natgillin/translations-raw huggingface dataset:
Based on the analysis of pooled placebo-controlled trials, comprising a total of 1923 patients on MIRAPEXIN and 1354 patients on placebo, adverse drug reactions were frequently reported for both groups.
Analiza zbranih s placebom nadzorovanih preskušanj, ki je zajela 1923 bolnikov, zdravljenih z zdravilom MIRAPEXIN, in 1354 bolnikov, ki so prejemali placebo, je pokazala, da so o neželenih učinkih pogosto poročali v obeh skupinah.
63% of patients on MIRAPEXIN and 52% of patients on placebo reported at least one adverse drug reaction.
V skupini z zdravilom MIRAPEXIN je poročalo 63%, v skupini s placebom pa 52% bolnikov o vsaj enem neželenem učinku.
Tables 1 and 2 display the frequency of adverse drug reactions from placebo-controlled clinical trials in Parkinson’ s disease and Restless Legs Syndrome.
Preglednici 1 in 2 kažeta pogostnost neželenih učinkov v s placebom nadzorovanih kliničnih preskušanjih pri Parkinsonovi bolezni in sindromu nemirnih nog.
The adverse drug reactions reported in these tables are those events that occurred in 0.1% or more of patients treated with MIRAPEXIN and were reported significantly more often in patients taking MIRAPEXIN than placebo, or where the event was considered clinically relevant.
Neželeni učinki v preglednicah, o katerih so poročali, so dogodki, ki so se pojavili pri 0, 1% z zdravilom MIRAPEXIN zdravljenih bolnikov ali več, in o katerih so poročali pomembno pogosteje pri bolnikih, ki so jemali zdravilo MIRAPEXIN, kot pri tistih, ki so jemali placebo, ali pa je bil dogodek ocenjen kot klinično pomemben.
However, the majority of common adverse drug reactions were mild to moderate, they usually start early in therapy, and most tended to disappear even as therapy was continued.
Pogosti neželeni učinki so bili večinoma blagi do zmerni, običajno so se pojavljali v zgodnjem obdobju zdravljenja in večina jih je izginila, četudi so bolniki zdravljenje nadaljevali.
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, < 1/ 10); uncommon (≥ 1/ 1,000, < 1/ 100); rare (≥ 1/ 10,000, < 1/ 1,000); very rare (< 1/ 10,000); not known (cannot be estimated form the available data).
Neželeni učinki so navedeni po organskih sistemih in razvrščeni po pogostnosti (pričakovano število bolnikov, ki bodo doživeli neželen učinek) v naslednje skupine: zelo pogosti (≥ 1/ 10); pogosti (≥ 1/ 100, < 1/ 10); občasni (≥ 1/ 1. 000, < 1/ 100); redki (≥ 1/ 10. 000, < 1/ 1. 000); zelo redki (< 1/ 10. 000); neznana (ni mogoče oceniti iz razpoložljivih podatkov).
Parkinson’ s disease, most common adverse events The most commonly (≥ 5%) reported adverse drug reactions in patients with Parkinson’ s disease more frequent with MIRAPEXIN treatment than with Placebo were nausea, dyskinesia, hypotension, dizziness, somnolence, insomnia, constipation, hallucination, headache and fatigue.
Parkinsonova bolezen, najpogostnejši neželeni dogodki Neželeni učinki, o katerih so najpogosteje poročali (≥ 5%) pri bolnikih s Parkinsonovo boleznijo in so bili med zdravljenjem z zdravilom MIRAPEXIN pogostnejši kot med jemanjem placeba, so bili slabost, diskinezija, hipotenzija, omotica, zaspanost, nespečnost, zaprtost, halucinacije, glavobol in utrujenost.
The incidence of somnolence is increased at doses higher than 1.5 mg/ day (see section 4.2).
Pogostnost zaspanosti se poveča pri odmerkih nad 1, 5 mg na dan (glejte poglavje 4. 2).
More frequent adverse drug reactions in combination with levodopa were dyskinesia.
Pogostnejši neželeni učinki v kombinaciji z levodopo so bile diskinezije.
Hypotension may occur at the beginning of treatment, especially if MIRAPEXIN is titrated too fast.
Hipotenzija se lahko pojavi na začetku zdravljenja, zlasti če prehitro večamo odmerek zdravila MIRAPEXIN.
-7- Table 1:
Preglednica 1:
Parkinson’ s disease System Organ Class Psychiatric disorders
Parkinsonova bolezen Organski sistem Psihiatrične motnje
abnormal dreams, behavioural symptoms of impulse control disorders and compulsions; confusion, hallucinations, insomnia, restlessness
nenormalne sanje, vedenjski simptomi motenj nadzora impulzov in kompulzije, zmedenost, halucinacije, nespečnost, nemir
compulsive shopping, delusion, hypersexuality, libido disorder, paranoia, pathological gambling
kompulzivno nakupovanje, blodnje, hiperseksualnost, motnje libida, paranoja, patološko hazardiranje
Not known Nervous system disorders
Neznana Bolezni živčevja
binge eating, hyperphagia
prenajedanje, hiperfagija
Very common Common Uncommon Eye disorders
Zelo pogosti Pogosti Občasni Očesne bolezni
dizziness, dyskinesia, somnolence amnesia, headache hyperkinesia, sudden onset of sleep, syncope
omotica, diskinezija, somnolenca amnezija, glavobol hiperkinezija, nenaden nepremagljiv spanec, sinkopa
visual disturbance including vision blurred and visual acuity reduced
motnje vida v obliki meglenega vida in zmanjšane ostrine vida
Very common Gastrointestinal disorders
Zelo pogosti Pogosti Bolezni kože in podkožja
hypotension
navzea zaprtje, bruhanje
Very common Common Skin and subcutaneous tissue Uncommon
Občasni
nausea constipation, vomiting disorders hypersensitivity, pruritus, rash
preobčutljivost, pruritus, izpuščaj
weight decrease weight increase
zvečanje telesne mase
Restless Legs Syndrome, most common adverse events The most commonly (≥ 5%) reported adverse drug reactions in patients with Restless Legs Syndrome treated with MIRAPEXIN were nausea, headache, dizziness and fatigue.
7 Sindrom nemirnih nog, najpogostnejši neželeni dogodki Najpogostnejši (≥ 5%) neželeni učinki, o katerih so poročali pri bolnikih s sindromom nemirnih nog, ki so se zdravili z zdravilom MIRAPEXIN, so bili navzea, glavobol, omotica in utrujenost.
Nausea and fatigue were more often reported in female patients treated with MIRAPEXIN (20.8% and 10.5%, respectively) compared to males (6.7% and 7.3%, respectively).
O slabosti in utrujenosti so med zdravljenjem z zdravilom MIRAPEXIN pogosteje poročali pri ženskah (20, 8% in 10, 5%) kot pri moških (6, 7% in 7, 3%).
-8- Table 2:
Preglednica 2:
Restless Legs Syndrome System Organ Class Psychiatric disorders
Sindrom nemirnih nog Organski sistem Psihiatrične motnje
Common Uncommon Not known Nervous system disorders
Pogosti Občasni Neznana Bolezni živčevja
abnormal dreams, insomnia confusion, hallucinations, libido disorder, restlessness behavioural symptoms of impulse control disorders and compulsions such as binge eating, compulsive shopping, hypersexuality and pathological gambling; delusion, hyperphagia, paranoia
nenormalne sanje, nespečnost zmedenost, halucinacije, motnje libida vedenjski simptomi motenj nadzora impulzov in kompulzije v obliki prenajedanje, kumpulzivnega nakupovanja, hiperseksualnost in patološko hazardiranje, blodnje, hiperfagija, paranoja
Common Uncommon Not known Eye disorders
Pogosti Občasni Neznana Očesne bolezni
dizziness, headache, somnolence sudden onset of sleep, syncope amnesia, dyskinesia, hyperkinesia
omotica, glavobol, zaspanost nenaden nepremagljiv spanec, sinkopa amnezija, diskinezija, hiperkinezija
Uncommon Vascular disorders
Občasni Žilne bolezni
Very common Common
Zelo pogosti Pogosti Bolezni kože in podkožja
nausea constipation, vomiting
navzea zaprtje, bruhanje
fatigue peripheral oedema
utrujenost periferni edem
weight decrease, weight increase
zmanjšanje telesne mase, zvečanje telesne mase
Somnolence MIRAPEXIN is associated with somnolence (8.6%) and has been associated uncommonly with excessive daytime somnolence and sudden sleep onset episodes (0.1%).
Zaspanost Zdravilo MIRAPEXIN povezujejo z zaspanostjo (8, 6%), občasno tudi s preveliko zaspanostjo čez dan in epizodami nenadnega spanca (0, 1%).
Libido disorders MIRAPEXIN may be associated with libido disorders (increased (0.1%) or decreased (0.4%)).
Motnje libida Zdravilo MIRAPEXIN lahko povzroči motnje libida (povečanje (0, 1%) ali zmanjšanje (0, 4%)).
See also section 4.4.
Motnje nadzora impulzov in kompulzivno vedenje Pri bolnikih, ki so se zdravili z dopaminskimi agonisti, tudi zdravilom MIRAPEXIN, zaradi Parkinsonove bolezni, so poročali o znakih patološkega hazardiranja, povečanem libidu in hiperseksualnosti, ki so po zmanjšanju odmerka ali ukinitvi zdravljenja prenehali (Glejte tudi poglavje 4. 4).
In a cross-sectional, retrospective screening and case-control study including 3090 Parkinson’ s disease patients, 13.6% of all patients receiving dopaminergic or non-dopaminergic treatment had symptoms of an impulse control disorder during the past six months.
V presečni, retrospektivni presejalni raziskavi s kontrolno skupino, ki je zajela 3090 bolnikov s Parkinsonovo boleznijo, je imelo 13, 6% vseh bolnikov, ki so prejemali dopaminergično ali nedopaminergično zdravljenje, v preteklih šestih mesecih simptome motnje nadzora impulzov.
There is no clinical experience with massive overdosage.
Z močno prevelikimi odmerki ni kliničnih izkušenj.
The expected adverse events would be those related to the pharmacodynamic profile of a dopamine agonist, including nausea, vomiting,
Pričakovani neželeni učinki bi morali biti povezani s farmakodinamskimi lastnostmi agonistov dopamina, vključno z navzeo, bruhanjem, hiperkinezijo, halucinacijami, agitacijo in hipotenzijo.
There is no established antidote for overdosage of a dopamine agonist.
Ni uveljavljenega antidota za preveliko odmerjanje agonistov dopamina.
Pharmacotherapeutic group: dopamine agonists, ATC code:
Farmakoterapevtska skupina: agonisti dopamina, Oznaka ATC:
Pramipexole alleviates Parkinsonian motor deficits by stimulation of dopamine receptors in the striatum.
Pramipeksol ublaži motorične motnje pri Parkinsonovi bolezni s stimulacijo receptorjev dopamina v striatumu.
Clinical trials in Parkinson’ s disease
Klinična preskušanja pri Parkinsonovi bolezni
In patients MIRAPEXIN alleviates signs and symptoms of idiopathic Parkinson’ s disease.
Pri bolnikih zdravilo MIRAPEXIN ublaži znake in simptome idiopatske Parkinsonove bolezni.
Controlled clinical trials included approximately 2100 patients of Hoehn and Yahr stages I – IV.
V kontroliranih kliničnih preskušanjih je bilo vključenih približno 2100 bolnikov v stadijih I- IV po Hoehnovi in Yahru.
Out of these, approximately 900 were in more advanced stages, received concomitant levodopa therapy, and suffered from motor complications.
Od teh jih je približno 900 v bolj napredovalih stadijih sočasno prejemalo levodopo in so trpeli za motoričnimi zapleti.
In early and advanced Parkinson’ s disease, efficacy of MIRAPEXIN in the controlled clinical trials was maintained for approximately six months.
Pri bolnikih z zgodnjo in napredovalo Parkinsonovo boleznijo, je bila učinkovitost zdravila MIRAPEXIN v kontroliranih kliničnih preskušanjih vzdrževana približno šest mesecev.
However there was no significant difference during the maintenance phase.
V vzdrževalni fazi pa med zdraviloma ni bilo značilne razlike.
These points should be considered when initiating pramipexole treatment in patients with Parkinson’ s disease.
Naštete izsledke je treba upoštevati ob uvajanju zdravljenja s pramipeksolom pri bolnikih s Parkinsonovo boleznijo.
Clinical trials in Restless Legs Syndrome
Klinična preskušanja pri sindromu nemirnih nog
The efficacy of MIRAPEXIN was evaluated in four placebo-controlled clinical trials in approximately 1000 patients with moderate to very severe idiopathic Restless Legs Syndrome.
Učinkovitost zdravila MIRAPEXIN so ocenili v štirih s placebom nadzorovanih kliničnih preskušanjih pri približno 1000 bolnikih z zmernim do zelo hudim idiopatskim sindromom nemirnih nog.
Efficacy was demonstrated in controlled trials in patients treated for up to 12 weeks.
V nadzorovanih preskušanjih so učinkovitost dokazali pri bolnikih, ki so se zdravili do 12 tednov.
Maintenance of effect has not been sufficiently tested.
Trajanje učinka še ni dovolj preskušeno.
The mean change from baseline in the Restless Legs Syndrome Rating Scale (IRLS) and the Clinical Global Impression-Improvement (CGI-I) were the primary efficacy outcome measures.
9 Primarni merili za oceno izida zdravljenja glede na njegovo učinkovitost sta bili srednja sprememba glede na izhodiščno stanje pri vrednotenju z lestvico za oceno sindroma nemirnih nog (Restless Legs Syndrome Rating Scale – RLSRS) in izboljšanje, ocenjeno z lestvico CGI- I (Clinical Global Impression- Improvement).
For both primary endpoints statistically significant differences have been observed for the pramipexole dose groups 0.25 mg, 0.5 mg and 0.75 mg in comparison to placebo.
Pri obeh primarnih opazovanih dogodkih so v primerjavi s placebom ugotovili statistično pomembne razlike v skupinah, ki so prejemale po 0, 25 mg, 0, 5 mg ali 0, 75 mg pramipeksola.
The adjusted mean difference was -4.3 points (CI 95% -6.4; -2.1
Po 12 tednih zdravljenja se je izhodiščno število točk na lestvici IRLS v skupini, ki je prejemala placebo, zmanjšalo s 23, 5 na 14, 1, v skupinah, ki so prejemale pramipeksol (skupno za vse odmerke) pa s 23, 4 na 9, 4 točke.
points, p-value < 0.0001).
Prilagojena srednja razlika je bila – 4, 3 točke (95- odstotni interval zaupanja – 6, 4; – 2, 1 točke, p < 0, 0001).
CGI-I responder rates (improved, very much improved) were 51.2% and 72.0% for placebo and pramipexole respectively (difference 20% CI 95%:
Odstotek odzivnosti na zdravljenje je bil glede na oceno, pridobljeno z lestvico CGI- I (izboljšanje, zelo veliko izboljšanje), pri placebu 51, 2%, pri pramipeksolu pa 72, 0% (razlika 20%, 95- interval zaupanja:
Efficacy was observed with 0.088 mg of base (0.125 mg of salt) per day after the first week of treatment.
Učinkovitost so zasledili pri 0, 088 mg pramipeksola (0, 125 mg soli) na dan po prvem tednu zdravljenja.
In a placebo-controlled polysomnography study over 3 weeks MIRAPEXIN significantly reduced the number of periodic limb movements during time in bed.
V 3- tedenskem s placebom nadzorovanem preskušanju s polisomnografijo je zdravilo MIRAPEXIN pomembno zmanjšalo število periodičnih premikov okončine v času, ko so bili bolniki v postelji.
The absolute bioavailability is greater than 90% and the maximum plasma concentrations occur between 1 and 3 hours.
Absolutna biološka uporabnost je več kot 90%, do največjih plazemskih koncentracij pa pride po 1 do 3 urah.
In humans, the protein binding of pramipexole is very low (< 20%) and the volume of distribution is large (400 l).
Pri človeku je vezava pramipeksola na proteine zelo majhna (< 20%), volumen porazdelitve pa je velik (400 l).
8-fold compared to plasma).
Pri podganah so opazili visoke koncentracije v možganskih tkivih (približno 8- krat večje kot v plazmi).
Approximately 90% of 14 C-labelled dose is excreted through the kidneys while less than 2% is found in the faeces.
Približno 90% odmerka, označenega s 14 C, se izloči skozi ledvica, medtem ko v fecesu najdemo manj kot 2% odmerka.
The total clearance of pramipexole is approximately 500 ml/ min and the renal clearance is approximately 400 ml/ min.
Skupni očistek pramipeksola je približno 500 ml/ min, ledvični očistek pa je približno 400 ml/ min.
The elimination half-life (t½) varies from 8 hours in the young to 12 hours in the elderly.
Razpolovni čas (t1/ 2) izločanja variira od 8 ur pri mladih do 12 ur pri starejših ljudeh.
Decreases in diastolic and systolic pressure and heart rate were noted in the minipig, and a tendency to an hypotensive effect was discerned in the monkey.
Pri miniprašičih so opazili zmanjšanja diastoličnega in sistoličnega tlaka ter srčnega utripa, pri opicah pa težnjo k hipotenzivnem učinku.
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.
Ista študija je tudi pokazala, da je bil pramipeksol v odmerkih 2 mg/ kg (soli) ali več povezan z degeneracijo mrežnice pri albino podganah.
6.1 List of excipients
10 6. 1 Seznam pomožnih snovi
Mannitol, maize starch, anhydrous colloidal silica, povidone K 25, magnesium stearate
manitol koruzni škrob brezvodni koloidni silicijev dioksid povidon K 25 magnezijev stearat
10 tablets per aluminium blister strips Cartons containing 3 or 10 blister strips (30 or 100 tablets)
10 tablet v pretisnih omotih iz aluminija Zloženke vsebujejo 3 ali 10 pretisnih omotov (30 ali 100 tablet).
Boehringer Ingelheim International GmbH D-55216 Ingelheim am Rhein Germany
Boehringer Ingelheim International GmbH D- 55216 Ingelheim am Rhein Nemčija
23 February 1998 Date of Renewal of the authorisation:
23. februar 1998 Datum podaljšanja dovoljenja:
23 February 2008
23. februar 2008
MIRAPEXIN 0.18 mg tablets
MIRAPEXIN 0, 18 mg tablete
MIRAPEXIN 0.18 mg tablets contain 0.18 mg of pramipexole base (as 0.25 mg of pramipexole dihydrochloride monohydrate).
Zdravilo MIRAPEXIN 0, 18 mg tablete vsebujejo 0, 18 mg pramipeksola (kar ustreza 0, 25 mg pramipeksolijevega dihidroklorid monohidrata).
MIRAPEXIN is indicated for symptomatic treatment of moderate to severe idiopathic Restless Legs Syndrome in dosages up to 0.54 mg of vase (0.75 mg of salt) (see section 4.2).
Zdravilo MIRAPEXIN je indicirano za simptomatsko zdravljenje zmernega do hudega idiopatskega sindroma nemirnih nog v odmerkih do 0, 54 mg pramipeksola (0, 75 mg soli) (glejte poglavje 4. 2).
Initial treatment:
Začetek zdravljenja:
Ascending – Dose Schedule of MIRAPEXIN
12 Shema povečevanja odmerka zdravila MIRAPEXIN Teden
Abrupt discontinuation of dopaminergic therapy can lead to the development of aneuroleptic malignant syndrome.
Nagla prekinitev zdravljenja z agonisti dopamina lahko privede do razvoja nevroleptičnega malignega sindroma.
Restless Legs Syndrome
13 Sindrom nemirnih nog
If the treatment is interrupted for more than a few days it should be re-initiated by dose titration carried out as above.
Če zdravljenje prekinemo za več kot nekaj dni, moramo pri njegovem ponovnem uvajanju odmerek večati po zgornji shemi.
Patients with a creatinine clearance above 20 mL/ min require no reduction in daily dose.
Bolnikom z večjim očistkom kreatinina od 20 ml/ min dnevnega odmerka ni treba zmanjšati.
When prescribing MIRAPEXIN tablets in a patient with Parkinson’ s disease with renal impairment a reduced dose is suggested in line with section 4.2.
Pri predpisovanju zdravila MIRAPEXIN bolnikom s Parkinsonovo boleznijo in ledvično okvaro je priporočljivo zmanjšano odmerjanje, opisano v poglavju 4. 2.
Dyskinesia In advanced Parkinson’ s disease, in combination treatment with levodopa, dyskinesia can occur during the initial titration of MIRAPEXIN.
14 Diskinezija Pri bolnikih z napredovalo Parkinsonovo boleznijo, ki jemljejo zdravilo v kombinaciji z levodopo, se lahko med začetnim stopnjevanjem odmerka zdravila MIRAPEXIN pojavijo diskinezije.
Impulse control disorders and compulsive behaviours Pathological gambling, increased libido and hypersexuality have been reported in patients treated with dopamine agonists for Parkinson’ s disease, including MIRAPEXIN.
Motnje nadzora impulzov in kompulzivno vedenje Pri bolnikih, pri kateri so Parkinsonovo bolezen zdravili z dopaminskimi agonisti, tudi zdravilom MIRAPEXIN, so poročali o patološkem hazardiranju, povečanem libidu in hiperseksualnosti.
Augmentation Reports in the literature indicate treatment of Restless Legs Syndrome with dopaminergic medicinal products can result in augmentation.
Poslabšanje simptomov Poročila v literaturi kažejo, da je mogoča posledica zdravljenja sindroma nemirnih nog z dopaminergičnimi zdravili poslabšanje simptomov.
Plasma protein binding Pramipexole is bound to plasma proteins to a very low (< 20%) extent, and little biotransformation is seen in man.
Vezava na beljakovine v plazmi Pramipeksol se veže na plazemske proteine v zelo majhni meri (< 20%) in pri človeku je opažena le manjša biotransformacija.
As anticholinergics are mainly eliminated by biotransformation, the potential for an interaction is limited, although an interaction with anticholinergics has not been investigated.
15 raziskovali, je možnost le- teh majhna, ker se antiholinergiki izločajo v glavnem z biotransformacijo.
Expected adverse events
Pričakovani neželeni dogodki Pričakovani neželeni učinki med zdravljenjem z zdravilomMIRAPEXIN so: nenormalne sanje, amnezija, vedenjski simptomi motenj nadzora impulzov in kompulzije, kot so prenajedanje in kompulzivno nakupovanje, hiperseksualnost in patološko hazardiranje, stanje zmedenosti, zaprtost, omotica, blodnje, diskinezije, utrujenost, halucinacije, glavobol, hiperkinezija, hiperfagija, hipotenzija, nespečnost, motnje libida, slabost, paranoja, periferni edem, pruritus, izpuščaj in druge oblike
The following adverse reactions are expected under the use of MIRAPEXIN: abnormal dreams, amnesia, behavioural symptoms of impulse control disorders and compulsions such as binge eating, compulsive shopping, hypersexuality and pathological gambling; confusion, constipation, delusion, dizziness, dyskinesia, fatigue, hallucinations, headache, hyperkinesia, hyperphagia, hypotension, insomnia, libido disorders, nausea, paranoia, peripheral oedema, pruritus, rash and other hypersensitivity; restlessness, somnolence, sudden onset of sleep, syncope, visual disturbance including vision blurred and visual acuity reduced, vomiting, weight decrease, weight increase.
16 preobčutljivosti; nemir, zaspanost, nenaden nepremagljiv spanec, sinkopa, motnje vida v obliki meglenega vida in zmanjšane ostrine vida, bruhanje, zmanjšanje telesne mase, povečanje telesne mase.
Restless Legs Syndrome, most common adverse events The most commonly (≥ 5%) reported adverse drug reactions in patients with Restless Legs Syndrome treated with MIRAPEXIN were nausea, headache, dizziness and fatigue.
17 Sindrom nemirnih nog, najpogostnejši neželeni dogodki Najpogostnejši (≥ 5%) neželeni učinki, o katerih so poročali pri bolnikih s sindromom nemirnih nog, ki so se zdravili z zdravilom MIRAPEXIN, so bili navzea, glavobol, omotica in utrujenost.
4.9 Overdose
18 4. 9 Preveliko odmerjanje
If signs of central nervous system stimulation are present, a neuroleptic agent may be indicated.
Če so prisotni znaki stimulacije osrednjega živčnega sistema, je lahko indicirani nevroleptik.
The mean change from baseline in the Restless Legs Syndrome Rating Scale (IRLS) and the Clinical Global Impression-Improvement (CGI-I) were the primary efficacy outcome measures.
19 Primarni merili za oceno izida zdravljenja glede na njegovo učinkovitost sta bili srednja sprememba glede na izhodiščno stanje pri vrednotenju z lestvico za oceno sindroma nemirnih nog (Restless Legs Syndrome Rating Scale – RLSRS) in izboljšanje, ocenjeno z lestvico CGI- I (Clinical Global Impression- Improvement).
6.1 List of excipients
20 6. 1 Seznam pomožnih snovi
Mannitol, maize starch, anhydrous colloidal silica, povidone K 25,
manitol koruzni škrob brezvodni koloidni silicijev dioksid povidon K 25 magnezijev stearat
MIRAPEXIN 0.35 mg tablets
MIRAPEXIN 0, 35 mg tablete
MIRAPEXIN 0.35 mg tablets contain 0.35 mg of pramipexole base (as 0.5 mg of pramipexole dihydrochloride monohydrate).
Zdravilo MIRAPEXIN 0, 35 mg tablete vsebujejo 0, 35 mg pramipeksola (kar ustreza 0, 5 mg pramipeksolijevega dihidroklorid monohidrata).
MIRAPEXIN is indicated 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).
Zdravilo MIRAPEXIN je indicirao 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).
MIRAPEXIN is indicated for symptomatic treatment of moderate to severe idiopathic Restless Legs Syndrome in dosages up to 0.54 mg of base (0.75 mg of salt) (see section 4.2).
Zdravilo MIRAPEXIN je indicirao za simptomatsko zdravljenje zmernega do hudega idiopatskega sindroma nemirnih nog v odmerkih do 0, 54 mg pramipeksola (0, 75 mg soli) (glejte poglavje 4. 2).