natgillin/translations-raw huggingface dataset:
Creatininclearance påvirkede den systemiske eksponering af 5 ’ - DFUR (35% stigning i AUC, når creatininclearance aftog med 50%) og FBAL (114% stigning i AUC, når creatininclearance aftog med 50%).
Creatinine clearance was found to influence the systemic exposure to 5’ -DFUR (35% increase in AUC when creatinine clearance decreases by 50%) and to FBAL (114% increase in AUC when creatinine clearance decreases by 50%).
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.
FBAL’ s AUC steg med alderen (20% stigning i alder medførte 15% stigning i FBAL’ s AUC).
The AUC of FBAL increased with age (20% increase in age results in a 15% increase in the AUC of FBAL).
Etniske faktorer:
Ethnic factors:
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).
Patienter af japansk oprindelse havde også omkring 25% lavere Cmax og 34% lavere AUC for FBAL end patienter af kaukasisk oprindelse.
Japanese patients had also about 25% lower Cmax and 34% lower AUC for FBAL than Caucasian patients.
Der forekom ingen signifikant forskel i eksponeringen af andre metabolitter (5´- DFCR, 5´- DFUR og 5- FU).
No significant differences occurred in the exposure to other metabolites (5'-DFCR, 5'-DFUR, and 5-FU).
Efter behandling med capecitabin er der set hudtoksicitet, karakteriseret ved degenerative/ regressive forandringer.
Skin toxicity, characterised by degenerative/ regressive changes, was observed with capecitabine.
Der blev set kardiovaskulær toksicitet (f. eks. forlængelse af PR - og QT- intervallet) hos cynomolgusabe efter intravenøs administration (100 mg/ kg), men ikke efter gentagen oral dosering (1379 mg/ m2/ dag)
PR- and QT-interval prolongation) was detectable in cynomolgus monkeys after intravenous administration (100 mg/ kg) but not after repeated oral dosing (1379 mg/ m2/ day).
22 Et to- års carcinogenicitetsstudie på mus gav ikke holdepunkter for at capecitabin var carcinogent.
A two-year mouse carcinogenicity study produced no evidence of carcinogenicity by capecitabine.
Desuden indtraf der i en 13- ugers undersøgelse atrofiske og degenerative forandringer i reproduktionsorganerne hos hanmus; forandringerne var dog reversible efter en stoffri periode.
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.
Capecitabin var ikke mutagent in vitro overfor bakterier (Ames test) eller overfor celler fra pattedyr (kinesisk hamster V79/ HPRT gene mutation assay).
Capecitabine was not mutagenic in vitro to bacteria (Ames test) or mammalian cells (Chinese hamster V79/ HPRT gene mutation assay).
5- FU) klastogent på humane lymfocytter (in vitro), og der var et positivt trend i in vivo mikronukleustesten på mus.
However, similar to other nucleoside analogues (ie, 5-FU), capecitabine was clastogenic in human lymphocytes (in vitro) and a positive trend occurred in mouse bone marrow micronucleus tests (in vivo).
Tabletkernen: vandfri lactose, croscarmellosenatrium, hypromellose, mikrokrystallinsk cellulose, magnesiumstearat
Tablet core: anhydrous lactose, croscarmellose sodium, hypromellose, microcrystalline cellulose, magnesium stearate.
Tabletovertrækket: hypromellose, titandioxid (E171), gul og rød jernoxid (E172), talcum.
Tablet coating: hypromellose, titanium dioxide (E171), yellow and red iron oxide (E172), talc.
PVC/ PVDC blistre
PVC/ PVDC blisters
60 filmovertrukne tabletter (6 blistre á 10 tabletter)
60 film-coated tablets (6 blisters of 10 tablets)
02 februar 2001 Dato for første genregistrering:
02 February 2001 Date of first renewal:
02 februar 2006
02 February 2006
500 mg capecitabin.
500 mg capecitabine.
52 mg vandfri lactose.
52 mg anhydrous lactose.
Ferskenfarvet filmovertrukket, bikonveks, aflang tablet med mærkningen ” 500 ” på den ene side og ” Xeloda ” på den anden side.
Peach film-coated tablet of biconvex, oblong shape with the marking ‘ 500’ on the one side and ‘ Xeloda’ on the other side.
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 dagligt 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).
25 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).
Inklusion 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 Xeloda- dosis 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.
Dosis pr.
Full dose
150 mg - 1 2 - 1 2 - 1 2
Number of 150 mg
500 mg 3 3 3 4 4 4 5 5 5
tablets and/ or 500 mg tablets per
(mg) 1150 1300 1450 1500 1650 1800 1950 2000 2150
(75%)
(mg) 800 800 950 1000 1000 1150 1300 1300 1450
(50%)
26 Tabel 2
1250 mg/ m2
1000 mg/ m2 dosering (hver 750 mg/ m2 500 mg/ m2 dosering skal gives morgen og aften)
administration (each administration to be given morning and evening)
Legemsover -
950 mg/ m2
Dosis pr.
625 mg/ m2
Dosis pr. dosering
Dose per
fladeareal 2 (m)
Dose per
≤1, 26
≤ 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
1150 1 2 800
1500 1650 1800 2000 2150 2300 2500 2650 2800
1,
- 1 2 - 1 2 - 1 2
26 1150 1 2
3 1150 3 1300 3 1450 4 1500 4 1650 4 1800 5 1950 5 2000 5 2150
800
800 800 950 1000 1000 1150 1300 1300 1450
600
26 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)
1, 27 - 1, 38
Full dose
1300 2 2 1000
Number of 150 mg
27 - 1, 38 1300 2 2
Reduced dose
1000
Reduced dose
1, 39 - 1, 52
tablets and/ or 500 mg tablets per
1450 3 2 1100
(75%)
39 - 1, 5
(50%)
2 1450 3 2
1000 mg/ m2
1100
administration (each administration to be given morning and evening)
750
750 mg/ m2
1, 53 1, 67 1, 79 1, 93 2, 07
500 mg/ m2
- 1, 66 - 1, 78 - 1, 92 - 2, 06 - 2, 18
Body Surface 2
1600 1750 1800 2000 2150
Dose per
4 5 2 - 1
Dose per
2 2 3 4 4
Dose per
1200 1300 1400 1500 1600
Area (m)
800 800 900 1000 1050
administration (mg)
≥
150 mg
2, 19
500 mg administration (mg)
2300 2
administration (mg)
4
1150 1300 1450 1600 1750 1800 2000 2150 2300
1750
1 2 3 4 5 2 - 1 2
1100
600 600 750 800 800 900 1000 1050 1100
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 Doses of Xeloda omitted for toxicity are not replaced.
Xeloda- doser som ikke tages på grund af toksicitet erstattes ikke.
The following are the recommended dose modifications for toxicity:
Dosisreduktion af Xeloda (3- ugers serier eller kontinuerlig behandling)
27 Table 3 Xeloda Dose Reduction Schedule (3-weekly Cycle or Continuous Treatment)
ved 4. forekomst • Grad 3
-4th appearance • Grade 3
Dosisændringer under en
-3rd appearance • Grade 4
Dosisjustering for
Discontinue treatment permanently
graduering *
Not
behandlingsserie
applicable
ved 1. forekomst
-1st appearance
Seponer behandlingen permanent eller
Discontinue permanently or If physician deems it to be in the patient’ s best interest to continue, interrupt until resolved to grade 0-1
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 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, og behandlingen kan kun genoptages, når 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.
Dosisændring på grund af toksicitet når Xeloda anvendes kontinuerligt i kombination med andre lægemidler:
28 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.
28 Nyreinsufficiens:
Renal impairment:
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 1250mg/ m2 is recommended.
Til patienter med moderat nyreinsufficiens ved baseline er det for en initialdosis på 1000 mg/ m2 ikke nødvendigt med dosisjustering.
In patients with moderate renal impairment at baseline, no dose reduction is required for a starting dose of 1000mg/ m2.
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.
Hvis patienterne under behandlingen får uønskede hændelser af grad 2, 3 eller 4 tilrådes omhyggelig overvågning og øjeblikkelig afbrydelse af behandlingen med efterfølgende dosisjustering som beskrevet i Tabel 3 ovenover.
Careful monitoring and prompt treatment interruption is recommended if the patient develops a grade 2, 3 or 4 adverse event during treatment and subsequent dose adjustment as outlined in Table 3 above.
Xeloda bør seponeres, hvis den beregnede kreatininclearance 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.
Behandlingsrelaterde bivirkninger af sværhedsgrad 3 eller 4 var dog hyppigere hos patienter ≥ 60 år sammenlignet med yngre patienter.
However, grade 3 or 4 treatment-related adverse reactions were more frequent in patients ≥ 60 years of age compared to younger patients.
- I kombination med docetaxel 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 behandlingrelaterede 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).
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.
29 Diarré.
29 4.4 Special warnings and precautions for use
Patienter med svær diarré bør monitoreres omhyggeligt og gives væske og elektrolyttilskud, hvis de dehydreres.
Most adverse reactions are reversible and do not require permanent discontinuation of therapy, although doses may need to be withheld or reduced.
Dehydrering:
Dehydration.
Grad 1 hand- foot syndrome 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.
Disse resultater tyder på en interaktion, sandsynligvis på grund af capecitabins hæmning af cytokrom P450 2C9 isoenzymsystemet.
These results suggest an interaction, probably due to an inhibition of the cytochrome P450 2C9 isoenzyme system
30 Leverinsufficiens.
30 by capecitabine.
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.
Sorivudin og analoger: der er beskrevet en klinisk signifikant interaktion mellem de to lægemidler, sorivudine og 5- FU, som et resultat af sorivudines hæmning af dihydropyrimidindehydrogenase.
Sorivudine and analogues: a clinically significant drug-drug interaction between sorivudine and 5-FU, resulting from the inhibition of dihydropyrimidine dehydrogenase by sorivudine, has been described.
Antacida: man har undersøgt virkningen af et antacidum indeholdende aluminiumhydroxid og magnesiumhydroxid på capecitabins farmakokinetik.
31 Antacid: the effect of an aluminum hydroxide and magnesium hydroxide-containing antacid on the pharmacokinetics of capecitabine was investigated.
31 Allopurinol: der er set interaktion mellem allopurinol og 5- FU, med mulig nedsat effekt af 5- FU.
Allopurinol: interactions with allopurinol have been observed for 5-FU; with possible decreased efficacy of 5-FU.
Der foreligger ingen undersøgelser af brugen af Xeloda hos gravide, men det antages imidlertid at Xeloda kan forårsage føtale skader, hvis det gives til gravide.
There are no studies in pregnant women using Xeloda; however, it should be assumed that Xeloda may cause foetal harm if administered to pregnant women.
Sikkerhedsprofilen for Xeloda- monoterapi i populationerne med metastatisk brystkræft, metastatisk kolorektalkræft og adjuverende kolonkræft er sammenlignelige.
The safety profiles of Xeloda monotherapy for the metastatic breast cancer, metastatic colorectal
32 De mest almindelige rapporterede og/ eller klinisk relevante behandlingsrelaterede bivirkninger var gastrointestinale symptomer (specielt diarré, kvalme, opkastning, mavesmerter og stomatitis), hand - foot syndrom (palmo- plantar erytrodysæstesi), træthed, asteni, anoreksi, kardiotoksicitet, øget renal dysfunktion hos dem med præeksisterende kompromitteret nyrefunktion samt trombose/ embolisme.
The most commonly reported and/ or clinically relevant treatment-related adverse drug reactions (ADRs) were gastrointestinal disorders (especially diarrhoea, nausea, vomiting, abdominal pain, stomatitis), hand-foot syndrome (palmar-plantar erythrodysesthesia), fatigue, asthenia, anorexia, cardiotoxicity, increased renal dysfunction on those with preexisting compromised renal function, and thrombosis/ embolism.
De bivirkninger, der af den behandlende investigator blev vurderet som muligvis, sandsynligvis eller tvivlsomt relateret til administrationen af Xeloda er angivet i tabel 4 for Xeloda- monoterapi og i tabel 5 for Xeloda givet i kombination med forskellige kemoterapiregimer indenfor flere indikationer. De efterfølgende overskrifter rangerer bivirkningerne efter hyppighed: meget almindelig (≥ 1/ 10), almindelig (≥ 1/ 100, < 1/ 10) og ikke almindelig (≥ 1/ 1000, < 1/ 100).
ADRs considered by the investigator to be possibly, probably, or remotely related to the administration of Xeloda are listed in Table 4 for Xeloda given as a single agent and in Table 5 for Xeloda given in combination with different chemotherapy regimens in multiple indications.
Alle grader Alle grader
All grades All grades
Alvorlige og/ eller
Severe and/ or
livstruende (grad 3- 4) eller vurderet som klinisk relevant Infektioner og parasitære sygdomme
Lifethreatening (grade 3-4) or considered medically relevant Infections and infestations
Herpes viral infektion, Nasopharyngitis, Infektion i de nedre luftveje
Herpes, viral infection, Nasopharyngitis, Lower respiratory tract infection
33 Systemorganklasse
33
livstruende (grad 3- 4) eller vurderet som klinisk relevant Metabolisme og ernæring
Lifethreatening (grade 3-4) or considered medically relevant Immune system disorders
Dehydrering, Nedsat appetit, Vægttab
Dehydration, Decreased appetite, Weight decreased
Hovedpine, Sløvhed, Svimmelhed, Paræstesi, Smagsforstyrrelser
Headache, Lethargy, Dizziness, Parasthesia, Dysgeusia
34 Systemorganklasse
34
livstruende (grad 3- 4) eller vurderet som klinisk relevant Mave- tarmkanalen
Lifethreatening (grade 3-4) or considered medically relevant Skin and subcutaneous tissue disorders
Palmar- plantar erythrodysæsthesi syndrom
Palmar-plantar erythrodysaesthesia syndrome
Hævelse af led, Knoglesmerter, Ansigtssmerter, Muskuloskeletal stivhed, Muskelsvaghed
Joint swelling, Bone pain, Facial pain, Musculoskeletal stiffness, Muscular weakness,
Meget almindelig
Oedema, Chills, Influenza like illness, Rigors, Body temperature increased
Alle grader Alle grader
Injury, poisoning and procedural complications
Alvorlige og/ eller
-
Sammenfatning af relaterede bivirkninger, som blev rapporteret hos patienter, der blev behandlet med Xeloda i kombinationsbehandling set ud over bivirkninger efter behandling med Xeloda- monoterapi eller set i en højere frekvensgruppe sammenlignet med Xeloda- monoterapi
35 Table 5 Summary of related ADRs reported in patients treated with Xeloda in combination treatment in addition to those seen with Xeloda monotherapy or seen at a higher frequency grouping compared to Xeloda monotherapy Body System
Knoglemarvsdepression, +febril
Bone marrow depression,
neutropeni
+ Febrile Neutropenia
Hikke, pharyngolaryngeal smerte, dysfoni
Hiccups, Pharyngolaryngeal pain, Dysphonia
Øvre gastrointestinal blødning, sår i munden, gastritis, abdominal distension, gastroøsofageal refluxsygdom, smerter i munden, dysfagi, rektal blødning, nedre abdominalsmerter
Upper gastrointestinal haemorrhage, Mouth ulceration, Gastritis, Abdominal distension, Gastroesophageal reflux disease, Oral pain, Dysphagia, Rectal haemorrhage, Abdominal pain lower
Erfaringer efter markedsføringen Efter markedsføringen er der yderligere blevet identificeret følgende alvorlige bivirkninger:
Post-Marketing Experience The following additional serious adverse reactions have been identified during post-marketing exposure:
- Meget sjælden: der er blevet rapporteret leversvigt og kolestatisk hepatitis i kliniske studier og
- Very rare: hepatic failure and cholestatic hepatitis have been reported during clinical trials and
efter markedsføringen.
post-marketing exposure
For en capecitabindosis på 1000 mg/ m2 to gange daglig på dagene 1 til 14 hver 3. uge blev der observeret hand- foot syndrom i alle grader med en hyppighed på 22% til 30% i capecitabin- kombinationsbehandling.
For the capecitabine dose of 1000 mg/ m2 twice daily on days 1 to 14 every 3 weeks, a frequency of 22% to 30% of all-grade HFS was observed in capecitabine combination therapy.
En metaanalyse af 13 kliniske studier med data fra mere end 3800 patienter, som er blevet behandlet med capecitabin- monoterapi eller capecitabin i kombination med forskellige kemoterapiregimer indenfor flere indikationer (kolonkræft, kolorektalkræft, ventrikelkræft og brystkræft) viste, at hand - foot syndrom (alle grader) forekom hos 1788 (47%) patienter gennemsnitligt 155 [95%
A meta-analysis of 13 clinical trials with data from over 3800 patients treated with capecitabine monotherapy or capecitabine in combination with different chemotherapy regimens in multiple indications (colon, colorectal, gastric and breast cancer) showed that HFS (all grades) occurred in 1788 (47%) patients after a median time of 155 [95% CI 135, 187] days after starting treatment with capecitabine.
Følgende kovarianter var statistisk signifikant associeret med en faldende risiko for udviklingen af diarré: øget kumulativ capecitabin- dosis (0, 1 * kg) og med stigende relativ dosisintensitet i de første seks uger.
The following covariates were statistically significantly associated with a decreased risk of developing diarrhea: increasing cumulative capecitabine dose (0.1*kg) and increasing relative dose intensity in the first six weeks
Encephalopati:
37 Encephalopathy:
Baseret på en samlet analyse af kliniske sikkerhedsdata fra 7 kliniske studier, blev der ud over de bivirkninger, som er anført i tabel 4 og 5, observeret encephalopati som værende forbundet med anvendelsen af Xeloda- monoterapi med en hyppighed på mindre end 0, 1%.
In addition to the ADRs described in Tables 4 and 5, and based on the above pooled analysis from clinical safety data from 7 clinical trials, encephalopathy was also associated with the use of Xeloda monotherapy with an incidence of less than 0.1%.