natgillin/translations-raw huggingface dataset:
I tilfælde af overdosering anbefales det, at symptomatisk, understøttende behandling indledes iht. 
In the event of overdose, it is recommended that symptomatic supportive treatment be initiated as clinically indicated.
Erfaringen fra ikkekontrollerede kliniske forsøg svarer til erfaringen fra de placebokontrollerede kliniske forsøg. 
The experience in uncontrolled clinical trials is consistent with the experience in the placebo-controlled clinical trials.
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. 
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.
Patienten må kun tage den glemte dosis, hvis doserne kan tages med 4 timers mellemrum. 
The patient may take the missed dose only if they leave 4 hours between doses.
Renal tubulær epitelregeneration, som er tegn på skader, blev observeret hos alle arter. 
Renal tubule epithelial regeneration, suggestive of injury, was observed in all species.
Kapselprægning (sort blæk) 
Capsule print (black ink)
Det er ikke relevant at bruge Tecfidera til børn under 10 år på indikationen relapsing-remitterende multipel sklerose. 
There is no relevant use of Tecfidera in children aged less than 10 years for the indication of relapsing remitting multiple sclerosis.
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. 
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.
Disse data skal betragtes med forsigtighed under hensyntagen til begrænsningerne i studiets design (ingen kontrolgruppe og sammenligning af før med efter dosering) (se pkt. 
These data should be considered cautiously regarding limitations of the study design (no control arm, pre- versus post-dose comparison) (see section 4.2).
Lymfocyttallene skal følges indtil normalisering. 
Lymphocyte counts should be followed until recovery.
Hver enterokapsel skal sluges hel med lidt vand. 
Swallow each capsule whole, with some water.
Der er ingen eller utilstrækkelige data fra anvendelse af dimethylfumarat til gravide kvinder. 
There are no or limited amount of data from the use of dimethyl fumarate in pregnant women.
Den mekanisme, hvormed dimethylfumarat udøver en terapeutisk effekt ved multipel sklerose, er ikke til fulde klarlagt. 
The mechanism by which dimethyl fumarate exerts therapeutic effects in multiple sclerosis is not fully understood.
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. 
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.
Der foreligger ingen kliniske data om effekt og sikkerhed ved levende, svækkede vacciner hos patienter, der får Tecfidera. 
No clinical data are available on the efficacy and safety of live attenuated vaccines in patients taking Tecfidera.
Tecfidera er ikke blevet undersøgt i kombination med anti-neoplastiske eller immunsuppressive terapier, og der skal derfor udvises forsigtighed ved samtidig administration. 
Tecfidera has not been studied in combination with anti-neoplastic or immunosuppressive therapies and caution should, therefore, be used during concomitant administration.
Efter markedsføring var de fleste tilfælde af herpes zoster-infektion ikke alvorlige og ophørte ved behandling. 
In the post-marketing setting most cases of herpes zoster infection were non-serious and resolved with treatment.
Der er begrænsede tilgængelige data om ALC hos patienter med herpes zoster-infektion efter markedsføringen. 
Limited data is available on ALC in patients with herpes zoster infection in the post-marketing setting.
Indtagelse af moderate mængder alkohol øgede ikke eksponeringen for dimethylfumarat og var ikke forbundet med flere bivirkninger. 
Consumption of moderate amounts of alcohol did not alter exposure to dimethyl fumarate and was not associated with an increase in adverse reactions.
De fleste patienter, herunder de, der oplevede en alvorlig herpes zoster-infektion, havde lymfocyttal over den nedre normalgrænse. 
Most subjects, including those who experienced a serious herpes zoster infection, had lymphocyte counts above the lower limit of normal.
Symptomerne kan inkludere dyspnø, hypoksi, hypotension, angioødem, udslæt eller nældefeber. 
Symptoms may include dyspnoea, hypoxia, hypotension, angioedema, rash or urticaria.
Det er observeret, at bivirkningerne ophørte efter seponering af behandlingen. 
Resolution of the adverse reactions has been observed after treatment was discontinued.
Derfor blev alle farmakokinetiske analyser i relation til dimethylfumarat udført med monomethylfumaratkoncentrationer i plasma. 
Therefore, all pharmacokinetic analyses related to dimethyl fumarate were performed with plasma monomethyl fumarate concentrations.
Du skal omgående informere lægen, hvis du har mistanke om, at du har symptomer på helvedesild. 
You should inform your doctor immediately if you suspect you have any symptoms of shingles.
Titandioxid (E171) Brilliant Blue FCF (E133) Gul jernoxid (E172) 
Titanium dioxide (E171) Brilliant Blue FCF (E133) Yellow iron oxide (E172)
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). 
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).
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). 
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).
240 mg kapsler: 56 eller 168 kapsler i PVC/PE/PVDC-PVC aluminium blisterpakninger. 
240 mg capsules: 56 or 168 capsules in PVC/PE/PVDC-PVC aluminium blister packs.
Må ikke opbevares ved temperaturer over 30 ºC Opbevar blisterpakningen i den ydre karton for at beskytte mod lys 
Do not store above 30ºC Keep the blisters in the outer carton in order to protect from light
I kliniske studier af multipel sklerose blev samtidig kortvarig, intravenøs kortikosteroidbehandling af attakker ikke forbundet med en klinisk relevant stigning i infektioner. 
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.
Symptomerne varierer fra patient til patient, men omfatter typisk gangbesvær, balanceproblemer og synsforstyrrelser (f.eks. sløret syn eller dobbeltsyn). 
Symptoms vary from patient to patient, but typically include walking difficulties, feeling off balance and visual difficulties (e.g. blurred or double vision).
Samlet set steg Cmax og AUC nogenlunde proportionalt med dosis i det undersøgte dosisinterval (120 mg til 360 mg). 
Overall, Cmax and AUC increased approximately doseproportionally in the dose range studied (120 mg to 360 mg).
Forholdet mellem fordele og risici ved behandlingen bør afvejes og drøftes med patienten i relation til andre tilgængelige behandlingsmuligheder. 
The benefit/risk balance of the therapy should be reconsidered in discussion with the patient in the context of other therapeutic options available.
Der er ikke udført studier, som evaluerer Tecfideras effektivitet og sikkerhed hos patienter, der er skiftet fra andre sygdomsmodificerende behandlinger til Tecfidera. 
No studies have been performed evaluating the efficacy and safety of Tecfidera when switching patients from other disease modifying therapies to Tecfidera.
Ved det første tegn eller symptom, der tyder på PML, bør Tecfidera seponeres, og der skal udføres passende diagnostiske evalueringer. 
At the first sign or symptom suggestive of PML, Tecfidera should be withheld and appropriate diagnostic evaluations need to be performed.
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. 
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.
Langtidskroniske studiet hos hunde blev udført med oral administration af dimethylfumarat-kapslen. 
The chronic dog study was conducted with oral administration of the dimethyl fumarate capsule.
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. 
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).
120 mg kapsler: 14 kapsler i PVC/PE/PVDC-PVC aluminium blisterpakninger. 
120 mg capsules: 14 capsules in PVC/PE/PVDC-PVC aluminium blister packs.
Ketoner i urinen 
Ketones measured in urine
Der er ingen data om virkningerne af dimethylfumarat på fertiliteten hos mennesker. 
There are no data on the effects of dimethyl fumarate on human fertility.
Efter behandlingsstart skal der foretages komplet blodtælling, der inkluderer lymfocytter, hver 3. måned. 
After starting therapy, complete blood counts, including lymphocytes, must be performed every 3 months.
Den begrænsede langtidserfaring med Tecfidera kan bidrage til den lave evidens angående en potentiel forbindelse mellem dimethylfumarat og Fanconis syndron ved indikationen MS. 
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.
Placebo Tecfidera 240 mg to gange dagligt 
Placebo Tecfidera 240 mg twice a day
Der blev observeret nyreforandringer efter gentagen oral administration af dimethylfumarat hos mus, rotter, hunde og aber. 
Kidney changes were observed after repeated oral administration of dimethyl fumarate in mice, rats, dogs, and monkeys.
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. 
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.
Efter normalisering, og hvis der ikke er andre behandlingsmuligheder, skal beslutningen om at genstarte behandlingen med Tecfidera efter behandlingsafbrydelse baseres på et klinisk skøn. 
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.
Der blev set en forbigående stigning i middel-eosinofiltallene i løbet af behandlingens første 2 måneder. 
A transient increase in mean eosinophil counts was seen during the first 2 months of therapy.
Oralt administreret dimethylfumarat undergår en hurtig præsystemisk hydrolyse ved hjælp af esteraser og omdannes til dets primære metabolit, monomethylfumarat, som også er aktivt. 
Orally administered dimethyl fumarate undergoes rapid presystemic hydrolysis by esterases and is converted to its primary metabolite, monomethyl fumarate, which is also active.
Skulle der være klinisk mistanke om PML, skal MR-skanning foretages med det samme til diagnostisk formål. 
In case of clinical suspicion of PML, MRI should be performed immediately for diagnostic purposes.
Tecfidera kan påvirke antallet af hvide blodlegemer, dine nyrer og din lever. 
Tecfidera may affect your white blood cell counts, your kidneys and liver.
I gennemsnit faldt lymfocyttallene cirka 30% under baselineværdien. 
On average, lymphocyte counts decreased by approximately 30% of baseline value.
Patienter med alvorlige infektioner bør ikke starte behandling med Tecfidera, før infektionen/infektionerne er overstået. 
Patients with serious infections should not start treatment with Tecfidera until the infection(s) is resolved.
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. 
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.
Andre cirkulerende metabolitter inkluderede fumarsyre, citronsyre og monomethylfumarat. 
Other circulating metabolites included fumaric acid, citric acid and monomethyl fumarate.
Den øgede hyppighed af forhøjede leveraminotransferaser hos patienter behandlet med Tecfidera i forhold til placebo sås primært i de første 6 måneder af behandlingen. 
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.
Kapslen eller dens indhold må ikke knuses, deles, opløses, suttes eller tygges, da mikrotabletternes syreresistente overtræk forebygger gastrointestinal irritation. 
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.
Downstream-metaboliseringen af fumarsyre sker gennem tricarboxylsyrecyklussen med CO2-udskillelse som den primære eliminationsvej. 
The downstream metabolism of fumaric acid occurs through the tricarboxylic acid cycle, with exhalation of CO2 serving as a primary route of elimination.
I sjældne tilfælde kan der forekomme hypofosfatæmisk osteomalaci med ikke-lokaliserede knoglesmerter, forhøjet alkalisk fosfatase i serum og stress-frakturer. 
In rare cases hypophosphataemic osteomalacia with nonlocalised bone pain, elevated alkaline phosphatase in serum and stress fractures may occur.
Rødme beskrives sædvanligvis som rødme eller hedestigning, men kan inkludere andre gener (f.eks. varme, rødlige pletter, kløe og brændende fornemmelse). 
Flushing is usually described as flushing or hot flush, but can include other events (e.g. warmth, redness, itching, and burning sensation).
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. 
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.
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. 
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.
Relevansen af disse fund for risikoen hos mennesker kendes ikke. 
The relevance of these findings to human risk is unknown.
Fire procent (4%) af patienterne behandlet med Tecfidera afbrød behandlingen pga. gastrointestinale hændelser. 
Four per cent (4%) of patients treated with Tecfidera discontinued due to gastrointestinal events.
Studie 2 inkluderede glatirameracetat som undersøgelsesblindet (dvs. at den studieansvarlige læge/investigatoren, der vurderede responsen på studiebehandlingen, var blindet) referencekomparator. 
Study 2 contained a rater-blinded (i.e. study physician/ investigator assessing the response to study treatment was blinded) reference comparator of glatiramer acetate.
Disse tilfælde kan forekomme når som helstunder behandlingen. 
These events may occur at any time during treatment.
Patienter med progressiv multipel sklerose deltog ikke i disse studier. 
Subjects with progressive forms of MS were not included in these studies.
Det vides ikke, om det aktive stof i Tecfidera udskilles i modermælk. 
It is not known whether the active substance of Tecfidera passes into breast milk.
Herpes zoster-infektioner 
Herpes zoster infections
Baseret på kliniske, farmakologiske studier er dosisjustering ikke nødvendig (se pkt. 
Based on clinical pharmacology studies, no dose adjustments are needed (see section 5.2).
Dimethylfumarat demonstrerede terapeutisk aktivitet i flere modeller med inflammatoriske eller neuroinflammatoriske skader. 
Dimethyl fumarate demonstrated therapeutic activity in multiple models of inflammatory and neuroinflammatory injury.
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. 
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.
Patienterne fik 120 mg Tecfidera to gange dagligt i 7 dage efterfulgt af 240 mg to gange dagligt i 24 uger. 
Subjects received Tecfidera 120 mg twice a day for 7 days followed by 240 mg twice a day for 24 weeks.
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. 
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.
Hos mennesker metaboliseres dimethylfumarat i vidt omfang, og under 0,1% af dosis udskilles som umetaboliseret dimethylfumarat i urinen. 
In humans, dimethyl fumarate is extensively metabolised with less than 0.1% of the dose excreted as unchanged dimethyl fumarate in urine.
Der blev ikke observereret misdannelser ved nogen dosis af dimethylfumarat hos rotter eller kaniner. 
No malformations were observed at any dose of dimethyl fumarate in rats or rabbits.
Det er vist, at dimethylfumarat opregulerer Nrf2afhængige antioxidantgener hos patienter (f.eks. NAD(P)H-dehydrogenase, quinon 1; [NQO1]). 
Dimethyl fumarate has been shown to up regulate Nrf2-dependent antioxidant genes in patients (e.g. NAD(P)H dehydrogenase, quinone 1; [NQO1]).
Kapselindhold (syreresistente mikrotabletter) 
Capsule contents (enteric-coated microtablets)
Data fra prækliniske studier tyder ikke på, at dimethylfumarat er forbundet med en øget risiko for nedsat fertilitet (se pkt. 
Data from preclinical studies do not suggest that dimethyl fumarate would be associated with an increased risk of reduced fertility (see section 5.3).
Der blev ikke observeret nogen negative kliniske konsekvenser i de kliniske forsøg. 
No untoward clinical consequences were observed in clinical trials.
Der er ikke udført interaktionsstudier med orale præventionsmidler med andre progestogener, men det forventes ikke, at Tecfidera påvirker deres virkning. 
No interaction studies have been performed with oral contraceptives containing other progestogens, however an effect of Tecfidera on their exposure is not expected.
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). 
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).
Et kort behandlingsforløb med 75 mg acetylsalicylsyre uden entero-overtræk kan gavne patienter, der er påvirket af intolerabel rødme (se pkt. 
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).
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) 
- 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)
Kapslen må ikke deles, knuses, opløses, suttes eller tygges, idet dette kan øge hyppigheden af nogle af bivirkningerne. 
Do not divide, crush, dissolve, suck or chew the capsule as this may increase some side effects.
Der er rapporteret tilfælde af overdosering med Tecfidera. 
Cases of overdose with Tecfidera have been reported.
Forhøjede aminotransferaser ≥ 3 gange ULN med samtidige forhøjelser i totalt bilirubin > 2 gange ULN blev ikke observeret i placebokontrollerede studier. 
Elevations in transaminases ≥3 times ULN with concomitant elevations in total bilirubin >2 times ULN, were not observed in placebo-controlled studies.
Tecfidera bør ikke anvendes under amning. 
Tecfidera should not be used during breast-feeding.
Farmakokinetiske data er bestemt hos patienter med multipel sklerose og hos raske frivillige. 
Pharmacokinetic data were obtained in subjects with multiple sclerosis and healthy volunteers.
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. 
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.
Dette kan medføre irritation i maven, især hos personer der allerede har tilbøjelighed til dette. 
This could cause inflammation of the stomach (gastritis), especially in people already prone to gastritis.
MINDSTEKRAV TIL MÆRKNING PÅ BLISTER ELLER STRIP VARMEFORSEGLET BLISTERKORT 
MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS HEAT SEALED BLISTER CARD