FrancophonIA/ELRC3.0 huggingface dataset:
English: In mice, the incidence of renal tubular carcinoma was increased at 75 mg/kg/day, at equivalent exposure (AUC) to the recommended human dose.
Danish: Hos musene var hyppigheden af renalt tubulært karcinom øget ved 75 mg/kg/dag, svarende til eksponeringen (AUC) ved den anbefalede humane dosis.
English: PML cases have occurred with dimethyl fumarate and other medicinal products containing fumarates in the setting of moderate to severe prolonged lymphopenia.
Danish: Der er observeret PML med dimethylfumarat og andre lægemidler, der indeholder fumarater, hos patienter med moderat til svær, langvarig lymfopeni.
English: 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.
Danish: Benefit/risk for patienter med lymfocyttal ≥ 0,5x109/l og < 0,8x109/l i mere end 6 måneder skal vurderes.
English: Changes in renal laboratory tests have been seen in clinical trials in subjects treated with dimethyl fumarate (see section 4.8).
Danish: Der er set ændringer i laboratorieværdier på nyreparametre i kliniske forsøg hos patienter behandlet med dimethylfumarat (se pkt.
English: The active substance is dimethyl fumarate.
Danish: Aktivt stof: dimethylfumarat.
English: The effect of Tecfidera on the ability to drive or use machines is not known.
Danish: Virkningen af Tecfidera på din evne til at føre motorkøretøjer og betjene maskiner er ikke kendt.
English: Patients treated with Tecfidera may develop severe prolonged lymphopenia (see section 4.8).
Danish: Patienter behandlet med Tecfidera kan udvikle svær, langvarig lymfopeni (se pkt.
English: Discontinuations due to elevated hepatic transaminases were <1% and similar in patients treated with Tecfidera or placebo.
Danish: Seponering på grund af forhøjede leveraminotransferaser var < 1% og sammenlignelig hos patienter behandlet med Tecfidera og placebo.
English: 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.
Danish: 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.
English: The contribution of prior immunosuppressive therapy to the development of PML in dimethyl fumarate treated patients is unknown.
Danish: Det er ukendt, om tidligere immunsuppressiv behandling kan have indflydelse på udviklingen af PML hos patienter behandlet med dimethylfumarat.
English: Hypoxia1
Danish: Hypoksi1
English: 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.
Danish: Hos mennesker metaboliseres dimethylfumarat ekstensivt af esteraser, inden det når systemkredsløbet, og der sker en yderligere metabolisering vha. tricarboxylsyrecyklussen uden involvering af CYPsystemet.
English: Interruption of Tecfidera should be considered in patients with lymphocyte counts <0.5x109/L persisting for more than 6 months.
Danish: Afbrydelse af behandlingen med Tecfidera bør overvejes hos patienter med lymfocyttal < 0,5x109/l i mere end 6 måneder.
English: Lymphocyte counts <0.5x109/l were observed in <1% of patients treated with placebo and 6% of patients treated with Tecfidera.
Danish: Lymfocyttal < 0,5x109/l blev observeret hos < 1% af de placebobehandlede patienter hos og 6% af de Tecfiderabehandlede patienter.
English: In the majority of patients who experienced gastrointestinal events, it was mild or moderate in severity.
Danish: Hos hovedparten af de patienter, der oplevede gastrointestinale gener, var de lette til moderate.
English: Tecfidera has not been studied in patients with renal or hepatic impairment.
Danish: Tecfidera er ikke blevet undersøgt hos patienter med nyre- eller leverinsufficiens.
English:  Call your doctor straight away if you experience any of these symptoms Severe Allergic reactions
Danish:  Ring straks til din læge, hvis du får nogle af disse symptomer
English: - 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
Danish: - 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.
English: 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).
Danish: Der blev ikke observeret øget forekomst af alvorlige infektioner hos patienter med lymfocyttal < 0,8x109/l eller < 0,5x109/l (se pkt.
English: Further metabolism occurs through the tricarboxylic acid cycle, with no involvement of the cytochrome P450 (CYP) system.
Danish: Yderligere metabolisering sker gennem tricarboxylsyrecyklussen uden involvering af CYP-systemet.
English: 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.
Danish: 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.
English: Data from healthy volunteer studies suggest that dimethyl fumarate-associated flushing is likely to be prostaglandin mediated.
Danish: Data fra studier med raske frivillige tyder på, at rødme relateret til dimethylfumarat sandsynligvis er medieret via prostaglandin.
English: 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.
Danish: 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.
English: PML has occurred in the setting of moderate to severe prolonged lymphopenia (see section 4.4).
Danish: PML er opstået i forbindelse med moderat til svær, langvarig lymfopeni (se pkt.
English: 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.
Danish: 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.
English: 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.
Danish: 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.
English: Effects on the immune system In preclinical and clinical studies, dimethyl fumarate demonstrated anti-inflammatory and immunomodulatory properties.
Danish: I prækliniske og kliniske studier udviste dimethylfumarat antiinflammatoriske og immunmodulerende egenskaber.
English: 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).
Danish: 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.
English: 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.
Danish: Idet dimethylfumarat og monomethylfumarat metaboliseres ved hjælp af esteraser uden involvering af CYP-systemet, blev farmakokinetikken hos individer med leverinsufficiens ikke evalueret.
English: Herpes zoster (shingles) may occur with Tecfidera treatment.
Danish: Herpes zoster (helvedesild) kan forekomme ved behandling med Tecfidera.
English: 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)
Danish: 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
English: 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.
Danish: 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).
English: Grade 2 and 3 lymphopenia prevailed in subjects with concurrent lymphocytopenia.
Danish: Lymfopeni af grad 2 og 3 var udbredt hos patienter med samtidig lymfocytopeni.
English: Dimethyl fumarate was negative in the in vivo micronucleus assay in the rat.
Danish: Dimethylfumarat var negativ i in vivo-mikronukleusanalysen hos rotter.
English: MS, such as fingolimod, natalizumab, teriflunomide, alemtuzumab, ocrelizumab or cladribine, or some commonly used cancer treatments (rituximab or mitoxantrone).
Danish: - 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)
English: Cases of herpes zoster have occurred with Tecfidera.
Danish: Der er forekommet tilfælde af herpes zoster med Tecfidera.
English: The starting dose is 120 mg twice a day.
Danish: Startdosis er 120 mg to gange dagligt.
English: 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
Danish: 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
English: Teл: +359 2 962 12 00
Danish: ТП ЕВОФАРМА Teл: +359 2 962 12 00
English: 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).
Danish: Hos de patienter, der måtte opleve rødme eller gastrointestinale bivirkninger, kan indtagelse af Tecfidera sammen med mad forbedre tolerancen (se pkt.
English: What Tecfidera is and what it is used for What Tecfidera is
Danish: Virkning og anvendelse Hvad Tecfidera er
English: Starting dose 120 mg twice a day.
Danish: Startdosis 120 mg to gange dagligt.
English: 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).
Danish: 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.
English: MedDRA System Organ Class Adverse reaction
Danish: MedDRA-systemorganklasse Bivirkning
English: The mechanism of dimethyl fumarate induced anaphylaxis is unknown.
Danish: Mekanismen bag anafylaksi induceret af dimethylfumarat er ikke kendt.
English: Regular dose 240 mg twice a day.
Danish: Normal dosis 240 mg to gange dagligt.
English: 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.
Danish: 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).
English: 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.
Danish: 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.
English: Green and white gastro-resistant hard capsules, size 0, printed with ‘BG-12 120 mg' containing microtablets.
Danish: Grønne og hvide, hårde enterokapsler, størrelse 0, præget med ‘BG-12 120 mg', der indeholder mikrotabletter.
English: 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
Danish: Oplys især, hvis du tager følgende: - medicin, der indeholder fumarsyreestere (fumarater), som anvendes til behandling af psoriasis
English: 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.
Danish: 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).
English: 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.
Danish: 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.
English: 14 gastro-resistant hard capsules
Danish: 14 hårde enterokapsler
English: Immune system disorders
Danish: Virkninger på immunsystemet
English: 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).
Danish: 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.
English: Caution should be used when treating patients with severe renal or severe hepatic impairment (see section 4.4).
Danish: Der skal udvises forsigtighed ved behandling af patienter med alvorlig nyre- eller leverinsufficiens (se pkt.
English: Tηλ: +30 210 8771500
Danish: Genesis Pharma SA Tηλ: +30 210 8771500
English: In clinical studies (both controlled and uncontrolled), 9% of patients had lymphocyte counts ≥0.5 x
Danish: I kliniske studier (både kontrollerede og ikke kontrollerede) havde 9% af patienterne lymfocyttal ≥ 0,5x109/l og < 0,8x109/l i mindst 6 måneder.
English: 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.
Danish: 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.
English: How to take Tecfidera
Danish: Sådan skal du tage Tecfidera
English: Package leaflet: Information for the patient Tecfidera 120 mg gastro-resistant hard capsules Tecfidera 240 mg gastro-resistant hard capsules dimethyl fumarate
Danish: Indlægsseddel: Information til patienten Tecfidera 120 mg enterokapsler, hårde Tecfidera 240 mg enterokapsler, hårde dimethylfumarat
English: This involves balancing the benefit of breast-feeding for your child, and the benefit of therapy for you.
Danish: Denne overvejelse vil afveje fordelen for dit barn ved at amme og fordelen for dig ved behandling.
English: 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
Danish: (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
English: 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.
Danish: 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.
English: Oral administration of dimethyl fumarate to male rats at 75, 250, and 375 mg/kg/day prior to and during mating had no effects on male fertility up to the highest dose tested (at least 2 times the recommended dose on an AUC basis).
Danish: Oral administration af dimethylfumarat til hanrotter i doser på 75, 250 og 375 mg/kg/dag før og under parring havde ingen virkning på hannernes fertilitet op til den højeste testede dosis (mindst 2 gange den anbefalede dosis baseret på AUC).
English: Green gastro-resistant hard capsules, size 0, printed with ‘BG-12 240 mg' containing microtablets.
Danish: Grønne, hårde enterokapsler, størrelse 0, præget med ‘BG-12 240 mg', der indeholder mikrotabletter.
English: Tue.
Danish: Tirs.
English: Oral administration of dimethyl fumarate at 25, 75, and 150 mg/kg/day to pregnant rabbits during organogenesis had no effect on embryo-fetal development and resulted in reduced maternal body weight at 7 times the recommended dose and increased abortion at 16 times the recommended dose, on an AUC basis.
Danish: Oral administration af dimethylfumarat i doser på 25, 75 og 150 mg/kg/dag til drægtige kaniner under organogenesen havde ingen virkning på den embryo-føtale udvikling, men resulterede i reduceret maternel kropsvægt ved 7 gange den anbefalede dosis og øgede antallet af aborter ved 16 gange den anbefalede dosis - baseret på AUC.
English: If you have taken too many capsules, talk to your doctor straight away.
Danish: Kontakt omgående din læge, hvis du har taget for mange kapsler.
English: Oral administration of dimethyl fumarate to female rats at 25, 100, and 250 mg/kg/day prior to and during mating, and continuing to Day 7 of gestation, induced reduction in the number of estrous stages per 14 days and increased the number of animals with prolonged diestrus at the highest dose tested (11 times the recommended dose on an AUC basis).
Danish: Oral administration af dimethylfumarat til hunrotter i doser på 25, 100 og 250 mg/kg/dag før og under parring og fortsat til den 7. gestationsdag, inducerede en reduktion i antallet af østrusstadier efter 14 dage og øgede antallet af dyr med forlænget diøstrus ved den højeste testede dosis (11 gange den anbefalede dosis baseret på AUC).
English: Gastrointestinal events tend to begin early in the course of treatment (primarily during the first month) and in patients who experience gastrointestinal events, these events may continue to occur intermittently throughout treatment with Tecfidera.
Danish: Gastrointestinale gener er tilbøjelige til at begynde tidligt i behandlingen (primært den første måned) og kan hos patienter, som oplever gastrointestinelle gener, optræde med mellemrum under hele behandlingen.
English: Tecfidera 240 mg: Each capsule contains 240 mg of dimethyl fumarate.
Danish: Tecfidera 240 mg: Hver enterokapsel indeholder 240 mg dimethylfumarat.
English: Silica, colloidal anhydrous
Danish: Silica, kolloid, vandfri
English: Hot flush
Danish: Rødme (flushing)
English: Flushing and gastrointestinal events tend to begin early in the course of treatment (primarily during the first month) and in patients who experience flushing and gastrointestinal events, these events may continue to occur intermittently throughout treatment with Tecfidera.
Danish: Rødme og gastrointestinale gener er tilbøjelige til at opstå tidligt i behandlingen (primært den første måned), og hos patienter, der får disse bivirkninger, kan de forekomme med mellemrum under den fortsatte behandling.
English: Tecfidera is indicated for the treatment of adult patients with relapsing remitting multiple sclerosis (see section 5.1 for important information on the populations for which efficacy has been established).
Danish: Tecfidera er indiceret til behandling af voksne patienter med relapsing-remitterende multipel sklerose (se pkt.
English: Rate ratio
Danish: Middel læsionsratio
English: Tecfidera 120 mg: Each capsule contains 120 mg of dimethyl fumarate.
Danish: Tecfidera 120 mg: Hver enterokapsel indeholder 120 mg dimethylfumarat.
English: The forestomach in rodents does not have a human counterpart.
Danish: Den forreste del af maven hos gnavere findes ikke tilsvarende hos mennesker.
English: Oral administration of dimethyl fumarate at 25, 100, and 250 mg/kg/day to rats during pregnancy and lactation resulted in lower body weights in the F1 offspring, and delays in sexual maturation in F1 males at 11 times the recommended dose on an AUC basis.
Danish: Oral administration af dimethylfumarat ved doser på 25, 100 og 250 mg/kg/dag til rotter under drægtighed og laktation resulterede i lavere kropsvægt hos F1-afkommet og forsinket kønsmodning hos F1-hanner ved 11 gange den anbefalede dosis baseret på AUC.