FrancophonIA/ELRC3.0 huggingface dataset:
English: The following are the recommended dose modifications for toxicity.
Danish: De anbefalede dosismodifikationer for toksicitet er følgende:
English: Children and adolescents Ecansya is not indicated in children and adolescents.
Danish: Børn og unge Ecansya er ikke beregnet til børn eller unge.
English: Treatment of eye disorders should be initiated as clinically appropriate.
Danish: Klinisk relevant behandling af øjensygdomme bør initieres.
English: Breast cancer
Danish: Brystkræft
English: Capecitabine is activated via several enzymatic steps (see section 5.2).
Danish: Capecitabin aktiveres via flere enzymatiske trin (se pkt.
English: 24.4 months
Danish: 24,4 måneder
English: If unscheduled laboratory assessments during a treatment cycle show that the neutrophil count drops below 1.0 x 10
Danish: Hvis uplanlagte laboratorieresultater under en behandlingsserie viser, at neutrofiltallet falder til under 1,0 x 10
English: Capecitabine was not mutagenic in vitro to bacteria (Ames test) or mammalian cells (Chinese hamster V79/HPRT gene mutation assay).
Danish: Capecitabin var ikke mutagent in vitro overfor bakterier (Ames test) eller overfor celler fra pattedyr (kinesisk hamster V79/HPRT gene mutation assay).
English: In animal studies effects on fertility were observed (see section 5.3).
Danish: Påvirkning af fertilitet blev observeret i dyrestudier (se pkt.
English: • Grade 1
Danish: • Grad 1
English: Ecansya tablets should be swallowed whole with water within 30 minutes after a meal.
Danish: Ecansya tabletter skal synkes hele med vand senest 30 minutter efter et måltid.
English: Titanium dioxide (E171)
Danish: Titandioxid (E171)
English: Ecansya has minor or moderate influence on the ability to drive and use machines.
Danish: Ecansya påvirker i mindre eller moderat grad evnen til at føre motorkøretøj og betjene maskiner.
English: Do not crush or cut tablets.
Danish: Du må ikke dele eller knuse tabletterne.
English: Table 9 Key efficacy results for the non-inferiority analysis of Study NO16967 PRIMARY ANALYSIS
Danish: Tabel 9 Nøgleresultater fra non-inferioritetsanalyserne af studie NO16967 PRIMÆRE ANALYSE
English: You must not breast-feed if you are taking Ecansya and for 2 weeks after the last dose.
Danish: Du må ikke amme, hvis du tager Ecansya og i 2 uger efter sidste dosis.
English: In an 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: SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT
Danish: SÆRLIG ADVARSEL OM, AT LÆGEMIDLET SKAL OPBEVARES UTILGÆNGELIGT FOR BØRN
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, som kan påvirke din identifikation med fingeraftryksscanner.
English: Patients with anorexia, asthenia, nausea, vomiting or diarrhoea may rapidly become dehydrated.
Danish: Patienter med anoreksi, asteni, kvalme, opkastning eller diarré kan hurtigt blive dehydrerede.
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: Do not take Ecansya - if you are allergic to capecitabine or any of the other ingredients of this medicine (listed in section 6).
Danish: Tag ikke Ecansya - hvis du er allergisk over for capecitabin eller et af de øvrige indholdsstoffer i Ecansya (angivet i punkt 6).
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: Caution must be exercised in patients with diabetes mellitus or electrolyte disturbances, as these may be aggravated during capecitabine treatment.
Danish: Der skal iagttages forsigtighed hos patienter med diabetes mellitus eller elektrolytforstyrrelser, da disse kan forværres under behandling med capecitabin.
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, som kan påvirke patientens identifikation.
English: Therefore, in the absence of serious toxicity the dose could be increased while carefully monitoring the patient.
Danish: Derfor vil dosis kunne øges ved udeblivelse af alvorlige toksicitet, under nøje overvågning af patienten.
English: The incorporation of 5-FU also leads to inhibition of RNA and protein synthesis.
Danish: Inkorporeringen af 5-FU medfører hæmning af RNA og proteinsyntesen.
English: Diabetes mellitus or electrolyte disturbances.
Danish: Diabetes mellitus eller elektrolytforstyrrelser
English: Montagnani et al used the results from the above three studies to provide an overall analysis of randomised studies comparing FOLFIRI and XELIRI treatment regimens in the treatment of mCRC.
Danish: Montagnani et al brugte resultaterne fra de tre ovenstående studier til at fremlægge en samlet analyse af randomiserede studier, der sammenligner FOLFIRI- og XELIRI-behandlingsregimer ved behandling af metastatisk kolorektalkræft.
English: 5-FU is further catabolised by the enzyme dihydropyrimidine dehydrogenase (DPD) to the much less toxic dihydro-5-fluorouracil (FUH2).
Danish: 5-FU nedbrydes yderligere af enzymet dihydropyrimidindehydrogenase (DPD) til det meget mindre toksiske dihydro-5-fluoruracil (FUH2).
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 forekommer moderat eller svær toksicitet.
English: Following a mean duration of follow-up for the study population of 26.2 months, treatment responses were as shown below:
Danish: Behandlingsresponset efter en gennemsnitlig opfølgningsperiode for studie-populationen på 26,2 måneder er som vist nedenfor:
English: In a preplanned multivariate Cox analysis, superiority of capecitabine compared with bolus 5-FU/LV was demonstrated.
Danish: I en forudplanlagt multivariat Cox-analyse blev det vist, at capecitabin er bedre sammenlignet med bolus 5-FU/LV.
English: At the end of treatment, 37% of patients in the XELIRI and 26% of patients in the FOLFIRI arm were without evidence of the disease (p=0.56).
Danish: Ved afslutningen af behandlingen havde 37 % af patienterne i XELIRI-armen og 26 % af patienterne i FOLFIRI-armen ingen tegn på sygdommen (p = 0,56).
English: Patients with severe diarrhoea should be carefully monitored and given fluid and electrolyte replacement if they become dehydrated.
Danish: Patienter med svær diarré bør monitoreres omhyggeligt og gives væske og elektrolyttilskud, hvis de dehydreres.
English: In all clinical trials, patients were instructed to administer capecitabine within 30 minutes after a meal.
Danish: I alle kliniske undersøgelser blev patienterne instrueret i at tage capecitabin senest 30 min efter et måltid.
English: In combination with other medicines the usual dose for adults may be less than 1250 mg/m2 of body surface area, and you may need to take the tablets over a different time period (e.g. every day, with no rest period).
Danish: I kombination med andre lægemidler kan den almindelige dosis for en voksen være mindre end 1250 mg/m2 legemsoverfladeareal, og det kan være nødvendigt, at du tager tabletterne i et andet tidsinterval (for eksempel hver dag uden pause).
English: Instead, continue your regular dosing schedule and check with your doctor.
Danish: I stedet for skal du fortsætte med at tage medicinen som planlagt og tjekke med din læge.
English: Acute renal failure secondary to dehydration might be potentially fatal.
Danish: Akut nyreinsufficiens sekundært til dehydrering kan potentielt være dødeligt.
English: This may also be relevant with folic acid supplementation for folate deficiency due to the similarity between folinic acid and folic acid.
Danish: Dette kan også være relevant ved supplement med folsyre mod folatmangel på grund af ligheden mellem folinsyre og folsyre.
English: All indications:
Danish: Alle indikationer
English: Dehydration should be prevented or corrected at the onset.
Danish: Dehydrering bør forebygges eller korrigeres så snart, den forekommer.
English: 10.4 months
Danish: 10,4 måneder
English: These results suggest an interaction, probably due to an inhibition of the cytochrome P450 2C9 isoenzyme system by capecitabine.
Danish: Disse resultater tyder på en interaktion, sandsynligvis på grund af capecitabins hæmning af cytokrom P450 2C9 isoenzymsystemet.
English: The requirements for submission of PSURs for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal.
Danish: Kravene for fremsendelse af periodiske, opdaterede sikkerhedsindberetninger for dette lægemiddel fremgår af listen over EU-referencedatoer (EURD list), som fastsat i artikel 107c, stk. 7, i direktiv 2001/83/EF, og alle efterfølgende opdateringer offentliggjort på Det Europæiske Lægemiddelagenturs hjemmeside http://www.ema.europa.eu.
English: Toxic leukoencephalopathy (very rare)
Danish: Toksisk leukoencefalopati (meget sjælden)
English: Food interaction
Danish: Interaktion med føde
English: Capecitabine was devoid of hepatic and CNS toxicities.
Danish: Capecitabin var fri for hepatisk og CNS toksicitet.
English: Creatinine clearance was found to influence the systemic exposure to 5'-DFUR (35% increase in AUC when creatinine clearance decreases by 50%) and to FBAL (114% increase in AUC when creatinine clearance decreases by 50%).
Danish: Creatininclearance påvirkede den systemiske eksponering af 5'-DFUR (35 % stigning i AUC, når creatininclearance aftog med 50 %) og FBAL (114 % stigning i AUC, når creatininclearance aftog med 50 %).
English: No information is available on hepatic impairment due to cirrhosis or hepatitis.
Danish: Der er ingen tilgængelig data vedrørende leverinsufficiens på grund af cirrhose eller hepatitis.
English: Ecansya contains capecitabine, which itself is not a cytostatic medicine.
Danish: Ecansya indeholder capecitabin, som i sig selv ikke virker cytostatisk.
English: Day 1, prior to FOLFOX-4, every 2 weeks
Danish: Dag 1, før FOLFOX-4, hver 2. uge
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: Gender, presence or absence of liver metastasis at baseline, Karnofsky Performance Status, total bilirubin, serum albumin, ASAT and ALAT had no statistically significant effect on the pharmacokinetics of 5'-DFUR, 5-FU and FBAL.
Danish: Køn, tilstedeværelse eller fravær af levermetastaser ved baseline, Karnofsky Performance Status, total bilirubin, serum-albumin, ASAT og ALAT havde ingen statistisk signifikant effekt på farmakokinetikken af 5'-DFUR, 5-FU og FBAL.
English: Currently, no comparative data are available on capecitabine monotherapy in colorectal cancer in comparison with first line combination regimens.
Danish: Der er for tiden ingen data om capecitabin-monoterapi af kolorektalkræft sammenlignet med 1. linjekombinationsbehandlinger.
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 behandlingsserie.
English: If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Danish: Hvis duer gravid, tror du er gravid, påtænker at blive gravid eller hvis du ammer, bør du snakke med din læge eller apoteketpersonalet inden du tager dette lægemiddel.
English: ( 1/100 to < 1/10), uncommon ( 1/1,000 to < 1/100), rare (≥1/10,000 to <1/1,000), very rare (<1/10,000).
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) meget sjælden (<1/10.000).
English: These dose adjustment recommendations for renal impairment apply both to monotherapy and combination use (see also section "Elderly" below).
Danish: Rekommendationer for dosisjustering ved nedsat nyrefunktion gælder både for monoterapi og for kombinationsbehandling (se også afsnittet om ældre nedenfor).
English: Capecitabine dose reduction decreases systemic exposure to 5-FU more than dose-proportionally, due to non-linear pharmacokinetics for the active metabolite.
Danish: Dosisreduktion af capecitabin nedsætter den systemiske eksponering for 5-FU mere end svarende til dosisproportionaliteten på grund af den aktive metabolits non-lineære farmakokinetik.
English: Further catalytic activation of 5'-DFUR then occurs by thymidine phosphorylase (ThyPase).
Danish: Den videre katalytiske aktivering af 5'-DFUR sker derefter ved hjælp af thymidinfosforylase (ThyPase).
English: See section 2 "Ecansya contains lactose".
Danish: Se punkt 2 ”Ecansya indeholder vandfri lactose”.
English: The sequential enzymatic biotransformation of capecitabine to 5-FU leads to higher concentrations within tumour tissues.
Danish: Den sekventielle enzymatiske biotransformation af capecitabin til 5-FU fører til højere koncentrationer inden i tumorcellerne.
English: When capecitabine and cisplatin are used in combination, the use of vitamin B6 (pyridoxine) is not advised for symptomatic or secondary prophylactic treatment of hand-foot syndrome, because of published reports that it may decrease the efficacy of cisplatin.
Danish: Hvis capecitabin og cisplatin anvendes i kombination, frarådes anvendelse af vitamin B6 (pyridoxin) til behandling af symptomatisk eller sekundær profylaktisk behandling af hånd- og fodsyndrom, da der er offentliggjort meddelelser om, at det kan nedsætte virkningen af cisplatin.
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 7.
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 7).
English: The parameters of capecitabine, 5'-deoxy-5-fluorocytidine (5'-DFCR) and 5'-deoxy-5-fluorouridine (5'-DFUR) measured on days 1 and 14 were similar.
Danish: Parametrene for capecitabin, 5'-deoxy-5-fluorocytidin (5'-DFCR) og 5'-deoxy-5-fluorouridin (5'-DFUR) var ens på dag 1 og 14.
English: After oral administration, capecitabine is rapidly and extensively absorbed, followed by extensive conversion to the metabolites, 5'-DFCR and 5'-DFUR.
Danish: Efter oral administration absorberes capecitabin hurtigt og fuldstændigt efterfulgt af en omfattende omdannelse til metabolitterne 5'-DFCR og 5‘-DFUR.
English: Patients with low or absent DPD activity, an enzyme involved in fluorouracil degradation, are at increased risk for severe, life-threatening, or fatal adverse reactions caused by fluorouracil.
Danish: Patienter med lav eller manglende aktivitet af DPD, et enzym, der er involveret i nedbrydningen af fluoruracil, har en højere risiko for svære, livstruende eller dødelige bivirkninger forårsaget af fluoruracil.
English: Since current safety and efficacy data are based upon administration with food, it is recommended that capecitabine be administered with food.
Danish: Da sikkerheds- og effektdata er baseret på administration sammen med maden anbefales det at tage capecitabin sammen med et måltid.
English: Other side-effects seen in this setting are the following:
Danish: Andre bivirkninger, der kan ses i den sammenhæng er:
English: In reproductive toxicity studies in animals, capecitabine administration caused embryolethality and teratogenicity.
Danish: I reproduktionstoksicitetsundersøgelser på dyr forårsagede administration af capecitabin embryoletalitet og teratogenicitet.
English: Administration with food decreases the rate of capecitabine absorption, but only results in a minor effect on the AUC of 5'-DFUR, and on the AUC of the subsequent metabolite 5-FU.
Danish: Administration sammen med føde nedsætter hastigheden af capecitabinabsorptionen, men medfører kun mindre virkning på 5‘-DFURs AUC og på AUC af den efterfølgende metabolit 5-FU.
English: Ecansya is available in blisters (Aluminium-aluminium or PVC/PVdC-aluminium) containing 30, 60 or 120 film-coated tablets.
Danish: Ecansya fås i blister (aluminium-aluminium eller PVC/PVdC-aluminium) indeholdende 30, 60 eller 120 filmovertrukne tabletter.
English: It is not known whether capecitabine is excreted in human breast milk.
Danish: Det er ukendt, om capecitabin udskilles i human mælk.
English: Haematology Patients with baseline neutrophil counts of <1.5 x 10
Danish: Hæmatologi Patienter, som ved baseline har et neutrofiltal < 1,5 x 10
English: There are no pharmacokinetic data on patients with severe hepatic impairment.
Danish: Der findes ingen farmakokinetiske data om patienter med svær leverinsufficiens.
English: 9/L should not be treated with capecitabine.
Danish: 9/l, bør ikke behandles med capecitabin.
English: Capecitabine has also been used in combination with oxaliplatin for the treatment of advanced gastric cancer.
Danish: Capecitabin har også været anvendt i kombination med oxaliplatin til behandling af fremskreden ventrikelkræft.
English: An effective method of contraception should be used during treatment and for 6 months after the last dose of capecitabine.
Danish: En effektiv præventionsmetode skal bruges under behandling og i 6 måneder efter sidste dosis af capecitabin.
English: HR (95% CI)
Danish: HR (95% KI)
English: Full dose
Danish: Fuld dosis
English: XELOX or XELOX+ Bevacizumab
Danish: XELOX eller XELOX+ Bevacizumab
English: In the event of accidental administration of brivudine to patients being treated with capecitabine, effective measures should be taken to reduce the toxicity of capecitabine.
Danish: I tilfælde af utilsigtet administration af brivudin til patienter, der behandles med capecitabin, bør der tages effektive foranstaltninger for at reducere toksiciteten af capecitabin.
English: The median overall survival was 10.0 months in cisplatin-based regimens and 10.4 months in oxaliplatin-based regimens.
Danish: Den mediane samlede overlevelse var 10,0 måneder for de cisplatinbaserede regimer og 10,4 måneder for de oxaliplatin-baserede regimer.
English: The efficacy data is based on a median observation time of 59 months for OS and 57 months for DFS.
Danish: Effektdata er baseret på en gennemsnitlig observationstid på 59 måneder for samlet overlevelse og 57 måneder for sygdomsfri overlevelse.
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS BLISTER
Danish: MINDSTEKRAV TIL MÆRKNING PÅ BLISTERKORT ELLER BLISTERSTRIPS BLISTER
English: MARKETING AUTHORISATION NUMBER (S)
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (NUMRE)
English: No significant differences occurred in the exposure to other metabolites (5'-DFCR, 5'-DFUR, and 5-FU).
Danish: Der forekom ingen signifikant forskel i eksponeringen af andre metabolitter (5´-DFCR, 5´-DFUR og 5-FU).
English: A comparison of XELOX plus bevacizumab versus FOLFOX-4 plus bevacizumab was a pre-specified exploratory analysis.
Danish: En sammenligning af XELOX plus bevacizumab versus FOLFOX-4 plus bevacizumab var en præspecificeret eksplorativ analyse.
English: There are no studies in pregnant women using capecitabine; however, it should be assumed that capecitabine may cause foetal harm if administered to pregnant women.
Danish: Der er ingen data fra anvendelse af capecitabin til gravide kvinder, men det antages imidlertid, at capecitabin kan forårsage føtale skader, hvis det gives til gravide.
English: Only after being absorbed by the body is it changed into an active anti-cancer medicine (more in tumour tissue than in normal tissue).
Danish: Kun når det er optaget i kroppen ændres det til et aktivt anti-cancer stof (fortrinsvis i svulstvæv).
English: For the dosing schedule of XELOX and FOLFOX-4 (without addition of placebo or bevacizumab), refer to table 6.
Danish: For doseringen af XELOX og FOLFOX-4 (uden tillæg af placebo eller bevacizumab) se tabel 6.
English: All grades
Danish: Alle grader
English: The Ecansya pivotal studies included females of childbearing potential and males only if they agreed to use an acceptable method of birth control to avoid pregnancy for the duration of the study and for a reasonable period thereafter.
Danish: De pivotale Ecansya-studier inkluderede kun kvinder i den fertile alder og mænd, hvis de indgik i en aftale om at anvende en egnet præventionsmetode for at undgå graviditet under studiet og i en passende periode efter studiet.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE YDRE KARTON
English: In the study published by Skof et al, patients were randomised to receive either FOLFIRI or XELIRI.
Danish: I studiet publiceret af Skof et al blev patienterne randomiseret til enten at få FOLFIRI eller XELIRI.
English: Adjuvant treatment in patients with stage III colon cancer is recommended for a duration of 6 months.
Danish: Adjuverende behandling af patienter med stadium III kolonkræft anbefales i en periode på 6 måneder.
English: As this medicinal product contains anhydrous lactose as an excipient, patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicine.
Danish: Da dette lægemiddel indeholder vandfri lactose som hjælpestof, bør patienter med arvelig galactoseintolerans, en særlig form for hereditær lactasemangel (Total Lactase deficiency) eller glucose/galactosemalabsorption ikke anvende dette lægemiddel.
English: The enzymes involved in the catalytic activation are found in tumour tissues but also in normal tissues, albeit usually at lower levels.
Danish: Enzymerne, som er involverede i den katalytiske aktivering findes i tumorvæv, men også i normalt væv, om end i lavere koncentrationer.
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: In addition, during a 13-week study, atrophic and degenerative changes occurred in reproductive organs of male mice; however these effects were reversible after a drug-free period (see section 4.6).
Danish: Desuden indtraf der i en 13-ugers undersøgelse atrofiske og degenerative forandringer i reproduktionsorganerne hos hanmus; forandringerne var dog reversible efter en stoffri periode (se pkt.
English: Accord Healthcare Limited, Sage house, 319 Pinner Road, Harrow HA1 4HF, United Kingdom Pharmacare Premium Limited, HHF 003, Hal Far Industrial Estate Birzebbugia, BBG 3000, Malta KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia
Danish: Accord Healthcare Limited, Sage house, 319 Pinner Road, Harrow HA1 4HF, Storbritannien Pharmacare Premium Limited, HHF 003, Hal Far Industrial Estate Birzebbugia, BBG 3000, Malta KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenien
English: - first-line treatment of advanced gastric cancer in combination with a platinum based regimen (see section 5.1).
Danish: - for 1. linjebehandling af fremskreden ventrikelkræft i kombination med et platinbaseret regime (se pkt.