FrancophonIA/ELRC3.0 huggingface dataset:
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 i en aftale om at anvende en egnet præventionsmetode for at undgå graviditet under studiet og i en passende periode efter studiet.
English: Capecitabine medac with food and drink You should take Capecitabine medac no later than 30 minutes after meals.
Danish: Brug af Capecitabine medac sammen med mad og drikke Du skal tage Capecitabine medac senest 30 minutter efter et måltid.
English: EPP ITT *EPP = eligible patient population; **ITT = intent-to-treat population.
Danish: Parameter: Samlet overlevelse EPP ITT *EPP=egnet patientpopulation; **ITT=intent-to-treat-population
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: 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: Capecitabine medac is available in blisters (Aluminium-Aluminium or PVC/PVdC-Aluminium).
Danish: Capecitabine medac fås i blistere (aluminium-aluminium eller PVC/PVdC-aluminium).
English: Patients were randomised to receive either FOLFIRI plus bevacizumab (Arm-A, n = 167) or XELIRI plus bevacizumab (Arm-B, n-166).
Danish: Patienterne blev randomiseret til enten at få FOLFIRI plus bevacizumab (arm-A, n = 167) eller XELIRI plus bevacizumab (arm-B, n = 166).
English: For terms marked with a “+”, the frequency count was based on grade 3 - 4 ADRs.
Danish: For termer markeret med ”+” er hyppigheden baseret på bivirkninger af grad 3-4.
English: Do not take the missed dose at all.
Danish: Du skal ikke tage den glemte dosis.
English: The efficacy data is based on a median observation time of 59 months for OS and 57 months for DFS.
Danish: Effektdata er baseret på en median observationstid på 59 måneder for samlet overlevelse og 57 måneder for sygdomsfri overlevelse.
English: Capecitabine medac belongs to the group of medicines called "cytostatic medicines", which stop the growth of cancer cells.
Danish: Capecitabine medac tilhører en gruppe lægemidler, som kaldes “cytostatika”, som standser væksten af kræftceller.
English: • pain or altered/abnormal sensation in the mouth, pain in the jaw
Danish: • smerter eller ændret/unormal følelse i munden, smerter i kæben
English: If you take more Capecitabine medac than you should If you take more Capecitabine medac than you should, contact your doctor as soon as possible before taking the next dose.
Danish: Hvis du har taget for mange Capecitabine medac-tabletter Hvis du har taget for mange Capecitabine medac-tabletter, skal du kontakte din læge hurtigst muligt, før du tager næste dosis.
English: There was a small increase in plasma concentrations of capecitabine and one metabolite 5'-deoxy-5-fluorocytidine (5'-DFCR); there was no effect on the 3 major metabolites: 5'-deoxy-5-fluorouridine (5'-DFUR), 5-FU and α-fluoro-β-alanine (FBAL).
Danish: Der var en mindre stigning i plasmakoncentrationerne af capecitabin og en af metabolitterne 5'-deoxy-5-fluorocytidin (5'-DFCR), men ingen virkning på de 3 hovedmetabolitter 5'-deoxy-5-fluorouridin (5'-DFUR), 5-FU og α-fluoro-β-alanin (FBAL).
English: Oxaliplatin on Day 1, every 3 weeks capecitabine oral twice daily for 2 weeks (followed by 1 week off- treatment)
Danish: Oxaliplatin på dag 1, hver 3. uge capecitabin oral to gange daglig i 2 uger (efterfulgt af 1 uge uden behandling)
English: Capecitabine is a non-cytotoxic fluoropyrimidine carbamate, which functions as an orally administered precursor of the cytotoxic moiety 5-FU.
Danish: Capecitabin er et non-cytotoksisk fluorpyrimidincarbamat, som virker som en oral administreret prækursor for det cytotoksiske 5-FU.
English: The enzymes involved in the catalytic activation are found in tumour tissues but also in normal tissues, albeit usually at lower levels.
Danish: Enzymerne, som er involverede i den katalytiske aktivering, findes i tumorvæv, men også i normalt væv, om end i lavere koncentrationer.
English: In human cancer xenograft models capecitabine demonstrated a synergistic effect in combination with docetaxel, which may be related to the upregulation of ThyPase by docetaxel.
Danish: I humane cancerxenotransplantationsmodeller har capecitabin vist en synergistisk effekt i kombination med docetaxel, som kan være relateret til docetaxels opregulering af ThyPase.
English: The study contained two parts: an initial 2-arm part in which 634 patients were randomised to two different treatment groups, including XELOX or FOLFOX-4, and a subsequent 2x2 factorial part in which 1,401 patients were randomised to four different treatment groups, including XELOX plus placebo, FOLFOX-4 plus placebo, XELOX plus bevacizumab, and FOLFOX-4 plus bevacizumab.
Danish: Studiet indeholdte to dele: En initial 2-arms del, i hvilken 634 patienter blev randomiseret i to forskellige behandlingsgrupper, inkluderende XELOX eller FOLFOX-4, og efterfølgende 2*2 design, i hvilken 1.401 patienter blev randomiseret til 4 forskellige behandlingsgrupper, inkluderende XELOX plus placebo, FOLFOX-4 plus placebo, XELOX plus bevacizumab og FOLFOX-4 plus bevacizumab.
English: This medicinal product contains less than 1 mmol sodium (23 mg) per film-coated tablet, that is to say essentially ‘sodium-free'.
Danish: Dette lægemiddel indeholder mindre end 1 mmol (23 mg) natrium pr. filmovertrukket tablet, dvs. den er i det væsentlige natrium-fri.
English: Only after being absorbed by the body is it changed into an active anti-cancer medicine (more in tumour tissue than in normal tissue).
Danish: Kun når det er optaget i kroppen, ændres det til et aktivt anti-cancer stof (fortrinsvis i svulstvæv).
English: • sweating, night sweats
Danish: • øget svedtendens, svedeture om natten
English: • for first-line treatment of advanced gastric cancer in combination with a platinum based regimen (see section 5.1).
Danish: • til 1. linjebehandling af fremskreden ventrikelkræft i kombination med et platinbaseret regime (se pkt.
English: According to immunohistochemical studies, ThyPase appears to be in large part localised in tumour stromal cells.
Danish: I henhold til immunohistokemiske studier synes ThyPase hovedsagelig lokaliseret i stromale tumorceller.
English: In addition, during a 13-week study, atrophic and degenerative changes occurred in reproductive organs of male mice; however these effects were reversible after a drug-free period (see section 4.6).
Danish: Desuden indtraf der i en 13 ugers undersøgelse atrofiske og degenerative forandringer i reproduktionsorganerne hos hanmus; forandringerne var dog reversible efter en stoffri periode (se pkt.
English: Capecitabine should be permanently discontinued in patients who experience a severe skin reaction during treatment.
Danish: Capecitabin skal seponeres permanent hos patienter, der oplever en alvorlig hudreaktion under behandlingen.
English: • unusual bleeding from the vagina
Danish: • usædvanlig blødning fra skeden
English: • problems with liver function (seen in blood tests) and increased blood bilirubin (excreted by the liver)
Danish: • problemer med leverfunktionen (målt i blodprøver) og øget blodbilirubin (udskilt i leveren)
English: Gender, presence or absence of liver metastasis at baseline, Karnofsky Performance Status, total bilirubin, serum albumin, aspartate-aminotransferase (ASAT) and alanine-aminotransferase (ALAT) had no statistically significant effect on the pharmacokinetics of 5'-DFUR, 5-FU and FBAL.
Danish: Køn, tilstedeværelse eller fravær af levermetastaser ved baseline, Karnofsky Performance Status, total bilirubin, serum-albumin, aspartataminotransferase (ASAT) og alaninaminotransferase (ALAT) havde ingen statistisk signifikant effekt på farmakokinetikken af 5'-DFUR, 5-FU og FBAL.
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: HFS also known as hand-foot skin reaction or palmar-plantar erythrodysesthesia or chemotherapy induced acral erythema.
Danish: HFS også kendt som hand-foot-hudreaktion, palmo-plantar erytrodysæstesi eller kemoterapiinduceret akralt erytem.
English: Care should be exercised when capecitabine is co-administered with 2C9 substrates (e.g. phenytoin).
Danish: Der bør udvises forsigtighed, når capecitabin administreres samtidig med 2C9substrater (fx phenytoin).
English: Body surface area (m²)
Danish: Legemsoverfladeareal (m²)
English: Overall response rate was 49 % in the XELIRI and 48 % in the FOLFIRI arm (p = 0.76).
Danish: Samlet responsrate var 49 % i XELIRI-armen og 48 % i FOLFIRI-armen (p = 0,76).
English: Cutaneous lupus erythematosus (rare), Severe skin reactions such as
Danish: Kutan lupus erythematosus (sjælden), Alvorlige hudreaktioner såsom
English: • radiotherapy and certain medicines used to treat cancer (folinic acid, oxaliplatin, bevacizumab,
Danish: • strålebehandling og visse lægemidler mod kræft (folinsyre, oxaliplatin, bevacizumab, cisplatin,
English: • difficulty speaking, impaired memory, loss of movement coordination, balance disorder,
Danish: • talebesvær, nedsat hukommelse, nedsat evne til at koordinere bevægelser, balanceforstyrrelser,
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 1,900 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: There is no data on capecitabine and impact on fertility.
Danish: Der er ingen data om capecitabin og påvirkning af fertilitet.
English: If grade 2 (or higher) dehydration occurs, capecitabine treatment should be immediately interrupted and the dehydration corrected.
Danish: Ved dehydrering af grad 2 (eller højere) bør behandlingen med capecitabin straks seponeres, og dehydreringen korrigeres.
English: There is some evidence that dexpanthenol is effective for HFS prophylaxis in patients treated with capecitabine.
Danish: Der er nogen evidens for, at dexpanthenol er virksomt som profylakse mod HFS hos patienter, der behandles med capecitabin.
English: Stevens-Johnson Syndrome and toxic Epidermal Necrolysis (very rare) (see section 4.4)
Danish: Stevens-Johnsons syndrom og toksisk epidermal nekrolyse (meget sjælden) (se pkt.
English: • In patients with severe renal impairment (creatinine clearance below 30 ml/min),
Danish: • Patienter med svær nyreinsufficiens (creatininclearance under 30 ml/min),
English: Very common All grades
Danish: Meget almindelig Alle grader
English: • certain types of arrhythmia (including ventricular fibrillation, torsade de pointes, and bradycardia)
Danish: • visse typer af hjerterytmeforstyrrelser (herunder såkaldt ventrikulær fibrillation, torsade de pointes og bradykardi)
English: Abdominal discomfort
Danish: Abdominal ubehag
English: See also interaction with coumarin-derivative anticoagulants below, and section 4.4.
Danish: Se også interaktion med antikoagulerende midler af coumarintypen nedenfor samt under pkt.
English: 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.
Danish: 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.
English: For patients with partial DPD deficiency (such as those with heterozygous mutations in the DPYD gene) and where the benefits of capecitabine are considered to outweigh the risks (taking into account the suitability of an alternative non-fluoropyrimidine chemotherapeutic regimen), these patients must be treated with extreme caution and frequent monitoring with dose adjustment according to toxicity.
Danish: For patienter med delvis DPD-mangel (fx med heterozygote mutationer i DPYD-genet), og hvor fordelene af capecitabin anses for at opveje risikoen (under hensyntagen til egnetheden af et alternativt ikke-fluorpyrimidin kemoterapeutisk regime), gælder, at de skal behandles med yderste forsigtighed og hyppig monitorering med dosisjustering i henhold til toksicitet.
English: UNIQUE IDENTIFIER - 2D BARCODE 2D barcode carrying the unique identifier included.
Danish: ENTYDIG IDENTIFIKATOR - 2D-STREGKODE <Der er anført en 2D-stregkode, som indeholder en entydig identifikator.>
English: 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).
Danish: 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).
English: Interferon alpha
Danish: Interferon-alfa
English: Capecitabine was devoid of hepatic and CNS toxicities.
Danish: Capecitabin var fri for hepatisk og CNS-toksicitet.
English: • Stevens-Johnson syndrome: if you experience painful red or purplish rash that spreads and blisters and/or other lesions begin to appear in the mucous membrane (e.g. mouth and lips), in particular if you had before light sensitivity, infections of the respiratory system (e.g. bronchitis) and/or fever.
Danish: • Stevens-Johnsons syndrom: hvis du oplever smertefuldt rødt eller lilla udslæt, der spreder sig og danner blistre og/eller andre læsioner, der opstår i slimhinderne (fx mund eller læber), især hvis du tidligere har været følsom over for lys, haft infektioner i luftvejene (fx bronkitis) og/eller feber.
English: The safety profiles of capecitabine monotherapy for the metastatic breast cancer, metastatic colorectal cancer and adjuvant colon cancer populations are comparable.
Danish: Sikkerhedsprofilen for capecitabin-monoterapi i populationerne med metastatisk brystkræft, metastatisk kolorektalkræft og adjuverende kolonkræft er sammenlignelig.
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: If no toxicity is observed in patients ≥ 60 years of age treated with a reduced capecitabine starting dose in combination with docetaxel, the dose of capecitabine may be cautiously escalated to 1,250 mg/m² twice daily.
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: 28 film-coated tablets 30 film-coated tablets 56 film-coated tablets 60 film-coated tablets 84 film-coated tablets 112 film-coated tablets 120 film-coated tablets
Danish: 28 filmovertrukne tabletter 30 filmovertrukne tabletter 56 filmovertrukne tabletter 60 filmovertrukne tabletter 84 filmovertrukne tabletter 112 filmovertrukne tabletter 120 filmovertrukne tabletter
English: Each pack contains 28, 30, 56, 60, 84, 112, or 120 film-coated tablets.
Danish: Hver pakning indeholder 28, 30, 56, 60, 84, 112 eller 120 filmovertrukne tabletter.
English: Cardiovascular toxicity (e.g. PR- and QT-interval prolongation) was detectable in cynomolgus monkeys after intravenous administration (100 mg/kg) but not after repeated oral dosing (1,379 mg/m²/day).
Danish: Der blev set kardiovaskulær toksicitet (f.eks. forlængelse af PR- og QT-intervallet) hos cynomolgusaber efter intravenøs administration (100 mg/kg), men ikke efter gentagen oral dosering (1.379 mg/m²/dag).
English: 5-Fluorouracil 400 mg/m² intravenous bolus, followed by
Danish: 5-fluorouracil 400 mg/m² intravenøs bolus, efterfulgt af
English: • if you have severely low levels of white cells or platelets in the blood (leukopenia, neutropenia or thrombocytopenia),
Danish: • hvis du har et stærkt nedsat antal hvide blodceller eller blodplader (leucopeni, neutropeni eller trombocytopeni)
English: See also section “Do not take Capecitabine medac”.
Danish: Se også afsnittet 'Tag ikke Capecitabine medac'.
English: DPD deficiency
Danish: DPD-mangel
English: • for the treatment of metastatic colorectal cancer (see section 5.1).
Danish: • til behandling af metastatisk kolorektalkræft (se pkt.
English: ThyPase activity was measured and found to be 4 times greater in primary colorectal tumour than in adjacent normal tissue.
Danish: ThyPaseaktiviteten var 4 gange større i primært kolorektalt tumorvæv end i det tilstødende normale væv.
English: • The active substance is capecitabine.
Danish: • Aktivt stof: capecitabin.
English: There is evidence that the metabolism of 5-FU in the anabolic pathway blocks the methylation reaction of deoxyuridylic acid to thymidylic acid, thereby interfering with the synthesis of deoxyribonucleic acid (DNA).
Danish: Der er holdepunkter, for at metabolismen af 5-FU i den anabolske pathway blokerer metyleringen af desoxyuridylsyre til thymidylssyre og derved interfererer med desoxyribonukleinsyresyntesen (DNA).
English: Film-coated tablets
Danish: filmovertrukne tabletter
English: • if you have a severe skin reaction.
Danish: • hvis du har en alvorlig hudreaktion
English: Median overall survival time was 703 days (95 % CI: 671; 745) in patients treated with capecitabine-containing regimens and 683 days (95 % CI: 646; 715) in patients treated with 5-FU-containing regimens.
Danish: Den mediane samlede overlevelse var 703 dage (95 % konfidensinterval: 671, 745) hos patienter, som blev behandlet med regimer, der indeholdt capecitabin, og 683 dage (95 % konfidensinterval: 646, 715) hos patienter, som blev behandlet med regimer, der indeholdt 5-FU.
English: • severe skin reaction such as skin rash, ulceration and blistering which may involve ulcers of the mouth, nose, genitalia, hands, feet and eyes (red and swollen eyes)
Danish: • svære hudreaktioner såsom hududslæt, sårdannelse og blæredannelse, som kan give sår i munden, næsen, kønsorganer, hænder, fødder og øjne (røde og opsvulmede øjne)
English: If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.You must not take Capecitabine medac if you are pregnant or think you might be.
Danish: Hvis du er gravid eller ammer, har mistanke om, at du er gravid, eller planlægger at blive gravid, skal du spørge din læge eller apoteketpersonalet til råds, før du tager dette lægemiddel.
English: The parameters of capecitabine, 5'-DFCR and 5'-DFUR measured on days 1 and 14 were similar.
Danish: Parametrene for capecitabin, 5'-DFCR og 5'-DFUR var ens på dag 1 og 14.
English: At the beginning of a treatment cycle, if a treatment delay is indicated for either capecitabine or the other medicinal product(s), then administration of all therapy should be delayed until the requirements for restarting all medicinal products are met.
Danish: Hvis det ved starten af en behandlingsserie er indiceret at udsætte enten behandlingen med capecitabine eller det andet lægemiddel/de andre lægemidler, skal behandlingen med alle lægemidler udsættes, indtil betingelserne for genoptagelse af behandling med alle lægemidler er opfyldt.
English: • decrease in blood sodium, magnesium or calcium, increase in blood sugar
Danish: • fald i indholdet af natrium, magnesium eller kalcium i blodet, øget mængde blodsukker
English: If grade 2 or 3 HFS 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 HFS, skal behandlingen med capecitabin afbrydes, indtil symptomerne forsvinder eller er aftaget i intensitet til grad 1.
English: Pack sizes: 28, 30, 56, 60, 84, 112 or 120 film-coated tablets.
Danish: Pakningsstørrelser: 28, 30, 56, 60, 84, 112 eller 120 filmovertrukne tabletter.
English: • if you are allergic to capecitabine or any of the other ingredients of this medicine (listed in section 6).
Danish: • hvis du er allergisk over for capecitabin eller et af de øvrige indholdsstoffer i Capecitabine medac (angivet i punkt 6).
English: • if you know that you do not have any activity of the enzyme dihydropyrimidine dehydrogenase (DPD),
Danish: • hvis du ved, at du ikke har nogen aktivitet af enzymet dihydropyrimidin dehydrogenase (DHP)
English: Deep vein thrombosis, Hypertension, Petechiae,
Danish: Dyb venethrombose, Hypertension, Petekkier,
English: In repeat-dose toxicity studies, daily oral administration of capecitabine to cynomolgus monkeys and mice produced toxic effects on the gastrointestinal, lymphoid and haemopoietic systems, typical for fluoropyrimidines.
Danish: I toksicitetsforsøg med gentagne doser førte daglig oral administration af capecitabin hos cynomolgusaber og mus til toksiske virkninger, typiske for fluorpyrimidiner, på det gastrointestinale, det lymfoide og det hæmatopoietiske system.
English: Your doctor may want you to take a combination of 150 mg, 300 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-, 300 mg- og 500 mg-tabletter.
English: Phase I studies evaluating the effect of capecitabine on the pharmacokinetics of either docetaxel or paclitaxel and vice versa showed no effect by capecitabine on the pharmacokinetics of docetaxel or paclitaxel (Cmax and AUC) and no effect by docetaxel or paclitaxel on the pharmacokinetics of 5'-DFUR.
Danish: Fase I-studier, som evaluerede capecitabins effekt på enten docetaxels eller paclitaxels farmakokinetik og vice versa, viste ingen effekt af capecitabin på hverken docetaxels eller paclitaxels farmakokinetik (Cmax og AUC) og ingen effekt af docetaxel eller paclitaxel på 5'-DFUR's farmakokinetik.
English: Talk to your doctor or pharmacist before taking Capecitabine medac
Danish: Kontakt lægen eller apotekspersonalet, før du tager Capecitabine medac
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: DPD deficiency is a rare condition present at birth that is not usually associated with health problems unless you receive certain medicines.
Danish: Det ses sjældent og er almindeligvis ikke forbundet med helbredsproblemer, med mindre man får bestemte lægemidler.
English: Pharmacare Premium Ltd HHF 003, Hal Far Industrial Estate Birzebbugia BBG 3000, Malta
Danish: Pharmacare Premium Limited HHF 003, Hal Far Industrial Estate Birzebbugia BBG 3000, Malta
English: Posology adjustments for special populations
Danish: Dosisjusteringer for særlige populationer
English: • pain in the joints or in the limbs (extremities), chest or back
Danish: • smerter i led eller lemmer (ekstremiteter), bryst eller ryg