natgillin/translations-raw huggingface dataset:
Maintenance treatment The individual dose should be in the range of 0.264 mg of base (0.375 mg of salt) to a maximum of 3.3 mg of base (4.5 mg of salt) per day.
Individuálna dávka má byť rozmedzí od 0, 264 mg bázy (0, 375 mg soli) maximálne do 3, 3 mg bázy v (4, 5 mg soli) denne.
During dose escalation in three pivotal studies, efficacy was observed starting at a daily dose of 1.1 mg of base (1.5 mg of salt).
Pri zvyšovaní dávky v troch pivotných š túdiách sa úč innosť pozorovala po dosiahnutí dennej dávky 1, 1 mg bázy (1, 5 mg soli).
Further dose adjustments should be done based on the clinical response and the occurrence of adverse reactions.
na klinickej odpovedi a na výskyte než iaducich úč inkov.
In clinical trials approximately 5% of patients were treated at doses below 1.1 mg (1.5 mg of salt).
V klinických štúdiách bolo približ 5% ne pacientov lieč ených dávkami menš než mg bázy (1, 5 mg soli).
In advanced Parkinson’ s disease, doses higher than 1.1 mg (1.5 mg of salt) per day can be useful in patients where a reduction of the levodopa therapy is intended.
dávky vyšie ako 1, 1 mg bázy (1, 5 mg soli) denne už né š
It is recommended that the dosage of levodopa is reduced during both the dose escalation and the maintenance treatment with Oprymea, depending on reactions in individual patients.
Odporúč sa, aby sa dávkovanie levodopy zniž poč zvyš
Treatment discontinuation Abrupt discontinuation of dopaminergic therapy can lead to the development of a neuroleptic malignant syndrome.
Náhle preruš dopaminergnej terapie môž viesť rozvoju neuroleptického malígneho syndrómu.
Therefore, pramipexole should be tapered off at a rate of 0.54 mg of base (0.75 mg of salt) per day until the daily dose has been reduced to 0.54 mg of base (0.75 mg of salt).
Preto sa má dávka pramipexolu znižovať postupne po 0, 54 mg bázy (0, 75 mg soli) denne až do dosiahnutia dennej dávky zredukovanej na 0, 54 mg bázy (0, 75 mg soli).
Thereafter the dose should be reduced by 0.264 mg of base (0.375 mg of salt) per day (see section 4.4).
Potom sa dávka zniž po uje 0, 264 mg bázy (0, 375 mg soli) denne (pozri č 4. 4). asť
Dosing in patients with renal impairment The elimination of pramipexole is dependent on renal function.
Dávkovanie u pacientov s poš
The following dosage schedule is suggested for initiation of therapy:
Vylučovanie pramipexolu závisí od funkcie oblič Pre zahájenie lieč sa navrhuje nasledovná schéma dávkovania:
Patients with a creatinine clearance above 50 ml/ min require no reduction in daily dose.
U pacientov s klírensom kreatinínu nad 50 ml/ min sa nevyž aduje zníž dennej dávky. enie U pacientov s hodnotami klírensu kreatinínu medzi 20 a 50 ml/ min sa má poč ná denná dávka iatoč Oprymey podávať
In patients with a creatinine clearance between 20 and 50 ml/ min, the initial daily dose of Oprymea 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).
Pacientom s klírensom kreatinínu nižím ako 20 ml/ min sa má denná dávka Oprymey podávať š jednorazovo, v dávke začínajúcej od 0, 088 mg bázy (0, 125 mg soli) denne.
In patients with a creatinine clearance less than 20 ml/ min, the daily dose of Oprymea should be administered in a single dose, starting at 0.088 mg of base (0.125 mg of salt) daily.
percentuálne v rovnakom rozsahu, ako sa zníž klírens kreatinínu, t. j. ak sa klírens kreatinínu zníž o
If renal function declines during maintenance therapy reduce Oprymea daily dose by the same percentage as the decline in creatinine clearance, i. e. if creatinine clearance declines by 30%, then reduce the Oprymea daily dose by 30%.
30%, potom redukujte dennú dávku Oprymey o 30%.
The daily dose can be administered in two divided doses if creatinine clearance is between 20 and 50 ml/ min, and as a single daily dose if creatinine clearance is less than 20 ml/ min.
Ak je klírens kreatinínu medzi 20 a 50 ml/ min, denná dávka môž byť
Dosing in patients with hepatic impairment Dose adjustment in patients with hepatic failure is probably not necessary, as approx.
a ak je klírens kreatinínu niží ako 20 ml/ min, denná asti, š
90% of absorbed active substance is excreted through the kidneys.
Dávkovanie u pacientov s poškodením pečene Úprava dávky u pacientov so zlyhaním peč pravdepodobne nie je nevyhnutná, pretož približ 90% absorbovaného lieč
However, the potential influence of hepatic insufficiency on Oprymea pharmacokinetics has not been investigated.
farmakokinetiku Oprymey sa vš neskúmal. ak
Dosing in children and adolescents Oprymea is not recommended for use in children and adolescents below 18 years due to a lack of data on safety and efficacy.
Dávkovanie u detí a mladistvých Neodporúč sa použ Oprymeu u detí a osôb mladš ako 18 rokov, kvôli chýbajúcim údajom o bezpeč
4.3 Contraindications
ívať
Hypersensitivity to the active substance or to any of the excipients.
ích
4.4 Special warnings and precautions for use
nosti a účinnosti.
3 When prescribing Oprymea in a patient with Parkinson’ s disease with renal impairment a reduced dose is suggested in line with section 4.2.
4. 3 Kontraindikácie
Hallucinations are known as a side-effect of treatment with dopamine agonists and levodopa.
Pri predpisovaní tabliet Oprymea pacientom s Parkinsonovou chorobou a s poš kodením funkcie oblič sa odporúč zníž dávkovanie podľ č 4. 2.
Patients should be informed that (mostly visual) hallucinations can occur.
(prevaž vizuálne) halucinácie. ne
In advanced Parkinson’ s disease, in combination treatment with levodopa, dyskinesias can occur during the initial titration of Oprymea.
3 Pri pokroč Parkinsonovej chorobe sa pri kombinovanej lieč s levodopou môž poč zač nej
If they occur, the dose of levodopa should be decreased.
Ak sa objavia, dávka levodopy sa má zníž. iť
Pramipexole has been associated with somnolence and episodes of sudden sleep onset, particularly in patients with Parkinson’ s disease.
Pramipexol sa spája so somnolenciou a epizódami náhleho upadnutia do spánku, obzvlá š u pacientov ť s Parkinsonovou chorobou.
Sudden onset of sleep during daily activities, in some cases without awareness or warning signs, has been reported uncommonly.
Menej č sa zaznamenalo náhle upadnutie do spánku poč bež
Patients must be informed of this and advised to exercise caution while driving or operating machines during treatment with Oprymea.
denných aktivít, niekedy bez toho, aby si to pacient uvedomil alebo pocítil varovné príznaky.
Patients who have experienced somnolence and/ or an episode of sudden sleep onset must refrain from driving or operating machines.
Pacienti o tom musia byť informovaní a oboznámení s tým, ž poč už
Furthermore a reduction of dosage or termination of therapy may be considered.
Pacienti, ktorí už
Because of possible additive effects, caution should be advised when patients are taking other sedating medication or alcohol in combination with pramipexole (see section 4.7 and section 4.8).
a/ alebo epizódami náhleho upadnutia do spánku, nesmú viesť toho je potrebné zváž zníž dávky alebo ukonč lieč Keďpacienti
Pathological gambling, increased libido and hypersexuality have been reported in patients treated with dopamine agonists for Parkinson’ s disease, including pramipexole.
U pacientov s Parkinsonovou chorobou, ktorí boli lieč dopamínovými agonistami vrátane ení pramipexolu sa zaznamenali patologické hráč stvo, zvýš libido a hypersexualita.
Furthermore, patients and caregivers should be aware of the fact that behavioural changes can occur.
Okrem toho, si ené pacienti a ošetrujúci personál majú byťvedomí skutoč nosti, ž sa môž vyskytnúť Má sa zváž redukcia dávky/ postupné vysadenie lieku. iť
Dose reduction/ taper or discontinuation should be considered.
zmeny v správaní.
Patients with psychotic disorders should only be treated with dopamine agonists if the potential benefits outweigh the risks.
Pacienti s psychotickými poruchami majú byť ení agonistami dopamínu len vtedy, ak oč prínos prevýšmož riziká. i né
Coadministration of antipsychotic medicinal products with pramipexole should be avoided (see section 4.5).
sa asného podávania pramipexolu a antipsychotických liekov (pozri č 4. 5). asť
Ophthalmologic monitoring is recommended at regular intervals or if vision abnormalities occur.
Odporúč sa oftalmologické sledovanie v pravidelných intervaloch alebo aj v prípade výskytu porúch a zraku.
In case of severe cardiovascular disease, care shou ld be taken.
adom na vš eobecné riziko posturálnej hypotenzie spojenej s
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.
Po náhlom ukonč dopaminergnej terapie boli hlásené príznaky naznač
Symptoms suggestive of neuroleptic malignant syndrome have been reported with abrupt withdrawal of dopaminergic therapy (see section 4.2)
Hlásenia v literatúre naznač ž lieč iných indikácií dopamínergnými liekmi môž viesť
Reports in the literature indicate that treatment of another indication with dopaminergic medicinal products can result in augmentation.
Augmentácia hovorí o skorš začom
Augmentation refers to the earlier onset of symptoms in the evening (or even afternoon), increase in symptoms, and spread of symptoms to involve other extremities.
Frekvencia augmentácie po dlhš použ
The frequency of augmentation after longer use of pramipexole and the appropriate management of these events have not been evaluated in controlled clinical trials.
pramipexolu a vhodný management týchto príhod neboli v kontrolovaných klinických š zhodnotené.
Pramipexole is bound to plasma proteins to a very low (< 20%) extent, and little biotransformation is seen in man.
U ľ je pozorovaná malá biotransformácia a veľ nízka (< 20%) väzba pramipexolu na plazmatické
Therefore, interactions with other medicinal products affecting plasma protein binding or elimination by biotransformation are unlikely.
Preto je interakcia s inými liekmi pôsobiacimi na väzbu na plazmatické bielkoviny alebo na vyluč ovanie biotransformáciou nepravdepodobná.
As anticholinergics are mainly eliminated by biotransformation, the potential for an interaction is limited, although an interaction with anticholinergics has not been investigated.
nosť interakcie je obmedzená, hoci sa interakcia s anticholínergikami
Cimetidine reduced the renal clearance of pramipexole by approximately 34%, presumably by inhibition of the cationic secretory transport system of the renal tubules.
Cimetidín zniž renálny klírens pramipexolu približ o 34%, pravdepodobne inhibíciou
Therefore, medicinal products
Ak sa Oprymea podáva v kombinácii s levodopou, odporúč sa pri zvyš
4 that are inhibitors of this active renal elimination pathway or are eliminated by this pathway, such as cimetidine and amantadine, may interact with pramipexole resulting in reduced clearance of either or both medicinal products.
4 Kvôli mož aditívnym vedľ ím úč
Reduction of the pramipexole dose should be considered when these medicinal products are administered concomitantly.
inkom sa vyž aduje opatrnosť pacientov už u ívajúcich iné
When Oprymea is given in combination with levodopa, it is recommended that the dosage of levodopa is reduced and the dosage of other anti-parkinsonian medicinal products is kept constant while increasing the dose of Oprymea.
sedatívne lieky alebo alkohol v kombinácii s pramipexolom.
Because of possible additive effects, caution should be advised when patients are taking other sedating medicinal products or alcohol in combination with pramipexole.
Treba sa vyhýbať asnému podávaniu antipsychotík s pramipexolom (pozri č 4. 4), napr. ak je mož oč
Coadministration of antipsychotic medicinal products with pramipexole should be avoided (see section 4.4), e. g. if antagonistic effects can be expected.
né akávať antagonistický úč inok.
The effect on pregnancy and lactation has not been investigated in humans.
U ľ sa neskúmal vplyv na priebeh gravidity a laktácie.
Pramipexole was not teratogenic in rats and rabbits, but was embryotoxic in the rat at maternotoxic doses (see section 5.3).
Pramipexol nebol teratogénny u potkanov a udí králikov, ale bol embryotoxický u potkanov pri dávkach toxických pre gravidnú samicu (pozri časť 5. 3).
Oprymea should not be used during pregnancy unless clearly necessary, i. e. if the potential benefit justifies the potential risk to the foetus.
Oprymea sa nemá použ poč gravidity ak to nie je vyslovene nevyhnutné, t. j. ak mož
As pramipexole treatment inhibits secretion of prolactin in humans, inhibition of lactation is expected.
prínos opodstatní mož riziko pre plod. né
The excretion of pramipexole into breast milk has not been studied in women.
Vyluč ovanie pramipexolu do materského mlieka u ž sa neskúmalo.
In rats, the concentration of active substance-related radioactivity was higher in breast milk than in plasma.
Pre chýbajúce údaje u ľ
In the absence of human data, Oprymea should not be used during breast-feeding.
sa Oprymea nemá už poč dojč
However, if its use is unavoidable, breast-feeding should be discontinued.
ívanie nevyhnuté, dojč sa má preruš enie
4.7 Effects on ability to drive and use machines
Oprymea môž mať ký vplyv na schopnosť
Oprymea can have a major influence on the ability to drive and use machines.
viesťvozidlá a obsluhovaťstroje.
Hallucinations or somnolence can occur.
Môž sa objaviť u halucinácie alebo somnolencia.
Patients being treated with Oprymea 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).
neho zranenia alebo smrti pacienta alebo jeho okolie (napr. obsluhovanie strojov) až dovtedy, kým neprekonajú takéto rekurentné epizódy a somnolenciu (pozri aj č 4. 4, 4. 5 a 4. 8). asti
4.8 Undesirable effects
4. 8 Než iaduce úč inky
The following adverse reactions are expected under the use of Oprymea: abnormal dreams, confusion, constipation, delusion, dizziness, dyskinesia, fatigue, hallucinations, headache, hyperkinesia, hypotension, increased eating (binge eating, hyperphagia), insomnia, libido disorders, nausea, peripheral oedema, paranoia, pathological gambling, hypersexuality and other abnormal behaviour; somnolence, weight increase, sudden onset of sleep; pruritus and rash and other hypersensitivity.
zápcha, delirantné predstavy, závraty, dyskinéza, únava, halucinácie, bolesť hlavy, hyperkinéza, hypotenzia, zvýš chuť jedlu (nekontrolované prejedanie sa, hyperfágia), nespavosťporuchy
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.
libida, nauzea, periférny edém, paranoja; patologické hráčstvo, hypersexualita a iné neobvyklé správanie; ospanlivosťzvýš telesnej hmotnosti, náhle upadnutie do spánku, svrbenie a vyráž a iná hypersenzitivita.
63% of patients on pramipexole and 52% of patients on placebo reported at least one adverse drug reaction.
63% pacientov už ívajúcich pramipexol a 52% pacientov už ívajúcich placebo hlásili aspoň jeden než iaduci účinok.
The most commonly (≥ reported adverse reactions in patients with Parkinson’ s disease more 5%) frequent with pramipexole treatment than with placebo were nausea, dyskinesia, hypotension, dizziness, somnolence, insomnia, constipation, hallucination, headache and fatigue.
(≥ u pacientov s Parkinsonovou chorobou boli nauzea, inky 5%)
The incidence of somnolence is increased at doses higher than 1.5 mg/ day (see section 4.2).
astejš pri lieč pramipexolom ako pri lieč placebom.
More frequent adverse drug
Výskyt ospanlivosti sa
5 reaction in combination with levodopa was dyskinesia.
zvyš pri dávkach vyš ako 1, 5 mg/ deň
Hypotension may occur at the beginning of treatment, especially if pramipexole is titrated too fast.
Na začiatku lieč sa môž objaviť pramipexol titrovaný príliš rýchlo.
The most commonly (≥
hypotenzia, najmä ak je
5%) reported adverse drug reactions in patients with other indication treated
Najč astejš hlásené (≥5%) než
with pramipexole were nausea, headache, dizziness and fatigue.
Nauzea a únava boli č astejš hlásené u ž lieč
Nausea and fatigue were more often reported in female patients (20.8% and 10.5%, respectively) compared to males (6.7% and 7.3%, respectively).
pramipexolom (20, 8%, respektíve 10, 5%) v porovnaní s muž (6, 7% respektíve 7, 3%). mi
Tables 1 and 2 display the frequency of adverse reactions from placebo-controlled clinical trials.
5 Tabuľ 1 a 2 zobrazujú frekvenciu výskytu než
The adverse reactions reported in these tables are those events that occurred in 1% or more of patients treated with pramipexole and were reported significantly more often in patients taking pramipexole than placebo, or where the event was considered clinically relevant.
kách sú tie, ktoré sa objavili u 1
However, the majority of common adverse reactions were mild to moderate, they usually start early in therapy, and most tended to disappear even as therapy was continued.
iatku lieč a väčinou mali tendenciu vymiznúťdokonca aj pri by š,
Table 1:
Tabuľ 1:
Very common Adverse Reactions (≥ 1/ 10) System organ class
1/ 10)
Adverse reaction
Než iaduce úč inky
Pramipexole N= 1,923 (%)
Pramipexol N= 1, 923 (%)
Dizziness Dyskinesia
Závraty Dyskinéza
Gastrointestinal disorders Vascular disorders
Poruchy a ochorenia gastrointestinálneho traktu
Nausea Hypotension
Cievne poruchy
17.2 12.6
Hypotenzia
Table 2:
Tabuľ 2:
Common Adverse Reactions (≥ 1/ 100 to < 1/ 10) System organ class
inky 1/ 100 až 1/ 10) < Zatriedenie podľ systémových Než orgánov
Adverse reaction
iaduce účinky
Abnormal dreams Confusional state Hallucinations Insomnia
Neobvyklé sny Stav zmätenosti Halucinácie Nespavosť
Somnolence Headache
Somnolencia Bolesť hlavy
Peripheral oedema
Periférny opuch
Pramipexole is associated with somnolence (8.6%) and has been associated uncommonly with excessive daytime somnolence and sudden sleep onset episodes (0.1%).
Pozri tiež asť
See also section 4.4.
č 4. 4.
Pramipexole may be associated with libido disorders (increased (0.1%) or decreased (0.4%)).
Pramipexol sa môž spájať poruchami libida (zvýš (0, 1%) alebo zníž (0, 4%) libido).
Patients treated with dopamine agonists for Parkinson’ s disease, including pramipexole, especially at high doses, have been reported as exhibiting signs of pathological gambling, increase libido and hypersexuality, generally reversible upon treatment discontinuation.
pramipexolu, hlavne pri ich vysokých dávkach preukazovali znaky patologického hráč zvýš stva, eného libida a hypersexuality, ktoré sú vo vš eobecnosti reverzibilné po preruš lieč ení by.
There is no clinical experience with massive overdose.
Oč
The expected adverse events would be those related to the pharmacodynamic profile of a dopamine agonist, including nausea, vomiting, hyperkinesia, hallucinations, agitation and hypotension.
farmakodynamickým profilom dopamínových agonistov, vrátane nauzey, vracania, hyperkinézy, halucinácií, nepokoja a hypotenzie.
There is no established antidote for overdose 6 of a dopamine agonist.
Pre predávkovanie dopamínovými agonistami nie je stanovená protilátka.
If signs of central nervous system stimulation are present, a neuroleptic agent may be indicated.
Ak sa vyskytnú príznaky stimulácie centrálneho nervového systému, môž byť podanie neuroleptík.
Management of the overdose may require general supportive measures, along with gastric lavage, intravenous fluids, administration of activated charcoal and electrocardiogram monitoring.
s výplachom ž alúdka, intravenóznym podaním tekutín, podaním aktívneho uhlia a monitorovaním EKG.
Pharmacotherapeutic group: dopamine agonists, ATC code:
Farmakoterapeutická skupina: agonisti dopamínu, ATC kód:
Pramipexole is a dopamine agonist that binds with high selectivity and specificity to the D2 subfamily of dopamine receptors of which it has a preferential affinity to D 3 receptors, and has full intrinsic activity.
Má plnú vnútornú aktivitu.
Pramipexole alleviates Parkinsonian motor deficits by stimulation of dopamine receptors in the striatum.
Pramipexol zmierň parkinsonovský motorický deficit stimuláciou dopamínových receptorov v uje striate.
Animal studies have shown that pramipexole inhibits dopamine synthesis, release, and turnover.
Pokusy na zvieratách ukázali, ž pramipexol inhibuje syntézu dopamínu, jeho vyluč premenu.
In human volunteers, a dose-dependent decrease in prolactin was observed.
níkov sa pozorovalo zníž sekrécie prolaktínu v závislosti od dávky. enie
Clinical trials in Parkinson’ s disease
Klinické š túdie Parkinsonovej choroby
In patients pramipexole alleviates signs and symptoms of idiopathic Parkinson 's disease.
U pacientov užívajúcich pramipexol sa zmiernili príznaky a symptómy idiopatickej Parkinsonovej choroby.
Controlled clinical trials included approximately 2100 patients of Hoehn and Yahr stages I – IV.
tádiu I – IV podľa
Out of these, approximately 900 were in more advanced stages, received concomitant levodopa therapy, and suffered from motor complications.
Okrem nich bolo približ 900 pacientov v pokroč ích š
In early and advanced Parkinson’ s disease, efficacy of pramipexole in the controlled clinical trials was maintained for approximately six months.
súč levodopu a mali motorické komplikácie. asne
In open continuation trials lasting for more than three years there were no signs of decreasing efficacy.
V otvorených pokrač
In a controlled double blind clinical trial of 2 year duration, initial treatment with pramipexole significantly delayed the onset of motor complications, and reduced their occurrence compared to initial treatment with levodopa.
V kontrolovanej dvojr oč dvojito zaslepenej š
This delay in motor complications with pramipexole should be balanced against a greater improvement in motor function with levodopa (as measured by the mean change in UPDRS-score).
Toto
The overall incidence of hallucinations and somnolence was generally higher in the escalation phase with the pramipexole group.
oddialenie nástupu motorických komplikácií pri pramipexole vyrovnáva výraznejš zlepšie
However there was no significant difference during the maintenance phase.
Tieto skutoč
These points should be considered when initiating pramipexole treatment in patients with Parkinson´s disease.
zváž, keďsa u pacientov s Parkinsonovou chorobou zač lieč pramipexolom.
The absolute bioavailability is greater than 90% and the maximum plasma concentrations occur between 1 and 3 hours.
Súč
Concomitant administration with food did not reduce the extent of pramipexole absorption, but the rate of absorption was reduced.
podanie s jedlom nezniž ovalo množ absorbovaného pramipexolu, ale zniž
In humans, the protein binding of pramipexole is very low (< 20%) and the volume of distribution is large (400 l).
U ľ je väzba pramipexolu na bielkoviny veľ nízka (< 20%) a distribuč objem je rozsiahly (400 l).
High brain tissue concentrations were observed in the rat (approx.
udí Vysoké koncentrácie v mozgovom tkanive sa
8-fold compared to plasma).
(približ 8- násobok koncentrácie v plazme). ne
Pramipexole is metabolised in man only to a small extent.
Pramipexol sa u ľ metabolizuje len v malom rozsahu. udí
Approximately 90% of 14 C-labelled dose is excreted through the kidneys while less than 2% is found in the faeces.
Celkový klírens pramipexolu
The total clearance of pramipexole is approximately 500 ml/ min and the renal clearance is approximately 400 ml/ min.
je približ 500 ml/ min a renálny klírens je približ 400 ml/ min.
The elimination half-life (t½) varies from 8 hours in the young to 12 hours in the elderly.
Eliminač polč (t¹/ 2) kolíš od 8
7 5.3 Preclinical safety data
7 U miniprasiat sa zaznamenalo zníž diastolického i systolického tlaku a pokles tepovej frekvencie. enie Sklon k hypotenznému úč sa zaznamenal u opíc. inku
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.
Pramipexol