FrancophonIA/ELRC3.0 huggingface dataset:
English: Whitening, breakage, and malocclusion were observed in teeth of rats treated with trifluridine/tipiracil hydrochloride, which are considered rodent specific and not relevant for human.
Danish: Hvidfarvning, brud og malokklusion blev observeret i tænderne hos rotter behandlet med trifluridin/ tipiracilhydrochlorid, men dette anses for gnaverspecifikt og ikke relevant for mennesker.
English: Study treatment was administered orally twice daily after morning and evening meals for 5 days a week with 2 days rest for 2 weeks, followed by 14 days rest, repeated every 4 weeks.
Danish: Behandlingen i studiet blev administreret oralt 2 gange dagligt, efter morgen- og aftenmåltiderne, med 5 dages behandling og 2 dages pause i 2 uger, efterfulgt af 14 dages pause og gentaget hver 4. uge.
English: • blood test result indicating inflammation (C-Reactive Protein increased)
Danish: • blodprøveresultat, der tyder på inflammation (betændelseslignende reaktion) (øget niveau af Creaktivt protein)
English: The efficacy and safety of Lonsurf in metastatic colorectal cancer was compared between a high exposure group (>median) and a low-exposure group (≤median) based on the median AUC value of trifluridine.
Danish: Lonsurfs virkning og sikkerhed ved metastatisk kolorektal cancer blev sammenlignet mellem en højeksponerings-gruppe (> median) og en laveksponerings-gruppe (≤ median) baseret på median-AUC for trifluridin.
English: The DCR (complete response or partial response or stable disease) was significantly higher in patients treated with Lonsurf (44% vs 16%, p < 0.0001).
Danish: DCR (komplet respons, partielt respons eller stabil sygdom) var signifikant højere hos patienter, som blev behandlet med Lonsurf (44 % versus 16 %, p < 0,0001).
English: All patients received prior treatment with fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy.
Danish: Alle patienter havde tidligere fået behandling med fluorpyrimidin-, oxaliplatin- og irinotecan-baseret kemoterapi.
English: Tipiracil hydrochloride was the major component and 6-hydroxymethyluracil was the major metabolite consistently in human plasma, urine, and faeces.
Danish: Tipiracilhydrochlorid var den vigtigste komponent og 6-hydroxymethyluracil var hovedmetabolitten i humant plasma, urin og fæces.
English: If you are not sure, talk to your doctor before taking Lonsurf.
Danish: Hvis du ikke er sikker, så tal med din læge, før du tager Lonsurf.
English: Protein total decreased
Danish: Nedsat total-protein
English: Do not use this medicine after the expiry date which is stated on the outer carton or blister tray after “EXP.” The expiry date refers to the last day of that month.
Danish: Brug ikke lægemidlet efter den udløbsdato, der står på den ydre pakning eller blisterpakningen efter ”EXP”.
English: Women of childbearing potential / Contraception in males and females
Danish: Kvinder i den fertile alder/Prævention til mænd og kvinder
English: This is because Lonsurf can affect the way some other medicines work.
Danish: Dette skyldes, at Lonsurf kan påvirke den måde, anden medicin virker på, og ligeledes kan visse andre lægemidler påvirke den måde, Lonsurf virker på.
English: • Interstitial lung disease has been reported in patients receiving the medicine.
Danish: • Betændelseslignende reaktioner i lungerne er indberettet hos patienter, der får denne medicin.
English: In nonclinical studies, trifluridine/tipiracil hydrochloride demonstrated antitumour activity against both 5-fluorouracil (5-FU) sensitive and resistant colorectal cancer cell lines.
Danish: I ikke-kliniske studier demonstrerede trifluridin/tipiracilhydrochlorid antitumoraktivitet overfor både 5-fluoruracil (5-FU) følsomme og resistente kolorektal cancer-cellelinjer.
English: The cytotoxic activity of trifluridine/tipiracil hydrochloride against several human tumour xenografts correlated highly with the amount of trifluridine incorporated into DNA, suggesting this as the primary mechanism of action.
Danish: Den cytotoksiske aktivitet af trifluridin/tipiracilhydrochlorid mod adskillige humane tumorxenotransplantater korrelerede stærkt med mængden af trifluridin inkorporeret i DNA, hvilket antyder, at dette er den primære virkningsmekanisme.
English: The influence of gastrectomy on PK parameters was not able to be examined in the population PK analysis because there were few patients who had undergone gastrectomy (1% of overall).
Danish: Det var ikke muligt at undersøge indflydelsen af gastrektomi på de farmakokinetiske parametre i en farmakokinetisk populationsanalyse, fordi der kun var få patienter, som havde undergået gastrektomi (1 % af den samlede population).
English: Caution is required when using medicinal products that are human thymidine kinase substrates, e.g., zidovudine.
Danish: Forsigtighed er påkrævet ved brug sammen med lægemidler, som er substrater for human thymidinkinase, f.eks. zidovudin.
English: Feeling of body temperature change Xerosis
Danish: Følelse af forandret kropstemperatur Xerose
English: • The active substances are trifluridine and tipiracil.
Danish: • Aktive stoffer: Trifluridin og tipiracil.
English: Therefore, when using antiviral medicinal products that are human thymidine kinase substrates, monitor for possible decreased efficacy of the antiviral medicinal product, and consider switching to an alternative antiviral medicinal product that is not a human thymidine kinase substrate, such as lamivudine, didanosine and abacavir (see section 5.1).
Danish: Når der anvendes antivirale lægemidler, som er substrater for human thymidinkinase, skal der derfor monitoreres for muligt nedsat effekt af det antivirale lægemiddel, og det bør overvejes at skifte til et andet antiviralt lægemiddel, der ikke er et substrat for human thymidinkinase, som f.eks. lamivudin, didanosin og abacavir (se pkt.
English: Table 2 - Dose interruption and resumption criteria for haematological toxicities related to myelosuppression
Danish: Tabel 2 - Kriterier for doseringsafbrydelse og doseringsgenoptagelse ved hæmatologisk toksicitet relateret til myelosuppression
English: Lonsurf has been shown to cause embryo-foetal lethality and embryo-foetal toxicity in pregnant rats when given at dose levels lower than the clinical exposure.
Danish: Det er vist, at Lonsurf kan forårsage embryoføtal død og embryoføtal toksicitet hos drægtige rotter, når det blev givet ved dosisniveauer lavere end svarende til klinisk eksponering.
English: Activated partial thromboplastin time prolonged
Danish: Forlænget aktiveret partiel tromboplastintid
English: The adverse drug reactions observed from the 533 treated patients with metastatic colorectal cancer in the placebo-controlled Phase III (RECOURSE) clinical trial and the 335 treated patients with metastatic gastric cancer in the placebo-controlled Phase III (TAGS) clinical trial, are shown in Table 5.
Danish: De bivirkninger, der blev observeret hos 533 behandlede patienter med metastatisk kolorektal cancer i det placebokontrollerede kliniske fase III-studie (RECOURSE) og hos 335 behandlede patienter med metastatisk gastrisk cancer i det placebokontrollerede kliniske fase III-studie (TAGS), er vist i tabel 5.
English: • shingles (pain and vesicular rash on skin over nerve tracts affected by nerve inflammation from herpes zoster virus)
Danish: • helvedesild (smerte og udslæt med små blærer på huden over nervebanerne på grund nervebetændelse forårsaget af herpes zoster virus)
English: Patients with nausea, vomiting, diarrhoea and other gastrointestinal toxicities should be carefully monitored, and anti-emetic, anti-diarrhoeal and other measures, such as fluid/electrolyte replacement therapy, should be administered as clinically indicated.
Danish: Patienter med kvalme, opkastning, diarré og andre gastrointestinale bivirkninger skal overvåges nøje, og antiemetisk, anti-diarré og andre foranstaltninger, såsom væske/elektrolyt-substitutionsbehandling skal administreres som klinisk indiceret.
English: Lonsurf is used to treat adults with colon or rectal cancer - sometimes called ‘colorectal' cancer and stomach cancer (including cancer of the junction between the oesophagus and the stomach).
Danish: Lonsurf anvendes til at behandle voksne med tyktarms- eller endetarmskræft - sommetider kaldet "kolorektal kræft” og mavekræft (herunder kræft i overgangen mellem spiserøret og mavesækken).
English: Trifluridine was shown to be genotoxic in a reverse mutation test in bacteria, a chromosomal aberration test in mammal-cultured cells, and a micronucleus test in mice.
Danish: Det er vist, at trifluridin er genotoksisk i en revers mutationstest i bakterier, en kromosomaberrationstest i dyrkede pattedyrsceller og en mikronukleustest i mus.
English: Tests and checks
Danish: Laboratorieprøver og kontrol
English: The median number of prior lines of therapy for metastatic disease was 3.
Danish: Mediantallet af førstelinjebehandlinger af metastatisk sygdom var 3.
English: Tablets per dose (2x daily)
Danish: Tabletter pr. dosis (2 × dagligt)
English: Very common: may affect more than 1 in 10 people:
Danish: Meget almindelig: Kan forekomme hos flere end 1 ud af 10 personer
English: Trifluridine was mainly eliminated by metabolism via TPase to form an inactive metabolite, FTY.
Danish: Trifluridin blev hovedsageligt elimineret ved metabolisme via TPase ved dannelse af den inaktive metabolit FTY.
English: The signs include intense stomach or abdominal pain that can be associated with vomiting, blocked or partly blocked bowel, fever or swelling of the abdomen.
Danish: Symptomerne inkluderer intense mavesmerter, som kan være forbundet med opkastning, blokeret eller delvist blokeret tarm, feber eller opsvulmning af maven.
English: Papaellinas Ltd. Τηλ: +357 22741741
Danish: C.A. Papaellinas Ltd. Τηλ: +357 22741741
English: Neutrophils
Danish: Neutrofiler
English: The increases in the corpus luteum count and implanting embryo count observed in female rats at high doses were not considered adverse (see section 4.6).
Danish: Stigningerne i antal corpora lutea og implanterede embryoner, observeret i hunrotter ved høje doser, blev ikke anset som en negativ virkning (se pkt.4.6).
English: Therefore, women of child-bearing potential must use highly effective contraceptive measures while taking Lonsurf and for 6 months after stopping treatment.
Danish: Kvinder i den fertile alder skal derfor bruge meget effektive præventionsmidler, mens de tager Lonsurf og i 6 måneder efter, behandlingen er stoppet.
English: Following uptake into cancer cells, trifluridine, is phosphorylated by thymidine kinase, further metabolised in cells to a deoxyribonucleic acid DNA substrate, and incorporated directly into DNA, thereby interfering with DNA function to prevent cell proliferation.
Danish: Efter optagelse i cancerceller fosforyleres trifluridin af thymidinkinase, som intracellulært metaboliseres yderligere til et deoxyribonukleinsyre (DNA)-substrat og inkorporeres direkte i DNA og dermed interfererer med DNA-funktionen og hindrer celleproliferation.
English: The signs include unusual bruising or bleeding (see section 2).
Danish: Symptomerne inkluderer usædvanlige blå mærker eller blødning (se punkt 2).
English: • sore throat, hoarse voice, problems with your voice
Danish: • ondt i halsen, hæs stemme, problemer med din stemme
English: Serious infections have been reported following treatment with Lonsurf (see section 4.8).
Danish: Der er rapporteret alvorlige infektioner efter behandling med Lonsurf (se pkt.
English: Breast-feeding should be discontinued during treatment with Lonsurf.
Danish: Amning bør afbrydes under behandling med Lonsurf.
English: • feeling of spinning (vertigo)
Danish: • følelse af, at alting snurrer rundt (vertigo)
English: The mean relative ratio of AUC in patients with mild (n=38) and moderate (n=16) renal impairment compared to patients with normal renal function (n=84) were 1.31 and 1.43 for trifluridine, respectively, and 1.34 and 1.65 for tipiracil hydrochloride, respectively.
Danish: Det gennemsnitlige relative forhold mellem AUC hos patienter med let (n = 38) og moderat (n = 16) nedsat nyrefunktion sammenlignet med patienter med normal nyrefunktion (n = 84) var henholdsvis 1,31 og 1,43 for trifluridin og 1,34 og 1,65 for tipiracilhydrochlorid.
English: A higher exposure of Lonsurf was observed in moderate renal impairment (CrCl = 30 to 59 mL/min).
Danish: En højere eksponering af Lonsurf blev observeret ved moderat nedsat nyrefunktion (CrCl = 30 til 59 ml /min).
English: MARKETING AUTHORISATION NUMBER(S) EU/1/16/1096/001-006
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/16/1096/001-006
English: The clinical efficacy and safety of Lonsurf were evaluated in an international, randomised, doubleblind, placebo-controlled Phase III study (RECOURSE) in patients with previously treated metastatic colorectal cancer.
Danish: Lonsurfs kliniske effekt og sikkerhed blev evalueret i et internationalt, randomiseret, dobbeltblindt placebo-kontrolleret fase III-studie (RECOURSE) hos patienter, som tidligere var behandlet for metastatisk kolorektal cancer.
English: • If you forget a dose, talk to your doctor or pharmacist.
Danish: • Hvis du har glemt at tage en dosis, skal du tale med din læge eller apotekspersonalet.
English: However, trifluridine is rapidly degraded by TPase and readily metabolised by a first-pass effect following oral administration, hence the inclusion of the TPase inhibitor, tipiracil hydrochloride.
Danish: Trifluridin nedbrydes imidlertid hurtigt af TPase og metaboliseres hurtigt efter oral administration ved en first-pass effekt, hvorfor TPase-hæmmeren, tipiracilhydrochlorid, er tilsat.
English: Thus it is unlikely to cause an interaction with other medicinal products, at recommended doses, due to inhibition of OCT2 and MATE1.
Danish: Det er derfor ikke sandsynligt, at det i de anbefalede doser forårsager interaktion med andre lægemidler på grund af hæmning af OCT2 eller MATE1.
English: Lonsurf caused an increase in the incidence of gastrointestinal toxicities including nausea, vomiting and diarrhoea.
Danish: Lonsurf forårsagede en stigning i forekomsten af gastrointestinal toksicitet, herunder kvalme, opkastning og diarré.
English: • increased lactate dehydrogenase level in your blood
Danish: • øget niveau af lactatdehydrogenase i blodet
English: Menstrual disorder
Danish: Menstruationsforstyrrelser
English: Based on the population PK analysis, liver function parameters including alkaline phosphatase (ALP, 36-2322 U/L), aspartate aminotransferase (AST, 11-197 U/L), alanine aminotransferase (ALT, 5-182 U/L) , and total bilirubin (0.17-3.20 mg/dL) were not significant covariates for PK parameters of either trifluridine or tipiracil hydrochloride.
Danish: Baseret på en farmakokinetisk populationsanalyse var leverfunktionsparametrene, herunder alkalisk fosfatase (ALP, 36-2.322 E/l), aspartataminotransferase (ASAT, 11-197 E/l), alaninaminotransferase (ALAT, 5-182 E/ l) og total-bilirubin (0,17-3,20 mg /dl), ikke signifikante kovariater for de farmakokinetiske parametre hverken for trifluridin eller tipiracilhydrochlorid.
English: • low levels of phosphates, sodium, potassium or calcium in your blood
Danish: • lavt indhold af fosfater, natrium, kalium eller calcium i blodet
English: In the Phase III clinical trials, treatment-related infections occurred more frequently in Lonsurf-treated patients (5.8%) compared to those receiving placebo (1.8%).
Danish: I de kliniske fase III-studier forekom behandlingsrelaterede infektioner oftere hos Lonsurf-behandlede patienter (5,8 %) end hos patienter i placebo-gruppen (1,8 %).
English: The recommended starting dose of Lonsurf in adults is 35 mg/m2/dose administered orally twice daily on Days 1 to 5 and Days 8 to 12 of each 28-day cycle as long as benefit is observed or until unacceptable toxicity occurs (see section 4.4).
Danish: Den anbefalede startdosis af Lonsurf hos voksne er 35 mg/m dagligt på dag 1 til 5 og dag 8 til 12 i hver 28-dages-cyklus, så længe der observeres behandlingsmæssige fordele eller indtil uacceptabel toksicitet (se pkt.
English: Urinary tract infection Gingivitis
Danish: Urinvejsinfektion Gingivitis
English: • vision troubles as blurred vision, double vision, decreased vision, cataracts
Danish: • synsproblemer som sløret syn, dobbeltsyn, nedsat syn, grå stær
English: The mean t1/2 values for tipiracil hydrochloride on Day 1 of Cycle 1 and on Day 12 of Cycle 1 were 2.1 hours and 2.4 hours, respectively.
Danish: De gennemsnitlige halveringstider af tipiracilhydrochlorid på henholdsvis dag 1 og dag 12 i cyklus 1 var 2,1 timer og 2,4 timer.
English: Table 1 - Starting dose calculation according to body surface area (BSA)
Danish: Tabel 1 - Beregning af startdosis ud fra kroppens overfladeareal (BSA)
English: • pain or discomfort in your arms or legs
Danish: • smerte eller ubehag i dine arme eller ben
English: Dose in mg (2x daily)
Danish: Dosis i mg (2x dagligt)
English: Sixty one percent (61%, N = 485) of all randomised patients received a fluoropyrimidine as part of their last treatment regimen prior to randomisation, of which 455 (94%) were refractory to the fluoropyrimidine at that time.
Danish: 61 % (N = 485) af alle randomiserede patienter fik fluorpyrimidin, som en del af deres sidste behandlingsregime før randomisering, hvor (94 %) var refraktære overfor fluorpyrimidin på dette tidspunkt.
English: The European Medicines Agency has waived the obligation to submit the results of studies with Lonsurf in all subsets of the paediatric population in refractory metastatic colorectal cancer and in refractory metastatic gastric cancer (see section 4.2 for information on paediatric use).
Danish: Det Europæiske lægemiddelagentur har dispenseret fra kravet om at fremlægge resultaterne af studier med Lonsurf i alle undergrupper af den pædiatriske population ved refraktær metastatisk kolorektal cancer og ved refraktær metastatisk gastrisk cancer (se pkt.
English: Fatigue, dizziness or malaise may occur during treatment (see section 4.8).
Danish: Træthed, svimmelhed og utilpashed kan forekomme under behandlingen (se pkt.
English: The most frequently observed adverse drug reactions (≥ 30%) in patients receiving Lonsurf are neutropenia (53% [34% ≥ Grade 3]), nausea (34% [1% ≥ Grade 3]), fatigue (32% [4% ≥ Grade 3]), anaemia (32% [12% ≥ Grade 3]).
Danish: De hyppigst observerede bivirkninger (≥ 30 %) hos patienter i behandling med Lonsurf er neutropeni (53 % [34 % ≥ grad 3]), kvalme (34 % [1 % ≥ grad 3]), træthed (32 % [4 % ≥ grad 3]), anæmi (32 % [12 % ≥ grad 3]).
English: In the pharmacokinetic (PK) analyses of the multiple dose administration of Lonsurf (35 mg/m2/dose, twice daily for 5 days a week with 2 days rest for 2 weeks followed by a 14-day rest, repeated every 4 weeks), trifluridine area under the concentration-time curve from time 0 to the last measurable concentration (AUC0-last) was approximately 3-fold higher and maximum concentration (Cmax) was approximately 2-fold higher after multiple dose administration (Day 12 of Cycle 1) of Lonsurf than after single-dose (Day 1 of Cycle 1).
Danish: I de farmakokinetiske analyser efter multipel administrationen af Lonsurf (35 mg/m dagligt med 5 dages behandling og 2 dages pause i 2 uger, efterfulgt af 14 dages pause og gentaget hver 4. uge), var arealet under koncentration-tid-kurven fra tid 0 til den sidste målbare koncentration (AUC0-sidste) for trifluridin ca. 3 gange højere, og maksimumkoncentrationen (Cmax) var cirka 2 gange højere efter administration af multiple doser (dag 12 i cyklus 1) af Lonsurf end efter en enkelt dosis (dag 1 i cyklus 1).
English: Contribution of tipiracil hydrochloride
Danish: Bidrag fra tipiracilhydrochlorid
English: • high blood sugar (hyperglycaemia), increased salt, urea, creatinine and potassium in your blood
Danish: • højt blodsukker (hyperglykæmi), øget indhold af natrium, urinstof, kreatinin og kalium i blodet
English: (febrile neutropenia) and blood infection (septic shock) may occur
Danish: Som følge af neutropeni kan der opstå feber (febril neutropeni) og infektion i blodet (septisk shock)
English: S.A. Servier Benelux N.V.
Danish: Luxembourg/Luxemburg S.A. Servier Benelux N.V.
English: • viral infection
Danish: • virusinfektion
English: Lonsurf is indicated as monotherapy for the treatment of adult patients with metastatic colorectal cancer (CRC) who have been previously treated with, or are not considered candidates for, available therapies including fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapies, anti-VEGF agents, and anti-EGFR agents.
Danish: Lonsurf er indiceret som monoterapi til behandling af metastatisk kolorektal cancer hos voksne patienter, som tidligere er blevet behandlet med, eller som ikke anses som kandidater til, tilgængelige behandlinger, herunder fluorpyrimidin-, oxaliplatin- og irinotecan-baseret kemoterapi, anti-VEGFmidler, og anti-EGFR-midler.
English: Table 5 - Adverse drug reactions reported in clinical trials in patients treated with Lonsurf System Organ Class (MedDRA)a
Danish: Tabel 5 - Bivirkninger rapporteret i kliniske studier hos patienter behandlet med Lonsurf Systemorganklasse (MedDRA)
English: Toxicology assessment of trifluridine/tipiracil hydrochloride was performed in rats, dogs and monkeys.
Danish: Der blev udført en toksikologisk vurdering af trifluridin/tipiracilhydrochlorid hos rotter, hunde og aber.
English: Rash Alopecia Pruritus Dry skin
Danish: Udslæt Alopeci Pruritus Tør hud
English: Recommended dose adjustments
Danish: Anbefalede dosis modifikationer
English: The Lonsurf survival benefit was maintained after adjusting for all significant prognostic factors, namely, time since diagnosis of first metastasis, ECOG PS and number of metastatic sites (hazard ratio: 0.69; 95% CI [0.58 to 0.81]).
Danish: Lonsurfs overlevelsesfordel blev opretholdt efter justering for alle væsentlige prognostiske faktorer, tid siden diagnosticering af den første metastase, ECOG-PS og antal metastatiske steder (hazard ratio: 0,69; 95 % CI [0,58 til 0,81]).
English: Tipiracil hydrochloride was an inhibitor of OCT2 and MATE1 in vitro, but at concentrations substantially higher than human plasma Cmax at steady state.
Danish: Tipiracilhydrochlorid var en hæmmer af OCT2 og MATE1 in vitro, men ved koncentrationer væsentligt højere end human plasmaCmax ved steady state.
English: 0.0003 (1-sided), 0.0006 (2-sided)
Danish: 0,0003 (1-sidet), 0,0006 (2-sidet)
English: If the above applies to you (or you are not sure), talk to your doctor or pharmacist before taking Lonsurf.
Danish: Hvis ovenstående gælder for dig (eller hvis du er i tvivl), så tal med din læge eller apotekspersonalet, før du tager Lonsurf.
English: • raised itchy rash, red skin, blisters, skin sloughing off, hives, acne
Danish: • hævet kløende udslæt, rød hud, blister, huden falder af, nældefeber, acne
English: The most serious observed adverse drug reactions in patients receiving Lonsurf are bone marrow suppression and gastrointestinal toxicity (see section 4.4).
Danish: De alvorligste observerede bivirkninger hos patienter, der fik Lonsurf, er knoglemarvssuppression og gastrointestinal toksicitet (se pkt.
English: Vertigo Ear discomfort
Danish: Vertigo Ubehag i øret
English: Other medicines and Lonsurf
Danish: Brug af anden medicin sammen med Lonsurf
English: Lonsurf is comprised of an antineoplastic thymidine-based nucleoside analogue, trifluridine, and the thymidine phosphorylase (TPase) inhibitor, tipiracil hydrochloride, at a molar ratio 1:0.5 (weight ratio,
Danish: Lonsurf består af en antineoplastisk thymidin-baseret nukleosidanalog, trifluridin, og thymidinfosforylase- (TPase-) hæmmeren tipiracilhydrochlorid i et molforhold 1:0,5 (vægtforhold,
English: 50a a At a total daily dose of 50 mg, patients should take 1 x 20 mg/8.19 mg tablet in the morning and 2 x 15 mg/6.14 mg tablets in the evening.
Danish: Ved en total daglig dosis på 50 mg skal patienten tage en 20 mg/8,19 mg tablet om morgenen og to 15 mg/6,14 mg tabletter om aftenen.