FrancophonIA/ELRC3.0 huggingface dataset:
English: If you have severe liver problems, you should not take Gilenya.
Danish: Hvis du har alvorlige leverproblemer, må du ikke tage Gilenya.
English: Vigilance for skin lesions is warranted and a medical evaluation of the skin is recommended at initiation, and then every 6 to 12 months taking into consideration clinical judgement.
Danish: Der skal udvises opmærksomhed på hudlæsioner, og en medicinsk vurdering af huden anbefales ved start, og derefter hver 6. til 12. måned baseret på en klinisk vurdering.
English: • While on treatment, women must not become pregnant.
Danish: • Under behandling må kvinder ikke blive gravide.
English: Effective diagnostic and therapeutic strategies should be employed in patients with symptoms of infection while on therapy.
Danish: Der skal iværksættes effektive diagnostiske og terapeutiske strategier hos patienter, der får symptomer på infektion, mens de er i behandling.
English: This could be serious (see “If you stop taking Gilenya” in section 3, and also section 4, “Possible side effects”).
Danish: Dette kan være alvorligt (se ”Hvis du holder op med at tage Gilenya” i punkt 3, og også punkt 4 ”Bivirkninger”).
English: Data from preclinical studies do not suggest that fingolimod would be associated with an increased risk of reduced fertility (see section 5.3).
Danish: Data fra prækliniske undersøgelser tyder ikke på, at fingolimod ville være forbundet med øget risiko for nedsat fertilitet (se pkt.
English: If you forget to take Gilenya
Danish: Hvis du har glemt at tage Gilenya
English: Caution is also indicated when stopping fingolimod therapy due to the risk of a rebound (see “Return of disease activity (rebound) after fingolimod discontinuation” above).
Danish: Forsigtighed er også indiceret, når man stopper fingolimodbehandling på grund af risikoen for recidiv (se ”Fornyet sygdomsaktivitet (recidiv) efter seponering af fingolimod” ovenfor).
English: Weight decreased*** Blood triglycerides increased
Danish: Vægttab*** Forhøjede blodtriglycerider
English: Some patients presented with blurred vision or decreased visual acuity, but others were asymptomatic and diagnosed on routine ophthalmological examination.
Danish: Nogle patienter henvendte sig med tågesyn eller nedsat synsskarphed, men andre var asymptomatiske og blev diagnosticeret ved rutinemæssig oftalmologisk undersøgelse.
English: - After Gilenya treatment is stopped, symptoms of MS can return and may become worse than they were before or during treatment.
Danish: - Efter behandlingsophør med Gilenya kan symptomer på MS komme tilbage og måske blive værre, end de var før eller under behandling.
English: Animal studies have shown that this redistribution reduces the infiltration of pathogenic lymphocytes, including pro-inflammatory Th17 cells, into the CNS, where they would be involved in nerve inflammation and nervous tissue damage.
Danish: Dyrestudier har vist, at denne omfordeling reducerer patogene lymfocytcellers, inklusive pro-inflammatoriske Th17-cellers, infiltration af CNS, hvor de ville blive impliceret i nerveinflammation og beskadigelse af nervevæv.
English: • Women exposed to GILENYA during pregnancy are encouraged to join the pregnancy exposure registry that monitors outcomes of pregnancy.
Danish: • Kvinder, som er eksponeret for GILENYA under graviditet opfordres til at deltage i graviditetsregisterstudiet, som monitorerer udfaldet af graviditeter.
English: Gilenya is not intended for use in children below 10 years old as it has not been studied in MS patients in this age group.
Danish: Gilenya er ikke beregnet til brug hos børn under 10 år, da lægemidlet ikke er undersøgt hos MSpatienter i denne aldersgruppe.
English: Fingolimod and its metabolites crossed the placental barrier in pregnant rabbits.
Danish: Fingolimod og dets metabolitter krydsede placentabarrieren hos drægtige kaniner.
English: 84 capsules (3 packs of 28)
Danish: 84 kapsler (3 pakninger med hver 28)
English: Fingolimod treatment is not associated with a decrease in cardiac output.
Danish: Behandling med fingolimod er ikke forbundet med et fald i hjerteminutvolumen.
English: • Physicians should assess Tanner staging and measure height and weight as per standard of care;
Danish: • Lægen skal vurdere Tanners stadium og måle højde og vægt som en del af standardbehandlingen;
English: - if, in the last 6 months, you have had heart attack, angina, stroke or warning of a stroke or certain types of heart failure.
Danish: - Hvis du inden for de seneste 6 måneder har haft hjerteanfald, hjertekrampe, slagtilfælde eller advarsel om slagtilfælde eller visse typer hjertesvigt.
English: The maximal decline in heart rate is seen within 6 hours post dose, with 70% of the negative chronotropic effect achieved on the first day.
Danish: Det maksimale fald i hjertefrekvensen ses inden for 6 timer efter dosering, og 70 % af den negative kronotrope virkning opnås den første dag.
English: A core pharmacodynamic effect of Gilenya is a dose-dependent reduction of the peripheral lymphocyte count to 20-30% of baseline values.
Danish: En vigtig farmakodynamisk effekt af Gilenya er en dosisafhængig reduktion af det perifere lymfocyttal til 20-30 % af udgangsværdierne.
English: They usually did not require treatment and resolved within the first 24 hours on treatment.
Danish: De har normalt ikke været behandlingskrævende og er ophørt i løbet af de første 24 timers behandling.
English: MRI findings may be apparent before clinical signs or symptoms.
Danish: MR-scanningsfund kan være tilstede før kliniske tegn eller symptomer.
English: Least Square Mean # One patient randomised to receive interferon beta-1a by intramuscular injection was unable to swallow the double-dummy medication and discontinued from study.
Danish: Mindste kvadraters gennemsnit # Én patient, som blev randomiseret til at få interferon beta-1a ved intramuskulær injektion, kunne ikke synke double-dummy medicinen og ophørte i studiet.
English: C] fingolimod, the major fingolimod-related components in blood, as judged from their contribution to the AUC up to 34 days post dose of total radiolabelled components, are fingolimod itself (23%), fingolimod phosphate (10%), and inactive metabolites (M3 carboxylic acid metabolite (8%), M29 ceramide metabolite (9%) and M30 ceramide metabolite (7%)).
Danish: C] fingolimod er de vigtigste fingolimod-relaterede komponenter i blodet, bedømt ud fra deres bidrag til AUC op til 34 dage efter dosering for samlet antal radioaktivt mærkede komponenter, fingolimod selv (23 %) fingolimodphosphat (10 %) samt inaktive metabolitter (M3 karboxylsyremetabolit (8 %), M29 ceramidmetabolit (9 %) og M30 ceramidmetabolit (7 %)).
English: If discontinuation of fingolimod is deemed necessary, the possibility of recurrence of exceptionally high disease activity should be considered and patients should be monitored for relevant signs and symptoms and appropriate treatment initiated as required (see “Stopping therapy” below).
Danish: Hvis det vurderes at være nødvendigt at seponere fingolimod, bør muligheden for tilbagevendende usædvanlig høj sygdomsaktivitet tages i betragtning og patienterne bør monitoreres for relevante tegn og symptomer, og passende behandling bør initieres om nødvendigt (se ”Behandlingsophør” nedenfor).
English: Potent inhibitors of transporter proteins are not expected to influence fingolimod disposition.
Danish: Potente hæmmere af transportproteiner forventes ikke at indvirke på fingolimods fordeling.
English: Further analyses of clinical trial data demonstrate consistent treatment effects in highly active subgroups of relapsing remitting multiple sclerosis patients.
Danish: Yderligere analyser af de kliniske forsøgsdata viser konsekvent behandlingseffekt hos yderst aktive undergrupper af recidiverende-remitterende multipel sklerose.
English: - In the controlled paediatric trial D2311, cases of seizures, anxiety, depressed mood and depression have been reported with a higher incidence in patients treated with fingolimod compared to patients treated with interferon beta-1a.
Danish: - I det kontrollerede pædiatriske studie D2311 er der indberettet tilfælde af krampeanfald, angst, nedtrykthed og depression med en højere forekomst hos patienter behandlet med fingolimod sammenlignet med patienter behandlet med interferon beta-1a.
English: PML is an opportunistic infection caused by John Cunningham virus (JCV), which may be fatal or result in severe disability.
Danish: PML er en opportunistisk infektion forårsaget af JohnCunningham-virus (JCV) og kan være dødelig eller medføre svær invaliditet.
English: After 34 days, the recovery of the administered dose is 89%.
Danish: Efter 34 dage er 89 % af den indgivne dosis udskilt.
English: Regarding the signal ‘autoimmune haemolytic anaemia (AIHA)', the PRAC concluded that the cumulative review provided by the MAH as well as the plausible theoretical mechanism support a causal relationship between therapy with fingolimod and occurrence of AIHA:
Danish: Vedrørende det autoimmune hæmatolytiske anæmi (AIHA)-signal har PRAC konkluderet, at den samlede gennemgang udleveret af indehaveren af markedsføringstilladelsen samt den plausible teoretiske mekanisme understøtter en årsagssammenhæng mellem behandling med fingolimod og forekomsten af AIHA:
English: These cases have been confounded by concomitant medicinal products and/or pre-existing disease.
Danish: Disse tilfælde er set ved samtidig medicinering med andre lægemidler og/eller forudeksisterende sygdom.
English: • Stopping GILENYA therapy may result in return of disease activity.
Danish: • Stop af behandlingen med Gilenya kan medføre fornyet sygdomsaktivitet.
English: Starting other therapies during this interval will result in concomitant exposure to fingolimod.
Danish: Påbegyndelse af anden behandling i denne periode, vil medføre samtidig eksponering for fingolimod.
English: The majority of T and B lymphocytes regularly traffic through lymphoid organs and these are the cells mainly affected by fingolimod.
Danish: De fleste T- og B-lymfocytter passerer normalt gennem lymfeorganerne, og det er hovedsagelig disse celler, der påvirkes af fingolimod.
English: The capsules should always be swallowed intact, without opening them.
Danish: Kapslerne skal altid synkes hele og må ikke åbnes.
English: If the treatment interruption is of shorter duration than the above, the treatment should be continued with the next dose as planned.
Danish: Hvis afbrydelse af behandlingen er af kortere varighed end nævnt ovenfor, skal behandlingen fortsætte med den næste dosis som planlagt.
English: *** Adverse drug reactions from spontaneous reports and literature **** The frequency category and risk assessment were based on an estimated exposure of more than 24,000 patients to fingolimod 0.5 mg in all clinical trials.
Danish: *** Bivirkninger fra spontane indberetninger og litteraturen **** Frekvenskategori og risikovurdering blev baseret på en estimeret behandling af mere end 24.000 patienter med fingolimod 0,5 mg fra de kliniske studier.
English: Before you start Gilenya, your doctor will confirm whether you have enough white blood cells in your blood and may want to repeat a check regularly.
Danish: Før du starter behandling med Gilenya vil din læge kontrollere, om du har nok hvide blodlegemer i blodet, og han vil måske gentage kontrollen regelmæssigt.
English: Gilenya can generally be started immediately after discontinuation of interferon or glatiramer acetate.
Danish: Gilenya kan normalt startes straks efter seponering af interferon eller glatirameracetat.
English: There are no data on the effects of fingolimod on labour and delivery.
Danish: Der foreligger ingen data vedrørende fingolimods virkning på fødselsveer og forløsning.
English: Fingolimod is a sphingosine 1-phosphate receptor modulator.
Danish: Fingolimod er en sphingosin-1-fosfat-receptor-modulator.
English: On the basis of the scientific conclusions for fingolimod the CHMP is of the opinion that the benefitrisk balance of the medicinal product(s) containing fingolimod is unchanged subject to the proposed changes to the product information.
Danish: På baggrund af de videnskabelige konklusioner for fingolimod er CHMP af den opfattelse, at benefit/risk-forholdet for det lægemiddel/de lægemidler, der indeholder fingolimod, forbliver uændret under forudsætning af, at de foreslåede ændringer indføres i produktinformationen.
English: • Patients will be informed by their doctor of the need for effective contraception while on treatment and for 2 months after discontinuation.
Danish: • Patienter bliver informeret af deres læge om nødvendigheden af effektiv kontraception under behandling og i 2 måneder efter seponering.
English: A third study targeting the same adult patient population was completed after registration of Gilenya.
Danish: Et tredie studie på samme voksne patientpopulation blev afsluttet, efter Gilenya var godkendt.
English: Irregular heartbeat usually returns to normal in less than one day.
Danish: Uregelmæssig hjerterytme bliver sædvanligvis normal igen i løbet af mindre end en dag.
English: The treatment should be initiated and supervised by a physician experienced in multiple sclerosis.
Danish: Behandlingen bør indledes og gennemføres under opsyn af en læge med erfaring i multipel sklerose.
English: - if you are allergic to fingolimod or any of the other ingredients of this medicine (listed in section 6).
Danish: - Hvis du er allergisk over for fingolimod eller et af de øvrige indholdsstoffer i Gilenya (angivet i punkt 6).
English: If liver transaminases rise above 5 times the ULN, more frequent monitoring should be instituted, including serum bilirubin and alkaline phosphatase (ALP) measurement.
Danish: Hvis lever-aminotransferaser stiger til over 5 gange ULN, bør hyppigere monitorering indledes, inklusive måling af serumbilirubin og alkalisk fosfatase (ALP).
English: Low lymphocyte counts are maintained with chronic daily dosing.
Danish: Lave lymfocyttal vedvarer under kronisk daglig dosering.
English: The same may apply if you are resuming Gilenya after a break in treatment, depending on both how long the break was and how long you had been taking Gilenya before the break.
Danish: Det samme kan gælde, hvis du genoptager Gilenya-behandlingen, efter den har været afbrudt, afhængig af både hvor lang tid den har været afbrudt, og hvor længe du har taget Gilenya før afbrydelsen.
English: • GILENYA is teratogenic.
Danish: • Gilenya er teratogent.
English: Autonomic responses of the heart, including diurnal variation of heart rate and response to exercise are not affected by fingolimod treatment.
Danish: Hjertets autonom respons, herunder daglige frekvensvariationer og respons på motion, påvirkes ikke af behandling med fingolimod.
English: * p<0.01,** p<0.001, compared to interferon beta-1a All analyses of clinical endpoints were intent-to-treat.
Danish: * p<0,01,** p<0,001, sammenlignet med beta-1a interferon Alle analyser of kliniske endepunkter var intent-to-treat.
English: Furthermore, the receptor affected by fingolimod (sphingosine 1-phosphate receptor) is known to be involved in vascular formation during embryogenesis.
Danish: Endvidere er det kendt, at den receptor, der påvirkes af fingolimod (sphingosin1-fosfatreceptoren), er involveret i kardannelsen under embryogenesen.
English: The safety and efficacy of Gilenya in children aged below 10 years have not yet been established.
Danish: Pædiatrisk population Gilenyas sikkerhed og virkning hos børn under 10 år er endnu ikke klarlagt.
English: Fingolimod phosphate binds at low nanomolar concentrations to sphingosine 1-phosphate (S1P) receptor 1 located on lymphocytes, and readily crosses the blood-brain barrier to bind to S1P receptor 1 located on neural cells in the central nervous system (CNS).
Danish: Fingolimodphosphat binder sig ved lave nanomolære koncentrationer til sphingosin-1-fosfat (S1P)-receptor1 på lymfocytter og passerer let blod-hjernebarrieren for at binde sig til S1P-receptor1 på nerveceller i centralnerveystemet (CNS).
English: Tell your doctor straight away if you experience any of these symptoms during your treatment with Gilenya, because it could be serious.
Danish: Fortæl det straks til din læge, hvis du oplever nogen af disse symptomer, mens du er i behandling med Gilenya, da det kan være alvorligt.
English: Fingolimod is transformed in humans by reversible stereoselective phosphorylation to the pharmacologically active (S)-enantiomer of fingolimod phosphate.
Danish: Fingolimod omdannes hos mennesker ved en reversibel, stereoselektiv fosforylering til den farmakologisk aktive (S)-enantiomer fingolimodphosphat.
English: Gilenya is indicated as single disease modifying therapy in highly active relapsing remitting multiple sclerosis for the following groups of adult patients and paediatric patients aged 10 years and older:
Danish: Gilenya er indiceret som sygdomsmodificerende behandling i monoterapi ved meget aktiv recidiverende-remitterende multipel sklerose hos følgende grupper af voksne patienter og pædiatriske patienter i alderen 10 år og ældre:
English: The pharmacologically active metabolite responsible for efficacy is fingolimod phosphate.
Danish: Den farmakologisk aktive metabolit som er ansvarlig for virkningen er fingolimodphosphat.
English: - There are very limited data available in children between 10-12 years old, less than 40 kg or at Tanner stage <2 (see sections 4.8 and 5.1).
Danish: - Der er meget begrænsede data tilgængelige fra børn i alderen mellem 10-12 år, under 40 kg eller på Tanners stadium <2 (se pkt.
English: o Specific recommendations regarding vaccination for patients initiating GILENYA treatment.
Danish: o Specifikke anbefalinger vedrørende vaccination af patienter, der skal starte i behandling med Gilenya.
English: Caution is required in this subgroup population (see “Paediatric population” in section 4.8).
Danish: Der skal udvises forsigtighed i denne undergruppe (se “Pædiatrisk population” under pkt.
English: If discontinuation of Gilenya is deemed necessary, patients should be monitored during this time for relevant signs of a possible rebound.
Danish: Hvis seponering af Gilenya anses for nødvendigt, skal patienterne i denne periode overvåges for relevante tegn på en mulig recidiv.
English: Swallow each capsule whole
Danish: Oral anvendelse Synk hver kapsel hel
English: Before you start treatment with Gilenya your doctor will explain the risk to you and ask you to do a pregnancy test in order to ensure that you are not pregnant.
Danish: Inden du begynder behandling med Gilenya, vil din læge forklare risikoen for dig og bede dig om at tage en graviditetstest for at være sikker på, at du ikke er gravid.
English: This will usually go back to normal within 2 months of stopping treatment.
Danish: Det vil sædvanligvis vende tilbage til normalt niveau indenfor 2 måneder efter, at behandlingen er stoppet.
English: These patients should not receive concomitant phototherapy with UV-B-radiation or PUVA-photochemotherapy.
Danish: Disse patienter bør ikke modtage samtidig behandling med UV-B-stråling eller PUVA-fotokemoterapi.
English: A CBC is recommended prior to initiating Gilenya to ensure that immune effects of the previous therapy (i.e. cytopenia) have resolved.
Danish: CBC anbefales før initiering af Gilenya for at sikre, at den tidligere behandlings virkning på immunsystemet (dvs. cytopeni) er ophørt.
English: For the same reason, a decision to use prolonged concomitant treatment with corticosteroids should be taken after careful consideration.
Danish: Af samme grund skal en beslutning om at anvende længerevarende samtidig behandling med kortikosteroider tages efter nøje overvejelser.
English: Neither dialysis nor plasma exchange results in removal of fingolimod from the body.
Danish: Hverken dialyse eller plasmaudskiftning medfører, at fingolimod fjernes fra kroppen.
English: Based on human experience, post-marketing data suggest that use of fingolimod is associated with a 2-fold increased risk of major congenital malformations when administered during pregnancy compared with the rate observed in the general population (2-3%; EUROCAT).
Danish: Humane data efter markedsføringen antyder, at anvendelse af fingolimod under graviditeten er forbundet med en 2 gange forhøjet risko for alvorlige medfødte misdannelser sammenlignet med hyppigheden hos den generelle befolkning (2-3 %; EUROCAT).
English: The combination of fingolimod with potent CYP450 inducers should be used with caution.
Danish: Kombination af fingolimod og potente CYP-induktorer bør ske med forsigtighed.
English: If JCV testing is undertaken, it should be considered that the influence of lymphopenia on the accuracy of anti-JCV antibody testing has not been studied in fingolimod-treated patients.
Danish: Hvis JCV-test foretages, skal det tages i betragtning, at indflydelsen af lymfopeni på nøjagtigheden af anti-JCVantistoftesten ikke er undersøgt hos patienter behandlet med fingolimod.
English: - more than 2 weeks after one month of treatment.
Danish: - mere end 2 uger efter den første måned af behandlingen.
English: Your chance of developing macular oedema is higher if you have diabetes or have had an inflammation of the eye called uveitis.
Danish: Risikoen for at udvikle makulaødem er højere, hvis du har diabetes eller har haft en øjenbetændelse, som kaldes uveitis.
English: Annualised relapse rate (primary endpoint) Percentage of patients remaining relapse-free at 24 months
Danish: Årlig relapsrate (primært endepunkt) Procentdel af patienter, som forblev relapsfrie ved 24 måneder
English: Autoimmune haemolytic anaemia*** Peripheral oedema***
Danish: Autoimmun hæmolytisk anæmi*** Perifert ødem***
English: Be sure to tell your doctor about any changes in your vision.
Danish: Det er vigtigt, at du siger det til din læge, hvis du oplever nogen som helst ændringer i dit syn.
English: In particular, the following should be noted when prescribing Gilenya to paediatric patients: - Precautions should be followed at the time of the first dose (see “Bradyarrhythmia” above).
Danish: Man skal især være opmærksom på følgende, når Gilenya ordineres til pædiatriske patienter: - Ved første dosis skal forsigtighedsreglerne følges (se “Bradykardi” ovenfor).
English: - if you have or have had visual disturbances or other signs of swelling in the central vision area (macula) at the back of the eye (a condition known as macular oedema, see below),
Danish: - Hvis du har eller har haft synsforstyrrelser eller andre tegn på hævelse i det centrale synsområde (makula) bag i øjet (en tilstand, der kaldes makulaødem, se nedenfor),
English: With continued daily dosing, the lymphocyte count continues to decrease over a two-week period, reaching a minimal count of approximately 500 cells/microlitre or approximately 30% of baseline.
Danish: Ved fortsat daglig dosering vil lymfocyttallet fortsat falde gennem en to-ugers periode og nå ned på et minimunsniveau på cirka 500 celler/mikroliter eller cirka 30 % af udgangssværdien.
English: Fingolimod was excreted in milk of treated animals during lactation at concentrations 2-fold to 3-fold higher than that found in maternal plasma.
Danish: Fingolimod blev udskilt i mælken hos behandlede dyr under laktation, i koncentrationer, der er 2-3 gange højere end dem, der er fundet i maternel plasma.
English: - if you have severe lung problems or smoker's cough.
Danish: - Hvis du har alvorlige lungeproblemer eller tobakshoste.
English: Elimination of fingolimod following discontinuation of therapy may take up to two months and vigilance for infection should therefore be continued throughout this period.
Danish: Udskillelse af fingolimod efter seponering af behandlingen kan tage op til to måneder; man skal derfor fortsat være på vagt over for infektioner i hele denne periode.
English: Fingolimod is eliminated by oxidative biotransformation catalysed mainly via CYP4F2 and possibly other isoenzymes and subsequent fatty acid-like degradation to inactive metabolites.
Danish: Fingolimod elimineres ved oxidativ biotransformation, hovedsageligt katalyseret af CYP4F2 og muligvis andre isoenzymer, og efterfølgende fedtsyrelignende nedbrydning til inaktive metabolitter.