FrancophonIA/ELRC3.0 huggingface dataset:
English: Herpes zoster, Urinary tract infection, Oral candidiasis, Upper respiratory tract infection, Rhinitis, Influenza,
Danish: Herpes zoster, Urinvejsinfektion, Oral candidiasis, Øvre luftvejsinfektion, Rhinitis, Influenza, +Infektion, Oral herpes
English: Pyrexia, Weakness, +Lethargy, Temperature intolerance
Danish: Pyreksi, Svaghed, +Letargi,
English: General disorders and administration site conditions
Danish: Almene symptomer og reaktioner på administationsstedet
English: Iron oxide yellow (E172)
Danish: Jernoxid, rød (E172)
English: • fluid collection in the kidneys, increased frequency of urination during the night, incontinence,
Danish: • væskeophobning i nyrerne, øget trang til at lade vandet om natten, inkontinens, blod i urinen,
English: Given as monotherapy, the recommended starting dose for capecitabine in the adjuvant treatment of colon cancer, in the treatment of metastatic colorectal cancer or of locally advanced or metastatic breast cancer is 1,250 mg/m² administered twice daily (morning and evening; equivalent to 2,500 mg/m² total daily dose) for 14 days followed by a 7-day rest period.
Danish: Den anbefalede initialdosis af capecitabin-monoterapi til adjuverende behandling af kolonkræft, til behandling af metastatisk kolorektalkræft eller af lokalt fremskreden eller metastatisk brystkræft er 1.250 mg/m² administreret to gange dagligt (morgen og aften, svarende til en daglig dosis på 2.500 mg/m²) i 14 dage, efterfulgt af 7 dages pause.
English: In combination with docetaxel, the recommended starting dose of capecitabine in the treatment of metastatic breast cancer is 1,250 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: In combination treatment, the recommended starting dose of capecitabine should be reduced to 800-1,000 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 800-1.000 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: 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 intravenøst mht. sygdomsfri overlevelse i protokolpopulationen (hazard ratio 0,92; 95 % konfidensinterval 0,80-1,06).
English: The XELIRI regimens included capecitabine 1,000 mg/m² twice daily on days 1 to 14 of a 3-week cycle combined with irinotecan 250 mg/m² on day 1.
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/m² på dag 1.
English: • shortness of breath, nose bleeds, cough, runny nose
Danish: • stakåndethed, blødning fra næsen, hoste, løbende næse
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: The results of a meta-analysis of 14 clinical trials with data from over 4,700 patients treated with capecitabine showed that in all studies combined, the following covariates were statistically significantly associated with an increased risk of developing diarrhoea: increasing capecitabine starting dose (gram), increasing duration of study treatment (weeks), increasing age (by 10 year increments), and female gender.
Danish: En metaanalyse af 14 kliniske studier med data fra mere end 4.700 patienter, som er blevet behandlet med capecitabin, viste i alle studier kombineret, at følgende kovarianter var statistisk signifikant associeret med en øget risiko for udviklingen af diarré: stigende capecitabin-startdosis (gram), længere behandlingsvarighed (uger), stigende alder (ved 10-års forøgelse) samt kvindeligt køn.
English: For the capecitabine dose of 1,250 mg/m² twice daily on days 1 to 14 every 3 weeks, a frequency of 53 % to 60 % of all-grades HFS was observed in capecitabine monotherapy trials (comprising studies in adjuvant therapy in colon cancer, treatment of metastatic colorectal cancer, and treatment of breast cancer) and a frequency of 63 % was observed in the capecitabine/docetaxel arm for the treatment of metastatic breast cancer.
Danish: For capecitabindosis på 1.250 mg/m² to gange dagligt på dagene 1 til 14 hver 3. uge blev der observeret HFS i alle grader med en hyppighed på 53 % til 60 % i capecitabin-monoterapistudierne (bestående af studier i adjuverende behandling af kolonkræft, behandling af metastatisk kolorektalkræft og behandling af brystkræft).
English: Do not take Capecitabine medac
Danish: Tag ikke Capecitabine medac:
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 1, every 3 weeks).
Danish: I alt blev 156 patienter randomiseret til behandling med 5-FU (800 mg/m² 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: Colon, colorectal and advanced gastric cancer: meta-analysis
Danish: Kolonkræft, kolorektalkræft og fremskreden ventrikelkræft, metaanalyse
English: Median PFS was 10.0 and 8.9 months; p = 0.64, overall survival 25.7 and 27.5 months; p = 0.55 and response rates 45.5 and 39.8 %; p = 0.32 for FOLFIRI-Bev and XELIRI-Bev, respectively.
Danish: For henholdsvis FOLFIRI plus bevacizumab og XELIRI plus bevacizumab var den mediane PFS 10,0 og 8,9 måneder; p = 0,64, samlet overlevelse var 25,7 og 27,5 måneder; p = 0,55, og responsrater 45,5 % og 39,8 %; p = 0,32.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/12/802/001-014
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/12/802/001-014
English: Vascular disorders Lower limb oedema, Hypertension, +Embolism and thrombosis
Danish: Ødem i underekstremiteter, Hypertension, +Embolisme og tromboser
English: Thrombophlebitis
Danish: Trombocytopeni
English: Non-inferiority of the XELOX-containing arms compared with the FOLFOX-4-containing arms in the overall comparison was demonstrated in terms of progression-free survival (PFS) in the eligible patient population and the intent-to-treat population (see table 7).
Danish: I den egnede patientpopulation og intent-to-treat-populationen blev der demonstreret non-inferioritet af XELOX-armen sammenlignet med FOLFOX-4-armen med hensyn til progressionsfri overlevelse (progression-free survival, PFS) (se tabel 7).
English: Febrile neutropenia, Pancytopenia, Granulocytopenia, Thrombocytopenia, Leukopenia, Haemolytic anaemia, INR increased/Prothrombin time prolonged
Danish: Febril neutropeni, Pancytopeni, Granulocytopeni, Thrombocytopeni, Leukopeni, Hæmolytisk anæmi, Øget INR/forlænget protrombintid
English: • hiccups, change in voice
Danish: • hikke, stemmeændringer
English: Each 150 mg film-coated tablet contains 150 mg capecitabine Each 300 mg film-coated tablet contains 300 mg capecitabine Each 500 mg film-coated tablet contains 500 mg capecitabine
Danish: Hver 150 mg filmovertrukket tablet indeholder 150 mg capecitabin Hver 300 mg filmovertrukket tablet indeholder 300 mg capecitabin Hver 500 mg filmovertrukket tablet indeholder 500 mg capecitabin
English: Anhydrous lactose Cellulose, microcrystalline (E460) Croscarmellose sodium (E468) Hypromellose (E464) Magnesium stearate (E572)
Danish: Mikrokrystallinsk cellulose (E 460) Croscarmellosenatrium (E468) Hypromellose (E464) Magnesiumstearat (E572)
English: Oxaliplatin 130 mg/m² intravenous 2 hr
Danish: Oxaliplatin 130 mg/m² intravenøs over 2 timer
English: In this trial, 1,987 patients were randomised to treatment with capecitabine (1,250 mg/m² twice daily for 2 weeks followed by a 1-week rest period and given as 3-week cycles for 24 weeks) or 5-FU and leucovorin (Mayo Clinic regimen: 20 mg/m² leucovorin intravenous followed by 425 mg/m² intravenous bolus 5-FU, on days 1 to 5, every 28 days for 24 weeks).
Danish: I dette studie blev 1.987 patienter randomiseret til behandling med capecitabin (1.250 mg/m² to gange dagligt i 2 uger, efterfulgt af en uges pause, givet som 3-ugers-serier i 24 uger) eller til behandling med 5-FU og leucovorin (Mayo Clinic-regime: 20 mg/m² leucovorin intravenøst, efterfulgt af 425 mg/m² 5-FU intravenøst som bolus på dag 1 til 5, hver 28. dag i 24 uger).
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 19 November 2012
Danish: DATO FOR FØRSTE MARKEDSFØRINGSTILLADELSE/FORNYELSE AF TILLADELSEN
English: Capecitabine medac 150 mg film-coated tablets Capecitabine medac 300 mg film-coated tablets Capecitabine medac 500 mg film-coated tablets capecitabine
Danish: Capecitabine medac 150 mg filmovertrukne tabletter Capecitabine medac 300 mg filmovertrukne tabletter Capecitabine medac 500 mg filmovertrukne tabletter capecitabin
English: For Arm B, the XELIRI regimen used capecitabine 1,000 mg/m² twice daily for 14 days + irinotecan 250 mg/m² on day 1.
Danish: I arm-B bestod det anvendte XELIRI-regime af 1.000 mg/m² capecitabin 2 gange dagligt i 14 dage plus 250 mg/m² irinotecan på dag 1.
English: A population pharmacokinetic analysis was carried out after capecitabine treatment of 505 patients with colorectal cancer dosed at 1,250 mg/m² twice daily.
Danish: Efter capecitabin-behandling af 505 patienter med kolorektalkræft, som fik 1.250 mg/m² to gange dagligt, blev der foretaget en populationsfarmakokinetisk analyse.
English: Day 1, prior to XELOX, every 3 weeks 5-Fluorouracil: intravenous bolus injection immediately after leucovorin
Danish: 5-Fluorouracil: intravenøs bolus injektion umiddelbart efter leucovorin
English: In the all-randomised population, capecitabine was shown to be superior to 5-FU/LV for disease-free survival (hazard ratio 0.849; 95 % CI 0.739-0.976; p = 0.0212), as well as for overall survival (hazard ratio 0.828; 95 % CI 0.705-0.971; p = 0.0203).
Danish: I den samlede randomiseringspopulation blev capecitabin vist at være bedre end 5-FU/LV mht. sygdomsfri overlevelse (hazard ratio 0,849; 95 % konfidensinterval 0,739 - 0,976; p = 0,0212) og mht. samlet overlevelse (hazard ratio 0,828; 95 % konfidensinterval 0,705 - 0,971; p = 0,0203).
English: Capecitabine medac dose calculations
Danish: Capecitabine medac-dosisberegninger
English: The results of a meta-analysis of 14 clinical trials with data from over 4,700 patients treated with capecitabine showed that in all studies combined, increasing age (by 10 year increments) was statistically significantly associated with an increased risk of developing HFS and diarrhoea and with a decreased risk of developing neutropenia.
Danish: Resultaterne fra en metaanalyse af 14 kliniske studier med data fra mere end 4.700 patienter, som er blevet behandlet med capecitabin, viste, at i alle studier kombineret, var stigende alder (ved 10-års forøgelse) statistisk signifikant associeret med en øget risiko for udviklingen af HFS og diarré og med en faldende risiko for at udvikle neutropeni.
English: Leucovorin 200 mg/m² intravenous 2 hr
Danish: Leucovorin 200 mg/m² intravenøs over 2 timer
English: Monotherapy with capecitabine in metastatic colorectal cancer Data from two identically designed, multi centre, randomised, controlled phase III clinical trials (SO14695; SO14796) support the use of capecitabine for first line treatment of metastatic colorectal cancer.
Danish: Monoterapi med capecitabin ved metastatisk kolorektalkræft Data fra to identisk designede, randomiserede, kontrollerede, kliniske multicenterstudier i fase III (SO14695; SO14796) støtter anvendelsen af capecitabin til 1. linjebehandling af metastatisk kolorektalkræft.
English: • in combination with docetaxel (see section 5.1) for the treatment of patients with locally advanced or metastatic breast cancer after failure of cytotoxic chemotherapy.
Danish: 5.1) til behandling af patienter med lokalt fremskreden eller metastatisk brystkræft efter svigt af cytotoksisk kemoterapi.
English: 6.5 Nature and contents of container Aluminium/aluminium or PVC/PVdC/Aluminium blisters.
Danish: Aluminium/aluminium- eller PVC/PVdC/aluminium-blistere.
English: In the all-randomised population, tests for difference of capecitabine vs 5-FU/LV in disease-free and overall survival showed hazard ratios of 0.88 (95 % CI 0.77 - 1.01; p = 0.068) and 0.86 (95 % CI 0.74 - 1.01; p = 0.060), respectively.
Danish: I testene hos den samlede randomiseringspopulation for forskel mellem capecitabin og 5-FU/LV mht. sygdomsfri og samlet overlevelse var hazard ratios hhv. 0,88 (95 % konfidensinterval 0,77 - 1,01; p = 0,068) og 0,86 (95 % konfidensinterval 0,74 - 1,01; p = 0,060).
English: 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: When capecitabine was used in combination with other medicinal products, elderly patients (≥ 65 years) experienced more grade 3 and grade 4 adverse drug reactions (ADRs), including those leading to discontinuation, compared to younger patients.
Danish: Ældre patienter (≥ 65 år) havde, sammenlignet med yngre patienter, flere bivirkninger af grad 3 og 4, inklusive dem, som førte til seponering, når capecitabin blev anvendt i kombination med andre lægemidler.
English: Colon and colorectal cancer
Danish: Kolon- og kolorektalkræft
English: 150 mg 300 mg 500 mg
Danish: 150 mg 300 m g
English: This medicine does not require any special storage conditions.
Danish: Aluminium/aluminium-blistere Dette lægemiddel kræver ingen særlige forholdsregler vedrørende opbevaringen.
English: Capecitabine medac may make you feel dizzy, nauseous or tired.
Danish: Capecitabine medac forårsage svimmelhed, kvalme og træthed.
English: ADRs are added according to the highest incidence seen in any of the major combination trials.
Danish: Bivirkningerne er anført i frekvensgruppering ud fra den højeste hyppighed set i et af de store kliniske studier.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/12/802/029-042
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/12/802/029-042
English: • Grade 2 -1st appearance
Danish: • Grad 2 - ved 1. forekomst
English: In these trials, a total of 236 patients were treated with capecitabine (1,250 mg/m² twice daily for 2 weeks followed by 1-week rest period).
Danish: I disse studier blev 236 patienter behandlet med capecitabin (1.250 mg/m² to gange dagligt i 2 uger efterfulgt af en uges pause).
English: What you need to know before you take Capecitabine medac
Danish: Det skal du vide, før du begynder at tage Capecitabine medac
English: fungal infections (including those of the mouth), influenza, gastroenteritis, tooth abscess
Danish: (herunder i munden), influenza, gastroenteritis (tarminfektion), tandbylder
English: For PVC/PVdC-aluminium blisters:
Danish: SÆRLIGE OPBEVARINGSBETINGELSER PVC/PVdC/-aluminium-blistere:
English: skin loss, skin inflammation, nail disorder
Danish: hudtab, betændelse i huden, neglelidelser
English: The incidence of grade 3 or 4 adverse reactions in patients with moderate renal impairment (creatinine clearance 30 - 50 ml/min) is increased compared to the overall population (see sections 4.2 and 4.3).
Danish: Sammenlignet med hele populationen er hyppigheden af bivirkninger af grad 3 eller 4 forøget hos patienter med moderat nyreinsufficiens (creatininclearance 30-50 ml/min) (se pkt.
English: +Neutropenia, +Leukopenia, +Anaemia, +Neutropenic fever, Thrombocytopenia
Danish: Blod og lymfesystem +Neutropeni, +Leukopeni, +Anæmi, +Neutropenisk feber,
English: Table 5 lists ADRs associated with the use of capecitabine in combination with different chemotherapy regimens in multiple indications based on safety data from over 3,000 patients.
Danish: Tabel 5 viser de bivirkninger, der er forbundet med anvendelsen af capecitabin administreret i kombination med forskellige kemoterapiregimer inden for flere indikationer.
English: Pharyngitis, Oral candidiasis, Influenza, Gastroenteritis, Fungal infection, Infection, Tooth abscess
Danish: Urinvejsinfektion, Cellulitis, Tonsillitis, Faryngitis, Oral candidiasis, Influenza, Gastroenteritis, Svampeinfektion, Infektion, Tandbyld
English: • bleeding from the gut, constipation, pain in upper abdomen, indigestion, excess wind, dry mouth
Danish: • blødning fra tarmen, forstoppelse, smerter i den øvre del af maven, fordøjelsesbesvær, luft i maven, tør mund
English: Abdominal distension,
Danish: Nedre abdominale smerter,
English: 120 Patients were randomised to a modified XELIRI regimen with capecitabine 800 mg/m² twice daily for two weeks followed by a 7-day rest period), irinotecan (200 mg/m² as a 30 minute infusion on day 1 every 3 weeks), and bevacizumab (7.5 mg/kg as a 30 to 90 minute infusion on day 1every 3 weeks);
Danish: 120 patienter blev randomiseret til at få et modficeret XELIRI-regime med capecitabin (800 mg/m² 2 gange dagligt i to uger efterfulgt af 7 dages pause), irinotecan (200 mg/m² som infusion over 30 minutter på dag 1 hver tredje uge) og bevacizumab (7,5 mg/kg som infusion over 30 til 90 minutter på dag 1 hver tredje uge).
English: • skin ulcer and blister, reaction of the skin with sunlight, reddening of palms, swelling or pain of the face
Danish: • sår og blister på huden, hudreaktion ved udsættelse for sollys, rødfarvning af håndfladerne,
English: Table 2 Standard and reduced dose calculations according to body surface area for a starting dose of capecitabine of 1,000 mg/m²
Danish: Tabel 2 Standard og reducerede dosisberegninger ud fra legemsoverfladeareal for en initialdosis af capecitabin på 1.000 mg/m² Dosisniveau på 1.000 mg/m² (to gange dagligt)
English: In this trial, 160 patients were randomised to treatment with capecitabine (1,000 mg/m² twice daily for 2 weeks followed by a 7-day rest period) and cisplatin (80 mg/m² as a 2-hour infusion every 3 weeks).
Danish: I dette studie blev 160 patienter randomiseret til behandling med capecitabin (1.000 mg/m² to gange dagligt i 2 uger efterfulgt af 7 dages pause) og cisplatin (80 mg/m² som en 2timers infusion hver 3. uge).
English: In patients with unrecognised DPD deficiency treated with capecitabine as well as in those patients who test negative for specific DPYD variations, life-threatening toxicities manifesting as acute overdose may occur (see section 4.9).
Danish: Livstruende toksiciteter, der manifesterer sig som akut overdosis, kan forekomme hos patienter med uopdaget DPD-mangel behandlet med capecitabin samt hos de patienter, der testes negative for specifikke DPYD-variationer (se pkt.
English: XELOX/ XELOX+P/ XELOX+BV (EPP*: N = 967; ITT**: N = 1,017)
Danish: XELOX+BV (EPP*: N = 967; ITT**:
English: MARKETING AUTHORISATION NUMBER(S) EU/1/12/802/015-028
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/12/802/015-028
English: In this trial, 255 patients were randomised to treatment with capecitabine (1,250 mg/m² twice daily for 2 weeks followed by 1-week rest period and docetaxel 75 mg/m² as a 1 hour intravenous infusion every 3 weeks).
Danish: I dette studie randomiseredes 255 patienter til behandling med capecitabin (1.250 mg/m² to gange dagligt i 2 uger efterfulgt af en uges pause og behandling med docetaxel 75 mg/m² som 1 times intravenøs infusion hver 3. uge).
English: Lacrimal duct stenosis (rare), Corneal disorders (rare), Keratitis (rare), Punctate keratitis (rare)
Danish: Stenosis canaliculus lacrimalis (sjælden), Hornhinde-sygdom (sjælden), Keratitis (sjælden), Punktat keratitis (sjælden)
English: At the dose of 1,250 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 1.250 mg/m² efter indtagelse af føde var peak-plasmakoncentrationerne på dag 14 (Cmax, µg/ml) for capecitabin, 5'-DFCR, 5'-DFUR, 5-FU og
English: In these trials, 603 patients were randomised to treatment with capecitabine (1,250 mg/m² twice daily for 2 weeks followed by a 1-week rest period and given as 3-week cycles).
Danish: I studierne blev 603 patienter randomiseret til behandling med capecitabin (1.250 mg/m² to gange dagligt i 2 uger, efterfulgt af en uges pause, og givet som 3-ugers-serier).
English: Sequential treatment consisted of first-line capecitabine (1,250 mg/m² twice daily for 14 days), second-line irinotecan (350 mg/m² on day 1), and third-line combination of capecitabine (1,000 mg/m² twice daily for 14 days) with oxaliplatin (130 mg/m² on day 1).
Danish: Den sekventielle behandling bestod af 1. linjebehandling med capecitabin (1.250 mg/m² to gange daglig i 14 dage), 2. linjebehandling med irinotecan (350 mg/m² på dag 1) og 3. linjebehandling en kombination af capecitabin (1.000 mg/m² 2 gange dagligt i 14 dage) med oxaliplatin (130 mg/m² på dag 1).
English: • Grade 3 -1st appearance
Danish: • Grad 3 - ved 1. forekomst
English: Constipation, Dyspepsia Upper gastrointestinal haemorrhage, Mouth ulceration, Gastritis,
Danish: Obstipation, Dyspepsi Øvre gastrointestinal blødning, Sår i munden, Gastritis, Abdominal distension,
English: 127 patients were randomised to treatment with capecitabine (1,000 mg/m² twice daily for two weeks followed by a 7-day rest period), oxaliplatin (130 mg/m² as a 2 hour infusion on day 1 every 3 weeks), and bevacizumab (7.5 mg/kg as a 30 to 90 minute infusion on day 1 every 3 weeks).
Danish: 127 patienter blev randomiseret til behandling med capecitabin (1.000 mg/m² 2 gange dagligt i to uger efterfulgt af 7 dages pause), oxaliplatin (130 mg/m² som infusion over 2 timer på dag 1 hver tredje uge) og bevacizumab (7,5 mg/kg som infusion over 30 til 90 minutter på dag 1 hver tredje uge).
English: Dysphagia, Rectal haemorrhage, Abdominal pain lower, Oral dysaesthesia, Paraesthesia oral, Hypoaesthesia oral,
Danish: Gastroøsofageal refluxsygdom, Smerter i munden, Dysfagi, Rektal blødning, Nedre abdominalsmerter, Oral dysæstesi, Oral paræstesi, Oral hypoæstesi,
English: Administration of capecitabine should be interrupted if treatment-related elevations in bilirubin of > 3.0 x ULN or treatment-related elevations in hepatic aminotransferases (ALT, AST) of > 2.5 x ULN occur.
Danish: Hvis der forekommer behandlingsrelaterede stigninger af bilirubin > 3,0 x UNL eller af hepatiske aminotransferaser (ALAT og ASAT) > 2,5 x UNL, skal behandlingen med capecitabin straks afbrydes.
English: If the calculated creatinine clearance decreases during treatment to a value below 30 ml/min, Capecitabine medac should be discontinued.
Danish: Capecitabine medac bør seponeres, hvis den beregnede creatininclearance under behandling falder til et niveau under 30 ml/min.
English: In the EORTC study patients were randomised to receive either open label FOLFIRI (n = 41) or XELIRI (n = 44) with additional randomisation to either double-blind treatment with celecoxib or placebo.
Danish: I EORTC-studiet blev patienterne randomiseret til ublindet at få enten FOLFIRI (n = 41) eller XELIRI (n = 44).
English: • Grade 4 -1st appearance
Danish: • Grad 4 - ved 1. forekomst