qanastek/EMEA-V3 huggingface dataset:
10.
yra
DATE OF REVISION OF THE TEXT
,
Detailed information on this medicinal product is available on the website of the European Medicines Agency (EMEA) http: / /www. emea. europa. eu/.
Seligilino ir levodopos farmakokinetikos sąveika nepasireiškia.
17 1.
ina
NAME OF THE MEDICINAL PRODUCT
klirensą
Oprymea 0.35 mg tablets
daug 34  t, dėkatijoninėsekrecinė maž (turbū l
2.

QUALITATIVE AND QUANTITATIVE COMPOSITION
perneš sistemos funkcijos slopinimo inkstųkanalė
Each tablet contains 0.35 mg pramipexole base (as 0.5 mg pramipexole dihydrochloride monohydrate).
liuose), todėvaistiniai preparatai, kurie slopina l
Please note:
aktyvią inkstų
Pramipexole doses as published in the literature refer to the salt form.
ją
For a full list of excipients, see section 6.1.
sekrecinęsistemą arba patys per ją skiriami, pvz., cimetidinas ir amantadinas, gali iš
PHARMACEUTICAL FORM
sąveikauti su pramipeksoliu, mažindami bet kurio vaistinio preparato arba jųabiejų klirensąJei tokių. vaistiniųpreparatųvartojama kartu su pramipeksoliu, reikia apsvarstyti pramipeksolio dozė s maž inimo galimybę
Tablet.
.
The tablet can be divided into equal halves.
12 Oprymea vartojant kartu su levodopa, rekomenduojama pastarojo doz ę inti, o kitųvaistinių maž preparatų parkinsonizmo dozėnekeisti, nors Oprymea doz ė bū didinama.
4.
nuo
4.1 Therapeutic indications
s
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).
ir tų
4.2 Posology and method of administration
Pacientus, kartu su pramipeksoliu vartojanč kitokiųraminamų
Parkinson’ s disease The tablets should be taken orally, swallowed with water, and can be taken either with or without food.
jųvaistiniųpreparatųarba alkoholio,
The daily dosage is administered in equally divided doses 3 times a day.
reikia į ti, kad gali pasireikš adityvus poveikis.
Providing patients do not experience intolerable side-effects, the dosage should be titrated to achieve a maximal therapeutic effect.
Reikia vengti kartu vartoti pramipeksolio ir vaistiniųpreparatų psichozė( ž 4. 4 skyrių pvz., tuo atveju, jei poveikis gali bū prieš ti ingas negu laukiama.
Ascending – Dose Schedule of OPRYMEA Week
4. 6 Nėtumo ir ž š indymo laikotarpis
Dosage (mg of base)
Koks pramipeksolio poveikis pasireiš nėtumo ir ž
Total Daily Dose (mg of base)
kia š
Dosage (mg of salt)
indymo laikotarpiu nežinoma, nes tyrimųsu
Total Daily Dose (mg of salt)
žmonė neatlikta.
1 2 3
mis
3 x 0.088 3 x 0.18 3 x 0.35
su iurkė
0.264 0.54 1.1
iais
3 x 0.125 3 x 0.25 3 x 0.5
nesukė, tač ž
0.375 0.75 1.50
lė iau iurkių
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.
patelė vartojant toksines preparato dozes, pasireiš embriotoksinis ms kė
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).
poveikis (ž 5. 3 skyrių
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.
).
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).
Nėtumo laikotarpiu Oprymea galima vartoti tik bū atveju, pvz., jei tikima, kad gydomasis š tinu poveikis motinai bus didesnis už pavojųvaisiui.
Dosing in patients with renal impairment The elimination of pramipexole is dependent on renal function.
Kadangi pramipeksolis slopina prolaktino išsiskyrimą monė gali bū slopinamas pieno išsiskyrimas.
The following dosage schedule is suggested for initiation of therapy:
Ar vaisto patenka įmoters pienąnež
Patients with a creatinine clearance above 50 ml/ min require no reduction in daily dose.
ž
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).
ms,
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.
ti
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%.
,
Dosing in patients with hepatic impairment Dose adjustment in patients with hepatic failure is probably not necessary, as approx.
Tyrimai su
90% of absorbed active substance is excreted through the kidneys.
ž mis, kurioms iurkė
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.
Kadangi tyrimų žsu monė neatlikta, ž
4.3 Contraindications
iagos, parodėkad jų,
Hypersensitivity to the active substance or to any of the excipients.
pieno radioaktyvumas buvo
4.4 Special warnings and precautions for use
mis
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.
Jei tai
Patients should be informed that (mostly visual) hallucinations can occur.
neį manoma, ž indymą reikia nutraukti.
If they occur, the dose of levodopa should be decreased.
4. 7 Poveikis gebė jimui vairuoti ir valdyti mechanizmus
Patients must be informed of this and advised to exercise caution while driving or operating machines during treatment with Oprymea.
Oprymea gebė vairuoti ir dirbti su mechanizmais veikia stipriai. jimą
Furthermore a reduction of dosage or termination of therapy may be considered.
Oprymea vartojimo laikotarpiu gali atsirasti haliucinacijųarba mieguistumas.
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).
Pacientus, kurie vartoja Oprymea ir kuriems pasireiš mieguistumas ir (arba) prasideda staigū
Furthermore, patients and caregivers should be aware of the fact that behavioural changes can occur.
miego priepuoliai, bū informuoti, kad vaisto vartojimo laikotarpiu nevairuotųir nedirbtų mesio
Patients with psychotic disorders should only be treated with dopamine agonists if the potential benefits outweigh the risks.
tina
Coadministration of antipsychotic medicinal products with pramipexole should be avoided (see section 4.5).
dė
Ophthalmologic monitoring is recommended at regular intervals or if vision abnormalities occur.
reikalaujanč darbo tol, kol toks poveikis nepraeis, nes dėsumažjusio budrumo tiek pacientui, tiek
In case of severe cardiovascular disease, care should be taken.
io
Reports in the literature indicate that treatment of another indication with dopaminergic medicinal products can result in augmentation.
ė
4.5 Interaction with other medicinal products and other forms of interaction
kitiems ž monė galimas sunkus ar net mirtinas suž
Pramipexole is bound to plasma proteins to a very low (< 20%) extent, and little biotransformation is seen in man.
alojimas, pvz., dirbant su mechanizmais (ž 4. 4, r.
There is no pharmacokinetic interaction with selegiline and levodopa.
4. 5 ir 4. 8 skyrius).
Reduction of the pramipexole dose should be considered when these medicinal products are administered concomitantly.
4. 8 Nepageidaujamas poveikis
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.
Vartojant Oprymea gali pasireikš toliau iš
Because of possible additive effects, caution should be advised when patients are taking other sedating medicinal products or alcohol in combination with pramipexole.
ti
Coadministration of antipsychotic medicinal products with pramipexole should be avoided (see section 4.4), e. g. if antagonistic effects can be expected.
vardytas šalutinis poveikis: nenormalū
4.6 Pregnancy and lactation
sapnai, sumiš s
Oprymea should not be used during pregnancy unless clearly necessary, i. e. if the potential benefit justifies the potential risk to the foetus.
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
However, if its use is unavoidable, breast-feeding should be discontinued.
dimas, svorio didė jimas, staigus miego
4.7 Effects on ability to drive and use machines
priepuolis, niež ir bė
Oprymea can have a major influence on the ability to drive and use machines.
ulys
Hallucinations or somnolence can occur.
rimas ar kitokia padidėjusio jautrumo reakcija.
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).
Remiantis sukauptų placebu kontroliuotų klinikiniųtyrimųkuriuose 1 923 pacientai vartojo, pramipeksolį 1 354 pacientai vartojo placebąanalizė duomenimis, nepageidaujamos reakcijos daž pasireiš
4.8 Undesirable effects
ir abiejų
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.
kė
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.
grupiųpacientams.
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,
Daž niausios (%) pastebė nepageidaujamos reakcijos ligoniams, sirgusiems Parkinsono liga ir 5
21 dizziness, somnolence, insomnia, constipation, hallucination, headache and fatigue.
Vartojant didesnę 1, 5 mg paros dozę
The incidence of somnolence is increased at doses higher than 1.5 mg/ day (see section 4.2).
mieguistumo pasireiškimo daž didė (ž 4. 2 skyrių Jei kartu vartojama levodopa, daž
More frequent adverse drug reaction in combination with levodopa was dyskinesia.
pasireiš diskinezija.
Very common Adverse Reactions (≥ 1/ 10) System organ class
sistemųklasės
Adverse reaction
Organų sistemų klasė
22 There is no clinical experience with massive overdose.
farmakodinaminiu poveikiu, įskaitant pykinimą,
There is no established antidote for overdose of a dopamine agonist.
antidoto nė Jei atsiranda CNS sujaudinimo simptomųreikė vartoti neuroleptikų Perdozavimas
Pramipexole alleviates Parkinsonian motor deficits by stimulation of dopamine receptors in the striatum.
uotajame kū esanč dopamino receptorius ir ne ius
Pramipexole shows linear kinetics and a small inter-patient variation of plasma levels.
Pramipeksolio farmakokinetika yra tiesinėjo koncentracijos plazmoje skirtumai tarp į ių
The total
matomis.
23 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.
5.3 Preclinical safety data
5. 3 Ikiklinikiniųsaugumo tyrimųduomenys
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.
Kartotiniųpramipeksolio dozių toksinio poveikio tyrimai parodėkad jis veikia daugiausia CNS ir, pateliųdauginimosi sistemos funkcijas, tikriausiai dėper didelio farmakodinaminio pramipeksolio l poveikio.
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.
Pastebė kad preparatas retina mažjųkiaulių irdies susitraukimus bei maž sistolinį diastolinį
The potential effects of pramipexole on reproductive function have been investigated in rats and rabbits.
Bež ionė pastebė kraujospū io mažjimo tendencija.
Pramipexole was not teratogenic in rats and rabbits but was embryotoxic in the rat at maternally toxic doses.
Dėgyvū rūių
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.
pramipeksolio poveikis pateliųvaikingumui ir patinųvislumui galutinai neiš tirtas.
In a carcinogenicity study, male rats developed Leydig cell hyperplasia and adenomas, explained by the prolactin-inhibiting effect of pramipexole.
Tiriant, ar preparatas sukelia kancerogeninį poveikį, pastebė kad ž
This finding is not clinically relevant to man.
iurkiųpatinams atsirado Laydigo lą
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.
kad pramipeksolis slopina prolaktino iš siskyrimąToks poveikis klinikai nereikš parodėkad baltosioms ž ms, vartojusioms 2 mg/ kg
The latter finding was not observed in pigmented rats, nor in a 2-year albino mouse carcinogenicity study or in any other species investigated.
ž iurkė nei baltosioms pelė 2 metųtrukmė kancerogeninio poveikio tyrimųmetu, nei kitoms
6.
s
PHARMACEUTICAL PARTICULARS
tirtųgyvū rūims. nų š
6.1 List of excipients
FARMACINĖINFORMACIJA
Not all pack sizes may be marketed.
plokš teles.
6.6 Special precautions for disposal
Gali bū tiekiamos ne visųdydž pakuotė
24 Any unused product or waste material should be disposed of in accordance with local requirements.
6. 6 Specialū reikalavimai atliekoms tvarkyti < ir vaistiniam preparatui ruoš
MARKETING AUTHORISATION HOLDER
Specialiųreikalavimų ra. nė
KRKA, d. d., Novo mesto, Š marješ cesta 6, 8501 Novo mesto, Slovenia ka
KRKA, d. d., Novo mesto, Šmarješ cesta 6, 8501 Novo mesto, Slovė
EU/ 1/ 08/ 469/ 011 30 tablets:
EU/ 1/ 08/ 469/ 006 ių
EU/ 1/ 08/ 469/ 012 60 tablets:
EU/ 1/ 08/ 469/ 007 ių 60 tableč:
EU/ 1/ 08/ 469/ 013 90 tablets:
EU/ 1/ 08/ 469/ 008 ių 90 tableč:
EU/ 1/ 08/ 469/ 014 100 tablets:
EU/ 1/ 08/ 469/ 009 ių 100 tableč:
EU/ 1/ 08/ 469/ 015
EU/ 1/ 08/ 469/ 010 ių
Oprymea 0.7 mg tablets
Oprymea 0, 35 mg tabletė s
Each tablet contains 0.7 mg pramipexole base (as 1 mg pramipexole dihydrochloride monohydrate).
Vienoje Oprymea 0, 35 mg tabletė yra 0, 35 mg pramipeksolio bazė atitinkanč 0, 5 mg
0.70 mg: white, round, with bevelled edges, both sides scored, with imprint "P9" on both halves of one side of the tablet.
spaudas „ P8 ".
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 18
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).
Didž
In clinical trials approximately 5% of patients were treated at doses below 1.1 mg (1.5 mg of salt).
daug 5
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.
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
However, the potential influence of hepatic insufficiency on Oprymea pharmacokinetics has not been investigated.
inoma, nes tokiųtyrimų neatlikta.
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.
Oprymea nerekomenduojama vartoti vaikams ir jaunesniems kaip 18 metųpaaugliams, nes duomenų apie saugumą veiksmingumą ra.
Hypersensitivity to the active substance or to any of the excipients.
iagai arba bet kuriai pagalbinei medž iagai.
4.4 Special warnings and precautions for use
4. 4 Specialū į jimai ir atsargumo priemonė
27 When prescribing Oprymea in a patient with Parkinson’ s disease with renal impairment a reduced dose is suggested in line with section 4.2.
funkcijos sutrikimas, skiriama Oprymea
Hallucinations are known as a side-effect of treatment with dopamine agonists and levodopa.
tableč, patariama dozę inti, laikantis 4. 2 skyriuje pateiktos nuorodos.
Patients should be informed that (mostly visual) hallucinations can occur.
reikia informuoti, kad toks poveikis galimas ir kad daž niausiai bū regė na
In advanced Parkinson’ s disease, in combination treatment with levodopa, dyskinesias can occur during the initial titration of Oprymea.
Progresavusia Parkinsono liga sergantiems pacientams Oprymea vartojant kartu dozė nustatymo metu galima diskinezija.
If they occur, the dose of levodopa should be decreased.
su levodopa, pradinė
Pramipexole has been associated with somnolence and episodes of sudden sleep onset, particularly in patients with Parkinson’ s disease.
Oprymea gali sukelti mieguistumą staigius miego priepuolius, ypač
Sudden onset of sleep during daily activities, in some cases without awareness or warning signs, has been reported uncommonly.
nai. mones, vartojanč Oprymea, bū apie tokią ius tina
Patients must be informed of this and advised to exercise caution while driving or operating machines during treatment with Oprymea.
Be to, reikė apsvarstyti dozavimo maž
Patients who have experienced somnolence and/ or an episode of sudden sleep onset must refrain from driving or operating machines.
nutraukimo galimybęJei kartu su pramipeksoliu vartojama ir kitokiųraminamų ar geriama alkoholio,
Furthermore a reduction of dosage or termination of therapy may be considered.
. gali pasireikš adityvus poveikis, todėpacientą
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).
Pastebė kad Parkinsono liga sergantiems pacientams, vartojantiems dopamino agonistųį
Pathological gambling, increased libido and hypersexuality have been reported in patients treated with dopamine agonists for Parkinson’ s disease, including pramipexole.
Todėpacientai ir slaugytojai turi ž
Furthermore, patients and caregivers should be aware of the fact that behavioural changes can occur.
Tokiu atveju
Dose reduction/ taper or discontinuation should be considered.
reikia apsvarstyti dozė sumaž
Patients with psychotic disorders should only be treated with dopamine agonists if the potential benefits outweigh the risks.
Ligoniai, kuriųpsichika sutrikusi, dopamino agonistųgali vartoti tik tuo atveju, jei manoma, kad gydomasis poveikis bus didesnis už
In case of severe cardiovascular disease, care should be taken.
Jei sergama sunkia š irdies ir kraujagysliųliga, bū atidi ligonio priež ra.
Symptoms suggestive of neuroleptic malignant syndrome have been reported with abrupt withdrawal of dopaminergic therapy (see section 4.2)
vaistųvartojimąpasireiš simptomai, verč kia iantys
28 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.
sekrecinęsistemą arba patys per ją skiriami, pvz., cimetidinas ir amantadinas, gali iš
Reduction of the pramipexole dose should be considered when these medicinal products are administered concomitantly.
sąveikauti su pramipeksoliu, mažindami bet kurio vaistinio preparato arba jųabiejų klirensąJei tokių. vaistiniųpreparatųvartojama kartu su pramipeksoliu, reikia apsvarstyti pramipeksolio dozė s maž inimo galimybę
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 Oprymea vartojant kartu su levodopa, rekomenduojama pastarojo doz ę inti, o kitųvaistinių maž preparatų parkinsonizmo dozėnekeisti, nors Oprymea doz ė bū didinama.
Because of possible additive effects, caution should be advised when patients are taking other sedating medicinal products or alcohol in combination with pramipexole.
Pacientus, kartu su pramipeksoliu vartojanč kitokiųraminamų
29 reaction in combination with levodopa was dyskinesia.
pasireiš diskinezija.
There is no clinical experience with massive overdose.
farmakodinaminiu poveikiu,
The expected adverse events would be those related to the pharmacodynamic profile of a dopamine agonist, including nausea, vomiting, hyperkinesia, hallucinations, agitation and hypotension.
vėmimąhiperkinezijąhaliucinacijas, sujaudinimą hipotenzijąDopamino agonistųperdozavus,
There is no established antidote for overdose 30 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.
22 gydomas į prastinė palaikomojo gydymo priemonė kartu plaunamas skrandis, į
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.
Jis labai selektyviai ir specifiš jungiasi su dopamino D2 kai pogrupio receptoriais, iškuriųD3 receptoriams afinitetas yra didž iausias, ir turi visąvidinįaktyvumą.
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 pager ė
However there was no significant difference during the maintenance phase.
Tokio poveikio galimybę serganč ligonius gydyti pramipeksoliu. ius
The total clearance of pramipexole is approximately 500 ml/ min and the renal clearance is approximat ely 400 ml/ min.
500 ml/ min., inkstų klirensas yra maž daug 400 ml/ min.
31 5.3 Preclinical safety data
5. 3 Ikiklinikiniųsaugumo tyrimųduomenys
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.
23 Pastebė kad preparatas retina mažjųkiaulių irdies susitraukimus bei maž sistolinį diastolinį
Any unused product or waste material should be disposed of in accordance with local requirements.
6. 6 Specialū reikalavimai atliekoms tvarkyti < ir vaistiniam preparatui ruoš
32 7.
ti
8.
ka
EU/ 1/ 08/ 469/ 016 30 tablets:
EU/ 1/ 08/ 469/ 011 ių 30 tableč:
EU/ 1/ 08/ 469/ 017 60 tablets:
EU/ 1/ 08/ 469/ 012 ių 60 tableč:
EU/ 1/ 08/ 469/ 018 90 tablets:
EU/ 1/ 08/ 469/ 013 ių 90 tableč:
EU/ 1/ 08/ 469/ 019 100 tablets:
EU/ 1/ 08/ 469/ 014 ių 100 tableč:
EU/ 1/ 08/ 469/ 020
EU/ 1/ 08/ 469/ 015 ių
Oprymea 1.1 mg tablets
Oprymea 0. 7 mg tabletė s
Each tablet contains 1.1 mg pramipexole base (as 1.5 mg pramipexole dihydrochloride monohydrate).
Vienoje Oprymea 0, 7 mg tabletė yra 0, 7 mg pramipeksolio bazė atitinkanč 1 mg
1.1 mg: white, round, with bevelled edges, both sides scored.
spaudas „ P9 ".
Total Daily Dose (mg of salt)
Gerti tris kartus po 0, 35
1 2 3
1, 1
3 x 0.088 3 x 0.18 3 x 0.35
Gerti tris kartus po 0, 5
3 x 0.125 3 x 0.25 3 x 0.5
kas
0.375 0.75 1.50
turi ti
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.
druskos) iki didž iausios paros dozė - 3, 3 mg bazė (4, 5 mg druskos).
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).
Reikia žinoti, kad jei vartojama didesnė daž (ž 4. 8 skyrių nis r.).
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.
Didž
However, the potential influence of hepatic insufficiency on Oprymea pharmacokinetics has not been investigated.
 absorbuotos veikliosios medž
4.3 Contraindications
tina, nes maž
Hypersensitivity to the active substance or to any of the excipients.
iagos išsiskiria pro inkstus, tač koks gali bū kepenų iau ti
4.4 Special warnings and precautions for use
funkcijos
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.
nepakankamumo poveikis Oprymea farmakokinetikai než
Hallucinations are known as a side-effect of treatment with dopamine agonists and levodopa.
inoma, nes tokiųtyrimų neatlikta.
Patients should be informed that (mostly visual) hallucinations can occur.
Dozavimas vaikams ir paaugliams
In advanced Parkinson’ s disease, in combination treatment with levodopa, dyskinesias can occur during the initial titration of Oprymea.
Oprymea nerekomenduojama vartoti vaikams ir jaunesniems kaip 18 metųpaaugliams, nes duomenų apie saugumą veiksmingumą ra.
If they occur, the dose of levodopa should be decreased.
4. 3 Kontraindikacijos
Pramipexole has been associated with somnolence and episodes of sudden sleep onset, particularly in patients with Parkinson’ s disease.
Padidė s jautrumas veikliajai medž
Sudden onset of sleep during daily activities, in some cases without awareness or warning signs, has been reported uncommonly.
ję
Furthermore a reduction of dosage or termination of therapy may be considered.
iagai arba bet kuriai pagalbinei medž iagai.
Dose reduction/ taper or discontinuation should be considered.
4. 4 Specialū į jimai ir atsargumo priemonė
Patients with psychotic disorders should only be treated with dopamine agonists if the potential benefits outweigh the risks.
s spė
Ophthalmologic monitoring is recommended at regular intervals or if vision abnormalities occur.
27 Jei serganč Parkinsono liga ligoniui, kuriam yra inkstų
In case of severe cardiovascular disease, care should be taken.
funkcijos sutrikimas, skiriama Oprymea
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.
tableč, patariama dozę inti, laikantis 4. 2 skyriuje pateiktos nuorodos.
Symptoms suggestive of neuroleptic malignant syndrome have been reported with abrupt withdrawal of dopaminergic therapy (see section 4.2)
maž
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.
Yra ž inoma, kad vartojant dopamino agonistųir levodopos gali pasireikš šti alutinis poveikis – atsirasti haliucinacijų Pacientą
The frequency of augmentation after longer use of pramipexole and the appropriate management of these events have not been evaluated in controlled clinical trials.
.
4.5 Interaction with other medicinal products and other forms of interaction
reikia informuoti, kad toks poveikis galimas ir kad daž niausiai bū regė na
Pramipexole is bound to plasma proteins to a very low (< 20%) extent, and little biotransformation is seen in man.
haliucinacijų.
Therefore, interactions with other medicinal products affecting plasma protein binding or elimination by biotransformation are unlikely.
Progresavusia Parkinsono liga sergantiems pacientams Oprymea vartojant kartu dozė nustatymo metu galima diskinezija.
There is no pharmacokinetic interaction with selegiline and levodopa.
Jei taip atsitinka, levodopos dozę
Therefore, medicinal products
su levodopa, pradinė
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.
s
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.
s
Because of possible additive effects, caution should be advised when patients are taking other sedating medicinal products or alcohol in combination with pramipexole.
reikia maž inti.
Coadministration of antipsychotic medicinal products with pramipexole should be avoided (see section 4.4), e. g. if antagonistic effects can be expected.
Oprymea gali sukelti mieguistumą staigius miego priepuolius, ypač
4.6 Pregnancy and lactation
Parkinsono liga sergantiems
The effect on pregnancy and lactation has not been investigated in humans.
Dieną dirbant kai kada gali atsirasti staigiųmiego priepuolių iš be ankstinio suvokimo ar į jamų pož spė jų ymių tač taip atsitinka nedaž Ž
Pramipexole was not teratogenic in rats and rabbits, but was embryotoxic in the rat at maternotoxic doses (see section 5.3).
nai. mones, vartojanč Oprymea, bū apie tokią ius tina
Oprymea should not be used during pregnancy unless clearly necessary, i. e. if the potential benefit justifies the potential risk to the foetus.
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
As pramipexole treatment inhibits secretion of prolactin in humans, inhibition of lactation is expected.
tinka staigus miego priepuolis, vairuoti ar
The excretion of pramipexole into breast milk has not been studied in women.
iais renginiais negalima.
In rats, the concentration of active substance-related radioactivity was higher in breast milk than in plasma.
Be to, reikė apsvarstyti dozavimo maž
In the absence of human data, Oprymea should not be used during breast-feeding.
nutraukimo galimybęJei kartu su pramipeksoliu vartojama ir kitokiųraminamų ar geriama alkoholio,
However, if its use is unavoidable, breast-feeding should be discontinued.
. gali pasireikš adityvus poveikis, todėpacientą
4.7 Effects on ability to drive and use machines
jųvaistinių preparatų
Oprymea can have a major influence on the ability to drive and use machines.
4. 8 skyrius).
Hallucinations or somnolence can occur.
apie tai reikia į ti (ž 4. 7 ir spė r.
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).
Pastebė kad Parkinsono liga sergantiems pacientams, vartojantiems dopamino agonistųį
4.8 Undesirable effects
ta,
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.
, skaitant ir
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.
pramipeksolį, atsiranda patologinis potraukis azartiniams ž aidimams, sustiprė lytinis potraukis ir ja seksualumas.
63% of patients on pramipexole and 52% of patients on placebo reported at least one adverse drug reaction.
Todėpacientai ir slaugytojai turi ž
The incidence of somnolence is increased at doses higher than 1.5 mg/ day (see section 4.2).
Tokiu atveju
More frequent adverse drug
reikia apsvarstyti dozė sumaž
37 reaction in combination with levodopa was dyskinesia.
nutraukimo galimybę ko
Hypotension may occur at the beginning of treatment, especially if pramipexole is titrated too fast.
Ligoniai, kuriųpsichika sutrikusi, dopamino agonistųgali vartoti tik tuo atveju, jei manoma, kad gydomasis poveikis bus didesnis už
The most commonly (≥
galimą alą ž.
5%) reported adverse drug reactions in patients with other indication treated
vartoti vaistinius preparatus nuo psichozė (ž 4. 5 skyrių s r.).
with pramipexole were nausea, headache, dizziness and fatigue.
Rekomenduojama reguliariai, ypač atveju, jei trinka rega, atlikti oftalmologinius tyrimus. tuo
Tables 1 and 2 display the frequency of adverse reactions from placebo-controlled clinical trials.
Jei sergama sunkia š irdies ir kraujagysliųliga, bū atidi ligonio priež ra.
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.
Vartojant dopaminerginio
Table 1:
tina
Very common Adverse Reactions (≥ 1/ 10) System organ class
poveikio vaistų rekomenduojama nuolat matuoti kraujospū, ypač
Adverse reaction
gydymo pradž
Pramipexole N= 1,923 (%)
kadangi yra ioje,
Nervous system disorders
didelis ortostatinė hipotenzijos pavojus. s
Dizziness Dyskinesia
Pastebė kad staigiai nutraukus dopaminerginių
15.5 12.9
ta,
Gastrointestinal disorders Vascular disorders
vaistųvartojimąpasireiš simptomai, ver kia
17.2 12.6
č iantys
Table 2:
4. 2 skyrių
Common Adverse Reactions (≥ 1/ 100 to < 1/ 10) System organ class
Mokslinė literatū duomenys rodo, kad dopaminerginio poveikio vaistiniųpreparatų
Adverse reaction
vartojant
Pramipexole N= 1,923 (%)
kitokiai indikacijai, bū gali pasunkė Tokį
Psychiatric disorders
poveikįrodo anksti vakare arba net po pietų
Abnormal dreams Confusional state Hallucinations Insomnia
atsirandantys simptomai, kurie sunkė ir apima kitas galū Kontroliuotų bū s pasunkė
3.5 3.0 6.6 8.2
nes.
Nervous system disorders
klinikiniųtyrimųmetu
Somnolence Headache
gydymas netirti.
8.6 6.5
iau
Gastrointestinal disorders
), monių
Constipation
organizme jo
5.5
du
General disorders and administration site conditions
išorganizmo daugiausiai iš siskiria biotransformacijos bū jų veikos galimybė nedidelėnors
Fatigue
du, są
6.1
yra
Peripheral oedema
Cimetidinas maž pramipeksolio inkstų
1.9
ina
Pramipexole is associated with somnolence (8.6%) and has been associated uncommonly with excessive daytime somnolence and sudden sleep onset episodes (0.1%).
daug 34  t, dėkatijoninėsekrecinė maž (turbū l
See also section 4.4.
perneš sistemos funkcijos slopinimo inkstųkanalė
Pramipexole may be associated with libido disorders (increased (0.1%) or decreased (0.4%)).
liuose), todėvaistiniai preparatai, kurie slopina l
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.
sekrecinęsistemą arba patys per ją skiriami, pvz., cimetidinas ir amantadinas, gali iš
4.9 Overdose
sąveikauti su pramipeksoliu, mažindami bet kurio vaistinio preparato arba jųabiejų klirensąJei tokių.
There is no clinical experience with massive overdose.
28 vaistiniųpreparatųvartojama kartu su pramipeksoliu, reikia apsvarstyti pramipeksolio dozė s maž inimo galimybę.
The expected adverse events would be those related to the pharmacodynamic profile of a dopamine agonist, including nausea, vomiting, hyperkinesia, hallucinations, agitation and hypotension.
Oprymea vartojant kartu su levodopa, rekomenduojama pastarojo doz ę inti, o kitųvaistinių maž preparatų parkinsonizmo dozėnekeisti, nors Oprymea doz ė bū didinama.
There is no established antidote for overdose 38 of a dopamine agonist.
Pacientus, kartu su pramipeksoliu vartojanč kitokiųraminamų
If signs of central nervous system stimulation are present, a neuroleptic agent may be indicated.
jųvaistiniųpreparatųarba alkoholio,
Management of the overdose may require general supportive measures, along with gastric lavage, intravenous fluids, administration of activated charcoal and electrocardiogram monitoring.
Reikia vengti kartu vartoti pramipeksolio ir vaistiniųpreparatų psichozė( ž 4. 4 skyrių pvz., tuo atveju, jei poveikis gali bū prieš ti ingas negu laukiama.
5.
s r.
PHARMACOLOGICAL PROPERTIES
4. 6 Nėtumo ir ž š indymo laikotarpis
5.1 Pharmacodynamic properties
Koks pramipeksolio poveikis pasireiš nėtumo ir ž
Pharmacotherapeutic group: dopamine agonists, ATC code:
indymo laikotarpiu nežinoma, nes tyrimųsu
N04BC05.
žmonė neatlikta.
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.
poveikis (ž 5. 3 skyrių
Pramipexole alleviates Parkinsonian motor deficits by stimulation of dopamine receptors in the striatum.
Nėtumo laikotarpiu Oprymea galima vartoti tik bū atveju, pvz., jei tikima, kad gydomasis š tinu poveikis motinai bus didesnis už pavojųvaisiui.
Animal studies have shown that pramipexole inhibits dopamine synthesis, release, and turnover.
Kadangi pramipeksolis slopina prolaktino išsiskyrimą monė gali bū slopinamas pieno išsiskyrimas.
In human volunteers, a dose-dependent decrease in prolactin was observed.
Tyrimai su
Clinical trials in Parkinson’ s disease
ž mis, kurioms iurkė
In patients pramipexole alleviates signs and symptoms of idiopathic Parkinson 's disease.
Kadangi tyrimų žsu monė neatlikta, ž
Controlled clinical trials included approximately 2100 patients of Hoehn and Yahr stages I – IV.
Jei tai
Out of these, approximately 900 were in more advanced stages, received concomitant levodopa therapy, and suffered from motor complications.
neį manoma, ž indymą reikia nutraukti.
In early and advanced Parkinson’ s disease, efficacy of pramipexole in the controlled clinical trials was maintained for approximately six months.
Oprymea gebė vairuoti ir dirbti su mechanizmais veikia stipriai. jimą
In open continuation trials lasting for more than three years there were no signs of decreasing efficacy.
Oprymea vartojimo laikotarpiu gali atsirasti haliucinacijųarba mieguistumas.
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.
Pacientus, kurie vartoja Oprymea ir kuriems pasireiš mieguistumas ir (arba) prasideda staigū
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).
miego priepuoliai, bū informuoti, kad vaisto vartojimo laikotarpiu nevairuotųir nedirbtų mesio
The overall incidence of hallucinations and somnolence was generally higher in the escalation phase with the pramipexole group.
reikalaujanč darbo tol, kol toks poveikis nepraeis, nes dėsumažjusio budrumo tiek pacientui, tiek
However there was no significant difference during the maintenance phase.
kitiems ž monė galimas sunkus ar net mirtinas suž
These points should be considered when initiating pramipexole treatment in patients with Parkinson´s disease.
alojimas, pvz., dirbant su mechanizmais (ž 4. 4, r.
5.2 Pharmacokinetic properties
4. 8 Nepageidaujamas poveikis
Pramipexole is rapidly and completely absorbed following oral administration.
Vartojant Oprymea gali pasireikš toliau iš
The absolute bioavailability is greater than 90% and the maximum plasma concentrations occur between 1 and 3 hours.
vardytas šalutinis poveikis: nenormalū
Pramipexole shows linear kinetics and a small inter-patient variation of plasma levels.
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
In humans, the protein binding of pramipexole is very low (< 20%) and the volume of distribution is large (400 l).
dimas, svorio didė jimas, staigus miego
8-fold compared to plasma).
priepuolis, niež ir bė
Pramipexole is metabolised in man only to a small extent.
rimas ar kitokia padidėjusio jautrumo reakcija.
Renal excretion of unchanged pramipexole is the major route of elimination.
grupiųpacientams.
Approximately 90% of 14 C-labelled dose is excreted through the kidneys while less than 2% is found in the faeces.
63% pacientųvartojusiųpramipeksolį 52% pacientų, ir,
The total clearance of pramipexole is approximately 500 ml/ min and the renal clearance is approximately 400 ml/ min.
iausiai viena nepageidaujamo poveikio reakcija.
The elimination half-life (t½) varies from 8 hours in the young to 12 hours in the elderly.
niausios (%) pastebė nepageidaujamos reakcijos ligoniams, sirgusiems Parkinsono liga ir 5
39 5.3 Preclinical safety data
29 vartojusiems pramipeksolį
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.
, pasireiš kusios daug daž niau, palyginus su tokiomis placebą vartojusių
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.
pacientų buvo pykinimas, diskinezija, hipotenzija, svaigulys, mieguistumas, nemiga, vidurių, už jimas, haliucinacijos, galvos skausmas ir nuovargis.
The potential effects of pramipexole on reproductive function have been investigated in rats and rabbits.
4. 2 skyrių Jei kartu vartojama levodopa, daž ja r).
Pramipexole was not teratogenic in rats and rabbits but was embryotoxic in the rat at maternally toxic doses.
pasireiš diskinezija.
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.
Gydymo pradž ypač atveju, jei pramipeksolio dozė greitai,
Pramipexole was not genotoxic.
atsirasti hipotenzija.
In a carcinogenicity study, male rats developed Leydig cell hyperplasia and adenomas, explained by the prolactin-inhibiting effect of pramipexole.
Daž niausios (%) pastebė nepageidaujamos reakcijos ligoniams, vartojusiems pramipeksolį 5
This finding is not clinically relevant to man.
kitokiai indikacijai, buvo pykinimas, galvos skausmas, svaigulys ir nuovargis.
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.
Moterims, vartojusioms pramipeksolį, pykinimas ir nuovargis (atitinkamai 20, 8% ir 10, 5%) atsirasdavo daž niau, negu vyrams (atitinkamai 6, 7% ir 7, 3%).
The latter finding was not observed in pigmented rats, nor in a 2-year albino mouse carcinogenicity study or in any other species investigated.
Š lentelė pateiktos nepageidaujamos reakcijos yra tokie
6.
se
PHARMACEUTICAL PARTICULARS
daugelis daž pasireiš
6.1 List of excipients
kusių nepageidaujamų
Mannitol Maize starch Pregelatinised maize starch Povidone K25 Colloidal anhydrous silica Magnesium stearate
buvo nesunkios arba vidutinio sunkumo, jos
6.2 Incompatibilities
atsirasdavo gydymo pradž ir turė
Not applicable.
davo tę siamas.
6.3 Shelf life
17, 2 12, 6
2 years.
2 lentelėDaž nepageidaujamos reakcijos (
6.4 Special precautions for storage
1/ 100 - < 1/ 10)
Store in the original package in order to protect from light.
Organųsistemųklasė
6.5 Nature and contents of container
Nepageidaujamos reakcijos
Blister pack (Al/ Al foil):
Pramipeksolis n = 1923 (%)
20, 30, 60, 90 or 100 tablets.
Psichikos sutrikimai
Not all pack sizes may be marketed.
Nenormalū sapnai s Konfū zija Haliucinacijos Nemiga
6.6 Special precautions for disposal
Mieguistumas Galvos skausmas Vidurių kietė už jimas
Any unused product or waste material should be disposed of in accordance with local requirements.
Bendrieji sutrikimai ir vartojimo vietos pažeidimai
40 7.
6, 1 1, 9
MARKETING AUTHORISATION HOLDER
Pramipeksolis sukelia mieguistumą
KRKA, d. d., Novo mesto, Š marješ cesta 6, 8501 Novo mesto, Slovenia ka
(8, 6
8.
).
MARKETING AUTHORISATION NUMBER(S)
potraukįjis gali sustiprė (0, 1 ) arba susilpnė (0, 4 ).
20 tablets:
:
EU/ 1/ 08/ 469/ 021 30 tablets:
atvejų 
EU/ 1/ 08/ 469/ 022 60 tablets:
atvejų 
EU/ 1/ 08/ 469/ 024 100 tablets:
įskaitant pramipeksoliu, ypač didesnė dozė pasireiš patologinio potraukio azartiniams
EU/ 1/ 08/ 469/ 025
mis,
9.
kia
DATE OF FIRST AUTHORISATION/ RENEWAL OF THE AUTHORISATION
žaidimams pož ymiai, sustiprė lytinis potraukis ir seksualumas.
12/ 9/ 2008
arba sumaž inus
10.
, ie
DATE OF REVISION OF THE TEXT
ymiai paprastai praeina.
Detailed information on this medicinal product is available on the website of the European Medicines Agency (EMEA) http: / /www. emea. europa. eu/.
Manoma, kad nepageidaujamas poveikis turė ti susijęsu dopamino agonistų
41 ANNEX II
tųbū
A.
s
MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE
farmakodinaminiu poveikiu, įskaitant pykinimą,
B.
ir
CONDITIONS OF THE MARKETING AUTHORISATION
antidoto nė Jei atsiranda CNS sujaudinimo simptomųreikė vartoti neuroleptikų Perdozavimas
42 A.
tų
MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE
gydomas į prastinė palaikomojo gydymo priemonė kartu plaunamas skrandis, į
Name and address of the manufacturer responsible for batch release
injekuojama skysč, duodama aktyvintos anglies ir stebima elektrokardiograma. ių
Krka, d. d., Novo mesto Š marješ cesta 6 ka 8501 Novo mesto Slovenia
FARMAKOLOGINĖ SAVYBĖ
B.
S
CONDITIONS OF THE MARKETING AUTHORISATION
5. 1 Farmakodinaminė savybė
 CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE IMPOSED ON THE MARKETING AUTHORISATION HOLDER
Farmakoterapinėgrupė dopamino agonistai, ATC kodas – N04BC05. –
Medicinal product subject to medical prescription.
Pramipeksolis yra dopamino agonistas.
 CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
Tiriant savanorius nustatyta, kad kuo didesnėdozė vartojama, tuo prolaktino iš siskiria maž iau.
Not aplicable.
Maž
 OTHER CONDITIONS
daug 900 pacientų
Pharmacovigilance system
nesius buvo tiriamas pramipeksolio poveikis
The MAH must ensure that the system of pharmacovigilance, as described in version DescPhSys 000001/ 15 (13 October 2008) presented in Module 1.8.1. of the Marketing Authorisation Application, is in place and functioning before and whilst the product is on the market.
Ilgiau kaip 3 metus trukusiais ios atviraisiais klinikiniais tyrimais nustatyta, kad preparato veiksmingumas nemažja. ė 2 metų
PSURs
dvigubai aklu metodu atliktųtyrimųmetu nustatyta, kad jei gydymas
The PSUR submission schedule for Oprymea tablets should follow PSURs submission schedule for the reference medicinal product.
Tokį lesnį
43 ANNEX III
atsiranda daug vė
LABELLING AND PACKAGE LEAFLET
ir jų na maž negu tais liau bū iau
44 A.
vė
LABELLING
vartojant
45 PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND IMMEDIATE PACKAGING
pramipeksolio, reikia derinti su didesniu motorinė funkcijos pagerė
BOX for blisters
jimu, vartojant levodopos
NAME OF THE MEDICINAL PRODUCT
(vertinant vidutinį
Oprymea 0.088 mg tablets Pramipexole
Apskritai haliucinacijos ir mieguistumas daž
2.
niau
STATEMENT OF ACTIVE SUBSTANCE(S)
5. 2 Farmakokinetinė savybė s s
Each tablet contains 0.088 mg pramipexole equivalent to 0.125 mg pramipexole dihydrochloride monohydrate.
Absoliutus biologinis
3.
kai
LIST OF EXCIPIENTS
, didž
PHARMACEUTICAL FORM AND CONTENTS
Jei preparato vartojama kartu su maistu, absorbuoto vaisto kiekis nemažja, tač absorbcijos greitis
20 tablets
lė ja.
5.
tė
METHOD AND ROUTE(S) OF ADMINISTRATION
vairių
Read the package leaflet before use.
pacientų nedideli.
Oral use
iau
6.
),
SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF THE REACH AND SIGHT OF CHILDREN
iurkiųsmegenų audiniuose preparato
Keep out of the reach and sight of children.
koncentracija bū didelė