FrancophonIA/ELRC3.0 huggingface dataset:
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 Eastern Cooperative Oncology Group (ECOG) performance status at baseline (0
Danish: I alle studierne kombineret var følgende kovarianter statistisk signifikant associeret med en øget risiko for udviklingen af HFS: stigende capecitabinstartdosis (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 Eastern Cooperative Oncology Group (ECOG)-performancestatus ved baseline (0 versus ≥ 1).
English: fainting, nerve damage (neuropathy) and problems with sensation
Danish: besvimelse, nerveskader (neuropati) og problemer med følesansen
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: 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 skal: utilpashed, diarré, betændelse eller sår i tarme eller munden, smerter eller blødning fra tarme eller mave, nedsat antal af visse blodceller (såkaldt knoglemarvsdepression).
English: Dihydropyrimidinase cleaves the pyrimidine ring to yield 5-fluoro-ureidopropionic acid (FUPA).
Danish: Dihydropyrimidinase spalter pyrimidinringen til 5-fluoro-ureidopropionsyre (FUPA).
English: • In patients with known complete absence of dihydropyrimidine dehydrogenase (DPD) activity
Danish: • Patienter med kendt fuldstændig mangel på dihydropyrimidindehydrogenase (DPD)-aktivitet (se pkt.
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- og fod hudreaktioner end patienter behandlet med FOLFIRI plus bevacizumab med signifikant højere frekevens af forsinkelse i behandling, dosisreduktioner og seponering af behandling.
English: The usual dose for adults is 1,250 mg/m² of body surface area taken two times daily (morning and evening).
Danish: Den normale dosis til voksne er 1.250 mg/m² legemsoverflade to gange dagligt (morgen og aften).
English: • interferon alpha
Danish: • interferon-alfa
English: Two examples are provided here: A person whose body weight is 64 kg and height is 1.64 m has a body surface area of 1.7 m² and should take 4 tablets of 500 mg and 1 tablet of 150 mg two times daily.
Danish: Her følger to eksempler: En person, som vejer 64 kg, og som er 1,64 m høj, har et legemsoverfladeareal på 1,7 m² og skal tage 4 tabletter a 500 mg og 1 tablet a 150 mg to gange dagligt.
English: Bone marrow depression, +Febrile neutropenia
Danish: Knoglemarvsdepression, +Febril neutropeni
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: 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: The overall safety profile of capecitabine is based on data from over 3,000 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 inden for flere indikationer.
English: • DPD Deficiency: if you have a known DPD deficiency, you are at an increased risk of acute early-onset of toxicity and severe, life-threatening, or fatal adverse reactions caused by Capecitabine medac (e.g. stomatitis, mucosal inflammation, diarrhoea, neutropenia, and neurotoxicity).
Danish: • DPD-mangel: hvis du ved, at du har DPD-mangel, har du en øget risiko for akut tidlig indtræden af bivirkninger og svære, livstruende eller dødelige bivirkninger forårsaget af Capecitabine medac (f.eks. mundbetændelse, betændelseslignende reaktion (inflammation) i slimhinder, diarré, neutropeni og neurotoksicitet).
English: Capecitabine medac contains capecitabine, which itself is not a cytostatic medicine.
Danish: Capecitabine medac indeholder capecitabin, som i sig selv ikke virker cytostatisk.
English: However, similar to other nucleoside analogues (i.e., 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 en positiv trend i in vivo-mikronukleustesten på knoglemarv fra mus.
English: If you have an unrecognised DPD deficiency and take Capecitabine medac, you are at an increased risk of acute early-onset of severe forms of the side effects listed under section 4 Possible side effects.
Danish: Hvis du har DPD-mangel uden at vide det og tager Capecitabine medac, har du en øget risiko for akut tidlig indtræden af bivirkningerne, anført i punkt 4 Bivirkninger, i svær form.
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: • medicines for seizures or tremors (phenytoin)
Danish: • medicin mod kramper eller rystelser (phenytoin)
English: The median PFS was 5.6 months (capecitabine + cisplatin) versus 5.0 months (5-FU + cisplatin).
Danish: Den mediane PFS var 5,6 måneder (capecitabin + cisplatin) versus 5,0 måneder (5-FU + cisplatin).
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: 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: Number of 150 mg tablets, 300 mg tablets and/or 500 mg tablets per administration (each administration to be given morning and evening)
Danish: Antal 150 mg tabletter, 300 mg tabletter og/eller 500 mg tabletter pr. dosering (hver dosering skal gives morgen og aften)
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: 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: 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: 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: 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: • irregular heartbeat and palpitations (arrhythmias), chest pain and heart attack (infarction)
Danish: • uregelmæssig hjerterytme og hjertebanken (arytmier), brystsmerter og hjerteanfald (infarkt)
English: A person whose body weight is 80 kg and height is 1.80 m has a body surface area of 2.00 m² and should take 5 tablets of 500 mg two times daily.
Danish: En person, som vejer 80 kg, og som er 1,80 m høj, har et legemsoverfladeareal på 2,00 m² og skal tage 5 tabletter a 500 mg to gange dagligt.
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: If unscheduled laboratory assessments during a treatment cycle show that the neutrophil count drops below 1.0 x 109/L or that the platelet count drops below 75 x 109/L treatment with capecitabine should be interrupted.
Danish: Hvis uplanlagte laboratorieresultater under en behandlingsserie viser, at neutrofiltallet falder til under 1,0 x 109/l, eller antallet af blodplader falder til under 75 x 109/l, bør behandling med capecitabin seponeres.
English: - In combination with docetaxel: an increased incidence of grade 3 or 4 treatment-related adverse reactions and treatment-related serious adverse reactions were observed in patients 60 years of age or more (see section 5.1).
Danish: • I kombination med docetaxel: Der blev observeret en øget incidens af grad 3 eller 4 behandlingsrelaterede bivirkninger og behandlingsrelaterede alvorlige bivirkninger hos patienter på 60 år og derover (se pkt.
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: For hand-foot syndrome (HFS) and hyperbilirubinaemia, see section 4.4.
Danish: Vedrørende hånd- og fodsyndrom (HFS) og hyperbilirubinæmi se pkt.
English: XELOX was demonstrated to be non-inferior to FOLFOX-4 in terms of PFS 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 PFS i per-protokolpopulationen og intent-to-treatpopulationen (se tabel 9).
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 lokalt fremskreden eller metastatisk brystkræft efter svigt af taxaner og et kemoterapiregime indeholdende et antracyklin, eller hos hvem antracyklin-behandling ikke er indiceret.
English: A two-year mouse carcinogenicity study produced no evidence of carcinogenicity by capecitabine.
Danish: Et to-års carcinogenicitetsstudie på mus gav ikke holdepunkter, for at capecitabin var carcinogent.
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 inden for flere indikationer.
English: • blood clots in the deep veins, high or low blood pressure, hot flushes, cold limbs (extremities),
Danish: • blodprop i de dybe vener, højt eller lavt blodtryk, hedeture, kolde lemmer (ekstremiteter), lilla pletter på huden
English: blood in the urine, increase in blood creatinine (sign of kidney dysfunction)
Danish: øget indhold af kreatinin i blodet (tegn på nedsat nyrefunktion)
English: XELOX or XELOX+ Bevacizumab
Danish: XELOX eller XELOX + Bevacizumab
English: Elderly patients (see section 4.2)
Danish: Ældre patienter (se pkt.
English: The pharmacokinetics of capecitabine have been evaluated over a dose range of 5023,514 mg/m²/day.
Danish: Capecitabins farmakokinetik er undersøgt i dosisintervallet 502 - 3.514 mg/m²/dag.
English: The most commonly reported and/or clinically relevant treatment-related ADRs were gastrointestinal disorders (especially diarrhoea, nausea, vomiting, abdominal pain, stomatitis), HFS (palmar-plantar erythrodysesthesia), fatigue, asthenia, anorexia, cardiotoxicity, increased renal dysfunction on those with pre-existing 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), HFS (palmo-plantar erytrodysæstesi), træthed, asteni, anoreksi, kardiotoksicitet, øget renal dysfunktion hos dem med præeksisterende kompromitteret nyrefunktion samt trombose/embolisme.
English: • lumps under the skin (lipoma)
Danish: • fedtknuder under huden (lipomer)
English: Parameter: Overall survival PPP
Danish: Parameter: Samlet overlevelse PPP ITT
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 capecitabine (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 capecitabin (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: 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 3,000 mg/m² per day whereas it is only 2,000 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: Dihydropyrimidine dehydrogenase (DPD) deficiency Rarely, unexpected, severe toxicity (e.g. stomatitis, diarrhoea, mucosal inflammation, neutropenia and neurotoxicity) associated with 5-fluorouracil (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-fluoruracil (5-FU) er tilskrevet manglende DPD-aktivitet.
English: Median survival was 442 days (capecitabine + docetaxel) vs. 352 days (docetaxel alone).
Danish: Den mediane overlevelse var 442 dage (capecitabin + docetaxel) vs. 352 dage (docetaxel alene).
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 Systemorgan klasse
English: Detailed information on this medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu.
Danish: Yderligere oplysninger om Capecitabine medac findes på Det Europæiske Lægemiddelagenturs hjemmeside http://www.ema.europa.eu/
English: There is no relevant use of Capecitabine medac in the paediatric population in the indications colon, colorectal, gastric and breast cancer.
Danish: Anvendelse af Capecitabine medac er ikke relevant inden for den pædiatriske population i indikationerne kolonkræft, kolorektal kræft, gastrisk kræft og brystkræft.
English: Capecitabine medac should only be prescribed by a qualified physician experienced in the utilisation of anti-neoplastic medicinal products.
Danish: Capecitabine medac må kun ordineres af en kvalificeret læge med erfaring i brug af antineoplastiske lægemidler.
English: • infections of the lungs or respiratory system (e.g. pneumonia or bronchitis)
Danish: • infektioner i lunger eller luftveje (f.eks. lungebetændelse eller bronkitis)
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 bivirkningersammenlignet med patienter < 60 år.
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 5-FU/LV monoterapi-armen (9 %).
English: • fever, swelling in the limbs, feeling ill
Danish: • feber, hævelser i lemmer, følelse af at være syg
English: In patients with moderate renal impairment at baseline, a dose reduction to 75 % for a starting dose of 1,250 mg/m² is recommended.
Danish: Til patienter med moderat nyreinsufficiens ved baseline anbefales det at reducere dosis til 75 % af en initialdosis på 1.250 mg/m².
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 PFS on-treatment bekræftede dog ikke resultaterne fra den generelle PFS og samlede overlevelse: Hazard ratioen for XELOX versus FOLFOX-4 var 1,24 med 97,5 % konfidensinterval 1,07 - 1,44.
English: Grade 3 HFS 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 HFS 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: Do not use this medicine after the expiry date which is stated on the carton and blister after EXP.
Danish: Brug ikke Capecitabine medac efter den udløbsdato, der står på pakningen og på blisterkortet efter EXP. Udløbsdatoen er den sidste dag i den nævnte måned.
English: 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).
Danish: 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).
English: The MTD of capecitabine was 2,000 mg/m² per day when combined with interferon alpha- 2a (3 MIU/m² per day) compared to 3,000 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: 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 intravenøs infusion hver 3. uge).
English: The European Medicines Agency has waived the obligation to conduct studies with capecitabine in all subsets of the paediatric population in adenocarcinoma of the colon and rectum, gastric adenocarcinoma and breast carcinoma (see section 4.2 for information on paediatric use).
Danish: Det Europæiske Lægemiddelagentur har dispenseret fra kravet om at udføre studier med capecitabin i alle undergrupper af den pædiatriske population med adenokarcinom i colon og rektum, ventrikeladenokarcinom og brystkarcinom (se pkt.
English: • gout medicines (allopurinol)
Danish: • medicin mod urinsyregigt (allopurinol)
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: Do not give Capecitabine medac to children and adolescents.
Danish: Giv ikke Capecitabine medac til børn eller unge.
English: Capecitabine medac should only be prescribed by a doctor experienced in the use of anticancer medicines.
Danish: Capecitabine medac må kun ordineres af en læge, der har erfaring med anvendelse af kræftmedicin.