natgillin/translations-raw huggingface dataset:
Standard og reducerede initialdosisberegninger af Xeloda på 1250 mg/ kg og 1000 mg/ kg ud fra legemsoverfladeareal er anført i henholdsvis tabel 1 og 2.
Standard and reduced dose calculations according to body surface area for starting doses of Xeloda of 1250 mg/ m2 and 1000 mg/ m2 are provided in tables 1 and 2, respectively.
5. 1):
Recommended posology (see section 5.1):
Monoterapi Kolonkræft, kolorektalkræft og brystkræft Den anbefalede initialdosis ved Xeloda- monoterapi, til adjuverende behandling af kolonkræft, til behandling af metastatisk kolorektalkræft eller af lokalt fremskreden eller metastatisk brystkræft er 1250 mg/ m2 administreret to gange dagligt (morgen og aften, svarende til en daglig dosis på 2500 mg/ m2) i 14 dage, efterfulgt af 7 dages pause.
Monotherapy Colon, colorectal and breast cancer Given as single agent, the recommended starting dose for Xeloda in the adjuvant treatment of colon cancer, in the treatment of metastatic colorectal cancer or of locally advanced or metastatic breast cancer is 1250 mg/ m2 administered twice daily (morning and evening; equivalent to 2500 mg/ m2 total daily dose) for 14 days followed by a 7-day rest period.
5. 1).
2 Combination therapy Colorectal and gastric cancer In combination treatment, the recommended starting dose of Xeloda should be reduced to 800 – 1000 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).
Inklusionen af biologiske lægemidler i et kombinationsregime har ingen effekt på initialdosis af Xeloda.
The inclusion of biological agents in a combination regimen has no effect on the starting dose of Xeloda.
Præmedicinering til opretholdelse af adækvat hydrering og antiemetisk behandling påbegyndes, i henhold til produktresumeet for cisplatin, før administration af cisplatin, hos de patienter, som får kombinationsbehandling med Xeloda og cisplatin.
Premedication to maintain adequate hydration and anti-emesis according to the cisplatin summary of product characteristics should be started prior to cisplatin administration for patients receiving the Xeloda plus cisplatin combination.
Brystkræft I kombination med docetaxel er den anbefalede initialdosis af Xeloda til behandling af metastatisk brystkræft 1250 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.
Breast cancer In combination with docetaxel, the recommended starting dose of Xeloda in the treatment of metastatic breast cancer is 1250 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.
Præmedicinering med et oralt kortikosteroid, som f. eks. dexamethason, af patienter, som får en kombination af Xeloda og docetaxel, bør ifølge produktresumeet for docetaxel påbegyndes, før der gives docetaxel.
Pre-medication with an oral corticosteroid such as dexamethasone according to the docetaxel summary of product characteristics should be started prior to docetaxel administration for patients receiving the Xeloda plus docetaxel combination.
Xeloda- dosisberegninger
Xeloda Dose Calculations
Standard og reducerede dosisberegninger ud fra legemsoverfladeareal for en Xeloda - initial dosis på 1250 mg/ m2 2 Dosisniveau på 1250 mg/ m (to gange dagligt)
Table 1 Standard and reduced dose calculations according to body surface area for a starting dose of Xeloda of 1250 mg/ m2 2 Dose level 1250 mg/ m (twice daily)
Fuld dosis Antal 150 mg Reduceret dosis Reduceret dosis tabletter og/ eller (75%) (50%) 500 mg tabletter pr.
Number of 150 mg tablets and/ or 500 mg tablets per
1250 mg/ m2 dosering (hver 950 mg/ m2 625 mg/ m2 dosering skal gives morgen og aften)
Reduced dose (50%)
Legemsover -
1250 mg/ m2
2
administration (each administration to be given morning and evening)
Dosis pr.
950 mg/ m2
Dosis pr. dosering
625 mg/ m2
Dosis pr. dosering
Body Surface 2
fladeareal (m) ≤1, 26 1, 27 – 1, 38 1, 39 - 1, 52 1, 53 - 1, 66 1, 67 - 1, 78 1, 79 - 1, 92 1, 93 - 2, 06 2, 07 - 2, 18 ≥2, 19
Dose per
dosering 1500 1650 1800 2000 2150 2300 2500 2650 2800
Area (m)
(mg)
administration (mg)
150 mg - 1 2 - 1 2 - 1 2
150 mg
500 mg 3 3 3 4 4 4 5 5 5
500
(mg) 1150 1300 1450 1500 1650 1800 1950 2000 2150
mg administration (mg)
(mg) 800 800 950 1000 1000 1150 1300 1300 1450
administration (mg)
3 Tabel 2
- 1 2 - 1 2 - 1 2
Standard og reducerede dosisberegninger ud fra legemsoverfladeareal for en Xeloda - initial dosis på 1000 mg/ m2 2 Dosisniveau på 1000 mg/ m (to gange dagligt)
3 Table 2 Standard and reduced dose calculations according to body surface area for a starting dose of Xeloda of 1000 mg/ m2 2 Dose level 1000 mg/ m (twice daily)
1000 mg/ m2 dosering (hver 750 mg/ m2 500 mg/ m2 dosering skal gives morgen og aften)
Reduced dose (75%)
Legemsover -
Reduced dose (50%)
Dosis pr.
1000 mg/ m2
Dosis pr. dosering
750 mg/ m2
Dosis pr. dosering
500 mg/ m2
fladeareal 2 (m)
Body Surface 2
dosering
Area (m)
(mg)
mg administration (mg)
1, 53 1, 67 1, 79 1, 93 2, 07
administration (mg)
- 1, 66 - 1, 78 - 1, 92 - 2, 06 - 2, 18
≤ 1.26 1.27 - 1.38 1.39 - 1.52 1.53 - 1.66 1.67 - 1.78 1.79 - 1.92 1.93 - 2.06 2.07 - 2.18 ≥ 2.19
1600 1750 1800 2000 2150
1150 1300 1450 1600 1750 1800 2000 2150 2300
2 2 3 4 4
1 2 3 4 5 2 - 1 2
1200 1300 1400 1500 1600
2 800 2 1000 2 1100 2 1200 2 1300 3 1400 4 1500 4 1600 4 1750
800 800 900 1000 1050
600 600 750 800 800 900 1000 1050 1100
Dosisjusteringer under behandlingen:
Posology adjustments during treatment:
Generelt Toksicitet som skyldes administration af Xeloda kan behandles symptomatisk og/ eller med modifikation af Xeloda- dosis (afbrydelse af behandlingen eller reduktion af dosis).
General Toxicity due to Xeloda administration may be managed by symptomatic treatment and/ or modification of the dose (treatment interruption or dose reduction).
For de toksiciteter, for hvilke den behandlende læge anser det for usandsynligt, at disse kan udvikle sig til at blive alvorlige eller livstruende, som f. eks. alopeci, smagsændringer og negleforandringer, kan behandlingen fortsættes med uændret dosis uden dosisreduktion eller behandlingsafbrydelse.
For those toxicities considered by the treating physician to be unlikely to become serious or life-threatening, e. g. alopecia, altered taste, nail changes, treatment can be continued at the same dose without reduction or interruption.
Patienter, som tager Xeloda, skal informeres om nødvendigheden af straks at stoppe behandlingen, hvis der kommer moderat eller svær toksicitet.
Patients taking Xeloda should be informed of the need to interrupt treatment immediately if moderate or severe toxicity occurs.
Xeloda- doser som ikke tages på grund af toksicitet erstattes ikke.
Doses of Xeloda omitted for toxicity are not replaced.
Dosisreduktion af Xeloda (3- ugers serier eller kontinuerlig behandling)
4 Table 3 Xeloda Dose Reduction Schedule (3-weekly Cycle or Continuous Treatment)
Dosisjustering for
Toxicity grades*
behandlingsserie
Dose changes within a treatment cycle
næste serie/ dosis af begyndelsesdosis)
Dose adjustment for next cycle/ dose (% of starting dose)
• Grad 2
• Grade 2
ved 1. forekomst
-1st appearance -2nd appearance -3rd appearance
Afbryd behandlingen indtil toksiciteten er reduceret til grad 0- 1
Interrupt until resolved to grade 0-1
ved 2. forekomst ved 3. forekomst
-4th appearance
ved 4. forekomst • Grad 3
Discontinue treatment permanently
Seponer behandlingen permanent
Not
ved 1. forekomst ved 2. forekomst ved 3. forekomst • Grad 4
-1st appearance -2nd appearance
Afbryd behandlingen indtil toksiciteten er reduceret til grad 0- 1 Seponer behandlingen permanent
Interrupt until resolved to grade 0-1
75% 50% Ikke relevant
75% 50%
Toksicitet
-3rd appearance
Dosisændringer under en
Discontinue treatment permanently
Dosisjustering for
Not applicable
graduering *
• Grade 4
behandlingsserie
-1st appearance
ved 1. forekomst
Discontinue
Seponer behandlingen permanent eller
permanently or
hvis lægen skønner at det bedste for patienten er at fortsætte så afbryd behandlingen indtil toksiciteten er reduceret til grad 0- 1
If physician deems it to be in the patient’ s best interest to continue, interrupt until resolved to grade 0-1
* I følge National Cancer Institute of Canada Clinical Trial Group (NCIC CTG) Common Toxicity Criteria (version 1) eller Common Terminology Criteria for Adverse Events (CTCAE) fra Cancer Therapy Evaluation Program, US National Cancer Institute, version 3, 0.
*According to the National Cancer Institute of Canada Clinical Trial Group (NCIC CTG) Common Toxicity Criteria (version 1) or the Common Terminology Criteria for Adverse Events (CTCAE) of the Cancer Therapy Evaluation Program, US National Cancer Institute, version 3.0.
4. 4).
For hand-foot syndrome and hyperbilirubinemia, see section 4.4.
Patienter, som ved baseline har et neutrofiltal < 1, 5 x 109/ l og/ eller et trombocyttal < 100 x 109/ l, bør ikke behandles med Xeloda.
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 Xeloda.
Hvis uplanlagte laboratorieresultater under en behandlingscyklus 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 Xeloda seponeres.
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 Xeloda should be interrupted.
Dosisændringer på grund af toksicitet når Xeloda anvendes i tre ugers serie i kombination med andre lægemidler:
Dose modifications for toxicity when Xeloda is used as a 3 weekly cycle in combination with other agents:
Når Xeloda anvendes i tre ugers serie i kombination med andre lægemidler, skal dosisændring foretages i henhold til tabel 3 ovenfor for Xeloda og efter det pågældende produktresumé for det andet lægemiddel/ de andre lægemidler.
Dose modifications for toxicity when Xeloda is used as a 3 weekly cycle in combination with other agents should be made according to Table 3 above for Xeloda and according to the appropriate summary of product characteristics for the other agent(s).
Hvis det ved starten af en behandlingsserie er indiceret at udsætte enten behandlingen med Xeloda 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 Xeloda or the other agent(s), then administration of all agents should be delayed until the requirements for restarting all drugs are met.
For de toksiske virkninger, der af den behandlende læge under en behandlingsserie ikke anses for at være relateret til Xeloda, bør behandlingen med Xeloda fortsætte, og dosis af det andet lægemiddel bør justeres i henhold til det pågældende produktresumé.
During a treatment cycle for those toxicities considered by the treating physician not to be related to Xeloda, Xeloda should be continued and the dose of the other agent should be adjusted according to the appropriate Prescribing Information.
Hvis behandling med det/ de andet/ andre lægemiddel/ lægemidler skal afbrydes permanent, kan behandlingen med Xeloda genoptages, når betingelserne for genoptagelse af behandlingen med Xeloda er opfyldt.
If the other agent(s) have to be discontinued permanently, Xeloda treatment can be resumed when the requirements for restarting Xeloda are met.
Dosisændring på grund af toksicitet når Xeloda anvendes kontinuerligt i kombination med andre lægemidler:
5 Dose modifications for toxicity when Xeloda is used continuously in combination with other agents:
Dosisændring på grund af toksicitet, når Xeloda anvendes kontinuerligt i kombination med andre lægemidler, skal foretages efter tabel 3 ovenfor for Xeloda og efter det pågældende produktresumé for det andet lægemiddel / de andre lægemidler.
Dose modifications for toxicity when Xeloda is used continuously in combination with other agents should be made according to Table 3 above for Xeloda and according to the appropriate summary of product characteristics for the other agent(s).
På grund af utilstrækkelige tilgængelige sikkerheds - og effektdata hos patienter med nedsat leverfunktion er der ingen anbefalet dosering.
Hepatic impairment: insufficient safety and efficacy data are available in patients with hepatic impairment to provide a dose adjustment recommendation.
Xeloda er kontraindiceret til patienter med svær nyreinsufficiens (creatininclearance under 30 ml/ min ved baseline) [Cockcroft og Gault].
Xeloda is contraindicated in patients with severe renal impairment (creatinine clearance below 30 ml/ min [Cockcroft and Gault] at baseline).
Incidensen af bivirkninger af sværhedsgrad 3 eller 4 er højere hos patienter med moderat nyreinsufficiens (creatininclearance 30 – 50 ml/ min ved baseline), sammenlignet med den samlede population.
The incidence of grade 3 or 4 adverse reactions in patients with moderate renal impairment (creatinine clearance 30-50 ml/ min at baseline) is increased compared to the overall population.
Til patienter med moderat nyreinsufficiens ved baseline anbefales det at reducere dosis til 75% af en initialdosis på 1250 mg/ m2.
In patients with moderate renal impairment at baseline, a dose reduction to 75% for a starting dose of 1250 mg/ m2 is recommended.
Til patienter med
In patients with moderate renal impairment at baseline, no dose reduction is required for a starting dose of 1000 mg/ m2.
5 moderat nyreinsufficiens ved baseline er det for en initialdosis på 1000 mg/ m2 ikke nødvendigt med dosisjustering. 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.
Xeloda 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, Xeloda should be discontinued.
Rekommendationer for dosisjustering ved nyreinsufficiens gælder både for monoterapi og for kombinationsbehandling (se også afsnittet om ældre nedenfor).
These dose adjustment recommendations for renal impairment apply both to monotherapy and combination use (see also section “ Elderly” below).
Der er ingen erfaring med behandling af børn (under 18 år).
There is no experience in children (under 18 years).
Under monoterapi med Xeloda er justering af initialdosis ikke nødvendig.
During Xeloda monotherapy, no adjustment of the starting dose is needed.
Ældre patienter ((≥ 65 år) havde, sammenlignet med yngre patienter, flere bivirkninger af grad 3 og 4, inklusiv dem, som førte til seponering, når Xeloda blev anvendt i kombination med andre lægemidler.
When Xeloda was used in combination with other agents, elderly patients (≥ 65 years) experienced more grade 3 and grade 4 adverse drug reactions, including those leading to discontinuation, compared to younger patients.
Der blev observeret en øget incidens af grad 3 eller 4
- In combination with docetaxel: an increased incidence of grade 3 or 4 treatment-related adverse
behandlingsrelaterede bivirkninger og behandlingsrelaterede alvorlige bivirkninger hos patienter på 60 år og derover (se pkt.
reactions and treatment-related serious adverse reactions were observed in patients 60 years of age or more (see section 5.1).
Til patienter på 60 år og derover anbefales det at reducere initialdosis af Xeloda til 75% af vanlig initialdosis (950 mg/ m2 to gange dagligt).
For patients 60 years of age or more, a starting dose reduction of Xeloda to 75% (950 mg/ m2 twice daily) is recommended.
Hvis der ikke ses toksicitet hos patienter ≥ 60 år, som behandles med en nedsat initial Xeloda- dosis i kombination med docetaxel, kan Xeloda- dosis med forsigtighed øges til 1250 mg/ m2 to gange dagligt.
If no toxicity is observed in patients ≥ 60 years of age treated with a reduced Xeloda starting dose in combination with docetaxel, the dose of Xeloda may be cautiously escalated to 1250 mg/ m2 twice daily.
Til patienter på 65 år og derover bør der anvendes en reduceret
- In combination with irinotecan: for patients 65 years of age or more, a starting dose reduction of
initialdosis på 800 mg/ m2 Xeloda to gange dagligt.
Xeloda to 800 mg/ m2 twice daily is recommended.
4. 5). • Hvis der forekommer kontraindikationer til enhver af stofferne i kombinationsregimet, bør det pågældende stof ikke anvendes.
• History of severe and unexpected reactions to fluoropyrimidine therapy, • Hypersensitivity to capecitabine or to any of the excipients or fluorouracil, • In patients with known dihydropyrimidine dehydrogenase (DPD) deficiency, • During pregnancy and lactation, • In patients with severe leucopenia, neutropenia, or thrombocytopenia, • In patients with severe hepatic impairment, • In patients with severe renal impairment (creatinine clearance below 30 ml/ min), • Treatment with sorivudine or its chemically related analogues, such as brivudine (see section 4.5), • If contraindications exist to any of the agents in the combination regimen, that agent should not be used.
4. 4 Særlige advarsler og forsigtighedsregler vedrørende brugen
6 4.4 Special warnings and precautions for use
Dosisbegrænsende toksicitet omfatter diarré, mavesmerter, kvalme, stomatitis og hand- foot syndrome (hand- foot hudreaktioner, palmo- plantar erythrodysæstesi).
Dose limiting toxicities include diarrhoea, abdominal pain, nausea, stomatitis and hand-foot syndrome (hand-foot skin reaction, palmar-plantar erythrodysesthesia).
Der kan anvendes standardbehandling imod diarré (f. eks. loperamid).
Standard antidiarrhoeal treatments (e. g. loperamide) may be used.
NCIC CTC grad 2 diarré defineres som en øgning til 4 til 6 afføringer/ dag eller natlige afføringer, grad 3 diarré som som en øgning til 7 til 9 afføringer/ dag eller inkontinens og malabsorption, og grad 4 diarré som en øgning til flere end 10 afføringer/ dag eller stærkt blodig diarré eller behov for parenteral støttebehandling.
Grade 4 diarrhoea is an increase of ≥ 10 stools/ day or grossly bloody diarrhoea or the need for parenteral support.
4. 2).
Dose reduction should be applied as necessary (see section 4.2).
6 Dehydrering.
Dehydration.
Ved dehydrering af grad 2 (eller højere), bør behandlingen med Xeloda straks seponeres, og dehydreringen korrigeres.
If Grade 2 (or higher) dehydration occurs, Xeloda treatment should be immediately interrupted and the dehydration corrected.
4. 2).
Dose modifications applied should be applied for the precipitating adverse event as necessary (see section 4.2).
Hand- foot syndrom (også kendt som hand- foot hudreaktion, palmo- plantar erythrodysæstesi eller kemoterapiinduceret acralt erytem).
Hand-foot syndrome (also known as hand-foot skin reaction or palmar-plantar erythrodysesthesia or chemotherapy induced acral erythema).
Grad 1 hand- foot syndrom defineres som følelsesløshed, dysæstesi/ paræstesi, prikken, hævelse eller erytem uden smerter af hænderne og/ eller fødderne og/ eller ubehag der ikke påvirker patienternes daglige aktiviteter.
Grade 1 hand- foot syndrome is defined as numbness, dysesthesia/ paresthesia, tingling, painless swelling or erythema of the hands and/ or feet and/ or discomfort which does not disrupt the patient’ s normal activities.
Grad 2 hand- foot syndrom defineres som smertefuld erytem og hævelse af hænderne og/ eller fødderne og/ eller ubehag der påvirker patienternes daglige aktiviteter.
Grade 2 hand- foot syndrome is painful erythema and swelling of the hands and/ or feet and/ or discomfort affecting the patient’ s activities of daily living.
Grad 3 hand- foot syndrom 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.
Grade 3 hand- foot syndrome 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.
Hvis der optræder grad 2 eller 3 hand- foot syndrome skal behandlingen med Xeloda afbrydes indtil symptomerne forsvinder eller er aftaget i intensitet til grad 1.
If grade 2 or 3 hand- foot syndrome occurs, administration of Xeloda should be interrupted until the event resolves or decreases in intensity to grade 1.
Efter grad 3 hand- foot syndrom skal dosis sættes ned.
Following grade 3 hand- foot syndrome, subsequent doses of Xeloda should be decreased.
Hvis Xeloda og cisplatin anvendes i kombination, frarådes anvendelse af vitamin B6 (pyridoxin) til behandling af symptomatisk eller sekundær profylaktisk behandling af hand- foot- syndrom, da der er offentliggjort meddelelser om, at det kan nedsætte virkningen af cisplatin.
When Xeloda and cisplatin are used in combination, the use of vitamin B6 (pyridoxine) is not advised for symptomatic or secondary prophylactic treatment of hand– foot syndrome, because of published reports that it may decrease the efficacy of cisplatin.
Behandling med fluoropyromidin har været ledsaget af kardiotoksicitet, inklusiv myokardieinfarkt, angina pectoris, dysrytmier, kardiogent chok, pludselig død og elektrokardiografiske ændringer.
Cardiotoxicity has been associated with fluoropyrimidine therapy, including myocardial infarction, angina, dysrhythmias, cardiogenic shock, sudden death and electrocardiographic changes.
Der er rapporteret om kardiale arytmier, angina pectoris, myokardieinfarkt, hjerteinsufficiens og kardiomyopati hos patienter som får Xeloda.
Cardiac arrhythmias, angina pectoris, myocardial infarction, heart failure and cardiomyopathy have been reported in patients receiving Xeloda.
4. 8).
Caution must be exercised in patients with history of significant cardiac disease, arrhythmias and angina pectoris (See section 4.8).
Hypo - eller hypercalcæmi.
Hypo- or hypercalcaemia.
Der er rapporteret om hypo - og hypercalcæmi under behandling med Xeloda.
Hypo- or hypercalcaemia has been reported during Xeloda treatment.
4. 8).
Caution must be exercised in patients with pre-existing hypo- or hypercalcaemia (see section 4.8).
4. 8).
Caution must be exercised in patients with central or peripheral nervous system disease, e. g. brain metastasis or neuropathy (see section 4.8).
Der skal iagttages forsigtighed hos patienter med diabetes mellitus eller elektrolytforstyrrelser, da disse kan forværres under behandling med Xeloda.
Caution must be exercised in patients with diabetes mellitus or electrolyte disturbances, as these may be aggravated during Xeloda treatment.
Antikoagulantia af coumarintypen.
7 Coumarin-derivative anticoagulation.
I et lægemiddel- interaktionsstudie med enkeltdosis administration af warfarin, var der en signifikant stigning i middel- AUC (+ 57%) af S- warfarin.
In a drug interaction study with single-dose warfarin administration, there was a significant increase in the mean AUC (+57%) of S-warfarin.
4. 5).
Patients receiving concomitant Xeloda and oral coumarin-derivative anticoagulant therapy should have their anticoagulant response (INR or prothrombin time) monitored closely and the anticoagulant dose adjusted accordingly (see section 4.5).
Da der ikke findes sikkerheds - og effektdata hos patienter med leverinsufficiens skal anvendelsen af Xeloda kontrolleres omhyggeligt hos patienter med let til moderat leverdysfunktion, uanset om der er levermetastaser eller ej.
In the absence of safety and efficacy data in patients with hepatic impairment, Xeloda use should be carefully monitored in patients with mild to moderate liver dysfunction, regardless of the presence or absence of liver metastasis.