FrancophonIA/ELRC3.0 huggingface dataset:
English: After oral administration, dimethyl fumarate is not detected in plasma because it is rapidly hydrolysed by esterases to its active metabolite monomethyl fumarate.
Danish: Efter oral administration kan dimethylfumarat ikke påvises i plasma, fordi det hurtigt hydrolyseres af esteraser til dets aktive metabolit monomethylfumarat.
English: The safety and efficacy of Skilarence was assessed in one double-blind, 3-arm, placebo- and active comparator-controlled Phase III study (1102) in patients with moderate to severe plaque psoriasis (Study 1102).
Danish: Sikkerheden og effekten af Skilarence blev undersøgt i et dobbeltblindet, 3-armet, placebo- og aktiv komparator kontrolleret fase III-studie (1102) i patienter med moderat til alvorlig plaque psoriasis (Studie 1102).
English: It has not been studied in patients with pre-existing low leukocyte or lymphocyte counts.
Danish: Det er ikke blevet undersøgt hos patienter med eksisterende lave leukocyt- og lymfocyttal.
English: If treatment success was observed before the maximum dose of 720 mg/day of dimethyl fumarate was reached, no further increase of dosage was necessary and the dosage was to be steadily reduced to an individual maintenance dose.
Danish: Hvis der blev observeret behandlingssucces før den maksimale dosis på 720 mg/dag af dimethylfumarat var nået, var det ikke nødvendigt at foretage yderligere dosisforøgelse, og dosis skulle reduceres jævnt til en individuel vedligeholdelsesdosis.
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 normalt blodsukkerniveau), hyperaminoaciduri og phosphaturi (muligvis sideløbende med hypophosphatæmi).
English: Renal findings in dogs included minimal to moderate tubular hypertrophy, increased incidence and severity of tubular vacuolation and minimal to slight tubular degeneration, which were considered toxicologically relevant.
Danish: Nyrefund i hunde omfattede minimal til moderat tubulær hypertrofi, øget forekomst og sværhedsgrad af tubulær vakuolisering samt minimal til let tubulær degenerering, hvilket blev vurderet som toksikologisk relevant.
English: How to take Skilarence 4.
Danish: Sådan skal du tage Skilarence 4.
English: Use effective methods of contraception to avoid becoming pregnant during treatment with Skilarence (see also “Other medicines and Skilarence” above).
Danish: Brug sikker prævention for at undgå graviditet under behandling med Skilarence (se også ”Brug af anden medicin sammen med Skilarence” ovenfor).
English: Therefore, the tablets should not be crushed, divided, dissolved or chewed.
Danish: Tabletterne må derfor ikke knuses, deles, opløses eller tygges.
English: The biotransformation of dimethyl fumarate does not involve cytochrome P450 isoenzymes.
Danish: Biotransformationen af dimethylfumarat involverer ikke cytokrom P450-systemet isoenzymer.
English: Very common Very common Common Common Very rare Very rare
Danish: Meget almindelig Meget almindelig Almindelig Almindelig Meget sjælden Meget sjælden
English: E-08740 Sant Andreu de la Barca, Barcelona Spain
Danish: E-08740 Sant Andreu de la Barca, Barcelona Spanien
English: Caution should be exercised when prescribing medicinal products with a narrow therapeutic index that require absorption in the intestinal tract.
Danish: Der bør udvises forsigtighed ved ordination af lægemidler med et snævert terapeutisk indeks, som kræver absorption i tarmkanalen.
English: 593, Sant Andreu de la Barca, Barcelona, 08740, Spain
Danish: 593, Sant Andreu de la Barca, Barcelona, 08740, Spanien
English: Patients should be made aware that they are likely to experience flushing in the first few weeks of taking Skilarence (see section 4.8).
Danish: Patienter bør gøres opmærksomme på, at de sandsynligvis vil opleve rødmen i de første få uger af behandlingen med Skilarence (se pkt.
English: Risk factors can include previous immunosuppressive treatment and the existence of certain concomitant disorders (such as some autoimmune disorders or malignant haematological conditions).
Danish: Risikofaktorer kan omfatte tidligere immunosuppressiv behandling og tilstedeværelse af visse samtidige lidelser (såsom visse autoimmune lidelser eller maligne hæmatologiske tilstande).
English: Typical symptoms associated with PML are diverse, become worse 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.
Danish: Typiske symptomer forbundet med PML er meget forskellige, de forværres over nogle dage til uger, og omfatter tiltagende svaghed i den ene side af kroppen eller bevægeforstyrrelser, synsforstyrrelser og ændringer i tænkemåde, hukommelse og orientering, der fører til forvirring og personlighedsændringer.
English: During the Phase III placebo-controlled clinical trial, renal function was not seen to deteriorate during therapy across treatment groups.
Danish: I det placebokontrollerede kliniske fase III-studie sås der under behandlingen ingen påvirkning af nyrefunktionen på tværs af behandlingsgrupper.
English: Skilarence with alcohol
Danish: Brug af Skilarence sammen med alkohol
English: The kidney was identified as a major target organ of toxicity in non-clinical studies.
Danish: Nyren blev identificeret som et vigtigt målorgan for toksicitet i non-kliniske forsøg.
English: Early diagnosis of Fanconi syndrome and discontinuation of Skilarence treatment are important to prevent the onset of renal impairment and osteomalacia, as the syndrome is usually reversible.
Danish: Det er vigtigt at foretage en tidlig diagnose af Fanconis syndrom og seponere Skilarence-behandlingen for at forhindre opståen af nedsat nyrefunktion og osteomalaci, da syndromet normalt er reversibelt.
English: In particular, in the clinical study there was a slight decrease in mean lymphocyte counts starting between weeks 3 and 5 and reaching a maximum in week 12 where approximately one third of patients had lymphocyte values below 1.0x10
Danish: Specielt i det kliniske studie var der et mindre fald i middellymfocyttallet, startende mellem uge 3 og 5, og det nåede et maksimum i uge 12, hvor cirka en tredjedel af patienterne havde lymfocytværdier under 1,0x10
English: Some of these side effects, such as reddening of the face or body (flushing), diarrhoea, stomach problems and nausea usually improve as you continue treatment.
Danish: Nogle af disse bivirkninger, såsom rødfarvning af ansigt eller krop (rødmen), diarré, maveproblemer og kvalme, forbedres normalt, når du fortsætter behandlingen.
English: See the instructions in the patient leaflet of the contraceptive you are taking.
Danish: Se instruktionerne i indlægssedlen for det præventionsmiddel, du tager.
English: The majority of patients reported a “very large” or “extremely large” effect of psoriasis on their life based on the Dermatology Life Quality Index (DLQI), with a mean DLQI score of 11.5.
Danish: De fleste patienter berettede, at psoriasis havde en ”meget stor” eller ”ekstremt stor” effekt på deres liv baseret på DLQI indeks (valideret mål af livskvaliteten i psoriasis) med en gennemsnitlig DLQI-score på 11,5.
English: Importantly, Fanconi syndrome can occur without elevated creatinine levels or low glomerular filtration rate.
Danish: Det skal fremhæves, at Fanconis syndrom kan forekomme uden forhøjede kreatininniveauer eller lav glomerulær filtrationshastighed.
English: 704 patients were randomised to receive Skilarence, an active comparator (Fumaderm, a combination product with the same content of dimethyl fumarate plus 3 monoethyl fumarate salts) and placebo in a ratio of 2:2:1.
Danish: 704 patienter blev randomiseret til at modtage Skilarence, en aktiv komparator (Funaderm, et kombinationsprodukt med samme indhold af dimethylfumarat plus 3 monoethylfumaratsalte) og placebo i forholdet 2:2:1.
English: When switching patients from such therapies to Skilarence, the half-life and mode of action of the other therapy should be considered in order to avoid additive effects on the immune system.
Danish: Når patienter skiftes over fra sådanne behandlinger til Skilarence, bør halveringstiden og virkningsmekanismen for den anden behandling overvejes for at undgå additiv indvirkning på immunsystemet.
English: Fanconi syndrome is a rare but serious kidney disorder which may occur with Skilarence.
Danish: Fanconis syndrom er en sjælden, men alvorlig nyrelidelse, som kan forekomme med Skilarence.
English: Dimethyl fumarate does not show any binding affinity to serum proteins which may further contribute to its rapid elimination from the circulation.
Danish: Dimethylfumarat viser ikke nogen bindingsaffinitet over for serumproteiner, hvilket yderligere kan bidrage til dets hurtige eliminering i kredsløbet.
English: If you notice you are passing more urine, are more thirsty and drinking more than normal, your muscles seem weaker, you break a bone, or just have aches and pains, talk to your doctor as soon as possible so that this can be investigated further.
Danish: Hvis du opdager, du lader mere vand, er mere tørstig og drikker mere end normalt, dine muskler virker svagere, du brækker en knogle eller bare har ømhed og smerter, skal du hurtigst muligt tale med din læge, så det kan undersøges nærmere.
English: In case of unclear symptoms Fanconi syndrome should be considered and appropriate examinations should be performed.
Danish: Hvis der er uklare symptomer, bør det overvejes, om det kan være Fanconis syndrom, og passende undersøgelser bør iværksættes.
English: Placebo with a difference of 22.2% for PASI 75 and 20.0% for PGA score clear or almost clear, superiority of Fumaderm vs Placebo with a difference of 25.0% for PASI 75 and 24.4% for PGA score clear or almost clear; b Non-inferiority of Skilarence vs. Fumaderm with a difference of -2.8% for PASI 75 and -4.4% for PGA score clear or almost clear.
Danish: PGA=Physician's Global Assessment (Lægens overordnede vurdering); a Superioritet af Skilarence vs. Placebo med en forskel på 22,2 % for PASI 75 og 20,0 % for PGA-score klar eller næsten klar, overlegen Fumaderm vs placebo med en forskel på 25,0 % for PASI 75 og 24,4 % for PGA-scoren klar eller næsten klar; b Non-inferioritet af Skilarence vs Fumaderm med en forskel på -2,8 % for PASI 75 og -4,4 % for PGA-scoren klar eller næsten klar.
English: Tel. +34 93 291 30 00
Danish: Tlf.: +34 93 291 30 00
English: The most serious side effects that may occur with Skilarence are allergic or hypersensitivity reactions; kidney failure or a kidney disease called Fanconi syndrome; or a severe brain infection called progressive multifocal leukoencephalopathy (PML).
Danish: De mest alvorlige bivirkninger, der kan opstå med Skilarence, er allergiske reaktioner eller overfølsomhedsreaktioner; nyresvigt eller en nyresygdom kaldet Fanconis syndrom; eller en alvorlig hjerneinfektion kaldet progressiv multifokal leukoencefalopati (PML).
English: Rare side effects (may affect up to 1 in 1,000 people): - allergic skin reaction
Danish: Sjældne bivirkninger (kan påvirke op til 1 ud af 1.000 personer): - allergisk hudreaktion
English: Skilarence has not been studied in patients with pre-existing gastrointestinal disease.
Danish: Skilarence er ikke undersøgt hos patienter som har en eksisterende gastrointestinal sygdom.
English: In the clinical study a total of 20.8% of patients receiving Skilarence experienced flushing, which was mild in the majority of cases (see section 4.4).
Danish: I det kliniske studie oplevede i alt 20,8 % af patienterne, som fik Skilarence, rødmen, som var mild i de fleste tilfælde (se pkt.
English: Two-sided 99.24% CI
Danish: Tosidet 99,24 % CI
English: The most common adverse reactions observed with Skilarence in the Phase III clinical study (1102) in psoriasis patients were gastrointestinal events (62.7%), flushing (20.8%) and lymphopenia (10.0%).
Danish: De mest almindelige bivirkninger, som er observeret med Skilarence i det kliniske fase III-studie (1102) hos psoriasispatienter, var gastrointestinale hændelser (62,7 %), rødmen (20,8 %) og lymfopeni (10,0 %).
English: Do not take Skilarence - if you are allergic to dimethyl fumarate or any of the other ingredients of this medicine (listed in section 6) - if you have severe problems with your stomach or intestines - if you have severe liver or kidney problems - if you are pregnant or breast-feeding
Danish: Tag ikke Skilarence - hvis du er allergisk over for dimethylfumarat eller et af de øvrige indholdsstoffer i dette lægemiddel (angivet i punkt 6) - hvis du har alvorlige problemer med din mave eller tarme - hvis du har alvorlige lever- eller nyreproblemer - hvis du er gravid eller ammer
English: More than 90% of these diarrhoea events were of mild to moderate severity (see section 4.4).
Danish: Mere end 90 % af disse diarréhændelser var af mild til moderat sværhedsgrad (se pkt.
English: Marketing Authorisation Holder Almirall, S.A.
Danish: Indehaver af markedsføringstilladelsen Almirall, S.A.
English: Pre-existing gastrointestinal disease
Danish: Allerede eksisterende gastrointestinal sygdom
English: The European Medicines Agency has waived the obligation to submit the results of studies with Skilarence in all subsets of the paediatric population in this indication (see section 4.2 for information on paediatric use).
Danish: Det Europæiske Lægemiddelagentur har dispenseret fra kravet om at fremlægge resultater af studier med Skilarence i alle undergrupper af den pædiatriske population med denne indikation (se pkt.
English: Published clinical experience with dimethyl fumarate-containing products shows that individual episodes of flushing usually begin shortly after taking the tablets and resolve within a few hours.
Danish: Offentliggjorte kliniske erfaringer med dimethylfumarat-holdige produkter viser, at individuelle episoder af rødmen begynder kort tid efter at tabletterne er taget, og forsvinder inden for få timer.
English: In rare cases hypophosphataemic osteomalacia with non-localised bone pain, elevated alkaline phosphatase in serum and stress fractures may occur.
Danish: I sjældne tilfælde kan der forekomme hypophosphatæmisk osteomalaci med ikke-lokaliserede knoglesmerter, forhøjet alkalisk fosfatase i serum samt stressfrakturer.
English: At week 16, patients treated with Skilarence had a lower mean DLQI compared to placebo (5.4 vs 8.8).
Danish: I uge 16 havde patienter behandlet med Skilarence en lavere gennemsnitlig DLQI sammenlignet med placebo (5,4 vs. 8,8).
English: Based on the pharmacology of dimethyl fumarate, a need for dose adjustment in the elderly is not expected.
Danish: Vurderet ud fra dimethylfumarats farmakologiske egenskaber forventes der ikke at være behov for at foretage dosisjustering hos ældre.
English: Dimethyl fumarate has been shown to cross the placental membrane into foetal blood in rats.
Danish: Dimethylfumarat er påvist at krydse placentamembranen ind i det føtale blod i rotter.
English: There is no evidence for Skilarence interaction with cytochrome P450 and the most common efflux and uptake transporters, thus no interactions are expected with medicinal products metabolised or transported by these systems (see section 5.2).
Danish: Der er ingen beviser for, at Skilarence interagerer med cytochrom P450 og de mest almindelige effluxog optagelsestransportører, så der forventes ikke interaktioner med lægemidler, der metaboliseres eller transporteres af disse systemer (se pkt.
English: During treatment a complete blood count with differential should be performed every 3 months.
Danish: Under behandlingen skal der udføres en komplet blodtælling (med differentialtælling og trombocyttælling) hver 3. måned.
English: Fumaderm = Active comparator, a combination product with the same content of dimethyl fumarate plus 3 monoethyl hydrogen fumarate salts; n=number of patients with available data; N=number of patients in population; PASI=Psoriasis Area Severity Index; PGA=Physician's Global Assessment; a Superiority of Skilarence vs.
Danish: Fumaderm = Aktiv komparator, et kombinationsprodukt med samme indhold af dimethylfumarat plus 3 monoethylhydrogenfumaratsalte; n=number of patients with available data (antal patienter med tilgængelige data); N=number of patients in population (antal patienter i population); PASI=Psoriasis Area Severity Index;
English: After oral administration of a single Skilarence 120 mg tablet in healthy subjects, monomethyl fumarate reached plasma peak concentrations of around 1325 ng/mL and 1311 ng/mL under fasted or fed conditions, respectively.
Danish: Efter oral administration af en enkelt tablet Skilarence på 120 mg til raske forsøgspersoner opnåede monomethylfumarat plasma-peakkoncentrationer på omkring 1325 ng/ml og 1311 ng/ml i hhv. fastende eller mæt tilstand.
English: The anti-inflammatory and immunomodulating effects of dimethyl fumarate and its metabolite monomethyl fumarate are not fully elucidated but are thought to be mainly due to the interaction with the intracellular reduced glutathione of cells directly involved in the pathogenesis of psoriasis.
Danish: De anti-inflammatoriske og immunmodulerende virkninger af dimethylfumarat og dets metabolit monomethylfumarat er ikke fuldstændigt belyst, men menes hovedsagelig at skyldes interaktionen med den intracellulære reducerede glutathion i celler, der direkte indgår i patogenesen af psoriasis.
English: The main activity of dimethyl fumarate and monomethyl fumarate is considered to be immunomodulatory, resulting in a shift in T helper cells (Th) from the Th1 and Th17 profile to a Th2 phenotype.
Danish: Hovedaktiviteten af dimethylfumarat og monomethylfumarat anses for at være immunmodulerende, hvilket resulterer i et skift i T-hjælpercellerne (Th) fra en Th1- og Th17-profil til en Th2-fænotype.
English: If you get severe or prolonged diarrhoea with Skilarence, other medicines may not work as well as they should.
Danish: Hvis du får alvorlig eller længerevarende diarré med Skilarence, vil anden medicin muligvis ikke virke så godt, som den burde.
English: Further studies have shown that dimethyl fumarate (and to a lesser extent monomethyl fumarate) reacts partially with reduced glutathione forming a glutathioneadduct.
Danish: Yderligere studier har vist, at dimethylfumarat (og i mindre udstrækning monomethylfumarat) reagerer delvist med reduceret glutathion og danner en glutathion-addukt.
English: Skilarence tablets are used to treat moderate to severe plaque psoriasis in adults.
Danish: Skilarence-tabletter bruges til at behandle moderat til svær plaque psoriasis hos voksne.
English: Prior to initiating treatment with Skilarence, a current complete blood count (including differential blood count and platelet count) should be available.
Danish: Før påbegyndelse af behandling med Skilarence skal der foreligge en aktuel komplet blodtælling (herunder differentialtælling og trombocyttal).
English: 3/279 (1.1%) of the patients started on Skilarence.
Danish: (1,1 %) af de patienter, der startede med Skilarence.
English: What Skilarence is
Danish: Hvad er Skilarence
English: Patients began treatment with tablets containing 30 mg/day dimethyl fumarate or placebo, titrating up to a maximum of 720 mg/day in both active treatment arms as described in section 4.2.
Danish: Patienter påbegyndte behandling med tabletter indeholdende 30 mg/dag dimethylfumarat eller placebo med optitrering til maksimalt 720 mg/dag i begge aktive behandlingsarme som beskrevet i pkt.
English: After clinically relevant improvement of the skin lesions has been achieved, consideration should be given to gradual reduction of the daily dose of Skilarence to the maintenance dose required by the individual.
Danish: Efter at der er opnået klinisk relevant forbedring af hudlæsioner, bør det overvejes gradvist at reducere den daglige dosis Skilarence til den vedligeholdelsesdosis, som er nødvendig for den enkelte patient.
English: No studies on the ability to drive and use machines have been conducted.
Danish: Der er ikke foretaget undersøgelser af indflydelsen på evnen til at føre motorkøretøjer og betjene maskiner.
English: • The guide for healthcare professionals shall contain the following key elements: o Relevant information on PML (e.g. seriousness, severity, frequency, time to onset, reversibility of the AE as applicable) o Details of the population at higher risk for PML o Details on how to minimise the risk of PML through appropriate monitoring and management, including laboratory monitoring of lymphocyte and leukocyte prior to and during treatment, and criteria for treatment discontinuation o Key messages to convey in counselling of patients
Danish: • Vejledningen for sundhedspersonale skal indeholde følgende hovedelementer: o Relevant information om PML (f.eks. alvorlighed, sværhedsgrad, hyppighed, tid til start, reversibilitet af uønsket hændelse hvis relevant) o Oplysninger om population med højere risiko for PML o Oplysninger om, hvordan risikoen for PML minimeres gennem passende overvågning og behandling, herunder laboratorieovervågning af lymfocyt- og leukocyttælling før og under behandlingen samt kriterier for behandlingsophør o Vigtigste budskaber, som skal formidles under rådgivning af patienter
English: Your dose will be increased every week as shown in the table below (switching to 120 mg Skilarence tablets from week 4 onwards).
Danish: Din dosis vil blive øget, hver uge, som vist i nedenstående tabel (skift til 120 mg Skilarence-tabletter fra uge 4 og frem).
English: Allergic or hypersensitivity reactions are rare but may be very serious.
Danish: Allergiske reaktioner eller overfølsomhedsreaktioner Allergiske reaktioner eller overfølsomhedsreaktioner er sjældne, men kan være meget alvorlige.
English: Swallow Skilarence tablets whole with liquid.
Danish: Slug Skilarence tabletterne hele med væske.
English: If you have a serious infection, either before starting treatment with Skilarence or during treatment, your doctor may advise you not to take Skilarence until the infection has resolved.
Danish: Hvis du har en alvorlig infektion, enten før behandlingen med Skilarence eller under behandlingen, vil din læge muligvis råde dig til ikke at tage Skilarence, før infektionen er opklaret.
English: Dosage modifications may also be necessary if abnormalities in laboratory parameters are observed (see section 4.4).
Danish: Dosisændringer kan også være nødvendige, hvis der ses afvigelser i laboratorieværdier (se pkt.
English: Opportunistic infections/progressive multifocal leukoencephalopathy (PML) Cases of opportunistic infections, particularly of progressive multifocal leukoencephalopathy (PML) have been reported with other dimethyl fumarate-containing products (see section 4.8).
Danish: Opportunistiske infektioner/progressiv multifokal leukoencefalopati (PML) Tilfælde af opportunistiske infektioner, især af progressiv multifokal leukoencefalopati (PML) er blevet indberettet med andre dimethylfumarat-holdige produkter (se pkt.
English: Evening of dimethyl fumarate
Danish: Aften af dimethylfumarat
English: Skilarence may have a minor influence on the ability to drive and use machines.
Danish: Skilarence kan i mindre grad påvirke evnen til at føre motorkøretøj og betjene maskiner.
English: Methacrylic acid-ethyl acrylate copolymer (1:1) Talc
Danish: Methacrylsyre - ethylacrylat copolymer (1:1) Talcum
English: Despite the high inter-subject variability, the exposure measured as AUC and Cmax was generally dose-proportional after single dose administration of 4 x 30 mg dimethyl fumarate tablets (total dose of 120 mg) and 2 x 120 mg dimethyl fumarate tablets (total dose of 240 mg).
Danish: På trods af den store variation mellem forsøgspersoner var den eksponering, som måltes som AUC og Cmax generelt proportional med dosis efter administration af en enkelt dosis på 4 x 30 mg dimethylfumarat-tabletter (samlet dosis på 120 mg) og 2 x 120 mg dimethylfumarat-tabletter (samlet dosis på 240 mg).