FrancophonIA/ELRC3.0 huggingface dataset:
English: • The Committee was of the view that results of the submitted bioequivalence studies showed that Merisone 50 and 150 mg tablets was bioequivalent to the reference medicinal product Mydeton 50 and 150-mg tablets under fasting conditions;
Slovenian: • odbor CHMP je menil, da so rezultati predloženih bioekvivalenčnih študij pokazali, da so 50- in 150-miligramske tablete zdravila Merisone biološko enakovredne 50- in 150-miligramskim tabletam referenčnega zdravila Mydeton v pogojih na tešče;
English: The CHMP noted that the excipients mannitol and betaine found in the product subject to the referral but not in the reference medicinal product, had no effect on the bioequivalence of these products in fasting state.
Slovenian: Odbor CHMP je upošteval, da pomožni snovi manitol in betain, ki ju vsebuje zdravilo, ki je predmet napotitve, ne pa tudi referenčno zdravilo, nista vplivali na biološko enakovrednost teh zdravil v pogojih na tešče.
English: Therefore based on the results of the submitted bioequivalence studies, the CHMP members agreed that Merisone 50 and 150 mg tablets are bioequivalent to the reference medicinal product Mydeton 50 and 150-mg tablets (Gedeon Richter Plc) under fasting conditions.
Slovenian: Člani odbora CHMP so se na podlagi rezultatov predloženih bioekvivalenčnih študij strinjali, da so 50- in 150-miligramske tablete zdravila Merisone biološko enakovredne 50- in 150-miligramskim tabletam referenčnega zdravila Mydeton (Gedeon Richter Plc) v pogojih na tešče.
English: However more recently the effect of food on the bioavailability of tolperisone has been established to be significant and was reflected accordingly in the SmPC of the reference medicinal product at the time of submission of the MAA subject to this referral1.
Slovenian: Vendar so kasneje ugotovili, da hrana pomembno vpliva na biološko uporabnost tolperizona, zato je bila ta ugotovitev ob predložitvi vloge za pridobitev dovoljenja za promet z zdravilom, ki je predmet te napotitve1, ustrezno vključena v povzetek glavnih značilnosti zdravila za referenčno zdravilo.
English: Because the within-subject coefficient of variation is higher than 30%, the applicant was of the view that according to the current bioequivalence guideline extended limits could have been used to show bioequivalence, which would have been in this case 71.25%
Slovenian: Ker je bil koeficient spremenljivosti pri posamezniku višji od 30 %, je predlagatelj menil, da bi lahko v skladu z veljavnimi smernicami o
English: 2 Co-ordination group for mutual recognition and decentralised procedures - human
Slovenian: Usklajevalna skupina za postopek z medsebojnim priznavanjem in decentralizirani postopek - zdravila za uporabo v humani medicini bioekvivalenci za dokaz bioekvivalence uporabili širši razpon mejnih vrednosti, v tem primeru
English: A positive change indicates improvement.
Slovenian: Pozitivna sprememba je znak izboljšanja.
English: Diagnosis should be made according to current guidelines.
Slovenian: Diagnozo je treba postaviti skladno z veljavnimi smernicami.
English: Last Observation Carried Forward
Slovenian: Zadnje opažanje preneseno naprej
English: In addition, a post-hoc definition of response is provided in the same table.
Slovenian: V isti tabeli je navedena tudi naknadna opredelitev odziva.
English: Treatment usually starts with a low dose.
Slovenian: • Zdravljenje se običajno začne z nizkim odmerkom.
English: CIBIC-Plus: improvement
Slovenian: CIBIC-Plus: izboljšanje
English: The in vivo micronucleus test was negative.
Slovenian: Test mikronukleusa in vivo je bil negativen.
English: Use of scopolamine as an antidote is not recommended.
Slovenian: Uporaba skopolamina kot antidota ni priporočena.
English: Individual response to rivastigmine cannot be predicted.
Slovenian: Odziva posameznika na rivastigmin ni mogoče predvideti.
English: To benefit from your medicine, take it every day.
Slovenian: • Da vam bo zdravilo pomagalo, ga morate jemati vsak dan.
English: Dose titration should then be carried out as described above.
Slovenian: Takrat je treba odmerek titrirati enako, kot je opisano zgoraj.
English: The use of Rivastigmine Teva in children and adolescents (age below 18 years) is not recommended.
Slovenian: Uporaba zdravila Rivastigmine Teva pri otrocih in mladostnikih (mlajših od 18 let) ni priporočena.
English: No target organ toxicity was observed.
Slovenian: Ciljnih organov za toksičnost niso opazili.
English: No safety margins to human exposure were achieved in the animal studies due to the sensitivity of the animal models used.
Slovenian: V študijah pri živalih varnostnih meja za izpostavljenost pri človeku niso dosegli zaradi občutljivosti živalskega modela, ki so ga uporabili.
English: Rivastigmine is rapidly and completely absorbed.
Slovenian: Absorpcija Rivastigmin se hitro in popolnoma absorbira.
English: Patients with Alzheimer's disease may lose weight.
Slovenian: Bolniki z Alzheimerjevo boleznijo lahko shujšajo.
English: Táncsics Mihály út 82
Slovenian: Táncsics Mihály út 82 Madžarska
English: If you have not taken Rivastigmine Teva for several days, do not take the next dose until you have talked to your doctor.
Slovenian: Če zdravila Rivastigmine Teva niste jemali že nekaj dni, ne vzemite naslednjega odmerka, dokler se ne pogovorite s svojim zdravnikom.
English: Most cases of accidental overdose have not been associated with any clinical signs or symptoms and almost all of the patients concerned continued rivastigmine treatment.
Slovenian: Večina primerov naključnega prevelikega odmerjanja ni bila povezana s kakršnimi koli kliničnimi znaki ali simptomi, skoraj vsi bolniki pa so nadaljevali zdravljenje z rivastigminom.
English: Teva Eesti esindus UAB Sicor Biotech Eesti filiaal
Slovenian: Teva Eesti esindus UAB Sicor Biotech Eesti
English: If you find you have forgotten to take your dose of Rivastigmine Teva, wait and take the next dose at the usual time.
Slovenian: Če ugotovite, da ste pozabili vzeti odmerek zdravila Rivastigmine Teva, počakajte in vzemite naslednji odmerek ob običajnem času.
English: Peak plasma concentrations are reached in approximately 1 hour.
Slovenian: Najvišje koncentracije v plazmi so dosežene v približno 1 uri.
English: ADAS-Cog: improvement of at least 4 points
Slovenian: ADAS-Cog: izboljšanje za vsaj 4
English: Clinical monitoring is recommended for these adverse reactions.
Slovenian: Priporočen je klinični nadzor teh neželenih reakcij.
English: Patients without visual hallucinations
Slovenian: Bolniki brez vizualnih halucinacij
English: The MAH must ensure that the system of pharmacovigilance presented in Module 1.8.1. of the Marketing Authorisation Application, is in place and functioning before and whilst the product is on the market.
Slovenian: Imetnik dovoljenja za promet z zdravilom mora zagotoviti, da je sistem farmakovigilance, predložen v modulu 1.8.1 dovoljenja za promet z zdravilom, vzpostavljen in deluje, preden da zdravilo v promet in ves čas trženja zdravila.
English: Motor dysfunction
Slovenian: Motorična disfunkcija
English: In massive overdose, atropine can be used.
Slovenian: Pri izjemnem prevelikem odmerjanju se lahko uporabi atropin.
English: While bioavailability of rivastigmine is greater in elderly than in young healthy volunteers, studies in Alzheimer patients aged between 50 and 92 years showed no change in bioavailability with age.
Slovenian: Biološka uporabnost rivastigmina je pri starejših večja kot pri mladih zdravih prostovoljcih, vendar študije pri bolnikih z Alzheimerjevo boleznijo, starih od 50 do 92 let, niso pokazale spremembe biološke uporabnosti glede na starost.
English: Your doctor will tell you what dose of Rivastigmine Teva to take.
Slovenian: Zdravnik vam bo povedal, kakšen odmerek zdravila Rivastigmine Teva morate jemati.
English: TEVA UK Ltd Brampton Road, Hampden Park, Eastbourne, East Sussex, BN22 9AG United Kingdom
Slovenian: TEVA UK Ltd Brampton Road, Hampden Park, Eastbourne, East Sussex, BN22 9AG Velika Britanija
English: Table 1 *
Slovenian: Tabela 1 *
English: Shellac glaze-45%
Slovenian: glazura iz šelaka - 45 %
English: Maintenance treatment can be continued for as long as a therapeutic benefit for the patient exists.
Slovenian: Vzdrževalno zdravljenje se lahko nadaljuje, dokler pri bolniku obstaja koristen terapevtski učinek.
English: However, Rivastigmine Teva may be used in this patient population and close monitoring is necessary.
Slovenian: Vendar se zdravilo Rivastigmine Teva v tej populaciji bolnikov lahko uporabi in potrebno je natančno spremljanje.
English: ITT: Intent-To-Treat; RDO: Retrieved Drop Outs
Slovenian: ITT: Intent-To-Treat (namera zdravljenja); RDO: Retrieved Drop Outs (nadomeščeni izpadli).
English: In vitro, this metabolite shows minimal inhibition of acetylcholinesterase (<10 %).
Slovenian: In vitro ta presnovek kaže minimalno zaviranje acetilholinesteraze (< 10 %).
English: Ingestion of 46 mg occurred in one case; following conservative management the patient fully recovered within 24 hours.
Slovenian: V enem primeru je bolnik zaužil 46 mg; po konservativnem zdravljenju je v 24 urah popolnoma okreval.
English: Your doctor will slowly increase your dose depending on how you respond to the treatment.
Slovenian: • Zdravnik vam bo odmerek počasi zviševal glede na vaš odziv na zdravljenje.
English: Rivastigmine should not be used during pregnancy unless clearly necessary.
Slovenian: Rivastigmin se ne sme uporabljati med nosečnostjo, razen če je to nujno potrebno.
English: Adverse reactions in Table 1 are listed according to MedDRA system organ class and frequency category.
Slovenian: Neželeni učinki v Tabeli 1 so v skladu z MeDRA razvrščeni po organskih sistemih in pogostnosti.
English: It readily crosses the blood brain barrier and has an apparent volume of distribution in the range of 1.8 - 2.7 l/kg.
Slovenian: Rivastigmin hitro prehaja skozi krvno možgansko pregrado, navidezni volumen porazdelitve pa je v območju 1,8 - 2,7 l/kg.
English: In case of severe vomiting associated with rivastigmine treatment, appropriate dose adjustments as recommended in section 4.2 must be made.
Slovenian: Pri hudem bruhanju, povezanim z zdravljenjem z rivastigminom, je treba odmerek ustrezno prilagoditi, kot je priporočeno v poglavju 4.2.
English: Therapy with rivastigmine should only be started if a caregiver is available who will regularly monitor intake of the medicinal product by the patient.
Slovenian: Zdravljenje z rivastigminom se lahko začne samo, če je na voljo skrbnik, ki bo redno nadzoroval, ali bolnik pravilno jemlje zdravilo.
English: The most commonly reported adverse reactions are gastrointestinal, including nausea (38 %) and vomiting (23 %), especially during titration.
Slovenian: Najpogostejše neželene reakcije, o katerih so poročali, so gastrointestinalne, vključno z navzeo (38 %) in bruhanjem (23 %), posebej med titriranjem odmerka.
English: Usually, the side effects slowly go away as your body gets used to the medicine.
Slovenian: Običajno neželeni učinki počasi izzvenijo, ko se telo zdravila navadi.
English: - if you have a low body weight.
Slovenian: - če imate majhno telesno maso,
English: Response Measure
Slovenian: Meritev odziva
English: Rivastigmine Teva is used for the treatment of memory disorders in patients with Alzheimer's disease.
Slovenian: Zdravilo Rivastigmine Teva se uporablja za zdravljenje spominskih motenj pri bolnikih z Alzheimerjevo boleznijo.
English: Due to the known vagotonic effect of cholinesterase inhibitors on heart rate, bradycardia and/or syncope may also occur.
Slovenian: Glede na znan vagotonični učinek zaviralcev holinesteraze na hitrost srčnega utripa, se lahko pojavita tudi bradikardija in/ali sinkopa.
English: If any of these apply to you, your doctor may need to monitor you more closely while you are on this medicine.
Slovenian: Če karkoli od navedenega velja za vas, vas bo morda moral zdravnik med jemanjem zdravila spremljati bolj pozorno.
English: As a consequence of rivastigmine's interaction with its target enzyme, the increase in bioavailability is about 1.5-fold greater than that expected from the increase in dose.
Slovenian: Zaradi interakcije rivastigmina s svojim ciljnim encimom, je povečanje biološke uporabnosti približno 1,5krat večje, kot bi bilo pričakovati zaradi povečanja odmerka.
English: • The signs of Parkinson's disease get worse or getting similar signs - such as stiff muscles,
Slovenian: • poslabšanje znakov Parkinsonove bolezni ali pojav podobnih znakov - na primer togih mišic ali težav
English: If after 3 months of maintenance dose treatment the patient's rate of decline in dementia symptoms is not altered favourably, the treatment should be discontinued.
Slovenian: Če se po 3 mesecih zdravljenja z vzdrževalnim odmerkom stopnja simptomov demence ne spremeni v bolnikovo korist, je treba zdravljenje prekiniti.
English: Not all pack sizes may be marketed.
Slovenian: Na tržišču morda ni vseh navedenih pakiranj.
English: 1 Based on ANCOVA with treatment and country as factors and baseline ADAS-Cog as a covariate.
Slovenian: 1 Na podlagi analize kovariance (ANCOVA), pri kateri sta bila zdravljenje in država dejavnika, izhodiščni rezultat ADAS-Cog pa kovariat.
English: The incidence and severity of adverse reactions generally increase with higher doses.
Slovenian: Pogostnost in stopnja neželenih učinkov se pri večjih odmerkih na splošno povečata.
English: Less than 1 % of the administered dose is excreted in the faeces.
Slovenian: Manj kot 1 % uporabljenega odmerka se izloča z blatom.
English: Where symptoms have occurred, they have included nausea, vomiting and diarrhoea, hypertension or hallucinations.
Slovenian: Kadar so se simptomi pojavili, so vključevali navzeo, bruhanje in diarejo, hipertenzijo ali halucinacije.
English: Rivastigmine 6-12 mg N=379
Slovenian: Rivastigmin 6-12 mg N = 379
English: Possible dose adjustments or temporarily stopping treatment can be considered if needed.
Slovenian: Po potrebi se lahko prilagodi odmerek ali začasno ustavi zdravljenje.
English: They may respond to a dose reduction.
Slovenian: Ti bolniki se lahko odzovejo na zmanjšanje odmerka.
English: In peri/postnatal studies in rats, an increased gestation time was observed.
Slovenian: V peri- in postnatalnih študijah pri podganah so opazili povečan čas gestacije.
English: Absolute bioavailability after a 3 mg dose is about 36 % ± 13 %.
Slovenian: Absolutna biološka uporabnost po 3miligramskem odmerku je približno 36 % ± 13 %.
English: Therefore, the clinical benefit of rivastigmine should be reassessed on a regular basis, especially for patients treated at doses less than 3 mg twice a day.
Slovenian: Zato je treba klinično korist rivastigmina ocenjevati redno, zlasti pri bolnikih, ki prejemajo odmerke, manjše od 3 mg dvakrat na dan.
English: Tell your caregiver that you are taking Rivastigmine Teva.
Slovenian: • Povejte svojemu negovalcu, da jemljete zdravilo Rivastigmine Teva.
English: Take Rivastigmine Teva twice a day, in the morning and evening, with food.
Slovenian: • Zdravilo Rivastigmine Teva jemljite s hrano dvakrat na dan, zjutraj in zvečer.
English: Inhibition of butyrylcholinesterase activity in CSF of 14 Alzheimer patients treated by rivastigmine was similar to that of AChE.
Slovenian: Zaviranje aktivnosti butirilholinesteraze v cerebrospinalni tekočini pri 14 bolnikih z Alzheimerjevo boleznijo, ki so prejemali rivastigmin, je bilo podobno kot pri AChE.
English: Rivastigmine Teva should not be given at the same time as other medicines with similar effects to Rivastigmine Teva.
Slovenian: Zdravila Rivastigmine Teva se ne sme jemati sočasno z drugimi zdravili, ki imajo podobne učinke kot zdravilo Rivastigmine Teva.
English: At least 4 points improvement on ADAS-Cog with no worsening on CIBIC-Plus and PDS *p<0.05, **p<0.01, ***p<0.001
Slovenian: PDS: izboljšanje za vsaj 10 % 26*** Izboljšanje rezultata ADAS-Cog za vsaj 4 točke brez poslabšanja rezultata CIBIC-Plus in PDS *p<0,05, **p<0,01, ***p<0,001
English: It is not known if rivastigmine is excreted into human milk.
Slovenian: Ni znano, ali se rivastigmin izloča v mleko pri človeku.
English: Furthermore, rivastigmine can induce dizziness and somnolence, mainly when initiating treatment or increasing the dose.
Slovenian: Poleg tega lahko rivastigmin povzroči omotico in somnolenco, predvsem ob začetku zdravljenja ali povečanju odmerka.
English: Discontinuation should also be considered when evidence of a therapeutic effect is no longer present.
Slovenian: Zdravljenje je treba prekiniti tudi, ko znakov terapevtskega učinka ni več.
English: Computerweg 10, 3542 DR Utrecht The Netherlands
Slovenian: Computerweg 10, 3542 DR Utrecht Nizozemska
English: Such events appeared to occur particularly after dose increments or high doses of rivastigmine.
Slovenian: Takšni primeri so se pojavili zlasti po povečanju odmerka ali pri uporabi velikih odmerkov rivastigmina.
English: Rivastigmine should be administered twice a day, with morning and evening meals.
Slovenian: Rivastigmin je treba dajati dvakrat na dan, ob zajtrku in večerji.
English: In overdose accompanied by severe nausea and vomiting, the use of antiemetics should be considered.
Slovenian: Če preveliko odmerjanje spremljata huda navzea in bruhanje, je treba pretehtati možnost uporabe antiemetikov.
English: The effective dose is 3 to 6 mg twice a day; to achieve maximum therapeutic benefit patients should be maintained on their highest well tolerated dose.
Slovenian: Učinkoviti odmerek je 3 do 6 mg dvakrat na dan; za doseganje največjega terapevtskega učinka je treba uporabiti največji odmerek, ki ga bolniki dobro prenašajo.
English: Administration of rivastigmine with food delays absorption (tmax) by 90 min and lowers Cmax and increases AUC by approximately 30 %.
Slovenian: Uporaba rivastigmina skupaj s hrano upočasni absorpcijo (tmax) za 90 min in zmanjša vrednost Cmax ter poveča vrednost AUC za približno 30 %.
English: Rivastigmine is rapidly and extensively metabolised (half-life in plasma approximately 1 hour), primarily via cholinesterase-mediated hydrolysis to the decarbamylated metabolite.
Slovenian: Rivastigmin se presnavlja hitro in v veliki meri (razpolovni čas v plazmi je približno 1 ur), predvsem s holinesterazno hidrolizo v dekarbamiliran presnovek.
English: Symptomatic treatment for other adverse reactions should be given as necessary.
Slovenian: Po potrebi je treba uporabiti simptomatsko zdravljenje za druge neželene reakcije.
English: If you forget to take Rivastigmine Teva
Slovenian: Če ste pozabili vzeti zdravilo Rivastigmine Teva
English: Total plasma clearance of rivastigmine was approximately 130 l/h after a 0.2 mg intravenous dose and decreased to 70 l/h after a 2.7 mg intravenous dose.
Slovenian: Po 0,2-miligramskem intravenskem odmerku je bil skupni plazemski očistek rivastigmina približno 130 l/h mg, po 2,7-miligramskem intravenskem odmerku pa se je zmanjšal na 70 l/h.
English: An initial dose of 0.03 mg/kg intravenous atropine sulphate is recommended, with subsequent doses based on clinical response.
Slovenian: Priporočen je intravenski odmerek 0,03 mg/kg atropinijevega sulfata, naknadni odmerki pa naj temeljijo na kliničnem odzivu.
English: In addition, Rivastigmine Teva 3 mg, 4.5 mg and 6 mg hard capsules contain red iron oxide (E172) and yellow iron oxide (E 172).
Slovenian: Zdravila Rivastigmine Teva 3 mg, 4,5 mg in 6 mg trde kapsule vsebujejo tudi rdeči železov oksid (E172) in rumeni železov oksid (E 172).
English: THE MARKETING AUTHORISATION HOLDER Medicinal product subject to restricted medical prescription (See Annex I: Summary of Product Characteristics, Section 4.2 ).
Slovenian: Izdaja zdravila je le na recept (glejte Dodatek I: povzetek glavnih značilnosti zdravila, poglavje 4.2).
English: Extrapyramidal symptoms (including worsening of Parkinson's disease)
Slovenian: Ekstrapiramidni simptomi (vključno s poslabšanjem Parkinsonove bolezni)
English: • Liver disorders (yellow skin, yellowing of the whites of eyes, abnormal darkening of the urine or unexplained nausea, vomiting, tiredness and loss of appetite)
Slovenian: • jetrne motnje (porumenelost kože, porumenelost očesnih beločnic, nenormalno temen urin ali nepojasnjena slabost v želodcu, bruhanje, utrujenost in izguba apetita)
English: Cardiac arrhythmia (e.g. bradycardia, atrio-ventricular block, atrial fibrillation and tachycardia)
Slovenian: Srčna aritmija (npr. bradikardija, atrioventrikularni blok, atrijska fibrilacija in tahikardija)
English: As a consequence, rivastigmine has minor or moderate influence on the ability to drive and use machines.
Slovenian: Posledično ima rivastigmin blag ali zmeren vpliv na sposobnost vožnje in upravljanja s stroji.
English: Pharmacotherapeutic group: anticholinesterases, ATC code: N06DA03
Slovenian: Farmakoterapevtska skupina: antiholinesteraze, oznaka ATC: N06DA03.
English: Caution is recommended in treating patients predisposed to such diseases.
Slovenian: Pri zdravljenju bolnikov, ki so nagnjeni k tem boleznim, je priporočena previdnost.
English: Similarly a larger treatment effect was observed in those patients with visual hallucinations (see Table 6).
Slovenian: Podobno so boljši učinek zdravljenja opazili pri bolnikih z vizualnimi halucinacijami (glejte tabelo 6).
English: Elevated liver function tests
Slovenian: Zvišane vrednosti jetrnih laboratorijskih preiskav
English: If any of these side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
Slovenian: Če katerikoli neželeni učinek postane resen ali če opazite kateri koli neželeni učinek, ki ni omenjen v tem navodilu, obvestite svojega zdravnika ali farmacevta.
English: Unchanged rivastigmine is not found in the urine; renal excretion of the metabolites is the major route of elimination.
Slovenian: V urinu niso odkrili nespremenjenega rivastigmina; glavna pot izločanja je izločanje presnovkov skozi ledvice.
English: Do not open or crush the capsules.
Slovenian: • Kapsul ne odpirajte in ne drobite.
English: These include the ADAS-Cog (a performance based measure of cognition), the CIBIC-Plus (a comprehensive global assessment of the patient by the physician incorporating caregiver input), and the PDS (a caregiver-rated assessment of the activities of daily living including personal hygiene, feeding, dressing, household chores such as shopping, retention of ability to orient oneself to surroundings as well as involvement in activities relating to finances, etc.).
Slovenian: Ta orodja so ADAS-Cog (meritev kognicije na podlagi učinkovitosti), CIBIC-Plus (obsežna globalna ocena bolnika, pri kateri zdravnik upošteva informacije skrbnika), in PDS (skrbnikova ocena dejavnosti v vsakdanjem življenju, vključno z osebno higieno, prehranjevanjem, oblačenjem, gospodinjskimi opravili, kot so nakupovanje, ohranjanje zmožnosti orientacije v okolju in sodelovanje pri dejavnostih, povezanih s financami, itd.).
English: Based on evidence from in vitro and animal studies the major cytochrome P450 isoenzymes are minimally involved in rivastigmine metabolism.
Slovenian: Na podlagi študij in vitro in pri živalih so ugotovili, da pomembnejši izoencimi citokroma P450 minimalno sodelujejo v presnovi rivastigmina.
English: Table 3 lists the number and percentage of patients from the specific 24-week clinical study conducted with rivastigmine in patients with dementia associated with Parkinson's disease with pre-defined adverse events that may reflect worsening of parkinsonian symptoms.
Slovenian: V tabeli 3 so navedena števila in odstotki bolnikov iz specifične 24-tedenske klinične študije z rivastigminom pri bolnikih z demenco, povezano s Parkinsonovo boleznijo, z vnaprej opredeljenimi neželenimi dogodki, ki lahko odražajo poslabšanje simptomov Parkinsonove bolezni.
English: Special Populations
Slovenian: Posebne skupine
English: Although a treatment effect was demonstrated in the overall study population, the data suggested that a larger treatment effect relative to placebo was seen in the subgroup of patients with moderate dementia associated with Parkinson's disease.
Slovenian: Čeprav so učinek zdravljenja pokazali pri celotni populaciji bolnikov, ki so sodelovali v študiji, podatki kažejo, da so relativno boljši učinek glede na placebo opazili v podskupini bolnikov z zmerno demenco, povezano s Parkinsonovo boleznijo.