natgillin/translations-raw huggingface dataset:
De bivirkninger, der er specifikke for RLS-patienter, såsom augmentation og reboundeffekter, er blevet drøftet. 
The adverse events that are specific to RLS patients, such as augmentation and rebound effects have been discussed.
På grund af risiko for hypotension, bør patienter med alvorlig kardiovaskulær sygdom (specielt hjerteinsufficiens) behandles med forsigtighed. 
Due to the risk of hypotension, patients with severe cardiovascular disease (in particular coronary insufficiency) should be treated with caution.
Meget sjældent er der set ændret leverfunktion (unormale blodprøver). 
Very rarely, cases of altered liver function (abnormal blood tests) have been reported.
Hos patienter over 65 år er reduktion af den systemiske clearance af ropinirol med omkring 30% mulig. 
In patients over 65 years of age, a reduction in the systemic clearance of ropinirole by about 30% is possible.
Efter behandlingsinitiering øges daglig dosis indtil optimal terapeutisk respons opnås. 
Following treatment initiation, the daily dose should be increased until optimal therapeutic response is achieved.
Eliminationshalveringstiden for ropinirol er gennemsnitlig 6 timer. 
The elimination half-life of ropinirole is 6 hours on average.
Fortæl lægen hvis du oplever bivirkninger som bekymrer dig. 
Tell your doctor if you notice any side effects and they worry you.
Anvend ikke efter udløbsdatoen, som er angivet på æsken flasken. 
Do not use ADARTREL after the expiry date which is stated on the carton.
Størstedelen af patienterne i de kliniske forsøg var af kaukasisk oprindelse. 
In clinical studies most patients were of Caucasian origin.
Hvis behandlingen afbrydes i mere end et par dage bør re-initiering ske med dosistitrering som beskrevet ovenfor. 
If treatment is interrupted for more than a few days it should be re-initiated by dose titration carried out as above.
Patienter der er intolerante over for laktose, skal lægge mærke til, at hver Adartrel tablet indeholder en lille mængde lactose. 
Patients who are intolerant to lactose should note that each ADARTREL tablet contains a small amount of lactose.
Brug af Adartrel til børn med Restless Legs Syndrome er ikke undersøgt og derfor ordineres Adartrel normalt ikke til børn under 18 år. 
The use of ADARTREL in children with Restless Legs Syndrome has not been studied and therefore ADARTREL is not usually prescribed in patients under 18 years of age.
Vigtige oplysninger om visse af indholdsstofferne i Adartrel 
Important information about some of the ingredients of ADARTREL
• du får Adartrel, og lægen vil ordinere dig anden medicin. 
- you are taking ADARTREL and the doctor is going to prescribe you any other medicine.
Inden afslutningen af den gensidige anerkendelses-procedure indbragte Spanien og Nederlandene en sag for EMEA ud fra den betragtning, at dette lægemiddel muligvis udgør en risiko for folkesundheden, eftersom sikkerhed og virkning for ropinirol til langtidsbehandling af Restless Legs Syndrome (RLS) efter deres opfattelse ikke er påvist. 
Before the end of a mutual recognition procedure, Spain and the Netherlands, presented to the EMEA a referral considering that this medicinal product might present a risk to public health since they were of the opinion that safety and efficacy in long-term treatment of ropinirole in restless legs syndrome had not been demonstrated.
Disse påvirkninger anses for at være et species relateret fænomen og giver ikke anledning til risiko ved klinisk anvendelse af ropinirol. 
These lesions are considered to be a species specific phenomenon and do not constitute a hazard with regard to the clinical use of ropinirole.
FAGLIGE KONKLUSIONER OG BEGRUNDELSER FOR ÆNDRING AF PRODUKTRESUMEER, ETIKETTERING OG INDLÆGSSEDLER FREMLAGT AF EMEA 
SCIENTIFIC CONCLUSIONS AND GROUNDS FOR AMENDMENT OF THE SUMMARY OF PRODUCT CHARACTERISTICS, LABELLING AND PACKAGE LEAFLET PRESENTED BY THE EMEA
Sammen med mad bliver Cmax forsinket omkring 2,6 time og peak plasma niveau reduceres med 25% uden effekt på den mængde der er biotilgængelig. 
In the presence of food, Cmax is delayed by about 2.6 hours and the peak plasma level is reduced by 25%, with no effect on the bioavailable quantity.
Når du starter med at tage Adartrel, vil dosis blive øget gradvist. 
When you first start taking ADARTREL, the dose you take will be increased gradually.
Ropinirols plasma proteinbinding er ikke høj (<40%) og uden effekt på distributionen som er meget udtalt (distributionsvolumen er af størrelsesordenen 7 l/kg). 
The binding of ropinirole to plasma proteins is not high (<40%), with no effect on the distribution, which is very extensive (volume of distribution in the order of 7 l/kg).
Ikke almindelige bivirkninger er forvirring og oplevelse af hallucinationer. 
Uncommon side effects are feeling confused and experiencing hallucinations.
De spørgsmål, der blev drøftet, vedrørte oplysninger om virkning i de kliniske undersøgelser, navnlig hos andelen af patienter med en funktionel påvirkning samt langtidsvirkningen, sikkerheden og benefit/risk-forholdet. 
The issues discussed included the efficacy data provided in the clinical trials, particularly in the subset of patients having a functional impact and the long-term efficacy and safety as well as the benefit-risk ratio.
På dette tidspunkt bør dosis og behovet for fortsat behandling overvejes. 
At this time the dose prescribed and the need for continued treatment should be considered.
Du bør konsultere din læge eller apotek, hvis du er usikker. 
You should check with your doctor or pharmacist if you are not sure.
Hver pakke indeholder 2 eller 12 tabletter. 
Each pack contains 2 or 12 tablets.
EVENTUELLE SÆRLIGE FORHOLDSREGLER VED BORTSKAFFELSE AF UBRUGTE LÆGEMIDLER ELLER AFFALD FRA SÅDANNE Ikke relevant 
SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE
Patienter med svære psykotiske lidelser bør kun behandles med dopaminagonister, såfremt potentielle fordele opvejer risici. 
Patients with major psychotic disorders should not be treated with dopamine agonists unless the potential benefits outweigh the risks.
Ropinirolclearance er nedsat hos patienter over 65 år. 
The clearance of ropinirole is decreased in patients over 65 years of age.
Forøgede plasmakoncentrationer af ropinirol er blevet observeret hos patienter behandlet med HRT (Hormone Replacement Therapy). 
Increased plasma concentrations of ropinirole have been observed in patients treated with hormone replacement therapy.
Dette forekommer når man hviler sig eller er inaktiv, for eksempel når man sidder eller ligger ned, og er værst om aftenen eller om natten. 
These feelings occur during periods of rest or inactivity such as sitting or lying down, especially in bed, and are worse in the evening or at night.
Tolerabilitetsprofilen for ropinirol skal i denne patientpopulation ifølge dokumentationen analyseres på baggrund af den fysiske tilstand, som i væsentlig grad påvirker patienternes livskvalitet, hvilket navnlig skyldes, at RLS-patienter lider af kronisk søvnløshed. 
According to the literature, the tolerability profile of ropinirole in this population of patients must be analysed in the context of a physical condition that significantly affects the quality of life of patients mainly due to the fact that RLS patients suffer with chronic insomnia.
Meget sjældne (<1/10.000) tilfælde af leverreaktioner, primært øgning af leverenzymer, er rapporteret. 
Very rare cases of hepatic reactions (<1/10,000), mainly increase of liver enzymes, have been reported.
Hvis du har en fornemmelse af, at virkningen af Adartrel er for kraftig eller for svag, så tal med lægen eller apoteket om det. 
If you have the impression that the effect of ADARTREL is too strong or too weak, talk to your doctor or pharmacist.
Tel +33 1 39 178000 <[Se bilag I - Udfyldes nationalt]> 
France tel +33 1 39 178000 [See Annex I- to be completed nationally] 8 MARKETING AUTHORISATION NUMBER(S) [To be completed nationally]
Det kan være nødvendigt at justere dosis 
Your doctor may need to adjust your dose.
Der er blevet fremlagt en indgående vurdering af de mest almindelige bivirkninger i målgruppen (scoringsresultat ved baseline på 24-40 point). 
A detailed assessment of the most common adverse events in the target population (IRLS baseline score 24-40 points) has been provided.
Det antages, at symptomerne på overdosering med ropinirol er relateret til dets dopaminerge aktivitet. 
It is anticipated that the symptoms of ropinirole overdose will be related to its dopaminergic activity.
Under behandling med Adartrel skal du være særlig opmærksom, hvis du skal køre eller håndtere maskiner. 
During treatment with ADARTREL take special care when you drive or operate machinery.
Patienterne skal imidlertid informeres om dette fænomen, og de bør rådes til at være forsigtige, hvis de fører motorkøretøj eller betjener maskiner, mens de er i behandling med Ropinirol. 
Nevertheless, patients must be informed of this phenomenon and advised to exercise caution while driving or operating machines during treatment with ropinirole.
Behandlingsregime (uge 2 og fremefter) 
Therapeutic regimen (week 2 onwards)
Disse symptomer kan lindres ved relevant behandling med dopamin antagonister såsom neuroleptika eller metoklopramid. 
These symptoms may be alleviated by appropriate treatment with dopamine antagonists such as neuroleptics or metoclopramide.
Individuel dosistitrering anbefales i henhold til effekt og tolerans. 
Individual dose titration against efficacy and tolerability is recommended.
Toksikologi: Den toksikologiske profil er pricipielt bestemt af lægemidlets farmakologiske profil: adfærdsændringer, hypoprolactæmi, fald i blodtryk og hjertefrekvens, ptose og spytafsondring. 
Toxicology: The toxicology profile is principally determined by the pharmacological activity of the drug: behavioural changes, hypoprolactinaemia, decrease in blood pressure and heart rate, ptosis and salivation.
Doser over 4 mg en gang daglig er ikke undersøgt i Restless Legs Syndrome patienter. 
Doses above 4 mg once daily have not been investigated in Restless Legs Syndrome patients.
I den moderate til svære RLS-population ses fordelene ved behandling med ropinirol i alle resultatermålt på en ensartet måde. 
In the moderate to severe RLS population the benefit of treating with ropinirole is seen in all outcomes measured in a consistent way.
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.