natgillin/translations-raw huggingface dataset:
Tecfidera er medicin, der indeholder det aktive stof dimethylfumarat. 
Tecfidera is a medicine that contains the active substance dimethyl fumarate.
Lægemiddelinduceret leverskade, herunder forhøjede leverenzymer (≥ 3 øvre normalgrænse, upper limit of normal (ULN)) og forhøjede niveauer af totalt bilirubin (≥ 2 ULN), kan forekomme som følge af behandling med dimethylfumarat. 
Drug-induced liver injury, including liver enzyme increase (≥ 3 upper limit of normal (ULN)) and elevation of total bilirubin levels (≥ 2 ULN) can result from treatment with dimethyl fumarate.
Dimethylfumarat er ikke blevet undersøgt hos patienter med eksisterende lave lymfocyttal, og der skal udvises forsigtighed ved behandling af disse patienter. 
Dimethyl fumarate has not been studied in patients with pre-existing low lymphocyte counts and caution should be exercised when treating these patients.
I kliniske studier oplevede 3 ud af i alt 2.560 patienter behandlet med dimethylfumarat alvorlig rødme, der formodentlig var overfølsomheds- eller anafylaktoide reaktioner. 
In clinical trials, 3 patients out of a total of 2,560 patients treated with dimethyl fumarate experienced serious flushing symptoms that were probable hypersensitivity or anaphylactoid reactions.
En tidlig diagnosticering af Fanconis syndrom og seponering af dimethylfumarat-behandlingen er vigtig for at forhindre opståen af nyreinsufficiens og osteomalaci, da syndromet normalt er reversibelt. 
Early diagnosis of Fanconi syndrome and discontinuation of dimethyl fumarate treatment are important to prevent the onset of renal impairment and osteomalacia, as the syndrome is usually reversible.
Kaliumhydroxid Sort jernoxid (E172) 
Potassium hydroxide Black iron oxide (E172)
Hvis rødmen ledsages af et rødt udslæt eller nældefeber, og du samtidig får et eller flere af følgende symptomer: 
However, should flushing be accompanied by a red rash or hives and you get any of these symptoms:
I testis blev der observeret degeneration af det seminiferøse epitel hos rotter og hunde. 
In the testes, degeneration of the seminiferous epithelium was seen in rats and dogs.
I kliniske studier med psoriasis-patienter påvirkede dimethylfumarat lymfocytfenotyper via en nedregulering af proinflammatoriske cytokinprofiler (TH1, TH17) og viste tendens til antiinflammatorisk produktion (TH2). 
In clinical studies with psoriasis patients, dimethyl fumarate affected lymphocyte phenotypes through a down-regulation of pro-inflammatory cytokine profiles (TH1, TH17), and biased towards anti-inflammatory production (TH2).
In vitro-studier af CYP-induktion viste ikke interaktion mellem Tecfidera og p-piller. 
In vitro CYP induction studies did not demonstrate an interaction between Tecfidera and oral contraceptives.
Der blev ikke identificeret potentielle risici for interaktion med andre lægemidler i in vitrostudier af CYP-hæmning og -induktion, et p-glykoprotein-studie eller studier af dimethylfumarats og monomethylfumarats proteinbinding (en primær metabolit af dimethylfumarat). 
Potential drug interaction risks were not identified from in vitro CYP-inhibition and induction studies, a p-glycoprotein study, or studies of the protein binding of dimethyl fumarate and monomethyl fumarate (a primary metabolite of dimethyl fumarate).
Det er vist, at dimethylfumarat passerer placentamembranen ind i føtalt blod hos rotter og kaniner med ratio af føtal:maternel plasmakoncentration på henholdsvist 0,48-0,64 og 0,1. 
Dimethyl fumarate has been shown to cross the placental membrane into fetal blood in rats and rabbits, with ratios of fetal to maternal plasma concentrations of 0.48 to 0.64 and 0.1 respectively.
Hos rotter var hyppigheden af renalt tubulært karcinom øget ved 100 mg/kg/dag, en omtrent 2 gange højere eksponering end ved den anbefalede humane dosis. 
In rats, the incidence of renal tubular carcinoma was increased at 100 mg/kg/day, approximately 2 times higher exposure than the recommended human dose.
Indtagelse af mere end en lille mængde (mere end 50 ml) stærk alkohol (mere end 30 volumen%; f.eks. spiritus) skal undgås den første time efter indtagelse af Tecfidera, da alkohol kan interagere med denne medicin. 
Consumption of more than a small quantity (more than 50 ml) of strong alcoholic drinks (more than 30% alcohol by volume, e.g. spirits) should be avoided within an hour of taking Tecfidera, as alcohol can interact with this medicine.
Efter 7 dage øges dosis til den anbefalede vedligeholdelsesdosis på 240 mg to gange dagligt (se pkt. 
After 7 days, the dose should be increased to the recommended maintenance dose of 240 mg twice a day (see section 4.4).
Patienter med multipel sklerose fik to doser på 240 mg med 4 timers mellemrum som en del af et tre gange dagligt dosisregime. 
In subjects with multiple sclerosis, two 240 mg doses were administered 4 hours apart as part of a three times a day dosing regimen.
Alvorlige gastrointestinale hændelser, herunder gastroenteritis og gastritis, blev set hos 1% af patienterne behandlet med Tecfidera (se pkt. 
The incidence of serious gastrointestinal events, including gastroenteritis and gastritis, was seen in 1% of patients treated with Tecfidera (see section 4.2).
Efter administration af 240 mg to gange dagligt sammen med mad var den mediane peak-værdi (Cmax) 1,72 mg/l, og det totale areal under kurven (AUC) for eksponering var 8,02 timer∙mg/l hos patienter med multipel sklerose. 
Following 240 mg twice a day administered with food, the median peak (Cmax) was 1.72 mg/l and overall area under the curve (AUC) exposure was 8.02 h.mg/l in subjects with multiple sclerosis.
I studie 1 havde patienterne følgende mediane baseline-værdier: Alder 39 år, sygdomsvarighed 7,0 år, EDSS-score 2,0. 
In Study 1, patients had the following median baseline characteristics: age 39 years, disease duration 7.0 years, EDSS score 2.0.
I studie 2 havde patienterne følgende mediane baseline-værdier: Alder 37 år, sygdomsvarighed 6,0 år, EDSS-score 2,5. 
In Study 2, patients had the following median baseline characteristics: age 37 years, disease duration 6.0 years, EDSS score 2.5.
Der blev set forhøjede alaninaminotransferase og aspartataminotransferase ≥ 3 gange ULN hos henholdsvis 5% og 2% af patienterne behandlet med placebo og hos 6% og 2% af patienterne behandlet med Tecfidera. 
Elevations of alanine aminotransferase and aspartate aminotransferase ≥3 times ULN, respectively, were seen in 5% and 2% of patients treated with placebo and 6% and 2% of patients treated with Tecfidera.
5.1) skal det imidlertid overvejes at seponere behandlingen med Tecfidera, hvis patienten udvikler en alvorlig infection, og fordele og risici skal revurderes, før behandlingen genoptages. 
However, due to Tecfidera immunomodulatory properties (see section 5.1), if a patient develops a serious infection, suspending treatment with Tecfidera should be considered and the benefits and risks should be reassessed prior to re-initiation of therapy.
Magnetisk resonansskanning (MR-skanning) 
Magnetic Resonance imaging (MRI)
De hyppigste bivirkninger (≥ 10%) hos patienter behandlet med dimethylfumarat var rødme og gastrointestinale gener (dvs. diaré, kvalme, abdominalsmerter, smerter i den øverste del af abdomen). 
The most common adverse reactions (incidence ≥10%) for patients treated with dimethyl fumarate were flushing and gastrointestinal events (i.e. diarrhoea, nausea, abdominal pain, abdominal pain upper).
Sammenlignet med placebo observeredes der hos patienter behandlet med Tecfidera en klinisk relevant og statistisk signifikant reduktion i det primære endepunkt i studie 1 - antal patienter med attakker efter 2 år - og i det primære endepunkt i studie 2 - årlig attakrate efter 2 år. 
Compared to placebo, subjects treated with Tecfidera had a clinically meaningful and statistically significant reduction on: the primary endpoint in Study 1, proportion of subjects relapsed at 2 years; and the primary endpoint in Study 2, annualised relapse rate at 2 years.
Baseret på data fra placebokontrollerede studier havde størstedelen af de patienter, der oplevede en stigning, leveraminotransferaser, som lå under 3 gange den øvre normalgrænse (ULN). 
Based on data from placebo-controlled studies, the majority of patients with elevations had hepatic transaminases that were <3 times the upper limit of normal (ULN).
En vurdering af niveauerne af serum-aminotransferaser (f.eks.alaninaminotransferase (ALAT), aspartataminotransferase (ASAT)) og totalt bilirubin anbefales før behandlingsstart og under behandlingen, efter klinisk indikation. 
Assessment of serum aminotransferases (e.g. alanine aminotransferase (ALT), aspartate aminotransferase (AST)) and total bilirubin levels are recommended prior to treatment initiation and during treatment as clinically indicated.
Der sås små numeriske forskelle i responset over for tetanustoksoid og pheumokok serotype 3-polysaccharid i ikke-pegyleret interferons favør. 
Small numerical differences in the response to tetanus toxoid and pneumococcal serotype 3 polysaccharide were noted in favour of non-pegylated interferon.
Prækliniske studier indikerer, at dimethylfumarats farmakodynamiske respons formentlig primært sker via aktivering af transkriptionsfaktorens Nuclear Factor (erythroid-derived 2)Related Factor 2 (Nrf2) transkriptionsproces. 
Preclinical studies indicate that dimethyl fumarate pharmacodynamic responses appear to be primarily mediated through activation of the Nuclear factor (erythroid-derived 2)-like 2 (Nrf2) transcriptional pathway.
Forhøjet alaninaminotransferase Almindelig Lægemiddelinduceret leverskade1 
Aspartate aminotransferase increased Common Alanine aminotransferase increased Common Drug-induced liver injury1
Inden behandling med Tecfidera bør der foretages en aktuel komplet blodtælling, der inkluderer lymfocytter. 
Prior to initiating treatment with Tecfidera, a current complete blood count, including lymphocytes, must be performed.
kan dette dog være tegn på en svær overfølsomhedsreaktion (anafylaksi) 
then this may represent a severe allergic reaction (anaphylaxis)
Fundene blev observeret hos rotter ved omtrent den anbefalede dosis og hos hunde ved 3 gange den anbefalede dosis (baseret på AUC). 
The findings were observed at approximately the recommended dose in rats and 3 times the recommended dose in dogs (AUC basis).
Tilfælde med anafylaksi/anafylaktoide reaktioner er blevet rapporteret efter administration af Tecfidera hos patienter efter markedsføringen. 
Cases of anaphylaxis/anaphylactoid reaction have been reported following Tecfidera administration in the post-marketing setting.
Da nyrerne er en sekundær eliminationsvej for dimethylfumarat og står for under 16% af den administrerede dosis, blev der ikke foretaget nogen evaluering af farmakokinetikken hos individer med nyreinsufficiens. 
Since the renal pathway is a secondary route of elimination for dimethyl fumarate accounting for less than 16% of the dose administered, evaluation of pharmacokinetics in individuals with renal impairment was not conducted.
Hyppigheden af gastrointestinale gener (f.eks. diaré [14% versus 10%], kvalme [12% versus 9%], øvre abdominalsmerter [10% versus 6%], abdominalsmerter [9% versus 4%], opkastning [8% versus 5%] og dyspepsi [5% versus 3%]) var højere hos de patienter, der fik Tecfidera, sammenlignet med placebo. 
The incidence of gastrointestinal events (e.g. diarrhoea [14% versus 10%], nausea [12% versus 9%], upper abdominal pain [10% versus 6%], abdominal pain [9% versus 4%], vomiting [8% versus 5%] and dyspepsia [5% versus 3%]) was increased in patients treated with Tecfidera compared to placebo, respectively.
Relevansen af disse fund kendes ikke hos mennesker. 
The relevance of these findings to humans is not known.
vanddrivende medicin (diuretika), visse typer smertestillende midler (såsom ibuprofen og andre lignende lægemidler mod gigt og medicin, som købes uden recept) og medicin, der indeholder lithium - vaccination med visse typer vacciner (levende, svækkede vacciner) under behandling med Tecfidera kan forårsage, at du får en infektion, og skal derfor undgås. 
- medicines that affect the kidneys including some antibiotics (used to treat infections), “water tablets” (diuretics), certain types of painkillers (such as ibuprofen and other similar antiinflammatories and medicines purchased without a doctor's prescription) and medicines that contain lithium - Taking Tecfidera with certain types of vaccines (live vaccines) may cause you to get an infection and should, therefore, be avoided.
- hævelse af ansigt, læber, mund eller tunge (angioødem) - hivende vejrtrækning, vejrtrækningsbesvær eller kortåndethed (dypnø, hypoksi) - svimmelhed eller bevidstløshed (hypotension) 
- swelling of the face, lips, mouth or tongue (angioedema) - wheezing, difficulty breathing or shortness of breath (dyspnoea, hypoxia) - dizziness or loss of consciousness (hypotension)
De bivirkninger, som blev rapporteret hyppigere hos patienter behandlet med Tecfidera end hos patienter behandlet med placebo, angives i tabellen nedenfor. 
Adverse reactions, which were more frequently reported in Tecfidera versus placebo-treated patients, are presented in the table below.
Hvis behandlingen fortsættes på trods af et vedvarende lymfocyttal < 0,5x109/l, anbefales nøjere overvågning (se også underafsnittet om progressiv multifokal leukoencefalopati (PML)). 
If treatment is continued despite a persistent lymphocyte count < 0.5x109/L, enhanced vigilance is recommended (see also subsection on PML).
På grund af studiedesignet blev høj sygdomsaktivitet defineret som følger: - Patienter med 2 eller flere attakker i løbet af ét år og med en eller flere Gd-forstærkede læsioner på MRI (n = 42 i DEFINE, n = 51 i CONFIRM) eller; - Patienter, der ikke har responderet på et fuldstændigt og tilstrækkeligt behandlingsforløb (af mindst et års varighed) af beta-interferon, og som har haft mindst 1 attak i det forudgående år, mens de var i behandling, og mindst 9 T2-hyperintense læsioner påvist ved kraniel MRscanning eller mindst 1 Gd-forstærket læsion, eller patienter, der har haft en uændret eller øget attakrate i det forudgående år sammenlignet med de foregående 2 år (n = 177 i DEFINE, n = 141 i CONFIRM). 
Due to the design of the studies, high disease activity was defined as follows: - Patients with 2 or more relapses in one year, and with one or more Gd-enhancing lesions on brain MRI (n=42 in DEFINE; n=51 in CONFIRM) or, - Patients who have failed to respond to a full and adequate course (at least one year of treatment) of beta-interferon, having had at least 1 relapse in the previous year while on therapy, and at least 9 T2-hyperintense lesions in cranial MRI or at least 1 Gd-enhancing lesion, or patients having an unchanged or increased relapse rate in the prior year as compared to the previous 2 years (n=177 in DEFINE; n=141 in CONFIRM).
Tecfideras farmakokinetik hos disse unge patienter svarede til den, der tidligere var set hos voksne patienter (Cmax: 2,00±1,29 mg/l; AUC0-12t: 3,62±1,16 timer∙mg/l, hvilket svarer til en samlet daglig AUC på 
The pharmacokinetics of Tecfidera in these adolescent patients was consistent with that previously observed in adult patients (Cmax: 2.00±1.29 mg/l; AUC0-12hr: 3.62±1.16 h.mg/l, which corresponds to an overall daily AUC of 7.24 h.mg/l).
I et lille 24 ugers åbent, ikke kontrolleret studie med pædiatriske patienter i alderen 13 til 17 år med RRMS (120 mg to gange dagligt i 7 dage efterfulgt af 240 mg to gange dagligt i resten af behandlingsperioden; sikkerhedspopulation, n=22), efterfulgt af et 96 ugers forlængelsesstudie (240 mg to gange dagligt; sikkerhedspopulation n=20), syntes sikkerhedsprofilen at svare til den, der sås hos voksne patienter. 
In a small 24-week open-label uncontrolled study in paediatric patients with RRMS aged 13 to 17 years (120 mg twice a day for 7 days followed by 240 mg twice a day for the remainder of treatment; safety population, n=22), followed by a 96 week extension study (240mg twice per day ; safety population n=20), the safety profile appeared similar to that observed in adult patients.
Fundene i den forreste del af maven hos mus og rotter bestod af pladeepitel-hyperplasi og hyperkeratose, inflammation, og planocellulært papillom og karcinom i studier af 3 måneders varighed eller længere. 
Findings in the forestomach of mice and rats consisted of squamous epithelial hyperplasia and hyperkeratosis; inflammation; and squamous cell papilloma and carcinoma in studies of 3 months or longer in duration.
Disse data er udledt fra 2 pivotale, placebo-kontrollerede, dobbeltblinde kliniske fase 3-forsøg med i alt 1.529 patienter behandlet med Tecfidera i op til 24 måneder med en total eksponering på 2.371 personår (se pkt. 
These data were derived from 2 pivotal Phase 3 placebo-controlled, double-blind clinical trials with a total of 1,529 patients treated with Tecfidera and for up to 24 months with an overall exposure of 2,371 person-years (see section 5.1).
Bivirkningerne beskrevet i punkterne om toksikologi og reproduktionstoksicitet herunder er ikke observeret i kliniske studier, men er set i dyrestudier efter eksponering for plasmakoncentrationer, der svarer til human-terapeutiske doser. 
The adverse reactions described in the Toxicology and Reproduction toxicity sections below were not observed in clinical studies, but were seen in animals at exposure levels similar to clinical exposure levels.
I fase 3-studier hos MS-patienter faldt middel-lymfocyttallet i gennemsnit med cirka 30% i forhold til baseline-værdien i løbet af det første år med Tecfiderabehandling med et efterfølgende plateau. 
In Phase 3 studies in MS patients, upon treatment with Tecfidera mean lymphocyte counts decreased on average by approximately 30% of their baseline value over the first year with a subsequent plateau.
Progressiv multifokal leukoencefalopati (PML)1 
Progressive multifocal leukoencephalopathy (PML) 1
Mad har ingen klinisk signifikant virkning på eksponeringen for dimethylfumarat. 
Food does not have a clinically significant effect on exposure of dimethyl fumarate.
Interstitiel fibrose og kortikal atrofi blev observeret ved 6 gange den anbefalede dosis baseret på AUC. 
Interstitial fibrosis and cortical atrophy were observed at 6 times the recommended dose based on AUC.
Der blev udført to 2-års randomiserede, dobbeltblinde, placebo-kontrollerede studier [studie 1 (DEFINE) med 1.234 patienter og studie 2 (CONFIRM) med 1.417 patienter] med patienter med relapsing-remitterende multipel sklerose (RRMS). 
Two, 2-year, randomised, double-blind, placebo controlled studies [Study 1 (DEFINE) with 1234 subjects and Study 2 (CONFIRM) with 1417 subjects] of subjects with relapsing-remitting multiple sclerosis (RRMS) were performed.
Niveauet af 1,25-dihydroxyvitamin D faldt hos patienter behandlet med Tecfidera sammenlignet med placebo (mediant fald i procent fra baseline efter 2 år på henholdsvist 25% og 15%), og niveauet for parathyroideahormon (PTH) steg hos patienter behandlet med Tecfidera sammenlignet med placebo (median stigning i procent fra baseline efter 2 år på henholdsvist 29% og 15%). 
Levels of 1,25-dihydroxyvitamin D decreased in Tecfidera treated patients relative to placebo (median percentage decrease from baseline at 2 years of 25% versus 15%, respectively) and levels of parathyroid hormone (PTH) increased in Tecfidera treated patients relative to placebo (median percentage increase from baseline at 2 years of 29% versus 15%, respectively).
I et in vivo-studie medførte samtidig administration af Tecfidera og et oralt præventionsmiddel (norgestimat og etinylestradiol) ingen relevant ændring i virkningen af det orale præventionsmiddel. 
In an in vivo study, co-administration of Tecfidera with a combined oral contraceptive (norgestimate and ethinyl estradiol) did not elicit any relevant change in oral contraceptive exposure.
Køn og alder havde ikke nogen klinisk signifikant virkning på dimethylfumarats farmakokinetik. 
Gender and age did not have a clinically significant impact on the pharmacokinetics of dimethyl fumarate.
I de placebo-kontrollerede studier var måling af ketoner i urinen (1+ eller højere) højere hos patienter behandlet med Tecfidera (45%) sammenlignet med placebo (10%). 
In the placebo-controlled studies, measurement of urinary ketones (1+ or greater) was higher in patients treated with Tecfidera (45%) compared to placebo (10%).
I kliniske studier har 34% af Tecfidera-behandlede patienter oplevet rødme. 
In clinical trials, 34% of Tecfidera treated patients experienced flushing.
Den anbefalede vedligeholdelsesdosis på 240 mg to gange dagligt bør genoptages inden for 1 måned. 
Within 1 month, the recommended maintenance dose of 240 mg twice a day should be resumed.
I to studier med raske frivillige medførte administration af 325 mg (eller ækvivalent hermed) acetylsalicylsyre uden entero-overtræk, 30 minutter før Tecfidera med administration i henholdsvis 4 dage og 4 uger, ikke en ændring i Tecfideras farmakokinetiske profil. 
In two healthy volunteer studies, the administration of 325 mg (or equivalent) non-enteric coated acetylsalicylic acid, 30 minutes prior to Tecfidera, dosing over 4 days and over 4 weeks, respectively, did not alter the pharmacokinetic profile of Tecfidera.
Et lymfocyttal < 0,2x109/l blev observeret hos 1 Tecfiderabehandlet patient og hos ingen af de placebobehandlede patienter. 
A lymphocyte count <0.2x109/l was observed in 1 patient treated with Tecfidera and in no patients treated with placebo.
En sjælden, men alvorlig nyresygdom (Fanconis syndrom) er blevet indberettet for lægemidler indeholdende dimethylfumarat i kombination med andre fumarsyreestere anvendt til behandling af psoriasis (en hudsygdom). 
A rare but serious kidney disorder (Fanconi Syndrome) has been reported for a medicine containing dimethyl fumarate, in combination with other fumaric acid esters, used to treat psoriasis (a skin disease).
Der er indberettet tilfælde af Fanconis syndrom for et lægemiddel indeholdende dimethylfumarat i kombination med andre fumarsyreestere. 
Cases of Fanconi syndrome have been reported for a medicinal product containing dimethyl fumarate in combination with other fumaric acid esters.
Når det blev indberettet, oplevede de fleste patienter dog grad 2 (< 0,8×109/l til 0,5×109/l) eller grad 3 (< 0,5×109/l til 0,2×109/l) lymfopeni (se pkt. 
However, when reported, most patients experienced grade 2 (< 0.8 × 109/L to 0.5 × 109/L) or grade 3 (<0.5 × 109/L to 0.2 × 109/L) lymphopenia (see section 4.4).
56 hårde enterokapsler 168 hårde enterokapsler 
56 gastro-resistant hard capsules 168 gastro-resistant hard capsules
Odds-ratio 
Hazard ratio
Det forventes ikke, at Tecfidera påvirker din evne til at føre motorkøretøj og betjene maskiner. 
Tecfidera is not expected to affect your ability to drive and use machines.
Du kan tage den glemte dosis, hvis du lader mindst 4 timer gå mellem hver dosis, eller skal du vente til næste planlagte dosis. 
You may take the missed dose if you leave at least 4 hours between the doses.
Prækliniske studier hos gnavere, kaniner og aber blev udført med en opløsning af dimethylfumarat (dimethylfumarat i 0,8% hypromellose) administreret oralt med en sonde. 
Nonclinical studies in rodent, rabbits, and monkeys were conducted with a dimethyl fumarate suspension (dimethyl fumarate in 0.8% hydroxypropyl methylcellulose) administered by oral gavage.
I prækliniske modeller reducerer dimethylfumarat og monomethylfumarat, den primære metabolit af dimethylfumarat, signifikant immuncelleaktiveringen og den efterfølgende frigivelse af pro-inflammatoriske cytokiner som respons på inflammatoriske stimuli. 
Dimethyl fumarate and monomethyl fumarate, the primary metabolite of dimethyl fumarate, significantly reduced immune cell activation and subsequent release of proinflammatory cytokines in response to inflammatory stimuli in preclinical models.
Moderstoffet eller monomethylfumarat akkumuleres ikke ved administration af flere doser dimethylfumarat som del at det terapeutiske regime. 
Accumulation of parent drug or monomethyl fumarate does not occur with multiple doses of dimethyl fumarate at the therapeutic regimen.
I alt 3% af patienterne behandlet med Tecfidera afbrød behandlingen pga. rødme. 
Overall, 3% of patients treated with Tecfidera discontinued due to flushing.