FrancophonIA/ELRC3.0 huggingface dataset:
English: This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodiumfree'.
Slovenian: To zdravilo vsebuje manj kot 1 mmol (23 mg) natrija na tableto, kar v bistvu pomeni 'brez natrija'.
English: This is to avoid postural hypotension (a fall in blood pressure on standing up).
Slovenian: To je potrebno, da bi se izognili posturalni hipotenzji (padcu krvenga tlaka pri vstajanju).
English: The adjusted mean difference was -4.3 points (CI 95% -6.4; -2.1 points, p-value <0.0001).
Slovenian: Prilagojena srednja razlika je bila -4,3 točke (95-odstotni interval zaupanja -6,4; -2,1 točke, p < 0,0001).
English: In rats, the concentration of active substance-related radioactivity was higher in breast milk than in plasma.
Slovenian: Pri podganah, ki so jim dajali radioaktivno označeno zdravilno učinkovino, so opazili večjo radioaktivnost v materinem mleku kot v plazmi.
English: Maintenance treatment
Slovenian: Vzdrževalno zdravljenje
English: A sudden stop could cause you to develop a medical condition called neuroleptic malignant syndrome which may represent a major health risk.
Slovenian: Nenadna prekinitev lahko povzroči razvoj bolezenskega stanja, imenovanega nevroleptični maligni sindrom, ki lahko predstavlja večjo nevarnost za zdravje.
English: Hallucinations
Slovenian: Halucinacije
English: Parkinson's disease
Slovenian: Parkinsonova bolezen
English: In particular, you may experience forward flexion of the head and neck (also called antecollis), forward bending of the lower back (also called camptocormia) or sidewards bending of the back (also called pleurothotonus or Pisa Syndrome).
Slovenian: Zlasti se lahko pojavi upognjenost glave in vratu naprej (imenovana tudi antekolis), upognjenost spodnjega dela hrbta naprej (imenovana tudi kamptokormija) ali upognjenost hrbta v stran (imenovana tudi plevrototonus ali sindrom Pisa).
English: • treat the symptoms of moderate to severe primary Restless Legs Syndrome in adults.
Slovenian: • zdravljenje simptomov zmernega do hudega primarnega sindroma nemirnih nog pri odraslih.
English: This leaflet was last revised in {MM/YYYY}.
Slovenian: Navodilo je bilo nazadnje revidirano dne
English: The Netherlands
Slovenian: Nederland
English: • Urge to behave in an unusual way*
Slovenian: • siljenje v neobičajno vedenje*,
English: • Uncontrollable excessive shopping or spending*
Slovenian: • čezmerno nakupovanje ali trošenje denarja, ki ga ne morete nadzorovati*;
English: Ask your doctor or pharmacist for advice before taking any medicine.
Slovenian: Posvetujte se z zdravnikom ali s farmacevtom, preden vzamete katero koli zdravilo.
English: UNIQUE IDENTIFIER - 2D BARCODE 18.
Slovenian: EDINSTVENA OZNAKA - DVODIMENZIONALNA ČRTNA KODA 18.
English: Patients should be informed that (mostly visual) hallucinations can occur.
Slovenian: Bolnike moramo seznaniti, da lahko doživijo halucinacije, predvsem vidne.
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 preskušanjih je približno 5 % bolnikov jemalo odmerke pod 1,1 mg pramipeksola (1,5 mg soli).
English: Rare: • Mania (agitation, feeling elated or over-excited)
Slovenian: Redki: • manija (agitacija, vznesenost ali prevelika vznemirjenost)
English: Patients must be informed of this and advised to exercise caution while driving or operating machines during treatment with Pramipexole Teva.
Slovenian: Bolnike moramo s tem seznaniti in jim svetovati, naj bodo previdni pri vožnji in upravljanju s stroji med zdravljenjem z zdravilom Pramipeksol Teva.
English: In a clinical trial with healthy volunteers, where pramipexole prolonged-release tablets were titrated faster (every 3 days) than recommended up to 3.15 mg pramipexole base (4.5 mg of salt) per day, an increase in blood pressure and heart rate was observed.
Slovenian: V kliničnem preskušanju pri zdravih prostovoljcih, v katerem so odmerke pramipeksol tablet s podaljšanim sproščanjem povečevali hitreje (vsake 3 dni), kot je priporočeno, in sicer do 3,15 mg pramipeksola (4,5 mg soli) na dan, sta se povečala krvni tlak in srčna frekvenca.
English: Possible independent risk factors for impulse control disorders included dopaminergic treatments and higher doses of dopaminergic treatment, younger age ( ≤ 65 years), not being married and self-reported family history of gambling behaviours.
Slovenian: Možni neodvisni dejavniki tveganja za motnje nadzora impulzov so bili dopaminergično zdravljenje in dopaminergično zdravljenje z večjimi odmerki, nižja starost (≤ 65 let), neporočenost in samoporočanje o hazarderskem vedenju v družinski anamnezi.
English: Clinical efficacy and safety in Restless Legs Syndrome The efficacy of pramipexole was evaluated in four placebo-controlled clinical trials in approximately 1,000 patients with moderate to very severe idiopathic Restless Legs Syndrome.
Slovenian: Klinična učinkovitost in varnost pri sindromu nemirnih nog Učinkovitost pramipeksola so ocenili v štirih s placebom nadzorovanih kliničnih preskušanjih pri približno 1.000 bolnikih z zmernim do zelo hudim idiopatskim sindromom nemirnih nog.
English: The total clearance of pramipexole is approximately 500 ml/min and the renal clearance is approximately 400 ml/min.
Slovenian: Skupni očistek pramipeksola je približno 500 ml/min, ledvični očistek znaša približno 400 ml/min.
English: Table 1: Parkinson's disease
Slovenian: Preglednica 1: Parkinsonova bolezen
English: • mexiletine (to treat irregular heartbeats, a condition known as ventricular arrhythmia)
Slovenian: • meksiletin (za zdravljenje neenakomernega bitja srca, stanje poznano kot ventrikularna aritmija)
English: No studies on the effect on human fertility have been conducted.
Slovenian: Študij o vplivu na plodnost pri človeku niso izvedli.
English: A total of 63 patients were randomised (43 on pramipexole, 20 on placebo).
Slovenian: Triinšestdeset bolnikov so naključno razvrstili (43 v zdravljenje s pramipeksolom, 20 s placebom).
English: Hypotension may occur at the beginning of treatment, especially if pramipexole is titrated too fast.
Slovenian: Hipotenzija se lahko pojavi na začetku zdravljenja, zlasti če prehitro večamo odmerek pramipeksola.
English: The effect of Pramipexole Teva on the unborn child is not known.
Slovenian: Učinek zdravila Pramipeksol Teva na nerojenega otroka ni znan.
English: The same study also showed that, at doses of 2 mg/kg (of salt) and higher, pramipexole was associated with retinal degeneration in albino rats.
Slovenian: Ista študija je pokazala tudi, da je bil pramipeksol v odmerkih po 2 mg/kg soli in več povezan z degeneracijo mrežnice pri albino podganah.
English: • Psychosis (e.g. comparable with symptoms of schizophrenia).
Slovenian: • Psihoza (na primer podobni simptomi kot pri shizofreniji).
English: If you have severe kidney disease, Pramipexole Teva may not be a suitable treatment for you.
Slovenian: Če imate hudo ledvično bolezen, zdravilo Pramipeksol Teva morda za vas ni primerno zdravilo.
English: Do not store above 25 °C.
Slovenian: Shranjujte pri temperaturi do 25 ºC.
English: Hallucinations are known as a side effect of treatment with dopamine agonists and levodopa.
Slovenian: Halucinacije so znane kot neželeni učinek zdravljenja z agonisti dopamina in levodopo.
English: Longer term efficacy was evaluated in a placebo-controlled clinical trial.
Slovenian: Učinkovitost zdravljenja v daljšem obdobju so ocenili v s placebom nadzorovanem kliničnem preskušanju.
English: Your doctor will review your treatment after 3 months to decide whether or not to continue the treatment.
Slovenian: Zdravnik bo po 3 mesecih preveril učinek zdravljenja in se odločil, ali ga boste nadaljevali.
English: In early and advanced Parkinson's disease, efficacy of pramipexole in controlled clinical trials was maintained for approximately six months.
Slovenian: Pri bolnikih z zgodnjo in napredovalo Parkinsonovo boleznijo se je učinkovitost pramipeksola v približno 6-mesečnih nadzorovanih kliničnih preskušanjih ohranjala.
English: In these cases Pramipexole Teva may affect your ability to drive and operate machinery.
Slovenian: V teh primerih lahko zdravilo Pramipeksol Teva zmanjša vašo sposobnost za vožnjo ali upravljanje strojev.
English: Augmentation was observed in 11.8% of patients in the pramipexole group (N = 152) and 9.4% of patients in the placebo group (N = 149).
Slovenian: Pojavilo se je pri 11,8 % bolnikov v skupini, ki je jemala pramipeksol (n = 152), in pri 9,4 % bolnikov v skupini, ki je jemala placebo (n = 149).
English: The efficacy of pramipexole (0.0625-0.5 mg/day) with paediatric patients aged 6-17 years with Tourette Disorder was evaluated in a 6-week, double-blind, randomised, placebo-controlled flexible dose study.
Slovenian: Učinkovitost pramipeksola (0,0625 do 0,5 mg na dan) pri 6 do 17 let starih pediatričnih bolnikih s Tourettovim sindromom so ocenili v 6-tedenski, dvojno slepi, s placebom nadzorovani raziskavi z naključnim izborom preizkušancev, v kateri so uporabili fleksibilno odmerjanje.
English: In case of persistent symptoms, it may be necessary to increase the pramipexole dose temporarily (see section 4.8).
Slovenian: Če simptomi vztrajajo, bo morda potrebno odmerek pramipeksola začasno povečati (glejte poglavje 4.8).
English: If you experience these side effects, you must not drive or operate machinery.
Slovenian: Če te neželene učinke opazite, ne smete voziti ali upravljati strojev.
English: compulsive shopping, pathological gambling, hypersexuality, binge eating)
Slovenian: kompulzivno nakupovanje, patološko hazardiranje, hiperseksualnost, prenajedanje)
English: Adverse events occurring in at least 5% of patients in the pramipexole group and more common in the pramipexole-treated patients than in patients on placebo were: headache (27.9%, placebo 25.0%), somnolence (7.0%, placebo 5.0%), nausea (18.6%, placebo 10.0%), vomiting (11.6%, placebo 0.0%), upper abdominal pain (7.0%, placebo 5.0%), orthostatic hypotension (9.3%, placebo 5.0%), myalgia (9.3%, placebo 5.0%), sleep disorder (7.0%, placebo 0.0%), dyspnoea (7.0%, placebo 0.0%) and upper respiratory tract infection (7.0%, placebo 5.0%).
Slovenian: (27,9 %, placebo 25,0 %), zaspanost (7,0 %, placebo 5,0 %), siljenje na bruhanje (18,6 %, placebo 10,0 %), bruhanje (11,6 %, placebo 0,0 %), bolečina v zgornjem delu trebuha (7,0 %, placebo 5,0 %), ortostatska hipotenzija (9,3 %, placebo 5,0 %), mialgija (9,3 %, placebo 5,0 %), motnja spanja (7,0 %, placebo 0,0 %), dispneja (7,0 %, placebo 0,0 %) in okužba zgornjih dihalnih poti
English: In patients pramipexole alleviates signs and symptoms of idiopathic Parkinson's disease.
Slovenian: Pri bolnikih pramipeksol zmanjšuje znake in simptome idiopatske Parkinsonove bolezni.
English: • Hypotension (low blood pressure)
Slovenian: • hipotenzija (nizek krvni tlak),
English: The daily dose is administered in equally divided doses 3 times a day.
Slovenian: Dnevni odmerek damo razdeljen v enake odmerke trikrat dnevno.
English: Pramipexole Teva 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 Pramipeksol Teva je pri odraslih indicirano za zdravljenje znakov in simptomov idiopatske Parkinsonove bolezni, same (brez levodope) ali v kombinaciji z levodopo, to je v napredovanem in poznem stadiju bolezni, ko prične z napredovanjem bolezni učinek levodope popuščati, postane nestalen in se pojavljajo fluktuacije terapevtskega učinka (konec odmerka ali vklopno-izklopni pojavi).
English: Augmentation was specifically investigated in a controlled clinical trial over 26 weeks.
Slovenian: Poslabšanje simptomov so raziskovali v nadzorovanem kliničnem preskušanju, ki je trajalo 26 tednov.
English: With 95 % certainty, the frequency category is not greater than uncommon, but might be lower.
Slovenian: S 95-% gotovostjo se ne pojavlja pogosteje kot občasni neželeni učinki, morda celo redkeje.
English: If affected, do not drive or use machines.
Slovenian: Če se pri vas pojavijo, ne vozite in ne upravljajte strojev.
English: Placebocontrolled clinical trials included approximately 1,800 patients of Hoehn and Yahr stages I - V treated with pramipexole.
Slovenian: V s placebom kontroliranih kliničnih preskušanjih je bilo vključenih približno 1.800 bolnikov v stadijih I -V po Hoehnovi in Yahru, ki so se zdravili s pramipeksolom.
English: Lowest maintenance dose Highest maintenance dose
Slovenian: Najmanjši vzdrževalni odmerek
English: Common: • Urge to behave in an unusual way
Slovenian: Pogosti: • siljenje v neobičajno vedenje,
English: Sudden onset of sleep during daily activities, in some cases without awareness or warning signs, has been reported uncommonly.
Slovenian: Občasno so opažali nenaden spanec med vsakdanjimi dejavnostmi, pri nekaterih bolnikih brez zavedanja ali opozorilnih znakov.
English: • cimetidine (to treat excess stomach acid and stomach ulcers)
Slovenian: • cimetidin (zdravilo za zdravljenje čezmernega izločanja želodčne kisline in želodčnih razjed)
English: The daily dose can be administered in two divided doses if creatinine clearance is between 20 and 50 ml/min, and as a single daily dose if creatinine clearance is less than 20 ml/min.
Slovenian: Dnevni odmerek lahko razdelimo v dva ločena odmerka, če je očistek kreatinina med 20 in 50 ml/min, oziroma ga damo v enkratnem odmerku, če je očistek kreatinina manjši kot 20 ml/min.
English: Repeated dose toxicity studies showed that pramipexole exerted functional effects, mainly involving the CNS and female reproductive system, and probably resulting from an exaggerated pharmacodynamic effect of pramipexole.
Slovenian: Študije toksičnosti pri ponavljajočih se odmerkih so pokazale, da je pramipeksol imel funkcijske učinke, predvsem na osrednji živčni sistem in ženski reproduktivni sistem, verjetno zaradi pretiranega farmakodinamičnega delovanja.
English: Neuropharmacological evidence suggests primary dopaminergic system involvement.
Slovenian: Nevrofarmakološki podatki kažejo, da v njem sodeluje primarni dopaminergični sistem.
English: • Paranoia (e.g. excessive fear for one's own well-being)*
Slovenian: • paranoja (npr. prevelik strah za lastno dobrobit)*,
English: 1 This side effect has been observed in post-marketing experience.
Slovenian: 1 Ta neželeni učinek so opazili v obdobju trženja.
English: Your doctor will then discuss with you if you should continue to take Pramipexole Teva.
Slovenian: Zdravnik se bo z vami pogovoril o tem, ali naj zdravljenje z zdravilom Pramipeksol Teva nadaljujete.
English: If this happens, your doctor may want to adjust or change your medication.
Slovenian: Če pride do tega, vam bo zdravnik morda prilagodil odmerke ali zamenjal zdravilo.
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: Ker se antiholinergiki večinoma izločajo s presnovo, so možnosti za medsebojno delovanje omejene, niso pa jih proučevali.
English: If you suffer from Restless Legs Syndrome, you may experience the following side effects:
Slovenian: Če imate sindrom nemirnih nog, so možni naslednji neželeni učinki:
English: • You may experience vomiting, restlessness, or any of the side effects as described in chapter 4
Slovenian: • boste morda izkusili bruhanje, nemir ali katerega od neželenih učinkov, opisanih v poglavju 4 “Možni neželeni učinki”.
English: • Delirium (decreased awareness, confusion, loss of reality)*
Slovenian: • delirij (zmanjšano zavedanje, zmedenost, izguba občutka za resničnost)*.
English: Pramipexole Teva should not be used in children or adolescents with Tourette Disorder because of a negative benefit-risk balance for this disorder (see section 5.1).
Slovenian: Zdravila Pramipeksol Teva se ne sme uporabljati pri otrocih in mladostnikih s Tourettovo boleznijo zaradi negativnega razmerja med koristmi in tveganji za to bolezen (glejte poglavje 5.1).
English: The primary endpoint was change from baseline on the Total Tic Score (TTS) of the Yale Global Tic Severity Scale (YGTSS).
Slovenian: Primarni opazovani dogodek je bila sprememba skupne ocene resnosti tikov na lestvici YGTSS (Yale Global Tic Severity Scale).
English: Clinical efficacy and safety in Tourette Disorder
Slovenian: Klinična učinkovitost in varnost pri Tourettovem sindromu
English: Efficacy was observed with 0.088 mg of base (0.125 mg of salt) per day after the first week of treatment.
Slovenian: Učinkovitost so zasledili pri 0,088 mg baze (0,125 mg soli) na dan po prvem tednu zdravljenja.
English: • Altered or increased sexual interest and behaviour of significant concern to you or to others, for example, an increased sexual drive.
Slovenian: • spremenjeno ali povečano spolno zanimanje in vedenje, ki vam ali drugim povzroča znatno zaskrbljenost, na primer povečan libido*;
English: Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Slovenian: Druga zdravila in zdravilo Pramipeksol Teva Obvestite svojega zdravnika ali farmacevta, če jemljete, ste pred kratkim jemali ali pa boste morda začeli jemati katero koli drugo zdravilo.
English: • Changes in sleep pattern, such as sleeplessness (insomnia) and sleepiness
Slovenian: Pogosti: • sprememba vzorca spanja, na primer nespečnost (insomnia) in zaspanost,
English: • Contact your doctor or nearest hospital casualty department immediately for advice.
Slovenian: • nemudoma vprašajte za nasvet svojega zdravnika ali v najbližjo bolnišnico,
English: Therefore, do not take Pramipexole Teva if you are pregnant unless your doctor tells you to do so.
Slovenian: Pramipeksol Teva,če ste noseči, razen če vam je tako svetoval zdravnik.
English: • Confusion
Slovenian: • zmedenost
English: Inhibitors/competitors of active renal elimination pathway Cimetidine reduced the renal clearance of pramipexole by approximately 34 %, presumably by inhibition of the cationic secretory transport system of the renal tubules.
Slovenian: Zaviralci/snovi, ki tekmujejo za aktivno pot izločanja skozi ledvice Cimetidin je zmanjšal ledvični očistek pramipeksola za približno 34 %, verjetno z zaviranjem kationskega izločevalnega prenašalnega sistema v ledvičnih cevkah.
English: In a pharmacoepidemiological study pramipexole use was associated with an increased risk of cardiac failure compared with non-use of pramipexole (observed risk ratio 1.86; 95% CI, 1.21
Slovenian: V farmakoepidemiološki študiji so uporabo pramipeksola v primerjavi z njegovo neuporabo povezovali s povečanim tveganjem srčnega popuščanja (razmerje tveganja je bilo 1,86; 95-odstotni IZ, 1,21-2,85).
English: Name and address of the manufacturer responsible for batch release
Slovenian: Ime in naslov izdelovalcev, odgovornih za sproščanje serij
English: Do not use this medicine after the expiry date which is stated on the carton after EXP.
Slovenian: Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na zunanji ovojnini, poleg oznake EXP. Rok uporabnosti zdravila se izteče na zadnji dan navedenega meseca.
English: • Inappropriate antidiuretic hormone secretion*
Slovenian: • neustrezno izločanje antidiuretičnega hormona*
English: Kaplan-Meier analysis of time to augmentation showed no significant difference between pramipexole and placebo groups.
Slovenian: Kaplan-Meierjeva analiza časa do poslabšanja simptomov ni pokazala značilne razlike med skupino, ki je jemala pramipeksol, in skupino, ki je jemala placebo.
English: Plasma protein binding
Slovenian: Vezava na beljakovine v plazmi
English: In case of severe cardiovascular disease, care should be taken.
Slovenian: Pri bolnikih s hudimi srčnožilnimi boleznimi moramo biti previdni.
English: • Cardiac failure (heart problems which can cause shortness of breath or ankle swelling)*
Slovenian: • srčno popuščanje (srčne motnje, ki lahko povzročajo težave z dihanjem in otekanjem gležnjev)*
English: The majority of adverse drug reactions usually start early in therapy and most tend to disappear even as therapy is continued.
Slovenian: Večina neželenih učinkov na zdravilo se običajno pojavi na začetku zdravljenja, nato pa jih z nadaljevanjem zdravljenja večina izgine.
English: Pramipexole is commonly associated with somnolence and has been associated uncommonly with excessive daytime somnolence and sudden sleep onset episodes (see also section 4.4).
Slovenian: Pramipeksol se pogosto povezuje z zaspanostjo in občasno s preveliko zaspanostjo čez dan ter epizodami nenadnega spanca (glejte tudi poglavje 4.4).
English: Pharmachemie B.V. Swensweg 5, Postbus 552, 2003 RN Haarlem The Netherlands
Slovenian: Swensweg 5, Postbus 552 2003 RN Haarlem Nizozemska
English: Endocrine disorders inappropriate antidiuretic hormone secretion1
Slovenian: Bolezni endokrinega sistema neustrezno izločanje antidiuretičnega hormona1
English: • Dyspnoea (difficulties to breathe)
Slovenian: • dispneja (težave pri dihanju)
English: It is recommended that the dose of levodopa is reduced during both the dose escalation and the maintenance treatment with Pramipexole Teva, depending on reactions in individual patients (see section 4.5).
Slovenian: Priporočljivo je, da odmerke levodope zmanjšamo tako med titriranjem kot med vzdrževalnim zdravljenjem z zdravilom Pramipeksol Teva, odvisno od posameznikovega odziva (glejte poglavje 4.5).
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 pri podganah imel embriotoksične učinke v odmerkih, toksičnih za mater (glejte poglavje 5.3).
English: If dystonia occurs, the dopaminergic medication regimen should be reviewed and an adjustment in the dose of pramipexole considered.
Slovenian: Če se pojavi distonija, je treba pregledati režim dopaminergičnega zdravljenja in razmisliti o prilagoditvi odmerka pramipeksola.
English: • Binge eating (eating large amounts of food in a short time period) or compulsive eating (eating more food than normal and more than is needed to satisfy your hunger)*
Slovenian: - prenajedanje* (uživanje velikih količin hrane v kratkem obdobju) ali kompulzivno uživanje hrane (uživanje večjih količin hrane od normalnih in več,
English: There is no relevant use of Pramipexole Teva in the paediatric population for the indication of Parkinson's Disease.
Slovenian: Zdravilo Pramipeksol Teva ni namenjeno za uporabo pri pediatrični populaciji za indikacijo Parkinsonova bolezen.
English: The other ingredients are mannitol, microcrystalline cellulose, sodium starch glycolate, povidone, magnesium stearate, sodium stearyl fumarate, colloidal silicon dioxide.
Slovenian: Pomožne snovi so manitol, mikrokristalna celuloza, natrijev karboksimetilškrob, povidon, magnezijev stearat, natrijev stearilfumarat, koloidni silicijev dioksid.
English: In a 26 week placebo controlled trial, rebound of RLS symptoms (worsening of symptom severity as compared to baseline) was observed in 10% of patients (14 out of 135) after abrupt discontinuation of treatment.
Slovenian: V 26-tedenskem, s placebom nadzorovanem preskušanju, so se simptomi sindroma nemirnih nog po nenadni ukinitvi zdravljenja ponovili (poslabšanje simptomov v primerjavi z njihovo izhodiščno jakostjo) pri 10 % bolnikov (pri 14 od 135).
English: No difference was observed for pramipexole as compared to placebo for either the primary endpoint or for any of the secondary efficacy endpoints including YGTSS total score, Patient Global Impression of Improvement (PGI-I), Clinical Global Impression of Improvement (CGI-I), or Clinical Global Impressions of Severity of Illness (CGI-S).
Slovenian: Med pramipeksolom in placebom ni bilo razlik pri primarnem opazovanem dogodku niti pri nobenem od sekundarnih opazovanih dogodkov, kar je pokazala skupna ocena na lestvici YGTSS ter ocene na lestvicah PGI-I (Patient Global Impression of Improvement), CGI-I (Clinical Global Impression of Improvement) in CGI-S (Clinical Global Impressions of Severity of