FrancophonIA/ELRC3.0 huggingface dataset:
English: Treatment with siponimod resulted in an increase of systolic and diastolic blood pressure starting early after treatment initiation, reaching maximum effect after approximately 6 months of treatment (systolic 3 mmHg, diastolic 1.2 mmHg) and staying stable thereafter.
Danish: Behandling med siponimod førte til en stigning i systolisk og diastolisk blodtryk, som startede tidligt efter start af behandlingen, og nåede den maksimale virkning efter ca. 6 måneders behandling (systolisk 3 mmHg, diastolisk 1,2 mmHg) og forblev stabilt derefter.
English: A few patients experienced mild to moderate symptoms including dizziness and non-cardiac chest pain, which resolved within 24 hours without intervention (see section 4.8).
Danish: Nogle få patienter oplevede lette til moderate symptomer, herunder svimmelhed og ikke kardiologiske brystsmerter, som forsvandt inden for 24 timer uden intervention (se pkt.
English: Siponimod induces a dose-dependent reduction of the peripheral blood lymphocyte count within 6 hours of the first dose, due to the reversible sequestration of lymphocytes in lymphoid tissues.
Danish: Siponimod inducerer en dosisafhængig reduktion i antallet af lymfocytter i perifert blod inden for 6 timer efter den første dosis som følge af den reversible tilbageholdelse af lymfocytter i lymfevæv.
English: Animal studies have demonstrated siponimod-induced embryotoxicity and foetotoxicity in rats and rabbits and teratogenicity in rats, including embryo-foetal deaths and skeletal or visceral malformations at exposure levels comparable to the human exposure at the daily dose of 2 mg (see section 5.3).
Danish: Dyreforsøg har påvist siponimod-induceret embryotoksicitet og føtotoksicitet hos rotter og kaniner samt teratogenicitet hos rotter, herunder embryoføtal død og skeletale eller viscerale misdannelser ved eksponeringsniveauer, der var sammenlignelige med den humane eksponering ved en daglig dosis på 2 mg (se pkt.
English: Table 3 Clinical and MRI results of study A2304
Danish: Tabel 3 Kliniske resultater og MR-scanningsresultater i studie A2304
English: An ophthalmological evaluation is therefore recommended 3-4 months after treatment initiation.
Danish: Det anbefales derfor at foretage en oftalmologisk undersøgelse 3-4 måneder efter påbegyndt behandling.
English: Median age was 49 years, median disease duration was 16 years and median EDSS score was 6.0 at baseline.
Danish: Den mediane alder var 49 år, den mediane sygdomsvarighed var 16 år, og den mediane EDSS-score var 6,0 ved baseline.
English: • Initiate treatment with a titration pack that lasts for 5 days.
Danish: • Initiér behandling med en titreringspakning med 5 dages behandling.
English: Figure 2 Patients with 3- and 6-month CDP based on EDSS-Kaplan-Meier curvesSubgroup with active SPMS (full analysis set, study A2304)
Danish: Figur 2 Patienter med 3- og 6-måneders CDP baseret på EDSS-Kaplan-Meier-kurverUndergruppe med aktiv SPMS (fuldt analysesæt, studie A2304)
English: Your doctor may want you to have eye examinations before you start treatment and regularly while you are on treatment.
Danish: Din læge vil muligvis bede dig om at få foretaget en øjenundersøgelse, før du starter behandling og regelmæssigt under behandling.
English: Siponimod should not be used during breast-feeding.
Danish: Siponimod må ikke anvendes under amning.
English: In repeat-dose toxicity studies in mice, rats and monkeys, siponimod markedly affected the lymphoid system (lymphopenia, lymphoid atrophy and reduced antibody response), which is consistent with its primary pharmacological activity at S1P1 receptors (see section 5.1).
Danish: I studier af toksiciteten efter gentagne doser hos mus, rotter og aber påvirkede siponimod lymfesystemet markant (lymfopeni, lymfoid atrofi og nedsat antistofrespons), hvilket er i overensstemmelse med dets primære farmakologiske aktivitet ved S1P1-receptorerne (se pkt.
English: Siponimod has not been studied in combination with antineoplastic, immune-modulating or immunosuppressive therapies.
Danish: Siponimod er ikke blevet undersøgt i kombination med antineoplastiske, immunmodulerende eller immunsupprimerende behandlinger.
English: However, an increase in the rate of herpes zoster infections was reported on siponimod (2.5%) compared to placebo (0.7%).
Danish: Der blev dog rapporteret en stigning i antallet af herpes zoster-infektioner med siponimod (2,5 %) sammenlignet med placebo (0,7 %).
English: Mayzent contains lactose and soya lecithin
Danish: Mayzent indeholder lactose og sojalecithin
English: Siponimod binds selectively to two out of five G-protein-coupled receptors (GPCRs) for S1P, namely S1P1 and S1P5.
Danish: Siponimod bindes selektivt til to ud af fem G-protein-koblede receptorer (GPCR'er) for S1P dvs. S1P1 og S1P5.
English: If treatment with siponimod is considered in patients with pre-existing significant QT prolongation or who are already being treated with QT-prolonging medicinal products with known arrhythmogenic properties, advice from a cardiologist should be sought prior to initiation of treatment in order to determine the most appropriate monitoring strategy during treatment initiation.
Danish: Hvis behandling med siponimod overvejes til patienter med præ-eksisterende signifikant QT-forlængelse eller til patienter, som allerede behandles med QT-forlængende lægemidler med kendte arytmogene egenskaber, skal der søges råd hos en kardiolog inden behandlingsstart med henblik på at fastlægge den bedst egnede monitoreringsstrategi under behandlingsstart.
English: Median age was 47 years, median disease duration was 15 years and median EDSS score at baseline was 6.0.
Danish: Median alder var 47 år, median sygdomsvarighed var 15 år og median EDSS-score ved baseline var 6,0.
English: PBPK modelling indicates a differential CYP2C9 genotype-dependent inhibition and induction of CYP3A4 pathways.
Danish: PBPK-modellering indikerer en differentiel CYP2C9-genotypeafhængig hæmning og induktion af CYP3A4-veje.
English: • Patients should be informed about the risk of skin malignancies while on treatment with siponimod and should be cautioned against exposure to sunlight without protection.
Danish: • Patienter skal informeres om risikoen for hudmaligniteter under behandling med siponimod og skal advares mod udsættelse for sollys uden beskyttelse.
English: An up-titration regimen is used to reach the clinically therapeutic dose of 2 mg siponimod after 6 days and 4 additional days of dosing are required to reach the steady-state plasma concentrations.
Danish: Der skal anvendes et optitreringsskema til at nå den klinisk terapeutiske dosis på 2 mg siponimod efter 6 dage, og det tager yderligere 4 dage med administration at nå steady state-plasmakoncentrationerne.
English: • medicines that slow down the heartbeat, such as diltiazem or verapamil (which belong to a group of medicines called calcium channel blockers), digoxin or ivabradine.
Danish: • lægemidler, der medfører langsom hjerterytme, som fx diltiazem eller verapamil (som tilhører en gruppe lægemidler, der kaldes calciumantagonister), digoxin eller ivabradin.
English: The recommended maintenance dose of siponimod in all other CYP2C9 genotype patients is 2 mg.
Danish: Den anbefalede vedligeholdelsesdosis af siponimod hos patienter med alle andre CYP2C9-genotyper er 2 mg.
English: Effective diagnostic and therapeutic strategies should be employed in patients with symptoms of infection while on therapy.
Danish: Der skal iværksættes effektive strategier for diagnosticering og behandling af patienter, der får symptomer på infektion under behandlingen.
English: Tell your doctor straight away if you think your MS worsens after you have stopped treatment with Mayzent (see “If you stop taking Mayzent” in section 3).
Danish: Fortæl det straks til lægen, hvis du mener, at din MS er forværret, efter du har stoppet behandling med Mayzent (se “Hvis du stopper med at tage Mayzent” i punkt 3).
English: Most AV blocks and sinus pauses occurred above the therapeutic dose of 2 mg, with notably higher incidence under non-titrated conditions compared to dose titration conditions.
Danish: De fleste tilfælde af AV-blok og sinuspause forekom over den terapeutiske dosis på 2 mg, og der var en tydelig højere incidens ved manglende dosistitrering sammenlignet med dosistitrerede betingelser.
English: Treatment starts with 0.25 mg once daily on days 1 and 2, followed by once-daily doses of 0.5 mg on day 3, 0.75 mg on day 4, and 1.25 mg on day 5, to reach the patient's prescribed maintenance dose of siponimod starting on day 6 (see Table 1).
Danish: Behandlingen startes med 0,25 mg en gang dagligt på dag 1 og 2, efterfulgt af en daglig dosis på 0,5 mg på dag 3, 0,75 mg på dag 4 og 1,25 mg på dag 5, således at patientens ordinerede vedligeholdelsesdosis af siponimod startes på dag 6 (se tabel 1).
English: • Pack containing 120 tablets
Danish: • Pakning med 120 tabletter
English: Suspension of treatment with siponimod should be considered if a patient develops a serious infection.
Danish: Det skal overvejes at afbryde siponimod-behandlingen midlertidigt, hvis patienten udvikler en alvorlig infektion.
English: Effective contraception should be maintained for at least 10 days following discontinuation of treatment with siponimod.
Danish: Effektiv kontraception skal fortsættes i mindst 10 dage efter seponering af behandling med siponimod.
English: Atrioventricular conduction
Danish: Atrioventrikulær overledning
English: • Patients should report any unexpected neurological or psychiatric symptoms/signs (such as sudden onset of severe headache, confusion, seizures and vision changes) or accelerated neurological deterioration to their doctors.
Danish: • Patienter skal indberette uventede neurologiske eller psykiatriske symptomer/tegn (så som pludselig indtræden af alvorlig hovedpine, forvirring, krampeanfald og synsforandringer) eller accelereret neurologisk forværring til deres læger.
English: Absolute lymphocyte counts <0.2 x 10
Danish: Absolut lymfocyttal <0,2 x 10
English: • wearing appropriate protective clothing.
Danish: • gå med tøj, der beskytter mod solen.
English: • Should a patient develop any unexpected neurological or psychiatric symptoms/signs or accelerated neurological deterioration, a complete physical and neurological examination should promptly be scheduled and MRI should be considered.
Danish: • Skulle en patient udvikle hvilke som helst neurologiske eller psykiatriske symptomer/tegn eller accelereret neurologisk forværring skal der straks planlægges en komplet fysisk og neurologisk undersøgelse og MR-scanning bør overvejes.
English: • Before starting siponimod, test for antibodies to varicella zoster virus (VZV) in patients without a physician-confirmed history of varicella or without documentation of a full course of vaccination against VZV.
Danish: • Inden behandlingen med siponimod initieres testes der for antistoffer mod varicella zoster virus (VZV) hos patienter uden lægebekræftet varicella i anamnesen eller uden dokumenteret gennemført vaccinationsprogram mod VZV.
English: At months 3 and 6 of treatment in the phase III clinical study in patients with SPMS, mean changes from baseline in FEV1 in the siponimod group were -0.1 L at each time point, with no change in the placebo group.
Danish: 3 og 6 måneder inde i behandlingen i det kliniske fase III-studie med patienter med SPMS var middelændringerne i FEV1 i forhold til baseline i siponimod-gruppen -0,1 l for begge tidspunkter, og der var ingen ændring i placebogruppen.
English: Siponimod concentration increases in an apparent dose proportional manner after multiple once-daily doses of siponimod 0.3 mg to 20 mg.
Danish: Siponimodkoncentrationerne stiger på en tilsyneladende dosisproportionel måde efter gentagen administration en gang dagligt af siponimod i doser på 0,3 mg til 20 mg.
English: Proportion of patients with 3-month confirmed 20% increase in timed 25-foot walk test Risk reduction
Danish: Andel af patienter med 3-måneders bekræftet 20 % stigning i 25 skridts gangtest på tid Risikoreduktion
English: • lung function test results showing decreased function
Danish: • lungefunktionstest, som viser nedsat funktion
English: Proportion of patients with 6-month confirmed disability progression
Danish: Andel af patienter med 6-måneders bekræftet invaliditetsprogression Risikoreduktion
English: With continued daily dosing, the lymphocyte count continues to decrease, reaching a nadir median (90% CI) lymphocyte count of approximately 0.560 (0.271-1.08) cells/nL in a typical CYP2C9*1*1 or *1*2 non-Japanese SPMS patient, corresponding to 20-30% of baseline.
Danish: Lymfocyttallet fortsætter med at falde ved uafbrudt daglig dosering og når et nadir for mediant lymfocyttal (90 % CI) på ca. 0,560 (0,271-1,08) celler/nl hos en typisk ikke-japansk CYP2C9*1*1eller *1*2-SPMS-patient, svarende til 20-30 % af baseline.
English: Starting treatment
Danish: Start af behandling
English: • Liver function tests should be performed before starting treatment and repeated if there are symptoms suggestive of hepatic dysfunction.
Danish: • Der skal foretages leverfunktionsundersøgelser, før behandling indledes og gentages, hvis der er symptomer i overenstemmelse med leverdysfunktion.
English: What Mayzent contains • The active substance is siponimod.
Danish: Mayzent indeholder: • Aktivt stof: siponimod.
English: Before initiation of treatment, women of childbearing potential must be informed of this risk to the foetus, must have a negative pregnancy test and must use effective contraception during treatment and for at least 10 days after treatment discontinuation (see sections 4.3 and 4.6).
Danish: Før behandlingen initieres, skal fertile kvinder informeres om denne risiko for fosteret; der skal foreligge en negativ graviditetstest og de skal anvende effektiv kontraception under behandlingen og i mindst 10 dage efter seponering af behandlingen (se pkt.
English: • Before initiating treatment, a recent complete blood count (CBC) (i.e. within 6 months or after discontinuation of prior therapy) should be available.
Danish: • Inden behandlingen initieres, skal der foreligge en nylig komplet blodtælling (CBC) (dvs. inden for de seneste 6 måneder eller efter seponering af tidligere behandling).
English: What you need to know before you take Mayzent
Danish: Det skal du vide, før du begynder at tage Mayzent
English: If any of these side effects becomes severe, tell your doctor or pharmacist.
Danish: Hvis nogen af disse bivirkninger bliver alvorlige, skal du fortælle det til lægen eller apotekspersonalet.
English: Compared to CYP2C9*1*1 subjects, individuals with the CYP2C9*2*2, *1*3, *2*3 and *3*3 genotypes have 20%, 35-38%, 45-48% and 74% smaller CL/F values, respectively.
Danish: Sammenlignet med patienter med CYP2C9*1*1 har patienter med genotyperne CYP2C9*2*2, *1*3, *2*3 og *3*3 henholdsvis 20 %, 35-38 %, 45-48 % og 74 % mindre CL/F-værdier.
English: Prompt diagnostic evaluation should be performed in patients with symptoms and signs consistent with cryptococcal meningitis; appropriate treatment, if diagnosed, should be initiated.
Danish: Diagnostisk evaluering skal straks udføres hos patienter med symptomer og tegn i overenstemmelse med kryptokomeningitis; passende behandling initieres, hvis diagnosen stilles.
English: Test requires a DNA sample obtained via blood or saliva (buccal swab).
Danish: En test kræver en DNA-prøve fra blod eller spyt (kindskrab).
English: In the extension part of the phase III clinical study, a case of cryptococcal meningitis (CM) has been reported (see section 4.4).
Danish: I forlængelsesdelen af det kliniske fase III-studie blev der rapporteret et tilfælde med kryptokokmeningitis (se pkt.
English: When stopping siponimod for planning a pregnancy the possible return of disease activity should be considered.
Danish: Ved ophør af behandling med siponimod på grund af planlægning af graviditet skal en mulig tilbagevenden af sygdomsaktivitet overvejes.
English: Blood pressure effects
Danish: Virkning på blodtrykket
English: Your doctor will need to prescribe a new titration pack.
Danish: Lægen vil udskrive en ny titreringspakning til dig.
English: Due to the characteristics and duration of alemtuzumab immune suppressive effects described in its product information, initiating treatment with siponimod after alemtuzumab is not recommended.
Danish: På grund af karakteristikken og varigheden af alemtuzumabs immunsupprimerende virkninger, der er beskrevet i lægemidlets produktinformation, frarådes indledning af behandling med siponimod efter behandling med alemtuzumab.
English: • Periodic safety update reports (PSURs) The requirements for submission of PSURs for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal.
Danish: Kravene for fremsendelse af PSUR´er for dette lægemiddel fremgår af listen over EUreferencedatoer (EURD list), som fastsat i artikel 107c, stk. 7, i direktiv 2001/83/EF, og alle efterfølgende opdateringer offentliggjort på Det Europæiske Lægemiddelagenturs hjemmeside http://www.ema.europa.eu.
English: • Patients should read the package leaflet thoroughly before starting treatment and should keep the package leaflet in case they need to refer to it again during treatment.
Danish: • Før opstart af behandling skal patienterne gennemlæse indlægssedlen grundigt og gemme indlægssedlen i tilfælde af, at de har brug for at læse den igen under behandling.
English: Do not use this medicine after the expiry date which is stated on the carton/blister foil after “EXP”.
Danish: Brug ikke lægemidlet efter den udløbsdato, der står på æsken/blisteren efter EXP. Udløbsdatoen er den sidste dag i den nævnte måned.
English: Initiation of siponimod treatment has been associated with transient atrioventricular conduction delays that follow a similar temporal pattern to the observed decrease in heart rate during dose titration.
Danish: Påbegyndelse af behandling med siponimod er blevet forbundet med forbigående forsinkelser i atrioventrikulær overledning, som fulgte det samme tidsmæssige mønster som de observerede fald i hjertefrekvensen under dosistitrering.
English: It does this by: - making some white blood cells (called lymphocytes) less able to move freely within the body,
Danish: Det gør det ved at: - nedsætte evnen hos visse hvide blodlegemer (kaldet lymfocytter) til at bevæge sig frit i kroppen og - forhindre disse blodlegemer i at nå frem til hjernen og rygmarven.
English: Due to the characteristics and duration of alemtuzumab immune suppressive effects described in its product information, initiating treatment with siponimod after alemtuzmab is not recommended unless the benefits of treatment clearly outweigh the risks for the individual patient (see section 4.4).
Danish: På grund af karakteristikken og varigheden af alemtuzumabs immunsupprimerende virkninger, som beskrevet i lægemidlets produktinformation, frarådes behandlingsstart med siponimod efter behandling med alemtuzumab, medmindre fordelene tydeligt opvejer risikoen for den enkelte patient (se pkt.
English: Patients without a physician-confirmed history of varicella or without documentation of a full course of vaccination against VZV should be tested for antibodies to VZV before starting siponimod (see below section “Vaccination”).
Danish: Patienter uden lægebekræftet varicella i anamnesen eller uden dokumenteret fuldført vaccinationsprogram mod VZV skal testes for antistoffer mod VZV, inden behandlingen med siponimod påbegyndes (se “Vaccination” nedenfor).
English: • The importance of reporting adverse reactions.
Danish: • Vigtigheden af at indrapportere bivirkninger.
English: Siponimod did not affect male and female fertility in rats up to the highest dose tested, representing an approximate 19-fold safety margin based on human systemic exposure (AUC) at a daily dose of 2 mg.
Danish: Siponimod påvirkede ikke han- og hundyrs fertilitet hos rotter op til den højeste testede dosis, som svarer til omtrent 19 gange sikkerhedsmargen baseret på human systemisk eksponering (AUC) med en daglig dosering på 2 mg.
English: Therefore, before initiation of treatment in women of childbearing potential a negative pregnancy test result must be available and counselling should be provided regarding serious risk to the foetus.
Danish: Inden initiering af behandling til fertile kvinder skal der derfor foreligge en negativ graviditetstest, og kvinden skal rådgives om den alvorlige risiko for fosteret.
English: Patients homozygous for CYP2C9*3 (CYP2C9*3*3 genotype: approximately 0.3 to 0.4% of the population) should not be treated with siponimod.
Danish: Patienter, der er homozygote for CYP2C9*3 (CYP2C9*3*3-genotype: ca. 0,3 til 0,4 % af befolkningen), må ikke behandles med siponimod.
English: Time to 3-month CDP versus placebo
Danish: Tid til 3-måneders CDP kontra placebo
English: Co-administration with siponimod did not reveal clinically relevant effects on the pharmacokinetics and pharmacodynamics of the combined ethinylestradiol and levonorgestrel oral contraceptive.
Danish: Samtidig administration med siponimod viste ingen kliniske relevante virkninger på farmakokinetik og farmakodynamik af orale kontraceptiva med kombination af ethinylestradiol og levonorgestrel.
English: Time to 6-month CDP versus placebo
Danish: Tid til 6-måneders CDP kontra placebo
English: However, should a patient on siponimod treatment develop any unexpected neurological or psychiatric symptoms/signs (e.g. cognitive deficits, behavioural changes, cortical visual disturbances or any other neurological cortical symptoms/signs or any symptom/sign suggestive of an increase in intracranial pressure) or accelerated neurological deterioration, a complete physical and neurological examination should promptly be scheduled and MRI should be considered.
Danish: Hvis en patient, der får behandling med siponimod, imidlertid udvikler uventede neurologiske eller psykiske symptomer/tegn (f.eks. kognitive svækkelser, adfærdsændringer, kortikale synsforstyrrelser eller andre neurologiske, kortikale symptomer/tegn eller symptom/tegn tydende på en stigning i det intrakranielle tryk) eller accelereret neurologisk forværring, skal der straks planlægges en komplet fysisk og neurologisk undersøgelse, og en MR-scanning skal overvejes.
English: • Patients with a history of second-degree Mobitz type II atrioventricular (AV) block, third-degree AV block, sino-atrial heart block or sick sinus syndrome, if they do not wear a pacemaker.
Danish: • patienter med anamnese med 2. grads Mobitz type II atrioventrikulært blok (AVblok), AV-blok af 3. grad, sinoatrialt hjerteblok eller syg sinussyndrom, hvis de ikke bruger pacemaker.
English: Time to onset of 3-month and 6-month CDP was significantly delayed for siponimod, with reduction in risk of 3-month CDP by 21% compared to placebo (hazard ratio [HR] 0.79, p=0.0134) and reduction in risk of 6-month CDP by 26% compared to placebo (HR 0.74, p=0.0058).
Danish: Tiden til 3-måneders og 6-måneders CDP blev signifikant forsinket ved siponimod, og der var en reduktion i risiko for 3-måneders CDP med 21 % sammenlignet med placebo (hazard ratio [HR] 0,79, p=0,0134) og en reduktion i risiko for 6-måneders CDP med 26 % sammenlignet med placebo (HR 0,74, p=0,0058).
English: Change from baseline in T2 lesion volume (mm
Danish: MR-scanningsendepunkter Ændring fra baseline i T2-læsionsvolumen (mm
English: The pregnancy-specific patient reminder card shall contain the following key messages:
Danish: Patientkortet specifikt rettet mod graviditet skal indeholde følgende vigtige informationer:
English: Pulmonary function
Danish: Lungefunktion
English: No cases of progressive multifocal leukoencephalopathy (PML) have been reported for siponimod in the development programme; however, they have been reported for another S1P receptor modulator.
Danish: Der er ikke rapporteret nogen tilfælde af progressiv multifokal leukoencefalopati (PML) for siponimod i udviklingsprogrammet, men tilfælde er rapporteret for en anden S1P-receptormodulator.
English: Siponimod may be combined with most types of CYP2C9 and CYP3A4 inducers.
Danish: Siponimod kan kombineres med de fleste typer CYP2C9- og CYP3A4-induktorer.
English: Titration dose
Danish: Titrering Titreringsdosis