natgillin/translations-raw huggingface dataset:
The effect of Pradaxa in preventing blood clots in patients who have undergone a hip or knee replacement is comparable to that of enoxaparin.
Učinkovitost zdravila Pradaxa pri preprečevanju nastajanja krvnih strdkov pri bolnikih po operativni vstavitvi umetnega kolka ali kolena je primerljiva z učinkovitostjo enoksaparina.
In the second study, blood clots or blood-clot-related death occurred in 0.4% (3 out of 681) of patients treated with Pradaxa, compared with 5.6% (37 out of 662) of patients treated with placebo.
V drugi študiji so se krvni strdki oziroma smrt bolnika zaradi krvnih strdkov pojavili pri 0,4 % (3 od 681) bolnikov, zdravljenih z zdravilom Pradaxa, v primerjavi s 5,6 % (37 od 662) bolnikov, zdravljenih s placebom.
Treatment and prevention of DVT and PE
Zdravljenje ter preprečevanje globoke venske tromboze in pljučne embolije
Blood clots or blood-clot-related death occurred in 2.7% (68 out of 2,553) of patients treated with Pradaxa, compared with 2.4% (62 out of 2,554) of patients treated with warfarin.
Krvni strdki oziroma smrt bolnika zaradi krvnih strdkov so se pojavili pri 2,7% (68 od 2 553) bolnikov, zdravljenih z zdravilom Pradaxa, v primerjavi z 2,4% (62 od 2 554) bolnikov, zdravljenih z varfarinom.
In the first study, blood clots or blood-clot-related death occurred in 1.8% (26 out of 1,430) of patients treated with Pradaxa, compared with 1.3% (18 out of 1,426) of patients treated with warfarin.
V prvi študiji so se krvni strdki oziroma smrt bolnika zaradi krvnih strdkov pojavili pri 1,8% (26 od 1 430) bolnikov, zdravljenih z zdravilom Pradaxa, v primerjavi z 1,3% (18 od 1 426) bolnikov, zdravljenih z varfarinom.
During the treatment period, blood clots were detected in 6% of the patients taking 220 mg Pradaxa (53 out of 880), compared with 7% of the patients receiving enoxaparin (60 out of 897).
Med zdravljenjem so krvne strdke odkrili pri 6 % (53 od 880) bolnikov, ki so prejemali 220-miligramski odmerek zdravila Pradaxa, v primerjavi s 7 % (60 od 897) bolnikov, ki so prejemali enoksaparin.
During the treatment period, blood clots were detected in 36% of the patients taking 220 mg Pradaxa (183 out of 503), compared with 38% of the patients receiving enoxaparin (193 out of 512).
Med zdravljenjem so krvne strdke odkrili pri 36 % (183 od 503) bolnikov, ki so prejemali 220-miligramski odmerek zdravila Pradaxa, v primerjavi z 38 % (193 od 512) bolnikov, ki so prejemali enoksaparin.
Pradaxa was as effective as warfarin in reducing formation of blood clots in the veins (DVT) or lungs (PE), or blood-clot-related death during treatment.
Zdravilo Pradaxa je bilo pri preprečevanju nastajanja krvnih strdkov v venah ali pljučih ali smrti, povezane s krvnimi strdki, enako učinkovito kot varfarin.
• life-time maximum dose
• vseživljenjski največji odmerek
• evaluation of the left-ventricular ejection fraction (LVEF)
• ocena iztisnega deleža levega prekata (LVEF)
Conditions to the marketing authorisations
Pogoji dovoljenj za promet z zdravilom
The Marketing Authorisation Holders of Novantrone and associated names shall submit for assessment to the Reference Member State a Risk Management Plan containing key elements as described in the CHMP assessment report.
Imetniki dovoljenja za promet z zdravilom Novantrone in povezanimi imeni referenčni državi članici v oceno predložijo načrt za obvladovanje tveganj, ki vsebuje ključne elemente, opisane v poročilu o oceni zdravila odbora CHMP.
The Marketing Authorisation Holder(s) shall ensure that in each Member State where Novantrone and associated names are marketed, all healthcare professional (HCP) and patients/carers who are expected to prescribe and dispense or use Novantrone in treatment of multiple sclerosis have access to/are provided with the following educational package:
Imetnik(-i) dovoljenja za promet z zdravilom zagotovijo, da bodo v vsaki državi članici, kjer se tržijo zdravilo Novantrone in povezana imena, vsi zdravstveni delavci in bolniki/negovalci, za katere se pričakuje, da bodo predpisovali in izdajali ali uporabljali zdravilo Novantrone za zdravljenje multiple skleroze, imeli dostop do naslednjega izobraževalnega paketa/ga prejeli: Brošura za zdravstvene delavce z naslednjimi ključnimi elementi:
National Competent Authorities of Member State(s) or Reference Member State(s) if applicable, shall ensure that the following conditions are fulfilled by the MAH(s):
Pristojni nacionalni organi ene ali več držav članic ali referenčnih držav članic bodo zagotovili, kjer je to ustrezno, da imetnik(-i) dovoljenja za promet z zdravilom izpolnjuje(-jo) naslednje pogoje:
• signs and symptoms of cardiotoxicity and haematotoxicity
• znaki in simptomi kardiotoksičnosti in hematotoksičnosti
• Novantrone could cause cardiotoxicity o need for echocardiogram or multiple-gated acquisition (MUGA) evaluation of the left-ventricular ejection fraction (LVEF) prior to administration of each dose and yearly for up to 5 years after the end of therapy.
• Zdravilo Novantrone lahko povzroči kardiotoksičnost o znaki in simptomi o potreba po ultrazvoku srca ali oceni iztisnega deleža levega prekata (LVEF) z radioizotopsko ventrikulografijo (MUGA) pred vsakim odmerkom in vsako leto 5 let po koncu zdravljenja
• key signs and symptoms regarding cardiotoxicity and haematotoxicity
• ključni znaki in simptomi, povezani s kardiotoksičnostjo in hematotoksičnostjo
• Novantrone could cause haematotoxicity, including secondary acute myeloid leukaemia and myelodysplastic syndrome o the need for monitoring at the start and prior to each treatment administration
• Zdravilo Novantrone lahko povzroči hematotoksičnost, vključno s sekundarno akutno mieloično levkemijo in mielodisplastičnim sindromom o znaki in simptomi o potreba po spremljanju na začetku in pred vsakim odmerkom Kontrolni seznam za zdravstvene delavce z naslednjimi ključnimi elementi:
• Information on the need of regular monitoring, and when it should be carried out, for cardiotoxicity and haematotoxicity
• informacije o potrebi po rednem spremljanju glede kardiotoksičnosti in hematotoksičnosti ter o tem, kdaj ga izvesti Opozorilna kartica za bolnika z naslednjimi ključnimi elementi:
Patient information document including the following key-elements:
• celotna krvna slika, skupaj s trombociti Dokument z informacijami za bolnike z naslednjimi ključnimi elementi:
The final study report will be available 6 months after the last patient visit in the study.
Zaključno poročilo o študiji bo na voljo 6 mesecev po zadnjem obisku zadnjega bolnika.
Treatment initiation (week 1)
Uvajanje zdravljenja (1. teden)
Undesirable effects should be closely monitored.
Neželene učinke je treba skrbno nadzirati.
OVERALL SUMMARY OF THE SCIENTIFIC EVALUATION OF ADARTREL (see Annex I)
SPLOŠNI POVZETEK ZNANSTVENEGA VREDNOTENJA ZDRAVILA ADARTREL (glejte Dodatek I)
Remember to take your medicine.
Ne pozabite jemati zdravila.
In clinical studies most patients were of Caucasian origin.
V kliničnih študijah je bila večina bolnikov kavkaškega porekla.
Dose (mg)/once daily 1 * To achieve optimal improvement in some patients.
Odmerek (mg)/enkrat na dan 1 * Za dosego optimalnega izboljšanja pri posameznih bolnikih.
Module 5 - Clinical
Modul 5 - Klinični del
Do not take more tablets than your doctor has recommended.
Ne jemljite večjega števila tablet, kot vam je svetoval vaš zdravnik.
The amended SPC is endorsed by the CHMP.
Spremenjeni in dopolnjeni SPC je CHMP podprl.
No clinically significant effect on the QT interval was observed.
Opaženih ni bilo nobenih klinično pomembnih učinkov na QT interval.
Population-related characteristics
Značilnosti, povezane s populacijo
Other experience with ropinirole
Druge izkušnje z uporabo ropinirola
Following treatment initiation, the daily dose should be increased until optimal therapeutic response is achieved.
Po uvodnem obdobju zdravljenja moramo dnevni odmerek povečevati, dokler ne dosežemo optimalnega terapevtskega odziva.
Ropinirole is also indicated for the treatment of Parkinson's disease.
Ropinirol je indiciran tudi za zdravljenje Parkinsonove bolezni.
Your doctor will advise you to discontinue this medicine.
Zdravnik vam bo svetoval, da zdravljenje s tem zdravilom prekinete.
Your doctor will decide on the dose you need to take each day and you should follow the doctor's instructions.
Zdravnik vam bo predpisal odmerek, ki ga boste morali jemati vsak dan. Zdravnikova navodila morate natančno upoštevati.
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.
Pred koncem postopka medsebojnega priznavanja sta Španija in Nizozemska pri EMEA sprožili napotitveni postopek zaradi možnosti, da zdravilo predstavlja tveganje za javno zdravje, ker sta bili mnenja, da varnost in učinkovitost pri dolgotrajnem zdravljenju sindroma nemirnih nog z ropinirolom nista bili dokazani.
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.
Obravnavana vprašanja so vključevala med drugim podatke o učinkovitosti, pridobljene v kliničnih preizkušanjih zlasti v podskupini bolnikov, pri katerih je prizadeta funkcionalnost, o dolgoročni učinkovitosti in varnosti kot tudi o razmerju med koristmi in tveganji.
Take ADARTREL once a day by mouth, every day at about the same time each day.
Zdravilo ADARTREL jemljite enkrat na dan, vsak dan približno ob istem času.
6.6 Special precautions for disposal No special requirements.
Posebni varnostni ukrepi za odstranjevanje Ni posebnih zahtev.
The use of ADARTREL during pregnancy is not recommended.
Uporabe zdravila ADARTREL med nosečnostjo ne priporočamo.
Invented name Strengths
Izmišljeno ime Jakosti
The elimination half-life of ropinirole is 6 hours on average.
Srednji razpolovni čas izločanja ropinirola je 6 ur.
At this time the dose prescribed and the need for continued treatment should be considered.
V tem času je treba ovrednotiti predpisani odmerek in oceniti potrebo po kontinuiranem zdravljenju.
The patient's response to ropinirole should be evaluated after 3 months treatment (see section 5.1).
Bolnikov odziv na zdravljenje z ropinirolom je treba oceniti po 3 mesecih zdravljenja (glejte poglavje 5.1).
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.
Ti občutki se pojavijo med obdobji počitka ali telesne neaktivnosti, npr. med sedenjem ali ležanjem, še posebej med spanjem, in se proti večeru ali ponoči poslabšajo.
The expected recruitment period is 18 months.
Vključevanje bolnikov bo predvidoma trajalo 18 mesecev.
Ropinirole may be taken with food, to improve gastrointestinal tolerance.
Bolniki lahko ropinirol jemljejo skupaj s hrano, kar izboljša gastrointestinalno toleranco.
The increase in dosage should be gradual and titrated against the symptomatic response.
Povečevanje odmerka mora biti postopno in v skladu s simptomatskim odzivom.
The bioavailability of ropinirole varies greatly between individuals.
Med posamezniki biološka uporabnost ropinirola zelo variira.
Ropirinol has been granted a marketing authorisation by France on 30 June 2004.
Francija je 30. junija 2004 odobrila dovoljenje za promet za zdravilo Ropinirol.
Your doctor may need to adjust your dose.
Zdravnik bo morda moral odmerek zdravila prilagoditi.
A rebound phenomenon following discontinuation of ropinirole treatment (end of treatment rebound) cannot be excluded.
Rebound fenomena po prekinitvi zdravljenja z ropinirolom (rebound ob koncu zdravljenja) ne moremo izključiti.
SmithKline Beecham Pharmaceuticals, Manor Royal, Crawley, West Sussex RH10 9QJ, United Kingdom
SmithKline Beecham Pharmaceuticals, Manor Royal, Crawley, West Sussex RH10 9QJ, Velika Britanija
If treatment is interrupted for more than a few days it should be re-initiated by dose titration carried out as above.
Če se zdravljenje prekine za več kot nekaj dni, ga je potrebno ponovno uvesti s postopnim povečevanjem odmerka, kot je opisano zgoraj.
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.
V prisotnosti hrane se Cmax zakasni za približno 2,6 ure, največje plazemske vrednosti pa se zmanjšajo za 25 %, vendar brez učinka na količino biološke uporabnosti.
These symptoms may be alleviated by appropriate treatment with dopamine antagonists such as neuroleptics or metoclopramide.
Takšne simptome je možno ublažiti z ustreznim zdravljenjem z antagonisti dopamina, kot so nevroleptiki ali metoklopramid.
Very rarely, cases of altered liver function (abnormal blood tests) have been reported.
Zelo redko so poročali o spremenjenem delovanju jeter (nenormalnih rezultatih krvnih preiskav).
The exact dose of ADARTREL people take can be different.
Natančen odmerek zdravila ADARTREL, ki ga jemljejo bolniki, je lahko različen.
These lesions are considered to be a species specific phenomenon and do not constitute a hazard with regard to the clinical use of ropinirole.
Te spremembe so dozdevno vrstno specifični fenomen in za klinično uporabo ropinirola ne predstavljajo tveganja.
Ropinirole is a non ergoline D2/D3 dopamine agonist which stimulates striatal dopamine receptors.
Ropinirol je neergolinski D2/D3 agonist dopamina, ki stimulira dopaminske receptorje v striatumu.
If you are unsure, it is essential that you talk to your doctor.
Če o navedenem niste popolnoma prepričani, je zelo pomembno, da se posvetujete s svojim zdravnikom.
1 WHAT ADARTREL IS AND WHAT IT IS USED FOR
KAJ JE ZDRAVILO ADARTREL IN ZA KAJ GA UPORABLJAMO
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.
O teh dogodkih so večinoma poročali v začetnih dveh tednih zdravljenja, stopnja izključitve iz zdravljenja z ropinirolom je bila nizka in podobna tisti pri zdravljenju s placebom.
Therapeutic regimen (week 2 onwards)
Režim zdravljenja (od 2. tedna dalje)
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.
V skladu z dokumentacijo mora biti profil primernosti ropinirola v tej populaciji bolnikov analiziran ob upoštevanju fizičnega stanja bolnikov, ki pomembno vpliva na njihovo kakovost življenja, predvsem zaradi dejstva, da bolniki s sindromom nemirnih nog trpijo tudi za kronično nespečnostjo.
Nevertheless, patients must be informed of this phenomenon and advised to exercise caution while driving or operating machines during treatment with ropinirole.
Kljub temu pa je bolnike o tem fenomenu potrebno poučiti in jim svetovati, naj bodo med zdravljenjem z ropinirolom pri vožnji ali upravljanju vozil in strojev previdni.
If you have the impression that the effect of ADARTREL is too strong or too weak, talk to your doctor or pharmacist.
Če menite, da je učinek zdravila ADARTREL premočan ali prešibak, se posvetujte s svojim zdravnikom ali s farmacevtom.
If you find you have forgotten to take your dose of ADARTREL do not take an extra dose to make up for forgotten individual doses.
Če ugotovite, da ste pozabili vzeti odmerek zdravila ADARTREL, ne vzemite dodatnega odmerka, da bi tako nadoknadili pozabljene posamične odmerke.
Very rare cases of hepatic reactions (<1/10,000), mainly increase of liver enzymes, have been reported.
Poročali so tudi o zelo redkih (< 1/10.000) primerih jetrnih reakcij, predvsem povišanih vrednostih jetrnih encimov.
Adverse drug reactions are listed below by system organ class and frequency.
Neželene reakcije so v nadaljevanju navedene glede na organski sistem in pogostnost.
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.
Toksikologija: Toksikološki profil v glavnem določa farmakološka aktivnost ropinirola: vedenjske spremembe, hipoprolaktinemija, zmanjšanje krvnega tlaka in srčne frekvence, ptoza in povečano izločanje sline.
The reported rates in the literature of augmentation associated with dopamine agonists including ropinirole are generally lower than the ones reported for levodopa.
V literaturi zabeležene stopnje avgmentacije, povezane z agonisti dopamina, vključno z ropinirolom so na splošno nižje kot tiste, poročane za levodopo.
In patients over 65 years of age, a reduction in the systemic clearance of ropinirole by about 30% is possible.
Pri bolnikih, starejših od 65 let, je sistemski očistek ropinirola lahko manjši za približno 30 %.
ADARTREL belongs to a group of medicines called dopamine agonists.
Zdravilo ADARTREL spada v skupino zdravil, ki jih imenujemo agonisti dopamina.
Important information about some of the ingredients of ADARTREL Patients who are intolerant to lactose should note that each ADARTREL tablet contains a small amount of lactose.
Pomembne informacije o nekaterih sestavinah zdravila ADARTREL Bolniki, ki ne prenašajo laktoze, morajo vedeti, da vsaka tableta ADARTREL vsebuje majhno količino laktoze.
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).
Pogostnost iz kliničnih raziskav je določena na osnovi pojavnosti, ki je bila višja od pojavnosti pri placebu in je definirana kot zelo pogosti (> 1/10), pogosti (> 1/100, < 1/10) ali občasni (> 1/1.000, < 1/100).
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.
Uporabe zdravila ADARTREL pri otrocih s sindromom nemirnih nog, mlajših od 18 let niso preučevali, zato se zdravilo ADARTREL bolnikom, mlajšim od 18 let običajno ne predpisuje.
You can take ADARTREL with or without food.
Zdravilo ADARTREL lahko jemljete skupaj s hrano ali brez nje.
In patients already receiving hormone replacement therapy, ropinirole treatment may be initiated in the usual manner.
Pri bolnikih, ki se že zdravijo z nadomestno hormonsko terapijo, se lahko zdravljenje z ropinirolom uvede na običajen način.
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.
V varnostnem profilu so predstavljeni neprijetni stranski učinki kot so navzea in bruhanje, ki pa so večinoma težave v zgodnji fazi zdravljenja in se štejejo za obvladljive.
6 FURTHER INFORMATION
DODATNE INFORMACIJE
Patients who have experienced somnolence and/or an episode of sudden sleep onset must refrain from driving or operating machines.
Bolniki, pri katerih se je pojavila somnolenca in/ali epizoda nenadnega nastopa spanja, morajo vožnjo ali upravljanje vozil in strojev opustiti.
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.
Ker - je bil namen napotitve, da se dokaže varnost in učinkovitost ropinirola pri dolgotrajnem zdravljenju bolnikov s sindromom nemirnih nog, - je bil na podlagi predložene dokumentacije in znanstvene razprave znotraj Odbora Povzetek glavnih značilnosti zdravila, ki ga je predlagal vlagatelj, spremenjen kot je določeno v Dodatku III.
Show them the package.
Pokažite jima škatlico vašega zdravila.
It is anticipated that the symptoms of ropinirole overdose will be related to its dopaminergic activity.
Pričakuje se, da bodo simptomi prevelikega odmerjanja ropinirola povezani z njegovim dopaminergičnim delovanjem.
Due to the risk of hypotension, patients with severe cardiovascular disease (in particular coronary insufficiency) should be treated with caution.
Pri zdravljenju bolnikov s hudo kardiovaskularno boleznijo (še posebej bolnikov s koronarno insuficienco) je zaradi tveganja za hipotenzijo potrebna previdnost.
Domperidone antagonises the dopaminergic actions of ropinirole peripherally and does not cross the blood-brain barrier.
Domperidon nasprotuje dopaminergičnemu delovanju ropinirola periferno in ne prehaja preko hematoencefalne bariere.
Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucosegalactose malabsorption should not take this medicine.
Bolniki z redko dedno intoleranco za galaktozo, laponsko obliko zmanjšane aktivnosti laktaze ali malabsorpcijo glukoze/galaktoze ne smejo jemati tega zdravila.
Like all medicines, ADARTREL can cause side effects, although not everybody gets them.
Kot vsa zdravila ima lahko tudi zdravilo ADARTREL neželene učinke, ki pa se ne pojavijo pri vseh bolnikih.
There are no adequate data from the use of ropinirole in pregnant women.
O uporabi ropinirola pri nosečnicah ni dovolj podatkov.
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.
Podatki, pridobljeni iz programa kliničnih preizkušanj ropinirola s študijami do 52 tednov trajajočih zdravljenj z ropinirolom, so pomirjujoči, v kolikor je sporočena klinična pomembnost potencialnih epizod avgmentacije.
Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.
Znotraj vsake skupine, ki označuje pogostnost, so neželeni učinki navedeni od bolj do manj resnega.
Severe renal impairment (creatinine clearance <30 ml/min)
Huda okvara ledvic (kreatininski očistek < 30 ml/min).
Pharmacotherapeutic group: Dopamine agonist, ATC code: N04BC04.
Farmakoterapevtska skupina: Agonisti dopamina, Oznaka ATC: N04BC04
This Marketing Authorisation is subject to conditions considered essential for the safe and effective use of the medicinal product, which are that a long-term, double-blind, placebo controlled trial should be conducted as a post-marketing commitment (see Annexe IV).
Dovoljenje za promet je odvisno od pogojev, za katere se šteje, da so bistveni za varno in učinkovito uporabo zdravila, to pomeni, da mora biti kot del postmarketinških obveznosti izvedeno dolgoročno, dvojno slepo, s placebom kontrolirano preizkušanje (glejte Dodatek IV).
The starting dose is 0.25 mg once daily.
Začetni odmerek je 0,25 mg enkrat na dan.
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.
V tem okviru so podatki o varnosti iz kliničnih preizkušanj pokazali, da sta primernost in varnostni profil ropinirola sprejemljiva pri bolnikih s sindromom nemirnih nog v razponu odmerkov od 0,25 - 4 mg/dan.
The benefit-risk assessment is considered favourable for the moderate to severe RLS as defined in the SPC.
Razmerje med koristmi in tveganji se šteje za ugodno pri zmernem do hudem sindromu nemirnih nog kot je definiran v SPC.
CONDITIONS OF THE MARKETING AUTHORISATION The conditions considered essential for the safe and effective use of the Ropirinole are the following Post-Authorisation Commitment requested by the CHMP and to be submitted to the Reference Member State in the timeline are detailed below:
POGOJI DOVOLJENJA ZA PROMET Z ZDRAVILOM Pogoji, ki se smatrajo nujni za varno in učinkovito uporabo ropinirola so naslednja zaveza predlagatelja na zahtevo CHMP, da bo po pridobitvi dovoljenja za promet referenčni državi članici predal v spodaj navedenih rokih naslednje: