FrancophonIA/ELRC3.0 huggingface dataset:
English: Use of siponimod in these patients results in substantially elevated siponimod plasma levels.
Danish: Brug af siponimod hos disse patienter medførte markant forhøjede siponimod-plasmaniveauer.
English: The efficacy of siponimod has been investigated in a phase III study evaluating once-daily doses of 2 mg in patients with SPMS.
Danish: Siponimods virkning er blevet undersøgt i et fase III-studie, som evaluerede doser på 2 mg en gang dagligt hos patienter med SPMS.
English: If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking any medicine.
Danish: Hvis du er gravid eller ammer, har mistanke om, at du er gravid, eller planlægger at blive gravid, skal du spørge din læge eller apotekspersonalet til råds, før du tager dette lægemiddel.
English: When switching from other disease-modifying therapies, the half-life and mode of action of the other therapy must be considered to avoid an additive immune effect whilst at the same time minimising the risk of disease reactivation.
Danish: Ved skift fra andre sygdomsmodificerende behandlinger skal der tages hensyn til den anden behandlings halveringstid og virkningsmekanisme for at undgå en additiv immunsupprimerende virkning og samtidig minimere risikoen for reaktivering af sygdommen.
English: Difference in percentage brain volume change
Danish: Forskel i procentvis ændring af hjernevolumen
English: Patients above 61 years of age were not included.
Danish: Patienter over 61 år blev ikke inkluderet.
English: However, other skin malignancies, including melanoma, have also been reported in patients treated with siponimod and in patients on long-term therapy with another S1P modulator.
Danish: Der er dog også rapporteret om andre hudmaligniteter, herunder melanom, hos patienter, der fik behandling med siponimod, samt hos patienter i langvarig behandling med en anden S1P-modulator.
English: • Physician's Checklist to consider prior to prescribing Mayzent;
Danish: • Lægens tjekliste, som skal tages i betragtning, inden Mayzent ordineres;
English: After siponimod therapy has been stopped, siponimod remains in the blood for up to 10 days.
Danish: Efter seponering af behandling med siponimod forbliver siponimod i blodet i op til 10 dage.
English: Extended observation (>6 hours after first dose): o If, at the 6-hour time point, the heart rate is at the lowest value following the first dose, extend heart rate monitoring for at least 2 more hours and until the heart rate increases again.
Danish: Forlænget observation (>6 timer efter første dosis): o Hvis hjertefrekvensen efter 6 timer er på den laveste værdi efter den første dosis, forlænges monitoreringen af hjertefrekvensen i mindst 2 timer yderligere, og indtil hjertefrekvensen stiger igen.
English: In monkeys, effects on muscle and skin were additionally observed.
Danish: Hos aber blev der desuden observeret virkninger på muskler og hud.
English: Number of patients at risk Siponimod
Danish: Antal patienter med risiko Siponimod
English: The European Medicines Agency has deferred the obligation to submit the results of studies with siponimod in one or more subsets of the paediatric population in the treatment of multiple sclerosis (see section 4.2 for information on paediatric use).
Danish: Det Europæiske Lægemiddelagentur har udsat forpligtelsen til at fremlægge resultaterne af studier med siponimod i en eller flere undergrupper af den pædiatriske population ved behandling af multipel sklerose (se pkt.
English: Advise women of potential serious risks to the foetus if siponimod is used during pregnancy or if the patient becomes pregnant while taking it.
Danish: Kvinder skal vejledes om potentielle alvorlige risici for fosteret, hvis siponimod anvendes under graviditet, eller hvis patienten bliver gravid, mens hun tager det.
English: The receptor affected by siponimod (sphinosine-1-phosphate receptor) is known to be involved in vascular formation during embryogenesis.
Danish: Den receptor, der påvirkes af siponimod (sphingosin1-fosfatreceptor), vides at være involveret i vaskulær dannelse under embryogenesen.
English: Table 1 Dose titration regimen to reach maintenance dosage
Danish: Tabel 1 Dosistitreringsskema til opnåelse af vedligeholdelsesdosis
English: The negative chronotropic effect of co-administration of siponimod and propranolol was evaluated in a dedicated pharmacodynamic/safety study.
Danish: Den negative kronotrope virkning af samtidig administration af siponimod og propranolol blev undersøgt i et dedikeret farmakodynamisk-/sikkerhedstudie.
English: Women of childbearing potential/Contraception in females
Danish: Fertile kvinder/kontraception til kvinder
English: - if you are pregnant or could become pregnant and are not using effective contraception.
Danish: - hvis du er gravid eller kan blive gravid og ikke bruger effektiv prævention.
English: Class Ia and class III antiarrhythmic medicinal products have been associated with cases of torsades de pointes in patients with bradycardia.
Danish: Antiarytmika af klasse Ia og klasse III er blevet forbundet med tilfælde af torsades de pointes hos patienter med bradyarytmi.
English: Siponimod had no effect on male reproductive organs in rats and monkeys or on fertility parameters in rats.
Danish: Siponimod havde ingen virkning på mandlige kønsorganer hos rotter og aber eller fertilitetsparametre hos rotter.
English: Protein binding of siponimod is >99.9% in healthy subjects and in patients with hepatic or renal impairment.
Danish: Siponimods proteinbinding er >99,9 % hos raske forsøgsdeltagere og hos patienter med nedsat lever- eller nyrefunktion.
English: No interaction studies have been performed with oral contraceptives containing other progestagens, however an effect of siponimod on the efficacy of oral contraceptives is not expected.
Danish: Der er ikke udført interaktionsstudier med orale kontraceptiva med andre progestagener, men siponimod forventes ikke at have en virkning på orale kontraceptivas virkning.
English: Patients were randomised 2:1 to receive either once-daily siponimod 2 mg or placebo.
Danish: Patienterne blev randomiseret 2:1 til at få enten siponimod 2 mg eller placebo en gang dagligt.
English: Do not use this medicine if you notice that the pack is damaged or shows signs of tampering.
Danish: Brug ikke lægemidlet, hvis du bemærker, at æsken/blisteren er beskadiget eller viser tegn på at have været åbnet.
English: • Patients must use effective contraception during the treatment with siponimod.
Danish: • Patienter skal bruge effektiv kontraception under behandling med siponimod.
English: Initiation of treatment may result in decreased heart rate and indirect prolongation of the QT interval during the titration phase.
Danish: Indledning af behandling kan medføre nedsat hjertefrekvens og indirekte forlængelse af QT-intervallet i titreringsfasen.
English: • Monitor patients carefully for signs and symptoms of infections during and after treatment with siponimod:
Danish: • Overvåg patienterne nøje for tegn og symptomer på infektioner under og efter behandling med siponimod:
English: • Doctors will provide counselling before treatment initiation and regularly thereafter regarding the potential teratogenic risk of siponimod and required actions to minimise this risk.
Danish: • Læger vil sørge for rådgivning inden behandlingsstart og regelmæssigt derefter om siponimods potentielle teratogene risiko og nødvendige handlinger for at minimere denne risiko.
English: Do not use Mayzent during pregnancy, if you are trying to become pregnant or if you are a woman who could become pregnant and you are not using effective contraception.
Danish: Tag ikke Mayzent under graviditet, hvis du forsøger at blive gravid, eller hvis du er en kvinde, der kan blive gravid og ikke anvender sikker prævention.
English: Patients with hypertension uncontrolled by medication were excluded from participation in clinical studies and special care is indicated if patients with uncontrolled hypertension are treated with siponimod.
Danish: Patienter med hypertension, som ikke var medicinsk kontrolleret, blev ekskluderet fra deltagelse i de kliniske studier, og der skal udvises særlig forsigtighed hos patienter med ukontrolleret hypertension, som behandles med siponimod.
English: White blood cells fight infection, so you may get infections more easily while you are taking Mayzent (and up to 3 to 4 weeks after you stop taking it).
Danish: Hvide blodlegemer bekæmper infektion, så du kan blive mere modtagelig over for infektioner, når du tager Mayzent (og i op til 3 til 4 uger efter, at du er holdt op med at tage det).
English: • Siponimod should be stopped at least 10 days before a pregnancy is planned.
Danish: • Siponimod skal seponeres mindst 10 dage inden planlægning af graviditet.
English: If the overdose constitutes first exposure to siponimod or occurs during the dose titration phase of siponimod it is important to observe for signs and symptoms of bradycardia, which could include overnight monitoring.
Danish: Hvis overdoseringen sker ved den første eksponering for siponimod eller sker i dosistitreringsfasen med siponimod, er det vigtigt at observere for tegn og symptomer på bradyarytmi, hvilket kan omfatte monitorering natten over.
English: MRI evaluations were performed at screening and every 12 months.
Danish: Der blev udført MR-scanninger ved screening og hver 12. måned.
English: Although the majority of cases occurred within 3 to 4 months of commencing siponimod, cases were also reported in patients treated with siponimod for more than 6 months (see section 4.4).
Danish: Størstedelen af tilfældene forekom inden for 3 til 4 måneder efter påbegyndt behandling med siponimod, men der blev også rapporteret tilfælde hos patienter, som havde været i behandling med siponimod i mere end 6 måneder (se pkt.
English: The effect of siponimod on human fertility has not been evaluated.
Danish: Siponimods virkning på human fertilitet er ikke klarlagt.
English: Anti-arrhythmic medicinal products, QT-prolonging medicinal products, medicinal products that may decrease heart rate
Danish: Antiarytmika, QT-forlængende lægemidler og lægemidler, der kan nedsætte hjertefrekvensen
English: Siponimod is contraindicated in patients with active malignancies.
Danish: Siponimod er kontraindiceret hos patienter med aktiv malignitet.
English: With continued dosing heart rate starts increasing after day 6 and reaches placebo levels within 10 days after treatment initiation.
Danish: Ved fortsat administration begynder hjertefrekvensen at stige efter dag 6 og når placeboniveauer inden for 10 dage efter indledning af behandlingen.
English: 9/l in a patient already receiving siponimod 1 mg should lead to interruption of siponimod therapy until the level reaches 0.6 x 10 9/l when re-initiation of siponimod can be considered.
Danish: 9/l hos en patient, som allerede får siponimod 1 mg, bør føre til afbrydelse af siponimod-behandlingen, indtil værdien når 0,6 x 10 9/l, hvorefter man kan overveje at indlede behandling med siponimod igen.
English: • high blood pressure (hypertension), sometimes with symptoms such as headache and dizziness
Danish: • højt blodtryk (hypertension), nogle gange med symptomer, som fx hovedpine og svimmelhed
English: • An ophthalmological evaluation 3-4 months after treatment initiation with siponimod is recommended.
Danish: • En oftalmologisk vurdering 3-4 måneder efter initiering af behandling med siponimod anbefales.
English: Due to its functional antagonism at S1P1 receptors, initial titration of siponimod successively desensitises GIRK channels until the maintenance dose is reached.
Danish: På grund af den funktionelle antagonisme ved S1P1-receptorer desensitiverer den indledende titrering successivt GIRK-kanaler, indtil vedligeholdelsesdosis nås.
English: • regularly applying sunscreen with a high degree of UV protection.
Danish: • regelmæssigt bruge solcreme med en høj faktor.
English: - Immunodeficiency syndrome.
Danish: - Immundefektsyndrom.
English: The single-dose pharmacokinetic parameters were not different between Japanese and Caucasian healthy subjects, indicating absence of ethnic sensitivity on the pharmacokinetics of siponimod.
Danish: De farmakokinetiske parametre for en enkelt dosis var ikke forskellige for japanske og kaukasiske raske forsøgsdeltagere, hvilket indikerer fravær af etnisk sensitivitet på siponimods farmakokinetik.
English: • Mayzent is contraindicated in:
Danish: • Anvendelse af Mayzent er kontraindiceret hos:
English: Results from the study showed a variable but consistent risk reduction in the time to 3- and 6-month CDP with siponimod compared to placebo in subgroups defined based on gender, age, pre-study relapse activity, baseline MRI disease activity, disease duration and disability levels at baseline.
Danish: Resultater fra studiet viste en variabel, men konsistent risikoreduktion i tiden til 3- og 6-måneders CDP med siponimod sammenlignet med placebo i undergrupper defineret på baggrund af køn, alder, attakaktivitet før studiet, MR-scanningspåvist sygdomsaktivitet ved baseline, sygdomsvarighed og invaliditetsniveauer ved baseline.
English: • If siponimod is discontinued, the possibility of recurrence of high disease activity should be considered.
Danish: • Hvis siponimod seponeres bør risikoen for tilbagevendende høj sygdomsaktivitet tages i betragtning.
English: Treatment with siponimod should be initiated and supervised by a physician experienced in the management of multiple sclerosis.
Danish: Behandling med siponimod skal indledes og gennemføres under opsyn af en læge med erfaring i behandling af multipel sklerose.
English: • For patients with certain heart problems, an ECG before initiating treatment with siponimod will be needed.
Danish: • For patienter med visse hjerteproblemer skal der foretages EKG før initiering af behandling med siponimod.
English: Steady state was reached after approximately 6 days of multiple once-daily administration of siponimod.
Danish: Steady state blev nået efter ca. 6 dage med gentagen administration af siponimod en gang dagligt.
English: A thorough QT study demonstrated no significant direct QT-prolonging effect and siponimod is not associated with an arrhythmogenic potential related to QT prolongation.
Danish: Et grundigt QT-studie viste ingen signifikant direkte QT-forlængende virkning, og siponimod er ikke forbundet med et arytmogent potentiale i forbindelse med QT-forlængelse.
English: Annualised relapse rate (ARR) Rate reduction
Danish: Årlig attakhyppighed (Annualised relapse rate ARR)
English: If pharmacological treatment is required, monitoring should be continued overnight and 6-hour monitoring should be repeated after the second dose.
Danish: Ved behov for farmakologisk behandling bør monitoreringen fortsættes natten over, og 6-timers monitorering bør gentages efter den anden dosis.
English: The primary endpoint of the study was the time to 3-month confirmed disability progression (CDP) determined as at least a 1-point increase from baseline in EDSS (0.5 point increase for patients with baseline EDSS of 5.5 or more) sustained for 3 months.
Danish: Studiets primære endepunkt var tiden til 3-måneders bekræftet invaliditetsprogression (confirmed disability progression, CDP) fastlagt som mindst en stigning på 1 point i forhold til baseline i EDSS (0,5 points stigning for patienter med EDSS ved baseline på 5,5 eller derover) opretholdt i 3 måneder.
English: Discontinue treatment if significant liver injury is confirmed.
Danish: Seponér behandlingen, hvis der konstateres signifikant leverskade.
English: Reduction of the peripheral blood lymphocytes
Danish: Reduktion af lymfocytter i perifert blod
English: 9/l, if confirmed, should lead to dose reduction to 1 mg, because in clinical studies siponimod dose was reduced in patients with absolute lymphocyte counts <0.2 x 10 9/l.
Danish: 9/l bør efter bekræftelse føre til dosisreduktion til 1 mg, fordi siponimod-dosis i kliniske studier blev reduceret hos patienter med absolut lymfocyttal <0,2 x 10
English: - if you have an immunodeficiency syndrome.
Danish: - hvis du har immundefektsyndrom.
English: These observations were slightly higher (approximately 0.15 L mean change from baseline in FEV1) in patients with respiratory disorders such as chronic obstructive pulmonary disease (COPD) or asthma treated with siponimod.
Danish: Disse observationer var en anelse højere (en middelændring i FEV1 på cirka 0,15 L i forhold til baseline) hos patienter med luftvejssygdomme såsom kronisk obstruktiv lungesygdom (KOL) eller astma, der blev behandlet med siponimod.
English: Additional secondary endpoints included time to 6-month CDP, percent brain volume change and measures of inflammatory disease activity (annualised relapse rate, MRI lesions).
Danish: Andre sekundære endepunkter omfattede tid til 6-måneders CDP, procentvis ændring i hjernevolumen og målinger af inflammatorisk sygdomsaktivitet (årlig attakhyppighed, MR-læsioner).
English: • Patients will be informed by their doctor of the need for effective contraception while on treatment and for 10 days after discontinuation.
Danish: • Patienter vil af deres læge blive informeret om nødvendigheden for effektiv kontraception under behandling og i 10 dage efter seponering.
English: On chronic treatment, this reduction did not translate into clinically significant adverse events and was not associated with an increase in reports of cough or dyspnoea (see section 5.1).
Danish: Ved kronisk behandling medførte denne reduktion ingen klinisk signifikante bivirkninger og var ikke forbundet med en øget rapportering af hoste eller dyspnø (se pkt.
English: Since siponimod reduces blood lymphocyte counts via re-distribution in secondary lymphoid organs, peripheral blood lymphocyte counts cannot be utilised to evaluate the lymphocyte subset status of a patient treated with siponimod.
Danish: Da siponimod nedsætter antallet af lymfocytter i blodet på grund af redistribution til sekundære lymfoide organer, kan tællinger af det perifere lymfocyttal ikke anvendes til at evaluere status for en delmængde af lymfocytter hos en patient, der behandles med siponimod.
English: Siponimod is eliminated from the systemic circulation mainly due to metabolism and subsequent biliary/faecal excretion.
Danish: Siponimod elimineres hovedsageligt fra den systemiske cirkulation på grund af metabolisering og efterfølgende udskillelse i galde/fæces.
English: If you are a woman who could become pregnant, your doctor will inform you about this risk before you start treatment with Mayzent and will ask you to do a pregnancy test in order to ensure that you are not pregnant.
Danish: Hvis du er en kvinde og kan blive gravid, vil din læge informere dig om denne risiko, før du starter behandling med Mayzent, og vil bede dig om at tage en graviditetstest for at sikre, at du ikke er gravid.
English: ALT levels returned to normal within approximately 1 month after discontinuation of siponimod (see section 4.4).
Danish: ALAT-niveauerne vendte tilbage til normale niveauer inden for ca. 1 måned efter seponering af siponimod (se pkt.
English: Patients should tell any doctor they see that they are being treated with siponimod.
Danish: Patienterne skal fortælle alle læger, de konsulterer, at de er i behandling med siponimod.
English: These toxicities developed at more than 30-fold higher systemic siponimod levels than the AUC-based human exposure at the maintenance dose of 2 mg/day.
Danish: Disse toksiciteter opstod ved systemiske niveauer af siponimod, som var mere end 30 gange højere end den AUC-baserede eksponering hos mennesker ved vedligeholdelsesdosen på 2 mg/dag.
English: • Patients need to have chickenpox vaccination 1 month before starting siponimod treatment, if the patient is not protected against the virus.
Danish: • Patienter skal vaccineres mod skoldkopper 1 måned inden behandling med siponimod starter, hvis patienten ikke er beskyttet mod denne virus.
English: You may not notice any symptoms in the early stages of macular oedema, and it can cause some of the same visual symptoms as an MS attack (optic neuritis).
Danish: Du bemærker muligvis ikke nogen symptomer i de tidlige faser af makulaødem, og det kan medføre nogle af de samme synsforstyrrelser som et MS-attak (synsnervebetændelse).
English: Your doctor will advise you on this if this is relevant for you.
Danish: Din læge vil fortælle dig, om det er relevant for dig.
English: o Extend heart rate monitoring for at least overnight in a medical facility and until resolution of findings in patients requiring pharmacological intervention during monitoring at treatment initiation/re-initiation.
Danish: o Forlæng monitoreringen af hjertefrekvensen mindst natten over på hospitalet, og indtil tilstanden er ophørt, hos patienter med behov for farmakologisk intervention under monitorering ved initiering/genstart af behandlingen.
English: You must use effective contraception while taking Mayzent and for at least 10 days after you stop taking it to avoid becoming pregnant.
Danish: Du skal bruge sikker prævention, imens du tager Mayzent og i mindst 10 dage efter, at du er holdt op med at tage det, for at undgå at blive gravid.
English: Siponimod can generally be started immediately after discontinuation of beta interferon or glatiramer acetate.
Danish: Behandling med siponimod kan generelt påbegyndes umiddelbart efter seponering af betainterferon eller glatirameracetat.
English: • Counsel the patient in case of inadvertent pregnancy.
Danish: • Patienten skal rådgives i tilfælde af en utilsigtet graviditet.
English: The possibility of severe exacerbation of disease after stopping siponimod treatment should be considered.
Danish: Muligheden for svær sygdomsforværring efter seponering af behandlingen med siponimod skal tages i betragtning.
English: Your doctor may want to perform blood tests to check your liver function before prescribing Mayzent.
Danish: Din læge vil muligvis tage blodprøver for at kontrollere din leverfunktion inden ordination af Mayzent.
English: Before the start of treatment your blood will also be tested to check how well your liver is working.
Danish: Der vil også blive taget blodprøver inden behandling for at kontrollere, hvor godt din lever virker.
English: Since initiation of treatment results in decreased heart rate, siponimod should not be used concomitantly with these medicinal products during treatment initiation.
Danish: Da indledning af behandlingen medfører reduceret hjertefrekvens, må siponimod ikke bruges samtidigt med disse lægemidler under behandlingsstart.
English: The exposure levels (AUC) at the respective NOAELs for embryofoetal (rats and rabbits) and pre/postnatal (rats) development were below the human systemic exposure (AUC) at a daily dose of 2 mg and consequently no safety margin exists.
Danish: Eksponeringsniveauerne (AUC) ved de respektive NOAEL'er for embryoføtal (rotter og kaniner) og den præ-/postnatale (rotter) udvikling lå under den systemiske eksponering (AUC) hos mennesker ved en daglig dosis på 2 mg, og der findes således ingen sikkerhedsmargen.
English: Patients who are hypersensitive to peanut or soya should not take siponimod (see section 4.3).
Danish: Patienter, som er overfølsomme over for jordnødder eller soja, bør ikke anvende siponimod (se pkt.
English: Average cumulative number of Gd-enhancing T1 weighted lesions (95% CI) Rate reduction
Danish: Gennemsnitligt kumulativt antal Gd-forstærkende, T1-vægtede læsioner (95 % CI)
English: Interference with haematological testing
Danish: Interferens med serologisk testning
English: Worsening of MS after stopping Mayzent treatment Do not stop taking Mayzent or change your dose without talking to your doctor first.
Danish: Forværring af MS efter stop af behandling med Mayzent Du må ikke stoppe med at tage Mayzent eller ændre din dosis uden først at have talt med din læge.