FrancophonIA/ELRC3.0 huggingface dataset:
English: 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).
Slovenian: 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).
English: Patients already taking MIRAPEXIN tablets may be switched to MIRAPEXIN prolonged-release tablets overnight, at the same daily dose.
Slovenian: Bolnikom, ki že jemljejo MIRAPEXIN tablete, jih lahko čez noč zamenjamo za MIRAPEXIN tablete s podaljšanim sproščanjem v enakem dnevnem odmerku.
English: 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)
Slovenian: 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).
English: In a carcinogenicity study, male rats developed Leydig cell hyperplasia and adenomas, explained by the prolactin-inhibiting effect of pramipexole.
Slovenian: V raziskavi kancerogenosti so samci podgan razvili hiperplazijo Leydigovih celic in adenome, kar so razložili z dejstvom, da pramipeksol zavira sintezo prolaktina.
English: If you suffer from Parkinson's disease you should not stop treatment with MIRAPEXIN abruptly.
Slovenian: Če imate Parkinsonovo bolezen, zdravljenja z zdravilom MIRAPEXIN ne smete nenadoma prekiniti.
English: 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).
Slovenian: 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).
English: 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.
Slovenian: 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.
English: In a placebo-controlled polysomnography study over 3 weeks MIRAPEXIN significantly reduced the number of periodic limb movements during time in bed.
Slovenian: 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.
English: If you forget to take a dose of MIRAPEXIN, but remember within 12 hours of your usual time, take your tablet straightaway and then take your next tablet at the usual time.
Slovenian: Če ste pozabili vzeti običajni odmerek zdravila MIRAPEXIN, vendar ste se nanj spomnili, preden je poteklo 12 ur od takrat, ko odmerek običajno vzamete, pozabljeno tableto vzemite takoj, naslednjo pa ob običajnem času.
English: As pramipexole treatment inhibits secretion of prolactin in humans, inhibition of lactation is expected.
Slovenian: Ker zdravljenje s pramipeksolom zavira izločanje prolaktina pri človeku, je pričakovana inhibicija dojenja.
English: The efficacy and tolerability of an overnight switch from MIRAPEXIN tablets to MIRAPEXIN prolonged-release tablets at the same daily dose were evaluated in a double-blind clinical study in patients with early Parkinson's disease.
Slovenian: Učinkovitost in prenašanje prehoda z MIRAPEXIN tablet na MIRAPEXIN tablete s podaljšanim sproščanjem v enakem dnevnem odmerku so ocenili v dvojno slepem kliničnem preskušanju pri bolnikih z zgodnjo Parkinsonovo boleznijo.
English: All strengths of MIRAPEXIN are available in aluminium blister strips of 10 tablets per strip, in cartons containing 3 or 10 blister strips (30 or 100 tablets).
Slovenian: Vse jakosti zdravila MIRAPEXIN so na voljo v pretisnih trakovih iz aluminija z 10 tabletami v enem traku, v škatlah po 3 ali 10 pretisnih trakov (30 ali 100 tablet).
English: The other ingredients are hypromellose 2208, maize starch, carbomer 941, colloidal anhydrous silica, magnesium stearate.
Slovenian: Pomožne snovi so hipromeloza 2208, koruzni škrob, karbomer 941, brezvodni silicijev dioksid in magnezijev stearat.
English: The European Medicines Agency has waived the obligation to submit the results of studies with MIRAPEXIN in all subsets of the paediatric population in Parkinson's Disease (see section 4.2 for information on paediatric use).
Slovenian: Evropska agencija za zdravila je odstopila od zahteve za predložitev rezultatov študij z zdravilom MIRAPEXIN pri Parkinsonovi bolezni za vse podskupine pediatrične populacije (za podatke o uporabi pri pediatrični populaciji glejte poglavje 4.2).
English: These points should be considered when initiating pramipexole treatment in patients with Parkinson's disease.
Slovenian: Naštete izsledke je treba upoštevati ob uvajanju zdravljenja s pramipeksolom pri bolnikih s Parkinsonovo boleznijo.
English: Other medicines and MIRAPEXIN
Slovenian: Druga zdravila in zdravilo MIRAPEXIN
English: NAME OF THE MARKETING AUTHORISATION HOLDER Boehringer Ingelheim (Logo)
Slovenian: IME IMETNIKA DOVOLJENJA ZA PROMET Z ZDRAVILOM Boehringer Ingelheim (Logo)
English: The use of MIRAPEXIN tablets should be considered.
Slovenian: Presoditi je treba o uporabi MIRAPEXIN tablet.
English: A decreased body weight by 30 kg results in an increase in
Slovenian: Če se telesna masa zmanjša za 30 kg, se Cmax poveča za 45 %.
English: In a Phase I trial, where pramipexole immediate release and prolonged-release tablets were assessed in fasted state, the minimum and peak plasma concentration (Cmin, Cmax) and exposure (AUC) of the same daily dose of MIRAPEXIN prolonged-release tablets given once daily and MIRAPEXIN tablets given three times a day were equivalent.
Slovenian: V preskušanju I. faze, v katerem so ocenjevali tablete pramipeksola s takojšnjim in s podaljšanim sproščanjem pri teščih preizkušancih, so bile minimalna in največja koncentracija v plazmi (Cmin, Cmax) ter izpostavljenost (AUC) enakovredne ob enakem dnevnem odmerku MIRAPEXIN tablet s podaljšanim sproščanjem, enkrat na dan, in MIRAPEXIN tablet, trikrat na dan.
English: Cartons containing 3 or 10 blister strips (30 or 100 tablets).
Slovenian: Škatle vsebujejo 3 ali 10 pretisnih trakov (30 ali 100 tablet).
English: Table 2: Restless Legs Syndrome Body System Very common
Slovenian: Preglednica 2: sindrom nemirnih nog Organski sistem
English: Clinical efficacy and safety in Tourette Disorder
Slovenian: Klinično učinkovitost in varnost pri Tourettovem sindromu
English: Each blister strip contains 10 prolonged-release tablets.
Slovenian: En pretisni trak vsebuje 10 tablet s podaljšanim sproščanjem.
English: Date of latest renewal: 23 February 2008
Slovenian: DATUM PRIDOBITVE/PODALJŠANJA DOVOLJENJA ZA PROMET Z ZDRAVILOM Datum prve pridobitve: 23. februar 1998 Datum zadnjega podaljšanja: 23. februar 2008
English: When prescribing MIRAPEXIN in a patient with Parkinson's disease with renal impairment a reduced dose is suggested in line with section 4.2.
Slovenian: Pri predpisovanju zdravila MIRAPEXIN bolnikom s Parkinsonovo boleznijo in ledvično okvaro je priporočljivo zmanjšano odmerjanje, opisano v poglavju 4.2.
English: Therefore, do not take MIRAPEXIN if you are pregnant unless your doctor tells you to do so.
Slovenian: Toda če ste noseči, ne jemljite zdravila MIRAPEXIN, razen če vam je tako svetoval zdravnik.
English: Manifestations observed include pathological gambling, compulsive shopping, binge eating, and compulsive sexual behaviour (hypersexuality).
Slovenian: Pojavljali so se v obliki patološkega hazardiranja, kompulzivnega nakupovanja, prenajedanja in kompulzivnega spolnega vedenja (hiperseksualnosti).
English: Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu.
Slovenian: Navodilo je bilo nazadnje revidirano dne {MM/LLLL} Podrobne informacije o zdravilu so objavljene na spletni strani Evropske agencije za zdravila: http://www.ema.europa.eu
English: Patients with a creatinine clearance above 50 ml/min require no reduction in daily dose or dosing frequency.
Slovenian: Pri bolnikih z očistkom kreatinina nad 50 ml/min ni potrebno zmanjšati dnevnega odmerka ali pogostnosti odmerjanja.
English: Two trials were conducted in patients with early Parkinson's disease and one trial was conducted in patients with advanced Parkinson's disease.
Slovenian: Dva preskušanja sta zajela bolnike z zgodnjo obliko Parkinsonove bolezni, eno pa bolnike z njeno napredovalo stopnjo.
English: If you are switching from MIRAPEXIN (immediate release) tablets Your doctor will base your dose of MIRAPEXIN prolonged-release tablets on the dose of MIRAPEXIN (immediate release) tablets you were taking.
Slovenian: Če zamenjavate MIRAPEXIN tablete (s takojšnjim sproščanjem) Zdravnik vam bo odmerek MIRAPEXIN tablet s podaljšanim sproščanjem določil na podlagi odmerka MIRAPEXIN tablet (s takojšnjim sproščanjem), ki ste jih jemali do takrat.
English: Cartons containing 1, 3 or 10 blister strips (10, 30 or 100 prolonged-release tablets).
Slovenian: Škatle vsebujejo 1, 3 ali 10 pretisnih trakov (10, 30 ali 100 tablet s podaljšanim sproščanjem).
English: Tell your doctor if you experience symptoms such as depression, apathy, anxiety, fatigue, sweating or pain after stopping or reducing your MIRAPEXIN treatment.
Slovenian: Povejte zdravniku, če se pojavijo simptomi, kot so depresija, apatija, anksioznost, utrujenost, znojenje ali bolečina, potem ko prenehate zdravljenje z zdravilom MIRAPEXIN ali vam zmanjšajo odmerek.
English: The safety and efficacy of MIRAPEXIN in children below 18 years has not been established.
Slovenian: Varnost in učinkovitost zdravila MIRAPEXIN pri otrocih, mlajših od 18 let, še nista dokazani.
English: The European Medicines Agency has deferred the obligation to submit the results of studies with MIRAPEXIN in one or more subsets of the paediatric population in Restless Legs Syndrome (see section 4.2 for information on paediatric use).
Slovenian: Evropska agencija za zdravila je začasno odložila zahtevo za predložitev rezultatov študij z zdravilom MIRAPEXIN pri sindromu nemirnih nog za eno ali več podskupin pediatrične populacije (za podatke o uporabi pri pediatrični populaciji glejte poglavje 4.2).
English: - Dystonia (inability of keeping your body and neck straight and upright (axial dystonia)).
Slovenian: - Distonija (nezmožnost pokončne drže telesa in vratu (aksialna distonija)).
English: You can take MIRAPEXIN with or without food.
Slovenian: Zdravilo MIRAPEXIN lahko jemljete s hrano ali brez.
English: MIRAPEXIN 1.05 mg, 1.57 mg, 2.1 mg, 2.62 mg and 3.15 mg prolonged-release tablets are white to off-white and of oval shape.
Slovenian: MIRAPEXIN 1,05 mg, 1,57 mg, 2,1 mg, 2,62 mg in 3,15 mg tablete s podaljšanim sproščanjem so bele do skoraj bele in ovalne.
English: 63% of patients on pramipexole and 52% of patients on placebo reported at least one adverse drug reaction.
Slovenian: V skupini s pramipeksolom je poročalo 63 %, v skupini s placebom pa 52 % bolnikov, o vsaj enem neželenem učinku.
English: MIRAPEXIN prolonged-release tablets is a specially designed tablet from which the active ingredient is gradually released, once the tablet has been ingested.
Slovenian: Zdravilo MIRAPEXIN tablete s podaljšanim sproščanjem je posebno zasnovana tableta, iz katere se zdravilna učinkovina sprošča postopoma po zaužitju tablete.
English: Do not stop taking MIRAPEXIN without first talking to your doctor.
Slovenian: Zdravila MIRAPEXIN ne prenehajte jemati brez posveta s svojim zdravnikom.
English: Animal studies have shown that pramipexole inhibits dopamine synthesis, release, and turnover.
Slovenian: Poskusi na živalih so pokazali, da pramipeksol zavira sintezo, sproščanje in hitrost obračanja ('turnover') dopamina.
English: If you take more MIRAPEXIN than you should If you accidentally take too many tablets, - Contact your doctor or nearest hospital casualty department immediately for advice.
Slovenian: Če ste vzeli večji odmerek zdravila MIRAPEXIN, kot bi smeli Če ste nenamerno vzeli več tablet, kot bi smeli: - nemudoma vprašajte za nasvet svojega zdravnika ali v najbližjo bolnišnico, - boste morda izkusili bruhanje, nemir ali katerega od neželenih učinkov, opisanih v poglavju 4
English: In clinical trials approximately 5% of patients were treated at doses below 1.1 mg of base (1.5 mg of salt).
Slovenian: V kliničnih preskušanjih so približno 5 % bolnikov zdravili z odmerki pod 1,1 mg baze (1,5 mg soli).
English: Pramipexole was not teratogenic in rats and rabbits but was embryotoxic in the rat at maternally toxic doses.
Slovenian: Pramipeksol ni bil teratogen pri podganah ali zajcih, vendar je bil pri podganah, v odmerkih, toksičnih za samico, embriotoksičen.
English: Since the 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.
Slovenian: 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.
English: The daily dose should not exceed 6 tablets MIRAPEXIN 0.088 mg or a dose of 0.54 mg (0.75 mg pramipexole salt).
Slovenian: Dnevni odmerek ne sme preseči 6 tablet zdravila MIRAPEXIN po 0,088 mg oziroma 0,54 mg (0,75 mg pramipeksolijeve soli).
English: If you forget to take MIRAPEXIN
Slovenian: Če ste pozabili vzeti zdravilo MIRAPEXIN
English: You will need to have your blood pressure checked regularly, especially at the beginning of treatment.
Slovenian: - Huda srčna ali žilna bolezen: Zlasti na začetku zdravljenja si boste morali redno meriti krvni tlak.
English: The symptoms include: - akinesia (loss of muscle movement) - rigid muscles - fever - unstable blood pressure - tachycardia (increased heart rate) - confusion - depressed level of consciousness (e.g. coma)
Slovenian: Simptomi so: - akinezija (nezmožnost za gibanje), - otrdele mišice, - vročina, - nestabilen krvni tlak, - tahikardija (zvečan srčni utrip), - zmedenost, - zmanjšana zavest (na primer koma).
English: Ophthalmologic monitoring Ophthalmologic monitoring is recommended at regular intervals or if vision abnormalities occur.
Slovenian: Oftalmološki pregledi Priporočljivi so redni oftalmološki pregledi, še posebno, če se pojavijo motnje vida.
English: All tablets have the Boehringer Ingelheim company symbol embossed on one side and the codes P6, P7, P8, or P9 on the other side, representing the tablet strengths 0.088 mg, 0.18 mg, 0.35 mg, and 0.7 mg, respectively.
Slovenian: Na vseh tabletah je na eni strani vtisnjen znak podjetja Boehringer Ingelheim, na drugi strani pa oznake P6, P7, P8 ali P9, ki pomenijo jakosti tablet 0,088 mg, 0,18 mg, 0,35 mg in 0,7 mg.
English: SPECIAL STORAGE CONDITIONS Do not store above 30°C.
Slovenian: POSEBNA NAVODILA ZA SHRANJEVANJE Shranjujte pri temperaturi do 30 C.
English: Very common: - Nausea (sickness)
Slovenian: Zelo pogosti: - slabost (siljenje na bruhanje).
English: There is no relevant use of MIRAPEXIN in the paediatric population for the indication of Parkinson's Disease.
Slovenian: Zdravilo MIRAPEXIN ni namenjeno za uporabo pri pediatrični populaciji za indikacijo Parkinsonova bolezen.
English: - Psychosis (e.g. comparable with symptoms of schizophrenia) - Vision impairment.
Slovenian: - Psihoza (na primer podobni simptomi kot pri shizofreniji).
English: You should avoid taking MIRAPEXIN together with antipsychotic medicines.
Slovenian: Zdravila MIRAPEXIN po možnosti ne smete jemati hkrati z antipsihotiki.
English: Swallow whole, do not chew, divide or crush.
Slovenian: Pogoltnite celo, ne žvečite je niti delite ali drobite.
English: Restless Legs Syndrome, most common adverse reactions The most commonly (≥ 5%) reported adverse drug reactions in patients with Restless Legs Syndrome treated with pramipexole were nausea, headache, dizziness and fatigue.
Slovenian: Sindrom nemirnih nog, najpogostnejši neželeni učinki Najpogostnejši ( 5%) neželeni učinki, o katerih so poročali pri bolnikih s sindromom nemirnih nog, ki so se zdravili s pramipeksolom, so bili navzea, glavobol, omotica in utrujenost.
English: Maintenance treatment
Slovenian: Vzdrževalno zdravljenje:
English: Because of possible additive effects, caution should be advised when patients are taking other sedating medicinal products or alcohol in combination with pramipexole (see sections 4.5, 4.7 and section 4.8).
Slovenian: 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 poglavja 4.5, 4.7 in 4.8).
English: If you stop taking MIRAPEXIN
Slovenian: Če ste prenehali jemati zdravilo MIRAPEXIN
English: 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.
Slovenian: Priporočeni začetni odmerek zdravila MIRAPEXIN je 0,088 mg pramipeksola (0,125 mg soli) enkrat na dan, 2-3 ure pred spanjem.
English: - Sleepiness and episodes of suddenly falling asleep
Slovenian: - Zaspanost in epizode nepremagljivega spanca.
English: Based on the analysis of pooled placebo-controlled trials, comprising a total of 1,923 patients on pramipexole and 1,354 patients on placebo, adverse drug reactions were frequently reported for both groups.
Slovenian: Analiza zbranih s placebom nadzorovanih preskušanj, ki je zajela 1.923 bolnikov, zdravljenih s pramipeksolom in 1.354 bolnikov, ki so prejemali placebo, je pokazala, da so o neželenih učinkih pogosto poročali v obeh skupinah.
English: st week
Slovenian: 1. teden
English: After switching to MIRAPEXIN prolonged-release tablets, the dose may be adjusted depending on the patient's therapeutic response (see section 5.1).
Slovenian: Po prehodu na MIRAPEXIN tablete s podaljšanim sproščanjem lahko njihov odmerek prilagodimo odzivanju na zdravljenje (glejte poglavje
English: The other ingredients are mannitol, maize starch, anhydrous colloidal silica, povidone K 25 and magnesium stearate.
Slovenian: Pomožne snovi so: manitol, koruzni škrob, brezvodni silicijev dioksid, povidon K 25, magnezijev stearat.
English: The safety and efficacy of MIRAPEXIN prolonged-release tablets in the treatment of Parkinson's disease was evaluated in a multinational drug development program consisting of three randomised, controlled trials.
Slovenian: Varnost in učinkovitost MIRAPEXIN tablet s podaljšanim sproščanjem so ocenili v večnacionalnem programu razvoja zdravil, v sklopu katerega so izvedli tri nadzorovana preskušanja pri naključno izbranih bolnikih s Parkinsonovo boleznijo.
English: Each tablet contains 0.26 mg, 0.52 mg, 1.05 mg, 1.57 mg, 2.1 mg, 2.62 mg, or 3.15 mg pramipexole as 0.375 mg, 0.75 mg, 1.5 mg, 2.25 mg, 3 mg, 3.75 mg, or 4.5 mg pramipexole dihydrochloride monohydrate, respectively.
Slovenian: Ena tableta vsebuje 0,26 mg, 0,52 mg, 1,05 mg, 1,57 mg, 2,1 mg, 2,62 mg ali 3,15 mg pramipeksola, v obliki 0,375 mg, 0,75 mg, 1,5 mg, 2,25 mg, 3 mg, 3,75 mg ali 4,5 mg pramipeksolijevega diklorida monohidrata.
English: Take your MIRAPEXIN (immediate release) tablets as normal the day before you switch.
Slovenian: MIRAPEXIN tablete (s takojšnjim sproščanjem) vzemite na dan pred zamenjavo zdravila kot običajno.
English: All tablets have the Boehringer Ingelheim company symbol embossed on one side and the codes P1, P2, P3, P12, P4, P13, or P5 on the other side, representing the tablet strengths 0.26 mg, 0.52 mg, 1.05 mg, 1.57 mg, 2.1 mg, 2.62 mg and 3.15 mg, respectively.
Slovenian: Na vseh tabletah je na eni strani vtisnjen znak podjetja Boehringer Ingelheim, na drugi strani pa oznake P1, P2, P3, P12, P4, P13 ali P5, ki pomenijo jakost tablet 0,26 mg, 0,52 mg, 1,05 mg, 1,57 mg, 2,1 mg, 2,62 mg oziroma 3,15 mg.
English: There is no relevant use of MIRAPEXIN prolonged-release tablets in the paediatric population for the indication of Parkinson's Disease.
Slovenian: Zdravilo MIRAPEXIN tablete s podaljšanim sproščanjem ni namenjeno za uporabo pri pediatrični populaciji za indikacijo Parkinsonova bolezen.
English: Children and adolescents MIRAPEXIN is not recommended for use in children or adolescents under 18 years.
Slovenian: Otroci in mladostniki Uporabe zdravila MIRAPEXIN pri otrocih in mladostnikih, mlajših od 18 let, ne priporočamo.
English: When MIRAPEXIN is given in combination with levodopa, it is recommended that the dose of levodopa is reduced and the dose of other anti-parkinsonian medicinal products is kept constant while increasing the dose of MIRAPEXIN.
Slovenian: 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.
English: MIRAPEXIN 0.7 mg tablets are white, of round shape, and flat.
Slovenian: MIRAPEXIN 0,7 mg tablete so bele, okrogle in ploščate.
English: 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.
Slovenian: 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.
English: In a double-blind placebo-controlled trial including a total of 517 patients with advanced Parkinson's disease who were on concomitant levodopa therapy superiority of MIRAPEXIN prolonged-release tablets over placebo was demonstrated after 18 weeks of treatment on both the primary (UPDRS Parts II+III score) and the key secondary (off-time) efficacy endpoints.
Slovenian: V dvojno slepem, s placebom nadzorovanim preskušanjem pri skupno 517 bolnikih z napredovalo Parkinsonovo boleznijo, ki so sočasno jemali levodopo, so po 18 tednih zdravljenja dokazali prednost MIRAPEXIN tablet s podaljšanim sproščanjem pred placebom na podlagi primarnih (ocena na lestvici UPDRS, II.
English: MIRAPEXIN is not recommended for use in children and adolescents below 18 years since the efficacy and safety has not been established in this population.
Slovenian: Zdravilo MIRAPEXIN ni primerno za uporabo pri otrocih in mladostnikih, mlajših od 18 let, ker pri njih učinkovitost in varnost zdravila še nista dokazani.
English: “Possible side effects”.
Slovenian: (Možni neželeni učinki).
English: (mg of base)
Slovenian: (mg)