natgillin/translations-raw huggingface dataset:
sníž dávek nebo ukonč léč Vzhledem k mož aditivním úč m je nutná opatrnost v
Patients who have experienced somnolence and/ or an episode of sudden sleep onset must refrain from driving or operating machines.
pramipexolem (viz bod 4. 7 a bod 4. 8).
Furthermore a reduction of dosage or termination of therapy may be considered.
Patologické hráč zvýš libido a hypersexualita byly hláš u pacientů Parkinsonovou nemocí
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).
Pacienti a lidé o ně ující by mě být upozorně
Pathological gambling, increased libido and hypersexuality have been reported in patients treated with dopamine agonists for Parkinson’ s disease, including pramipexole.
na skutečnost, ž se mohou objevit poruchy chování.
Furthermore, patients and caregivers should be aware of the fact that behavioural changes can occur.
Z dů
In case of severe cardiovascular disease, care should be taken.
12 Pokud se podává Oprymea v kombinaci s levodopou, doporuč se bě zvyš
12 that are inhibitors of this active renal elimination pathway or are eliminated by this pathway, such as cimetidine and amantadine, may interact with pramipex ole resulting in reduced clearance of either or both medicinal products.
Na základě analýzy souhrnu placebem kontrolovaných studií, které zahrnuly celkem 1923 pacientů léčených pramipexolem a 1354 pacientůléč ených placebem, byly v obou skupinách č hláš nežádoucí úč.
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.
63% pacientůléč
63% of patients on pramipexole and 52% of patients on placebo reported at least one adverse drug reaction.
ených pramipexolem a 52% pacientů ených placebem ohlásilo léč
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.
nejméně jeden nežádoucí úč po léku. inek
The incidence of somnolence is increased at doses higher than 1.5 mg/ day (see section 4.2).
Nejč ji (≥5%) hláš
More frequent adverse drug
enými než ádoucími úč u pacientů Parkinsonovou nemocí, č jšpo inky s
13 reaction in combination with levodopa was dyskinesia.
podání pramipexolu než podání placeba, byly nauzea, dyskineze, hypotenze, závratěsomnolence,
Hypotension may occur at the beginning of treatment, especially if pramipexole is titrated too fast.
Č jš než
The most commonly (≥
1, 5
5%) reported adverse drug reactions in patients with other indication treated
Velmi č než asté ádoucí úč (≥1/ 10) inky
Very common Adverse Reactions (≥ 1/ 10) System organ class
Viz
Pramipexole is associated with somnolence (8.6%) and has been associated uncommonly with excessive daytime somnolence and sudden sleep onset episodes (0.1%).
č také bod 4. 4.
See also section 4.4.
14 4. 9 Př edávkování
4.9 Overdose
Pro př př
The expected adverse events would be those related to the pharmacodynamic profile of a dopamine agonist, including nausea, vomiting, hyperkinesia, hallucinations, agitation and hypotension.
ípad edávkování agonistou dopaminu není stanovano ž
There is no established antidote for overdose 14 of a dopamine agonist.
, podáním aktivního uhlí a ilně
If signs of central nervous system stimulation are present, a neuroleptic agent may be indicated.
monitorováním elektrokardiogramu.
Management of the overdose may require general supportive measures, along with gastric lavage, intravenous fluids, administration of activated charcoal and electrocardiogram monitoring.
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 D 2 subfamily of dopamine receptors of which it has a preferential affinity to D 3 receptors, and has full intrinsic activity.
označ 14C je vylouč ledvinami, zatímco méně 2% se nachází ve stolici.
Approximately 90% of 14 C-labelled dose is excreted through the kidneys while less than 2% is found in the faeces.
Celková clearance
The total clearance of pramipexole is approximately 500 ml/ min and the renal clearance is approximat ely 400 ml/ min.
15 pramipexolu je př ně ml/ min a renální clearance je př ně ml/ min.
15 5.3 Preclinical safety data
nebyl teratogenní u potkanů králíků ale 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.
Krka, d. d., Novo mesto, Slovinsko 8.
KRKA, d. d., Novo mesto, Š marješ cesta 6, 8501 Novo mesto, Slovenia ka
REGISTRAČ Č
8.
NÍ ÍSLO( A)
MARKETING AUTHORISATION NUMBER(S)
EU/ 1/ 08/ 469/ 006 30 tablet:
EU/ 1/ 08/ 469/ 006 30 tablets:
EU/ 1/ 08/ 469/ 007 60 tablet:
EU/ 1/ 08/ 469/ 007 60 tablets:
EU/ 1/ 08/ 469/ 008 90 tablet:
EU/ 1/ 08/ 469/ 008 90 tablets:
EU/ 1/ 08/ 469/ 009 100 tablet:
EU/ 1/ 08/ 469/ 009 100 tablets:
Oprymea 0, 35 mg tablety
Oprymea 0.35 mg tablets
Jedna tableta obsahuje pramipexolum báze 0, 35 mg (ve forměpramipexoli dihydrochloridum monohydricum 0, 5 mg).
Each tablet contains 0.35 mg pramipexole base (as 0.5 mg pramipexole dihydrochloride monohydrate).
0, 35 mg: bílé, oválné, se zkosenými hranami, s pů rýhou na obou stranách a vyraž
0.35 mg: white, oval, with bevelled edges, both sides scored, with imprint "P8" on both halves of one side of the tablet.
18 Je vš tř poznamenat, ž výskyt somnolence narů př 4. 8).
18 However, it should be noted that the incidence of somnolence is increased at doses higher than 1.5 mg/ day (see section 4.8).
Pacienti musí inek by být informováni o možnosti výskytu halucinací (vě inou zrakových). tš
19 When prescribing Oprymea in a patient with Parkinson’ s disease with renal impairment a reduced dose is suggested in line with section 4.2.
Cimetidin sniž renální clearance pramipexolu př ně 34%, pravdě
20 Cimetidine reduced the renal clearance of pramipexole by approximately 34%, presumably by inhibition of the cationic secretory transport system of the renal tubules.
inhibují tuto aktivní renální vyluč ovací cestu anebo jsou touto cestou vylučovány, jako je cimetidin a amantadin, mohou interagovat s pramipexolem, což léčivých př ípravků Pokud jsou tyto léč př
Therefore, medicinal products 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.
nutno zváž sníž dávky pramipexolu.
Reduction of the pramipexole dose should be considered when these medicinal products are administered concomitantly.
přípravku Oprymea dávku levodopy sníž a dávkování jiných antiparkinsonik udrž konstantní.
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.
ených pramipexolem a 52% pacientů ených placebem ohlásilo léč
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,
nejméně jeden nežádoucí úč po léku. inek
21 dizziness, somnolence, insomnia, constipation, hallucination, headache and fatigue.
Nejč ji (≥5%) hláš
The incidence of somnolence is increased at doses higher than 1.5 mg/ day (see section 4.2).
enými než ádoucími úč u pacientů Parkinsonovou nemocí, č jšpo inky s
More frequent adverse drug reaction in combination with levodopa was dyskinesia.
Závratě Dyskineze
Dizziness Dyskinesia
15, 5 12, 9
15.5 12.9
Gastrointestinální poruchy
Gastrointestinal disorders Vascular disorders
Cévní poruchy
Nausea Hypotension
Hypotenze
17.2 12.6
Pro př př
22 There is no clinical experience with massive overdose.
Pokud jsou př ítomny příznaky stimulace centrálního nervového systému, můe být ž indikováno podání neuroleptického př ípravku.
The expected adverse events would be those related to the pharmacodynamic profile of a dopamine agonist, including nausea, vomiting, hyperkinesia, hallucinations, agitation and hypotension.
Zvládnutí předávkování můe vyž podpů opatř spolu s lavážž
There is no established antidote for overdose of a dopamine agonist.
í aludku, podáním tekutin nitrož, podáním aktivního uhlí a ilně
If signs of central nervous system stimulation are present, a neuroleptic agent may be indicated.
Pramipexol je agonista dopaminu, který se s vysokou selektivitou a specificitou váž 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.
než
The total
Eliminač poloč
23 clearance of pramipexole is approximately 500 ml/ min and the renal clearance is approximately 400 ml/ min.
23 5. 3 Př edklinické údaje vztahující se k bezpeč nosti
5.3 Preclinical safety data
nebyly nežádoucí
Pramipexole was not genotoxic.
úč pramipexolu na graviditu a samčplodnost úplně
In a carcinogenicity study, male rats developed Leydig cell hyperplasia and adenomas, explained by the prolactin-inhibiting effect of pramipexole.
objasně ny.
This finding is not clinically relevant to man.
Pramipexol nebyl genotoxický.
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.
Ve studii kancerogenity se vyvinula u samcůpotkanů Leydigových buně a adenomy, což vysvě prolaktin inhibič úč
The latter finding was not observed in pigmented rats, nor in a 2-year albino mouse carcinogenicity study or in any other species investigated.
se
6.
Toto
PHARMACEUTICAL PARTICULARS
Stejná studie též
6.1 List of excipients
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
Mannitol Maize starch Pregelatinised maize starch Povidone K25 Colloidal anhydrous silica Magnesium stearate
žádného jiného zkoumaného druhu.
6.2 Incompatibilities
FARMACEUTICKÉ ÚDAJE
Not applicable.
6. 1 Seznam pomocných látek
6.3 Shelf life
6. 2 Inkompatibility
2 years.
6. 3 Doba použ itelnosti
6.4 Special precautions for storage
6. 4 Zvláš opatř pro uchovávání
Store in the original package in order to protect from light.
Uchovávejte v původním obalu, aby byl př ípravek chráně př svě
6.5 Nature and contents of container
echen nepouž př itý ípravek nebo odpad musí být zlikvidován v souladu s místními pož adavky.
24 Any unused product or waste material should be disposed of in accordance with local requirements.
EU/ 1/ 08/ 469/ 011 30 tablet:
EU/ 1/ 08/ 469/ 011 30 tablets:
EU/ 1/ 08/ 469/ 012 60 tablet:
EU/ 1/ 08/ 469/ 012 60 tablets:
EU/ 1/ 08/ 469/ 013 90 tablet:
EU/ 1/ 08/ 469/ 013 90 tablets:
EU/ 1/ 08/ 469/ 014 100 tablet:
EU/ 1/ 08/ 469/ 014 100 tablets:
Oprymea 0, 7 mg tablety
Oprymea 0.7 mg tablets
Jedna tableta obsahuje pramipexolum báze 0, 7 mg (ve forměpramipexoli dihydrochloridum monohydricum 0, 1 mg).
Each tablet contains 0.7 mg pramipexole base (as 1 mg pramipexole dihydrochloride monohydrate).
e
3.
soli.
Tablet.
Z tohoto důvodu budou dávky uvádě jak pro bázi pramipexolu, tak i pro sůpramipexolu (v závorce).
0.70 mg: white, round, with bevelled edges, both sides scored, with imprint "P9" on both halves of one side of the tablet.
ny
4.
l
Oprymea is indicated 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).
Úplný seznam pomocných látek viz bod 6. 1.
4.2 Posology and method of administration
LÉKOVÁ FORMA
The daily dosage is administered in equally divided doses 3 times a day.
Tableta.
Providing patients do not experience intolerable side-effects, the dosage should be titrated to achieve a maximal therapeutic effect.
0, 7 mg: bílé, kulaté, se zkosenými hranami, s pů rýhou na obou stranách a vyraž
Ascending – Dose Schedule of OPRYMEA Week
lící
Dosage (mg of base)
eným symbolem
Total Daily Dose (mg of base)
„ P9 “ na obou polovinách jedné strany tablety.
Dosage (mg of salt)
Tabletu lze dě na dvě
Total Daily Dose (mg of salt)
lit
1 2 3
stejné poloviny.
3 x 0.088 3 x 0.18 3 x 0.35
KLINICKÉ ÚDAJE
0.264 0.54 1.1
4. 1 Terapeutické indikace
3 x 0.125 3 x 0.25 3 x 0.5
Př ípravek Oprymea je indikován k léč projevů př
0.375 0.75 1.50
bě
If a further dose increase is necessary the daily dose should be increased by 0.54 mg base (0.75 mg salt) at weekly intervals up to a maximum dose of 3.3 mg of base (4.5 mg of salt) per day.
idiopatické Parkinsonovy nemoci, buď
26 However, it should be noted that the incidence of somnolence is increased at doses higher than 1.5 mg/ day (see section 4.8).
samostatně
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.
(bez levodopy) nebo v kombinaci s levodopou, tj. v prů hu onemocně až pozdních bě ní do
Thereafter the dose should be reduced by 0.264 mg of base (0.375 mg of salt) per day (see section 4.4).
stádií, kdy se úč levodopy vytrácí nebo je promě
The following dosage schedule is suggested for initiation of therapy:
nlivý a kdy dochází k výkyvů
Patients with a creatinine clearance above 50 ml/ min require no reduction in daily dose.
léč m ebného efektu
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).
„ on- off “ kolísání). né
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.
4. 2 Dávkování a způ podání sob
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.
Denní dávka
However, the potential influence of hepatic insufficiency on Oprymea pharmacokinetics has not been investigated.
ívají
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.
ívat
Hypersensitivity to the active substance or to any of the excipients.
je podávána ve stejnomě rozdě
4.4 Special warnings and precautions for use
rně
Patients should be informed that (mostly visual) hallucinations can occur.
lených dávkách 3x denně
If they occur, the dose of levodopa should be decreased.
.
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).
Zahajovací léč ba
Dose reduction/ taper or discontinuation should be considered.
Dávky je tř zvyš postupně dých 5 - 7 dní od poč ní dávky 0, 264 mg báze (0, 375 mg
Patients with psychotic disorders should only be treated with dopamine agonists if the potential benefits outweigh the risks.
eba
Coadministration of antipsychotic medicinal products with pramipexole should be avoided (see section 4.5).
ovat
Ophthalmologic monitoring is recommended at regular intervals or if vision abnormalities occur.
kaž
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.
áteč
Symptoms suggestive of neuroleptic malignant syndrome have been reported with abrupt withdrawal of dopaminergic therapy (see section 4.2)
soli).
Reports in the literature indicate that treatment of another indication with dopaminergic medicinal products can result in augmentation.
Pokud pacienti netrpí ž ádnými neúnosnými nežádoucími úč inky, dávka by mě být titrována la tak, aby se dosáhlo maximálního terapeutického úč inku.
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.
Schéma zvyš ování dávky tablet př ípravku Oprymea Týden
4.5 Interaction with other medicinal products and other forms of interaction
Dávka (mg báze) Celková denní dávka (mg báze)
Pramipexole is bound to plasma proteins to a very low (< 20%) extent, and little biotransformation is seen in man.
Dávka (mg soli)
Therefore, medicinal products
Celková denní dávka (mg soli)
Reduction of the pramipexole dose should be considered when these medicinal products are administered concomitantly.
1 2 3
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.
3 x 0, 088 0, 264 3 x 0, 18 0, 54 3 x 0, 35 1, 1
Because of possible additive effects, caution should be advised when patients are taking other sedating medicinal products or alcohol in combination with pramipexole.
3 x 0, 125 3 x 0, 25 3 x 0, 5
Coadministration of antipsychotic medicinal products with pramipexole should be avoided (see section 4.4), e. g. if antagonistic effects can be expected.
0, 375 0, 75 1, 50
4.6 Pregnancy and lactation
Pokud je tř dávku dále zvýš je nutno denní dávku navyš o 0, 54 mg báze (0, 75 mg soli) v
Pramipexole was not teratogenic in rats and rabbits, but was embryotoxic in the rat at maternotoxic doses (see section 5.3).
eba
However, if its use is unavoidable, breast-feeding should be discontinued.
it,
4.7 Effects on ability to drive and use machines
týdenních intervalech až maximální dávky 3, 3 mg báze (4, 5 mg soli) denně
Oprymea can have a major influence on the ability to drive and use machines.
do
Hallucinations or somnolence can occur.
.
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).
26 Je vš tř poznamenat, ž výskyt somnolence narů př 4. 8).
4.8 Undesirable effects
ak
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.
eba e
63% of patients on pramipexole and 52% of patients on placebo reported at least one adverse drug reaction.
stá i dávkách vyších než mg/ den (viz bod š 1, 5
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.
Udrž ovací léč ba Jednotlivá dávka se má pohybovat v rozmezí od 0, 264 mg báze (0, 375 mg soli) do maximálně mg báze (4, 5 mg soli) denněBě zvyš. hem ování dávky ve tř pivotních studiích byla úč ech innost
More frequent adverse drug
pozorována od denní dávky 1, 1 mg báze (1, 5 mg soli).
29 reaction in combination with levodopa was dyskinesia.
Dalšúpravy dávky je nutno provést na základě í klinické odpově a výskytu než
Hypotension may occur at the beginning of treatment, especially if pramipexole is titrated too fast.
ádoucích úč.
The most commonly (≥
pacientů ibliž 5%
5%) reported adverse drug reactions in patients with other indication treated
léč dávkami nižími než mg (1, 5 mg soli).
with pramipexole were nausea, headache, dizziness and fatigue.
U pokroč Parkinsonovy nemoci mohou být dávky
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).
1, 1
Tables 1 and 2 display the frequency of adverse reactions from placebo-controlled clinical trials.
vyší než mg báze (1, 5 mg soli) denně iteč u pacientů kde se př
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.
už né,
Adverse reaction
edpokládá sníž dávky ení
Pramipexole N= 1,923 (%)
Doporuč se sniž dávkování levodopy jak bě zvyš
Nervous system disorders
ování dávek př
Dizziness Dyskinesia
ípravku
15.5 12.9
Oprymea, tak i bě udrž pacientů.
Gastrointestinal disorders Vascular disorders
ovací léč tímto př by
Nausea Hypotension
Př ení léč
17.2 12.6
eruš
Table 2:
Z
Common Adverse Reactions (≥ 1/ 100 to < 1/ 10) System organ class
eruš
Adverse reaction
by
Pramipexole N= 1,923 (%)
ž
Psychiatric disorders
tohoto dů vodu je tř pramipexol postupně
Abnormal dreams Confusional state Hallucinations Insomnia
eba
3.5 3.0 6.6 8.2
redukovat o 0, 54 mg báze (0, 75 mg soli) dennědo
Nervous system disorders
Poté je nutno dávku sniž o 0, 264 mg báze
Somnolence Headache
ovat
8.6 6.5
(viz
Gastrointestinal disorders
Dávkování u pacientů poruchou funkce ledvin s Vylučování pramipexolu je závislé na renální funkci.
Constipation
uje
5.5
U pacientů clearance kreatininu nad 50 ml/ min není tř sniž denní dávku.
General disorders and administration site conditions
eba
Fatigue
ovat
6.1
U pacientů clearance kreatininu mezi 20 a 50 ml/ min je nutno zahajovací denní dávku př
Peripheral oedema
s
1.9
Oprymea podat ve dvou rozdě lených dávkách, zpoč 0, 088 mg báze (0, 125 mg soli) dvakrát denně átku (0, 176 mg báze/ 0, 25 mg soli denně).
Pramipexole is associated with somnolence (8.6%) and has been associated uncommonly with excessive daytime somnolence and sudden sleep onset episodes (0.1%).
ípravku Oprymea podávat
See also section 4.4.
jednorázovězpoč v dávce 0, 088 mg báze (0, 125 mg soli) denně
Pramipexole may be associated with libido disorders (increased (0.1%) or decreased (0.4%)).
,
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.
uje hem
4.9 Overdose
ovací léč sniž denní dávku př by, te
There is no clinical experience with massive overdose.
stejné procento, o které klesla clearance kreatininu, tj. pokud clearance kreatininu poklesne o 30%, pak sniž denní dávku př
The expected adverse events would be those related to the pharmacodynamic profile of a dopamine agonist, including nausea, vomiting, hyperkinesia, hallucinations, agitation and hypotension.
ípravku Oprymea o 30%.
There is no established antidote for overdose 30 of a dopamine agonist.
Pokud je clearance kreatininu mezi 20 a
If signs of central nervous system stimulation are present, a neuroleptic agent may be indicated.
20
Management of the overdose may require general supportive measures, along with gastric lavage, intravenous fluids, administration of activated charcoal and electrocardiogram monitoring.
lených dávkách, pokud je clearance kreatininu niží š
PHARMACOLOGICAL PROPERTIES
Dávkování u pacientů poruchou funkce jater s
5.1 Pharmacodynamic properties
Úprava dávek u pacientůs poruchou funkce jater pravděpodobněnení nutná, protož př ně e ibliž 90% vstřebané léč látky je vyluč
Pharmacotherapeutic group: dopamine agonists, ATC code:
ováno ledvinami.
N04BC05.