FrancophonIA/ELRC3.0 huggingface dataset:
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: Leganto can cause unusual urges or cravings which you cannot resist such as the impulse, drive or temptation to do things that could harm yourself or others.
Danish: Leganto kan forårsage usædvanlige lyster eller fristelser, som De ikke kan modstå, såsom impulsen, lysten eller fristelsen til at udføre en handling, der kan skade Dem selv eller andre.
English: A dose reduction might be needed in case of worsening of the hepatic impairment.
Danish: Det kan være nødvendigt at nedsætte dosis, hvis den nedsatte leverfunktion forværres.
English: If you have used a different patch (e.g. Leganto 4 mg/24 h instead of Leganto 2 mg/24 h) than your doctor told you to, contact your doctor or hospital for advice immediately, and follow their advice on changes of patches.
Danish: Hvis De har anvendt et andet plaster, end det lægen har foreskrevet (fx Leganto 4 mg/24 timer i stedet for Leganto 2 mg/24 timer),skal De straks henvende Dem til Deres læge eller på skadestuen for at få råd, og følge deres rådgivning om ombytning af plastrene.
English: Rotigotine significantly reduced the periodic limb movement index (PLMI) from 50.9 to 7.7 versus 37.4 to 32.7 for placebo (p<0.0001).
Danish: Rotigotin reducerede antallet af periodiske benbevægelser (periodic limb movement index (PLMI)) signifikant fra 50,9 til 7,7 vs. 37,4 til 32,7 for placebo (p<0,0001).
English: The difference was 5.28 points and statistically significant (p<0.0001).
Danish: Forskellen var 5,28 point og statistisk signifikant (p<0,0001).
English: Side effects more likely at the start of treatment You may feel sick (nausea) and vomit at the start of treatment.
Danish: Bivirkninger som hyppigst optræder ved starten af behandlingen De kan få kvalme og opkastninger i starten af behandlingen.
English: In case of suspected overdose, removal of the patch(es) should be considered because after removal of the patch(es) the active substance input is stopped and the plasma concentration of rotigotine decreases rapidly.
Danish: Ved mistanke om overdosering bør fjernelse af plasteret/plastrene overvejes, idet optagelsen af det aktive stof stopper efter fjernelse af plasteret/plastrene, hvorefter plasmakoncentrationen af rotigotin hurtigt falder.
English: • low blood pressure when standing up, high blood pressure
Danish: • lavt blodtryk når De rejser Dem, højt blodtryk
English: After 6 months of maintenance treatment in patients with moderate to severe RLS, the baseline IRLS score improved from 30.7 to 20.7 for placebo and from 30.2 to 13.8 for rotigotine.
Danish: Efter 6 måneders vedligeholdelsesbehandling af patienter med moderat til svær RLS var baseline IRLS scoren forbedret fra 30,7 til 20,7 for placebo og fra 30,2 til 13,8 for rotigotin.
English: • ‘anti-psychotic' medicines - used to treat certain mental illnesses
Danish: • ‘antipsykotisk' medicin - bruges til at behandle visse psykiske lidelser
English: Abnormal thinking and behaviour
Danish: Abnorm tankegang og adfærd
English: One half of the release liner should be removed and the sticky side should be applied and pressed firmly to the skin.
Danish: Den ene halvdel af den aftagelige beskyttelsesfilm fjernes, og den klæbende side påsættes og presses fast mod huden.
English: Erythema, hyperhidrosis, pruritus
Danish: Erythem,hyper hidrosis, pruritus
English: Rotigotine was not teratogenic in all three species, but was embryotoxic in rats and mice at materno-toxic doses.
Danish: Rotigotin var ikke teratogen hos nogen af de tre arter, men var embrytoksisk hos rotter og mus ved maternotoksiske doser.
English: Animal studies do not indicate any teratogenic effects in rats and rabbits, but embryo-toxicity was observed in rats and mice at materno-toxic doses (see section 5.3).
Danish: Dyrestudier viser ingen teratogene virkninger hos rotter og kaniner, men embryotoksicitet sås hos rotter og mus ved maternotoksiske doser (se pkt.
English: • unusual urges or cravings which you cannot resist and that could harm yourself or others - the symptoms are mainly seen in patients with Parkinson's disease
Danish: • Usædvanlige lyster eller fristelser, som De ikke kan modstå og som kan skade Dem selv eller andre - symptomerne ses hovedsageligt hos patienter med Parkinsons sygdom.
English: Although these adverse reactions are believed to be related to the ergoline structure of these compounds, whether other, nonergot derived dopamine agonists can cause them is unknown.
Danish: Selvom disse bivirkninger menes at være relateret til stoffernes ergoline struktur, vides det ikke, om andre non-ergoline dopaminagonister kan forårsage dem.
English: Co-administration of rotigotine (3 mg/24 h) did not affect the pharmacodynamics and pharmacokinetics of oral contraceptives (0.03 mg ethinylestradiol, 0.15 mg levonorgestrel).
Danish: Samtidig administration af rotigotin (3 mg/24 t) havde ingen effekt på orale kontraceptiva (0,03 mg ethinyløstradiol, 0,15 mg levonorgestrel).
English: • binge eating (eating large amount of food in a short period of time) or compulsive eating (eating more food than normal and more than needed to satisfy hunger)
Danish: • uhæmmet madindtagelse (indtagelse af store mængder mad i løbet af kort tid) eller konstant trang til madindtagelse (indtagelse af mere mad end normalt og mere end der er behov for, til at tilfredsstille sulten)
English: Because rotigotine decreases prolactin secretion in humans, inhibition of lactation is expected.
Danish: Da rotigotin nedsætter prolaktinsekretionen hos mennesker, forventes det, at mælkedannelsen hæmmes.
English: Abnormal thinking and behaviour have been reported and can consist of a variety of manifestations including paranoid ideation, delusions, hallucinations, confusion, psychotic-like behaviour, disorientation, aggressive behaviour, agitation, and delirium.
Danish: Der er rapporteret om abnorm tankegang og adfærd, som kan manifestere sig på forskellige måder, inklusive paranoide tanker, vrangforestillinger, hallucinationer, forvirring, psykose-lignende adfærd, desorientering, aggressiv adfærd, agitation og delirium.
English: • dropped head syndrome
Danish: • dropped head syndrom
English: With rotigotine, the mean reductions in “off” time were 2.7 and 2.1 hours, respectively whereas in the placebo-treated arm a reduction of 0.9 hours was observed.
Danish: Med rotigotin var middelreduktionen i “off”tid henholdsvis 2,7 og 2,1 timer, mens der i den placebobehandlede arm sås en reduktion på 0,9 timer.
English: In the ropinirole group, patients were titrated to their optimal dose up to a maximum of 24 mg/day over 13 weeks.
Danish: I ropinirol-gruppen blev patienterne titreret til deres optimale dosis op til maksimum på 24 mg/dag i 13 uger.
English: If a Parkinson's disease patient is insufficiently controlled while on treatment with rotigotine switching to another dopamine agonist might provide additional benefit (see section 5.1)
Danish: Hvis tilstanden hos en patient med Parkinsons sygdom ikke kan bringes tilstrækkeligt under kontrol ved behandling med rotigotin, kan skift til en anden dopaminagonist muligvis forbedre tilstanden yderligere (se pkt.
English: In a multicenter, double-blind, randomized, 2-way, crossover study in 52 outpatients, the skin adhesion of the improved room temperature patch formulation was compared to the cold storage formulation, using the 8 mg/24 h rotigotine patch.
Danish: I et multi-center, dobbeltblindt, randomiseret, 2-vejs, overkrydsningsstudie med 52 ambulante patienter blev hudadhæsionen af den forbedrede stuetemperatur plasterformulering sammenlignet med formuleringen til kølig opbevaring ved brug af 8 mg/24 timer rotigotinplaster.
English: To avoid skin burns, Leganto should be removed if the patient has to undergo magnetic resonance imaging (MRI) or cardioversion.
Danish: For at undgå forbrænding af huden skal Leganto fjernes, hvis patienten skal have foretaget MR-scanning eller kardioversion.
English: 190 patients received rotigotine, and 97 placebo.
Danish: 190 patienter blev behandlet med rotigotin, og 97 med placebo.
English: For both primary endpoints statistically significant differences have been observed for the doses 1 mg/24 h, 2 mg/24 h and 3 mg/24 h in comparison to placebo.
Danish: For begge primære endpoints er der blevet observeret statistiske signifikante forskelle ved doser på 1 mg/24 t, 2 mg/24 t og 3 mg/24 t ved sammenligning med placebo.
English: Rotigotine did not influence male fertility in rats, but clearly reduced female fertility in rats and mice, because of the effects on prolactin levels which are particularly significant in rodents.
Danish: Rotigotin påvirkede ikke hanrotters fertilitet, men reducerede tydeligt fertiliteten hos hunrotter og mus på grund af påvirkningen af prolaktinniveauet, som er særlig signifikant hos gnavere.
English: Rotigotine did not induce gene mutations in the Ames test, but did show effects in the in vitro Mouse Lymphoma Assay with metabolic activation and weaker effects without metabolic activation.
Danish: Rotigotin inducerede ikke genmutationer i Ames-testen, men udviste mutagene effekter i invitromuselymfomtesten med metabolisk aktivering og svagere effekt uden metabolisk aktivering.
English: • increased or abnormal liver function test results
Danish: • øgede eller unormale resultater af leverfunktionstest
English: • Release liner: Transparent fluoropolymer coated polyester film.
Danish: • Aftagelig beskyttelsesfilm: Transparent fluoropolymerovertrukken polyesterfilm.
English: The patches of 2 mg/24 h are used for the treatment of Parkinson´s disease and Restless Leg Syndrome.
Danish: Plastrene på 2 mg/24 timer kan bruges til behandlingen af Parkinsons sygdom og restless legs-syndrom.
English: Co-administration of omeprazole (inhibitor of CYP2C19), in doses of 40 mg/day, had no effect on the pharmacokinetics and metabolism of rotigotine in healthy volunteers.
Danish: Samtidig administration af omeprazol (CYP2C19-hæmmer) i doser på 40 mg/dag, havde ingen effekt på rotigotins farmakokinetik eller metabolisme hos raske frivillige.
English: Because rotigotine is a dopamine agonist, it is assumed that dopamine antagonists, such as neuroleptics (e.g. phenothiazines, butyrophenones, thioxanthenes) or metoclopramide, may diminish the effectiveness of Leganto, and co-administration should be avoided.
Danish: Da rotigotin er en dopaminagonist, antages det, at dopaminantagonister som neuroleptika (fx fenothiaziner, butyrofenoner, thioxanthener) eller metoclopramid kan reducere Legantos behandlingseffekt, og samtidig brug bør undgås.
English: A reduction of dosage or termination of therapy should be carefully considered.
Danish: Det bør nøje overvejes at nedsætte dosis eller seponere behandlingen.
English: Take off the old patch and use a new one.
Danish: Tag det gamle plaster af og sæt et nyt plaster på.
English: Read the package leaflet before use.
Danish: ADMINISTRATIONSMETODE Læs indlægssedlen inden brug.
English: This will remove any stickiness that stays on your skin.
Danish: Dette vil fjerne eventuelt resterende klæbemiddel på huden.
English: In studies SP824 and SP825 conducted since the initial comparative trial, rotigotine and ropinirole at equivalent doses were shown to have comparable efficacy.
Danish: I studierne SP824 og SP825, som er udført siden det første sammenlignende studie, er det vist at effekten afrotigotin og ropinirol kan sammenlignes ved equivalente doser.
English: Two pivotal trials (SP512 Part I and SP513 Part I) investigating the effectiveness of rotigotine in the treatment of the signs and symptoms of idiopathic Parkinson's disease were conducted in patients who were not receiving concomitant dopamine agonist therapy and were either L-dopa naïve or previous L-dopa treatment was ≤ 6 months.
Danish: To pivotale studier (SP512 del I og SP513 del I), som undersøgte rotigotins behandlingseffekt ved tegn og symptomer på idiopatisk Parkinsons sygdom blev udført med patienter, som ikke samtidig blev behandlet med en dopaminagonist, og som enten var levodopa-naive, eller hvor den tidligere levodopa-behandling varede ≤ 6 måneder.
English: • Hold the other half of the rigid release liner.
Danish: • Hold på den anden halvdel af den stive aftagelige beskyttelsesfilm
English: Cases of retroperitoneal fibrosis, pulmonary infiltrates, pleural effusion, pleural thickening, pericarditis and cardiac valvulopathy have been reported in some patients treated with ergot-derived dopaminergic agents.
Danish: Der er rapporteret tilfælde med retroperitoneal fibrose, lungeinfiltrater, pleuraeksudat, pleural fortykkelse, pericarditis og kardial valvulopati hos nogle patienter, som er blevet behandlet med dopaminerge ergolinderivater.
English: The incidence of some dopaminergic adverse reactions, such as hallucinations, dyskinesia, and peripheral oedema generally is higher when given in combination with L-dopa in Parkinson's patients.
Danish: Incidensen af nogle dopaminerge bivirkninger, såsom hallucinationer, dyskinesi og perifere ødemer, er generelt højere i kombination med levodopa hos patienter med Parkinsons sygdom.
English: Currently available data are described in section 5.2 but no recommendation on a posology can be made.
Danish: 5.2, men der kan ikke gives nogle anbefalinger vedrørende dosering.
English: Unexpected accumulation of rotigotine levels may also occur at acute worsening of renal function (see section 5.2).
Danish: Der kan forekomme uventet akkumulering af rotigotinkoncentrationen ved akut forværring af nyrefunktionen (se pkt.
English: Leganto is indicated for the treatment of the signs and symptoms of early-stage idiopathic Parkinson's disease as monotherapy (i.e. without levodopa) or in combination with levodopa, i.e. over the course of the disease, through to late stages when the effect of levodopa wears off or becomes inconsistent and fluctuations of the therapeutic effect occur (end of dose or ‘on-off' fluctuations).
Danish: Leganto er indiceret som monoterapi (dvs. uden levodopa) til behandling af tegn og symptomer på idiopatisk Parkinsons sygdom i tidlige stadier eller i kombination med levodopa, dvs. under hele sygdommens forløb og i de sene stadier, hvor virkningen af levodopa aftager eller bliver svingende, og der optræder udsving i den terapeutiske effekt (ved slutningen af hver dosis eller ”on-off”-udsving).
English: Transparent fluoropolymer coated polyester film.
Danish: Transparent fluoropolymerovertrukken polyesterfilm.
English: How to take off a used patch
Danish: Hvordan tages et brugt plaster af?
English: Treatment differences for the coprimary variables were statistically significant (p=0.0002 and p<0.0001).
Danish: Behandlingsforskelle for de co-primære variable var statistisk signifikant (p=0,0002 og p<0,0001).
English: • Hold the patch in both hands with the release liner facing you.
Danish: • Hold plasteret i begge hænder med den aftagelige beskyttelsesfilm ind mod Dem selv.
English: You may find it helpful to tell a member of your family or carer that you are using this medicine and ask them to read this leaflet.
Danish: Det kan være en hjælp at fortælle et familiemedlem eller en omsorgsperson, at De bruger dette lægemiddel og få dem til at læse denne indlægsseddel.
English: Rotigotine is believed to elicit its beneficial effect on Parkinson's disease by activation of the D3, D2 and D1 receptors of the caudate-putamen in the brain.
Danish: Det menes, at rotigotins positive effekt på Parkinsons sygdom opnås ved aktivering af D3-, D2- og D1receptorerne i nucleus caudatus og putamen i hjernen.
English: • movements you cannot control related to Parkinson's disease (dyskinesia)
Danish: • ufrivillige bevægelser relateret til Parkinsons sygdom (dyskinesi)
English: In a randomized, open-label study (SP825) in patients with early-stage Parkinson's disease, 25 patients were randomized to rotigotine treatment and 26 to ropinirole.
Danish: I et randomiseret, åbent studie (SP825) med patienter med Parkinsons sygdom i tidligt stadie, blev 25 patienter randomiseret til behandling med rotigotin og 26 til ropinirol.
English: Then, the patch is fold back and the second part of the release liner is removed.
Danish: Derefter foldes plasteret tilbage, og den anden halvdel af den aftagelige beskyttelsesfilm fjernes.
English: The active substance is rotigotine.
Danish: Aktivt stof: rotigotin.
English: • If you need to stick the patch to a hairy area of skin, you must shave the area at least 3 days before sticking the patch there.
Danish: • Placer ikke plasteret på behårede hudområder; De skal barbere det pågældende område mindst 3 dage før, plasteret sættes på.
English: • Change the patches at about the same time every day.
Danish: • Udskift plastrene på nogenlunde samme tidspunkt hver dag.
English: The most likely adverse reactions would be those related to the pharmacodynamic profile of a dopamine agonist, including nausea, vomiting, hypotension, involuntary movements, hallucinations, confusion, convulsions and other signs of central dopaminergic stimulation.
Danish: De mest sandsynlige bivirkninger er relateret til dopaminagonistens farmakodynamiske profil, herunder kvalme, opkastning, hypotension, ufrivillige bevægelser, hallucinationer, forvirring, kramper og andre tegn på central dopaminerg stimulering.
English: They will discuss ways of managing or reducing symptoms.
Danish: Lægen vil tale med Dem om, hvordan symptomerne kan håndteres eller mindskes.
English: Side effects when using Leganto for Parkinson's disease Tell your doctor, pharmacist or nurse if you get any of the following side effects:
Danish: Bivirkninger, hvis De bruger Leganto mod Parkinsons sygdom Fortæl det til lægen, apotekspersonalet eller sundhedspersonalet, hvis De får en eller flere af følgende bivirkninger:
English: Clinical studies in Parkinson's disease
Danish: Kliniske studier ved Parkinsons sygdom
English: The following table covers adverse drug reactions from the pooled studies mentioned above in patients with Restless Legs Syndrome and from post-marketing experience.
Danish: Følgende tabel omfatter bivirkninger fra ovennævnte sammenfattede studier med patienter med restless legs-syndrom og fra erfaring efter markedsføring.
English: What Leganto is Leganto contains the active substance rotigotine.
Danish: Leganto indeholder det aktive stof rotigotin.
English: • Then put the sticky half of the patch onto your skin.
Danish: • Sæt den klæbende halvdel af plasteret på huden.
English: Rotigotine is metabolised by N-dealkylation as well as direct and secondary conjugation.
Danish: Rotigotin metaboliseres i høj grad. Rotigotin metaboliseres både ved N-dealkylering og ved direkte og sekundær konjugation.
English: Neuroleptic malignant syndrome
Danish: Malignt neuroleptikumsyndrom
English: Motor symptoms (UPDRS Part III) improved by 6.3 ± 1.3 points in rotigotine-treated patients, and by 5.9 ± 1.3 points in the ropinirolegroup after 4 weeks of maintenance.
Danish: Motoriske symptomer (UPDRS del III) blev forbedret med 6,3 ± 1,3 point hos patienter behandlet med rotigotin, og med 5,9 ± 1,3 point i ropinirol-gruppen efter vedligeholdelse i 4 uger.
English: If a generalised skin reaction (e.g. allergic rash, including erythematous, macular, papular rash or pruritus) associated with the use of Leganto is observed, Leganto should be discontinued.
Danish: Hvis der observeres en generaliseret hudreaktion (fx allergisk udslæt, inklusive erythem, maculopapulært udslæt eller pruritus) i forbindelse med anvendelsen af Leganto, skal behandlingen seponeres.
English: On the first day of treatment, start with Leganto 2 mg (package marked “Week 1”), and use one Leganto 2 mg transdermal patch daily.
Danish: På behandlingens første dag skal De begynde med Leganto 2 mg (æske mærket “Uge 1)“, og anvende et Leganto 2 mg depotplaster dagligt.
English: Plasma levels of conjugates of rotigotine and its desalkyl metabolites increase with impaired renal function.
Danish: Plasmaniveauet af rotigotinkonjugater og dets desalkylmetabolitter øges med nedsat nyrefunktion.
English: Fold back the other half of the patch and remove the other side of the release liner.
Danish: Fold den anden halvdel af plasteret tilbage og fjern resten af den aftagelige beskyttelsesfilm.
English: Impulse control disorders
Danish: Impulskontrolforstyrrelser
English: These events have also been observed during treatment with rotigotine, but the incidence was similar to that observed in placebo-treated patients.
Danish: Disse hændelser er også blevet observeret under behandling med rotigotin, men forekomsten var på niveau med forekomsten observeret hos patienter, som fik placebo.
English: Each pack of 28 transdermal patches for a 4 week treatment schedule contains: 7 transdermal patches of Leganto 2 mg/24 h
Danish: Hver pakning med 28 depotplastre til en 4-ugers behandlingsplan indeholder: 7 depotplastre med Leganto 2 mg/24 timer
English: Efficacy was determined by the subject's response to therapy in terms of responder and absolute points improvement in the scores of ADL and Motor Examination combined (UPDRS part II+III).
Danish: Virkningen blev bedømt i henhold til patientens respons på behandling som respondentforbedring og forbedring af absolut pointtal i de samlede scorer for dagligdagsaktiviteter og motorisk undersøgelse (UPDRS del II og III).
English: Sleep (PDSS) improved by 4.1 ± 13.8 points for rotigotinetreated patients, and by 2.5 ± 13.5 points for ropinirole-treated patients.
Danish: Søvn (PDSS) blev forbedret med 4,1 ± 13,8 point hos patienter behandlet med rotigotin, og med 2,5 ± 13,5 point hos patienter behandlet med ropinirol.
English: Do not take the following medicines while using Leganto - because they may decrease its effect:
Danish: Anvend ikke følgende lægemidler, mens De bruger Leganto - da disse kan forringe virkningen af Leganto:
English: Patients and carers should be made aware that behavioural symptoms of impulse control disorders including pathologic gambling, increased libido, hypersexuality, compulsive spending or buying, binge eating and compulsive eating can occur in patients treated with dopamine agonists, including rotigotine.
Danish: Patienter og plejere skal gøres opmærksomme på, at adfærdsmæssige symptomer på impulskontrolforstyrrelser, herunder ludomani, øget libido, hyperseksualitet, tvangshandlinger forbundet med forbrug eller indkøb, uhæmmet madindtagelse og tvangshandlinger forbundet med madindtagelse kan forekomme hos patienter, der behandles med dopaminagonister, herunder rotigotin.
English: • Restless Legs Syndrome (RLS) - this can be associated with discomfort in your legs or arms, urge to move around, sleep disturbance and feeling tired or sleepy during the day.
Danish: • Restless legs-syndrom (uro i benene (RLS)) - en tilstand som karakteriseres ved ubehag i arme eller ben, trang til at bevæge sig rundt, søvnforstyrrelser og følelse af at være træt eller døsig i løbet af dagen.
English: The Leganto treatment initiation pack contains 4 different packages (one for each strength) with 7 patches in each package.
Danish: Leganto-pakken til indledende behandling indeholder 4 forskellige æsker (en for hver styrke) med 7 plastre i hver æske.
English: The following table covers adverse drug reactions from the pooled studies mentioned above in patients with Parkinson's disease and from post-marketing experience.
Danish: Følgende tabel omfatter bivirkninger fra ovennævnte sammenfattede studier med patienter med Parkinsons sygdom og fra erfaring efter markedsføring.
English: Other medicines and Leganto
Danish: Brug af anden medicin sammen med Leganto
English: • increased levels of creatine phosphokinase (CPK) in blood in Japanese patients (CPK is an enzyme found mainly in skeletal muscles)
Danish: • forhøjede niveauer af kreatinfosfokinase (CK) i blodet hos japanske patienter (CK er et enzym,
English: Put the patch in the original sachet and then throw it away safely, out of the reach of children.
Danish: Læg plasteret i det brev, det var pakket i, og kasser det på en sikker måde, så det er uden for børns rækkevidde.