natgillin/translations-raw huggingface dataset:
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.
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.
Dopaminagonister virker som det naturligt forekommende stof i hjernen: Dopamin.
Dopamine agonists act like a naturally occurring chemical in your brain called dopamine.
UDLØBSDATO exp {MM YYYY} BATCHNUMMER lot {XYYYY} ANDET
EXPIRY DATE exp {MM YYYY}
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.
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.
B. MÆRKNING PÅ EMBALLAGE
B. LABELLING
Virkningen af Adartrel kan øges eller mindskes sammen med anden medicin, og virkningen af anden medicin kan påvirkes af Adartrel.
The effect of ADARTREL may be increased or decreased by other medicines and vice versa.
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.
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.
Neuroleptika og andre centralt aktive dopaminantagonister, som for eksempel sulpirid eller metoklopramid, kan formindske effektiviteten af ropinirol.
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.
Reduktion af dosis eller seponering af behandlingen bør desuden overvejes.
Furthermore, a reduction of dosage or termination of therapy may be considered.
Svær nedsat nyrefunktion (kreatininclearance < 30 ml/min).
Severe renal impairment (creatinine clearance <30 ml/min)
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.
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.
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.
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.
Ropinirol metaboliseres primært af den isoforme CYP1A2 af cytochrome P450.
Ropinirole is mainly metabolised by the isoform CYP1A2 of cytochrome P450.
Man starter med 0,25 mg en gang dagligt.
The starting dose is 0.25 mg once daily.
Analysen af alvorlige bivirkninger var normal i den overordnede gruppe af patienter, der var tilmeldt de kliniske undersøgelser af ropinirol.
The analysis of Serious Adverse Events (SAE) was unremarkable in the overall group of patients enrolled in the ropinirole clinical studies.
Den primære metabolit er 100 gange mindre potent end ropinirol i dyremodeller til undersøgelse af den dopaminerge funktion.
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.
- De øvrige indholdsstoffer er
- The other ingredients are Tablet core:
I en 12 ugers placebokontrolleret polysomnografiundersøgelse i Restless Legs Syndrome patienter blev effekten af ropinirolbehandling undersøgt på periodiske benbevægelser (PLM) i søvne.
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.
Ropinirol metaboliseres fortrinsvis af cytochrom P450 isoenzymet CYP1A2.
Ropinirole is principally metabolised by the cytochrome P450 isoenzyme CYP1A2.
Benefit/risk-forholdet for den moderate til svære RLS, som defineret i produktresuméet, anses for at være gunstigt.
The benefit-risk assessment is considered favourable for the moderate to severe RLS as defined in the SPC.
Titandioxid (E171) Polysorbat 80 (E433)
Titanium dioxide (E171) Polysorbate 80 (E433).
Adartrel er indiceret til symptomatisk behandling af moderat til svær idiopatisk Restless Legs Syndrome (RLS) (se afsnit 5.1).
ADARTREL is indicated for the symptomatic treatment of moderate to severe idiopathic Restless Legs Syndrome (see section 5.1).
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).
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).
Hvis du er meget søvnig eller pludselig falder i søvn uden varsel, så lad være med at køre eller bruge maskiner.
If you suffer from extreme sleepiness or suddenly fall asleep without apparently feeling sleepy, do not drive or use machinery, and contact your doctor.
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.
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.
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.
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.
- 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.
- 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.
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.
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.
Slug tabletten hel med et glas vand.
Swallow the ADARTREL tablet(s) whole with water.
- 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.
- 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.
Hvis bivirkningerne fortager sig, kan der igen gradvist optitrereres.
If the undesirable effect abates, gradual up-titration can be re-instituted.
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.
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.
Hvis denne dosis er veltolereret, øges dosis til 0,5 mg en gang dagligt resten af ugen.
If this dose is well tolerated the dose should be increased to 0.5 mg once daily for the remainder of week 1.
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.
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.
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).
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.
Lactose monohydrat Mikrokrystallinsk cellulose Natrium croscarmellose Magnesiumstearat.
Lactose monohydrate Microcrystalline cellulose Croscarmellose sodium Magnesium stearate.
Tabel 3: Bivirkninger rapporteret ved brug til patienter med Parkinsons sygdom i kliniske undersøgelser i doser op til 24 mg/dag
Adverse drug reactions reported in Parkinson's disease clinical trials at doses up to 24 mg/day
Moderat til svær Restless Legs Syndrome viser sig ofte ved søvnproblemer eller svært ubehag i arme eller ben.
Moderate to severe Restless Legs Syndrome is typically represented by patients who have difficulty sleeping or severe discomfort in their legs or arms.
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.
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.
Adartrel bør kun ordineres til patienter med moderat til svær idiopatisk Restless Legs Syndrome.
ADARTREL should only be prescribed to patients with moderate to severe idiopathic Restless Legs Syndrome.
Dosis kan derefter øges med 0,5 mg om ugen over de næste 2 uger til en dosis på 2 mg en gang daglig.
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.
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.
Taking ADARTREL with food and drink Taking ADARTREL with food may reduce the likelihood of you feeling or being sick.
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).
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.
Svær nedsat leverfunktion.
Severe hepatic impairment.
Må ikke opbevares ved over 25ºC.
Do not store above 25°C.
Der skal gennemføres en langsigtet, dobbeltblind, placebokontrolleret undersøgelse som en del af forpligtelserne efter markedsføring (se bilag IV).
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).
Lægen vil råde dig til at holde op med at tage Adartrel.
Your doctor will advise you to discontinue this medicine.
1 HVAD ADARTREL ER, OG HVAD DET ANVENDES TIL Adartrel hører til den gruppe af medicin som kaldes dopaminagonister.
ADARTREL belongs to a group of medicines called dopamine agonists.
Til nogle patienter kan dosis øges gradvist op til maksimalt 4 mg en gang daglig for at opnå optimal forbedring.
In some patients, to achieve optimal improvement, the dose may be increased gradually up to a maximum of 4 mg once a day.
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.
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).
Hvad Adartrel indeholder - Det aktive stof er ropinirol (som hydrchlorid)
6 FURTHER INFORMATION What ADARTREL contains - The active substance is ropinirole (as hydrochloride)
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.
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Antikvalmemiddel, som for eksempel domperidon, kan bruges, om nødvendigt.
Anti-nausea medicinal products that are not centrally active dopamine antagonists, such as domperidone, may be used, if required.
2 HVAD DU SKAL GØRE, FØR DU BEGYNDER AT TAGE ADARTREL
2 BEFORE YOU TAKE ADARTREL
Behandling af bivirkninger
Management of undesirable effects
Det nævnte post-marketing commitment er krævet af CHMP og skal inden for den givne tidsfrist indsendes til referencemedlemsstaten:
CONDITIONS OF THE MARKETING AUTHORISATION The conditions considered essential for the safe and effective use of the Ropirinole are the following Post-Authorisation Commitment requested by the CHMP and to be submitted to the Reference Member State in the timeline are detailed below:
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.
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 as soon as possible.
Patienter i behandling med ropinirol og som har oplevet somnolens og/eller episoder med pludselig falden i søvn, skal oplyses om, at de skal undlade at føre motorkøretøj og undgå at deltage i aktiviteter (f.eks. betjening af maskiner), hvor nedsat opmærksomhed kan bringe deres eget eller andres liv og helbred i fare.
Patients being treated with ropinirole and presenting with somnolence and/or sudden sleep episodes must be informed to refrain from driving or engaging in activities where impaired alertness may put themselves or others at risk of serious injury or death (e.g. operating machines) until such effects have resolved (see also Section 4.4).
Adartrel bør altid tages i nøje overensstemmelse med din læges instruktioner.
Always take ADARTREL exactly as your doctor has told you.
Vær særlig forsigtig med at anvende Adartrel:
Take special care with ADARTREL
Adartrel kan give overvældende søvnighed i løbet af dagen, og meget sjældent kan dette føre til at du pludselig falder i søvn uden forudgående varsel.
ADARTREL can cause excessive daytime somnolence (excessive drowsiness) and very rarely sudden sleep onset episodes where patients fall asleep suddenly without apparently feeling sleepy.
Middeldosis i kliniske forsøg var 2 mg en gang daglig for patienter med moderat til svær Restless Legs Syndrome.
The average dose in clinical trials, in patients with moderate to severe Restless Legs Syndrome, was 2 mg once a day.
Adartrel kan give ekstrem søvnighed og risiko for pludselig at falde i søvn uden varsel.
However, ADARTREL can cause extreme sleepiness (somnolence) and sudden sleep onset episodes.
Efter to dage kan lægen øge dosis til 0,5 mg en gang dagligt i resten af den første uge.
After two days your doctor will probably increase your dose to 0.5 mg once daily for the remainder of your first week of treatment.
Derefter kan lægen fortsætte med at øge dosis gradvist med 0,5mg pr uge over 3 uger op til en dosis på 2 mg pr dag.
Then your doctor may increase your dose by 0.5mg per week over three weeks to a dose of 2mg per day.
Til oralt brug ADVARSEL OM, AT LÆGEMIDLET SKAL OPBEVARES UTILGÆNGELIGT FOR BØRN Opbevares utilgængeligt for børn.
SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT
Markedsføringsindehaveren har for nylig foretaget en undersøgelse af ropinirols effekt på den kardiale overledning.
A recent study has been conducted by the MAH in healthy volunteers on the effects of ropinirole on cardiac conduction.
Ikke almindeligt (>1/1000 og <1/100) er der i forbindelse med ropinirolbehandling rapporteret postural hypotension eller hypotension, sjældent i svær grad.
Following ropinirole therapy, postural hypotension or hypotension has been reported uncommonly (>1/1,000, <1/100), rarely severe.
Du må ikke tage Adartrel, hvis du er gravid.
The use of ADARTREL during pregnancy is not recommended.
Domperidon antagoniserer perifert den dopaminerge virkning af ropinirol og passerer ikke blodhjernebarrieren, hvorfor det anvendes som antiemeticum hos patienter behandlet med centralt virkende dopaminagonister.
Domperidone antagonises the dopaminergic actions of ropinirole peripherally and does not cross the blood-brain barrier.
Den præcise dosis Adartrel man skal tage, varierer fra patient til patient.
The exact dose of ADARTREL people take can be different.
* For at opnå optimal bedring i nogle patienter
Dose (mg)/once daily 1 * To achieve optimal improvement in some patients.
ATC-kode: N04BC04
Pharmacotherapeutic group: Dopamine agonist, ATC code: N04BC04.
West Sussex RH10 9QJ, United Kingdom
SmithKline Beecham Pharmaceuticals, Manor Royal, Crawley, West Sussex RH10 9QJ, United Kingdom
Da tabletterne indeholder laktose, bør produktet ikke anvendes til patienter med arvelig galactoseintolerans, en særlig form af heriditær lactasemangel (Lapp Lactase deficiency) eller glucose / galactose malabsorption.
Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucosegalactose malabsorption should not take this medicine.
Må ikke opbevares ved over 25◦C.
Do not store above 25 °C.
Spørg din læge eller apotek, hvis du har yderligere spørgsmål.
- If you have any further questions, ask your doctor or your pharmacist.
Tyg ikke tabletterne.
Do not chew the tablet(s).
Synkope, somnolens, svimmelhed (inklusiv vertigo) 4.8.1.1.1.3 Vaskulære lidelser
Syncope, somnolence, dizziness (including vertigo)
Tabletkerne: Lactose monohydrat, mikrokrystallinsk cellulose, natrium croscarmellose,
lactose monohydrate, microcrystalline cellulose, croscarmellose sodium, magnesium stearate
GENEREL KLASSIFIKATION FOR UDLEVERING <[Udfyldes nationalt]>
GENERAL CLASSIFICATION FOR SUPPLY {To be completed nationally} 15.
Lyserød oval tablet mærket ”GS” på den ene side og ”GYG” på den anden.
Pink oval-shaped, marked "GS" on one side and "GYG" on the other.
Adartrel må kun bruges under graviditet hvis lægen har vurderet den gavn du kan have af det og den potentielle risiko som fosteret udsættes for.
ADARTREL should only be used during pregnancy after your doctor has considered the benefit to you and the potential risk of harm to your unborn child. Tell your doctor immediately if you are pregnant, you think you might be or are planning to become pregnant.
Hos patienter med mild til moderat nedsat nyrefunktion (kreatininclearance mellem 30 og 50 ml/min) er dosisjustering ikke nødvendig.
No dosage adjustment is necessary in patients with mild to moderate renal impairment (creatinine clearance between 30 and 50 ml/min).
Adartrel 1 mg filmovertrukne tabletter
ADARTREL 1 mg film-coated tablets
Hvis patienter holder op eller starter på at ryge under behandling med ropinirol, kan dosisjustering være nødvendig.
Smoking is known to induce CYP1A2 metabolism, therefore if patients stop or start smoking during treatment with ropinirole, dose adjustment maybe required.
Opkastning, abdominalsmerter, halsbrand 4.8.1.1.1.9 Generelle symptomer og forstyrrelser ved applikationssted Almindelig
Vomiting, abdominal pain, heartburn General disorders and administration site conditions Common
7 INDEHAVER AF MARKEDSFØRINGSTILLADELSEN Laboratoire GlaxoSmithKline
7 MARKETING AUTHORISATION HOLDER Laboratoire GlaxoSmithKline 100, route de Versailles
Hvis patienten oplever betydelige bivirkninger bør dosisreduktion overvejes.
Dose reduction should be considered if patients experience significant undesirable effects.
Patientkarakteristika
Population-related characteristics
Adartrel 0,25 mg filmovertrukne tabletter
ADARTREL 0.25 mg film-coated tablets
Bivirkningerne var milde til moderate og forbigående eller kom ved øgning af dosis.
Undesirable effects were normally mild to moderate and experienced at the start of therapy or on increase of dose and few patients withdrew from the clinical studies due to undesirable effects.
Adartrel 2 mg filmovertrukne tabletter
ADARTREL 2 mg film-coated tablets
Inden du begynder at tage medicinen, så fortæl lægen lægen, hvis du:
Take special care with ADARTREL Tell your doctor before you start to take this medicine if you:
Hvid oval tablet mærket ”GS” på den ene side og ”MLE” på den anden.
White oval-shaped, marked "GS" on one side and "MLE" on the other.
Jernoxid rød (E172) Indigocarmin (E132)
Titanium dioxide (E171) Iron oxide yellow (E172) Indigo carmine aluminium lake (E132).
Gul oval tablet mærket ”GS” på den ene side og ”TES” på den anden.
Yellow oval-shaped, marked "GS" on one side and "TES" on the other.
8 MARKEDSFØRINGSTILLADELSESNUMMER (NUMRE) <[Udfyldes nationalt]>
8 MARKETING AUTHORISATION NUMBER(S)
Kvalme er en mulig bivirkning ved Adartrel.
Taking ADARTREL with food may decrease the occurrence of nausea (feeling sick) which is a possible side effect of ADARTREL.
Hvis du er i tvivl, så spørg lægen.
If you are unsure, it is essential that you talk to your doctor.
Adartrel 1 mg filmovertrukne tabletter Ropinirol (som hydrochlorid)
ADARTREL 1 mg film-coated tablets Ropinirole (as hydrochloride)
Opbevares i den originale emballage 6.5 Emballage (art og indhold) PVC/PCTFE/Aluminium blister med 28 eller 84 tabletter Ikke alle pakningsstørrelser er nødvendigvis markedsført.
6.5 Nature and contents of container PVC/PCTFE/Aluminium blister.
Filmovertræk: Hypromellose, macrogol 400, titandioxid (E171), polysorbat 80 (E433) Produktets udseende og pakningstørrelse
hypromellose, macrogol 400, titanium dioxide (E171), polysorbate 80 (E433).
Adartrel 0,5 mg filmovertrukne tabletter
ADARTREL 0.5 mg film-coated tablets
Ropinirol bør ikke anvendes i ammeperioden.
Ropinirole should not be used in nursing mothers as it may inhibit lactation.
• du får anden medicin for Restless Legs Syndrome
Tell your doctor if: - you are already receiving any other medicines for Restless Legs Syndrome.
Farmakoterapeutisk klassifikation: Dopaminagonist.
5.1 Pharmacodynamic properties Pharmacotherapeutic group: Dopamine agonist, ATC code: N04BC04.
Adartrel 2 mg filmovertrukne tabletter Ropinirol (som hydrochlorid)
ADARTREL 2 mg film-coated tablets Ropinirole (as hydrochloride)
Kontakt lægen før du tager denne medicin, hvis lægen har fortalt dig at du ikke tåler visse sukkerarter.
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.