natgillin/translations-raw huggingface dataset:
Reduction of the pramipexole dose should be considered when these medicinal products are administered concomitantly.
În cazul administră concomitente a acestor medicamente, trebuie avută vedere reducerea dozei de pramipexol.
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.
20 Când Oprymea este administrat în asociere cu levodopa, se recomandă doza de levodopa să redusăiar doza altor medicamente antiparkinsoniene să menţ
Because of possible additive effects, caution should be advised when patients are taking other sedating medicinal products or alcohol in combination with pramipexole.
Datorităposibilelor efecte aditive, se recomandăprudenţîn cazul în care pacienţ sunt trataţ alte
Coadministration of antipsychotic medicinal products with pramipexole should be avoided (see section 4.4), e. g. if antagonistic effects can be expected.
Trebuie evitatăadministrarea concomitentă medicamente antipsihotice şpramipexol (vezi pct.
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.
Din analiza datelor obţinute din studiile clinice controlate cu placebo, cuprinzând un numă de 1923 r pacienţi trataţ pramipexol ş1354 pacienţcă li s- a administrat placebo, a rezultat că fost
63% of patients on pramipexole and 52% of patients on placebo reported at least one adverse drug reaction.
63% dintre pacienţ că li s- a administrat
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.
Cele mai frecvente (≥ 5%) reacţ adverse raportate la pacienţ cu boală
The incidence of somnolence is increased at doses higher than 1.5 mg/ day (see section 4.2).
crescută doze mai mari de 1, 5 mg/ zi (vezi pct. 4. 2).
More frequent adverse drug
Reacţ adverse mai frecvente în cazul asocierii
29 reaction in combination with levodopa was dyskinesia.
cu levodopa au fost dischineziile.
Hypotension may occur at the beginning of treatment, especially if pramipexole is titrated too fast.
La începutul tratamentului poate săapară hipotensiune arterialăîn, special dacă doza de pramipexol este crescută prea repede.
The most commonly (≥
21 Cele mai frecvente (≥5%) reacţ adverse raportate la pacienţ trataţ pramipexol pentru altă
5%) reported adverse drug reactions in patients with other indication treated
i cu
with pramipexole were nausea, headache, dizziness and fatigue.
indicaţ au fost greaţ cefalee, ameţ şobosealăGreaţşoboseala au fost raportate mai des la
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).
pacienţ de sex feminin (20, 8% şrespectiv 10, 5%) comparativ cu bă ii (6, 7% şrespectiv 7, 3%)
There is no established antidote for overdose 30 of a dopamine agonist.
Dacă
Management of the overdose may require general supportive measures, along with gastric lavage, intravenous fluids, administration of activated charcoal and electrocardiogram monitoring.
22 generale de susţ inere, lavaj gastric, administrare intravenoasă lichide, administrare de că activat
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.
subfamilia D2 a receptorilor pentru dopaminăavând o afinitate preponderentă activitate intrinsecă totală.
The total clearance of pramipexole is approximately 500 ml/ min and the renal clearance is approximat ely 400 ml/ min.
Clearance- ul total al pramipexolului este de aproximativ 500 ml/ min, iar clearance- ul renal de aproximativ 400 ml/ min.
31 5.3 Preclinical safety data
23 5. 3 Date preclinice de siguranţ ă
Any unused product or waste material should be disposed of in accordance with local requirements.
Fă cerinţ speciale. ră e
32 7.
24 7.
EU/ 1/ 08/ 469/ 016 30 tablets:
EU/ 1/ 08/ 469/ 011 30 comprimate:
EU/ 1/ 08/ 469/ 017 60 tablets:
EU/ 1/ 08/ 469/ 012 60 comprimate:
EU/ 1/ 08/ 469/ 018 90 tablets:
EU/ 1/ 08/ 469/ 013 90 comprimate:
EU/ 1/ 08/ 469/ 019 100 tablets:
EU/ 1/ 08/ 469/ 014 100 comprimate:
EU/ 1/ 08/ 469/ 020
EU/ 1/ 08/ 469/ 015
Oprymea 1.1 mg tablets
Oprymea 0, 7 mg comprimate
Each tablet contains 1.1 mg pramipexole base (as 1.5 mg pramipexole dihydrochloride monohydrate).
Fiecare comprimat conţ pramipexol bază mg (sub formă diclorhidrat de pramipexol monohidrat 1 mg).
1.1 mg: white, round, with bevelled edges, both sides scored.
0, 70 mg: comprimate de culoare albărotunde, cu margini teş cu linie mediană ambele feţ
34 However, it should be noted that the incidence of somnolence is increased at doses higher than 1.5 mg/ day (see section 4.8).
ionat căincidenţ somnolenţ creş la doze mai mari de 1, 5 mg pe zi (vezi pct. a ei te
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).
reducerea dozei zilnice.
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.
La pacienţ cu clearance al creatininei între 20 ş50 ml/ min, doza zilnică ială Oprymea trebuie
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%.
în
Dosing in patients with hepatic impairment Dose adjustment in patients with hepatic failure is probably not necessary, as approx.
prize, începând cu 0, 088 mg bază
90% of absorbed active substance is excreted through the kidneys.
(0, 125 mg sare) de două
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.
pe zi (0, 17 mg ori
4.3 Contraindications
bază / 0, 25 mg sare pe zi).
Hypersensitivity to the active substance or to any of the excipients.
La pacienţ cu clearance al creatininei sub 20 ml/ min, doza zilnică Oprymea se administrează
4.4 Special warnings and precautions for use
priză unicăîncepând cu 0, 088 mg bază
35 When prescribing Oprymea in a patient with Parkinson’ s disease with renal impairment a reduced dose is suggested in line with section 4.2.
,
Patients should be informed that (mostly visual) hallucinations can occur.
(0, 125 mg sare) pe zi.
In advanced Parkinson’ s disease, in combination treatment with levodopa, dyskinesias can occur during the initial titration of Oprymea.
Dacă funcţ renală alterează parcursul tratamentului de întreţ
If they occur, the dose of levodopa should be decreased.
inere, doza zilnică
Sudden onset of sleep during daily activities, in some cases without awareness or warning signs, has been reported uncommonly.
trebuie redusă acelaşprocentaj cu cel cu care scade funcţ renalăde exemplu, dacă
Patients must be informed of this and advised to exercise caution while driving or operating machines during treatment with Oprymea.
clearance- ul
Furthermore, patients and caregivers should be aware of the fact that behavioural changes can occur.
creatininei scade cu 30%, atunci doza zilnică Oprymea trebuie redusă 30%.
Dose reduction/ taper or discontinuation should be considered.
Dacă creatininei este cuprins între 20 ş50 ml/ min,
Patients with psychotic disorders should only be treated with dopamine agonists if the potential benefits outweigh the risks.
de doza zilnică
Coadministration of antipsychotic medicinal products with pramipexole should be avoided (see section 4.5).
cu
Ophthalmologic monitoring is recommended at regular intervals or if vision abnormalities occur.
clearance- ul
In case of severe cardiovascular disease, care should be taken.
i
Symptoms suggestive of neuroleptic malignant syndrome have been reported with abrupt withdrawal of dopaminergic therapy (see section 4.2)
poate fi divizată
Reports in the literature indicate that treatment of another indication with dopaminergic medicinal products can result in augmentation.
două în
4.5 Interaction with other medicinal products and other forms of interaction
prize, iar dacă
Pramipexole is bound to plasma proteins to a very low (< 20%) extent, and little biotransformation is seen in man.
clearance- ul creatininei este sub 20 ml/ min, sub formă doză
Therefore, interactions with other medicinal products affecting plasma protein binding or elimination by biotransformation are unlikely.
Administrarea la pacienţ cu insuficienţhepatică ii ă La pacienţ cu insuficienţhepatică
As anticholinergics are mainly eliminated by biotransformation, the potential for an interaction is limited, although an interaction with anticholinergics has not been investigated.
ajustarea dozei probabil nu este necesarădeoarece aproximativ,
There is no pharmacokinetic interaction with selegiline and levodopa.
absorbităeste excretată cale renalăTotuş influenţinsuficienţ hepatice pe. i, a ei
Cimetidine reduced the renal clearance of pramipexole by approximately 34%, presumably by inhibition of the cationic secretory transport system of the renal tubules.
asupra farmacocineticii Oprymea nu a fost practic investigată.
Therefore, medicinal products
Administrarea la copii şadolescenţ
36 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.
Oprymea nu este recomandat pentru utilizare la copii şadolescenţ vârsta sub 18 ani, datorită datelor privind siguranţşeficacitatea. ai
Reduction of the pramipexole dose should be considered when these medicinal products are administered concomitantly.
Hipersensibilitate la substanţ activă la oricare dintre excipienţ medicamentului.
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.
ii
Because of possible additive effects, caution should be advised when patients are taking other sedating medicinal products or alcohol in combination with pramipexole.
4. 4 Atenţ ri speciale şprecauţ pentru utilizare
Coadministration of antipsychotic medicinal products with pramipexole should be avoided (see section 4.4), e. g. if antagonistic effects can be expected.
şinsuficienţrenală recomandă i ă se reducerea dozei de Oprymea, aş a
4.6 Pregnancy and lactation
4. 2.
The effect on pregnancy and lactation has not been investigated in humans.
Halucinaţ sunt cunoscute ca reacţ adversă tratamentul cu agoniş dopaminergici şlevodopa.
Pramipexole was not teratogenic in rats and rabbits, but was embryotoxic in the rat at maternotoxic doses (see section 5.3).
i asupra posibilită apariţ halucinaţ (mai ales vizuale). ţii iei iilor
Oprymea should not be used during pregnancy unless clearly necessary, i. e. if the potential benefit justifies the potential risk to the foetus.
În stadiile avansate ale bolii Parkinson, în timpul creş iniţ a dozei de Oprymea administrat în
As pramipexole treatment inhibits secretion of prolactin in humans, inhibition of lactation is expected.
În această
The excretion of pramipexole into breast milk has not been studied in women.
situaţ doza de levodopa trebuie redusă ie,.
In rats, the concentration of active substance-related radioactivity was higher in breast milk than in plasma.
Pramipexol a fost asociat cu somnolenţşepisoade de somn cu instalare bruscămai ales la pacienţ
In the absence of human data, Oprymea should not be used during breast-feeding.
Instalarea bruscă
However, if its use is unavoidable, breast-feeding should be discontinued.
somnului în timpul activită zilnice, în unele cazuri fă a fi a ţilor
4.7 Effects on ability to drive and use machines
conş sau fă semne de avertizare, a fost raportată puţ frecvent.
Oprymea can have a major influence on the ability to drive and use machines.
asupra acestui fapt şavertizaţ manifeste prudenţatunci când conduc vehicule sau lucrează
Hallucinations or somnolence can occur.
utilaje în timpul tratamentului cu Oprymea.
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).
ii
4.8 Undesirable effects
ă i/ sau episoade de
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.
somn cu instalare bruscă trebuie avută vedere micş
63% of patients on pramipexole and 52% of patients on placebo reported at least one adverse drug reaction.
În plus,
The incidence of somnolence is increased at doses higher than 1.5 mg/ day (see section 4.2).
orarea dozei sau întreruperea tratamentului.
More frequent adverse drug
Datorită posibilelor efecte
37 reaction in combination with levodopa was dyskinesia.
aditive, se recomandă
Hypotension may occur at the beginning of treatment, especially if pramipexole is titrated too fast.
prudenţîn cazul în care pacienţ sunt trataţ ă ii
The most commonly (≥
i concomitent cu alte medicamente
5%) reported adverse drug reactions in patients with other indication treated
4. 8)
with pramipexole were nausea, headache, dizziness and fatigue.
Dependenţ patologică jocurile de noroc, creş
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).
de
Tables 1 and 2 display the frequency of adverse reactions from placebo-controlled clinical trials.
terea libidoului şhipersexualitatea au fost raportate i
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.
În plus,
Very common Adverse Reactions (≥ 1/ 10) System organ class
pacienţ şpersonalul medical trebuie să conş i de faptul că să
Adverse reaction
modifică de ri
Pramipexole N= 1,923 (%)
comportament.
Nervous system disorders
orarea dozei / întreruperea tratamentului prin
Dizziness Dyskinesia
beneficiile
15.5 12.9
4. 5).
Gastrointestinal disorders Vascular disorders
În cazul existenţ bolilor cardiovasculare severe, se recomandă
Nausea Hypotension
prudenţ Se recomandă ă.
17.2 12.6
monitorizarea
Table 2:
4. 2). a
Common Adverse Reactions (≥ 1/ 100 to < 1/ 10) System organ class
Datele din literaturăindicăfaptul căîn cazul altei indicaţ tratamentul cu medicamente
Adverse reaction
,
Pramipexole N= 1,923 (%)
ii,
Psychiatric disorders
Exacerbarea se referă declanş
Abnormal dreams Confusional state Hallucinations Insomnia
la
3.5 3.0 6.6 8.2
area
Nervous system disorders
simptomelor seara mai devreme (sau chiar după
Somnolence Headache
amiaza), la accentuarea simptomelor şla
8.6 6.5
extinderea i
Gastrointestinal disorders
simptomelor spre alte extremită În studiile clinice controlate nu s- a evaluat frecvenţexacerbă
Constipation
ţ i.
5.5
rii
General disorders and administration site conditions
după administrare prelungită pramipexolului şgestionarea corespunză
Fatigue
a
Peripheral oedema
toare a acestor evenimente.
1.9
iune
Pramipexole is associated with somnolence (8.6%) and has been associated uncommonly with excessive daytime somnolence and sudden sleep onset episodes (0.1%).
La om, pramipexolul se leagă proteinele plasmatice într- o proporţ foarte mică 20%),
See also section 4.4.
(<
Pramipexole may be associated with libido disorders (increased (0.1%) or decreased (0.4%)).
biotransformarea fiind redusăDe aceea, sunt improbabile interacţ cu alte medicamente care
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.
.
4.9 Overdose
iuni
There is no clinical experience with massive overdose.
afectează legarea de proteinele plasmatice sau eliminarea prin biotransformare.
The expected adverse events would be those related to the pharmacodynamic profile of a dopamine agonist, including nausea, vomiting, hyperkinesia, hallucinations, agitation and hypotension.
Deoarece anticolinergicele sunt eliminate mai ales prin biotransformare, posibilitatea interacţiunilor este redusă, deşinteracţ i iunile cu anticolinergice nu au fost practic investigate.
There is no established antidote for overdose 38 of a dopamine agonist.
Nu existăinteracţiuni farmacocinetice cu selegilina sau cu levodopa.
If signs of central nervous system stimulation are present, a neuroleptic agent may be indicated.
Cimetidina reduce clearance- ul renal al pramipexolului cu aproximativ 34%, probabil datorită
Management of the overdose may require general supportive measures, along with gastric lavage, intravenous fluids, administration of activated charcoal and electrocardiogram monitoring.
De aceea, medicamentele care i inhibă calea activă eliminare renală sunt eliminate pe această
5.
de
5.1 Pharmacodynamic properties
sau
N04BC05.
cale, cum sunt cimetidina şi
Pramipexole alleviates Parkinsonian motor deficits by stimulation of dopamine receptors in the striatum.
amantadina, pot interacţ cu pramipexolul, cu reducerea clearance- ului unuia sau al ambelor iona medicamente.
Animal studies have shown that pramipexole inhibits dopamine synthesis, release, and turnover.
În cazul administră concomitente a acestor medicamente, trebuie avută vedere reducerea dozei de pramipexol.
In human volunteers, a dose-dependent decrease in prolactin was observed.
28 Când Oprymea este administrat în asociere cu levodopa, se recomandă doza de levodopa să redusăiar doza altor medicamente antiparkinsoniene să menţ
Clinical trials in Parkinson’ s disease
inutăconstantă perioada în care în
In patients pramipexole alleviates signs and symptoms of idiopathic Parkinson 's disease.
doza de Oprymea este crescută.
Out of these, approximately 900 were in more advanced stages, received concomitant levodopa therapy, and suffered from motor complications.
Datorităposibilelor efecte aditive, se recomandăprudenţîn cazul în care pacienţ sunt trataţ alte
In open continuation trials lasting for more than three years there were no signs of decreasing efficacy.
medicamente sedative sau consumă uturi alcoolice în timpul tratamentului cu pramipexol. bă
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).
Trebuie evitatăadministrarea concomitentă medicamente antipsihotice şpramipexol (vezi pct.
The overall incidence of hallucinations and somnolence was generally higher in the escalation phase with the pramipexole group.
i
However there was no significant difference during the maintenance phase.
4. 4), de exemplu dacăsunt de aşteptat efecte antagoniste.
5.2 Pharmacokinetic properties
4. 6 Sarcina şală
Pramipexole is rapidly and completely absorbed following oral administration.
Efectul asupra sarcinii şală rii nu a fost investigat la om.
Pramipexole shows linear kinetics and a small inter-patient variation of plasma levels.
Pramipexolul nu a demonstrat potenţ
In humans, the protein binding of pramipexole is very low (< 20%) and the volume of distribution is large (400 l).
teratogen la ş obolan şiepure, dar s- a dovedit embriotoxic la ş
High brain tissue concentrations were observed in the rat (approx.
obolan în doze materno- toxice (vezi
8-fold compared to plasma).
pct. 5. 3).
Pramipexole is metabolised in man only to a small extent.
Deoarece Oprymea inhibă Oprymea în laptele matern
Approximately 90% of 14 C-labelled dose is excreted through the kidneys while less than 2% is found in the faeces.
La ş
The total clearance of pramipexole is approximately 500 ml/ min and the renal clearance is approximately 400 ml/ min.
la
39 5.3 Preclinical safety data
obolan, concentraţ de substanţactivă ia ă
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.
marcatăradioactiv a fost mai mare în lapte decât în plasmăÎn absenţdatelor disponibile la om,
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.
a
The potential effects of pramipexole on reproductive function have been investigated in rats and rabbits.
Oprymea nu trebuie administrată perioada ală rii.
Pramipexole was not teratogenic in rats and rabbits but was embryotoxic in the rat at maternally toxic doses.
Totuş dacă recomandă întreruperea ală rii. ptă
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.
i,
Pramipexole was not genotoxic.
tratamentul este absolut necesar, se
In a carcinogenicity study, male rats developed Leydig cell hyperplasia and adenomas, explained by the prolactin-inhibiting effect of pramipexole.
4. 7 Efecte asupra capacităii de a conduce vehicule şde a folosi utilaje
This finding is not clinically relevant to man.
Oprymea poate avea o influenţmajoră Pot să apară halucinaţ şsomnolenţ
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.
asupra capacităii de a conduce vehicule şde a folosi utilaje. ţ i
The latter finding was not observed in pigmented rats, nor in a 2-year albino mouse carcinogenicity study or in any other species investigated.
Pacienţ aflaţ tratament cu Oprymea şcare prezintă
6.
ii
PHARMACEUTICAL PARTICULARS
i în i somnolenţşă i/ sau episoade de so
6.1 List of excipients
somnolenţşă i/ sau episoade de somn cu
Mannitol Maize starch Pregelatinised maize starch Povidone K25 Colloidal anhydrous silica Magnesium stearate
vehicule şsă se angajeze în activită (de exemplu, i nu ţi
6.2 Incompatibilities
folosirea de utilaje) în care
Not applicable.
afectarea atenţ ar iei
6.3 Shelf life
putea să pună ei sau pe persoanele din jur în - i pe
2 years.
4. 4, 4. 5 ş4. 8). i i
6.4 Special precautions for storage
când aceste episoade recurente sau somnolenţnu dispar a
Store in the original package in order to protect from light.
4. 8 Reacţ adverse ii
6.5 Nature and contents of container
În cazul administră de Oprymea sunt de aş
Blister pack (Al/ Al foil):
toarele reacţ adverse: vise neobiş ii
20, 30, 60, 90 or 100 tablets.
, eli,,
Not all pack sizes may be marketed.
hipotensiune arterialăcreş
6.6 Special precautions for disposal
terea apetitului alimentar (hiperfagie), insomnie, tulbură de libidou, ri
Any unused product or waste material should be disposed of in accordance with local requirements.
greaţ edem periferic, paranoia; dependenţpatologică jocuri de noroc, hipersexualitate şalt
40 7.
ă, ă
MARKETING AUTHORISATION HOLDER
i
KRKA, d. d., Novo mesto, Š marješ cesta 6, 8501 Novo mesto, Slovenia ka
comportament anormal, somnolenţ creş
8.
ă,
MARKETING AUTHORISATION NUMBER(S)
terea greută somn cu instalare bruscăprurit şerupţ ţ
20 tablets:
ii,; i
EU/ 1/ 08/ 469/ 021 30 tablets:
cutanată i alte manifestă de hipersensibilitate.