FrancophonIA/ELRC3.0 huggingface dataset:
English: This mutagenic effect could be attributed to a clastogenic effect of rotigotine.
Danish: Denne mutagene effekt kan muligvis tilskrives rotigotins clastogene effekt.
English: Talk to your doctor if they last for a long time or if you are worried about them.
Danish: Fortæl det til lægen, hvis bivirkningerne varer i lang tid, eller hvis De er bekymret over dem.
English: • Restless Legs Syndrome - lowered by 1 mg every other day.
Danish: • Restless legs-syndrom - nedsættes med 1 mg hver anden dag.
English: If you experience such symptoms either before or after beginning treatment with Leganto, contact your doctor as your treatment may need to be adjusted.
Danish: Hvis De oplever sådanne symptomer, enten før eller efter De begynder med Leganto, så kontakt Deres Læge, da det kan være nødvendigt at justere behandlingen.
English: Because rotigotine enters your bloodstream through your skin, food or drink does not affect the way this medicine is absorbed by the body.
Danish: Da rotigotin kommer ind i blodbanen igennem huden, påvirker mad eller drikke ikke den måde, hvorpå denne medicin optages i kroppen.
English: Leganto should be discontinued gradually.
Danish: Leganto bør seponeres gradvist.
English: Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu.
Danish: Yderligere oplysninger om dette lægemiddel findes på Det Europæiske Lægemiddelagenturs hjemmeside: http://www.ema.europa.eu.
English: Leganto is indicated for the symptomatic treatment of moderate to severe idiopathic Restless Legs Syndrome (RLS) in adults.
Danish: Leganto er indiceret til symptomatisk behandling af moderat til svær idiopatisk restless legs-syndrom (RLS) hos voksne.
English: In isolated cases, people have fallen asleep while driving and this has caused accidents.
Danish: I enkelte tilfælde er mennesker faldet i søvn under bilkørslen, og det har forårsaget ulykker.
English: • Whenever the risk management system is modified, especially as the result of new information being received that may lead to a significant change to the benefit/risk profile or as the result of an important (pharmacovigilance or risk minimisation) milestone being reached
Danish: • når risikostyringssystemet ændres, særligt som følge af, at der er modtaget nye oplysninger, der kan medføre en væsentlig ændring i risk/benefit-forholdet, eller som følge af, at en vigtig milepæl
English: These symptoms are either reduced or their duration is shortened with Leganto treatment.
Danish: Disse symptomer vil enten mindskes eller deres varighed forkortes ved behandling med Leganto.
English: If the patient forgets to apply the patch at the usual time of the day or if the patch becomes detached, another patch should be applied for the remainder of the day.
Danish: Hvis patienten glemmer at påsætte plasteret på det sædvanlige tidspunkt på dagen, eller hvis plasteret løsner sig, bør et nyt plaster påsættes til resten af dagen.
English: These effects are usually mild or moderate and only last for a short time.
Danish: Disse bivirkninger er som regel lette eller moderate og varer kun i kort tid.
English: Women of childbearing potential should use effective contraception to prevent pregnancy during treatment with rotigotine.
Danish: Kvinder i den fertile alder skal anvende sikker kontraception for at forebygge graviditet under behandlingen med rotigotin.
English: If you stop using Leganto
Danish: Hvis De holder op med at bruge Leganto
English: Because therapy with Leganto is initiated at a low dose and gradually titrated according to clinical tolerability to obtain the optimum therapeutic effect, adjustment of the dose based on gender, weight, or age is not necessary.
Danish: Da behandling med Leganto indledes med en lav dosis og gradvis titreres i overensstemmelse med klinisk tolerabilitet for at opnå optimal behandlingseffekt, er det ikke nødvendigt at foretage dosisjustering baseret på køn, vægt eller alder.
English: Injury, poisoning and procedural complications
Danish: Traumer, forgiftninger og behandlingsko mplikationer
English: • craving large doses of medicines like Leganto - more than needed for the illness.
Danish: • trang til høje doser af lægemidler som Leganto - mere end nødvendigt mod sygdommen.
English: Ophthalmologic monitoring is recommended at regular intervals or if vision abnormalities occur.
Danish: Oftalmologisk monitorering anbefales med regelmæssige mellemrum, eller hvis der forekommer synsanomalier.
English: If you think that too much heat has been applied, contact your doctor or pharmacist.
Danish: Hvis De tror, der har været påført for meget varme, så kontakt Deres læge eller apotekspersonalet.
English: In long-term clinical studies with rotigotine, the majority of augmentation episodes were seen in the first and second years of treatment.
Danish: I langvarige kliniske studier med rotigotin blev størstedelen af augmentationsepisoder set i løbet af det første og andet behandlingsår.
English: A further multinational double-blind study (SP889) was conducted in 287 patients with early or advanced stages of Parkinson's disease who had unsatisfactory early morning motor symptom control.
Danish: Der blev udført yderligere et multinationalt dobbeltblindt studie (SP889) med 287 patienter med Parkinsons sygdom i tidlige og fremskredne stadier, som havde utilfredsstillende kontrol af motoriske symptomer tidligt om morgenen.
English: • If you have forgotten to change the patch at your usual time, change it as soon as you remember.
Danish: • Hvis De har glemt at skifte plasteret på det normale tidspunkt, skal De skifte det, så snart De husker det.
English: If application site reactions occur which last for more than a few days or are persistent, if there is an increase in severity, or if the skin reaction spreads outside the application site, an assessment of the risk/benefit balance for the individual patient should be conducted.
Danish: Hvis der forekommer reaktioner på applikationsstedet, som varer mere end nogle få dage, eller som er vedvarende, hvis deres sværhedsgrad øges, eller hvis hudreaktionerne breder sig ud over applikationsstedet, bør der foretages en vurdering af fordele og ulemper for den enkelte patient.
English: Open the sachet.
Danish: Åbn brevet.
English: The primary outcome assessment was the score for the Activities of Daily Living (ADL) component (Part II) plus the Motor Examination component (Part III) of the Unified Parkinson's Disease Rating Scale (UPDRS).
Danish: Den primære resultatvurdering var scoren for dagligdagsaktiviteter (del II) samt motorisk undersøgelse (del III) på UPDR-skalaen (Unified Parkinson's Disease Rating Scale).
English: • aggressive behaviour
Danish: • aggressiv adfærd
English: 4 mg of Leganto every day may be an effective dose for some patients.
Danish: 4 mg Leganto dagligt kan være en effektiv dosis for nogle patienter.
English: However, a contribution of these metabolites to clinical effects is unlikely.
Danish: Det er imidlertid usandsynligt, at disse metabolitter påvirker den kliniske effekt.
English: In clinical studies in Parkinson's patients, the 6 month-specific rates of peripheral oedema remained at about 4% through the entire observation period up to 36 months.
Danish: I kliniske studier med patienter med Parkinsons sygdom var den specifikke hyppighed af perifere ødemer efter 6 måneder ca. 4%, og den forblev på dette niveau i det samlede observationstidsrum på op til 36 måneder.
English: • Flank (your side, between the ribs and hips).
Danish: • Siden af kroppen (mellem ribbenene og hoften).
English: This is because rotigotine may pass into your breast milk and affect your baby.
Danish: Dette skyldes, at rotigotin kan udskilles i modermælken og påvirke Deres barn.
English: Limited pharmacokinetic data obtained in adolescent patients with RLS (13-17 years, n=24) following treatment with multiple doses of 0.5 to 3mg/24h showed that systemic exposure to rotigotine was similar to that observed in adults.
Danish: Begrænsede farmakokinetiske data fra unge patienter med RLS (13-17 år, n=24) efter behandling med gentagne doser på 0,5 til 3 mg/24 timer viste, at den systemiske eksponering for rotigotin var sammenlignelig med den, der blev observeret hos voksne.
English: In the absence of human data, breast-feeding should be discontinued.
Danish: Da der ikke findes data for mennesker, bør amning ophøre.
English: Because the patch is administered transdermally, no effect of food and gastrointestinal conditions is expected.
Danish: Da plasteret administreres transdermalt, forventes mad og gastrointestinale sygdomme ikke at interferere.
English: If you forget to change the patch at your usual time
Danish: Hvis De glemmer at skifte plasteret på det normale tidspunkt
English: If you experience these symptoms after beginning treatment with Leganto, contact your doctor.
Danish: Hvis De oplever sådanne symptomer, efter De begynder med Leganto, så kontakt Deres Læge.
English: After a single dose of rotigotine, binding to melanin-containing tissues (i.e., eyes) in the pigmented rat and monkey was evident, but was slowly cleared over the 14-day observation period.
Danish: Efter en enkelt dosis rotigotin var der en tydelig binding til væv, som indeholder melanin (dvs. øjne), hos den pigmenterede rotte og abe, men den fortog sig langsomt i løbet af 14-dages observationsperioden.
English: • sedating medicines such as benzodiazepines or medicines used to treat mental illness or depression.
Danish: • beroligende medicin såsom benzodiazepiner eller medicin til at behandle psykiske lidelser eller depression.
English: • Talk to your doctor if you have a skin reaction that lasts longer than a few days or is severe.
Danish: • Fortæl det til lægen, hvis De har en hudreaktion, som varer længere end nogle få dage eller hvis det er en alvorlig hudreaktion.
English: Because of possible additive effects, caution should be advised when patients are taking sedating medicinal products or other CNS (central nervous system) depressants (e.g. benzodiazepines, antipsychotics, antidepressants) or alcohol in combination with rotigotine.
Danish: På grund af mulig additiv effekt bør der udvises forsigtighed, når patienter tager beroligende lægemidler eller andre CNS (centralnervesystem)depressiva(fx benzodiazepiner, antipsykotika, antidepressiva) eller indtager alkohol i kombination med rotigotin.
English: Neuroleptics
Danish: Neuroleptika
English: Irritability, oedema peripheral
Danish: Irritabilitet, perifere ødemer
English: Leganto may potentiate the dopaminergic adverse reaction of L-dopa and may cause and/or exacerbate pre-existing dyskinesia, as described with other dopamine agonists.
Danish: Leganto kan forstærke levodopas dopaminerge bivirkning og forårsage og/eller forværre allerede eksisterende dyskinesi, som beskrevet med andre dopaminerge agonister.
English: Leganto was not investigated in patients with severe hepatic impairment.
Danish: Leganto er ikke undersøgt hos patienter med svært nedsat leverfunktion.
English: Leganto may cause other behaviours and abnormal thinking.
Danish: Leganto kan forårsage andre typer af adfærdsændringer og unormal tankegang.
English: The backing layer of Leganto contains aluminium.
Danish: Legantos yderste lag indeholder aluminium.
English: The efficacy of rotigotine was evaluated in 5 placebo-controlled trials with more than 1,400 patients with idiopathic Restless Legs Syndrome (RLS).
Danish: Rotigotins virkning blev vurderet i5 placebokontrollerede studier med mere end 1.400 patienter med idiopatisk restless legs-syndrom (RLS).
English: Differences in bioavailability of rotigotine ranged from 2% (upper arm versus flank) to 46% (shoulder versus thigh).
Danish: Forskellene i rotigotins biotilgængelighed lå i intervallet fra 2% (overarm vs. side) til 46% (skulder vs. lår).
English: • abnormal thinking or behaviour - most of the symptoms occur more frequently in patients with
Danish: • Unormal tankegang eller adfærd - de fleste symptomer forekommer mere hyppigt hos patienter med Parkinsons sygdom.
English: The improved room temperature patch formulation showed better skin adhesion than the cold storage formulation with >90% of patches showing sufficient adhesion (i.e. >70% of the patch area adhering) compared to <83%.
Danish: Den forbedrede stuetemperatur plasterformulering viste bedre hudadhæsion, >90 % af plastrene viste tilstrækkelig adhæsion (dvs. >70 % af plasterområdet klæber), sammenlignet med <83 % af plastrene med formuleringen til kølig opbevaring.
English: Neuroleptics given as antiemetic should not be given to patients taking dopamine agonists (see also section 4.5).
Danish: Neuroleptika bør ikke gives som antiemetikum til patienter, som tager dopaminagonister (se også pkt.
English: • Avoid sunlight and solarium exposure on areas of skin showing any kind of skin reaction caused by the patch.
Danish: • Undgå sollys og solarium på hudområder, hvor der er nogen form for hudreaktion på grund af plasteret.
English: Two additional pivotal trials (SP650DB and SP515) were conducted in patients who were receiving concomitant levodopa therapy.
Danish: Der blev foretaget to yderligere pivotale studier (SP650DB og SP515) med patienter, som samtidig blev behandlet med levodopa.
English: These may include:
Danish: Disse kan være:
English: Leganto may make you feel very sleepy, and you may fall asleep very suddenly.
Danish: Leganto kan gøre Dem meget træt, og De falder måske i søvn meget pludseligt.
English: • feeling agitated, disorientated, confused or paranoid
Danish: • følelse af rastløs uro, desorientering, forvirring eller paranoia
English: Retinal degeneration was observed by transmission microscopy at a dose equivalent to 2.8 times the maximum recommended human dose on a mg/m² basis in a 3-month study in albino rats.
Danish: Der sås retinal degeneration ved hjælp af transmissionsmikroskopi ved en dosis svarende til 2,8 gange den maksimale anbefalede dosis for mennesker på mg/m2-basis i et 3-måneders studie med albinorotter.
English: Rotigotine has been associated with somnolence and episodes of sudden sleep onset.
Danish: Rotigotin har været forbundet med søvnighed og episoder med pludseligt indsættende søvn.
English: • Do not touch the sticky side of the patch with your fingers.
Danish: • Rør ikke ved plasterets klæbende side med fingrene.
English: Fold the used patch with the sticky side inwards.
Danish: Fold det brugte plaster sammen med den klæbende side indad.
English: This includes medicines obtained without a prescription and herbal medicines.
Danish: Dette gælder også lægemidler som ikke er købt på recept samt naturlægemidler.
English: • Each patch is packed in a separate sachet.
Danish: • Hvert plaster ligger i et særskilt brev.
English: The adjusted mean difference was -6.5 points (CI95% -8.7; -4.4, p <0.0001).
Danish: Den justerede gennemsnitsforskel var -6,5 point (CI95% -8,7; -4,4, p<0,0001).
English: You may have to use more than one patch to reach your dose, as prescribed by your doctor.
Danish: Det kan være nødvendigt at bruge mere end ét plaster til at opnå dosis ordineret af Deres læge.
English: • your eyes need checking regularly while using Leganto.
Danish: • Deres øjne jævnligt bør undersøges under behandling med Leganto.
English: There is no relevant use of Leganto in the paediatric population in Parkinson's disease.
Danish: Der er ingen relevant indikation i den pædiatriske population for anvendelse af Leganto til Parkinsons sygdom.
English: The effectiveness of rotigotine in the treatment of the signs and symptoms of idiopathic Parkinson's disease was evaluated in a multinational drug development program consisting of four pivotal, parallel, randomized, double-blind placebo controlled studies and three studies investigating specific aspects of Parkinson's disease.
Danish: Rotigotins behandlingseffekt ved tegn og symptomer på idiopatisk Parkinsons sygdom er vurderet i et multinationalt lægemiddeludviklingsprogram bestående af fire pivotale, parallelle, randomiserede, dobbeltblinde, placebokontrollerede studier samt tre studier, som undersøgte bestemte aspekter af Parkinsons sygdom.
English: What to do with the used and unused patches
Danish: Håndtering af brugte og ubrugte plastre
English: • Keep it pressed for about
Danish: • Hold fast i omkring
English: Treatment initiation pack
Danish: Pakke til indledende behandling
English: The sticky side of the patch is covered by a transparent release liner.
Danish: Den klæbende side af plasteret er dækket af en gennemsigtig aftagelig beskyttelsesfilm.
English: This study failed to demonstrate non-inferiority of rotigotine to ropinirole.
Danish: Dette studie kunne ikke demonstrere non-infirioritet af rotigotin overfor ropinirol.
English: You should take Leganto 2 mg for 7 days (e.g. if you start on a Sunday, switch to the next dose on the following Sunday.).
Danish: Anvend Leganto 2 mg i 7 dage (hvis De fx begynder en søndag, skal De skifte til næste dosis den følgende søndag.
English: You should discuss with your doctor if it is safe for you to drink alcohol while using Leganto.
Danish: De skal spørge Deres læge, om det er sikkert for Dem, at drikke alkohol, mens De bruger Leganto.
English: • Do not stick the patch on broken or damaged skin - or on skin that is red or irritated.
Danish: • Placer ikke plasteret på sprukken eller beskadiget hud eller på hud, som er rød eller irriteret.
English: Which strength patches to use The dose of Leganto will depend on your illness - see below.
Danish: Hvilken plaster-styrke skal bruges Dosis af Leganto vil afhænge af Deres sygdom - se nedenstående.
English: If you have to stop taking this medicine, see ‘If you stop using Leganto' in section 3.
Danish: Hvis De skal holde op med at bruge denne medicin, se punkt 3 ‘Hvis De holder op med at bruge Leganto'.
English: Rotating the site of patch application may result in day-to-day differences in plasma levels.
Danish: Skiftende applikationssteder kan give forskelle fra dag til dag i plasmaniveauet.
English: • unusual urges or cravings which you cannot resist and that could harm yourself or others
Danish: • Usædvanlige lyster eller fristelser, som De ikke kan modstå og som kan skade Dem selv eller andre
English: Your doctor will let you know if it is safe to keep taking these medicines while using Leganto.
Danish: Deres læge vil fortælle Dem, om det er sikkert at fortsætte brugen af disse lægemidler under behandling med Leganto.
English: In a carcinogenicity study, male rats developed Leydig cell tumours and hyperplasia.
Danish: I et carcinogenicitetsstudie udviklede hanrotter Leydig celle-tumorer og -hyperplasi.
English: • Do not let the area of the patch get hot - for example too much sunlight, saunas, hot baths, heating pads or hot-water bottles.
Danish: • Lad ikke området, hvor plasteret sidder, blive varmt - for eksempel for meget sollys, sauna, varme bade, varmepuder eller varmedunke.
English: Also do this if it spreads outside the area of skin that was covered by the patch.
Danish: Fortæl det også hvis hudreaktionen breder sig ud over området, som plasteret dækker.
English: Talk to your doctor before using Leganto if you are taking:
Danish: Fortæl det til Deres læge før De bruger Leganto, hvis De anvender:
English: It is square-shaped with rounded edges.
Danish: Det er kvadratisk med afrundede hjørner.
English: Put the sticky side of the patch onto clean, dry, healthy skin on the following areas as shown in grey on the pictures opposite:
Danish: Sæt den klæbende side af plasteret på ren, tør og sund hud på et af følgende områder, som er markeret med gråt på billedet i modsatte side:
English: Efficacy was determined by the subject's response to therapy in terms of responder and absolute improvement in the time spent “off”.
Danish: Virkningen blev bedømt i henhold til patientens respons på behandlingen som respondentforbedring og absolut forbedring med hensyn til “off”-tiden.
English: • Stick the new patch on a different area of the skin each day.
Danish: • Sæt det nye plaster på et nyt område på huden hver dag.
English: In a 5-year open-label treatment study, augmentation occurred in 11.9% of patients treated with the approved dosages for RLS (1-3 mg/24 h), and 5.1% were considered clinically significant.
Danish: I et 5-årigt åbent behandlingsstudie forekom augmentation hos 11,9% af de patienter, som blev behandlet med de godkendte doser for RLS (1-3 mg/24 t), og blev anset som klinisk signifikant hos 5,1%.
English: • The patches should not be cut into pieces.
Danish: • Plastrene må ikke klippes i mindre stykker.
English: Application site reactions
Danish: Reaktioner på applikationsstedet
English: Leganto contains sodium metabisulphite, a sulphite that may cause allergic-type reactions including anaphylactic symptoms and life threatening or less severe asthmatic episodes in certain susceptible people.
Danish: Leganto indeholder natriumpyrosulfit, en sulfit der kan forårsage allergilignende reaktioner, herunder anafylaktiske symptomer og livstruende eller mindre alvorlige astmatiske anfald hos visse disponerede personer.
English: Regarding the functional activity at the various receptor subtypes and their distribution in the brain, rotigotine is a D2 and D3 receptor agonist acting also on D1, D4 and D5 receptors.
Danish: Med hensyn til den funktionelle aktivitet af de forskellige undergrupper af receptorer og deres lokalisering i hjernen er rotigotin en D2- og D3-receptoragonist, som også aktiverer D1-, D4 og D5
English: Rotigotine is a non-ergolinic dopamine agonist for the treatment of signs and symptoms of Parkinson's disease and Restless Legs Syndrome.
Danish: Rotigotin er en non-ergolin dopaminagonist til behandling af tegn og symptomer på Parkinsons sygdom og restless legs-syndrom.
English: Caution is advised when treating patients with severe hepatic impairment, which may result in lower rotigotine clearance.
Danish: Det tilrådes at udvise forsigtighed ved behandling af patienter med svært nedsat leverfunktion, som kan resultere i nedsat rotigotinclearance.
English: This effect was not confirmed in vivo in the Mouse Micronucleus Test in the rat Unscheduled DNA Synthesis (UDS) test.
Danish: Denne effekt bekræftedes dog ikke invivo i musemikronukleustesten eller i UDS-testen (Unscheduled DNA Synthesis) med rotter.
English: Switching to rotigotine was feasible, with minor dose adjustment (median 2 mg/24 h) being necessary in only 2 patients switching from ropinirole, 5 patients from pramipexole and 4 patients from cabergoline.
Danish: Skiftet til rotigotin var gennemførligt og mindre dosistilpasning (median 2 mg/24 timer) var kun nødvendigt hos 2 patienter som skiftede fra ropinirol, 5 patienter fra pramipexol og 4 patienter fra cabergolin.
English: • difficulty falling asleep, sleep disorder, difficulty sleeping, nightmare, unusual dreams
Danish: • besvær med at falde i søvn, søvnforstyrrelser, forstyrret søvn, mareridt, usædvanlige drømme
English: • Do not put the patch in an area where it can be rubbed by tight clothing.
Danish: • Placer ikke plasteret på steder, hvor det kan gnide mod tætsiddende tøj.
English: You must take your Leganto patch off just before undergoing magnetic resonance imaging (MRI) or cardioversion to avoid skin burns because the patch contains aluminium.
Danish: De skal tage Leganto-plasteret af umiddelbart før, De skal have foretaget magnetisk resonans (MR)scanning eller kardioversion for at undgå forbrændinger på huden, fordi plasteret indeholder aluminium.
English: • If you have forgotten to stick on a new patch after removing the old one, use a new patch as soon as you remember.
Danish: • Hvis De har glemt at sætte et nyt plaster på, efter De har taget det gamle af, sættes et nyt plaster på, så snart De husker det.
English: Skin adhesion was measured on 2 consecutive days of 24 hours patch application.
Danish: Hudadhæsion blev målt i 2 på hinanden følgende dage med 24 timers plasterapplikation.
English: In subjects with moderate hepatic impairment or mild to severe renal impairment, no relevant increases of rotigotine plasma levels were observed.
Danish: Hos patienter med moderat nedsat leverfunktion eller let til svært nedsat nyrefunktion sås ingen relevante stigninger i rotigotins plasmaniveauer.