natgillin/translations-raw huggingface dataset:
Pacienti musí inek by být informováni o možnosti výskytu halucinací (vě inou zrakových). tš
Patients should be informed that (mostly visual) hallucinations can occur.
titrace př ípravku Oprymea objevit dyskineze.
In advanced Parkinson’ s disease, in combination treatment with levodopa, dyskinesias can occur during the initial titration of Oprymea.
Pokud k tomu dojde, je tř sníž dávku levodopy. eba it
If they occur, the dose of levodopa should be decreased.
Pramipexol je spojován s výskytem somnolence a epizodami náhlého upadnutí do spánku, a to zejména u pacientů Parkinsonovou nemocí.
Pramipexole has been associated with somnolence and episodes of sudden sleep onset, particularly in patients with Parkinson’ s disease.
denních aktivit, v některých př ípadech si toho pacient nebyl vě čneměvarující př
Sudden onset of sleep during daily activities, in some cases without awareness or warning signs, has been reported uncommonly.
Pacienti musí být o této skuteč nosti informováni a upozorně na nutnou opatrnost přř nebo obsluze strojů hem léč př
Patients must be informed of this and advised to exercise caution while driving or operating machines during treatment with Oprymea.
Pacienti, kteřzaznamenali spavost a/ nebo í
Patients who have experienced somnolence and/ or an episode of sudden sleep onset must refrain from driving or operating machines.
epizody náhlého upadnutí do spánku, nesmí ř vozidla a obsluhovat stroje.
Furthermore a reduction of dosage or termination of therapy may be considered.
případech, kdy pacienti už jiné léky se sedativním úč
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).
Patologické hráč zvýš libido a hypersexualita byly hláš u pacientů Parkinsonovou nemocí
Pathological gambling, increased libido and hypersexuality have been reported in patients treated with dopamine agonists for Parkinson’ s disease, including pramipexole.
Pacienti a lidé o ně ující by mě být upozorně
Furthermore, patients and caregivers should be aware of the fact that behavioural changes can occur.
Je tř zváž sníž dávky čpostupné vysazení léčby.
Dose reduction/ taper or discontinuation should be considered.
Pacienti s psychotickým onemocně by mě být léč agonisty dopaminu pouze tehdy, pokud potenciální př př í rizika. ínos eváž
Patients with psychotic disorders should only be treated with dopamine agonists if the potential benefits outweigh the risks.
asnému podávání antipsychotických léků pramipexolem (viz bod 4. 5). s
Coadministration of antipsychotic medicinal products with pramipexole should be avoided (see section 4.5).
V pravidelných intervalech nebo v př ípaděporuchy zraku se doporuč oftalmologické kontroly. ují
Ophthalmologic monitoring is recommended at regular intervals or if vision abnormalities occur.
Z dů
In case of severe cardiovascular disease, care shou ld be taken.
posturální hypotenze spojené s dopaminergní léč se doporuč zejména na poč léč monitorovat krevní tlak.
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.
Zprávy z literatury naznač ž přléč dalšindikace dopaminergními léč
Symptoms suggestive of neuroleptic malignant syndrome have been reported with abrupt withdrawal of dopaminergic therapy (see section 4.2)
Augmentace se týká č jš nástupu symptomů er (nebo dokonce
Reports in the literature indicate that treatment of another indication with dopaminergic medicinal products can result in augmentation.
odpoledne), zvýš intenzity symptomů rozšení symptomů dalškonč
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.
augmentací po delš už ím íváním přípravku Oprymea a vhodné oš ení tě událostí nebylo etř chto hodnoceno v kontrolovaných klinických studiích.
The frequency of augmentation after longer use of pramipexole and the appropriate management of these events have not been evaluated in controlled clinical trials.
4. 5 Interakce s jinými léč ivými př ípravky a jiné formy interakce
4.5 Interaction with other medicinal products and other forms of interaction
Z tě
Pramipexole is bound to plasma proteins to a very low (< 20%) extent, and little biotransformation is seen in man.
léčivými přípravky, které ovlivň vazbu na plazmatické bílkoviny nebo vyluč
Therefore, interactions with other medicinal products affecting plasma protein binding or elimination by biotransformation are unlikely.
omezený, i když interakce s anticholinergiky nebyla studována.
As anticholinergics are mainly eliminated by biotransformation, the potential for an interaction is limited, although an interaction with anticholinergics has not been investigated.
Nedochází k ž ádným farmakokinetickým interakcím se selegilinem a levodopou.
There is no pharmacokinetic interaction with selegiline and levodopa.
Cimetidin sniž renální clearance pramipexolu př ně 34%, pravdě
Cimetidine reduced the renal clearance of pramipexole by approximately 34%, presumably by inhibition of the cationic secretory transport system of the renal tubules.
ivé ípravky, které
Therefore, medicinal products
4 Pokud se podává Oprymea v kombinaci s levodopou, doporuč se bě 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.
přípravku Oprymea dávku levodopy sníž a dávkování jiných antiparkinsonik udrž konstantní.
Reduction of the pramipexole dose should be considered when these medicinal products are administered concomitantly.
V případech, kdy pacienti už jiné léky se sedativním pů
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.
pramipexolem, je vzhledem k mož aditivním úč m nutná opatrnost.
Because of possible additive effects, caution should be advised when patients are taking other sedating medicinal products or alcohol in combination with pramipexole.
asnému podávání antipsychotických léků pramipexolem (viz bod 4. 4), např s.
Coadministration of antipsychotic medicinal products with pramipexole should be avoided (see section 4.4), e. g. if antagonistic effects can be expected.
jestliž můe být oč
4.6 Pregnancy and lactation
ekáván antagonistický úč inek.
The effect on pregnancy and lactation has not been investigated in humans.
Př
Pramipexole was not teratogenic in rats and rabbits, but was embryotoxic in the rat at maternotoxic doses (see section 5.3).
hem hotenství, pokud to není zcela nutné, tj. jen pokud
Oprymea should not be used during pregnancy unless clearly necessary, i. e. if the potential benefit justifies the potential risk to the foetus.
Protož léč pramipexolem u lidí sniž sekreci prolaktinu, oč
As pramipexole treatment inhibits secretion of prolactin in humans, inhibition of lactation is expected.
pramipexolu do mateř ského mléka nebylo u ž studováno.
The excretion of pramipexole into breast milk has not been studied in women.
ském mléce než plazměVzhledem k nedostatku údajů č ka by v. u lově
In rats, the concentration of active substance-related radioactivity was higher in breast milk than in plasma.
ípravek Oprymea podáván bě kojení, pokud je to mož Avš pokud hem né.
In the absence of human data, Oprymea should not be used during breast-feeding.
nevyhnutelné, je nutno kojení př it. eruš
However, if its use is unavoidable, breast-feeding should be discontinued.
4. 7 Úč inky na schopnost ř a obsluhovat stroje ídit
4.7 Effects on ability to drive and use machines
Př ípravek Oprymea můe mít velký vliv na schopnost ř a obsluhovat stroje.
Oprymea can have a major influence on the ability to drive and use machines.
obsluze strojů a to do té doby, dokud takové opakující se epizody a somnolence nevymizí (viz též), body 4. 4, 4. 5 a 4. 8).
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).
ípravku Oprymea se př
4.8 Undesirable effects
edém, paranoia; patologické hráč (gambling), hypersexualita nebo jiné abnormální chování; ství somnolence, zvýš tě ení lesné hmotnosti, náhlé upadnutí do spánku; pruritus a vyráž nebo jiné ka projevy hypersenzitivity.
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.
63% pacientůléč
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.
ených pramipexolem a 52% pacientů ených placebem ohlásilo léč
63% of patients on pramipexole and 52% of patients on placebo reported at least one adverse drug reaction.
podání pramipexolu než podání placeba, byly nauzea, dyskineze, hypotenze, závratěsomnolence,
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.
Incidence somnolence se zvyš s dávkami uje vyšími než mg/ den (viz bod 4. 2).
The incidence of somnolence is increased at doses higher than 1.5 mg/ day (see section 4.2).
Č jš než
More frequent adverse drug
1, 5
5 reaction in combination with levodopa was dyskinesia.
Hypotenze se můe vyskytnout na zač léč zvláš pokud je pramipexol titrován př rychle. íliš
Hypotension may occur at the beginning of treatment, especially if pramipexole is titrated too fast.
átku by,
The most commonly (≥
5 Nejč ji (≥5%) hláš
5%) reported adverse drug reactions in patients with other indication treated
pramipexolem byly nauzea, bolest hlavy, závratě únava.
with pramipexole were nausea, headache, dizziness and fatigue.
(20, 8% a 10, 5%, v tomto poř ve srovnání s muž( 6, 7% a 7, 3%, v tomto poř
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).
Tabulky 1 a 2 zobrazují frekvenci než ádoucích úč v placebem kontrolovaných klinických inků studiích.
Tables 1 and 2 display the frequency of adverse reactions from placebo-controlled clinical trials.
ípady, které se vyskytly u 1% a
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.
Nicméně tš č vě ina astých
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.
asté ádoucí úč (≥1/ 10) inky
Very common Adverse Reactions (≥ 1/ 10) System organ class
Tř orgánových ída Než ádoucí úč systémů
Adverse reaction
Pramipexol N = 1923 (%)
Pramipexole N= 1,923 (%)
Závratě Dyskineze Nauzea
Dizziness Dyskinesia
15, 5 12, 9 17, 2
15.5 12.9
Cévní poruchy
Gastrointestinal disorders Vascular disorders
Hypotenze
Nausea Hypotension
12, 6
17.2 12.6
Časté než ádoucí úč (≥1/ 100 až 1/ 10)
Common Adverse Reactions (≥ 1/ 100 to < 1/ 10) System organ class
Tř orgánových systémů ída Než ádoucí úč
Adverse reaction
Abnormální sny Stav zmatenosti
Abnormal dreams Confusional state Hallucinations Insomnia
Halucinace Insomnie
3.5 3.0 6.6 8.2
Somnolence Bolest hlavy
Somnolence Headache
8, 6 6, 5
8.6 6.5
Celkové a jinde nezař azené poruchy a lokální reakce po
General disorders and administration site conditions
a epizodami náhlého upadnutí do spánku (0, 1%).
Pramipexole is associated with somnolence (8.6%) and has been associated uncommonly with excessive daytime somnolence and sudden sleep onset episodes (0.1%).
Pramipexol můe být spojován s poruchami libida (zvýš (0, 1%) nebo sníž (0, 4%)).
Pramipexole may be associated with libido disorders (increased (0.1%) or decreased (0.4%)).
vysokých dávkách, byly hláš př eny ípady zjevných př íznakůpatologického hráč zvýš ství, eného libida a hypersexuality, které byly obvykle po př ení léč nebo sníž dávky reverzibilní.
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.
Př edávkování
4.9 Overdose
Nejsou ž ádné klinické zkuš enosti s masivním př edávkováním.
There is no clinical experience with massive overdose.
vztah k farmakodynamickému profilu agonistůdopaminu, vč nauzey, zvracení, hyperkineze, etně
The expected adverse events would be those related to the pharmacodynamic profile of a dopamine agonist, including nausea, vomiting, hyperkinesia, hallucinations, agitation and hypotension.
6 halucinací, agitace a hypotenze.
There is no established antidote for overdose 6 of a dopamine agonist.
Pro př př ípad edávkování agonistou dopaminu není stanovano ž ádné antidotum.
If signs of central nervous system stimulation are present, a neuroleptic agent may be indicated.
Zvládnutí předávkování můe vyž podpů opatř spolu s lavážž
Management of the overdose may require general supportive measures, along with gastric lavage, intravenous fluids, administration of activated charcoal and electrocardiogram monitoring.
N04BC05
N04BC05.
Pramipexol je agonista dopaminu, který se s vysokou selektivitou a specificitou vá ž na dopaminové e receptory podskupiny D2, z nichž př má ednostní afinitu k receptorů D3, a má plnou vnitř aktivitu.
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.
Pramipexol zmírň parkinsonické motorické deficity stimulací receptorů
Pramipexole alleviates Parkinsonian motor deficits by stimulation of dopamine receptors in the striatum.
na zvířatech ukázaly, ž pramipexol inhibuje syntézu dopaminu, jeho uvolň
Animal studies have shown that pramipexole inhibits dopamine synthesis, release, and turnover.
U zdravých dobrovolníků pozorován pokles prolaktinu závislý na dávce. byl
In human volunteers, a dose-dependent decrease in prolactin was observed.
Klinické studie u Parkinsonovy nemoci Pramipexol u pacientů klinické studie zahrnuly
Clinical trials in Parkinson’ s disease
Kontrolované
In patients pramipexole alleviates signs and symptoms of idiopathic Parkinson 's disease.
V této ve skupině
Controlled clinical trials included approximately 2100 patients of Hoehn and Yahr stages I – IV.
bylo př ně pacientův pokroč ích stádiích a ti byli souč ibliž 900 ilejš
Out of these, approximately 900 were in more advanced stages, received concomitant levodopa therapy, and suffered from motor complications.
trvala dva roky, zahájení léč pramipexolem významně
In early and advanced Parkinson’ s disease, efficacy of pramipexole in the controlled clinical trials was maintained for approximately six months.
Toto oddálení motorických
In open continuation trials lasting for more than three years there were no signs of decreasing efficacy.
5. 2 Farmakokinetické vlastnosti
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.
Pramipexol je po perorálním podání rychle a kompletně je vyší než
However there was no significant difference during the maintenance phase.
Absolutní biologická dostupnost
5.2 Pharmacokinetic properties
š
Pramipexole is rapidly and completely absorbed following oral administration.
Souč
The absolute bioavailability is greater than 90% and the maximum plasma concentrations occur between 1 and 3 hours.
podávání s jídlem nesníž rozsah absorpce pramipexolu, ale rychlost absorpce byla sníž
Concomitant administration with food did not reduce the extent of pramipexole absorption, but the rate of absorption was reduced.
U č ka je vazba pramipexolu na proteiny velmi nízká (< 20%) a distribuč objem je vysoký (400
In humans, the protein binding of pramipexole is very low (< 20%) and the volume of distribution is large (400 l).
U potkanů byly pozorovány vysoké koncentrace v mozku (př něibliž osminásobné ve srovnání s plazmou).
8-fold compared to plasma).
Pramipexol je u č ka metabolizován pouze v malé míř
Pramipexole is metabolised in man only to a small extent.
Př ně
Renal excretion of unchanged pramipexole is the major route of elimination.
Celková clearance
Approximately 90% of 14 C-labelled dose is excreted through the kidneys while less than 2% is found in the faeces.
Eliminač poloč
The total clearance of pramipexole is approximately 500 ml/ min and the renal clearance is approximately 400 ml/ min.
(t ½) kolísá od 8 hodin u mladých jedincůdo 12 hodin u starš jedinců
The elimination half-life (t½) varies from 8 hours in the young to 12 hours in the elderly.
7 5. 3 Př edklinické údaje vztahující se k bezpeč nosti
7 5.3 Preclinical safety data
Studie toxicity po opakovaných dávkách ukázaly, ž pramipexol ovlivň funkce zejména v oblasti CNS a reprodukč systému samic, které pravdě
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.
Poklesy diastolického a systolického tlaku a srdeč frekvence byly zaznamenány u miniprasat, a u ní opic byl zaznamenán sklon k hypotenznímu úč
Decreases in diastolic and systolic pressure and heart rate were noted in the mini pig, and a tendency to an hypotensive effect was discerned in the monkey.
Mož úč pramipexolu na reprodukč funkci byly zkoumány u potkanůa králíkůPramipexol
The potential effects of pramipexole on reproductive function have been investigated in rats and rabbits.
nebyl teratogenní u potkanů králíkůale byl embryotoxický u potkanův dávkách toxických pro
Pramipexole was not teratogenic in rats and rabbits but was embryotoxic in the rat at maternally toxic doses.
Vzhledem k selekci zvíř ecích druhů omezení zkoumaných parametrů
Due to the selection of animal species and the limited parameters investigated, the adverse effects of pramipexole on pregnancy and male fertility have not been fully elucidated.
Ve studii kancerogenity se vyvinula u samcůpotkanů Leydigových buně a adenomy, což vysvě prolaktin inhibič úč
In a carcinogenicity study, male rats developed Leydig cell hyperplasia and adenomas, explained by the prolactin-inhibiting effect of pramipexole.
Toto
This finding is not clinically relevant to man.
ukázala, ž v dávce 2 mg/ kg (soli) a vyší e š
The same study also showed that, at doses of 2 mg/ kg (of salt) and higher, pramipexole was associated with retinal degeneration in albino rats.
byl pramipexol spojen s degenerací sítnice u albinotických potkanůPoslední nález nebyl pozorován. ani u pigmentovaných potkanů ani ve dvouleté studii kancerogenity u albinotických myš ani u
The latter finding was not observed in pigmented rats, nor in a 2-year albino mouse carcinogenicity study or in any other species investigated.
mannitol kukuř ný š ič krob předbobtnalý kukuř ný š ič krob povidon 25 koloidní bezvodý oxid kř itý emič magnesium- stearát
Mannitol Maize starch Pregelatinised maize starch Povidone K25 Colloidal anhydrous silica Magnesium stearate
Neuplatň se uje
Not applicable.
6. 3 Doba použ itelnosti
6.3 Shelf life
6. 4 Zvláš opatř pro uchovávání
6.4 Special precautions for storage
Uchovávejte v původním obalu, aby byl př ípravek chráně př svě
Store in the original package in order to protect from light.
Blistr (Al/ hliníková fólie):
Blister pack (Al/ Al foil):
20, 30, 60, 90 nebo 100 tablet.
20, 30, 60, 90 or 100 tablets.
Na trhu nemusí být vš echny velikosti balení.
Not all pack sizes may be marketed.
6. 6 Zvláš opatř pro likvidaci př
6.6 Special precautions for disposal
echen nepouž př itý ípravek nebo odpad musí být zlikvidován v souladu s místními pož adavky.
Any unused product or waste material should be disposed of in accordance with local requirements.
REGISTRAČ Č NÍ ÍSLO( A)
MARKETING AUTHORISATION NUMBER(S)
20 tablet:
20 tablets:
EU/ 1/ 08/ 469/ 001 30 tablet:
EU/ 1/ 08/ 469/ 001 30 tablets:
EU/ 1/ 08/ 469/ 002 60 tablet:
EU/ 1/ 08/ 469/ 002 60 tablets:
EU/ 1/ 08/ 469/ 003 90 tablet:
EU/ 1/ 08/ 469/ 003 90 tablets:
EU/ 1/ 08/ 469/ 004 100 tablet:
EU/ 1/ 08/ 469/ 004 100 tablets:
Podrobné informace o tomto př ípravku získáte na webových stránkách Evropské lékové agentury (EMEA): http: // www. emea. europa. eu /.
Detailed information on this medicinal product is available on the website of the European Medicines Agency (EMEA) http: / /www. emea. europa. eu/.
Oprymea 0, 18 mg tablety
Oprymea 0.18 mg tablets
Jedna tableta obsahuje pramipexolum báze 0, 18 mg (ve forměpramipexoli dihydrochloridum monohydricum 0, 25 mg).
Each tablet contains 0.18 mg pramipexole base (as 0.25 mg pramipexole dihydrochloride monohydrate).
0, 18 mg: bílé, oválné, se zkosenými hranami, s pů rýhou na obou stranách a vyraž
0.18 mg: white, oval, with bevelled edges, both sides scored, with imprint "P7" on both halves of one side of the tablet.
stejné poloviny.
The tablet can be divided into equal halves.
10 Je vš tř poznamenat, ž výskyt somnolence narů př 4. 8).
10 However, it should be noted that the incidence of somnolence is increased at doses higher than 1.5 mg/ day (see section 4.8).
Pokud je clearance kreatininu mezi 20 a
In patients with a creatinine clearance less than 20 ml/ min, the daily dose of Oprymea shou ld be administered in a single dose, starting at 0.088 mg of base (0.125 mg of salt) daily.
Hypersenzitivita na léč látku nebo na kteroukoli pomocnou látku tohoto př
Hypersensitivity to the active substance or to any of the excipients.
doporuč sníž dávky v souladu s bodem 4. 2.
4.4 Special warnings and precautions for use
Pacienti musí inek by být informováni o možnosti výskytu halucinací (vě inou zrakových). tš
11 When prescribing Oprymea in a patient with Parkinson’ s disease with renal impairment a reduced dose is suggested in line with section 4.2.
titrace př ípravku Oprymea objevit dyskineze.
Hallucinations are known as a side-effect of treatment with dopamine agonists and levodopa.
Pokud k tomu dojde, je tř sníž dávku levodopy. eba it
Patients should be informed that (mostly visual) hallucinations can occur.
Pramipexol je spojován s výskytem somnolence a epizodami náhlého upadnutí do spánku, a to zejména u pacientů Parkinsonovou nemocí.
In advanced Parkinson’ s disease, in combination treatment with levodopa, dyskinesias can occur during the initial titration of Oprymea.
Méně asto byl hláš náhlý nástup spánku bě
If they occur, the dose of levodopa should be decreased.
denních aktivit, v některých př ípadech si toho pacient nebyl vě čneměvarující př
Pramipexole has been associated with somnolence and episodes of sudden sleep onset, particularly in patients with Parkinson’ s disease.
Pacienti, kteřzaznamenali spavost a/ nebo í
Sudden onset of sleep during daily activities, in some cases without awareness or warning signs, has been reported uncommonly.
Dále je nutno zváž
Patients must be informed of this and advised to exercise caution while driving or operating machines during treatment with Oprymea.