FrancophonIA/ELRC3.0 huggingface dataset:
English: Non-clinical safety pharmacology and genotoxicity data reveal no special hazard for humans.
Danish: Ikke-klinisk sikkerhedsfarmakologi- og genotoksicitetsdata påviste ingen særlige farer for mennesker.
English: If PML is suspected, treatment with Skilarence should be stopped immediately and further appropriate neurological and radiological examinations performed.
Danish: Hvis der er mistanke om PML, skal behandling med Skilarence omgående stoppes, og yderligere relevante neurologiske og radiologiske undersøgelser udføres.
English: Uncommon Not known Not known
Danish: Ikke almindelig Ikke kendt Ikke kendt
English: Fanconi syndrome
Danish: Fanconis syndrom
English: There are limited data from the use of dimethyl fumarate in pregnant women.
Danish: Der er begrænsede data for anvendelse af dimethylfumarat til gravide kvinder.
English: The demographic and baseline characteristics were well balanced between the treatment groups.
Danish: De demografiske karakteristika og baselinekarakteristika var velafbalancerede mellem behandlingsgrupperne.
English: It changes the activity of the immune system and reduces the production of substances involved in causing psoriasis.
Danish: Det ændrer immunsystemets aktivitet og reducerer produktionen af stoffer, der bidrager til at forårsage psoriasis.
English: Your doctor will check how well your condition is improving after you start taking Skilarence and will check for side effects.
Danish: Din læge vil kontrollere, i hvor høj grad din tilstand forbedres, efter at du begynder at tage Skilarence, og vil undersøge, om der er nogen bivirkninger.
English: Depending on the results of these blood and urine tests, your doctor may reduce your dose of Skilarence or stop treatment.
Danish: Afhængigt af resultaterne af disse blod- og urinprøver kan lægen nedsætte Skilarence-dosen eller stoppe behandlingen.
English: Of the 699 patients, most were Caucasian (99%) and male (65%), and the mean age was 44 years.
Danish: Ud af de 699 patienter var de fleste kaukasere (99 %) og mænd (65 %) og gennemsnitsalderen var 44 år.
English: Therapy should be discontinued and caution is advised if other pathological results occur.
Danish: Behandlingen bør afbrydes, og der skal udvises forsigtighed, hvis andre patologiske resultater fremkommer.
English: In case of individual intolerability of the increased dosage during weeks 4 to 16, the patient was to return to the last tolerated dose taken since the start of week 4, which was to be maintained until end of the treatment period (week 16).
Danish: I tilfælde af individuel intolerance overfor den øgede dosis i uge 4 til 16 skulle patienten vende tilbage til den sidst tolererede dosis, der blev taget siden starten af uge 4, og den skulle opretholdes ind til behandlingsperiodens afslutning (uge 16).
English: If a particular dose increase is not tolerated, it may be temporarily reduced to the last tolerated dose.
Danish: Hvis en bestemt dosisøgning ikke tolereres, kan den midlertidigt reduceres til den sidste tolererede dosis.
English: Talk to your doctor if you have bad diarrhoea and are concerned that other medicines you are taking might not work.
Danish: Tal med din læge, hvis du har en slem diarré og er bekymret for, at anden medicin, som du tager, muligvis ikke virker.
English: Do not use this medicine after the expiry date which is stated on the carton and the blister after “EXP”.
Danish: Brug ikke lægemidlet efter den udløbsdato, der står på pakningen efter ”EXP”.
English: The mean and median values of lymphocytes remained within the normal range during the clinical study.
Danish: Middel- og medianværdier af lymfocytter lå fortsat inden for det normale område under det kliniske studie.
English: Acute lymphatic leukaemia* Irreversible pancytopenia*
Danish: Akut lymfatisk leukæmi* Irreversibel pancytopeni*
English: Take the next dose at the usual time and continue taking the medicine exactly as described in this leaflet or exactly as agreed with your doctor.
Danish: Tag den næste dosis på det sædvanlige tidspunkt, og fortsæt med at tage medicinen nøjagtigt som beskrevet i denne indlægsseddel eller efter lægens anvisning.
English: Before treatment
Danish: Før behandling
English: Hence it is reasonable to expect the long-term efficacy of Skilarence to also be comparable to dimethyl fumarate-containing products.
Danish: Det er derfor rimeligt at forvente, at langtidsvirkningen af Skilarence også vil være sammenlignelig med dimethylfumarat-holdige produkter.
English: This helps to reduce stomach problems and other side effects.
Danish: Det hjælper med at begrænse maveproblemer og andre bivirkninger.
English: Vaccination during treatment with Skilarence has not been studied.
Danish: Vaccination under behandling med Skilarence er ikke blevet undersøgt.
English: This could cause stomach and intestinal problems.
Danish: Dette kan forårsage mave og tarmproblemer.
English: Do not crush, break, dissolve or chew your tablets, as they have a special coating to help prevent irritation of your stomach.
Danish: Du må ikke knuse, dele, opløse eller tygge tabletterne, da de har et særligt overtræk for at forhindre irritation i maven.
English: Leukopenia: If a marked decrease in the total number of white blood cells is found, the situation should be monitored carefully and treatment with Skilarence should be discontinued at levels below 3.0x10
Danish: Leukopeni: Hvis der opstår et markant fald i det totale antal hvide blodlegemer, skal situationen overvåges nøje, og behandling med Skilarence bør afbrydes ved niveauer under 3,0x10
English: Brain infection called PML
Danish: Hjerneinfektion kaldet PML
English: PML is an opportunistic infection caused by the John-Cunningham virus (JCV) that can be fatal or cause severe disabilities.
Danish: PML er en opportunistisk infektion, der er forårsaget af John Cunningham virus (JCV), der kan være dødelig eller forårsage svære handicap.
English: Your doctor will advise you on what care you need to take during Skilarence treatment.
Danish: Din læge vil fortælle dig, hvilken pleje du skal have under behandlingen med Skilarence.
English: This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodiumfree'.
Danish: Dette lægemiddel indeholder mindre end 1 mmol (23 mg) natrium pr. tablet, dvs. det er i det væsentlige natriumfrit.
English: From the fourth week, treatment is switched to only 1 tablet of Skilarence 120 mg in the evening.
Danish: Fra fjerde uge ændres behandlingen til blot 1 tablet Skilarence 120 mg om aftenen.
English: If you need a vaccination, talk to your doctor.
Danish: Hvis du skal vaccineres, skal du tale med din læge.
English: Skilarence tablets must be swallowed whole with fluid during or immediately after a meal.
Danish: Skilarence-tabletter skal synkes hele med væske under eller umiddelbart efter et måltid.
English: Avoid strong alcoholic drinks (more than 50 ml of spirits containing more than 30% alcohol by volume) during treatment with Skilarence, as alcohol can interact with this medicine.
Danish: Undgå stærke alkoholiske drikkevarer (mere end 50 ml spiritus, der indeholder mere end 30 % alkohol) under behandling med Skilarence, da alkohol kan interagere med denne medicin.
English: However, there was an increased number of foetuses with the variations “supernumerary liver lobe” and “abnormal iliac alignment” at maternally toxic doses.
Danish: Der var imidlertid et øget antal fostre med variationerne ”supernumerary liver lobe” (overtal af leverlapper) og ”abnormal iliac alignment” (unormal iliaca tilpasning) ved maternelt toksiske doser.
English: Most adverse reactions were considered mild and did not lead to discontinuation of study treatment.
Danish: De fleste bivirkninger blev anset for at være milde og førte ikke til seponering af forsøgsbehandlingen.
English: If treatment success is observed before the maximum dose is reached, no further increase of dose is necessary.
Danish: Hvis der konstateres behandlingssucces, før den maksimale dosis er nået, er det ikke nødvendigt at øge dosis yderligere.
English: 9/L or higher for two consecutive blood tests at which point monitoring can again be performed every 3 months.
Danish: 9/l eller derover i to måneder i træk, hvorefter blodprøver igen kan tages hver 3. måned.
English: Persistent moderate or severe lymphopenia during treatment with dimethyl fumarate is also considered a risk factor for PML.
Danish: Vedvarende moderat eller svær lymfopeni under behandling med dimethylfumarat anses også for at være en risikofaktor for PML.
English: For symptoms see below.
Danish: Symptomerne er beskrevet nedenfor.
English: Patients received treatment for up to 16 weeks and follow-up visits were planned for up to 12 months after treatment was stopped.
Danish: Patienterne modtog behandling i op til 16 uger og opfølgende konsultationer var planlagt i op til 12 måneder efter, at behandlingen var afsluttet.
English: Fertility There are no human or animal data on the effects of Skilarence on fertility.
Danish: Fertilitet Der findes ingen humane data eller data fra dyreforsøg om virkningerne af Skilarence på fertiliteten.
English: This interaction with glutathione leads to the inhibition of translocation into the nucleus and the transcriptional activity of the nuclear factor kappa-light-chain-enhancer of activated B-cells (NF-κB).
Danish: Denne interaktion med glutathion fører til hæmning af translokation til kernen og den transkriptionelle aktivitet af den nukleare faktor kappa-light-chain-enhancer af aktiverede B-celler (NF-κB).
English: Taking Skilarence with food delayed the tmax of monomethyl fumarate from 3.5 to 9.0 hours.
Danish: Indtagelse af Skilarence med føde forsinkede tmax af monomethylfumarat fra 3,5 til 9,0 timer.
English: In particular, if you are taking a contraceptive medicine (the pill), the effect may be reduced and you may need to use other barrier methods to prevent pregnancy.
Danish: Især hvis du tager svangerskabsforebyggende medicin (p-piller), kan virkningen mindskes, og det kan være nødvendigt at bruge andre barrieremetoder til at forhindre graviditet.
English: A transient increase in mean values of eosinophils was noted as early as week 3, reached a maximum at week 5 and 8, and had returned to baseline values at week 16.
Danish: En forbigående stigning i middelværdier af eosinofile bemærkedes allerede i uge 3, nåede et maksimum i uge 5 og 8, og var vendt tilbage til værdier ved baseline i uge 16.
English: Patients receiving Skilarence should be instructed to report symptoms of infection to a physician.
Danish: Patienter, der får Skilarence, skal instrueres i at rapportere symptomer på infektion til en læge.
English: - Dimethyl fumarate or other fumarates.
Danish: - Dimethylfumarat eller andre fumarater.
English: Patients who develop lymphopenia should be monitored for signs and symptoms of opportunistic infections, particularly for symptoms indicative of PML.
Danish: Patienter, som udvikler lymfopeni, bør overvåges for tegn og symptomer på opportunistiske infektioner, især for symptomer på PML.
English: If a patient develops an infection during treatment with Skilarence, suspension of treatment should be considered and the benefits and risks should be reassessed prior to re-initiation of therapy.
Danish: Hvis en patient udvikler en infektion under behandling med Skilarence, bør det overvejes at indstille behandlingen, og fordele og risici bør revurderes, før behandlingen genoptages.
English: Skilarence is intended for use under the guidance and supervision of a physician experienced in the diagnosis and treatment of psoriasis.
Danish: Skilarence er beregnet til brug under vejledning og opsyn af en læge, som har erfaring med diagnosticering og behandling af psoriasis.
English: Reproduction toxicity No fertility or pre- and post-natal development studies have been conducted with Skilarence.
Danish: Reproduktionstoksicitet Der er ikke foretaget fertilitets- eller præ og post-natale udviklingsstudier med Skilarence.
English: If the side effects are not troublesome, your dose will be increased until your condition is well controlled.
Danish: Hvis bivirkningerne ikke er generende, øges din dosis, indtil din tilstand er under kontrol.
English: In cases of severe or prolonged diarrhoea during treatment with Skilarence, absorption of other medicinal products may be affected.
Danish: I tilfælde af svær eller længerevarende diarré under behandling med Skilarence kan absorption af andre lægemidler blive påvirket.
English: Experience with related products containing dimethyl fumarate shows treatment benefit for at least up to 24 months.
Danish: Erfaringer med relaterede produkter, som indeholder dimethylfumarat, viser behandlingsmæssige fordele i op til mindst 24 måneder.
English: 9/L, the blood test must be repeated and if the levels are confirmed to be below 0.7x10
Danish: 9/l, skal blodprøven gentages, og hvis det bekræftes, at niveauerne er under 0,7x10
English: Diarrhoea was a common adverse reaction (36.9%) among patients taking Skilarence, leading to medicinal product withdrawal in about 10% of patients.
Danish: Diarré var en almindelig bivirkning (36,9 %) hos patienter, der tog Skilarence, og førte til at lægemidlet blev seponeret hos omkring 10 % af patienterne.
English: Consumption of large quantities of strong alcoholic drinks (more than 30% alcohol by volume) should be avoided because it may lead to increased dissolution rates of Skilarence and, therefore, may increase the frequency of gastrointestinal adverse reactions.
Danish: Det bør undgås at indtage store mængder stærke alkoholiske drikke (mere end 30 % alkohol), da det kan føre til øgede opløsningshastigheder for Skilarence, og kan derfor øge hyppigheden af gastrointestinale bivirkninger.
English: Further metabolism occurs through oxidation via the tricarboxylic acid cycle forming carbon dioxide and water.
Danish: Yderligere metabolisme sker gennem iltning via tricarboxylsyrecyklussen, som danner kuldioxid og vand.
English: Further improvement was seen by week 16
Danish: Yderligere forbedringer blev set i uge 16 (
English: Skilarence is an immunomodulator and may affect the way the immune system responds to infection.
Danish: Skilarence er en immunmodulator og kan påvirke immunsystemets reaktion på infektion.
English: The coating of the gastro-resistant tablets is designed to prevent gastric irritation.
Danish: Overtrækket på enterotabletterne er designet til at forebygge gastrisk irritation.
English: If you forget to take Skilarence
Danish: Hvis du har glemt at tage Skilarence
English: There were no effects on foetal body weights or malformations attributed to maternal administration of dimethyl fumarate during the embryo-foetal development study in rats.
Danish: Der var ingen indvirkning på fostervægt eller misdannelser, som kunne tilskrives maternel administration af dimethylfumarat under det embryo-føtale udviklingsstudie i rotter.
English: 9/L but is ≥0.7 x10
Danish: 9/l men er ≥ 0,7x10
English: During treatment with Skilarence, simultaneous use of other fumaric acid derivatives (topical or systemic) should be avoided.
Danish: Under behandling med Skilarence bør samtidig anvendelse af andre fumarsyrederivater (topiske eller systemiske) undgås.
English: Proteinuria* Renal failure* Fanconi syndrome*
Danish: Proteinuri* Nyresvigt* Fanconis syndrom*
English: Symptoms include fever, pain, aching muscles, headache, loss of appetite and a general feeling of weakness.
Danish: Symptomer omfatter feber, smerte, ømme muskler, hovedpine, appetitløshed og en generel svaghedsfornemmelse.
English: Pharmacotherapeutic group: Other immunosuppressants, ATC code: L04AX07
Danish: Farmakoterapeutisk klassifikation: Andre immunosuppressive midler, ATC-kode: L04AX07.
English: The active ingredient in Skilarence, dimethyl fumarate, is also used in other medicines such as tablets, ointments and baths.
Danish: Det aktive indholdsstof i Skilarence, dimethylfumarat, bruges også i andre lægemidler, såsom tabletter, salver og badeprodukter.
English: No apparent dose relationship and no risk factors for the occurrence of these adverse reactions could be identified.
Danish: Der kunne ikke identificeres en klar relation til dosis eller til risikofaktorer for forekomsten af disse bivirkninger.
English: The maximum daily dose allowed is 720 mg (3 x 2 tablets of Skilarence 120 mg).
Danish: Den maksimalt tilladte daglige dosis er 720 mg (3 x 2 tabletter Skilarence 120 mg).
English: Unconjugated dimethyl fumarate, however, cannot be detected in the plasma of animals or psoriatic patients following oral administration.
Danish: Ukonjugeret dimethylfumarat kan imidlertid ikke påvises i plasmaet hos dyr eller psoriasispatienter efter oral administration.
English: It is recommended to monitor hepatic function (SGOT, SGPT, gamma-GT, AP) prior to initiation of treatment and every 3 months thereafter, since elevation of hepatic enzymes has been observed in some patients in the Phase III study.
Danish: Det anbefales at overvåge leverfunktionen (SGOT, SGPT, gamma-GT, AP) før behandlingsstart og derefter hver 3. måned, da der er observeret en stigning i leverenzymniveauet hos nogle patienter i fase III-studiet.
English: The MAH shall ensure that in each Member State where Skilarence is marketed, healthcare professionals who are expected to prescribe and dispense Skilarence have access to the following educational package.
Danish: Indehaveren af markedsføringstilladelsen skal sikre, at sundhedspersonale i alle de medlemsstater, hvor Skilarence markedsføres, som forventes at ordinere og udlevere Skilarence, har adgang til følgende uddannelsespakke
English: Indigo carmine (E132)
Danish: Indigotin (E132)
English: Clinical studies of Skilarence did not include sufficient numbers of patients aged 65 years and above to determine whether they respond differently compared to patients under 65 years (see section 5.2).
Danish: Kliniske studier med Skilarence omfattede ikke et tilstrækkeligt antal patienter i alderen 65 år og derover til at afgøre, om de reagerer anderledes sammenlignet med patienter under 65 år (se pkt.
English: If you have severe side effects after an increase in dose, your doctor may recommend that you temporarily go back to the last dose.
Danish: Hvis du har alvorlige bivirkninger efter en dosisstigning, vil din læge muligvis anbefale, at du midlertidigt går tilbage til den sidste dosis.
English: Skilarence may cause problems with your blood, liver or kidneys.
Danish: Skilarence kan forårsage problemer med dit blod, din lever eller dine nyrer.
English: Rebound (defined as worsening of ≥125% of baseline PASI value) was assessed after 2 months off treatment and was shown not to be a clinical concern with fumaric acid esters, as it was documented in very few patients (Skilarence 1.1% and active comparator 2.2%, compared to 9.3% in the placebo group).
Danish: Rebound (defineret som en forværring på ≥125 % af PAS-værdien ved baseline) blev vurderet efter 2 måneder uden behandling og blev påvist ikke at være et klinisk problem med fumarsyreestere, da det blev set hos meget få patienter (Skilarence 1,1 % og aktiv komparator 2,2 % sammenlignet med 9,3 % i placebogruppen).
English: 9/L were observed in 1/29 (3.5%) patient at 6 months and 0/28 (0%) at 12 months after stopping treatment.
Danish: 9/l hos 1/29 (3,5 %) af patienterne efter 6 måneder og 0/28 (0 %) 12 måneder efter behandlingsafslutning.
English: Progressive multifocal leukoencephalopathy (PML) is a rare but serious brain infection that can lead to severe disability or death.
Danish: Progressiv multifokal leukoencefalopati (PML) er en sjælden, men alvorlig hjerneinfektion, som kan føre til alvorlig invaliditet eller død.
English: Progressive multifocal leukoencephalopathy*
Danish: Progressiv multifokal leukoencefalopati*
English: Progression might involve symptoms such as polyuria, polydipsia and proximal muscle weakness.
Danish: Progression kan indebære symptomer såsom polyuri, polydipsi og proksimal muskelsvaghed.
English: Prior to launch of Skilarence in each Member State the Marketing Authorisation Holder (MAH) must agree about the content and format of the educational programme, including communication media, distribution modalities, and any other aspects of the programme, with the National Competent Authority.
Danish: • Yderligere risikominimeringsforanstaltninger Inden lanceringen af Skilarence i hver medlemsstat skal indehaveren af markedsføringstilladelsen opnå enighed om indholdet og formatet af uddannelsesprogrammet, herunder kommunikationsmedier, distributionsmodaliteter og andre aspekter af programmet, med den nationale kompetente myndighed.
English: Maintenance of long term efficacy has been well described for other dimethyl fumarate-containing products, and therefore the treatment benefits seen with Skilarence at 16 weeks can be expected to be maintained in patients treated over the long term for at least 24 months.
Danish: Opretholdelse af langtidsvirkning er velbeskrevet for andre dimethylfumarat-holdige produkter, og de behandlingsmæssige fordele som ses med Skilarence efter 16 uger, kan derfor forventes opretholdt hos patienter behandlet i mindst 24 måneder.
English: The safety and efficacy of Skilarence in paediatric patients below the age of 18 years have not been established.
Danish: Sikkerhed og virkning af Skilarence hos børn og unge under 18 år er ikke klarlagt.
English: Non-inferiority of Skilarence vs. Fumaderm PASI 75, n (%) p-value
Danish: Non-inferioritet af Skilarence vs. Fumaderm PASI 75, n (%) p-værdi b
English: Warnings and precautions Talk to your doctor or pharmacist before taking Skilarence.
Danish: Advarsler og forsigtighedsregler Kontakt lægen eller apotekspersonalet, før du tager Skilarence.
English: This dose is then increased by 1 Skilarence 120 mg tablet per week at different times of day for the subsequent 5 weeks, as shown in the table below.
Danish: Denne dosis øges herefter med 1 Skilarence 120 mg tablet om ugen på forskellige tidspunkter på dagen i de efterfølgende 5 uger som vist i nedenstående tabel.
English: After your condition has improved sufficiently, your doctor will consider how to gradually reduce the daily dose of Skilarence to what you need to maintain your improvement.
Danish: Når din tilstand er tilstrækkeligt forbedret, vil din læge overveje, hvordan den daglige dosis Skilarence gradvist kan reduceres til, hvad du har brug for til at opretholde din forbedring.
English: The plasma protein binding of monomethyl fumarate is around 50%.
Danish: Plasmaproteinbindingen af monomethylfumarat er omkring 50 %.
English: Long-term efficacy data are currently not available for Skilarence, however, in the pharmacokinetic and clinical studies the systemic exposure, efficacy and safety of Skilarence were shown to be comparable to the active comparator containing dimethyl fumarate.
Danish: Langtids effektdata findes pt ikke for Skilarence, men i de farmakokinetiske og kliniske studier blev den systemiske påvirkning, effekt og sikkerhed af Skilarence påvist at være sammenlignelig med den aktive komparator, som indeholder dimethylfumarat.
English: Most patients had moderate psoriasis based on Psoriasis Area and Severity Index (PASI) and Physician's Global Assessment (PGA) scores at baseline: the mean PASI score at baseline was 16.35 and 60% of patients scored as moderate on the PGA.
Danish: De fleste patienter havde moderat psoriasis baseret på PASI score (Psoriasis Area and Severity Index) og lægens overordnede vurdering (PGA; Physician's Global Assessment) ved baseline: den gennemsnitlige PASI-score ved baseline var 16,35, og 60 % af patienterne scoredes som moderate ved PGA.
English: The apparent terminal elimination half-life of monomethyl fumarate is about 2 hours.
Danish: Den tilsyneladende terminale halveringstid af monomethylfumarat er cirka 2 timer.
English: Hepatic enzymes increased Serum creatinine increased*
Danish: Forhøjede leverenzymer Serum kreatinin øget*
English: What you need to know before you take Skilarence 3.
Danish: Det skal du vide, før du begynder at tage Skilarence 3.