qanastek/EMEA-V3 huggingface dataset:
Providing patients do not experience intolerable side-effects, the dosage should be titrated to achieve a maximal therapeutic effect.
Pacientams, kuriems netoleruojamo nepageidaujamo poveikio nepasireiš dozękia, didinti tol, kol terapinis poveikis tampa didž iausias.
Ascending – Dose Schedule of OPRYMEA Week
Oprymea dozė didinimo grafikas s Savaitė
Dosage (mg of base)
Bendra
Total Daily Dose (mg of base)
s (mg) pramipeksolio druskos bazės dozė (mg) paros dozė( mg) 1 Gerti tris kartus 0, 264 Gerti tris kartus po 0, 088 po 0, 125
Dosage (mg of salt)
pramipeksolio druskos paros dozė (mg) 0, 375
Total Daily Dose (mg of salt)
2 Gerti tris kartus 0, 54 Gerti tris kartus po 0, 18 po 0, 25
1 2 3
0, 75
3 x 0.088 3 x 0.18 3 x 0.35
2 Gerti tris kartus 1, 1 Gerti tris kartus po 0, 35 po 0, 5 2
0.264 0.54 1.1
1, 50
3 x 0.125 3 x 0.25 3 x 0.5
Jei dozę reikia didinti ir toliau, paros dozė savaitę bū didinama po 0, 54 mg bazė kas turi ti druskos) iki didž iausios paros dozė - 3, 3 mg bazė (4, 5 mg druskos). s s
0.375 0.75 1.50
(0, 75 mg s
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.
Reikia žinoti, kad jei vartojama didesnė daž (ž 4. 8 skyrių nis r.).
2 However, it should be noted that the incidence of somnolence is increased at doses higher than 1.5 mg/ day (see section 4.8).
Didž
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.
Trijųdozėdidinimo pagrindinių
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).
pastebė kad poveikis prasideda vartojant 1, 1 mg bazė (1, 5 mg druskos) paros dozęVė
Further dose adjustments should be done based on the clinical response and the occurrence of adverse reactions.
atsižvelgus į klinikinį vaisto poveikį š ir alutinio poveikio pasireiš, dozę
In clinical trials approximately 5% of patients were treated at doses below 1.1 mg (1.5 mg of salt).
daug 5 
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.
Parkinsono liga progresuoja ir levodopos vartojimą kaip 1, 1 mg bazė (1, 5 mg druskos) paros dozęAtsiž
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.
Gydymo nutraukimas
Treatment discontinuation Abrupt discontinuation of dopaminergic therapy can lead to the development of a neuroleptic malignant syndrome.
Todėpramipeksolio dozavimą
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).
druskos) per parątol, kol paros dozė
Thereafter the dose should be reduced by 0.264 mg of base (0.375 mg of salt) per day (see section 4.4).
4. 4 skyrių
Dosing in patients with renal impairment The elimination of pramipexole is dependent on renal function.
Pacientai, kuriųinkstųfunkcija susilpnė jusi Pramipeksolio iš siskyrimas priklauso nuo pacientųinkstųfunkcijos.
The following dosage schedule is suggested for initiation of therapy:
Gydymo pradž ioje rekomenduojamas toliau nurodytas dozavimas:
Patients with a creatinine clearance above 50 ml/ min require no reduction in daily dose.
Jei kreatinino klirensas yra didesnis kaip 50 ml/ min., paros dozėkoreguoti nereikia. s
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).
Jei kreatinino klirensas yra 20 – 50 ml/ min., pradinę
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.
Jei kreatinino klirensas yra mažesnis kaip 20 ml/ min., reikia vartoti vienkartinęparos dozęt. y., pradž gerti 0, 088 mg bazė( 0, 125 mg druskos) dozę
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%.
pač santykiu, kuriuo mažja kreatinino klirensas, pvz.: jei kreatinino klirensas sumažja 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.
Jei
Dosing in patients with hepatic impairment Dose adjustment in patients with hepatic failure is probably not necessary, as approx.
dozę reikia padalyti ir gerti per du kartus, o jei kreatinino klirensas yra maž esnis kaip 20 ml/ min., vartoti vienkartinę vaisto paros dozę.
90% of absorbed active substance is excreted through the kidneys.
Pacientai, kuriųkepenų funkcija susilpnėjusi Ligoniams, sergantiems kepenųfunkcijos nepakankamumu, dozė koreguoti nebū 90%
However, the potential influence of hepatic insufficiency on Oprymea pharmacokinetics has not been investigated.
iagos išsiskiria pro inkstus, tač koks gali bū kepenų iau ti
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.
nepakankamumo poveikis Oprymea farmakokinetikai než
4.3 Contraindications
Dozavimas vaikams ir paaugliams
Hypersensitivity to the active substance or to any of the excipients.
Oprymea nerekomenduojama vartoti vaikams ir jaunesniems kaip 18 metųpaaugliams, nes duomenų apie saugumą veiksmingumą ra.
4.4 Special warnings and precautions for use
nė
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 Kontraindikacijos
Hallucinations are known as a side-effect of treatment with dopamine agonists and levodopa.
iagai arba bet kuriai pagalbinei medž iagai.
Patients should be informed that (mostly visual) hallucinations can occur.
Jei serganč Parkinsono liga ligoniui, kuriam yra inkstų
In advanced Parkinson’ s disease, in combination treatment with levodopa, dyskinesias can occur during the initial titration of Oprymea.
funkcijos sutrikimas, skiriama Oprymea
If they occur, the dose of levodopa should be decreased.
tableč, patariama dozę inti, laikantis 4. 2 skyriuje pateiktos nuorodos.
Pramipexole has been associated with somnolence and episodes of sudden sleep onset, particularly in patients with Parkinson’ s disease.
3 Yra ž inoma, kad vartojant dopamino agonistųir levodopos gali pasireikš šti alutinis poveikis – atsirasti haliucinacijų Pacientą
Sudden onset of sleep during daily activities, in some cases without awareness or warning signs, has been reported uncommonly.
reikia informuoti, kad toks poveikis galimas ir kad daž niausiai bū regė na
Patients must be informed of this and advised to exercise caution while driving or operating machines during treatment with Oprymea.
Progresavusia Parkinsono liga sergantiems pacientams Oprymea vartojant kartu dozė nustatymo metu galima diskinezija.
Patients who have experienced somnolence and/ or an episode of sudden sleep onset must refrain from driving or operating machines.
Dieną dirbant kai kada gali atsirasti staigiųmiego priepuolių iš be ankstinio suvokimo ar į jamų pož spė jų ymių tač taip atsitinka nedaž Ž
Furthermore a reduction of dosage or termination of therapy may be considered.
nai. mones, vartojanč Oprymea, bū apie tokią ius tina
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).
galimybęspė ir patarti vaisto vartojimo laikotarpiu atsargiai vairuoti ar dirbti su mechanizmais. į ti Pacientams, kuriems pasireiš mieguistumas ir (arba) iš dirbti su veikianč į
Pathological gambling, increased libido and hypersexuality have been reported in patients treated with dopamine agonists for Parkinson’ s disease, including pramipexole.
nutraukimo galimybęJei kartu su pramipeksoliu vartojama ir kitokiųraminamų ar geriama alkoholio,
Furthermore, patients and caregivers should be aware of the fact that behavioural changes can occur.
. gali pasireikš adityvus poveikis, todėpacientą
Dose reduction/ taper or discontinuation should be considered.
apie tai reikia į ti (ž 4. 7 ir spė r.
Patients with psychotic disorders should only be treated with dopamine agonists if the potential benefits outweigh the risks.
pramipeksolį, atsiranda patologinis potraukis azartiniams ž aidimams, sustiprė lytinis potraukis ir ja seksualumas.
Coadministration of antipsychotic medicinal products with pramipexole should be avoided (see section 4.5).
vartoti vaistinius preparatus nuo psichozė (ž 4. 5 skyrių s r.).
Ophthalmologic monitoring is recommended at regular intervals or if vision abnormalities occur.
Rekomenduojama reguliariai, ypač atveju, jei trinka rega, atlikti oftalmologinius tyrimus. tuo
In case of severe cardiovascular disease, care shou ld be taken.
Jei sergama sunkia š irdies ir kraujagysliųliga, bū atidi ligonio priež ra.
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.
poveikio vaistų rekomenduojama nuolat matuoti kraujospū, ypač
Symptoms suggestive of neuroleptic malignant syndrome have been reported with abrupt withdrawal of dopaminergic therapy (see section 4.2)
Pastebė kad staigiai nutraukus dopaminerginių
Reports in the literature indicate that treatment of another indication with dopaminergic medicinal products can result in augmentation.
4. 2 skyrių
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.
Mokslinė literatū duomenys rodo, kad dopaminerginio poveikio vaistiniųpreparatų
The frequency of augmentation after longer use of pramipexole and the appropriate management of these events have not been evaluated in controlled clinical trials.
atsirandantys simptomai, kurie sunkė ir apima kitas galū Kontroliuotų bū s pasunkė
4.5 Interaction with other medicinal products and other forms of interaction
jimo daž numas po ilgalaikio pramipeksolio vartojimo bei tinkamas tokiųsutrikimų
Pramipexole is bound to plasma proteins to a very low (< 20%) extent, and little biotransformation is seen in man.
Pramipeksolis su plazmos baltymais jungiasi labai maž (maž kaip 20 ž
Therefore, interactions with other medicinal products affecting plasma protein binding or elimination by biotransformation are unlikely.
biotransformuojama nedaug, todėsą l veika su kitais vaistiniais preparatais dėjungimosi su plazmos l baltymais arba išsiskyrimo biotransformacijos bū netikė Kadangi anticholinerginiai preparatai
As anticholinergics are mainly eliminated by biotransformation, the potential for an interaction is limited, although an interaction with anticholinergics has not been investigated.
išorganizmo daugiausiai iš siskiria biotransformacijos bū jų veikos galimybė nedidelėnors
Cimetidine reduced the renal clearance of pramipexole by approximately 34%, presumably by inhibition of the cationic secretory transport system of the renal tubules.
daug 34  t, dėkatijoninėsekrecinė maž (turbū l
Therefore, medicinal products
liuose), todėvaistiniai preparatai, kurie slopina l
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 Oprymea vartojant kartu su levodopa, rekomenduojama pastarojo dozę inti, o kitųvaistinių maž preparatų parkinsonizmo dozėnekeisti, nors Oprymea doz ė bū didinama.
Reduction of the pramipexole dose should be considered when these medicinal products are administered concomitantly.
Pacientus, kartu su pramipeksoliu vartojanč kitokiųraminamų
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.
jųvaistiniųpreparatųarba alkoholio,
Because of possible additive effects, caution should be advised when patients are taking other sedating medicinal products or alcohol in combination with pramipexole.
reikia į ti, kad gali pasireikš adityvus poveikis.
Coadministration of antipsychotic medicinal products with pramipexole should be avoided (see section 4.4), e. g. if antagonistic effects can be expected.
Reikia vengti kartu vartoti pramipeksolio ir vaistiniųpreparatų psichozė( ž 4. 4 skyrių pvz., tuo atveju, jei poveikis gali bū prieš ti ingas negu laukiama.
4.6 Pregnancy and lactation
4. 6 Nėtumo ir ž š indymo laikotarpis
The effect on pregnancy and lactation has not been investigated in humans.
Eksperimentų ž mis ir triuš metu pramipeksolis teratogeninio poveikio
Pramipexole was not teratogenic in rats and rabbits, but was embryotoxic in the rat at maternotoxic doses (see section 5.3).
patelė vartojant toksines preparato dozes, pasireiš embriotoksinis ms kė
Oprymea should not be used during pregnancy unless clearly necessary, i. e. if the potential benefit justifies the potential risk to the foetus.
Nėtumo laikotarpiu Oprymea galima vartoti tik bū atveju, pvz., jei tikima, kad gydomasis š tinu poveikis motinai bus didesnis už pavojųvaisiui.
As pramipexole treatment inhibits secretion of prolactin in humans, inhibition of lactation is expected.
Kadangi pramipeksolis slopina prolaktino išsiskyrimą monė gali bū slopinamas pieno išsiskyrimas.
The excretion of pramipexole into breast milk has not been studied in women.
Tyrimai su
In rats, the concentration of active substance-related radioactivity was higher in breast milk than in plasma.
Kadangi tyrimų žsu monė neatlikta, ž
In the absence of human data, Oprymea should not be used during breast-feeding.
Jei tai
However, if its use is unavoidable, breast-feeding should be discontinued.
neį manoma, ž indymą reikia nutraukti.
4.7 Effects on ability to drive and use machines
4. 7 Poveikis gebė jimui vairuoti ir valdyti mechanizmus
Oprymea can have a major influence on the ability to drive and use machines.
Oprymea gebė vairuoti ir dirbti su mechanizmais veikia stipriai. jimą
Hallucinations or somnolence can occur.
Oprymea vartojimo laikotarpiu gali atsirasti haliucinacijųarba mieguistumas.
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).
Pacientus, kurie vartoja Oprymea ir kuriems pasireiš mieguistumas ir (arba) prasideda staigū
4.8 Undesirable effects
4. 5 ir 4. 8 skyrius).
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.
viduriųuž jimas, manija, svaigulys, diskinezija, nuovargis, haliucinacijos, galvos skausmas, kietė hiperkinezija, hipotenzija, gausus valgymas (prisivalgymas, persivalgymas), nemiga, lytinio potraukio sutrikimas, pykinimas, periferinė edema, paranoja, patologinis potraukis azartiniams ž aidimams, padidė s seksualumas ir kitoks nenormalus elgesys; apsnū
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.
Remiantis sukauptų placebu kontroliuotų klinikiniųtyrimųkuriuose 1 923 pacientai vartojo, pramipeksolį 1 354 pacientai vartojo placebąanalizė duomenimis, nepageidaujamos reakcijos daž pasireiš
63% of patients on pramipexole and 52% of patients on placebo reported at least one adverse drug reaction.
63% pacientųvartojusiųpramipeksolį 52% pacientų, ir,
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.
Daž niausios (%) pastebė nepageidaujamos reakcijos ligoniams, sirgusiems Parkinsono liga ir 5
The incidence of somnolence is increased at doses higher than 1.5 mg/ day (see section 4.2).
vartojusiems pramipeksolį, pasireiš kusios daug daž niau, palyginus su tokiomis placebąvartojusių pacientų buvo pykinimas, diskinezija, hipotenzija, svaigulys, mieguistumas, nemiga, vidurių, už jimas, haliucinacijos, galvos skausmas ir nuovargis.
More frequent adverse drug
Vartojant didesnę 1, 5 mg paros dozę
Hypotension may occur at the beginning of treatment, especially if pramipexole is titrated too fast.
Gydymo pradž ypač atveju, jei pramipeksolio dozė greitai,
The most commonly (≥
atsirasti hipotenzija.
5%) reported adverse drug reactions in patients with other indication treated
Daž niausios (%) pastebė nepageidaujamos reakcijos ligoniams, vartojusiems pramipeksolį 5
with pramipexole were nausea, headache, dizziness and fatigue.
kitokiai indikacijai, buvo pykinimas, galvos skausmas, svaigulys ir nuovargis.
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).
Moterims, vartojusioms pramipeksolį, pykinimas ir nuovargis (atitinkamai 20, 8% ir 10, 5%) atsirasdavo daž niau, negu vyrams (atitinkamai 6, 7% ir 7, 3%).
Tables 1 and 2 display the frequency of adverse reactions from placebo-controlled clinical trials.
1 ir 2 lentelė pateiktas nepageidaujamų
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.
reiškiniai, kurie atsirado 1% ar daugiau ligonių vartojusių
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.
negu pacientams, vartojusiems placebą
Table 1:
1 
Very common Adverse Reactions (≥ 1/ 10) System organ class
Organųsistemųklasė s
Adverse reaction
Nepageidaujamos reakcijos
Pramipexole N= 1,923 (%)
Pramipeksolis n = 1923 (%)
Nervous system disorders
Nervųsistemos sutrikimai Virš
Dizziness Dyskinesia
Svaigulys Diskinezija
Gastrointestinal disorders Vascular disorders
kinimo trakto sutrikimai Kraujagysliųsutrikimai
Nausea Hypotension
Pykinimas Hipotenzija
Table 2:
2 lentelėDaž nepageidaujamos reakcijos (
Common Adverse Reactions (≥ 1/ 100 to < 1/ 10) System organ class
1/ 100 - < 1/ 10)
Adverse reaction
Organųsistemųklasė
Abnormal dreams Confusional state Hallucinations Insomnia
Nenormalū sapnai s Konfū zija Haliucinacijos Nemiga
Nervous system disorders
Bendrieji sutrikimai ir vartojimo vietos pažeidimai
Somnolence Headache
Nuovargis Periferinė edemos s
8.6 6.5
6, 1 1, 9
Gastrointestinal disorders
Pramipeksolis sukelia mieguistumą
Constipation
(8, 6
5.5
) r.
General disorders and administration site conditions
potraukįjis gali sustiprė (0, 1 ) arba susilpnė (0, 4 ).
Fatigue
atvejų 
6.1
ti
Peripheral oedema
atvejų 
1.9
kia
Pramipexole is associated with somnolence (8.6%) and has been associated uncommonly with excessive daytime somnolence and sudden sleep onset episodes (0.1%).
Nutraukus gydymą dozęš pož
See also section 4.4.
arba sumaž inus
Pramipexole may be associated with libido disorders (increased (0.1%) or decreased (0.4%)).
ymiai paprastai praeina.
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.
Manoma, kad nepageidaujamas poveikis turė ti susijęsu dopamino agonistų
4.9 Overdose
tųbū
There is no clinical experience with massive overdose.
farmakodinaminiu poveikiu, įskaitant pykinimą,
The expected adverse events would be those related to the pharmacodynamic profile of a dopamine agonist, including nausea, vomiting, hyperkinesia, hallucinations, agitation and hypotension.
vė mimąhiperkinezijąhaliucinacijas, sujaudinimą hipotenzijąDopamino agonistųperdozavus,
There is no established antidote for overdose 6 of a dopamine agonist.
antidoto nė Jei atsiranda CNS sujaudinimo simptomųreikė vartoti neuroleptikų Perdozavimas
If signs of central nervous system stimulation are present, a neuroleptic agent may be indicated.
gydomas į prastinė palaikomojo gydymo priemonė kartu plaunamas skrandis, į
Management of the overdose may require general supportive measures, along with gastric lavage, intravenous fluids, administration of activated charcoal and electrocardiogram monitoring.
injekuojama skysč, duodama aktyvintos anglies ir stebima elektrokardiograma. ių
PHARMACOLOGICAL PROPERTIES
FARMAKOLOGINĖ SAVYBĖ
5.1 Pharmacodynamic properties
5. 1 Farmakodinaminė savybė
N04BC05.
Farmakoterapinėgrupė dopamino agonistai, ATC kodas – N04BC05. –
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.
Jis labai selektyviai ir specifiš jungiasi su dopamino D2 kai pogrupio receptoriais, iškuriųD3 receptoriams afinitetas yra didž iausias, ir turi visąvidinįaktyvumą.
Pramipexole alleviates Parkinsonian motor deficits by stimulation of dopamine receptors in the striatum.
Pramipeksolis stimuliuoja galvos smegenųdryž
Animal studies have shown that pramipexole inhibits dopamine synthesis, release, and turnover.
maž motorikos sutrikimąTyrimų gyvū metu nustatyta, kad vaistas slopina dopamino
In human volunteers, a dose-dependent decrease in prolactin was observed.
sintezęiš, siskyrimą apykaitą
Clinical trials in Parkinson’ s disease
Tiriant savanorius nustatyta, kad kuo didesnėdozė vartojama, tuo prolaktino iš siskiria maž iau.
In patients pramipexole alleviates signs and symptoms of idiopathic Parkinson 's disease.
Klinikiniai Parkinsono ligos tyrimai Ligoniams, sergantiems idiopatine Parkinsono liga, pramipeksolis lengvina jos simptomus.
Controlled clinical trials included approximately 2100 patients of Hoehn and Yahr stages I – IV.
Buvo atlikti kontroliuoti klinikiniai tyrimai, kuriųmetu tirta maž daug 2100 pacientųserganč – IV (pagal
Out of these, approximately 900 were in more advanced stages, received concomitant levodopa therapy, and suffered from motor complications.
daug 900 pacientų
In early and advanced Parkinson’ s disease, efficacy of pramipexole in the controlled clinical trials was maintained for approximately six months.
Ilgiau kaip 3 metus trukusiais ios atviraisiais klinikiniais tyrimais nustatyta, kad preparato veiksmingumas nemažja. ė 2 metų
In open continuation trials lasting for more than three years there were no signs of decreasing efficacy.
dvigubai aklu metodu atliktųtyrimųmetu nustatyta, kad jei gydymas
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.
Tokį lesnį
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).
pramipeksolio, reikia derinti su didesniu motorinė funkcijos pagerė
The overall incidence of hallucinations and somnolence was generally higher in the escalation phase with the pramipexole group.
pasireikš davo pramipeksolio dozė didinimo laikotarpiu, nors didelio skirtumo nuo palaikomojo s gydymo laikotarpio nebuvo.
However there was no significant difference during the maintenance phase.
Tokio poveikio galimyb ę serganč ligonius gydyti pramipeksoliu. ius
These points should be considered when initiating pramipexole treatment in patients with Parkinson´s disease.
reikė apsvarstyti pradedant Parkinsono liga tų
5.2 Pharmacokinetic properties
5. 2 Farmakokinetinė savybė s s
Pramipexole is rapidly and completely absorbed following oral administration.
Absoliutus biologinis
The absolute bioavailability is greater than 90% and the maximum plasma concentrations occur between 1 and 3 hours.
vaisto prieinamumas yra didesnis kaip 90  iausia koncentracija plazmoje bū po 1 – 3 valandų
Concomitant administration with food did not reduce the extent of pramipexole absorption, but the rate of absorption was reduced.
Jei preparato vartojama kartu su maistu, absorbuoto vaisto kiekis nemažja, tač absorbcijos greitis
Pramipexole shows linear kinetics and a small inter-patient variation of plasma levels.
Pramipeksolio farmakokinetika yra tiesinėjo koncentracijos plazmoje skirtumai tarp į
In humans, the protein binding of pramipexole is very low (< 20%) and the volume of distribution is large (400 l).
Nustatyta, kad ž
High brain tissue concentrations were observed in the rat (approx.
(maždaug 8 kartus didesnė
8-fold compared to plasma).
tokią kuri bū plazmoje). už, na
Pramipexole is metabolised in man only to a small extent.
Žmoniųorganizme pramipeksolis metabolizuojamas maž ai.
Renal excretion of unchanged pramipexole is the major route of elimination.
Daugiausia nepakitusio pramipeksolio iš siskiria pro inkstus.
Approximately 90% of 14 C-labelled dose is excreted through the kidneys while less than 2% is found in the faeces.
Maž daug 90  C ž to vaisto dozė 14 išsiskiria pro inkstus ir maž kaip 2 su iš iau –
The total clearance of pramipexole is approximately 500 ml/ min and the renal clearance is approximately 400 ml/ min.
500 ml/ min., inkstų klirensas yra maž daug 400 ml/ min.
The elimination half-life (t½) varies from 8 hours in the young to 12 hours in the elderly.
Vaisto pusinė eliminacijos laikas (t½) s jauniems ž monė yra 8 valandos, o senyviems – 12 valandų
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.
Pramipeksolio poveikis dauginimosi funkcijai buvo tirtas su ž mis ir triuš Teratogeninio poveikio gyvūnams preparatas nesukė, tač vaikingoms ž
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.
Dėgyvū rūių
The potential effects of pramipexole on reproductive function have been investigated in rats and rabbits.
pramipeksolio poveikis pateliųvaikingumui ir patinųvislumui galutinai neiš tirtas.
Pramipexole was not teratogenic in rats and rabbits but was embryotoxic in the rat at maternally toxic doses.
Pramipeksolis nesukelia genotoksinio poveikio.
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.
Tiriant, ar preparatas sukelia kancerogeninį poveikį, pastebė kad ž
Pramipexole was not genotoxic.
iurkiųpatinams atsirado Laydigo lą
In a carcinogenicity study, male rats developed Leydig cell hyperplasia and adenomas, explained by the prolactin-inhibiting effect of pramipexole.
steliųhiperplazija ir adenomųtikriausiai, dėto,, l
This finding is not clinically relevant to man.
Be to, tyrimas
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.
ž iurkė nei baltosioms pelė 2 metųtrukmė kancerogeninio poveikio tyrimųmetu, nei kitoms
The latter finding was not observed in pigmented rats, nor in a 2-year albino mouse carcinogenicity study or in any other species investigated.
tirtųgyvū rūims. nų š
PHARMACEUTICAL PARTICULARS
FARMACINĖINFORMACIJA
6.1 List of excipients
6. 1 Pagalbiniųmedž iagųsą as raš
Mannitol Maize starch Pregelatinised maize starch Povidone K25 Colloidal anhydrous silica Magnesium stearate
Manitolis, kukurū zųkrakmolas, pregelifikuotas kukurū krakmolas, zų povidonas K25, koloidinis silicio dioksidas, bevandenis, magnio stearatas.
6.4 Special precautions for storage
6. 4 Specialios laikymo są lygos
Store in the original package in order to protect from light.
Laikyti gamintojo pakuotė kad preparatas bū apsaugotas nuo š
6.5 Nature and contents of container
viesos.
Blister pack (Al/ Al foil):
6. 5 Pakuotė jos turinys ir
20, 30, 60, 90 or 100 tablets.
Dėutėkurioje yra 20, 30, 60, 90 arba 100 tableč, supakuotų aliuminio/ aliuminio folijos lizdines
Not all pack sizes may be marketed.
Specialiųreikalavimų ra. nė
6.6 Special precautions for disposal
RINKODAROS TEISĖ TURĖ
Any unused product or waste material should be disposed of in accordance with local requirements.
KRKA, d. d., Novo mesto, Šmarješ cesta 6, 8501 Novo mesto, Slovė
MARKETING AUTHORISATION NUMBER(S)
RINKODAROS TEISĖ NUMERIS (- IAI) S
20 tablets:
20 tableč,:
EU/ 1/ 08/ 469/ 001 30 tablets:
EU/ 1/ 08/ 469/ 001 ių 30 tableč:
EU/ 1/ 08/ 469/ 002 60 tablets:
EU/ 1/ 08/ 469/ 002 ių
EU/ 1/ 08/ 469/ 003 90 tablets:
EU/ 1/ 08/ 469/ 003 ių 90 tableč:
EU/ 1/ 08/ 469/ 004 100 tablets:
EU/ 1/ 08/ 469/ 004 ių 100 tableč:
EU/ 1/ 08/ 469/ 005
EU/ 1/ 08/ 469/ 005 ių
DATE OF FIRST AUTHORISATION/ RENEWAL OF THE AUTHORISATION
RINKODAROS TEISĖ SUTEIKIMO / ATNAUJINIMO DATA S
DATE OF REVISION OF THE TEXT
TEKSTO PERŽ ROS DATA IŪ
Detailed information on this medicinal product is available on the website of the European Medicines Agency (EMEA) http: / /www. emea. europa. eu/.
informacijąapie špreparatą į galite rasti Europos vaistųagentū (EMEA) ros
Oprymea 0.18 mg tablets
Oprymea 0, 18 mg tabletė s
Each tablet contains 0.18 mg pramipexole base (as 0.25 mg pramipexole dihydrochloride monohydrate).
Vienoje Oprymea 0, 18 mg tabletė yra 0, 18 mg pramipeksolio bazė atitinkanč 0, 25 mg
Pramipexole doses as published in the literature refer to the salt form.
nurodoma pramipeksolio druskos pavidalu, todėvaisto dozes reikia l
Therefore, doses will be expressed in terms of both pramipexole base and pramipexole salt (in brackets).
nurodyti ir kaip pramipeksolio bazė ir kaip pramipeksolio druskos (toliau pramipeksolio druskos s, dozė nurodoma skliausteliuose).
For a full list of excipients, see section 6.1.
iagos iš vardytos 6. 1 skyriuje.
0.18 mg: white, oval, with bevelled edges, both sides scored, with imprint "P7" on both halves of one side of the tablet.
spaudas „ P7 ".
The tablet can be divided into equal halves.
Tabletę galima dalyti į lygias dalis. dvi
Initial treatment Dosages should be increased gradually from a starting-dose of 0.264 mg of base (0.375 mg of salt) per day and then increased every 5 - 7 days.
Pradinis gydymas
Ascending – Dose Schedule of OPRYMEA Week
Gydymą
Dosage (mg of base)
bū
Total Daily Dose (mg of base)
pramipeksoliu reikia pradė nuo 0, 264 mg bazė ti
Dosage (mg of salt)
(0, 375 mg s
Total Daily Dose (mg of salt)
druskos) dozė per parąpo to dozę
1 2 3
,
3 x 0.088 3 x 0.18 3 x 0.35
didinti kas 5 – 7 paras.
0.264 0.54 1.1
reikia palaipsniui
3 x 0.125 3 x 0.25 3 x 0.5
Oprymea dozė didinimo grafikas s Savaitė
0.375 0.75 1.50
Bendra
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.
s (mg) pramipeksolio druskos bazės dozė (mg) paros dozė( mg) 1 Gerti tris kartus 0, 264 Gerti tris kartus po 0, 088 po 0, 125
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).
pramipeksolio druskos paros dozė (mg) 0, 375
In clinical trials approximately 5% of patients were treated at doses below 1.1 mg (1.5 mg of salt).
2 Gerti tris kartus 0, 54 Gerti tris kartus po 0, 18 po 0, 25
Treatment discontinuation Abrupt discontinuation of dopaminergic therapy can lead to the development of a neuroleptic malignant syndrome.
0, 75
The following dosage schedule is suggested for initiation of therapy:
2 Gerti tris kartus 1, 1 Gerti tris kartus po 0, 35 po 0, 5 10
Patients with a creatinine clearance above 50 ml/ min require no reduction in daily dose.
1, 50
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).
Jei dozę reikia didinti ir toliau, paros dozė savaitę bū didinama po 0, 54 mg bazė kas turi ti druskos) iki didž iausios paros dozė - 3, 3 mg bazė (4, 5 mg druskos). s s
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.
Reikia žinoti, kad jei vartojama didesnė daž (ž 4. 8 skyrių nis r.).
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.
kaip 1, 5 mg paros dozėdaugė mieguistumo pasireiš, ja kimo
90% of absorbed active substance is excreted through the kidneys.
Palaikomasis gydymas
However, the potential influence of hepatic insufficiency on Oprymea pharmacokinetics has not been investigated.
Didž
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.
s
4.3 Contraindications
iausia
Hypersensitivity to the active substance or to any of the excipients.
Trijųdozėdidinimo pagrindinių
4.4 Special warnings and precautions for use
s s
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.
tyrimųmetu
Patients should be informed that (mostly visual) hallucinations can occur.
pastebė kad poveikis prasideda vartojant 1, 1 mg bazė (1, 5 mg druskos) paros dozęVė
In advanced Parkinson’ s disease, in combination treatment with levodopa, dyskinesias can occur during the initial titration of Oprymea.
atsižvelgus į klinikinį vaisto poveikį š ir alutinio poveikio pasireiš, dozę
If they occur, the dose of levodopa should be decreased.
reikia koreguoti.
Sudden onset of sleep during daily activities, in some cases without awareness or warning signs, has been reported uncommonly.
pacientųbuvo gydomi maž kaip 1, 1 mg bazė (1, 5 mg
Patients must be informed of this and advised to exercise caution while driving or operating machines during treatment with Oprymea.
s
Furthermore a reduction of dosage or termination of therapy may be considered.
Jei galima skirti didesnę
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).
Parkinsono liga progresuoja ir levodopos vartojimą kaip 1, 1 mg bazė (1, 5 mg druskos) paros dozęAtsiž
Furthermore, patients and caregivers should be aware of the fact that behavioural changes can occur.
rekomenduojama levodopos dozę inti tiek Oprymea dozė didinimo, tiek palaikomojo gydymo metu.
Dose reduction/ taper or discontinuation should be considered.
Gydymo nutraukimas
Patients with psychotic disorders should only be treated with dopamine agonists if the potential benefits outweigh the risks.
maž
Coadministration of antipsychotic medicinal products with pramipexole should be avoided (see section 4.5).
s
Ophthalmologic monitoring is recommended at regular intervals or if vision abnormalities occur.
Todėpramipeksolio dozavimą
In case of severe cardiovascular disease, care should be taken.
vartojimągali pasireikš piktybinis neurolepsinis, ti
Symptoms suggestive of neuroleptic malignant syndrome have been reported with abrupt withdrawal of dopaminergic therapy (see section 4.2)
l
Reports in the literature indicate that treatment of another indication with dopaminergic medicinal products can result in augmentation.
reikė tųmaž
4.5 Interaction with other medicinal products and other forms of interaction
laipsniš po 0, 54 mg bazė (0, 75 mg inti kai,
Pramipexole is bound to plasma proteins to a very low (< 20%) extent, and little biotransformation is seen in man.
druskos) per parątol, kol paros dozė
Therefore, interactions with other medicinal products affecting plasma protein binding or elimination by biotransformation are unlikely.
,
There is no pharmacokinetic interaction with selegiline and levodopa.
sumažs iki 0, 54 mg bazė( 0, 75 ė
Therefore, medicinal products
Po to dozę s
Reduction of the pramipexole dose should be considered when these medicinal products are administered concomitantly.
4. 4 skyrių
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.
inti
Because of possible additive effects, caution should be advised when patients are taking other sedating medicinal products or alcohol in combination with pramipexole.
s
Coadministration of antipsychotic medicinal products with pramipexole should be avoided (see section 4.4), e. g. if antagonistic effects can be expected.
(ž
4.6 Pregnancy and lactation
).
The effect on pregnancy and lactation has not been investigated in humans.
Pacientai, kuriųinkstųfunkcija susilpnė jusi Pramipeksolio iš siskyrimas priklauso nuo pacientųinkstųfunkcijos.
Pramipexole was not teratogenic in rats and rabbits, but was embryotoxic in the rat at maternotoxic doses (see section 5.3).
Gydymo pradž ioje rekomenduojamas toliau nurodytas dozavimas:
Oprymea should not be used during pregnancy unless clearly necessary, i. e. if the potential benefit justifies the potential risk to the foetus.
Jei kreatinino klirensas yra didesnis kaip 50 ml/ min., paros dozėkoreguoti nereikia. s
As pramipexole treatment inhibits secretion of prolactin in humans, inhibition of lactation is expected.
Jei kreatinino klirensas yra 20 – 50 ml/ min., pradinę
The excretion of pramipexole into breast milk has not been studied in women.
0, 176 mg bazė (0, 25 mg druskos) paros dozę s
In the absence of human data, Oprymea should not be used during breast-feeding.
reikia padalyti pusiau ir gerti per 2 kartus, t. y. po 0, 088 mg bazė( 0, 125 mg druskos). s
However, if its use is unavoidable, breast-feeding should be discontinued.
Jei kreatinino klirensas yra mažesnis kaip 20 ml/ min., reikia vartoti vienkartinęparos dozęt. y., pradž gerti 0, 088 mg bazė( 0, 125 mg druskos) dozę
4.7 Effects on ability to drive and use machines
.
Oprymea can have a major influence on the ability to drive and use machines.
Jei inkstų funkcija palaikomojo gydymo metu pablogė Oprymea paros dozę
Hallucinations or somnolence can occur.
pač santykiu, kuriuo mažja kreatinino klirensas, pvz.: jei kreatinino klirensas sumažja 30 
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).
,
4.8 Undesirable effects
preparato paros dozę
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.
Jei
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.
dozę reikia padalyti ir gerti per du kartus, o jei kreatinino klirensas yra maž esnis kaip 20 ml/ min., vartoti vienkartinę vaisto paros dozę.
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.
Pacientai, kuriųkepenų funkcija susilpnėjusi Ligoniams, sergantiems kepenųfunkcijos nepakankamumu, dozė koreguoti nebū 90%
The incidence of somnolence is increased at doses higher than 1.5 mg/ day (see section 4.2).
 absorbuotos veikliosios medž
More frequent adverse drug
tina, nes maž
Hypotension may occur at the beginning of treatment, especially if pramipexole is titrated too fast.
iagos išsiskiria pro inkstus, tač koks gali bū kepenų iau ti
The most commonly (≥
funkcijos
5%) reported adverse drug reactions in patients with other indication treated
nepakankamumo poveikis Oprymea farmakokinetikai než
with pramipexole were nausea, headache, dizziness and fatigue.
inoma, nes tokiųtyrimų neatlikta.
Tables 1 and 2 display the frequency of adverse reactions from placebo-controlled clinical trials.
Dozavimas vaikams ir paaugliams
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.
Oprymea nerekomenduojama vartoti vaikams ir jaunesniems kaip 18 metųpaaugliams, nes duomenų apie saugumą veiksmingumą ra.
Table 1:
nė
Adverse reaction
4. 3 Kontraindikacijos
Pramipexole N= 1,923 (%)
Padidė s jautrumas veikliajai medž
Nervous system disorders
iagai arba bet kuriai pagalbinei medž iagai.
Dizziness Dyskinesia
4. 4 Specialū į jimai ir atsargumo priemonė
15.5 12.9
s spė
Gastrointestinal disorders Vascular disorders
s
Nausea Hypotension
Jei serganč Parkinsono liga ligoniui, kuriam yra inkstų
17.2 12.6
iam
Table 2:
tableč, patariama dozę inti, laikantis 4. 2 skyriuje pateiktos nuorodos.
Common Adverse Reactions (≥ 1/ 100 to < 1/ 10) System organ class
reikia informuoti, kad toks poveikis galimas ir kad daž niausiai bū regė na
Adverse reaction
haliucinacijų.
Pramipexole N= 1,923 (%)
su levodopa, pradinė
Psychiatric disorders
reikia maž inti.
Abnormal dreams Confusional state Hallucinations Insomnia
Oprymea gali sukelti mieguistumą staigius miego priepuolius, ypač
3.5 3.0 6.6 8.2
ir
Nervous system disorders
Parkinsono liga sergantiems
Somnolence Headache
ligoniams.
8.6 6.5
, iau
Gastrointestinal disorders
nai. mones, vartojanč Oprymea, bū apie tokią ius tina
Constipation
galimybęspė ir patarti vaisto vartojimo laikotarpiu atsargiai vairuoti ar dirbti su mechanizmais. į ti Pacientams, kuriems pasireiš mieguistumas ir (arba) iš dirbti su veikianč į
5.5
kia
General disorders and administration site conditions
tinka staigus miego priepuolis, vairuoti ar
Fatigue
iais renginiais negalima.
6.1
tų
Peripheral oedema
inimo arba gydymo
1.9
nutraukimo galimybęJei kartu su pramipeksoliu vartojama ir kitokiųraminamų ar geriama alkoholio,
Pramipexole is associated with somnolence (8.6%) and has been associated uncommonly with excessive daytime somnolence and sudden sleep onset episodes (0.1%).
. gali pasireikš adityvus poveikis, todėpacientą
See also section 4.4.
4. 8 skyrius).
Pramipexole may be associated with libido disorders (increased (0.1%) or decreased (0.4%)).
apie tai reikia į ti (ž 4. 7 ir spė r.
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.
Pastebė kad Parkinsono liga sergantiems pacientams, vartojantiems dopamino agonistųį
4.9 Overdose
, skaitant ir
The expected adverse events would be those related to the pharmacodynamic profile of a dopamine agonist, including nausea, vomiting, hyperkinesia, hallucinations, agitation and hypotension.
pramipeksolį, atsiranda patologinis potraukis azartiniams ž aidimams, sustiprė lytinis potraukis ir ja seksualumas.
There is no established antidote for overdose 14 of a dopamine agonist.
Todėpacientai ir slaugytojai turi ž
If signs of central nervous system stimulation are present, a neuroleptic agent may be indicated.
Tokiu atveju
Management of the overdose may require general supportive measures, along with gastric lavage, intravenous fluids, administration of activated charcoal and electrocardiogram monitoring.
reikia apsvarstyti dozė sumaž
5.
s
PHARMACOLOGICAL PROPERTIES
inimo arba laipsniš
5.1 Pharmacodynamic properties
nutraukimo galimybę ko
N04BC05.
.
Animal studies have shown that pramipexole inhibits dopamine synthesis, release, and turnover.
Ligoniai, kuriųpsichika sutrikusi, dopamino agonistųgali vartoti tik tuo atveju, jei manoma, kad gydomasis poveikis bus didesnis už
In human volunteers, a dose-dependent decrease in prolactin was observed.
galimą alą ž.
Clinical trials in Parkinson’ s disease
Reikia vengti kartu su pramipeksoliu
In patients pramipexole alleviates signs and symptoms of idiopathic Parkinson 's disease.
vartoti vaistinius preparatus nuo psichozė (ž 4. 5 skyrių s r.).
Out of these, approximately 900 were in more advanced stages, received concomitant levodopa therapy, and suffered from motor complications.
Rekomenduojama reguliariai, ypač atveju, jei trinka rega, atlikti oftalmologinius tyrimus. tuo
In early and advanced Parkinson’ s disease, efficacy of pramipexole in the controlled clinical trials was maintained for approximately six months.
Jei sergama sunkia š irdies ir kraujagysliųliga, bū atidi ligonio priež ra.
However there was no significant difference during the maintenance phase.
Vartojant dopaminerginio
These points should be considered when initiating pramipexole treatment in patients with Parkinson´s disease.
tina
5.2 Pharmacokinetic properties
iū
In humans, the protein binding of pramipexole is very low (< 20%) and the volume of distribution is large (400 l).
poveikio vaistų rekomenduojama nuolat matuoti kraujospū, ypač
High brain tissue concentrations were observed in the rat (approx.
dį
8-fold compared to plasma).
gydymo pradž
Pramipexole is metabolised in man only to a small extent.
kadangi yra ioje,
Renal excretion of unchanged pramipexole is the major route of elimination.
didelis ortostatinė hipotenzijos pavojus. s
15 5.3 Preclinical safety data
Pastebė kad staigiai nutraukus dopaminerginių
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.
ta,
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.
vaistųvartojimąpasireiš simptomai, ver kia
The potential effects of pramipexole on reproductive function have been investigated in rats and rabbits.
č iantys
This finding is not clinically relevant to man.
galvoti apie piktybinįneurolepsinįsindromą r.
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.
4. 2 skyrių
6.
(ž
6.1 List of excipients
).
Mannitol Maize starch Pregelatinised maize starch Povidone K25 Colloidal anhydrous silica Magnesium stearate
Mokslinė literatū duomenys rodo, kad dopaminerginio poveikio vaistiniųpreparatų
6.2 Incompatibilities
vartojant
Not applicable.
kitokiai indikacijai, bū gali pasunkė Tokį
6.3 Shelf life
klė
2 years.
ti.
6.4 Special precautions for storage
poveikįrodo anksti vakare arba net po pietų
Store in the original package in order to protect from light.
atsirandantys simptomai, kurie sunkė ir apima kitas galū Kontroliuotų bū s pasunkė
6.5 Nature and contents of container
ja
20, 30, 60, 90 or 100 tablets.
nes.
Not all pack sizes may be marketed.
klinikiniųtyrimųmetu
6.6 Special precautions for disposal
klė