FrancophonIA/ELRC3.0 huggingface dataset:
English: When you do remember to take ADARTREL, take your next dose of ADARTREL at the usual time.
Slovenian: Ko se spomnite, vzemite naslednji odmerek zdravila ADARTREL ob običajnem času.
English: Tell your doctor if: - you are already receiving any other medicines for Restless Legs Syndrome.
Slovenian: Svojemu zdravniku povejte: - če ste se že kdaj zdravili s katerim koli drugim zdravilom za zdravljenje sindroma nemirnih nog.
English: However, for the CHMP, this population of patients should be defined as moderate to severe idiopathic RLS.
Slovenian: Vendar pa bi za CHMP ta populacija bolnikov morala biti definirana kot bolniki z zmernim do hudim idiopatičnim sindromom nemirnih nog.
English: Whilst the adverse events of nausea, vomiting, dizziness and somnolence occurred more frequently with ropinirole treatment than with placebo, the majority of patients had events that were mild to moderate in severity.
Slovenian: Čeprav so se neželeni učinki, navzea, bruhanje, omotica in somnolenca, pojavili pogosteje pri zdravljenju z ropinirolom kot s placebom, so bili pri večini bolnikov ti dogodki blagi do zmerni.
English: A pharmacokinetic interaction study between ropinirole (at a dose of 2 mg, three times a day) and theophylline, a substrate of CYP1A2, revealed no change in the pharmacokinetics of either ropinirole or theophylline.
Slovenian: S študijo farmakokinetičnih interakcij med ropinirolom (v odmerku 2 mg trikrat na dan) in teofilinom, substratom za CYP1A2, spremembe farmakokinetičnih lastnosti ropinirola ali teofilina niso bile ugotovljene.
English: ADARTREL is usually taken just before bedtime, but can be taken up to 3 hours before going to bed.
Slovenian: Zdravilo ADARTREL se običajno jemlje neposredno pred spanjem, vendar pa ga lahko vzamete do 3 ure pred načrtovanim nočnim počitkom.
English: As the potential risk for humans is unknown, it is recommended that ropinirole is not used during pregnancy unless the potential benefit to the patient outweighs the potential risk to the foetus.
Slovenian: Ker možno tveganje za ljudi ni znano, uporabe ropinirola med nosečnostjo ne priporočamo, razen če možna korist za mater prevlada nad kakršnim koli možnim tveganjem za plod.
English: Doses above 4 mg once daily have not been investigated in Restless Legs Syndrome patients.
Slovenian: Raziskave z odmerki, višjimi od 4 mg enkrat na dan pri bolnikih s sindromom nemirnih nog niso bile izvedene.
English: Hence its value as an anti-emetic in patients treated with centrally acting dopamine agonists.
Slovenian: Od tod izvira njegova antiemetična vrednost pri bolnikih, ki se zdravijo s centralno delujočimi agonisti dopamina.
English: SCIENTIFIC CONCLUSIONS AND GROUNDS FOR AMENDMENT OF THE SUMMARY OF PRODUCT CHARACTERISTICS, LABELLING AND PACKAGE LEAFLET PRESENTED BY THE EMEA
Slovenian: ZNANSTVENI ZAKLJUČKI IN PODLAGA ZA DOPOLNILO POVZETKOV GLAVNIH ZNAČILNOSTI ZDRAVILA, OZNAČEVANJE IN NAVODILA ZA UPORABO, PREDSTAVLJENI S STRANI EVROPSKE AGENCIJE ZA ZDRAVILA
English: Also uncommonly, ADARTREL can reduce blood pressure, which may make you feel dizzy or faint especially when standing up from a sitting or lying position.
Slovenian: Občasno lahko zdravilo ADARTREL povzroči tudi zmanjšanja krvnega tlaka, zaradi česar se lahko počutite omotični ali omedlite, še posebej ko vstanete iz sedečega ali ležečega položaja.
English: When you first start taking ADARTREL, the dose you take will be increased gradually.
Slovenian: Ko boste prvič pričeli z jemanjem zdravila ADARTREL, boste postopoma jemali večji odmerek.
English: Each pack contains 28 or 84 tablets.
Slovenian: Vsaka škatla vsebuje 28 ali 84 tablet.
English: France tel +33 1 39 178000 [See Annex I- to be completed nationally] 8 MARKETING AUTHORISATION NUMBER(S) [To be completed nationally]
Slovenian: France tel +33 1 39 178000 [Glejte Dodatek I - Izpolni država članica]
English: The more common side effects of ADARTREL can happen when some patients first start their therapy and/or when the dose is increased.
Slovenian: Najpogostejši neželeni učinki zdravila ADARTREL se lahko pojavijo, ko se posamezni bolniki prvič pričnejo zdraviti z zdravilom in/ali pri povečevanju odmerka.
English: Uncommon side effects are feeling confused and experiencing hallucinations.
Slovenian: Občasna neželena učinka sta zmedenost in halucinacije.
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).
Slovenian: Vpliv na sposobnost razmnoževanja: Pri dajanju ropinirola brejim podganam v odmerkih, ki so bili toksični za mater so opazili: pri 60 mg/kg (približno 15-kraten AUC pri največjem odmerku pri človeku) zmanjšana telesna masa fetusov, pri 90 mg/kg (približno 25-kraten AUC pri največjem odmerku pri človeku) povečan odstotek smrtnosti fetusov in pri 150 mg/kg (približno 40-kraten AUC pri največjem odmerku pri človeku) malformacije prstov.
English: What ADARTREL is and what it is used for Before you take ADARTREL How to take ADARTREL Possible side effects
Slovenian: Kaj je zdravilo ADARTREL in za kaj ga uporabljamo Kaj morate vedeti, preden boste vzeli zdravilo ADARTREL Kako jemati zdravilo ADARTREL Možni neželeni učinki
English: Do not chew the tablet(s).
Slovenian: Tablete (tablet) ne smete žvečiti.
English: Ropinirole should be taken just before bedtime, however the dose can be taken up to 3 hours before retiring.
Slovenian: Bolnik mora ropinirol vzeti neposredno pred spanjem, vendar pa lahko odmerek ropinirola vzame tudi do 3 ure pred načrtovanim počitkom.
English: The MAH agreed to revise the SPC, sections 4.2 and 5.1, to specify that ropinirole is indicated in moderate to severe idiopathic restless legs syndrome.
Slovenian: Imetnik dovoljenja za promet se je strinjal, da bo revidiral razdelka 4.2 in 5.1 v SPC tako, da bo natančno navedel, da je ropinirol indiciran za zdravljenje zmernega do hudega idiopatičnega sindroma nemirnih nog.
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).
Slovenian: Ropinirola ne smemo uporabljati za zdravljenje nevroleptične akatizije, tasikinezije (z nevroleptiki povzročene kompulzivne težnje za hojo) ali sekundarnega sindroma nemirnih nog (npr. zaradi odpovedi ledvic, anemije zaradi pomanjkanja železa ali nosečnosti).
English: In Parkinson's disease, ropinirole has been associated uncommonly with somnolence and episodes of sudden sleep onset (see section 4.8) however, in Restless Legs Syndrome, this phenomenon is very rare.
Slovenian: Pri bolnikih s Parkinsonovo boleznijo je bila uporaba ropinirola občasno povezana s somnolenco in z epizodami nenadnega nastopa spanja (glejte poglavje 4.8), vendar pa je ta fenomen pri bolnikih s sindromom nemirnih nog zelo redek.
English: In Restless Legs Syndrome clinical trials the most common adverse drug reaction was nausea (approximately 30% of patients).
Slovenian: Med kliničnimi raziskavami pri bolnikih s sindromom nemirnih nog je bila navzea najpogostejši neželeni dogodek (pojavila se je pri približno 30 % bolnikov).
English: Not all packs may be available.
Slovenian: Na trgu ni vseh navedenih pakiranj.
English: The nature of these events is consistent with the established safety profile of ropinirole and the dopamine agonist class of drugs.
Slovenian: Narava teh dogodkov se sklada s poznanim varnostnim profilom ropinirola in z razredom zdravil, v katerega spadajo agonisti dopamina.
English: PVC/PCTFE/Aluminium blister.
Slovenian: PVC/PCTFE/aluminij pretisni omoti.
English: Genotoxicity: Genotoxicity was not observed in the usual battery of in vitro and in vivo tests.
Slovenian: Genotoksičnost: Z običajnimi in vitro in in vivo testi genotoksičnosti niso ugotovili.
English: Usually the only relief is obtained by walking about or moving the affected limbs, which often leads to problems sleeping.
Slovenian: Bolnikom običajno edino olajšanje predstavlja hoja ali premikanje prizadete okončine, kar pogosto povzroči težave s spanjem (nespečnost).
English: The analysis of Serious Adverse Events (SAE) was unremarkable in the overall group of patients enrolled in the ropinirole clinical studies.
Slovenian: Analiza resnih neželenih učinkov ni pokazala posebnosti v celotni skupini bolnikov, ki so sodelovali v kliničnih študijah z ropinirolom.
English: Swallow the ADARTREL tablet(s) whole with water.
Slovenian: Tableto (tablete) ADARTREL pogoltnite celo (cele) skupaj z vodo.
English: 10 DATE OF REVISION OF THE TEXT {MM/YYYY} [To be completed nationally]
Slovenian: DATUM ZADNJE REVIZIJE BESEDILA {MM/LLLL} [Izpolni država članica]
English: Do not use ADARTREL after the expiry date which is stated on the carton.
Slovenian: Zdravila ADARTREL ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli.
English: In patients with mild to moderate renal impairment (creatinine clearance between 30 and 50 ml/min), no change in the pharmacokinetics of ropinirole is observed.
Slovenian: Pri bolnikih z blago do zmerno okvaro ledvic (kreatininski očistek med 30 in 50 ml/min) spremembe farmakokinetičnih lastnosti ropinirola niso bile opažene.
English: A recent study has been conducted by the MAH in healthy volunteers on the effects of ropinirole on cardiac conduction.
Slovenian: Imetnik dovoljenja za promet z zdravilom je pred nedavnim izvedel študijo na zdravih prostovoljcih o učinkih ropinirola na srčno prevajanje.
English: Therefore the CHMP has recommended that there are no objections for the granting of the Marketing Authorisation for Adartel, in the treatment of symptomatic treatment of moderate to severe idiopathic restless legs syndrome.
Slovenian: Zato je CHMP priporočil, da ni nobenih ovir za odobritev dovoljenja za promet za Adartrel za simptomatsko zdravljenje zmernega do hudega idiopatičnega sindroma nemirnih nog.
English: If you have missed taking ADARTREL for more than a few days consult your doctor for advice on restarting ADARTREL.
Slovenian: Če ste zdravilo ADARTREL pozabili jemati več kot nekaj dni, se o ponovnem pričetku jemanja zdravila ADARTREL posvetujte s svojim zdravnikom.
English: If the undesirable effect abates, gradual up-titration can be re-instituted.
Slovenian: Če se neželeni učinki s tem ublažijo, lahko odmerek nato zopet postopno povečujemo.
English: The most common side effects are: - feeling or being sick - dizziness (or spinning sensation) - feeling drowsy - fatigue (mental or physical tiredness) - stomach pain - fainting - nervousness
Slovenian: Najpogostejši neželeni učinki so: - slabost ali občutek slabosti; - omotica (ali občutek vrtoglavosti); - zaspanost; - utrujenost (duševna ali fizična izčrpanost); - bolečine v trebuhu; - omedlevica; - živčnost.
English: Packs of 28 or 84 tablets.
Slovenian: Pakiranje po 28 ali 84 tablet.
English: If this occurs, you should see your doctor.
Slovenian: V tem primeru morate obiskati svojega zdravnika.
English: During treatment with ropinirole, paradoxical worsening of Restless Legs Syndrome symptoms occurring with earlier onset (augmentation), and reoccurrence of symptoms in the early morning hours (early morning rebound), may be observed.
Slovenian: Med zdravljenjem z ropinirolom se lahko pojavi paradoksno poslabšanje simptomov sindroma nemirnih nog z zgodnejšim pojavom (avgmentacija) in ponovitev simptomov v zgodnjih jutranjih urah (zgodnji jutranji rebound).
English: During treatment with ADARTREL you may experience unusual worsening of symptoms (e.g. symptoms become worse, start earlier in the day or after less time at rest, or affect other parts of your body such as your arms).
Slovenian: Med zdravljenjem z zdravilom ADARTREL se lahko vaši bolezenski znaki poslabšajo (npr. postanejo hujši, se pričnejo prej ali kmalu po končanem počitku, ali pa prizadenejo druge dele telesa, npr. roke).
English: This medicine does not usually affect people's normal activities.
Slovenian: Vpliv na sposobnost upravljanja vozil in strojev To zdravilo običajno ne vpliva na vsakdanje dejavnosti.
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.
Slovenian: Klinični del Predati končno poročilo o opravljeni klinični študiji (ROR104836), “26-tedenska, randomizirana, dvojno slepa, s placebom nadzorovana študija paralelnih skupin o vrednotenju varnosti in učinkovitosti ropinirola in nadaljnje vrednotenje pojavnosti avgmentacije in rebounda v nadaljnjih 40 tednih podaljšanega zdravljenja pri osebah z zmerno do hudo obliko sindroma nemirnih nog.”
English: If you forget to take ADARTREL
Slovenian: Če ste pozabili vzeti zdravilo ADARTREL
English: After three months of treatment with ADARTREL, your doctor may adjust your dose or discontinue your treatment depending on your symptoms and how you feel.
Slovenian: Po treh mesecih zdravljenja z zdravilom ADARTREL bo zdravnik ocenil uspešnost zdravljenja in glede na bolezenske znake ter vaše počutje odmerek zdravila prilagodil ali pa zdravljenje prekinil.
English: Dopamine agonists act like a naturally occurring chemical in your brain called dopamine.
Slovenian: Agonisti dopamina delujejo tako kot naravna substanca, ki se nahaja v možganih in jo imenujemo dopamin.
English: Furthermore, a reduction of dosage or termination of therapy may be considered.
Slovenian: Še več, morda bo celo potrebno razmisliti o zmanjšanju odmerka ali opustitvi zdravljenja.
English: INFORMATION IN BRAILLE {To be completed nationally}
Slovenian: PODATKI V BRAILLOVI PISAVI {Izpolni država članica}
English: Take special care with ADARTREL Tell your doctor before you start to take this medicine if you:
Slovenian: Bodite posebno pozorni pri jemanju zdravila ADARTREL Preden začnete jemati zdravilo ADARTREL, morate svojemu zdravniku povedati:
English: The MAH agreed to revise also section 5.1, to specify that ropinirole treated patients had higher IRLS scores at follow up assessment compared to placebo treated patients.
Slovenian: Imetnik dovoljenja za promet se je strinjal tudi, da bo razdelek 5.1 revidiral tako, da bo v njem natančno navedel, da so bile vrednosti na MLSNN v naknadni oceni višje pri bolnikih, ki so prejemali ropinirol, kot pri bolnikih, ki so prejemali placebo.
English: 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).
Slovenian: Bolnike, pri katerih se med zdravljenjem z ropinirolom pojavijo somnolenca in/ali epizode nenadnega nastopa spanja, je potrebno opozoriti, da dokler tovrstni učinki ne minejo, ne smejo voziti vozil ali opravljati tistih del (npr. upravljanje strojev), kjer bi zaradi njihove zmanjšane zbranosti lahko prišlo do hujših ali celo smrtnih poškodb pri njih samih ali njihovih sodelavcih (glejte tudi poglavje 4.4).
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
Slovenian: Ne jemljite zdravila ADARTREL - če ste alergični na (preobčutljivi za) zdravilno učinkovino ropinirol ali katero koli drugo sestavino zdravila ADARTREL; - če imate hujšo bolezen jeter; - če imate hujšo bolezen ledvic.
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).
Slovenian: Vezava ropinirola na plazemske proteine ni visoka (< 40 %) in ne vpliva na porazdelitev.
English: Each pack contains 2 or 12 tablets.
Slovenian: Vsaka škatla vsebuje 2 tableti ali 12 tablet.
English: METHOD AND ROUTE(S) OF ADMINISTRATION Read the package leaflet before use
Slovenian: POSTOPEK IN POT(I) UPORABE ZDRAVILA Pred uporabo preberite priloženo navodilo.
English: ADARTREL is indicated for the symptomatic treatment of moderate to severe idiopathic Restless Legs Syndrome (see section 5.1).
Slovenian: Zdravilo ADARTREL je indicirano za simptomatsko zdravljenje zmernega do hudega idiopatičnega sindroma nemirnih nog (glejte poglavje 5.1).
English: 6.5 Nature and contents of container PVC/PCTFE/Aluminium blister.
Slovenian: Vrsta ovojnine in vsebina PVC/PCTFE/aluminij pretisni omoti.
English: ADARTREL relieves the discomfort and reduces the urge to move the limbs that disrupt night time sleep.
Slovenian: Zdravilo ADARTREL olajša občutek neugodja in zmanjšuje potrebo po premikanju okončin in tako prispeva k boljšemu nočnemu počitku.
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.
Slovenian: S farmakokinetično študijo (ropinirol v odmerku 2 mg trikrat na dan) je bilo ugotovljeno, da se zaradi ciprofloksacina povečata tako Cmax kot AUC ropinirola, in sicer Cmax za 60 %, AUC pa za 84 %, kar predstavlja možno tveganje za pojav neželenih dogodkov.
English: Table 2 lists the adverse drug reactions reported for ropinirole in the 12-week clinical trials at ≥1.0% above the placebo rate or those reported uncommonly but known to be associated with ropinirole.
Slovenian: V tabeli 2 so navedene neželene reakcije katerih odstotek za ropinirol je bil med 12-tedenskimi kliničnimi raziskavami za ≥ 1,0 % večji kot odstotek za placebo, oziroma tiste o katerih so poročali občasno, vendar pa so bile povezane z ropinirolom.
English: Lactose monohydrate Microcrystalline cellulose Croscarmellose sodium Magnesium stearate.
Slovenian: monohidrat laktoze mikrokristalna celuloza natrijev premrežen karmelozat magnezijev stearat
English: Packs of 2 or 12 tablets.
Slovenian: Pakiranje po 2 ali 12 tablet.
English: OTHER SPECIAL WARNING(S), IF NECESSARY To be taken as directed by your doctor.
Slovenian: DRUGA POSEBNA OPOZORILA, ČE SO POTREBNA Zdravilo uporabljajte natančno po zdravnikovih navodilih!
English: Psychiatric disorders Common
Slovenian: Psihiatrične motnje pogosti
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.
Slovenian: Pri dolgotrajnih študijah z velikimi odmerki (50 mg/kg) so le pri albino podganah ugotovili degeneracijo mrežnice, kar je bilo verjetno povezano s povečano izpostavljenostjo svetlobi.
English: If any of the side effects become serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist as soon as possible.
Slovenian: Če kateri koli neželeni učinek postane resen ali če opazite kateri koli neželene učinek, ki ni omenjen v tem navodilu, čim prej obvestite svojega zdravnika ali farmacevta.
English: If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
Slovenian: Če vam je zdravnik kdaj povedal, da določenih sladkorjev ne prenašate, se, preden prvič vzamete to zdravilo, posvetujte s svojim zdravnikom.
English: 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.
Slovenian: Po prvih dveh dneh zdravljenja bo vaš zdravnik odmerek verjetno povečal na 0,5 mg enkrat na dan. Tolikšen odmerek boste jemali v preostanku prvega tedna zdravljenja.
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.
Slovenian: Pri odmerku 120 mg/kg (približno 30-kraten AUC pri največjem odmerku pri človeku) teratogeni učinki pri podganah niso bili opaženi, pri kuncih pa ni bilo indikacij, ki bi nakazovale učinek na razvoj.
English: ADARTREL can cause excessive daytime somnolence (excessive drowsiness) and very rarely sudden sleep onset episodes where patients fall asleep suddenly without apparently feeling sleepy.
Slovenian: Zdravilo ADARTREL lahko povzroči prekomerno somnolenco (zaspanost) preko dneva, v zelo redkih primerih pa lahko bolniki tudi nenadoma, brez predhodnega očitnega občutka zaspanosti, zaspijo.
English: A combined analysis of data from moderate to severe Restless Legs Syndrome patients, in the four 12-week placebo-controlled studies, indicated that ropinirole-treated patients reported significant improvements over placebo on the parameters of the Medical Outcome Study Sleep Scale (scores on 0-100 range except sleep quantity).
Slovenian: Kombinirana analiza podatkov, pridobljenih pri bolnikih z zmernim do hudim sindromom nemirnih nog med štirimi 12-tedenskimi s placebom nadzorovanimi študijami kaže, da je, v primerjavi s placebom, pri bolnikih, zdravljenih z ropinirolom prišlo do pomembnega izboljšanja parametrov na lestvici spanja (Medical Outcome Study Sleep Scale; rezultati na lestvici od 0 do 100, razen količine spanja).
English: - If any of the side effects become serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
Slovenian: - Če kateri koli neželeni učinek postane resen ali če opazite kateri koli neželeni učinek, ki ni omenjen v tem navodilu, obvestite svojega zdravnika ali farmacevta.
English: Neuroleptics and other centrally active dopamine antagonists, such as sulpiride or metoclopramide, may diminish the effectiveness of ropinirole and, therefore, concomitant use of these medicinal products with ropinirole should be avoided.
Slovenian: Nevroleptiki in drugi centralno delujoči antagonisti dopamina, npr. sulpirid ali metoklopramid, lahko zmanjšajo učinkovitost ropinirola.
English: A 12-week placebo-controlled polysomnography study in Restless Legs Syndrome patients examined the effect of treatment with ropinirole on periodic leg movements of sleep.
Slovenian: Z 12-tedensko s placebom nadzorovano polisomnografsko študijo v katero so bili vključeni bolniki s sindromom nemirnih nog so raziskovali učinek zdravljenja z ropinirolom na periodično gibanje nog med spanjem.
English: If you take more ADARTREL than you should or if someone else has taken your medicine, tell a doctor or pharmacist immediately.
Slovenian: Če ste vzeli večji odmerek zdravila ADARTREL kot bi smeli, ali če je kdo drug vzel vaše zdravilo, se o tem nemudoma posvetujte s svojim zdravnikom ali farmacevtom.
English: In a combined analysis of moderate to severe Restless Legs Syndrome patients from the four 12-week studies, the adjusted treatment difference for the change from baseline in IRLS scale total score at week 12 Last Observation Carried Forward (LOCF) Intention To Treat population was -4.0 points (95% CI -5.6,2.4, p<0.0001; baseline and week 12 LOCF mean IRLS points: ropinirole 28.4 and 13.5; placebo 28.2 and 17.4).
Slovenian: S kombinirano analizo podatkov, pridobljenih pri bolnikih z zmernim do hudim sindromom nemirnih nog, vključenih v štiri 12-tedenske študije so ugotovili, da je bila prilagojena razlika zaradi zdravljenja, glede na spremembo skupnega rezultata na MLSNN od izhodišča do 12. tedna (Last Observation Carried Forward; LOCF) -4,0 točke (95 % interval zaupanja: -5,6, -2,4; p < 0,0001; povprečno število točk v izhodišču oziroma v 12. tednu LOCF na MLSNN: ropinirol 28,4 oziroma 13,5; placebo 28,2 oziroma 17,4).
English: 9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION {DD month YYYY}
Slovenian: DATUM PRIDOBITVE/PODALJŠANJA DOVOLJENJA ZA PROMET {DD mesec LLLL} [Izpolni država članica]
English: Film coat:
Slovenian: Filmska obloga: