natgillin/translations-raw huggingface dataset:
Der er begrænsede data for anvendelse af dimethylfumarat til gravide kvinder.
There are limited data from the use of dimethyl fumarate in pregnant women.
De demografiske karakteristika og baselinekarakteristika var velafbalancerede mellem behandlingsgrupperne.
The demographic and baseline characteristics were well balanced between the treatment groups.
Det ændrer immunsystemets aktivitet og reducerer produktionen af stoffer, der bidrager til at forårsage psoriasis.
It changes the activity of the immune system and reduces the production of substances involved in causing psoriasis.
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.
Your doctor will check how well your condition is improving after you start taking Skilarence and will check for side effects.
Afhængigt af resultaterne af disse blod- og urinprøver kan lægen nedsætte Skilarence-dosen eller stoppe behandlingen.
Depending on the results of these blood and urine tests, your doctor may reduce your dose of Skilarence or stop treatment.
Ud af de 699 patienter var de fleste kaukasere (99 %) og mænd (65 %) og gennemsnitsalderen var 44 år.
Of the 699 patients, most were Caucasian (99%) and male (65%), and the mean age was 44 years.
Behandlingen bør afbrydes, og der skal udvises forsigtighed, hvis andre patologiske resultater fremkommer.
Therapy should be discontinued and caution is advised if other pathological results occur.
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).
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).
Hvis en bestemt dosisøgning ikke tolereres, kan den midlertidigt reduceres til den sidste tolererede dosis.
If a particular dose increase is not tolerated, it may be temporarily reduced to the last tolerated dose.
Tal med din læge, hvis du har en slem diarré og er bekymret for, at anden medicin, som du tager, muligvis ikke virker.
Talk to your doctor if you have bad diarrhoea and are concerned that other medicines you are taking might not work.
Brug ikke lægemidlet efter den udløbsdato, der står på pakningen efter ”EXP”.
Do not use this medicine after the expiry date which is stated on the carton and the blister after “EXP”.
Middel- og medianværdier af lymfocytter lå fortsat inden for det normale område under det kliniske studie.
The mean and median values of lymphocytes remained within the normal range during the clinical study.
Akut lymfatisk leukæmi* Irreversibel pancytopeni*
Acute lymphatic leukaemia* Irreversible pancytopenia*
Tag den næste dosis på det sædvanlige tidspunkt, og fortsæt med at tage medicinen nøjagtigt som beskrevet i denne indlægsseddel eller efter lægens anvisning.
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.
Før behandling
Before treatment
Det er derfor rimeligt at forvente, at langtidsvirkningen af Skilarence også vil være sammenlignelig med dimethylfumarat-holdige produkter.
Hence it is reasonable to expect the long-term efficacy of Skilarence to also be comparable to dimethyl fumarate-containing products.
Det hjælper med at begrænse maveproblemer og andre bivirkninger.
This helps to reduce stomach problems and other side effects.
Vaccination under behandling med Skilarence er ikke blevet undersøgt.
Vaccination during treatment with Skilarence has not been studied.
Dette kan forårsage mave og tarmproblemer.
This could cause stomach and intestinal problems.
Du må ikke knuse, dele, opløse eller tygge tabletterne, da de har et særligt overtræk for at forhindre irritation i maven.
Do not crush, break, dissolve or chew your tablets, as they have a special coating to help prevent irritation of your stomach.
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
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
Hjerneinfektion kaldet PML
Brain infection called PML
PML er en opportunistisk infektion, der er forårsaget af John Cunningham virus (JCV), der kan være dødelig eller forårsage svære handicap.
PML is an opportunistic infection caused by the John-Cunningham virus (JCV) that can be fatal or cause severe disabilities.
Din læge vil fortælle dig, hvilken pleje du skal have under behandlingen med Skilarence.
Your doctor will advise you on what care you need to take during Skilarence treatment.
Dette lægemiddel indeholder mindre end 1 mmol (23 mg) natrium pr. tablet, dvs. det er i det væsentlige natriumfrit.
This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodiumfree'.
Fra fjerde uge ændres behandlingen til blot 1 tablet Skilarence 120 mg om aftenen.
From the fourth week, treatment is switched to only 1 tablet of Skilarence 120 mg in the evening.
Hvis du skal vaccineres, skal du tale med din læge.
If you need a vaccination, talk to your doctor.
Skilarence-tabletter skal synkes hele med væske under eller umiddelbart efter et måltid.
Skilarence tablets must be swallowed whole with fluid during or immediately after a meal.
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.
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.
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.
However, there was an increased number of foetuses with the variations “supernumerary liver lobe” and “abnormal iliac alignment” at maternally toxic doses.
De fleste bivirkninger blev anset for at være milde og førte ikke til seponering af forsøgsbehandlingen.
Most adverse reactions were considered mild and did not lead to discontinuation of study treatment.
Hvis der konstateres behandlingssucces, før den maksimale dosis er nået, er det ikke nødvendigt at øge dosis yderligere.
If treatment success is observed before the maximum dose is reached, no further increase of dose is necessary.
9/l eller derover i to måneder i træk, hvorefter blodprøver igen kan tages hver 3. måned.
9/L or higher for two consecutive blood tests at which point monitoring can again be performed every 3 months.
Vedvarende moderat eller svær lymfopeni under behandling med dimethylfumarat anses også for at være en risikofaktor for PML.
Persistent moderate or severe lymphopenia during treatment with dimethyl fumarate is also considered a risk factor for PML.
Symptomerne er beskrevet nedenfor.
For symptoms see below.
Patienterne modtog behandling i op til 16 uger og opfølgende konsultationer var planlagt i op til 12 måneder efter, at behandlingen var afsluttet.
Patients received treatment for up to 16 weeks and follow-up visits were planned for up to 12 months after treatment was stopped.
Fertilitet Der findes ingen humane data eller data fra dyreforsøg om virkningerne af Skilarence på fertiliteten.
Fertility There are no human or animal data on the effects of Skilarence on fertility.
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).
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).
Indtagelse af Skilarence med føde forsinkede tmax af monomethylfumarat fra 3,5 til 9,0 timer.
Taking Skilarence with food delayed the tmax of monomethyl fumarate from 3.5 to 9.0 hours.
Især hvis du tager svangerskabsforebyggende medicin (p-piller), kan virkningen mindskes, og det kan være nødvendigt at bruge andre barrieremetoder til at forhindre graviditet.
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.
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.
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.
Patienter, der får Skilarence, skal instrueres i at rapportere symptomer på infektion til en læge.
Patients receiving Skilarence should be instructed to report symptoms of infection to a physician.
- Dimethylfumarat eller andre fumarater.
- Dimethyl fumarate or other fumarates.
Patienter, som udvikler lymfopeni, bør overvåges for tegn og symptomer på opportunistiske infektioner, især for symptomer på PML.
Patients who develop lymphopenia should be monitored for signs and symptoms of opportunistic infections, particularly for symptoms indicative of PML.
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.
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.
Skilarence er beregnet til brug under vejledning og opsyn af en læge, som har erfaring med diagnosticering og behandling af psoriasis.
Skilarence is intended for use under the guidance and supervision of a physician experienced in the diagnosis and treatment of psoriasis.
Reproduktionstoksicitet Der er ikke foretaget fertilitets- eller præ og post-natale udviklingsstudier med Skilarence.
Reproduction toxicity No fertility or pre- and post-natal development studies have been conducted with Skilarence.
Hvis bivirkningerne ikke er generende, øges din dosis, indtil din tilstand er under kontrol.
If the side effects are not troublesome, your dose will be increased until your condition is well controlled.
I tilfælde af svær eller længerevarende diarré under behandling med Skilarence kan absorption af andre lægemidler blive påvirket.
In cases of severe or prolonged diarrhoea during treatment with Skilarence, absorption of other medicinal products may be affected.
Erfaringer med relaterede produkter, som indeholder dimethylfumarat, viser behandlingsmæssige fordele i op til mindst 24 måneder.
Experience with related products containing dimethyl fumarate shows treatment benefit for at least up to 24 months.
9/l, skal blodprøven gentages, og hvis det bekræftes, at niveauerne er under 0,7x10
9/L, the blood test must be repeated and if the levels are confirmed to be below 0.7x10
Diarré var en almindelig bivirkning (36,9 %) hos patienter, der tog Skilarence, og førte til at lægemidlet blev seponeret hos omkring 10 % af patienterne.
Diarrhoea was a common adverse reaction (36.9%) among patients taking Skilarence, leading to medicinal product withdrawal in about 10% of patients.
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.
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.
Yderligere metabolisme sker gennem iltning via tricarboxylsyrecyklussen, som danner kuldioxid og vand.
Further metabolism occurs through oxidation via the tricarboxylic acid cycle forming carbon dioxide and water.
Yderligere forbedringer blev set i uge 16 (
Further improvement was seen by week 16
Skilarence er en immunmodulator og kan påvirke immunsystemets reaktion på infektion.
Skilarence is an immunomodulator and may affect the way the immune system responds to infection.
Overtrækket på enterotabletterne er designet til at forebygge gastrisk irritation.
The coating of the gastro-resistant tablets is designed to prevent gastric irritation.
Hvis du har glemt at tage Skilarence
If you forget to take Skilarence
Der var ingen indvirkning på fostervægt eller misdannelser, som kunne tilskrives maternel administration af dimethylfumarat under det embryo-føtale udviklingsstudie i rotter.
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.
9/l men er ≥ 0,7x10
9/L but is ≥0.7 x10
Under behandling med Skilarence bør samtidig anvendelse af andre fumarsyrederivater (topiske eller systemiske) undgås.
During treatment with Skilarence, simultaneous use of other fumaric acid derivatives (topical or systemic) should be avoided.
Proteinuri* Nyresvigt* Fanconis syndrom*
Proteinuria* Renal failure* Fanconi syndrome*
Symptomer omfatter feber, smerte, ømme muskler, hovedpine, appetitløshed og en generel svaghedsfornemmelse.
Symptoms include fever, pain, aching muscles, headache, loss of appetite and a general feeling of weakness.
Farmakoterapeutisk klassifikation: Andre immunosuppressive midler, ATC-kode: L04AX07.
Pharmacotherapeutic group: Other immunosuppressants, ATC code: L04AX07
Det aktive indholdsstof i Skilarence, dimethylfumarat, bruges også i andre lægemidler, såsom tabletter, salver og badeprodukter.
The active ingredient in Skilarence, dimethyl fumarate, is also used in other medicines such as tablets, ointments and baths.
Der kunne ikke identificeres en klar relation til dosis eller til risikofaktorer for forekomsten af disse bivirkninger.
No apparent dose relationship and no risk factors for the occurrence of these adverse reactions could be identified.
Den maksimalt tilladte daglige dosis er 720 mg (3 x 2 tabletter Skilarence 120 mg).
The maximum daily dose allowed is 720 mg (3 x 2 tablets of Skilarence 120 mg).
Ukonjugeret dimethylfumarat kan imidlertid ikke påvises i plasmaet hos dyr eller psoriasispatienter efter oral administration.
Unconjugated dimethyl fumarate, however, cannot be detected in the plasma of animals or psoriatic patients following oral administration.
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.
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.
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
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.
Indigotin (E132)
Indigo carmine (E132)
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.
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).
Hvis du har alvorlige bivirkninger efter en dosisstigning, vil din læge muligvis anbefale, at du midlertidigt går tilbage til den sidste dosis.
If you have severe side effects after an increase in dose, your doctor may recommend that you temporarily go back to the last dose.
Skilarence kan forårsage problemer med dit blod, din lever eller dine nyrer.
Skilarence may cause problems with your blood, liver or kidneys.
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).
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).
9/l hos 1/29 (3,5 %) af patienterne efter 6 måneder og 0/28 (0 %) 12 måneder efter behandlingsafslutning.
9/L were observed in 1/29 (3.5%) patient at 6 months and 0/28 (0%) at 12 months after stopping treatment.
Progressiv multifokal leukoencefalopati (PML) er en sjælden, men alvorlig hjerneinfektion, som kan føre til alvorlig invaliditet eller død.
Progressive multifocal leukoencephalopathy (PML) is a rare but serious brain infection that can lead to severe disability or death.
Progressiv multifokal leukoencefalopati*
Progressive multifocal leukoencephalopathy*
Progression kan indebære symptomer såsom polyuri, polydipsi og proksimal muskelsvaghed.
Progression might involve symptoms such as polyuria, polydipsia and proximal muscle weakness.
• 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.
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.
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.
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.
Sikkerhed og virkning af Skilarence hos børn og unge under 18 år er ikke klarlagt.
The safety and efficacy of Skilarence in paediatric patients below the age of 18 years have not been established.
Non-inferioritet af Skilarence vs. Fumaderm PASI 75, n (%) p-værdi b
Non-inferiority of Skilarence vs. Fumaderm PASI 75, n (%) p-value
Advarsler og forsigtighedsregler Kontakt lægen eller apotekspersonalet, før du tager Skilarence.
Warnings and precautions Talk to your doctor or pharmacist before taking Skilarence.
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.
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.
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.
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.
Plasmaproteinbindingen af monomethylfumarat er omkring 50 %.
The plasma protein binding of monomethyl fumarate is around 50%.
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.
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.
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.
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.
Den tilsyneladende terminale halveringstid af monomethylfumarat er cirka 2 timer.
The apparent terminal elimination half-life of monomethyl fumarate is about 2 hours.
Forhøjede leverenzymer Serum kreatinin øget*
Hepatic enzymes increased Serum creatinine increased*
Det skal du vide, før du begynder at tage Skilarence 3.
What you need to know before you take Skilarence 3.
Efter oral administration kan dimethylfumarat ikke påvises i plasma, fordi det hurtigt hydrolyseres af esteraser til dets aktive metabolit monomethylfumarat.
After oral administration, dimethyl fumarate is not detected in plasma because it is rapidly hydrolysed by esterases to its active metabolite monomethyl fumarate.
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).
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).
Det er ikke blevet undersøgt hos patienter med eksisterende lave leukocyt- og lymfocyttal.
It has not been studied in patients with pre-existing low leukocyte or lymphocyte counts.
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.
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.
De vigtigste tegn er: Proteinuri, glukosuri (med normalt blodsukkerniveau), hyperaminoaciduri og phosphaturi (muligvis sideløbende med hypophosphatæmi).
The most important signs are: proteinuria, glucosuria (with normal blood sugar levels), hyperaminoaciduria and phosphaturia (possibly concurrent with hypophosphatemia).
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.
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.
Sådan skal du tage Skilarence 4.
How to take Skilarence 4.
Brug sikker prævention for at undgå graviditet under behandling med Skilarence (se også ”Brug af anden medicin sammen med Skilarence” ovenfor).
Use effective methods of contraception to avoid becoming pregnant during treatment with Skilarence (see also “Other medicines and Skilarence” above).