FrancophonIA/ELRC3.0 huggingface dataset:
English: For the full list of all side effects reported with Galvus, including side effects occurring when Galvus is taken with other antidiabetes medicines, see the package leaflet.
Danish: Den fuldstændige liste over alle de indberettede bivirkninger ved Galvus, hvis det anvendes sammen med andre lægemidler mod sukkersyge, fremgår af indlægssedlen Galvus bør ikke anvendes hos patienter, der er overfølsomme (allergiske) over for vildagliptin eller andre af indholdsstofferne.
English: How is Galvus used?
Danish: Hvordan anvendes Galvus?
English: How does Galvus work?
Danish: Hvordan virker Galvus?
English: • together with metformin, a thiazolidinedione or a sulphonylurea (dual therapy) when the patient's diabetes is insufficiently controlled by this other medicine taken alone, but it is only used in combination with a sulphonylurea in patients who cannot take metformin;
Danish: • sammen med metformin, et thiazolidindion eller et sulfonylurinstof (som dobbelt behandling), når patientens sukkersyge ikke kan kontrolleres tilfredsstillende med denne anden medicin alene.
English: Five of these studies looked at the effects of Galvus taken alone in a total of 3,644 patients, comparing it with placebo (a dummy treatment), metformin, rosiglitazone (a thiazolidinedione) or gliclazide (a sulphonylurea).
Danish: Det blev her sammenlignet med placebo (virkningsløs behandling), med metformin, rosiglitazon (et thiazolidindion) eller gliclazid (et sulfonylurinstof).
English: You will have to restart at day 1.
Danish: Du skal starte forfra ved dag 1.
English: Siponimod is taken with or without food.
Danish: Siponimod kan tages med eller uden mad.
English: • Other reminders:
Danish: • Andre påmindelser:
English: From Cox modelling for time to progression
Danish: Fra Cox-modellering for tid til progression
English: Race/Ethnicity
Danish: Race/etnicitet
English: It must be repeated at suitable intervals.
Danish: Dette skal gentages med passende intervaller.
English: Mayzent is taken once daily.
Danish: Mayzent skal tages en gang dagligt.
English: You may not feel anything or you may feel dizzy or tired.
Danish: Det kan være, at du ikke kan mærke det, eller du kan føle dig svimmel eller træt.
English: Missed dose after day 6
Danish: Glemte doser efter dag 6
English: From a model for recurrent events
Danish: Fra en model for tilbagevendende hændelser
English: Other side effects include those listed below.
Danish: Andre bivirkninger omfatter dem, der er anført nedenfor.
English: 78% of patients had been previously treated with a therapy for their MS.
Danish: 78 % af patienterne var tidligere blevet behandlet for deres MS.
English: Do not give this medicine to children and adolescents below 18 years of age because it has not yet been studied in this age group.
Danish: Dette lægemiddel må ikke gives til børn og unge under 18 år, da det endnu ikke er undersøgt hos denne aldersgruppe.
English: These could be serious and possibly even life-threatening.
Danish: Disse infektioner kan være alvorlige og endda livstruende.
English: Follow the instructions on the pack (see also the “Titration pack” table).
Danish: Følg instruktionerne på pakningen (se også tabellen “Titreringspakning”).
English: For further clarifications please refer to your local laboratory.
Danish: For yderligere afklaring henvises til det lokale laboratorium.
English: Up to month 24
Danish: Op til måned 24
English: In both species, prenatal mortality was increased.
Danish: Hos begge arter var den prænatale mortalitet forhøjet.
English: Specific measures are also included in the Physician Education Pack.
Danish: Særlige forholdsregler er også inkluderet i uddannelsesmaterialet til læger.
English: Such events have not been reported for siponimod in the development programme.
Danish: Der er ikke rapporteret sådanne hændelser for siponimod i udviklingsprogrammet.
English: • if you think your MS is getting worse or if you notice any new or unusual symptoms.
Danish: • hvis du synes, at din MS bliver værre, eller hvis du bemærker nye eller usædvanlige symptomer.
English: Characteristics in specific groups or special populations
Danish: Karakteristika i bestemte grupper eller særlige populationer
English: Take tablet(s) at the same time every day.
Danish: Tag tabletterne på samme tidspunkt hver dag.
English: - Active malignancies.
Danish: - Aktive maligniteter.
English: Elderly patients (65 years of age and above)
Danish: Ældre patienter (65 år og derover)
English: Tests before and during treatment
Danish: Prøver før og under behandling
English: Take the tablet with water.
Danish: Tag tabletten sammen med vand.
English: - if you have an active cancer.
Danish: - hvis du har en aktiv kræftsygdom.
English: Patients who experienced bradycardia were generally asymptomatic.
Danish: Patienter, som oplevede bradyarytmi, var generelt asymptomatiske.
English: Average over month 12 and month 24
Danish: Gennemsnit af måned 12 og måned 24
English: On day 6, you will switch to your regular treatment dose.
Danish: På dag 6 overgår du til den sædvanlige behandlingsdosis.
English: In rare cases, the test result may indicate that you should not take Mayzent.
Danish: I sjældne tilfælde kan resultaterne af prøven vise, at du ikke må tage Mayzent.
English: How quickly this medicine is broken down (metabolised) in the body varies from patient to patient and different people therefore require different doses.
Danish: Hvor hurtigt dette lægemiddel nedbrydes i kroppen (metaboliseres) er forskelligt fra patient til patient, og forskellige patienter skal derfor have forskellige doser.
English: Mayzent is for oral use.
Danish: Mayzent er til oral anvendelse.
English: Your doctor may decide to keep you under observation.
Danish: Lægen kan beslutte, at du skal holdes under observation.
English: The safety and efficacy of siponimod in children and adolescents aged 0 to 18 years have not yet been established.
Danish: Siponimods sikkerhed og virkning hos børn og unge i alderen 0 til 18 år er endnu ikke klarlagt.
English: • if you have high blood pressure that cannot be controlled by medicines.
Danish: • hvis du har forhøjet blodtryk, som ikke kan kontrolleres med medicin.
English: The siponimod fraction found in plasma is 68% in humans.
Danish: Siponimodfraktionen fundet i plasma er 68 % i mennesker.
English: Assessments of CBC are also recommended periodically during treatment.
Danish: Vurderinger af CBC anbefales også periodisk under behandlingen.
English: Unexpected neurological or psychiatric symptoms/signs
Danish: Uventede neurologiske eller psykiske symptomer/tegn
English: Post-dose declines on the following days are less pronounced.
Danish: Faldene efter administration på de efterfølgende dage er mindre udtalte.
English: Both are single nucleotide polymorphisms.
Danish: Begge er enkeltnukleotid-polymorfismer.
English: (Primary endpoint)
Danish: (Primært endepunkt)
English: Frequency in Caucasians
Danish: Hyppighed hos kaukasere
English: cysts and polyps) Common
Danish: cyster og polypper) Almindelig
English: Siponimod readily crosses the blood-brain barrier.
Danish: Siponimod passerer let blod-hjernebarrieren.
English: Non-confirmatory p-value; hierarchical testing procedure terminated before reaching endpoint
Danish: Ikke-bekræftende p-værdi; hierarkisk testprocedure fastlagt inden endepunkt nås
English: Your doctor may ask you to stop taking these to avoid an increased effect on the immune system.
Danish: Lægen vil muligvis bede dig om at stoppe med at tage disse for at undgå en øget virkning på immunsystemet.
English: Estimated CL/F (L/h)
Danish: Estimeret CL/F (l/t)
English: The effect persisted with continued treatment.
Danish: Effekten fortsatte med fortsat behandling.
English: • vaccines.
Danish: • vacciner.
English: The film-coated tablets should be swallowed whole with water.
Danish: De filmovertrukne tabletter skal synkes hele sammen med vand.
English: Your doctor will tell you whether your illness allows you to drive vehicles and use machines safely.
Danish: Din læge vil fortælle dig, om din sygdom gør dig i stand til sikkert at føre motorkøretøj og bruge maskiner.
English: This may increase your risk of developing skin cancer.
Danish: Det kan øge din risiko for at få hudkræft.
English: • Patients with the below conditions.
Danish: • patienter med nedenstående tilstande.
English: Additional exposure of 0.25 mg on day 5 does not compromise patient safety.
Danish: Yderligere eksponering for 0,25 mg på dag 5 har ingen betydning for patientsikkerheden.
English: • if you have ever had liver problems.
Danish: • hvis du nogensinde har haft leverproblemer.
English: Confirmed at 6 months [Nominal p-value for endpoints not included in the hierarchical testing and not adjusted for multiplicity]
Danish: Bekræftet ved 6 måneder [Nominel p-værdi for endepunkter der ikke er inkluderet i det hierarkiske testforløb og ikke justeret for multiplicitet]
English: In the phase III clinical study, 1% of all discontinuations met one of these criteria.
Danish: I det kliniske fase III-studie opfyldte 1 % af alle seponeringer et af disse kriterier.
English: An apparent systemic clearance (CL/F) of 3.11 l/h was estimated in MS patients.
Danish: En tilsyneladende systemisk clearance (CL/F) på 3,11 l/t blev estimeret hos MS-patienter.
English: Mayzent helps to protect the central nervous system (CNS) from attacks by the body's own immune system.
Danish: Mayzent er med til at beskytte centralnervesystemet (CNS) mod angreb fra kroppens eget immunsystem.
English: The risk of recurrence after re-challenge has not been evaluated.
Danish: Risikoen for tilbagefald efter genoptagelse af behandlingen er ikke blevet undersøgt.
English: New onset third-degree AV block occurring at any time b.
Danish: Nyopstået AV-blok af 3. grad på et hvilket som helst tidspunkt b.
English: At least overnight extended monitoring is recommended.
Danish: Forlænget monitorering mindst natten over anbefales.
English: • What multiple sclerosis is.
Danish: • Information om multipel sclerose.
English: Study duration was variable for individual patients (median study duration was 21 months, range: 1 day to 37 months).
Danish: Studiets varighed var forskellig for de enkelte patienter (median varighed af studiet var 21 måneder, interval: 1 dag til 37 måneder).
English: It may also cause your heartbeat to become irregular at the beginning of treatment.
Danish: Det kan også medføre, at din hjerterytme bliver uregelmæssig i starten af behandlingen.
English: Talk to your doctor if you have any concerns.
Danish: Tal med lægen, hvis du er bekymret om noget.
English: Your doctor will advise you on this.
Danish: Din læge vil rådgive dig om dette.
English: • involuntary shaking of the body (tremor)
Danish: • ufrivillige rystelser af kroppen (tremor)
English: There is no specific antidote to siponimod available.
Danish: Der er ingen specifik antidot for siponimod tilgængelig.
English: Mayzent may pass into breast milk and there is a risk of serious side effects for the baby.
Danish: Mayzent kan passere over i modermælken, og der er risiko for alvorlige bivirkninger for barnet.
English: o Appropriate management should be initiated and observation continued until the symptoms/findings have resolved if the following events are observed: a.
Danish: o Relevant behandling skal iværksættes, og observationen fortsætte, indtil symptomerne/fundene er ophørt, hvis følgende hændelser observeres: a.
English: Neither dialysis nor plasma exchange would result in meaningful removal of siponimod from the body.
Danish: Hverken dialyse eller plasmaudskiftning medfører betydningsfuld fjernelse af siponimod fra kroppen.
English: Mayzent lowers the number of white cells in your blood.
Danish: Mayzent nedsætter antallet af hvide blodlegemer i dit blod.
English: If you need to have a vaccination, talk to your doctor first.
Danish: Hvis du skal vaccineres, skal du tale med lægen først.
English: Risk of infections
Danish: Risiko for infektioner
English: - if blood tests show that your body cannot break down this medicine well enough, you should not take it (see “Blood tests before and during treatment” below).
Danish: - hvis blodprøver viser, at din krop ikke kan nedbryde dette lægemiddel godt nok, bør du ikke tage det (se “Prøver før og under behandlingen” nedenfor).
English: • Mayzent is not recommended in:
Danish: • Mayzent anbefales ikke til:
English: • Bradyarrhythmia (including conduction defects) during treatment initiation:
Danish: • Bradyarytmi (herunder overledningsforstyrrelser) ved initiering af behandling:
English: Study A2304 (EXPAND) in SPMS
Danish: Studie A2304 (EXPAND) med SPMS
English: The most common adverse drug reactions are headache (15%) and hypertension (12.6%).
Danish: De mest almindelige bivirkninger er hovedpine (15 %) og hypertension (12,6 %).
English: During and for up to 4 weeks after treatment with siponimod vaccinations may be less effective.
Danish: Under og i op til 4 uger efter behandling med siponimod kan vaccinationer være mindre effektive.
English: This reduces the recirculation of T cells into the central nervous system (CNS) to limit central inflammation.
Danish: Dette reducerer recirkulationen af T-celler ind i centralnervesystemet (CNS), hvilket kan begrænse central inflammation.
English: Bradycardia Atrioventricular block (first and second degree)
Danish: Bradyarytmi Atrioventrikulært blok (1. og 2. grad)
English: • Infections, including varicella zoster reactivation, reactivation of the other viral infections, PML and other rare opportunistic infections:
Danish: • Infektioner, herunder reaktivering af varicella zoster, reaktivering af de øvrige virusinfektioner, PML og andre sjældne opportunistiske infektioner:
English: Pharmacotherapeutic group: Immunosuppressants, selective immunosuppressants, ATC code: L04AA42
Danish: Farmakoterapeutisk klassifikation: immunosuppressiva, selektive immunosuppressiva, ATC-kode: L04AA42
English: Change in cognitive processing speed on Symbol Digit Modality Test score was an exploratory endpoint.
Danish: Ændring i kognitiv proceshastighed målt ved Symbol Digit Modality Test score var et eksploratorisk endepunkt.
English: In these patients, it is recommended that an electrocardiogram (ECG) is obtained prior to dosing and at the end of the observation period.
Danish: Hos disse patienter anbefales det, at der indhentes et elektrokardiogram (EKG) inden dosering og ved afslutningen af observationsperioden.
English: The time (Tmax) to reach maximum plasma concentrations (Cmax) after multiple oral administration of siponimod is about 4 hours (range: 2 to 12 hours).
Danish: Tiden (Tmax) til opnåelse af maksimale plasmakoncentrationer (Cmax) efter flere orale administrationer af siponimod er ca. 4 timer (interval: 2 til 12 timer).
English: Melanocytic naevus
Danish: Melanocytisk naevus
English: Make sure to tell your doctor if you are taking or receiving any of the following medicines or therapies:
Danish: Det er vigtigt, at du fortæller det til lægen, hvis du tager eller får nogen af følgende lægemidler eller behandlinger:
English: • if you have an infection.
Danish: • hvis du har en infektion.
English: It can occur in patients taking medicines like Mayzent and other medicines used for treating MS.
Danish: Den kan forekomme hos patienter, der tager lægemidler som fx Mayzent og andre lægemidler, der bruges til at behandle MS.
English: Potential to prolong the QT interval
Danish: Potentiale for forlængelse af QT-intervallet
English: • Potential long-term safety implications in CYP2C9 poor metabolisers:
Danish: • De potentielle langsigtede, sikkerhedsmæssige konsekvenser hos dårlige CYP2C9metabolisatorer:
English: You will be given a titration pack, with which your dose will be gradually increased over 5 days.
Danish: Du vil få udleveret en titreringspakning, hvor din dosis øges gradvist i løbet af 5 dage.
English: • blood test results showing increased liver enzyme levels
Danish: • blodprøveresultater, der viser forhøjede leverenzymniveauer
English: Mayzent is not expected to affect your ability to drive and use machines when you are on your regular treatment dose.
Danish: Mayzent forventes ikke at påvirke din evne til at føre motorkøretøj og bruge maskiner, når du får den almindelige behandlingsdosis.
English: If it is almost time for your next dose, skip the missed dose and continue as usual.
Danish: Hvis det næsten er tid til den næste dosis, skal du springe den glemte dosis over og fortsætte som normalt.
English: If this applies to you, note that it is nevertheless safe for you to take five 0.25 mg tablets on day 5 of the titration period as indicated above.
Danish: Bemærk, at selvom dette gør sig gældende for dig, er det stadig sikkert for dig at tage fem 0,25 mg tabletter på dag 5 i titreringsperioden, som nævnt ovenfor.
English: The majority of elevations occurred within 6 months of starting treatment.
Danish: Størstedelen af forhøjelserne forekom inden for 6 måneder efter påbegyndelse af behandlingen.
English: • if you have never had chickenpox and have not been vaccinated against it. You may be at greater risk of complications if you develop chickenpox during Mayzent treatment.
Danish: • hvis du aldrig har haft skoldkopper og ikke er vaccineret mod det. Du kan have større risiko for komplikationer, hvis du får skoldkopper under behandling med Mayzent.
English: There is no experience with Mayzent in elderly patients.
Danish: Der er ingen erfaring med anvendelse af Mayzent til ældre patienter.
English: Information that the monitoring may need to extend overnight, if the patient experiences symptoms during the first 6 hours.
Danish: Information om, at monitoreringen kan blive forlænget til natten over, hvis patienten oplever symptomer i løbet af de første 6 timer.
English: At the start of treatment you may occasionally feel dizzy.
Danish: I starten af behandlingen kan du af og til føle dig svimmel.
English: • Patient/Caregiver Guide to be provided to all patients;
Danish: • Patient-/omsorgspersonskort, som skal udleveres til alle patienter;
English: There are no or limited amount of data available from the use of siponimod in pregnant women.
Danish: Der er ingen eller kun utilstrækkelige data om anvendelse af siponimod til gravide kvinder.
English: Neoplasms benign, malignant and unspecified (incl.
Danish: Benigne, maligne og uspecificerede neoplasmer (inkl.
English: Your doctor may monitor you closely at the start of treatment if you are at risk of your heartbeat becoming slower or irregular.
Danish: Lægen vil muligvis overvåge dig tæt i starten af behandlingen, hvis der er risiko for, at din hjertefrekvens bliver langsommere eller uregelmæssig.
English: The absolute oral bioavailability of siponimod is approximately 84%.
Danish: Siponimods absolutte orale biotilgængelighed er ca. 84 %.
English: These measures must be implemented before siponimod is prescribed to female patients and during treatment.
Danish: Disse forholdsregler skal implementeres, før siponimod ordineres til kvindelige patienter og under behandling.
English: You should limit your exposure to the sun and UV rays by:
Danish: Du skal begrænse udsættelsen for sol og UV-stråler ved at:
English: Siponimod did not exert any phototoxic or dependence potential and was not genotoxic in vitro and in vivo.
Danish: Siponimod udøvede intet fototoksisk potentiale eller afhængighedspotentiale og var ikke genotoksisk in vitro og in vivo.
English: Potential of other medicinal products to affect siponimod pharmacokinetics
Danish: Andre lægemidlers potentiale for at påvirke siponimods farmakokinetik
English: • if you have severe breathing problems when sleeping (sleep apnoea).
Danish: • hvis du har alvorlige vejrtrækningsproblemer under søvn (søvnapnø).
English: Treatment with Mayzent will be overseen by a doctor who is experienced in the treatment of MS.
Danish: Behandling med Mayzent vil blive overvåget af en læge med erfaring i behandling af MS.
English: Number of patients at risk
Danish: Antal patienter med risiko
English: • Women exposed to siponimod during pregnancy are encouraged to join the pregnancy exposure programme (PRegnancy outcomes Intensive Monitoring, PRIM) that monitors outcomes of pregnancy.
Danish: • Kvinder eksponeret for siponimod under graviditet opfordres til at tilmelde sig graviditetseksponeringsprogrammet (Pregnancy outcomes Intensive Monitoring, PRIM), som monitorerer udfald af graviditet.
English: In addition, the corresponding frequency category for each adverse drug reaction is based on the following convention: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000).
Danish: Desuden er de tilsvarende kategorier for hyppigheden af bivirkninger baseret på følgende konvention: meget almindelig (≥1/10), almindelig (≥1/100 til <1/10), ikke almindelig (≥1/1.000 til <1/100), sjælden (≥1/10.000 til <1/1.000) og meget sjælden (<1/10.000).
English: The median EDSS was 6.0 at baseline.
Danish: Den gennemsnitlige EDSS var 6,0 ved baseline.
English: Low lymphocyte counts are maintained with daily dosing.
Danish: Lave lymfocyttal opretholdes med daglig dosering.
English: Talk to your doctor before taking Mayzent:
Danish: Kontakt lægen, før du tager Mayzent:
English: If any of the above applies to you, tell your doctor before taking Mayzent.
Danish: Hvis noget af ovenstående gælder for dig, skal du fortælle det til lægen, før du tager Mayzent.
English: During the first 6 days of treatment initiation the recommended daily dose should be taken once daily in the morning with or without food.
Danish: I løbet af de første 6 dages indledende behandling skal den anbefalede daglige dosis tages en gang dagligt om morgenen med eller uden mad.
English: One patient (with a history of depression) who took 84 mg siponimod experienced a slight elevation in liver transaminases.
Danish: Én patient (med depression i anamnesen), som fik 84 mg siponimod, oplevede en let forhøjelse i levertransaminaser.
English: Fertility and reproductive toxicity
Danish: Fertilitet og reproduktionstoksicitet
English: • There is an increased risk of infections including serious infections, in patients treated with siponimod.
Danish: • Der er øget risiko for infektioner, også alvorlige infektioner, hos patienter, som behandles med siponimod.
English: The majority of cases occurred within the first 3-4 months of therapy.
Danish: Størstedelen af tilfældene forekom i de første 3-4 måneder af behandlingen.
English: Your doctor may need to stop or reduce your Mayzent dose if the white blood cell count is too low.
Danish: Det kan blive nødvendigt for lægen at stoppe eller nedsætte din dosis af Mayzent, hvis antallet af hvide blodlegemer er for lavt.
English: Your doctor may decide not to prescribe Mayzent because it could intensify the effect on irregular heartbeat.
Danish: Lægen kan beslutte ikke at ordinere Mayzent, da det kan forstærke virkningen på uregelmæssig hjerterytme.
English: • Reproductive toxicity:
Danish: • Reproduktionstoksicitet:
English: Do not take Mayzent - if you are allergic to siponimod, peanut, soya or any of the other ingredients of this medicine
Danish: Tag ikke Mayzent - hvis du er allergisk over for siponimod, jordnødder, soja eller et af de øvrige indholdsstoffer i
English: - if you have certain types of irregular or abnormal heartbeat (arrhythmia) and you do not have a pacemaker.
Danish: - hvis du har visse typer af uregelmæssig eller unormal hjerterytme (arytmi), og du ikke har en pacemaker.
English: • if you are planning to have any vaccinations.
Danish: • hvis du planlægger at blive vaccineret.
English: If anything indicates that you may be at higher risk of suffering from these effects, your doctor may decide to monitor you more closely at the start of treatment, refer you first to a heart specialist (cardiologist), or choose not to give you Mayzent.
Danish: Hvis der er noget, der tyder på, at du kan have en højere risiko for disse virkninger, vil lægen muligvis beslutte at overvåge dig tættere i starten af behandlingen, først henvise dig til en hjertespecialist (kardiolog) eller vælge ikke at give dig Mayzent.