natgillin/translations-raw huggingface dataset:
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). 
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.
Tag ikke Capecitabine medac: 
Do not take Capecitabine medac
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). 
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).
Kolonkræft, kolorektalkræft og fremskreden ventrikelkræft, metaanalyse 
Colon, colorectal and advanced gastric cancer: meta-analysis
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. 
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.
MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/12/802/001-014 
MARKETING AUTHORISATION NUMBER(S) EU/1/12/802/001-014
Ødem i underekstremiteter, Hypertension, +Embolisme og tromboser 
Vascular disorders Lower limb oedema, Hypertension, +Embolism and thrombosis
Trombocytopeni 
Thrombophlebitis
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). 
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).
Febril neutropeni, Pancytopeni, Granulocytopeni, Thrombocytopeni, Leukopeni, Hæmolytisk anæmi, Øget INR/forlænget protrombintid 
Febrile neutropenia, Pancytopenia, Granulocytopenia, Thrombocytopenia, Leukopenia, Haemolytic anaemia, INR increased/Prothrombin time prolonged
• hikke, stemmeændringer 
• hiccups, change in voice
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 
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
Mikrokrystallinsk cellulose (E 460) Croscarmellosenatrium (E468) Hypromellose (E464) Magnesiumstearat (E572) 
Anhydrous lactose Cellulose, microcrystalline (E460) Croscarmellose sodium (E468) Hypromellose (E464) Magnesium stearate (E572)
Oxaliplatin 130 mg/m² intravenøs over 2 timer 
Oxaliplatin 130 mg/m² intravenous 2 hr
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). 
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).
DATO FOR FØRSTE MARKEDSFØRINGSTILLADELSE/FORNYELSE AF TILLADELSEN 
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 19 November 2012
Capecitabine medac 150 mg filmovertrukne tabletter Capecitabine medac 300 mg filmovertrukne tabletter Capecitabine medac 500 mg filmovertrukne tabletter capecitabin 
Capecitabine medac 150 mg film-coated tablets Capecitabine medac 300 mg film-coated tablets Capecitabine medac 500 mg film-coated tablets capecitabine
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. 
For Arm B, the XELIRI regimen used capecitabine 1,000 mg/m² twice daily for 14 days + irinotecan 250 mg/m² on day 1.
Efter capecitabin-behandling af 505 patienter med kolorektalkræft, som fik 1.250 mg/m² to gange dagligt, blev der foretaget en populationsfarmakokinetisk analyse. 
A population pharmacokinetic analysis was carried out after capecitabine treatment of 505 patients with colorectal cancer dosed at 1,250 mg/m² twice daily.
5-Fluorouracil: intravenøs bolus injektion umiddelbart efter leucovorin 
Day 1, prior to XELOX, every 3 weeks 5-Fluorouracil: intravenous bolus injection immediately after leucovorin
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). 
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).
Capecitabine medac-dosisberegninger 
Capecitabine medac dose calculations
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. 
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.
Leucovorin 200 mg/m² intravenøs over 2 timer 
Leucovorin 200 mg/m² intravenous 2 hr
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. 
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.
5.1) til behandling af patienter med lokalt fremskreden eller metastatisk brystkræft efter svigt af cytotoksisk kemoterapi. 
• 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.
Aluminium/aluminium- eller PVC/PVdC/aluminium-blistere. 
6.5 Nature and contents of container Aluminium/aluminium or PVC/PVdC/Aluminium blisters.
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). 
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.
Parameter: Progressionsfri overlevelse PPP ITT Parameter: Samlet overlevelse PPP ITT *PPP = per protokol-population; **ITT = intent-to-treat-population 
ITT *PPP = per-protocol population; **ITT = intent-to-treat population.
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. 
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.
Kolon- og kolorektalkræft 
Colon and colorectal cancer
150 mg 300 m g 
150 mg 300 mg 500 mg
Aluminium/aluminium-blistere Dette lægemiddel kræver ingen særlige forholdsregler vedrørende opbevaringen. 
This medicine does not require any special storage conditions.
Capecitabine medac forårsage svimmelhed, kvalme og træthed. 
Capecitabine medac may make you feel dizzy, nauseous or tired.
Bivirkningerne er anført i frekvensgruppering ud fra den højeste hyppighed set i et af de store kliniske studier. 
ADRs are added according to the highest incidence seen in any of the major combination trials.
MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/12/802/029-042 
MARKETING AUTHORISATION NUMBER(S) EU/1/12/802/029-042
• Grad 2 - ved 1. forekomst 
• Grade 2 -1st appearance
I disse studier blev 236 patienter behandlet med capecitabin (1.250 mg/m² to gange dagligt i 2 uger efterfulgt af en uges pause). 
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).
Det skal du vide, før du begynder at tage Capecitabine medac 
What you need to know before you take Capecitabine medac
(herunder i munden), influenza, gastroenteritis (tarminfektion), tandbylder 
fungal infections (including those of the mouth), influenza, gastroenteritis, tooth abscess
SÆRLIGE OPBEVARINGSBETINGELSER PVC/PVdC/-aluminium-blistere: 
For PVC/PVdC-aluminium blisters:
hudtab, betændelse i huden, neglelidelser 
skin loss, skin inflammation, nail disorder
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. 
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).
Blod og lymfesystem +Neutropeni, +Leukopeni, +Anæmi, +Neutropenisk feber, 
+Neutropenia, +Leukopenia, +Anaemia, +Neutropenic fever, Thrombocytopenia
Tabel 5 viser de bivirkninger, der er forbundet med anvendelsen af capecitabin administreret i kombination med forskellige kemoterapiregimer inden for flere indikationer. 
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.
Urinvejsinfektion, Cellulitis, Tonsillitis, Faryngitis, Oral candidiasis, Influenza, Gastroenteritis, Svampeinfektion, Infektion, Tandbyld 
Pharyngitis, Oral candidiasis, Influenza, Gastroenteritis, Fungal infection, Infection, Tooth abscess
• blødning fra tarmen, forstoppelse, smerter i den øvre del af maven, fordøjelsesbesvær, luft i maven, tør mund 
• bleeding from the gut, constipation, pain in upper abdomen, indigestion, excess wind, dry mouth
Nedre abdominale smerter, 
Abdominal distension,
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). 
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);
• sår og blister på huden, hudreaktion ved udsættelse for sollys, rødfarvning af håndfladerne, 
• skin ulcer and blister, reaction of the skin with sunlight, reddening of palms, swelling or pain of the face
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) 
Table 2 Standard and reduced dose calculations according to body surface area for a starting dose of capecitabine of 1,000 mg/m²
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). 
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).
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. 
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).
XELOX+BV (EPP*: N = 967; ITT**: 
XELOX/ XELOX+P/ XELOX+BV (EPP*: N = 967; ITT**: N = 1,017)
MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/12/802/015-028 
MARKETING AUTHORISATION NUMBER(S) EU/1/12/802/015-028
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). 
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).
Stenosis canaliculus lacrimalis (sjælden), Hornhinde-sygdom (sjælden), Keratitis (sjælden), Punktat keratitis (sjælden) 
Lacrimal duct stenosis (rare), Corneal disorders (rare), Keratitis (rare), Punctate keratitis (rare)
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 
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.
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). 
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).
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). 
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).
• Grad 3 - ved 1. forekomst 
• Grade 3 -1st appearance
Obstipation, Dyspepsi Øvre gastrointestinal blødning, Sår i munden, Gastritis, Abdominal distension, 
Constipation, Dyspepsia Upper gastrointestinal haemorrhage, Mouth ulceration, Gastritis,
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). 
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).
Gastroøsofageal refluxsygdom, Smerter i munden, Dysfagi, Rektal blødning, Nedre abdominalsmerter, Oral dysæstesi, Oral paræstesi, Oral hypoæstesi, 
Dysphagia, Rectal haemorrhage, Abdominal pain lower, Oral dysaesthesia, Paraesthesia oral, Hypoaesthesia oral,
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. 
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.
Capecitabine medac bør seponeres, hvis den beregnede creatininclearance under behandling falder til et niveau under 30 ml/min. 
If the calculated creatinine clearance decreases during treatment to a value below 30 ml/min, Capecitabine medac should be discontinued.
I EORTC-studiet blev patienterne randomiseret til ublindet at få enten FOLFIRI (n = 41) eller XELIRI (n = 44). 
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.
• Grad 4 - ved 1. forekomst 
• Grade 4 -1st appearance
Bivirkningerne er baseret på en samlet analyse af kliniske sikkerhedsdata fra 7 kliniske studier med 949 patienter (2 fase III- og 5 fase II-kliniske studier i metastatisk kolorektalkræft og metastatisk brystkræft) og omfatter: kardiomyopati, hjerteinsufficiens, dødsfald og ventrikulære ekstrasystoler. 
In addition to the ADRs described in tables 4 and 5, the following ADRs with an incidence of less than 0.1 % were associated with the use of capecitabine monotherapy based on a pooled analysis from clinical safety data from 7 clinical trials including 949 patients (2 phase III and 5 phase II clinical trials in metastatic colorectal cancer and metastatic breast cancer): cardiomyopathy, cardiac failure, sudden death, and ventricular extrasystoles.
12,1 måneder p = 0,30 
P = 0.30
Hyperhidrose, Erytematøst udslæt, Urticaria, Nattesved 
Alopecia, Nail disorder Hyperhidrosis, Rash subcutaneous tissue disorders erythematous, Urticaria, Night sweats
Kombinationsbehandlingen bestod af 1. linjebehandling med capecitabin (1.000 mg/m² to gange daglig i 14 dage) kombineret med irinotecan (250 mg/m² på dag 1) (XELIRI) og 2. linjebehandling med capecitabin (1.000 mg/m² to gange dagligt i 14 dage) plus oxaliplatin (130 mg/m² på dag 1). 
Combination treatment consisted of first-line capecitabine (1,000 mg/m² twice daily for 14 days) combined with irinotecan (250 mg/m² on day 1) (XELIRI) and second-line capecitabine (1,000 mg/m² twice daily for 14 days) plus oxaliplatin
Alopeci, 
Hiccups,
• hvis du har forstyrrelser i kalkstofskiftet (måles vha. blodprøver) 
• if you have calcium imbalances (seen in blood tests),
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. 
supports these results with a HR of 0.78 (95 % CI = [0.67; 0.92]; p = 0.0024) for XELOX vs. 5-FU/LV.
95,5 % af den indgivne capecitabindosis genfandtes i urinen. 
Capecitabine and its metabolites are predominantly excreted in urine; 95.5 % of administered capecitabine dose is recovered in urine.
Du må ikke tage Capecitabine medac, hvis du er gravid eller tror, du er det. Du må ikke amme, hvis du tager Capecitabine medac og i 2 uger efter sidste dosis. 
You must not breast-feed if you are taking Capecitabine medac and for 2 weeks after the last dose.
Præmedicinering med antiemetika i overensstemmelse med produktresumeet for oxaliplatin anbefales til patienter, som får kombinationen af capecitabin og oxaliplatin. 
Premedication with antiemetics according to the oxaliplatin summary of product characteristics is recommended for patients receiving the capecitabine plus oxaliplatin combination.Adjuvant treatment in patients with stage III colon cancer is recommended for a duration of 6 months.
• lægemidler til behandling af folsyremangel 
• medicines used to treat folic acid deficiency
Kuldegysninger, Influenzalignende symptomer, Kulderystelser, Øget kropstemperatur 
Oedema, Chills, Influenza-like illness, Rigors, Body temperature increased
- ved 2. forekomst - ved 3. forekomst 
-2nd appearance -3rd appearance
• udslæt, tør eller kløende hud 
• rash, dry or itchy skin
Ondt i halsen, Pharynxdysæstesi 
Sore throat, Dysaesthesia pharynx
Capecitabine medac 300 mg filmovertrukne tabletter De filmovertrukne tabletter er hvide til off-white, aflange, bikonvekse tabletter, 14,6 mm lange og 6,7 mm brede, præget med ”300” på den ene side og jævne på den anden side. 
The film-coated tablets are white to off white, oblong shaped, biconvex tablets of 14.6 mm in length and 6.7 mm in width, debossed with ‘300' on one side and plain on other side.
Data fra et randomiseret, kontrolleret, klinisk fase III-multicenterstudie støtter anvendelsen af capecitabin i kombination med docetaxel til behandling af patienter med lokalt fremskreden eller metastatisk brystkræft, hos hvem cytotoksisk kemoterapi, inklusive et antracyklin, har svigtet. 
Combination therapy with capecitabine and docetaxel in locally advanced or metastatic breast cancer Data from one multicentre, randomised, controlled phase III clinical trial support the use of capecitabine in combination with docetaxel for treatment of patients with locally advanced or metastatic breast cancer after failure of cytotoxic chemotherapy, including an anthracycline.
20 mg/m² leucovirin intravenøst efterfulgt af en 5-FU bolus på 425 mg/m² intravenøst på dag 1 til 5, hver 28. dag). 
604 patients were randomised to treatment with 5-FU and leucovorin (Mayo regimen: 20 mg/m² leucovorin intravenous followed by 425 mg/m² intravenous bolus 5-FU, on days 1 to 5, every 28 days).
LISTE OVER HJÆLPESTOFFER Indeholder også vandfri lactose og natrium. 
LIST OF EXCIPIENTS Also contains anhydrous lactose and sodium, read the package leaflet before use.
Øget tåresekretion Synsforstyrrelser, Tørre øjne, Øjensmerter, 
Lacrimation increased Visual disorders, Dry eye, Eye pain, Visual impairment, Vision blurred
Capecitabine medac 150 mg filmovertrukne tabletter Hypromellose (E464), titandioxid (E 171), gul jernoxid (E172), rød jernoxid (E 172), talkum. 
Capecitabine medac 150 mg film-coated tablets Hypromellose (E464), titanium dioxide (E171), yellow iron oxide (E172), red iron oxide (E172), talc
Hyperbilirubinæmi, Unormal leverfunktionstest 
Hyperbilirubinaemia, Liver function test abnormalities
INFORMATION I BRAILLESKRIFT Capecitabine medac 300 mg 
INFORMATION IN BRAILLE Capecitabine medac 300 mg
• hævelse (ødem), kulderystelser og stivhed 
• swelling (oedema), chills and rigors
Tabel 1 Standard og reducerede dosisberegninger ud fra legemsoverfladeareal for en initialdosis af capecitabin på 1.250 mg/m² Dosisniveau på 1.250 mg/m² (to gange dagligt) 
Table 1 Standard and reduced dose calculations according to body surface area for a starting dose of capecitabine of 1,250 mg/m².