FrancophonIA/ELRC3.0 huggingface dataset:
English: For more information about treatment with Sifrol, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Sifrol, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: It is available as ‘immediaterelease' white tablets (round: 0.088, 0.7 and 1.1 mg; oval: 0.18 and 0.35 mg) and as ‘prolongedrelease' white tablets (round: 0.26 and 0.52 mg; oval: 1.05, 1.57, 2.1, 2.62 and 3.15 mg).
Danish: Det fås som hvide tabletter med øjeblikkelig frigivelse (runde: 0,088, 0,7 og 1,1 mg, ovale: 0,18 og 0,35 mg) og hvide depottabletter (runde: 0,26 og 0,52 mg, ovale: 1,05, 1,57, 2,1, 2,62 og 3,15 mg).
English: Sifrol can be used either on its own or in combination with levodopa (another medicine for Parkinson's disease), at any stage of disease including the later stages when levodopa starts becoming less effective;
Danish: Sifrol kan enten anvendes alene eller i kombination med levodopa (et andet lægemiddel til behandling af Parkinsons sygdom) på ethvert stadium af sygdommen, herunder de senere stadier, når levodopa begynder at blive mindre effektivt.
English: Similar results were seen in the first three studies of early Parkinson's disease, with greater improvements after four or 24 weeks.
Danish: Tilsvarende resultater sås i de tre første undersøgelser af Parkinsons sygdom i et tidligt stadium, hvor der var større bedring efter fire eller 24 uger.
English: The recommended starting dose is 0.088 mg, but, if needed, this can be increased every four to seven days to reduce symptoms further, to a maximum of 0.54 mg.
Danish: Den anbefalede startdosis er 0,088 mg, men om nødvendigt kan dosen sættes op hver fjerde til hver syvende dag for at dæmpe symptomerne yderligere indtil en maksimal dosis på 0,54 mg.
English: The results of the second study were insufficient to prove the longterm effectiveness of Sifrol.
Danish: Resultaterne af den anden undersøgelse var ikke tilstrækkelige til at bevise, at Sifrol var effektivt ved langtidsbehandling.
English: To support the use of the prolonged-release tablets, the company presented the results of studies showing that the immediate- and prolonged-release tablets produced the same levels of the active substance in the body.
Danish: For at understøtte anvendelsen af depottabletterne fremlagde virksomheden resultaterne af undersøgelser, der viste, at tabletter med øjeblikkelig frigivelse og depottabletter dannede de samme mængder af det aktive stof i kroppen.
English: • Parkinson's disease, a progressive brain disorder that causes shaking, slow movement and muscle stiffness.
Danish: • Parkinsons sygdom, der er en fremadskridende hjernesygdom, som medfører rysten, langsomme bevægelser og muskelstivhed.
English: Immediate-release tablets release the active substance immediately, and prolonged-release tablets release it slowly over a few hours.
Danish: Ved tabletter med øjeblikkelig frigivelse frigives det aktive stof straks, og ved depottabletter frigives det langsomt i løbet af få timer.
English: The main measure of effectiveness was the time until symptoms got worse.
Danish: Behandlingens virkning blev hovedsagelig bedømt på den tid, der gik, indtil symptomerne blev værre.
English: Sifrol should not be used in people who may be hypersensitive (allergic) to pramipexole or any of the other ingredients.
Danish: Sifrol bør ikke anvendes til patienter, som kan være overfølsomme (allergiske) over for pramipexol eller andre af indholdsstofferne.
English: Sifrol was also more effective that levodopa at improving movement symptoms in early disease.
Danish: Sifrol var også mere effektivt end levodopa til at forbedre bevægelsessymptomer i et tidligt stadium af sygdommen.
English: Sifrol is a medicine that contains the active substance pramipexole.
Danish: Sifrol er et lægemiddel, der indeholder det aktive stof pramipexol.
English: The main measure of effectiveness was the change in the severity of Parkinson's disease.
Danish: Virkningen blev hovedsagelig bedømt på ændringen i sværhedsgraden af Parkinsons sygdom.
English: The CHMP decided that Sifrol's benefits are greater than its risks and recommended that it be given marketing authorisation.
Danish: CHMP besluttede, at fordelene ved Sifrol opvejer risiciene, og anbefalede udstedelse af markedsføringstilladelse for Sifrol.
English: The active substance in Sifrol, pramipexole, is a dopamine agonist (a substance that imitates the action of dopamine).
Danish: Det aktive stof i Sifrol, pramipexol, er en dopaminagonist (et stof, som efterligner virkningen af dopamin).
English: The first compared Sifrol with placebo over 12 weeks in 344 patients and measured the improvement in symptoms.
Danish: Den første sammenlignede Sifrol med placebo i 12 uger hos 344 patienter og målte forbedringerne i symptomerne.
English: In patients with Parkinson's disease, the following side effects are also seen in more than 1 patient in 10: dizziness, dyskinesia (difficulty controlling movement) and somnolence (sleepiness).
Danish: Hos patienter med Parkinsons sygdom optræder desuden følgende bivirkninger hos flere end 1 ud af 10 patienter: svimmelhed, dyskinesi (ufrivillige bevægelser) og somnolens (søvnighed).
English: What is the risk associated with Sifrol?
Danish: Hvilken risiko er der forbundet med Sifrol?
English: For restless legs syndrome, Sifrol immediate-release tablets should be taken once a day, two to three hours before going to bed.
Danish: Ved Restless Legs Syndrome skal Sifrol-tabletter med øjeblikkelig frigivelse tages én gang dagligt to til tre timer før sengetid.
English: For Parkinson's disease, the starting dose is either one 0.088-mg immediate-release tablet three times a day or one 0.26-mg prolonged-release tablet once a day.
Danish: For Parkinsons sygdom er startdosis enten en 0,088-mg-tablet med øjeblikkelig frigivelse tre gange dagligt eller en 0,26-mg-depottablet én gang dagligt.
English: The additional studies showed that the prolonged-release tablets were as effective as the immediaterelease tablets in treating Parkinson's disease.
Danish: De yderligere undersøgelser viste, at depottabletterne var lige så effektive som tabletterne med øjeblikkelig frigivelse til behandling af Parkinsons sygdom.
English: Patients can be switched from the immediate- to the prolonged-release tablets overnight, but the dose might need to be adjusted depending on the patient's response.
Danish: Patienter kan skifte fra tabletter med øjeblikkelig frigivelse til depottabletter i løbet af en nat, men det kan være nødvendigt at tilpasse dosen afhængigt af, hvordan patienten reagerer.
English: The maximum daily dose is three 1.1-mg immediate-release tablets or one 3.15-mg prolonged-release tablet.
Danish: Den maksimale daglige dosis er tre 1,1-mg-tabletter med øjeblikkelig frigivelse eller én 3,15-mgdepottablet.
English: The prolonged-release tablets are not suitable for restless legs syndrome.
Danish: Depottabletterne er ikke egnede til behandling af Restless Legs Syndrome.
English: In restless legs syndrome, Sifrol immediate-release tablets were more effective than placebo at reducing symptoms over 12 weeks, but the difference between placebo and Sifrol was greatest after four weeks before getting smaller.
Danish: Sifrol-tabletter med øjeblikkelig frigivelse var mere effektive end placebo til at reducere symptomer ved Restless Legs Syndrome i løbet af 12 uger, men forskellen mellem placebo og Sifrol var størst efter fire uger og blev siden mindre.
English: The most common side effect with Sifrol (seen in more than 1 patient in 10) is nausea (feeling sick).
Danish: De hyppigste bivirkninger ved Sifrol (som optræder hos flere end 1 ud af 10 patienter) er kvalme.
English: Why has Sifrol been approved?
Danish: Hvorfor blev Sifrol godkendt?
English: They also showed that patients can be safely switched from immediate- to prolonged-release tablets, although dose adjustments were needed in a small number of patients.
Danish: De viste også, at det er sikkert for patienter at skifte fra tabletter med øjeblikkelig frigivelse til depottabletter, selvom det var nødvendigt at justere dosen hos et mindre antal patienter.
English: For the full list of all side effects reported with Sifrol, see the package leaflet.
Danish: Den fuldstændige liste over alle de indberettede bivirkninger ved Sifrol fremgår af indlægssedlen.
English: It also presented studies comparing the two tablets in early and advanced Parkinson's disease, and looking at switching patients from immediate- to prolonged-release tablets.
Danish: Virksomheden fremlagde også undersøgelser, som sammenlignede de to tabletter i et tidligt og et fremskredent stadium af Parkinsons sygdom og overgangen fra tabletter med øjeblikkelig frigivelse til depottabletter.
English: The second included 150 patients who took Sifrol for six months, and compared the effects of remaining on Sifrol with switching to placebo.
Danish: I den anden undersøgelse af 150 patienter, som fik Sifrol i seks måneder, sammenlignedes virkningerne af at fortsætte med Sifrol med at skifte til placebo.
English: What is Sifrol?
Danish: Hvad er Sifrol?
English: In the study of patients with advanced Parkinson's disease, patients taking Sifrol immediate-release tablets had larger improvements after 24 weeks of steady-dose treatment than those taking placebo.
Danish: I undersøgelsen af patienter med fremskreden Parkinsons sygdom var der større bedring hos de patienter, der fik 24 ugers behandling med Sifrol-tabletter med øjeblikkelig frigivelse i fast dosering, end hos dem, der fik placebo.
English: What is Sifrol used for?
Danish: Hvad anvendes Sifrol til?
English: In Parkinson's disease, Sifrol immediate-release tablets have been studied in five main studies.
Danish: Virkningen af Sifrol-tabletter med øjeblikkelig frigivelse til behandling af Parkinsons sygdom er blevet undersøgt i fem hovedundersøgelser.
English: The fifth study compared Sifrol with levodopa in 300 patients with early disease, and measured the number of patients who had movement symptoms.
Danish: I den femte undersøgelse blev virkningen af Sifrol sammenlignet med virkningen af levodopa hos 300 patienter med sygdommen i et tidligt stadium.
English: What benefit has Sifrol shown during the studies?
Danish: Hvilken fordel viser undersøgelserne, at der er ved Sifrol?
English: How has Sifrol been studied?
Danish: Hvordan blev Sifrol undersøgt?
English: The way pramipexole works in restless legs syndrome is not fully understood.
Danish: Det vides endnu ikke med nøjagtighed, hvordan pramipexol virker mod Restless Legs Syndrome.
English: The syndrome is thought to be caused by problems in the way dopamine works in the brain, which may be corrected by pramipexole.
Danish: Syndromet menes at skyldes problemer med den måde, dopamin virker på i hjernen.
English: How is Sifrol used?
Danish: Hvordan anvendes Sifrol?
English: Four studies compared Sifrol with placebo (a dummy treatment): one study in 360 patients with advanced disease who were already taking levodopa that was starting to become less effective, and three studies in a total of 886 patients with early disease who were not receiving levodopa.
Danish: Tre undersøgelser omfattede i alt 886 patienter, som var i et tidligt stadium af sygdommen, og som ikke fik levodopa.
English: How does Sifrol work?
Danish: Hvordan virker Sifrol?
English: In restless legs syndrome, Sifrol immediate-release tablets have also been studied in two main studies.
Danish: Der blev også foretaget to hovedundersøgelser af virkningen af Sifrol-tabletter med øjeblikkelig frigivelse til behandling af Restless Legs Syndrome.
English: This could be serious.
Danish: Dette kan være alvorligt.
English: Final Study report by 15 December
Danish: Afsluttende studierapport inden 15. december
English: Following single oral administration of [
Danish: Efter en enkelt oral administration af [
English: This is called demyelination.
Danish: Det kaldes demyelinisering.
English: The following should be considered:
Danish: Det følgende skal overvejes:
English: Date of first authorisation: 17 March 2011 Date of latest renewal: 23 November 2015
Danish: Dato for første markedsføringstilladelse: 17. marts 2011 Dato for seneste fornyelse: 23. november 2015
English: Any infection that you already have may get worse.
Danish: Enhver infektion, som du allerede har, kan forværres.
English: The patients recovered spontaneously.
Danish: Patienterne kom sig spontant.
English: Children and adolescents (10 years of age and above):
Danish: Børn og unge (10 år og derover):
English: The dose depends on body weight:
Danish: Dosis afhænger af kropsvægten:
English: Take Gilenya once a day with a glass of water.
Danish: Tag Gilenya en gang daglig sammen med et glas vand.
English: It must be repeated at suitable intervals.
Danish: Det skal gentages med passende intervaller.
English: Gilenya can be taken with or without food.
Danish: Gilenya kan tages sammen med eller uden mad.
English: In this case, it is recommended to repeat the first-dose observation period.
Danish: I dette tilfælde, anbefales det at gentage observationsperioden for første dosis.
English: Other vaccines may not work as well as usual if given during this period.
Danish: Andre vacciner vil måske ikke være så effektive som normalt, hvis de gives i denne periode.
English: • Signs and symptoms of infection;
Danish: • Tegn og symptomer på infektion;
English: This increases your risk of developing cancers, in particular skin cancers.
Danish: Dette øger din risiko for at udvikle kræft, især hudkræft.
English: Specific measures are also included in the Physician Information Pack.
Danish: Særlige forholdsregler er også inkluderet i Lægeinformationspakken.
English: • With third degree AV block occurring at any time;
Danish: • Med 3. grads AV-blok opstået på et hvilket som helst tidspunkt;
English: Teriflunomide is also eliminated slowly from the plasma.
Danish: Teriflunomid elimineres også langsomt fra plasma.
English: Infections could be serious and life-threatening.
Danish: Infektioner kan være alvorlige og livstruende.
English: Week Monday Tuesday Wednesday Thursday Friday Saturday Sunday
Danish: Uge Mandag Tirsdag Onsdag Torsdag Fredag Lørdag Søndag
English: - if you have an active cancer.
Danish: - Hvis du har en aktiv kræftsygdom.
English: White blood cells fight infection.
Danish: Hvide blodlegemer bekæmper infektioner.
English: - if you have high blood pressure that cannot be controlled by medicines.
Danish: - Hvis du har for højt blodtryk, som ikke kan kontrolleres med medicin.
English: • Vaccines.
Danish: • Vacciner.
English: If you are a woman, your doctor will also recommend HPV screening.
Danish: Hvis du er en kvinde, vil din læge også anbefale HPV-screening.
English: Other dosing regimens have not been approved.
Danish: Andre dosisregimer er ikke blevet godkendt.
English: Specifically for Pediatric patients:
Danish: Særligt for pædiatriske patienter:
English: This increase persisted with continued treatment.
Danish: Denne stigning persisterede under fortsat behandling.
English: Expanded Disability Status Score (EDSS) was between 0 and 5.5.
Danish: Expanded Disability Status Score (EDSS) var mellem 0 og 5,5.
English: There were, nevertheless, more neurological and psychiatric disorders observed in the study.
Danish: Ikke desto mindre blev der observeret flere neurologiske og psykiske forstyrrelser i studiet.
English: You may need to be monitored more closely.
Danish: Du skal måske undersøges nøjere.
English: The warnings and precautions listed above also apply to children and adolescents.
Danish: Ovennævnte advarsler og forsigtighedsregler gælder også for børn og unge.
English: The patient was excluded from the full analysis and safety set.
Danish: Patienten blev ekskluderet fra det komplette analyse- og sikkerhedssæt.
English: After oral administration, about 81% of the dose is slowly excreted in the urine as inactive metabolites.
Danish: Efter oral administration udskiltes ca. 81 % af dosis langsomt i urinen som inaktive metabolitter.
English: The possibility of recurrence of exceptionally high disease activity should be considered.
Danish: Risikoen for tilbagevendende usædvanlig høj sygdomsaktivitet bør tages i betragtning.
English: Early on, there may not be any symptoms.
Danish: Tidligt i behandlingen er der måske ingen symptomer.
English: Your doctor may monitor your electrocardiogram continuously during that time.
Danish: Din læge kan vælge at overvåge dit elektrokardiogram hele tiden i denne periode.
English: • Corticosteroids, due to a possible added effect on the immune system.
Danish: • Kortikosteroider, grundet mulig additiv virkning på immunsystemet.
English: - if you have been told you have an abnormal electrocardiogram.
Danish: - Hvis du har fået fortalt, at du har et unormalt elektrokardiogram.
English: Your doctor may decide to keep you under observation at the time you take the next dose.
Danish: Din læge kan beslutte at holde dig under observation, når du tager næste dosis.
English: S1P4 could partially contribute to the effect but was not the main receptor responsible for the lymphoid depletion.
Danish: S1P4 kunne delvist bidrage til virkningen, men var ikke den vigtigste receptor, som var ansvarlig for lymfoid depletion.
English: Patients may be monitored with continuous ECG during the first 6 hours.
Danish: Patienter kan monitoreres ved et kontinuerligt ekg i de første 6 timer.
English: Fingolimod absorption is slow (tmax of 12-16 hours) and extensive (≥85%).
Danish: Absorptionen af fingolimod er langsom (tmax på 12-16 timer) og omfattende (≥85 %).
English: The apparent absolute oral bioavailability is 93% (95% confidence interval: 79-111%).
Danish: Den tilsyneladende absolutte orale biotilgængelighed er 93 % (95 % konfidensinterval: 79-111 %).
English: Without an accelerated elimination procedure, clearance of teriflunomide from plasma can take from several months up to 2 years.
Danish: Uden en accelereret eliminationsprocedure kan clearence af teriflunomid fra plasma tage fra flere måneder til op til 2 år.
English: Your ability to drive and use machines may be impaired during and potentially after this time period.
Danish: Din evne til at køre bil eller betjene maskiner kan være nedsat i og muligvis efter denne periode.
English: - if you plan to get vaccinated.
Danish: - Hvis du skal vaccineres.
English: The majority of patients were Tanner stage 2 or higher (94.4%) and were >40 kg (95.3%).
Danish: Størstedelen af patienterne var på Tanners stadium 2 eller mere (94,4 %) og vejede >40 kg (95,3 %).
English: Delay in diagnosis and treatment may lead to permanent neurological sequelae.
Danish: Forsinkelse i diagnose og behandling kan føre til permanente neurologiske sequelae.
English: • Monitoring requirements at treatment initiation:
Danish: • Påkrævet monitorering ved behandlingsstart:
English: Frequencies were defined using 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); not known (cannot be estimated from the available data).
Danish: Hyppighed blev defineret ved brug af 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); meget sjælden (<1/10.000); ikke kendt (kan ikke estimeres ud fra forhåndenværende data).
English: • What multiple sclerosis is;
Danish: • Hvad multipel sklerose er;
English: The clinical relevance of this finding is unknown.
Danish: Den kliniske relevans af disse fund er ikke kendt.
English: Symptoms of a relapse may disappear completely when the relapse is over, but some problems may remain.
Danish: Symptomerne på et anfald kan forsvinde fuldstændigt, når anfaldet er ovre, men nogle af problemerne kan fortsætte.
English: Never take a double dose to make up for a forgotten dose.
Danish: Du må ikke tage en dobbeltdosis som erstatning for den glemte dosis.
English: Nausea***
Danish: Kvalme***
English: Neutrophil count decreased * Not reported in Studies FREEDOMS, FREEDOMS II and TRANSFORMS.
Danish: Nedsat neutrofiltal * Ikke rapporteret i studierne FREEDOMS, FREEDOMS II og TRANSFORMS.
English: Fingolimod blood clearance is 6.32.3 l/h, and the average apparent terminal half-life (t1/2) is 6-9 days.
Danish: Fingolimods blod-clearance er 6,32,3 l/h, og den gennemsnitlige tilsyneladende terminale halveringstid (t1/2) er 6-9 dage.
English: • What GILENYA is and how it works;
Danish: • Hvad GILENYA er, og hvordan det virker;
English: You should limit your exposure to the sun and UV rays by:
Danish: Du bør begrænse din udsættelse for sol og UV-stråler ved at:
English: Monocytes are unaffected by fingolimod.
Danish: Monocytterne påvirkes ikke af fingolimod.
English: • Doctors will provide counselling in the event of pregnancy and evaluation of the outcome of any pregnancy.
Danish: • Læger vil give rådgivning i tilfælde af graviditet og vil vurdere udfaldet af enhver graviditet.
English: This post-dose effect persists over the following days, although usually to a milder extent, and usually abates over the next weeks.
Danish: Denne efter-dosis-virkning varer ved de følgende dage, sædvanligvis i mildere grad, og aftager som regel i løbet af de efterfølgende uger.
English: Otherwise, it may not be possible for the doctor to understand the results of the test, and for certain types of blood test your doctor may need to take more blood than usual.
Danish: Ellers kan lægen måske ikke forstå resultaterne, og for visse blodprøvers vedkommende skal der måske bruges mere blod end normalt.
English: - Long-term safety data in the paediatric population are not available.
Danish: - Der er ingen tilgængelige langtidssikkerhedsdata for den pædiatriske population.
English: Annualised relapse rate (primary endpoint)
Danish: Annualiseret relapsrate (primært endepunkt)
English: Fingolimod has been studied in combination with atenolol and diltiazem.
Danish: Fingolimod er blevet undersøgt i kombination med atenolol og diltiazem.
English: The preclinical safety profile of fingolimod was assessed in mice, rats, dogs and monkeys.
Danish: Den prækliniske sikkerhedsprofil for fingolimod er vurderet hos mus, rotter, hunde og aber.
English: The risk of recurrence after re-challenge has not been evaluated.
Danish: Risikoen for tilbagefald efter genprovokation er ikke vurderet.
English: Long-term exposure to the sun and a weak immune system can affect the risk of developing Merkel cell carcinoma.
Danish: Langvarig udsættelse for sol og et svagt immunsystem kan påvirke risikoen for udvikling af Merkelcelle karcinom.
English: MRI endpoints
Danish: MRI endepunkter
English: Inhaled salmeterol has also been shown to have a modest positive chronotropic effect.
Danish: Inhaleret salmoterol er også vist at have moderat positiv kronotrop virkning.
English: As a result, you may feel dizzy or tired, or be consciously aware of your heartbeat, or your blood pressure may drop.
Danish: Du kan derfor føle dig svimmel eller træt eller mærke dit hjerte slå, eller dit blodtryk kan falde.
English: PML is a serious condition that may lead to severe disability or death.
Danish: PML er en alvorlig tilstand, som kan medføre svær invaliditet eller døden.
English: PML can only occur in the presence of a JCV infection.
Danish: PML kan kun opstå i nærvær af JCV-infektion.
English: This has generally been observed within 12 weeks after stopping fingolimod, but has also been reported up to 24 weeks after fingolimod discontinuation.
Danish: Dette er generelt blevet set inden for 12 uger efter ophør af behandling med fingolimod, men er også blevet rapporteret i op til 24 uger efter seponering.
English: If you need to receive a vaccine, seek your doctor's advice first.
Danish: Hvis du skal vaccineres, skal du først søge råd hos din læge.
English: Surveillance should include vigilance for both skin malignancies and mycosis fungoides.
Danish: Overvågningen skal omfatte årvågenhed for både hudmaligniteter og mycosis fungoides.
English: The majority of cases occurred within the first 3-4 months of therapy.
Danish: Størstedelen af tilfældene forekom inden for de første 3-4 måneder af behandlingen.