natgillin/translations-raw huggingface dataset:
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 Xeloda straks afbrydes.
Administration of Xeloda 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.
Behandlingen med Xeloda- monoterapi kan genoptages, når bilirubin er faldet til ≤ 3, 0 x UNL eller levertransaminaserne er faldet til ≤ 2, 5 x UNL.
Treatment with Xeloda monotherapy may be resumed when bilirubin decreases to ≤ 3.0 x ULN or hepatic aminotransferases decrease to ≤ 2.5 x ULN.
4. 3).
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 section 4.2 and 4.3).
7 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.
Interaktion med andre lægemidler:
Interaction with other medicinal products:
Antikoagulantia af coumarintypen: der er rapporteret om ændrede koagulationsparametre og/ eller ændret blødning hos patienter som tog Xeloda sammen med antikoagulantia af coumarintypen såsom warfarin og phenprocoumon.
Coumarin-derivative anticoagulants: altered coagulation parameters and/ or bleeding have been reported in patients taking Xeloda concomitantly with coumarin-derivative anticoagulants such as warfarin and phenprocoumon.
Disse bivirkninger indtraf fra flere dage og op til flere måneder efter påbegyndelsen af behandlingen med Xeloda og, i nogle få tilfælde, i op til en måned efter ophør med Xeloda.
These reactions occurred within several days and up to several months after initiating Xeloda therapy and, in a few cases, within one month after stopping Xeloda.
I et klinisk farmakokinetisk interaktionsstudie øgede behandling med Xeloda, efter en enkelt dosis på 20 mg warfarin, S- warfarin- AUC med 57%, og INR- værdien steg med 91%.
In a clinical pharmacokinetic interaction study, after a single 20 mg dose of warfarin, Xeloda treatment increased the AUC of S-warfarin by 57% with a 91% increase in INR value.
Da R- warfarins metabolisme ikke var påvirket, tyder disse resultater på, at capecitabin nedregulerer isoenzym 2C9, men ikke har effekt på isoenzymerne 1A2 og 3A4.
Since metabolism of R- warfarin was not affected, these results indicate that capecitabine down-regulates isozyme 2C9, but has no effect on isozymes 1A2 and 3A4.
Patienter som tager antikoagulantia af coumarintypen sammen med Xeloda skal kontrolleres regelmæssigt mht. ændringer i deres koagulationsparametre (PT eller INR), og antikoagulansdosis skal om nødvendigt justeres.
Patients taking coumarin-derivative anticoagulants concomitantly with Xeloda should be monitored regularly for alterations in their coagulation parameters (PT or INR) and the anti-coagulant dose adjusted accordingly.
Phenytoin: i enkelte tilfælde er der, under samtidig behandling med Xeloda og phenytoin, rapporteret om stigninger i plasmakoncentrationerne af phenytoin, som har medført symptomer på fenytoinintoksikation.
Phenytoin: increased phenytoin plasma concentrations resulting in symptoms of phenytoin intoxication in single cases have been reported during concomitant use of Xeloda with phenytoin.
Patienter, som tager phenytoin og Xeloda samtidigt, skal kontrolleres regelmæssigt mht. stigninger i phenytoin- plasmakoncentrationerne.
Patients taking phenytoin concomitantly with Xeloda should be regularly monitored for increased phenytoin plasma concentrations.
Folinsyre: et studie om kombination af Xeloda og folinsyre tyder på, at folinsyre ikke har væsentlig effekt på farmakokinetikken af Xeloda og dets metabolitter.
Folinic acid: a combination study with Xeloda and folinic acid indicated that folinic acid has no major effect on the pharmacokinetics of Xeloda and its metabolites.
Folinsyre har imidlertid en effekt på Xelodas farmakodynamik og dets toksicitet kan blive forstærket af folinsyre: maksimum tolererbar dosis (MTD) af Xeloda efter behandling med Xeloda alene er ved intermitterende behandling 3000 mg/ m2 pr. dag, hvorimod den kun er 2000 mg/ m2 pr. dag, når Xeloda kombineres med folinsyre (30 mg oralt to gange dagligt).
However, folinic acid has an effect on the pharmacodynamics of Xeloda and its toxicity may be enhanced by folinic acid: the maximum tolerated dose (MTD) of Xeloda alone using the intermittent regimen is 3000 mg/ m2 per day whereas it is only 2000 mg/ m2 per day when Xeloda was combined with folinic acid (30 mg orally bid).
Sorivudin og analoger: der er beskrevet en klinisk signifikant interaktion mellem de to lægemidler, sorivudin og 5- FU, som et resultat af sorivudins hæmning af dihydropyrimidindehydrogenase.
8 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.
4. 3).
Therefore, Xeloda must not be administered concomitantly with sorivudine or its chemically related analogues, such as brivudine (see section 4.3).
Der skal være en periode på mindst 4 uger mellem endt behandling med sorivudin eller dets kemisk beslægtede stoffer, såsom brivudin og initieringen af Xelodabehandling.
There must be at least a 4-week waiting period between end of treatment with sorivudine or its chemically related analogues such as brivudine and start of Xeloda therapy.
Antacida: man har undersøgt virkningen af et antacidum indeholdende aluminiumhydroxid og magnesiumhydroxid på capecitabins farmakokinetik.
Antacid: the effect of an aluminum hydroxide and magnesium hydroxide-containing antacid on the pharmacokinetics of capecitabine was investigated.
Der var en mindre stigning i plasmakoncentrationerne af capecitabin og en af metabolitterne (5’ DFCR), men ingen virkning på de 3 hovedmetabolitter (5’ DFUR, 5- FU og FBAL).
There was a small increase in plasma concentrations of capecitabine and one metabolite (5’ -DFCR); there was no effect on the 3 major metabolites (5’ -DFUR, 5-FU and FBAL).
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.
Samtidig anvendelse af allopurinol og Xeloda bør undgås.
Concomitant use of allopurinol with Xeloda should be avoided.
Interaktion med cytokrom P- 450: vedrørende potentielle interaktioner med isoenzymerne 1A2, 2C9 og 3A4 se interaktioner med antikoagulantia af coumarintypen.
For potential interactions with isozymes 1A2, 2C9 and 3A4, see interactions with coumarin-derivative anticoagulation.
Xelodas MTD var 2000 mg/ m2/ dag, når det kombineredes med interferon alfa- 2a (3 MIE/ m2/ dag) sammenlignet med 3000 mg/ m2/ dag, når Xeloda blev givet alene.
Interferon alpha: the MTD of Xeloda was 2000 mg/ m2 per day when combined with interferon alpha- 2a (3 MIU/ m2 per day) compared to 3000 mg/ m2 per day when Xeloda was used alone.
MTD for Xeloda alene ved anvendelse af det intermitterende regime er 3000 mg/ m2 pr. dag, hvorimod MTD er 2000 mg/ m2 pr. dag, når Xeloda kombineres med stråleterapi ved kolorektalkræft, enten ved anvendelse af en kontinuerlig behandling eller anvendt dagligt fra mandag til fredag under en seks ugers serie med stråleterapi.
Radiotherapy: the MTD of Xeloda alone using the intermittent regimen is 3000 mg/ m2 per day, whereas, when combined with radiotherapy for rectal cancer, the MTD of Xeloda is 2000 mg/ m2 per day using either a continuous schedule or given daily Monday through Friday during a 6-week course of radiotherapy.
Interaktion med føde: i alle kliniske undersøgelser blev patienterne instrueret i at tage Xeloda senest 30 min efter et måltid.
In all clinical trials, patients were instructed to administer Xeloda within 30 minutes after a meal.
Da sikkerheds - og effektdata er baseret på administration sammen med maden anbefales det at tage Xeloda sammen med et måltid.
Since current safety and efficacy data are based upon administration with food, it is recommended that Xeloda be administered with food.
5. 2).
Administration with food decreases the rate of capecitabine absorption (see section 5.2).
Der foreligger ingen undersøgelser om 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.
I reproduktionstoksicitetsundersøgelser på dyr forårsagede administration af Xeloda embryoletalitet og teratogenicitet.
In reproductive toxicity studies in animals, Xeloda administration caused embryolethality and teratogenicity.
Xeloda er kontraindiceret under graviditet.
Xeloda is contraindicated during pregnancy.
Kvinder i den fødedygtige alder skal have besked på, at de ikke må blive gravide, så længe de behandles med Xeloda.
Women of childbearing potential should be advised to avoid becoming pregnant while receiving treatment with Xeloda.
Hvis en patient bliver gravid under behandling med Xeloda, skal patienten informeres om den mulige fare for fostret.
If the patient becomes pregnant while receiving Xeloda, the potential hazard to the foetus must be explained.
Det vides ikke om Xeloda udskilles med human modermælk.
It is not known whether Xeloda is excreted in human breast milk.
Der er fundet betragtelige mængder af capecitabin og dets metabolitter i mælken hos diegivende mus.
In lactating mice, considerable amounts of capecitabine and its metabolites were found in milk.
Amning skal afbrydes under behandling med Xeloda.
Breast-feeding should be discontinued while receiving treatment with Xeloda.
Xeloda påvirker i mindre eller moderat grad evnen til at føre motorkøretøj eller betjene maskiner.
Xeloda has minor or moderate influence on the ability to drive and use machines.
Xeloda kan forårsage svimmelhed, træthed og kvalme.
Xeloda may cause dizziness, fatigue and nausea.
Den overordnede sikkerhedsprofil for Xeloda er baseret på data fra flere end 3000 patienter, der fik Xeloda- monoterapi eller Xeloda i kombination med forskellige kemoterapiregimer indenfor flere indikationer.
The overall safety profile of Xeloda is based on data from over 3000 patients treated with Xeloda as monotherapy or Xeloda in combination with different chemotherapy regimens in multiple indications.
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 cancer and adjuvant colon cancer populations are comparable.
5. 1.
See section 5.1 for details of major studies, including study designs and major efficacy results.
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.
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.
Inden for hver enkelt frekvensgruppe er bivirkningerne opstillet efter, hvor alvorlige de er.
The following headings are used to rank the ADRs by frequency: very common (≥ 1/ 10), common (≥ 1/ 100, < 1/ 10) and uncommon (≥ 1/ 1,000, < 1/ 100).
De alvorligste bivirkninger er anført først.
Within each frequency grouping, ADRs are presented in order of decreasing seriousness.
Xeloda- monoterapi:
Xeloda Monotherapy:
Tabel 4 anfører de bivirkninger, der er forbundet med anvendelsen af Xeloda- monoterapi baseret på en samlet analyse af sikkerhedsdata fra 3 store studier med flere end 1900 patienter (studierne M66001, SO14695 og SO14796).
Table 4 lists ADRs associated with the use of Xeloda monotherapy based on a pooled analysis of safety data from three major studies including over 1900 patients (studies M66001, SO14695, and SO14796).
Bivirkningerne er anført i passende frekvensgruppering ud fra den overordnede hyppighed i den samlede analyse..
ADRs are added to the appropriate frequency grouping according to the overall incidence from the pooled analysis.
Sammenfatning af relaterede bivirkninger, som blev rapporteret hos patienter behandlet med Xeloda- monoterapi
Table 4 Summary of related ADRs reported in patients treated with Xeloda monotherapy
Alle grader
All grades All grades
Alle grader
Severe and/ or Life-
Alvorlige og/ eller livstruende (grad 3- 4) eller vurderet som klinisk relevant
threatening (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
Sepsis, Urinvejsinfektion, Cellulitis, Tonsillitis, Pharyngitis, Oral candidiasis, Influenza, Gastroenteritis, Svampeinfektion, Infektion, Tandbyld
Sepsis, Urinary tract infection, Cellulitis, Tonsillitis, Pharyngitis, Oral candidiasis, Influenza, Gastroenteritis, Fungal infection, Infection, Tooth abscess
Benigne, maligne og uspecificerede tumorer (inkl. cyster og polypper)
Neoplasm benign, malignant and unspecified
Febril neutropeni, Pancytopeni, Granulocytopeni, Thrombocytopeni, Leukopeni, Hæmolytisk anæmi, Øget international normaliseret ratio (INR) / forlænget protrombintid
Febrile neutropenia, Pancytopenia, Granulocytopenia, Thrombocytopenia, Leucopenia, Haemolytic anaemia, International Normalised Ratio (INR) increased/ Prothrombin time prolonged
Immunsystemet Metabolisme og ernæring
Body System
- Anoreksi
Uncommon
- Dehydrering, Nedsat appetit, Vægttab
All grades All grades
Hypersensitivitet Diabetes, Hypokaliæmi, Appetitforstyrrelser, Underernæring, Hypertriglyceridæmi
threatening (grade 3-4) or considered medically relevant Immune system disorders
Psykiske forstyrrelser
-
Søvnløshed, Depression
Hypersensitivity
Konfusion, Panikanfald, Nedtrykthed, Nedsat libido
Metabolism and nutrition disorders
10 Systemorganklasse
Anorexia
Meget almindelig
Dehydration, Decreased appetite, Weight decreased
Almindelig
Diabetes, Hypokalaemia, Appetite disorder, Malnutrition, Hypertriglyceridaemia,
Alle grader
-
Alle grader
Insomnia, Depression
Alvorlige og/ eller
Confusional state, Panic attack, Depressed mood, Libido decreased
livstruende (grad 3- 4) eller vurderet som klinisk relevant Nervesystemet
Nervous system disorders
Dyspnø, Epistaxis, Hoste, Rindende næse
Dyspnoea, Epistaxis, Cough, Rhinorrhea
11 Systemorganklasse
11
Meget almindelig
Body System
Almindelig
Very
Alle grader
Uncommon
Alvorlige og/ eller
Severe and/ or Life-
livstruende (grad 3- 4) eller vurderet som klinisk relevant Hud og subkutane væv
threatening (grade 3-4) or considered medically relevant Skin and subcutaneous tissue disorders
Palmar- plantar erythrodysæstesi syndrom
Palmar-plantar erythrodysaesthesia syndrome
Sår i huden, Udslæt, Urticaria, Fotosensitivitets - reaktioner, Palmart erythem, Hævelse i ansigtet, Purpura
Skin ulcer, Rash, Urticaria, Photosensitivity reaction, Palmar erythema, Swelling face, Purpura
Feber, Letargi, Perifere ødemer, Utilpashed, Brystsmerter
Pyrexia, Lethargy, Oedema peripheral, Malaise, Chest pain
Traumer, forgiftninger og behandlings - komplikationer
Injury, poisoning and procedural complications
Blister, Overdosis
Blister, Overdose
Xeloda i kombinationsbehandling:
Xeloda in combination therapy:
De er baseret på sikkerhedsdata fra flere end 1400 patienter.
Table 5 lists ADRs associated with the use of Xeloda in combination with different chemotherapy regimens in multiple indications based on safety data from over 1400 patients.
Bivirkningerne er kun anført, hvis de er set ud over dem, set med Xeloda- monoterapi eller set i en højere frekvensgruppe sammenlignet med Xeloda- monoterapi (se tabel 4).
ADRs are added to the appropriate frequency grouping (Very common or Common) according to the highest incidence seen in any of the major clinical trials and are only added when they were seen in addition to those seen with Xeloda monotherapy or seen at a higher frequency grouping compared to Xeloda monotherapy (see Table 4).
Ikke almindelige bivirkninger, der er rapporteret ved behandling med Xeloda i kombination med andre lægemidler, er i overensstemmelse med de bivirkningsrapporteringer, der er rapporteret for Xeloda - monoterapi eller for monoterapi med kombinationslægemidlet (i litteratur og/ eller respektive produktresuméer).
Uncommon ADRs reported for Xeloda in combination therapy are consistent with the ADRs reported for Xeloda monotherapy or reported for monotherapy with the combination agent (in literature and/ or respective summary of product characteristics).
Nogle af bivirkningerne er reaktioner, som er almindeligt observeret med kombinationslægemidlet (f. eks. perifer sensorisk neuropati med docetaxel eller oxaliplatin, hypertension set med bevacizumab); en forværring ved Xeloda- behandlingen kan dog ikke udelukkes.
Some of the ADRs are reactions commonly seen with the combination agent (e. g. peripheral sensory neuropathy with docetaxel or oxaliplatin, hypertension seen with bevacizumab); however an exacerbation by Xeloda therapy can not be excluded.
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
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
Herpes zoster, urinvejsinfektion, oral candidiasis, øvre luftvejsinfektion, rhinitis, influenza, +infektion
Herpes zoster, Urinary tract infection, Oral candidiasis, Upper respiratory tract infection, Rhinitis, Influenza, +Infection
Neutropeni, +leukopeni,
Neutropenia, +Leucopenia,
Knoglemarvsdepression, +febril
Bone marrow depression, +Febrile
anæmi, +neutropenisk feber,
Anaemia, +Neutropenic fever,
neutropeni
Neutropenia
trombocytopeni Immunsystemet Metabolisme og ernæring
Thrombocytopenia Immune system disorders Metabolism and nutrition disorders
- Nedsat appetit
- Appetite decreased
Hypersensitivitet Hypokaliæmi, hyponatriæmi, hypomagnesiæmi, hypokalcæmi, hyperglycæmi
Hypersensitivity Hypokalaemia, Hyponatremia, Hypomagnesaemia, Hypocalcaemia, Hyperglycaemia
- Smagsforstyrrelser, paræstesi og dysæstesi, perifer neuropati, dysgeusi, hovedpine
- Taste disturbance, Paraesthesia and dysaesthesia, Peripheral neuropathy, Dysgeusia, Headache
Søvnforstyrrelser, angst Neurotoksicitet, tremor, neuralgi, hypersensitivitetsreaktioner
Sleep disorder, Anxiety Neurotoxicity, Tremor, Neuralgia, Hypersensitivity reaction
Øjne Øre og labyrint Hjerte
Eye disorders Ear and labyrinth disorders Cardiac disorders
Øget tåresekretion - -
Lacrimation increased - -
Visuelle forstyrrelser, tørre øjne Tinnitus, hypoakusis Atrieflimren, iskæmisk hjertesygdom/ infarkt
Visual disorders, Dry eye Tinnitus, Hypoacusis Atrial fibrillation, Cardiac ischemia/ infarction
Rødmen, hypotension, hypertensiv krise
Flushing, Hypotension, Hypertensive crisis
Ondt i halsen, pharynxdysæstesi
Respiratory, thoracic and mediastinal system disorders Gastrointestinal disorders
Hikke, pharyngolaryngeal smerte, dysfoni
Sore throat, Dysaesthesia pharynx Constipation, Dyspepsia
Øvre gastrointestinal blødning, sår i munden, gastritis, abdominal distension, gastroøsofageal refluxsygdom, smerter i munden, dysfagi, rektal blødning, nedre abdominalsmerter
Hiccups, Pharyngolaryngeal pain, Dysphonia Upper gastrointestinal haemorrhage, Mouth ulceration, Gastritis, Abdominal distension, Gastroesophageal reflux disease, Oral pain, Dysphagia, Rectal haemorrhage, Abdominal pain lower
- Alopeci, neglesygdomme
- Alopecia, Nail disorder
Unormal leverfunktion Hyperhidrosis, erytematøst udslæt, urticaria, nattesved
Hepatic function abnormal Hyperhidrosis, Rash erythematous, Urticaria, Night sweats
Knogler, led, muskler og bindevæv Nyrer og urinveje
Musculoskeletal and connective tissue disorders Renal and urinary disorder
Myalgi, artralgi, smerter i ekstremiteterne -
Myalgia, Arthralgia, Pain in extremity -
Kæbesmerter, muskelspasmer, trismus, muskelsvaghed Hæmaturi, proteinuri, nedsat renal kreatininclearance
Pain in jaw, Muscle spasms, Trismus, Muscular weakness Haematuria, Proteinuria, Creatinine renal clearance decreased
Pyreksi, svaghed, +letargi
Pyrexia, Weakness, +Lethargy
Mukosal inflammation, smerter i ekstremiteterne, smerter, temperaturintolerance, kuldegysninger, brystsmerter, influenzalignende symptomer, + feber
Mucosal inflammation, Pain in limb, Pain, Temperature intolerance, Chills, Chest pain, Influenza-like illness, +Fever
Traumer, forgiftninger og behandlingskomplikationer +
Injury, poisoning and procedural complications +
For hver term er hyppigheden baseret på bivirkninger af alle grader.
For each term, the frequency count was based on ADRs of all grades.
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.
Erfaringer efter markedsføringen Efter markedsføringen er der yderligere blevet identificeret følgende alvorlige bivirkninger:
The following additional serious adverse reactions have been identified during post-marketing exposure:
- Meget sjælden: stenose af tårekanalen
- Very rare: lacrimal duct stenosis
- Meget sjælden: der er rapporteret leversvigt og kolestatisk hepatitis i kliniske studier og efter
- Very rare: hepatic failure and cholestatic hepatitis have been reported during clinical trials and
markedsføringen.
post-marketing exposure
4. 4):
Hand-foot syndrome (see section 4.4):
Den observerede hyppighed var på 63% i capecitabin/ docetaxel- armen i behandlingen af metastatisk brystkræft.
For the capecitabine dose of 1250 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.
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