FrancophonIA/ELRC3.0 huggingface dataset:
English: These points should be considered when initiating pramipexole treatment in patients with Parkinson´s disease.
Slovenian: Omenjene ugotovitve je treba upoštevati ob uvajanju zdravljenja s pramipeksolom pri bolnikih s Parkinsonovo boleznijo.
English: Boxes of 20, 30, 60, 90 and 100 tablets in blisters of 10 tablets are available.
Slovenian: Na voljo so škatle z 20, s 30, 60, z 90 in s 100 tabletami v pretisnih omotih po 10 tablet.
English: Patients being treated with Oprymea 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 recurrent episodes and somnolence have resolved (see also sections 4.4, 4.5 and 4.8).
Slovenian: Bolnikom, pri katerih se med zdravljenjem z zdravilom Oprymea pojavlja zaspanost in/ali imajo nenadne epizode spanja, je treba svetovati, naj ne vozijo in naj se ne ukvarjajo z dejavnostmi, pri katerih se zaradi poslabšane budnosti poveča nevarnost resnih poškodb ali smrti (npr. pri upravljanju strojev), dokler ponavljajoče se epizode nenadnega spanja in zaspanost ne minejo (glejte še poglavja 4.4, 4.5 in 4.8).
English: Within the system organ classes, adverse reactions are listed under headings of frequency (number of patients expected to experience the reaction), using the following categories: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100); rare (≥ 1/10,000 to < 1/1,000); very rare (< 1/10,000); not known (cannot be estimated from the available data .
Slovenian: Neželeni učinki so navedeni po organskih sistemih in razvrščeni po pogostosti (pričakovano število bolnikov, ki bodo doživeli neželen učinek) v naslednje skupine: zelo pogosti (≥ 1/10), pogosti (≥ 1/100 do < 1/10), občasni (≥ 1/1.000 do < 1/100), redki (≥ 1/10.000 do < 1/1.000), zelo redki (< 1/10.000), neznana pogostnost (ni mogoče oceniti iz razpoložljivih podatkov.
English: Ophthalmologic monitoring is recommended at regular intervals or if vision abnormalities occur.
Slovenian: Oftalmološki pregledi Priporočljivi so redni oftalmološki pregledi, še posebno, če se pojavijo motnje vida.
English: Efficacy was maintained in 87 of 103 patients switched to pramipexole prolonged-release tablets.
Slovenian: Učinkovitost je ostala po prehodu na pramipeksol tablete s podaljšanim sproščanjem enaka pri 87 od 103 bolnikov.
English: Pramipexole was not teratogenic in rats and rabbits, but was embryotoxic in the rat at maternotoxic doses (see section 5.3).
Slovenian: Pramipeksol ni bil teratogen pri podganah in zajcih, vendar je bil embriotoksičen pri podganah v odmerkih, toksičnih za samico (glejte poglavje 5.3).
English: 7 tablets of Oprymea 1.05 mg
Slovenian: 7 tablet Oprymea 1,05 mg
English: However, if its use is unavoidable, breast-feeding should be discontinued.
Slovenian: Če pa se njegovi uporabi ne moremo izogniti, mora mati prenehati dojiti.
English: The European Medicines Agency has deferred the obligation to submit the results of studies with pramipexole in one or more subsets of the paediatric population in Restless Legs Syndrome (see section 4.2 for information on paediatric use).
Slovenian: Evropska agencija za zdravila je začasno odložila zahtevo za predložitev rezultatov študij z zdravilom Oprymea pri sindromu nemirnih nog za eno ali več podskupin pediatrične populacije (za podatke o uporabi pri pediatrični populaciji glejte poglavje 4.2).
English: Boxes of 10, 30, 90 and 100 tablets in blisters of 10 tablets are available.
Slovenian: Na voljo so škatle z 10, s 30, z 90 in s 100 tabletami v pretisnih omotih po 10 tablet.
English: Oprymea is not recommended for use in children and adolescents below 18 years since the efficacy and safety has not been established in this population.
Slovenian: Zdravilo Oprymea ni primerno za uporabo pri otrocih in mladostnikih, mlajših od 18 let, ker pri njih učinkovitost in varnost zdravila še nista dokazani.
English: Dose adjustment in patients with hepatic failure is probably not necessary, as approx. 90% of absorbed active substance is excreted through the kidneys.
Slovenian: Prilagoditev odmerka pri bolnikih z jetrno odpovedjo verjetno ni potrebna, ker se približno 90 % absorbirane zdravilne učinkovine izloči skozi ledvica.
English: The expected adverse reactions would be those related to the pharmacodynamic profile of a dopamine agonist, including nausea, vomiting, hyperkinesia, hallucinations, agitation and hypotension.
Slovenian: Pričakovani neželeni učinki bi morali biti povezani s farmakodinamskimi lastnostmi agonistov dopamina, vključno z navzeo, bruhanjem, hiperkinezijo, halucinacijami, agitacijo in hipotenzijo.
English: Co-administration of antipsychotic medicinal products with pramipexole should be avoided (see section 4.4), e.g. if antagonistic effects can be expected.
Slovenian: Sočasni uporabi antipsihotičnih zdravil in pramipeksola se je treba izogibati (glejte poglavje 4.4), npr. kadar je pričakovan antagonistični učinek.
English: Week 1
Slovenian: 1. teden
English: Based on the analysis of pooled placebo-controlled trials, comprising a total of 1,923 patients on pramipexole and 1,354 patients on placebo, adverse drug reactions were frequently reported for both groups.
Slovenian: Analiza podatkov s placebom nadzorovanih kliničnih preizkušanj, v katerih je sodelovalo 1.923 bolnikov, zdravljenih s pramipeksolom, in 1.354 bolnikov, ki so jemali placebo, je pokazala, da so o neželenih učinkih pogosto poročali v obeh skupinah.
English: The recommended starting dose of Oprymea is 0.088 mg of base (0.125 mg of salt) taken once daily 2-3 hours before bedtime.
Slovenian: Priporočeni začetni odmerek zdravila Oprymea je 0,088 mg pramipeksola (0,125 mg soli) enkrat na dan, 2-3 ure pred spanjem.
English: Insomnia hallucinations abnormal dreams confusion behavioural symptoms of impulse control disorders and compulsions compulsive shopping pathological gambling restlessness hypersexuality delusion libido disorder paranoia delirium binge eating hyperphagia mania
Slovenian: Psihiatrične motnje nespečnost halucinacije nenormalne sanje zmedenost vedenjski simptomi motenj nadzora impulzov in kompulzije kompulzivno nakupovanje patološko hazardiranje nemir hiperseksualnost blodnje motnje libida paranoja delirij prenajedanje hiperfagija manija
English: When Oprymea is given in combination with levodopa, it is recommended that the dose of levodopa is reduced and the dose of other anti-parkinsonian medicinal products is kept constant while increasing the dose of Oprymea.
Slovenian: Če se zdravilo Oprymea daje skupaj z levodopo, in povečujemo njegov odmerek, je priporočljivo zmanjšati odmerek levodope, medtem ko naj ostanejo odmerki drugih antiparkinsonikov nespremenjeni.
English: In clinical trials approximately 5% of patients were treated at doses below 1.1 mg of base (1.5 mg of salt).
Slovenian: V kliničnih preizkušanjih so približno 5 % bolnikov zdravili z dnevnimi odmerki, manjšimi od 1,1 mg (1,5 mg soli).
English: In a double-blind placebo-controlled trial including a total of 517 patients with advanced Parkinson's disease who were on concomitant levodopa therapy superiority of pramipexole prolonged-release tablets over placebo was demonstrated after 18 weeks of treatment on both the primary (UPDRS Parts II+III score) and the key secondary (off-time) efficacy endpoints.
Slovenian: V dvojno slepem, s placebom nadzorovanim preskušanjem pri skupno 517 bolnikih z napredovalo Parkinsonovo boleznijo, ki so sočasno jemali levodopo, so po 18 tednih zdravljenja dokazali prednost pramipeksol tablet s podaljšanim sproščanjem pred placebom na podlagi primarnih (ocena na lestvici UPDRS, II.
English: When the intake of a dose is missed, Oprymea prolonged-release tablets should be taken within 12 hours after the regularly scheduled time.
Slovenian: Če bolnik pozabi vzeti odmerek tablet Oprymea s podaljšanim sproščanjem, ga mora vzeti do 12 ur po predvidenem času jemanja pozabljenega odmerka.
English: Pramipexole was not teratogenic in rats and rabbits but was embryotoxic in the rat at maternally toxic doses.
Slovenian: Pramipeksol ni bil teratogen pri podganah in zajcih, vendar je bil pri podganah v odmerkih, toksičnih za samico, embriotoksičen.
English: In advanced Parkinson's disease, pramipexole doses higher than 1.05 mg of base (1.5 mg of salt) per day can be useful in patients where a reduction of the levodopa therapy is intended.
Slovenian: Odmerki pramipeksola, večji od 1,05 mg baze (1,5 mg soli) na dan, so lahko koristni pri bolnikih z napredovalo Parkinsonovo boleznijo, pri katerih je predvideno zmanjšanje zdravljenja z levodopo.
English: The safety and efficacy of pramipexole prolonged-release tablets in the treatment of Parkinson's disease was evaluated in a multinational drug development program consisting of three randomised, controlled trials.
Slovenian: Varnost in učinkovitost pramipeksol tablet s podaljšanim sproščanjem so ocenili v večnacionalnem programu razvoja zdravil, v sklopu katerega so izvedli tri nadzorovana preskušanja pri naključno izbranih bolnikih s Parkinsonovo boleznijo.
English: A more frequent adverse drug reaction in combination with levodopa was dyskinesia.
Slovenian: Pogostnejši neželeni učinek v kombinaciji z levodopo je bila diskinezija.
English: Once daily.
Slovenian: peroralna uporaba enkrat na dan
English: Animal studies have shown that pramipexole inhibits dopamine synthesis, release, and turnover.
Slovenian: Poskusi na živalih so pokazali, da pramipeksol zavira sintezo, sproščanje in hitrost izrabe ("turnover") dopamina.
English: 3-week treatment initiation pack
Slovenian: Pakiranje za tritedensko začetno zdravljenje
English: Since the daily dose for the treatment of Restless Legs Syndrome will not exceed 0.54 mg of base (0.75 mg of salt) Oprymea can be discontinued without tapering off.
Slovenian: Prekinitev zdravljenja Ker dnevni odmerek za zdravljenje sindroma nemirnih nog ni večji od 0,54 mg pramipeksola (0,75 mg soli), lahko zdravilo Oprymea ukinemo brez postopnega zmanjševanja odmerka.
English: Total Daily Dose (mg of base)
Slovenian: Dnevni odmerek (mg baze)
English: Oprymea is indicated in adults for treatment of the signs and symptoms of idiopathic Parkinson's disease, alone (without levodopa) or in combination with levodopa, i.e. over the course of the disease, through to late stages when the effect of levodopa wears off or becomes inconsistent and fluctuations of the therapeutic effect occur (end of dose or "on off" fluctuations).
Slovenian: Zdravilo Oprymea je pri odraslih indicirano za zdravljenje znakov in simptomov idiopatske Parkinsonove bolezni, samo (brez levodope) ali v kombinaciji z levodopo, to je v napredovalem in poznem stadiju bolezni, ko začne učinek levodope popuščati, postane nestalen in se pojavljajo nihanja terapevtskega učinka (pojemanje učinka odmerka ali vklopno-izklopni pojavi).
English: TREATMENT INITIATION PACK ONLY MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
Slovenian: SAMO ZA PAKIRANJE ZA ZAČETEK ZDRAVLJENJA PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA PRETISNEM OMOTU ALI DVOJNEM TRAKU
English: Because of possible additive effects, caution should be advised when patients are taking other sedating medicinal products or alcohol in combination with pramipexole (see sections 4.4, 4.7 and 4.8).
Slovenian: Zaradi možnih aditivnih učinkov svetujemo bolnikom previdnost pri jemanju drugih sedativnih zdravil ali alkohola v kombinaciji s pramipeksolom (glejte poglavja 4.4, 4.7 in 4.8).
English: Based on the analysis of pooled placebo-controlled trials, comprising a total of 1,778 Parkinson's disease patients on pramipexole and 1,297 patients on placebo, adverse drug reactions were frequently reported for both groups.
Slovenian: Skupna analiza s placebom nadzorovanih preskušanj pri 1.778 bolnikih s Parkinsonovo boleznijo, ki so jemali pramipeksol, in 1.297 bolnikih, ki so jemali placebo, je pokazala, da so bili neželeni učinki pogosti v obeh skupinah.
English: Oprymea is indicated in adults for treatment of the signs and symptoms of idiopathic Parkinson's disease, alone (without levodopa) or in combination with levodopa, i.e. over the course of the disease, through to late stages when the effect of levodopa wears off or becomes inconsistent and fluctuations of the therapeutic effect occur (end of dose or “on off” fluctuations).
Slovenian: Zdravilo Oprymea je indicirano pri odraslih za zdravljenje znakov in simptomov idiopatske Parkinsonove bolezni, samo (brez levodope) ali v kombinaciji z levodopo, v napredovalem in poznem stadiju bolezni, ko začne učinek levodope popuščati, postane nestalen in se pojavljajo nihanja terapevtskega učinka (pojemanje učinka odmerka ali vklopno-izklopni pojavi).
English: Common: - Changes in sleep pattern, such as sleeplessness (insomnia) and sleepiness - Tiredness (fatigue) - Headache - Abnormal dreams - Constipation - Dizziness - Vomiting (being sick)
Slovenian: Pogosti: - sprememba vzorca spanja, na primer nespečnost (insomnija) in zaspanost, - utrujenost, - glavobol, - nenormalne sanje, - zaprtje, - omotica, - bruhanje (slabost).
English: As anticholinergics are mainly eliminated by biotransformation, the potential for an interaction is limited, although an interaction with anticholinergics has not been investigated.
Slovenian: Čeprav interakcij z antiholinergiki niso raziskovali, je možnost le-teh majhna, ker se antiholinergiki izločajo v glavnem z biotransformacijo.
English: It is recommended that the dose of levodopa is reduced during both the dose escalation and the maintenance treatment with Oprymea, depending on reactions in individual patients (see section 4.5).
Slovenian: Priporočljivo je, da se glede na reakcije posameznih bolnikov odmerjanje levodope zmanjša tako med povečevanjem odmerka zdravila Oprymea kot med vzdrževalnim zdravljenjem z zdravilom Oprymea (glejte poglavje 4.5).
English: Take your Oprymea (immediate release) tablets as normal the day before you switch.
Slovenian: Zdravilo Oprymea tablete (s takojšnjim sproščanjem) vzemite na dan pred zamenjavo zdravila kot običajno.
English: 1 tablet Oprymea 0.35 mg and 1 tablet Oprymea 0.18 mg
Slovenian: 1 tableta zdravila Oprymea po 0,35 mg in 1 tableta zdravila Oprymea po 0,18 mg
English: Therefore, doses will be expressed in terms of both pramipexole base and pramipexole salt (in brackets).
Slovenian: Zato so tu odmerki izraženi za obe obliki, za pramipeksol in pramipeksolijevo sol.
English: A precise frequency estimation is not possible as the side effect did not occur in a clinical trial database of 1,395 patients with Restless Legs Syndrome treated with pramipexole.
Slovenian: Njegove pogostnosti ni možno natančno oceniti, ker se ni pojavil v zbirki podatkov iz kliničnih preskušanj, v kateri so podatki o 1395 bolnikih s sindromom nemirnih nog, ki so se zdravili s pramipeksolom.
English: Patients being treated with Oprymea 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 recurrent episodes and somnolence have resolved (see also sections 4.4, 4.5, and 4.8).
Slovenian: Bolnikom, pri katerih se med zdravljenjem s pramipeksolom pojavlja zaspanost in/ali imajo nenadne epizode spanja, je treba svetovati, naj ne vozijo in naj se ne ukvarjajo z dejavnostmi, pri katerih se zaradi poslabšane budnosti poveča nevarnost resnih poškodb ali smrti (npr. pri upravljanju strojev), dokler ponavljajoče se epizode nenadnega spanja in zaspanost ne minejo (glejte še poglavja 4.4, 4.5 in
English: 7 tablets of Oprymea 0.52 mg
Slovenian: 7 tablet Oprymea 0,52 mg
English: In advanced Parkinson's disease, in combination treatment with levodopa, dyskinesia can occur during the initial titration of Oprymea.
Slovenian: Pri bolnikih z napredovalo Parkinsonovo boleznijo, ki jemljejo zdravilo v kombinaciji z levodopo, se lahko med začetnim stopnjevanjem odmerka zdravila Oprymea pojavijo diskinezije.
English: Parkinson's disease, most common adverse reactions The most commonly (≥5%) reported adverse drug reactions in patients with Parkinson's disease more frequent with pramipexole treatment than with placebo were nausea, dyskinesia, hypotension, dizziness, somnolence, insomnia, constipation, hallucination, headache and fatigue.
Slovenian: Parkinsonova bolezen, najpogostejši neželeni učinki Neželeni učinki, o katerih so pri bolnikih s Parkinsonovo boleznijo najpogosteje poročali (≥ 5 %) in so bili med zdravljenjem s pramipeksolom pogostejši kot med jemanjem placeba, so bili slabost, diskinezija, hipotenzija, omotica, zaspanost, nespečnost, zaprtost, halucinacije, glavobol in utrujenost.
English: The most commonly (≥ 5%) reported adverse drug reactions in patients with Parkinson's disease more frequent with pramipexole treatment than with placebo were nausea, dyskinesia, hypotension, dizziness, somnolence, insomnia, constipation, hallucination, headache and fatigue.
Slovenian: Neželeni učinki, o katerih so najpogosteje poročali ( 5%) pri bolnikih s Parkinsonovo boleznijo in so bili med zdravljenjem s pramipeksolom pogostnejši kot med jemanjem placeba, so bili slabost, diskinezija, hipotenzija, omotica, zaspanost, nespečnost, zaprtost, halucinacije, glavobol in utrujenost.
English: Week 3
Slovenian: 3. teden
English: IJ
Slovenian: C
English: As pramipexole treatment inhibits secretion of prolactin in humans, inhibition of lactation is expected.
Slovenian: Zdravljenje s pramipeksolom zavira izločanje prolaktina pri človeku, zato je pričakovano zaviranje laktacije.
English: The dose will be increased every 5-7 days as directed by your doctor until your symptoms are controlled (maintenance dose).
Slovenian: Odmerek boste po zdravnikovih navodilih vsakih 5 do 7 dni povečevali, dokler ne bodo simptomi pod nadzorom (vzdrževalni odmerek).
English: This delay in motor complications with pramipexole should be balanced against a greater improvement in motor function with levodopa (as measured by the mean change in UPDRS-score).
Slovenian: O tem odlogu motoričnih zapletov pri pramipeksolu je treba presoditi glede na večje izboljšanje motorične funkcije pri levodopi (izmerjeno s srednjo spremembo pri klinični nevrološki preiskavi za bolnike s Parkinsonovo boleznijo - po lestvici UPDRS).
English: The once daily administration of pramipexole prolonged-release tablets causes less frequent fluctuations in the pramipexole plasma concentration over 24 hours compared to the three times daily administration of pramipexole immediate release tablets.
Slovenian: Pri jemanju pramipeksol tablet s podaljšanim sproščanjem enkrat na dan prihaja v primerjavi z jemanjem tablet pramipeksola s takojšnjim sproščanjem trikrat na dan manj pogosto do nihanja koncentracije pramipeksola v plazmi tekom 24 ur.
English: If you have moderate kidney disease, the usual starting dose is 1 tablet Oprymea 0.088 mg twice a day.
Slovenian: Če imate zmerno hudo ledvično bolezen, bo vaš začetni odmerek 1 tableta zdravila Oprymea po 0,088 mg 2-krat na dan.
English: Tourette Disorder
Slovenian: Tourettov sindrom
English: Uncommon: - Paranoia (e.g. excessive fear for one's own well-being) - Delusion - Excessive daytime sleepiness and suddenly falling asleep - Amnesia (memory disturbance)
Slovenian: Občasni: - paranoja (npr. prevelik strah za lastno blaginjo), - blodnje, - prevelika zaspanost podnevi in nenaden spanec,
English: If you have kidney disease, your doctor may advise you to take the usual starting dose of 0.26 mg prolonged-release tablets only every other day for the first week.
Slovenian: Če imate ledvično bolezen, vam bo morda zdravnik svetoval, da jemljete prvi teden običajni začetni odmerek tablet s podaljšanim sproščanjem po 0,26 mg vsak drugi dan. Nato bo lahko povečal pogostnost jemanja na eno tableto s podaljšanim sproščanjem po 0,26 mg vsak dan.
English: After 12 hours, the missed dose should be left out and the next dose should be taken on the following day at the next regularly scheduled time.
Slovenian: Če mine več kot 12 ur, mora pozabljeni odmerek izpustiti, naslednjega pa vzeti naslednji dan ob običajni uri.
English: Patients with a creatinine clearance above 50 ml/min require no reduction in daily dose or dosing frequency.
Slovenian: Pri bolnikih z očistkom kreatinina nad 50 ml/min ni potrebno zmanjšati priporočenega dnevnega odmerka ali pogostnosti odmerjanja.
English: If a further dose increase is necessary, doses should be increased by 0.26 mg pramipexole base at weekly intervals up to a maximum dose of 1.57 mg pramipexole base (2.25 mg of salt) per day.
Slovenian: Če je potrebno, lahko odmerke povečujemo za 0,26 mg pramipeksolijev baze v tedenskih razmikih do največ 1,57 mg pramipeksolijeve baze (2,25 mg soli) na dan.
English: Oprymea 2.62 mg prolonged-release tablets are white or almost white, round (diameter 10 mm),
Slovenian: Oprymea 1,05 mg tablete s podaljšanim sproščanjem so bele ali skoraj bele, okrogle (premera 10 mm),
English: Initial treatment
Slovenian: Začetek zdravljenja
English: INNER BOX (week 1)
Slovenian: NOTRANJA ŠKATLA (1. teden)
English: Further dose adjustments should be done based on the clinical response and the occurrence of adverse reactions.
Slovenian: Na osnovi kliničnega odziva in pojavnosti neželenih učinkov odmerek nadalje prilagodimo.
English: When prescribing Oprymea in a patient with Parkinson's disease with renal impairment a reduced dose is suggested in line with section 4.2.
Slovenian: Bolnikom s Parkinsonovo boleznijo in ledvično okvaro predpisujemo manjše odmerke, kar je opisano v poglavju 4.2.
English: Simply leave out that dose completely and then take your next dose at the right time.
Slovenian: Odmerek izpustite in naslednjega vzemite ob predvidenem času.
English: If you are taking levodopa, the dose of levodopa is recommended to be reduced when you start treatment with Oprymea.
Slovenian: Če jemljete levodopo, je njen odmerek na začetku zdravljenja z zdravilom Oprymea priporočljivo zmanjšati.
English: Severe cardiovascular disease
Slovenian: Huda srčnožilna bolezen
English: A maximum daily dose of 1.1 mg pramipexole base (1.5 mg of salt) should not be exceeded.
Slovenian: Največjega dnevnega odmerka, to je 1,1 mg pramipeksola (1,25 mg soli), ne smemo prekoračiti.
English: If renal function declines during maintenance therapy the Oprymea daily dose should be reduced by the same percentage as the decline in creatinine clearance, i.e. if creatinine clearance declines by 30%, then the Oprymea daily dose should be reduced by 30%.
Slovenian: Če ledvično delovanje med vzdrževalnim zdravljenjem oslabi, dnevni odmerek zdravila Oprymea zmanjšamo za enak odstotek, za kakršnega se je zmanjšal kreatininski očistek.
English: TREATMENT INITIATION PACK ONLY PARTICULARS TO APPEAR ON THE OUTER PACKAGING
Slovenian: SAMO ZA PAKIRANJE ZA ZAČETEK ZDRAVLJENJA PODATKI NA ZUNANJI OVOJNINI
English: In severe kidney disease, the usual starting dose is just 1 tablet Oprymea 0.088 mg a day.
Slovenian: Pri hudi ledvični bolezni je običajni odmerek 1 tableta zdravila Oprymea po 0,088 mg na dan.
English: Pramipexole prolonged-release tablets were non-inferior to pramipexole immediate release tablets as assessed on the UPDRS Parts II+III score at week 33.
Slovenian: Pramipeksol tablete s podaljšanim sproščanjem so bile enakovredne tabletam pramipeksola s takojšnjim sproščanjem, kar je pokazala ocena po lestvici UPDRS, II.
English: Cardiac disorders cardiac failure
Slovenian: Srčne bolezni srčno popuščanje
English: INNER BOX (week 2)
Slovenian: NOTRANJA ŠKATLA (2. teden)
English: Each prolonged-release tablet contains 0.26 mg, 0.52 mg, 1.05 mg, 1.57 mg, 2.1 mg, 2.62 mg or 3.15 mg pramipexole as 0.375 mg, 0.75 mg, 1.5 mg, 2.25 mg, 3 mg, 3.75 mg or 4.5 mg pramipexole dihydrochloride monohydrate, respectively.
Slovenian: Ena tableta s podaljšanim sproščanjem vsebuje 0,26 mg, 0,52 mg, 1,05 mg, 1,57 mg, 2,1 mg, 2,62 mg ali 3,15 mg pramipeksola v obliki 0,375 mg, 0,75 mg, 1,5 mg, 2,25 mg, 3 mg, 3,75 mg ali 4,5 mg pramipeksolijevega dihidroklorida monohidrata.