natgillin/translations-raw huggingface dataset:
The PASS final study report submitted by the MAHs complies with their obligation to perform a survey among health care professionals to evaluate their knowledge and attitudes on prescribing conditions of thiocolchicoside containing medicinal products, as imposed during the Article 31 procedure EMEA/H/A
Končno poročilo študije PASS, ki so ga predložili imetniki dovoljenja za promet, se sklada z njihovo obveznostjo, ki jim je bila v postopku EMEA/H/A-1361 odrejena skladno s členom 31, da med zdravstvenimi delavci izvedejo raziskavo za oceno njihovega znanja in stališča o predpisovanju zdravil, ki vsebujejo tiokolhikozid, in odnosa do tega.
Changes to be made to the conditions of the marketing authorisation(s) of medicinal product(s) containing the active substance thiocolchicoside concerned by the noninterventional imposed PASS final report
Spremembe pogoja (pogojev) za promet z zdravili, ki vsebujejo zdravilno učinkovino tiokolhikozid, ki jih je treba vnesti in ki jih zadeva končno poročilo odrejene neintervencijske študije PASS
Taking into account the PRAC Assessment Report for the non-interventional imposed PASS final report for the medicinal product(s) containing the active substance thiocolchicoside and concerned by the PASS final report , the scientific conclusions are as follows:
Upoštevajoč poročilo Odbora za oceno tveganja na področju farmakovigilance (PRAC) o končnem poročilu odrejene neintervencijske študije o varnosti zdravila po pridobitvi dovoljenja za promet (PASS) za zdravila, ki vsebujejo zdravilno učinkovino tiokolhikozid, in ob izraženi zaskrbljenosti zaradi končnega poročila te študije bili sprejeti naslednji znanstveni zaključki.
The following changes to the conditions of the marketing authorisation(s) of medicinal products containing the active substance thiocolchicoside concerned by the PASS final report are recommended:
Priporočajo se naslednje spremembe pogojev za promet z zdravili, ki vsebujejo zdravilno učinkovino tiokolhikozid in jih zadeva končno poročilo študije PASS:
Frequency cannot be estimated from the available data
pogostnosti ni mogoče oceniti iz razpoložljivih podatkov
Once daily.
Enkrat na dan.
Take care if you are using any medicines that calm you down (have a sedative effect) or if you are drinking alcohol.
Bodite previdni, če jemljete kakršnakoli zdravila, ki vas pomirijo (imajo sedativni učinek) ali pijete alkohol.
Maintenance of efficacy was shown in patients treated for 33 weeks.
Ohranitev učinkovitosti so pokazili pri bolnikih, ki so se zdravili 33 tednov.
PHARMACEUTICAL FORM AND CONTENTS 30 tablets
FARMACEVTSKA OBLIKA IN VSEBINA 30 tablet
The latter finding was not observed in pigmented rats, nor in a 2-year albino mouse carcinogenicity study or in any other species investigated.
Zadnje ugotovitve niso opazili niti pri pigmentiranih podganah niti v raziskavi kancerogenosti pri 2-letnih albino miših ali katerikoli drugi raziskovani vrsti.
Total exposure (AUC) was not affected by concomitant food intake.
Celotna izpostavljenost (AUC) ni bila spremenjena ob sočasnem jemanjem hrane.
Also, it can pass into the breast milk and can reach your baby.
Poleg tega se lahko tudi izloča v mleko in doseže otroka.
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.
The potential effects of pramipexole on reproductive function have been investigated in rats and rabbits.
Potencialne učinke pramipeksola na reproduktivni sistem so raziskovali pri podganah in zajcih.
Pharmacotherapeutic group: anti-Parkinson drugs, dopamine agonists, ATC code: N04BC05.
Farmakoterapevtska skupina: antiparkinsoniki, agonisti dopamina, Oznaka ATC: N04BC05.
Do not take MIRAPEXIN: - if you are allergic to pramipexole or to any of the other ingredients of this medicine (listed in section 6).
Ne jemljite zdravila MIRAPEXIN: - če ste alergični na pramipeksol ali katero koli sestavino tega zdravila (navedeno v poglavju 6).
Tablets can be divided into equal halves.
Tablete lahko razdelimo na enaki polovici.
Approximately 90% of C-labelled dose is excreted through the kidneys while less than 2% is found in the faeces.
Približno 90 % odmerka, označenega s C, se izloči skozi ledvica, medtem ko v fecesu najdemo manj kot 2 % odmerka.
Due to the selection of animal species and the limited parameters investigated, the adverse effects of pramipexole on pregnancy and male fertility have not been fully elucidated.
Zaradi izbire živalskih vrst in omejenih raziskovanih parametrov neželeni učinki pramipeksola na nosečnost in fertilnost samcev niso bili v celoti pojasnjeni.
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).
Augmentation refers to the earlier onset of symptoms in the evening (or even the afternoon), increase in symptoms, and spread of symptoms to involve other extremities.
Poslabšanje pomeni pojav simptomov v zgodnejših večernih urah (ali celo popoldne), povečanje simptomov in njihovo razširitev na druge okončine.
The effect on pregnancy and lactation has not been investigated in humans.
Učinka na nosečnost in dojenje pri človeku niso raziskovali.
There is no pharmacokinetic interaction with selegiline and levodopa.
Ni farmakokinetičnih interakcij s selegilinom in levodopo.
The effect of MIRAPEXIN on the unborn child is not known.
Učinek zdravila MIRAPEXIN na nerojenega otroka ni znan.
Patients with psychotic disorders should only be treated with dopamine agonists if the potential benefits outweigh the risks.
Bolnike s psihotičnimi motnjami zdravimo z agonisti dopamina le, kadar potencialna korist opravičuje tveganje.
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.
While body weight has no impact on the AUC, it was found to influence the volume of distribution and therefore the peak concentrations Cmax.
Telesna masa ne vpliva na AUC, vpliva pa na volumen porazdelitve in s tem na največjo koncentracijio (Cmax).
The tablets may be taken either with or without food and should be taken each day at about the same time.
Tablete lahko jemljete ob jedi ali ne, mora pa jih vzeti vsak dan ob približno isti uri.
It is recommended to monitor blood pressure, especially at the beginning of treatment, due to the general risk of postural hypotension associated with dopaminergic therapy.
Priporočljivo je spremljanje krvnega tlaka, zlasti na začetku zdravljenja, ker je z dopaminergičnim zdravljenjem povezano splošno tveganje za posturalno hipotenzijo.
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 23 February 1998
DATUM PRIDOBITVE/PODALJŠANJA DOVOLJENJA ZA PROMET Z ZDRAVILOM Datum prve odobritve: 23. februar 1998 Datum zadnjega podaljšanja: 23. februar 2008
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 to < 1/10); uncommon (≥ 1/1,000 to < 1/100); rare (≥ 1/10,000 to < 1/1,000); very rare (< 1/10,000); not known (cannot be estimated from 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 do < 1/10); občasni (≥ 1/1.000 do < 1/100); redki (≥ 1/10.000 do < 1/1.000); zelo redki (< 1/10.000), neznana pogostnost (ni mogoče oceniti iz razpoložljivih podatkov).
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 indiciran nevroleptik.
What MIRAPEXIN is and what it is used for
Kaj je zdravilo MIRAPEXIN in za kaj ga uporabljamo
Absorption
Absorbcija
- Strong impulse to gamble excessively despite serious personal or family consequences.
- močna želja po čezmernem hazardiranju ne glede na posledice za vas ali za družino,
Adverse events occurring in at least 5% of patients in the pramipexole group and more common in the pramipexole-treated patients than in patients on placebo were: headache (27.9%, placebo 25.0%), somnolence (7.0%, placebo 5.0%), nausea (18.6%, placebo 10.0%), vomiting (11.6%, placebo 0.0%), upper abdominal pain (7.0%, placebo 5.0%), orthostatic hypotension (9.3%, placebo 5.0%), myalgia (9.3%, placebo 5.0%), sleep disorder (7.0%, placebo 0.0%), dyspnoea (7.0%, placebo 0.0%) and upper respiratory tract infection (7.0%, placebo 5.0%).
Neželeni dogodki, ki so se v skupini s pramipeksolom pojavili pri najmanj 5 % bolnikov, in so bili pri bolnikih, ki so se zdravili s pramipeksolom, pogostejši kot pri placebu, so bili: glavobol (27,9 %, placebo 25,0 %), zaspanost (7,0 %, placebo 5,0 %), siljenje na bruhanje (18,6 %, placebo 10,0 %), bruhanje (11,6 %, placebo 0,0 %), bolečina v zgornjem delu trebuha (7,0 %, placebo 5,0 %), ortostatska hipotenzija (9,3 %, placebo 5,0 %), mialgija (9,3 %, placebo 5,0 %), motnja spanja (7,0 %, placebo 0,0 %), dispneja (7,0 %, placebo 0,0 %) in okužba zgornjih dihalnih poti (7,0%, placebo 5,0%).
If they occur, the dose of levodopa should be decreased.
Če se te pojavijo, zmanjšamo odmerek levodope.
If during treatment your kidney problems get worse, you should contact your doctor as soon as possible.
Če se vam bodo ledvične težave med zdravljenjem povečale, se morate čim hitreje posvetovati z zdravnikom.
In rats, the concentration of active substance-related radioactivity was higher in breast milk than in plasma.
Pri podganah je bila koncentracija radioaktivnega markerja iz zdravilne učinkovine večja v mleku kot v plazmi.
OPA/aluminium/PVC-aluminium blisters.
Pretisni omoti OPA/aluminij/PVC-aluminij.
Concomitant administration with food did not reduce the extent of pramipexole absorption, but the rate of absorption was reduced.
Sočasno jemanje s hrano stopnje absorpcije pramipeksola ne zmanjša, vendar pa se zmanjša hitrost absorpcije.
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 %).
PHARMACEUTICAL FORM AND CONTENTS 10 prolonged-release tablets 30 prolonged-release tablets 100 prolonged-release tablets
FARMACEVTSKA OBLIKA IN VSEBINA 10 tablet s podaljšanim sproščanjem 30 tablet s podaljšanim sproščanjem 100 tablet s podaljšanim sproščanjem
However, the potential influence of hepatic insufficiency on MIRAPEXIN pharmacokinetics has not been investigated.
Vendar pa potencialnega vpliva jetrne insuficience na farmakokinetiko zdravila MIRAPEXIN niso raziskovali.
If you do, there is a danger you could overdose, because the medicine may be released into your body too quickly.
Če jih boste, je možno, da bo odmerek prevelik, ker se bo zdravilo prehitro sprostilo.
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.
Tablets are scored on both sides and breakable in halves.
Tablete imajo zarezo na obeh straneh in jih lahko razdelimo na enaki polovici.
Each blister strip contains 10 tablets.
En pretisni trak vsebuje 10 tablet.
However, in Phase III trials in Parkinson's disease patients no clinically meaningful influence of body weight on the therapeutic effect and tolerability of MIRAPEXIN prolonged-release tablets was detected.
Toda v preskušanjih III. faze pri bolnikih s Parkinsonovo boleznijo niso zasledili klinično pomembnega vpliva telesne mase na terapevtski učinek in prenašanje MIRAPEXIN tablet s podaljšanim sproščanjem.
Rottendorf Pharma GmbH Ostenfelder Strasse 51 - 61 59320 Ennigerloh Germany
Rottendorf Pharma GmbH Ostenfelder Strasse 51 - 61 59320 Ennigerloh Nemčija
MIRAPEXIN with food, drink and alcohol You should be cautious while drinking alcohol during treatment with MIRAPEXIN.
Zdravilo MIRAPEXIN skupaj s hrano, pijačo in alkoholom Če med zdravljenjem z zdravilom MIRAPEXIN pijete alkohol, morate biti previdni.
Patients with kidney disease If you have severe kidney disease, MIRAPEXIN may not be a suitable treatment for you.
Bolniki z ledvično boleznijo Če imate hudo ledvično bolezen, zdravilo MIRAPEXIN morda za vas ni primerno zdravilo.
In a clinical trial with healthy volunteers, where MIRAPEXIN prolonged-release tablets were titrated faster (every 3 days) than recommended up to 3.15 mg pramipexole base (4.5 mg of salt) per day, an increase in blood pressure and heart rate was observed.
V kliničnem preskušanju pri zdravih prostovoljcih, v katerem so odmerke MIRAPEXIN tablet s podaljšanim sproščanjem povečevali hitreje (vsake 3 dni), kot je priporočeno, in sicer do 3,15 mg pramipeksolijeve baze (4,5 mg soli) na dan, sta se povečala krvni tlak in srčna frekvenca.
There is no established antidote for overdose of a dopamine agonist.
Ni uveljavljenega antidota za preveliko odmerjanje agonistov dopamina.
The following dose schedule is suggested for initiation of therapy:
Za začetek zdravljenja je priporočljivo naslednje odmerjanje:
Investigations weight decrease including decreased appetite weight increase This side effect has been observed in post-marketing experience.
Preiskave zmanjšanje telesne mase, vključno z zmanjšanjem apetita povečanje telesne mase Ta neželeni učinek so opazili v obdobju trženja.
Patients must be informed of this and advised to exercise caution while driving or operating machines during treatment with MIRAPEXIN.
Bolnike je treba nanje opozoriti in jim svetovati, naj bodo med zdravljenjem z zdravilom MIRAPEXIN pri vožnji in upravljanju strojev previdni.
Your doctor will then discuss with you if you should continue to take MIRAPEXIN.
Zdravnik se bo z vami pogovoril o tem, ali naj zdravljenje z zdravilom MIRAPEXIN nadaljujete.
In the Phase III studies that established safety and efficacy of MIRAPEXIN prolonged-release tablets, patients were instructed to take study medication without regard to food intake.
V preskušanjih III. faze, v katerih so proučevali varnost in učinkovitost MIRAPEXIN tablet s podaljšanim sproščanjem, so bolnikom naročili, naj preskušano zdravilo jemljejo ne glede na obroke hrane.
MIRAPEXIN should not be used in children or adolescents with Tourette Disorder because of a negative benefit-risk balance for this disorder (see section 5.1).
Zdravila MIRAPEXIN ne smemo uporabiti pri otrocih in mladostnikih s Tourettovim sindromom, ker ima pri tej motnji negativno razmerje med koristjo in tveganjem (glejte poglavje 5.1).
Decreases in diastolic and systolic pressure and heart rate were noted in the minipig, and a tendency to a 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.
Management of the overdose may require general supportive measures, along with gastric lavage, intravenous fluids, administration of activated charcoal and electrocardiogram monitoring.
Zdravljenje prevelikega odmerjanja lahko ob izpiranju želodca, dajanju intravenskih tekočin, dajanju aktivnega oglja in spremljanju elektrokardiograma zahteva splošne podporne ukrepe.
Repeated dose toxicity studies showed that pramipexole exerted functional effects, mainly involving the CNS and female reproductive system, and probably resulting from an exaggerated pharmacodynamic effect of pramipexole.
Raziskave toksičnosti po večkratnih odmerkih so pokazale, da pramipeksol kaže funkcionalne učinke, večinoma na osrednji živčni sistem in ženski reproduktivni sistem, ki so verjetno posledica povečanega farmakodinamskega učinka pramipeksola.
Then take your MIRAPEXIN prolonged-release tablets next morning and do not take any more MIRAPEXIN (immediate release) tablets.
MIRAPEXIN tablete s podaljšanim sproščanjem vzemite naslednje jutro, MIRAPEXIN tablet (s takojšnjim sproščanjem) pa ne jemljite več.
MIRAPEXIN can reduce the production of breast milk.
Zdravilo MIRAPEXIN lahko zmanjša količino mleka.
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).
What MIRAPEXIN is and what it is used for What you need to know before you take MIRAPEXIN How to take MIRAPEXIN
Kaj je zdravilo MIRAPEXIN in za kaj ga uporabljamo Kaj morate vedeti, preden boste vzeli zdravilo MIRAPEXIN Kako jemati zdravilo MIRAPEXIN Možni neželeni učinki
Take MIRAPEXIN prolonged-release tablets only once a day and each day at about the same time.
Vzemite MIRAPEXIN tablete s podaljšanim sproščanjem samo enkrat na dan in jih jemljite vsak dan ob približno isti uri.
Therefore, doses will be expressed in terms of both pramipexole base and pramipexole salt (in brackets).
Zato so tu odmerki izraženi za obe obliki, za pramipeksol in pramipeksolijevo sol (v oklepaju).
How to store MIRAPEXIN Contents of the pack and other information
Shranjevanje zdravila MIRAPEXIN Vsebina pakiranja in dodatne informacije
What you need to know before you take MIRAPEXIN
Kaj morate vedeti, preden boste vzeli zdravilo MIRAPEXIN
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.
However, if its use is unavoidable, breast-feeding should be discontinued.
Če pa se njegovi uporabi ne moremo izogniti, moramo dojenje prekiniti.
Reports in the literature indicate that treatment of Restless Legs Syndrome with dopaminergic medicinal products can result in augmentation.
Poročila v literaturi kažejo, da je mogoča posledica zdravljenja sindroma nemirnih nog z dopaminergičnimi zdravili poslabšanje simptomov.
In patients pramipexole alleviates signs and symptoms of idiopathic Parkinson's disease.
Pri bolnikih pramipeksol ublaži znake in simptome idiopatske Parkinsonove bolezni.
MIRAPEXIN can have a major influence on the ability to drive and use machines.
Zdravilo MIRAPEXIN ima pomemben vpliv na sposobnost vožnje in upravljanja strojev.
Some patients have reported the occurrence of remnants in faeces which may resemble intact MIRAPEXIN prolonged-release tablets.
Nekateri bolniki so poročali o pojavu ostankov v blatu, ki so lahko podobni intaktnim MIRAPEXIN tabletam s podaljšanim sproščanjem.
MIRAPEXIN contains the active substance pramipexole and belongs to a group of medicines known as dopamine agonists, which stimulate dopamine receptors in the brain.
Zdravilo MIRAPEXIN vsebuje zdravilno učinkovino pramipeksol in sodi v skupino zdravil, poimenovanih dopaminski agonisti, ki spodbujajo dopaminske receptorje v možganih.
The treatment of patients with a creatinine clearance below 30 ml/min with MIRAPEXIN prolongedrelease tablets is not recommended as no data are available for this patient population.
Bolnikom s kreatininskim očistkom manjšim od 30 ml/min, ne priporočamo zdravljenja z MIRAPEXIN tabletami s podaljšanim sproščanjem, ker za to skupino bolnikov ni podatkov.
In these cases MIRAPEXIN may affect your ability to drive and operate machinery.
V teh primerih lahko zdravilo MIRAPEXIN zmanjša vašo sposobnost za vožnjo ali upravljanje strojev.
MIRAPEXIN is indicated in adults for treatment of the signs and symptoms of idiopathic Parkinson's disease, alone (without levodopa) or in combination with levodopa, i.e. over the course of the disease, through to late stages when the effect of levodopa wears off or becomes inconsistent and fluctuations of the therapeutic effect occur (end of dose or “on off” fluctuations).
Zdravilo MIRAPEXIN je pri odraslih indicirano za zdravljenje znakov in simptomov idiopatske Parkinsonove bolezni, samo (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).
Patients already taking MIRAPEXIN tablets may be switched to MIRAPEXIN prolonged-release tablets overnight, at the same daily dose.
Bolnikom, ki že jemljejo MIRAPEXIN tablete, jih lahko čez noč zamenjamo za MIRAPEXIN tablete s podaljšanim sproščanjem v enakem dnevnem odmerku.
Take care if you are taking the following medicines: - cimetidine (to treat excess stomach acid and stomach ulcers) - amantadine (which can be used to treat Parkinson's disease) - mexiletine (to treat irregular heartbeats, a condition known as ventricular arrhythmia) - zidovudine (which can be used to treat the acquired immune deficiency syndrome (AIDS), a disease of the human immune system) - cisplatin (to treat various types of cancers) - quinine (which can be used for the prevention of painful night-time leg cramps and for the treatment of a type of malaria known as falciparum malaria (malignant malaria)) - procainamide (to treat irregular heart beat)
Bodite previdni, če jemljete naslednja zdravila: - cimetidin (zdravilo za zdravljenje čezmernega izločanja želodčne kisline in želodčnih razjed), - amantadin (zdravilo, ki ga lahko uporabljamo v zdravljenju Parkinsonove bolezni), - meksiletin (za zdravljenje neenakomernega bitja srca, stanje poznano kot ventrikularna aritmija), - zidovudin (zdravilo, ki ga lahko uporabljamo za zdravljenje sindroma pridobljene imunske pomanjkljivosti (AIDS), bolezni imunskega sistema pri človeku), - cisplatin (zdravilo za zdravljenje različnih oblik raka), - kinin (zdravilo, ki ga lahko uporabljajo za preprečevanje bolečih nočnih krčev v nogah in zdravljenje oblike malarije, imenovane falciparum malaria (maligna malarija)), - prokainamid (zdravilo za zdravljenje nerednega srčnega utripa).
In a carcinogenicity study, male rats developed Leydig cell hyperplasia and adenomas, explained by the prolactin-inhibiting effect of pramipexole.
V raziskavi kancerogenosti so samci podgan razvili hiperplazijo Leydigovih celic in adenome, kar so razložili z dejstvom, da pramipeksol zavira sintezo prolaktina.
If you suffer from Parkinson's disease you should not stop treatment with MIRAPEXIN abruptly.
Če imate Parkinsonovo bolezen, zdravljenja z zdravilom MIRAPEXIN ne smete nenadoma prekiniti.
MIRAPEXIN is indicated in adults for symptomatic treatment of moderate to severe idiopathic Restless Legs Syndrome in doses up to 0.54 mg of base (0.75 mg of salt) (see section 4.2).
Zdravilo MIRAPEXIN je pri odraslih 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).
Intake of a high fat meal induced an increase in peak concentration (Cmax) of about 24% after a single dose administration and about 20% after multiple dose administrations and a delay of about 2 hours in time to reach peak concentration in healthy volunteers.
Pri zdravih prostovoljcih je obrok z veliko vsebnostjo maščob sprožil povečanje največje koncentracije (Cmax) za približno 24 % po jemanju enkratnega odmerka in za približno 20 % po jemanju več odmerkov ter podaljšanje časa do največje koncentracije za približno 2 uri.