FrancophonIA/ELRC3.0 huggingface dataset:
English: Standard and reduced dose calculations according to body surface area for starting doses of Ecansya of 1250 mg/m2 and 1000 mg/m2 are provided in tables 1 and 2, respectively.
Danish: Standard og reducerede initialdosisberegninger af Ecansya på 1.250 mg/m2 og 1.000 mg/m2 ud fra legemsoverfladeareal er anført i henholdsvis tabel 1 og 2.
English: Parameter: Progression-free Survival EPP ITT Parameter: Overall Survival EPP ITT
Danish: Parameter: Progressionsfri overlevelse EPP ITT Parameter: Samlet overlevelse EPP ITT
English: Schedule
Danish: Plan
English: 5 mg/kg intravenous 30-90 mins
Danish: 5 mg/kg intravenøs 30-90 min.
English: An analysis of safety data in patients treated with capecitabine monotherapy (colorectal cancer) with baseline renal impairment showed an increase in the incidence of treatment-related grade 3 and 4 adverse reactions compared to patients with normal renal function (36% in patients without renal impairment n=268, vs. 41% in mild n=257 and 54% in moderate n=59, respectively) (see section 5.2).
Danish: En analyse af sikkerhedsdata fra patienter, som fik capecitabin-monoterapi (kolorektalkræft) og som havde nyreinsufficiens ved baseline, viste, at der var en stigning i hyppigheden af behandlingsrelaterede bivirkninger, grad 3 og 4, sammenlignet med patienter med normal nyrefunktion (36 % hos patienter uden nyreinsufficiens n=268 vs. henholdsvis 41 % hos patienter med let nyreinsufficiens n=257 og 54 % hos patienter med moderat nyreinsufficiens n=59) (se pkt.
English: How to store Ecansya 6.
Danish: Sådan skal du tage Ecansya 4.
English: In case of exposure of either patient or caregiver to crushed or cut Ecansya tablets adverse drug reactions could occur (see Section 4.8).
Danish: I tilfælde, hvor enten patienten eller patientens omsorgsperson udsættes for delte eller knuste Ecansya tabletter, kan der opstå bivirkninger (se pkt
English: Table 4 Summary of related ADRs reported in patients treated with capecitabine monotherapy Body System Very Common
Danish: Tabel 4 Sammenfatning af relaterede bivirkninger, som blev rapporteret hos patienter behandlet med capecitabin-monoterapi
English: Acute renal failure secondary to dehydration (rare)
Danish: Akut nyresvigt som følge af dehydrering (sjælden)
English: Uncommon side-effects (may affect up to 1 in 100 people) include: - blood infection, urinary tract infection, infection of the skin, infections in the nose and throat,
Danish: Ikke almindelige bivirkninger (kan påvirke op til 1 ud af 100 personer): - betændelse i blodet, urinvejsinfektion, betændelse i huden, næse- og halsinfektioner, svamp
English: Dose limiting toxicities include diarrhoea, abdominal pain, nausea, stomatitis and hand-foot syndrome (hand-foot skin reaction, palmar-plantar erythrodysesthesia).
Danish: Dosisbegrænsende toksicitet omfatter diarré, mavesmerter, kvalme, stomatitis og hånd- og fodsyndrom (hånd- og fodhudreaktioner, palmoplantar erytrodysæstesi).
English: For PVC/PVdC-aluminium blisters
Danish: PVC/PVdC/aluminium-blistere:
English: Table 7 Key efficacy results for the non-inferiority analysis of Study NO16966 PRIMARY ANALYSIS XELOX/XELOX+P/
Danish: Tabel 7 Nøgleresultaterne for effekt af non-inferioritetsanalysen af studie NO16966 PRIMÆRE ANALYSE XELOX/XELOX+P/ XELOX+BV (EPP*: N=967; ITT**: N=1017)
English: However, the on-treatment PFS analysis did not confirm the results of the general PFS and OS analysis: the hazard ratio of XELOX versus FOLFOX-4 was 1.24 with 97.5% CI 1.07 - 1.44.
Danish: Analysen af progressionsfri overlevelse on-treatment bekræftede dog ikke resultaterne fra den generelle progressionsfri overlevelse og samlede overlevelse: Hazard ratioen for XELOX versus FOLFOX-4 var 1,24 med 97,5 % konfidensinterval 1,07 - 1,44.
English: Adjuvant treatment in patients with stage III colon cancer is recommended for a total of 6 months.
Danish: Den anbefalede totale behandlingsvarighed for adjuverende behandling af patienter med stadium III kolonkræft er 6 måneder.
English: Capecitabine should only be prescribed by a doctor experienced in the use of anticancer medicines.
Danish: Ecansya må kun ordineres af læger med erfaring i brug af kræftmedicin.
English: Talc
Danish: Talcum
English: Dose modifications for toxicity when capecitabine is used as a 3 weekly cycle in combination with other medicinal products
Danish: Dosisændringer på grund af toksicitet når capecitabin anvendes i tre ugers serie i kombination med andre lægemidler
English: Cardiotoxicity.
Danish: Kardiotoksicitet
English: Grade 3 hand-foot syndrome is moist desquamation, ulceration, blistering and severe pain of the hands and/or feet and/or severe discomfort that causes the patient to be unable to work or perform activities of daily living.
Danish: Grad 3 hånd- og fodsyndrom defineres som fugtig afskalning, ulceration, blisterdannelse og svær smerte af hænderne og/eller fødderne og/eller svært ubehag der forårsager at patienten ikke kan passe sit arbejde og er ude af stand til at udføre daglige aktiviteter.
English: Capecitabine in combination with cisplatin was non-inferior to 5-FU in combination with cisplatin in terms of progression-free survival in the per protocol analysis (hazard ratio 0.81; 95% CI 0.63 - 1.04).
Danish: Capecitabin var i kombination med cisplatin non-inferiørt i forhold til 5-FU i kombination med cisplatin med hensyn til progressionsfri overlevelse i per protokolanalysen (hazard ratio 0,81; 95 % konfidensinterval 0,63 - 1,04).
English: Angina unstable, Angina pectoris, Myocardial ischaemia/infarction, Atrial fibrillation, Arrhythmia, Tachycardia, Sinus tachycardia, Palpitations
Danish: Ustabil angina, Angina pectoris, Myokardiel iskæmi/infarkt, Atrieflimmer, Arytmi,
English: Hepatic function abnormal
Danish: Unormal leverfunktion
English: P=0.45
Danish: 25,5 måneder p = 0,45
English: What you need to know before you take Ecansya
Danish: Det skal du vide, før du begynder at tage Ecansya
English: In combination with docetaxel, the recommended starting dose of capecitabine in the treatment of metastatic breast cancer is 1250 mg/m2 twice daily for 14 days followed by a 7-day rest period, combined with docetaxel at 75 mg/m2 as a 1 hour intravenous infusion every 3 weeks.
Danish: I kombination med docetaxel er den anbefalede initialdosis af capecitabin til behandling af metastatisk brystkræft 1.250 mg/m2 to gange dagligt i 14 dage efterfulgt af 7 dages pause, kombineret med docetaxel 75 mg/m2 givet som 1 times intravenøs infusion hver 3. uge.
English: Pulmonary embolism, Pneumothorax, Haemoptysis, Asthma, Dyspnoea exertional
Danish: Pulmonær emboli, Pneumothorax, Hæmoptyse, Asthma,
English: Parameter: Progression-free Survival EPP ITT Parameter: Overall Survival EPP ITT *EPP=eligible patient population; **ITT=intent-to-treat population
Danish: Parameter: Samlet overlevelse EPP ITT *EPP=egnet patientpopulation; **ITT=intent-to-treat population
English: Median PFS was 7.6 months for FOLFIRI, 5.9 months for mIFL (p=0.004) for the comparison with FOLFIRI), and 5.8 months for XELIRI (p=0.015).
Danish: Den mediane progressionsfri overlevelse var 7,6 måneder for FOLFIRI, 5,9 måneder for mIFL (p = 0,004 ved sammenligning med FOLFIRI) og 5,8 måneder for XELIRI (p = 0,015).
English: Grade 2 hand-foot syndrome is painful erythema and swelling of the hands and/or feet and/or discomfort affecting the patient's activities of daily living.
Danish: Grad 2 hånd- og fodsyndrom defineres som smertefuld erytem og hævelse af hænderne og/eller fødderne og/eller ubehag der påvirker patienternes daglige aktiviteter.
English: The hazard ratio for duration of survival (overall survival) was similar to the hazard ratio for progression-free survival (hazard ratio 0.85; 95% CI 0.641.13).
Danish: Resultatet for hazard ratio for varighed af overlevelse (samlet overlevelse) svarede til resultatet for hazard ratio for progressionsfri overlevelse (hazard ratio 0,85, 95 % konfidensinterval 0,64 - 1,13).
English: Ecansya is used in the treatment of colon, rectal, gastric, or breast cancers.
Danish: Ecansya bruges til behandling af kræft i tyktarm, endetarm, mave eller bryst.
English: A population pharmacokinetic analysis was carried out after capecitabine treatment of 505 patients with colorectal cancer dosed at 1250 mg/m2 twice daily.
Danish: Farmakokinetik i specielle populationer Efter capecitabin-behandling af 505 patienter med kolorektalkræft, som fik 1250 mg/m2 to gange dagligt, blev der foretaget en populationsfarmakokinetisk analyse.
English: In the largest study (BICC-C), patients were randomised to receive either open label FOLFIRI (n=144), bolus 5-FU (mIFL) (n=145) or XELIRI (n=141) and were additionally randomised to receive either double-blind treatment with celecoxib or placebo.
Danish: I det største studie (studie BICC-C) blev patienterne randomiseret til ublindet enten at få FOLFIRI (n=144), bolus-5-fluoruracil (mIFL) (n=145) eller XELIRI (n=141).
English: Sleep disorder, Anxiety
Danish: Søvnforstyrrelser, Angst
English: If the calculated creatinine clearance decreases during treatment to a value below 30 ml/min, Ecansya should be discontinued.
Danish: Ecansya bør seponeres, hvis den beregnede creatininclearance under behandling falder til et niveau under 30 ml/min.
English: A total of 156 patients were randomised to treatment with 5-FU (800 mg/m2 per day, continuous infusion on days 1 to 5 every 3 weeks) and cisplatin (80 mg/m2 as a 2-hour infusion on day
Danish: I alt blev 156 patienter randomiseret til behandling med 5-FU (800 mg/m dagligt som kontinuerlig infusion på dag 1 til 5 hver 3. uge) og cisplatin (80 mg/m2 som en 2-timers infusion på dag 1 hver 3. uge).
English: For the capecitabine dose of 1000 mg/m2 twice daily on days 1 to 14 every 3 weeks, a frequency of 22% to 30% of all-grade HFS was observed in capecitabine combination therapy.
Danish: For en capecitabindosis på 1.000 mg/m to gange daglig på dagene 1 til 14 hver 3. uge blev der observeret hånd- og fodsyndrom i alle grader med en hyppighed på 22 % til 30 % i capecitabin-kombinationsbehandling.
English: In addition to the ADRs described in tables 4 and 5, and based on the above pooled analysis from clinical safety data from 7 clinical trials, encephalopathy was also associated with the use of capecitabine monotherapy with an incidence of less than 0.1%.
Danish: Baseret på en samlet analyse af kliniske sikkerhedsdata fra 7 kliniske studier, blev der ud over de bivirkninger, som er anført i tabel 4 og 5, observeret encephalopati som værende forbundet med anvendelsen af capecitabin-monoterapi med en hyppighed på mindre end 0,1 %.
English: FOLFOX-4 or FOLFOX-4 + Bevacizumab
Danish: FOLFOX-4 + Bevacizumab
English: 120 film-coated tablets
Danish: 120 filmovertrukne tabletter
English: Rare side effects (may affect up to 1 in 1,000 people) include: - narrowing or blockage of tear duct (lacrimal duct stenosis) - liver failure - inflammation leading to dysfunction or obstruction in bile secretion (cholestatic hepatitis) - specific changes in the electrocardiogram (QT prolongation) - certain types of arrhythmia (including ventricular fibrillation, torsade de pointes, and bradycardia) - eye inflammation causing eye pain and possibly eyesight problems - inflammation of the skin causing red scaly patches due to an immune system illness
Danish: Sjældne bivirkninger (kan påvirke op til 1 ud af 1.000 personer): - forsnævring eller blokering af tårekanalen, - leversvigt, - betændelse der medfører, at kroppens udskillelse af galde nedsættes eller ophører (kolestatisk hepatitis), - bestemte ændringer i EKG'et (QT-forlængelse), - bestemte former for forstyrrelser i hjerterytmen (ventrikelflimren, torsades de pointes og bradykardi), - inflammation i øjet, der medfører smerter i øjet og muligvis problemer med synet, - inflammation i huden, der medfører røde skællende pletter på grund af en sygdom i immunsystemet.
English: In first-line treatment the median progression-free survival in the intent-to-treat population was 5.8 months (95%CI 5.1 - 6.2 months) for capecitabine monotherapy and 7.8 months (95%CI 7.0 - 8.3 months; p=0.0002) for XELIRI.
Danish: I 1. linjebehandlingen var den mediane progressionsfri overlevelse i intent-to-treat-populationen 5,8 måneder (95 % konfidensinterval 5,1 - 6,2 måneder) for capecitabin-monoterapi og 7,8 måneder (95 % konfidensinterval 7,0 -8,3 måneder; p = 0,0002) for XELIRI.
English: - Hand-and-foot skin-reaction: if you have pain, swelling, redness or tingling of hands and/or feet.
Danish: - Hudsymptomer på hænder og fødder: hvis du har smerter, hævelse, rødme eller prikken i hænder og/eller fødder.
English: 30 film-coated tablets
Danish: 30 filmovertrukne tabletter
English: Table 2 Standard and reduced dose calculations according to body surface area for a starting dose of capecitabine of 1000 mg/m2
Danish: Tabel 2 Standard og reducerede dosisberegninger ud fra legemsoverfladeareal for en initialdosis af Ecansya på 1.000 mg/m2
English: The XELIRI regimens included capecitabine 1000 mg/m twice daily on days 1 to 14 of a three-week cycle combined with irinotecan 250 mg/m2 on day1.
Danish: XELIRI-regimerne inkluderede capecitabin 1.000 mg/m2 2 gange dagligt på dag 1-14 i en serie på 3 uger kombineret med irinotecan 250 mg/m på dag 1.
English: Dehydration, Weight decreased
Danish: Dehydrering, Vægttab
English: Treatment with brivudine can be started 24 hours after the last dose of capecitabine (see section 4.3 and 4.5).
Danish: Behandling med brivudin kan initieres 24 timer efter sidste dosis af capecitabin (se pkt.
English: Folinic acid/folic acid: a combination study with capecitabine and folinic acid indicated that folinic acid has no major effect on the pharmacokinetics of capecitabine and its metabolites.
Danish: Et studie om kombination af capecitabin og folinsyre tyder på, at folinsyre ikke har væsentlig effekt på farmakokinetikken af capecitabin og dets metabolitter.
English: In combination treatment, the recommended starting dose of capecitabine should be reduced to 800 - 1000 mg/m2 when administered twice daily for 14 days followed by a 7-day rest period, or to 625 mg/m2 twice daily when administered continuously (see section 5.1).
Danish: Ved kombinationsbehandling skal den anbefalede initialdosis af capecitabin reduceres til 8001.000 mg/m2, når det administreres to gange daglig i 14 dage efterfulgt af en pause på 7 dage eller til 625 mg/m2 to gange daglig, når det gives kontinuerligt (se pkt.
English: Data from a multicentre, randomised, controlled phase II study (AIO KRK 0604) supports the use of capecitabine at a starting dose of 800 mg/m2 for 2 weeks every 3 weeks in combination with irinotecan and bevacizumab for the first-line treatment of patients with metastatic colorectal cancer.
Danish: Data fra et randomiseret, kontrolleret fase II-multicenterstudie (AIO KRK 0604) støtter anvendelsen af en initial capecitabin-dosis på 800 mg/m2 i 2 uger hver 3. uge i kombination med irinotecan og bevacizumab som 1. linjebehandling af patienter med metastatisk kolorektalkræft.
English: Renal impairment (see section 4.2, 4.4, and 5.2):
Danish: 4.2, 4.4 og 5.2)
English: A meta-analysis of 14 clinical trials with data from over 4700 patients treated with capecitabine monotherapy or capecitabine in combination with different chemotherapy regimens in multiple indications (colon, colorectal, gastric and breast cancer) showed that patients on capecitabine who developed hand-foot syndrome (HFS) had a longer overall survival compared to patients who did not develop HFS: median overall survival 1100 days (95% CI 1007;1200) vs 691 days (95% CI 638;754) with a hazard ratio of 0.61 (95% CI 0.56; 0.66).
Danish: En metaanalyse af 14 kliniske studier med data fra mere end 4.700 patienter, som er blevet behandlet med capecitabin-monoterapi eller capecitabin i kombination med forskellige kemoterapiregimer indenfor flere indikationer (kolonkræft, kolorektalkræft, ventrikelkræft og brystkræft) viste, at patienter behandlet med capecitabin, som udviklede hånd- og fodsyndrom, havde en længere samlet overlevelse sammenlignet med patienter, som ikke udviklede hånd- og fodsyndrom: gennemsnitlige samlede overlevelse var 1.100 dage (95 % konfidensinterval 1.007; 1.200) versus 691 dage (95 % konfidensinterval 638; 754).
English: Table 1 Standard and reduced dose calculations according to body surface area for a starting dose of capecitabine of 1250 mg/m
Danish: Tabel 1 Standard og reducerede dosisberegninger ud fra legemsoverfladeareal for en initialdosis af capecitabin på 1.250 mg/m
English: General disorders and administration site conditions
Danish: Almenesymptomer og reaktioner på administrationsstedet
English: Confusional state, Panic attack, Depressed mood, Libido decreased
Danish: Konfusion, Panikanfald, Nedtrykthed, Nedsat libido
English: Data from a randomised multicentre, phase III study comparing capecitabine to 5-FU and oxaliplatin to cisplatin in patients with advanced gastric cancer supports the use of capecitabine for the first-line treatment of advanced gastric cancer (REAL-2).
Danish: Data fra et randomiseret fase III-multicenterstudie, der sammenlignede capecitabin med 5-FU og i kombination med enten oxaliplatin eller cisplatin til patienter med fremskreden ventrikelkræft, støtter anvendelse af capecitabin til 1. linjebehandling af fremskreden ventrikelkræft (REAL-2).
English: Patients receiving concomitant capecitabine and oral coumarin-derivative anticoagulant therapy should have their anticoagulant response (INR or prothrombin time) monitored closely and the anticoagulant dose adjusted accordingly (see section 4.5).
Danish: Hos patienter, som samtidig får behandling med capecitabin og orale antikoagulantia af coumarintypen, skal antikoagulansresponset (INR eller protrombintiden) monitoreres tæt, og antikoagulansdosis justeres, om nødvendigt (se pkt.
English: Colon, colorectal and breast cancer
Danish: Kolonkræft, kolorektalkræft og brystkræft
English: weeks followed by 1-week rest period and docetaxel 75 mg/m2 as a 1 hour intravenous infusion every
Danish: uger efterfulgt af en uges pause og behandling med docetaxel 75 mg/m2 som 1 times intravøs infusion hver 3. uge).
English: A meta-analysis of 14 clinical trials with data from over 4700 patients treated with capecitabine monotherapy or capecitabine in combination with different chemotherapy regimens in multiple indications (colon, colorectal, gastric and breast cancer) showed that HFS (all grades) occurred in 2066 (43%) patients after a median time of 239 [95% CI 201, 288] days after starting treatment with capecitabine.
Danish: En metaanalyse af 14 kliniske studier med data fra mere end 4.700 patienter, som er blevet behandlet med capecitabin-monoterapi eller capecitabin i kombination med forskellige kemoterapiregimer indenfor flere indikationer (kolonkræft, kolorektalkræft, ventrikelkræft og brystkræft) viste, at håndog fodsyndrom (alle grader) forekom hos 2.066 (43 %) patienter gennemsnitligt 239 [95 % konfidensinterval 201, 288] dage efter behandlingsstart med capecitabin.
English: 5-Fluorouracil 400 mg/m intravenous bolus, followed by 600 mg/ 2 intravenous 22 hr
Danish: Fluorouracil 400 mg/m intravenøs bolus, efterfulgt af
English: Dose level 1000 mg/m 2 (twice daily)
Danish: Dosisniveau på 1.000 mg/m 2 (to gange dagligt)
English: Constipation, Dyspepsia Upper gastrointestinal haemorrhage, Mouth ulceration, Gastritis, Abdominal distension, Gastroesophageal reflux disease, Oral pain, Dysphagia, Rectal haemorrhage, Abdominal pain lower, Oral dysaesthesia, Paraesthesia oral, Hypoaesthesia oral, Abdominal discomfort
Danish: Øvre gastrointestinal blødning, Sår i munden, Gastritis, Abdominal distension, Gastroøsofageal refluxsygdom, Smerter i munden, Dysfagi, Rektal blødning, Nedre abdominalsmerter, Oral dysæstesi, Oral paræstesi, Oral hypoæstesi, Abdominal ubehag
English: 95% CI
Danish: (95% KI)
English: In this treatment subgroup comparison, XELOX plus bevacizumab was similar compared to FOLFOX-4 plus bevacizumab in terms of progression-free survival (hazard ratio 1.01; 97.5% CI 0.84 - 1.22).
Danish: Sammenligningen viste, at XELOX plus bevacizumab svarede til FOLFOX-4 plus bevacizumab med hensyn til progressionsfri overlevelse (hazard ratio 1,01; 97,5 % konfidensinterval 0,84 - 1,22).
English: Hiccups, Pharyngolaryngeal pain, Dysphonia
Danish: Hikke, Faryngolaryngeal smerte, Dysfoni
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 bruger anden medicin, har brugt anden medicin eller planlægger at bruge anden medicin.
English: Lacrimation increased Visual disorders, Dry eye, Eye pain, Visual impairment, Vision blurred
Danish: Øget tåresekretion Synsforstyrrelser, Tørre øjne, Øjensmerter, Synsnedsættelse, Sløret syn
English: In the primary analysis for DFS in the ITT population, XELOX was shown to be significantly superior to 5-FU/LV (HR=0.80, 95% CI=[0.69; 0.93]; p=0.0045).
Danish: I den primære analyse af sygdomsfri overlevelse hos ITT-populationen, viste XELOX sig at være signifikant superior i forhold til 5-FU/LV (hazard ratio = 0,80, 95 % konfidensinterval = [0,69; 0,93], p = 0,0045).
English: Dose modifications for toxicity when capecitabine is used continuously in combination with other medicinal products should be made according to table 3 above for capecitabine and according to the appropriate summary of product characteristics for the other medicinal product(s).
Danish: Dosisændring på grund af toksicitet, når capecitabin anvendes kontinuerligt i kombination med andre lægemidler, skal foretages efter tabel 3 ovenfor for capecitabin og efter det pågældende produktresumé for det andet lægemiddel/de andre lægemidler.
English: 60 film-coated tablets
Danish: 60 filmovertrukne tabletter
English: +Fever,
Danish: Feber,
English: Capecitabine was at least equivalent to intravenous 5-FU/LV in disease-free survival in per protocol population (hazard ratio 0.92; 95% CI 0.80-1.06).
Danish: Capecitabin var mindst ækvivalent med 5-FU/LV intravenøs mht. sygdomsfri overlevelse i protokolpopulationen (hazard ratio 0,92; 95 % konfidensinterval 0,80-1,06).
English: The analysis for the secondary endpoint of RFS supports these results with a HR of 0.78 (95% CI=[0.67; 0.92]; p=0.0024) for XELOX vs. 5-FU/LV.
Danish: Analysen for det sekundære endepunkt, relapsfri overlevelse, støtter dissse resultater med en hazard ratio på 0,78 (95 % konfidensinterval = [0,67; 0,92], p = 0,0024) for XELOX versus 5-FU/LV.
English: Interferon alpha: 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: Interferon-alfa Capecitabins MTD var 2.000 mg/m 2/dag, når det kombineredes med interferon alfa-2a (3 MIE/m 2/dag)
English: Lipoma
Danish: Lipom
English: -2nd appearance -3rd appearance -4th appearance
Danish: ved 2. forekomst ved 3. forekomst ved 4. forekomst
English: Haematuria, Proteinuria, Creatinine renal clearance decreased, Dysuria
Danish: Hæmaturi, Proteinuri, Nedsat renal kreatininclearance, Dysuri
English: Skin toxicity, characterised by degenerative/regressive changes, was observed with capecitabine.
Danish: Efter behandling med capecitabin er der set hudtoksicitet, karakteriseret ved degenerative/regressive forandringer.
English: In this trial, 255 patients were randomised to treatment with capecitabine (1250 mg/m2 twice daily for 2
Danish: I dette studie randomiseredes 255 patienter til behandling med capecitabin (1.250 mg/m2 to gange dagligt i 2
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Ecansya 150 mg film-coated tablets Each film-coated tablet contains 150 mg capecitabine.
Danish: KVALITATIV OG KVANTITATIV SAMMENSÆTNING Ecansya 150 mg filmovertrukne tabletter Hver filmovertrukket tablet indeholder 150 mg capecitabin.