FrancophonIA/ELRC3.0 huggingface dataset:
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.
Croatian: Djelotvornost i podnošljivost prijelaza „preko noći“ s MIRAPEXIN tableta na MIRAPEXIN tablete s produljenim oslobađanjem u jednakoj dnevnoj dozi ocjenjivane su u dvostruko-slijepom kliničkom ispitivanju na bolesnicima u ranom stadiju Parkinsonove bolesti.
English: In particular, you may experience forward flexion of the head and neck (also called antecollis), forward bending of the lower back (also called camptocormia) or sidewards bending of the back (also called pleurothotonus or Pisa Syndrome).
Croatian: Konkretno, možete doživjeti savijanje glave i vrata prema naprijed (koje se naziva i antekolis), savijanje donjeg dijela leđa prema naprijed (što se naziva i kamptokormija) ili bočno savijanje leđa (što se naziva i pleurototonus ili Pisa sindrom).
English: 63% of patients on pramipexole and 52% of patients on placebo reported at least one adverse drug reaction.
Croatian: 63% bolesnika na pramipeksolu i 52% bolesnika na placebu prijavilo je najmanje jednu nuspojavu.
English: Sudden onset of sleep during daily activities, in some cases without awareness or warning signs, has been reported uncommonly.
Croatian: U manje čestim slučajevima zabilježena je pojava iznenadnog usnivanja tijekom dana, prilikom obavljanja svakodnevnih aktivnosti bez prethodnih svjesnih ili upozoravajućih znakova pospanosti.
English: Children and adolescents MIRAPEXIN is not recommended for use in children or adolescents under 18 years.
Croatian: Djeca i adolescenti MIRAPEXIN se ne preporučuje za primjenu kod djece i adolescenata mlađih od 18 godina.
English: - treat the symptoms of moderate to severe primary Restless Legs Syndrome in adults.
Croatian: - liječenju simptoma umjerenog do teškog primarnog sindroma nemirnih nogu.
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).
Croatian: Europska agencija za lijekove izuzela je obvezu podnošenja rezultata ispitivanja lijeka MIRAPEXIN u svim podskupinama pedijatrijske populacije s Parkinsonovom bolešću (vidjeti dio 4.2 za informacije o pedijatrijskoj primjeni).
English: MIRAPEXIN prolonged-release tablets is a specially designed tablet from which the active ingredient is gradually released, once the tablet has been ingested.
Croatian: MIRAPEXIN tablete s produljenim oslobađanjem posebno su oblikovane tablete iz kojih se djelatna tvar postupno oslobađa nakon što se tableta proguta.
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).
Croatian: Europska agencija za lijekove odgodila je obvezu podnošenja rezultata ispitivanja lijeka MIRAPEXIN u jednoj ili više podskupina pedijatrijske populacije sa sindromom nemirnih nogu (vidjeti dio 4.2 za informacije o pedijatrijskoj primjeni).
English: 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).
Croatian: MIRAPEXIN se ne smije primjenjivati u djece i adolescenata s Touretteovim sindromom zbog negativnog omjera koristi i rizika za ovaj poremećaj (vidjeti dio 5.1).
English: MIRAPEXIN should not be used during breast-feeding.
Croatian: MIRAPEXIN se ne bi trebao primjenjivati tijekom dojenja.
English: The safety and efficacy of MIRAPEXIN in children below 18 years has not been established.
Croatian: Sigurnost i djelotvornost MIRAPEXINA u djece u dobi do 18 godina nisu ustanovljene.
English: Only one patient switched to MIRAPEXIN prolonged-release tablets experienced a drug-related adverse event leading to withdrawal.
Croatian: Samo je jedan bolesnik koji je prešao na MIRAPEXIN tablete s produljenim oslobađanjem imao nuspojavu povezanu s lijekom koja je dovela do prekida terapije.
English: 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 (CGI-I and PGI-I responder rates) efficacy endpoints in a double-blind placebo-controlled trial including a total of 539 patients with early Parkinson's disease.
Croatian: Veća djelotvornost MIRAPEXIN tableta s produljenim oslobađanjem u odnosu na placebo pokazana je nakon 18 tjedana liječenja i u primarnim (rezultat prema UPDRS - dijelovima II+III) i ključnim sekundarnim (stopa odgovora prema CGI-I i PGI-I) mjerama ishoda za djelotvornost u dvostrukoslijepom, placebom kontroliranom ispitivanju koje je uključivalo ukupno 539 bolesnika s ranim stadijem Parkinsonove bolesti.
English: Ascending dose schedule of MIRAPEXIN Week
Croatian: Postupak povećanja doze MIRAPEXINA Tjedan
English: In patients with a creatinine clearance between 30 and 50 ml/min, treatment should be started with 0.26 mg MIRAPEXIN prolonged-release tablets every other day.
Croatian: Kod bolesnika s klirensom kreatinina između 30 i 50 ml/min, liječenje treba započeti s MIRAPEXIN 0,26 mg tabletom s produljenim oslobađanjem svaki drugi dan.
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.
Croatian: Kada se MIRAPEXIN propisuje bolesnicima s Parkinsonovom bolešću koji imaju oštećenje bubrega, preporučuje se snižena doza u skladu s dijelom 4.2.
English: If you are taking levodopa, the dose of levodopa is recommended to be reduced when you start treatment with MIRAPEXIN.
Croatian: Ako uzimate levodopu, preporučuje se snižavanje doze levodope pri započinjanju liječenja MIRAPEXINOM.
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.
Croatian: Sve tablete imaju utisnut simbol tvrtke Boehringer Ingelheim na jednoj strani te oznake P6, P7, P8 ili P9 na drugoj strani, što, istim redoslijedom, predstavlja jačine tableta od 0,088 mg, 0,18 mg, 0,35 mg i 0,7 mg.
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.
Croatian: U dvostruko-slijepom, placebom kontroliranom ispitivanju, koje je uključivalo ukupno 517 bolesnika s uznapredovalom Parkinsonovom bolešću koji su bili na istovremenoj terapiji levodopom, pokazana je superiornost MIRAPEXIN tableta s produljenim oslobađanjem u odnosu na placebo nakon 18 tjedana liječenja i za primarne (rezultat prema UPDRS dijelovima II+III) i ključne sekundarne (offtime) mjere ishoda za djelotvornost.
English: Patients with kidney disease If you have severe kidney disease, MIRAPEXIN may not be a suitable treatment for you.
Croatian: Ako imate tešku bolest bubrega, MIRAPEXIN možda neće biti prikladan za Vaše liječenje.
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.
Croatian: S obzirom da dnevna doza u liječenju sindroma nemirnih nogu neće prelaziti 0,54 mg baze (0,75 mg soli), liječenje MIRAPEXINOM se može prekinuti bez postupnog snižavanja doze.
English: MIRAPEXIN can have a major influence on the ability to drive and use machines.
Croatian: MIRAPEXIN može značajno utjecati na sposobnost upravljanja vozilima i rada sa strojevima.
English: MIRAPEXIN is used to: - treat the symptoms of primary Parkinson's disease in adults.
Croatian: MIRAPEXIN se primjenjuje u: - liječenju simptoma primarne Parkinsonove bolesti kod odraslih.
English: MIRAPEXIN prolonged-release tablets are a once-a-day oral formulation of pramipexole.
Croatian: MIRAPEXIN tablete s produljenim oslobađanjem su jednokratna dnevna oralna formulacija pramipeksola.
English: MIRAPEXIN has been associated with sleepiness and episodes of suddenly falling asleep, particularly in patients with Parkinson's disease.
Croatian: MIRAPEXIN je povezan s pospanošću i epizodama iznenadnog usnivanja, osobito kod bolesnika s Parkinsonovom bolešću.
English: Patients and carers should be made aware that behavioural symptoms of impulse control disorders including pathological gambling, increased libido, hypersexuality, compulsive spending or buying, binge eating and compulsive eating can occur in patients treated with dopamine agonists including MIRAPEXIN.
Croatian: Bolesnici i njihovi njegovatelji moraju biti svjesni simptoma poremećaja kontrole nagona uključujući patološku želju za kockanjem, pojačani libido, hiperseksualnost, kompulzivno trošenje ili kupovanje, prejedanje i kompulzivno jedenje koji se mogu javiti kod bolesnika liječenih dopaminskim agonistima, uključujući MIRAPEXIN.
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).
Croatian: Dnevna doza ne smije prelaziti 6 tableta MIRAPEXIN 0,088 mg ili dozu od 0,54 mg (0,75 mg soli pramipeksola).
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.
Croatian: MIRAPEXIN 1,05 mg, 1,57 mg, 2,1 mg, 2,62 mg i 3,15 mg tablete s produljenim oslobađanjem su bijele do gotovo bijele boje i ovalnog oblika.
English: You should have regular eye examinations during treatment with MIRAPEXIN.
Croatian: Potreban je redovit pregled očiju tijekom liječenja MIRAPEXINOM.
English: (eating more food than normal and more than is needed to satisfy your hunger)* - Mania (agitation, feeling elated or over-excited)* - Delirium (decreased awareness, confusion, loss of reality)*
Croatian: (jedenje veće količine hrane nego što je normalno i više nego je potrebno za utaženje gladi)* - manija (uznemirenost, osjećaj ushita ili pretjeranog uzbuđenja)* - delirij (poremećaj svijesti, smetenost, gubitak osjećaja za stvarnost)*
English: In a 26 week placebo controlled trial, rebound of RLS symptoms (worsening of symptom severity as compared to baseline) was observed in 10% of patients (14 out of 135) after abrupt discontinuation of treatment.
Croatian: U 26-tjednom placebom kontroliranom ispitivanju primijećen je “rebound” fenomen simptoma sindroma nemirnih nogu (pogoršanje težine simptoma u usporedbi s početnim vrijednostima) kod 10% bolesnika (14 od 135) nakon naglog prekida liječenja.
English: The other ingredients are mannitol, maize starch, anhydrous colloidal silica, povidone K 25 and magnesium stearate.
Croatian: Drugi sastojci su manitol, kukuruzni škrob, koloidni, bezvodni silicijev dioksid, povidon K25, magnezijev stearat.
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)
Croatian: Simptomi uključuju sljedeće: - akinezija (gubitak pokretnosti mišića) - ukočenost mišića - vrućica - nestabilni krvni tlak - tahikardija (ubrzan rad srca) - smetenost - smanjena razina svijesti (npr. koma).
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.
Croatian: U ispitivanju faze I, u kojem su ocjenjivane pramipeksol tablete s trenutnim oslobađanjem i pramipeksol tablete s produljenim oslobađanjem natašte, minimalne i maksimalne koncentracije u plazmi (Cmin, Cmax) i ekspozicija (AUC) jednakoj dnevnoj dozi MIRAPEXIN tableta s produljenim oslobađanjem, primjenjivanih jedanput dnevno i MIRAPEXIN tableta primjenjivanih tri puta dnevno, bile su jednake.
English: Some patients have reported the occurrence of remnants in faeces which may resemble intact MIRAPEXIN prolonged-release tablets.
Croatian: Neki su bolesnici prijavili pojavu ostataka u stolici koji bi mogli nalikovati čitavim MIRAPEXIN tabletama s produljenim oslobađanjem.
English: MIRAPEXIN is not recommended for use in children and adolescents below 18 years due to a lack of data on safety and efficacy.
Croatian: Primjena MIRAPEXINA se ne preporučuje u djece i adolescenata u dobi do 18 godina zbog nedostatnih podataka o sigurnosti i djelotvornosti.
English: The use of MIRAPEXIN has not been studied in haemodialysis patients, or in patients with severe renal impairment.
Croatian: Primjena MIRAPEXINA nije ispitivana u bolesnika na hemodijalizi, ili bolesnika s teškim bubrežnim oštećenjem.
English: If dystonia occurs, the dopaminergic medication regimen should be reviewed and an adjustment in the dose of pramipexole considered.
Croatian: U slučaju pojave distonije potrebno je preispitati režim uzimanja dopaminergičkih lijekova i razmotriti prilagodbu doze pramipeksola.
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).
Croatian: Sve jačine lijeka MIRAPEXIN dostupne su u aluminijskim blisterima s 10 tableta, u kutijama s 3 ili 10 blistera (30 ili 100 tableta).
English: There is no relevant use of MIRAPEXIN in the paediatric population for the indication of Parkinson's Disease.
Croatian: Nema relevantne primjene MIRAPEXINA u pedijatrijskoj populaciji za indikaciju Parkinsonove bolesti.
English: MIRAPEXIN is used to treat the symptoms of primary Parkinson's disease in adults.
Croatian: MIRAPEXIN se primjenjuje u liječenju simptoma primarne Parkinsonove bolesti kod odraslih.
English: In these cases MIRAPEXIN may affect your ability to drive and operate machinery.
Croatian: U spomenutim slučajevima, MIRAPEXIN može utjecati na sposobnost upravljanja vozilima i rada na strojevima.
English: If you stop taking MIRAPEXIN
Croatian: Ako prestanete uzimati MIRAPEXIN
English: UNIQUE IDENTIFIER - HUMAN READABLE DATA
Croatian: JEDINSTVENI IDENTIFIKATOR - PODACI ČITLJIVI LJUDSKIM OKOM PC: {broj} [oznaka lijeka]
English: A lower maintenance dose of three MIRAPEXIN 0.088 mg tablets a day is also possible.
Croatian: Također je moguća niža doza održavanja od tri MIRAPEXINA 0,088 mg tablete dnevno.
English: Your doctor will then discuss with you if you should continue to take MIRAPEXIN.
Croatian: Liječnik će s Vama razmotriti je li potreban nastavak liječenja MIRAPEXINOM.
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.
Croatian: Preporučena početna doza MIRAPEXINA je 0,088 mg baze (0,125 mg soli) jedanput dnevno 2-3 sata prije spavanja.
English: Dose adjustment in patients with hepatic failure is not required, as approx. 90% of absorbed active substance is excreted through the kidneys.
Croatian: Podešavanje doze kod bolesnika sa zatajenjem jetre nije potrebno, s obzirom da se oko 90% apsorbirane djelatne tvari izlučuje putem bubrega.
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.
Croatian: Sve tablete imaju simbol tvrtke Boehringer Ingelheim otisnut s jedne strane i oznake P1, P2, P3, P12, P4, P13, ili P5 s druge strane, koji predstavljaju jačinu tableta od 0,26 mg, 0,52 mg, 1,05 mg, 1,57 mg, 2,1 mg, 2,62 mg i 3,15 mg, po istom redoslijedu.
English: If you forget to take MIRAPEXIN
Croatian: Ako ste zaboravili uzeti MIRAPEXIN
English: It is recommended that the dose of levodopa is reduced during both the dose escalation and the maintenance treatment with MIRAPEXIN, depending on reactions in individual patients (see section
Croatian: Preporučuje se smanjiti dozu levodope za vrijeme postupnog povećavanja doze, kao i za vrijeme terapije održavanja MIRAPEXINOM, ovisno o reakcijama pojedinog bolesnika (vidjeti dio 4.5).
English: All strengths of MIRAPEXIN are available in aluminium blister strips of 10 tablets per strip, in cartons containing 1, 3 or 10 blister strips (10, 30 or 100 prolonged-release tablets).
Croatian: Sve jačine lijeka MIRAPEXIN dostupne su u aluminijskim blisterima s 10 tableta, u kutijama s 1, 3, ili 10 blistera (10, 30 ili 100 tableta s produljenim oslobađanjem).
English: 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).
Croatian: U bolesnika s klirensom kreatinina između 20 i 50 ml/min, početna dnevna doza MIRAPEXINA treba se podijeliti u dvije odvojene doze, počevši od 0,088 mg baze (0,125 mg soli) dva puta dnevno, (0,176 mg baze/0,25 mg soli dnevno).
English: st week
Croatian: 1. tjedan
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.
Croatian: Kada se MIRAPEXIN primjenjuje u kombinaciji s levodopom, preporučuje se sniziti dozu levodope i ne mijenjati doze ostalih antiparkinsonika, dok se povisuje doza MIRAPEXINA.
English: - Binge eating (eating large amounts of food in a short time period) or compulsive eating (eating more food than normal and more than is needed to satisfy your hunger)* - Delirium (decreased awareness, confusion, loss of reality)
Croatian: - pretjerano kupovanje ili trošenje koje se ne može kontrolirati - prejedanje (jedenje ogromnih količina hrane u kratkom razdoblju) ili kompulzivno jedenje (jedenje veće količine hrane nego što je normalno i više nego je potrebno za utaženje gladi)* - delirij (poremećaj svijesti, smetenost, gubitak osjećaja za stvarnost)
English: Cartons containing 1, 3 or 10 blister strips (10, 30 or 100 prolonged-release tablets).
Croatian: Kutije sadrže 1, 3 ili 10 blistera (10, 30, ili 100 tableta s produljenim oslobađanjem).
English: During the first week, the usual daily dose is 0.26 mg pramipexole.
Croatian: Tijekom prvog tjedna, uobičajna dnevna doza je 0,26 mg pramipeksola.
English: In advanced Parkinson's disease, pramipexole doses higher than 1.05 mg of base (1.5 mg of salt) per day can be useful in patients where a reduction of the levodopa therapy is intended.
Croatian: U uznapredovaloj Parkinsonovoj bolesti, dnevne doze više od 1,05 mg baze (1,5 mg soli) mogu biti korisne kod bolesnika kojima se namjerava sniziti doza levodope.
English: The once daily administration of MIRAPEXIN prolonged-release tablets causes less frequent fluctuations in the pramipexole plasma concentration over 24 hours compared to the three times daily administration of pramipexole immediate release tablets.
Croatian: Jednokratna dnevna primjena MIRAPEXIN tableta s produljenim oslobađanjem rjeđe izaziva fluktuacije u koncentracijama pramipeksola u plazmi tijekom 24 sata u usporedbi s trokratnom dnevnom primjenom pramipeksol tableta s trenutnim oslobađanjem.
English: There is no relevant use of MIRAPEXIN prolonged-release tablets in the paediatric population for the indication of Parkinson's Disease.
Croatian: Nema relevantne primjene MIRAPEXIN tableta s produljenim oslobađanjem u pedijatrijskoj populaciji za indikaciju Parkinsonove bolesti.
English: Cartons containing 3 or 10 blister strips (30 or 100 tablets).
Croatian: Kutije sadrže 3 ili 10 blistera (30 ili 100 tableta)
English: Tell your doctor if you or your family/carer notices that you are developing mania (agitation, feeling elated or over-excited) or delirium (decreased awareness, confusion, loss of reality).
Croatian: Obavijestite liječnika ako Vi ili Vaša obitelj / skrbnik primijetite razvoj manije (uznemirenost, osjećaj ushita ili pretjeranog uzbuđenja) ili delirija (poremećaj svijesti, konfuzija, gubitak osjećaja za stvarnost).
English: In advanced Parkinson's disease, pramipexole doses higher than 1.1 mg of base (1.5 mg of salt) per day can be useful in patients where a reduction of the levodopa therapy is intended.
Croatian: U uznapredovaloj Parkinsonovoj bolesti, dnevne doze više od 1,1 mg baze (1,5 mg soli) mogu biti korisne kod bolesnika kojima se namjerava sniziti doza levodope.
English: Store in the original package to protect the tablets from light.
Croatian: Čuvati u originalnom pakiranju radi zaštite tableta od svjetlosti.
English: Tell your doctor if you or your family/carer notices that you are developing mania (agitation, feeling elated or over-excited) or delirium (decreased awareness, confusion or loss of reality).
Croatian: Obavijestite liječnika ako Vi ili Vaša obitelj / skrbnik primijetite razvoj manije (uznemirenost, osjećaj ushita ili pretjeranog uzbuđenja) ili delirija (poremećaj svijesti, konfuzija ili gubitak osjećaja za stvarnost).
English: Parkinson's disease and are also taking levodopa, you might develop dyskinesia during the up titration of MIRAPEXIN.
Croatian: Parkinsonovu bolest te također uzimate levodopu, može doći do razvoja diskinezije tijekom povećavanja doze MIRAPEXINA.
English: During the first week, the usual dose is 1 tablet MIRAPEXIN 0.088 mg three times a day (equivalent to 0.264 mg daily):
Croatian: Tijekom prvog tjedna, uobičajena doza je 1 tableta MIRAPEXINA 0,088 mg tri puta dnevno (što odgovara 0,264 mg dnevno):
English: If you have moderate kidney disease, the usual starting dose is 1 tablet MIRAPEXIN 0.088 mg twice a day.
Croatian: Ako imate umjerenu bolest bubrega, uobičajena početna doza je 1 tableta MIRAPEXINA 0,088 mg dvaput dnevno.
English: Parkinson's disease The daily dose is to be taken divided into 3 equal doses.
Croatian: Ukupna dnevna doza se uzima podijeljena u 3 jednake doze.
English: What MIRAPEXIN looks like and contents of the pack MIRAPEXIN 0.26 mg and 0.52 mg prolonged-release tablets are white to off-white, of round shape, and have bevelled edges.
Croatian: Kako MIRAPEXIN izgleda i sadržaj pakiranja MIRAPEXIN 0,26 mg i 0,52 mg tablete s produljenim oslobađanjem su bijele do gotovo bijele boje, okruglog oblika, te imaju kose rubove.
English: During the first week, the usual dose is 1 tablet MIRAPEXIN 0.088 mg once a day (equivalent to 0.088 mg daily):
Croatian: Tijekom prvog tjedna, uobičajena doza je 1 tableta MIRAPEXIN 0,088 mg jedanput dnevno (što odgovara 0,088 mg dnevno):
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.
Croatian: Primjena MIRAPEXINA se ne preporučuje u djece i adolescenata u dobi do 18 godina jer njegova sigurnost i djelotvornost nije ustanovljena za ovu populaciju.
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.
Croatian: U bolesnika s klirensom kreatinina manjim od 20 ml/min, MIRAPEXIN je potrebno primijeniti u jednokratnoj dozi, počevši od 0,088 mg baze (0,125 mg soli) dnevno.
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.
Croatian: Na temelju analize zbirnih podataka iz placebom kontroliranih ispitivanja, koja su obuhvatila 1923 bolesnika na pramipeksolu i 1354 bolesnika na placebu, nuspojave su se često prijavljivale za obje grupe.