FrancophonIA/ELRC3.0 huggingface dataset:
English: A minimum washout period of 7 days is recommended between administration of Teysuno and other fluoropyrimidines.
Danish: Der anbefales en udvaskningsfase på 7 dage mellem indgift af Teysuno og andre fluoropyrimidiner.
English: Most adverse reactions are reversible and can be managed by symptomatic therapy, dose interruptions and dose reductions.
Danish: De fleste bivirkninger er reversible og kan behandles symptomatisk, med afbrydelse af dosis og med dosisreduktion.
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.
Danish: Gimeracil og uracil AUC0-12 værdier var sammenlignelige for de to grupper, hvilket tyder på, at DPD-hæmning var ens hos gruppen af asiatiske og hos gruppen af kaukasiske patienter.
English: A Phase I study investigated the pharmacokinetics of Teysuno monotherapy in Asian (Chinese/Malay) and Caucasian (US) patients.
Danish: Et fase I-forsøg undersøgte farmakokinetikken af Teysuno som monoterapi hos asiatiske (kinesiske/malaysiske) og kaukasiske (amerikanske) patienter.
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.
Danish: Selvom CYP2A6-varianter er associeret med farmakokinetisk variabilitet af tegafur, er AUC for gimeracil, som er påvirket af nyrefunktionen, den vigtigste determinant i den farmakokinetiske variabilitet af 5-FU.
English: The recommended dose of cisplatin with this regimen is 75 mg/m2 by intravenous infusion administered once every 4 weeks.
Danish: Den anbefalede dosis cisplatin med dette regimen er 75 mg/m2 via intravenøs infusion givet en gang hver 4. uge.
English: • History of severe and unexpected reactions to fluoropyrimidine therapy.
Danish: • Tidligere alvorlige og uventede reaktioner over for fluoropyrimidinbehandling i anamnesen.
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.
Danish: Denne analyse viste også, at trenden i ændringer af Teysunos farmakokinetik, der blev observeret med stigende alder, var relateret til ændringer i nyrefunktionen, målt ved creatinin-clearance.
English: o If you have fever of 38.5o C or higher, stop taking Teysuno and contact your doctor immediately.
Danish: o Hvis du har 38,5 oC eller højere feber, skal du holde op med at tage Teysuno og kontakte lægen med det samme.
English: Capsule contents Lactose monohydrate Magnesium stearate
Danish: Kapselindhold Laktose monohydrat Magnesiumstearat
English: Treatment with brivudine can be started 24 hours after the last dose of Teysuno.
Danish: Behandling med brivudin kan initieres 24 timer efter sidste dosis af Teysuno.
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.
Danish: Patientens BSA skal genberegnes og Teysuno-dosen justeres tilsvarende, hvis der for en patient sker en vægtøgning eller et vægttab på ≥10 % i forhold til den vægt, der blev anvendt til den foregående beregning af BSA, og ændringen helt tydeligt ikke er relateret til væskeretention.
English: Grade 3 or higherc First occurrence
Danish: Grad 3 eller højerec Første forekomst
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%).
Danish: I et studie med patienter med nedsat nyrefunktion var de hyppigst forekommende bivirkninger, der blev rapporteret i alle cykler på tværs af alle kohorter, diarré (57,6 %), kvalme (42,4 %), opkastning (36,4 %), træthed (33,3 %) og anæmi (24,2 %).
English: As renal function decreased, there was an increase in 5-FU steady state exposure.
Danish: Efterhånden som nyrefunktionen blev nedsat, var der en øgning af steady state-eksponeringen for 5-FU.
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).
Danish: Behandling med Teysuno i kombination med cisplatin kan være associeret med et midlertidigt fald i den glomerulære filtrationshastighed, primært forårsaget af prærenale faktorer (f.eks. dehydrering, elektrolytforstyrrelse osv.).
English: Cisplatin will be stopped after 6 treatment cycles.
Danish: Behandlingen med cisplatin vil blive stoppet efter 6 behandlingsforløb.
English: Start cisplatin treatment at a 50% dose reduction from the previous cycle
Danish: Påbegynd cisplatinbehandling ved en 50 % lavere dosis end det foregående behandlingsforløb
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.
Danish: Det skal tilstræbes at sikre tidlig detektion af øjenreaktioner, inklusive en tidlig oftalmologisk undersøgelse i tilfælde af persisterende eller synsnedsættende øjensymptomer, såsom tåresekretion eller symptomer i cornea.
English: Creatinine clearance (CrCl) must be determined for every cycle before the start of treatment on Day 1.
Danish: Creatinin-clearance (CrCl) skal bestemmes for hvert behandlingsforløb ved starten af behandlingen på dag 1.
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]).
Danish: Patienter med lave leukocyttal skal kontrolleres nøje for infektion og risiko for andre komplikationer ved neutropeni og behandles på medicinsk indikation (f.eks. med antibiotika, granulocytkoloni-stimulerende faktor [G-CSF]).
English: Renal function, as reflected by creatinine clearance, was the primary factor that influenced gimeracil exposure and 5-FU exposure.
Danish: Nyrefunktion, vist ved creatinin-clearance, var den primære faktor, der påvirkede eksponeringen for gimeracil og eksponeringen for 5-FU.
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).
Danish: Der var et fald på 15 % i AUC0-inf for 5-FU efter indtagelse af mad kontra i fastende tilstand, og eksponering for tegafur blev ikke ændret af mad (dermed påvist mangel på virkning fra mad).
English: If cisplatin is discontinued before 6 cycles, Teysuno treatment alone can be resumed when the criteria for restarting it are met.
Danish: Hvis cisplatin seponeres inden 6 behandlingsforløb, kan behandling med Teysuno alene genoptages, når kriterierne for genoptagelse er opfyldt.
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.
Danish: Derfor forventes den daglige eksponering for 5-FU at være sammenlignelig i disse grupper, da den daglige eksponering hos patienter i gruppen med svært nedsat nyrefunktion er baseret på administration af Teysuno én gang dagligt, mens den daglige eksponering for 5-FU hos patienter med normal nyrefunktion er baseret på administration af Teysuno to gange dagligt.
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.
Danish: En farmakokinetisk populationsanalyse af Teysuno-komponenter og -metabolitter vurderede påvirkningen fra forskellige faktorer, inklusive køn, alder, kost, etnicitet (kaukasier vs. asiatisk), nyrefunktion og leverfunktion hos 315 patienter.
English: Teysuno was not found to be mutagenic when tested in the in vitro Ames assay.
Danish: Teysuno blev fundet ikke at være mutagen ved testning med in-vitro Ames analysen.
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.
Danish: I fase III (FLAGS) forsøget var AUC for tegafur signifikant højere hos patienter med CYP2A6*4 allelen, men der blev ikke fundet nogen signifikant forskel for AUC for 5-FU og for forekomsten af bivirkninger.
English: Adjustments during treatment
Danish: Justering under behandlingen
English: Carriers of HBV who require treatment with Teysuno should be closely monitored for signs and symptoms of active HBV infection throughout therapy, and follow-up monitoring for hepatic function tests or viral markers are recommended.
Danish: Smittebærere af HBV, der har behov for behandling med Teysuno, skal monitoreres nøje for tegn og symptomer på aktiv HBV-infektion under hele behandlingen, og opfølgende kontrol med leverfunktionstest eller virusmarkører anbefales.
English: As with other fluoropyrimidines, Teysuno administration caused embryolethality and teratogenicity in animals (see section 5.3).
Danish: Ligesom med andre fluoropyrimidiner forårsagede indgift af Teysuno embryonal letalitet og teratogenicitet hos dyr (se pkt.
English: • Co-administration of other fluoropyrimidines with Teysuno.
Danish: • Samtidig indgift af andre fluoropyrimidiner med Teysuno.
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).
Danish: c Ifølge den behandlende læges skøn kan patienter fortsætte behandlingen uden dosisnedsættelse ellerafbrydelse på grund af bivirkninger (uanset grad), der efter al sandsynlighed ikke bliver alvorlige eller livstruende (f.eks. alopeci, ændret seksualfunktion og tør hud).
English: Dose modifications for special populations
Danish: Dosisændringer for særlige populationer
English: Contraceptive measures must be taken by both male and female patients during and up to 6 months after stopping treatment with Teysuno.
Danish: Både mandlige og kvindelige patienter skal bruge kontraceptiva under behandling og op til 6 måneder efter endt behandling med Teysuno.
English: Treatment with Teysuno produced various skin effects in rat (keratosis of footpad and tail) and dog (skin crusts and erosions).
Danish: Behandling med Teysuno producerede forskellige hudpåvirkninger hos rotter (keratose af fodpuder og hale) og hunde (hudskorper og erosioner).
English: The oteracil component of Teysuno did not affect the pharmacokinetic profiles of 5-FU, tegafur, gimeracil, FBAL, or uracil.
Danish: Oteracilkomponenten i Teysuno påvirkede ikke de farmakokinetiske profiler af 5-FU, tegafur, gimeracil, FBAL og uracil.
English: Patients with rare hereditory problems of galactose intolerance, the Lapp lactase deficiency or glucose/galactose malabasorption should not take this medicinal product.
Danish: Patienter med sjældne arvelige sygdomme såsom galactoseintolerans, Lapp lactasemangel eller glucose-galactose-malabsorption bør ikke tage dette lægemiddel.
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.
Danish: o Hvis du bliver dehydreret, kan du få symptomer såsom mundtørhed, svækkelse, tør hud, svimmelhed, kramper o Prøv at spise hyppige, små måltider.
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.
Danish: Men på grund af mulig additiv farmakodynamisk virkning (myelotoksicitet) tilrådes det at udvise forsigtighed, eftersom samtidig indgift kan øge risikoen for og sværhedsgraden af hæmatologisk toksicitet af Teysuno.
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.
Danish: Seponer behandlingen a I henhold til Common Terminology Criteria for Adverse Events (CTCAE) i Cancer Therapy Evaluation Program, US National Cancer Institute, version 3.0. b Ved kvalme og/eller opkastning af grad 2 skal den antiemetiske behandling optimeres inden pausen i behandling med Teysuno.
English: In a Japanese Phase I study that utilized 5 dose groups with doses ranging from 25 to 200 mg/body, there was a dose-proportional increase in exposure for tegafur, gimeracil and oteracil.
Danish: I et japansk fase I-forsøg, der anvendte 5 dosisgrupper med doser fra 25 til 200 mg/patient, var der en dosisproportional øgning af eksponeringen for tegafur, gimeracil og oteracil.
English: The most common treatment-related ocular disorders among patients in studies in Europe/United States of America (EU/USA) treated with Teysuno in combination with cisplatin were lacrimal disorders (8.8%), including increased lacrimation, dry eye, and acquired dacryostenosis (see section 4.8).
Danish: De mest almindelige, behandlingsrelaterede øjensygdomme blandt patienter i forsøg i Europa/USA, der blev behandlet med Teysuno i kombination med cisplatin, var tårevejslidelser (8,8 %), inklusive tåresekretion, tørre øjne og erhvervet dacryostenosis (se pkt.
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).
Danish: Du må ikke tage brivudin (et lægemiddel mod virus til behandling af helvedesild eller skoldkopper) samtidig med at du får Teysuno-behandling (dette gælder også perioder, hvor du holder pause og ikke tager Teysuno kapsler).
English: Teysuno was clastogenic in vitro using Chinese hamster lung cells and was weakly clastogenic in vivo in mouse bone marrow.
Danish: Teysuno var klastogen in-vitro ved brug af lungeceller fra kinesiske hamstre, og var svagt klastogen in-vivo i knoglemarv fra mus.
English: a Expressed as tegafur content.
Danish: a Udtrykt som tegafurindhold.
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).
Danish: Sikkerhedsprofilen af Teysuno i et kontrolforsøg af sikkerheden efter markedsføring i Japan af 4.177 patienter, der blev behandlet med Teysuno for fremskreden ventrikelcancer, var generelt den samme som den, der ses med dette regime og i de japanske registreringsforsøg (dvs. vigtigste toksiciteter var leukocytopeni, anoreksi og kvalme/opkastning).
English: Frequent monitoring of phenytoin blood/plasma levels is advised when Teysuno and phenytoin are administered concomitantly.
Danish: Der tilrådes hyppig kontrol af phenytoinniveauer i blod/plasma, hvis Teysuno og phenytoin indgives samtidigt.
English: Resumption criteria for Teysuno treatment
Danish: Kriterier for genoptagelse af Teysuno-behandling
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.
Danish: Administration af Teysuno til smittebærere af hepatitis B-virus, HBc-antigen-negative og HBcantistof-positive patienter eller HBs-antigen-negative og HBs-antistof-positive patienter kan medføre reaktivering af hepatitis B.
English: System Organ Classa
Danish: Systemorganklassea
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.
Danish: Hyppigheden af medicinsk relevante sjældne og meget sjældne bivirkninger estimeres ud fra kontrol efter markedsføring af 866.000 patienter i Asien (hovedsageligt japanere), der har fået Teysunobaseret behandling.
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.
Danish: Dosis for en patient i kohorten med svær nyreinsufficiens blev reduceret til 13,2 mg/m2 én gang dagligt ved start af cyklus 12 pga. en bivirkning (grad 2 diarré) i cyklus 11.
English: o If you experience diarrhoea, avoid high-fibre, fatty and spicy foods.
Danish: o Hvis du har diarré, skal du undgå fiberholdig, fed og krydret mad.
English: Suspend treatment until resumption criterion is met (see Table 6) and then resume dosing at one reduced dose level.
Danish: Indstil behandlingen, indtil kriterierne for genoptagelse er opfyldt (se tabel 6) og genindled dernæst behandlingen ved en dosis, der er nedsat med ét niveau.
English: The gimeracil component did not affect the pharmacokinetic profile of tegafur.
Danish: Gimeracilkomponenten påvirkede ikke den farmakokinetiske profil af tegafur.
English: Contusion, medication error a Adverse reactions in the Investigations system organ class (SOC) have been reallocated to clinically appropriate SOCs related to their target organ.
Danish: Contusio, medicineringsfejl a Bivirkninger i systemorganklassen for undersøgelse er blevet omfordelt til klinisk passende systemorganklasser, der er relateret til målorganet.
English: Teysuno should only be prescribed by a qualified physician experienced in treating cancer patients with anti-neoplastic medicinal products.
Danish: Teysuno bør kun ordineres af kvalificerede læger, der har erfaring med behandling af cancerpatienter med antineoplastiske lægemidler.
English: Teysuno will be given with another anti-cancer medicine called cisplatin.
Danish: Teysuno vil blive givet sammen med et andet anti-cancer lægemiddel, der hedder cisplatin.
English: If you take more Teysuno than you should If you take more capsules than you should, contact your doctor immediately.
Danish: Hvis du har taget for meget Teysuno Hvis du tager flere kapsler, end du har fået anvist, skal du straks kontakte din læge.
English: Cisplatin a Expressed as tegafur content.
Danish: Cisplatin a Udtrykt som tegafurindhold.
English: Teysuno with food and drink Teysuno should be taken at least one hour before or one hour after a meal.
Danish: Brug af Teysuno sammen med mad og drikke Teysuno skal tages mindst en time inden eller en time efter et måltid.
English: Patients with anorexia, asthenia, nausea, vomiting, diarrhoea, stomatitis, and gastrointestinal obstruction should be monitored closely for signs of dehydration.
Danish: Patienter med anoreksi, asteni, kvalme, opkastning, diarré, stomatitis og gastrointestinal obstruktion bør kontrolleres nøje for tegn på dehydrering.
English: The washout period described in the SmPC of other fluoropyrimidine medicinal products should be followed if Teysuno is to be administered subsequent to other fluoropyrimidine medicinal products.
Danish: Den udvaskningsfase, der beskrives i produktresumeerne til andre fluoropyrimidiner, bør følges, hvis Teysuno skal indgives efter andre fluoropyrimidiner.
English: There are no clinical data on the distribution of radiolabeled components of Teysuno.
Danish: Der foreligger ingen kliniske data om distributionen af Teysunos radiomærkede komponenter.
English: FdUMP and reduced folate are bound to thymidylate synthase leading to formation of a ternary complex which inhibits DNA synthesis.
Danish: FdUMP og reduceret folat bindes til thymidylatsyntase, hvilket fører til dannelse af et ternært kompleks, som hæmmer DNA-syntese.
English: NAME OF THE MARKETING AUTHORISATION HOLDER Nordic Group B.V.
Danish: Indehaver af markedsføringstilladelsen Nordic Group B.V.
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.
Danish: Blandt de 593 patienter, der blev behandlet med Teysuno i kombination med cisplatin, var de mest almindeligt forekommende alvorlige bivirkninger (min. grad 3 med en hyppighed på mindst 10 %) neutropeni, anæmi og træthed.
English: Patients treated with Teysuno in combination with cisplatin should be closely monitored and laboratory tests, including haematology, liver function, renal function, and serum electrolytes, should be performed frequently.
Danish: Patienter, der behandles med Teysuno i kombination med cisplatin, bør kontrolleres nøje, og der bør hyppigt foretages laboratorieprøver, inklusive hæmatologi, leverfunktion, nyrefunktion og serumelektrolytter.
English: Other medicines and Teysuno Tell your doctor if you are taking , have recently taken or might take any other medicines.
Danish: Brug af anden medicin sammen med Teysuno Fortæl det til lægen, hvis du tager anden medicin, har gjort det for nylig eller planlægger at gøre det.
English: Refer to the cisplatin SmPC for the effects of cisplatin on fertility, pregnancy and lactation.
Danish: Der henvises til produktresumeet til cisplatin vedrørende cisplatins virkning på fertilitet, graviditet og amning.
English: In addition, 5-fluorouridine-triphosphate (FUTP) is incorporated into RNA causing disruption of RNA functions.
Danish: Derudover inkorporeres 5-fluorouridine-triphosphate (FUTP) i RNA, hvilket hæmmer RNAfunktioner.
English: The frequencies of very common, common, and uncommon adverse reactions are from 593 patients treated with Teysuno in combination with cisplatin in clinical trials.
Danish: Hyppigheden af meget almindelige, almindelige og ikke almindelige bivirkninger stammer fra 593 patienter, der blev behandlet med Teysuno i kombination med cisplatin i kliniske forsøg.
English: You must not breastfeed if you are taking Teysuno.
Danish: Du må ikke amme, hvis du tager Teysuno.
English: The combination of tegafur, gimeracil, and oteracil was set at 1:0.4:1 molar ratio as optimum in order to maintain 5-FU exposure and thus sustain anti-tumour activity while reducing toxicity associated with 5-FU alone.
Danish: Kombinationen af tegafur, gimeracil og oteracil blev sat til 1:0.4:1 molar ratio som optimalt for at opretholde eksponering for 5-FU og dermed bevare antitumor aktivitet, mens den toksicitet, der alene er associeret med 5-FU, reduceres.
English: This interaction, which leads to increased fluoropyrimidine toxicity, is potentially fatal.
Danish: Interaktionen, som medfører øget fluorpyrimidintoksicitet, er potentielt dødelig.
English: 42 capsules
Danish: 42 kapsler
English: Although no intravenous data are available for Teysuno in humans, the volume of distribution could be roughly estimated from the apparent volume of distribution and urinary excretion data as 16 l/m2, 17 l/m2, and 23 l/m2 for tegafur, gimeracil and oteracil, respectively.
Danish: Selvom der ikke foreligger data om intravenøs brug af Teysuno hos mennesker, kan distributionsvolumen groft estimeres ud fra den åbenbare distributionsvolumen og data over urinudskillelse som 16 l/m2, 17 l/m2 og 23 l/m2 for hhv. tegafur, gimeracil og oteracil.
English: There are no side effects caused by stopping treatment with Teysuno.
Danish: Der er ingen bivirkninger ved at stoppe behandlingen med Teysuno.