FrancophonIA/ELRC3.0 huggingface dataset:
English: Different MedDRA preferred terms that were considered clinically similar have been grouped into a single term.
Danish: Forskellige, foretrukne MedDRA-termer, der blev anset som klinisk ens, er blevet samlet i en enkelt term.
English: Exposure of 5-FU was not statistically significantly different between the two groups.
Danish: Forskellen i eksponering for 5-FU var ikke statistisk signifikant mellem de to grupper.
English: Terms for treatment-related ocular toxicities have been combined as follows.
Danish: Betingelser for behandlingsrelateret toksicitet i øjnene er blevet kombineret som følger.
English: NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER Nordic Group B.V., Siriusdreef 41, 2132 WT Hoofddorp, The Netherlands 12.
Danish: NAVN OG ADRESSE PÅ INDEHAVEREN AF MARKEDSFØRINGSTILLADELSEN Nordic Group B.V., Siriusdreef 41, 2132 WT Hoofddorp, Holland 12.
English: If both medicinal products are considered to be causing the toxicity or it is not possible to distinguish them, then dose reduction should be performed for both according to the recommended dose reduction schedule.
Danish: Hvis begge lægemidler anses for at forårsage toksiciteten, eller det ikke er muligt at skelne mellem dem, skal der foretages dosisreduktion af begge i henhold til den anbefalede dosisreduktionsplan.
English: Like all medicines, Teysuno can cause side effects, although not everybody gets them.
Danish: Teysuno kan som al anden medicin give bivirkninger, men ikke alle får bivirkninger.
English: Do not take the missed dose at all and do not take a double dose to make up for a forgotten dose.
Danish: Du må ikke tage den glemte dosis overhovedet, og du må ikke tage en dobbeltdosis som erstatning for den glemte dosis.
English: Once the Teysuno dose has been reduced, it should not be increased again.
Danish: Når dosis af Teysuno er blevet nedsat, bør den ikke sættes op igen.
English: Instead, continue your regular dosing schedule and check with your doctor.
Danish: Fortsæt i stedet med den sædvanlige doseringsplan og spørg din læge.
English: Studies in animals have shown reproductive toxicity.
Danish: Dyreforsøg har vist reproduktionstoksicitet.
English: Millmount Healthcare Limited Block7, City North Business Campus, Stamullen Co. Meath, K32 YD60 Ireland
Danish: Millmount Healthcare Limited Block7, City North Business Campus, Stamullen Co. Meath, K32 YD60 Irland
English: See also section “Do not take Teysuno”.
Danish: Se også afsnittet 'Tag ikke Teysuno'.
English: - Weakness and fatigue, which could be side effects caused by other medicines.
Danish: - Svækkelse og træthed, som kan være bivirkninger af andre lægemidler.
English: Maintain treatment at same dose level
Danish: Fortsæt behandlingen på samme dosisniveau
English: No dose modification
Danish: Ingen dosisændring
English: o Take plenty of liquids between meals to replace lost fluids and prevent dehydration, low blood volume, and imbalance of salts or chemicals in the blood.
Danish: o Drik masser af væske mellem måltiderne for at erstatte den mistede væske og forhindre dehydrering, lav blodmængde og ubalance af salte og kemikalier i blodet.
English: Tegafur is a prodrug of 5-FU with good oral bioavailability.
Danish: Tegafur er et pro-drug af 5-FU med god oral biotilgængelighed.
English: • At the request of the EMA
Danish: • på anmodning fra Det Europæiske Lægemiddelagentur
English: o To prevent infection, keep away from crowded places, gargle upon returning home, and wash your hands before meals and before and after using the bathroom.
Danish: o For at undgå infektion bør du holde dig fra steder med mange mennesker, gurgle hals når du kommer hjem og vaske hænder inden måltider og før og efter toiletbesøg.
English: Suspend treatment until Grade 0 or 1
Danish: Indstil behandlingen indtil grad 0 eller 1
English: Teysuno capsules are usually taken for 21 days followed by a 7 day rest period (when no capsules are taken).
Danish: Teysuno-kapsler skal normalt tages i 21 dage efterfulgt af en hvileperiode på 7 dage (hvor der ikke tages nogen kapsler).
English: You must not take Teysuno if you are pregnant or think you might be.
Danish: Du må ikke tage Teysuno, hvis du er gravid, eller hvis du tror, at du måske er gravid.
English: Refer to “Dose modifications for special populations / Renal impairment for guidance.”
Danish: Der henvises til Dosisændringer for særlige populationer / Nedsat nyrefunktion for vejledning.
English: Glucose/galactose intolerance/malabsorption
Danish: Glucose-/galactoseintolerans/malabsorption
English: 6.6 Special precautions for disposal and other handling Hands should be washed after handling capsules.
Danish: 6.6 Regler for destruktion og anden håndtering Vask hænderne efter håndtering af kapslerne.
English: PCTFE/PVC/Al opaque blisters containing 14 capsules each.
Danish: PCTFE/PVC/Al uigennemsigtige blisterpakninger à 14 kapsler.
English: Patients taking Teysuno should be informed of the risks and instructed to contact their physician immediately if moderate or severe toxicity occurs.
Danish: Patienter, der tager Teysuno, skal informeres om risiciene og instrueres i at kontakte deres læge øjeblikkeligt, hvis der forekommer moderat eller svær toksicitet.
English: Oteracil AUC0-12 in the Asian group was approximately half that of the Caucasian group, however, this difference was not statistically significant due to its large individual variability.
Danish: Oteracil AUC0-12 hos den asiatiske gruppe var ca. halvdelen af samme hos gruppen af kaukasiske patienter, men denne forskel var ikke statistisk signifikant på grund af dens store individuelle variabilitet.
English: The activity of a coumarin-derivative anticoagulant was enhanced by Teysuno.
Danish: Aktiviteten af et coumarin-deriveret antikoagulant blev forstærket af Teysuno.
English: During a treatment cycle, dose adjustment should be performed for each individual medicinal product that is considered to be causally related to the toxicity, if such a distinction can be made.
Danish: Under et behandlingsforløb skal der foretages dosisjustering for hvert enkelt lægemiddel, der anses som kausalt relateret til toksiciteten, hvis en sådan skelnen er mulig.
English: Dose limiting toxicities include diarrhoea and dehydration.
Danish: Dosisbegrænsende toksiciteter inkluderer diarré og dehydrering.
English: Before starting treatment, you must tell your doctor or pharmacist if you are pregnant, if you think you are pregnant, or if you intend to become pregnant.
Danish: Du skal fortælle det til lægen eller på apoteket inden behandlingen, hvis du er gravid, hvis du tror, du er gravid, eller hvis du har planer om at blive gravid.
English: Therefore, the CYP2A6 polymorphism differences between Asian and Western populations do not appear to be the key determinant for differences in the MTD between populations.
Danish: Derfor lader forskelle i CYP2A6 polymorfisme hos den asiatiske og vestlige population ikke til at være den vigtigste determinant for forskelle i MTD mellem populationer.
English: It is not known whether Teysuno or its metabolites are excreted in human milk.
Danish: Det vides ikke, om Teysuno eller dets metabolitter udskilles i human mælk.
English: Table 7: Adverse reactions reported by decreasing seriousness in each frequency grouping
Danish: Tabel 7: Bivirkninger indberettet efter faldende sværhedsgrad i hver hyppighedsgruppering
English: Nitroimidazoles, including metronidazole and misonidazole
Danish: Nitroimidazoler, inklusive metronidazol og misonidazol
English: A population pharmacokinetics analysis demonstrated that 5-FU exposure also tended to increase with age, but the extent of the increase was within the range of individual variability.
Danish: En farmakokinetisk analyse af populationen påviste, at eksponering for 5-FU også havde tendens til at stige med alderen, men omfanget af stigningen lå inden for området af individuel variabilitet.
English: Dose suspension/adjustment should be implemented with the occurrence of Grade 2 or higher diarrhoea if symptoms persist despite adequate treatment.
Danish: Pausering/justering af dosis bør iværksættes ved forekomst af diarré grad 2 eller værre, hvis symptomerne persisterer på trods af adækvat behandling.
English: In the event of accidental administration of brivudine to patients being treated with Teysuno, effective measures should be taken to reduce the toxicity of Teysuno.
Danish: I tilfælde af utilsigtet administration af brivudin til patienter, der behandles med Teysuno, bør der tages effektive foranstaltninger for at reducere toksiciteten af Teysuno.
English: No consistent relationship was seen between absolute QTcF interval values or change from Baseline values and maximum plasma concentration of Teysuno components.
Danish: Der sås intet konsekvent forhold mellem absolutte værdier for QTcF-intervaller eller ændring fra baselineværdier og maksimal plasmakoncentration af Teysuno-komponenter.
English: No dose limiting toxicities were observed in the first cycle of treatment.
Danish: Der blev ikke observeret dosisbegrænsende toksicitet i den første behandlingscyklus.
English: • Known dihydropyrimidine dehydrogenase (DPD) deficiency.
Danish: • Kendt DPD-mangel (dihydropyrimidin-dehydrogenase).
English: Teysuno was not carcinogenic in either the rat or the mouse.
Danish: Teysuno var ikke karcinogent hos hverken rotter eller mus.
English: Therefore, Teysuno cannot be used as a substitute for other oral 5-FU products.
Danish: Derfor kan Teysuno ikke bruges som erstatning for andre orale 5-FU-produkter.
English: o If you feel tired and have fever together with loss of appetite, contact your doctor immediately.
Danish: o Hvis du er træt eller har feber samtidig med, at du mister appetitten, skal du kontakte lægen med det samme.
English: If Grade 2 (or higher) dehydration occurs, treatment should be immediately suspended and the dehydration corrected.
Danish: Ved forekomst af dehydrering af grad 2 eller værre, skal behandlingen straks indstilles og dehydreringen korrigeres.
English: If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
Danish: Hvis din læge har fortalt dig, at du ikke kan tåle visse sukkerarter, skal du kontakte din læge, inden du begynder at tage denne medicin.
English: Medical management of overdose should include customary therapeutic and supportive medical interventions aimed at correcting the presenting clinical manifestations and preventing their possible complications.
Danish: Medicinsk behandling af overdosering består af individuelt tilpassede terapeutiske og støttende interventioner rettet mod korrektion af tilstedeværende kliniske manifestationer, samt at forebygge deres potentielle komplikationer.
English: The dose should be modified as recommended in section 4.2.
Danish: Dosis bør ændres som anbefalet i pkt.
English: The overall safety profile of Teysuno in combination with cisplatin is based primarily on clinical study data from 593 patients with advanced gastric cancer treated with this regimen.
Danish: Den samlede sikkerhedsprofil af Teysuno i kombination med cisplatin er primært baseret på data fra kliniske forsøg med 593 patienter med fremskreden ventrikelcancer, der blev behandlet med dette regime.
English: Patients with low platelet counts are at increased risk for bleeding and should be monitored carefully.
Danish: Patienter med lave trombocyttal har øget risiko for blødning og skal kontrolleres nøje.
English: Patients should be tested for HBV infection before initiating treatment with Teysuno.
Danish: Patienterne skal testes for HBV-infektion, inden behandling med Teysuno initieres.
English: Creatinine clearance
Danish: Creatinin clearance
English: Eighteen additional PK studies were performed using the relevant regimen as monotherapy.
Danish: Atten yderligere farmakokinetiske forsøg blev udført med det relevante regime som monoterapi.
English: 5-AZU and CA do not inhibit OPRT enzyme activity.
Danish: 5-AZU og CA hæmmer ikke OPRT-enzymaktivitet.
English: In addition, hyperpigmentation in the skin and eyes and corneal opacity in dogs and cataracts in rats were observed following repeat dosing.
Danish: Derudover blev der observeret hyperpigmentering af huden og øjnene og corneauklarhed hos hunde og katarakt hos rotter efter gentagne doser.
English: Doses omitted for toxicity are not replaced; and, if a patient vomits after taking a dose, this dose should not be replaced.
Danish: Udeladte doser på grund af toksicitet erstattes ikke, og hvis en patient kaster op efter indtagelse af en dosis, bør denne dosis ikke erstattes.
English: Experts in liver disease and in the treatment of hepatitis B should be consulted before treatment is initiated in patients with positive hepatitis B serology (including those with active disease) and for patients who test positive for HBV infection during treatment.
Danish: Eksperter inden for leversygdom og behandling af hepatitis B bør konsulteres, inden behandlingen initieres hos patienter med en positiv hepatitis B-serologi (herunder patienter med aktiv sygdom), og for patienter, der testes positive for HBV-infektion under behandlingen.
English: However, it is to be noted that the exposure to 5-FU can be variable and unexpectedly higher in patients with severe renal impairment due to the impact of fluctuations in renal function in these patients.
Danish: Det skal dog bemærkes, at eksponeringen for 5-FU kan være variabel og uventet højere hos patienter med svært nedsat nyrefunktion, da den kan påvirkes af fluktuationer i nyrefunktionen hos disse patienter.
English: The only Grade 3 or higher adverse reaction was reduced visual acuity.
Danish: Den eneste bivirkning af grad 3 eller derover var nedsat visuel akuitet.
English: Your doctor may reduce the dose if you have side effects that are too severe.
Danish: Din læge kan nedsætte dosen, hvis du får alvorlige bivirkninger.
English: Each dose in mg (each dosing)a
Danish: Hver dosis i mg (hver dosering)a
English: No dose limiting toxicities were observed in Cycle 1 in patients with moderate or severe renal impairment.
Danish: Der blev ikke observeret dosisbegrænsende toksicitet i cyklus 1 hos patienter med moderat eller svær nyreinsufficiens.
English: 30 to 49 ml/min Start treatment at one reduced dose level
Danish: 30-49 ml/min Påbegynd behandling ved en dosis, der er nedsat med ét niveau
English: Always take Teysuno exactly as your doctor has told you.
Danish: Tag altid Teysuno nøjagtigt efter lægens anvisninger.
English: Each term is presented in its most common category only and within each frequency grouping, adverse reactions are presented in order of decreasing seriousness.
Danish: Hver term er kun præsenteret i dens mest almindeligt forekommende kategori, og bivirkningerne er anført efter faldende sværhedsgrad inden for hver hyppighedsgruppering.
English: Concomitant administration of a proton pump inhibitor (PPI) reduced the effect of food on the pharmacokinetic profile of oteracil, but not by a sufficient margin to completely negate the food effect.
Danish: Samtidig indgift af en protonpumpehæmmer (PPI) reducerede madens virkning på den farmakokinetiske profil af oteracil, men ikke med så tilstrækkelig margin at madens virkning helt kan udelukkes.
English: However, since no DPD inducers are currently known, the interaction between a DPD inducer and Teysuno cannot be evaluated.
Danish: Siden man imidlertid ikke i øjeblikket har kendskab til nogen DPD-inducere, kan interaktionen mellem en DPD-inducer og Teysuno ikke evalueres.
English: There is therefore a high risk for developmental toxicity at clinical doses, primarily due to tegafur (5-FU) and to oteracil to a lesser extent.
Danish: Der er derfor en højere risiko for udvikling af toksicitet ved kliniske doser, primært pga. tegafur (5-FU) og i mindre grad pga. oteracil.
English: Treatment days missed in a cycle where medicinal product was held due to toxicity should not be replaced.
Danish: De dage i et behandlingsforløb, hvor lægemidlet ikke gives på grund af toksicitet, bør ikke erstattes.
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).
Danish: Følgende betegnelser anvendes til at angive bivirkningerne efter hyppighed: Meget almindelig (≥ 1/10), almindelig (≥ 1/100 til < 1/10), ikke almindelig (≥ 1/1.000 til < 1/100), sjælden (≥ 1/10.000 til < 1/1.000), meget sjælden (< 1/10.000) og ikke kendt (kan ikke estimeres ud fra forhåndenværende data).
English: If the patient becomes pregnant while receiving Teysuno, treatment should be discontinued and the potential risk to the foetus must be explained.
Danish: Hvis en patient bliver gravid under behandling med Teysuno, skal behandlingen seponeres, og de potentielle risici for fostret skal forklares.
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.
Danish: Data fra et multicenter, multinationalt (eksklusive Asien), randomiseret, kontrolleret, åbent, klinisk fase III forsøg (FLAGS) understøtter brug af Teysuno i kombination med cisplatin til behandling af patienter med fremskreden ventrikelcancer.
English: A study of the effect of Teysuno on cardiac repolarisation conducted in advanced cancer patients met the definition for a negative study according to International Conference on Harmonisation (ICH) guidelines.
Danish: Et forsøg med virkningen af Teysuno på repolarisation af hjertet, der blev udført hos patienter med fremskreden cancer, opfyldte definitionen på et negativt forsøg i henhold til retningslinjerne fra International Conference on Harmonisation (ICH).
English: However, the increase in 5-FU exposure tended to be greater than proportional to the increasing tegafur dose.
Danish: Den øgede eksponering for 5-FU havde tendens til at være større end proportional med øgningen af tegafurdosen.
English: Dehydration and any associated electrolyte disturbances should be prevented or corrected at onset.
Danish: Dehydrering og eventuelt associerede elektrolytforstyrrelser bør forebygges eller korrigeres ved start.
English: Consistent with the lower CYP2A6 activity in the Asian patients, tegafur AUC0-12 was higher and T1/2 was longer in the Asian group compared to the Caucasian group.
Danish: Konsekvent med den lavere CYP2A6aktivitet hos asiatiske patienter var tegafur AUC0-12 højere og T1/2 længere hos den asiatiske gruppe i sammenligning med gruppen af kaukasiske patienter.
English: Post-marketing surveillance experience in gastric cancer patients
Danish: Erfaring fra kontrol efter markedsføring hos patienter med ventrikelcancer
English: Despite the lack of DLTs in the last cohort, the dose of cisplatin was not elevated beyond 75 mg/m2.
Danish: På trods af at der blev observeret dosisbegrænsende toksiciteter i den sidste kohorte, blev cisplatindosis ikke øget over 75 mg/m2.
English: Pharmacokinetics in special populations
Danish: Farmakokinetik hos specifikke populationer
English: If a DPD inducer were to be concomitantly administered with Teysuno, the exposure of 5-FU might not reach the efficacious level.
Danish: Hvis en DPD-inducer skal indgives samtidigt med Teysuno, vil eksponeringen for 5-FU eventuelt ikke nå det effektive niveau.
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).
Danish: Med hensyn til det primære endpoint overlevelse, var Teysuno i kombination med cisplatin noninferior sammenlignet med 5-FU i kombination med cisplatin (se tabel 9).
English: Grade 1 Any occurrence
Danish: Grad 1 Enhver forekomst
English: - Liver: yellow eyes and skin, changes in blood tests which show the way the liver is working,
Danish: - Lever: Gulfarvning af øjne og hud, ændringer i blodprøver der viser, hvordan leveren fungerer.
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).
Danish: De fleste øjenreaktioner vil forsvinde eller blive forbedret ved pausering af lægemidlet og korrekt behandling (instillation af kunstige tårer, antibiotiske øjendråber, implantation af glas- eller siliconerør i tårepunkterne eller -kanalerne og/eller brug af briller i stedet for kontaktlinser).
English: Even if you do not feel hungry, continue to eat as much as you can to maintain good nutrition.
Danish: Forsøg at spise så meget, du kan, så du kan få tilstrækkeligt med ernæring - også selvom du ikke er sulten.
English: 20 mg capsulea (white)
Danish: 20 mg kapsela (hvid)
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.
Danish: Der foreligger imidlertid begrænsede data om CYP2A6*4/*4 genotype hos japanske patienter i behandling med Teysuno, der tyder på signifikant reducerede 5-FU-niveauer hos denne subpopulation.
English: 5-FU is activated within cells by phosphorylation to its active metabolite, 5-fluoro-deoxyuridine-monophosphate (FdUMP).
Danish: 5-FU aktiveres inden i cellerne ved fosforylering til dets aktive metabolit, 5-fluoro-deoxyuridine-monophosphate (FdUMP).
English: There have been some case reports of foetal abnormalities.
Danish: Der har været indberettet tilfælde af fosteranomalier.
English: Coumarin-derivative anticoagulant
Danish: Coumarin-derivativt antikoagulant
English: CYP2A6 inhibitors
Danish: CYP2A6-hæmmere
English: Based on non-clinical data, allopurinol may decrease anti-tumour activity due to suppression of phosphorylation of 5-FU.
Danish: På grundlag af ikke-kliniske data kan allopurinol reducere antitumor aktivitet på grund af supprimering af fosforylering af 5-FU.
English: Also, you need to be particularly careful if you are taking any of the following: - other fluoropyrimidine based medicines such as the anti-fungal flucytosine.
Danish: Du skal også være særlig forsigtig, hvis du tager et eller flere af følgende lægemidler: andre fluoropyrimidinbaserede lægemidler såsom flucytosin, et middel mod svampevækst/-infektion.
English: Similar inhibition was seen following single and multiple dosing.
Danish: Den samme hæmning blev set efter enkelt- og flerdosis.
English: a Treatment for patients with CrCl <30 ml/min is not recommended unless the benefits of Teysuno treatment clearly outweigh the risks.
Danish: a Behandling af patienter med CrCl <30 ml/min anbefales ikke, medmindre fordelene ved Teysunobehandlingen klart opvejer risiciene.
English: At the initiation of subsequent cycles of treatment
Danish: Ved indledning af efterfølgende behandlingsforløb
English: Studies in Japanese patients have suggested an effect of CYP2A6*4 polymorphism on Teysuno pharmacokinetics.
Danish: Forsøg med japanske patienter har tydet på en virkning af CYP2A6*4 polymorfisme på farmakokinetikken af Teysuno.
English: Fatal cases have been reported following capecitabine interaction.
Danish: Der er rapporteret dødelige tilfælde som følge af lægemiddelinteraktion med capecitabin.
English: See Table 2 for the details of the number of Teysuno capsules to be administered for each dose level.
Danish: Der henvises til tabel 2 for oplysninger om det antal Teysuno-kapsler, der skal indgives på hvert dosisniveau.
English: Toxicity due to Teysuno administration should be managed with symptomatic treatment and/or treatment interruption or dose reduction.
Danish: Toksicitet forårsaget af Teysuno bør behandles symptomatisk og/eller ved at afbryde behandlingen eller reducere dosis.
English: Date of latest renewal: 19 November 2015
Danish: Dato for første tilladelse: 14 marts, 2011 Dato for seneste fornyelse: 19 november, 2015
English: These changes with age were related to changes in renal function as measured by creatinine clearance (see section 5.2).
Danish: Disse ændringer med alderen var relateret til ændringer i nyrefunktionen, målt ved creatinin-clearance (se pkt.