FrancophonIA/ELRC3.0 huggingface dataset:
English: These changes are well-known effects of dopamine agonists in rats after life-long therapy and assessed as not relevant to man.
Danish: Disse ændringer er velkendte effekter af dopaminagonister hos rotter efter livslang behandling og vurderes som ikke relevante for mennesker.
English: 81.5% of these patients were on concomitant levodopa therapy.
Danish: 81,5% af patienterne blev samtidig behandlet med levodopa.
English: • falling asleep suddenly without warning
Danish: • falder i søvn pludseligt uden varsel
English: • Please follow the instructions of the prescriber carefully.
Danish: • Følg lægens vejledning nøje.
English: It belongs to a group of medicines called ‘dopamine agonists'.
Danish: Det tilhører en gruppe lægemidler ved navn ‘dopaminagonister'.
English: The patch should be pressed down firmly with the palm of the hand for about 30 seconds, so that it sticks well.
Danish: Plasteret skal presses fast mod huden med håndfladen i omkring 30 sekunder, så det klæber godt.
English: The pharmacokinetic profile shows a biphasic elimination with an initial half-life of about 2 to 3 hours.
Danish: Den farmakokinetiske profil viser en bifasisk elimination med en initial halveringstid på ca. 2-3 timer.
English: Leganto can cause side effects that change your behaviour (how you act).
Danish: Leganto kan forårsage bivirkninger, som ændrer Deres adfærd (hvordan De handler).
English: • rash over larger parts of the body
Danish: • udslæt over store områder på kroppen
English: The relevance of these findings to humans is not known.
Danish: Relevansen af disse fund for mennesker kendes ikke.
English: Rotigotine should not be used during pregnancy.
Danish: Rotigotin bør ikke anvendes under graviditet.
English: Within the system organ classes, adverse reactions are listed under headings of frequency (number of patients expected to experience the reaction), using the following categories: 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 (antal patienter, som forventes at få reaktionen) ved brug af følgende kategorier: 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: • Slowly and carefully peel off the used patch.
Danish: • Tag langsomt og forsigtigt det brugte plaster af.
English: • if you have serious liver problems, your doctor may need to change the dose.
Danish: • Hvis De har alvorlige leverproblemer, kan det være nødvendigt at ændre dosis.
English: Both indications:
Danish: Begge indikationer:
English: • Always check that the patch has not fallen off after activities such as bathing, showering or exercising.
Danish: • Kontroller altid, at plasteret ikke er faldet af efter aktiviteter såsom karbad, brusebad eller motionsudøvelse.
English: To prevent the patch becoming loose or falling off
Danish: For at forebygge at plasteret løsner sig eller falder af
English: In two openlabel, follow-up studies over a subsequent 12 months, the rate of clinically relevant augmentation was 2.9%.
Danish: I to åbne opfølgningsstudier i de efterfølgende 12 måneder var hyppigheden af klinisk relevant augmentation 2,9%.
English: Leganto is applied once a day.
Danish: Leganto påsættes en gang dagligt.
English: In this study, the majority of augmentation episodes occurred in the first and second years of treatment.
Danish: I dette studie optrådte størstedelen af augmentationsepisoderne i løbet af det første og andet behandlingsår.
English: Approximately 71% of the rotigotine dose is excreted in urine and a smaller part of about 23% is excreted in faeces.
Danish: Ca. 71% af rotigotindosen udskilles med urinen, og en mindre del på omkring 23% udskilles i fæces.
English: If you have any unpleasant reactions, contact your doctor.
Danish: Hvis De har nogen ubehagelige reaktioner, skal De kontakte Deres læge.
English: Do not use a double dose to make up for a forgotten dose.
Danish: De må ikke bruge en dobbeltdosis som erstatning for det glemte plaster.
English: Ю СИ БИ България ЕООД Teл.
Danish: Ю СИ БИБългария ЕООД Teл.
English: Therefore, it is recommended to taper treatment (see section 4.2).
Danish: Det anbefales derfor at nedtrappe behandlingen (se pkt.
English: • Do not use creams, oils, lotions, powders or other skin products where you will put the patch.
Danish: • Anvend ikke creme, olie, lotion, pudder eller andre hudprodukter, hvor De skal sætte plasteret.
English: • strong impulse to gamble too much - even if this seriously affects you or your family
Danish: • stærk impuls til at spille for meget - også hvis det har alvorlige personlige eller familiære konsekvenser
English: If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.
Danish: Hvis De er gravid eller ammer, har mistanke om, at De er gravid, eller planlægger at blive gravid, skal De spørge Deres læge eller apotekspersonalet til råds, før De bruger dette lægemiddel.
English: This is because:
Danish: Dette er fordi:
English: Rotigotine may have major influence on the ability to drive and use machines.
Danish: Rotigotin kan i væsentlig grad påvirke evnen til at føre motorkøretøj og betjene maskiner.
English: After use the patch still contains active substance.
Danish: Efter brug indeholder plasteret stadig aktivt stof.
English: Sulphite sensitivity
Danish: Sulfit-overfølsomhed
English: Therefore, the relevance of the one positive in vitro mutagenicity test is not known.
Danish: Derfor kendes relevansen af denne ene positive invitro mutagenicitetstest ikke.
English: • You may get redness and itching on the skin where the patch has been - these reactions are usually mild or moderate.
Danish: • De kan få rødme og kløe på huden, hvor plasteret har siddet - disse reaktioner er normalt lette eller moderate.
English: Which strength patches to use
Danish: Hvilken plaster-styrke skal bruges
English: Dopamine is a messenger in the brain which is important for movement.
Danish: Dopamin er et signalstof i hjernen, som er vigtig for bevægelse.
English: See ‘Changes to your behaviour and abnormal thinking' in section 4 for more information.
Danish: Se ‘Ændringer i adfærd og unormal tankegang' under punkt 4 for yderligere information.
English: Depending on the patient's response, not all of the following dose steps may be required or additional higher doses may be needed after week 4, which are not covered by this package.
Danish: Afhængigt af patientens respons er alle følgende dosistrin muligvis ikke nødvendige eller det kan efter uge 4 være nødvendigt med højere doser, som ikke er indeholdt i denne pakke.
English: It is recommended that the application site should be rotated on a daily basis (e.g. from the right side to the left side and from the upper body to the lower body).
Danish: Det anbefales, at applikationsstedet veksles dagligt (fx fra højre side til venstre side og fra overkrop til underkrop).
English: (incl.
Danish: (inkl.
English: Retinal degeneration was not observed during the routine histopathological evaluation of the eyes in any of the toxicology studies in any species used.
Danish: Der sås ingen retinal degeneration under den rutinemæssige, histopatologiske vurdering af øjnene i nogen af de toksikologiske studier hos nogen af de anvendte arter.
English: This includes seeing or hearing things that are not real (hallucinations), movements you cannot control related to Parkinson's disease (‘dyskinesia'), and swelling of legs and feet.
Danish: Dette inkluderer, at De ser eller hører ting, som ikke eksisterer (hallucinationer), bevægelser De ikke kan kontrollere relateret til Parkinsons sygdom (‘dyskinesi') og hævede ben og fødder.
English: Sudden onset of sleep during daily activities, in some cases without awareness of any warning signs, has been reported.
Danish: Der er rapporteret om pludselig søvn under daglige aktiviteter, i visse tilfælde uden at patienten har bemærket nogen advarselstegn.
English: If it is necessary to discontinue rotigotine, this should be done gradually to prevent neuroleptic malignant syndrome.
Danish: Hvis det er nødvendigt at seponere rotigotin, bør dette ske gradvist for at undgå malignt neuroleptikasyndrom.
English: Since it ran more or less parallel with a decreased relative total growth of the cells, it may be related to a cytotoxic effect of the compound.
Danish: Da den mutagene effekt forløb mere eller mindre parallelt med en reduceret relativ total vækst af cellerne, kan den muligvis tilskrives stoffets cytotoksiske effekt.
English: Do not use Leganto if:
Danish: Brug ikke Leganto hvis:
English: • medicines that lower blood pressure.
Danish: • medicin, som nedsætter blodtrykket.
English: The effects of rotigotine on reproduction have been investigated in rats, rabbits and mice.
Danish: Rotigotins påvirkning af reproduktionen er undersøgt hos rotter, kaniner og mus.
English: The clearance of rotigotine after transdermal administration is approximately 10 l/min and its overall elimination half-life is 5 to 7 hours.
Danish: Rotigotins clearance efter transdermal administration er ca. 10 l/min., og den totale eliminationshalveringstid er 5-7 timer.
English: • Before opening the sachet decide where you are going to stick this new patch and check you have removed any old patch.
Danish: • Inden åbning af brevet, skal De beslutte Dem for, hvor De skal sætte det nye plaster og kontrollere, at De har fjernet det gamle plaster.
English: Studies in rats have shown that rotigotine and/or its metabolite(s) are excreted in breast milk.
Danish: Studier med rotter har vist, at rotigotin og/eller dets metabolit(ter) udskilles i mælk.
English: • Do not stick Leganto on the same area of skin twice within 14 days.
Danish: • Sæt ikke Leganto på det samme hudområde to gange inden for 14 dage.
English: Steady-state concentrations are reached after one to two days of patch application and are maintained at a stable level by once daily application in which the patch is worn for 24 hours.
Danish: Steady-state-koncentrationer opnås efter en til to dages brug af plasteret og opretholdes på et stabilt niveau ved applikation en gang daglig, hvor plasteret bæres i 24 timer.
English: The changes from baseline in the International RLS Rating Scale (IRLS) and CGI-item 1 (severity of illness) were primary efficacy parameters.
Danish: Ændringen fra baseline af International RLS Rating Scale (IRLS) og CGI-item 1 (sværhedsgrad af sygdom) var primære virkningsparametre.
English: These packages are usually needed for the first four weeks of therapy, but depending on your response to Leganto, you may not need to use all of the dose packages included or you may need additional higher doses after week 4, which are not covered by this package.
Danish: Der er som regel brug for disse æsker til de første fire ugers behandling, men afhængig af Deres reaktion på Leganto har De måske ikke brug for at anvende alle de medfølgende dosisæsker eller De kan få brug for højere doser efter uge 4, som ikke er indeholdt i pakken.
English: The in vitro binding of rotigotine to plasma proteins is approximately 92%.
Danish: Rotigotins invitro-binding til plasmaproteiner er ca. 92%.
English: This should be considered when prescribing rotigotine.
Danish: Dette bør tages i betragtning ved ordinering af rotigotin.
English: The safety and efficacy of rotigotine in children and adolescents have not yet been established.
Danish: Rotigotins sikkerhed og virkning hos børn og unge er endnu ikke klarlagt.
English: These are usually mild or moderate in intensity and transient even if treatment is continued.
Danish: Disse er som regel lette eller moderate i intensitet og forbigående, selvom behandlingen fortsætter.
English: • loss of consciousness, involuntary movements (dyskinesia)
Danish: • tab af bevidsthed, ufrivillige bevægelser (dyskinesi)
English: Augmentation refers to the earlier onset of symptoms in the evening (or even the afternoon), increase in severity of symptoms, and spread of symptoms to involve other body parts.
Danish: Augmentation vil sige, at symptomerne optræder tidligere om aftenen (eller tilmed om eftermiddagen), og at symptomerne forværres og involverer andre kropsdele.
English: Do not use this medicine after the expiry date which is stated on the label and box.
Danish: Brug ikke lægemidlet efter den udløbsdato, der står på etiketten og æsken.
English: Leganto is available in different strength patches which release the medicine over 24 hours.
Danish: Leganto findes i forskellige plaster-styrker, som frigiver medicinen over 24 timer.
English: If any of the above apply to you, do not use Leganto.
Danish: Hvis et eller flere af ovenstående punkter gælder for Dem, skal De ikke bruge Leganto.
English: • visual disturbances such as seeing colours or lights
Danish: • synsforstyrrelser såsom at se farver eller lys
English: • you need to have a magnetic resonance imaging (MRI) scan (diagnostic pictures of the inside of the body, created using magnetic rather than x-ray energy)
Danish: • De skal have foretaget en magnetisk resonans (MR)-scanning (diagnostiske billeder af kroppens inderside dannet ved hjælp af magnetisk energi i stedet for røntgenenergi).
English: Or on your upper body one day, then on your lower body the day after that.
Danish: Eller på Deres overkrop den ene dag og på Deres underkrop den næste dag.
English: Leganto can cause loss of consciousness.
Danish: Leganto kan forårsage bevidsthedstab.
English: Leganto is a patch that is put on the skin.
Danish: Leganto er et plaster, som sættes på huden.
English: This can happen especially when you start using Leganto or when your dose is increased.
Danish: Dette forekommer især, når De begynder med at bruge Leganto eller når Deres dosis øges.
English: The sticky side of the patch should not be touched.
Danish: Den klæbende side af plasteret bør ikke berøres.
English: Following this procedure, rebound (worsening of symptoms beyond initial intensity after discontinuation of treatment) has not been observed.
Danish: Når denne fremgangsmåde er fulgt, er der ikke blevet observet rebound-fænomen (forværring af symptomer i forhold til udgangssymptomer efter seponering af behandlingen).
English: • your blood pressure needs checking regularly while using Leganto, especially at the start of the treatment.
Danish: • Deres blodtryk bør måles regelmæssigt under behandling med Leganto, især i starten af behandlingen.
English: There are no adequate data from the use of rotigotine in pregnant women.
Danish: Der er utilstrækkelige data fra anvendelse af rotigotin til gravide kvinder.
English: Following application, rotigotine is continuously released from the transdermal patch and absorbed through the skin.
Danish: Efter applikation frigives rotigotin kontinuerligt fra depotplasteret og absorberes gennem huden.
English: The percentage of subjects discontinuing was 25-38% over the first year, 10% in the second year, and 11% in the third year.
Danish: Procentdelen af patienter, som seponerede behandlingen, var 25-38% det første år, 10% det andet år og 11% det tredje år.
English: The patch should be applied at approximately the same time every day.
Danish: Plasteret bør påsættes på omtrent samme tidspunkt hver dag.
English: Leganto is for transdermal use.
Danish: Leganto er til transdermal anvendelse.
English: For information on fertility studies, please see section 5.3.
Danish: For information vedrørende fertilitetsstudier, se pkt.
English: Leganto is available in the following pack-sizes:
Danish: Leganto findes i følgende pakningsstørrelser:
English: In vitro results indicate that different CYP isoforms are able to catalyse the N-dealkylation of rotigotine.
Danish: Invitro-resultater viser, at forskellige CYP-isoformer er i stand til at katalysere rotigotins N-dealkylering.
English: The discontinuation rate was studied in 3 clinical trials ranging up to 3 years in duration.
Danish: Seponeringsfrekvensen blev undersøgt i 3 kliniske studier af op til 3 års varighed.
English: Tell your doctor if you lose consciousness or feel dizzy.
Danish: Fortæl det til lægen, hvis De mister bevidstheden eller føler Dem svimmel.
English: Do not stop using Leganto without talking to your doctor.
Danish: Stop ikke med at bruge Leganto uden først at tale med Deres læge.
English: • Parkinson's disease - lowered by 2 mg every other day.
Danish: • Parkinsons sygdom - nedsættes med 2 mg hver anden dag.
English: Doses higher than the approved dose range for RLS should be avoided as this may lead to higher rates of augmentation (see section 5.1).
Danish: Det bør undgås at anvende doser, som er højere end den godkendte dosis for RLS, da dette kan medføre højere forekomst af augmentation (se pkt.
English: Leganto should not be placed on skin that is red, irritated or damaged (see section 4.4).
Danish: Leganto må ikke placeres på hud, som er rød, irriteret eller beskadiget (se pkt.
English: There is no known antidote for overdose of dopamine agonists.
Danish: Der er ingen kendt antidot mod overdosis af dopaminagonister.
English: Pharmacotherapeutic group: Anti-parkinson drugs, dopamine agonists; ATC code: N04BC09
Danish: Farmakoterapeutisk klassifikation: Anti-parkinson midler, dopaminagonister; ATC-kode: N04BC09
English: • Leave the patch on your skin for 24 hours, then take it off and put on a new one.
Danish: • Lad plasteret sidde på huden i 24 timer, tag det derefter af og sæt et nyt plaster på.
English: Furthermore, in this study a higher dose of 4 mg/24 h that is unapproved in RLS was also used and led to higher rates of augmentation.
Danish: I dette studie blev der ydermere givet en højere dosis på 4 mg/24 t, som ikke er godkendt til RLS, hvilket medførte højere forekomst af augmentation.
English: • Shoulder or upper arm.
Danish: • Skulder eller overarm.
English: A sudden stop could lead to a medical condition called ‘neuroleptic malignant syndrome' which could be life-threatening.
Danish: Et pludseligt ophør med behandlingen kan medføre, at De udvikler en sygdomstilstand, der kaldes ‘malignt neuroleptikasyndrom', som kan være livstruende.
English: The dose recommendations made are in nominal dose.
Danish: Dosisanbefalingerne er angivet som den nominelle dosis.
English: Dopamine agonists are known to impair the systemic regulation of the blood pressure resulting in postural/orthostatic hypotension.
Danish: Dopaminagonister er kendt for at svække den systemiske regulering af blodtrykket og dermed forårsage postural/ortostatisk hypotension.
English: Each patch is packed in a sachet and should be applied directly after the sachet has been opened.
Danish: Hvert plaster er pakket i et brev og bør påsættes umiddelbart efter åbning af brevet.
English: Use and handling
Danish: Anvendelse og håndtering
English: After removal, the used patch should be folded in half, adhesive side inwards so that the matrix layer is not exposed, placed in the original sachet and then discarded.
Danish: Efter at plasteret er fjernet, bør det brugte plaster foldes på midten med den klæbende side indad, således at matrixlaget ikke er synligt, placeres i det originale brev og derefter bortskaffes.
English: Prescribers should continually reassess patients for drowsiness or sleepiness, as patients may not acknowledge drowsiness or sleepiness until directly questioned.
Danish: Ordinerende læger bør løbende vurdere patienterne for døsighed eller søvnighed, da patienterne muligvis ikke erkender døsighed eller søvnighed, før de bliver direkte adspurgt.
English: The majority of the adverse reactions of increased CPK observed in all double-blind and open-label studies resolved and were considered mild in severity.
Danish: Hovedparten af bivirkningerne ved forhøjet CK, som blev observeret i alle dobbeltblinde og åbne studier, ophørte og blev vurderet som milde.
English: • Make sure that you take the old patch off before putting on a new one.
Danish: • Sørg for at tage det gamle plaster af, før De sætter et nyt på.
English: • delusions and hallucinations (seeing or hearing things that are not real)
Danish: • vrangforestillinger og hallucinationer (ser eller hører ting, som ikke eksisterer)
English: • seeing or hearing things that are not real (hallucinations)
Danish: • De ser eller hører ting, som ikke er virkelige (hallucinationer)
English: • Parkinson's disease - Leganto can be used on its own or with another medicine called levodopa.
Danish: • Parkinsons sygdom - Leganto kan bruges alene eller sammen med et andet lægemiddel ved navn levodopa.
English: Leganto may affect your blood pressure.
Danish: Leganto kan påvirke Deres blodtryk.
English: If there is a skin rash or irritation from the transdermal system, direct sunlight on the area should be avoided until the skin heals, as exposure could lead to changes in the skin color.
Danish: Hvis depotplasteret forårsager hududslæt eller irritation, bør direkte sollys på området undgås, til huden heler, da udsættelse for sollys kan medføre ændringer i hudfarven.
English: Dialysis would not be expected to be beneficial as rotigotine is not eliminated by dialysis.
Danish: Dialyse kan ikke forventes at have nogen gavnlig virkning, idet rotigotin ikke fjernes ved dialyse.
English: • If the edges of the patch lift, the patch may be taped down with adhesive medical tape.
Danish: • Hvis plasterets kanter løsner sig, kan plasteret fastgøres med selvklæbende medicinsk tape.
English: This makes sure the patch is touching the skin and the edges stick down well.
Danish: Dette sikrer, at plasteret sidder fast på huden, og kanterne klæber godt.
English: • unable to achieve or maintain an erection
Danish: • manglende evne til at få eller bevare rejsning (erektion)
English: Thin, matrix-type, square-shaped with rounded edges, consisting of three layers.
Danish: Tyndt, matrixtype, kvadratisk med afrundede hjørner, bestående af tre lag.
English: • you may feel very sleepy or fall asleep suddenly - see ‘Driving and using machines' in section 2.
Danish: • De kan føle dem meget træt eller pludselig falde i søvn - se ‘Trafik- og arbejdssikkerhed' under punkt 2.
English: • you need ‘cardioversion' (specific treatment for abnormal heart beat).
Danish: • De har behov for ‘kardioversion'(specifik behandling af unormale hjerteslag).
English: The patch remains on the skin for 24 hours and will then be replaced by a new one at a different site of application.
Danish: Plasteret bør blive siddende på huden i 24 timer og bør derefter erstattes af et nyt plaster på et andet applikationssted.
English: INTERMEDIATE BOX (WITHOUT BLUE BOX) BOX OF 28 PATCHES
Danish: INDRE ÆSKE (UDEN “BLUE BOX”) ÆSKE MED 28 PLASTRE
English: • you are allergic to rotigotine or any of the other ingredients of this medicine (listed in section 6)
Danish: • De er allergisk over for rotigotin eller et af de øvrige indholdsstoffer i Leganto (angivet i punkt 6).
English: In repeated dose and long-term toxicity studies, the major effects were associated with the dopamine agonist related pharmacodynamic effects and the consequent decrease of prolactin secretion.
Danish: I studier med gentagne doser og langtidstoksicitet blev de primære effekter forbundet med dopaminagonistrelateret farmakodynamisk effekt og den deraf følgende reducerede prolaktinsekretion.
English: This is so that your family or carer can tell you, or your doctor, if they are worried about any changes in your behaviour.
Danish: Deres familie eller omsorgspersonen kan fortælle Dem eller Deres læge, hvis de er bekymret for forandringer i Deres adfærd.
English: Changes in behaviour and abnormal thinking
Danish: Ændringer i adfærd og unormal tankegang
English: Main metabolites are sulfates and glucuronide conjugates of the parent compound as well as N-desalkyl-metabolites, which are biologically inactive.
Danish: Hovedmetabolitterne er sulfater og glucuronidkonjugater af moderstoffet samt N-desalkyl-metabolitter, som er biologisk inaktive.
English: In a placebo-controlled, 7-week trial polysomnographic parameters were investigated.
Danish: I et placebokontrolleret studie med en varighed på 7 uger, blev polysomnografiske parametre undersøgt.