FrancophonIA/ELRC3.0 huggingface dataset:
English: Overall, Cmax and AUC increased approximately doseproportionally in the dose range studied (120 mg to 360 mg).
Danish: Samlet set steg Cmax og AUC nogenlunde proportionalt med dosis i det undersøgte dosisinterval (120 mg til 360 mg).
English: The benefit/risk balance of the therapy should be reconsidered in discussion with the patient in the context of other therapeutic options available.
Danish: Forholdet mellem fordele og risici ved behandlingen bør afvejes og drøftes med patienten i relation til andre tilgængelige behandlingsmuligheder.
English: No studies have been performed evaluating the efficacy and safety of Tecfidera when switching patients from other disease modifying therapies to Tecfidera.
Danish: Der er ikke udført studier, som evaluerer Tecfideras effektivitet og sikkerhed hos patienter, der er skiftet fra andre sygdomsmodificerende behandlinger til Tecfidera.
English: At the first sign or symptom suggestive of PML, Tecfidera should be withheld and appropriate diagnostic evaluations need to be performed.
Danish: Ved det første tegn eller symptom, der tyder på PML, bør Tecfidera seponeres, og der skal udføres passende diagnostiske evalueringer.
English: Commonly used medicinal products in patients with multiple sclerosis, intramuscular interferon beta-1a and glatiramer acetate, were clinically tested for potential interactions with dimethyl fumarate and did not alter the pharmacokinetic profile of dimethyl fumarate.
Danish: Hyppigt anvendte lægemidler til patienter med multipel sklerose, intramuskulær interferon beta-1a og glatirameracetat, blev testet klinisk for potentielle interaktioner med dimethylfumarat og ændrede ikke dimethylfumarats farmakokinetiske profil.
English: The chronic dog study was conducted with oral administration of the dimethyl fumarate capsule.
Danish: Langtidskroniske studiet hos hunde blev udført med oral administration af dimethylfumarat-kapslen.
English: Clinical studies of Tecfidera had limited exposure to patients aged 55 years and above, and did not include sufficient numbers of patients aged 65 and over to determine whether they respond differently than younger patients (see section 5.2).
Danish: Der foreligger begrænsede data fra de kliniske studier om anvendelse af Tecfidera hos patienter fra og med 55 år, og studierne inkluderede ikke et tilstrækkeligt antal patienter fra og med 65 år til at kunne fastslå, om de reagerer anderledes end yngre patienter (se pkt.
English: 120 mg capsules: 14 capsules in PVC/PE/PVDC-PVC aluminium blister packs.
Danish: 120 mg kapsler: 14 kapsler i PVC/PE/PVDC-PVC aluminium blisterpakninger.
English: Ketones measured in urine
Danish: Ketoner i urinen
English: There are no data on the effects of dimethyl fumarate on human fertility.
Danish: Der er ingen data om virkningerne af dimethylfumarat på fertiliteten hos mennesker.
English: After starting therapy, complete blood counts, including lymphocytes, must be performed every 3 months.
Danish: Efter behandlingsstart skal der foretages komplet blodtælling, der inkluderer lymfocytter, hver 3. måned.
English: The limited long-term experience with Tecfidera could contribute to the low evidence regarding a potential association of dimethyl fumarate and Fanconi syndrome in the MS indication.
Danish: Den begrænsede langtidserfaring med Tecfidera kan bidrage til den lave evidens angående en potentiel forbindelse mellem dimethylfumarat og Fanconis syndron ved indikationen MS.
English: Placebo Tecfidera 240 mg twice a day
Danish: Placebo Tecfidera 240 mg to gange dagligt
English: Kidney changes were observed after repeated oral administration of dimethyl fumarate in mice, rats, dogs, and monkeys.
Danish: Der blev observeret nyreforandringer efter gentagen oral administration af dimethylfumarat hos mus, rotter, hunde og aber.
English: Dimethyl fumarate was administered orally at doses of 25, 75, 200 and 400 mg/kg/day in mice, and at doses of 25, 50, 100, and 150 mg/kg/day in rats.
Danish: Dimethylfumarat blev administreret oralt i doser på 25, 75, 200 og 400 mg/kg/dag hos mus og i doser på 25, 50, 100 og 150 mg/kg/dag hos rotter.
English: Upon recovery and in the absence of alternative treatment options, decisions about whether or not to restart Tecfidera after treatment discontinuation should be based on clinical judgement.
Danish: Efter normalisering, og hvis der ikke er andre behandlingsmuligheder, skal beslutningen om at genstarte behandlingen med Tecfidera efter behandlingsafbrydelse baseres på et klinisk skøn.
English: A transient increase in mean eosinophil counts was seen during the first 2 months of therapy.
Danish: Der blev set en forbigående stigning i middel-eosinofiltallene i løbet af behandlingens første 2 måneder.
English: Orally administered dimethyl fumarate undergoes rapid presystemic hydrolysis by esterases and is converted to its primary metabolite, monomethyl fumarate, which is also active.
Danish: Oralt administreret dimethylfumarat undergår en hurtig præsystemisk hydrolyse ved hjælp af esteraser og omdannes til dets primære metabolit, monomethylfumarat, som også er aktivt.
English: In case of clinical suspicion of PML, MRI should be performed immediately for diagnostic purposes.
Danish: Skulle der være klinisk mistanke om PML, skal MR-skanning foretages med det samme til diagnostisk formål.
English: Tecfidera may affect your white blood cell counts, your kidneys and liver.
Danish: Tecfidera kan påvirke antallet af hvide blodlegemer, dine nyrer og din lever.
English: On average, lymphocyte counts decreased by approximately 30% of baseline value.
Danish: I gennemsnit faldt lymfocyttallene cirka 30% under baselineværdien.
English: Patients with serious infections should not start treatment with Tecfidera until the infection(s) is resolved.
Danish: Patienter med alvorlige infektioner bør ikke starte behandling med Tecfidera, før infektionen/infektionerne er overstået.
English: Over the full treatment period (120-week), ARR was 0.2 representing an 84.5% relative reduction in relapses (n=20; 95% CI [66.8, 92.8], p<0.0001), when compared to the year prior to treatment initiation.
Danish: Gennem hele behandlingsperioden (120 uger) var den årlige attakrate 0,2, hvilket udgør en 84,5% relativ reduktion i attakker (n=20; 95% CI [66,8, 92,8], p < 0,0001) sammenlignet med året inden behandlingsstart.
English: Other circulating metabolites included fumaric acid, citric acid and monomethyl fumarate.
Danish: Andre cirkulerende metabolitter inkluderede fumarsyre, citronsyre og monomethylfumarat.
English: The increased incidence of elevations of hepatic transaminases in patients treated with Tecfidera relative to placebo was primarily seen during the first 6 months of treatment.
Danish: Den øgede hyppighed af forhøjede leveraminotransferaser hos patienter behandlet med Tecfidera i forhold til placebo sås primært i de første 6 måneder af behandlingen.
English: The capsule or its contents should not be crushed, divided, dissolved, sucked or chewed as the enteric-coating of the microtablets prevents irritant effects on the gut.
Danish: Kapslen eller dens indhold må ikke knuses, deles, opløses, suttes eller tygges, da mikrotabletternes syreresistente overtræk forebygger gastrointestinal irritation.
English: The downstream metabolism of fumaric acid occurs through the tricarboxylic acid cycle, with exhalation of CO2 serving as a primary route of elimination.
Danish: Downstream-metaboliseringen af fumarsyre sker gennem tricarboxylsyrecyklussen med CO2-udskillelse som den primære eliminationsvej.
English: In rare cases hypophosphataemic osteomalacia with nonlocalised bone pain, elevated alkaline phosphatase in serum and stress fractures may occur.
Danish: I sjældne tilfælde kan der forekomme hypofosfatæmisk osteomalaci med ikke-lokaliserede knoglesmerter, forhøjet alkalisk fosfatase i serum og stress-frakturer.
English: Flushing is usually described as flushing or hot flush, but can include other events (e.g. warmth, redness, itching, and burning sensation).
Danish: Rødme beskrives sædvanligvis som rødme eller hedestigning, men kan inkludere andre gener (f.eks. varme, rødlige pletter, kløe og brændende fornemmelse).
English: On the basis of the scientific conclusions for dimethyl fumarate (multiple sclerosis) the CHMP is of the opinion that the benefit-risk balance of the medicinal product(s) containing dimethyl fumarate (multiple sclerosis) is unchanged subject to the proposed changes to the product information.
Danish: På baggrund af de videnskabelige konklusioner for dimethylfumarat (multipel sklerose) er CHMP af den opfattelse, at benefit/risk-forholdet for det lægemiddel/de lægemidler, der indeholder dimethylfumarat (multipel sklerose), forbliver uændret under forudsætning af, at de foreslåede ændringer indføres i produktinformationen.
English: Symptoms may include new or worsening weakness on one side of the body; clumsiness; changes in vision, thinking, or memory; or confusion or personality changes lasting for more than several days.
Danish: Symptomerne kan inkludere ny eller forværret svaghed i den ene side af kroppen, klodsethed, synsændringer, ændret tankevirksomhed eller hukommelse, forvirring eller personlighedsforandringer, der varer mere end nogle dage.
English: The relevance of these findings to human risk is unknown.
Danish: Relevansen af disse fund for risikoen hos mennesker kendes ikke.
English: Four per cent (4%) of patients treated with Tecfidera discontinued due to gastrointestinal events.
Danish: Fire procent (4%) af patienterne behandlet med Tecfidera afbrød behandlingen pga. gastrointestinale hændelser.
English: Study 2 contained a rater-blinded (i.e. study physician/ investigator assessing the response to study treatment was blinded) reference comparator of glatiramer acetate.
Danish: Studie 2 inkluderede glatirameracetat som undersøgelsesblindet (dvs. at den studieansvarlige læge/investigatoren, der vurderede responsen på studiebehandlingen, var blindet) referencekomparator.
English: These events may occur at any time during treatment.
Danish: Disse tilfælde kan forekomme når som helstunder behandlingen.
English: Subjects with progressive forms of MS were not included in these studies.
Danish: Patienter med progressiv multipel sklerose deltog ikke i disse studier.
English: It is not known whether the active substance of Tecfidera passes into breast milk.
Danish: Det vides ikke, om det aktive stof i Tecfidera udskilles i modermælk.
English: Herpes zoster infections
Danish: Herpes zoster-infektioner
English: Based on clinical pharmacology studies, no dose adjustments are needed (see section 5.2).
Danish: Baseret på kliniske, farmakologiske studier er dosisjustering ikke nødvendig (se pkt.
English: Dimethyl fumarate demonstrated therapeutic activity in multiple models of inflammatory and neuroinflammatory injury.
Danish: Dimethylfumarat demonstrerede terapeutisk aktivitet i flere modeller med inflammatoriske eller neuroinflammatoriske skader.
English: This resulted in a minimal accumulation of exposure yielding an increase in the median Cmax of 12% compared to the twice daily dosing (1.72 mg/l for twice daily compared to 1.93 mg/l for three times daily) with no safety implications.
Danish: Dette resulterede i en minimal eksponeringsakkumulation, som gav en stigning i den mediane Cmax på 12% sammenlignet med dosering to gange dagligt (1,72 mg/l for dosering to gange dagligt sammenlignet med 1,93 mg/l for dosering tre gange dagligt) uden sikkerhedsimplikationer.
English: Subjects received Tecfidera 120 mg twice a day for 7 days followed by 240 mg twice a day for 24 weeks.
Danish: Patienterne fik 120 mg Tecfidera to gange dagligt i 7 dage efterfulgt af 240 mg to gange dagligt i 24 uger.
English: Assessment of renal function (e.g. creatinine, blood urea nitrogen and urinalysis) is recommended prior to treatment initiation, after 3 and 6 months of treatment, every 6 to 12 months thereafter and as clinically indicated.
Danish: Vurdering af nyrefunktion (f.eks. kreatinin, blodureanitrogen og urinundersøgelse) anbefales inden behandlingsstart, 3 og 6 måneder efter behandlingsstart og derefter hver 6. til 12. måned samt på klinisk indikation.
English: In humans, dimethyl fumarate is extensively metabolised with less than 0.1% of the dose excreted as unchanged dimethyl fumarate in urine.
Danish: Hos mennesker metaboliseres dimethylfumarat i vidt omfang, og under 0,1% af dosis udskilles som umetaboliseret dimethylfumarat i urinen.
English: No malformations were observed at any dose of dimethyl fumarate in rats or rabbits.
Danish: Der blev ikke observereret misdannelser ved nogen dosis af dimethylfumarat hos rotter eller kaniner.
English: Dimethyl fumarate has been shown to up regulate Nrf2-dependent antioxidant genes in patients (e.g. NAD(P)H dehydrogenase, quinone 1; [NQO1]).
Danish: Det er vist, at dimethylfumarat opregulerer Nrf2afhængige antioxidantgener hos patienter (f.eks. NAD(P)H-dehydrogenase, quinon 1; [NQO1]).
English: Capsule contents (enteric-coated microtablets)
Danish: Kapselindhold (syreresistente mikrotabletter)
English: Data from preclinical studies do not suggest that dimethyl fumarate would be associated with an increased risk of reduced fertility (see section 5.3).
Danish: Data fra prækliniske studier tyder ikke på, at dimethylfumarat er forbundet med en øget risiko for nedsat fertilitet (se pkt.
English: No untoward clinical consequences were observed in clinical trials.
Danish: Der blev ikke observeret nogen negative kliniske konsekvenser i de kliniske forsøg.
English: No interaction studies have been performed with oral contraceptives containing other progestogens, however an effect of Tecfidera on their exposure is not expected.
Danish: Der er ikke udført interaktionsstudier med orale præventionsmidler med andre progestogener, men det forventes ikke, at Tecfidera påvirker deres virkning.
English: The pharmacokinetic profile of 240 mg dimethyl fumarate twice a day was evaluated in a small, openlabel, uncontrolled study in patients with RRMS aged 13 to 17 years (n=21).
Danish: Dimethylfumarats farmakokinetiske profil ved en dosis på 240 mg to gange dagligt blev evalueret i et lille, åbent, ikke kontrolleret studie med patienter i alderen 13 til 17 år med RRMS (n=21).
English: A short course of treatment with 75 mg non-enteric coated acetylsalicylic acid may be beneficial in patients affected by intolerable flushing (see section 4.5).
Danish: Et kort behandlingsforløb med 75 mg acetylsalicylsyre uden entero-overtræk kan gavne patienter, der er påvirket af intolerabel rødme (se pkt.
English: - 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)
Danish: Forekomsten af bivirkninger herunder udtrykkes i henhold til følgende kategorier: - Meget almindelig (≥ 1/10) - Almindelig (≥ 1/100 til < 1/10) - Ikke almindelig (≥ 1/1.000 til < 1/100) - Sjælden (≥ 1/10.000 til < 1/1.000) - Meget sjælden (< 1/10.000) - Ikke kendt (hyppighed kan ikke estimeres ud fra forhåndenværende data)
English: Do not divide, crush, dissolve, suck or chew the capsule as this may increase some side effects.
Danish: Kapslen må ikke deles, knuses, opløses, suttes eller tygges, idet dette kan øge hyppigheden af nogle af bivirkningerne.
English: Cases of overdose with Tecfidera have been reported.
Danish: Der er rapporteret tilfælde af overdosering med Tecfidera.
English: Elevations in transaminases ≥3 times ULN with concomitant elevations in total bilirubin >2 times ULN, were not observed in placebo-controlled studies.
Danish: Forhøjede aminotransferaser ≥ 3 gange ULN med samtidige forhøjelser i totalt bilirubin > 2 gange ULN blev ikke observeret i placebokontrollerede studier.
English: Tecfidera should not be used during breast-feeding.
Danish: Tecfidera bør ikke anvendes under amning.
English: Pharmacokinetic data were obtained in subjects with multiple sclerosis and healthy volunteers.
Danish: Farmakokinetiske data er bestemt hos patienter med multipel sklerose og hos raske frivillige.
English: Typical symptoms associated with PML are diverse, progress over days to weeks, and include progressive weakness on one side of the body or clumsiness of limbs, disturbance of vision, and changes in thinking, memory, and orientation leading to confusion and personality changes.
Danish: Typiske symptomer forbundet med PML er forskellige, udvikles i løbet af dage eller uger og omfatter progressiv svaghed i den ene side af kroppen eller klodsethed af lemmer, synsforstyrrelser og ændret tankegang, hukommelse og orientering, hvilket fører til forvirring og personlighedsændringer.
English: This could cause inflammation of the stomach (gastritis), especially in people already prone to gastritis.
Danish: Dette kan medføre irritation i maven, især hos personer der allerede har tilbøjelighed til dette.
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS HEAT SEALED BLISTER CARD
Danish: MINDSTEKRAV TIL MÆRKNING PÅ BLISTER ELLER STRIP VARMEFORSEGLET BLISTERKORT
English: Tecfidera is a medicine that contains the active substance dimethyl fumarate.
Danish: Tecfidera er medicin, der indeholder det aktive stof dimethylfumarat.
English: 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.
Danish: 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.
English: Dimethyl fumarate has not been studied in patients with pre-existing low lymphocyte counts and caution should be exercised when treating these patients.
Danish: Dimethylfumarat er ikke blevet undersøgt hos patienter med eksisterende lave lymfocyttal, og der skal udvises forsigtighed ved behandling af disse patienter.
English: 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.
Danish: I kliniske studier oplevede 3 ud af i alt 2.560 patienter behandlet med dimethylfumarat alvorlig rødme, der formodentlig var overfølsomheds- eller anafylaktoide reaktioner.
English: 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.
Danish: 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.
English: Potassium hydroxide Black iron oxide (E172)
Danish: Kaliumhydroxid Sort jernoxid (E172)
English: However, should flushing be accompanied by a red rash or hives and you get any of these symptoms:
Danish: Hvis rødmen ledsages af et rødt udslæt eller nældefeber, og du samtidig får et eller flere af følgende symptomer:
English: In the testes, degeneration of the seminiferous epithelium was seen in rats and dogs.
Danish: I testis blev der observeret degeneration af det seminiferøse epitel hos rotter og hunde.
English: 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).
Danish: I kliniske studier med psoriasis-patienter påvirkede dimethylfumarat lymfocytfenotyper via en nedregulering af proinflammatoriske cytokinprofiler (TH1, TH17) og viste tendens til antiinflammatorisk produktion (TH2).
English: In vitro CYP induction studies did not demonstrate an interaction between Tecfidera and oral contraceptives.
Danish: In vitro-studier af CYP-induktion viste ikke interaktion mellem Tecfidera og p-piller.
English: 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).
Danish: 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).
English: DK-3400 Hillerod
Danish: DK-3400 Hillerød
English: 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.
Danish: 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.
English: 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.
Danish: 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.
English: 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.
Danish: 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.
English: After 7 days, the dose should be increased to the recommended maintenance dose of 240 mg twice a day (see section 4.4).
Danish: Efter 7 dage øges dosis til den anbefalede vedligeholdelsesdosis på 240 mg to gange dagligt (se pkt.
English: In subjects with multiple sclerosis, two 240 mg doses were administered 4 hours apart as part of a three times a day dosing regimen.
Danish: Patienter med multipel sklerose fik to doser på 240 mg med 4 timers mellemrum som en del af et tre gange dagligt dosisregime.
English: The incidence of serious gastrointestinal events, including gastroenteritis and gastritis, was seen in 1% of patients treated with Tecfidera (see section 4.2).
Danish: Alvorlige gastrointestinale hændelser, herunder gastroenteritis og gastritis, blev set hos 1% af patienterne behandlet med Tecfidera (se pkt.
English: 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.
Danish: 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.
English: In Study 1, patients had the following median baseline characteristics: age 39 years, disease duration 7.0 years, EDSS score 2.0.
Danish: I studie 1 havde patienterne følgende mediane baseline-værdier: Alder 39 år, sygdomsvarighed 7,0 år, EDSS-score 2,0.
English: In Study 2, patients had the following median baseline characteristics: age 37 years, disease duration 6.0 years, EDSS score 2.5.
Danish: I studie 2 havde patienterne følgende mediane baseline-værdier: Alder 37 år, sygdomsvarighed 6,0 år, EDSS-score 2,5.
English: 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.
Danish: 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.
English: 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.
Danish: 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.