natgillin/translations-raw huggingface dataset:
Hver filmovertrukket tablet indeholder 150 mg, 300 mg eller 500 mg capecitabin. 
Each film-coated tablet contains 150 mg, 300 mg or 500 mg capecitabine.
- Stevens-Johnsons syndrom: hvis du oplever smertefuldt rødt eller lilla udslæt, der spreder sig og danner blistre og/eller andre læsioner, der opstår i slimhinderne (fx mund eller læber), især hvis du tidligere har været følsom over for lys, haft infektioner i luftvejene (fx bronkitis) og/eller feber. 
- Steven-Johnson syndrome: if you experience painful red or purplish rash that spreads and blisters and/or other lesions begin to appear in the mucous membrane (e.g. mouth and lips), in particular if you had before light sensitivity, infections of the respiratory system (e.g. bronchitis) and/or fever.
Tabel 3 Dosisreduktion af capecitabin (3-ugers serier eller kontinuerlig behandling) Toksicitet graduering* 
Table 3 Capecitabine dose reduction schedule (3 weekly cycle or continuous treatment)
Den mediane tid til progression var 140 dage (capecitabin) vs. 144 dage (Mayo regime). 
The median time to progression was 140 days (capecitabine) vs. 144 days (Mayo regimen).
Capecitabin var dog ligesom andre nukleosidanaloger (dvs. 5-FU) klastogent på humane lymfocytter (in vitro), og der var et positivt trend i in vivo mikronukleustesten på mus. 
However, similar to other nucleoside analogues (ie, 5-FU), capecitabine was clastogenic in human lymphocytes (in vitro) and a positive trend occurred in mouse bone marrow micronucleus tests (in vivo).
Tid indtil progressiv sygdom var længere i kombinationsarmen med capecitabin + docetaxel (p < 0,0001). 
Time to progressive disease was superior in the capecitabine + docetaxel combination arm (p<0.0001).
Almindelig Alle grader 
Common All grades
I alle studierne kombineret var følgende kovarianter statistisk signifikant associeret med en øget risiko for udviklingen af håndog fodsyndrom: stigende capecitabin-startdosis (gram), faldende kumulativ capecitabin-dosis (0,1 *kg), stigende relativ dosisintensitet i de første seks uger, længere behandlingsvarighed (uger), stigende alder (ved 10-års forøgelse), kvindeligt køn og med en god ECOG performancestatus ved baseline (0 versus ≥1). 
In all studies combined, the following covariates were statistically significantly associated with an increased risk of developing HFS: increasing capecitabine starting dose (gram), decreasing cumulative capecitabine dose (0.1*kg), increasing relative dose intensity in the first six weeks, increasing duration of study treatment (weeks), increasing age (by 10 year increments), female gender, and good ECOG performance status at baseline (0 versus ≥1).
Median samlet overlevelse ITT konfidensinterval 
Median overall survival ITT
konfidensinterval Median progressionsfri overlevelse ITT 
Median progression free survival ITT
Studier med capecitabin-monoterapi indikerer, at capecitabin har effekt i fremskreden ventrikelkræft. 
Studies with capecitabine monotherapy indicate that capecitabine has activity in advanced gastric cancer.
De bivirkninger, der af den behandlende investigator blev vurderet som muligvis, sandsynligvis eller tvivlsomt relateret til administrationen af capecitabin er angivet i tabel 4 for capecitabin-monoterapi og i tabel 5 for capecitabin givet i kombination med forskellige kemoterapiregimer indenfor flere indikationer. 
ADRs considered by the investigator to be possibly, probably, or remotely related to the administration of capecitabine are listed in table 4 for capecitabine given as monotherapy and in table 5 for capecitabine given in combination with different chemotherapy regimens in multiple indications.
Der optrådte ingen klinisk betydende forskelle i eksponeringen for capecitabin eller dets metabolitter, frit platin eller total platin, når capecitabin blev administreret i kombination med oxaliplatin eller i kombination med oxaliplatin og bevacizumab. 
Oxaliplatin: no clinically significant differences in exposure to capecitabine or its metabolites, free platinum or total platinum occurred when capecitabine was administered in combination with oxaliplatin or in combination with oxaliplatin and bevacizumab.
Capecitabin kan forårsage svimmelhed, træthed og kvalme. 
Capecitabine may cause dizziness, fatigue and nausea.
Hvis en patient bliver gravid under behandling med capecitabin, skal hun informeres om den mulige risiko for fostret. 
If the patient becomes pregnant while receiving capecitabine, the potential hazard to the foetus must be explained.
Toksiciteten ved behandlingerne var sammenlignelig på nær neutropeni, som blev rapporteret oftere hos patienter i FOLFIRI-armen. 
Toxcity was similar between treatments with the exception of neutropenia reported more commonly in patients treated with FOLFIRI.
Præmedicinering med antiemetika i overensstemmelse med produktresumeet for oxaliplatin anbefales til patienter, som får kombinationen af capecitabin og oxaliplatin. 
Premedication with antiemetics according to the oxaliplatin summary of product characteristics is recommended for patients receiving the capecitabine plus oxaliplatin combination.
Bevacizumab havde ingen klinisk signifikant virkning på capecitabins farmakokinetiske parametre eller dets metabolitter under tilstedeværelse af oxaliplatin. 
Bevacizumab: there was no clinically significant effect of bevacizumab on the pharmacokinetic parameters of capecitabine or its metabolites in the presence of oxaliplatin.
Patienter med særlige heterozygote DPYD varianter (inklusiv DPYD*2A, c.1679T>G, c.2846A>T og c.1236G>A/HapB3 varianter) har vist at have en øget risiko for svær toksicitet hvis de behandles med capecitabin. 
Patients with certain heterozygous DPYD variants (including DPYD*2A, c.1679T>G, c.2846A>T and c.1236G>A/HapB3 variants) have been shown to have increased risk of severe toxicity when treated with capecitabine.
Selvom DPD-mangel ikke kan fastsættes præcist, er det kendt, at patienter med visse homozygote eller visse sammensatte heterozygote mutationer i DPYD-genlocuset (fx DPYD*2A, c.1679T>G, c.2846A>T og c.1236G>A/HapB3 varianter), som kan forårsage fuldstændigt eller næsten fuldstændigt fravær af DPD-enzymaktivitet (bestemt ved laboratorieprøver), har den højeste risiko for livstruende eller dødelig toksicitet, og disse patienter bør ikke behandles med Ecansya (se pkt. 
Although DPD deficiency cannot be precisely defined, it is known that patients with certain homozygous or certain compound heterozygous mutations in the DPYD gene locus (e.g. DPYD*2A, c.1679T>G, c.2846A>T and c.1236G>A/HapB3 variants), which can cause complete or near complete absence of DPD enzymatic activity (as determined from laboratory assays), have the highest risk of life-threatening or fatal toxicity and should not be treated with Ecansya (see section 4.3).
Den mediane overlevelse var 392 dage (capecitabin) vs. 391 dage (Mayo regime). 
Median survival was 392 days (capecitabine) vs. 391 days (Mayo regimen).
De totale objektive responsrater i den totale randomiserede population (investigators vurdering) var 41,6 % (capecitabin + docetaxel) vs. 29,7 % (docetaxel alene); p = 0,0058. 
The overall objective response rates in the all-randomised population (investigator assessment) were 41.6% (capecitabine + docetaxel) vs. 29.7% (docetaxel alone); p = 0.0058.
Man har undersøgt virkningen af et antacidum indeholdende aluminiumhydroxid og magnesiumhydroxid på capecitabins farmakokinetik. 
Antacid: the effect of an aluminium hydroxide and magnesium hydroxide-containing antacid on the pharmacokinetics of capecitabine was investigated.
Hvis du er en mandlig patient og din kvindelige partner kan blive gravid, så skal du anvende sikker prævention under behandling med Ecansya og i 3 måneder efter sidste dosis. 
If you are a male patient and your female partner could become pregnant, you should use effective contraception during treatment with Ecansya and for 3 months after the last dose.
Seponer behandlingen permanent eller hvis lægen skønner at det bedste for patienten er at fortsætte så afbryd behandlingen indtil toksiciteten er reduceret til grad 0-1 
If physician deems it to be in the patient's best interest to continue, interrupt until resolved to grade 0-1
Parameter: Progressionsfri overlevelse PPP ITT Parameter: Samlet overlevelse PPP ITT *PPP=per protokol population; **ITT=intent-to-treat population 
Parameter: Progression-free Survival PPP ITT Parameter: Overall Survival PPP ITT *PPP=per-protocol population; **ITT=intent-to-treat population
Du kan få følgende bivirkninger, hvis du kommer til at tage meget mere capecitabin end du skulle: kvalme, diarré, irritation eller sårdannelse i tarmen eller munden, smerter og blødning fra tarmene eller maven eller påvirkning af knoglemarven (nedsat antal bestemte former for blodlegemer). 
You might get the following side effects if you take a lot more capecitabine than you should: feeling or being sick, diarrhoea, inflammation or ulceration of the gut or mouth, pain or bleeding from the intestine or stomach, or bone marrow depression (reduction in certain kinds of blood cells).
Den mediane samlede overlevelse var 10,9 måneder for de capecitabinbaserede regimer og 9,6 måneder for de 5-FU-baserede regimer. 
The median overall survival was 10.9 months in capecitabine-based regimens and 9.6 months in 5-FU based regimens.
Raten for 5 års samlet overlevelse var 78 % for XELOX versus 74 % for 5-FU/LV. 
The 5 year OS rate was 78% for XELOX versus 74% for 5-FU/LV.
Endeligt spalter -ureido-propionase FUPA til -fluoro--alanin (FBAL), som udskilles i urinen. 
-fluoro--alanine (FBAL) which is cleared in the urine.
Tabel 4 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). 
Capecitabine Monotherapy Table 4 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).
Tabel 5 Sammenfatning af relaterede bivirkninger, som blev rapporteret hos patienter, der blev behandlet med capecitabin i kombinationsbehandling set ud over bivirkninger efter behandling med capecitabin-monoterapi eller set i en højere frekvensgruppe sammenlignet med capecitabin-monoterapi 
Table 5 Summary of related ADRs reported in patients treated with capecitabine in combination treatment in addition to those seen with capecitabine monotherapy or seen at a higher frequency grouping compared to capecitabine monotherapy
Capecitabins farmakokinetik er undersøgt i dosisintervallet 502 - 3.514 mg/m2/dag. 
The pharmacokinetics of capecitabine have been evaluated over a dose range of 502-3514 mg/m2/day.
Aluminium/aluminium-blistere: 
For Aluminium-aluminium blisters
Fluorpyrimidinterapi har været ledsaget af kardiotoksicitet, inklusive myokardieinfarkt, angina pectoris, dysrytmier, kardiogent shock, pludselig død og ekg-ændringer (herunder meget sjældne tilfælde af QT-forlængelse). 
Cardiotoxicity has been associated with fluoropyrimidine therapy, including myocardial infarction, angina, dysrhythmias, cardiogenic shock, sudden death and electrocardiographic changes (including very rare cases of QT prolongation).
Den mediane progressionsfrie overlevelse var 5,6 måneder (capecitabin + cisplatin) versus 5,0 måneder (5-FU + cisplatin). 
The median progression-free survival was 5.6 months (capecitabine + cisplatin) versus 5.0 months (5-FU + cisplatin).
Hvis patienterne under behandlingen får uønskede hændelser af grad 2, 3 eller 4 tilrådes omhyggelig overvågning og øjeblikkelig afbrydelse af behandlingen med efterfølgende dosisjustering som beskrevet i tabel 3 ovenfor. 
Careful monitoring and prompt treatment interruption is recommended if the patient develops a grade 2, 3 or 4 adverse event during treatment and subsequent dose adjustment as outlined in table 3 above.
En analyse af sikkerhedsdata fra patienter  60 år, som behandledes med capecitabin-monoterapi og en analyse af patienter, som behandledes med capecitabin plus docetaxel, viste en stigning i incidensen af behandlingsrelaterede bivirkninger af grad 3 og 4 og af behandlingsrelaterede alvorlige bivirkninger, sammenlignet med patienter < 60 år. 
An analysis of safety data in patients ≥ 60 years of age treated with capecitabine monotherapy and an analysis of patients treated with capecitabine plus docetaxel combination therapy showed an increase in the incidence of treatment-related grade 3 and 4 adverse reactions and treatment-related serious adverse reactions compared to patients < 60 years of age.
Forholdet mellem koncentrationen af 5-FU i tumor og plasma var 21,4 (spændvidde: 3,9 - 59,9, n=8), mens forholdet mellem normalt væv og plasma var 8,9 (spændvidde: 3,0 - 25,8, n=8). 
The ratio of 5-FU concentration in tumour to plasma was 21.4 (ranged from 3.9 to 59.9, n=8) whereas the ratio in healthy tissues to plasma was 8.9 (ranged from 3.0 to 25.8, n=8).
Den mediane varighed for overlevelse var 10,5 måneder (capecitabin + cisplatin) versus 9,3 måneder (5-FU + cisplatin). 
The median duration of survival was 10.5 months (capecitabine + cisplatin) versus 9.3 months (5-FU + cisplatin).
7,5 mg/kg intravenøs 30-90 min 
7.5 mg/kg intravenous 30-90 mins
Til patienter med moderat nedsat nyrefunktion ved baseline anbefales det at reducere dosis til 75 % af en initialdosis på 1.250 mg/m2. 
In patients with moderate renal impairment at baseline, a dose reduction to 75% for a starting dose of 1250 mg/m2 is recommended.
Ecansya kan inducere alvorlige hudreaktioner såsom Stevens-Johnsons syndrom og toksisk epidermal nekrolyse. 
Severe skin reactions: Ecansya can induce severe skin reactions such as Stevens-Johnson syndrome and Toxic Epidermal Necrolysis.
- Mundbetændelse: hvis du har smerter, rødme, hævelse eller sår i din mund og/eller hals. 
- Stomatitis: if you have pain, redness, swelling or sores in your mouth and/or throat.
Data fra et randomiseret klinisk studie (Souglakos et al, 2012), som sammenlignede FOLFIRI + bevacizumab med XELIRI + bevacizumab, viste ingen signifikant forskel i progressionsfri overlevelse og samlet overlevelse mellem de to behandlinger. 
Data from a randomised clinical study (Souglakos et al, 2012) comparing FOLFIRI + bevacizumab with XELIRI + bevacizumab showed no significant differences in PFS or OS between treatments.
Antal 150 mg tabletter og/eller 300 mg tabletter og/eller 500 mg tabletter pr. dosering (hver dosering skal gives morgen og aften) 
Number of 150 mg tablets, 300 mg tablets and/or 500 mg tablets per administration (each administration to be given morning and evening)
- som monoterapi til behandling af patienter med lokal fremskreden eller metastatisk brystkræft efter svigt af taxaner og et kemoterapiregime indeholdende et antracyklin eller hos hvem antracyklin-behandling ikke er indiceret. 
- as monotherapy for the treatment of patients with locally advanced or metastatic breast cancer after failure of taxanes and an anthracycline containing chemotherapy regimen or for whom further anthracycline therapy is not indicated.
Tabel 8 Nøgleresultater for effekt fra AIO KRK-studiet XELOX + bevacizumab 
Table 8 Key efficacy results for AIO KRK study XELOX + bevacizumab
Eliminationshalveringstiden (t½, timer) for capecitabin, 5'-DFCR, 5'-DFUR, 5-FU og FBAL var 0,85, 1,11, 0,66, 0,76 og 3,23. 
The elimination half-life (t1/2 in hours) of capecitabine, 5'-DFCR, 5'-DFUR, 5-FU and FBAL were 0.85, 1.11, 0.66, 0.76 and 3.23 respectively.
Der er rapporteret om hypo- og hyperkalcæmi under behandling med capecitabin. 
Hypo- or hypercalcaemia has been reported during capecitabine treatment.
Ventrikelflimmer (sjælden), QT-forlængelse (sjælden), Torsades de pointes (sjælden), Bradykardi (sjælden), Karspasme (sjælden) 
QT prolongation (rare), Torsade de pointes (rare), Bradycardia (rare), Vasospasm (rare)
** Baseret på erfaringer efter markedsføring kan vedvarende eller svært palmar-plantar erytrodysæstesi syndrom i sidste ende forårsage, at fingeraftrykket forsvinder (se pkt. 
Rigors, Body temperature increased ** Based on the post-marketing experience, persistent or severe palmar-plantar erythrodysaesthesia syndrome can eventually lead to loss of fingerprints (see section 4.4.)
Kontusion + For hver term er hyppigheden baseret på bivirkninger af alle grader. 
+ For each term, the frequency count was based on ADRs of all grades.
Den mediane overlevelse var 442 dage (docetaxel + capecitabin) vs. 352 dage (docetaxel alene). 
Median survival was 442 days (capecitabine + docetaxel) vs. 352 days (docetaxel alone).
Du skal fortælle din læge, hvis du er overfølsom over for eller reagerer kraftigt på dette lægemiddel - hvis du tidligere har haft alvorlige bivirkninger ved fluorpyrimidin-behandling (en gruppe af kræftlægemidler som fluorouracil) - hvis du er gravid eller ammer - hvis du har meget få hvide blodlegemer eller blodplader i blodet (leukopeni, neutropeni eller trombocytopeni) - hvis du har svære lever eller nyreproblemer - hvis du ved, at du ikke har nogen aktivitet af enzymet dihydropyrimidindehydrogenase (DPD), - 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). 
You must inform your doctor if you know that you have an allergy or over-reaction to this medicine, - if you previously have had severe reactions to fluoropyrimidine therapy (a group of anticancer medicines, such as fluorouracil), - if you are pregnant or breast-feeding, - if you have severely low levels of white cells or platelets in the blood (leucopenia, neutropenia or thrombocytopenia), - if you have severe liver or kidney problems, - if you know that you do not have any activity of the enzyme dihydropyrimidine dehydrogenase (DPD) - 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.
Herpes zoster, Urinvejsinfektion, Oral candidiasis, Øvre luftvejsinfektion, Rhinitis, Influenza, 
Herpes zoster, Urinary tract infection, Oral candidiasis, Upper respiratory tract infection, Rhinitis, Influenza,
Det er ikke relevant at anvende capecitabin hos den pædiatriske population til indikationerne kolonkræft, kolorektalkræft, ventrikelkræft og brystkræft. 
There is no relevant use of capecitabine in the paediatric population in the indications colon, colorectal, gastric and breast cancer.
Paræstesi, Dysæstesi, Perifer neuropati, Perifer sensorisk neuropati, Dysgeusi, Hovedpine 
Paraesthesia, Dysaesthesia, Peripheral neuropathy, Peripheral sensory neuropathy, Dysgeusia, Headache
Der var flere patienter  60 år, som behandledes med capecitabin plus docetaxel, som måtte stoppe behandlingen tidligt på grund af bivirkninger, sammenlignet med patienter < 60 år. 
Patients ≥ 60 years of age treated with capecitabine plus docetaxel also had more early withdrawals from treatment due to adverse reactions compared to patients < 60 years of age.
Der er rapporteret om ændrede koagulationsparametre og/eller ændret blødning hos patienter som tog capecitabin sammen med antikoagulantia af coumarintypen såsom warfarin og phenprocoumon. 
Coumarin-derivative anticoagulants: altered coagulation parameters and/or bleeding have been reported in patients taking capecitabine concomitantly with coumarin-derivative anticoagulants such as warfarin and phenprocoumon.
- metastatisk kolorektalkræft (se pkt. 
- metastatic colorectal cancer (see section 5.1).
LISTE OVER HJÆLPESTOFFER Indeholder også vandfri lactose. 
LIST OF EXCIPIENTS Also contains lactose.
Stråleterapi MTD for capecitabin alene ved anvendelse af det intermitterende regime er 3.000 mg/m2 pr. dag, hvorimod MTD er 2.000 mg/m2 pr. dag, når capecitabin kombineres med stråleterapi ved kolorektalkræft, enten ved anvendelse af en kontinuerlig behandling eller anvendt dagligt fra mandag til fredag under en seks ugers serie med stråleterapi. 
Radiotherapy: the MTD of capecitabine alone using the intermittent regimen is 3000 mg/m2 per day, whereas, when combined with radiotherapy for rectal cancer, the MTD of capecitabine is 2000 mg/m per day using either a continuous schedule or given daily Monday through Friday during a 6-week course of radiotherapy.
Overlevelsen var bedre i kombinationsarmen med capecitabin + docetaxel (p = 0,0126). 
Survival was superior in the capecitabine + docetaxel combination arm (p=0.0126).
Kolon- og kolorektalkræft: 
Colon and colorectal cancer:
Ecansya er indiceret som behandling af: - for den adjuverende behandling af patienter, som er opereret for stadium III (Dukes stadium C) 
Ecansya is indicated for the treatment of: - for the adjuvant treatment of patients following surgery of stage III (Dukes' stage C) colon cancer (see section 5.1).
Dosisbegrænsende toksicitet 
Dose limiting toxicities
Neutropeni, Anæmi 
Neutropenia, Anaemia
Hos ITT-populationen var raten for behandlingsophør på grund af bivirkninger højere i XELOX kombinationsterapi-armen (21 %) sammenlignet med den i 5-FU/LV monoterapi-armen (9 %). 
The rate of withdrawal due to adverse events was higher in the XELOX combination therapy arm (21%) as compared with that of the 5-FU/LV monotherapy arm (9%) in the ITT population.
Diarré 
Diarrhoea.
Fremskreden ventrikelkræft: 
Advanced gastric cancer:
For de toksiske virkninger, der af den behandlende læge under en behandlingsserie ikke anses for at være relateret til capecitabin, bør behandlingen med capecitabin fortsætte, og dosis af det andet lægemiddel bør justeres i henhold til det pågældende produktresumé. 
During a treatment cycle for those toxicities considered by the treating physician not to be related to capecitabine, capecitabine should be continued and the dose of the other medicinal product should be adjusted according to the appropriate Prescribing Information.
Sjælden, uventet, svær toksicitet (fx stomatitis, diarré, slimhindeinflammation, neutropeni og neurotoksicitet) i forbindelse med 5-FU er tilskrevet manglende DPD-aktivitet. 
Dihydropyrimidine dehydrogenase (DPD) deficiency: Rarely, unexpected, severe toxicity (e.g. stomatitis, diarrhoea, mucosal inflammation, neutropenia and neurotoxicity) associated with 5-FU has been attributed to a deficiency of DPD activity.
1. linjebehandling med XELIRI var dog forbundet med en øget incidens af gastrointestinal toksicitet og neutropeni (26 % og 11 % for henholdsvis XELIRI og 1. linjebehandling med capecitabin). 
However this was associated with an increased incidence of gastrointestinal toxicity and neutropenia during first-line treatment with XELIRI (26% and 11% for XELIRI and first line capecitabine respectively).
Til patienter på 60 år og derover anbefales det at reducere initialdosis af capecitabin til 75 % af vanlig initialdosis (950 mg/m2 to gange dagligt). 
For patients 60 years of age or more, a starting dose reduction of capecitabine to 75% (950 mg/m2 twice daily) is recommended.
Patienter som tager antikoagulantia af coumarintypen sammen med capecitabin skal kontrolleres regelmæssigt mht. ændringer i deres koagulationsparametre (PT eller INR), og antikoagulansdosis skal om nødvendigt justeres. 
Patients taking coumarinderivative anticoagulants concomitantly with capecitabine should be monitored regularly for alterations in their coagulation parameters (PT or INR) and the anticoagulant dose adjusted accordingly.
Ikke almindelige bivirkninger, der er rapporteret ved behandling med capecitabin i kombination med andre lægemidler, er i overensstemmelse med de bivirkningsrapporteringer, der er rapporteret for capecitabin-monoterapi eller for monoterapi med kombinationslægemidlet (i litteratur og/eller respektive produktresuméer). 
Uncommon ADRs reported for capecitabine in combination therapy are consistent with the ADRs reported for capecitabine monotherapy or reported for monotherapy with the combination medicinal product (in literature and/or respective summary of product characteristics).
Du kan finde yderligere information om Ecansya på Det Europæiske Lægemiddelagenturs hjemmeside http://www.ema.europa.eu. 
Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu.