FrancophonIA/ELRC3.0 huggingface dataset:
English: During the first 6 days of treatment, if you have forgotten to take your dose on one day, call your doctor before you take the next dose.
Danish: Hvis du i løbet af de første 6 dage glemmer at tage din dosis en dag, skal du kontakte lægen, inden du tager den næste dosis.
English: Tell your doctor straight away if you think your MS worsens after you have stopped treatment with Mayzent.
Danish: Fortæl det omgående til lægen, hvis du synes, at din MS bliver værre, efter at du er stoppet med at tage Mayzent.
English: • While on treatment, women must not become pregnant.
Danish: • Kvinder må ikke blive gravide under behandling.
English: Within each system organ class, the adverse drug reactions are ranked by frequency, with the most frequent reactions first.
Danish: Inden for de enkelte systemorganklasser er bivirkningerne anført efter hyppighed i faldende rækkefølge.
English: With continued up-titration, further heart rate decreases are seen on subsequent days, with maximal decrease from day 1 (baseline) reached on day 5 to 6.
Danish: Der er set yderligere fald i hjertefrekvensen ved fortsat optitrering på de efterfølgende dage, og det maksimale fald i forhold til dag 1 (baseline) blev nået på dag 5 til 6.
English: MAINTENANCE
Danish: VEDLIGEHOLDELSE
English: Treatment with siponimod can then be initiated and treatment with beta blocker can be re-initiated after siponimod has been up-titrated to the target maintenance dose (see section 4.5).
Danish: Derefter kan behandling med siponimod indledes, og behandling med betablokkeren kan genoptages, når siponimod er blevet optitreret til den tilsigtede vedligeholdelsesdosis (se pkt.
English: Missed dose(s) during treatment initiation
Danish: Glemte doser under behandlingsstart
English: Table 4 CYP2C9 genotype effect on siponimod CL/F and systemic exposure
Danish: Tabel 4 Virkningen af CYP2C9-genotype på siponimods CL/F og systemisk eksponering
English: Siponimod was not studied in patients with significant QT prolongation (QTc >500 msec) or who were treated with QT-prolonging medicinal products.
Danish: Siponimod er ikke blevet undersøgt hos patienter med signifikant QT-forlængelse (QTc >500 msek.)
English: Siponimod treatment should be suspended until CM has been excluded.
Danish: Behandling med siponimod bør indstilles indtil CM er udelukket.
English: The use of live attenuated vaccines may carry the risk of infection and should therefore be avoided during siponimod treatment and for up to 4 weeks after treatment (see section 4.4).
Danish: Brugen af levende, svækkede vacciner kan indebære en risiko for infektion og skal derfor undgås under behandling med siponimod og i op til 4 uger efter behandlingen (se pkt.
English: Siponimod should be stopped at least 10 days before a pregnancy is planned (see section 4.4).
Danish: Siponimod skal seponeres mindst 10 dage inden planlægning af en graviditet (se pkt.
English: The relative rate reduction of cumulative number of Gd-enhancing T1 weighted lesions over 24 months was 85% (rate ratio 0.155; 95% CI: 0.104, 0.231) compared to placebo.
Danish: Den relative hastighedsreduktion af det samlede antal Gd-opladende T1vægtede læsioner over 24 måneder var 85 % (frekvensratio 0,155; 95 % CI: 0,104, 0,231) sammenlignet med placebo.
English: • carbamazepine and certain other medicines can lower the levels of Mayzent in your blood and can therefore stop it from working properly.
Danish: • carbamazepin og visse andre lægemidler, som kan sænke niveauet af Mayzent i dit blod og dermed forhindre det i at virke rigtigt.
English: Siponimod has not been studied in patients with arrhythmias requiring treatment with class Ia (e.g. quinidine, procainamide) or class III (e.g. amiodarone, sotalol) antiarrhythmic medicinal products.
Danish: Siponimod er ikke undersøgt hos patienter med arytmier, som kræver behandling med antiarytmika af klasse Ia (f.eks. quinidin, procainamid) eller klasse III (f.eks. amiodaron, sotalol).
English: It is recommended that these patients should undergo an ophthalmological evaluation prior to initiating therapy and regularly while receiving siponimod therapy to detect macular oedema.
Danish: Det anbefales, at disse patienter får foretaget en oftalmologisk vurdering, før behandlingen indledes, og herefter regelmæssigt under behandlingen med siponimod for at opdage tilfælde af makulaødem.
English: • Should a pregnancy occur during treatment or within 10 days following discontinuation of treatment with siponimod, it should be immediately reported to the doctor or to Novartis by calling [insert local number] or visiting [insert URL], irrespective of adverse outcomes observed.
Danish: • Hvis der opstår graviditet under behandlingen eller inden for 10 dage efter seponering af behandlingen med siponimod, skal det straks indberettes til lægen eller Novartis ved at kontakte [indsæt lokalt nummer] eller gå ind på [indsæt URL], uanset de observerede utilsigtede udfald.
English: Although no dose adjustment is needed in patients with mild or moderate hepatic impairment, caution should be exercised when initiating treatment in these patients (see sections 4.4 and 5.2).
Danish: Skønt det ikke er nødvendigt at justere dosis til patienter med let eller moderat nedsat leverfunktion, skal der udvises forsigtighed ved initiering af behandling af disse patienter (se pkt.
English: • Do not prescribe siponimod in patients homozygous for CYP2C9*3*3.
Danish: • Udskriv ikke siponimod til patienter, der er homozygote for CYP2C9*3*3.
English: Difference in T2 lesion volume change
Danish: Forskel i ændring af T2-læsionsvolumen
English: While in rats a higher number of foetuses with external, skeletal and visceral malformations (e.g. cleft palate and misshapen clavicles, cardiomegaly and oedema) were noted, in rabbit foetuses skeletal and visceral variations were predominantly observed.
Danish: Hos rotter blev der noteret et højere antal fostre med eksterne, skeletale og viscerale misdannelser (f.eks. ganespalte og misformede klavikler, kardiomegali og ødem), mens der hos kaninfostre fortrinsvis blev observeret skeletale og viscerale afvigelser.
English: Recent (i.e. within last 6 months) transaminase and bilirubin levels should be available before initiation of treatment with siponimod.
Danish: Der skal foreligge nylige resultater for transaminase- og bilirubinniveauer (dvs. indhentet inden for de seneste 6 måneder) inden indledning af behandling med siponimod.
English: Patients who develop symptoms suggestive of hepatic dysfunction should have liver enzymes checked and siponimod should be discontinued if significant liver injury is confirmed.
Danish: Patienter, der udvikler symptomer, som tyder på hepatisk dysfunktion skal have kontrolleret deres leverenzymer, og siponimod skal seponeres, hvis signifikant leverskade bekræftes.
English: In carcinogenicity investigations, siponimod induced lymphoma, haemangioma and haemangiosarcoma in mice, whereas follicular adenoma and carcinoma of the thyroid gland were identified in male rats.
Danish: I undersøgelser af karcinogeniciteten inducerede siponimod lymfom, hæmangiom og hæmangiosarkom hos mus, hvorimod follikulært adenom og thyreoideakarcinom blev påvist hos hanrotter.
English: Mayzent is indicated for the treatment of adult patients with secondary progressive multiple sclerosis (SPMS) with active disease evidenced by relapses or imaging features of inflammatory activity (see section 5.1).
Danish: Mayzent er indiceret til behandling af voksne patienter med sekundær progressiv multipel sklerose (SPMS) med aktiv sygdom vist ved attakker eller radiologiske tegn på inflammatorisk aktivitet (se pkt.
English: Siponimod causes a transient reduction in heart rate and atrioventricular conduction on treatment initiation (see sections 4.4 and 4.8), which is mechanistically related to the activation of G-protein-coupled inwardly rectifying potassium (GIRK) channels via S1P1 receptor stimulation leading to cellular hyperpolarisation and reduced excitability.
Danish: 4.4 og 4.8), som er mekanistisk relateret til aktiveringen af G-protein-aktiverede inward-rectifyer kaliumkanaler (GIRK) via S1P1-receptorstimulation, som fører til cellehyperpolarisering og reduceret excitabilitet.
English: • The signs and symptoms of infection during, and up to one month after treatment with siponimod need to be reported immediately to the prescriber.
Danish: • Tegnene og symptomerne på infektion under og op til 1 måned efter behandling med siponimod skal straks rapporteres til den ordinerende læge.
English: In CYP2C9*2*2 patients, a 2.7-fold increase in the AUC of siponimod is expected in the presence of moderate CYP2C9/CYP3A4 inhibitors.
Danish: Hos CYP2C9*2*2-patienter forventes der en 2,7-folds stigning i siponimods AUC ved tilstedeværelse af moderate CYP2C9-/CYP3A4-hæmmere.
English: Two population pharmacokinetic analyses indicated that CYP2C9*1*1 and *1*2 subjects behave as extensive metabolisers, *2*2 and *1*3 subjects as intermediate metabolisers and *2*3 and *3*3 subjects as poor metabolisers.
Danish: To farmakokinetiske populationsanalyser indikerede, at patienter med CYP2C9*1*1 og *1*2 fungerer som ekstensive metabolisatorer, patienter med *2*2 og *1*3 er intermediære metabolisatorer, og patienter med *2*3 og *3*3 er dårlige metabolisatorer.
English: • Arrange an ophthalmological evaluation prior to initiating therapy and follow-up evaluations while receiving therapy in patients with a history of diabetes mellitus, uveitis or underlying/co-existing retinal disease.
Danish: • Der skal udføres en oftalmologisk vurdering inden initiering af behandlingen samt opfølgende vurderinger under behandlingen for patienter med diabetes mellitus, uveitis eller underliggende/samtidig retinasygdom i anamnesen.
English: • Before starting treatment, a DNA sample via blood or saliva (buccal swab) is taken to determine the CYP2C9 genotype to help determine appropriate dosing of siponimod.
Danish: • Før opstart af behandling tages en DNA-test fra blod eller spyt (kindskrab) til fastlæggelse af CYP2C9-genotype, som skal bruges til at bestemme den rigtige dosis siponimod.
English: A transient, dose-dependent decrease in heart rate was observed during the initial dosing phase and plateaued at doses ≥5 mg. Bradyarrhythmic events (AV blocks and sinus pauses) were detected with a higher incidence under siponimod treatment compared to placebo.
Danish: Der blev observeret et forbigående, dosisafhængigt fald i hjertefrekvens i den indledende doseringsfase, som nåede plateau ved doser ≥5 mg. Bradyarytmihændelser (AV-blok og sinuspauser) blev påvist med højere incidens ved behandling med siponimod sammenlignet med placebo.
English: A full course of vaccination with varicella vaccine is recommended for antibody-negative patients prior to commencing treatment with siponimod, following which initiation of treatment should be postponed for 1 month to allow the full effect of vaccination to occur (see section 4.8).
Danish: Et fuldt vaccinationsprogram med varicellavaccine anbefales for antistofnegative patienter, inden behandlingen med siponimod påbegyndes, hvorefter behandlingsstart skal udskydes i 1 måned for at give vaccinationen tid til at virke fuldt ud (se pkt.
English: • Should a pregnancy occur during treatment or within 10 days following discontinuation of treatment with siponimod, please report it to Novartis by calling [insert local number] or visiting [insert URL], irrespective of adverse outcomes observed.
Danish: • Hvis der opstår graviditet under behandlingen eller inden for 10 dage efter seponering af behandlingen med siponimod, skal det indberettes til Novartis ved at kontakte [indsæt lokalt nummer] eller gå ind på [indsæt URL], uanset de observerede utilsigtede udfald.
English: Siponimod is contraindicated in patients with severe liver impairment (Child-Pugh class C).
Danish: Siponimod er kontraindiceret hos patienter med svært nedsat leverfunktion (Child-Pugh klasse C).
English: • Cryptococcal infections (a type of fungal infection), including cryptococcal meningitis with symptoms such as headache together with stiff neck, sensitivity to light, feeling sick (nausea) or confusion.
Danish: • Kryptokokinfektioner (en type svampeinfektion), herunder kryptokokmeningitis med symptomer, som fx hovedpine sammen med nakkestivhed, lysoverfølsomhed, kvalme eller forvirring.
English: Experience is limited in patients receiving concurrent therapy with heart-rate-lowering calcium channel blockers (such as verapamil or diltiazem) or other substances that may decrease heart rate (e.g. ivabradine or digoxin) as these medicinal products were not studied in patients receiving siponimod in clinical studies.
Danish: Der er begrænset erfaring med patienter, som får samtidig behandling med calciumantagonister, som sænker hjertefrekvensen (som f.eks. verapamil eller diltiazem) eller andre stoffer, som kan reducere hjertefrekvensen (f.eks. ivabradin eller digoxin), da disse lægemidler ikke er undersøgt hos patienter, som fik siponimod i kliniske studier.
English: Pregnant women should be advised of potential serious risks to the foetus, and ultrasonography examinations should be performed.
Danish: Gravide kvinder skal vejledes om potentielle alvorlige risici for fosteret, og der skal foretages ultralydsscanninger.
English: The effects of end-stage renal disease or haemodialysis on the pharmacokinetics of siponimod have not been studied.
Danish: Virkningerne af nyresygdom i slutstadiet eller hæmodialyse på siponimods farmakokinetik er ikke blevet undersøgt.
English: The recommended maintenance dose is 1 mg daily in patients with a CYP2C9*2*3 genotype (1.4-1.7% of the population) and in patients with a *1*3 genotype (9-12% of the population) to avoid increased exposure to siponimod (see sections 4.2 and 5.2).
Danish: Den anbefalede vedligeholdelsesdosis er 1 mg dagligt hos patienter med CYP2C9*2*3-genotype (1,4-1,7 % af befolkningen) og hos patienter med en *1*3-genotype (9-12 % af befolkningen) for at undgå øget eksponering for siponimod (se pkt.
English: • Be vigilant for skin malignancies while on treatment with siponimod.
Danish: • Vær opmærksom på hudmaligniteter under behandling med siponimod.
English: • Adjust the maintenance dose to 1 mg in patients with CYP2C9*2*3 or *1*3 genotypes.
Danish: • Justér vedligeholdelsesdosis til 1 mg hos patienter med CYP2C9*2*3- eller *1*3genotyper.
English: If post-dose bradyarrhythmia or conduction-related symptoms occur or if ECG 6 hours post-dose shows new onset second-degree or higher AV block or QTc ≥500 msec, appropriate management should be initiated and observation continued until the symptoms/findings have resolved.
Danish: Hvis der forekommer bradyarytmi efter dosering eller overledningsrelaterede symptomer, eller hvis EKG'et 6 timer efter dosering viser nyopstået AV-blok af 2. grad eller højere, eller QTc ≥500 msek., skal passende behandling iværksættes og observationen fortsættes, indtil symptomerne/fundene ikke længere er til stede.
English: • if you have symptoms such as unexplained nausea, vomiting, abdominal pain, tiredness, yellowing of the skin or whites of the eyes or abnormally dark urine.
Danish: • hvis du har symptomer, som fx uforklarlig kvalme, opkastning, mavesmerter, træthed, gulfarvning af huden eller det hvide i øjnene eller unormalt mørk urin.
English: Mean siponimod half-life and Cmax (total and unbound) were comparable between subjects with severe renal impairment and healthy subjects.
Danish: Siponimods middelhalveringstid og Cmax (total og ubundet) var sammenlignelig for patienter med svært nedsat nyrefunktion og raske forsøgsdeltagere.
English: The efficacy of vaccination is not considered to be compromised if siponimod treatment is paused 1 week prior to vaccination until 4 weeks after (see section 4.4).
Danish: Virkningen af vaccination anses ikke at være kompromitteret, hvis behandling med siponimod afbrydes midlertidigt 1 uge før vaccinationen og først genoptages 4 uger efter (se pkt.
English: Medical advice should be given regarding the risk of harmful effects to the foetus associated with treatment and ultrasonography examinations should be performed.
Danish: Kvinden skal have lægefaglig rådgivning vedrørende risikoen for skadelige virkninger på fosteret forbundet med behandlingen, og der skal laves ultralydsscanninger.
English: However, because of an expected reduction in siponimod exposure, the appropriateness and possible benefit of the treatment should be considered when siponimod is combined: - with strong CYP3A4/moderate CYP2C9 inducers (e.g. carbamazepine) in all patients regardless of genotype - with moderate CYP3A4 inducers (e.g. modafinil) in patients with a CYP2C9*1*3 or *2*3
Danish: På grund af en forventet reduktion i eksponering for siponimod skal behandlingens egnethed og mulige fordele dog tages i betragtning ved kombination af siponimod og: - stærke CYP3A4-/moderate CYP2C9-induktorer (f.eks. carbamazepin) hos alle patienter uanset genotype - moderate CYP3A4-induktorer (f.eks. modafinil) hos patienter med en CYP2C9*1*3- eller
English: • Be informed before treatment initiation and regularly thereafter by their physician about siponimod serious risks to the foetus and about the contraindication in pregnant women and in women of childbearing potential not using effective contraception, facilitated by the Pregnancy Reminder Card.
Danish: • Før behandlingsstart og regelmæssigt derefter informeres af deres læge om siponimods alvorlige risici for fosteret og om konitraindikation hos gravide kvinder og hos fertile kvinder, der ikke anvender effektiv kontraception, ved hjælp af patientkortet specifikt rettet mod graviditet.
English: Treatment has to be started with a titration pack that lasts for 5 days.
Danish: Behandlingen skal indledes med en titreringspakning med 5 dages behandling.
English: If resting heart rate is ≤50 bpm, then beta-blocker treatment should be interrupted until the baseline heart rate is >50 bpm.
Danish: Hvis hjertefrekvensen i hvile er ≤50 slag/minut, skal behandlingen med betablokkeren afbrydes, indtil baseline-hjertefrekvensen er >50 slag/minut.
English: • Exercise caution when administering concomitant treatment with anti-neoplastic, immune-modulating or immunosuppressive therapies (including corticosteroids) due to the risk of additive immune system effects.
Danish: • Der skal udvises forsigtighed i forbindelse med samtidig anvendelse af antineoplastiske, immunmodulerende eller immunsupprimerende behandlinger (herunder kortikosteroider) på grund af risikoen for additive virkninger på immunsystemet.
English: The use of live attenuated vaccines should be avoided while patients are taking siponimod and for 4 weeks after stopping treatment (see section 4.5).
Danish: Brugen af levende, svækkede vacciner skal undgås, mens patienten tager siponimod og i 4 uger efter seponering af behandlingen (se pkt.
English: The highest daily post-dose decrease in absolute hourly mean heart rate is observed on day 1, with the pulse declining on average 5 to 6 beats per minute (bpm).
Danish: Efter dosering er det højeste daglige fald i absolut middelhjertefrekvens over en time observeret på dag 1, og pulsen falder i gennemsnit med 5 til 6 slag/minut.
English: Mayzent 0.25 mg film-coated tablets are available in the following pack sizes:
Danish: Mayzent 0,25 mg filmovertrukne tabletter fås i følgende pakningsstørrelser:
English: Active disease in SPMS is when there are still relapses or when MRI (magnetic resonance imaging) results show signs of inflammation.
Danish: Aktiv sygdom ved SPMS vil sige, at der stadig er attakker eller, når MR-scanningsfund viser tegn på inflammation.
English: How much Mayzent to take
Danish: Så meget Mayzent skal du tage
English: CYP2C9 is a polymorphic enzyme and the drug-drug interaction (DDI) effect in the presence of CYP3A or CYP2C9 perpetrator drugs is predicted to be dependent on the CYP2C9 genotype.
Danish: CYP2C9 er et polymorft enzym, og virkningerne af lægemiddelinteraktioner ved tilstedeværelse af andre lægemidler, der metaboliseres af CYP3A eller CYP2C9 forventes at afhænge af CYP2C9-genotypen.
English: - if you have ever had progressive multifocal leukoencephalopathy or cryptococcal meningitis.
Danish: - hvis du nogensinde har haft progressiv multifokal leukoencefalopati eller kryptokokmeningitis.
English: Siponimod increased the placebo-corrected baseline-adjusted mean QTcF (ΔΔQTcF) by more than 5 ms, with a maximum mean effect of 7.8 ms (2 mg) and 7.2 ms (10 mg), respectively, at 3 h post-dose.
Danish: Siponimod øgede den placebo-korrigerede baseline-justerede middel-QTcF (ΔΔQTcF) med mere end 5 msek., og den maksimale middelvirkning var henholdsvis 7,8 msek.
English: Siponimod should be used with caution in the elderly (see section 4.2).
Danish: Siponimod skal anvendes med forsigtighed til ældre (se pkt.
English: - Hypersensitivity to the active substance, or to peanut, soya or any of the excipients listed in section 6.1.
Danish: - Overfølsomhed over for det aktive stof, jordnødder, soja eller over for et eller flere af hjælpestofferne anført i pkt.
English: When stopping siponimod therapy for vaccination, the possible return of disease activity should be considered (see below section “Stopping siponimod therapy”).
Danish: Ved seponering af behandling med siponimod for vaccination bør risikoen for fornyet sygdomsaktivitet overvejes (se afsnit ”Ophør af behandling med siponimod” nedenfor).
English: Based on clinical pharmacology studies, no dose adjustment is needed in patients with renal impairment (see section 5.2).
Danish: Vurderet på grundlag af kliniske farmakologistudier er det ikke nødvendigt at justere dosis til patienter med nedsat nyrefunktion (se pkt.
English: Dose-limiting toxicities in animal species were nephrotoxicity in mice, body weight development in rats and adverse CNS and gastrointestinal effects in monkeys.
Danish: Dosisbegrænsende toksiciteter i dyrearter var nefrotoksicitet hos mus, ændring af legemsvægt hos rotter og bivirkninger på centralnervesystemet og mave-tarm-kanalen hos aber.
English: Mayzent 2 mg film-coated tablets are available in packs containing 28 tablets.
Danish: Mayzent 2 mg filmovertrukne tabletter fås i pakninger med 28 tabletter.
English: However, residual pharmacodynamic effects, such as lowering effects on peripheral lymphocyte count, may persist for up to 3-4 weeks after the last dose.
Danish: Tilbageværende farmakodynamiske virkninger som f.eks. sænkende virkning på det perifere lymfocyttal kan dog vedvare i op til 3-4 uger efter den sidste dosis.
English: In the phase III clinical study in patients with SPMS the overall rate of infections was comparable between the patients on siponimod and those on placebo (49.0% versus 49.1%, respectively).
Danish: I det kliniske fase III-studie hos patienter med SPMS var den samlede forekomst af infektioner sammenlignelig mellem de patienter, der fik siponimod, og dem, der fik placebo (henholdsvis 49,0 % og 49,1 %).
English: Vascular disorders Very common
Danish: Vaskulære sygdomme Meget almindelig
English: During and for up to 4 weeks after stopping treatment with Mayzent, you should not be given certain types of vaccine (called live attenuated vaccines) as they could trigger the infection that they were supposed to prevent (see section 2).
Danish: Du må ikke få visse typer vacciner (kaldet levende, svækkede vacciner) under og i op til 4 uger efter ophør med behandling med Mayzent, da de kan udløse den infektion, de skulle forebygge (se punkt 2).
English: • If the maintenance dose is interrupted for 4 or more consecutive daily doses, treatment must be re-initiated with a new titration pack.
Danish: • Hvis vedligeholdelsesdosis afbrydes med 4 eller flere sammenhængende daglige doser, skal behandlingen genstartes med en ny titreringspakning.
English: • if you have symptoms such as sudden onset of severe headache, confusion, seizures and vision changes.
Danish: • hvis du har symptomer, som fx pludselig kraftig hovedpine, forvirring, krampeanfald og synsforandringer.
English: United Kingdom Novartis Pharmaceuticals UK Ltd. Tel: +44 1276 698370
Danish: Novartis Pharmaceuticals UK Ltd. Tel: +44 1276 698370