natgillin/translations-raw huggingface dataset:
Capecitabine Teva tilhører en gruppe lægemidler som kaldes “cytostatika”, som standser væksten af kræftceller. 
Capecitabine Teva belongs to the group of medicines called "cytostatic medicines", which stop the growth of cancer cells.
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. 
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.
Hos aber blev der set abort og embryoletalitet efter høje doser, men der var ikke tegn på teratogenicitet. 
In monkeys, abortion and embryolethality were observed at high doses, but there was no evidence of teratogenicity.
Se også afsnittet 'Tag ikke Capecitabine Teva. 
See also section “Do not take Capecitabine Teva”.
• infektion af blodet, urinvejsinfektion, infektion i huden, infektioner i næsen og halsen, 
• blood infection, urinary tract infection, infection of the skin, infections in the nose and throat,
AUC0-∞ værdierne (μg•time/ml var 7,75; 7,24; 24,6; 2,03 og 36,3. 
The AUC0-∞ values in μg•h/ml were 7.75, 7.24, 24.6, 2.03 and 36.3.
Capecitabine Teva-dosis er baseret på arealet af din legemsoverflade. 
The dose of Capecitabine Teva is based on your body surface area.
• talebesvær, hukommelsessvigt, tab af bevægelseskoordination, balanceproblemer, besvimelse, 
• difficulty speaking, impaired memory, loss of movement coordination, balance disorder,
Øget kropstemperatur ** Baseret på erfaringer efter markedsføring kan vedvarende eller svært palmar-plantar erytrodysæstesi syndrom i sidste ende forårsage, at fingeraftrykket forsvinder (se pkt. 
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)
Da data for sikkerhed og virkning er baseret på administration sammen med maden anbefales det at tage capecitabin sammen med et måltid. 
Since current safety and efficacy data are based upon administration with food, it is recommended that capecitabine be administered with food.
Der er set interaktion mellem allopurinol og 5-FU, med mulig nedsat effekt af 5-FU. 
Interactions with allopurinol have been observed for 5-FU; with possible decreased efficacy of 5-FU.
Det kan være din læge vil have at du for hver dosis skal tage en kombination af 150 mg og 500 mg tabletter. 
Your doctor may want you to take a combination of 150 mg and 500 mg tablets for each dose.
- 1. linjebehandling af fremskreden ventrikelkræft i kombination med et platinbaseret regime (se pkt. 
- first-line treatment of advanced gastric cancer in combination with a platinum-based regimen (see section 5.1).
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”). 
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).
• infektioner i lungen eller åndedrætssystemet (f.eks. lungebetændelse eller bronkitis), 
• infections of the lungs or respiratory system (e.g. pneumonia or bronchitis)
Der er ingen data om capecitabin og dets virkning på fertiliteten. 
There is no data on capecitabine and impact on fertility.
capecitabin var fri for hepatisk og CNS toksicitet. 
Capecitabine was devoid of hepatic and CNS toxicities.
Du må ikke tage den glemte dosis. 
Do not take the missed dose at all.
Giv ikke Capecitabine Teva til børn eller unge. 
Do not give capecitabine to children and adolescents.
Yderligere oplysninger om dette lægemiddel findes på Det Europæiske Lægemiddelagenturs hjemmeside http://www.ema.europa.eu. 
Detailed information on this medicinal product is available on the website of the European Medicines Agency: http://www.ema.europa.eu/.
• visse typer arytmier (herunder ventrikelflimren, torsade de pointes og bradykardi) 
• certain types of arrhythmia (including ventricular fibrillation, torsade de pointes, and bradycardia)
Capecitabin påvirker i mindre eller moderat grad evnen til at føre motorkøretøj og betjene maskiner. 
Capecitabine has minor or moderate influence on the ability to drive and use machines.
Antal 150 mg tabletter og/eller 500 mg tabletter pr. dosering (hver dosering skal gives morgen og aften) 
Number of 150 mg tablets and/or 500 mg tablets per administration (each administration to be given morning and evening)
Tabletterne fås i blisterpakninger med 10 filmovertrukne tabletter. 
The tablets are available in blisters containing 10 film-coated tablets.
Data for virkning er baseret på en gennemsnitlig observationstid på 59 måneder for samlet overlevelse og 57 måneder for sygdomsfri overlevelse. 
The efficacy data is based on a median observation time of 59 months for OS and 57 months for DFS.
Pyreksi, svaghed, +letargi, temperaturintolerance 
Pyrexia, Weakness, +Lethargy, Temperature intolerance
(≥ 1/10), almindelig (≥ 1/100, < 1/10), ikke almindelig (≥ 1/1.000, < 1/100), sjælden (≥ 1/10.000 til 
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).
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. 
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.
Capecitabine Teva skal seponeres permanent hos patienter, der oplever en alvorlig hudreaktion under behandlingen. 
Capecitabine Teva should be permanently discontinued in patients who experience a severe skin reaction during treatment.
• smerter eller forandret/unormal fornemmelse i munden, smerter i kæben 
• pain or altered/abnormal sensation in the mouth, pain in the jaw
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.
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. 
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.
• smerter i led eller i lemmerne (ekstremiteterne), bryst eller ryg 
• pain in the joints, or in the limbs (extremities), chest or back
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. 
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.
Administration Capecitabine Teva filmovertrukne tabletter skal synkes med vand senest 30 minutter efter et måltid. 
Method of administration Capecitabine Teva film-coated tablets should be swallowed with water within 30 minutes after a meal.
som udskilles i urinen. 
(FBAL) which is cleared in the urine.
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. 
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.
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 diarrhoea: increasing cumulative capecitabine dose (0.1*kg) and increasing relative dose intensity in the first six weeks.
• problemer med leveren (ses i blodprøver) og forhøjet bilirubin i blodet (udskilles i leveren) 
• problems with liver function (seen in blood tests) and increased blood bilirubin (excreted by the liver)
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). 
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).
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. 
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.
• Patienter med svær leukopeni, neutropeni eller trombocytopeni, 
• In patients with severe leukopenia, neutropenia, or thrombocytopenia,
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. 
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.
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. 
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.
CYP2C9-substrater 
Cytochrome P-450 2C9 substrates
• hikke, forandret stemme 
• hiccups, change in voice
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. 
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.
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). 
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).
Capecitabine Teva indeholder capecitabin, som i sig selv ikke virker cytostatisk. 
Capecitabine Teva contains capecitabine, which itself is not a cytostatic medicine.
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). 
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).
Der er rapporteret om ændrede koagulationsparametre og/eller ændret blødning hos patienter, som tog capecitabin sammen med antikoagulantia af coumarintypen såsom warfarin og phenprocoumon. 
Altered coagulation parameters and/or bleeding have been reported in patients taking capecitabine concomitantly with coumarin-derivative anticoagulants such as warfarin and phenprocoumon.
• fald i natrium, magnesium eller kalcium i blodet, forhøjet blodsukker 
• decrease in blood sodium, magnesium or calcium, increase in blood sugar
Capecitabine Teva kan inducere alvorlige hudreaktioner såsom Stevens-Johnsons syndrom og toksisk epidermal nekrolyse. 
Capecitabine Teva can induce severe skin reactions such as Stevens-Johnson syndrome and Toxic Epidermal Necrolysis.
I henhold til immunohistokemiske studier synes thymidinfosforylase hovedsageligt lokaliseret i stromale tumorceller 
According to immunohistochemical studies, thymidine phosphorylase appears to be in large part localised in tumour stromal cells.
• Graviditet og amning, 
• During pregnancy and lactation,
Der er ingen bivirkninger forbundet med at stoppe behandlingen med Capecitabine Teva. 
There are no side effects caused by stopping treatment with capecitabine.
Capecitabin er kontraindiceret til patienter med svær nyreinsufficiens (creatininclearance under 30 ml/min ved baseline) [Cockcroft og Gault]. 
Capecitabine is contraindicated in patients with severe renal impairment (creatinine clearance below 30 ml/min [Cockcroft and Gault] at baseline).
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.
Et studie om kombination af capecitabin og folinsyre tyder på, at folinsyre ikke har væsentlig effekt på farmakokinetikken af capecitabin og dets metabolitter. 
A combination study with capecitabine and folinic acid indicated that folinic acid has no major effect on the pharmacokinetics of capecitabine and its metabolites.
Oftalmologiske komplikationer 
Ophthalmologic complications
Doseringsjusteringer for særlige populationer 
Posology adjustments for special populations
Der er ikke gennemført formelle interaktionsstudier med capecitabin og andre CYP2C9-substrater bortset fra warfarin. 
Other than warfarin, no formal interaction studies between capecitabine and other CYP2C9 substrates have been conducted.
Hvis du har taget brivudin, skal du vente mindst 4 uger efter endt behandling med brivudin før du må starte behandling med capecitabin. 
If you have taken brivudine you must wait for at least 4 weeks after stoping brivudine before starting to take capecitabine.
Traumer, forgiftninger og behandlingskomplikatio ner 
Injury, poisoning and procedural complications
Ved 2. forekomst 
-2nd appearance
Capecitabine Teva 500 mg filmovertrukne tabletter EU/1/12/761/002 
Capecitabine Teva 500 mg film-coated tablets EU/1/12/761/002
• Patienter med svær nyreinsufficiens (creatininclearance under 30 mg/min) 
• In patients with severe renal impairment (creatinine clearance below 30 ml/min),
- 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. 
- 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).
Bevacizumab havde ingen klinisk signifikant virkning på capecitabins farmakokinetiske parametre eller dets metabolitter under tilstedeværelse af oxaliplatin. 
There was no clinically significant effect of bevacizumab on the pharmacokinetic parameters of capecitabine or its metabolites in the presence of oxaliplatin.
Behandlingsrelaterede bivirkninger af sværhedsgrad 3 eller 4 var dog hyppigere hos patienter ≥ 60 år sammenlignet med yngre patienter. 
treatment-related adverse reactions were more frequent in patients ≥60 years of age compared to younger patients.
Capecitabins farmakokinetik er undersøgt i dosisintervallet 502-3.514 mg/m2/dag. 
The pharmacokinetics of capecitabine have been evaluated over a dose range of 502-3514 mg/m2/day.
Opbevares i den originale pakning som beskyttelse mod fugt. 
Store in the original package to protect from moisture.
Ventrikelflimmer (sjælden), QT-forlængelse (sjælden), Torsades de pointes (sjælden), Bradykardi (sjælden), Karspasme (sjælden) 
Ventricular fibrillation (rare), QT prolongation (rare), Torsade de pointes (rare), Bradycardia (rare), Vasospasm (rare)
Det er ikke relevant at anvende capecitabine hos den pædiatriske population til indikationerne kolon-, kolorektal, tarm- og brystcancer. 
There is no relevant use of capecitabine in the paediatric population in the indications colon, colorectal, gastric and breast cancer.
TEVA GmbH Tel: +49 73140208 
Deutschland TEVA GmbH Tel: +49 73140208
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 
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)
• uregelmæssig hjerterytme og hjertebanken (arytmier), smerter i brystet og hjerteanfald (infarkt) 
• irregular heartbeat and palpitations (arrhythmias), chest pain and heart attack (infarction)
Tabletovertrækket Macrogol (400) Hypromellose Titaniumdioxide(E171) Gul jernoxid (E172) Rød jernoxid (E172) 
Tablet coating Macrogol (400) Hypromellose Titanium dioxide (E171) Yellow iron oxide (E172) Red iron oxide (E172)
• fald i antallet af hvide eller røde blodlegemer (ses i blodprøver) 
• decreases in the number of white blood cells or red blood cells (seen in tests),
Man har undersøgt virkningen af et antacidum indeholdende aluminiumhydroxid og magnesiumhydroxid på capecitabins farmakokinetik. 
The effect of an aluminium hydroxide and magnesium hydroxide-containing antacid on the pharmacokinetics of capecitabine was investigated.
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. 
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.
Tid indtil progressiv sygdom var længere i kombinationsarmen med capecitabin + docetaxel (p< 0,0001). 
Time to progressive disease was superior in the capecitabine + docetaxel combination arm (p<0.0001).
Da den potentielt skadelige virkning for det ammende spædbarn er ukendt, skal amning afbrydes under behandling med capecitabin og i 2 uger efter sidste dosis. 
As the potential for harm to the nursing infant is unknown, breast-feeding should be discontinued while receiving treatment with capecitabine and for 2 weeks after the final dose.
Tabel 9 Nøgleresultater for virkning fra non-inferioritetsanalyserne af studie NO16967 
Table 9 Key efficacy results for the non-inferiority analysis of Study NO16967 PRIMARY ANALYSIS
• Patienter med svær leverinsufficiens, 
• In patients with severe hepatic impairment,
Hånd- og fodsyndrom også kendt som hånd- og fodhudreaktion, palmo-plantar erythrodysæstesi eller kemoterapiinduceret acralt erytem). 
Hand and foot syndrome also known as hand-foot skin reaction or palmar-plantar erythrodysesthesia or chemotherapy induced acral erythema.
Hvis du har taget for mange Capecitabine Teva-tabletter skal du kontakte lægen så hurtigt som muligt, før du tager næste dosis. 
If you take more Capecitabine Teva than you should If you take more Capecitabine Teva than you should, contact your doctor as soon as possible before taking the next dose.
5 mg/kg intravenøs 30-90 min 
5 mg/kg intravenous 30-90 mins
I alle studierne kombineret var følgende kovarianter statistisk signifikant associeret med en øget risiko for udviklingen af hånd- og fodsyndrom: stigende capecitabin-startdosis (gram), faldende kumulativ capecitabin-dosis (0,1*kg), stigende relativ dosisintensitet i de første seks uger, længere behandlingsvarighed (uger), stigende alder (ved 10-års forøgelse), kvindeligt køn og med en god ECOG performancestatus ved baseline (0 versus ≥1). 
In all studies combined, the following covariates were statistically significantly associated with an increased risk of developing HFS: increasing capecitabine starting dose (gram), decreasing cumulative capecitabine dose (0.1*kg), increasing relative dose intensity in the first six weeks, increasing duration of study treatment (weeks), increasing age (by 10 year increments), female gender, and good ECOG performance status at baseline (0 versus ≥1).
De totale objektive responsrater i den totale randomiserede population (investigators vurdering) var 41,6 % (capecitabin + docetaxel) vs. 29,7 % (docetaxel alene); p=0,0058. 
The overall objective response rates in the all-randomised population (investigator assessment) were 41.6% (capecitabine + docetaxel) vs. 29.7% (docetaxel alone); p = 0.0058.
Der er nogen evidens for, at dexpanthenol er virksomt som profylakse mod hånd- og fodsyndrom hos patienter, der behandles med capecitabin. 
There is some evidence that dexpanthenol is effective for hand-foot syndrome prophylaxis in patients treated with Capecitabine.
(ekstremiteter), lilla pletter på huden 
purple spots on the skin
Capecitabine Teva må kun ordineres af en kvalificeret læge med erfaring i brug af antineoplastiske lægemidler. 
Capecitabine Teva should only be prescribed by a qualified physician experienced in the utilisation of anti-neoplastic medicinal products.
7.5 mg/kg intravenøs 30-90 min 
7.5 mg/kg intravenous 30-90 mins
Kutan lupus erythematosus (sjælden), Alvorlige hudreaktioner såsom StevensJohnsons syndrom og toksisk epidermal nekrolyse (meget sjælden) (se pkt. 
Cutaneous lupus erythematosus (rare), Severe skin reactions such as Stevens-Johnson Syndrome and toxic Epidermal Necrolysis (very rare) (see section 4.4.)
Forholdet mellem koncentrationen af 5-FU i tumor og plasma var 21,4 (spændvidde: 3,9-59,9, n=8), mens forholdet mellem normalt væv og plasma var 8,9 (spændvidde: 3,0-25,8, n=8). 
The ratio of 5-FU concentration in tumour to plasma was 21.4 (ranged from 3.9 to 59.9, n=8) whereas the ratio in healthy tissues to plasma was 8.9 (ranged from 3.0 to 25.8, n=8).
• betændelse i venerne (thromboflebitis) 
• inflammation of the veins (thrombophlebitis)
forhøjet kreatinin i blodet (tegn på dårligt fungerende nyre) 
blood in the urine, increase in blood creatinine (sign of kidney dysfunction)
• blodpropper i de dybe vener, højt eller lavt blodtryk, hedestigninger, kolde lemmer 
• blood clots in the deep veins, high or low blood pressure, hot flushes, cold limbs (extremities),