natgillin/translations-raw huggingface dataset:
• Hallucinations (seeing, hearing or feeling things that are not there).
• Halucinacije (vidite, čujete ili osjećate stvari koje nisu prisutne).
The tablet can be divided into two equal doses.
Tableta se može razdijeliti na jednake doze.
You may experience that symptoms start earlier than usual, be more intense and involve other limbs.
Do pojave simptoma može doći ranije nego obično, mogu biti intenzivniji te uključivati druge udove.
• Psychosis (e.g. comparable with symptoms of schizophrenia).
• Psihoza (npr. usporedivo sa simptomima shizofrenije)
What you need to know before you take Pramipexole Accord 3.
Što morate znati prije nego počnete uzimati Pramipeksol Accord 3.
However, the potential influence of hepatic insufficiency on Pramipexole Accord pharmacokinetics has not been investigated.
Međutim, potrebno je znati da potencijalni utjecaj insuficijencije jetre na farmakokinetiku Pramipeksol Accorda nije istraživan.
Pramipexole Accord can be taken with or without food.
Pramipeksol Accord se može uzimati sa ili bez hrane.
Risk Management Plan (RMP) The MAH shall perform the required pharmacovigilance activities and interventions detailed in the agreed RMP presented in Module 1.8.2 of the Marketing Authorisation and any agreed subsequent updates of the RMP.
Nositelj odobrenja obavljat će zadane farmakovigilancijske aktivnosti i intervencije, detaljno objašnjene u dogovorenom Planu upravljanja rizikom (RMP), koji se nalazi u Modulu 1.8.2 Odobrenja za stavljanje lijeka u promet, te svim sljedećim dogovorenim ažuriranim verzijama RMP-a.
Ophthalmologic monitoring is recommended at regular intervals or if vision abnormalities occur.
Preporučuje se oftalmološki pregled u redovitim intervalima ili ako se pojave poremećaji vida.
Pramipexole Accord can reduce the production of breast milk.
Pramipeksol Accord može smanjiti stvaranje majčinog mlijeka.
In a pharmacoepidemiological study pramipexole use was associated with an increased risk of cardiac failure compared with non-use of pramipexole (observed risk ratio 1.86; 95% CI, 1.21
U farmakoepidemiološkom ispitivanju, primjena pramipeksola bila je povezana s povećanim rizikom od zatajenja srca u usporedbi s neprimjenom pramipeksola (primijećeni omjer rizika 1,86; 95% CI; 1,21-2,85).
The efficacy of pramipexole (0.0625-0.5 mg/day) with paediatric patients aged 6-17 years with Tourette Disorder was evaluated in a 6-week, double-blind, randomised, placebo-controlled flexible dose study.
Djelotvornost pramipeksola (0,0625-0,5 mg/dan) ocjenjivana je na pedijatrijskim bolesnicima u dobi od 6-17 godina s Touretteovim sindromom tijekom 6 tjedana u dvostruko-slijepom, randomiziranom, placebom kontroliranom, fleksibilnom ispitivanju doza.
• Do not use this medicine after the expiry date which is stated on the carton after EXP.
• Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na kutiji iza oznake
Cimetidine reduced the renal clearance of pramipexole by approximately 34%, presumably by inhibition of the cationic secretory transport system of the renal tubules.
Cimetidin smanjuje klirens pramipeksola u bubrezima za oko 34%, vjerojatno inhibicijom kationskog sekrecijskog transportnog sustava u renalnim tubulima.
The European Medicines Agency has waived the obligation to submit the results of studies with Pramipexole Accord in all subsets of the paediatric population in Parkinson's Disease (see section 4.2 for information on paediatric use).
Europska agencija za lijekove izuzela je obvezu podnošenja rezultata ispitivanja Pramipeksol Accorda u svim podskupinama pedijatrijske populacije s Parkinsonovom bolešću (vidjeti dio 4.2 za informacije o pedijatrijskoj primjeni).
Pack-sizes of 30 or 100 tablets
Veličina pakiranja: 30 ili 100 tableta.
Therefore, medicinal products that are inhibitors of this active renal elimination pathway or are eliminated by this pathway, such as cimetidine, amantadine, mexiletine, zidovudine, cisplatin, quinine, and procainamide, may interact with pramipexole resulting in reduced clearance of pramipexole.
Stoga, lijekovi koji su inhibitori tog aktivnog renalnog puta eliminacije ili se tim putem odstranjuju, kao što su cimetidin, amantidin i meksiletin, zidovudin, cisplatin, kinin i prokainamid, mogu stupiti u interakciju s pramipeksolom, što može rezultirati smanjenim klirensom pramipeksola.
What Pramipexole Accord tablet looks like and contents of the pack
Kako Pramipeksol Accord izgleda i sadržaj pakiranja
Marketing Authorisation Holder and Manufacturer Marketing Authorisation Holder Accord Healthcare S.L.U.
Nositelj odobrenja za stavljanje lijeka u promet i proizvođač Nositelj odobrenja za stavljanje lijeka u promet Accord Healthcare S.L.U.
Rare: • Mania (agitation, feeling elated or over excited)
Rijetko: - manija (uznemirenost, osjećaj ushita ili pretjeranog uzbuđenja)
CONSITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE
UVJETI ILI OGRANIČENJA VEZANI UZ OPSKRBU I PRIMJENU
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.
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 terapija levodope.
Dose adjustment in patients with hepatic failure is probably not necessary, as approx. 90% of absorbed active substance is excreted through the kidneys.
Prilagođavanje doze u bolesnika s oštećenom funkcijom jetre vjerojatno nije potrebno jer se oko 90% apsorbiranog lijeka izlučuje putem bubrega.
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.
Smanjenje dijastoličkog i sistoličkog tlaka i broja otkucaja srca uočeno je kod minijaturnih svinja, kao i sklonost k hipotenzivnom učinku kod majmuna.
Tell your doctor if you experience any of these behaviours; he will discuss ways of managing or reducing the symptoms.
Obavijestite svog liječnika ako doživite bilo koje od ovih ponašanja; on će razmotriti načine na koje se mogu zbrinuti ili smanjiti simptomi.
Patients being treated with Pramipexole Accord 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).
Bolesnike koji su tijekom liječenja Pramipeksol Accordom imali somnolenciju i/ili epizode iznenadnog usnivanja potrebno je upozoriti da ne upravljaju motornim vozilima ili obavljaju nekakve druge aktivnosti gdje bi njihova smanjena mogućnost reagiranja ponekad mogla ugroziti vlastitu ili tuđu sigurnost te dovesti do rizika za tešku ozljedu ili smrt (npr. upravljanje strojevima), sve dok takve opetovane epizode i somnolencija ne prestanu (vidjeti također dijelove 4.4, 4.5 i 4.8).
It is recommended that the dose of levodopa is reduced during both the dose escalation and the maintenance treatment with Pramipexole Accord, depending on reactions in individual patients (see section 4.5).
Preporučuje se smanjiti dozu levodope za vrijeme postupnog povećavanja doze, kao i za vrijeme terapije održavanja Pramipeksol Accordom, ovisno o reakcijama pojedinog bolesnika (vidjeti dio 4.5).
Pramipexole Accord with food, drink and alcohol You should be cautious while drinking alcohol during treatment with Pramipexole Accord.
Pramipeksol Accord s hranom,pićem i alkoholom Potreban je oprez prilikom konzumacije alkohola tijekom liječenja Pramipeksol Accordom.
What Pramipexole Accord is and what it is used for
Što je Pramipeksol Accord i za što se koristi
Pramipexole Accord contains the active substance pramipexole and belongs to a group of medicines known as dopamine agonists, which stimulate dopamine receptors in the brain.
Pramipeksol Accord sadrži djelatnu tvar pramipeksol i pripada skupini lijekova poznatih kao agonisti dopamina koji stimuliraju dopaminske receptore u mozgu.
Pramipexole Accord 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).
Pramipeksol Accord je indiciran za liječenje znakova i simptoma idiopatske Parkinsonove bolesti u odraslih, u obliku monoterapije (bez levodope) ili u kombinaciji s levodopom, tj. tijekom trajanja bolesti, pa sve do u uznapredovaloj fazi, kada učinak levodope jenjava ili postane nestalan te dolazi do fluktuacija u terapijskom učinku (učinak "kraja doze” i “on-off” razdoblja).
Tell your doctor if you experience symptoms such as depression, apathy, anxiety, fatigue, sweating or pain after stopping or reducing your Pramipexole Accord treatment.
Obavijestite svog liječnika ako osjetite simptome poput depresije, apatije, tjeskobe, umora, znojenja ili boli nakon prestanka liječenja ili sniženja doze Pramipeksol Accorda.
Pramipexole alleviates parkinsonian motor deficits by stimulation of dopamine receptors in the striatum.
Pramipeksol reducira “parkinsonske” motorne deficite, stimulirajući dopaminske receptore u strijatumu.
SPECIAL STORAGE CONDITIONS Store below 30°C.
POSEBNE MJERE ČUVANJA Čuvati na temperaturi ispod 30°C.
Other medicines and Pramipexole Accord
Drugi lijekovi i Pramipeksol Accord
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.
Studije o toksičnosti ponavljanih doza pokazuju da pramipeksol dovodi do funkcionalnih učinaka uglavnom putem djelovanja na središnji živčani sustav i ženski reproduktivni sustav, najvjerojatnije kao rezultat povećanog farmakodinamičkog učinka pramipeksola.
• Dyskinesia (e.g. abnormal, uncontrolled movements of the limbs).
• Diskinezija (npr. abnormalni, nekontrolirani pokreti udova).
These are called impulse control disorders and can include behaviours such as addictive gambling, excessive eating or spending, an abnormally high sex drive or preoccupation with an increase in sexual thoughts or feelings.
Ovakva ponašanja se nazivaju poremećaji kontrole nagona i mogu uključivati ponašanja kao što su; ovisnost o kockanju, prejedanje ili pretjerano trošenje, abnormalna seksualna želja ili zaokupljenost učestalim seksualnim mislima ili osjećajima.
The safety and efficacy of Pramipexole Accord in children below 18 years has not been established.
Sigurnost i djelotvornost Pramipeksol Accorda u djece ispod 18 godina starosti nije ustanovljena.
Pramipexole Accord is not recommended for use in children and adolescents below 18 years since the efficacy and safety has not been established in this population.
Accorda se ne preporučuje u djece i adolescenata ispod 18 godina starosti jer njegova sigurnost i djelotvornost nisu ustanovljene za ovu populaciju.
Parkinson's disease, most common adverse reactions
Parkinsonova bolest, najčešće nuspojave
• Store below 30°C.
• Čuvati na temperaturi ispod 30°C.
PARTICULARS TO APPEAR ON THE OUTER PACKAGING Carton for blisters
PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU Kutija za blistere
Clinical efficacy and safety in Tourette Disorder
Klinička djelotvornost i sigurnost kod Touretteovog sindroma
During dose escalation in pivotal studies, efficacy was observed starting at a daily dose of 1.1 mg of base (1.5 mg of salt).
Pri povećavanju doze, u u pivotalnim studijama, djelotvornost je primijećena počevši od dnevne doze od 1,1 mg baze (1,5 mg soli).
In animal studies, pramipexole affected oestrous cycles and reduced female fertility as expected for a dopamine agonist.
U studijama na životinjama, pramipeksol je utjecao na spolne cikluse i smanjenu plodnost ženki, kao što se očekivalo za dopaminske agoniste.
What you need to know before you take Pramipexole Accord
Što morate znati prije nego počnete uzimati Pramipeksol Accord
If you suffer from Parkinson's disease you should not stop treatment with Pramipexole Accord abruptly.
Ako patite od Parkinsonove bolesti, ne smijete naglo prekidati liječenje Pramipeksol Accordom.
• if you are allergic to pramipexole or to any of the other ingredients of this medicine (listed in section 6).
Nemojte uzimati Pramipeksol Accord: • ako ste alergični na pramipeksol ili neki drugi sastojak ovog lijeka (naveden u dijelu 6).
The active ingredient is pramipexole.
Djelatna tvar je pramipeksol.
In the absence of human data, Pramipexole Accord should not be used during breast-feeding.
U nedostatku podataka za ljude, Pramipeksol Accord se ne smije primjenjivati tijekom dojenja.
CONDISTIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
UVJETI ILI OGRANIČENJA VEZANI UZ SIGURNU I UČINKOVITU PRIMJENU LIJEKA
If you stop taking Pramipexole Accord
Ako prestanete uzimati Pramipeksol Accord
Ophthalmologic monitoring
Oftalmološki pregled
Pramipexole is metabolised in man only to a small extent.
Pramipeksol se u ljudi metabolizira u maloj količini.
The other ingredients are mannitol, cellulose microcrystalline, maize starch, silica colloidal anhydrous, povidone K 30 and magnesium stearate.
Pomoćne tvari su manitol, mikrokristalična celuloza, kukuruzni škrob, koloidni, bezvodni silicijev dioksid, povidon K30, magnezijev stearat.
Pramipexole Accord 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).
Pramipeksol Accord se ne smije primjenjivati u djece i adolescenata s Touretteovim sindromom zbog negativnog omjera koristi i rizika za ovaj poremećaj (vidjeti dio 5.1).
Pramipexole was not teratogenic in rats and rabbits but was embryotoxic in the rat at maternally toxic doses.
Pramipeksol nije bio teratogen kod štakora i kunića, ali je bio embriotoksičan u štakora primijenjen u dozama toksičnima za majku.
Very common: • Nausea (sickness)
Vrlo često: - mučnina
• Vision impairment.
• Oštećenje vida.
Pramipexole was not teratogenic in rats and rabbits, but was embryotoxic in the rat at maternotoxic doses (see section 5.3).
Pramipeksol se nije pokazao teratogenim na štakorima i kunićima, ali je bio embriotoksičan na štakorima pri dozama toksičnima za majku (vidjeti dio 5.3).
Pramipexole Accord tablets are packed in alu-alu blisters.
Pramipeksol Accord tablete su pakirane u Al/Al blistere.
You should avoid taking Pramipexole Accord together with antipsychotic medicines.
Potrebno je izbjegavati istovremenu primjenu Pramipeksol Accorda i antipsihotičnih lijekova.
Your doctor will then discuss with you if you should continue to take Pramipexole Accord.
Liječnik će s Vama razmotriti je li potreban nastavak liječenja Pramipeksol Accordom.
Manufacturer Accord Healthcare Limited, Sage house, 319 Pinner road, North Harrow
Sage house, 319 Pinner road,
There is no relevant use of Pramipexole Accord in the paediatric population for the children of Parkinson's disease.
Nema relevantne primjene Pramipeksol Accorda u pedijatrijskoj populaciji s Parkinsovom bolešću.
If renal function declines during maintenance therapy the Pramipexole Accord daily dose should be reduced by the same percentage as the decline in creatinine clearance, i.e. if creatinine clearance declines by 30%, then the Pramipexole Accord daily dose should be reduced by 30%.
Accorda je potrebno sniziti u istom postotku za koji se smanjio klirens kreatinina, tj. ako se klirens smanjio za 30%, tada je potrebno sniziti ukupnu dnevnu dozu Pramipeksol Accorda za 30%.
Any unused product or waste material should be disposed of in accordance with local requirement.
Neiskorišteni lijek ili otpadni materijal potrebno je zbrinuti sukladno nacionalnim propisima.
If you take more Pramipexole Accord than you should If you accidentally take too many tablets,
Ako slučajno uzmete previše tableta,
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
Bolesnici i njegovatelji trebaju znati da se bihevioralni simptomi poremećaja kontrole nagona, uključujući patološku želju za kockanjem, pojačan libido i hiperseksualnost, kompulzivno trošenje ili kupovanje, prejedanje i kompulzivno jedenje mogu javiti kod bolesnika liječenih dopaminskim agonistima protiv Parkinsonove bolesti, uključujući Pramipeksol Accord.
If you forget to take Pramipexole Accord
Ako ste zaboravili uzeti Pramipeksol Accord
You should have regular eye examinations during treatment with Pramipexole Accord.
Potreban je redovit pregled očiju tijekom liječenja Pramipeksol Accordom.
If you suffer from other indication, you may experience the following side effects:
Ako patite od druge bolesti kod koje se primijenjuje lijek, moguće su sljedeće nuspojave:
When prescribing Pramipexole Accord in a patient with Parkinson's disease with renal impairment a reduced dose is suggested in line with section 4.2.
Kada se Pramipeksol Accord propisuje bolesnicima s Parkinsovom bolešću koji imaju oštećenje bubrega, preporučuje se snižena doza u skladu s dijelom 4.2.
• Sleepiness and episodes of suddenly falling asleep.
• Pospanost i epizode iznenadnog usnivanja
Pramipexole Accord has major influence on the ability to drive and use machines.
Pramipeksol Accord značajno utječe na sposobnost upravljanja vozilima i rada sa strojevima.
How to store Pramipexole Accord 6.
Kako čuvati Pramipeksol Accord 6.
Libido disorders
Poremećaji libida
Pramipexole Accord 0.088 mg tablets Pramipexole Accord 0.18 mg tablets Pramipexole Accord 0.35 mg tablets Pramipexole Accord 0.7 mg tablets Pramipexole Accord 1.1 mg tablets
Pramipeksol Accord 0,088 mg tablete Pramipeksol Accord 0,18 mg tablete Pramipeksol Accord 0,35 mg tablete Pramipeksol Accord 0,7 mg tablete Pramipeksol Accord 1,1 mg tablete
A precise frequency estimation is not possible as the side effect did not occur in a clinical trial database of 2,762 patients with Parkinson's Disease treated with pramipexole.
Precizna ocjena učestalosti nije moguća, s obzirom da se nuspojava nije pojavila u bazi podataka kliničkog ispitivanja od 2762 bolesnika s Parkinsonovom bolešću liječenih pramipeksolom.
If you are taking levodopa, the dose of levodopa is recommended to be reduced when you start treatment with Pramipexole Accord.
Ako uzimate levodopu, preporučuje se snižavanje doze levodope pri započinjanju liječenja Pramipeksol Accordom.
Very rare may affect up to 1 in 10,000 people
Vrlo često može se javiti u više od 1 na 10 osoba
The most commonly (≥ 5%) reported adverse drug reactions in patients with other indication treated with pramipexole were nausea, headache, dizziness and fatigue.
Najčešće (≥5%) prijavljene nuspojave u bolesnika sa drugim indikacijama, u liječenju pramipeksolom bile su mučnina, glavobolja, omaglica i umor.
When Pramipexole Accord 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 Pramipexole Accord.
Kad se Pramipeksol Accord primjenjuje u kombinaciji s levodopom, preporučuje se sniziti dozu levodope i ne mijenjati doze ostalih antiparkinsonika, dok se povisuje doza Pramipeksol Accorda.
METHOD AND ROUTE(S) OF ADMINISTRATION: Read the package leaflet before use.
NAČIN I PUT(EVI) PRIMJENE LIJEKA Prije uporabe pročitajte uputu o lijeku.
In patients with a creatinine clearance less than 20 ml/min, the daily dose of Pramipexole Accord should be administered in a single dose, starting at 0.088 mg of base (0.125 mg of salt) daily.
U bolesnika s klirensom kreatinina manjim od 20 ml/min, Pramipeksol Accord je potrebno primjeniti u jednokratnoj dozi, počevši od 0,088 mg baze (0,125 mg soli) dnevno.
• zidovudine (which can be used to treat the acquired immune deficiency syndrome (AIDS), a disease of the human immune system)
- zidovudin (koji se može primjenjivati u liječenju stečenog sindroma imunodeficijencije (AIDS),
In these cases Pramipexole Accord may affect your ability to drive and operate machinery.
U spomenutim slučajevima, Pramipeksol Accord može utjecati na sposobnost upravljanja vozilima i rada na strojevima.
• You may experience vomiting, restlessness, or any of the side effects as described in chapter 4
• Mogu se javiti povraćanje, nemir, ili neka od nuspojava koja je opisana pod točkom 4. „Moguće nuspojave“.
Children and adolescents Pramipexole Accord is not recommended for use in children or adolescents under 18 years.
Accord se ne preporučuje za primjenu kod djece i adolescenata mlađih od 18 godina.
behavioural symptoms of impulse control disorders and compulsions1
bihevioralni simptomi u vidu poremećaja kontrole nagona i kompulzije1 (kao što je:
• treat the symptoms of primary Parkinson's disease in adults.
Pramipeksol Accord se primjenjuje u: - liječenju simptoma primarne Parkinsonove bolesti u odraslih osoba.
(such as: compulsive shopping, pathological gambling, hypersexuality, binge eating)
kompulzivno kupovanje, patološko kockanje, hiperseksualnost, epizode prejedanja)
Pramipexole Accord should not be used during breast-feeding.
Pramipeksol Accord se ne smije primjenjivati tijekom dojenja.
In clinical studies and post-marketing experience cardiac failure has been reported in patients with pramipexole.
U kliničkim ispitivanjima i tijekom razdoblja nakon stavljanja gotovog lijeka u promet prijavljeno je zatajenje srca kod bolesnika na pramipeksolu.
Pramipexole Accord has been associated with sleepiness and episodes of suddenly falling asleep, particularly in patients with Parkinson's disease.
Pramipeksol Accord je povezan s pospanošću i epizodama iznenadnog usnivanja, osobito kod bolesnika s Parkinsonovom bolešću.
A lower maintenance dose of three Pramipexole Accord 0.088 mg tablets a day is also possible.
Također je moguća niža doza održavanja od tri Pramipeksol Accorda 0,088 mg tablete dnevno.
• 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))
bolesti imunološkog sustava ljudi); - cisplatin (za liječenje raznih tipova raka); - kinin (koji se može primjenjivati u prevenciji bolnih grčeva nogu tijekom noći i za liječenje tipa malarije poznatog kao falciparum malaria (maligna malarija)); - prokainamid (za liječenje nepravilnih otkucaja srca).
Insomnia hallucinations abnormal dreams confusion behavioural symptoms of impulse control disorders and compulsions compulsive shopping pathological gambling restlessness hypersexuality delusion libido disorder paranoia delirium binge eating1 hyperphagia1
Psihijatrijski poremećaji nesanica halucinacije abnormalni snovi smetenost bihevioralni simptomi u vidu poremećaja kontrole nagona i kompulzija kompulzivno kupovanje patološko kockanje nemir hiperseksualnost sumanutost poremećaj libida paranoja delirij epizode prejedanja1 hiperfagija1
• Changes in sleep pattern, such as sleeplessness (insomnia) and sleepiness
Često: - promjene u obrascu spavanja, kao što su nesanica i pospanost - umor - glavobolja - neobični snovi - zatvor - omaglica - povraćanje
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 4.4, 4.7 and
Zbog mogućih dodatnih učinaka, oprez je potreban u bolesnika koji uzimaju sedative ili alkohol u kombinaciji s pramipeksolom (vidjeti dijelove 4.4, 4.7 i 4.8).
HA1 4HF, Middlesex, United Kingdom
Middlesex, HA1 4HF,
A precise frequency estimation is not possible as the side effect did not occur in a clinical trial database of 1,395 patients with other indication treated with pramipexole.
Precizna ocjena učestalosti nije moguća, s obzirom da se nuspojava nije pojavila u bazi podataka kliničkog ispitivanja 1395 bolesnika s drugom indikacijom liječenih pramipeksolom.
Accord Healthcare Ltd.
Accord Healthcare Limited,