natgillin/translations-raw huggingface dataset:
Stoffer, der kaldes ketoner, som kroppen producerer naturligt, er meget almindelige i urinanalyser under Tecfidera-behandling.
Substances called ketones, which are naturally produced in the body, very commonly show up in urine tests while taking Tecfidera.
Middel og mediane lymfocyttal forblev inden for normalgrænserne.
Mean and median lymphocyte counts remained within normal limits.
MS er en kronisk sygdom, der påvirker centralnervesystemet (CNS), herunder hjernen og rygmarven.
MS is a long-term condition that affects the central nervous system (CNS), including the brain and the spinal cord.
Opbevar blisterpakningen i den ydre karton for at beskytte mod lys.
Keep the blisters in the outer carton in order to protect from light.
Det skal også bemærkes, at en test, der er negativ for JCV-antistoffer (ved normale lymfocyttal), ikke udelukker muligheden for efterfølgende JCV-infektion.
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.
Rødme i ansigtet eller på kroppen er en meget almindelig bivirkning.
Reddening of the face or body (flushing) is a very common side effect.
Behandling med Tecfidera kan generelt indledes umiddelbart efter seponering af interferon eller glatirameracetat.
Tecfidera can generally be started immediately after discontinuation of interferon or glatiramer acetate.
Hvis lymfocyttallet ligger under normalområdet, skal der foretages en grundig evaluering af mulige årsager, før behandlingen med Tecfidera indledes.
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.
Tecfidera bør kun anvendes under graviditet, hvis det er strengt nødvendigt, og den potentielle fordel for kvinden opvejer den potentielle risiko for fosteret.
Tecfidera should be used during pregnancy only if clearly needed and if the potential benefit justifies the potential risk to the foetus.
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.
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
- hvis du er allergisk over for dimethylfumarat eller et af de øvrige indholdsstoffer i Tecfidera (angivet i punkt 6).
- if you are allergic to dimethyl fumarate or any of the other ingredients of this medicine (listed in section 6).
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).
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).
Det du skal vide, før du begynder at tage Tecfidera Tag ikke Tecfidera:
What you need to know before you take Tecfidera Do not take Tecfidera:
Behandlingen må ikke genoptages (se pkt.
Treatment should not be restarted (see section 4.8).
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.
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.
Der blev udført karcinogenicitetsstudier af dimethylfumarat i op til 2 år på mus og rotter.
Carcinogenicity studies of dimethyl fumarate were conducted for up to 2 years in mice and rats.
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.
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.
Bivirkningerne angives med MedDRA-foretrukne termer i henhold til MedDRA-systemorganklassen.
The adverse reactions are presented as MedDRA preferred terms under the MedDRA System Organ Class.
Indledningsvist metaboliseres det af esteraser, som findes alle steder i gastrointestinalkanal, blod og væv, inden det når systemkredsløbet.
It is initially metabolised by esterases, which are ubiquitous in the gastrointestinal tract, blood and tissues, before it reaches the systemic circulation.
Moderat lave til meget lave lymfocyttal - Antallet af lymfocytter (en type hvide blodlegemer) kan være nedsat i en længere periode.
Moderately low to very low lymphocyte counts - Lymphocyte counts (a type of white blood cell) may be decreased for a long period of time.
Det er ukendt, om dimethylfumarat eller dets metabolitter udskilles i human mælk.
It is unknown whether dimethyl fumarate or its metabolites are excreted in human milk.
I tilfælde af uklare symptomer bør Fanconis syndrom overvejes, og passende undersøgelser foretages.
In case of unclear symptoms Fanconi syndrome should be considered and appropriate examinations should be performed.
Et enkeltdosis-studie med 240 mg 14C-dimethylfumarat identificerede glucose som den dominerende metabolit i humant plasma.
A single 240 mg 14C-dimethyl fumarate dose study identified glucose as the predominant metabolite in human plasma.
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.
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.
PML kan kun opstå, hvis patienten har JCV-infektion.
PML can only occur in the presence of a JCV infection.
Prins Mauritslaan 13 1171 LP Badhoevedorp Holland
1171 LP Badhoevedorp The Netherlands
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%.
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%.
Under hensyntagen til PRAC's vurderingsrapport om PSUR'en/PSUR'erne for dimethylfumarat (multipel sklerose) er CHMP nået frem til følgende videnskabelige konklusioner:
Taking into account the PRAC Assessment Report on the PSUR(s) for dimethyl fumarate (multiple sclerosis), the scientific conclusions of CHMP are as follows:
Tecfideras sikkerhed hos pædiatriske patienter under 18 år med multipel sklerose er endnu ikke klarlagt.
The safety of Tecfidera in paediatric patients with multiple sclerosis below the age of 18 has not yet been established.
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).
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).
Progression kan omfatte symptomer såsom polyuri, polydipsi og proksimal muskelsvaghed.
Progression might involve symptoms such as polyuria, polydipsia and proximal muscle weakness.
Methacrylsyre-methylmethacrylat copolymer (1:1) Methacrylsyre-ethylacrylat copolymer (1:1) dispersion 30% Simeticon
Methacrylic acid - methyl methacrylate copolymer (1:1) Methacrylic acid - ethyl acrylate copolymer (1:1) dispersion 30% Simeticone
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.
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.
Den lavere fostervægt og den forsinkede ossifikation blev betragtet som værende sekundært til maternel toksicitet (reduceret kropsvægt og fødeindtagelse).
The lower fetal weight and delayed ossification were considered secondary to maternal toxicity (reduced body weight and food consumption).
CO2-udskillelse er den primære eliminationsvej for dimethylfumarat og redegør for 60% af dosis.
Exhalation of CO2 is the primary route of dimethyl fumarate elimination accounting for 60% of the dose.
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.
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.
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.
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.
I de placebokontrollerede studier havde de fleste patienter (> 98%) normale lymfocytværdier inden behandlingsstart.
In the placebo-controlled studies most patients (>98%) had normal lymphocyte values prior to initiating treatment.
Denne indlægsseddel blev senest ændret {MM/ÅÅÅÅ}.
This leaflet was last revised in {MM YYYY}.
De vigtigste tegn er: proteinuri, glukosuri (med normalte blodsukkerniveauer), hyperaminoaciduri og fosfaturi (muligvis samtidigt med hypofosfatæmi).
The most important signs are: proteinuria, glucosuria (with normal blood sugar levels), hyperaminoaciduria and phosphaturia (possibly concurrent with hypophosphatemia).
Overvåg patienter, der tager Tecfidera, for tegn og symptomer på herpes zoster, især hvis der er rapporteret samtidig lymfocytopeni.
Monitor patients taking Tecfidera for signs and symptoms of herpes zoster especially when concurrent lymphocytopenia is reported.
En midlertidig dosisreduktion til 120 mg to gange dagligt kan reducere forekomsten af rødme og gastrointestinale bivirkninger.
Temporary dose reduction to 120 mg twice a day may reduce the occurrence of flushing and gastrointestinal adverse reactions.
Patienterne skal informeres om, at de skal afbryde behandlingen og straks søge lægehjælp, hvis de oplever tegn eller symptomer på anafylaksi.
Patients should be instructed to discontinue Tecfidera and seek immediate medical care if they experience signs or symptoms of anaphylaxis.
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.