natgillin/translations-raw huggingface dataset:
Hvis dette sker, skal behandlingen vurderes og dosisjustering eller seponering må overvejes.
If this occurs, treatment should be reviewed and dosage adjustment or discontinuation of treatment may be considered.
Bivirkningerne nedenfor er delt op i organklasser og hyppighed.
Adverse drug reactions are listed below by system organ class and frequency.
Brug af ropinirol mod Restless Legs Syndrome
Use of ropinirole in Restless Legs Syndrome
Reproduktionstoksicitet er set i dyreforsøg (se afsnit 5.3).
Studies in animals have shown reproductive toxicity (see section 5.3).
GlaxoSmithKline forventer at fremsende den endelige study report juli 2009
GlaxoSmithKline expect to submit the final study report by
Gentoksicitet: Gentoksicitet blev ikke observeret i de sædvanlige standard in vitro og in vivo undersøgelser.
Genotoxicity: Genotoxicity was not observed in the usual battery of in vitro and in vivo tests.
Medlemsstat
Member state
Hvad Adartrel er, og hvad det anvendes til Hvad du skal gøre, før du begynder at tage Adartrel Hvordan du tager Adartrel Hvilke mulige bivirkninger har Hvordan du opbevarer Adartrel Yderligere oplysninger
What ADARTREL is and what it is used for Before you take ADARTREL How to take ADARTREL Possible side effects
6.4 Særlige opbevaringsforhold Må ikke opbevares ved over 25◦C.
6.4 Special precautions for storage Do not store above 25 °C.
Selvom sikkerhedsprofilen er forbundet med ubehagelige bivirkninger såsom kvalme og opkastning, forekommer disse hovedsageligt tidligt i behandlingen og anses for at være håndterbare.
The safety profile although pledged by uncomfortable adverse events like nausea and vomiting is mostly a problem in the early phase of the treatment and is considered manageable.
Filmovertræk Hypromellose Macrogol 400
Hypromellose Macrogol 400
På denne baggrund viser de kliniske undersøgelsesdata om sikkerhed, at ropinirol har en acceptabel tolerabilitet og sikkerhedsprofil hos RSL-patienter over det relevante dosisområde 0,25- 4mg/dag.
In this context the clinical trial safety data demonstrate that ropinirole has an acceptable tolerability and safety profile in RLS patients over the dose range 0.25 - 4mg/day.
At indsende den endelige study report fra den kliniske undersøgelse (ROR104836), “A randomised, double-blind, placebo-controlled, parallel group study to evaluate the efficacy and safety of ropinirole for 26 weeks and to further evaluate the incidence of augmentation and rebound for a further 40 weeks open label extension treatment period in subjects suffering from moderate to severe Restless Legs Syndrome.” Undersøgelsen forventes at starte i februar 2006.
To submit the final study report from the clinical study (ROR104836), “A randomised, double-blind, placebocontrolled, parallel group study to evaluate the efficacy and safety of ropinirole for 26 weeks and to further evaluate the incidence of augmentation and rebound for a further 40 weeks open label extension treatment period in subjects suffering from moderate to severe Restless Legs Syndrome.” The study is expected to commence in Feb 06.
Der er ingen tilgængelige data for patienter med svær nedsat nyrefunktion.
No data are available in patients with severe renal impairment.
Et rebound-fænomen efter ropinirolbehandlingens ophør (rebound ved slutningen af behandlingen) kan ikke udelukkes.
A rebound phenomenon following discontinuation of ropinirole treatment (end of treatment rebound) cannot be excluded.
Hos patienter, der allerede får ropinirol, kan det derfor være nødvendigt at justere dosis af ropinirol, når lægemidler der vides at hæmme CYP1A2, f.eks. ciprofloxacin, enoxacin eller fluvoxamin introduceres eller seponeres.
Hence, in patients already receiving ropinirole, the dose of ropinirole may need to be adjusted when medicinal products known to inhibit CYP1A2, e.g. ciprofloxacin, enoxacin or fluvoxamine, are introduced or withdrawn.
Det er imidlertid meget vigtigt, at hovedparten af tilfældene af augmentation i forbindelse med ropinirol var af begrænset klinisk betydning, eftersom patienterne generelt fortsatte med ropinirol-behandling uden seponering, og i hovedparten af tilfældene øgede forskerne ikke doseringen af ropinirol som følge af augmentationen.
More importantly the majority of the ropinirole episodes of augmentation had limited clinical significance as generally patients continued on ropinirole treatment without discontinuation and, in the majority of the events the investigators did not increase the dose of ropinirole as a result of the augmentation.
Hver pakke indeholder 28 eller 84 tabletter.
Each pack contains 28 or 84 tablets.
Hyppigheden fra kliniske undersøgelser er bestemt som incidens i forhold til placebo og er klassificeret som: meget almindelig (>1/10) eller almindelig (>1/100 og <1/10) eller ikke almindelig (>1/1000 og <1/100).
Frequencies from clinical trials are determined as excess incidence over placebo and are classed as very common (>1/10) or common (>1/100, <1/10) or uncommon (>1/1,000, <1/100).
Der blev kun i albinorotter observeret retinal degenerering i et langtidsstudie med høj dosering (50 mg/kg), sandsynligvis forbundet med en øget lyspåvirkning.
In the albino rat only, retinal degeneration was observed in a long term study at a high dose (50 mg/kg), probably associated with an increased exposure to light.
Karcinogenicitet: I et toårigt forsøg udført i mus og rotter i doser op til 50 mg/kg var der ingen tegn på karcinogen effekt i mus.
Carcinogenicity: From two-year studies conducted in the mouse and rat at dosages up to 50 mg/kg there was no evidence of any carcinogenic effect in the mouse.
Der var ingen teratogene effekter i rotter ved 120 mg/kg (ca. 30 gange AUC af den maksimale humane dosering) og ingen indikation af effekt på udvikling hos kanin.
There were no teratogenic effects in the rat at 120 mg/kg (approximately 30 times the AUC at the maximum dose in humans) and no indication of an effect on development in the rabbit.
Imidlertid kan det blive nødvendigt at justere ropinirol dosis i overensstemmelse med klinisk respons, såfremt HRT ophører eller introduceres under behandling med ropinirol.
However, it may be necessary to adjust the ropinirole dose, in accordance with clinical response, if hormone replacement therapy is stopped or introduced during treatment with ropinirole.
Ud fra følgende betragtninger: - formålet med indbringelsen af sagen var at påvise sikkerhed og virkning ved langtidsbehandling af Restless Legs Syndrome med ropinirol, - på grundlag af den forelagte dokumentation og den faglige drøftelse i udvalget ændres det af ansøgeren foreslåede produktresumé som angivet i bilag III.
Whereas, the scope of the referral was that the safety and efficacy in long-term treatment of ropinirole in restless legs syndrome should be demonstrated, based on the documentation submitted and the scientific discussion within the Committee, the Summary of Products Characteristic proposed by the applicant has been amended as set out in Annexe III.
Arten af disse bivirkninger er i overensstemmelse med den etablerede sikkerhedsprofil for ropinirol og lægemiddelklassen af dopaminagonister.
The nature of these events is consistent with the established safety profile of ropinirole and the dopamine agonist class of drugs.
4 HVILKE MULIGE BIVIRKNINGER ADARTREL HAR Som alle andre lægemidler kan Adartrel have bivirkninger, selvom ikke alle får bivirkninger.
Like all medicines, ADARTREL can cause side effects, although not everybody gets them.
Du bør ikke tage Adartrel: - hvis du er allergisk (overfølsom ) over for det aktive indholdsstof, ropinirol, eller et af de øvrige indholdsstoffer i Adartrel - hvis du har en svær leversygdom - hvis du har en svær nyresygdom
Do not take ADARTREL - if you are allergic (hypersensitive) to the active ingredient, ropinirole, or any of the other ingredients of ADARTREL - if you have serious liver disease - if you have serious kidney disease
9 DATO FOR FØRSTE TILLADELSE/FORNYELSE AF TILLADELSEN
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION {DD month YYYY}
Normalt er den eneste lindring at gå rundt eller at bevæge ben og arme, hvilket ofte fører til problemer med at sove om natten.
Usually the only relief is obtained by walking about or moving the affected limbs, which often leads to problems sleeping.
Adartrel lindrer ubehaget og mindsker trangen til at bevæge ben og arme, som forstyrrer nattesøvnen.
ADARTREL relieves the discomfort and reduces the urge to move the limbs that disrupt night time sleep.
Derfor forventes det ikke at ropinirol vil udkonkurrere metabolismen af andre lægemidler som metaboliseres af CYP1A2.
Therefore, it is not expected that ropinirole will compete with the metabolism of other medicinal products which are metabolised by CYP1A2.
Statistisk signifikant forskel i periodiske benbevægelser i søvne sås mellem ropinirol og placebo fra baseline til uge 12.
A statistically significant difference in the periodic leg movements of sleep was seen between ropinirole and placebo from baseline to week 12.
Indehaveren af markedsføringstilladelsen og fremstiller Indehaver af markedsføringstilladelse:
Marketing Authorisation Holder and Manufacturer Marketing Authorisation Holder:
Den korrigerede behandlingsforskel mellem ropinirol og placebo var: Søvnforstyrrelse (-15,2, 95% CI -19,37, -10,94; p<0,0001), søvnmængde (0,7 time, 95% CI 0,49, 0,94; p<0,0001), søvnsufficiens (18,6, 95% CI 13,77, 23,45; p<0,0001) og somnolens om dagen (-7,5, 95% CI10,86, -4,23; p<0,0001)
The adjusted treatment differences between ropinirole and placebo were: sleep disturbance (-15.2, 95% CI -19.37, -10.94; p<0.0001), sleep quantity (0.7 hours, 95% CI 0.49, 0.94); p<0.0001), sleep adequacy (18.6, 95% CI 13.77, 23.45; p<0.0001) and daytime somnolence (-7.5, 95% CI -10.86, -4.23; p<0.0001).
Ropinirols biotilgængelighed er ca. 50% (36-57%) og gennemsnitlige peak koncentrationer (Cmax) af lægemidlet opnås ved en mediantid på 1.5 time efter dosering.
The bioavailability of ropinirole is about 50% (36% to 57%), with Cmax reached on average 1.5 hours after the dose.
Rapporter efter markedsføring
Post marketing reports
Hvis du holder op med at tage Adartrel
If you stop taking ADARTREL
Ropinirol er en non-ergolin dopamin D2/D3 agonist, som stimulerer striatale dopamin receptorer.
Ropinirole is a non ergoline D2/D3 dopamine agonist which stimulates striatal dopamine receptors.
Ingen farmakokinetisk interaktion er observeret mellem ropinirol og domperidon (som bruges til behandling af kvalme og opkastning), som ville nødvendiggøre dosisjustering af et af lægemidlerne.
No pharmacokinetic interaction has been seen between ropinirole and domperidone (a medicinal product used to treat nausea and vomiting) that would necessitate dosage adjustment of either medicinal product.
Uomdannet ropinirol og metabolitter udskilles hovedsagelig via nyrerne.
Unchanged ropinirole and the metabolites are mainly excreted through the kidneys.
Et farmakokinetisk studie (med en dosis på 2 mg ropinirol 3 gange daglig) viste, at ciprofloxacin øgede Cmax og AUC for ropinirol med henholdsvis 60% og 84% med en potentiel risiko for bivirkninger.
A pharmacokinetic study (with a ropinirole dose of 2 mg, three times a day) revealed that ciprofloxacin increased the Cmax and AUC of ropinirole by 60% and 84% respectively, with a potential risk of adverse events.
<[Se bilag I - Udfyldes nationalt]>
[See Annex I- to be completed nationally]
Reproduktionstoksicitet: Administration af ropinirol til gravide rotter i toksiske doser for moderen resulterede i nedsat fødselsvægt ved 60 mg/kg (ca. 15 gange AUC af den maksimale humane dosering), øget føtal død ved 90 mg/kg (ca. 25 gange AUC af den maksimale humane dosering) og malformationer af fingre og tæer ved 150 mg/kg (ca. 40 gange AUC af den maksimale humane dosering).
Reproductive Toxicity: Administration of ropinirole to pregnant rats at maternally toxic doses resulted in decreased foetal body weight at 60 mg/kg (approximately 15 times the AUC at the maximum dose in humans), increased foetal death at 90 mg/kg (approximately 25 times the AUC at the maximum dose in humans) and digit malformations at 150 mg/kg (approximately 40 times the AUC at the maximum dose in humans).
Adartrel tages som regel lige før sengetid, men kan tages op til tre timer før.
ADARTREL is usually taken just before bedtime, but can be taken up to 3 hours before going to bed.
10 DATO FOR ÆNDRING AF TEKSTEN <MM/ÅÅ> <[Udfyldes nationalt]>
10 DATE OF REVISION OF THE TEXT {MM/YYYY} [To be completed nationally]
I kliniske forsøg blev dosis øget med 0,5 mg hver uge op til 3 mg en gang daglig og derefter med 1 mg op til den maksimalt anbefalede dosis på 4 mg en gang daglig som vist i tabel 1.
In clinical trials the dose was increased by 0.5 mg each week to 3 mg once a day and then by 1 mg up to the maximum recommended dose of 4 mg once a day as shown in table 1.
Hvis De glemmer at tage Adartrel
If you forget to take ADARTREL
Patienter, der har oplevet somnolens og/eller episoder, hvor de pludseligt falder i søvn, skal undlade at føre motorkøretøj eller betjene maskiner.
Patients who have experienced somnolence and/or an episode of sudden sleep onset must refrain from driving or operating machines.
Farmakokinetikken af ropinirol er overordnet lineær (Cmax og AUC) i det terapeutiske interval mellem 0,25 mg og 4 mg efter enkelt dosis og efter gentagne doser.
The pharmacokinetics of ropinirole are linear overall (Cmax and AUC) in the therapeutic range between 0.25 mg and 4 mg, after a single dose and after repeated dosing.
Ropinirol skal gives med forsigtighed til patienter med moderat leversvigt.
Ropinirole should be administered with caution to patients with moderate hepatic impairment.
Erfaringsgrundlaget for anvendelse af ropinirol til gravide er ringe.
There are no adequate data from the use of ropinirole in pregnant women.
Opbevares i den originale pakning
Store in the original package
Baseret på in-vitro data, har ropinirol kun lille potentiale for hæmning af cytochrom P450 ved terapeutiske doser.
Based on in-vitro data, ropinirole has little potential to inhibit cytochrome P450 at therapeutic doses.
Som eneste lægemiddelrelateret påvirkning sås i rotter Leydig cell hyperplasi og testikel adenom som et resultat af ropinirols hypoprolactinæmiske effekt.
In the rat, the only drug-related lesions were Leydig cell hyperplasia and testicular adenoma resulting from the hypoprolactinaemic effect of ropinirole.
Disse bivirkninger blev generelt først indberettet i løbet af de første to uger af behandlingen, og seponeringsraten for behandling med ropinirol var lav og svarede til den for behandling med placebo.
These events were generally first reported during the initial two weeks of treatment and the rate of discontinuation from ropinirole treatment was low and similar to that from placebo treatment.
Oplysningerne fra det kliniske undersøgelsesprogram for ropinirol, som omfatter undersøgelser af behandling med ropinirol af en varighed på op til 52 uger, er tilfredsstillende for så vidt angår den kliniske betydning af mulige indberettede tilfælde af augmentation.
The data generated from the ropinirole clinical trial programme with studies of up to 52-week duration of ropinirole treatment is reassuring as far as the clinical significance of potential episodes of augmentation reported.
3 HVORDAN DU TAGER ADARTREL
3 HOW TO TAKE ADARTREL
Ropinirol bør ikke bruges til behandling af neuroleptisk akathisia og tasikinesia (neuroleptisk induceret ufrivillig trang til at gå), eller sekundær Restless Legs Syndrome (for eksempel forårsaget af nyresvigt, jernmangel eller graviditet).
Ropinirole should not be used to treat neuroleptic akathisia, tasikinesia (neuroleptic-induced compulsive tendency to walk), or secondary Restless Legs Syndrome (e.g. caused by renal failure, iron deficiency anaemia or pregnancy).
CHMP er imidlertid af den opfattelse, at denne patientpopulations tilstand bør defineres som moderat til svær idiopatisk RSL.
However, for the CHMP, this population of patients should be defined as moderate to severe idiopathic RLS.
Tabel 2: Bivirkninger rapporteret i 12-ugers RLS kliniske undersøgelser (ropinirol n=309, placebo n=307)
Adverse drug reactions reported in 12-week Restless Legs Syndrome clinical trials (ropinirole n=309, placebo n=307)
Derfor er det usandsynligt, at ropinirol vil påvirke andre lægemidlers farmakokinetik via en cytochrom P450 mekanisme.
Hence, ropinirole is unlikely to affect the pharmacokinetics of other medicinal products, via a cytochrome P450 mechanism.
Hvis du har glemt at tage Adartrel i mere end få dage, så tal med din læge om, hvordan du skal starte behandlingen igen.
If you have missed taking ADARTREL for more than a few days consult your doctor for advice on restarting ADARTREL.
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.
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.
Den anbefalede initiale dosis er 0,25 mg en gang dagligt i 2 dage (administreret som nævnt ovenfor).
The recommended initial dose is 0.25 mg once daily (administered as above) for 2 days.
Den dokumenterede indberetningsfrekvens for augmentation i forbindelse med dopaminagonister, herunder ropinirol, er generelt lavere end for levodopa.
The reported rates in the literature of augmentation associated with dopamine agonists including ropinirole are generally lower than the ones reported for levodopa.
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).
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).
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.
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.
Hvis du ammer, må du ikke tage Adartrel, da mælkeproduktionen kan påvirkes.
ADARTREL should not be used during breast-feeding as milk production may be affected.
Hos patienter i HRT-behandling , kan behandling med ropinirol initieres på normal vis.
In patients already receiving hormone replacement therapy, ropinirole treatment may be initiated in the usual manner.
Hvis dine symptomer bliver værre efter du er stoppet med at tage Adartrel, så kontakt lægen.
If your symptoms worsen after you stop treatment with ADARTREL, you should contact your doctor.
Ropinirol bør tages lige før sengetid, men kan tages op til tre timer før.
Ropinirole should be taken just before bedtime, however the dose can be taken up to 3 hours before retiring.
INFORMATION I BRAILLE-SKRIFT <[Udfyldes nationalt]>
INFORMATION IN BRAILLE {To be completed nationally}
Hallucinationer forekom ikke almindeligt i en åben langtidsundersøgelse.
Hallucinations were reported uncommonly in the open label long-term studies.
Hos patienter med mild til moderat nedsat nyrefunktion (kreatinin clearance mellem 30 og 50 ml/min) er der ikke set ændring i ropinirols farmakokinetik.
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.
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.
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.
De mere almindelige bivirkninger af Adartrel kan forekomme i starten af behandlingen eller når dosis øges.
The more common side effects of ADARTREL can happen when some patients first start their therapy and/or when the dose is increased.
I kliniske undersøgelser vedrørende RLS var den mest almindelige bivirkning kvalme (cirka 30% af patienterne).
In Restless Legs Syndrome clinical trials the most common adverse drug reaction was nausea (approximately 30% of patients).
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).
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).
Opkastning, kvalme,
Vomiting, nausea
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).
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.
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.
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.
Middeldosis af ropinirol i patienterne med moderat til svær RLS var 2,0 mg/dag.
The mean dose of ropinirole for the moderate to severe patients was 2.0 mg/day.
Hvis du har problemer med at huske at tage din medicin, så spørg apoteket til råds.
If you have trouble remembering when to take your medicine, ask your pharmacist for some hints.
Denne indlægsseddel blev senest godkendt den { MM/ÅÅÅÅ }
This leaflet was last approved in
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).
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).
Dosis kan evt. øges til 1 mg en gang daglig i uge 2.
The dose may be increased to 1 mg once a day at week 2.
Efter 3 måneders behandling med Adartrel, kan lægen - afhængig af hvordan du har det - justere dosis eller afbryde behandlingen.
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.
Fortæl straks lægen, hvis du ammer eller hvis du planlægger at amme dit barn.
Tell your doctor immediately if you are breast-feeding or if you are planning to breast-feed.