FrancophonIA/ELRC3.0 huggingface dataset:
English: In two healthy volunteer studies, the occurrence and severity of flushing over the dosing period was reduced.
Danish: I to studier med raske frivillige blev forekomsten og sværhedsgraden af rødme reduceret i doseringsperioden.
English: If herpes zoster occurs, appropriate treatment for herpes zoster should be administered.
Danish: Dersom der forekommer herpes zoster, skal der administreres en egnet behandling mod herpes zoster.
English: Pharmacotherapeutic group: Antineoplastic and immunomodulating agents, ATC code: L04AX07
Danish: Farmakoterapeutisk klassifikation: Antineoplastiske og immunmodulerende midler, ATC-kode: L04AX07
English: Based on the mode of action of the active substance there are no theoretical reasons for any requirement for dose adjustments in the elderly.
Danish: Baseret på det aktive stofs virkningmekanisme er der intet teoretisk grundlag for, at dosisjustering hos ældre er nødvendig.
English: Currently available data are described in sections 4.8, 5.1, and 5.2 but no recommendation on a posology can be made.
Danish: 4.8, 5.1 og 5.2, men der kan ikke gives nogen anbefalinger vedrørende dosering.
English: The terminal half-life of monomethyl fumarate is short (approximately 1 hour) and no circulating monomethyl fumarate is present at 24 hours in the majority of individuals.
Danish: Den terminale halveringstid af monomethylfumarat er kort (cirka 1 time), og der er ingen cirkulerende monomethylfumarat til stede efter 24 timer hos flertallet af individerne.
English: During treatment with Tecfidera, simultaneous use of other fumaric acid derivatives (topical or systemic) should be avoided.
Danish: Under behandling med Tecfidera bør samtidig brug af andre fumarsyrederivater (topiske eller systemiske) undgås.
English: Patients receiving Tecfidera should be instructed to report symptoms of infections to a physician.
Danish: Patienter, der får Tecfidera, skal informeres om at indberette symptomer på infektioner til en læge.
English: Before you start Tecfidera, your doctor will do a blood test to count the number of your white blood cells and will check that your kidneys and liver are working properly.
Danish: Inden du starter med at tage Tecfidera, vil din læge tage en blodprøve og bestemme antallet af hvide blodlegemer i dit blod samt kontrollere, at dine nyrer og din lever fungerer korrekt.
English: The pharmacokinetics in patients aged 65 and over has not been studied.
Danish: Farmakokinetikken hos patienter fra og med 65 år er ikke blevet undersøgt.
English: MRI imaging may be considered as part of increased vigilance in patients considered at increased risk of PML.
Danish: MR-billeddiagnostik kan overvejes som en del af en nøjere overvågning af patienter, der menes at have en øget risiko for PML.
English: Having a low white blood cell count for a long period of time can increase your risk of infection, including a risk of a rare brain infection called progressive multifocal leukoencephalopathy (PML).
Danish: Har du et lavt antal hvide blodlegemer gennem længere tid, kan det øge din risiko for infektion, herunder risikoen for en sjælden hjerneinfektion kaldet progressiv multifokal leukoencefalopati (PML).
English: Severe active gastrointestinal disease
Danish: Alvorlig, aktiv gastrointestinal sygdom
English: If you forget to take Tecfidera
Danish: Hvis du har glemt at tage Tecfidera
English: Substances called ketones, which are naturally produced in the body, very commonly show up in urine tests while taking Tecfidera.
Danish: Stoffer, der kaldes ketoner, som kroppen producerer naturligt, er meget almindelige i urinanalyser under Tecfidera-behandling.
English: Mean and median lymphocyte counts remained within normal limits.
Danish: Middel og mediane lymfocyttal forblev inden for normalgrænserne.
English: MS is a long-term condition that affects the central nervous system (CNS), including the brain and the spinal cord.
Danish: MS er en kronisk sygdom, der påvirker centralnervesystemet (CNS), herunder hjernen og rygmarven.
English: Keep the blisters in the outer carton in order to protect from light.
Danish: Opbevar blisterpakningen i den ydre karton for at beskytte mod lys.
English: It should also be noted that a negative anti JCV antibody test (in the presence of normal lymphocyte counts) does not preclude the possibility of subsequent JCV infection.
Danish: Det skal også bemærkes, at en test, der er negativ for JCV-antistoffer (ved normale lymfocyttal), ikke udelukker muligheden for efterfølgende JCV-infektion.
English: Reddening of the face or body (flushing) is a very common side effect.
Danish: Rødme i ansigtet eller på kroppen er en meget almindelig bivirkning.
English: Tecfidera can generally be started immediately after discontinuation of interferon or glatiramer acetate.
Danish: Behandling med Tecfidera kan generelt indledes umiddelbart efter seponering af interferon eller glatirameracetat.
English: If lymphocyte count is found to be below the normal range, thorough assessment of possible causes should be completed prior to initiation of treatment with Tecfidera.
Danish: Hvis lymfocyttallet ligger under normalområdet, skal der foretages en grundig evaluering af mulige årsager, før behandlingen med Tecfidera indledes.
English: Tecfidera should be used during pregnancy only if clearly needed and if the potential benefit justifies the potential risk to the foetus.
Danish: Tecfidera bør kun anvendes under graviditet, hvis det er strengt nødvendigt, og den potentielle fordel for kvinden opvejer den potentielle risiko for fosteret.
English: The frequencies described in the table below are based on 769 patients treated with Tecfidera 240 mg twice a day and 771 patients treated with placebo
Danish: Hyppighederne, som beskrives i tabellen nedenfor, er baseret på 769 patienter behandlet med Tecfidera 240 mg to gange dagligt og 771 patienter behandlet med placebo.
English: - if you are allergic to dimethyl fumarate or any of the other ingredients of this medicine (listed in section 6).
Danish: - hvis du er allergisk over for dimethylfumarat eller et af de øvrige indholdsstoffer i Tecfidera (angivet i punkt 6).
English: As Tecfidera gastro-resistant hard capsules contain microtablets, which are protected by an enteric coating, absorption does not commence until they leave the stomach (generally less than 1 hour).
Danish: Idet de hårde Tecfidera-enterokapsler indeholder mikrotabletter, som er beskyttede af et syreresistent overtræk, absorberes de først, når de forlader maven (generelt under 1 time).
English: What you need to know before you take Tecfidera Do not take Tecfidera:
Danish: Det du skal vide, før du begynder at tage Tecfidera Tag ikke Tecfidera:
English: Treatment should not be restarted (see section 4.8).
Danish: Behandlingen må ikke genoptages (se pkt.
English: The annualised relapse rate for glatiramer acetate and placebo was 0.286 and 0.401 respectively in Study 2, corresponding to a reduction of 29% (p=0.013), which is consistent with approved prescribing information.
Danish: Den årlige attakrate for glatirameracetat og placebo var henholdsvis 0,286 og 0,401 i studie 2, svarende til en reduktion på 29% (p=0,013), hvilket er i overensstemmelse med de godkendte registreringsstudier.
English: Carcinogenicity studies of dimethyl fumarate were conducted for up to 2 years in mice and rats.
Danish: Der blev udført karcinogenicitetsstudier af dimethylfumarat i op til 2 år på mus og rotter.
English: When switching patients from another disease modifying therapy to Tecfidera, the half-life and mode of action of the other therapy should be considered in order to avoid an additive immune effect while at the same time, reducing the risk of reactivation of MS.
Danish: Når patienter skifter fra en anden sygdomsmodificerende behandling til Tecfidera, skal den anden terapis halveringstid og virkningsmekanisme tages i betragtning for at undgå en additiv immuneffekt og samtidig nedsætte risikoen for reaktivering af MS.
English: The adverse reactions are presented as MedDRA preferred terms under the MedDRA System Organ Class.
Danish: Bivirkningerne angives med MedDRA-foretrukne termer i henhold til MedDRA-systemorganklassen.
English: It is initially metabolised by esterases, which are ubiquitous in the gastrointestinal tract, blood and tissues, before it reaches the systemic circulation.
Danish: Indledningsvist metaboliseres det af esteraser, som findes alle steder i gastrointestinalkanal, blod og væv, inden det når systemkredsløbet.
English: Moderately low to very low lymphocyte counts - Lymphocyte counts (a type of white blood cell) may be decreased for a long period of time.
Danish: Moderat lave til meget lave lymfocyttal - Antallet af lymfocytter (en type hvide blodlegemer) kan være nedsat i en længere periode.
English: It is unknown whether dimethyl fumarate or its metabolites are excreted in human milk.
Danish: Det er ukendt, om dimethylfumarat eller dets metabolitter udskilles i human mælk.
English: In case of unclear symptoms Fanconi syndrome should be considered and appropriate examinations should be performed.
Danish: I tilfælde af uklare symptomer bør Fanconis syndrom overvejes, og passende undersøgelser foretages.
English: A single 240 mg 14C-dimethyl fumarate dose study identified glucose as the predominant metabolite in human plasma.
Danish: Et enkeltdosis-studie med 240 mg 14C-dimethylfumarat identificerede glucose som den dominerende metabolit i humant plasma.
English: In placebo-controlled and uncontrolled clinical studies, a total of 2,468 patients have received Tecfidera and been followed for periods up to 4 years with an overall exposure equivalent to 3,588 person-years.
Danish: I placebokontrollerede og ikke-kontrollerede kliniske studier har i alt 2.468 patienter fået Tecfidera, og de er blevet fulgt i en periode på op til 4 år med en total eksponering, der svarer til 3.588 personår.
English: PML can only occur in the presence of a JCV infection.
Danish: PML kan kun opstå, hvis patienten har JCV-infektion.
English: 1171 LP Badhoevedorp The Netherlands
Danish: Prins Mauritslaan 13 1171 LP Badhoevedorp Holland
English: The apparent volume of distribution following oral administration of 240 mg dimethyl fumarate varies between 60 L and 90 L. Human plasma protein binding of monomethyl fumarate generally ranges between 27% and 40%.
Danish: Det tilsyneladende distributionsvolumen efter oral administration af 240 mg dimethylfumarat varierer mellem 60 l og 90 l. Plasmaproteinbindingen af monomethylfumarat hos mennesker ligger generelt mellem 27% og 40%.
English: Taking into account the PRAC Assessment Report on the PSUR(s) for dimethyl fumarate (multiple sclerosis), the scientific conclusions of CHMP are as follows:
Danish: Under hensyntagen til PRAC's vurderingsrapport om PSUR'en/PSUR'erne for dimethylfumarat (multipel sklerose) er CHMP nået frem til følgende videnskabelige konklusioner:
English: The safety of Tecfidera in paediatric patients with multiple sclerosis below the age of 18 has not yet been established.
Danish: Tecfideras sikkerhed hos pædiatriske patienter under 18 år med multipel sklerose er endnu ikke klarlagt.
English: The median number of new or newly enlarging T2 hyperintense lesions changed from 2 in the 8 week pre-treatment evaluation period to 0 in the final 8 weeks of the treatment period (median change -2, n=16).
Danish: Medianantallet af nye eller nyligt forstørrede hyperintense T2-læsioner ændrede sig fra 2 i evalueringsperioden på 8 uger forud for behandlingen til 0 de sidste 8 uger af behandlingsperioden (medianændring -2, n=16).
English: Progression might involve symptoms such as polyuria, polydipsia and proximal muscle weakness.
Danish: Progression kan omfatte symptomer såsom polyuri, polydipsi og proksimal muskelsvaghed.
English: Methacrylic acid - methyl methacrylate copolymer (1:1) Methacrylic acid - ethyl acrylate copolymer (1:1) dispersion 30% Simeticone
Danish: Methacrylsyre-methylmethacrylat copolymer (1:1) Methacrylsyre-ethylacrylat copolymer (1:1) dispersion 30% Simeticon
English: No studies on the ability to drive and use machines have been conducted but no effects potentially influencing this ability were found to be related to dimethyl fumarate in clinical studies.
Danish: Der er ikke foretaget studier af virkningen på evnen til at føre motorkøretøj og betjene maskiner, men der blev ikke set virkninger, der potentielt påvirker denne evne, i relation til dimethylfumarat i kliniske studier.
English: The lower fetal weight and delayed ossification were considered secondary to maternal toxicity (reduced body weight and food consumption).
Danish: Den lavere fostervægt og den forsinkede ossifikation blev betragtet som værende sekundært til maternel toksicitet (reduceret kropsvægt og fødeindtagelse).
English: Exhalation of CO2 is the primary route of dimethyl fumarate elimination accounting for 60% of the dose.
Danish: CO2-udskillelse er den primære eliminationsvej for dimethylfumarat og redegør for 60% af dosis.
English: The majority of cases were non-serious, however, serious cases, including disseminated herpes zoster, herpes zoster ophthalmicus, herpes zoster oticus, herpes zoster infection neurological, herpes zoster meningoencephalitis and herpes zoster meningomyelitis have been reported.
Danish: De fleste af tilfældene var ikke alvorlige, men der er indberettet alvorlige tilfælde, herunder dissemineret herpes zoster, herpes zoster ophthalmicus, herpes zoster oticus, neurologisk herpes zoster-infektion, herpes zoster meningoencefalitis og herpes zoster-meningomyelitis.
English: There was no case explicitly reporting Fanconi syndrome in the Multiple Sclerosis (MS) indication; however, it has been reported in literature that that female patients with psoriasis treated long-term with fumaric acid esters seem to be at particular risk.
Danish: Der var ingen rapporter om eksplicitte tilfælde af Fanconis syndrom ved indikationen multipel sklerose (MS), men i litteraturen er det dog rapporteret, at kvindelige patienter med psoriasis, som har fået langtidsbehandling med fumarsyreestere, ser ud til at have en særlig risiko.
English: In the placebo-controlled studies most patients (>98%) had normal lymphocyte values prior to initiating treatment.
Danish: I de placebokontrollerede studier havde de fleste patienter (> 98%) normale lymfocytværdier inden behandlingsstart.
English: This leaflet was last revised in {MM YYYY}.
Danish: Denne indlægsseddel blev senest ændret {MM/ÅÅÅÅ}.
English: The most important signs are: proteinuria, glucosuria (with normal blood sugar levels), hyperaminoaciduria and phosphaturia (possibly concurrent with hypophosphatemia).
Danish: De vigtigste tegn er: proteinuri, glukosuri (med normalte blodsukkerniveauer), hyperaminoaciduri og fosfaturi (muligvis samtidigt med hypofosfatæmi).
English: Monitor patients taking Tecfidera for signs and symptoms of herpes zoster especially when concurrent lymphocytopenia is reported.
Danish: Overvåg patienter, der tager Tecfidera, for tegn og symptomer på herpes zoster, især hvis der er rapporteret samtidig lymfocytopeni.
English: Temporary dose reduction to 120 mg twice a day may reduce the occurrence of flushing and gastrointestinal adverse reactions.
Danish: En midlertidig dosisreduktion til 120 mg to gange dagligt kan reducere forekomsten af rødme og gastrointestinale bivirkninger.
English: Patients should be instructed to discontinue Tecfidera and seek immediate medical care if they experience signs or symptoms of anaphylaxis.
Danish: Patienterne skal informeres om, at de skal afbryde behandlingen og straks søge lægehjælp, hvis de oplever tegn eller symptomer på anafylaksi.
English: In the event of overdose, it is recommended that symptomatic supportive treatment be initiated as clinically indicated.
Danish: I tilfælde af overdosering anbefales det, at symptomatisk, understøttende behandling indledes iht.
English: The experience in uncontrolled clinical trials is consistent with the experience in the placebo-controlled clinical trials.
Danish: Erfaringen fra ikkekontrollerede kliniske forsøg svarer til erfaringen fra de placebokontrollerede kliniske forsøg.
English: In an ongoing long-term extension study, in which 1736 MS patients are treated with Tecfidera, approximately 5% experienced one or more events of herpes zoster, the majority of which were mild to moderate in severity.
Danish: I et igangværende langtidsforlængelsesstudie, hvor 1.736 MS-patienter bliver behandlet med Tecfidera, oplevede cirka 5 % af patienterne et eller flere tilfælde af herpes zoster, hvoraf hovedparten var af let til moderat sværhedsgrad.
English: The patient may take the missed dose only if they leave 4 hours between doses.
Danish: Patienten må kun tage den glemte dosis, hvis doserne kan tages med 4 timers mellemrum.
English: Renal tubule epithelial regeneration, suggestive of injury, was observed in all species.
Danish: Renal tubulær epitelregeneration, som er tegn på skader, blev observeret hos alle arter.
English: Capsule print (black ink)
Danish: Kapselprægning (sort blæk)
English: There is no relevant use of Tecfidera in children aged less than 10 years for the indication of relapsing remitting multiple sclerosis.
Danish: Det er ikke relevant at bruge Tecfidera til børn under 10 år på indikationen relapsing-remitterende multipel sklerose.
English: Consumption of large quantities of strong alcoholic drinks (more than 30% alcohol by volume) should be avoided within an hour of taking Tecfidera, as alcohol may lead to increased frequency of gastrointestinal adverse reactions.
Danish: Indtagelse af store mængder stærke alkoholiske drikke (mere end 30 volumen-% alkohol) bør undgås inden for en time efter indtagelse af Tecfidera, da alkohol kan medføre en øget hyppighed af gastrointestinale bivirkninger.
English: These data should be considered cautiously regarding limitations of the study design (no control arm, pre- versus post-dose comparison) (see section 4.2).
Danish: Disse data skal betragtes med forsigtighed under hensyntagen til begrænsningerne i studiets design (ingen kontrolgruppe og sammenligning af før med efter dosering) (se pkt.
English: Lymphocyte counts should be followed until recovery.
Danish: Lymfocyttallene skal følges indtil normalisering.
English: Swallow each capsule whole, with some water.
Danish: Hver enterokapsel skal sluges hel med lidt vand.
English: There are no or limited amount of data from the use of dimethyl fumarate in pregnant women.
Danish: Der er ingen eller utilstrækkelige data fra anvendelse af dimethylfumarat til gravide kvinder.
English: The mechanism by which dimethyl fumarate exerts therapeutic effects in multiple sclerosis is not fully understood.
Danish: Den mekanisme, hvormed dimethylfumarat udøver en terapeutisk effekt ved multipel sklerose, er ikke til fulde klarlagt.
English: Based on the results of Analysis of Variance (ANOVA), body weight is the main covariate of exposure (by Cmax and AUC) in RRMS subjects, but did not affect safety and efficacy measures evaluated in the clinical studies.
Danish: På basis af resultaterne i variansanalysen (ANOVA) er kropsvægt hovedkovariansen for eksponering (Cmax og AUC) hos patienter med RRMS, men den havde ingen indflydelse på sikkerheden og virkningen i de kliniske studier.
English: No clinical data are available on the efficacy and safety of live attenuated vaccines in patients taking Tecfidera.
Danish: Der foreligger ingen kliniske data om effekt og sikkerhed ved levende, svækkede vacciner hos patienter, der får Tecfidera.
English: Tecfidera has not been studied in combination with anti-neoplastic or immunosuppressive therapies and caution should, therefore, be used during concomitant administration.
Danish: Tecfidera er ikke blevet undersøgt i kombination med anti-neoplastiske eller immunsuppressive terapier, og der skal derfor udvises forsigtighed ved samtidig administration.
English: In the post-marketing setting most cases of herpes zoster infection were non-serious and resolved with treatment.
Danish: Efter markedsføring var de fleste tilfælde af herpes zoster-infektion ikke alvorlige og ophørte ved behandling.
English: Limited data is available on ALC in patients with herpes zoster infection in the post-marketing setting.
Danish: Der er begrænsede tilgængelige data om ALC hos patienter med herpes zoster-infektion efter markedsføringen.
English: Consumption of moderate amounts of alcohol did not alter exposure to dimethyl fumarate and was not associated with an increase in adverse reactions.
Danish: Indtagelse af moderate mængder alkohol øgede ikke eksponeringen for dimethylfumarat og var ikke forbundet med flere bivirkninger.
English: Most subjects, including those who experienced a serious herpes zoster infection, had lymphocyte counts above the lower limit of normal.
Danish: De fleste patienter, herunder de, der oplevede en alvorlig herpes zoster-infektion, havde lymfocyttal over den nedre normalgrænse.
English: Symptoms may include dyspnoea, hypoxia, hypotension, angioedema, rash or urticaria.
Danish: Symptomerne kan inkludere dyspnø, hypoksi, hypotension, angioødem, udslæt eller nældefeber.
English: Resolution of the adverse reactions has been observed after treatment was discontinued.
Danish: Det er observeret, at bivirkningerne ophørte efter seponering af behandlingen.
English: Therefore, all pharmacokinetic analyses related to dimethyl fumarate were performed with plasma monomethyl fumarate concentrations.
Danish: Derfor blev alle farmakokinetiske analyser i relation til dimethylfumarat udført med monomethylfumaratkoncentrationer i plasma.
English: You should inform your doctor immediately if you suspect you have any symptoms of shingles.
Danish: Du skal omgående informere lægen, hvis du har mistanke om, at du har symptomer på helvedesild.
English: Titanium dioxide (E171) Brilliant Blue FCF (E133) Yellow iron oxide (E172)
Danish: Titandioxid (E171) Brilliant Blue FCF (E133) Gul jernoxid (E172)
English: Among the 10 patients with MRI data between weeks 64 and week 72 of the extension study, the median number of subjects with new or newly enlarging T2 hyperintense lesions was 0 (range 0,2).
Danish: Blandt de 10 patienter med MRI-data mellem uge 64 og uge 72 af forlængelsesstudiet var medianantallet af patienter med nye eller nyligt forstørrede hyperintense T2-læsioner 0 (interval 0,2).
English: The other ingredients are microcrystalline cellulose, croscarmellose sodium, talc, silica colloidal anhydrous, magnesium stearate, triethyl citrate, methacrylic acid - methyl methacrylate copolymer (1:1), methacrylic acid - ethyl acrylate copolymer (1:1) dispersion 30%, simeticone, sodium laurilsulfate , polysorbate 80, gelatin, titanium dioxide (E171), brilliant blue FCF (E133), yellow iron oxide (E172), shellac, potassium hydroxide and black iron oxide (E172).
Danish: Øvrige indholdsstoffer: mikrokrystallinsk cellulose, croscarmellosenatrium, talcum, silica, kolloid, vandfri, magnesiumstearat, triethylcitrat, methacrylsyre-methylmethacrylat copolymer (1:1), methacrylsyre-ethylacrylat copolymer (1:1) dispension 30%, simeticon, natriumlaurilsulfat, polysorbat 80, gelatine, titandioxid (E171), brilliant blue FCF (E133), gul jernoxid (E172), shellac, kaliumhydroxid og sort jernoxid (E172).
English: 240 mg capsules: 56 or 168 capsules in PVC/PE/PVDC-PVC aluminium blister packs.
Danish: 240 mg kapsler: 56 eller 168 kapsler i PVC/PE/PVDC-PVC aluminium blisterpakninger.
English: Do not store above 30ºC Keep the blisters in the outer carton in order to protect from light
Danish: Må ikke opbevares ved temperaturer over 30 ºC Opbevar blisterpakningen i den ydre karton for at beskytte mod lys
English: In multiple sclerosis clinical studies, the concomitant treatment of relapses with a short course of intravenous corticosteroids was not associated with a clinically relevant increase of infection.
Danish: I kliniske studier af multipel sklerose blev samtidig kortvarig, intravenøs kortikosteroidbehandling af attakker ikke forbundet med en klinisk relevant stigning i infektioner.
English: Symptoms vary from patient to patient, but typically include walking difficulties, feeling off balance and visual difficulties (e.g. blurred or double vision).
Danish: Symptomerne varierer fra patient til patient, men omfatter typisk gangbesvær, balanceproblemer og synsforstyrrelser (f.eks. sløret syn eller dobbeltsyn).