FrancophonIA/ELRC3.0 huggingface dataset:
English: However, for the CHMP, this population of patients should be defined as moderate to severe idiopathic RLS.
Danish: CHMP er imidlertid af den opfattelse, at denne patientpopulations tilstand bør defineres som moderat til svær idiopatisk RSL.
English: Adverse drug reactions reported in 12-week Restless Legs Syndrome clinical trials (ropinirole n=309, placebo n=307)
Danish: Tabel 2: Bivirkninger rapporteret i 12-ugers RLS kliniske undersøgelser (ropinirol n=309, placebo n=307)
English: Hence, ropinirole is unlikely to affect the pharmacokinetics of other medicinal products, via a cytochrome P450 mechanism.
Danish: Derfor er det usandsynligt, at ropinirol vil påvirke andre lægemidlers farmakokinetik via en cytochrom P450 mekanisme.
English: If you have missed taking ADARTREL for more than a few days consult your doctor for advice on restarting ADARTREL.
Danish: Hvis du har glemt at tage Adartrel i mere end få dage, så tal med din læge om, hvordan du skal starte behandlingen igen.
English: A pharmacokinetic interaction study between ropinirole (at a dose of 2 mg, three times a day) and theophylline, a substrate of CYP1A2, revealed no change in the pharmacokinetics of either ropinirole or theophylline.
Danish: En farmakokinetisk interaktionsundersøgelse mellem ropinirol (med en dosis på 2 mg 3 gange daglig) og theofyllin, som repræsentant for et CYP1A2-substrat, viste ingen ændringer i farmakokinetikken af hverken ropinirol eller theofyllin.
English: The recommended initial dose is 0.25 mg once daily (administered as above) for 2 days.
Danish: Den anbefalede initiale dosis er 0,25 mg en gang dagligt i 2 dage (administreret som nævnt ovenfor).
English: The reported rates in the literature of augmentation associated with dopamine agonists including ropinirole are generally lower than the ones reported for levodopa.
Danish: Den dokumenterede indberetningsfrekvens for augmentation i forbindelse med dopaminagonister, herunder ropinirol, er generelt lavere end for levodopa.
English: Although sufficient data are not available to adequately demonstrate the long term efficacy of ropinirole in Restless Legs Syndrome (see section 4.2), in a 36-week study, patients who continued on ropinirole demonstrated a significantly lower relapse rate compared with patients randomised to placebo (33% versus 58%, p=0.0156).
Danish: Der er ikke tilstrækkelige data tilgængelige til at bevise langtidseffekt af ropinirol i Restless Legs Syndrome (se sektion 4.2), men i en 36 ugers undersøgelse med patienter i fortsat behandling med ropinirol viste signifikant færre tilbagefald sammenlignet med patienter randomiseret til placebo (33% versus 58%, p=0,0156).
English: Therefore the CHMP has recommended that there are no objections for the granting of the Marketing Authorisation for Adartel, in the treatment of symptomatic treatment of moderate to severe idiopathic restless legs syndrome.
Danish: CHMP har derfor anbefalet, at der ikke fremsættes indsigelser mod udstedelse af en markedsføringstilladelse for Adartel til symptomatisk behandling af moderat til svær idiopatisk Restless Legs Syndrome.
English: ADARTREL should not be used during breast-feeding as milk production may be affected.
Danish: Hvis du ammer, må du ikke tage Adartrel, da mælkeproduktionen kan påvirkes.
English: In patients already receiving hormone replacement therapy, ropinirole treatment may be initiated in the usual manner.
Danish: Hos patienter i HRT-behandling , kan behandling med ropinirol initieres på normal vis.
English: If your symptoms worsen after you stop treatment with ADARTREL, you should contact your doctor.
Danish: Hvis dine symptomer bliver værre efter du er stoppet med at tage Adartrel, så kontakt lægen.
English: Ropinirole should be taken just before bedtime, however the dose can be taken up to 3 hours before retiring.
Danish: Ropinirol bør tages lige før sengetid, men kan tages op til tre timer før.
English: INFORMATION IN BRAILLE {To be completed nationally}
Danish: INFORMATION I BRAILLE-SKRIFT <[Udfyldes nationalt]>
English: Hallucinations were reported uncommonly in the open label long-term studies.
Danish: Hallucinationer forekom ikke almindeligt i en åben langtidsundersøgelse.
English: In patients with mild to moderate renal impairment (creatinine clearance between 30 and 50 ml/min), no change in the pharmacokinetics of ropinirole is observed.
Danish: Hos patienter med mild til moderat nedsat nyrefunktion (kreatinin clearance mellem 30 og 50 ml/min) er der ikke set ændring i ropinirols farmakokinetik.
English: Whilst the adverse events of nausea, vomiting, dizziness and somnolence occurred more frequently with ropinirole treatment than with placebo, the majority of patients had events that were mild to moderate in severity.
Danish: Bivirkninger som kvalme, svimmelhed, søvntrang og opkastning forekom hyppigere ved behandling med ropinirol end med placebo, men bivirkningerne hos størstedelen af patienterne var af mild til moderat sværhedsgrad.
English: The more common side effects of ADARTREL can happen when some patients first start their therapy and/or when the dose is increased.
Danish: De mere almindelige bivirkninger af Adartrel kan forekomme i starten af behandlingen eller når dosis øges.
English: In Restless Legs Syndrome clinical trials the most common adverse drug reaction was nausea (approximately 30% of patients).
Danish: I kliniske undersøgelser vedrørende RLS var den mest almindelige bivirkning kvalme (cirka 30% af patienterne).
English: In a combined analysis of moderate to severe Restless Legs Syndrome patients from the four 12-week studies, the adjusted treatment difference for the change from baseline in IRLS scale total score at week 12 Last Observation Carried Forward (LOCF) Intention To Treat population was -4.0 points (95% CI -5.6,2.4, p<0.0001; baseline and week 12 LOCF mean IRLS points: ropinirole 28.4 and 13.5; placebo 28.2 and 17.4).
Danish: Ved en kombineret analyse af patienter med moderat til svær RLS fra de fire 12-ugers undersøgelser var den tilnærmede behandlingsforskel for ændringen fra baseline i IRLS skalaens totale score uge 12 Last Observation Carried Forward (LOCF) Intention to Treat population -4,0 points (95% CI -5,6, -2,4, p<0,0001; baseline og uge 12 LOCF middel IRLS points: ropinirol 28,4 og 13,5; placebo 28,2 og 17,4).
English: Vomiting, nausea
Danish: Opkastning, kvalme,
English: If you suffer from these effects you must not drive or put yourself in a situation where sleepiness or falling asleep may put you at risk of serious injury or death (for example using machinery) until these episodes have been resolved.
Danish: Hvis du har mærket dette må du ikke køre bil eller bringe dig selv i en situation, hvor søvnighed eller det at falde i søvn kan give risiko for alvorlige skader eller død (for eksempel brug af maskiner).
English: Restless Legs Syndrome is a condition characterised by an irresistible urge to move the legs and occasionally the arms, usually accompanied by uncomfortable sensations such as tingling, burning or prickling.
Danish: Ved Restless Legs Syndrome har man en uimodståelig trang til at bevæge benene og somme tider også armene, normalt ledsaget af ubehag i form af snurren, prikken eller en brændende fornemmelse.
English: The mean dose of ropinirole for the moderate to severe patients was 2.0 mg/day.
Danish: Middeldosis af ropinirol i patienterne med moderat til svær RLS var 2,0 mg/dag.
English: If you have trouble remembering when to take your medicine, ask your pharmacist for some hints.
Danish: Hvis du har problemer med at huske at tage din medicin, så spørg apoteket til råds.
English: This leaflet was last approved in
Danish: Denne indlægsseddel blev senest godkendt den { MM/ÅÅÅÅ }
English: In Parkinson's disease, ropinirole is associated with somnolence and has been associated uncommonly (>1/1,000, <1/100) with excessive daytime somnolence and sudden sleep onset episodes, however, in Restless Legs Syndrome, this phenomenon is very rare (<1/10,000).
Danish: Ved Parkinsons sygdom er ropinirol forbundet med somnolens og har ikke almindeligt (>1/1000, <1/100) været forbundet med udpræget somnolens i dagtimerne og pludselig indtræden af søvn, men ved behandling af Restless Legs Syndrome er dette fænomen meget sjældent (<1/10.000).
English: The dose may be increased to 1 mg once a day at week 2.
Danish: Dosis kan evt. øges til 1 mg en gang daglig i uge 2.
English: After three months of treatment with ADARTREL, your doctor may adjust your dose or discontinue your treatment depending on your symptoms and how you feel.
Danish: Efter 3 måneders behandling med Adartrel, kan lægen - afhængig af hvordan du har det - justere dosis eller afbryde behandlingen.
English: Tell your doctor immediately if you are breast-feeding or if you are planning to breast-feed.
Danish: Fortæl straks lægen, hvis du ammer eller hvis du planlægger at amme dit barn.
English: In the four 12-week efficacy studies, patients with Restless Legs Syndrome were randomised to ropinirole or placebo, and the effects on the IRLS scale scores at week 12 were compared to baseline.
Danish: I de fire 12 ugers effektstudier blev patienter med Restless Legs Syndrome randomiseret til at få ropinirol eller placebo og effekten på scoren på IRSL skalaen i uge 12 blev sammenlignet med baseline.
English: Dopamine agonists act like a naturally occurring chemical in your brain called dopamine.
Danish: Dopaminagonister virker som det naturligt forekommende stof i hjernen: Dopamin.
English: EXPIRY DATE exp {MM YYYY}
Danish: UDLØBSDATO exp {MM YYYY} BATCHNUMMER lot {XYYYY} ANDET
English: In Parkinson's disease, ropinirole has been associated uncommonly with somnolence and episodes of sudden sleep onset (see section 4.8) however, in Restless Legs Syndrome, this phenomenon is very rare.
Danish: Ved Parkinsons sygdom er ropinirol - ikke almindeligt - sat i forbindelse med somnolens og episoder, hvor patienten pludseligt falder i søvn (se sektion 4.8), men ved Restless Legs Syndrome et dette fænomen meget sjældent.
English: B. LABELLING
Danish: B. MÆRKNING PÅ EMBALLAGE
English: The effect of ADARTREL may be increased or decreased by other medicines and vice versa.
Danish: Virkningen af Adartrel kan øges eller mindskes sammen med anden medicin, og virkningen af anden medicin kan påvirkes af Adartrel.
English: If you find you have forgotten to take your dose of ADARTREL do not take an extra dose to make up for forgotten individual doses.
Danish: Hvis du finder ud af, at du har glemt at tage din dosis Adartrel, så lad være med at tage en ekstra dosis, men tag i stedet din næste dosis til sædvanlig tid.
English: Neuroleptics and other centrally active dopamine antagonists, such as sulpiride or metoclopramide, may diminish the effectiveness of ropinirole and, therefore, concomitant use of these medicinal products with ropinirole should be avoided.
Danish: Neuroleptika og andre centralt aktive dopaminantagonister, som for eksempel sulpirid eller metoklopramid, kan formindske effektiviteten af ropinirol.
English: Furthermore, a reduction of dosage or termination of therapy may be considered.
Danish: Reduktion af dosis eller seponering af behandlingen bør desuden overvejes.
English: Severe renal impairment (creatinine clearance <30 ml/min)
Danish: Svær nedsat nyrefunktion (kreatininclearance < 30 ml/min).
English: In clinical trials, although the average IRLS total scores 7-10 days after withdrawal of therapy were higher in ropinirole-treated patients than in placebo-treated patients, the severity of symptoms following withdrawal of therapy generally did not exceed the baseline assessment in ropinirole-treated patients.
Danish: Skønt middel IRLS total score 7-10 dage efter behandlingsstop var højere i ropinirolbehandlede patienter end i placebobehandlede patienter i kliniske undersøgelser, overskred sværhedsgraden af symptomerne efter behandlingsstop ikke baseline assessment i de ropinirolbehandlede patienter.
English: If during treatment your symptoms become worse, start earlier in the day or after less time at rest, or affect other parts of your body such as your arms, you should see your doctor who may adjust the dose of ADARTREL that you are taking.
Danish: Hvis dine symptomer bliver værre i forbindelse med behandlingen, eller starter tidligere på dagen, efter kortere tids hvile, eller generer andre steder på kroppen, bør du tale med lægen om at justere dosis af Adartrel.
English: Ropinirole is mainly metabolised by the isoform CYP1A2 of cytochrome P450.
Danish: Ropinirol metaboliseres primært af den isoforme CYP1A2 af cytochrome P450.
English: The starting dose is 0.25 mg once daily.
Danish: Man starter med 0,25 mg en gang dagligt.
English: The analysis of Serious Adverse Events (SAE) was unremarkable in the overall group of patients enrolled in the ropinirole clinical studies.
Danish: Analysen af alvorlige bivirkninger var normal i den overordnede gruppe af patienter, der var tilmeldt de kliniske undersøgelser af ropinirol.
English: None of the many metabolites formed are involved in the resulting activity of the product and the main metabolite is 100 times less potent than ropinirole in animal models examining dopaminergic function.
Danish: Den primære metabolit er 100 gange mindre potent end ropinirol i dyremodeller til undersøgelse af den dopaminerge funktion.
English: - The other ingredients are Tablet core:
Danish: - De øvrige indholdsstoffer er
English: A 12-week placebo-controlled polysomnography study in Restless Legs Syndrome patients examined the effect of treatment with ropinirole on periodic leg movements of sleep.
Danish: I en 12 ugers placebokontrolleret polysomnografiundersøgelse i Restless Legs Syndrome patienter blev effekten af ropinirolbehandling undersøgt på periodiske benbevægelser (PLM) i søvne.
English: Ropinirole is principally metabolised by the cytochrome P450 isoenzyme CYP1A2.
Danish: Ropinirol metaboliseres fortrinsvis af cytochrom P450 isoenzymet CYP1A2.
English: The benefit-risk assessment is considered favourable for the moderate to severe RLS as defined in the SPC.
Danish: Benefit/risk-forholdet for den moderate til svære RLS, som defineret i produktresuméet, anses for at være gunstigt.
English: Titanium dioxide (E171) Polysorbate 80 (E433).
Danish: Titandioxid (E171) Polysorbat 80 (E433)
English: ADARTREL is indicated for the symptomatic treatment of moderate to severe idiopathic Restless Legs Syndrome (see section 5.1).
Danish: Adartrel er indiceret til symptomatisk behandling af moderat til svær idiopatisk Restless Legs Syndrome (RLS) (se afsnit 5.1).
English: A combined analysis of data from moderate to severe Restless Legs Syndrome patients, in the four 12-week placebo-controlled studies, indicated that ropinirole-treated patients reported significant improvements over placebo on the parameters of the Medical Outcome Study Sleep Scale (scores on 0-100 range except sleep quantity).
Danish: En kombineret analyse af data fra de fire 12-ugers placebokontrollerede undersøgelser i moderat til svære Restless Legs Syndrome patienter viste, at patienter i ropinirolbehandling rapporterede signifikant forbedring i forhold til placebo på parametrene i Medical Outcome Study Sleep Scale (score på 0-100 undtagen søvnmængde).
English: If you suffer from extreme sleepiness or suddenly fall asleep without apparently feeling sleepy, do not drive or use machinery, and contact your doctor.
Danish: Hvis du er meget søvnig eller pludselig falder i søvn uden varsel, så lad være med at køre eller bruge maskiner.
English: The MAH agreed to revise also section 5.1, to specify that ropinirole treated patients had higher IRLS scores at follow up assessment compared to placebo treated patients.
Danish: Markedsføringsindehaveren indvilligede i at ændre afsnit 5.1 med henblik på at præcisere, at patienter behandlet med ropinirol havde et højere scoringsresultat på den internationale RLS-graderingsskala end patienter behandlet med placebo ved den opfølgende vurdering.
English: The MAH agreed to revise the SPC, sections 4.2 and 5.1, to specify that ropinirole is indicated in moderate to severe idiopathic restless legs syndrome.
Danish: Markedsføringsindehaveren indvilligede i at indføje en ændring i produktresuméets afsnit 4.2 og 5.1 med henblik på at præcisere, at ropinirol er indiceret til behandling af moderat til svær idiopatisk Restless Legs Syndrome.
English: - If any of the side effects become serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
Danish: - Hvis en bivirkning bliver alvorlig eller du bemærker nogen form for bivirkninger, som ikke er nævnt i denne indlægsseddel, bør du fortælle det til din læge eller apotek.
English: If you take more ADARTREL than you should Someone who has taken an overdose may experience; feeling or being sick, dizziness (or spinning sensation), feeling drowsy, fatigue (mental or physical tiredness), stomach pain, fainting or nervousness.
Danish: Hvis man har taget en overdosis kan man få kvalme eller kaste op, blive ør eller rundtosset, føle sig døsig eller træt, få mavepine, besvime eller blive nervøs.
English: Swallow the ADARTREL tablet(s) whole with water.
Danish: Slug tabletten hel med et glas vand.
English: - are pregnant or think you are pregnant - are breast-feeding - are intolerant to some sugars (e.g. lactose) - have liver disease - have a serious heart complaint - have a serious mental health problem In these situations your doctor should carefully supervise the treatment.
Danish: - er gravid eller tror du er gravid - du ammer - er overfølsom over for visse sukkerarter (f.eks. lactose) - har en leversygdom - hvis du har alvorlige hjerteproblemer - hvis du har eller har haft en alvorlig mental sygdom I disse tilfælde skal lægen overvåge behandlingen omhyggeligt.
English: If the undesirable effect abates, gradual up-titration can be re-instituted.
Danish: Hvis bivirkningerne fortager sig, kan der igen gradvist optitrereres.
English: Table 2 lists the adverse drug reactions reported for ropinirole in the 12-week clinical trials at ≥1.0% above the placebo rate or those reported uncommonly but known to be associated with ropinirole.
Danish: I tabel 2 er listet de bivirkninger der er rapporteret for ropinirol i 12 ugers undersøgelser, og som optræder ≥ 1% over hyppigheden for placebo, eller som er rapporteret som ikke almindelig, men hvor det vides, at de er forbundet med ropinirol.
English: If this dose is well tolerated the dose should be increased to 0.5 mg once daily for the remainder of week 1.
Danish: Hvis denne dosis er veltolereret, øges dosis til 0,5 mg en gang dagligt resten af ugen.
English: Also uncommonly, ADARTREL can reduce blood pressure, which may make you feel dizzy or faint especially when standing up from a sitting or lying position.
Danish: Adartrel kan også give blodtryksfald, som kan vise sig ved at du føler dig svimmel eller besvimer, når du rejser dig fra siddende eller liggende stilling.
English: The MAH has defined severe idiopathic RLS as those patients who have an International Restless Legs Syndrome Rating Scale (IRLS) baseline score of 24 points or more.
Danish: Markedsføringsindehaveren har defineret svær idiopatisk RSL som en tilstand hos patienter, der har opnået et scoringsresultat ved baseline på 24 point eller mere på den internationale RLSgraderingsskala (IRLS).
English: Lactose monohydrate Microcrystalline cellulose Croscarmellose sodium Magnesium stearate.
Danish: Lactose monohydrat Mikrokrystallinsk cellulose Natrium croscarmellose Magnesiumstearat.
English: Adverse drug reactions reported in Parkinson's disease clinical trials at doses up to 24 mg/day
Danish: Tabel 3: Bivirkninger rapporteret ved brug til patienter med Parkinsons sygdom i kliniske undersøgelser i doser op til 24 mg/dag
English: Moderate to severe Restless Legs Syndrome is typically represented by patients who have difficulty sleeping or severe discomfort in their legs or arms.
Danish: Moderat til svær Restless Legs Syndrome viser sig ofte ved søvnproblemer eller svært ubehag i arme eller ben.
English: The adverse drug reactions reported in patients with Parkinson's disease on ropinirole monotherapy and adjunct therapy at doses up to 24 mg/day at an excess incidence over placebo are described below.
Danish: Bivirkninger rapporteret ved brug til patienter med Parkinsons sygdom, enten som monoterapi eller som tillægsterapi i doser op til 24 mg/dag bestemt som incidens i forhold til placebo, er beskrevet nedenfor.
English: ADARTREL should only be prescribed to patients with moderate to severe idiopathic Restless Legs Syndrome.
Danish: Adartrel bør kun ordineres til patienter med moderat til svær idiopatisk Restless Legs Syndrome.
English: The dose may then be increased by 0.5 mg per week over the next two weeks to a dose of 2 mg once a day.
Danish: Dosis kan derefter øges med 0,5 mg om ugen over de næste 2 uger til en dosis på 2 mg en gang daglig.
English: Taking ADARTREL with food and drink Taking ADARTREL with food may reduce the likelihood of you feeling or being sick.
Danish: Hvordan man tager Adartrel sammen med mad og drikkevarer Hvis du tager Adartrel sammen med mad kan det mindske tendensen til at få kvalme eller opkastning.
English: During treatment with ropinirole, paradoxical worsening of Restless Legs Syndrome symptoms occurring with earlier onset (augmentation), and reoccurrence of symptoms in the early morning hours (early morning rebound), may be observed.
Danish: Ved behandling med ropinirol er observeret paradoksal forværring af Restless Legs Syndrome , hvor symptomerne begynder tidligere på dagen end forventet (augmentation) og symptomerne vender tilbage tidligt på morgenen (rebound effekt).
English: Severe hepatic impairment.
Danish: Svær nedsat leverfunktion.
English: Do not store above 25°C.
Danish: Må ikke opbevares ved over 25ºC.
English: This Marketing Authorisation is subject to conditions considered essential for the safe and effective use of the medicinal product, which are that a long-term, double-blind, placebo controlled trial should be conducted as a post-marketing commitment (see Annexe IV).
Danish: Der skal gennemføres en langsigtet, dobbeltblind, placebokontrolleret undersøgelse som en del af forpligtelserne efter markedsføring (se bilag IV).
English: Your doctor will advise you to discontinue this medicine.
Danish: Lægen vil råde dig til at holde op med at tage Adartrel.
English: GlaxoSmithKline GmbH & Co. KG, Theresienhöhe 11, 80339 München, Germany
Danish: KG, Theresienhöhe 11, 80339 München, Germany
English: ADARTREL belongs to a group of medicines called dopamine agonists.
Danish: 1 HVAD ADARTREL ER, OG HVAD DET ANVENDES TIL Adartrel hører til den gruppe af medicin som kaldes dopaminagonister.
English: In some patients, to achieve optimal improvement, the dose may be increased gradually up to a maximum of 4 mg once a day.
Danish: Til nogle patienter kan dosis øges gradvist op til maksimalt 4 mg en gang daglig for at opnå optimal forbedring.
English: During treatment with ADARTREL you may experience unusual worsening of symptoms (e.g. symptoms become worse, start earlier in the day or after less time at rest, or affect other parts of your body such as your arms).
Danish: Under behandling med Adartrel kan du opleve at symptomerne bliver værre, eller starter tidligere på dagen, efter kortere tids hvile, eller generer andre steder på kroppen.
English: 6 FURTHER INFORMATION What ADARTREL contains - The active substance is ropinirole (as hydrochloride)
Danish: Hvad Adartrel indeholder - Det aktive stof er ropinirol (som hydrchlorid)
English: Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Danish: Hvis du tager eller for nylig har taget andre lægemidler, bør du oplyse din læge eller apotek herom, også hvis der er tale om ikke-receptpligtige lægemidler.
English: Anti-nausea medicinal products that are not centrally active dopamine antagonists, such as domperidone, may be used, if required.
Danish: Antikvalmemiddel, som for eksempel domperidon, kan bruges, om nødvendigt.
English: 2 BEFORE YOU TAKE ADARTREL
Danish: 2 HVAD DU SKAL GØRE, FØR DU BEGYNDER AT TAGE ADARTREL
English: Management of undesirable effects
Danish: Behandling af bivirkninger