FrancophonIA/ELRC3.0 huggingface dataset:
English: Magnetic Resonance imaging (MRI)
Danish: Magnetisk resonansskanning (MR-skanning)
English: 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).
Danish: 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).
English: 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.
Danish: 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.
English: 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).
Danish: 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).
English: 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.
Danish: 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.
English: Small numerical differences in the response to tetanus toxoid and pneumococcal serotype 3 polysaccharide were noted in favour of non-pegylated interferon.
Danish: Der sås små numeriske forskelle i responset over for tetanustoksoid og pheumokok serotype 3-polysaccharid i ikke-pegyleret interferons favør.
English: 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.
Danish: Prækliniske studier indikerer, at dimethylfumarats farmakodynamiske respons formentlig primært sker via aktivering af transkriptionsfaktorens Nuclear Factor (erythroid-derived 2)Related Factor 2 (Nrf2) transkriptionsproces.
English: Aspartate aminotransferase increased Common Alanine aminotransferase increased Common Drug-induced liver injury1
Danish: Forhøjet alaninaminotransferase Almindelig Lægemiddelinduceret leverskade1
English: Prior to initiating treatment with Tecfidera, a current complete blood count, including lymphocytes, must be performed.
Danish: Inden behandling med Tecfidera bør der foretages en aktuel komplet blodtælling, der inkluderer lymfocytter.
English: then this may represent a severe allergic reaction (anaphylaxis)
Danish: kan dette dog være tegn på en svær overfølsomhedsreaktion (anafylaksi)
English: The findings were observed at approximately the recommended dose in rats and 3 times the recommended dose in dogs (AUC basis).
Danish: Fundene blev observeret hos rotter ved omtrent den anbefalede dosis og hos hunde ved 3 gange den anbefalede dosis (baseret på AUC).
English: Cases of anaphylaxis/anaphylactoid reaction have been reported following Tecfidera administration in the post-marketing setting.
Danish: Tilfælde med anafylaksi/anafylaktoide reaktioner er blevet rapporteret efter administration af Tecfidera hos patienter efter markedsføringen.
English: 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.
Danish: 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.
English: 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.
Danish: 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.
English: The relevance of these findings to humans is not known.
Danish: Relevansen af disse fund kendes ikke hos mennesker.
English: - 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.
Danish: 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.
English: - swelling of the face, lips, mouth or tongue (angioedema) - wheezing, difficulty breathing or shortness of breath (dyspnoea, hypoxia) - dizziness or loss of consciousness (hypotension)
Danish: - hævelse af ansigt, læber, mund eller tunge (angioødem) - hivende vejrtrækning, vejrtrækningsbesvær eller kortåndethed (dypnø, hypoksi) - svimmelhed eller bevidstløshed (hypotension)
English: Adverse reactions, which were more frequently reported in Tecfidera versus placebo-treated patients, are presented in the table below.
Danish: De bivirkninger, som blev rapporteret hyppigere hos patienter behandlet med Tecfidera end hos patienter behandlet med placebo, angives i tabellen nedenfor.
English: If treatment is continued despite a persistent lymphocyte count < 0.5x109/L, enhanced vigilance is recommended (see also subsection on PML).
Danish: Hvis behandlingen fortsættes på trods af et vedvarende lymfocyttal < 0,5x109/l, anbefales nøjere overvågning (se også underafsnittet om progressiv multifokal leukoencefalopati (PML)).
English: 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).
Danish: 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).
English: 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).
Danish: 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
English: 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.
Danish: 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.
English: 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.
Danish: 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.
English: 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).
Danish: 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.
English: 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.
Danish: 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.
English: 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.
Danish: 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.
English: Progressive multifocal leukoencephalopathy (PML) 1
Danish: Progressiv multifokal leukoencefalopati (PML)1
English: Food does not have a clinically significant effect on exposure of dimethyl fumarate.
Danish: Mad har ingen klinisk signifikant virkning på eksponeringen for dimethylfumarat.
English: Interstitial fibrosis and cortical atrophy were observed at 6 times the recommended dose based on AUC.
Danish: Interstitiel fibrose og kortikal atrofi blev observeret ved 6 gange den anbefalede dosis baseret på AUC.
English: 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.
Danish: 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).
English: 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).
Danish: 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%).
English: 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.
Danish: 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.
English: Gender and age did not have a clinically significant impact on the pharmacokinetics of dimethyl fumarate.
Danish: Køn og alder havde ikke nogen klinisk signifikant virkning på dimethylfumarats farmakokinetik.
English: In the placebo-controlled studies, measurement of urinary ketones (1+ or greater) was higher in patients treated with Tecfidera (45%) compared to placebo (10%).
Danish: 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%).
English: In clinical trials, 34% of Tecfidera treated patients experienced flushing.
Danish: I kliniske studier har 34% af Tecfidera-behandlede patienter oplevet rødme.
English: Within 1 month, the recommended maintenance dose of 240 mg twice a day should be resumed.
Danish: Den anbefalede vedligeholdelsesdosis på 240 mg to gange dagligt bør genoptages inden for 1 måned.
English: 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.
Danish: 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.
English: A lymphocyte count <0.2x109/l was observed in 1 patient treated with Tecfidera and in no patients treated with placebo.
Danish: Et lymfocyttal < 0,2x109/l blev observeret hos 1 Tecfiderabehandlet patient og hos ingen af de placebobehandlede patienter.
English: 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).
Danish: 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).
English: Cases of Fanconi syndrome have been reported for a medicinal product containing dimethyl fumarate in combination with other fumaric acid esters.
Danish: Der er indberettet tilfælde af Fanconis syndrom for et lægemiddel indeholdende dimethylfumarat i kombination med andre fumarsyreestere.
English: 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).
Danish: 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.
English: 56 gastro-resistant hard capsules 168 gastro-resistant hard capsules
Danish: 56 hårde enterokapsler 168 hårde enterokapsler
English: Hazard ratio
Danish: Odds-ratio
English: Tecfidera is not expected to affect your ability to drive and use machines.
Danish: Det forventes ikke, at Tecfidera påvirker din evne til at føre motorkøretøj og betjene maskiner.
English: You may take the missed dose if you leave at least 4 hours between the doses.
Danish: Du kan tage den glemte dosis, hvis du lader mindst 4 timer gå mellem hver dosis, eller skal du vente til næste planlagte dosis.
English: 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.
Danish: Prækliniske studier hos gnavere, kaniner og aber blev udført med en opløsning af dimethylfumarat (dimethylfumarat i 0,8% hypromellose) administreret oralt med en sonde.
English: 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.
Danish: 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.
English: Accumulation of parent drug or monomethyl fumarate does not occur with multiple doses of dimethyl fumarate at the therapeutic regimen.
Danish: Moderstoffet eller monomethylfumarat akkumuleres ikke ved administration af flere doser dimethylfumarat som del at det terapeutiske regime.
English: Overall, 3% of patients treated with Tecfidera discontinued due to flushing.
Danish: I alt 3% af patienterne behandlet med Tecfidera afbrød behandlingen pga. rødme.
English: Tecfidera should be taken with food (see section 5.2).
Danish: Tecfidera skal tages sammen med mad (se pkt.
English: Hazard ratio (95% CI) Proportion with 24 week confirmed disability progression Hazard ratio (95% CI)
Danish: 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)
English: Serious effects
Danish: Alvorlige bivirkninger
English: Tecfidera has not been studied in patients with severe active gastrointestinal disease and caution should, therefore, be used in these patients.
Danish: Tecfidera er ikke blevet undersøgt hos patienter med alvorlig, aktiv gastrointestinal sygdom, og der skal derfor udvises forsigtighed hos disse patienter.
English: The most commonly reported adverse reactions leading to discontinuation (incidence >1%) in patients treated with Tecfidera were flushing (3%) and gastrointestinal events (4%).
Danish: De hyppigst rapporterede bivirkninger, som førte til seponering (> 1%) hos patienter behandlet med Tecfidera, var rødme (3%) og gastrointestinale lidelser (4%).
English: 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.
Danish: 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.
English: The symptoms of PML may be similar to an MS relapse.
Danish: Symptomerne på PML kan ligne et MS-attak.
English: 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).
Danish: Hvis behandling fortsættes hos patienter med moderat til svær, langvarig lymfopeni, kan risikoen for en opportunistisk infektion, herunder PML, ikke udelukkes (se pkt.
English: Tecfidera has no or negligible influence on the ability to drive and use machines.
Danish: Tecfidera påvirker ikke eller kun i ubetydelig grad evnen til at føre motorkøretøj og betjene maskiner.
English: Tecfidera treatment should be started gradually to reduce the occurrence of flushing and gastrointestinal adverse reactions (see section 4.2).
Danish: Behandlingen med Tecfidera skal startes gradvist for at reducere forekomsten af rødme og gastrointestinale bivirkninger (se pkt.
English: What Tecfidera is used for Tecfidera is used to treat relapsing-remitting multiple sclerosis (MS) in adult patients.
Danish: Tecfidera anvendes til behandling af attakvis remitterende multipel sklerose (MS) hos voksne patienter.
English: Contents of the pack and other information What Tecfidera contains
Danish: Pakningsstørrelser og yderligere oplysninger Tecfidera indeholder:
English: 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.
Danish: Dimethylfumarateksponeringen stiger tilnærmelsesvist proportionalt med dosis (enkeltdoser og flere doser) i det undersøgte dosisinterval mellem 120 mg til 360 mg.
English: The forestomach of mice and rats does not have a human counterpart.
Danish: Den forreste del af maven hos mus og rotter findes ikke tilsvarende hos mennesker.
English: Tecfidera is not recommended during pregnancy and in women of childbearing potential not using appropriate contraception (see section 4.5).
Danish: Tecfidera bør ikke anvendes under graviditeten og til kvinder i den fertile alder, som ikke anvender sikker kontraception (se pkt.
English: Upon treatment with Tecfidera, mean lymphocyte counts decreased over the first year with a subsequent plateau.
Danish: Efter behandling med Tecfidera faldt de gennemsnitlige lymfocyttal i løbet af det første år, hvorefter de nåede et plateau.
English: Herpes zoster infections have been reported with Tecfidera use.
Danish: Der er indberettet herpes zoster-infektioner ved brug af Tecfidera.
English: However, Tecfidera should be taken with food due to improved tolerability with respect to flushing or gastrointestinal adverse events (see section 4.2).
Danish: Tecfidera bør dog tages sammen med mad, da det giver en bedre tolerance i forhold til rødme og gastrointestinale bivirkninger (se pkt.
English: Consider withholding Tecfidera treatment in patients with serious infections until the infection has resolved (see section 4.8).
Danish: Overvej at pausere Tecfidera-behandlingen hos patienter med alvorlige infektioner, indtil infektionen er overstået (se pkt.
English: Evidence from healthy volunteer studies suggests that Tecfidera-associated flushing is likely to be prostaglandin mediated.
Danish: Evidens fra studier med raske frivillige tyder på, at rødme relateret til Tecfidera sandsynligvis er medieret via prostaglandin.
English: 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).
Danish: 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).
English: Dimethyl fumarate and mono-methylfumarate were negative in a battery of in vitro assays (Ames, chromosomal aberration in mammalian cells).
Danish: Dimethylfumarat og monomethylfumarat var negative i primærcellen i in vitro-analyser (Ames, kromosomafvigelse i pattedyrceller).
English: Anaphylactic reactions
Danish: Analfylaktiske reaktioner
English: Other medicines and Tecfidera
Danish: Brug af anden medicin sammen med Tecfidera