FrancophonIA/ELRC3.0 huggingface dataset:
English: Capecitabine should only be prescribed by a qualified physician experienced in the utilisation of anti-neoplastic medicinal products.
Danish: Capecitabin må kun ordineres af en kvalificeret læge med erfaring i brug af antineoplastiske lægemidler.
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: Body System Very Common All grades
Danish: Systemorgan-klasse Meget almindelig Alle grader
English: Women of childbearing potential/Contraception in males and females Women of childbearing potential should be advised to avoid becoming pregnant while receiving treatment with capecitabine.
Danish: Kvinder i den fertile alder/prævention hos mænd og kvinder Kvinder i den fertile alder skal rådes til ikke at blive gravide, så længe de behandles med capecitabin.
English: Patients treated with XELIRI experienced excessive gastrointestinal toxicity compared with FOLFIRI (diarrhoea 48% and 14% for XELIRI and FOLFIRI respectively).
Danish: Patienter behandlet med XELIRI oplevede i langt højere grad gastrointestinal toksicitet sammenlignet med FOLFIRI (48 % og 14 % fik diarré ved henholdsvis XELIRI og FOLFIRI).
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), - 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 eller warfarin) - medicin mod kramper eller rystelser (phenytoin) - alfa-interferon - får strålebehandling og bestemte lægemidler mod kræft (folinsyre, oxaliplatin, bevacizumab,
English: Your doctor may want you to take a combination of 150 mg, 300 mg and 500 mg tablets for each dose.
Danish: Det kan være din læge vil have at du for hver dosis skal tage en kombination af 150 mg, 300 mg og 500 mg tabletter.
English: Following grade 3 hand-foot syndrome, subsequent doses of capecitabine should be decreased.
Danish: Efter grad 3 hånd- og fodsyndrom skal dosis sættes ned.
English: Administration with food decreases the rate of capecitabine absorption (see section 5.2).
Danish: Administration sammen med mad nedsætter absorptionshastigheden af capecitabin (se pkt.
English: During standard fertility studies, impairment of fertility was observed in female mice receiving capecitabine; however, this effect was reversible after a drug-free period.
Danish: I standardfertilitetsundersøgelser blev der observeret påvirkning af fertiliteten på hunmus, som fik capecitabin, men effekten var dog reversibel efter en stoffri periode.
English: Patients treated with XELIRI + bevacizumab reported a significantly higher incidence of diarrhoea, febrile neutropenia and hand-foot skin reactions than patients treated with FOLFIRI + bevacizumab with significantly increased treatment delays, dose reductions and treatment discontinuations.
Danish: Patienter behandlet med XELIRI plus bevacizumab rapporterede signifikant højere incidenser af diarré, febril neutropeni og hånd-fod-hudreaktioner end patienter behandlet med FOLFIRI plus bevacizumab med signifikant højere frekevens af forsinkelse i behandling, dosisreduktioner og seponering af behandling.
English: Anorexia
Danish: Anoreksi
English: The overall objective response rates in the all-randomised population (investigator assessment) were 25.7% (capecitabine) vs. 16.7% (Mayo regimen); p <0.0002.
Danish: De totale objektive responsrater i den totale randomiserede population var (investigators vurdering) 25,7 % (capecitabin) vs. 16,7 % (Mayo regime), p< 0,0002.
English: During capecitabine monotherapy, no adjustment of the starting dose is needed.
Danish: Under monoterapi med capecitabin er justering af initialdosis ikke nødvendig.
English: The overall safety profile of capecitabine is based on data from over 3000 patients treated with capecitabine as monotherapy or capecitabine in combination with different chemotherapy regimens in multiple indications.
Danish: Den overordnede sikkerhedsprofil for capecitabin er baseret på data fra flere end 3.000 patienter, der fik capecitabin-monoterapi eller capecitabin i kombination med forskellige kemoterapiregimer indenfor flere indikationer.
English: 256 patients were randomised to treatment with docetaxel alone (100 mg/m as a 1 hour intravenous infusion every 3 weeks).
Danish: 256 patienter blev randomiseret til behandling med docetaxel alene (100 mg/m som 1 times intravøs infusion hver 3. uge).
English: For hand-foot syndrome and hyperbilirubinemia, see section 4.4.
Danish: Vedrørende hånd- og fodsyndrom og hyperbilirubinæmi se pkt.
English: PHARMACEUTICAL FORM AND CONTENTS Film-coated tablet
Danish: LÆGEMIDDELFORM OG INDHOLD (PAKNINGSSTØRRELSE) Filmovertrukken tablet
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 sikkerheds- og effektdata 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: Lacrimation increased, Conjunctivitis, Eye irritation
Danish: Øget tåresekretion, Conjunctivitis, Øjenirritation
English: Dose per administration (mg)
Danish: Dosis pr. dosering (mg)
English: The usual dose for adults is 1250 mg/m2 of body surface area taken two times daily (morning and evening).
Danish: Den normale dosis til voksne er 1250 mg/m2 legemsoverflade to gange dagligt (morgen og aften).
English: According to a pharmacokinetic study in cancer patients with mild to moderate liver impairment due to liver metastases, the bioavailability of capecitabine and exposure to 5-FU may increase compared to patients with no liver impairment.
Danish: I henhold til et farmakokinetisk studie på kræftpatienter med let til moderat leverinsufficiens pga. levermetastaser kan capecitabins biotilgængelighed og eksponeringen for 5-FU øges sammenlignet med patienter uden leverinsufficiens.
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 andet lægemiddel/de andre lægemidler skal afbrydes permanent, kan behandlingen med capecitabin genoptages, når betingelserne for genoptagelse af behandlingen med capecitabin er opfyldt.
English: If you are a woman who could become pregnant you should use effective contraception during treatment with Ecansya 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 Ecansya og i 6 måneder efter sidste dosis.
English: Oxaliplatin 85 mg/m2 intravenous 2 hr
Danish: Oxaliplatin 85 mg/m2 intravenøs 2 timer
English: Based on genetic toxicity findings, male patients with female partners of reproductive potential should use effective contraception during treatment and for 3 months following the last dose of capecitabine.
Danish: Baseret på genetisk toksikologiske fund skal mandlige patienter, med kvindelige partnere i den fertile alder, anvende effektiv prævention under behandling og i 3 måneder efter sidste dosis af capecitabin.
English: The median time to progression was 186 days (capecitabine + docetaxel) vs. 128 days (docetaxel alone).
Danish: Den mediane tid indtil progression var 186 dage (capecitabin + docetaxel) vs. 128 dage (docetaxel alene).
English: 9/L, treatment with capecitabine should be interrupted.
Danish: 9/l, bør behandling med capecitabin seponeres.
English: Dose modifications for toxicity when capecitabine is used continuously in combination with other medicinal products
Danish: Dosisændring på grund af toksicitet når capecitabin anvendes kontinuerligt i kombination med andre lægemidler
English: However, folinic acid has an effect on the pharmacodynamics of capecitabine and its toxicity may be enhanced by folinic acid: the maximum tolerated dose (MTD) of capecitabine alone using the intermittent regimen is 3000 mg/m2 per day whereas it is only 2000 mg/m2 per day when capecitabine was combined with folinic acid (30 mg orally bid).
Danish: Folinsyre har imidlertid en effekt på capecitabins farmakodynamik og dets toksicitet kan blive forstærket af folinsyre: maksimum tolererbar dosis (MTD) af capecitabin efter behandling med capecitabin alene er ved intermitterende behandling 3.000 mg/m2 pr. dag, hvorimod den kun er 2.000 mg/m2 pr. dag, når capecitabin kombineres med folinsyre (30 mg oralt to gange dagligt).
English: In a clinical pharmacokinetic interaction study, after a single 20 mg dose of warfarin, capecitabine treatment increased the AUC of S-warfarin by 57% with a 91% increase in INR value.
Danish: I et klinisk farmakokinetisk interaktionsstudie øgede behandling med capecitabin, efter en enkelt dosis på 20 mg warfarin, S-warfarin-AUC med 57 %, og INR-værdien steg med 91 %.
English: Patients with moderately impaired renal function show an increased rate of dose reduction (44%) vs. 33% and 32% in patients with no or mild renal impairment and an increase in early withdrawals from treatment (21% withdrawals during the first two cycles) vs. 5% and 8% in patients with no or mild renal impairment.
Danish: Patienter med moderat nyreinsufficiens fik hyppigere dosis reduceret (44 %) vs. 33 % og 32 % hos patienter med ingen eller let nyreinsufficiens og havde flere tidlige behandlingsophør (21 % behandlingsophør i de første to serier) vs. 5 % og 8 % hos patienter med ingen eller let nyreinsufficiens.
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 noninferior i forhold til FOLFOX-4 med hensyn til progressionsfri overlevelse i per-protokolpopulationen og intent-to-treat-populationen (se tabel 9).
English: Each film-coated tablet contains 150 mg, 300 mg or 500 mg capecitabine.
Danish: Hver filmovertrukket tablet indeholder 150 mg, 300 mg eller 500 mg capecitabin.
English: - 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.
Danish: - 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.
English: Table 3 Capecitabine dose reduction schedule (3 weekly cycle or continuous treatment)
Danish: Tabel 3 Dosisreduktion af capecitabin (3-ugers serier eller kontinuerlig behandling) Toksicitet graduering*
English: The median time to progression was 140 days (capecitabine) vs. 144 days (Mayo regimen).
Danish: Den mediane tid til progression var 140 dage (capecitabin) vs. 144 dage (Mayo regime).
English: 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).
Danish: 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.
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: Common All grades
Danish: Almindelig Alle grader
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 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).
English: Median overall survival ITT
Danish: Median samlet overlevelse ITT konfidensinterval
English: Median progression free survival ITT
Danish: konfidensinterval Median progressionsfri overlevelse ITT
English: Studies with capecitabine monotherapy indicate that capecitabine has activity in advanced gastric cancer.
Danish: Studier med capecitabin-monoterapi indikerer, at capecitabin har effekt i fremskreden ventrikelkræft.
English: 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.
Danish: 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.
English: 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.
Danish: 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.
English: Capecitabine may cause dizziness, fatigue and nausea.
Danish: Capecitabin kan forårsage svimmelhed, træthed og kvalme.
English: If the patient becomes pregnant while receiving capecitabine, the potential hazard to the foetus must be explained.
Danish: Hvis en patient bliver gravid under behandling med capecitabin, skal hun informeres om den mulige risiko for fostret.
English: Toxcity was similar between treatments with the exception of neutropenia reported more commonly in patients treated with FOLFIRI.
Danish: Toksiciteten ved behandlingerne var sammenlignelig på nær neutropeni, som blev rapporteret oftere hos patienter i FOLFIRI-armen.
English: Premedication with antiemetics according to the oxaliplatin summary of product characteristics is recommended for patients receiving the capecitabine plus oxaliplatin combination.
Danish: Præmedicinering med antiemetika i overensstemmelse med produktresumeet for oxaliplatin anbefales til patienter, som får kombinationen af capecitabin og oxaliplatin.
English: Bevacizumab: there was no clinically significant effect of bevacizumab on the pharmacokinetic parameters of capecitabine or its metabolites in the presence of oxaliplatin.
Danish: Bevacizumab havde ingen klinisk signifikant virkning på capecitabins farmakokinetiske parametre eller dets metabolitter under tilstedeværelse af oxaliplatin.
English: 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.
Danish: 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.
English: 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).
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 Ecansya (se pkt.
English: Median survival was 392 days (capecitabine) vs. 391 days (Mayo regimen).
Danish: Den mediane overlevelse var 392 dage (capecitabin) vs. 391 dage (Mayo regime).
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: Antacid: the effect of an aluminium hydroxide and magnesium hydroxide-containing antacid on the pharmacokinetics of capecitabine was investigated.
Danish: Man har undersøgt virkningen af et antacidum indeholdende aluminiumhydroxid og magnesiumhydroxid på capecitabins farmakokinetik.
English: 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.
Danish: 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.
English: If physician deems it to be in the patient's best interest to continue, interrupt until resolved to grade 0-1
Danish: 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
English: Parameter: Progression-free Survival PPP ITT Parameter: Overall Survival PPP ITT *PPP=per-protocol population; **ITT=intent-to-treat population
Danish: Parameter: Progressionsfri overlevelse PPP ITT Parameter: Samlet overlevelse PPP ITT *PPP=per protokol population; **ITT=intent-to-treat population
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 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).
English: The median overall survival was 10.9 months in capecitabine-based regimens and 9.6 months in 5-FU based regimens.
Danish: Den mediane samlede overlevelse var 10,9 måneder for de capecitabinbaserede regimer og 9,6 måneder for de 5-FU-baserede regimer.
English: The 5 year OS rate was 78% for XELOX versus 74% for 5-FU/LV.
Danish: Raten for 5 års samlet overlevelse var 78 % for XELOX versus 74 % for 5-FU/LV.
English: -fluoro--alanine (FBAL) which is cleared in the urine.
Danish: Endeligt spalter -ureido-propionase FUPA til -fluoro--alanin (FBAL), som udskilles i urinen.
English: 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).
Danish: 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).
English: 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
Danish: 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
English: The pharmacokinetics of capecitabine have been evaluated over a dose range of 502-3514 mg/m2/day.
Danish: Capecitabins farmakokinetik er undersøgt i dosisintervallet 502 - 3.514 mg/m2/dag.
English: For Aluminium-aluminium blisters
Danish: Aluminium/aluminium-blistere:
English: 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).
Danish: 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).
English: The median progression-free survival was 5.6 months (capecitabine + cisplatin) versus 5.0 months (5-FU + cisplatin).
Danish: Den mediane progressionsfrie overlevelse var 5,6 måneder (capecitabin + cisplatin) versus 5,0 måneder (5-FU + cisplatin).
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: 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: 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: The median duration of survival was 10.5 months (capecitabine + cisplatin) versus 9.3 months (5-FU + cisplatin).
Danish: Den mediane varighed for overlevelse var 10,5 måneder (capecitabin + cisplatin) versus 9,3 måneder (5-FU + cisplatin).