FrancophonIA/ELRC3.0 huggingface dataset:
English: As cases of macular oedema have also occurred on longer-term treatment, patients should report visual disturbances at any time while on siponimod therapy and an evaluation of the fundus, including the macula, is recommended.
Danish: Da der også er forekommet tilfælde af makulaødem ved længerevarende behandling, skal patienterne til en hver tid indberette alle synsforstyrrelser under behandlingen, og det anbefales at foretage en vurdering af fundus, herunder makula.
English: The test identifies two variant alleles for CYP2C9: CYP2C9*2 (rs1799853, c.430C>T) and CYP2C9*3 (rs1057910, c.1075A>C).
Danish: Testen identificerer to variant alleller for CYP2C9: CYP2C9*2 (rs1799853, c.430C>T) og CYP2C9*3 (rs1057910, c.1075A>C).
English: In clinical studies, second-degree AV blocks, usually Mobitz type I (Wenckebach), have been observed in less than 1.7% of patients at the time of treatment initiation.
Danish: I kliniske studier er der blevet set AV-blok af 2. grad, som regel Mobitz type I (Wenckebach), hos under 1,7 % af patienterne på tidspunktet for behandlingsstart.
English: Mayzent can cause a swelling in the macula (the area of the eye that enables you to see shapes, colours and details) known as macular oedema.
Danish: Mayzent kan medføre hævelse af makula (den del af øjet, der gør det muligt for dig at se former, farver og detaljer).
English: If you have to restart Mayzent more than 4 days after you stopped taking it, your doctor will prescribe a new titration pack and you will have to restart treatment at day 1 again.
Danish: Hvis du skal genstarte behandlingen med Mayzent mere end 4 dage efter, at du stoppede med at tage det, vil lægen udskrive en ny titreringspakning, og du skal starte behandlingen forfra ved dag 1 igen.
English: • A pregnancy test must be carried out and negative results verified by the doctor before starting treatment.
Danish: • En graviditetstest skal foreligge og negative resultater skal være bekræftet af lægen før opstart af behandling.
English: • Patients should report immediately symptoms indicating low heart rate (such as dizziness, vertigo, nausea or palpitations) after the first dose of siponimod and during the titration period.
Danish: • Patienter skal straks indberette symptomer, der tyder på en lav hjertefrekvens (f.eks. ørhed, svimmelhed, kvalme eller palpitationer), efter den første dosis siponimod og i titreringsperioden.
English: If tested negative, vaccination is recommended and treatment with siponimod should be postponed for 1 month to allow the full effect of vaccination to occur.
Danish: Hvis testen er negativ anbefales vaccination og behandling med siponimod skal udsættes til 1 måned efter vaccination for at opnå den fulde virkning af vaccinen.
English: - if, in the last 6 months, you have had a heart attack, unstable angina, stroke or certain types of heart failure.
Danish: - hvis du inden for de sidste 6 måneder har haft hjerteanfald, ustabil hjertekrampe, slagtilfælde eller visse typer hjertesvigt.
English: Consequently, siponimod is contraindicated during pregnancy (see section 4.3).
Danish: Siponimod er derfor kontraindiceret under graviditet (se pkt.
English: In healthy subjects, the single maximum tolerated dose was determined to be 25 mg based upon the occurrence of symptomatic bradycardia after single doses of 75 mg. A few subjects received unintended doses of up to 200 mg daily for 3 to 4 days and experienced asymptomatic mild to moderate transient elevations of liver function tests.
Danish: Hos raske forsøgsdeltagere blev den maksimalt tolererede enkeltdosis fastlagt til at være 25 mg baseret på forekomsten af symptomatisk bradyarytmi efter enkelte doser på 75 mg. Nogle få forsøgsdeltagere fik utilsigtet doser på op til 200 mg dagligt i 3 til 4 dage og oplevede asymptomatisk forbigående let til moderat forhøjede resultater af leverfunktionsundersøgelser.
English: Siponimod and its metabolites are excreted in the milk of rats.
Danish: Siponimod og dets metabolitter udskilles i rottemælk.
English: After the first titration dose, the heart rate decrease starts within one hour and the day 1 decline is maximal at approximately 3 to 4 hours.
Danish: Efter den første titreringsdosis begynder faldet i hjertefrekvensen inden for en time, og faldet på dag 1 er størst efter ca. 3 til 4 timer.
English: Steady-state plasma concentrations are reached after approximately 6 days of once-daily dosing and steady-state levels are approximately 2- to 3-fold greater than after the initial dose.
Danish: Steady state-plasmakoncentrationerne nås efter ca. 6 dage med administration en gang dagligt, og steady state-niveauerne er ca. 2 til 3 gange højere end efter den indledende dosis.
English: Bradyarrhythmic effects are more pronounced when siponimod is added to beta-blocker therapy.
Danish: Bradyarytmivirkninger er mere udtalte, når siponimod gives i tillæg til behandling med betablokkere.
English: In the subgroup of patients (n=779) with active disease (defined as patients with relapse in the 2 years prior to the study and/or presence of Gd-enhancing T1 lesions at baseline) the baseline characteristics were similar to the overall population.
Danish: I undergruppen af patienter (n=779) med aktiv sygdom (defineret som patienter med attak i de 2 år forud for studiet og/eller forekomst af Gd-opladende T1-læsioner ved baseline) var karakteristika ved baseline de samme som for den totale population.
English: In such patients, treatment with siponimod should be considered only if the anticipated benefits outweigh the potential risks.
Danish: Hos sådanne patienter bør behandling med siponimod kun overvejes, hvis de forventede fordele opvejer de potentielle risici.
English: • Fever, sore throat and/or mouth ulcers due to infection (lymphopenia)
Danish: • Feber, ondt i halsen og/eller sår i munden på grund af infektion (lymfopeni)
English: Mayzent contains the active substance siponimod.
Danish: Mayzent indeholder det aktive stof siponimod.
English: Increased hepatic enzymes (mostly ALT elevation) have been reported in MS patients treated with siponimod.
Danish: En stigning i leverenzymer (for det meste forhøjet ALAT) er blevet rapporteret hos MS-patienter i behandling med siponimod.
English: Unchanged siponimod was not detected in urine.
Danish: Der blev ikke påvist uændret siponimod i urin.
English: - Severe liver impairment (Child-Pugh class C).
Danish: - Svært nedsat leverfunktion (Child-Pugh-klasse C).
English: A decision on whether or not siponimod should be re-initiated after resolution needs to take into account the potential benefits and risks for the individual patient.
Danish: Når der skal træffes beslutning om, hvorvidt behandling med siponimod skal genoptages, efter at makulaødemet er forsvundet, skal der tages hensyn til de potentielle fordele og risici for den enkelte patient.
English: • medicines for an irregular heartbeat, such as amiodarone, procainamide, quinidine or sotalol.
Danish: • lægemidler mod uregelmæssig hjerterytme, som fx amiodaron, procainamid, quinidin eller sotalol.
English: The addition of propranolol on top of siponimod pharmacokinetic/pharmacodynamic steady state had less pronounced negative chronotropic effects (less than additive) in comparison to addition of siponimod on top of propranolol pharmacokinetic/pharmacodynamic steady state (additive HR effect).
Danish: Tillæg af propranolol ved farmakokinetisk/farmakodynamisk steady state for siponimod havde mindre udtalte negative kronotrope virkninger (mindre end additive) sammenlignet med tillæg af siponimod ved farmakokinetisk/farmakodynamisk steady state for propranolol (additiv virkning på hjertefrekvensen).
English: Siponimod treatment with single or multiple doses for 28 days is not associated with clinically relevant increases in airway resistance as measured by forced expiratory volume in 1 second (FEV1) and forced expiratory flow (FEF) during expiration of 25 to 75% of the forced vital capacity (FEF25-75%).
Danish: Siponimodbehandling med enkelte eller flere doser i 28 dage er ikke forbundet med klinisk relevante stigninger i luftvejsmodstand målt ved forceret eksspiratorisk volumen i 1 sekund (FEV1) og forceret eksspiratorisk flow (FEF) under eksspiration af 25 til 75 % af forceret vitalkapacitet (FEF25-75 %).
English: The unbound siponimod pharmacokinetics AUC is 15% and 50% higher in subjects with moderate and severe hepatic impairment, respectively, in comparison with healthy subjects for the 0.25 mg single dose studied.
Danish: Den farmakokinetiske AUC for ubundet siponimod er henholdsvis 15 % og 50 % højere hos patienter med moderat og svært nedsat leverfunktion sammenlignet med raske forsøgsdeltagere ved den enkelte dosis på 0,25 mg, der blev undersøgt.
English: Due to the risk of serious cardiac rhythm disturbances or significant bradycardia, siponimod should not be used in patients with: - history of symptomatic bradycardia or recurrent syncope, - uncontrolled hypertension, or - severe untreated sleep apnoea.
Danish: På grund af risikoen for alvorlige forstyrrelser af hjerterytmen eller signifikant bradyarytmi må siponimod ikke bruges hos patienter med: - symptomatisk bradyarytmi eller tilbagevendende synkope i anamnesen - ukontrolleret hypertension - svær ubehandlet søvnapnø.
English: • if you have ever had any of the following conditions (even if you are receiving treatment for them): severe heart disease, irregular or abnormal heartbeat (arrhythmia), stroke or other disease related to the blood vessels in the brain, a slow heart rate, fainting, disturbance of heart rhythm (indicated by abnormal ECG results).
Danish: • hvis du nogensinde har haft af nogen af følgende tilstande (også selvom du er i behandling for dem): alvorlig hjertesygdom, uregelmæssig eller unormal hjerterytme (arytmi), slagtilfælde eller andre sygdomme relateret til blodkarrene i hjernen, langsom hjertefrekvens (puls), besvimelse, forstyrrelser i hjerterytmen (set ved unormale EKG-resultater).
English: • Irregular heartbeat (atrioventricular block)
Danish: • Uregelmæssig hjerterytme (atrioventrikulært blok)
English: Your blood may also be tested before the start of treatment and periodically during treatment to check the white blood cell count.
Danish: Der vil muligvis også blive taget blodprøver, inden du starter behandling, og regelmæssigt under behandling for at kontrollere antallet af hvide blodlegemer.
English: • if you have changes in your vision, for example if the centre of your vision becomes blurred or has shadows, a blind spot develops in the centre of your vision, or you have problems seeing colours or fine detail.
Danish: • hvis dit syn ændrer sig, fx ved at midten af synsfeltet bliver sløret eller har skygger, der udvikles en blind plet i midten af synsfeltet, eller du har problemer med at se farver eller små detaljer.
English: The results did not suggest an arrhythmogenic potential related to QT prolongation with siponimod.
Danish: Resultaterne tydede ikke på et arytmogent potentiale relateret til QT-forlængelse med siponimod.
English: • Patients should inform their doctor straight away if there is worsening of multiple sclerosis after stopping treatment with siponimod.
Danish: • Patienter skal informere deres læge straks, hvis forværring af multipel sklerose after seponering af siponimod forekommer.
English: Therefore, patients should not drive or use machines during the first day of treatment initiation with siponimod (see section 4.4).
Danish: Patienter bør derfor ikke føre motorkøretøj eller betjene maskiner i løbet af den første dag efter opstart af behandling med siponimod (se pkt.
English: However, dizziness may occasionally occur when initiating therapy with siponimod.
Danish: Der kan dog lejlighedsvis forekomme svimmelhed ved start af behandlingen med siponimod.
English: For patients receiving a stable dose of beta blocker, the resting heart rate should be considered before introducing treatment.
Danish: For patienter, der får en stabil dosis af en betablokker, skal hjertefrekvensen i hvile tages i betragtning inden behandlingsstart.
English: • Caution should be exercised in elderly patients with multiple co-morbidities, or advanced disease/disability (due to possible increased risks of, for example, infections, bradyarrhythmic events during treatment initiation).
Danish: • Der skal udvises forsigtighed over for ældre patienter med multiple komorbiditeter eller fremskreden sygdom/invaliditet (på grund af mulig øget risiko for eksempel for infektioner, bradyarytmi under opstart af behandling).
English: Although there are no data to establish that patients with pre-existing liver disease are at increased risk of developing elevated liver function test values when taking siponimod, caution should be exercised in patients with a history of significant liver disease.
Danish: Selvom der ikke er data, der tyder på, at patienter med præ-eksisterende leversygdom har øget risiko for at udvikle forhøjede leverfunktionstal ved behandling med siponimod, skal der udvises forsigtighed hos patienter med signifikant leversygdom i anamnesen.
English: Multiple doses of siponimod were associated with mild to moderate changes in FEV1 and FEF25-75% which were not dose- and daytime-dependent and were not associated with any clinical signs of increased airway resistance.
Danish: Flere doser af siponimod var forbundet med lette til moderate ændringer i FEV1 og FEF25-75 %, som ikke var afhængige af dosis og tidspunkt på dagen og ikke var forbundet med kliniske tegn på øget luftvejsmodstand.
English: The immune system effects of siponimod may increase the risk of infections (see section 4.8).
Danish: Siponimods virkning på immunsystemet kan øge risikoen for infektioner (se pkt.
English: Resumption of therapy will be dependent on whether or not another cause of liver injury is determined and on the benefits to the patient of resuming therapy versus the risks of recurrence of liver dysfunction.
Danish: Genoptagelse af behandlingen vil være afhængig af, om der findes en anden årsag til leverskaden, og af forholdet mellem den gavn, patienten har af at genoptage behandlingen versus risikoen for recidiv af hepatisk dysfunktion.
English: Your doctor will need to prescribe a new titration pack and you will have to restart treatment at day 1.
Danish: Lægen vil udskrive en ny titreringspakning til dig, og du skal starte behandlingen forfra ved dag 1.
English: In certain cases the patient may not receive treatment with siponimod due to specific CYP2C9 genotype status.
Danish: I visse tilfælde vil patienten ikke få behandling med siponimod på grund af specifik CYP2C9-genotype-status.
English: Clinical studies included patients up to the age of 61 years.
Danish: Kliniske studier inkluderede patienter under 61 år.
English: In the prenatal and postnatal development study performed in rats, there was in increased number of dead (stillborn or found dead before postnatal day 4) and malformed pups (male pups with urogenital malformations and/or decreased anogenital distance; pups of both sexes with oedema, swollen soft cranium, or flexed hindlimbs).
Danish: I studiet af den prænatale og postnatale udvikling, som blev udført på rotter, var der et øget antal døde (dødfødte eller dødfundne inden postnatale dag 4) og misdannede unger (unger af hankøn med urogenitale misdannelser og/eller reduceret anogenital afstand; unger af begge køn med ødem, hævet blødt kranium eller bøjede bagben).
English: • Rash with small fluid-filled blisters, appearing on reddened skin (symptoms of a viral infection called herpes zoster that can be severe)
Danish: • Udslæt med små væskefyldte blærer, hvor huden er rød (symptomer på en virusinfektion, der kaldes helvedesild (herpes zoster), som kan være alvorlig)
English: • Do not initiate siponimod treatment in patients with severe active infection until infection is resolved.
Danish: • Behandling med siponimod må ikke initieres hos patienter med en alvorlig aktiv infektion, før infektionen er ophørt.
English: Proportion of patients with 3-month confirmed disability progression (primary endpoint) Risk reduction
Danish: Andel af patienter med 3-måneders bekræftet invaliditetsprogression (primært endepunkt) Risikoreduktion
English: CYP2C9 is polymorphic and the genotype influences the fractional contributions of the two oxidative metabolism pathways to overall elimination.
Danish: CYP2C9 er polymorft, og genotypen påvirker de to oxidative metabolismevejes fraktionelle bidrag til samlet elimination.
English: Your doctor may want to vaccinate you against chickenpox before you start treatment.
Danish: Din læge vil muligvis vaccinere dig mod skoldkopper, før du starter behandling.
English: • Siponimod is not recommended in patients with cardiac disease or taking concomitant medicines known to decrease heart rate.
Danish: • Siponimod anbefales ikke til patienter med hjertesygdom, eller til patienter som tager samtidige lægemidler, der vides at nedsætte hjertefrekvensen.
English: Caution should be exercised during concomitant administration due to the risk of additive immune effects during such therapy and in the weeks after administration of any of these medicinal products is stopped (see section 4.4).
Danish: Der skal udvises forsigtighed ved samtidig administration på grund af risikoen for additive immunvirkninger under en sådan behandling og i ugerne efter ophør af administration af sådanne lægemidler (se pkt.
English: • Patients should call the doctor if a dose is missed during the first 6 days of treatment or for 4 or more consecutive days after initiating treatment with siponimod.
Danish: • Patienter skal kontakte lægen, hvis en dosis udelades i de første 6 dage af behandlingen eller hvis en dosis udelades i 4 eller flere sammenhængende dage, efter initiering af behandling med siponimod.
English: Key secondary endpoints were time to 3-month confirmed worsening of at least 20% from baseline in the timed 25-foot walk test (T25W) and change from baseline in T2 lesion volume.
Danish: Vigtige sekundære endepunkter var tiden til 3 måneders bekræftet forværring på mindst 20 % i forhold til baseline i 25 skridts gangtest (T25W) på tid og ændring i forhold til baseline i T2-læsionsvolumen.
English: The study involved randomisation of 1,651 patients to either siponimod 2 mg (N=1,105) or placebo (N=546); 82% of patients treated with siponimod and 78% of placebo-treated patients completed the study.
Danish: Studiet omfattede randomisering af 1.651 patienter til enten siponimod 2 mg (N = 1.105) eller placebo (N = 546); 82 % af de patienter, der fik siponimod, og 78 % af de patienter, der fik placebo, gennemførte studiet.
English: The macular oedema generally improved or resolved spontaneously after discontinuation of treatment.
Danish: Makulaødemet bedredes generelt eller ophørte spontant efter seponering af behandlingen.
English: Confirmed absolute lymphocyte counts <0.2 x 10
Danish: Et bekræftet absolut lymfocyttal <0,2 x 10
English: A peripheral lymphocyte count (CBC) is recommended prior to initiating siponimod to ensure that immune effects of the previous therapy (i.e. cytopenia) have resolved.
Danish: Det anbefales at indhente en perifer lymfocyttælling før initiering af behandlingen med siponimod for at sikre, at den tidligere behandlings virkning på immunsystemet (dvs. cytopeni) er ophørt.
English: Regular measurements of pulse rate and blood pressure are required and electrocardiograms should be performed (see sections 4.2 and 4.4).
Danish: Puls og blodtryk skal måles regelmæssigt, og der skal tages elektrokardiogrammer (se pkt.
English: No patients over 61 years of age were enrolled in clinical studies.
Danish: Der blev ikke inkluderet patienter over 61 år i kliniske studier.
English: Patients treated with siponimod should be cautioned against exposure to sunlight without protection.
Danish: Patienter, der får behandling med siponimod, skal advares mod eksponering for sollys uden beskyttelse.
English: • The other ingredients are: Tablet core: Lactose monohydrate (see “Mayzent contains lactose”), microcrystalline cellulose, crospovidone, glycerol dibehenate, colloidal anhydrous silica.
Danish: • Øvrige indholdsstoffer: Tabletkerne: lactosemonohydrat (se “Mayzent indeholder lactose”), cellulose; mikrokrystallinsk, crospovidon, glyceroldibehenat, silica; kolloid vandfri.
English: • Siponimod is contraindicated in patients with immunodeficiency syndrome.
Danish: • Siponimod er kontraindikeret hos patienter med immundefektsyndrom.
English: Start treatment with 0.25 mg on day 1, up-titrated to the maintenance dose of 2 mg or 1 mg on day 6 based on the CYP2C9 metaboliser status.
Danish: Start behandlingen med 0,25 mg på dag 1 og optitrer til vedligeholdelsesdosen på 2 mg eller 1 mg på dag 6, baseret på metaboliseringsstatus for CYP2C9.
English: This is due to the reversible sequestration of lymphocytes in lymphoid tissues (see section 5.1).
Danish: Dette skyldes den reversible tilbageholdelse af lymfocytter i lymfevæv (se pkt.
English: Figure 1 Patients with 3- and 6-month CDP based on EDSS-Kaplan-Meier curves (full analysis set, study A2304)
Danish: Figur 1 Patienter med 3- og 6-måneders CDP baseret på EDSS-Kaplan-Meier-kurver (fuldt analysesæt, studie A2304)
English: In the subgroup of patients (n=827) without signs and symptoms of disease activity (defined as patients without relapse in the 2 years prior to the study and without presence of Gd-enhancing T1 lesions at baseline), effects on 3-month and 6-month CDP were small (risk reductions were 7% and 13%, respectively).
Danish: I undergruppen af patienter (n=827) uden tegn og symptomer på sygdomsaktivitet (defineret som patienter uden attakker i de 2 år forud for studiet og uden forekomst af Gd-opladende T1-læsioner ved baseline), var virkninger på 3-måneders og 6-måneders CDP små (risikoreduktion var henholdsvis 7 % og 13 %).
English: If you forget to take Mayzent for 4 or more days in a row, call your doctor before you take the next dose.
Danish: Hvis du glemmer at tage Mayzent i 4 dage i træk eller mere, skal du kontakte lægen, inden du tager den næste dosis.
English: With regard to disease activity, features characteristic of inflammatory activity in SPMS can be relapse- or imaging-related (i.e. Gd-enhancing T1 lesions or active [new or enlarging] T2 lesions).
Danish: Sygdomsaktivitet i form af inflammatorisk aktivitet i SPMS kan være relateret til attak eller radiologiske fund (dvs. Gd-opladende T1-læsioner eller aktive [nye eller forstørrede] T2-læsioner).
English: The maximum decline in heart rate is seen in the first 6 hours post-dose.
Danish: Det maksimale fald i hjertefrekvens ses i de første 6 timer efter administration.
English: Other medicines and Mayzent
Danish: Brug af anden medicin sammen med Mayzent
English: If you stop taking Mayzent Do not stop taking Mayzent or change your dose without talking to your doctor first.
Danish: Hvis du stopper med at tage Mayzent Du må ikke stoppe med at tage Mayzent eller ændre dosis uden først at tale med lægen.
English: PARTICULARS TO APPEAR ON THE INNER PACKAGING
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN INDRE EMBALLAGE
English: • fluconazole and certain other medicines can increase the levels of Mayzent in the blood and are not recommended to be taken in combination with Mayzent.
Danish: • fluconazol og visse andre lægemidler, som kan øge niveauet af Mayzent i blodet og frarådes at blive anvendt i kombination med Mayzent.
English: Minor reductions in forced expiratory volume in 1 second (FEV1) and in the diffusing capacity of the lung for carbon monoxide (DLCO) values were observed with siponimod treatment.
Danish: Der blev observeret mindre reduktioner i værdierne for forceret ekspiratorisk volumen i 1 sekund (FEV1) og lungediffusionskapacitet for kulmonooxid (DLCO) ved behandling med siponimod.
English: • modafinil and certain other medicines can lower the levels of Mayzent in the blood of certain patients and can therefore stop it from working properly.
Danish: • modafinil og visse andre lægemidler kan sænke niveauet af Mayzent i blodet hos visse patienter og dermed forhindre det i at virke rigtigt.
English: If macular oedema is confirmed, your doctor may advise you to stop Mayzent treatment.
Danish: Hvis det bekræftes, at du har makulaødem, vil lægen muligvis råde dig til at stoppe behandlingen med Mayzent.