FrancophonIA/ELRC3.0 huggingface dataset:
English: In an interaction study with single-dose warfarin administration, there was a significant increase in the mean AUC (+57%) of S-warfarin.
Danish: I et interaktionsstudie med enkeltdosis administration af warfarin, var der en signifikant stigning i middel-AUC (+57 %) af S-warfarin.
English: Each pack contains 60 tablets.
Danish: Hver pakning indeholder 60 tabletter.
English: Discontinue permanently or If physician deems it to be in the patient's best interest to continue, interrupt until resolved to grade 0-1
Danish: Seponer behandlingen permanent eller hvis lægen skønner at det bedste for patienten er at fortsætte så afbryd behandlingen indtil toksiciteten er reduceret til grad 0-1
English: Each pack contains 120 tablets.
Danish: Hver pakning indeholder 120 tabletter.
English: Parameter: Progression-free Survival PPP
Danish: Parameter: Progressionsfri overlevelse PPP
English: FOLFOX-4 or FOLFOX-4 + Bevacizumab
Danish: FOLFOX-4 eller FOLFOX-4 + Bevacizumab
English: Hand and foot skin-reaction can lead to loss of fingerprint, which could impact your identification by fingerprint scan.
Danish: Hudsymptomer på hænder og fødder kan forårsage, at fingeraftrykket forsvinder, hvilket kan påvirke din identifikation med fingeraftryksscanner.
English: Hypo- or hypercalcaemia
Danish: Hypo- eller hyperkalcaemia
English: Persistent or severe hand-foot syndrome (Grade 2 and above) can eventually lead to loss of fingerprints which could impact patient identification.
Danish: Vedvarende eller svært hånd- og fodsyndrom (grad 2 og højere) kan i sidste ende forårsage, at fingeraftrykket forsvinder, hvilket kan påvirke patientens identifikation.
English: The median follow up at the time of the primary analyses in the intent-to-treat population was 1.5 years; data from analyses following an additional 1 year of follow up are also included in table 7.
Danish: Den mediane follow-up-tid på tidspunktet for de primære analyser i intent-to-treat-populationen var 1,5 år; data fra analyser efter yderligere et års follow-up fremgår også af tabel 7.
English: Furthermore, Capecitabine Teva is used to prevent new occurrence of colon cancer after complete removal of the tumour by surgery.
Danish: Desuden anvendes Capecitabine Teva til forebyggelse af ny optræden af tyktarmskræft efter fuldstændig fjernelse af svulsten ved operation.
English: taste changes
Danish: smagsforandringer
English: These dose adjustment recommendations for renal impairment apply both to monotherapy and combination use (see also section “Elderly” below).
Danish: Rekommendationer for dosisjustering ved nyreinsufficiens gælder både for monoterapi og for kombinationsbehandling (se også afsnittet om ældre nedenfor).
English: Toxicity due to capecitabine administration may be managed by symptomatic treatment and/or modification of the dose (treatment interruption or dose reduction).
Danish: Toksicitet som skyldes administration af capecitabin kan behandles symptomatisk og/eller med modifikation af capecitabin-dosis (afbrydelse af behandlingen eller reduktion af dosis).
English: Capecitabine Teva belongs to the group of medicines called "cytostatic medicines", which stop the growth of cancer cells.
Danish: Capecitabine Teva tilhører en gruppe lægemidler som kaldes “cytostatika”, som standser væksten af kræftceller.
English: The capecitabine pivotal studies included females of childbearing potential and males only if they agreed to use an acceptable method of birth control to avoid pregnancy for the duration of the study and for a reasonable period thereafter.
Danish: De pivotale capecitabin-studier inkluderede kun kvinder i den fertile alder og mænd, hvis de indgik aftale om at anvende en egnet præventionsmetode for at undgå graviditet under studiet og i en passende periode efter studiet.
English: In monkeys, abortion and embryolethality were observed at high doses, but there was no evidence of teratogenicity.
Danish: Hos aber blev der set abort og embryoletalitet efter høje doser, men der var ikke tegn på teratogenicitet.
English: See also section “Do not take Capecitabine Teva”.
Danish: Se også afsnittet 'Tag ikke Capecitabine Teva.
English: • blood infection, urinary tract infection, infection of the skin, infections in the nose and throat,
Danish: • infektion af blodet, urinvejsinfektion, infektion i huden, infektioner i næsen og halsen,
English: The AUC0-∞ values in μg•h/ml were 7.75, 7.24, 24.6, 2.03 and 36.3.
Danish: AUC0-∞ værdierne (μg•time/ml var 7,75; 7,24; 24,6; 2,03 og 36,3.
English: The dose of Capecitabine Teva is based on your body surface area.
Danish: Capecitabine Teva-dosis er baseret på arealet af din legemsoverflade.
English: • difficulty speaking, impaired memory, loss of movement coordination, balance disorder,
Danish: • talebesvær, hukommelsessvigt, tab af bevægelseskoordination, balanceproblemer, besvimelse,
English: Body temperature increased ** Based on the post-marketing experience, persistent or severe palmar-plantar erythrodysaesthesia syndrome can eventually lead to loss of fingerprints (see section 4.4)
Danish: Øget kropstemperatur ** Baseret på erfaringer efter markedsføring kan vedvarende eller svært palmar-plantar erytrodysæstesi syndrom i sidste ende forårsage, at fingeraftrykket forsvinder (se pkt.
English: Since current safety and efficacy data are based upon administration with food, it is recommended that capecitabine be administered with food.
Danish: Da data for sikkerhed og virkning er baseret på administration sammen med maden anbefales det at tage capecitabin sammen med et måltid.
English: Interactions with allopurinol have been observed for 5-FU; with possible decreased efficacy of 5-FU.
Danish: Der er set interaktion mellem allopurinol og 5-FU, med mulig nedsat effekt af 5-FU.
English: Your doctor may want you to take a combination of 150 mg and 500 mg tablets for each dose.
Danish: Det kan være din læge vil have at du for hver dosis skal tage en kombination af 150 mg og 500 mg tabletter.
English: - first-line treatment of advanced gastric cancer in combination with a platinum-based regimen (see section 5.1).
Danish: - 1. linjebehandling af fremskreden ventrikelkræft i kombination med et platinbaseret regime (se pkt.
English: Contact your doctor immediately if you are concerned about any of the side effects or if you notice any additional side effects not listed in the leaflet (see section 4 Possible side effects).
Danish: Kontakt din læge med det samme, hvis du er bekymret for en eller flere af bivirkningerne, eller hvis du får bivirkninger, som ikke fremgår af denne indlægsseddel (se punkt 4 ”Bivirkninger”).
English: • infections of the lungs or respiratory system (e.g. pneumonia or bronchitis)
Danish: • infektioner i lungen eller åndedrætssystemet (f.eks. lungebetændelse eller bronkitis),
English: There is no data on capecitabine and impact on fertility.
Danish: Der er ingen data om capecitabin og dets virkning på fertiliteten.
English: Capecitabine was devoid of hepatic and CNS toxicities.
Danish: capecitabin var fri for hepatisk og CNS toksicitet.
English: Do not take the missed dose at all.
Danish: Du må ikke tage den glemte dosis.
English: Danmark Teva Denmark A/S Tlf: +45 44985511
Danish: Teva Denmark A/S Tlf: +45 44985511
English: Do not give capecitabine to children and adolescents.
Danish: Giv ikke Capecitabine Teva til børn eller unge.
English: Detailed information on this medicinal product is available on the website of the European Medicines Agency: http://www.ema.europa.eu/.
Danish: Yderligere oplysninger om dette lægemiddel findes på Det Europæiske Lægemiddelagenturs hjemmeside http://www.ema.europa.eu.
English: • certain types of arrhythmia (including ventricular fibrillation, torsade de pointes, and bradycardia)
Danish: • visse typer arytmier (herunder ventrikelflimren, torsade de pointes og bradykardi)
English: Capecitabine has minor or moderate influence on the ability to drive and use machines.
Danish: Capecitabin påvirker i mindre eller moderat grad evnen til at føre motorkøretøj og betjene maskiner.
English: Number of 150 mg tablets and/or 500 mg tablets per administration (each administration to be given morning and evening)
Danish: Antal 150 mg tabletter og/eller 500 mg tabletter pr. dosering (hver dosering skal gives morgen og aften)
English: The tablets are available in blisters containing 10 film-coated tablets.
Danish: Tabletterne fås i blisterpakninger med 10 filmovertrukne tabletter.
English: The efficacy data is based on a median observation time of 59 months for OS and 57 months for DFS.
Danish: Data for virkning er baseret på en gennemsnitlig observationstid på 59 måneder for samlet overlevelse og 57 måneder for sygdomsfri overlevelse.
English: Pyrexia, Weakness, +Lethargy, Temperature intolerance
Danish: Pyreksi, svaghed, +letargi, temperaturintolerance
English: The following headings are used to rank the ADRs by frequency: very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100), rare (≥ 1/10,000 to < 1/1,000), very rare (< 1/10,000).
Danish: (≥ 1/10), almindelig (≥ 1/100, < 1/10), ikke almindelig (≥ 1/1.000, < 1/100), sjælden (≥ 1/10.000 til
English: Some of the ADRs are reactions commonly seen with the combination medicinal product (e.g. peripheral sensory neuropathy with docetaxel or oxaliplatin, hypertension seen with bevacizumab); however an exacerbation by capecitabine therapy can not be excluded.
Danish: 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 capecitabin-behandlingen kan dog ikke udelukkes.
English: Capecitabine Teva should be permanently discontinued in patients who experience a severe skin reaction during treatment.
Danish: Capecitabine Teva skal seponeres permanent hos patienter, der oplever en alvorlig hudreaktion under behandlingen.
English: • pain or altered/abnormal sensation in the mouth, pain in the jaw
Danish: • smerter eller forandret/unormal fornemmelse i munden, smerter i kæben
English: 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.
Danish: 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.
English: 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.
Danish: In vitro: 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.
English: • pain in the joints, or in the limbs (extremities), chest or back
Danish: • smerter i led eller i lemmerne (ekstremiteterne), bryst eller ryg
English: 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.
Danish: 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.
English: Method of administration Capecitabine Teva film-coated tablets should be swallowed with water within 30 minutes after a meal.
Danish: Administration Capecitabine Teva filmovertrukne tabletter skal synkes med vand senest 30 minutter efter et måltid.
English: (FBAL) which is cleared in the urine.
Danish: som udskilles i urinen.
English: United Kingdom Teva UK Limited Tel: +44 1977628500
Danish: Teva UK Limited Tel: +44 1977628500
English: Capecitabine is first metabolised by hepatic carboxylesterase to 5'-DFCR, which is then converted to 5'-DFUR by cytidine deaminase, principally located in the liver and tumour tissues.
Danish: Capecitabin metaboliseres først af hepatisk carboxylesterase til 5'-DFCR, som derefter omdannes til 5'-DFUR af cytidindeaminase, som fortrinsvis findes i leveren og i tumorvæv.
English: The following covariates were statistically significantly associated with a decreased risk of developing diarrhoea: increasing cumulative capecitabine dose (0.1*kg) and increasing relative dose intensity in the first six weeks.
Danish: 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.
English: • problems with liver function (seen in blood tests) and increased blood bilirubin (excreted by the liver)
Danish: • problemer med leveren (ses i blodprøver) og forhøjet bilirubin i blodet (udskilles i leveren)
English: You must not take brivudine (an anti-viral medicines for treatment of shingles or chickenpox) at the same time as capecitabine treatment (including during any rest periods when you are not taking any capecitabine tablets).
Danish: Du må ikke tage brivudin (et lægemiddel mod virus til behandling af helvedesild eller skoldkopper) samtidig med du får capecitabin-behandling (dette gælder også perioder, hvor du holder pause og ikke tager capecitabin tabletter).
English: For patients with partial DPD deficiency (such as those with heterozygous mutations in the DPYD gene) and where the benefits of Capecitabine Teva 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 adjusment according to toxicity.
Danish: For patienter med delvis DPD-mangel (fx med heterozygote mutationer i DPYD-genet), og hvor fordelene af Capecitabine Teva 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.
English: • In patients with severe leukopenia, neutropenia, or thrombocytopenia,
Danish: • Patienter med svær leukopeni, neutropeni eller trombocytopeni,
English: No clinically significant differences in exposure to capecitabine or its metabolites, free platinum or total platinum occurred when capecitabine was administered in combination with oxaliplatin or in combination with oxaliplatin and bevacizumab.
Danish: Der optrådte ingen klinisk betydende forskelle i eksponeringen for capecitabin eller dets metabolitter, frit platin eller total platin, når capecitabin blev administreret i kombination med oxaliplatin eller i kombination med oxaliplatin og bevacizumab.
English: 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 1250 mg/m2 twice daily.
Danish: 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.
English: Cytochrome P-450 2C9 substrates
Danish: CYP2C9-substrater
English: • hiccups, change in voice
Danish: • hikke, forandret stemme
English: If grade 2 or 3 hand-foot syndrome occurs, administration of capecitabine should be interrupted until the event resolves or decreases in intensity to grade 1.
Danish: Hvis der optræder grad 2 eller 3 hånd- og fodsyndrom, skal behandlingen med capecitabin afbrydes, indtil symptomerne forsvinder eller er aftaget i intensitet til grad 1.
English: 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 1900 patients (studies M66001, SO14695, and SO14796).
Danish: 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).
English: Capecitabine Teva contains capecitabine, which itself is not a cytostatic medicine.
Danish: Capecitabine Teva indeholder capecitabin, som i sig selv ikke virker cytostatisk.
English: Following oral administration of capecitabine to patients with colorectal cancer, the ratio of 5-FU concentration in colorectal tumours to adjacent tissues was 3.2 (ranged from 0.9 to 8.0).
Danish: Efter oral administration af capecitabin til patienter med kolorektalkræft var forholdet mellem koncentrationen af 5-FU i de kolorektale tumorer og i de tilstødende væv 3,2 (spændvidde: 0,9-8,0).
English: Altered coagulation parameters and/or bleeding have been reported in patients taking capecitabine concomitantly with coumarin-derivative anticoagulants such as warfarin and phenprocoumon.
Danish: Der er rapporteret om ændrede koagulationsparametre og/eller ændret blødning hos patienter, som tog capecitabin sammen med antikoagulantia af coumarintypen såsom warfarin og phenprocoumon.
English: • decrease in blood sodium, magnesium or calcium, increase in blood sugar
Danish: • fald i natrium, magnesium eller kalcium i blodet, forhøjet blodsukker
English: Capecitabine Teva can induce severe skin reactions such as Stevens-Johnson syndrome and Toxic Epidermal Necrolysis.
Danish: Capecitabine Teva kan inducere alvorlige hudreaktioner såsom Stevens-Johnsons syndrom og toksisk epidermal nekrolyse.
English: According to immunohistochemical studies, thymidine phosphorylase appears to be in large part localised in tumour stromal cells.
Danish: I henhold til immunohistokemiske studier synes thymidinfosforylase hovedsageligt lokaliseret i stromale tumorceller
English: • During pregnancy and lactation,
Danish: • Graviditet og amning,
English: There are no side effects caused by stopping treatment with capecitabine.
Danish: Der er ingen bivirkninger forbundet med at stoppe behandlingen med Capecitabine Teva.
English: Capecitabine is contraindicated in patients with severe renal impairment (creatinine clearance below 30 ml/min [Cockcroft and Gault] at baseline).
Danish: Capecitabin er kontraindiceret til patienter med svær nyreinsufficiens (creatininclearance under 30 ml/min ved baseline) [Cockcroft og Gault].
English: In patients with mild renal impairment (creatinine clearance 51-80 ml/min at baseline) no adjustment of the starting dose is recommended.
Danish: Til patienter med let nyreinsufficiens (creatininclearance 51-80 ml/min ved baseline) er dosisjustering ikke nødvendig.
English: A combination study with capecitabine and folinic acid indicated that folinic acid has no major effect on the pharmacokinetics of capecitabine and its metabolites.
Danish: Et studie om kombination af capecitabin og folinsyre tyder på, at folinsyre ikke har væsentlig effekt på farmakokinetikken af capecitabin og dets metabolitter.
English: Ophthalmologic complications
Danish: Oftalmologiske komplikationer
English: Posology adjustments for special populations
Danish: Doseringsjusteringer for særlige populationer
English: Other than warfarin, no formal interaction studies between capecitabine and other CYP2C9 substrates have been conducted.
Danish: Der er ikke gennemført formelle interaktionsstudier med capecitabin og andre CYP2C9-substrater bortset fra warfarin.
English: If you have taken brivudine you must wait for at least 4 weeks after stoping brivudine before starting to take capecitabine.
Danish: Hvis du har taget brivudin, skal du vente mindst 4 uger efter endt behandling med brivudin før du må starte behandling med capecitabin.
English: Injury, poisoning and procedural complications
Danish: Traumer, forgiftninger og behandlingskomplikatio ner
English: -2nd appearance
Danish: Ved 2. forekomst
English: Capecitabine Teva 500 mg film-coated tablets EU/1/12/761/002
Danish: Capecitabine Teva 500 mg filmovertrukne tabletter EU/1/12/761/002
English: • In patients with severe renal impairment (creatinine clearance below 30 ml/min),
Danish: • Patienter med svær nyreinsufficiens (creatininclearance under 30 mg/min)
English: - In combination with docetaxel: an increased incidence of grade 3 or 4 treatment-related adverse reactions and treatment-related serious adverse reactions were observed in patients 60 years of age or more (see section 5.1).
Danish: - I kombination med docetaxel: Der blev observeret en øget incidens af grad 3 eller 4 behandlingsrelaterede bivirkninger og behandlingsrelaterede alvorlige bivirkninger hos patienter på 60 år og derover (se pkt.
English: There was no clinically significant effect of bevacizumab on the pharmacokinetic parameters of capecitabine or its metabolites in the presence of oxaliplatin.
Danish: Bevacizumab havde ingen klinisk signifikant virkning på capecitabins farmakokinetiske parametre eller dets metabolitter under tilstedeværelse af oxaliplatin.
English: treatment-related adverse reactions were more frequent in patients ≥60 years of age compared to younger patients.
Danish: Behandlingsrelaterede bivirkninger af sværhedsgrad 3 eller 4 var dog hyppigere hos patienter ≥ 60 år sammenlignet med yngre patienter.
English: België/Belgique/Belgien Teva Pharma Belgium N.V./S.A./AG Tél/Tel: +32 38207373
Danish: Teva Pharma Belgium N.V./S.A./AG Tél/Tel: +32 38207373
English: The pharmacokinetics of capecitabine have been evaluated over a dose range of 502-3514 mg/m2/day.
Danish: Capecitabins farmakokinetik er undersøgt i dosisintervallet 502-3.514 mg/m2/dag.
English: Store in the original package to protect from moisture.
Danish: Opbevares i den originale pakning som beskyttelse mod fugt.
English: Ventricular fibrillation (rare), QT prolongation (rare), Torsade de pointes (rare), Bradycardia (rare), Vasospasm (rare)
Danish: Ventrikelflimmer (sjælden), QT-forlængelse (sjælden), Torsades de pointes (sjælden), Bradykardi (sjælden), Karspasme (sjælden)
English: There is no relevant use of capecitabine in the paediatric population in the indications colon, colorectal, gastric and breast cancer.
Danish: Det er ikke relevant at anvende capecitabine hos den pædiatriske population til indikationerne kolon-, kolorektal, tarm- og brystcancer.
English: Deutschland TEVA GmbH Tel: +49 73140208
Danish: TEVA GmbH Tel: +49 73140208
English: In addition to the above, when capecitabine is used alone, very common side effects which may affect more than 1 in 10 people are: - abdominal pain - rash, dry or itchy skin - tiredness - loss of appetite (anorexia)
Danish: Ud over dette kan Capecitabine Teva når det anvendes alene have følgende meget almindelige bivirkninger, som kan påvirke flere end 1 ud af 10 personer: mavesmerter udslæt, tør eller kløende hud træthed appetitløshed
English: • irregular heartbeat and palpitations (arrhythmias), chest pain and heart attack (infarction)
Danish: • uregelmæssig hjerterytme og hjertebanken (arytmier), smerter i brystet og hjerteanfald (infarkt)
English: Tablet coating Macrogol (400) Hypromellose Titanium dioxide (E171) Yellow iron oxide (E172) Red iron oxide (E172)
Danish: Tabletovertrækket Macrogol (400) Hypromellose Titaniumdioxide(E171) Gul jernoxid (E172) Rød jernoxid (E172)
English: • decreases in the number of white blood cells or red blood cells (seen in tests),
Danish: • fald i antallet af hvide eller røde blodlegemer (ses i blodprøver)
English: The effect of an aluminium hydroxide and magnesium hydroxide-containing antacid on the pharmacokinetics of capecitabine was investigated.
Danish: Man har undersøgt virkningen af et antacidum indeholdende aluminiumhydroxid og magnesiumhydroxid på capecitabins farmakokinetik.
English: Patients with hepatic impairment due to liver metastases According to a pharmacokinetic study in cancer patients with mild to moderate liver impairment due to liver metastases, the bioavailability of capecitabine and exposure to 5-FU may increase compared to patients with no liver impairment.
Danish: Patienter med leverinsufficiens pga. levermetastaser I henhold til et farmakokinetisk studie på kræftpatienter med let til moderat leverinsufficiens pga. levermetastaser kan capecitabins biotilgængelighed og eksponeringen for 5-FU øges sammenlignet med patienter uden leverinsufficiens.