FrancophonIA/ELRC3.0 huggingface dataset:
English: There are no side-effects caused by stopping treatment with capecitabine.
Danish: Der er ingen bivirkninger forbundet med at stoppe behandlingen med capecitabin.
English: The safety profiles of capecitabine monotherapy for the metastatic breast cancer, metastatic colorectal cancer and adjuvant colon cancer populations are comparable.
Danish: Sikkerhedsprofilen for capecitabin-monoterapi i populationerne med metastatisk brystkræft, metastatisk kolorektalkræft og adjuverende kolonkræft er sammenlignelige.
English: Do not take the missed dose at all.
Danish: Tag ikke den glemte dosis.
English: There was a small increase in plasma concentrations of capecitabine and one metabolite (5'-DFCR); there was no effect on the 3 major metabolites (5'-DFUR, 5-FU and FBAL).
Danish: Der var en mindre stigning i plasmakoncentrationerne af capecitabin og en af metabolitterne (5'DFCR), men ingen virkning på de 3 hovedmetabolitter (5'DFUR, 5-FU og FBAL).
English: The XELIRI has been compared with 5-FU + irinotecan (FOLFIRI) in three randomised studies in patients with metastatic colorectal cancer.
Danish: XELIRI er blevet sammenlignet med 5-fluoruracil + irinotecan (FOLFIRI) hos patienter med metastatisk kolorektalkræft i tre randomiserede studier.
English: Overall response rate was 49% in the XELIRI and 48% in the FOLFIRI arm (p=0.76).
Danish: Samlet responsrate var 49 % i XELIRI-armen og 48 % i FOLFIRI-armen (p = 0,76).
English: The study contained two parts: an initial 2-arm part in which 634 patients were randomised to two different treatment groups, including XELOX or FOLFOX-4, and a subsequent 2x2 factorial part in which 1401 patients were randomised to four different treatment groups, including XELOX plus placebo, FOLFOX-4 plus placebo, XELOX plus bevacizumab, and FOLFOX-4 plus bevacizumab.
Danish: Studiet indeholdte to dele: En initial 2-arms del, i hvilken 634 patienter blev randomiseret i to forskellige behandlingsgrupper, inkluderende XELOX eller FOLFOX-4, og efterfølgende 2*2 design, i hvilken 1.401 patienter blev randomiseret til 4 forskellige behandlingsgrupper, inkluderende XELOX plus placebo, FOLFOX-4 plus placebo, XELOX plus bevacizumab og FOLFOX-4 plus bevacizumab.
English: The AUC0- values in g•h/ml were 7.75, 7.24, 24.6, 2.03 and 36.3.
Danish: AUC0- værdierne (g•time/ml var 7,75; 7,24; 24,6; 2,03 og 36,3.
English: Some of the ADRs are reactions commonly seen with the combination medicinal product (e.g. peripheral sensory neuropathy with docetaxel or oxaliplatin, hypertension seen with bevacizumab); however an exacerbation by capecitabine therapy cannot be excluded.
Danish: Nogle af bivirkningerne er reaktioner, som er almindeligt observeret med kombinationslægemidlet (f.eks. perifer sensorisk neuropati med docetaxel eller oxaliplatin, hypertension set med bevacizumab); en forværring ved capecitabin-behandlingen kan dog ikke udelukkes.
English: For patients with partial DPD deficiency (such as those with heterozygous mutations in the DPYD gene) and where the benefits of Ecansya 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 adjustment according to toxicity.
Danish: For patienter med delvis DPD-mangel (fx med heterozygote mutationer i DPYD-genet), og hvor fordelene af Ecansya 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 is first metabolised by hepatic carboxylesterase to 5'-DFCR, which is then converted to 5-DFUR by cytidine deaminase, principally located in the liver and tumour tissues.
Danish: Capecitabin metaboliseres først af hepatisk carboxylesterase til 5'-DFCR, som derefter omdannes til 5'-DFUR af cytidindeaminase, som fortrinsvis findes i leveren og i tumorvæv.
English: There is evidence that the metabolism of 5-FU in the anabolic pathway blocks the methylation reaction of deoxyuridylic acid to thymidylic acid, thereby interfering with the synthesis of deoxyribonucleic acid (DNA).
Danish: Der er holdepunkter for at metabolismen af 5-FU i den anabolske pathway blokerer metyleringen af desoxyuridylsyre til thymidylssyre og derved interfererer med desoxyribonukleinsyresyntesen (DNA).
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 medicinal products.
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: 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: 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 2C9-substrater (fx phenytoin).
English: Capecitabine is a non-cytotoxic fluoropyrimidine carbamate, which functions as an orally administered precursor of the cytotoxic moiety 5-fluorouracil (5-FU).
Danish: Capecitabin er et non-cytotoksisk fluorpyrimidincarbamat, som virker som en oral administreret prækursor for det cytotoksiske 5- fluorouracil (5-FU).
English: Placebo or Bevacizumab
Danish: Placebo eller Bevacizumab
English: Posology adjustments during treatment
Danish: Dosisjusteringer under behandlingen
English: In human cancer xenograft models capecitabine demonstrated a synergistic effect in combination with docetaxel, which may be related to the upregulation of thymidine phosphorylase by docetaxel.
Danish: I humane cancerxenotransplantationsmodeller har capecitabin vist en synergistisk effekt i kombination med docetaxel, som kan være relateret til docetaxels opregulering af thymidinfosforylase.
English: Reduced dose
Danish: Reduceret dosis
English: Ask your pharmacist how to throw away medicines you no longer use.
Danish: Spørg apotekspersonalet hvordan du skal bortskaffe medicinrester.
English: Visual acuity reduced, Diplopia
Danish: Nedsat visual skarphed, Diplopi
English: Aluminium/aluminium or PVC/PVdC/aluminium blister containing 10 film-coated tablets.
Danish: Aluminium/aluminium- eller PVC/PVdC/aluminium-blistere indeholdende 10 filmovertrukne tabletter.
English: Detailed information on this medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu.
Danish: Yderligere information om dette lægemiddel findes på Det Europæiske Lægemiddelagenturs hjemmeside http://www.ema.europa.eu
English: 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: 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: Elderly.
Danish: Ældre.
English: Dose reduction should be applied as necessary (see section 4.2).
Danish: Dosis skal reduceres om nødvendigt (se pkt.
English: 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: 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: Body System Very Common
Danish: Systemorgan-klasse Meget almindelig
English: The following covariates were statistically significantly associated with a decreased risk of developing diarrhoea: increasing cumulative capecitabine dose (0.1*kg) and increasing relative dose intensity in the first six weeks.
Danish: Følgende kovarianter var statistisk signifikant associeret med en faldende risiko for udviklingen af diarré: øget kumulativ capecitabin-dosis (0,1 *kg) og med stigende relativ dosisintensitet i de første seks uger.
English: If grade 2 (or higher) dehydration occurs, capecitabine treatment should be immediately interrupted and the dehydration corrected.
Danish: Ved dehydrering af grad 2 (eller højere), bør behandlingen med capecitabin straks seponeres, og dehydreringen korrigeres.
English: What you need to know before you take Ecansya 3.
Danish: Det skal du vide, før du begynder at tage Ecansya 3.
English: Some of these side effects are more common when capecitabine is used with other medicines for the treatment of cancer.
Danish: Nogle af disse bivirkninger er mere almindelige, når capecitabin bruges sammen med anden kræftmedicin.
English: For those toxicities considered by the treating physician to be unlikely to become serious or life-threatening, e.g. alopecia, altered taste, nail changes, treatment can be continued at the same dose without reduction or interruption.
Danish: For de toksiciteter, for hvilke den behandlende læge anser det for usandsynligt, at disse kan udvikle sig til at blive alvorlige eller livstruende, som f.eks. alopeci, smagsændringer og negleforandringer, kan behandlingen fortsættes med uændret dosis uden dosisreduktion eller behandlingsafbrydelse.
English: Treatment with brivudine can be started 24 hours after the last dose of capecitabine.
Danish: Behandling med brivudin kan initieres 24 timer efter sidste dosis af capecitabin.
English: Toxicity grades* Dose changes within a treatment cycle Dose adjustment for next cycle/dose (% of starting dose)
Danish: Dosisjustering for næste serie/dosis (% af begyndelsesdosis)
English: Capecitabine in combination therapy
Danish: Capecitabin i kombinationsbehandling
English: Oxaliplatin on Day 1, every 2 weeks Leucovorin on Days 1 and 2, every 2 weeks
Danish: Oxaliplatin på dag 1, hver 2. uge Leucovorin på dag 1 og 2, hver 2.
English: Concomitant use of allopurinol with capecitabine should be avoided.
Danish: Samtidig anvendelse af allopurinol og capecitabin bør undgås.
English: You must not take brivudine (an anti-viral medicine for the treatment of shingles or chickenpox) at the same time as capecitabine treatment (including during any rest periods when you are not taking any capecitabine tablets).
Danish: Du må ikke tage brivudin (et lægemiddel mod virus til behandling af helvedesild eller skoldkopper) samtidig med du får capecitabin-behandling (dette gælder også perioder, hvor du holder pause og ikke tager capecitabin tabletter).
English: Dehydration.
Danish: Dehydrering
English: For terms marked with a “+”, the frequency count was based on grade 3-4 ADRs.
Danish: For termer markeret med ”+” er hyppigheden baseret på bivirkninger af grad 3-4.
English: Patients taking phenytoin concomitantly with capecitabine should be regularly monitored for increased phenytoin plasma concentrations.
Danish: Patienter, som tager phenytoin og capecitabin samtidigt, skal kontrolleres regelmæssigt mht. stigninger i phenytoin-plasmakoncentrationerne.
English: What Ecansya contains - The active substance is capecitabine.
Danish: Ecansya indeholder: - Aktivt stof: capecitabin.
English: Allopurinol: interactions with allopurinol have been observed for 5-FU; with possible decreased efficacy of 5-FU.
Danish: Der er set interaktion mellem allopurinol og 5-FU, med mulig nedsat effekt af 5-FU.
English: ADRs are added to the appropriate frequency grouping according to the overall incidence from the pooled analysis.
Danish: Bivirkningerne er anført i passende frekvensgruppering ud fra den overordnede hyppighed i den samlede analyse.
English: Patients were randomised to receive either FOLFIRI plus bevacizumab (Arm-A, n=167) or XELIRI plus bevacizumab (Arm-B, n-166).
Danish: FOLFIRI plus bevacizumab (arm-A, n=167) eller XELIRI plus bevacizumab (arm-B, n=166).
English: According to immunohistochemical studies, thymidine phosphorylase appears to be in large part localised in tumour stromal cells.
Danish: I henhold til immunohistokemiske studier synes thymidinfosforylase hovedsageligt lokaliseret i stromale tumorceller.
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 fluorpyrimidin som 1. linjebehandling, randomiseret til behandling med XELOX eller FOLFOX-4.
English: Posology adjustments for special populations
Danish: Dosisjusteringer for særlige populationer:
English: Brivudine must not be administered concomitantly with capecitabine.
Danish: Brivudin må ikke administreres samtidig med capecitabin.
English: If no toxicity is observed in patients 60 years of age treated with a reduced capecitabine starting dose in combination with docetaxel, the dose of capecitabine may be cautiously escalated to 1250 mg/m2 twice daily.
Danish: Hvis der ikke ses toksicitet hos patienter  60 år, som behandles med en nedsat initialdosis af capecitabin i kombination med docetaxel, kan capecitabin-dosis med forsigtighed øges til 1.250 mg/m2 to gange dagligt.
English: There must be at least a 4-week waiting period between end of treatment with brivudine and start of capecitabine therapy.
Danish: Der skal være en periode på mindst 4 uger mellem endt behandling med brivudin og initieringen af capecitabinbehandling.
English: Oxaliplatin on Day 1, every 3 weeks Capecitabine oral twice daily for 2 weeks (followed by 1 week offtreatment)
Danish: Oxaliplatin på dag 1, hver 3. uge Capecitabin oral to gange daglig i 2 uger (efterfulgt af 1 uge uden behandling)
English: In addition to the above, when Ecansya is used alone, very common side effects, which may affect more than 1 in 10 people are: - abdominal pain - rash, dry or itchy skin - tiredness - loss of appetite (anorexia)
Danish: Udover dette kan Ecansya, når det anvendes alene, have følgende meget almindelige bivirkninger, som kan påvirke flere end 1 ud af 10 personer: - mavesmerter - udslæt, tør eller kløende hud - træthed - appetitløshed
English: cisplatin, irinotecan), - medicines used to treat folic acid deficiency.
Danish: cisplatin, irinotecan) - lægemidler til behandling af folsyremangel.
English: Hypo- or hypercalcaemia.
Danish: Hypo- eller hyperkalcæmi
English: If grade 2 or 3 hand-foot syndrome occurs, administration of capecitabine should be interrupted until the event resolves or decreases in intensity to grade 1.
Danish: Hvis der optræder grad 2 eller 3 af hånd- og fodsyndrom skal behandlingen med capecitabin afbrydes indtil symptomerne forsvinder eller er aftaget i intensitet til grad 1.
English: The frequency of the heterozygous DPYD*2A genotype in the DPYD gene in Caucasian patients is around 1%, 1.1% for c.2846A>T, 2.6-6.3% for c.1236G>A/HapB3 variants and 0.07 to 0.1% for c.1679T>G.
Danish: Frekvensen af den heterozygote DPYD*2A genotype i DPYD genet hos kaukasiske patienter er omkring 1% (1,1% for c.2846A>T, 2,6-6,3% for c.1236G>A/HapB3 varianter og 0,07 til 0,1% for c.1679T>G).
English: Ecansya dose calculations
Danish: Ecansya-dosisberegninger
English: If you stop taking Ecansya
Danish: Hvis du holder op med at tage Ecansya
English: Cardiovascular toxicity (e.g. PR- and QT-interval prolongation) was detectable in cynomolgus monkeys after intravenous administration (100 mg/kg) but not after repeated oral dosing (1379 mg/m2/day).
Danish: Der blev set kardiovaskulær toksicitet (f.eks. forlængelse af PR- og QT-intervallet) hos cynomolgusabe efter intravenøs administration (100 mg/kg), men ikke efter gentagen oral dosering (1.379 mg/m2/dag).
English: Following oral administration of capecitabine to patients with colorectal cancer, the ratio of 5-FU concentration in colorectal tumours to adjacent tissues was 3.2 (ranged from 0.9 to 8.0).
Danish: Efter oral administration af capecitabin til patienter med kolorektalkræft var forholdet mellem koncentrationen af 5-FU i de kolorektale tumorer og i de tilstødende væv 3,2 (spændvidde: 0,9 - 8,0).
English: The time to peak plasma concentrations (Tmax in hours) were 1.50, 2.00, 2.00, 2.00 and 3.34.
Danish: Tiden indtil peak-plasmakoncentrationen (Tmax, timer) var 1,50; 2,00; 2,00; 2,00 og 3,34.
English: There is some evidence that dexpanthenol is effective for hand-foot syndrome prophylaxis in patients treated with Ecansya.
Danish: Der er nogen evidens for, at dexpanthenol er virksomt som profylakse mod hånd- og fodsyndrom hos patienter, der behandles med Ecansya.
English: If you have taken brivudine you must wait for at least 4 weeks after stopping brivudine before starting to take capecitabine.
Danish: Hvis du har taget brivudin, skal du vente mindst 4 uger efter endt behandling med brivudin før du må starte behandling med capecitabin.
English: -2nd appearance
Danish: ved 2. forekomst
English: Two examples are provided here: A person whose body weight is 64 kg and height is 1.64 m has a body surface area of 1.7 m2 and should take 4 tablets of 500 mg and 1 tablet of 150 mg two times daily.
Danish: Her følger to eksempler: En person, som vejer 64 kg, og som er 1,64 m høj, har et legemsoverfladeareal på 1,7 m2 og skal tage 4 tabletter á 500 mg og 1 tablet á 150 mg to gange dagligt.
English: Do not use this medicine after the expiry date which is stated on the carton and blister after EXP.
Danish: Brug ikke lægemidlet efter den udløbsdato, der står på æsken efter EXP. Udløbsdatoen er den sidste dag i den nævnte måned.
English: Vertigo, Ear pain
Danish: Vertigo, Øresmerter
English: Ecansya contains lactose
Danish: Ecansya indeholder vandfri lactose
English: If you cannot swallow Ecansya tablets whole, tell your healthcare provider.
Danish: Hvis du ikke kan sluge Ecansya tabletterne hele, skal du kontakte din læge eller sygeplejerske.
English: Thymidine phosphorylase activity was measured and found to be 4 times greater in primary colorectal tumour than in adjacent normal tissue.
Danish: Thymidinfosforylaseaktiviteten var 4 gange større i primært kolorektalt tumorvæv end i det tilstødende normale væv.
English: Not applicable.
Danish: Ikke relevant
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 capecitabin 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: In repeat-dose toxicity studies, daily oral administration of capecitabine to cynomolgus monkeys and mice produced toxic effects on the gastrointestinal, lymphoid and haemopoietic systems, typical for fluoropyrimidines.
Danish: I toksicitetsforsøg med gentagne doser førte dagligt oral administration af capecitabin til cynomolgusabe og mus til toksiske virkninger, typiske for fluorpyrimidiner, på det gastrointestinale, det lymfoide og det hæmatopoietiske system.
English: Febrile neutropenia, Pancytopenia, Granulocytopenia, Thrombocytopenia, Leukopenia, Haemolytic anaemia, International Normalised Ratio (INR) increased/ Prothrombin time prolonged
Danish: Febril neutropeni, Pancytopeni, Granulocytopeni, Thrombo-cytopeni, Leukopeni, Hæmolytisk anæmi, Øget international normaliseret ratio (INR)/forlænget protrombintid
English: If you forget to take Ecansya
Danish: Hvis du har glemt at tage Ecansya
English: A two-year mouse carcinogenicity study produced no evidence of carcinogenicity by capecitabine.
Danish: Et to-års carcinogenicitetsstudie på mus gav ikke holdepunkter for at capecitabin var carcinogent.
English: Hepatic failure (rare), Cholestatic hepatitis (rare)
Danish: Leversvigt (sjælden), Kolestatisk hepatitis (sjælden)
English: Phase I studies evaluating the effect of capecitabine on the pharmacokinetics of either docetaxel or paclitaxel and vice versa showed no effect by capecitabine on the pharmacokinetics of docetaxel or paclitaxel (Cmax and AUC) and no effect by docetaxel or paclitaxel on the pharmacokinetics of 5'-DFUR.
Danish: Fase I-studier, som evaluerede capecitabins effekt på enten docetaxels eller paclitaxels farmakokinetik og vice versa, viste ingen effekt af capecitabin på hverken docetaxels eller paclitaxels farmakokinetik (Cmax og AUC) og inden effekt af docetaxel eller paclitaxel på 5'-DFUR's farmakokinetik.
English: Standard antidiarrhoeal treatments (e.g. loperamide) may be used.
Danish: Der kan anvendes standardbehandling imod diarré (f.eks. loperamid).
English: Based on a pharmacokinetic study in cancer patients with mild to severe renal impairment, there is no evidence for an effect of creatinine clearance on the pharmacokinetics of intact drug and 5-FU.
Danish: Baseret på et farmakokinetisk studie hos kræftpatienter med let til svær nyreinsufficiens er der ingen tegn på effekt af creatininclearance på farmakokinetikken af det intakte lægemiddel og 5-FU.
English: Other medicines and Ecansya
Danish: Brug af anden medicin sammen med Ecansya
English: These adverse reactions may be more common in patients with a prior history of coronary artery disease.
Danish: Disse bivirkninger kan optræde hyppigere hos patienter med tidligere koronarinsufficiens.
English: If you have an unrecognised DPD deficiency and take Ecansya, you are at an increased risk of acute early-onset of severe forms of the side effects listed under section 4 Possible side effects.
Danish: Hvis du har DPD-mangel uden at vide det og tager Ecansya, har du en øget risiko for akut tidlig indtræden af bivirkningerne, anført i punkt 4 Bivirkninger, i svær form.
English: Capecitabine is contraindicated in patients with severe renal impairment (creatinine clearance below 30 ml/min [Cockcroft and Gault] at baseline).
Danish: Capecitabin er kontraindiceret til patienter med svær nedsat nyrefunktion (creatininclearance under 30 ml/min ved baseline) Cockcroft og Gault.
English: Film-coating
Danish: Filmovertrækket
English: A person whose body weight is 80 kg and height is 1.80 m has a body surface area of 2.00 m2 and should take 5 tablets of 500 mg two times daily.
Danish: En person, som vejer 80 kg, og som er 1,80 m høj, har et legemsoverfladeareal på 2,00 m2 og skal tage 5 tabletter á 500 mg to gange dagligt.
English: See also interaction with coumarin-derivative anticoagulants below, and section 4.4.
Danish: Se også interaktion med antikoagulerende lægemidler af coumarintypen nedenfor samt under pkt.
English: In embryotoxicity and teratogenicity studies in mice, dose-related increases in foetal resorption and teratogenicity were observed.
Danish: I embryotoksiske forsøg og i teratogenicitetsforsøg hos mus blev der set dosisrelaterede stigninger i føtal resorption og teratogenicitet.
English: Median overall survival time was 703 days (95% CI: 671; 745) in patients treated with capecitabine-containing regimens and 683 days (95% CI: 646; 715) in patients treated with 5-FU-containing regimens.
Danish: Den mediane samlede overlevelse var 703 dage (95 % konfidensinterval: 671, 745) hos patienter, som blev behandlet med regimer, der indeholdt capecitabin og 683 dage (95 % konfidensinterval: 646, 715) hos patienter, som blev behandlet med regimer, der indeholdt 5-FU.