natgillin/translations-raw huggingface dataset:
Humane plasmaundersøgelser in vitro har vist, at capecitabin, 5′ DFCR, 5′ DFUR og 5-FU er hhv. 54 %, 10 %, 62 % og 10 % bundet til protein, hovedsageligt til albumin. 
In vitro human plasma studies have determined that capecitabine, 5'-DFCR, 5'-DFUR and 5-FU are 54 %, 10 %, 62 % and 10 % protein bound, mainly to albumin.
Capecitabine medac fås i blistere (aluminium-aluminium eller PVC/PVdC-aluminium). 
Capecitabine medac is available in blisters (Aluminium-Aluminium or PVC/PVdC-Aluminium).
Patienterne blev randomiseret til enten at få FOLFIRI plus bevacizumab (arm-A, n = 167) eller XELIRI plus bevacizumab (arm-B, n = 166). 
Patients were randomised to receive either FOLFIRI plus bevacizumab (Arm-A, n = 167) or XELIRI plus bevacizumab (Arm-B, n-166).
For termer markeret med ”+” er hyppigheden baseret på bivirkninger af grad 3-4. 
For terms marked with a “+”, the frequency count was based on grade 3 - 4 ADRs.
Du skal ikke tage den glemte dosis. 
Do not take the missed dose at all.
Effektdata er baseret på en median observationstid på 59 måneder for samlet overlevelse og 57 måneder for sygdomsfri overlevelse. 
The efficacy data is based on a median observation time of 59 months for OS and 57 months for DFS.
Capecitabine medac tilhører en gruppe lægemidler, som kaldes “cytostatika”, som standser væksten af kræftceller. 
Capecitabine medac belongs to the group of medicines called "cytostatic medicines", which stop the growth of cancer cells.
• smerter eller ændret/unormal følelse i munden, smerter i kæben 
• pain or altered/abnormal sensation in the mouth, pain in the jaw
Hvis du har taget for mange Capecitabine medac-tabletter Hvis du har taget for mange Capecitabine medac-tabletter, skal du kontakte din læge hurtigst muligt, før du tager næste dosis. 
If you take more Capecitabine medac than you should If you take more Capecitabine medac than you should, contact your doctor as soon as possible before taking the next dose.
Der var en mindre stigning i plasmakoncentrationerne af capecitabin og en af metabolitterne 5'-deoxy-5-fluorocytidin (5'-DFCR), men ingen virkning på de 3 hovedmetabolitter 5'-deoxy-5-fluorouridin (5'-DFUR), 5-FU og α-fluoro-β-alanin (FBAL). 
There was a small increase in plasma concentrations of capecitabine and one metabolite 5'-deoxy-5-fluorocytidine (5'-DFCR); there was no effect on the 3 major metabolites: 5'-deoxy-5-fluorouridine (5'-DFUR), 5-FU and α-fluoro-β-alanine (FBAL).
Oxaliplatin på dag 1, hver 3. uge capecitabin oral to gange daglig i 2 uger (efterfulgt af 1 uge uden behandling) 
Oxaliplatin on Day 1, every 3 weeks capecitabine oral twice daily for 2 weeks (followed by 1 week off- treatment)
Capecitabin er et non-cytotoksisk fluorpyrimidincarbamat, som virker som en oral administreret prækursor for det cytotoksiske 5-FU. 
Capecitabine is a non-cytotoxic fluoropyrimidine carbamate, which functions as an orally administered precursor of the cytotoxic moiety 5-FU.
Enzymerne, som er involverede i den katalytiske aktivering, findes i tumorvæv, men også i normalt væv, om end i lavere koncentrationer. 
The enzymes involved in the catalytic activation are found in tumour tissues but also in normal tissues, albeit usually at lower levels.
I humane cancerxenotransplantationsmodeller har capecitabin vist en synergistisk effekt i kombination med docetaxel, som kan være relateret til docetaxels opregulering af ThyPase. 
In human cancer xenograft models capecitabine demonstrated a synergistic effect in combination with docetaxel, which may be related to the upregulation of ThyPase by docetaxel.
Studiet indeholdte to dele: En initial 2-arms del, i hvilken 634 patienter blev randomiseret i to forskellige behandlingsgrupper, inkluderende XELOX eller FOLFOX-4, og efterfølgende 2*2 design, i hvilken 1.401 patienter blev randomiseret til 4 forskellige behandlingsgrupper, inkluderende XELOX plus placebo, FOLFOX-4 plus placebo, XELOX plus bevacizumab og FOLFOX-4 plus bevacizumab. 
The study contained two parts: an initial 2-arm part in which 634 patients were randomised to two different treatment groups, including XELOX or FOLFOX-4, and a subsequent 2x2 factorial part in which 1,401 patients were randomised to four different treatment groups, including XELOX plus placebo, FOLFOX-4 plus placebo, XELOX plus bevacizumab, and FOLFOX-4 plus bevacizumab.
Dette lægemiddel indeholder mindre end 1 mmol (23 mg) natrium pr. filmovertrukket tablet, dvs. den er i det væsentlige natrium-fri. 
This medicinal product contains less than 1 mmol sodium (23 mg) per film-coated tablet, that is to say essentially ‘sodium-free'.
Kun når det er optaget i kroppen, ændres det til et aktivt anti-cancer stof (fortrinsvis i svulstvæv). 
Only after being absorbed by the body is it changed into an active anti-cancer medicine (more in tumour tissue than in normal tissue).
• øget svedtendens, svedeture om natten 
• sweating, night sweats
• til 1. linjebehandling af fremskreden ventrikelkræft i kombination med et platinbaseret regime (se pkt. 
• for first-line treatment of advanced gastric cancer in combination with a platinum based regimen (see section 5.1).
I henhold til immunohistokemiske studier synes ThyPase hovedsagelig lokaliseret i stromale tumorceller. 
According to immunohistochemical studies, ThyPase appears to be in large part localised in tumour stromal cells.
Desuden indtraf der i en 13 ugers undersøgelse atrofiske og degenerative forandringer i reproduktionsorganerne hos hanmus; forandringerne var dog reversible efter en stoffri periode (se pkt. 
In addition, during a 13-week study, atrophic and degenerative changes occurred in reproductive organs of male mice; however these effects were reversible after a drug-free period (see section 4.6).
Capecitabin skal seponeres permanent hos patienter, der oplever en alvorlig hudreaktion under behandlingen. 
Capecitabine should be permanently discontinued in patients who experience a severe skin reaction during treatment.
• usædvanlig blødning fra skeden 
• unusual bleeding from the vagina
• problemer med leverfunktionen (målt i blodprøver) og øget blodbilirubin (udskilt i leveren) 
• problems with liver function (seen in blood tests) and increased blood bilirubin (excreted by the liver)
Køn, tilstedeværelse eller fravær af levermetastaser ved baseline, Karnofsky Performance Status, total bilirubin, serum-albumin, aspartataminotransferase (ASAT) og alaninaminotransferase (ALAT) havde ingen statistisk signifikant effekt på farmakokinetikken af 5'-DFUR, 5-FU og FBAL. 
Gender, presence or absence of liver metastasis at baseline, Karnofsky Performance Status, total bilirubin, serum albumin, aspartate-aminotransferase (ASAT) and alanine-aminotransferase (ALAT) had no statistically significant effect on the pharmacokinetics of 5'-DFUR, 5-FU and FBAL.
Baseret på populationsfarmakokinetiske analyser, som omfattede patienter i mange aldre (27 - 86 år), og som omfattede 234 (46 %) patienter, som var mindst 65 år, spillede alderen ingen rolle for farmakokinetikken af 5'-DFUR og 5-FU. 
Based on the population pharmacokinetic analysis, which included patients with a wide range of ages (27 to 86 years) and included 234 (46 %) patients greater or equal to 65, age has no influence on the pharmacokinetics of 5'-DFUR and 5-FU.
HFS også kendt som hand-foot-hudreaktion, palmo-plantar erytrodysæstesi eller kemoterapiinduceret akralt erytem. 
HFS also known as hand-foot skin reaction or palmar-plantar erythrodysesthesia or chemotherapy induced acral erythema.
Der bør udvises forsigtighed, når capecitabin administreres samtidig med 2C9substrater (fx phenytoin). 
Care should be exercised when capecitabine is co-administered with 2C9 substrates (e.g. phenytoin).
Legemsoverfladeareal (m²) 
Body surface area (m²)
Samlet responsrate var 49 % i XELIRI-armen og 48 % i FOLFIRI-armen (p = 0,76). 
Overall response rate was 49 % in the XELIRI and 48 % in the FOLFIRI arm (p = 0.76).
Kutan lupus erythematosus (sjælden), Alvorlige hudreaktioner såsom 
Cutaneous lupus erythematosus (rare), Severe skin reactions such as
• strålebehandling og visse lægemidler mod kræft (folinsyre, oxaliplatin, bevacizumab, cisplatin, 
• radiotherapy and certain medicines used to treat cancer (folinic acid, oxaliplatin, bevacizumab,
• talebesvær, nedsat hukommelse, nedsat evne til at koordinere bevægelser, balanceforstyrrelser, 
• difficulty speaking, impaired memory, loss of movement coordination, balance disorder,
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). 
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 1,900 patients (studies M66001, SO14695, and SO14796).
Der er ingen data om capecitabin og påvirkning af fertilitet. 
There is no data on capecitabine and impact on fertility.
Ved dehydrering af grad 2 (eller højere) bør behandlingen med capecitabin straks seponeres, og dehydreringen korrigeres. 
If grade 2 (or higher) dehydration occurs, capecitabine treatment should be immediately interrupted and the dehydration corrected.
Der er nogen evidens for, at dexpanthenol er virksomt som profylakse mod HFS hos patienter, der behandles med capecitabin. 
There is some evidence that dexpanthenol is effective for HFS prophylaxis in patients treated with capecitabine.
Stevens-Johnsons syndrom og toksisk epidermal nekrolyse (meget sjælden) (se pkt. 
Stevens-Johnson Syndrome and toxic Epidermal Necrolysis (very rare) (see section 4.4)
• Patienter med svær nyreinsufficiens (creatininclearance under 30 ml/min), 
• In patients with severe renal impairment (creatinine clearance below 30 ml/min),
Meget almindelig Alle grader 
Very common All grades
• visse typer af hjerterytmeforstyrrelser (herunder såkaldt ventrikulær fibrillation, torsade de pointes og bradykardi) 
• certain types of arrhythmia (including ventricular fibrillation, torsade de pointes, and bradycardia)
Abdominal ubehag 
Abdominal discomfort
Se også interaktion med antikoagulerende midler af coumarintypen nedenfor samt under pkt. 
See also interaction with coumarin-derivative anticoagulants below, and section 4.4.
Da dette lægemiddel indeholder vandfri lactose som hjælpestof, bør patienter med arvelig galactoseintolerans, en særlig form for hereditær lactasemangel (Lapp Lactase deficiency) eller glucose/galactosemalabsorption ikke anvende denne medicin. 
As this medicinal product contains anhydrous lactose as an excipient, patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.
For patienter med delvis DPD-mangel (fx med heterozygote mutationer i DPYD-genet), og hvor fordelene af capecitabin anses for at opveje risikoen (under hensyntagen til egnetheden af et alternativt ikke-fluorpyrimidin kemoterapeutisk regime), gælder, at de skal behandles med yderste forsigtighed og hyppig monitorering med dosisjustering i henhold til toksicitet. 
For patients with partial DPD deficiency (such as those with heterozygous mutations in the DPYD gene) and where the benefits of capecitabine are considered to outweigh the risks (taking into account the suitability of an alternative non-fluoropyrimidine chemotherapeutic regimen), these patients must be treated with extreme caution and frequent monitoring with dose adjustment according to toxicity.
ENTYDIG IDENTIFIKATOR - 2D-STREGKODE <Der er anført en 2D-stregkode, som indeholder en entydig identifikator.> 
UNIQUE IDENTIFIER - 2D BARCODE 2D barcode carrying the unique identifier included.
Efter oral administration af 825 mg/m² capecitabin to gange dagligt i 14 dage, havde patienter af japansk oprindelse (n = 18) omkring 36 % lavere Cmax og 24 % lavere AUC for capecitabin end patienter af kaukasisk oprindelse (n = 22). 
Following oral administration of 825 mg/m² capecitabine twice daily for 14 days, Japanese patients (n = 18) had about 36 % lower Cmax and 24 % lower AUC for capecitabine than Caucasian patients (n = 22).
Interferon-alfa 
Interferon alpha
Capecitabin var fri for hepatisk og CNS-toksicitet. 
Capecitabine was devoid of hepatic and CNS toxicities.
• 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. 
• Stevens-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.
Sikkerhedsprofilen for capecitabin-monoterapi i populationerne med metastatisk brystkræft, metastatisk kolorektalkræft og adjuverende kolonkræft er sammenlignelig. 
The safety profiles of capecitabine monotherapy for the metastatic breast cancer, metastatic colorectal cancer and adjuvant colon cancer populations are comparable.
Patienter, som ved baseline har et neutrofiltal < 1,5 x 109/l og/eller et trombocyttal < 100 x 109/l, bør ikke behandles med capecitabin. 
Patients with baseline neutrophil counts of < 1.5 x 109/L and/or thrombocyte counts of < 100 x 109/L should not be treated with capecitabine.
Hvis der ikke ses toksicitet hos patienter ≥ 60 år, som behandles med en nedsat initial capecitabin-dosis i kombination med docetaxel, kan capecitabin-dosis med forsigtighed øges til 1.250 mg/m² to gange dagligt. 
If no toxicity is observed in patients ≥ 60 years of age treated with a reduced capecitabine starting dose in combination with docetaxel, the dose of capecitabine may be cautiously escalated to 1,250 mg/m² twice daily.
28 filmovertrukne tabletter 30 filmovertrukne tabletter 56 filmovertrukne tabletter 60 filmovertrukne tabletter 84 filmovertrukne tabletter 112 filmovertrukne tabletter 120 filmovertrukne tabletter 
28 film-coated tablets 30 film-coated tablets 56 film-coated tablets 60 film-coated tablets 84 film-coated tablets 112 film-coated tablets 120 film-coated tablets
Hver pakning indeholder 28, 30, 56, 60, 84, 112 eller 120 filmovertrukne tabletter. 
Each pack contains 28, 30, 56, 60, 84, 112, or 120 film-coated tablets.
Der blev set kardiovaskulær toksicitet (f.eks. forlængelse af PR- og QT-intervallet) hos cynomolgusaber efter intravenøs administration (100 mg/kg), men ikke efter gentagen oral dosering (1.379 mg/m²/dag). 
Cardiovascular toxicity (e.g. PR- and QT-interval prolongation) was detectable in cynomolgus monkeys after intravenous administration (100 mg/kg) but not after repeated oral dosing (1,379 mg/m²/day).
5-fluorouracil 400 mg/m² intravenøs bolus, efterfulgt af 
5-Fluorouracil 400 mg/m² intravenous bolus, followed by
• hvis du har et stærkt nedsat antal hvide blodceller eller blodplader (leucopeni, neutropeni eller trombocytopeni) 
• if you have severely low levels of white cells or platelets in the blood (leukopenia, neutropenia or thrombocytopenia),
Se også afsnittet 'Tag ikke Capecitabine medac'. 
See also section “Do not take Capecitabine medac”.
DPD-mangel 
DPD deficiency
• til behandling af metastatisk kolorektalkræft (se pkt. 
• for the treatment of metastatic colorectal cancer (see section 5.1).
ThyPaseaktiviteten var 4 gange større i primært kolorektalt tumorvæv end i det tilstødende normale væv. 
ThyPase activity was measured and found to be 4 times greater in primary colorectal tumour than in adjacent normal tissue.
• Aktivt stof: capecitabin. 
• The active substance is capecitabine.
Der er holdepunkter, for at metabolismen af 5-FU i den anabolske pathway blokerer metyleringen af desoxyuridylsyre til thymidylssyre og derved interfererer med desoxyribonukleinsyresyntesen (DNA). 
There is evidence that the metabolism of 5-FU in the anabolic pathway blocks the methylation reaction of deoxyuridylic acid to thymidylic acid, thereby interfering with the synthesis of deoxyribonucleic acid (DNA).
filmovertrukne tabletter 
Film-coated tablets
• hvis du har en alvorlig hudreaktion 
• if you have a severe skin reaction.
Den mediane samlede overlevelse var 703 dage (95 % konfidensinterval: 671, 745) hos patienter, som blev behandlet med regimer, der indeholdt capecitabin, og 683 dage (95 % konfidensinterval: 646, 715) hos patienter, som blev behandlet med regimer, der indeholdt 5-FU. 
Median overall survival time was 703 days (95 % CI: 671; 745) in patients treated with capecitabine-containing regimens and 683 days (95 % CI: 646; 715) in patients treated with 5-FU-containing regimens.
• svære hudreaktioner såsom hududslæt, sårdannelse og blæredannelse, som kan give sår i munden, næsen, kønsorganer, hænder, fødder og øjne (røde og opsvulmede øjne) 
• severe skin reaction such as skin rash, ulceration and blistering which may involve ulcers of the mouth, nose, genitalia, hands, feet and eyes (red and swollen eyes)
Hvis du er gravid eller ammer, har mistanke om, at du er gravid, eller planlægger at blive gravid, skal du spørge din læge eller apoteketpersonalet til råds, før du tager dette lægemiddel. 
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.You must not take Capecitabine medac if you are pregnant or think you might be.
Parametrene for capecitabin, 5'-DFCR og 5'-DFUR var ens på dag 1 og 14. 
The parameters of capecitabine, 5'-DFCR and 5'-DFUR measured on days 1 and 14 were similar.
Hvis det ved starten af en behandlingsserie er indiceret at udsætte enten behandlingen med capecitabine eller det andet lægemiddel/de andre lægemidler, skal behandlingen med alle lægemidler udsættes, indtil betingelserne for genoptagelse af behandling med alle lægemidler er opfyldt. 
At the beginning of a treatment cycle, if a treatment delay is indicated for either capecitabine or the other medicinal product(s), then administration of all therapy should be delayed until the requirements for restarting all medicinal products are met.
• fald i indholdet af natrium, magnesium eller kalcium i blodet, øget mængde blodsukker 
• decrease in blood sodium, magnesium or calcium, increase in blood sugar
Hvis der optræder grad 2- eller 3 HFS, skal behandlingen med capecitabin afbrydes, indtil symptomerne forsvinder eller er aftaget i intensitet til grad 1. 
If grade 2 or 3 HFS occurs, administration of capecitabine should be interrupted until the event resolves or decreases in intensity to grade 1.
Pakningsstørrelser: 28, 30, 56, 60, 84, 112 eller 120 filmovertrukne tabletter. 
Pack sizes: 28, 30, 56, 60, 84, 112 or 120 film-coated tablets.
• hvis du er allergisk over for capecitabin eller et af de øvrige indholdsstoffer i Capecitabine medac (angivet i punkt 6). 
• if you are allergic to capecitabine or any of the other ingredients of this medicine (listed in section 6).
• hvis du ved, at du ikke har nogen aktivitet af enzymet dihydropyrimidin dehydrogenase (DHP) 
• if you know that you do not have any activity of the enzyme dihydropyrimidine dehydrogenase (DPD),
Dyb venethrombose, Hypertension, Petekkier, 
Deep vein thrombosis, Hypertension, Petechiae,
I toksicitetsforsøg med gentagne doser førte daglig oral administration af capecitabin hos cynomolgusaber og mus til toksiske virkninger, typiske for fluorpyrimidiner, på det gastrointestinale, det lymfoide og det hæmatopoietiske system. 
In repeat-dose toxicity studies, daily oral administration of capecitabine to cynomolgus monkeys and mice produced toxic effects on the gastrointestinal, lymphoid and haemopoietic systems, typical for fluoropyrimidines.
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. 
Your doctor may want you to take a combination of 150 mg, 300 mg and 500 mg tablets for each dose.
Fase I-studier, som evaluerede capecitabins effekt på enten docetaxels eller paclitaxels farmakokinetik og vice versa, viste ingen effekt af capecitabin på hverken docetaxels eller paclitaxels farmakokinetik (Cmax og AUC) og ingen effekt af docetaxel eller paclitaxel på 5'-DFUR's farmakokinetik. 
Phase I studies evaluating the effect of capecitabine on the pharmacokinetics of either docetaxel or paclitaxel and vice versa showed no effect by capecitabine on the pharmacokinetics of docetaxel or paclitaxel (Cmax and AUC) and no effect by docetaxel or paclitaxel on the pharmacokinetics of 5'-DFUR.
Kontakt lægen eller apotekspersonalet, før du tager Capecitabine medac 
Talk to your doctor or pharmacist before taking Capecitabine medac
Til patienter med let nyreinsufficiens (creatininclearance 51 - 80 ml/min ved baseline) er dosisjustering ikke nødvendig. 
In patients with mild renal impairment (creatinine clearance 51 - 80 ml/min at baseline) no adjustment of the starting dose is recommended.
Det ses sjældent og er almindeligvis ikke forbundet med helbredsproblemer, med mindre man får bestemte lægemidler. 
DPD deficiency is a rare condition present at birth that is not usually associated with health problems unless you receive certain medicines.
Pharmacare Premium Limited HHF 003, Hal Far Industrial Estate Birzebbugia BBG 3000, Malta 
Pharmacare Premium Ltd HHF 003, Hal Far Industrial Estate Birzebbugia BBG 3000, Malta
Dosisjusteringer for særlige populationer 
Posology adjustments for special populations
• smerter i led eller lemmer (ekstremiteter), bryst eller ryg 
• pain in the joints or in the limbs (extremities), chest or back
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). 
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
besvimelse, nerveskader (neuropati) og problemer med følesansen 
fainting, nerve damage (neuropathy) and problems with sensation
Patienter behandlet med XELIRI oplevede i langt højere grad gastrointestinal toksicitet sammenlignet med FOLFIRI (48 % og 14 % fik diarré ved henholdsvis XELIRI og FOLFIRI). 
Patients treated with XELIRI experienced excessive gastrointestinal toxicity compared with FOLFIRI (diarrhoea 48 % and 14 % for XELIRI and FOLFIRI respectively).
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). 
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).
Dihydropyrimidinase spalter pyrimidinringen til 5-fluoro-ureidopropionsyre (FUPA). 
Dihydropyrimidinase cleaves the pyrimidine ring to yield 5-fluoro-ureidopropionic acid (FUPA).
• Patienter med kendt fuldstændig mangel på dihydropyrimidindehydrogenase (DPD)-aktivitet (se pkt. 
• In patients with known complete absence of dihydropyrimidine dehydrogenase (DPD) activity