FrancophonIA/ELRC3.0 huggingface dataset:
English: It should also be noted that a negative anti-JCV antibody test does not preclude the possibility of subsequent JCV infection.
Danish: Ligeledes skal man være opmærksom på, at en negativ anti-JCV-antistoftest ikke udelukker muligheden for en efterfølgende JCV-infektion.
English: The macula is a small area of the retina at the back of the eye which enables you to see shapes, colours, and details clearly and sharply.
Danish: Makula er et lille område på nethinden bag i øjet, som gør, at man kan se former, farver og detaljer tydeligt og skarpt.
English: Fingolimod was neither mutagenic nor clastogenic in animal studies.
Danish: Fingolimod var hverken mutagent eller klastogent i dyrestudierne.
English: These measures must be implemented before fingolimod is prescribed to female patients and during treatment.
Danish: Disse forholdsregler skal være implementeret inden fingolimod udskrives til kvindelige patienter og under behandling.
English: Pharmacotherapeutic group: Immunosuppressants, selective immunosuppressants, ATC code: L04AA27
Danish: Farmakoterapeutisk klassifikation: Immunsuppresiva, selektive immunsuppressiva, ATC-kode: L04AA27
English: Tell your doctor if you are taking any of the following medicines:
Danish: Fortæl det til lægen, hvis du tager følgende medicin:
English: Fingolimod and fingolimod phosphate are highly protein bound (>99%).
Danish: Fingolimod og fingolimodphosphat er stærkt proteinbundne (>99 %).
English: An accelerated elimination procedure as defined in the teriflunomide summary of product characteristics is recommended or alternatively washout period should not be shorter than 3.5 months.
Danish: Det anbefales at udføre en accelereret eliminationsprocedure som beskrevet i produktresumeet for teriflunomid, alternativt bør udvaskningsperioden ikke være kortere en 3,5 måned.
English: Gilenya can pass into breast milk and there is a risk of serious side effects for the baby.
Danish: Gilenya kan gå over i modermælk, og der er en risiko for alvorlige bivirkninger hos barnet.
English: Your doctor may have to do a blood test in order to exclude such abnormalities.
Danish: Din læge kan blive nødt til at tage en blodprøve for at udelukke sådanne uregelmæssigheder.
English: It was concluded that bradycardia could be mediated primarily by activation of inward-rectifying potassium channel or G-protein activated inwardly rectifying K
Danish: Det blev konkluderet, at bradykardi kunne medieres primært ved aktivering af inward-rectifier kaliumkanaler eller G-protein-aktiverede inward-rectifier K
English: Eighteen percent of patients reached a minimal count below 200 cells/microlitre on at least one occasion.
Danish: Atten procent af patienterne nåede et mindste lymfocyttal på under 200 celler/mikroliter ved mindst én lejlighed.
English: Switch from other treatments to Gilenya
Danish: Skift fra andre behandlinger til Gilenya
English: Talk to your doctor about reliable methods of contraception.
Danish: Tal med din læge om effektive præventionsmetoder.
English: Prior to launch of GILENYA in each Member State the Marketing Authorisation Holder (MAH) must agree about the content and format of the educational programme, including communication media, distribution modalities, and any other aspects of the programme, with the National Competent Authority (NCA).
Danish: Inden lancering af Gilenya i hvert enkelt medlemsland skal indehaveren af markedsføringstilladelsen (MAH) være enig i indholdet og formatet af uddannelsesprogrammet, herunder kommunikationsmedier, distributionsmetode og ethvert andet aspekt af programmet med den nationale lægemiddelmyndighed.
English: If you develop problems with your skin, your doctor may refer you to a dermatologist, who after consultation may decide that it is important for you to be seen on a regular basis.
Danish: Hvis du får problemer med din hud, kan din læge vælge at henvise dig til en hudlæge, som efter en konsultation måske beslutter, at det er vigtigt, at du bliver undersøgt regelmæssigt.
English: inflammation or infection of the eye (uveitis), or if you have diabetes (which can cause eye problems).
Danish: øjenbetændelse eller -infektion (uveitis), eller hvis du har diabetes (som kan forårsage øjenproblemer).
English: Fingolimod highly distributes in red blood cells, with the fraction in blood cells of 86%.
Danish: Fingolimod fordeles i høj grad i de røde blodceller med en fraktion i blodcellerne på 86 %.
English: After 12 months (month 36), 856 patients (93%) were still enrolled.
Danish: Efter 12 måneder (måned 36) deltog 856 patienter (93 %) fortsat.
English: channel (IKACh/GIRK) and that vasoconstriction seems to be mediated by a Rho kinase and calcium dependent mechanism.
Danish: kanaler (IKACh/GIRK), og at vasokonstriktion ser ud til blive medieret af en Rho kinase- og kalciumafhængig mekanisme.
English: Approximately 15-20% of T lymphocytes have an effector memory phenotype, cells that are important for peripheral immune surveillance.
Danish: Omkring 15-20 % af T-lymfocytterne har en effektor-hukommelsesfænotype; celler, der er vigtige for den perifere immunovervågning.
English: During and for up to two months after treatment with Gilenya vaccination may be less effective.
Danish: Under og i op til to måneder efter behandling med Gilenya kan vaccination være mindre effektiv.
English: Fingolimod is extensively distributed to body tissues with a volume of distribution of about 1,200260 litres.
Danish: Fingolimod fordeles i stort omfang i kroppens væv og har en fordelingsvolumen på omkring 1.200260 liter.
English: Formation of pharmacologically inactive non-polar ceramide analogues of fingolimod was also observed.
Danish: Dannelse af farmakologisk inaktive, ikke-polære ceramidanaloger til fingolimod blev også observeret.
English: Fingolimod and fingolimod phosphate are not excreted intact in urine but are the major components in the faeces, with amounts representing less than 2.5% of the dose each.
Danish: Fingolimod og fingolimodphosphat udskilles ikke intakt i urinen, men er de største bestanddele i faeces med mængder, som repræsenterer mindre end 2,5 % af dosis hver.
English: Alemtuzumab has profound and prolonged immunosuppressive effects.
Danish: Alemtuzumab har en kraftig og langvarig immunsupprimerende virkning.
English: Conduction abnormalities were typically transient and asymptomatic.
Danish: Ledningsforstyrrelser har typisk været forbigående og asymptomatiske.
English: Detailed information of adverse reactions with no recommendation should not be included in this section.
Danish: Detaljeret information om bivirkninger uden anbefaling skal ikke inkluderes i dette pkt.
English: All analyses of clinical endpoints were intent-to-treat.
Danish: Alle analyser af kliniske endepunkter var intent-to-treat.
English: Severe exacerbation of disease after Gilenya discontinuation***
Danish: Alvorlig sygdomsforværring efter seponering af Gilenya***
English: When evaluating a patient with a suspected infection that could be serious, referral to a physician experienced in treating infections should be considered.
Danish: Ved vurdering af en patient, hvor der er formodning om en infektion, der kan være alvorlig, bør det overvejes at henvise til en læge med erfaring i behandling af infektioner.
English: What is multiple sclerosis
Danish: Hvad er multipel sklerose
English: There are no data available for paediatric patients below 10 years old.
Danish: Der er ingen tilgængelige data for pædiatriske patienter under 10 år.
English: Gilenya is for oral use.
Danish: Gilenya er til oral anvendelse.
English: HPS is a rare condition that has been described in association with infections, immunosuppression and a variety of autoimmune diseases.
Danish: HPS er en sjælden tilstand, der har været beskrevet i forbindelse med infektioner, immunsuppression og forskellige autoimmune sygdomme.
English: Experience with Gilenya in elderly patients (over 65 years) is limited.
Danish: Erfaringer med Gilenya til ældre patienter (over 65 år) er begrænsede.
English: Although the estimated risk appears to increase with cumulative exposure over time, an exact relationship with the duration of treatment is unknown.
Danish: Selvom den anslåede risiko synes at øges med kumulativ eksponering over tid, er den nøjagtige sammenhæng med behandlingsvarigheden ikke kendt.
English: Laboratory tests involving the use of circulating mononuclear cells require larger blood volumes due to reduction in the number of circulating lymphocytes.
Danish: Laboratorietests, som indebærer anvendelse af cirkulerende mononukleære celler, kræver større blodmængder på grund af reduktionen af antallet af cirkulerende lymfocytter.
English: If you have never had chickenpox, your doctor will check your immunity against the virus that causes it (varicella zoster virus).
Danish: Hvis du aldrig har haft skoldkopper, vil lægen kontrollere din immunitet over for den virus, der giver skoldkopper (varicella zoster virus).
English: Talk to your doctor before taking Gilenya: - if you have severe breathing problems during sleep (severe sleep apnoea).
Danish: Kontakt lægen, før du tager Gilenya: - Hvis du har alvorlige åndedrætsproblemer under søvn (svær søvnapnø).
English: - Autoimmune form of anaemia (decreased amount of red blood cells) where red blood cells are destroyed (autoimmune haemolytic anaemia).
Danish: - Autoimmun form for blodmangel (nedsat antal røde blodlegemer), hvor røde blodlegemer bliver ødelagt (autoimmun hæmolytisk anæmi).
English: Assessments of CBC are also recommended periodically during treatment, at month 3 and at least yearly thereafter, and in case of signs of infection.
Danish: Periodisk CBC anbefales også under behandlingen, efter 3 måneder og mindst en gang årligt derefter og ved tegn på infektion.
English: • Cases of seizure, including status epilepticus, have been reported.
Danish: • Der er indberettet tilfælde af krampeanfald, herunder status epilepticus.
English: Taking into account the PRAC Assessment Report on the PSUR(s) for fingolimod, the scientific conclusions of CHMP are as follows:
Danish: Under hensyntagen til PRAC's vurderingsrapport om PSUR'en/PSUR'erne for fingolimod er CHMP nået frem til følgende videnskabelige konklusioner:
English: Shellac (E904)
Danish: Shellak (E 904)
English: * p<0.05, ** p<0.001, compared to interferon beta-1a.
Danish: * p<0,05, ** p<0,001, sammenlignet med interferon beta-1a.
English: Caution patients against exposure to sunlight without protection.
Danish: Advar patienter mod udsættelse for sollys uden beskyttelse.
English: Your doctor will consider whether you need to have a vaccination against HPV before starting treatment.
Danish: Din læge vil overveje, om du skal have vaccination mod HPV, inden du starter behandling.
English: Fingolimod can induce bradycardia upon treatment initiation.
Danish: Fingolimod kan inducere bradykardi ved behandlingsstart.
English: Clinical experience and pharmacokinetic information in patients aged above 65 years are limited.
Danish: Kliniske erfaring og viden om farmakokinetik hos patienter, som er over 65 år gamle, er begrænset.
English: Before initiating treatment with fingolimod, a baseline MRI should be available (usually within 3 months) as a reference.
Danish: Inden behandlingen med fingolimod initieres, skal en baseline-MR være til rådighed (som regel inden for 3 måneder) som reference.
English: Both studies included adult patients who had experienced ≥2 relapses in the prior 2 years or ≥1 relapse during the prior year.
Danish: Begge undersøgelser omfattede voksne patienter, som havde oplevet ≥2 tilbagefald i de foregående 2 år eller >1 tilbagefald i det foregående år.
English: Not known (frequency cannot be estimated from the available data): - Peripheral swelling
Danish: Ikke kendt (kan ikke vurderes ud fra tilgængelige data): - Perifer hævelse
English: Food intake does not alter Cmax or exposure (AUC) of fingolimod.
Danish: Fødeindtagelse ændrer ikke Cmax eller eksponeringen (AUC) for fingolimod.
English: Therefore, fingolimod is not expected to alter the pharmacokinetics of medicinal products that are CYP3A4 substrates.
Danish: Fingolimod forventes derfor ikke at ændre farmakokinetikken af lægemidler, som er CYP3A4-substrater.
English: Drug exposure in rabbits at these doses was similar to that in patients.
Danish: Eksponering i kaniner ved disse doser var sammenlignelig med eksponeringen hos patienter.
English: Patients with severe lung problems or with smoker's cough may have a higher chance of developing side effects.
Danish: Patienter med alvorlige lungeproblemer eller med tobakshoste kan have en øget risiko for at udvikle bivirkninger.
English: During and for up to 2 months after treatment with Gilenya, you should not receive certain types of vaccine (live attenuated vaccines) as they could trigger the infection that they were supposed to prevent.
Danish: Under og i op til 2 måneder efter behandling med Gilenya må du ikke få visse typer vaccine (levende, svækkede vacciner), da de kan udløse den infektion, som de skulle forebygge.
English: itching or pain of the skin, typically on the upper body or the face.
Danish: kløe eller smerter i huden, typisk på overkroppen eller i ansigtet.
English: Gilenya does not cure MS, but it helps to reduce the number of relapses and to slow down the progression of physical disabilities due to MS.
Danish: Gilenya helbreder ikke MS, men det hjælper med at nedsætte antallet af anfald og forsinker udviklingen af fysisk invaliditet grundet MS.
English: Due to the long half-life of natalizumab, elimination usually takes up to 2-3 months following discontinuation.
Danish: På grund af natalizumabs lange halveringstid tager eliminationen normalt op til 2-3 måneder efter behandlingsophør.
English: Bradycardia Atrioventricular block
Danish: Bradykardi Atrioventrikulært blok
English: After 12 months (month 24), 882 patients (86%) were still enrolled.
Danish: Efter 12 måneder (måned 24) deltog 882 patienter (86 %) fortsat.
English: Therefore, blood pressure should be regularly monitored during treatment with Gilenya.
Danish: Blodtrykket bør derfor monitoreres jævnligt under behandling med Gilenya.
English: Your doctor will tell you whether your illness allows you to drive vehicles, including a bicycle, and use machines safely.
Danish: Din læge vil fortælle dig, om det er tilladt at køre bil eller betjene maskiner, herunder at cykle, når man har din sygdom.
English: Herpes viral infections Bronchitis
Danish: Herpesvirusinfektioner Bronchitis
English: o Physicians are encouraged to enroll pregnant patients, or pregnant women may register themselves, in the GILENYA pregnancy registry.
Danish: o Læger opfordres til at registrere gravide patienter, eller gravide kvinder kan selv registrere sig, i GILENYA graviditetsregisteret.
English: It also explains what you should do to avoid becoming pregnant while you are taking Gilenya.
Danish: Det forklarer også, hvad du bør gøre for at undgå at blive gravid, mens du tager Gilenya.
English: The desired effect of Gilenya treatment is to reduce the amount of white blood cells in your blood.
Danish: Den ønskede virkning af Gilenya-behandlingen er en nedsættelse af antallet af hvide blodlegemer i blodet.
English: As Gilenya causes a slight elevation of blood pressure, your doctor may want to check your blood pressure regularly.
Danish: Da Gilenya forårsager en lille forhøjelse af blodtrykker, vil din læge måske måle dit blodtryk regelmæssigt.
English: Taking Gilenya at the same time each day will help you remember when to take your medicine.
Danish: Hvis du tager Gilenya på samme tidspunkt hver dag, vil du lettere kunne huske, hvornår du skal tage din medicin.
English: The following information is particularly important for children and adolescents and their caregivers: - Before you start Gilenya, your doctor will check your vaccination status.
Danish: Følgende oplysninger er særligt vigtige for børn og unge og deres omsorgspersoner: - Din læge vil tjekke din vaccinationsstatus, inden du starter med Gilenya.
English: Other enzymes like CYP3A4 may also contribute to its metabolism, notably in the case of strong induction of CYP3A4.
Danish: Andre enzymer som CYP3A4 kan også medvirke til dets metabolisering, især i tilfælde af kraftig induktion af CYP3A4.
English: Since there is a potential risk of malignant skin growths, patients treated with fingolimod should be cautioned against exposure to sunlight without protection.
Danish: Da der er en potentiel risiko for malign hudvækst, bør patienter, der behandles med fingolimod, advares mod udsættelse for sollys uden beskyttelse.
English: Animal studies and in vitro experiments indicate that fingolimod may also act via interaction with S1P receptors on neural cells.
Danish: Dyrestudier og in vitro-eksperimenter har vist, at fingolimod også kan virke ved at interagere med S1P-receptorer på nerveceller.
English: Fingolimod phosphate Cmax was slightly decreased by 34% but AUC was unchanged.
Danish: Fingolimodphosphat Cmax var lettere nedsat med 34 % men AUC var uændret.
English: If you have questions about how long to take Gilenya, talk to your doctor or your pharmacist.
Danish: Hvis du har spørgsmål om, hvor længe du skal tage Gilenya, skal du tale med din læge eller apoteket.
English: The mechanism of action of bradycardia and vasoconstriction were also studied in vitro in guinea pigs and isolated rabbit aorta and coronary artery.
Danish: Virkningsmekanismen for bradykardi og vasokonstriktion blev også undersøgt in vitro hos marsvin og isoleret aorta og koronararterie hos kaniner.
English: - Patients with highly active disease despite a full and adequate course of treatment with at least one disease modifying therapy (for exceptions and information about washout periods see sections 4.4 and 5.1).
Danish: - Patienter med højaktiv sygdom på trods af et fuldstændigt og tilstrækkeligt behandlingsforløb med mindst en sygdomsmodificerende behandling (for undtagelser og information om udvaskningsperioder, se pkt.
English: Women of childbearing potential / Contraception in females
Danish: Fertile kvinder/kontraception til kvinder
English: Continuous (real time) ECG monitoring is recommended; o Perform an ECG at the end of the 6-hour monitoring period.
Danish: Kontinuerlig (real time) ekg-monitorering anbefales; o Optag ekg ved afslutningen af 6-timers-monitoreringsperioden.
English: • Physicians should reassess on an annual basis the benefit of GILENYA treatment versus risk in each patient, especially pediatric patients.
Danish: • Lægen bør på årlig basis revurdere fordele ved Gilenya behandling mod risikoen for den enkelte patient, særligt for pædiatriske patienter.
English: MRI analyses used evaluable dataset.
Danish: Til MRI analyser anvendtes det datasæt, der kunne evalueres..
English: An ECG at 6 hours should also be performed and, in some circumstances, monitoring may involve an overnight stay;
Danish: Der skal optages et ekg efter 6 timer, og under visse omstændigheder kan monitorering betyde en overnatning;
English: • Patients should read the package leaflet thoroughly before starting treatment and should keep it in case they need to refer to it again during treatment;
Danish: • Patienterne bør læse indlægssedlen grundigt inden opstart af behandling og bør beholde den i tilfælde af, at de har behov for at læse den igen under behandling;
English: - more than 7 days during weeks 3 and 4 of treatment.
Danish: - mere end 7 dage i løbet af uge 3 og 4 i behandlingen.
English: However, F1 body weights, development, behaviour, and fertility were not affected by treatment with fingolimod.
Danish: Kropsvægt, udvikling, adfærd og fertilitet påvirkedes dog ikke af behandlingen med fingolimod hos F1.
English: If these effects are pronounced, tell your doctor, because you may need treatment right away.
Danish: Hvis disse virkninger er tydelige, skal du sige det til din læge; det er måske nødvendigt, at du bliver behandlet straks.
English: • Four cases without identified confounders and with supportive chronology and clinical course with improvement/recovery following discontinuation of fingolimod.
Danish: Fire tilfælde uden identificerede confounders og med understøttende kronologisk og klinisk forløb med forbedring/restitution efter ophør af fingolimod.
English: In rats, F1 generation pup survival was decreased in the early postpartum period at doses that did not cause maternal toxicity.
Danish: Hos rotter faldt overlevelsen for unger af F1-generationen i den tidlige post partum-periode ved doser, som ikke forårsagede maternel toksicitet.
English: Your doctor may switch you directly from beta interferon, glatiramer acetate or dimethyl fumarate to Gilenya if there are no signs of abnormalities caused by your previous treatment.
Danish: Lægen kan skifte din behandling direkte fra beta-interferon, glatirameracetat eller dimethylfumarat til Gilenya, hvis der ikke er nogen tegn på abnormiteter forårsaget af din tidligere behandling.
English: Hydroxypropylcellulose Hydroxypropylbetadex Magnesium stearate
Danish: Hydroxypropylcellulose Hydroxypropylbetadex Magnesiumstearat
English: Pooled results of Studies D2301 and D2302 showed a consistent and statistically significant reduction in annualised relapse rate compared to comparator in subgroups defined by gender, age, prior multiple sclerosis therapy, disease activity or disability levels at baseline.
Danish: Kombinerede resultater fra studie D2301 og D2302 viste en konsekvent og statistisk signifikant reduktion af den annualiserede anfaldsrate sammenlignet med komparator i delgrupper defineret ved køn, alder, tidligere behandling for multipel sklerose, sygdomsaktivitet eller invaliditetsniveau ved udgangspunktet.
English: The relationship of such events to Gilenya is uncertain.
Danish: Sammenhængen mellem Gilenya og disse hændelser er usikker.
English: Subjects on fingolimod treatment have a normal bronchodilator response to inhaled beta-agonists.
Danish: Forsøgspersoner, der er behandlet med fingolimod, har normal bronkodilatatorrespons over for inhalerede beta-agonister.
English: While you are taking Gilenya (and for up to 2 months after you stop taking it), you may get infections more easily.
Danish: Mens du tager Gilenya (og op til to måneder efter, at du er holdt op med at tage det), kan du være mere modtagelig over for infektioner.
English: Blood levels of fingolimod and fingolimod phosphate decline in parallel in the terminal phase, leading to similar half-lives for both.
Danish: Fingolimod- og fingolimodphosphat-niveauet i blodet falder parallelt i den terminale fase, således at begge har omtrent samme halveringstid.
English: Fingolimod phosphate has a smaller uptake in blood cells of <17%.
Danish: Fingolimodphosphat har en lavere optagelsesgrad i blodcellerne på <17 %.
English: A study in four healthy subjects who received a single intravenous dose of a radioiodolabelled analogue of fingolimod demonstrated that fingolimod penetrates into the brain.
Danish: Et studie hos fire raske forsøgspersoner, som fik en enkelt intravenøs dosis af en radioaktivt mærket fingolimodanalog, viste, at fingolimod penetrerer ind i hjernen.
English: Malignant melanoma****
Danish: Malignt melanom****
English: Gilenya can also cause an irregular heartbeat, especially after the first dose.
Danish: Gilenya kan også bevirke, at hjertet slår uregelmæssigt, især efter første dosis.
English: Gilenya helps to protect against attacks on the CNS by the immune system by reducing the ability of some white blood cells (lymphocytes) to move freely within the body and by stopping them from reaching the brain and spinal cord.
Danish: Gilenya hjælper med at beskytte mod immunsystemets attakker på CNS ved at nedsætte evnen hos nogle hvide blodlegemer (lymfocytter) til at bevæge sig frit i kroppen og ved at forhindre dem i at nå frem til hjernen og rygmarven.
English: • Doctors will provide counselling before treatment initiation and regularly thereafter regarding the teratogenic risk of GILENYA and required actions to minimise this risk.
Danish: • Læger vil give rådgivning inden opstart af behandling og derefter regelmæssigt om GILENYA´s teratogene risiko, og de nødvendige forholdsregler for at formindske risikoen.
English: Fingolimod is metabolised mainly by CYP4F2.
Danish: Fingolimod metaboliseres hovedsagligt af CYP4F2.