inklusive neutropeni, leukopeni, trombocytopeni, anæmi og pancytopeni, er indberettet for patienter, der er blevet behandlet med Teysuno i kombination med cisplatin.
English: • Contraindications for cisplatin; refer to the cisplatin SmPC.
Danish: • Kontraindikationer for cisplatin.
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).
Danish: I dette forsøg blev 521 patienter randomiseret til behandling med Teysuno (25 mg/m2 peroralt to gange dagligt i 21 dage efterfulgt af en hvileperiode på 7 dage) og cisplatin (75 mg/m2 intravenøs infusion en gang hver 4. uge), og 508 patienter blev randomiseret til behandling med 5-FU (1000 mg/m2/døgn som kontinuerlig intravenøs infusion på dag 1 til og med 5, gentaget hver 4. uge) og cisplatin (100 mg/m2 som intravenøs infusion på dag 1,
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.
Danish: De sædvanlige og reducerede doser af Teysuno og cisplatin samt beregninger i forhold til legemsoverflade (BSA - Body Surface Area) for doser af Teysuno givet i kombination med cisplatin er anført i hhv. tabel 1 og 2.
English: Vertigo, ear congestion, ear discomfort
Danish: Vertigo, tilstoppet øre, ubehag i øret
English: Teysuno capsules should be swallowed with water at least 1 hour before or 1 hour after a meal.
Danish: Teysuno-kapslerne skal synkes med vand mindst 1 time inden eller 1 time efter et måltid.
English: In vitro evaluation using primary cultures of human hepatocytes indicated that tegafur (0.7-70 µM), gimeracil (0.2-25 µM) and oteracil (0.04-4 µM) had little or no inductive effect on CYP1A2, CYP2B6 or CYP3A4/5 metabolic activities.
Danish: In-vitro-evaluering med primære dyrkninger af humane hepatocytter tydede på, at tegafur (0,770 µM), gimeracil (0,2-25 µM) og oteracil (0,04-4 µM) kun havde ringe eller ingen virkning på den metaboliske aktivitet af CYP1A2, CYP2B6 og CYP3A4/5.