natgillin/translations-raw huggingface dataset:
The Committee for Medicinal Products for Human Use (CHMP) decided that Mirapexin’ s benefits are greater than its risks for the treatment of the signs and symptoms of idiopathic Parkinson’ s disease alone or in combination with levodopa, and for the treatment of moderate to severe idiopathic restless legs syndrome in dosages up to 0.54 mg of base.
Odbor za zdravila za uporabo v humani medicini (CHMP) je zaključil, da so koristi zdravila Mirapexin pri zdravljenju znakov in simptomov idiopatske Parkinsonove bolezni samostojno ali v kombinaciji z levodopo in pri zdravljenju zmernega do hudega idiopatskega sindroma nemirnih nog v odmerkih do 0, 54 mg hidroksida večje od z njim povezanih tveganj.
The Committee recommended that Mirapexin be given marketing authorisation.
Odbor je priporočil, da se za zdravilo Mirapexin odobri dovoljenje za promet.
2/ 3 Other information about Mirapexin:
2/ 3 Druge informacije o zdravilu Mirapexin:
The marketing authorisation was renewed on 23 February 2003 and on 23 February 2008.
Dovoljenje za promet z zdravilom je bilo obnovljeno dne 23. februarja 2003 in 23. februarja 2008.
The full EPAR for Mirapexin can be found here.
Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Mirapexin je na voljo tukaj.
EU/ 1/ 97/ 051/ 001
Številka EU EU/ 1/ 97/ 051/ 001
Mirapexin
Izmišljeno ime Mirapexin
0.088 mg
Jakost 0, 088 mg
Tablet
Farmacevtska oblika Tableta
Oral use
Pot uporabe Peroralna uporaba
Blister (polyamide/ aluminium/ PVC)
Ovojnina Pretisni omot (poliamid/ aluminij/ PVC)
30 tablets
Velikost pakiranja 30 tablet
Blister (polyamide/ aluminium/ PVC)
Pretisni omot (poliamid/ aluminij/ PVC)
MIRAPEXIN 0.088 mg tablets
MIRAPEXIN 0, 088 mg tablete
MIRAPEXIN 0.088 mg tablets contain 0.088 mg of pramipexole base (as 0.125 mg of pramipexole dihydrochloride monohydrate).
Zdravilo MIRAPEXIN 0, 088 mg tablete vsebujejo 0, 088 mg pramipeksola (kar ustreza 0, 125 mg pramipeksolijevega dihidroklorid monohidrata).
Therefore, doses will be expressed in terms of both pramipexole base and pramipexole salt (in brackets).
Zato so tu odmerki izraženi za obe obliki, pramipeksol in pramipeksolijevo sol (v oklepaju).
All tablets are white and have a code embossed.
Vse tablete so bele, z vtisnjeno oznako.
Strength (mg salt) 0.125 0.25 0.5 1.0 1.5
Jakost (mg soli) 0, 125 0, 25 0, 5 1, 0 1, 5
Appearance flat, round, 6 mm diameter, no score flat, oval, 7.86 x 5.63 mm, scores on both sides flat, oval, 10.59 x 7.59 mm, scores on both sides flat, round, 9 mm diameter, scores on both sides flat, round, 11 mm diameter, scores on both sides
Videz tablete ravna, okrogla, premera 6 mm, brez zareze ravna, ovalna, 7, 86 x 5, 63 mm, z zarezo na obeh straneh ravna, ovalna, 10, 59 x 7, 59 mm, z zarezo na obeh straneh ravna, okrogla, premera 9 mm, z zarezo na obeh straneh ravna, okrogla, premera 11 mm, z zarezo na obeh straneh
All tablets can be divided into equal halves (with the exception of the 0.088/ 0.125 mg tablet).
Tablete lahko razdelimo na enaki polovici (z izjemo tablete po 0, 088/ 0, 125 mg).
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 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).
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 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).
Parkinson’ s disease
Parkinsonova bolezen
The tablets should be taken orally, swallowed with water, and can be taken either with or without food.
Tablete se lahko vzamejo z ali brez hrane.
The daily dosage is administered in equally divided doses 3 times a day.
Dnevni odmerek damo razdeljen v enake odmerke trikrat dnevno.
-2- Initial treatment:
Začetek zdravljenja:
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.
Zdravljenje pričnemo z začetnim odmerkom 0, 264 mg pramipeksola (0, 375 mg soli) na dan, ki ga postopno povečujemo vsakih 5- 7 dni.
Providing patients do not experience intolerable side-effects, the dosage should be titrated to achieve a maximal therapeutic effect.
V primeru, da bolniki ne trpijo za nevzdržnimi neželenimi učinki, odmerek prilagajamo, dokler ne dosežemo maksimalnega terapevtskega učinka.
Ascending – Dose Schedule of MIRAPEXIN
2 Shema povečevanja odmerka zdravila MIRAPEXIN Teden
Dosage (mg of salt)
Odmerek (mg soli)
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 večanje 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) na dan.
However, it should be noted that the incidence of somnolence is increased at doses higher than 1.5 mg/ day (see section 4.8).
Vendar pa je potrebno upoštevati, da je incidenca zaspanosti večja pri odmerkih, večjih od 1, 5 mg/ dan (glejte poglavje 4. 8).
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.
Individualni odmerek naj bo med 0, 264 mg pramipeksola (0, 375 mg soli) in 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).
Pri stopnjevanju odmerka so v treh ključnih študijah opazili učinkovitost pri dnevnih odmerkih 1, 1 mg pramipeksola (1, 5 mg soli) in več.
Further dose adjustments should be done based on the clinical response and the occurrence of undesirable effects.
Na osnovi kliničnega odziva in pojavnosti neželenih učinov odmerek nadalje prilagodimo.
In clinical trials approximately 5% of patients were treated at doses below 1.1 mg (1.5 mg of salt).
V kliničnih preskušanjih so približno 5% bolnikov zdravili z odmerki pod 1, 1 mg (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.
Odmerki, večji od 1, 1 mg (1, 5 mg soli) na dan, so lahko koristni pri bolnikih z napredovalo Parkinsonovo boleznijo, pri katerih je predvideno zmanjšanje zdravljenja z levodopo.
It is recommended that the dosage of levodopa is reduced during both the dose escalation and the maintenance treatment with MIRAPEXIN, depending on reactions in individual patients.
Priporočljivo je, da se glede na reakcije posameznih bolnikov odmerjanje levodope zmanjša tako med povečevanjem odmerka zdravila MIRAPEXIN kot med vzdrževalnim zdravljenjem z zdravilom MIRAPEXIN.
Treatment discontinuation:
Prekinitev zdravljenja:
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).
Zato moramo zdravljenje s pramipeksolom 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 zmanjšujemo odmerek za 0, 264 mg pramipeksola (0, 375 mg soli) na dan (glejte poglavje 4. 4).
The elimination of pramipexole is dependent on renal function.
Odmerjanje pri bolnikih z ledvično okvaro Izločanje pramipeksola je odvisno od ledvične funkcije.
The following dosage schedule is suggested for initiation of therapy:
Za začetek zdravljenja je priporočljivo naslednje odmerjanje:
Patients with a creatinine clearance above 50 ml/ min require no reduction in daily dose.
Pri bolnikih z očistkom kreatinina nad 50 ml/ min ni potrebno zmanjšati dnevnega odmerka.
In patients with a creatinine clearance between 20 and 50 ml/ min, the initial daily dose of MIRAPEXIN 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 MIRAPEXIN 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 MIRAPEXIN 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 MIRAPEXIN daily dose by the same percentage as the decline in creatinine clearance, i. e. if creatinine clearance declines by 30%, then reduce the MIRAPEXIN daily dose by 30%.
Če na primer očistek kreatinina upade za 30%, tudi dnevni odmerek zdravila MIRAPEXIN zmanjšamo za 30%.
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.
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.
90% of absorbed active substance is excreted through the kidneys.
Odmerjanje pri bolnikih z jetrno okvaro Prilagoditev odmerka pri bolnikih z jetrno odpovedjo verjetno ni potrebna, ker se približno 90% absorbirane zdravilne učinkovine izloči skozi ledvica.
Restless Legs Syndrome
3 Sindrom nemirnih nog
The tablets should be taken orally, swallowed with water, and can be taken either with or without food.
Bolnik jih lahko jemlje s hrano ali brez nje.
The recommended starting dose of MIRAPEXIN is 0.088 mg of base (0.125 mg of salt) taken once daily 2-3 hours before bedtime.
Priporočeni začetni odmerek zdravila MIRAPEXIN je 0, 088 mg pramipeksola (0, 125 mg soli) enkrat na dan, 2- 3 ure pred spanjem.
For patients requiring additional symptomatic relief, the dose may be increased every 4-7 days to a maximum of 0.54 mg of base (0.75 mg of salt) per day (as shown in the table below).
Bolnikom, ki potrebujejo dodatno lajšanje simptomov, lahko odmerek vsake 4- 7 dni povečujemo do največjega odmerka, ki je 0, 54 mg pramipeksola (0, 75 mg soli) na dan (kakor je prikazano v spodnji tabeli).
1 2* 3* 4* * if needed
Stopnje večanja odmerka 1 2 * 3 * 4 * * če je potrebno
0.088 0.18 0.35 0.54
Enkratni večerni odmerek (mg) 0, 088 0, 18 0, 35 0, 54
0.125 0.25 0.50 0.75
Enkratni večerni odmerek (mg soli) 0, 125 0, 25 0, 50 0, 75
As long-term efficacy of MIRAPEXIN in the treatment of RLS has not been sufficiently tested, patient´s response should be evaluated after 3 months treatment and the need for treatment continuation should be reconsidered.
Ker učinkovitost zdravila MIRAPEXIN med dolgotrajnim zdravljenjem sindroma nemirnih nog še ni dovolj preskušena, moramo bolnikov odziv na zdravljenje po 3 mesecih oceniti in presoditi, ali je treba zdravljenje nadaljevati.
Treatment discontinuation Since daily dose for the treatment of Restless Legs Syndrome will not exceed 0.54 mg of base (0.75 mg of salt) MIRAPEXIN can be discontinued without tapering off.
Prekinitev zdravljenja Ker dnevni odmerek za zdravljenje sindroma nemirnih nog ni večji od 0, 54 mg pramipeksola (0, 75 mg soli), lahko zdravilo MIRAPEXIN ukinemo brez postopnega zmanjševanja odmerka.
Rebound (worsening of symptoms after abrupt discontinuation of treatment) can not be excluded.
Povrnitvenega učinka (poslabšanja simptomov po nenadni prekinitvi zdravljenja) ne moremo izključiti.
Dosing in patients with renal impairment The elimination of pramipexole is dependent on renal function.
Odmerjanje za bolnike z ledvično okvaro Izločanje pramipeksola je odvisno od ledvične funkcije.
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.
The use of MIRAPEXIN has not been studied in hemodialysis patients, or in patients with severe renal impairment.
Pri bolnikih na hemodializi ali s hudo ledvično okvaro uporabe zdravila MIRAPEXIN niso raziskovali.
90% of absorbed active substance is excreted through the kidneys.
Odmerjanje za bolnike z jetrno okvaro Bolnikom z jetrno okvaro odmerka ni treba prilagajati, ker se približno 90% absorbirane zdravilne učinkovine izloči skozi ledvice.
Dosing in children and adolescents MIRAPEXIN is not recommended for use in children and adolescents below 18 years due to a lack of data on safety and efficacy.
Odmerjanje za otroke in mladostnike Zaradi pomanjkanja podatkov o varnosti in učinkovitosti uporaba zdravila MIRAPEXIN pri otrocih pod 18 let ni priporočljiva.
-4- When prescribing MIRAPEXIN 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.
Hallucinations Hallucinations are known as a side-effect of treatment with dopamine agonists and levodopa.
Halucinacije Halucinacije so znane kot neželeni učinek zdravljenja z agonisti dopamina in levodopo.
Dyskinesia In advanced Parkinson’ s disease, in combination treatment with levodopa, dyskinesia can occur during the initial titration of MIRAPEXIN.
4 Diskinezija Pri bolnikih z napredovalo Parkinsonovo boleznijo, ki jemljejo zdravilo v kombinaciji z levodopo, se lahko med začetnim stopnjevanjem odmerka zdravila MIRAPEXIN pojavijo diskinezije.
Sudden onset of sleep and somnolence MIRAPEXIN has been associated with somnolence and episodes of sudden sleep onset, particularly in patients with Parkinson’ s disease.
Nenaden nepremagljiv spanec in zaspanost Zdravilo MIRAPEXIN povezujejo z zaspanostjo in nenadnimi epizodami spanja, zlasti pri bolnikih s Parkinsonovo boleznijo.
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 nenadna epizoda spanja, ne smejo voziti ali upravljati strojev.
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 možnih aditivnih učinkov je treba bolnikom svetovati, naj bodo previdni, če jemljejo hkrati s pramipeksolom še druga zdravila s sedativnim učinkom ali uživajo alkohol (glejte poglavje 4. 7 in poglavje 4. 8).
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 katerih so Parkinsonovo bolezen zdravili z dopaminskimi agonisti, tudi zdravilom MIRAPEXIN, so poročali o patološkem hazardiranju, povečanem libidu in hiperseksualnosti.
Furthermore, patients and caregivers should be aware of the fact that other behavioural symptoms of impulse control disorders and compulsions such as binge eating and compulsive shopping can occur.
Poleg tega morajo bolniki in negovalci vedeti, da se lahko pojavijo drugi vedenjski simptomi motenj nadzora impulzov in kompulzije, kot sta prenajedanje in kompulzivno nakupovanje.
Dose reduction/ tapered discontinuation should be considered.
Presoditi moramo o zmanjšanju odmerka ali postopni ukinitvi zdravila.
Patients with psychotic disorders Patients with psychotic disorders should only be treated with dopamine agonists if the potential benefits outweigh the risks.
Bolniki s psihotičnimi motnjami Bolnike s psihotičnimi motnjami zdravimo z agonisti dopamina le, kadar potencialna korist opravičuje tveganje.
Coadministration of antipsychotic medicinal products with pramipexole should be avoided (see section 4.5).
Sočasni uporabi antipsihotičnih zdravil in pramipeksola se je treba izogibati (glejte poglavje 4. 5).
Severe cardiovascular disease In case of severe cardiovascular disease, care should be taken.
Huda srčno- žilna bolezen V primeru hudih kardiovaskularnih obolenj moramo biti previdni.
Neuroleptic malignant syndrome Symptoms suggestive of neuroleptic malignant syndrome have been reported with abrupt withdrawal of dopaminergic therapy (see section 4.2).
Nevroleptični maligni sindrom Pri nagli prekinitvi zdravljenja z agonisti dopamina so poročali o pojavu simptomov, ki nakazujejo na nevroleptični maligni sindrom (glejte poglavje 4. 2).
Augmentation Reports in the literature indicate that 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.
The controlled trials of MIRAPEXIN in patients with Restless Legs Syndrome were generally not of sufficient duration to adequately capture augmentation phenomena.
Nadzorovana preskušanja zdravila MIRAPEXIN pri bolnikih s sindromom nemirnih nog večinoma niso bila dovolj dolgotrajna, da bi lahko ustrezno zajela pojave poslabšanja simptomov.
The frequency of augmentation after longer use of MIRAPEXIN and the appropriate management of these events have not been evaluated in controlled clinical trials.
Pogostnosti poslabšanja simptomov po dolgotrajnejši uporabi zdravila MIRAPEXIN in ustreznega zdravljenja teh dogodkov v nadzorovanih kliničnih preskušanjih niso ovrednotili.
-5- 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.
5 raziskovali, je možnost le- teh majhna, ker se antiholinergiki izločajo v glavnem z biotransformacijo.
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.
Zaviralci/ snovi, ki tekmujejo za aktivno pot izločanja skozi ledvice Cimetidin je zmanjšal ledvični očistek pramipeksola za približno 34%, verjetno z inhibicijo kationskega sekretornega transportnega sistema v ledvičnih tubulih.
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.
Zato so z zdravili, ki to aktivno ledvično pot izločanja zavirajo ali se po njej izločajo, npr. s cimetidinom in amantadinom, možne interakcije s pramipeksolom, katerih posledica je zmanjšan očistek enega ali obeh zdravil.
Combination with levodopa When MIRAPEXIN 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 MIRAPEXIN.
Kombiniranje z levodopo Če se zdravilo MIRAPEXIN daje skupaj z levodopo, in povečujemo njegov odmerek, je priporočljivo zmanjšati odmerek levodope, medtem ko naj ostanejo odmerki drugih antiparkinsonikov enaki.
Because of possible additive effects, caution should be advised when patients are taking other sedating medicinal products or alcohol in combination with pramipexole.
Zaradi možnih aditivnih učinkov svetujemo bolnikom previdnost pri jemanju drugih sedativnih zdravil ali alkohola v kombinaciji s pramipeksolom.
Antipsychotic medicinal products Coadministration of antipsychotic medicinal products with pramipexole should be avoided (see section 4.4), e. g. if antagonistic effects can be expected.
Antipsihotiki Sočasni uporabi antipsihotičnih zdravil in pramipeksola se je treba izogibati (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 bil embriotoksičen pri podganah v odmerkih, toksičnih za samico (glejte poglavje 5. 3).
MIRAPEXIN should not be used during pregnancy unless clearly necessary, i. e. if the potential benefit justifies the potential risk to the foetus.
Zdravilo MIRAPEXIN uporabljamo med nosečnostjo le, če potencialne koristi opravičujejo potencialno tveganje za plod.
As MIRAPEXIN treatment inhibits secretion of prolactin in humans, inhibition of lactation is expected.
Ker zdravljenje z zdravilom MIRAPEXIN zavira izločanje prolaktina pri človeku, je pričakovana inhibicija dojenja.
The excretion of MIRAPEXIN into breast milk has not been studied in women.
Izločanja zdravila MIRAPEXIN v materino mleko pri ženskah niso raziskovali.
Patients being treated with MIRAPEXIN 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, pri katerih se med zdravljenjem z zdravilom MIRAPEXIN pojavlja zaspanost in/ ali imajo nenadne epizode spanja, je treba svetovati, naj ne vozijo in naj se ne ukvarjajo z dejavnostmi, pri katerih se zaradi poslabšane budnosti poveča nevarnost resnih poškodb ali smrti (npr. pri upravljanju strojev), dokler ponavljajoče se epizode nenadnega spanja in zaspanost ne minejo (glejte še poglavja 4. 4, 4. 5 in 4. 8).
-6- 4.8 Undesirable effects
4. 8 Neželeni učinki
Expected adverse events 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.
Pričakovani neželeni dogodki Pričakovani neželeni učinki med zdravljenjem z zdravilom MIRAPEXIN 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