FrancophonIA/ELRC3.0 huggingface dataset:
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 Neupro (angivet i punkt 6).
English: These symptoms are either reduced or their duration is shortened with Neupro treatment.
Danish: Disse symptomer enten mindskes eller deres varighed forkortes ved behandling med Neupro.
English: You should discuss with your doctor if it is safe for you to drink alcohol while using Neupro.
Danish: De skal spørge Deres læge, om det er sikkert for Dem, at drikke alkohol, mens De bruger Neupro.
English: Your doctor will let you know if it is safe to keep taking these medicines while using Neupro.
Danish: Deres læge vil fortælle Dem, om det er sikkert at fortsætte brugen af disse lægemidler under behandling med Neupro.
English: Because therapy with Neupro 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 Neupro 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: Neupro may decrease blood pressure when you stand up this effect may be worsened by the medicines used to lower blood pressure.
Danish: Neupro kan nedsætte blodtrykket, når De rejser Dem op dette kan forværres af den medicin, som anvendes til at sænke blodtrykket.
English: • your eyes need checking regularly while using Neupro.
Danish: • Deres øjne jævnligt bør undersøges under behandling med Neupro.
English: 4 mg of Neupro every day may be an effective dose for some patients.
Danish: 4 mg Neupro dagligt kan være en effektiv dosis for nogle patienter.
English: Neupro 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: Neupro kan forstærke levodopas dopaminerge bivirkning og forårsage og/eller forværre allerede eksisterende dyskinesi, som beskrevet med andre dopaminerge agonister.
English: There is no relevant use of Neupro in the paediatric population in Parkinson's disease.
Danish: Der er ingen relevant indikation i den pædiatriske population for anvendelse af Neupro til Parkinsons sygdom.
English: Do not breast-feed during treatment with Neupro.
Danish: De må ikke amme under behandling med Neupro.
English: Neupro was not investigated in patients with severe hepatic impairment.
Danish: Neupro er ikke undersøgt hos patienter med svært nedsat leverfunktion.
English: • your blood pressure needs checking regularly while using Neupro, especially at the start of the treatment.
Danish: • Deres blodtryk bør måles regelmæssigt under behandling med Neupro, især i starten af behandlingen.
English: If you experience these symptoms after beginning treatment with Neupro, contact your doctor.
Danish: Hvis De oplever sådanne symptomer, efter De begynder med Neupro, så kontakt Deres Læge.
English: You should take Neupro 2 mg for 7 days (e.g. if you start on a Sunday, switch to the next dose on the following Sunday).
Danish: Anvend Neupro 2 mg i 7 dage (hvis De fx begynder en søndag, skal De skifte til næste dosis den følgende søndag.
English: The backing layer of Neupro contains aluminium.
Danish: Neupros yderste lag indeholder aluminium.
English: If your doctor says you should stop Neupro, the daily dose should be lowered gradually:
Danish: Hvis Deres læge fortæller, at De skal stoppe med Neupro, bør Deres daglige dosis gradvist nedsættes:
English: Neupro may make you feel very sleepy, and you may fall asleep very suddenly.
Danish: Neupro kan gøre Dem meget træt, og De falder måske i søvn meget pludseligt.
English: Neupro 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: Neupro indeholder natriumpyrosulfit, en sulfit der kan forårsage allergilignende reaktioner, herunder anafylaktiske symptomer og livstruende eller mindre alvorlige astmatiske anfald hos visse disponerede personer.
English: Neupro may cause other behaviours and abnormal thinking.
Danish: Neupro kan forårsage andre typer af adfærdsændringer og unormal tankegang.
English: If you have used a different patch (e.g. Neupro 4 mg/24 h instead of Neupro 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 Neupro 4 mg/24 timer i stedet for Neupro 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: Neupro 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: Neupro 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: 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 Neupro, 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 Neupros behandlingseffekt, og samtidig brug bør undgås.
English: Obsessivecompulsive disorder, agitationd
Danish: Obsessivkompulsiv tilstand, agitationd
English: To avoid skin burns, Neupro should be removed if the patient has to undergo magnetic resonance imaging (MRI) or cardioversion.
Danish: For at undgå forbrænding af huden skal Neupro fjernes, hvis patienten skal have foretaget MR-scanning eller kardioversion.
English: Convulsion Dropped head syndromec,e
Danish: Dropped head syndromc, e
English: Using higher doses of Neupro than your doctor has prescribed may cause side effects such as feeling sick (nausea) or vomiting, low blood pressure, seeing or hearing things that are not real (hallucinations), feeling confused, very sleepy, having involuntary movements and convulsions.
Danish: Hvis De bruger højere doser Neupro, end lægen har ordineret, kan det give bivirkninger såsom kvalme eller opkastning, lavt blodtryk, De ser eller hører ting, der ikke er der (hallucinationer), følelse af forvirring, De bliver meget søvnig, ufrivillige bevægelser og kramper.
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 Deres dosis som ordineret af Deres læge.
English: What you need to know before you use Neupro
Danish: Det skal De vide, før De begynder at bruge Neupro
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 ropinirole-group 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 Neupro is observed, Neupro should be discontinued.
Danish: Hvis der observeres en generaliseret hudreaktion (fx allergisk udslæt, inklusive erythem, maculopapulært udslæt eller pruritus) i forbindelse med anvendelsen af Neupro, skal behandlingen seponeres.
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: On the first day of treatment, start with Neupro 2 mg (package marked “Week 1”), and use one Neupro 2 mg transdermal patch daily.
Danish: På behandlingens første dag skal De begynde med Neupro 2 mg (æske mærket “Uge 1)“, og anvende et Neupro 2 mg depotplaster dagligt.
English: Neupro 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: Neupro 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: Other medicines and Neupro
Danish: Brug af anden medicin sammen med Neupro
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: Sleep (PDSS) improved by 4.1 ± 13.8 points for rotigotine-treated 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: • 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 Deres dosis som ordineret af Deres læge.
English: Each pack of 28 transdermal patches for a 4 week treatment schedule contains: 7 transdermal patches of Neupro 2 mg/24 h
Danish: Hver pakning med 28 depotplastre til en 4-ugers behandlingsplan indeholder: 7 depotplastre med Neupro 2 mg/24 timer
English: UCB Α.Ε.
Danish: UCBΑ.Ε.
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: Brug af Neupro sammen med mad, drikke og alkohol Da rotigotin kommer ind i blodbanen igennem huden, påvirker mad eller drikke ikke den måde, hvorpå denne medicin optages i kroppen.
English: • dropped head syndrome
Danish: Dropped head syndromc
English: You must take your Neupro patch off just before undergoing magnetic resonance imaging (MRI) or cardioversion to avoid skin burns because the patch contains aluminium.
Danish: De skal tage Neupro-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: Neupro 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 - the symptoms are mainly seen in patients with Parkinson's disease.
Danish: Neupro 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 - symptomerne ses hovedsageligt hos patienter med Parkinsons sygdom.
English: The Neupro treatment initiation pack contains 4 different packages (one for each strength) with 7 patches in each package.
Danish: Neupro-pakken til indledende behandling indeholder 4 forskellige æsker (en for hver styrke) med 7 plastre i hver æske.
English: BOX OF 7 [14] [28] [30] PATCHES
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE ÆSKE MED 7 [14] [28] [30] PLASTRE
English: If you have to stop taking this medicine, see ‘If you stop using Neupro' in section 3.
Danish: Hvis De skal holde op med at bruge denne medicin, se ‘Hvis De holder op med at bruge Neupro' under punkt 3.
English: Neupro contains sodium metabisulphite (E223) Sodium metabisulphite (E223) may rarely cause severe hypersensitivity (allergic) reactions and bronchospasm (breathing distress caused by narrowing of the airways).
Danish: Neupro indeholder natriumpyrosulfit (E 223) Natriumpyrosulfit (E 223) kan i sjældne tilfælde forårsage alvorlige overfølsomhedsreaktioner (allergi) og astmalignende anfald (åndedrætsbesvær forårsaget af forsnævrede luftveje).
English: Aggressive behaviour/ aggressionb, disorientationd
Danish: Aggressiv opførsel/aggress ionb, desorienteringd
English: Neupro is used in adults to treat the signs and symptoms of:
Danish: Anvendelse Neupro anvendes af voksne til behandling af sygdomstegn og symptomer på:
English: Side effects when using Neupro for Parkinson's disease Tell your doctor, pharmacist or nurse if you get any of the following side effects:
Danish: Bivirkninger, hvis De bruger Neupro mod Parkinsons sygdom Fortæl det til lægen, apotekspersonalet eller sundhedspersonalet, hvis De får en eller flere af følgende bivirkninger:
English: Neupro treatment initiation pack contains 4 different packages (one for each strength) with 7 patches each, for the first four weeks of therapy.
Danish: Neupro-pakken til indledende behandling indeholder 4 forskellige æsker (en for hver styrke) med 7 plastre i hver æske til de første fire ugers behandling.
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: • Do not cut the Neupro patches into pieces.
Danish: • Klip ikke Neupro-plastrene i stykker.
English: 7 transdermal patches 14 transdermal patches 28 transdermal patches 30 transdermal patches
Danish: 7 depotplastre 14 depotplastre 28 depotplastre 30 depotplastre
English: Warnings and precautions Talk to your doctor, pharmacist or nurse before using Neupro.
Danish: Advarsler og forsigtighedsregler Kontakt lægen, apotekspersonalet eller sundhedspersonalet, før De bruger Neupro.
English: The majority of application site reactions were mild or moderate in intensity, limited to the application areas and resulted in discontinuation of Neupro in 7.2% of subjects.
Danish: Størstedelen af reaktionerne på applikationsstedet var lette eller moderate i intensitet, begrænset til applikationsområderne og førte hos 7,2% af patienterne til seponering af behandlingen med Neupro.
English: The majority of application site reactions were mild or moderate in intensity, limited to the application areas and resulted in discontinuation of treatment with Neupro in only 4.3% of all subjects receiving Neupro.
Danish: Størstedelen af reaktionerne på applikationsstedet var lette eller moderate i intensitet, begrænset til applikationsområderne og førte hos 4,3% af patienterne til seponering af behandlingen med Neupro.
English: Based on the analysis of pooled placebo-controlled clinical trials comprising a total of 748 Neupro- and 214 placebo-treated patients, 65.5% of the patients on Neupro and 33.2% of patients on placebo reported at least one adverse reaction.
Danish: Baseret på analysen af de samlede placebo-kontrollerede kliniske studier, som i alt omfatter 748 Neupro- og 214 placebo-behandlede patienter, rapporterede 65,5% af patienterne i Neupro-gruppen og 33,2% af patienterne i placebo-gruppen mindst en bivirkning.
English: Based on the analysis of pooled placebo-controlled clinical trials comprising a total of 1,307 Neuproand 607 placebo-treated patients, 72.5% of the patients on Neupro and 58.0% of patients on placebo reported at least one adverse reaction.
Danish: Baseret på analysen af de samlede placebo-kontrollerede kliniske studier, som i alt omfatter 1.307 Neupro- og 607 placebo-behandlede patienter, rapporterede 72,5% af patienterne i Neupro-gruppen og 58,0% af patienterne i placebo-gruppen mindst en bivirkning.
English: hypersexuality, libido increased), confusional state, disorientationd, agitationd
Danish: hyperseksualite t, øget libido), forvirring, desorienteringd, agitationd
English: This is known as ‘dopamine dysregulation syndrome' and can lead to use of too much Neupro.
Danish: Det kaldes ‘dopamin-dysregulations-syndrom' og kan føre til overforbrug af Neupro.
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.
English: Side effects when using Neupro for Restless Legs Syndrome Tell your doctor or pharmacist if you notice any of the following side effects:
Danish: Bivirkninger, hvis De bruger Neupro mod restless legs-syndrom Fortæl det til lægen, apotekspersonalet eller sundhedspersonalet, hvis De bemærker en eller flere af følgende bivirkninger:
English: Ю СИ БИ България ЕООД Teл.
Danish: ЮСИБИБългарияЕООД Teл.
English: For doses higher than 8 mg/24 h (doses prescribed by your doctor above the available strengths), multiple patches must be applied to achieve the final dose.
Danish: Til doser højere end 8 mg/24 timer (doser ordineret af Deres læge som er højere end de tilgængelige styrker) bruges flere plastre for at opnå den endelige dosis.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE KUN MULTIPACKS
English: How to use Neupro
Danish: Sådan skal De bruge Neupro
English: Fall e a High Level Term b Observed in open-label studies c Observed during post-marketing d Observed in 2011 data pool of double-blind placebo-controlled studies e Observed in studies performed in patients with Parkinson's disease
Danish: Falde a) Overordnet begreb (high level term) b) Observeret i åbne studier c) Observeret efter markedsføring d) Observeret i data pool af dobbeltblinde, placebokontrollerede studier i 2011 e) Observeret i studier med patienter med Parkinsons sygdom
English: Adverse drug reactions (ADRs) reported in more than 10% of patients treated with Neupro are nausea, application site reactions, asthenic conditions and headache.
Danish: Bivirkninger rapporteret hos mere end 10% af patienterne behandlet med Neupro er kvalme, reaktioner på administrationsstedet, asteniske symptomer og hovedpine.
English: For example, a daily dose of 14 mg can be reached by applying one patch of 6 mg/24 h and one patch of 8 mg/24 h and likewise, a daily dose of 16 mg can be reached by applying two patches of 8 mg/24 h.
Danish: For eksempel kan en daglig dosis på 14 mg nås ved at bruge ét plaster på 6 mg/24 timer og ét plaster på 8 mg/24 timer, og ligeledes kan en daglig dosis på 16 mg nås ved at bruge to plastre på 8 mg/24 timer.
English: This is known as ‘dopamine dysregulation syndrome' and can lead to use of too much Neupro
Danish: Det kaldes ‘dopamin-dysregulations-syndrom' og kan føre til overforbrug af Neupro
English: • Stick the Neupro patch onto your skin as soon as you have opened the sachet and removed the release liner.
Danish: • Neupro-plasteret skal klæbes på huden, så snart brevet er åbnet og den aftagelige beskyttelsesfilm er fjernet.
English: Psychotic disorder, obsessivecompulsive disorder, aggressive behaviour/ aggressionb, delusiond, deliriumd
Danish: Psykotisk lidelse, obsessivkompulsiv sygdom, aggressiv opførsel/aggres sionb, vrangforestillin gerd, deliriumd
English: Sleep attacks/sudden onset of sleep, paranoia, sexual desire disordersa
Danish: Søvnanfald/plu dselig søvn, paranoia, forstyrret seksuel adfærda
English: Always use this medicine exactly as your doctor or pharmacist has told you.
Danish: Brug altid Neupro nøjagtigt efter lægens eller apotekspersonalets anvisning.
English: In trials where the application sites were rotated as reflected in the instructions provided in the SmPC and package leaflet, 34.2% of 748 patients using Neupro, experienced application site reactions.
Danish: I studier, hvor applikationsstedet blev vekslet som beskrevet i instruktionerne i produktresumeet og indlægssedlen, fik 34,2% af de 748 patienter, som brugte Neupro, reaktioner på applikationssstedet.
English: The strengths are 1 mg/24 h, 2 mg/24 h and 3 mg/24 h for the treatment of Restless Leg Syndrome.
Danish: Styrkerne er: 1 mg/24 timer, 2 mg/24 timer og 3 mg/24 timer til behandlingen afrestless legs-syndrom.
English: The daily dose should be reduced in steps of 2 mg/24 h with a dose reduction preferably every other day, until complete withdrawal of Neupro (see section 4.4).
Danish: Den daglige dosis bør reduceres i trin på 2 mg/24 t, hvor dosisreduktion hver anden dag er at foretrække, indtil behandlingen med Neupro er ophørt helt (se pkt.
English: In trials where the application sites were rotated as reflected in the instructions provided in SmPC and package leaflet, 35.7% of 830 patients using the Neupro transdermal patch, experienced application site reactions.
Danish: I studier, hvor applikationsstedet blev vekslet som beskrevet i instruktionerne i produktresumeet og indlægssedlen, fik 35,7% af de 830 patienter, som brugte Neupro, reaktioner på applikationssstedet.
English: Boxes containing 7, 14, 28, 30 or 84 (multipack containing 3 packs of 28) patches, which are individually sealed in sachets.
Danish: Æsker indeholdende 7, 14, 28, 30 eller 84 (multipakning med 3 pakninger a 28) plastre, som er individuelt forseglede i breve.
English: The daily dose should be reduced in steps of 1 mg/24 h with a dose reduction preferably every other day, until complete withdrawal of Neupro (see section 4.4).
Danish: Den daglige dosis bør reduceres i trin på 1 mg/24 t, hvor dosisreduktion hver anden dag er at foretrække, indtil behandlingen med Neupro er ophørt helt (se pkt.
English: Hypersensitivity, which may include angioedema, tongue oedema and lip oedema
Danish: Overfølsomhed, hvilket kan omfatte angioødem og ødem i tunge og læbe
English: Adverse drug reactions (ADRs) reported in more than 10% of patients treated with Neupro transdermal patch are nausea, vomiting, application site reactions, somnolence, dizziness and headache.
Danish: Bivirkninger rapporteret hos mere end 10% af patienterne behandlet med Neupro er kvalme, opkastninger, reaktioner på applikationsstedet, døsighed, svimmelhed og hovedpine.
English: Tell your doctor if you notice any changes in behaviour, thinking or both, that are listed below.
Danish: Fortæl det til lægen, hvis De oplever ændringer i Deres adfærd, tankegang eller begge dele, se nedenstående liste.
English: For most patients with early stage Parkinson's disease, the right dose is reached within 3 or 4 weeks, at doses of 6 mg per day or 8 mg per day, respectively.
Danish: De fleste patienter med Parkinsons sygdom på tidlige stadier når den passende dosis inden for 3-4 uger ved doser på henholdsvis 6 mg dagligt eller 8 mg dagligt.
English: At the end of maintenance, the mean UPDRS part III score had improved by 7.0 points in rotigotine-treated patients (baseline 29.6), and by 3.9 points in the placebo group (baseline 32.0).
Danish: Ved slutningen af vedligeholdelsesbehandlingen var den gennemsnitligeUPDRS-score del III forbedret med 7,0 point hos de patienter, som blev behandlet med rotigotin (baseline 29,6), og med 3,9 point hos de patienter, som fik placebo (baseline 32,0).
English: The box contains 7, 14, 28, 30 or 84 (multipack containing 3 packs of 28) transdermal patches, individually sealed in sachets.
Danish: Æsken indeholder 7, 14, 28, 30 eller 84 (multipakning med 3 pakninger a 28) depotplastre, individuelt forseglede i breve.
English: What Neupro is Neupro contains the active substance rotigotine.
Danish: Virkning Neupro indeholder det aktive stof rotigotin.