natgillin/translations-raw huggingface dataset:
Tecfidera skal tages sammen med mad (se pkt. 
Tecfidera should be taken with food (see section 5.2).
Antal patienter Årlig attakrate Rate-ratio (95% CI) Andel med attakker Risiko-ratio (95% CI) Andel med 12-ugers bekræftet handikapprogression Risiko-ratio (95% CI) Andel med 24-ugers bekræftet invaliditetsprogression Risiko-ratio (95% CI) 
Hazard ratio (95% CI) Proportion with 24 week confirmed disability progression Hazard ratio (95% CI)
Alvorlige bivirkninger 
Serious effects
Tecfidera er ikke blevet undersøgt hos patienter med alvorlig, aktiv gastrointestinal sygdom, og der skal derfor udvises forsigtighed hos disse patienter. 
Tecfidera has not been studied in patients with severe active gastrointestinal disease and caution should, therefore, be used in these patients.
De hyppigst rapporterede bivirkninger, som førte til seponering (> 1%) hos patienter behandlet med Tecfidera, var rødme (3%) og gastrointestinale lidelser (4%). 
The most commonly reported adverse reactions leading to discontinuation (incidence >1%) in patients treated with Tecfidera were flushing (3%) and gastrointestinal events (4%).
Såfremt der foretages en JCV-test, skal man være opmærksom på, at det ikke er blevet undersøgt, om lymfopeni har indflydelse på nøjagtigheden af en JCVantistoftest hos patienter behandlet med dimethylfumarat. 
If JCV testing is undertaken, it should be considered that the influence of lymphopenia on the accuracy of anti-JCV antibody test has not been studied in dimethyl fumarate treated patients.
Symptomerne på PML kan ligne et MS-attak. 
The symptoms of PML may be similar to an MS relapse.
Hvis behandling fortsættes hos patienter med moderat til svær, langvarig lymfopeni, kan risikoen for en opportunistisk infektion, herunder PML, ikke udelukkes (se pkt. 
If therapy is continued in the presence of moderate to severe prolonged lymphopenia, the risk of an opportunistic infection, including PML, cannot be ruled out (see section 4.4 subsection PML).
Tecfidera påvirker ikke eller kun i ubetydelig grad evnen til at føre motorkøretøj og betjene maskiner. 
Tecfidera has no or negligible influence on the ability to drive and use machines.
Behandlingen med Tecfidera skal startes gradvist for at reducere forekomsten af rødme og gastrointestinale bivirkninger (se pkt. 
Tecfidera treatment should be started gradually to reduce the occurrence of flushing and gastrointestinal adverse reactions (see section 4.2).
Tecfidera anvendes til behandling af attakvis remitterende multipel sklerose (MS) hos voksne patienter. 
What Tecfidera is used for Tecfidera is used to treat relapsing-remitting multiple sclerosis (MS) in adult patients.
Pakningsstørrelser og yderligere oplysninger Tecfidera indeholder: 
Contents of the pack and other information What Tecfidera contains
Dimethylfumarateksponeringen stiger tilnærmelsesvist proportionalt med dosis (enkeltdoser og flere doser) i det undersøgte dosisinterval mellem 120 mg til 360 mg. 
Dimethyl fumarate exposure increases in an approximately dose proportional manner with single and multiple doses in the 120 mg to 360 mg dose range studied.
Den forreste del af maven hos mus og rotter findes ikke tilsvarende hos mennesker. 
The forestomach of mice and rats does not have a human counterpart.
Tecfidera bør ikke anvendes under graviditeten og til kvinder i den fertile alder, som ikke anvender sikker kontraception (se pkt. 
Tecfidera is not recommended during pregnancy and in women of childbearing potential not using appropriate contraception (see section 4.5).
Efter behandling med Tecfidera faldt de gennemsnitlige lymfocyttal i løbet af det første år, hvorefter de nåede et plateau. 
Upon treatment with Tecfidera, mean lymphocyte counts decreased over the first year with a subsequent plateau.
Der er indberettet herpes zoster-infektioner ved brug af Tecfidera. 
Herpes zoster infections have been reported with Tecfidera use.
Tecfidera bør dog tages sammen med mad, da det giver en bedre tolerance i forhold til rødme og gastrointestinale bivirkninger (se pkt. 
However, Tecfidera should be taken with food due to improved tolerability with respect to flushing or gastrointestinal adverse events (see section 4.2).
Overvej at pausere Tecfidera-behandlingen hos patienter med alvorlige infektioner, indtil infektionen er overstået (se pkt. 
Consider withholding Tecfidera treatment in patients with serious infections until the infection has resolved (see section 4.8).
Evidens fra studier med raske frivillige tyder på, at rødme relateret til Tecfidera sandsynligvis er medieret via prostaglandin. 
Evidence from healthy volunteer studies suggests that Tecfidera-associated flushing is likely to be prostaglandin mediated.
Hyppigheden af planocellulært papillom og karcinom i den ikke-glandulære mave (den forreste del af maven) steg hos mus ved en eksponering, der svarede til den anbefalede humane dosis, og hos rotter ved en eksponering, der svarede til under den anbefalede humane dosis (baseret på AUC). 
The incidence of squamous cell papilloma and carcinoma in the nonglandular stomach (forestomach) was increased at equivalent exposure to the recommended human dose in mice and below exposure to the recommended human dose in rats (based on AUC).
Dimethylfumarat og monomethylfumarat var negative i primærcellen i in vitro-analyser (Ames, kromosomafvigelse i pattedyrceller). 
Dimethyl fumarate and mono-methylfumarate were negative in a battery of in vitro assays (Ames, chromosomal aberration in mammalian cells).
Analfylaktiske reaktioner 
Anaphylactic reactions
Brug af anden medicin sammen med Tecfidera 
Other medicines and Tecfidera
Hos musene var hyppigheden af renalt tubulært karcinom øget ved 75 mg/kg/dag, svarende til eksponeringen (AUC) ved den anbefalede humane dosis. 
In mice, the incidence of renal tubular carcinoma was increased at 75 mg/kg/day, at equivalent exposure (AUC) to the recommended human dose.
Der er observeret PML med dimethylfumarat og andre lægemidler, der indeholder fumarater, hos patienter med moderat til svær, langvarig lymfopeni. 
PML cases have occurred with dimethyl fumarate and other medicinal products containing fumarates in the setting of moderate to severe prolonged lymphopenia.
Benefit/risk for patienter med lymfocyttal ≥ 0,5x109/l og < 0,8x109/l i mere end 6 måneder skal vurderes. 
The benefit/risk in patients with lymphocyte counts ≥0.5 x 109/L and <0.8 x 109/L for more than six months should be assessed.
Der er set ændringer i laboratorieværdier på nyreparametre i kliniske forsøg hos patienter behandlet med dimethylfumarat (se pkt. 
Changes in renal laboratory tests have been seen in clinical trials in subjects treated with dimethyl fumarate (see section 4.8).
Aktivt stof: dimethylfumarat. 
The active substance is dimethyl fumarate.
Virkningen af Tecfidera på din evne til at føre motorkøretøjer og betjene maskiner er ikke kendt. 
The effect of Tecfidera on the ability to drive or use machines is not known.
Patienter behandlet med Tecfidera kan udvikle svær, langvarig lymfopeni (se pkt. 
Patients treated with Tecfidera may develop severe prolonged lymphopenia (see section 4.8).
Seponering på grund af forhøjede leveraminotransferaser var < 1% og sammenlignelig hos patienter behandlet med Tecfidera og placebo. 
Discontinuations due to elevated hepatic transaminases were <1% and similar in patients treated with Tecfidera or placebo.
Hos hunde, der fik daglige orale doser af dimethylfumarat gennem 11 måneder, blev den beregnede margin for kortikal atrofi observeret ved 3 gange den anbefalede dosis baseret på AUC. 
In dogs that received daily oral doses of dimethyl fumarate for 11 months, the margin calculated for cortical atrophy was observed at 3 times the recommended dose based on AUC.
Det er ukendt, om tidligere immunsuppressiv behandling kan have indflydelse på udviklingen af PML hos patienter behandlet med dimethylfumarat. 
The contribution of prior immunosuppressive therapy to the development of PML in dimethyl fumarate treated patients is unknown.
Hypoksi1 
Hypoxia1
Hos mennesker metaboliseres dimethylfumarat ekstensivt af esteraser, inden det når systemkredsløbet, og der sker en yderligere metabolisering vha. tricarboxylsyrecyklussen uden involvering af CYPsystemet. 
In humans, dimethyl fumarate is extensively metabolised by esterases before it reaches the systemic circulation and further metabolism occurs through the tricarboxylic acid cycle, with no involvement of the cytochrome P450 (CYP) system.
Afbrydelse af behandlingen med Tecfidera bør overvejes hos patienter med lymfocyttal < 0,5x109/l i mere end 6 måneder. 
Interruption of Tecfidera should be considered in patients with lymphocyte counts <0.5x109/L persisting for more than 6 months.
Lymfocyttal < 0,5x109/l blev observeret hos < 1% af de placebobehandlede patienter hos og 6% af de Tecfiderabehandlede patienter. 
Lymphocyte counts <0.5x109/l were observed in <1% of patients treated with placebo and 6% of patients treated with Tecfidera.
Hos hovedparten af de patienter, der oplevede gastrointestinale gener, var de lette til moderate. 
In the majority of patients who experienced gastrointestinal events, it was mild or moderate in severity.
Tecfidera er ikke blevet undersøgt hos patienter med nyre- eller leverinsufficiens. 
Tecfidera has not been studied in patients with renal or hepatic impairment.
 Ring straks til din læge, hvis du får nogle af disse symptomer 
 Call your doctor straight away if you experience any of these symptoms Severe Allergic reactions
- leverbetændelse og forhøjede niveauer af leverenzymer (ALAT eller ASAT i kombination med bilirubin) - herpes zoster (helvedesild) med symptomer såsom blærer, brændende, kløende eller smertende hud, typisk på den ene side af overkroppen eller ansigtet og andre symptomer såsom feber og svaghed i de tidlige stadier af infektionen, efterfulgt af følelsesløshed, kløe elle røde plamager med svære smerter. 
- herpes zoster (shingles) with symptoms such as blisters, burning, itching or pain of the skin, typically on one side of the upper body or the face, and other symptoms, like fever and weakness in the early stages of infection, followed by numbness, itching or red patches with severe pain
Der blev ikke observeret øget forekomst af alvorlige infektioner hos patienter med lymfocyttal < 0,8x109/l eller < 0,5x109/l (se pkt. 
There was no increased incidence of serious infections observed in patients with lymphocyte counts <0.8x109/L or <0.5x109/L (see Section 4.8).
Yderligere metabolisering sker gennem tricarboxylsyrecyklussen uden involvering af CYP-systemet. 
Further metabolism occurs through the tricarboxylic acid cycle, with no involvement of the cytochrome P450 (CYP) system.
Forhøjede leverenzymer og tilfælde med lægemiddelinduceret leverskade (forhøjelser i aminotransferaser ≥ 3 gange ULN med samtidige forhøjelser i totalt bilirubin > 2 gange ULN) er blevet rapporteret efter markedsføring efter administration af TecfideraForhøjelserne ophørte, efter behandlingen blev seponeret. 
Increase of liver enzymes and cases of drug-induced liver injury (elevations in transaminases ≥3 times ULN with concomitant elevations in total bilirubin >2 times ULN), have been reported in post marketing experience following Tecfidera administration, which resolved upon treatment discontinuation.
Data fra studier med raske frivillige tyder på, at rødme relateret til dimethylfumarat sandsynligvis er medieret via prostaglandin. 
Data from healthy volunteer studies suggest that dimethyl fumarate-associated flushing is likely to be prostaglandin mediated.
I placebokontrollerede fase III-studier var forekomsten af infektioner (60% mod 58%) og alvorlige infektioner (2% mod 2%) sammenlignelig hos patienter behandlet med henholdsvis Tecfidera og placebo. 
In phase III placebo-controlled studies, the incidence of infections (60% vs 58%) and serious infections (2% vs 2%) was similar in patients treated with Tecfidera or placebo, respectively.
PML er opstået i forbindelse med moderat til svær, langvarig lymfopeni (se pkt. 
PML has occurred in the setting of moderate to severe prolonged lymphopenia (see section 4.4).
Hos aber, der fik daglige orale doser af dimethylfumarat gennem 12 måneder, blev enkeltcelle-nekrose observeret ved 2 gange den anbefalede dosis baseret på AUC. 
In monkeys that received daily oral doses of dimethyl fumarate for 12 months, single cell necrosis was observed at 2 times the recommended dose based on AUC.
Virkningen (se tabellen nedenfor) og sikkerheden blev demonstreret hos patienter med scorer på den udvidede skala over invaliditetsstatus (Expanded Disability Status Scale - EDSS) på mellem 0 og 5, begge inklusive, som havde oplevet mindst 1 attak i året inden randomiseringen eller inden for 6 uger før randomiseringen fik foretaget en MR-scanning, der viste mindst en gadoliniumforstærket (Gd+) læsion. 
Efficacy (see table below) and safety were demonstrated in subjects with Expanded Disability Status Scale (EDSS) scores ranging from 0 to 5 inclusive, who had experienced at least 1 relapse during the year prior to randomisation, or, in the 6 weeks before randomisation had a brain Magnetic Resonance Imaging (MRI) demonstrating at least one gadolinium-enhancing (Gd+) lesion.
I prækliniske og kliniske studier udviste dimethylfumarat antiinflammatoriske og immunmodulerende egenskaber. 
Effects on the immune system In preclinical and clinical studies, dimethyl fumarate demonstrated anti-inflammatory and immunomodulatory properties.
Hyppigheden af alvorlig rødme, som kan kendetegnes ved generaliseret erytem, udslæt og/eller pruritus, blev set hos under 1% af patienterne behandlet med Tecfidera (se pkt. 
The incidence of serious flushing, which may be characterised by generalised erythema, rash and/or pruritus, was seen in less than 1% of patients treated with Tecfidera (see sections 4.2, 4.4 and 4.5).
Idet dimethylfumarat og monomethylfumarat metaboliseres ved hjælp af esteraser uden involvering af CYP-systemet, blev farmakokinetikken hos individer med leverinsufficiens ikke evalueret. 
As dimethyl fumarate and monomethyl fumarate are metabolised by esterases, without the involvement of the CYP450 system, evaluation of phamacokinetics in individuals with hepatic impairment was not conducted.
Herpes zoster (helvedesild) kan forekomme ved behandling med Tecfidera. 
Herpes zoster (shingles) may occur with Tecfidera treatment.
Disse kan påvirke op til 1 ud af 10 personer: - tarmirritation - opkastning - dårlig fordøjelse - irritation i slimhinden i mave-tarmkanalen (mavekatar) - gener i mave og tarm - brændende fornemmelse - hedeture, varm fornemmelse - hudkløe - udslæt - lyserøde eller røde pletter på huden 
These may affect up to 1 in 10 people: - inflammation of the lining of the intestines (gastroenteritis) - being sick (vomiting) - indigestion (dyspepsia) - inflammation of the lining of the stomach (gastritis) - gastrointestinal disorder - burning sensation - hot flush, feeling hot - itchy skin (pruritus) - rash - pink or red blotches on the skin (erythema)
I et klinisk studie med deltagelse af i alt 71 patienter med relapsing-remitterende multipel sklerose som fik 240 mg Tecfidera to gange dagligt i mindst 6 måneder (n=38) eller ikke-pegyleret interferon i mindst 3 måneder (n=33) sås et sammenligneligt immunrespons (defineret som en ≥ fordobling af titer fra før til efter vaccinationen) over for tetanustoksoid (recall-antigen) og en konjugeret meningokok C polysaccharid-vaccine (neoantigen). 
In a clinical study involving a total of 71 patients with relapsing remitting multiple sclerosis, patients on Tecfidera 240 mg twice daily for at least 6 months (n=38) or non-pegylated interferon for at least 3 months (n=33), mounted a comparable immune response (defined as ≥2-fold increase from pre- to post-vaccination titer) to tetanus toxoid (recall antigen) and a conjugated meningococcal C polysaccharide vaccine (neoantigen), while the immune response to different serotypes of an unconjugated 23-valent pneumococcal polysaccharide vaccine (T-cell independent antigen) varied in both treatment groups.
Lymfopeni af grad 2 og 3 var udbredt hos patienter med samtidig lymfocytopeni. 
Grade 2 and 3 lymphopenia prevailed in subjects with concurrent lymphocytopenia.
Dimethylfumarat var negativ i in vivo-mikronukleusanalysen hos rotter. 
Dimethyl fumarate was negative in the in vivo micronucleus assay in the rat.
- medicin, der påvirker kroppens immunsystem, herunder andre lægemidler, der anvendes til behandling af MS, såsom fingolimod, natalizumab, teriflunomid, alemtuzumab, ocrelizumab eller cladribin, eller nogle hyppigt anvendte lægemidler mod kræft (rituximab eller mitoxantron) 
MS, such as fingolimod, natalizumab, teriflunomide, alemtuzumab, ocrelizumab or cladribine, or some commonly used cancer treatments (rituximab or mitoxantrone).
Der er forekommet tilfælde af herpes zoster med Tecfidera. 
Cases of herpes zoster have occurred with Tecfidera.
Startdosis er 120 mg to gange dagligt. 
The starting dose is 120 mg twice a day.
Disse kan påvirke flere end 1 ud af 10 personer: - rødme i ansigtet eller på kroppen med en varm, eventuel meget varm, brændende fornemmelse eller kløe (blussen) - løs afføring (diaré) - kvalme - mavesmerter eller mavekramper 
These may affect more than 1 in 10 people: - reddening of the face or body feeling warm, hot, burning or itchy (flushing) - loose stools (diarrhoea) - feeling sick (nausea) - stomach pain or stomach cramps
Hos de patienter, der måtte opleve rødme eller gastrointestinale bivirkninger, kan indtagelse af Tecfidera sammen med mad forbedre tolerancen (se pkt. 
For those patients who may experience flushing or gastrointestinal adverse reactions, taking Tecfidera with food may improve tolerability (see sections 4.4, 4.5 and 4.8).
Virkning og anvendelse Hvad Tecfidera er 
What Tecfidera is and what it is used for What Tecfidera is
Startdosis 120 mg to gange dagligt. 
Starting dose 120 mg twice a day.
Tecfidera er ikke blevet undersøgt hos patienter med alvorlig nyre- eller leverinsufficiens, og der skal derfor udvises forsigtighed ved brug hos disse patienter (se pkt. 
Tecfidera has not been studied in patients with severe renal or severe hepatic impairment and caution should, therefore, be used in these patients (see section 4.2).
MedDRA-systemorganklasse Bivirkning 
MedDRA System Organ Class Adverse reaction
Mekanismen bag anafylaksi induceret af dimethylfumarat er ikke kendt. 
The mechanism of dimethyl fumarate induced anaphylaxis is unknown.
Normal dosis 240 mg to gange dagligt. 
Regular dose 240 mg twice a day.
Yderligere havde 16% af patienterne en EDSS-score > 3,5, 28% havde haft ≥ 2 attakker i det forudgående år, og 42% havde tidligere fået anden godkendt behandling for MS. I MRI-kohorten havde 36% af patienterne gadolinium-forstærkede (Gd+) læsioner (gennemsnitligt 1,4). 
In addition, 16% of patients had an EDSS score >3.5, 28% had ≥2 relapses in the prior year and 42% had previously received other approved MS treatments.
I de placebo-kontrollerede studier var hyppigheden af rødme (34% versus 4%) og hedestigning (7% versus 2%) højere hos patienter behandlet med Tecfidera sammenlignet med placebo. 
In the placebo-controlled studies, the incidence of flushing (34% versus 4%) and hot flush (7% versus 2%) was increased in patients treated with Tecfidera compared to placebo, respectively.
Grønne og hvide, hårde enterokapsler, størrelse 0, præget med ‘BG-12 120 mg', der indeholder mikrotabletter. 
Green and white gastro-resistant hard capsules, size 0, printed with ‘BG-12 120 mg' containing microtablets.
Oplys især, hvis du tager følgende: - medicin, der indeholder fumarsyreestere (fumarater), som anvendes til behandling af psoriasis 
Tell your doctor or pharmacist if you are taking, have recently taken or might take any medicines, in particular: - medicines that contain fumaric acid esters (fumarates) used to treat psoriasis
Yderligere havde 17% af patienterne en EDSS-score > 3,5, 32% havde haft ≥ 2 attakker i det forudgående år, og 30% havde tidligere fået anden godkendt behandling for MS. I MRI-kohorten havde 45% af patienterne gadolinium-forstærkede (Gd+) læsioner (gennemsnitligt 2,4). 
In addition, 17% of patients had an EDSS score >3.5, 32% had ≥2 relapses in the prior year and 30% had previously received other approved MS treatments.
Da tidlig diagnosticering af Fanconis syndrom og seponering af det potentielle kausale lægemiddel, f.eks. dimethylfumarat, er vigtige elementer for at forhindre opståen af nyreinsufficiens og osteomalaci, anbefaler PRAC, at inkludere en advarsel i produktresuméets pkt. 
Since early diagnosis of Fanconi syndrome and discontinuation of the potentially causative drug, e.g. dimethyl fumarate, are important steps to prevent the onset of renal impairment and osteomalacia, the PRAC recommends the inclusion of a warning in SmPC section 4.4 to make physicians aware of the potential risk of Fanconi syndrome including the description of corresponding symptoms.
14 hårde enterokapsler 
14 gastro-resistant hard capsules
Virkninger på immunsystemet 
Immune system disorders
Samtidig behandling med nefrotoksiske lægemidler (såsom aminoglykosider, diuretika, non-steroide antiinflammatoriske lægemidler eller lithium) kan øge risikoen for renale bivirkninger (f.eks. proteinuri, se pkt. 
Concurrent therapy with nephrotoxic medicinal products (such as aminoglycosides, diuretics, nonsteroidal anti-inflammatory drugs or lithium) may increase the potential of renal adverse reactions (e.g. proteinuria see section 4.8) in patients taking Tecfidera (see section 4.4 Blood/laboratory tests).
Der skal udvises forsigtighed ved behandling af patienter med alvorlig nyre- eller leverinsufficiens (se pkt. 
Caution should be used when treating patients with severe renal or severe hepatic impairment (see section 4.4).
I kliniske studier (både kontrollerede og ikke kontrollerede) havde 9% af patienterne lymfocyttal ≥ 0,5x109/l og < 0,8x109/l i mindst 6 måneder. 
In clinical studies (both controlled and uncontrolled), 9% of patients had lymphocyte counts ≥0.5 x
2% af patienterne oplevede lymfocyttal <0,5x109/l i mindst 6 måneder, og hos denne gruppe forblev størstedelen af lymfocyttællingerne < 0,5x109/l ved fortsat behandling. 
109/L and <0.8 x 109/L for at least six months; 2% of patients experienced lymphocyte counts <0.5 x 109/L for at least six months, and in this group the majority of lymphocyte counts remained <0.5 x 109/L with continued therapy.
Sådan skal du tage Tecfidera 
How to take Tecfidera
Indlægsseddel: Information til patienten Tecfidera 120 mg enterokapsler, hårde Tecfidera 240 mg enterokapsler, hårde dimethylfumarat 
Package leaflet: Information for the patient Tecfidera 120 mg gastro-resistant hard capsules Tecfidera 240 mg gastro-resistant hard capsules dimethyl fumarate
Denne overvejelse vil afveje fordelen for dit barn ved at amme og fordelen for dig ved behandling. 
This involves balancing the benefit of breast-feeding for your child, and the benefit of therapy for you.
(95% CI) aAlle analyser af kliniske endepunkter var intent-to-treat; bMR-kohorte anvendtt ved MR-analyser *P-værdi < 0,05; **P-værdi < 0,01; ***P-værdi < 0,0001; #ikke statistisk signifikant 
No. subjects Mean (median) number of new or newly enlarging T2 lesions over 2 years Lesion mean ratio (95% CI) Mean (median) number of Gd lesions at 2 years Odds ratio (95% CI) Mean (median) number of new T1 hypointense lesions over 2 years Lesion mean ratio (95% CI) aAll analyses of clinical endpoints were intent-to-treat; bMRI analysis used MRI cohort *P-value < 0.05; **P-value < 0.01; ***P-value < 0.0001; #not statistically significant
Rødme er tilbøjelig til at starte tidligt under behandlingen (primært den første måned), og kan hos patienter, som oplever rødme, optræde med mellemrum under hele Tecfidera-behandlingen. 
Flushing events tend to begin early in the course of treatment (primarily during the first month) and in patients who experience flushing, these events may continue to occur intermittently throughout treatment with Tecfidera.