FrancophonIA/ELRC3.0 huggingface dataset:
English: The inflammatory cytokine production is reduced with induction of proapoptotic events, inhibition of keratinocyte proliferation, reduced expression of adhesion molecules, and diminished inflammatory infiltrate within psoriatic plaques.
Danish: Den inflammatoriske cytokinproduktion reduceres med induktion af proapoptotiske aktivitet, hæmning af keratinocytproliferation, reduceret ekspression af adhæsionsmolekyler og formindsket inflammatorisk infiltrat i plaque psoriasis.
English: Prior and concomitant treatment with immunosuppressive or immunomodulating therapies Limited data are available on the efficacy and safety of Skilarence in patients who have been previously treated with other immunosuppressive or immunomodulating therapies.
Danish: Tidligere og samtidig behandling med immunosuppressive eller immunmodulerende behandlinger Der findes begrænsede data om effekten og sikkerheden af Skilarence hos patienter, som tidligere er blevet behandlet med andre immunosuppressive eller immunmodulerende behandlinger.
English: No carcinogenicity studies have been performed for Skilarence.
Danish: Der er ikke udført karcinogenicitetsforsøg med Skilarence.
English: The following is a list of adverse reactions experienced by patients treated with Skilarence during the clinical study and with Fumaderm, a related medicinal product containing dimethyl fumarate along with other fumaric acid esters.
Danish: Følgende er en liste over bivirkninger oplevet af patienter, der blev behandlet med Skilarence under det kliniske studie og med Fumaderm, et relateret lægemiddel, som indeholder dimethylfumarat samt andre fumarsyreestere.
English: During the treatment free follow up, lymphocyte levels of <0.7x 10
Danish: Under den behandlingsfri opfølgning observeredes der lymfocytniveauer på <0,7x 10
English: *Additional adverse reactions reported with Fumaderm, a related medicinal product containing dimethyl fumarate along with other fumaric acid esters.
Danish: *Yderligere bivirkninger indberettet med Fumaderm, et relateret lægemiddel, som indeholder dimethylfumarat sammen med andre fumarsyreestere.
English: These adducts were detected in animal studies in the intestinal mucosa of rats and to a smaller extent in portal vein blood.
Danish: Disse addukter blev påvist i dyreundersøgelser i tarmslimhinder hos rotter og i mindre grad i portåren.
English: Haematological changes
Danish: Hæmatologiske forandringer
English: It is unknown whether dimethyl fumarate or its metabolites are excreted in human milk.
Danish: Amning Det er ukendt, om dimethylfumarat/metabolitter udskilles i human mælk.
English: Skilarence is indicated for the treatment of moderate to severe plaque psoriasis in adults in need of systemic medicinal therapy.
Danish: Skilarence er indiceret til behandling af moderat til svær plaque psoriasis hos voksne med behov for systemisk lægemiddelbehandling.
English: For patients with pre-existing infections of clinical relevance, the physician should decide if treatment with Skilarence should only be initiated once the infection has resolved.
Danish: For patienter med eksisterende klinisk relevante infektioner skal lægen afgøre, om behandlingen med Skilarence skal vente til infektionen er overstået.
English: By contrast, unconjugated monomethyl fumarate is detectable in plasma.
Danish: Ukonjugeret monomethylfumarat kan derimod påvises i plasma.
English: The objectives of the educational programme are to inform health care professionals about the risk of serious infections, mainly opportunistic infections such as progressive multifocal leukoencephalopathy (PML), and to provide guidance on the monitoring of lymphocyte and leukocyte count abnormalities.
Danish: Formålet med uddannelsesprogrammet er at informere sundhedspersonale om risikoen for alvorlige infektioner, primært opportunistiske infektioner, såsom progressiv multifokal leukoencefalopati (PML), og give vejledning om overvågning af lymfocyt- og leukocyttællingsabnormiteter.
English: Skilarence 30 mg is available in packs containing 42, 70 and 210 gastro-resistant tablets.
Danish: Skilarence 30 mg fås i pakninger indeholdende 42, 70 og 210 enterotabletter.
English: Gastrointestinal tolerability can be improved by following the dose titration schedule on initiating Skilarence treatment and by taking Skilarence with food (see sections 4.2 and 4.8).
Danish: Gastrointestinal tolerabilitet kan forbedres ved at følge tidsplanen for dosistitrering, når behandlingen med Skilarence påbegyndes, og ved at tage Skilarence med et måltid (se pkt.
English: However, as dimethyl fumarate is metabolised by esterases and the alkaline milieu of the small intestine without the involvement of cytochrome P450, hepatic impairment is not expected to influence exposure (see section 4.2).
Danish: Da dimethylfumarat imidlertid metaboliseres af esteraser og af det alkaliske miljø i tyndtarmen uden inddragelse af cytokrom P450, forventes nedsat leverfunktion ikke at have indflydelse på eksponeringen (se pkt.
English: What Skilarence is used for
Danish: Hvad bruges Skilarence til
English: Treatment should not be initiated if leukopenia below 3.0x10
Danish: Behandlingen bør ikke påbegyndes, ved leukopeni under 3,0x10
English: Renal function (e.g. creatinine, blood urea nitrogen and urinalysis) should be checked prior to initiation of treatment and every 3 months thereafter.
Danish: Nyrefunktion (f.eks. kreatinin, carbamid og urinanalyse) skal undersøges inden behandlingen påbegyndes og derefter hver 3. måned.
English: 9/L, blood monitoring should be performed monthly until levels return to 1.0x10
Danish: 9/l, skal der tages blodprøver en gang om måneden, indtil niveauet er 1,0x10x10
English: In vitro studies have shown that hydrolysis of dimethyl fumarate to monomethyl fumarate occurs rapidly at pH 8 (pH in the small intestine), but not at pH 1 (pH in the stomach).
Danish: In vitro forsøg har vist, at hydrolyse af dimethylfumarat til monomethylfumarat sker hurtigt ved pH 8 (pH i tyndtarmen), men ikke ved pH 1 (pH i ventriklen).
English: At 12 months after stopping treatment 3/28 (10.7%) of patients had lymphocyte values below 1.0x10
Danish: 12 måneder efter, at behandlingen blev stoppet, havde 3/28 (10,7 %) af patienterne lymfocytværdier under 1,0x10
English: The portion of dimethyl fumarate that reacts with glutathione, forming a glutathione-adduct, is metabolised further to its mercapturic acid, which is excreted in the urine.
Danish: Den del af dimethylfumarat, der reagerer med glutathion og danner en glutathion-addukt, metaboliseres yderligere til sin mercaptursyre, som udskilles i urinen.
English: Women of child-bearing potential
Danish: Kvinder i den fødedygtige alder
English: Based on available data suggesting that fumaric acid esters may activate cellular pathways related to the development of renal tumours, a potential tumorigenic activity of exogenously administered dimethyl fumarate on the kidneys cannot be excluded.
Danish: Baseret på tilgængelige data, som antyder, at fumarsyreestere kan aktivere cellulære veje i forbindelse med udviklingen af renale tumorer, kan det ikke udelukkes, at eksogent administreret dimethylfumarat vil give anledning til en potentielt kræftfremkaldende aktivitet i nyrerne.
English: The efficacy of oral contraceptives may be reduced and the use of an alternative barrier contraceptive method is recommended to prevent possible failure of contraception (see the prescribing information of the oral contraceptive).
Danish: Effekten af p-piller kan reduceres, og det anbefales at bruge en alternativ barrieremetode for at forhindre, at præventionen svigter (se ordinationsoplysningerne for p-pillerne).
English: Abdominal distension* Abdominal pain Nausea
Danish: Oppustet abdomen* Abdominalsmerter Kvalme
English: Skilarence 30 mg and Skilarence 120 mg Core:
Danish: Skilarence 30 mg og Skilarence 120 mg Kerne:
English: In vitro studies have shown that monomethyl fumarate at the therapeutic dose does not inhibit or induce any of the cytochrome P450 enzymes, it is not a substrate or inhibitor of P-glycoprotein and is not an inhibitor of the most common efflux and uptake transporters.
Danish: In vitro forsøg har vist, at monomethylfumarat ved den terapeutiske dosis ikke hæmmer eller inducerer nogen af cytokrom P450-enzymerne, det er ikke et substrat eller en hæmmer af P-glycoprotein og er ikke en hæmmer af de mest almindelige efflux- og optagelsestransportører.
English: In vitro studies have shown that dimethyl fumarate at a therapeutic dose does not inhibit CYP3A4/5 and BCRP and is a weak P-glycoprotein inhibitor.
Danish: In vitro studier har vist, at dimethylfumarat ved en terapeutisk dosis ikke hæmmer CYP3A4/5 og BCRP og er en svag Pglycoproteinhæmmer.
English: How many tablets to take during the day Number of tablets per day
Danish: Antal tabletter der skal tages dagligt
English: What you need to know before you take Skilarence
Danish: Det skal du vide, før du begynder at tage Skilarence
English: If you are affected, be careful when driving or using machines.
Danish: Du skal være forsigtig, når du fører motorkøretøj eller betjener maskiner, hvis du er påvirket.
English: Patients developing lymphopenia should be monitored after stopping treatment until their lymphocyte count has returned to the normal range (see section 4.8).
Danish: Patienter, som udvikler lymfopeni bør overvåges, efter at behandlingen er stoppet, indtil deres lymfocyttal er i det normale område (se pkt.
English: Titanium dioxide (E171) Simethicone
Danish: Titandioxid (E171)
English: These medicines taken together with Skilarence could increase the risk of side effects on your kidneys.
Danish: Når denne medicin tages sammen med Skilarence, kan det øge risikoen for bivirkninger i nyrerne.
English: You may feel dizzy or tired after taking Skilarence.
Danish: Der kan opstå svimmelhed eller træthed efter administration af Skilarence.
English: If the lymphocyte count falls below 0.7x10
Danish: Hvis lymfocyttallet falder under 0,7x10
English: - Other medicines that can affect your kidney function, such as methotrexate or ciclosporin (used to treat psoriasis), aminoglycosides (used to treat infections), diuretics (which increase urine), nonsteroidal anti-inflammatory drugs (used to treat pain) or lithium (used for bipolar disease and depression).
Danish: - Anden medicin, der kan påvirke din nyrefunktion, såsom methotrexat eller ciclosporin (anvendes til behandling af psoriasis), aminoglycosider (anvendes til behandling af infektioner), diuretika (som øger urinmængden), non-steroide anti-inflammatoriske lægemidler (bruges til behandling af smerter) eller lithium (bruges til bipolar sygdom og depression).
English: In patients experiencing diarrhoea during Skilarence treatment, the effect of oral contraceptives may be reduced and additional barrier methods of contraception may be necessary (see section 4.5).
Danish: Hos patienter, der får diarré under behandlingen med Skilarence, kan virkningen af orale præventionsmidler nedsættes, og det kan være nødvendigt at anvende yderligere barrieremetoder (se pkt.
English: Blue, film-coated, round, biconvex tablet with a diameter of approximately 11.6 mm.
Danish: Blå, filmovertrukket, rund, bikonveks tablet med en diameter på cirka 11,6 mm.
English: In the event of a clinically relevant change in renal function, particularly in the absence of alternative explanations, consideration should be given to dosage reduction or treatment discontinuation.
Danish: I tilfælde af en klinisk relevant ændring i nyrefunktionen, især ved mangel på alternative forklaringer, bør det overvejes at reducere doseringen eller seponere behandlingen.
English: Based on observations in the Phase III clinical study as well as on literature data, flushing is most likely to occur during the early weeks of treatment and tends to lessen with time.
Danish: Baseret på observationer i det kliniske fase III-studie og data fra litteraturen vil rødmen typisk forekomme i de første behandlingsuger, og det vil have tendens til at mindskes med tiden.
English: 9/L, which would represent
Danish: 9/l, hvilket repræsenterede 3/279
English: No data are available on the efficacy and safety of Skilarence when taken concomitantly with other immunosuppressive or immunomodulating therapies (see section 4.5).
Danish: Der findes ingen data om effekten og sikkerheden af Skilarence, når det tages samtidigt med andre immunosuppressive eller immunmodulerende behandlinger (se pkt.
English: Common Common Uncommon Not known
Danish: Almindelig Almindelig Ikke almindelig Ikke kendt
English: Dizziness*
Danish: Svimmelhed*
English: Blood and lymphatic system disorders
Danish: Blod og lymfesystem Lymfopeni Leukopeni
English: Data from the Phase III clinical study as well as from the literature show that changes in haematological parameters are most likely to occur during the first 3 months after starting treatment with dimethyl fumarate.
Danish: Data fra det kliniske fase III-studie samt fra litteraturen viser, at ændringer i hæmatologiske parametre typisk vil forekomme i løbet af de første 3 måneder efter start af behandling med dimethylfumarat.
English: Skilarence may decrease leukocyte and lymphocyte counts (see section 4.8).
Danish: Skilarence kan reducere leukocyt- og lymfocyttallene (se pkt.
English: Skilarence is contraindicated during pregnancy (see section 4.3).
Danish: Skilarence er kontraindiceret under graviditeten (se pkt.
English: Dizziness and fatigue may occur following administration of Skilarence (see section 4.8).
Danish: Der kan opstå svimmelhed og træthed efter administration af Skilarence (se pkt.
English: A part of the total dimethyl fumarate is hydrolysed by esterases and the alkaline milieu of the small intestine, while the remainder enters the portal vein blood.
Danish: En del af den samlede dimethylfumarat hydrolyseres af esteraser og det alkaliske miljø i tyndtarmen, mens resten går ind i portåren.
English: Each gastro-resistant tablet contains 136.8 mg lactose (as monohydrate).
Danish: Hver enterotablet indeholder 136,8 mg laktose (som monohydrat).
English: In the event of a clinically relevant change in hepatic parameters, particularly in the absence of alternative explanations, consideration should be given to dose reduction or treatment discontinuation.
Danish: I tilfælde af en klinisk relevant ændring i leverparametrene, især ved mangel på alternative forklaringer, bør det overvejes at reducere dosen eller seponere behandlingen.
English: Skilarence is not recommended in women of child-bearing potential not using appropriate contraception.
Danish: Skilarence bør ikke anvendes under graviditeten eller til kvinder i den fertile alder, som ikke anvender passende prævention.
English: Lymphopenia: If the lymphocyte count falls below 1.0x10
Danish: Lymfopeni: Hvis lymfocyttallet falder under 1,0x10
English: However, Skilarence has not been studied in patients with severe renal impairment, and some cases of renal toxicity have been reported during post-marketing surveillance with fumaric acid esters.
Danish: Skilarence er imidlertid ikke blevet undersøgt hos patienter med alvorligt nedsat nyrefunktion, og der er efter markedsføring indberettet tilfælde af nyretoksicitet med fumarsyreestere.
English: White, film-coated, round, biconvex tablet with a diameter of approximately 6.8 mm. Skilarence 120 mg
Danish: Hvid, filmovertrukket, rund, bikonveks tablet med en diameter på cirka 6,8 mm. Skilarence 120 mg
English: Superiority testing vs placebo PASI 75, n (%) p-value a a
Danish: Superioritetstestning vs placebo PASI 75, n (%) p-værdi Tosidet 99,24 % CI
English: If you notice new or worsening weakness on one side of the body; clumsiness; changes in vision, thinking or memory; confusion; or personality changes lasting several days, stop taking Skilarence and talk to your doctor straight away.
Danish: Hvis du bemærker en ny eller forværret svaghed i den ene side af kroppen, klodsethed, synsforstyrrelser eller tanke- eller hukommelsesændringer, forvirring eller personlighedsændringer af flere dages varighed, skal du holde op med at tage Skilarence og hurtigst muligt tale med din læge.
English: Since renal elimination plays a minor role in the clearance of Skilarence from plasma, it is unlikely that renal impairment would affect the pharmacokinetic characteristics, and so a need for dose adjustment in patients with mild to moderate renal impairment is not expected (see sections 4.2 and
Danish: Eftersom den renale udskillelse spiller en mindre rolle for clearance af Skilarence fra plasma, er det usandsynligt, at en nedsat nyrefunktion vil påvirke de farmakokinetiske egenskaber og derfor forventes det ikke at være nødvendigt at justere dosis hos patienter med mild til moderat nedsat nyrefunktion (se pkt.
English: - Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Danish: - Overfølsomhed over for det aktive stof eller over for ét eller flere af hjælpestofferne anført i pkt.
English: The no-observed adverse-effect-level (NOAEL) after 3 months of treatment was 30 mg/kg/day, which corresponds to 2.9-fold and 9.5-fold the human systemic exposure at the highest recommended dose (720 mg/day), as AUC and Cmax values, respectively.
Danish: Dosis uden observerede bivirkninger (No-Observed-Adverse-Effect-Level, NOAEL) efter 3 måneders behandling var 30 mg/kg/dag, hvilket svarer til 2,9 gange og 9,5 gange den humane systemiske eksponering ved den højeste anbefalede dosis (720 mg/dag) som henholdsvis AUC- og Cmax-værdier.
English: However, because renal elimination plays a minor role in the total clearance from plasma, it is unlikely that renal impairment may affect the pharmacokinetic characteristics of Skilarence (see section 4.2).
Danish: Da den renale udskillelse spiller en mindre rolle for den totale clearance fra plasma, er det usandsynligt, at en nedsat nyrefunktion kan påvirke Skilarence' farmakokinetiske egenskaber (se pkt.
English: PGA score clear or almost clear, n (%) p-value b
Danish: PGA-score klar eller næsten klar, n (%) p-værdi
English: Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicine.
Danish: Bør ikke anvendes til patienter med hereditærgalactoseintolerans, total lactasemangel eller glucose/galactosemalabsorption.
English: Skilarence should be used cautiously in combination with other systemic antipsoriatic therapy (e.g. methotrexate, retinoids, psoralens, ciclosporin, immunosuppressants or cytostatics) (see section 4.4).
Danish: Skilarence skal derfor anvendes med forsigtighed i kombination med anden systemisk antipsoriatisk terapi (f.eks. methotrexat, retinoider, psoralener, ciclosporin, immunosuppressiva eller cytostatika) (se pkt.
English: Do not breast-feed during treatment with Skilarence.
Danish: Du må ikke amme, mens du behandles med Skilarence.
English: Data from the Phase III clinical study as well as from the literature show that gastrointestinal disorders with dimethyl fumarate-containing products are most likely to occur during the first 2 to 3 months after starting treatment.
Danish: Data fra det kliniske fase III-studie og fra litteraturen viser, at gastrointestinale gener med dimethylfumarat-holdige produkter typisk forekommer i de første 2 til 3 måneder efter behandlingsstart.
English: During treatment
Danish: Under behandling
English: Concurrent therapy with nephrotoxic substances (e.g. methotrexate, ciclosporin, aminoglycosides, diuretics, NSAIDs or lithium) may increase the potential for renal adverse reactions (e.g. proteinuria) in patients taking Skilarence.
Danish: Samtidig behandling med nefrotoksiske stoffer (f.eks. methotrexat, ciclosporin, aminoglykosider, diuretika, NSAID eller lithium) kan øge risikoen for renale bivirkninger (f.eks. proteinuri) hos patienter, der tager Skilarence.
English: The NOAEL for maternal and embryo-foetal toxicity was 40 mg/kg/day, corresponding to 0.2-fold and 2.0-fold the human systemic exposure at the highest recommended dose (720 mg/day), as AUC and Cmax values, respectively.
Danish: NOAEL for maternel og embryoføtal toksicitet var 40 mg/kg/dag svarende til 0,2 gange og 2,0 gange den humane systemiske eksponering ved den højeste anbefalede dosis (720 mg/dag) som henholdsvis AUC- og Cmax-værdier.
English: - Other medicines used to treat psoriasis, such as methotrexate, retinoids, psoralens, ciclosporin, or other immunosuppressants or cytostatics (medicines that affect the immune system).
Danish: - Anden medicin, der bruges til at behandle psoriasis, såsom methotrexat, retinoider, psoralen, ciclosporin eller andre immunosuppresiva eller cytostatika (medicin som påvirker immunsystemet).
English: Taking these medicines with Skilarence could increase the risk of side effects on your immune system.
Danish: Hvis denne type medicin tages med Skilarence, kan risikoen for bivirkninger på dit immunsystem stige.
English: Very rare side effects (may affect up to 1 in 10,000 people): - acute lymphatic leukaemia (a type of blood cancer) - decrease in all types of blood cells (pancytopenia)
Danish: Meget sjældne bivirkninger (kan påvirke op til 1 ud af 10.000 personer): - akut lymfatisk leukæmi (en type blodkræft) - fald i alle typer blodceller (pancytopeni)
English: Lactose monohydrate Cellulose microcrystalline Croscarmellose sodium Colloidal anhydrous silica Magnesium stearate
Danish: Laktosemonohydrat Cellulose, mikrokrystallinsk Croscarmellosenatrium Silica, kolloid vandfri Magnesiumstearat
English: Each gastro-resistant tablet contains 34.2 mg lactose (as monohydrate).
Danish: Hver enterotablet indeholder 34,2 mg laktose (som monohydrat).
English: In the third week, Skilarence 30 mg is taken three times daily (1 tablet in the morning, 1 at midday, and 1 in the evening).
Danish: I tredje uge tages Skilarence 30 mg tre gange dagligt (1 tablet om morgenen, 1 ved middagstid og 1 om aftenen).
English: There was a trend in the efficacy endpoint PASI score mean % change from baseline, indicating the onset of a clinical response to Skilarence as early as week 3 (-11.8%) which became statistically significant compared to placebo by week 8 (-30.9%).
Danish: Der var en tendens for mean % ændring fra baseline af total score af effekt-endepunktet PASI, som indikerede start på et klinisk respons på Skilarence allerede i uge 3 (-11,8 %).
English: Skilarence is a medicine that contains the active substance dimethyl fumarate.
Danish: Skilarence er et lægemiddel, som indeholder det aktive stof dimethylfumarat.
English: However, if you become flushed and get any of the following signs: - wheezing, difficulty breathing or shortness of breath, - swelling of the face, lips, mouth or tongue stop taking Skilarence and call a doctor straight away.
Danish: Men hvis du blusser og får et af følgende tegn: - hvæsende vejrtrækning, vejrtrækningsbesvær eller åndenød - hævelse i ansigtet, på læberne eller på tungen skal du holde op med at tage Skilarence og straks søge læge.
English: Skilarence contains sodium
Danish: Skilarence indeholder natrium
English: Uncommon side effects (may affect up to 1 in 100 people): - dizziness - excess protein in the urine (proteinuria) - increase in serum creatinine (a substance in the blood used for measuring how well your kidneys are working)
Danish: Ikke-almindelige bivirkninger (kan påvirke op til 1 ud af 100 personer): - svimmelhed - øget indhold af protein i urinen (proteinuri) - stigning i serumkreatinin (et stof i blodet, der bruges til at måle, hvor godt dine nyrer fungerer)
English: Very common Very common Very common Very common Common Common Common Common
Danish: Meget almindelig Meget almindelig Almindelig Almindelig Almindelig Almindelig Almindelig
English: Allergic skin reaction*
Danish: Pruritus Allergisk hudreaktion*
English: For the total leukocyte count, a decline became apparent at week 12 of treatment; it slowly increased again at week 16 (end of treatment); and 12 months after stopping treatment all patients had values above 3.0x10
Danish: Det steg langsomt igen i uge 16 (behandlingsafslutning), og 12 måneder efter behandlingen stoppede, havde alle patienter værdier over 3,0x10
English: Skilarence is contraindicated in patients with severe gastrointestinal disease (see sections 4.3).
Danish: Skilarence er kontraindiceret hos patienter med alvorlig gastrointestinal sygdom (se pkt.