FrancophonIA/ELRC3.0 huggingface dataset:
English: This is calculated from your height and weight.
Danish: Det beregnes ud fra din højde og vægt.
English: Median Time to Event (Days)
Danish: Mediane tid til event (dage)
English: Ethnic factors.
Danish: Etniske faktorer.
English: Interaction studies have only been performed in adults.
Danish: Interaktionsstudier er kun udført hos voksne.
English: This advice is applicable to all indications and to all special populations.
Danish: Dette gælder for alle indikationer og for alle særlige populationer.
English: 8501 Novo mesto Slovenia
Danish: 8501 Novo mesto Slovenien
English: Immediate admission to hospital is recommended.
Danish: Øjeblikkelig hospitalsindlæggelse anbefales.
English: This increase is likely due to a change in renal function.
Danish: Denne stigning skyldes formentlig en ændring i nyrefunktionen.
English: The clinical relevance of these differences is unknown.
Danish: Den kliniske betydning af disse forskelle er ukendt.
English: • Risk management plan (RMP)
Danish: • Risikostyringsplan (RMP)
English: See table 6 for treatment regimens.
Danish: Se tabel 6 vedrørende behandlingsregimer.
English: This is extremely important, as taking more than one medicine at the same time can strengthen or weaken the effect of the medicines.
Danish: Det er meget vigtigt, da indtagelse af mere end et lægemiddel på samme tid kan forstærke eller forringe virkningen af lægemidlerne.
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 lægemidlet.
English: No special requirements.
Danish: Ingen særlige forholdsregler.
English: FBAL is a metabolite without antiproliferative activity.
Danish: FBAL er en metabolit uden antiproliferativ aktivitet.
English: All measures should be initiated to prevent systemic infections and dehydration.
Danish: Alle foranstaltninger bør indledes for at forhindre systemiske infektioner og dehydrering.
English: Fatal cases have been reported following this drug interaction.
Danish: Der er rapporteret dødelige tilfælde som følge af denne lægemiddelinteraktion.
English: This 21 day period is one treatment cycle.
Danish: Denne 21 dages periode er en behandlingsserie.
English: You must not take Ecansya if you are pregnant or think you might be.
Danish: Du må ikke tage Ecansya, hvis du er gravid eller tror du er det.
English: Once the dose has been reduced, it should not be increased at a later time.
Danish: Når dosis først er reduceret, bør den ikke sættes op igen på et senere tidspunkt.
English: - It is important that you take all your medicine as prescribed by your doctor.
Danish: - Det er vigtigt at du tager al din medicin som foreskrevet af din læge.
English: Median survival was 384 and 373 days.
Danish: Den mediane overlevelse var 384 og 373 dage.
English: D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND
Danish: D. BETINGELSER ELLER BEGRÆNSNINGER MED HENSYN TIL SIKKER OG
English: Ecansya may be used either alone or in combination with other medicines.
Danish: Ecansya kan anvendes enten alene eller i kombination med andre lægemidler.
English: - Nausea: if you lose your appetite, and the amount of food you eat each day is much less than usual.
Danish: - Kvalme: hvis du mister appetitten, og hvis du spiser meget mindre hver dag end du plejer.
English: It cannot be excluded that other rare variants may also be associated with an increased risk of severe toxicity.
Danish: Det kan ikke udelukkes at andre sjældne varianter også er forbundet med en øget risiko for toksicitet.
English: • Periodic safety update reports (PSURs)
Danish: • Periodiske, opdaterede sikkerhedsindberetninger (PSUR'er)
English: The median time to progression was 93 and 98 days.
Danish: Den mediane tid indtil progression var 93 og 98 dage.
English: Severe and/or Lifethreatening (grade 34) or considered medically relevant
Danish: Alvorlige og/eller livstruende (grad 34) eller vurderet som klinisk relevant
English: - Infection: if you experience signs of infection caused by bacteria or virus, or other organisms.
Danish: - Infektion: hvis du oplever tegn på infektion forårsaget af bakterier eller virus eller andre organismer.
English: +Infection, Oral herpes
Danish: +Infektion, Oral herpes
English: About 3% of the administered dose is excreted in urine unchanged.
Danish: Ca. 3 % af den indgivne dosis udskilles uændret i urinen.
English: BATCH NUMBER Lot
Danish: BATCHNUMMER Lot
English: 3 years
Danish: 3 år.
English: These toxicities were reversible.
Danish: De toksiske virkninger var reversible.
English: - Fever: if you have a temperature of 38°C or greater.
Danish: - Feber: hvis din temperatur stiger til 38 °C eller derover.
English: ADDITIONAL 6 MONTHS OF FOLLOW UP
Danish: 6 MÅNEDERS YDERLIGERE FOLLOW UP
English: Progression-free Survival after 6 months ITT
Danish: Progressionsfri overlevelse efter 6 måneder ITT
English: - Vomiting: if you vomit more than once in a 24-hour time period.
Danish: - Opkastning: hvis du kaster op mere end én gang i løbet af 24 timer.
English: ADDITIONAL 1 YEAR OF FOLLOW UP
Danish: ET ÅRS YDERLIGERE FOLLOW UP
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 20 April 2012
Danish: DATO FOR FØRSTE MARKEDSFØRINGSTILLADELSE/FORNYELSE AF TILLADELSEN Dato for første markedsføringstilladelse: 20 april 2012 Dato for fornyelse af tilladelsen: 9. december 2016
English: Treatment should not be restarted until the patient is rehydrated and any precipitating causes have been corrected or controlled.
Danish: Behandlingen bør ikke genoptages, før patienten er rehydreret, og udløsende årsager er korrigerede eller kontrollerede.
English: EFFECTIVE USE OF THE MEDICINAL PRODUCT
Danish: EFFEKTIV ANVENDELSE AF LÆGEMIDLET
English: See also section "Do not take Ecansya".
Danish: Se også afsnittet 'Tag ikke Ecansya'.
English: The AUC of 5-FU was 30%-35% higher on day 14.
Danish: AUC for 5-FU var 30-35 % højere på dag 14.
English: - If contraindications exist to any of the medicinal products in the combination regimen, that medicinal product should not be used.
Danish: - Hvis der forekommer kontraindikationer til et af lægemidlerne i kombinationsregimet, skal det pågældende lægemiddel ikke anvendes.
English: Rare/Very Rare (Post-Marketing Experience)
Danish: Sjælden/meget sjælden (erfaringer efter markedsføring)
English: Ecansya tablets should not be crushed or cut.
Danish: Ecansya tabletter må ikke deles eller knuses.
English: Faecal excretion is minimal (2.6%).
Danish: Udskillelse i fæces er minimal (2,6 %).
English: In this trial, 1002 patients were randomised in a 2x2 factorial design to one of the following 4 arms:
Danish: I dette studie blev 1002 patienter randomiseret i et 2x2 faktor design til en af følgende fire arme:
English: ANNEX II A. MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
Danish: BILAG II A. FREMSTILLER(E) ANSVARLIG(E) FOR BATCHFRIGIVELSE B. BETINGELSER ELLER BEGRÆNSNINGER VEDRØRENDE UDLEVERING OG ANVENDELSE C. ANDRE FORHOLD OG BETINGELSER FOR MARKEDSFØRINGSTILLADELSEN D. BETINGELSER ELLER BEGRÆNSNINGER MED HENSYN TIL SIKKER OG EFFEKTIV ANVENDELSE AF LÆGEMIDLET
English: Palmar-plantar erythrodysaesth esia syndrome**
Danish: Palmar-plantar erytrodysæstesi syndrom**
English: Data on the frequency of these DPYD variants in other populations than Caucasian is limited.
Danish: Der er begrænsede data for frekvensen af DPYD varianter i andre populationer end den kaukasiske.
English: Your doctor will prescribe a dose and treatment regimen that is right for you.
Danish: Din læge vil ordinere en dosis og en behandling som er rigtig for dig.
English: Ecansya tablets are usually taken for 14 days followed by a 7 day rest period (when no tablets are taken).
Danish: Ecansya-tabletter tages normalt i 14 dage efterfulgt af 7 dages pause (hvor der ikke tages tabletter).
English: Your doctor may instruct you to restart treatment at a lower dose.
Danish: Lægen vil måske bede dig om at begynde behandlingen igen med en lavere dosis.
English: Capecitabine is contraindicated during pregnancy.
Danish: Capecitabin er kontraindiceret under graviditet.
English: The dose of Ecansya is based on your body surface area.
Danish: Ecansya-dosis er baseret på arealet af din legemsoverflade.
English: The major metabolite excreted in urine is FBAL, which represents 57% of the administered dose.
Danish: Hovedmetabolitten som udskilles i urinen er FBAL, der repræsenterer 57 % af den indgivne dosis.
English: Permanent discontinuation should be considered based on clinical assessment of the onset, duration and severity of the observed toxicities.
Danish: Permanent seponering bør overvejes på baggrund af klinisk vurdering af debut, varighed og sværhedsgrad af de observerede toksiciteter.
English: There is no data on Ecansya and impact on fertility.
Danish: Der er ingen data om Ecansya og påvirkning af fertilitet.
English: Interaction with other medicinal products
Danish: Interaktion med andre lægemidler
English: - Take the tablets morning and evening as prescribed by your doctor.
Danish: - Tag tabletterne morgen og aften på den måde, som din læge har ordineret til dig.
English: Tell your doctor immediately if you experience any of these symptoms.
Danish: Kontakt straks lægen, hvis du oplever et eller flere af disse symptomer.
English: Your doctor may instruct you to decrease the dose and/or temporarily discontinue treatment with Ecansya.
Danish: Lægen vil måske bede dig om at sætte dosis ned og/eller midlertidigt afbryde behandlingen med Ecansya.
English: Name and address of the manufacturers responsible for batch release Accord Healthcare Ltd.
Danish: Navn og adresse på fremstillerne ansvarlige for batchfrigivelse Accord Healthcare Ltd.
English: Do not give Ecansya to children and adolescents.
Danish: Giv ikke Ecansya til børn eller unge.
English: These findings are expected effects of fluoropyrimidine derivatives.
Danish: Disse fund er forventede virkninger af fluorpyrimidinderivater.
English: If caught early, these side effects usually improve within 2 to 3 days after treatment discontinuation.
Danish: Hvis disse bivirkninger opdages hurtigt vil de normalt bedres i løbet af 2 til 3 dage efter, at behandlingen er stoppet.
English: Careful monitoring of patients 60 years of age is advisable.
Danish: Omhyggelig monitorering af patienter  60 år tilrådes.
English: This medicine does not require any special storage conditions.
Danish: Dette lægemiddel kræver ingen særlige forholdsregler vedrørende opbevaringen.
English: Interrupt until resolved to grade 0-1
Danish: Afbryd behandlingen indtil toksiciteten er reduceret til grad 0-1
English: - Take the tablets within 30 minutes after the end of a meal (breakfast and dinner) and swallow whole with water.
Danish: - Tag tabletterne senest 30 min efter et måltid (morgenmad og aftensmad) og slug dem hele med vand.
English: If these side effects continue, however, contact your doctor immediately.
Danish: Hvis bivirkningerne alligevel fortsætter skal du straks kontakte lægen.
English: 820 patients were randomised to receive either sequential treatment (n=410) or combination treatment (n=410).
Danish: 820 patienter blev randomiseret til at få enten sekventiel behandling (n = 410) eller kombinationsbehandling (n = 410).
English: Not applicable *According to the National Cancer Institute of Canada Clinical Trial Group (NCIC CTG) Common Toxicity Criteria (version 1) or the Common Terminology Criteria for Adverse Events (CTCAE) of the Cancer Therapy Evaluation Program, US National Cancer Institute, version 4.0.
Danish: Ikke relevant *I følge National Cancer Institute of Canada Clinical Trial Group (NCIC CTG) Common Toxicity Criteria (version 1) eller Common Terminology Criteria for Adverse Events (CTCAE) fra Cancer Therapy Evaluation Program, US National Cancer Institute, version 4.0.
English: Capecitabine can induce the occurrence of diarrhoea, which has been observed in up to 50% of patients.
Danish: 4.4) Capecitabin kan inducere forekomsten af diarré, hvilket er observeret i op til 50 % af patienterne.
English: All treatment cycles were administered at intervals of 3 weeks.
Danish: Alle behandlingsserier blev administreret med 3 ugers interval.
English: Table 6 Treatment regimens in study NO16966 (mCRC) Treatment
Danish: Tabel 6 Behandlingsregimer i studie NO16966 (mCRC)
English: It is therefore possible that Ecansya could affect your ability to drive a car or operate machines.
Danish: Det er derfor muligt, at Ecansya kan påvirke din evne til at køre bil, og betjene maskiner.
English: The patients who are tested negative for the above-mentioned alleles may still have a risk of severe adverse events.
Danish: Patienter som testes negative for de ovenfor nævnte alleler, vil muligvis stadig have en risiko for alvorlige bivirkninger.
English: Oral use
Danish: Oral anvendelse
English: Central or peripheral nervous system disease.
Danish: Centrale eller perifere nervesystem
English: A reduction of the starting dose in these patients may be considered to avoid serious toxicity.
Danish: Det kan overvejes at reducere startdosis hos disse patienter, for at undgå alvorlig toksicitet.
English: Do not take a double dose to make up for a forgotten dose.
Danish: Tag ikke dobbeltdosis for at erstatte den glemte dosis.
English: North Harrow, Middx HA1 4HF
Danish: North Harrow, Middx HA1 4HF Storbritannien
English: Hazard ratio 95% CI P value
Danish: Hazard ratio 95% konfidensinterval p-værdi
English: Discontinue treatment permanently
Danish: Seponer behandlingen permanent
English: Previous therapy should have included an anthracycline.
Danish: Tidligere behandling skal have omfattet et antracyklin.
English: This will help reduce the likelihood that the side effect continues or becomes severe.
Danish: Dermed nedsættes sandsynligheden for at bivirkningen fortsætter eller forværres.
English: Each pack contains 30, 60 or 120 film-coated tablets.
Danish: Hver pakke indeholder 30, 60 eller 120 filmovertrukne tabletter.
English: Tinnitus, Hypoacusis
Danish: Tinnitus, Hypoakusis
English: In the event of grade 2-4 acute toxicity, treatment must be discontinued immediately.
Danish: I tilfælde af akut toksicitet af grad 2-4 bør behandlingen straks afbrydes.
English: The effects of DNA and RNA deprivation are most marked on those cells which proliferate more rapidly and which metabolise 5-FU at a more rapid rate.
Danish: Virkningen af DNA og RNA deprivation er tydeligst på de celler, som prolifererer hurtigst, og som metaboliserer 5-FU hurtigere.
English: HR (97.5% CI)
Danish: HR (97,5% KI)
English: METHOD AND ROUTE (S) OF ADMINISTRATION Read the package leaflet before use.
Danish: ANVENDELSESMÅDE OG ADMINISTRATIONSVEJ(E) Læs indlægssedlen inden brug.
English: These reactions occurred within several days and up to several months after initiating capecitabine therapy and, in a few cases, within one month after stopping capecitabine.
Danish: Disse bivirkninger indtraf fra flere dage og op til flere måneder efter påbegyndelsen af behandlingen med capecitabin og, i nogle få tilfælde, i op til en måned efter ophør med capecitabin.
English: Ecansya belongs to the group of medicines called "cytostatic medicines", which stop the growth of cancer cells.
Danish: Ecansya tilhører en gruppe lægemidler som kaldes “cytostatika”, som standser væksten af kræftceller.
English: The AUC of FBAL increased with age (20% increase in age results in a 15% increase in the AUC of FBAL).
Danish: FBAL's AUC steg med alderen (20 % stigning i alder medførte 15 % stigning i FBAL's AUC).
English: Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V.
Danish: Læger og Sundhedspersoner anmodes om at indberette alle formodede bivirkninger via det nationale rapporteringssystem anført i Appendiks V.
English: UNIQUE IDENTIFIER - HUMAN READABLE DATA
Danish: ENTYDIG IDENTIFIKATOR - MENNESKELIGT LÆSBARE DATA PC
English: The enhanced toxicity may be relevant when switching from 5-FU/LV to a capecitabine regimen.
Danish: Den forstærkede toksicitet kan være relevant, når 5-FU/LV skiftes til et capecitabin-regime.
English: 9/L and/or thrombocyte counts of <100 x 10
Danish: 9/l og/eller et trombocyttal < 100 x 10
English: NAME OF THE MARKETING AUTHORISATION HOLDER KRKA
Danish: NAVN PÅ INDEHAVEREN AF MARKEDSFØRINGSTILLADELSEN KRKA
English: 5-fluorouracil intravenous bolus/infusion, each on Days 1 and 2, every 2 weeks
Danish: 5-fluorouracil intravenøs bolus/infusion, hver på dag 1 og 2, hver 2. uge
English: Ecansya should be permanently discontinued in patients who experience a severe skin reaction during treatment.
Danish: Ecansya skal seponeres permanent hos patienter, der oplever en alvorlig hudreaktion under behandlingen.
English: 5-Fluorouracil: intravenous bolus injection immediately after leucovorin
Danish: 5-Fluorouracil: intravenøs bolus injektion umiddelbart efter leucovorin
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: Den medicinske behandling af overdosering omfatter de sædvanlige terapeutiske og støttende medicinske interventioner, som sigter på at afhjælpe de kliniske symptomer og forebygge evt. komplikationer.
English: Other side effects are:
Danish: Andre bivirkninger kan være:
English: This interaction, which leads to increased fluoropyrimidine toxicity, is potentially fatal.
Danish: Interaktionen, som medfører øget fluorpyrimidintoksicitet, er potentiel dødelig.
English: Genotyping for these alleles is recommended to identify patients at increased risk for severe toxicity.
Danish: Det anbefales at bestemme genotypen af disse alleler for at identificere patienter med en øget risiko for svær toksicitet.
English: Japanese patients had also about 25% lower Cmax and 34% lower AUC for FBAL than Caucasian patients.
Danish: Patienter af japansk oprindelse havde også omkring 25 % lavere Cmax og 34 % lavere AUC for FBAL end patienter af kaukasisk oprindelse.
English: Doses of capecitabine omitted for toxicity are not replaced.
Danish: Capecitabin-doser som ikke tages på grund af toksicitet, erstattes ikke.
English: Film-coated tablet (tablet).
Danish: Filmovertrukken tablet (tablet).
English: Modified XELIRI+ bevacizumab (ITT: N= 120)
Danish: Modificeret XELIRI + bevacizumab (ITT: N = 120)
English: DPD deficiency: DPD deficiency is a rare condition present at birth that is not usually associated with health problems unless you receive certain medicines.
Danish: DPD-mangel er en sjælden, medfødt tilstand, der almindeligvis ikke er forbundet med helbredsproblemer, medmindre man får bestemte lægemidler.
English: Most adverse reactions are reversible and do not require permanent discontinuation of therapy, although doses may need to be withheld or reduced.
Danish: De fleste bivirkninger er reversible og kræver ikke seponering af behandlingen selvom nogle doser måske skal springes over eller reduceres.
English: Since metabolism of R-warfarin was not affected, these results indicate that capecitabine downregulates isozyme 2C9, but has no effect on isozymes 1A2 and 3A4.
Danish: Da R-warfarins metabolisme ikke var påvirket, tyder disse resultater på, at capecitabin nedregulerer isoenzym 2C9, men ikke har effekt på isoenzymerne 1A2 og 3A4.
English: No dose has been proven safe for patients with complete absence of DPD activity.
Danish: Ingen dosis er vist sikker hos patienter med fuldstændig mangel på DPD-aktivitet.
English: Body Surface Area (m
Danish: Legemsoverfladeareal (m
English: Since DNA and RNA are essential for cell division and growth, the effect of 5-FU may be to create a thymidine deficiency that provokes unbalanced growth and death of a cell.
Danish: Da DNA og RNA er nødvendige for celledelingen og cellevæksten, virker 5-FU muligvis ved at skabe et thymidindeficit, som provokerer ubalanceret vækst og død af en celle.
English: Furthermore, Ecansya is used to prevent new occurrence of colon cancer after complete removal of the tumour by surgery.
Danish: Desuden bruges Ecansya til forebyggelse af ny optræden af tyktarmskræft efter fuldstændig fjernelse af svulsten ved operation.
English: Toxicity due to capecitabine administration may be managed by symptomatic treatment and/or modification of the dose (treatment interruption or dose reduction).
Danish: Toksicitet som skyldes administration af capecitabin kan behandles symptomatisk og/eller med modifikation af dosis (afbrydelse af behandlingen eller reduktion af dosis).
English: The following factors were pre-specified in the statistical analysis plan for inclusion in the model: age, time from surgery to randomization, gender, CEA levels at baseline, lymph nodes at baseline, and country.
Danish: Følgende faktorer var præspecificerede i den statistiske analyseplan for inklusion i modellen: Alder, tid fra operation til randomisering, køn, CEA-værdier ved baseline, lymfeknuder ved baseline samt land.
English: If you take more Ecansya than you should, contact your doctor as soon as possible before taking the next dose.
Danish: Hvis du har taget for mange Ecansya-tabletter, skal du kontakte lægen så hurtigt som muligt, før du tager næste dosis.
English: The median follow up at the time of the analysis was 6.9 years.
Danish: Den mediane tid for follow/up på analysetidspunktet var 6,9 år.
English: The consequences of a reduced dose for efficacy are currently uncertain.
Danish: Konsekvenserne af en reduceret dosis i forhold til effekten er imidlertidig ukendt.
English: No studies have been conducted to assess the impact of capecitabine on milk production or its presence in human breast milk.
Danish: Der er ikke foretaget undersøgelser for at vurdere capecitabins påvirkning af mælkeproduktion eller udskillelse i human mælk.
English: STOP taking Ecansya immediately and contact your doctor if any of these symptoms occur: - Diarrhoea: if you have an increase of 4 or more bowel movements compared to your normal bowel movements each day or any diarrhoea at night.
Danish: STOP øjeblikkeligt med at tage Ecansya og kontakt lægen hvis du får nogle af følgende symptomer: - Diarré: hvis du har en øgning på 4 eller flere afføringer om dagen sammenlignet med dit normale antal daglige afføringer eller hvis du får diarré om natten.
English: Insomnia, Depression
Danish: Søvnløshed, Depression
English: Treatment should be discontinued if progressive disease or intolerable toxicity is observed.
Danish: Behandlingen skal seponeres, hvis sygdommen progredierer, eller der ses intolerabel toksicitet.
English: Although sensitivity analyses show that differences in regimen schedules and timing of tumor assessments impact the on-treatment PFS analysis, a full explanation for this result has not been found.
Danish: Selvom sensitivitetsanalyser viser, at forskelle i behandlingsskemaer og tidspunkt for tumorvurdering påvirker analysen for progressionsfri overlevelse on-treatment, er der ikke fundet en fyldestgørende forklaring på dette fund.
English: Day 1, prior to XELOX, every 3 weeks
Danish: Dag 1, før XELOX, hver 3. uge
English: Pharmacotherapeutic group: antineoplastic agents, antimetabolites, ATC code: L01BC06.
Danish: Farmakoterapeutisk klassifikation: Antineoplastiske midler, antimetabolit, ATC kode: L01BC06.
English: The overall objective response rates (investigator assessment) were 20% (first trial) and 25% (second trial).
Danish: De totale objektive responsrater (investigators vurdering) var 20 % (første studie) og 25 % (andet studie).
English: Ecansya with food and drink You should take Ecansya no later than 30 minutes after meals.
Danish: Brug af Ecansya sammen med mad og drikke Du skal tage Ecansya senest 30 minutter efter et måltid.
English: However, grade 3 or 4 treatment-related adverse reactions were more frequent in patients 60 years of age compared to younger patients.
Danish: Behandlingsrelaterede bivirkninger af sværhedsgrad 3 eller 4 var dog hyppigere hos patienter  60 år sammenlignet med yngre patienter.