natgillin/translations-raw huggingface dataset:
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.
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).
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.
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).
Hvad bruges Skilarence til
What Skilarence is used for
Behandlingen bør ikke påbegyndes, ved leukopeni under 3,0x10
Treatment should not be initiated if leukopenia below 3.0x10
Nyrefunktion (f.eks. kreatinin, carbamid og urinanalyse) skal undersøges inden behandlingen påbegyndes og derefter hver 3. måned.
Renal function (e.g. creatinine, blood urea nitrogen and urinalysis) should be checked prior to initiation of treatment and every 3 months thereafter.
9/l, skal der tages blodprøver en gang om måneden, indtil niveauet er 1,0x10x10
9/L, blood monitoring should be performed monthly until levels return to 1.0x10
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).
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).
12 måneder efter, at behandlingen blev stoppet, havde 3/28 (10,7 %) af patienterne lymfocytværdier under 1,0x10
At 12 months after stopping treatment 3/28 (10.7%) of patients had lymphocyte values below 1.0x10
Den del af dimethylfumarat, der reagerer med glutathion og danner en glutathion-addukt, metaboliseres yderligere til sin mercaptursyre, som udskilles i urinen.
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.
Kvinder i den fødedygtige alder
Women of child-bearing potential
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.
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.
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).
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).
Oppustet abdomen* Abdominalsmerter Kvalme
Abdominal distension* Abdominal pain Nausea
Skilarence 30 mg og Skilarence 120 mg Kerne:
Skilarence 30 mg and Skilarence 120 mg Core:
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.
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.
In vitro studier har vist, at dimethylfumarat ved en terapeutisk dosis ikke hæmmer CYP3A4/5 og BCRP og er en svag Pglycoproteinhæmmer.
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.
Antal tabletter der skal tages dagligt
How many tablets to take during the day Number of tablets per day
Det skal du vide, før du begynder at tage Skilarence
What you need to know before you take Skilarence
Du skal være forsigtig, når du fører motorkøretøj eller betjener maskiner, hvis du er påvirket.
If you are affected, be careful when driving or using machines.
Patienter, som udvikler lymfopeni bør overvåges, efter at behandlingen er stoppet, indtil deres lymfocyttal er i det normale område (se pkt.
Patients developing lymphopenia should be monitored after stopping treatment until their lymphocyte count has returned to the normal range (see section 4.8).
Titandioxid (E171)
Titanium dioxide (E171) Simethicone
Når denne medicin tages sammen med Skilarence, kan det øge risikoen for bivirkninger i nyrerne.
These medicines taken together with Skilarence could increase the risk of side effects on your kidneys.
Der kan opstå svimmelhed eller træthed efter administration af Skilarence.
You may feel dizzy or tired after taking Skilarence.
Hvis lymfocyttallet falder under 0,7x10
If the lymphocyte count falls below 0.7x10
- 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).
- 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).
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.
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).
Blå, filmovertrukket, rund, bikonveks tablet med en diameter på cirka 11,6 mm.
Blue, film-coated, round, biconvex tablet with a diameter of approximately 11.6 mm.
I tilfælde af en klinisk relevant ændring i nyrefunktionen, især ved mangel på alternative forklaringer, bør det overvejes at reducere doseringen eller seponere behandlingen.
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.
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.
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.
9/l, hvilket repræsenterede 3/279
9/L, which would represent
Der findes ingen data om effekten og sikkerheden af Skilarence, når det tages samtidigt med andre immunosuppressive eller immunmodulerende behandlinger (se pkt.
No data are available on the efficacy and safety of Skilarence when taken concomitantly with other immunosuppressive or immunomodulating therapies (see section 4.5).
Almindelig Almindelig Ikke almindelig Ikke kendt
Common Common Uncommon Not known
Svimmelhed*
Dizziness*
Blod og lymfesystem Lymfopeni Leukopeni
Blood and lymphatic system disorders
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.
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.
Skilarence kan reducere leukocyt- og lymfocyttallene (se pkt.
Skilarence may decrease leukocyte and lymphocyte counts (see section 4.8).
Skilarence er kontraindiceret under graviditeten (se pkt.
Skilarence is contraindicated during pregnancy (see section 4.3).
Der kan opstå svimmelhed og træthed efter administration af Skilarence (se pkt.
Dizziness and fatigue may occur following administration of Skilarence (see section 4.8).
En del af den samlede dimethylfumarat hydrolyseres af esteraser og det alkaliske miljø i tyndtarmen, mens resten går ind i portåren.
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.
Hver enterotablet indeholder 136,8 mg laktose (som monohydrat).
Each gastro-resistant tablet contains 136.8 mg lactose (as monohydrate).
I tilfælde af en klinisk relevant ændring i leverparametrene, især ved mangel på alternative forklaringer, bør det overvejes at reducere dosen eller seponere behandlingen.
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.
Skilarence bør ikke anvendes under graviditeten eller til kvinder i den fertile alder, som ikke anvender passende prævention.
Skilarence is not recommended in women of child-bearing potential not using appropriate contraception.
Lymfopeni: Hvis lymfocyttallet falder under 1,0x10
Lymphopenia: If the lymphocyte count falls below 1.0x10
Skilarence er imidlertid ikke blevet undersøgt hos patienter med alvorligt nedsat nyrefunktion, og der er efter markedsføring indberettet tilfælde af nyretoksicitet med fumarsyreestere.
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.
Hvid, filmovertrukket, rund, bikonveks tablet med en diameter på cirka 6,8 mm. Skilarence 120 mg
White, film-coated, round, biconvex tablet with a diameter of approximately 6.8 mm. Skilarence 120 mg
Superioritetstestning vs placebo PASI 75, n (%) p-værdi Tosidet 99,24 % CI
Superiority testing vs placebo PASI 75, n (%) p-value a a
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.
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.
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.
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
- Overfølsomhed over for det aktive stof eller over for ét eller flere af hjælpestofferne anført i pkt.
- Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
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.
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.
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.
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).
PGA-score klar eller næsten klar, n (%) p-værdi
PGA score clear or almost clear, n (%) p-value b
Bør ikke anvendes til patienter med hereditærgalactoseintolerans, total lactasemangel eller glucose/galactosemalabsorption.
Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicine.
Skilarence skal derfor anvendes med forsigtighed i kombination med anden systemisk antipsoriatisk terapi (f.eks. methotrexat, retinoider, psoralener, ciclosporin, immunosuppressiva eller cytostatika) (se pkt.
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).
Du må ikke amme, mens du behandles med Skilarence.
Do not breast-feed during treatment with Skilarence.
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.
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.
Under behandling
During treatment
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.
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.
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.
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.
- Anden medicin, der bruges til at behandle psoriasis, såsom methotrexat, retinoider, psoralen, ciclosporin eller andre immunosuppresiva eller cytostatika (medicin som påvirker immunsystemet).
- Other medicines used to treat psoriasis, such as methotrexate, retinoids, psoralens, ciclosporin, or other immunosuppressants or cytostatics (medicines that affect the immune system).
Hvis denne type medicin tages med Skilarence, kan risikoen for bivirkninger på dit immunsystem stige.
Taking these medicines with Skilarence could increase the risk of side effects on your immune system.
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)
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)
Laktosemonohydrat Cellulose, mikrokrystallinsk Croscarmellosenatrium Silica, kolloid vandfri Magnesiumstearat
Lactose monohydrate Cellulose microcrystalline Croscarmellose sodium Colloidal anhydrous silica Magnesium stearate
Hver enterotablet indeholder 34,2 mg laktose (som monohydrat).
Each gastro-resistant tablet contains 34.2 mg lactose (as monohydrate).
I tredje uge tages Skilarence 30 mg tre gange dagligt (1 tablet om morgenen, 1 ved middagstid og 1 om aftenen).
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).
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 %).
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%).
Skilarence er et lægemiddel, som indeholder det aktive stof dimethylfumarat.
Skilarence is a medicine that contains the active substance dimethyl fumarate.
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.
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.
Skilarence indeholder natrium
Skilarence contains sodium
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)
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)
Meget almindelig Meget almindelig Almindelig Almindelig Almindelig Almindelig Almindelig
Very common Very common Very common Very common Common Common Common Common
Pruritus Allergisk hudreaktion*
Allergic skin reaction*
Det steg langsomt igen i uge 16 (behandlingsafslutning), og 12 måneder efter behandlingen stoppede, havde alle patienter værdier over 3,0x10
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
Skilarence er kontraindiceret hos patienter med alvorlig gastrointestinal sygdom (se pkt.
Skilarence is contraindicated in patients with severe gastrointestinal disease (see sections 4.3).
Spørg lægen eller apotekspersonalet, hvis der er noget, du er i tvivl om.
Please ask your doctor or pharmacist if you are not sure.
Den første uge tages Skilarence 30 mg én gang dagligt (1 tablet om aftenen).
In the first week, Skilarence 30 mg is taken once daily (1 tablet in the evening).
Forstoppelse Abdominalt ubehag Flatulens
Constipation Abdominal discomfort
Der er ikke udført specifikke studier hos patienter med nedsat nyrefunktion.
No specific studies have been performed in patients with renal impairment.
Tabletstyrke
Tablet strength
- Graviditet og amning.
- Pregnancy and breast-feeding.
- Svært nedsat lever- eller nyrefunktion.
- Severe hepatic or renal impairment.
Skilarence indeholder laktose.
Skilarence contains lactose.
croscarmellosenatrium, silica, kolloid vandfri, magnesiumstearat, methacrylsyre-ethylacrylatcopolymer (1:1), talkum, triethylcitrat, titandioxid (E171), simethicon, indigokarmin (E132) og natriumhydroxid.
- the other ingredients are: lactose monohydrate, cellulose microcrystalline, croscarmellose sodium, colloidal anhydrous silica, magnesium stearate, methacrylic acid-ethyl acrylate copolymer (1:1), talc, triethyl citrate, titanium dioxide (E171), simethicone, indigo carmine (E132) and sodium hydroxide.
I uge 16 (behandlingsafslutning) var der ingen yderligere nedgang i lymfocyttallet.I behandlingsuge 16 viste 13/175 (7,4 %) af patienterne sig at have lymfocytniveauer <0,7x109/l.
At week 16 of treatment, 13/175 (7.4%) of patients were noted to have lymphocyte levels <0.7x 10
Skilarence 120 mg: Blister (PVC/PVDC-aluminium): 40, 70, 90, 100, 120, 180, 200, 240, 300, 360 og 400 enterotabletter
Pack sizes: 40, 70, 90, 100, 120, 180, 200, 240, 300, 360 and 400 gastro-resistant tablets.
Skilarence 30 mg er en hvid, rund tablet med en diameter på cirka 6,8 mm.
What Skilarence 30 mg looks like and contents of the pack Skilarence 30 mg is a white, round tablet with a diameter of approximately 6.8 mm.
EU/1/17/1201/001 42 tabletter EU/1/17/1201/013 70 tabletter EU/1/17/1201/014 210 tabletter
EU/1/17/1201/001 42 tablets EU/1/17/1201/013 70 tablets EU/1/17/1201/014 210 tablets
EU/1/17/1201/002 40 tabletter EU/1/17/1201/003 70 tabletter EU/1/17/1201/004 90 tabletter EU/1/17/1201/005 100 tabletter EU/1/17/1201/006 120 tabletter EU/1/17/1201/007 180 tabletter EU/1/17/1201/008 200 tabletter EU/1/17/1201/009 240 tabletter EU/1/17/1201/012 300 tabletter EU/1/17/1201/010 360 tabletter EU/1/17/1201/011 400 tabletter
EU/1/17/1201/002 40 tablets EU/1/17/1201/003 70 tablets EU/1/17/1201/004 90 tablets EU/1/17/1201/005 100 tablets EU/1/17/1201/006 120 tablets EU/1/17/1201/007 180 tablets EU/1/17/1201/008 200 tablets EU/1/17/1201/009 240 tablets EU/1/17/1201/012 300 tablets EU/1/17/1201/010 360 tablets EU/1/17/1201/011 400 tablets
Den anden uge tages Skilarence 30 mg to gange dagligt (1 tablet om morgenen og 1 tablet om aftenen).
In the second week, Skilarence 30 mg is taken twice daily (1 tablet in the morning and 1 in the evening).
Skilarence indeholder laktose
Skilarence contains lactose
Navn og adresse på den fremstiller, der er ansvarlig for batchfrigivelse Industrias Farmaceuticas Almirall, S.A.
Name and address of the manufacturer responsible for batch release
Efter 16 ugers behandling viste Skilarence sig at være bedre end placebo (p<0,0001) baseret på PASI 75 og PGA-scoren helet (clear) eller næsten helet (almost clear) og non-inferior (med en noninferioritetsmargin på 15 %) i forhold til den aktive komparator (p<0,0003) baseret på PASI 75.
PASI 75 and PGA score clear or almost clear and non-inferior (using a non-inferiority margin of -15%) to the active comparator (p<0.0003) based on PASI 75.
croscarmellosenatrium, silica, kolloid vandfri, magnesiumstearat, methacrylsyre-ethylacrylat copolymer (1:1), talcum, triethylcitrat, titandioxid (E171) og simethicon.
- the other ingredients are: lactose monohydrate, cellulose microcrystalline, croscarmellose sodium, colloidal anhydrous silica, magnesium stearate, methacrylic acid-ethyl acrylate copolymer (1:1), talc, triethyl citrate, titanium dioxide (E171) and simethicone.
Der er ikke behov for dosisjustering hos patienter med mild til moderat nedsat nyrefunktion (se pkt.
No dose adjustment is needed in patients with mild to moderate renal impairment (see section 5.2).
Hvis du mener, at du har taget for mange Skilarence-tabletter, skal du tale med din læge eller apotekspersonalet.
If you take more Skilarence than you should If you think you have taken too many Skilarence tablets, talk to your doctor or pharmacist.
Middag
Breakfast
Skilarence 30 mg: Blister (PVC/PVDC-aluminium): 42, 70 og 210 enterotabletter
Skilarence 30 mg 42, 70 and 210 gastro-resistant tablets in PVC/PVDC-aluminium blister packs.
Brug af anden medicin sammen med Skilarence Fortæl lægen eller apotekspersonalet, hvis du tager anden medicin eller har gjort det for nylig.
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.