FrancophonIA/ELRC3.0 huggingface dataset:
English: These lesions are considered to be a species specific phenomenon and do not constitute a hazard with regard to the clinical use of ropinirole.
Danish: Disse påvirkninger anses for at være et species relateret fænomen og giver ikke anledning til risiko ved klinisk anvendelse af ropinirol.
English: SCIENTIFIC CONCLUSIONS AND GROUNDS FOR AMENDMENT OF THE SUMMARY OF PRODUCT CHARACTERISTICS, LABELLING AND PACKAGE LEAFLET PRESENTED BY THE EMEA
Danish: FAGLIGE KONKLUSIONER OG BEGRUNDELSER FOR ÆNDRING AF PRODUKTRESUMEER, ETIKETTERING OG INDLÆGSSEDLER FREMLAGT AF EMEA
English: 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.
Danish: 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.
English: When you first start taking ADARTREL, the dose you take will be increased gradually.
Danish: Når du starter med at tage Adartrel, vil dosis blive øget gradvist.
English: 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).
Danish: Ropinirols plasma proteinbinding er ikke høj (<40%) og uden effekt på distributionen som er meget udtalt (distributionsvolumen er af størrelsesordenen 7 l/kg).
English: Uncommon side effects are feeling confused and experiencing hallucinations.
Danish: Ikke almindelige bivirkninger er forvirring og oplevelse af hallucinationer.
English: 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.
Danish: 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.
English: At this time the dose prescribed and the need for continued treatment should be considered.
Danish: På dette tidspunkt bør dosis og behovet for fortsat behandling overvejes.
English: You should check with your doctor or pharmacist if you are not sure.
Danish: Du bør konsultere din læge eller apotek, hvis du er usikker.
English: Each pack contains 2 or 12 tablets.
Danish: Hver pakke indeholder 2 eller 12 tabletter.
English: SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE
Danish: EVENTUELLE SÆRLIGE FORHOLDSREGLER VED BORTSKAFFELSE AF UBRUGTE LÆGEMIDLER ELLER AFFALD FRA SÅDANNE Ikke relevant
English: Patients with major psychotic disorders should not be treated with dopamine agonists unless the potential benefits outweigh the risks.
Danish: Patienter med svære psykotiske lidelser bør kun behandles med dopaminagonister, såfremt potentielle fordele opvejer risici.
English: The clearance of ropinirole is decreased in patients over 65 years of age.
Danish: Ropinirolclearance er nedsat hos patienter over 65 år.
English: Increased plasma concentrations of ropinirole have been observed in patients treated with hormone replacement therapy.
Danish: Forøgede plasmakoncentrationer af ropinirol er blevet observeret hos patienter behandlet med HRT (Hormone Replacement Therapy).
English: 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.
Danish: 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.
English: 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.
Danish: 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.
English: Very rare cases of hepatic reactions (<1/10,000), mainly increase of liver enzymes, have been reported.
Danish: Meget sjældne (<1/10.000) tilfælde af leverreaktioner, primært øgning af leverenzymer, er rapporteret.
English: If you have the impression that the effect of ADARTREL is too strong or too weak, talk to your doctor or pharmacist.
Danish: Hvis du har en fornemmelse af, at virkningen af Adartrel er for kraftig eller for svag, så tal med lægen eller apoteket om det.
English: France tel +33 1 39 178000 [See Annex I- to be completed nationally] 8 MARKETING AUTHORISATION NUMBER(S) [To be completed nationally]
Danish: Tel +33 1 39 178000 <[Se bilag I - Udfyldes nationalt]>
English: Your doctor may need to adjust your dose.
Danish: Det kan være nødvendigt at justere dosis
English: A detailed assessment of the most common adverse events in the target population (IRLS baseline score 24-40 points) has been provided.
Danish: Der er blevet fremlagt en indgående vurdering af de mest almindelige bivirkninger i målgruppen (scoringsresultat ved baseline på 24-40 point).
English: It is anticipated that the symptoms of ropinirole overdose will be related to its dopaminergic activity.
Danish: Det antages, at symptomerne på overdosering med ropinirol er relateret til dets dopaminerge aktivitet.
English: During treatment with ADARTREL take special care when you drive or operate machinery.
Danish: Under behandling med Adartrel skal du være særlig opmærksom, hvis du skal køre eller håndtere maskiner.
English: Nevertheless, patients must be informed of this phenomenon and advised to exercise caution while driving or operating machines during treatment with ropinirole.
Danish: 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.
English: Therapeutic regimen (week 2 onwards)
Danish: Behandlingsregime (uge 2 og fremefter)
English: These symptoms may be alleviated by appropriate treatment with dopamine antagonists such as neuroleptics or metoclopramide.
Danish: Disse symptomer kan lindres ved relevant behandling med dopamin antagonister såsom neuroleptika eller metoklopramid.
English: Individual dose titration against efficacy and tolerability is recommended.
Danish: Individuel dosistitrering anbefales i henhold til effekt og tolerans.
English: 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.
Danish: Toksikologi: Den toksikologiske profil er pricipielt bestemt af lægemidlets farmakologiske profil: adfærdsændringer, hypoprolactæmi, fald i blodtryk og hjertefrekvens, ptose og spytafsondring.
English: Doses above 4 mg once daily have not been investigated in Restless Legs Syndrome patients.
Danish: Doser over 4 mg en gang daglig er ikke undersøgt i Restless Legs Syndrome patienter.
English: In the moderate to severe RLS population the benefit of treating with ropinirole is seen in all outcomes measured in a consistent way.
Danish: I den moderate til svære RLS-population ses fordelene ved behandling med ropinirol i alle resultatermålt på en ensartet måde.
English: If this occurs, treatment should be reviewed and dosage adjustment or discontinuation of treatment may be considered.
Danish: Hvis dette sker, skal behandlingen vurderes og dosisjustering eller seponering må overvejes.
English: Adverse drug reactions are listed below by system organ class and frequency.
Danish: Bivirkningerne nedenfor er delt op i organklasser og hyppighed.
English: Use of ropinirole in Restless Legs Syndrome
Danish: Brug af ropinirol mod Restless Legs Syndrome
English: Studies in animals have shown reproductive toxicity (see section 5.3).
Danish: Reproduktionstoksicitet er set i dyreforsøg (se afsnit 5.3).
English: GlaxoSmithKline expect to submit the final study report by
Danish: GlaxoSmithKline forventer at fremsende den endelige study report juli 2009
English: Genotoxicity: Genotoxicity was not observed in the usual battery of in vitro and in vivo tests.
Danish: Gentoksicitet: Gentoksicitet blev ikke observeret i de sædvanlige standard in vitro og in vivo undersøgelser.
English: Member state
Danish: Medlemsstat
English: What ADARTREL is and what it is used for Before you take ADARTREL How to take ADARTREL Possible side effects
Danish: 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
English: 6.4 Special precautions for storage Do not store above 25 °C.
Danish: 6.4 Særlige opbevaringsforhold Må ikke opbevares ved over 25◦C.
English: 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.
Danish: Selvom sikkerhedsprofilen er forbundet med ubehagelige bivirkninger såsom kvalme og opkastning, forekommer disse hovedsageligt tidligt i behandlingen og anses for at være håndterbare.
English: Hypromellose Macrogol 400
Danish: Filmovertræk Hypromellose Macrogol 400
English: 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.
Danish: 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.
English: 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.
Danish: 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.
English: No data are available in patients with severe renal impairment.
Danish: Der er ingen tilgængelige data for patienter med svær nedsat nyrefunktion.
English: A rebound phenomenon following discontinuation of ropinirole treatment (end of treatment rebound) cannot be excluded.
Danish: Et rebound-fænomen efter ropinirolbehandlingens ophør (rebound ved slutningen af behandlingen) kan ikke udelukkes.
English: 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.
Danish: 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.
English: 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.
Danish: 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.
English: Each pack contains 28 or 84 tablets.
Danish: Hver pakke indeholder 28 eller 84 tabletter.
English: 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).
Danish: 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).
English: 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.
Danish: Der blev kun i albinorotter observeret retinal degenerering i et langtidsstudie med høj dosering (50 mg/kg), sandsynligvis forbundet med en øget lyspåvirkning.
English: 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.
Danish: 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.
English: 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.
Danish: 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.
English: 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.
Danish: Imidlertid kan det blive nødvendigt at justere ropinirol dosis i overensstemmelse med klinisk respons, såfremt HRT ophører eller introduceres under behandling med ropinirol.
English: 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.
Danish: 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.
English: The nature of these events is consistent with the established safety profile of ropinirole and the dopamine agonist class of drugs.
Danish: Arten af disse bivirkninger er i overensstemmelse med den etablerede sikkerhedsprofil for ropinirol og lægemiddelklassen af dopaminagonister.
English: Like all medicines, ADARTREL can cause side effects, although not everybody gets them.
Danish: 4 HVILKE MULIGE BIVIRKNINGER ADARTREL HAR Som alle andre lægemidler kan Adartrel have bivirkninger, selvom ikke alle får bivirkninger.
English: 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
Danish: 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
English: 9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION {DD month YYYY}
Danish: 9 DATO FOR FØRSTE TILLADELSE/FORNYELSE AF TILLADELSEN
English: Usually the only relief is obtained by walking about or moving the affected limbs, which often leads to problems sleeping.
Danish: Normalt er den eneste lindring at gå rundt eller at bevæge ben og arme, hvilket ofte fører til problemer med at sove om natten.
English: ADARTREL relieves the discomfort and reduces the urge to move the limbs that disrupt night time sleep.
Danish: Adartrel lindrer ubehaget og mindsker trangen til at bevæge ben og arme, som forstyrrer nattesøvnen.
English: Therefore, it is not expected that ropinirole will compete with the metabolism of other medicinal products which are metabolised by CYP1A2.
Danish: Derfor forventes det ikke at ropinirol vil udkonkurrere metabolismen af andre lægemidler som metaboliseres af CYP1A2.
English: A statistically significant difference in the periodic leg movements of sleep was seen between ropinirole and placebo from baseline to week 12.
Danish: Statistisk signifikant forskel i periodiske benbevægelser i søvne sås mellem ropinirol og placebo fra baseline til uge 12.
English: Marketing Authorisation Holder and Manufacturer Marketing Authorisation Holder:
Danish: Indehaveren af markedsføringstilladelsen og fremstiller Indehaver af markedsføringstilladelse:
English: 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).
Danish: 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)
English: The bioavailability of ropinirole is about 50% (36% to 57%), with Cmax reached on average 1.5 hours after the dose.
Danish: Ropinirols biotilgængelighed er ca. 50% (36-57%) og gennemsnitlige peak koncentrationer (Cmax) af lægemidlet opnås ved en mediantid på 1.5 time efter dosering.
English: Post marketing reports
Danish: Rapporter efter markedsføring
English: If you stop taking ADARTREL
Danish: Hvis du holder op med at tage Adartrel
English: Ropinirole is a non ergoline D2/D3 dopamine agonist which stimulates striatal dopamine receptors.
Danish: Ropinirol er en non-ergolin dopamin D2/D3 agonist, som stimulerer striatale dopamin receptorer.
English: 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.
Danish: 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.
English: Unchanged ropinirole and the metabolites are mainly excreted through the kidneys.
Danish: Uomdannet ropinirol og metabolitter udskilles hovedsagelig via nyrerne.
English: 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.
Danish: 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.
English: [See Annex I- to be completed nationally]
Danish: <[Se bilag I - Udfyldes nationalt]>
English: 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).
Danish: 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).
English: ADARTREL is usually taken just before bedtime, but can be taken up to 3 hours before going to bed.
Danish: Adartrel tages som regel lige før sengetid, men kan tages op til tre timer før.
English: 10 DATE OF REVISION OF THE TEXT {MM/YYYY} [To be completed nationally]
Danish: 10 DATO FOR ÆNDRING AF TEKSTEN <MM/ÅÅ> <[Udfyldes nationalt]>
English: 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.
Danish: 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.
English: If you forget to take ADARTREL
Danish: Hvis De glemmer at tage Adartrel
English: Patients who have experienced somnolence and/or an episode of sudden sleep onset must refrain from driving or operating machines.
Danish: Patienter, der har oplevet somnolens og/eller episoder, hvor de pludseligt falder i søvn, skal undlade at føre motorkøretøj eller betjene maskiner.
English: 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.
Danish: 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.
English: Ropinirole should be administered with caution to patients with moderate hepatic impairment.
Danish: Ropinirol skal gives med forsigtighed til patienter med moderat leversvigt.
English: There are no adequate data from the use of ropinirole in pregnant women.
Danish: Erfaringsgrundlaget for anvendelse af ropinirol til gravide er ringe.
English: Store in the original package
Danish: Opbevares i den originale pakning
English: Based on in-vitro data, ropinirole has little potential to inhibit cytochrome P450 at therapeutic doses.
Danish: Baseret på in-vitro data, har ropinirol kun lille potentiale for hæmning af cytochrom P450 ved terapeutiske doser.
English: In the rat, the only drug-related lesions were Leydig cell hyperplasia and testicular adenoma resulting from the hypoprolactinaemic effect of ropinirole.
Danish: Som eneste lægemiddelrelateret påvirkning sås i rotter Leydig cell hyperplasi og testikel adenom som et resultat af ropinirols hypoprolactinæmiske effekt.
English: 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.
Danish: 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.
English: 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.
Danish: 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.
English: 3 HOW TO TAKE ADARTREL
Danish: 3 HVORDAN DU TAGER ADARTREL
English: 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).
Danish: 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).