natgillin/translations-raw huggingface dataset:
Because Pramipexole Teva is a generic medicine, studies have been limited to tests to determine that it is bioequivalent to the reference medicine (i. e. that the two medicines produce the same levels of the active substance in the body).
Ker je zdravilo Pramipexole Teva generično zdravilo, so bile študije omejene na preskuse, s katerimi se dokazuje, da je biološko enakovredno referenčnemu zdravilu (tj. da zdravili dosegata enake ravni zdravilne učinkovine v telesu).
Therefore, the CHMP’ s view was that, as for Sifrol, the benefit outweighs the identified risk.
Zaradi tega je CHMP menil, da njegove koristi tako kot pri zdravilu Sifrol odtehtajo z njim povezana tveganja.
The European Commission granted a marketing authorisation valid throughout the EU for Pramipexole Teva to Teva Pharma B. V. on 18 December 2008.
Evropska komisija je dovoljenje za promet z zdravilom Pramipexole Teva, veljavno po vsej Evropski uniji, odobrila družbi Teva Pharma BV dne 18. decembra 2008.
Package size
tableta tableta
Tablet Tablet Tablet Tablet Tablet Tablet Tablet Tablet Tablet Tablet Tablet Tablet Tablet Tablet Tablet Tablet
pretisni omot (alu/ alu) vsebnik (HDPE) pretisni omot (alu/ alu) pretisni omot (alu/ alu) – enoodmerno pakiranje
Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use
pretisni omot (alu/ alu) vsebnik (HDPE) pretisni omot (alu/ alu) pretisni omot (alu/ alu) – enoodmerno pakiranje
blister (alu/ alu) blister (alu/ alu) - unit dose blister (alu/ alu) tablet container (HDPE) blister (alu/ alu) blister (alu/ alu) - unit dose blister (alu/ alu) tablet container (HDPE) blister (alu/ alu) blister (alu/ alu) - unit dose blister (alu/ alu) tablet container (HDPE) blister (alu/ alu) blister (alu/ alu) - unit dose blister (alu/ alu) tablet container (HDPE)
pretisni omot (alu/ alu) vsebnik (HDPE) pretisni omot (alu/ alu) pretisni omot (alu/ alu) – enoodmerno pakiranje
30 tablets 50 x 1 tablets 100 tablets 90 tablets 30 tablets 50 x 1 tablets 100 tablets 90 tablets 30 tablets 50 x 1 tablets 100 tablets 90 tablets 30 tablets 50 x 1 tablets 100 tablets 90 tablets
100 tablet 90 tablet 30 tablet 50 x 1 tableta
Pramipexole Teva 0.088 mg tablets
Pramipeksol Teva 0, 088 mg tablete
Each tablet contains 0.088 mg pramipexole base (as 0.125 mg pramipexole dihydrochloride monohydrate).
Ena tableta vsebuje 0, 088 mg pramipeksola (kar ustreza 0, 125 mg pramipeksolijevega diklorida monohidrata).
Pramipexole doses as published in the literature refer to the salt form.
Opomba Odmerki pramipeksola, objavljeni v literaturi, se nanašajo na sol.
White, round, flat face bevel edge tablet, 5.55 mm diameter, embossed with “ 93 ” on one side and “ P1” on the other side.
Bela, okrogla, ploska, topokotna tableta premera 5, 55 mm, z izbočeno oznako « 93 « na eni strani in « P1 « na drugi strani.
Pramipexole Teva 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 Pramipeksol Teva je 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).
The daily dosage is administered in equally divided doses 3 times a day.
Dnevni odmerek je razdeljen na 3 enake dele, ki jih bolniki jemljejo trikrat na dan.
Dosages should be increased gradually from a starting-dose of 0.264 mg of base (0.375 mg of salt) per day and then increased every 5 - 7 days.
Začetno zdravljenje Zdravljenje pričnemo z začetnim odmerkom 0, 264 mg pramipeksola (0, 375 mg soli) na dan, ki ga postopoma povečujemo vsakih 5- 7 dni.
Providing patients do not experience intolerable side-effects, the dosage should be titrated to achieve a maximal therapeutic effect.
Če bolniki prenašajo zdravilo brez neželenih učinkov, ki bi zahtevali prekinitev zdravljenja, odmerek prilagajamo dokler ne dosežemo maksimalnega terapevtskega učinka.
Ascending – Dose schedule of Pramipexole Teva Week
Režim povečevanja odmerkov zdravila Pramipeksol Teva Teden
If a further dose increase is necessary the daily dose should be increased by 0.54 mg base (0.75 mg salt) at weekly intervals up to a maximum dose of 3.3 mg of base (4.5 mg of salt) per day.
Če je potrebno nadaljnje povečanje odmerka, lahko dnevni odmerek v tedenskih intervalih povečujemo za 0, 54 mg pramipeksola (0, 75 mg soli) do največjega odmerka 3, 3 mg pramipeksola (4, 5 mg soli).
However, it should be noted that the incidence of somnolence is increased at doses higher than 1.5 mg/ day (see section 4.8).
2 Vendar pa je potrebno upoštevati, da je incidenca zaspanostivečja pri odmerkih, večjih od 1, 5 mg na dan (glejte poglavje 4. 8).
2 Maintenance treatment:
Vzdrževalno zdravljenje:
The individual dose should be in the range of 0.264 mg of base (0.375 mg of salt) to a maximum of 3.3 mg of base (4.5 mg of salt) per day.
Odmerek za posameznega bolnika naj bo v razponu od 0, 264 mg pramipeksola (0, 375 mg soli) do največ 3, 3 mg pramipeksola (4, 5 mg soli) na dan.
During dose escalation in three pivotal studies, efficacy was observed starting at a daily dose of 1.1 mg of base (1.5 mg of salt).
Med povečevanjem odmerka v treh ključnih študijah so učinek zasledili ob odmerku 1, 1 mg pramipeksola (1, 5 mg soli) na dan.
In clinical trials approximately 5% of patients were treated at doses below 1.1 mg (1.5 mg of salt).
V kliničnih preskušanjih je približno 5% bolnikov jemalo odmerke pod 1, 1 mg pramipeksola (1, 5 mg soli).
In advanced Parkinson’ s disease, doses higher than 1.1 mg (1.5 mg of salt) per day can be useful in patients where a reduction of the levodopa therapy is intended.
Pri bolnikih z napredovalo Parkinsonovo boleznijo so lahko koristni odmerki, večji od 1, 1 mg pramipeksola (1, 5 mg soli), če nameravamo zmanjšati odmerjanje levodope.
It is recommended that the dosage of levodopa is reduced during both the dose escalation and the maintenance treatment with Pramipexole Teva, depending on reactions in individual patients.
Priporočljivo je, da odmerke levodope zmanjšamo tako med titriranjem kot med vzdrževalnim zdravljenjem z zdravilom Pramipeksol Teva, odvisno od posameznikovega odziva.
Abrupt discontinuation of dopaminergic therapy can lead to the development of aneuroleptic malignant syndrome.
Nenadna prekinitev dopaminskega zdravljenja lahko privede do razvoja nevroleptičnega malignega sindroma.
Therefore, pramipexole should be tapered off at a rate of 0.54 mg of base (0.75 mg of salt) per day until the daily dose has been reduced to 0.54 mg of base (0.75 mg of salt).
Zdravljenje s pramipeksolom moramo zato ukinjati postopoma, in sicer tako, da zmanjšujemo odmerek za 0, 54 mg pramipeksola (0, 75 mg soli) na dan, dokler ni dnevni odmerek zmanjšan na 0, 54 mg pramipeksola (0, 75 mg soli).
Thereafter the dose should be reduced by 0.264 mg of base (0.375 mg of salt) per day (see section 4.4).
Nato odmerek zmanjšujemo za 0, 264 mg pramipeksola (0, 375 mg soli) na dan (glejte poglavje 4. 4).
Dosing in patients with renal impairment:
Odmerjanje pri bolnikih z ledvičnim popuščanjem:
The following dosage schedule is suggested for initiation of therapy:
Za uvajanje zdravljenja so priporočljivi naslednji odmerki.
Patients with a creatinine clearance above 50 ml/ min require no reduction in daily dose.
Pri bolnikih z očistkom kreatinina nad 50 ml/ min dnevnega odmerka ni potrebno prilagajati.
In patients with a creatinine clearance between 20 and 50 ml/ min, the initial daily dose of Pramipexole Teva should be administered in two divided doses, starting at 0.088 mg of base (0.125 mg of salt) twice a day (0.176 mg of base/ 0.25 mg of salt daily).
Začnemo z dajanjem 0, 088 mg pramipeksola (0, 125 mg soli) dvakrat dnevno (0, 176 mg h pramipeksola/ 0, 25 mg soli na dan).
In patients with a creatinine clearance less than 20 ml/ min, the daily dose of Pramipexole Teva should be administered in a single dose, starting at 0.088 mg of base (0.125 mg of salt) daily.
Bolnikom z očistkom kreatinina manjšim kot 20 ml/ min damo dnevni odmerek zdravila Pramipeksol Teva v enkratnem odmerku, pri čemer začnemo z dajanjem 0, 088 mg pramipeksola (0, 125 mg soli) dnevno.
If renal function declines during maintenance therapy, reduce Pramipexole Teva daily dose by the same percentage as the decline in creatinine clearance, i. e. if creatinine clearance declines by 30%, then reduce the Pramipexole Teva daily dose by 30%.
Na primer, če se je očistek kreatinina zmanjšal za 30%, zmanjšamo odmerek zdravila Pramipeksol Teva za 30%.
90% of absorbed active substance is excreted through the kidneys.
Odmerjanje pri bolnikih z jetrnim popuščanjem Prilaganje odmerka pri bolnikih z jetrnim popuščanjem verjetno ni potrebno, ker se približno 90% absorbirane zdravilne učinkovine izloča skozi ledvice.
However, the potential influence of hepatic insufficiency on pramipexole pharmacokinetics has not been investigated.
Morebitnega vpliva jetrnega popuščanja na farmakokinetiko pramipeksola niso proučevali.
Dosing in children and adolescents Pramipexole is not recommended for use in children and adolescents below 18 years due to lack of data on safety and efficacy.
Odmerjanje pri otrocih in mladostnikih Zaradi pomanjkanja podatkov o varnosti in učinkovitosti uporaba zdravila Pramipeksol Teva pri otrocih in mladostnikih, mlajših od 18 let, ni priporočljiva.
When prescribing Pramipexole Teva in a patient with Parkinson’ s disease with renal impairment a reduced dose is suggested in line with section 4.2.
3 Ko predpisujemo zdravilo Pramipeksol Teva bolnikom s Parkinsonovo boleznijo in ledvičnim popuščanjem, je priporočljivo, da zmanjšamo odmerek po navodilih iz poglavja 4. 2.
Hallucinations are known as an adverse event of treatment with dopamine agonists and levodopa.
Halucinacije so znan neželeni učinek zdravljenja z agonisti dopamina in levodopo.
3 In advanced Parkinson’ s disease, in combination treatment with levodopa, dyskinesias can occur during the initial titration of Pramipexole Teva.
Pri bolnikih z napredovalo Parkinsonovo boleznijo se lahko v kombinaciji z levodopo pojavijo diskinezije med začetnim titriranjem zdravila Pramipeksol Teva.
Pramipexole has been associated with somnolence and episodes of sudden sleep onset, particularly in patients with Parkinson’ s disease.
Pramipeksol je bil povezan z zaspanostjo in epizodami nenadnega spanca, zlasti pri bolnikih s Parkinsonovo boleznijo.
Patients must be informed of this and advised to exercise caution while driving or operating machines during treatment with pramipexole.
Bolnike moramo s tem seznaniti in jim svetovati, naj bodo previdni pri vožnji in upravljanju s stroji med zdravljenjem s pramipeksolom.
Patients who have experienced somnolence and/ or an episode of sudden sleep onset must refrain from driving or operating machines.
Bolniki, pri katerih se je že pojavila zaspanost in/ ali epizoda nenadnega spanca, ne smejo voziti ali upravljati s stroji.
Furthermore a reduction of dosage or termination of therapy may be considered.
Poleg tega je treba pri njih presoditi o zmanjšanju odmerka ali prekinitvi zdravljenja..
Because of possible additive effects, caution should be advised when patients are taking other sedating medicinal products or alcohol in combination with pramipexole (see section 4.7 and section 4.8).
Zaradi možnosti seštevanja učinka morajo biti bolniki previdni, če jemljejo druga sedativna zdravila ali uživajo alkohol sočasno s pramipeksolom (glejte poglavji 4. 7 in 4. 8).
Pathological gambling, increased libido and hypersexuality have been reported in patients treated with dopamine agonists for Parkinson’ s disease, including pramipexole.
Pri bolnikih, pri katerih so Parkinsonovo bolezen zdravili z dopaminskimi agonisti, tudi s pramipeksolom, so poročali o patološkem hazardiranju, povečanem libidu in hiperseksualnosti.
Furthermore, patients and caregivers should be aware of the fact that behavioural changes can occur.
Bolniki in negovalci morajo vedeti, da lahko pride do sprememb vedenja.
Dose reduction/ taper or discontinuation should be considered.
Razmisliti moramo o zmanjšanju odmerka ali postopni ukinitvi.
Coadministration of antipsychotic medicinal products with pramipexole should be avoided (see section 4.5).
Izogibati se moramo sočasnemu predpisovanju antipsihotikov in pramipeksola (glejte poglavje 4. 5).
Symptoms suggestive of neuroleptic malignant syndrome have been reported with abrupt withdrawal of dopaminergic therapy (see section 4.2)
Pri bolnikih, ki so nenadno prekinili dopaminsko zdravljenje, so opažali simptome, ki so kazali na nevroleptični maligni sindrom (glejte poglavje 4. 2).
The frequency of augmentation after longer use of pramipexole and the appropriate management of these events have not been evaluated in controlled clinical trials.
Pogostnosti poslabšanja po dolgoročnejšem jemanju pramipeksola in ustreznega obravnavanja tovrstnih bolnikov v nadzorovanih kliničnih preskušanjih niso proučevali.
Pramipexole is bound to plasma proteins to a very low (< 20%) extent, and little biotransformation is seen in man.
Vezava pramipeksola na beljakovine v plazmi je zelo majhna (< 20%) in pri človeku se presnovi le v manjši meri.
Cimetidine reduced the renal clearance of pramipexole by approximately 34%, presumably by inhibition of the cationic secretory transport system of the renal tubules.
Cimetidin je zmanjšal ledvični očistek pramipeksola za približno 34%, verjetno z zaviranjem kationskega izločevalnega prenašalnega sistema v ledvičnih cevkah.
Therefore, medicinal products that are inhibitors of this active renal elimination pathway or are eliminated by this pathway, such as cimetidine and amantadine, may interact with pramipexole resulting in reduced clearance of either or both medicinal products.
Zdravila, ki zavirajo to aktivno pot izločanja skozi ledvice ali se izločajo preko nje, na primer cimetidin in amantadin, lahko torej medsebojno delujejo s pramipeksolom tako, da se zmanjša ledvični očistek enega ali obeh zdravil.
4 When Pramipexole Teva is given in combination with levodopa, it is recommended that the dosage of levodopa is reduced and the dosage of other anti-parkinsonian medicinal products is kept constant while increasing the dose of Pramipexole Teva.
4 Ko pramipeksol predpisujemo v kombinaciji z levodopo, je priporočljivo, da zmanjšamo odmerek levodope in ohranjamo stalen odmerek drugih antiparkinsonikov med povečevanjem odmerka zdravila Pramipeksol Teva.
Because of possible additive effects, caution should be advised when patients are taking other sedating medicinal products or alcohol in combination with pramipexole.
Zaradi možnosti seštevanja učinka morajo biti bolniki previdni, če jemljejo druga sedativna zdravila ali uživajo alkohol sočasno s pramipeksolom.
Coadministration of antipsychotic medicinal products with pramipexole should be avoided (see section 4.4), e. g. if antagonistic effects can be expected.
Izogibati se moramo sočasnemu predpisovanju antipsihotikov in pramipeksola (glejte poglavje 4. 4), npr. kadar je pričakovan antagonistični učinek.
Pramipexole was not teratogenic in rats and rabbits, but was embryotoxic in the rat at maternotoxic doses (see section 5.3).
Pramipeksol ni bil teratogen pri podganah in zajcih, vendar je pri podganah imel embriotoksične učinke v odmerkih, toksičnih za mater (glejte poglavje 4. 3).
Pramipexole Teva should not be used during pregnancy unless clearly necessary, i. e. if the potential benefit justifies the potential risk to the foetus.
Zdravila Pramipeksol Teva ne smemo predpisovati med nosečnostjo, razen če je nujno potrebno, se pravi, če morebitna korist odtehta morebitno tveganje za plod.
Pramipexole Teva can have a major influence on the ability to drive an use machines.
Zdravilo Pramipeksol Teva ima pomemben vpliv na sposobnost vožnje in upravljanja s stroji.
Patients being treated with Pramipexole Teva 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).
Bolnikom, ki jemljejo zdravilo Pramipeksol Teva in opažajo zaspanost ali epizode nenadnega spanca ali oboje, moramo svetovati, naj ne vozijo ali se ukvarjajo z dejavnostmi, kjer bi zmanjšana budnost lahko povzročila resne poškodbe ali smrt bolnika ali drugih (na primer pri upravljanju strojev), dokler tovrstne epizode in zaspanost ne izginejo (glejte poglavja 4. 4, 4. 5 in 4. 8).
The following adverse reactions are expected under the use of Pramipexole Teva: abnormal dreams, confusion, constipation, delusion, dizziness, dyskinesia, fatigue, hallucinations, headache, hyperkinesia, hypotension, increased eating (binge eating, hyperphagia), insomnia, libido disorders, nausea, peripheral oedema, paranoia; pathological gambling, hypersexuality and other abnormal behaviour, somnolence, weight increase, sudden onset of sleep, pruritus and rash and other hypersensitivity.
Med jemanjem zdravila Pramipeksol Teva lahko pričakujemo naslednje neželene učinke: nenavadne sanje, zmedenost, zaprtje, blodnje, vrtoglavico, diskinezijo, utrujenost, halucinacije, glavobol, hiperkinezije, hipotenzijo, povečano prehranjevanje (preobjedanje, hiperfagijo), nespečnost, motnje libida, slabost, periferne otekline, paranojo; patološko hazardiranje, hiperseksualnost in drugo nenavadno vedenje, zaspanost, povečanje telesne mase, nenaden spanec, pruritus in izpuščaj in druge preobčutljivosti.
63% of patients on pramipexole and 52% of patients on placebo reported at least one adverse reaction.
O najmanj enem neželenem učinku je poročalo 63% bolnikov zdravljenih s pramipeksolom in 52% bolnikov, ki so prejemali placebo.
Table 1 and 2 displays the frequency of adverse reactions from placebo-controlled clinical trials in Parkinson’ s disease and another indication.
Preglednici 1 in 2 kažeta pogostnost neželenih učinkov v s placebom nadzorovanih kliničnih preskušanjih pri Parkinsonovi bolezni in drugih indikacijah.
The adverse reactions reported in these tables are those events that occurred in 0.1% or more of patients treated with pramipexole and were reported significantly more often in patients taking pramipexole 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% s pramipeksolom zdravljenih bolnikov ali več, in o katerih so poročali pomembno pogosteje pri bolnikih, ki so jemali pramipeksol, kot pri tistih, ki so jemali placebo, ali pa je bil dogodek ocenjen kot klinično pomemben.
However, the majority of common adverse 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.
5 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).
5 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).
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.
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.
More frequent adverse drug reactions in combination with levodopa was dyskinesia.
Pogostejši neželeni učinki v kombinaciji z levodopo so bile diskinezije.
Parkinson’ s disease System Organ Class Psychiatric disorders
Parkinsonova bolezen Neželeni učinek Organski sistem Psihiatrične motnje
Common Uncommon Not known Nervous system disorders
Pogosti Občasni Neznana
abnormal dreams, confusion, hallucinations, insomnia delusion, libido disorder, paranoia abnormal behaviour, hypersexuality, increased eating, pathological gambling
nenormalne sanje, zmedenost, halucinacije, nespečnost blodnje, motnje libida, paranoja nenormalno vedenje, hiperseksualnost, povečano uživanje hrane, patološko hazardiranje
Very common Common Uncommon Vascular disorders
Bolezni živčevja Žilne
dizziness, dyskinesia, somnolence headache hyperkinesias, sudden onset of sleep
Zelo pogosti Pogosti Občasni bolezni Zelo pogosti
Very common Gastrointestinal disorders
omotica, diskinezija, zaspanost glavobol hiperkinezija, nenaden nepremagljiv spanec hipotenzija
hypotension
Bolezni prebavil
nausea constipation
slabost zaprtje
The most commonly (≥ 5%) reported adverse drug reactions in patients with other indication treated with pramipexole were nausea, headache, dizziness and fatigue.
Najpogostejši (≥ 5%) neželeni učinki, o katerih so poročali pri bolnikih z drugo indikacijo, ki so se zdravili s pramipeksolom, so bili slabost, glavobol, omotica in utrujenost.
Nausea and fatigue were more often reported in female patients treated with pramipexole (20.8% and 10.5%, respectively) compared to males (6.7% and 7.3%, respectively).
O slabosti in utrujenosti so med zdravljenjem s pramipeksolom pogosteje poročali pri ženskah (20, 8% in 10, 5%) kot pri moških (6, 7% in 7, 3%).
Other Indication System Organ Class Psychiatric disorders
Druge indikacije Organski sistem Psihiatrične motnje
abnormal dreams, insomnia confusion, hallucination, libido disorder abnormal behaviour, delusion, hypersexuality, increased eating, paranoia, pathological gambling
nenormalne sanje, nespečnost zmedenost, halucinacije, motnje libida nenormalno vedenje, blodnje, hiperseksualnost, povečano uživanje hrane, paranoja, patološko hazardiranje
Common Uncommon Not known Vascular disorders
Pogosti Občasni Neznana Žilne bolezni
dizziness, headache, somnolence sudden onset of sleep dyskinesia, hyperkinesia
omotica, glavobol, zaspanost nenaden nepremagljiv spanec diskinezija, hiperkinezija
nausea constipation
Bolezni kože in podkožja
Pramipexole is associated with somnolence (8.6%) and has been associated uncommonly with excessive daytime somnolence and sudden sleep onset episodes (0.1%).
Pramipeksol se povezuje z zaspanostjo (8, 6%) in občasno s preveliko zaspanostjo čez dan ter epizodami nenadnega spanca (0, 1%).
Pramipexole may be associated with libido disorders (increased (0.1%) or decreased (0.4%)).
Pramipeksol lahko povzroči motnje libida: povečanje (0, 1%) ali zmanjšanje (0, 4%).
Patients treated with dopamine agonists for Parkison’ s disease, including pramipexole, especially at high doses, have been reported as exhibiting sings of pathological gambling, increased libido and hypersexuality, generally reversible upon reduction of the dose or treatment discontinuation.
Ti znaki so po zmanjšanju odmerka ali ukinitvi zdravila izginili.
See also section 4.4.
Glejte poglavje 4. 4.
N04B C05
N04BC05.
Pramipexole is a dopamine agonist that binds with high selectivity and specificity to the D2 subfamily of dopamine receptors of which it has a preferential affinity to D 3 receptors, and has full intrinsic activity.
Aktivnost pramipeksola je v celoti intrinzična.