FrancophonIA/ELRC3.0 huggingface dataset:
English: Time to progressive disease was superior in the capecitabine + docetaxel combination arm (p<0.0001).
Danish: Tid indtil progressiv sygdom var længere i kombinationsarmen med capecitabin + docetaxel (p< 0,0001).
English: As the potential for harm to the nursing infant is unknown, breast-feeding should be discontinued while receiving treatment with capecitabine and for 2 weeks after the final dose.
Danish: Da den potentielt skadelige virkning for det ammende spædbarn er ukendt, skal amning afbrydes under behandling med capecitabin og i 2 uger efter sidste dosis.
English: Table 9 Key efficacy results for the non-inferiority analysis of Study NO16967 PRIMARY ANALYSIS
Danish: Tabel 9 Nøgleresultater for virkning fra non-inferioritetsanalyserne af studie NO16967
English: • In patients with severe hepatic impairment,
Danish: • Patienter med svær leverinsufficiens,
English: Hand and foot syndrome also known as hand-foot skin reaction or palmar-plantar erythrodysesthesia or chemotherapy induced acral erythema.
Danish: Hånd- og fodsyndrom også kendt som hånd- og fodhudreaktion, palmo-plantar erythrodysæstesi eller kemoterapiinduceret acralt erytem).
English: If you take more Capecitabine Teva than you should If you take more Capecitabine Teva than you should, contact your doctor as soon as possible before taking the next dose.
Danish: Hvis du har taget for mange Capecitabine Teva-tabletter skal du kontakte lægen så hurtigt som muligt, før du tager næste dosis.
English: 5 mg/kg intravenous 30-90 mins
Danish: 5 mg/kg intravenøs 30-90 min
English: 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).
Danish: I alle studierne kombineret var følgende kovarianter statistisk signifikant associeret med en øget risiko for udviklingen af hånd- og 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).
English: 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.
Danish: De totale objektive responsrater i den totale randomiserede population (investigators vurdering) var 41,6 % (capecitabin + docetaxel) vs. 29,7 % (docetaxel alene); p=0,0058.
English: There is some evidence that dexpanthenol is effective for hand-foot syndrome prophylaxis in patients treated with Capecitabine.
Danish: Der er nogen evidens for, at dexpanthenol er virksomt som profylakse mod hånd- og fodsyndrom hos patienter, der behandles med capecitabin.
English: purple spots on the skin
Danish: (ekstremiteter), lilla pletter på huden
English: Capecitabine Teva should only be prescribed by a qualified physician experienced in the utilisation of anti-neoplastic medicinal products.
Danish: Capecitabine Teva må kun ordineres af en kvalificeret læge med erfaring i brug af antineoplastiske lægemidler.
English: 7.5 mg/kg intravenous 30-90 mins
Danish: 7.5 mg/kg intravenøs 30-90 min
English: Cutaneous lupus erythematosus (rare), Severe skin reactions such as Stevens-Johnson Syndrome and toxic Epidermal Necrolysis (very rare) (see section 4.4.)
Danish: Kutan lupus erythematosus (sjælden), Alvorlige hudreaktioner såsom StevensJohnsons syndrom og toksisk epidermal nekrolyse (meget sjælden) (se pkt.
English: 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).
Danish: 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).
English: • inflammation of the veins (thrombophlebitis)
Danish: • betændelse i venerne (thromboflebitis)
English: blood in the urine, increase in blood creatinine (sign of kidney dysfunction)
Danish: forhøjet kreatinin i blodet (tegn på dårligt fungerende nyre)
English: • blood clots in the deep veins, high or low blood pressure, hot flushes, cold limbs (extremities),
Danish: • blodpropper i de dybe vener, højt eller lavt blodtryk, hedestigninger, kolde lemmer
English: In the absence of safety and efficacy data in patients with hepatic impairment, capecitabine use should be carefully monitored in patients with mild to moderate liver dysfunction, regardless of the presence or absence of liver metastasis.
Danish: Da der ikke findes data for sikkerhed og virkning hos patienter med leverinsufficiens skal anvendelsen af capecitabin kontrolleres omhyggeligt hos patienter med let til moderat leverdysfunktion, uanset om der er levermetastaser eller ej.
English: 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.
Danish: Du skal fortælle din læge, hvis du er overfølsom over for eller reagerer kraftigt på dette lægemiddel, - hvis du tidligere har oplevet svære reaktioner på ‘fluorpyrimidin'-behandling (en gruppe af lægemidler mod kræft, som f.eks. fluoruracil), - hvis du er gravid eller ammer, - hvis du har meget lave tal for hvide blodlegemer eller blodplader (leukopeni, neutropeni eller trombocytopeni), - hvis du har alvorlige leversygdomme eller problemer med nyrerne, - hvis du ved, 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).
English: Before starting treatment, tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Danish: Fortæl altid lægen eller apotekspersonalet, hvis du tager anden medicin eller har gjort det for nylig.
English: Capecitabine should only be prescribed by a doctor experienced in the use of anticancer medicines.
Danish: Capecitabine Teva bør kun ordineres af en læge med erfaring i anvendelsen af lægemidler mod kræft.
English: Treatment with capecitabine monotherapy may be resumed when bilirubin decreases to ≤3.0 x ULN or hepatic aminotransferases decrease to ≤2.5 x ULN.
Danish: Behandlingen med capecitabin-monoterapi kan genoptages, når bilirubin er faldet til < 3,0 x UNL eller levertransaminaserne er faldet til ≤ 2,5 x UNL.
English: • decreases in blood cells including platelets, thinning of blood (seen in tests)
Danish: • fald i blodlegemer, herunder blodplader, fortynding af blod (ses i blodprøver)
English: 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.
Danish: 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.
English: • eye irritation, increased tears, eye redness (conjunctivitis)
Danish: • øjenirritation, øget tåreflod, røde øjne (konjunktivitis)
English: 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.
Danish: Sjælden, uventet, svær toksicitet (fx stomatitis, diarré, slimhindeinflammation, neutropeni og neurotoksicitet) i forbindelse med 5-FU er tilskrevet manglende DPD-aktivitet.
English: Table 7 Key efficacy results for the non-inferiority analysis of Study NO16966 PRIMARY ANALYSIS
Danish: Tabel 7 Nøgleresultaterne for virkning af non-inferioritetsanalysen af studie NO16966
English: The most commonly reported and/or clinically relevant treatment-related adverse drug reactions (ADRs) were gastrointestinal disorders (especially diarrhoea, nausea, vomiting, abdominal pain, stomatitis), hand-foot syndrome (palmar-plantar erythrodysesthesia), fatigue, asthenia, anorexia, cardiotoxicity, increased renal dysfunction on those with preexisting compromised renal function, and thrombosis/embolism.
Danish: De mest almindelige rapporterede og/eller klinisk relevante behandlingsrelaterede bivirkninger var gastrointestinale symptomer (specielt diarré, kvalme, opkastning, mavesmerter og stomatitis), håndog fodsyndrom (palmo-plantar erytrodysæstesi), træthed, asteni, anoreksi, kardiotoksicitet, øget renal dysfunktion hos dem med præeksisterende kompromitteret nyrefunktion samt trombose/embolisme.
English: XELOX was demonstrated to be non-inferior to FOLFOX-4 in terms of progression-free survival in the per-protocol population and intent-to-treat population (see table 9).
Danish: Det blev vist, at XELOX var non inferior i forhold til FOLFOX-4 med hensyn til progressionsfri overlevelse i per-protokolpopulationenog intent-to-treat-populationen (se tabel 9).
English: Body System
Danish: Systemorganklasse
English: The MTD of capecitabine was 2000 mg/m2 per day when combined with interferon alpha- 2a (3 MIU/m2 per day) compared to 3000 mg/m2 per day when capecitabine was used alone.
Danish: Capecitabins MTD var 2.000 mg/m2/dag, når det kombineredes med interferon alfa-2a (3 MIE/m2/dag) sammenlignet med 3.000 mg/m2/dag, når capecitabin blev givet alene.
English: LIST OF EXCIPIENTS Also contains lactose.
Danish: Indeholder også lactose.
English: If the other medicinal product(s) have to be discontinued permanently, capecitabine treatment can be resumed when the requirements for restarting capecitabine are met.
Danish: Hvis behandling med det/de andet/andre lægemiddel/lægemidler skal afbrydes permanent, kan behandlingen med capecitabin genoptages, når betingelserne for genoptagelse af behandlingen med capecitabin er opfyldt.
English: Myalgia, Arthralgia, Pain in extremity
Danish: Myalgi, artralgi, smerter i ekstremiteterne
English: Patients with renal impairment (see section 4.2, 4.4, and 5.2):
Danish: 4.2, 4.4, og 5.2):
English: • diabetes, decrease in blood potassium, malnutrition, increased blood triglycerides
Danish: • diabetes, fald i kalium i blodet, fejlernæring, øgede triglycerider i blodet
English: - 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.
Danish: - 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 antracyklinbehandling ikke er indiceret.
English: • Stomatitis: if you have pain, redness, swelling or sores in your mouth and/or throat.
Danish: • Mundbetændelse: hvis du har smerter, rødme, hævelse eller sår i din mund og/eller hals.
English: Hand-foot syndrome
Danish: Hånd- og fodsyndrom
English: Vertigo, Ear pain
Danish: Vertigo, øresmerter
English: 256 patients were randomised to treatment with docetaxel alone (100 mg/m2 as a 1 hour intravenous infusion every 3 weeks).
Danish: 256 patienter blev randomiseret til behandling med docetaxel alene (100 mg/m2 som 1 times intravøs infusion hver 3. uge).
English: NCIC CTC grade 2 diarrhoea is defined as an increase of 4 to 6 stools/day or nocturnal stools, grade 3 diarrhoea as an increase of 7 to 9 stools/day or incontinence and malabsorption.
Danish: NCIC CTC grad 2 diarré defineres som en øgning til 4 til 6 afføringer/dag eller natlige afføringer, grad 3 diarré som en øgning til 7 til 9 afføringer/dag eller inkontinens og malabsorption, og grad 4 diarré som en øgning til flere end 10 afføringer/dag eller stærkt blodig diarré eller behov for parenteral støttebehandling.
English: Pharyngolaryngeal pain, Dysphonia
Danish: Hikke, pharyngolaryngeal smerte, dysfoni
English: Store in the original package in order to protect from moisture.
Danish: Opbevares i den originale emballage som beskyttelse mod fugt.
English: • unusual bleeding from the vagina
Danish: • uforklarlig blødning fra skeden
English: Patients were randomised to receive either FOLFIRI plus bevacizumab (Arm-A, n=167) or XELIRI
Danish: Patienterne blev randomiseret til enten at få FOLFIRI plus bevacizumab (arm-A, n=167) eller XELIRI plus bevacizumab (arm-B, n=166).
English: 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.
Danish: 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.
English: Intestinal obstruction, Ascites, Enteritis, Gastritis,
Danish: Intestinal obstruktion, Ascites,
English: 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.
Danish: 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.
English: Survival was superior in the capecitabine + docetaxel combination arm (p=0.0126).
Danish: Overlevelsen var bedre i kombinationsarmen med capecitabin + docetaxel (p=0,0126).
English: 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/m2 per day using either a continuous schedule or given daily Monday through Friday during a 6-week course of radiotherapy.
Danish: 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.
English: The parameters of capecitabine, 5'-deoxy-5-fluorocytidine (5'-DFCR) and 5'-deoxy-5-fluorouridine (5'
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: 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.
Danish: Hos ITT-populationen var raten for behandlingsophør på grund af bivirkninger højere i XELOX kombinationsterapi-armen (21 %) sammenlignet med den i 5FU/LV monoterapi-armen (9 %).
English: In patients with moderate renal impairment at baseline, no dose reduction is required for a starting dose of 1000 mg/m2.
Danish: Til patienter med moderat nyreinsufficiens ved baseline er det for en initialdosis på 1.000 mg/m2 ikke nødvendigt med dosisjustering.
English: 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 lifethreatening or fatal toxicity and should not be treated with Capecitabine Teva (see section 4.3).
Danish: 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 Capecitabine Teva (se pkt.
English: • skin ulcer and blister, reaction of the skin with sunlight, reddening of palms, swelling or pain of the face
Danish: • sår og blæredannelse i huden, reaktion i huden over for sollys, rødmen af håndfladerne, hævelse af eller smerter i ansigtet
English: Paraesthesia, Dysaesthesia, Peripheral neuropathy, Peripheral sensory neuropathy, Dysgeusia, Headache
Danish: Paræstesi, dysæstesi, perifer neuropati, perifer sensorisk neuropati, dysgeusi, hovedpine
English: For patients 60 years of age or more, a starting dose reduction of capecitabine to 75% (950 mg/m2 twice daily) is recommended.
Danish: 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).
English: A clinically significant interaction between brivudine and fluoropyrimidines (e.g. capecitabine, 5-fluorouracil, tegafur), resulting from the inhibition of dihydropyrimidine dehydrogenase by sorivudine, has been described.
Danish: Der er beskrevet en klinisk signifikant interaktion mellem brivudin og fluorpyrimidiner (f.eks. capecitabin, 5-FU, tegafur), som et resultat af soivudins hæmning af dihydropyrimidindehydrogenase.
English: 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).
Danish: 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)
English: If you are a male patient and your female partner could become pregnant, you should use effective contraception during treatment with Capecitabine Teva and for 3 months after the last dose.
Danish: Hvis du er en mandlig patient og din kvindelige partner kan blive gravid, så skal du anvende sikker prævention under behandling med Capecitabine Teva og i 3 måneder efter sidste dosis.
English: - Tablet coating: macrogol 400, hypromellose, titanium dioxide (E171), yellow iron oxide (E172),
Danish: - Tabletovertræk: macrogol 400, hypromellose, titandioxid (E171), gul jernoxid (E172), rød jernoxid (E172).
English: Patients taking coumarin-derivative anticoagulants concomitantly with capecitabine should be monitored regularly for alterations in their coagulation parameters (PT or INR) and the anticoagulant dose adjusted accordingly.
Danish: 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.
English: At the dose of 1250 mg/m2 on day 14 with administration after food intake, the peak plasma concentrations (Cmax in μg/ml) for capecitabine, 5'-DFCR, 5'-DFUR, 5-FU and FBAL were 4.67, 3.05, 12.1, 0.95 and 5.46 respectively.
Danish: Efter en dosis på 1250 mg/m2 efter indtagelse af føde var peak-plasmakoncentrationerne på dag 14 (Cmax, μg/ml) for capecitabin, 5'-DFCR, 5'-DFUR, 5-FU og FBAL 4,67; 3,05; 12,1; 0,95 og 5,46.
English: Also, you need to be particularly careful if you are taking any of the following: - gout medicines (allopurinol), - blood-thinning medicines (coumarin, warfarin), - medicines for seizures or tremors (phenytoin), - certain medicines used to treat various cancers or virus infection (interferon alpha), - radiotherapy and certain medicines used to treat cancer (folinic acid, oxaliplatin, bevacizumab,
Danish: Du skal også være særlig forsigtig, hvis du tager: - medicin mod urinsyregigt (allopurinol), - blodfortyndende medicin (coumarin, warfarin), - medicin mod kramper eller rystelser (phenytoin), - visse lægemidler, der anvendes til at behandle forskellige kræftformer eller virusinfektioner
English: - The other ingredients are: - Tablet core: lactose, microcrystalline cellulose, hypromellose, croscarmellose sodium,
Danish: Øvrige indholdsstoffer: - Tabletkernen: lactose, mikrokrystallinsk cellulose, hypromellose, croscarmellosenatrium, magnesiumstearat.
English: The 3 year DFS rate was 71% for XELOX versus 67% for 5-FU/LV.
Danish: Raten for 3 års sygdomsfri overlevelse var 71 % for XELOX versus 67% for 5FU/LV.
English: If you are a woman who could become pregnant you should use effective contraception during treatment with Capecitabine Teva and for 6 months after the last dose.
Danish: Hvis du er en kvinde, der kan blive gravid, skal du anvende sikker prævention under behandling med Capecitabine Teva og i 6 måneder efter sidste dosis.
English: XELOX showed a trend towards superior OS with a HR of 0.87 (95% CI=[0.72; 1.05]; p=0.1486) which translates into a 13% reduction in risk of death.
Danish: XELOX viste en tendens til en bedre samlet overlevelse med en hazard ratio på 0,87 (95% konfidensinterval = [0,72; 1,05], p=0,1486), hvilket svarer til en reduktion i risikoen for dødsfald på 13 %.
English: 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).
Danish: Du kan få følgende bivirkninger, hvis du tager meget mere capecitabin, end du skulle: kvalme eller opkastning, diarré, betændelse eller sår i maven eller munden, smerter eller blødning fra tarmene eller knoglemarvsundertrykkelse.
English: Colon, colorectal and advanced gastric cancer: meta-analysis A meta-analysis of six clinical trials (studies SO14695, SO14796, M66001, NO16966, NO16967, M17032) supports capecitabine replacing 5-FU in mono- and combination treatment in gastrointestinal cancer.
Danish: Kolon, kolorektalkræft og fremskreden ventrikelkræft, metaanalyse En metaanalyse af seks kliniske forsøg (studie SO14695, SO14796, M66001, NO16966, NO16967 og M17032) støtter, at capecitabin kan erstatte 5-FU i mono- og kombinationsbehandling af gastrointestinal kræft.
English: Premedication to maintain adequate hydration and anti-emesis according to the cisplatin summary of product characteristics should be started prior to cisplatin administration for patients receiving the capecitabine plus cisplatin combination.
Danish: Præmedicinering til opretholdelse af tilstrækkelig hydrering og antiemetisk behandling påbegyndes, i henhold til produktresumeet for cisplatin, før administration af cisplatin, hos de patienter, som får kombinationsbehandling med Capecitabin og cisplatin.
English: Advanced gastric cancer
Danish: Fremskreden ventrikelkræft
English: Elderly During capecitabine monotherapy, no adjustment of the starting dose is needed.
Danish: Under monoterapi med capecitabin er justering af initialdosis ikke nødvendig.