FrancophonIA/ELRC3.0 huggingface dataset:
English: No clinical data exist concerning the use of Circadin in individuals with autoimmune diseases.
Danish: Circadin er ikke undersøgt hos patienter med autoimmunsygdomme.
English: DATE OF REVISION OF THE TEXT {DD month YYYY}
Danish: Oversigt over indlægssedlen:
English: Your doctor will tell you what dose you need to take, when to take it and for how long you need to take it.
Danish: Din læge vil fortælle dig, hvilken dosis du skal tage, hvornår du skal tage den, og hvor længe du skal tage den.
English: See Table 7 for treatment regimens.
Danish: Se tabel 7 vedrørende behandlingsregimer.
English: Date of first authorisation: 20 April 2012 Date of latest renewal: 09th January 2017
Danish: Dato for første markedsføringstilladelse: 20. april 2012 Dato for seneste fornyelse: 09. januar 2017
English: Also ou need to be particularly careful if you are taking any of the following:
Danish: Du skal også være særlig forsigtig, hvis du tager:
English: • Take the tablets morning and evening as prescribed by your doctor.
Danish: • Tag tabletterne morgen og aften som foreskrevet af din læge.
English: • Take the tablets within 30 minutes after the end of a meal (breakfast and dinner) and swallow them whole with water.
Danish: • Tag tabletterne senest 30 min efter et måltid (morgenmad og aftensmad), og slug dem hele med vand.
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: Once the dose has been reduced, it should not be increased at a later time.
Danish: Når dosis først er sat ned, bør den ikke sættes op igen på et senere tidspunkt.
English: Palmar-plantar erythrodysaesthesia syndrome**
Danish: Palmar-plantar erytrodysæstes i syndrom**
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: • 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: Capecitabine Accord may be used either alone or in combination with other medicines.
Danish: Capecitabine Accord kan anvendes enten alene eller i kombination med andre lægemidler.
English: Progression-free Survival after 6 months
Danish: Progressionsfri overlevelse efter 6 måneder ITT
English: *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: *Ifølge 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: The dose of Capecitabine Accord is based on your body surface area.
Danish: Din dosis af Capecitabine Accord er baseret på arealet af din legemsoverflade.
English: Capecitabine Accord is indicated for the treatment of:
Danish: Capecitabine Accord er indiceret til behandling af:
English: Name and address of the manufacturers responsible for batch release Accord Healthcare Ltd.
Danish: Navn og adresse på den fremstiller, der er ansvarlige for batchfrigivelse Accord Healthcare Ltd.
English: Severe and/or Lifethreatening (grade 3-4) or considered medically relevant
Danish: Ikke almindelig Alvorlige og/eller livstruende (grad 3-4) eller vurderet som klinisk relevant
English: • Fever: if you have a temperature of 38°C or greater.
Danish: Feber: hvis din temperatur stiger til 38 °C eller derover.
English: It is therefore possible that Capecitabine Accord could affect your ability to drive a car or operate machines.
Danish: Det er derfor muligt, at Capecitabine Accord kan påvirke din evne til at køre bil og betjene maskiner.
English: Table 7 Treatment regimens in study NO16966 (mCRC)
Danish: Tabe1 7 Behandlingsregimer i studie NO16966 (mCRC)
English: Cytochrome P-450 2C9 substrates
Danish: Cytokrom P-450 2C9-substrater
English: If these side effects continue, contact your doctor immediately.
Danish: Hvis bivirkningerne alligevel fortsætter skal du straks kontakte lægen.
English: Accord Healthcare Limited, Sage house, 319 Pinner Road, Harrow HA1 4HF, United Kingdom
Danish: Accord Healthcare Limited, Sage house, 319 Pinner Road, Harrow HA1 4HF, Storbritannien
English: Finally, β-ureido-propionase cleaves FUPA to α-fluoro-β-alanine (FBAL) which is cleared in the urine.
Danish: Endeligt spalter β-ureido-propionase FUPA til α-fluoro-β-alanin (FBAL), som udskilles i urinen.
English: Capecitabine Accord tablets are usually taken for 14 days followed by a 7 day rest period (when no tablets are taken).
Danish: Capecitabine Accord-tabletter tages normalt i 14 dage efterfulgt af 7 dages pause (hvor der ikke tages tabletter).
English: The following headings are used to rank the ADRs 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) and very rare (< 1/10,000).
Danish: De efterfølgende overskrifter rangerer bivirkningerne efter frekvens: 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) og meget sjælden (< 1/10.000).
English: STOP taking Capecitabine Accord immediately and contact your doctor if any of these symptoms occur:
Danish: STOP øjeblikkeligt med at tage Capecitabine Accord og kontakt lægen hvis nogle af følgende symptomer viser sig:
English: Your doctor may instruct you to decrease the dose and/or temporarily discontinue treatment with Capecitabine Accord.
Danish: Lægen vil måske bede dig om at sætte dosis ned og/eller midlertidigt afbryde behandlingen med Capecitabine Accord.
English: ITT *EPP=eligible patient population; **ITT=intent-to-treat population.
Danish: EPP ITT *EPP=egnet patientpopulation; **ITT=intent-to-treat population
English: In a interaction study with single-dose warfarin administration, there was a significant increase in the mean AUC (+57%) of S-warfarin.
Danish: I et interaktionsstudie med enkeltdosis administration af warfarin, var der en signifikant stigning i middel-AUC (+ 57 %) af S-warfarin.
English: Parameter: Overall Survival
Danish: Parameter: Samlet overlevelse
English: Careful monitoring during the first cycle of treatment is recommended for all patients.
Danish: Det anbefales at monitorere alle patienter omhyggeligt under den første behandlingscyklus.
English: The following factors were pre-specified in the statistical analysis plan for inclusion in the model: age, time from surgery to randomisation, 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: Aluminium/aluminium blisters This medicinal product does not require any special storage conditions.
Danish: Aluminium/aluminium-blistere Dette lægemiddel kræver ingen særlige forholdsregler vedrørende opbevaringen.
English: • if you are being treated now or have been treated in the last 4 weeks with brivudine as part of herpes zoster (chickenpox or shingles) therapy.
Danish: • hvis du bliver behandlet på nuværende tidspunkt eller inden for de sidste 4 uger har været behandlet med brivudin som en del af herpes zosterbehandling (skoldkopper eller helvedesild).
English: Parameter: Progression-free Survival
Danish: Parameter: Progressionsfri overlevelse
English: The inclusion of bevacizumab in a combination regimen has no effect on the starting dose of capecitabine.
Danish: Inklusionen af bevacizumab i et kombinationsregime har ingen effekt på initialdosis af capecitabin .
English: • if you previously have had severe reactions to fluoropyrimidine therapy (a group of anticancer medicines such as fluorouracil),
Danish: • hvis du tidligere har haft alvorlige bivirkninger ved fluoropyrimidin-behandling (en gruppe af kræftlægemidler som fluorouracil),
English: • a medicine to treat cancer (interferon alpha)
Danish: • et lægemiddel til behandling af kræft (interferon-alfa)
English: ** Based on the post-marketing experience, persistent or severe palmar-plantar erythrodysaesthesia syndrome can eventually lead to loss of fingerprints (see section 4.4)
Danish: ** Baseret på erfaringer efter markedsføring kan vedvarende eller svært palmar-plantar erytrodysæstesi-syndrom i sidste ende forårsage, at fingeraftrykket forsvinder (se pkt.
English: Capecitabine Accord belongs to the group of medicines called "cytostatic medicines", which stop the growth of cancer cells.
Danish: Capecitabine Accord tilhører en gruppe lægemidler som kaldes “cytostatika”, som standser væksten af kræftceller.
English: The median follow up at the time of the primary analyses in the intent-to-treat population was 1.5 years; data from analyses following an additional 1 year of follow up are also included in Table 8.
Danish: Den mediane follow-up-tid på tidspunktet for de primære analyser i intent-to-treat-populationen var 1,5 år; data fra analyser efter yderligere et års follow-up fremgår også af tabel 8.
English: You should take Capecitabine Accord no later than 30 minutes after meals.
Danish: Du skal tage Capecitabine Accord senest 30 minutter efter et måltid.
English: ITT *PPP=per-protocol population; **ITT=intent-to-treat population.
Danish: PPP ITT *PPP=per protokol population; **ITT=intent-to-treat population
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.
English: If you take more Capecitabine Accord than you should, contact your doctor as soon as possible before taking the next dose.
Danish: Hvis du har taget for mange Capecitabine Accord-tabletter, skal du kontakte din læge så hurtigt som muligt, før du tager næste dosis.
English: Interrupt until resolved to grade 0-1 100%
Danish: Afbryd behandlingen indtil toksiciteten er reduceret til grad 0-1
English: Furthermore, Capecitabine Accord is used to prevent new occurrence of colon cancer after complete removal of the tumour by surgery.
Danish: Desuden anvendes Capecitabine Accord til forebyggelse af ny optræden af tyktarmskræft efter fuldstændig fjernelse af svulsten ved operation.
English: In animal studies effects on fertility were observed (see section 5.3)
Danish: Påvirkning af fertilitet blev observeret i dyrestudier (se pkt.
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: See also section “Do not take Capecitabine Accord”.
Danish: Se også afsnittet 'Tag ikke Capecitabine Accord'.
English: • 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: 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: • if you know that you do not have any activity of the enzyme dihydropyrimidine dehydrogenase (DPD)
Danish: • hvis du ved, at du ikke har nogen aktivitet af enzymet dihydropyrimidindehydrogenase (DHP)
English: Persistent or severe hand-foot syndrome (Grade 2 and above) can eventually lead to loss of fingerprints which could impact patient identification.
Danish: Vedvarende eller svært hånd- og fodsyndrom (grad 2 og højere) kan i sidste ende forårsage, at fingeraftrykket forsvinder, hvilket kan påvirke identifikationen af patienten.
English: Do not give Capecitabine Accord to children and adolescent.
Danish: Giv ikke Capecitabine Accord til børn eller unge.
English: Detailed information on this medicinal product is available on the website of the European Medicines Agency: http://www.ema.europa.eu/.
Danish: Yderligere oplysninger om dette lægemiddel er tilgængelig på Det Europæiske Lægemiddelagenturs hjemmeside http://www.ema.europa.eu/
English: Doses of capecitabine omitted for toxicity are not replaced.
Danish: capecitabin -doser som ikke tages på grund af toksicitet erstattes ikke.
English: Hand and foot skin-reaction can lead to loss of fingerprint, which could impact your identification by fingerprint scan.
Danish: Hudsymptomer på hænder og fødder kan forårsage, at fingeraftrykket forsvinder, hvilket kan påvirke identifikation af dig med fingeraftryksscanner.
English: • Chest pain: if you experience pain localised to the centre of the chest, especially if it occurs during exercise.
Danish: Brystsmerter: Hvis du får smerter i midten af brystet, specielt hvis det sker under anstrengelse.
English: Patients taking capecitabine should be informed of the need to interrupt treatment immediately if moderate or severe toxicity occurs.
Danish: Patienter, som tager capecitabin, skal informeres om nødvendigheden af straks at stoppe behandlingen, hvis der kommer moderat eller svær toksicitet.
English: Titanium dioxide (E171)
Danish: Talkum Titandioxid (E171)
English: PRIMARY ANALYSIS XELOX/ XELOX+P/ XELOX+BV (EPP*: N=967; ITT**: N=1017)
Danish: PRIMÆRE ANALYSE XELOX/XELOX+P/ XELOX+BV (EPP*: N=967; ITT**: N=1017)
English: Contact your doctor immediately if you are concerned about any of the side effects or if you notice any additional side effects not listed in the leaflet (see section 4 Possible side effects.
Danish: Kontakt din læge med det samme, hvis du er bekymret for en eller flere af bivirkningerne, eller hvis du får bivirkninger, som ikke fremgår af denne indlægsseddel (se punkt 4 Bivirkninger).
English: • blood-thinning medicines (coumarin, warfarin),
Danish: • blodfortyndende medicin (coumarin eller warfarin)
English: Rare side effects (may affect up to 1 in 1,000 people) include:
Danish: Sjældne bivirkninger (kan påvirke op til 1 ud af 1.000 personer):
English: In vitro human plasma studies have determined that capecitabine, 5'-DFCR, 5'-DFUR and 5-FU are 54%, 10%, 62% and 10% protein bound, mainly to albumin.
Danish: Humane plasmaundersøgelser in vitro har vist at capecitabin, 5′-DFCR, 5′-DFUR og 5-FU er hhv. 54 %, 10 %, 62 % og 10 % bundet til protein, hovedsageligt til albumin.
English: - first-line treatment of advanced gastric cancer in combination with a platinum based regimen (see section 5.1).
Danish: - 1. linjebehandling af fremskreden ventrikelkræft i kombination med et platinbaseret regime (se pkt.
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 DPDaktivitet.
English: Pharmacotherapeutic group: antineoplastic agents, antimetabolites, pyrimidine analogues, ATC code: L01BC06
Danish: Farmakoterapeutisk klassifikation: antineoplastiske stoffer, antimetabolitter, pyrimidinanaloger, ATCkode: L01BC06
English: The pooled analysis includes 3097 patients treated with capecitabine -containing regimens and 3074 patients treated with 5-FU-containing regimens.
Danish: Den poolede analyse omfatter 3097 patienter, som blev behandlet med regimer, som indeholdt capecitabin, og 3074 patienter, som blev behandlet med regimer, som indeholdt 5-FU.
English: This leaflet was last revised in
Danish: Denne indlægsseddel blev senest revideret den {MM/ÅÅÅÅ}
English: For the dosing schedule of XELOX and FOLFOX-4 (without addition of placebo or bevacizumab), refer to Table 7.
Danish: For doseringen af XELOX og FOLFOX-4 (uden tillæg af placebo eller bevacizumab) se tabel 7.
English: Care should be exercised when capecitabine is co-administered with 2C9 substrates (e.g., phenytoin).
Danish: Der bør udvises forsigtighed, når capecitabin administreres samtidig med 2C9substrater (fx phenytoin).
English: Dehydration may cause acute renal failure, especially in patients with pre-existing compromised renal function or when capecitabine is given concomitantly with known nephrotoxic drugs.
Danish: Dehydrering kan forårsage akut nyreinsufficiens særligt hos patienter med eksisterende kompromitteret nyrefunktion, eller når capecitabin gives samtidigt med lægemidler med kendt nefrotoksisk effekt.
English: • if you have severe liver or kidney problems,
Danish: • hvis du har alvorlige leversygdomme eller problemer med nyrerne,
English: Capecitabine should be permanently discontinued in patients who experience a severe skin reaction during treatment.
Danish: Capecitabine Accord skal seponeres permanent hos patienter, der oplever en alvorlig hudreaktion under behandlingen.
English: Tablet coating Hypromellose (6cps) Talc
Danish: Tabletovertræk Hypromellose (6cps) Talkum
English: Method of administration Capecitabine Accord tablets should be swallowed with water within 30 minutes after a meal.
Danish: Capecitabine Accord filmovertrukne tabletter skal synkes sammen med vand inden for 30 minutter efter et måltid.
English: Your doctor may want you to take a combination of 150 mg and 500 mg tablets for each dose.
Danish: Det kan være, at din læge vil have, at du for hver dosis skal tage en kombination af 150 mg, 300 mg og 500 mg tabletter.
English: For patients with partial DPD deficiency (such as those with heterozygous mutations in the DPYD gene) and where the benefits of Capecitabine Accord are considered to outweigh the risks (taking into account the suitability of an alternative non-fluoropyrimidine chemotherapeutic regimen), these patients must be treated with extreme caution and frequent monitoring with dose adjusment according to toxicity.
Danish: For patienter med delvis DPD-mangel (fx med heterozygote mutationer i DPYD-genet), og hvor fordelene ved Capecitabine Accord anses for at opveje risikoen (under hensyntagen til egnetheden af et alternativt ikke-fluorpyrimidin kemoterapeutisk regime), gælder, at de skal behandles med yderste forsigtighed og hyppig monitorering med dosisjustering i henhold til toksicitet.
English: Capecitabine Accord contains capecitabine, which itself is not a cytostatic medicine.
Danish: Capecitabine Accord indeholder capecitabin, som i sig selv ikke virker cytostatisk.
English: Table 8 Key efficacy results for the non-inferiority analysis of Study NO16966
Danish: Tabel 8 Nøgleresultaterne for effekt af non-inferioritetsanalysen af studie NO16966
English: capecitabine 1000 mg/m2 oral twice daily
Danish: Capecitabin 1.000 mg/m2 oralt 2 gange daglig
English: • In patients with known complete absence of dihydropyrimidine dehydrogenase (DPD)
Danish: • Patienter med kendt fuldstændig mangel på dihydropyrimidindehydrogenase- (DPD-) aktivitet
English: Ethnic factors: Following oral administration of 825 mg/m2 capecitabine twice daily for 14 days, Japanese patients (n=18) had about 36% lower Cmax and 24% lower AUC for capecitabine than Caucasian patients (n=22).
Danish: Etniske faktorer: Efter oral administration af 825 mg/m2 capecitabin to gange dagligt i 14 dage, havde patienter af japansk oprindelse (n=18) omkring 36 % lavere Cmax og 24 % lavere AUC for capecitabin end patienter af kaukasisk oprindelse (n=22).
English: Like all medicines, this medicine can cause side effects, although not everybody gets them.
Danish: Capecitabine Accord kan som al anden medicin give bivirkninger, men ikke alle får bivirkninger.
English: Elderly: Based on the population pharmacokinetic analysis, which included patients with a wide range of ages (27 to 86 years) and included 234 (46%) patients greater or equal to 65, age has no influence on the pharmacokinetics of 5'-DFUR and 5-FU.
Danish: Ældre patienter: Baseret på populationsfarmakokinetiske analyser, som omfattede patienter i mange aldre (27 - 86 år), og som omfattede 234 (46 %) patienter, som var mindst 65 år, spillede alderen ingen rolle for farmakokinetikken af 5'-DFUR og 5-FU.
English: Capecitabine Accord contains lactose
Danish: Capecitabine Accord indeholder lactose
English: 150 mg 300 mg 500 mg Dose per administration (mg)
Danish: 150 mg 300 mg 500 mg Dosis pr. dosering (mg)
English: Table 5 Summary of related ADRs reported in patients treated with capecitabine monotherapy
Danish: Tabel 5 Sammenfatning af relaterede bivirkninger, som blev rapporteret hos patienter behandlet med capecitabin-monoterapi
English: Table 5 lists ADRs associated with the use of capecitabine monotherapy based on a pooled analysis of safety data from three major studies including over 1900 patients (studies M66001, SO14695, and SO14796).
Danish: Tabel 5 anfører de bivirkninger, der er forbundet med anvendelsen af capecitabin-monoterapi baseret på en samlet analyse af sikkerhedsdata fra 3 store studier med flere end 1.900 patienter (studierne M66001, SO14695 og SO14796).
English: Patients with baseline neutrophil counts of <1.5 x 109/L and/or thrombocyte counts of <100 x 109/L should not be treated with capecitabine.
Danish: Patienter, som ved baseline har et neutrofiltal < 1,5 x 109/l og/eller et trombocyttal < 100 x 109/l, bør ikke behandles med capecitabin .
English: In this trial, 627 patients with metastatic colorectal carcinoma who have received prior treatment with irinotecan in combination with a fluoropyrimidine regimen as first line therapy were randomised to treatment with XELOX or FOLFOX-4.
Danish: I denne undersøgelse blev 627 patienter med metastatisk kolorektalkræft, som tidligere havde fået behandling med irinotecan i kombination med fluoropyrimidin som 1. linjebehandling, randomiseret til behandling med XELOX eller FOLFOX-4.
English: At the beginning of a treatment cycle, if a treatment delay is indicated for either capecitabine or the other medicinal product(s), then administration of all therapy should be delayed until the requirements for restarting all medicinal products are met.
Danish: Hvis det ved starten af en behandlingsserie er indiceret at udsætte enten behandlingen med Capecitabine Accord eller det andet lægemiddel/de andre lægemidler, skal behandlingen med alle lægemidler udsættes, indtil betingelserne for genoptagelse af behandling med alle lægemidler er opfyldt.
English: Always take this medicine exactly as your doctor or pharmacist has told you.
Danish: Tag altid lægemiddelt nøjagtigt efter lægens eller apotekspersonalets anvisning.
English: Table 10 Key efficacy results for the non-inferiority analysis of Study NO16967
Danish: Tabel 10 Nøgleresultater fra non-inferioritetsanalyserne af studie NO16967
English: The AUC0-∞ values in μg•h/ml were 7.75, 7.24, 24.6, 2.03 and 36.3.
Danish: AUC0-∞ værdierne (µg•time/ml var 7,75; 7,24; 24,6; 2,03 og 36,3.
English: Altered coagulation parameters and/or bleeding have been reported in patients taking capecitabine concomitantly with coumarin-derivative anticoagulants such as warfarin and phenprocoumon.
Danish: Der er rapporteret om ændrede koagulationsparametre og/eller ændret blødning hos patienter som tog capecitabin sammen med antikoagulantia af coumarintypen såsom warfarin og phenprocoumon.
English: Capecitabine can induce severe skin reactions such as Stevens-Johnson syndrome and Toxic Epidermal Necrolysis.
Danish: Capecitabine Accord kan inducere alvorlige hudreaktioner såsom Stevens-Johnsons syndrom og toksisk epidermal nekrolyse.
English: Contusion + For each term, the frequency count was based on ADRs of all grades.
Danish: Kontusion + For hver term er hyppigheden baseret på bivirkninger af alle grader.
English: Capecitabine Accord with food and drink
Danish: Brug af Capecitabine Accord sammen med mad, drikke og alkohol
English: If unscheduled laboratory assessments during a treatment cycle show that the neutrophil count drops below 1.0 x 109/L or that the platelet count drops below 75 x 109/L, treatment with capecitabine should be interrupted.
Danish: Hvis uplanlagte laboratorieresultater under en behandlingscyklus viser, at neutrofiltallet falder til under 1,0 x 109/l, eller antallet af blodplader falder til under 75 x 109/l, bør behandling med capecitabin seponeres.