qanastek/EMEA-V3 huggingface dataset:
Pramipexole has been associated with somnolence and episodes of sudden sleep onset, particularly in patients with Parkinson’ s disease.
dzekļ
Dose reduction/ taper or discontinuation should be considered.
š vai aktivitā m (piemē anas tē
Patients with psychotic disorders should only be treated with dopamine agonists if the potential benefits outweigh the risks.
ram,
Coadministration of antipsychotic medicinal products with pramipexole should be avoided (see section 4.5).
mehā nismu apkalpoš anas), kuru laikā modrī traucē smagu traumu vai nā riskam (skatīapakš
Ophthalmologic monitoring is recommended at regular intervals or if vision abnormalities occur.
paš pacientu vai citus lī aut u dzcilvēkus
In case of severe cardiovascular disease, care should be taken.
punktu 4. 4, 4. 5, un 4. 8).
Symptoms suggestive of neuroleptic malignant syndrome have been reported with abrupt withdrawal of dopaminergic therapy (see section 4.2)
4. 8
Reports in the literature indicate that treatment of another indication with dopaminergic medicinal products can result in augmentation.
Nevē
4.5 Interaction with other medicinal products and other forms of interaction
lamā blakusparā bas
Pramipexole is bound to plasma proteins to a very low (< 20%) extent, and little biotransformation is seen in man.
dī
20 Cimetidine reduced the renal clearance of pramipexole by approximately 34%, presumably by inhibition of the cationic secretory transport system of the renal tubules.
Oprymea lietoš laikā
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.
anas
Because of possible additive effects, caution should be advised when patients are taking other sedating medicinal products or alcohol in combination with pramipexole.
sagaidā
Coadministration of antipsychotic medicinal products with pramipexole should be avoided (see section 4.4), e. g. if antagonistic effects can be expected.
šdas nevē mas ā
4.6 Pregnancy and lactation
lamas blakusparā
The effect on pregnancy and lactation has not been investigated in humans.
bas: neparasti sapņ apjukums, dī i,
Pramipexole was not teratogenic in rats and rabbits, but was embryotoxic in the rat at maternotoxic doses (see section 5.3).
aizcietējumi, murgi, reibonis, diskinē nogurums, halucinā
Oprymea should not be used during pregnancy unless clearly necessary, i. e. if the potential benefit justifies the potential risk to the foetus.
zija,
As pramipexole treatment inhibits secretion of prolactin in humans, inhibition of lactation is expected.
cijas, galvassā hiperkinē hipotensija, pes, ze,
In rats, the concentration of active substance-related radioactivity was higher in breast milk than in plasma.
pastiprinā ē (ēanas mā pā š s), bezmiegs, dzimumtieksmes traucē ta š
In the absence of human data, Oprymea should not be used during breast-feeding.
nija, rēanā
However, if its use is unavoidable, breast-feeding should be discontinued.
jumi, slikta dūa, perifē š ra
4.7 Effects on ability to drive and use machines
tū paranoja, patoloģ tieksme uz azartspē m, hiperseksualitā un citi uzvedī traucē
Oprymea can have a major influence on the ability to drive and use machines.
miegainī pieņ anā svarāpē ņ miega epizodes, nieze, izsitumi un citas paaugstinā jutī
Hallucinations or somnolence can occur.
reakcijas.
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).
Analizē apkopotu placebo kontrolē pējumu datus, kas ietvē pavisam 1923 pacientus, kuri lietoja
4.8 Undesirable effects
tu tī
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.
ra
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.
pramipeksolu un 1354 pacientus, kuri lietoja placebo, ziņ ojumi par blakusparā bā tika biežsaņ
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,
Pacientiem ar Parkinsona slimī visbiežk (≥ ziņ par sliktu dūu, diskinē hipotensiju, reiboni, miegainī bezmiegu, aizcietē
21 dizziness, somnolence, insomnia, constipation, hallucination, headache and fatigue.
pramipeksola grupāsalī, dzinot ar placebo).
The incidence of somnolence is increased at doses higher than 1.5 mg/ day (see section 4.2).
Miegainī incidence palielinā lietojot devas, kas pā 1, 5 mg/ dienā (skatīapakš
More frequent adverse drug reaction in combination with levodopa was dyskinesia.
blakusparā ba kombinā ar levodopa bija rotā dī cijā
Hypotension may occur at the beginning of treatment, especially if pramipexole is titrated too fast.
kumāī i, ja pramipeksola devu palielinā pā k strauji., paš ja rā
Gastrointestinal disorders Vascular disorders
Kuņa un zarnu trakta traucē
4.9 Overdose
rdozēana š
22 There is no clinical experience with massive overdose.
Sagaidā s š
The expected adverse events would be those related to the pharmacodynamic profile of a dopamine agonist, including nausea, vomiting, hyperkinesia, hallucinations, agitation and hypotension.
agonistu farmakodinamisko profilu, ietverot sliktu dūu, vemš hiperkinē halucinā uzbudinā
There is no established antidote for overdose of a dopamine agonist.
Ja nav ms
If signs of central nervous system stimulation are present, a neuroleptic agent may be indicated.
Pā ti dzekļ rdozēanas gadī
Management of the overdose may require general supportive measures, along with gastric lavage, intravenous fluids, administration of activated charcoal and electrocardiogram monitoring.
aktī s ogles ordinēanu un elektrokardiogrammas kontroli.
PHARMACOLOGICAL PROPERTIES
FARMAKOLOĢISKĀ Ī Ī S PAŠBAS
5.1 Pharmacodynamic properties
5. 1 Farmakodinamiskā ī ī s pašbas
The absolute bioavailability is greater than 90% and the maximum plasma concentrations occur between 1 and 3 hours.
Lietojot perorā pramipeksols ā un pilnī absorbē Absolū biopieejamī ir lielā par 90% un
The total
renss ir
23 clearance of pramipexole is approximately 500 ml/ min and the renal clearance is approximately 400 ml/ min.
renss ir apmē 400 ml/ min.
The elimination half-life (t½) varies from 8 hours in the young to 12 hours in the elderly.
Eliminā ram cijas pusperiods (t½) svā s no 8 rstā
5.3 Preclinical safety data
niskie dati par droš ību
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.
Atkā rtotu devu toksicitā pējumi pierā ja, ka pramipeksols funkcionā ietekmē
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.
pramipeksola farmakodinamiskais efekts.
The potential effects of pramipexole on reproductive function have been investigated in rats and rabbits.
nināanos, pē iem konstatē tendenci uz hipotensiju.
Pramipexole was not teratogenic in rats and rabbits but was embryotoxic in the rat at maternally toxic doses.
Potenciā pramipeksola ietekmi uz reproduktī funkciju pēja ž m un truš Pramipeksols nebija
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.
teratogē ž m un truš tač bija embriotoksisks ž m, ja to lietoja mā toksiskā
In a carcinogenicity study, male rats developed Leydig cell hyperplasia and adenomas, explained by the prolactin-inhibiting effect of pramipexole.
hiperplā un adenomas, ko var izskaidrot ar pramipeksola prolaktī inhibē o iedarbī Cilvē š atradne
This finding is not clinically relevant to man.
Š pašpējumā
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.
m 2 mg/ kg (sā un ja, nā urkā
The latter finding was not observed in pigmented rats, nor in a 2-year albino mouse carcinogenicity study or in any other species investigated.
pramipeksols bija saistī ar tī ts klenes deģenerā Pigmentē m ž m un divgadī m
PHARMACEUTICAL PARTICULARS
FARMACEITISKĀ Ī Ī S PAŠBAS
6.1 List of excipients
6. 1 Palī gvielu saraksts
Mannitol Maize starch Pregelatinised maize starch Povidone K25 Colloidal anhydrous silica Magnesium stearate
Povidons K25 Bezū dens koloidā silī dioksī lais cija ds Magnija stearā ts
6.2 Incompatibilities
6. 2 Nesaderī ba
Not applicable.
Nav piemē rojama.
6.3 Shelf life
6. 3 Uzglabāanas laiks š
6.4 Special precautions for storage
6. 4 Ī i uzglabāanas nosacī
Store in the original package in order to protect from light.
inā iepakojumālai aizsargā no gaismas., tu
Blister pack (Al/ Al foil):
Blisteri (Al/ Al folija):
20, 30, 60, 90 or 100 tablets.
20, 30, 60, 90 vai 100 tabletes.
Not all pack sizes may be marketed.
Visi iepakojuma lielumi tirgūvar nebū pieejami. t
6.6 Special precautions for disposal
6. 6 Ī i norā jumi atkritumu likvidēanai
24 Any unused product or waste material should be disposed of in accordance with local requirements.
Neizlietotā zā vai citus izlietotos materiā jā cina atbilstošvietē m prasī m
MARKETING AUTHORISATION HOLDER
REĢISTRĀCIJAS APLIECĪ BAS Ī NIEKS PAŠ
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, Slovē
20 tablets:
20 tabletes:
EU/ 1/ 08/ 469/ 011 30 tablets:
EU/ 1/ 08/ 469/ 006 30 tabletes:
EU/ 1/ 08/ 469/ 012 60 tablets:
EU/ 1/ 08/ 469/ 007 60 tabletes:
EU/ 1/ 08/ 469/ 013 90 tablets:
EU/ 1/ 08/ 469/ 008 90 tabletes:
EU/ 1/ 08/ 469/ 014 100 tablets:
EU/ 1/ 08/ 469/ 009 100 tabletes:
25 1.
cija
NAME OF THE MEDICINAL PRODUCT
http: // www. emea. europa. eu /.
Oprymea 0.7 mg tablets
Oprymea 0, 35 mg tabletes
2.
ls
QUALITATIVE AND QUANTITATIVE COMPOSITION
Pilnu palī gvielu sarakstu skatīapakš
Each tablet contains 0.7 mg pramipexole base (as 1 mg pramipexole dihydrochloride monohydrate).
punktā6. 1.
Please note:
ZĀ U FORMA Ļ
Pramipexole doses as published in the literature refer to the salt form.
0, 35 mg: baltas, ovā ar nošeltā malā un dalī
Therefore, doses will be expressed in terms of both pramipexole base and pramipexole salt (in brackets).
juma lī abā pusē tabletes vienā niju s s, pusē abā uz m
For a full list of excipients, see section 6.1.
dalījuma daļ ir uzdruka „ P8 ”.
3.
ām
PHARMACEUTICAL FORM
s
Tablet.
dā ās.
0.70 mg: white, round, with bevelled edges, both sides scored, with imprint "P9" on both halves of one side of the tablet.
slimī laikāieskaitot vēno stadiju, kad levodopas iedarbī bas, lī ba
The tablet can be divided into equal halves.
samazinā vai kļ nepastā ga un sā terapeitiskā iedarbī svā bas (devas beigu vai “ on- off ”
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.
Ja nepiecieš tā ka devas palielināana, dienas devu ar nedē intervā jā
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).
lu palielina par 0, 54 mg bā zes
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.
(0, 75 mg sā lī maksimā devai 3, 3 mg bā (4, 5 mg sā dienā
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.
Tā c pramipeksola deva jā pē samazina par 0, 54 mg bā (0, 75 mg sā dienākamē dienas deva sasniedz 0, 54 mg bā (0, 75 mg sā Turpmā deva jā
Ophthalmologic monitoring is recommended at regular intervals or if vision abnormalities occur.
na renss, tas ir, ja kreatinī klī na renss samazinā pars
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).
Devas bē
4.8 Undesirable effects
rniem un pusaudž
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.
iem
63% of patients on pramipexole and 52% of patients on placebo reported at least one adverse drug reaction.
Oprymea nav ieteicams lietoš bē anai rniem un pusaudž lī 18 gadu vecumam, jo nav informā droš un efektivitā
More frequent adverse drug
cijas par
29 reaction in combination with levodopa was dyskinesia.
ti.
The most commonly (≥
4. 3 Kontrindikācijas
5%) reported adverse drug reactions in patients with other indication treated
Paaugstinā jutī pret aktī vielu vai kā no palī
with pramipexole were nausea, headache, dizziness and fatigue.
vo
Tables 1 and 2 display the frequency of adverse reactions from placebo-controlled clinical trials.
du
Table 1:
gvielā m.
Very common Adverse Reactions (≥ 1/ 10) System organ class
4. 4 Ī i brī jumi un piesardzī lietoš
Adverse reaction
paš dinā
Pramipexole N= 1,923 (%)
Ordinē Oprymea Parkinsona slimī pacientiem ar nieru darbī traucē
Nervous system disorders
bas bas
Dizziness Dyskinesia
jumiem, nepiecieš devas ama
15.5 12.9
pielā
Gastrointestinal disorders Vascular disorders
ana atbilstošnorā jumiem
Nausea Hypotension
apakš
17.2 12.6
goš
Psychiatric disorders
kotnē s Oprymea devas jā
Abnormal dreams Confusional state Hallucinations Insomnia
palielināanas laikā novē diskinē Šdā jumā samazina levodopas deva.
3.5 3.0 6.6 8.2
ziju. ā gadī
Nervous system disorders
Pramipeksola lietoš ir saistī ar miegainī un pē ņ iemigš epizodē galvenokā pacientiem
Somnolence Headache
kšas
8.6 6.5
anas
Gastrointestinal disorders
ar Parkinsona slimī Retā novē pē ņ iemigš dienas aktivitāu laikādaž gadī
Constipation
ša ana š
5.5
os
General disorders and administration site conditions
Pacientus jā dina par šdu iespē jā
Fatigue
dinā
6.1
ā brī ā
Peripheral oedema
ju, iesaka bū
1.9
t
Pramipexole is associated with somnolence (8.6%) and has been associated uncommonly with excessive daytime somnolence and sudden sleep onset episodes (0.1%).
piesardzī terapijas laikā Oprymea, vadot transportlī us vai apkalpojot mehā
See also section 4.4.
nismus.
Pramipexole may be associated with libido disorders (increased (0.1%) or decreased (0.4%)).
Pacientiem, kuriem bijusi miegainī un/ vai pē ņ iemigš epizodes, jā vadīš vai mehā
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.
ba
4.9 Overdose
kšas
There is no clinical experience with massive overdose.
atturas no transportlī u dzekļ
The expected adverse events would be those related to the pharmacodynamic profile of a dopamine agonist, including nausea, vomiting, hyperkinesia, hallucinations, agitation and hypotension.
iespē Jā ro piesardzī vienlaikus ar pramipeksolu lietojot citas nomierinoš zā vai alkoholu, jo
There is no established antidote for overdose 30 of a dopamine agonist.
t apakš punktu 4. 7 un 4. 8).
If signs of central nervous system stimulation are present, a neuroleptic agent may be indicated.
Pacientiem ar Parkinsona slimī kuri lietojakuri lietoja dopamī agonistus, tai skaitā
Management of the overdose may require general supportive measures, along with gastric lavage, intravenous fluids, administration of activated charcoal and electrocardiogram monitoring.
ziņ par patoloģ tieksmi uz azartspē m, paaugstinā dzimumtieksmi, hiperseksualitā Bez tam,
5.
tu
PHARMACOLOGICAL PROPERTIES
pacienti un aprū speciā bū jā
5.1 Pharmacodynamic properties
listi tu informē iespē m uzvedī izmaiņm.
Pharmacotherapeutic group: dopamine agonists, ATC code:
pakā peniska devas samazināana/ pā
N04BC05.
rtraukšana.
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.
Pacienti ar psihozē jārstē dopamī agonistiem tikai tajos gadī
Pramipexole alleviates Parkinsonian motor deficits by stimulation of dopamine receptors in the striatum.
pārsniedz iespē jamo risku.
Animal studies have shown that pramipexole inhibits dopamine synthesis, release, and turnover.
Jā izvairā no antipsihotisko zā un pramipeksola vienlaikus lietoš (skatīapakš
In human volunteers, a dose-dependent decrease in prolactin was observed.
Oftalmoloģ kontrole jā regulā vai gadī, ja novē redzes traucē
Clinical trials in Parkinson’ s disease
Nopietnu kardiovaskulā slimī gadī
In patients pramipexole alleviates signs and symptoms of idiopathic Parkinson 's disease.
jumos jā ro piesardzī Tā pastā posturā hipotensijas ievē ba. kā v las
Out of these, approximately 900 were in more advanced stages, received concomitant levodopa therapy, and suffered from motor complications.
risks, kas saistī ar dopamī isko zā lietoš ieteicams kontrolēasinsspiedienu, ī i terapijas sā kumā.
In early and advanced Parkinson’ s disease, efficacy of pramipexole in the controlled clinical trials was maintained for approximately six months.
kši rtraucot lietot dopamī isko terapiju, ziņ par simptomiem, kas norā uz ļ
In open continuation trials lasting for more than three years there were no signs of decreasing efficacy.
neiroleptisko sindromu (skatīapakš
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.
punktu 4. 2).
5.2 Pharmacokinetic properties
Literatū pieejamie ziņ
Concomitant administration with food did not reduce the extent of pramipexole absorption, but the rate of absorption was reduced.
ojumi liecina, ka citu indikā ā š ar dopamī iskā zā m var izraisī ciju rstēana nerģ m lē
Pramipexole shows linear kinetics and a small inter-patient variation of plasma levels.
stā a pasliktināanos.
High brain tissue concentrations were observed in the rat (approx.
Pasliktināanā ietver agrā simptomu sā anos vakarā
8-fold compared to plasma).
(vai pat pē cpusdienā),
Pramipexole is metabolised in man only to a small extent.
simptomu pastiprināanos un simptomu izplatī
Renal excretion of unchanged pramipexole is the major route of elimination.
š uz citā ekstermitā m.
The elimination half-life (t½) varies from 8 hours in the young to 12 hours in the elderly.
Pasliktināanā biež pē anos m tē šs
31 5.3 Preclinical safety data
ilgā pramipeksola lietoš un atbilstoš š traucē
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.
as o
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.
jumu
The potential effects of pramipexole on reproductive function have been investigated in rats and rabbits.
ā š kontrolē klī rstēanas tos niskos pējumos tī
Pramipexole was not teratogenic in rats and rabbits but was embryotoxic in the rat at maternally toxic doses.
4. 5 Mijiedarbī ar citā zā m un citi mijiedarbī veidi
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.
Pramipeksols saistā ar plazmas olbaltumvielā ļ vā (< 20%), biotransformā cilvē ir vā
Pramipexole was not genotoxic.
izteikta.
In a carcinogenicity study, male rats developed Leydig cell hyperplasia and adenomas, explained by the prolactin-inhibiting effect of pramipexole.
Tā c mijiedarbī ar citā zā m, kas ietekmē
This finding is not clinically relevant to man.
saistī ar olbaltumvielā vai eliminā bu m ciju
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.
biotransformācijas ceļ ir maz ticama.
The latter finding was not observed in pigmented rats, nor in a 2-year albino mouse carcinogenicity study or in any other species investigated.
Tā antiholī iskie lī i galvenokā eliminē
6.
kā
PHARMACEUTICAL PARTICULARS
nerģ
6.1 List of excipients
dzekļ
Mannitol Maize starch Pregelatinised maize starch Povidone K25 Colloidal anhydrous silica Magnesium stearate
biotransformācijas ceļ mijiedarbī iespē ir ierobež lai gan mijiedarbī ar antiholī iskiem
6.2 Incompatibilities
bas ja ota, ba
Not applicable.
lī iem nav pēta.
6.3 Shelf life
dzekļ
2 years.
tī
6.4 Special precautions for storage
tisku mijiedarbī ar selegilī un levodopu nenovē bu nu ro.
Store in the original package in order to protect from light.
Cimetidī samazina pramipeksola nieru klī
6.5 Nature and contents of container
rensu apmē par 34%, domā ram
Blister pack (Al/ Al foil):
jams, inhibē nieru kanā u jot
20, 30, 60, 90 or 100 tablets.
mu. pē les,
Not all pack sizes may be marketed.
lā
6.6 Special precautions for disposal
cijas ceļ vai tiek u
Any unused product or waste material should be disposed of in accordance with local requirements.
tas ā ceļ cimetidī vai amantadī var mijiedarboties ar pramipeksolu, rezultā samazinot viena vai
32 7.
tā
MARKETING AUTHORISATION HOLDER
Ja šdas zā ordinē
KRKA, d. d., Novo mesto, Š marješ cesta 6, 8501 Novo mesto, Slovenia ka
u
8.
ā
MARKETING AUTHORISATION NUMBER(S)
vienlaikus ar pramipeksolu, jāapsver
20 tablets:
20
EU/ 1/ 08/ 469/ 017 60 tablets:
pramipeksola devas samazināanas nepiecieš ba.
EU/ 1/ 08/ 469/ 018 90 tablets:
Ja Oprymea ordinē
EU/ 1/ 08/ 469/ 020
kombinā ar levodopu, ieteicams levodopas devu samazinā saglabā konstantu cijā t, jot
DATE OF FIRST AUTHORISATION/ RENEWAL OF THE AUTHORISATION
cita pretparkinsonisma zā devu, kamēOprymea deva tiek paaugstinā
12/ 9/ 2008
ļu
10.
ta.
DATE OF REVISION OF THE TEXT
Tā iespē
Detailed information on this medicinal product is available on the website of the European Medicines Agency (EMEA) http: / /www. emea. europa. eu/.
kā jama aditī iedarbī jā ro piesardzī vienlaikus ar pramipeksolu lietojot citas
33 1.
va
Oprymea 1.1 mg tablets
ba, ievē
2.
ba,
QUALITATIVE AND QUANTITATIVE COMPOSITION
nomierinoš zā vai alkoholu. as les
Each tablet contains 1.1 mg pramipexole base (as 1.5 mg pramipexole dihydrochloride monohydrate).
Jāizvairā no antipsihotisko zā un pramipeksola vienlaikus lietoš (skatīapakš
Please note:
punktu 4. 4),
For a full list of excipients, see section 6.1.
piemē ram, ja ir sagaidā antagonistiska darbī
3.
ma
PHARMACEUTICAL FORM
4. 6 Grūtniecī un zī š
Tablet.
dīana
1.1 mg: white, round, with bevelled edges, both sides scored.
Ietekme uz grū tniecī un zīš cilvē nav pēta.
The tablet can be divided into equal halves.
Pramipeksols nebija teratogē ž m un
CLINICAL PARTICULARS
dī anu
4.1 Therapeutic indications
kam
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).
tī
4.2 Posology and method of administration
ns urkā
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).
plazmāTā pējumi ar cilvē. kā tī
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.
nismus.
Therefore, medicinal products
Oprymea lietoš laikā
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.
anas
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.
sagaidā
Because of possible additive effects, caution should be advised when patients are taking other sedating medicinal products or alcohol in combination with pramipexole.
šdas nevē
Coadministration of antipsychotic medicinal products with pramipexole should be avoided (see section 4.4), e. g. if antagonistic effects can be expected.
mas ā
The effect on pregnancy and lactation has not been investigated in humans.
bas:, neparasti sapņ dī
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.
Miegainī incidence palielinā lietojot devas, kas pā 1, 5 mg/ dienā (skatīapakš
The incidence of somnolence is increased at doses higher than 1.5 mg/ day (see section 4.2).
Visbiežk novē blakusparā ba kombinā ar levodopa bija ā rotā dī cijā
More frequent adverse drug
diskinē Hipotensiju novē terapijas sā
37 reaction in combination with levodopa was dyskinesia.
kumāī i, ja pramipeksola devu palielinā pā k strauji., paš ja rā
Hypotension may occur at the beginning of treatment, especially if pramipexole is titrated too fast.
Pacientiem ar citu indikā kurus ā ja ar pramipeksolu, visbiežk (≥ ziņ par sliktu dūu,
The most commonly (≥
rstē
There is no clinical experience with massive overdose.
Sagaidā s š
The expected adverse events would be those related to the pharmacodynamic profile of a dopamine agonist, including nausea, vomiting, hyperkinesia, hallucinations, agitation and hypotension.
Dopamī agonistu pā
There is no established antidote for overdose 38 of a dopamine agonist.
Ja nav ms
If signs of central nervous system stimulation are present, a neuroleptic agent may be indicated.
Pā ti dzekļ rdozēanas gadī š jumā
39 5.3 Preclinical safety data
kiem lī 12 stundā vecā dz m
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.
23 Atkā rtotu devu toksicitā pējumi pierā ja, ka pramipeksols funkcionā ietekmē
Any unused product or waste material should be disposed of in accordance with local requirements.
Neizlietotā zā vai citus izlietotos materiā jā cina atbilstošvietē m prasī m.
40 7.
24 7.
EU/ 1/ 08/ 469/ 021 30 tablets:
EU/ 1/ 08/ 469/ 011 30 tabletes:
EU/ 1/ 08/ 469/ 022 60 tablets:
EU/ 1/ 08/ 469/ 012 60 tabletes:
EU/ 1/ 08/ 469/ 023 90 tablets:
EU/ 1/ 08/ 469/ 013 90 tabletes:
EU/ 1/ 08/ 469/ 024 100 tablets:
EU/ 1/ 08/ 469/ 014 100 tabletes:
EU/ 1/ 08/ 469/ 025
EU/ 1/ 08/ 469/ 015
10.
jas
DATE OF REVISION OF THE TEXT
ZĀ U NOSAUKUMS Ļ
Detailed information on this medicinal product is available on the website of the European Medicines Agency (EMEA) http: / /www. emea. europa. eu/.
Katra tablete satur 0, 7 mg pramipeksola (pramipexole) bā (1 mg pramipeksola dihidrohlorī monohidrā veidā
41 ANNEX II
Uzmanī bu:
A.
ls
MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE
Tā c devas tiek norā tas pramipeksola bā un sā formai (iekavā
B.
ls
CONDITIONS OF THE MARKETING AUTHORISATION
Pilnu palī gvielu sarakstu skatīapakš
42 A.
KLĪ
MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE
tiskas Parkinsona slimī simptomu ā š monoterapijā bas rstēanai
Name and address of the manufacturer responsible for batch release
slimī laikāieskaitot vēno stadiju, kad levodopas iedarbī bas, lī ba
Krka, d. d., Novo mesto Š marješ cesta 6 ka 8501 Novo mesto Slovenia
li, s norij, uzdzerot ūdeni, tā var lietot ēanas laikā tukš dūāDiennakts s š vai ā š.
CONDITIONS OF THE MARKETING AUTHORISATION
kuma devu 0, 264 mg bā (0, 375 mg sā dienā tad zes ls) un
 CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE IMPOSED ON THE MARKETING AUTHORISATION HOLDER
palielinot to ik pē 5- 7 dienā Ja pacientam nav nepanesamu blakusparā bu, devu pakā jā
Medicinal product subject to medical prescription.
26 Tomē jāem vē, ka miegainī biež palielinā ja deva pā 4. 8).
 CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
(4, 5 mg sā dienāTrijos reģ cijas pējumos, palielinot devu, efektivitā novē sā ar dienas
Not aplicable.
ls).
 OTHER CONDITIONS
nisko atbildes
Pharmacovigilance system
reakciju un blakusparā bu raš
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.
paredzē levodopas devas mazināana, var būnepiecieš deva, kas augstā par 1, 1 mg bā (1, 5 mg
PSURs
ta š t
The PSUR submission schedule for Oprymea tablets should follow PSURs submission schedule for the reference medicinal product.
terapijas laikā atkarī no individuā pacienta atbildes reakcijas.
43 ANNEX III
nerģ s
LABELLING AND PACKAGE LEAFLET
rtraukš var izraisīļ ana t aundabī
44 A.
zes
LABELLING
ls).
45 PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND IMMEDIATE PACKAGING
samazina par 0, 264 mg bā (0, 375 mg sā dienā zes ls)
BOX for blisters
apakšpunktu 4. 4).
1.
bas
NAME OF THE MEDICINAL PRODUCT
Terapijas sā anai ieteicama šda dozēanas shēma:
Oprymea 0.088 mg tablets Pramipexole
Pacientiem ar kreatinī klī na rensu no 20 lī 50 ml/ min, Oprymea sā
2.
dz
STATEMENT OF ACTIVE SUBSTANCE(S)
reizes devā jā k ar 0, 088 mg bā (0, 125 mg sā divas reizes dienā dienā).
Each tablet contains 0.088 mg pramipexole equivalent to 0.125 mg pramipexole dihydrochloride monohydrate.
Pacientiem ar kreatinī klī na rensu zem 20 ml/ min, Oprymea dienas deva jā mē nozī vienāreizējā k ar, sā 0, 088 mg bā (0, 125 mg sā dienā
3.
ā
LIST OF EXCIPIENTS
samazina tiešpar tik i
4.
s,
PHARMACEUTICAL FORM AND CONTENTS
ml/ min, dienas deva jā mē
20 tablets
20 ml/ min.
5.
dz
METHOD AND ROUTE(S) OF ADMINISTRATION
Devas pacientiem ar aknu darbī traucē
Read the package leaflet before use.
farmakokinē nav pēta.
Oral use
cijas par
6.
ba
SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF THE REACH AND SIGHT OF CHILDREN
27 Ordinē Oprymea Parkinsona slimī pacientiem ar nieru darbī traucē
Keep out of the reach and sight of children.
punktā4. 2.
7.
ma
OTHER SPECIAL WARNING(S), IF NECESSARY
jā dina, ka var rasties halucinā brī cijas (parasti vizuā las).
8.
ti
EXPIRY DATE
ju, iesaka bū
EXP
bu,
SPECIAL STORAGE CONDITIONS
pramipeksolu, ziņ par ots
Store in the original package in order to protect from light.
Bū jā
10.
ļu
SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE
risks, kas saistī ar dopamī isko zā lietoš ieteicams kontrolēasinsspiedienu, ī i terapijas sā kumā.
11.
ots
NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER
neiroleptisko sindromu (skatīapakš
KRKA, d. d., Novo mesto, Š marješ cesta 6, 8501 Novo mesto, Slovenia ka
ojumi liecina, ka citu indikā ā š ar dopamī iskā zā m var izraisī ciju rstēana nerģ m lē
46 12.
vokļ
MARKETING AUTHORISATION NUMBER(S)
(vai pat pē cpusdienā),
EU/ 1/ 08/ 469/ 001
š uz citā ekstermitā m.
13.
kam
BATCH NUMBER
izteikta.
Batch
nerģ
14.
bas
GENERAL CLASSIFICATION FOR SUPPLY
Farmakokinē
Medicinal product subject to medical prescription.
tisku mijiedarbī ar selegilī un levodopu nenovē bu nu ro.
15.
lā
INSTRUCTIONS ON USE
cijas ceļ vai tiek u
16.
tā
INFORMATION IN BRAILLE
Ja šdas zā ordinē
Oprymea 0.088 mg
Ja Oprymea ordinē
47 PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND IMMEDIATE PACKAGING
cita pretparkinsonisma zā devu, kamēOprymea deva tiek paaugstinā
BOX for blisters
punktu 4. 4),
1.
ma
NAME OF THE MEDICINAL PRODUCT
4. 6 Grūtniecī un zī š
Oprymea 0.088 mg tablets Pramipexole
Pramipeksols nebija teratogē ž m un
2.
bu
STATEMENT OF ACTIVE SUBSTANCE(S)
(skatīapakš t punktu 5. 3).
Each tablet contains 0.088 mg pramipexole equivalent to 0.125 mg pramipexole dihydrochloride monohydrate.
Tā terapija ar pramipeksolu inhibē kā prolaktī sekrē cilvē Pramipeksola ekskrē mā pienā
3.
tu
LIST OF EXCIPIENTS
jā rtrauc anu, pā
4.
ju
PHARMACEUTICAL FORM AND CONTENTS
dzekļ un apkalpot mehā us nismus
30 tablets
nismus.
METHOD AND ROUTE(S) OF ADMINISTRATION
punktu 4. 4, 4. 5, un 4. 8).
Read the package leaflet before use.
reakcijas.
Oral use
tu tī
SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF THE REACH AND SIGHT OF CHILDREN
abā grupā Par vismaz vienu blakusparā bu ziņ 63% pacientu pramipeksola grupā 52% pacientu
Keep out of the reach and sight of children.
placebo grupā.
7.
ā
OTHER SPECIAL WARNING(S), IF NECESSARY
pramipeksola grupāsalī, dzinot ar placebo).
8.
s,
EXPIRY DATE
punktu 4. 2).
EXP
pē
9.
gi
SPECIAL STORAGE CONDITIONS
pacientu, kas ā ti ar k rstē
Store in the original package in order to protect from light.
Vairumā jumu biežziņ s zā
10.
dī
SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE
dz renas intensitā tā parasti bija vē tes, s rojamas terapijas sā kumā tā un m
11.
ta.
NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER
Blakusparā bas, par kurā ziņ ļ biež( ≥ Orgā sistē
48 12.
m ots
MARKETING AUTHORISATION NUMBER(S)
i 1/ 100 lī < 1/ 10) dz
EU/ 1/ 08/ 469/ 002
Pramipeksols N =
13.
mas
BATCH NUMBER
Psihiskie traucē
Batch
jumi
14.
mas
GENERAL CLASSIFICATION FOR SUPPLY
Galvassā pes Miegainī ba
Medicinal product subject to medical prescription.
Kuņa un zarnu trakta traucē
15.
rē
INSTRUCTIONS ON USE
jumi un reakcijas
INFORMATION IN BRAILLE
ievadī š vietā
Oprymea 0.088 mg
Perifē tū ra ska
49 PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND IMMEDIATE PACKAGING
Pramipeksola lietoš ir saistī ar miegainī (8, 6%), nereti tā
BOX for blisters
Skatī apakš
1.
ts
NAME OF THE MEDICINAL PRODUCT
jumiem (palielināanos 0, 1% vai samazināanos š š
Oprymea 0.088 mg tablets Pramipexole
Pacientiem, kas Parkinsona slimī terapijā
2.
bas
STATEMENT OF ACTIVE SUBSTANCE(S)
agonistus, ieskaitot pramipeksolu, na
Each tablet contains 0.088 mg pramipexole equivalent to 0.125 mg pramipexole dihydrochloride monohydrate.
augstā devā ziņ par patoloģ tieksmi uz azartspē m, paaugstinā dzimumtieksmi un
LIST OF EXCIPIENTS
hiperseksualitā kas pē terapijas pā
4.
4. 9
PHARMACEUTICAL FORM AND CONTENTS
blakusparā bas saistī ar mā dī
60 tablets
dopamī tas
METHOD AND ROUTE(S) OF ADMINISTRATION
agonistu farmakodinamisko profilu, ietverot sliktu dūu, vemš hiperkinē halucinā uzbudinā
Read the package leaflet before use.
jumu un hipotensiju.
Oral use
Dopamī agonistu pā
6.
š
SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF THE REACH AND SIGHT OF CHILDREN
ir centrā s nervu sistē stimulā
Keep out of the reach and sight of children.
Ja nav ms
7.
mas
OTHER SPECIAL WARNING(S), IF NECESSARY
cijas simptomi, indicē neiroleptiskie lī i.
8.
š
EXPIRY DATE
jumā
EXP
ve
9.
ic
SPECIAL STORAGE CONDITIONS
kumi līdztekus ar kuņa skaloš ģ
Store in the original package in order to protect from light.
aktī s ogles ordinēanu un elektrokardiogrammas kontroli.
10.
vā
SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE
Pramipeksols ir dopamī agonists, kas izteikti selektī un specifiski saistā ar dopamī receptoru D2
11.
jot
NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER
Pējumos ar dzī
KRKA, d. d., Novo mesto, Š marješ cesta 6, 8501 Novo mesto, Slovenia ka
vniekiem konstatē ka pramipeksols nomā ja,
50 12.
Klī
MARKETING AUTHORISATION NUMBER(S)
niskie pējumi Parkinsona
EU/ 1/ 08/ 469/ 003
Kontrolē klī
13.
pe c
BATCH NUMBER
No
Batch
cijā
14.
još
GENERAL CLASSIFICATION FOR SUPPLY
tos niskos pējumos pramipeksola tī
Medicinal product subject to medical prescription.
efektivitā saglabā s apmē 6 mē us.
15.
tī
INSTRUCTIONS ON USE
komplikā biež ja o
16.
ciju
INFORMATION IN BRAILLE
umu, salī dzinot ar sā kotnē
Oprymea 0.088 mg
terapiju ar ju
51 PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND IMMEDIATE PACKAGING
Š motoro komplikā aizkavēanā pramipeksola terapijas laikā bū lī
BOX for blisters
palielināanas fā.
NAME OF THE MEDICINAL PRODUCT
ajā zē tisku atširī nebija.
Oprymea 0.088 mg tablets Pramipexole
5. 2 Farmakokinē s ī ī tiskā pašbas
STATEMENT OF ACTIVE SUBSTANCE(S)
Pramipeksolam ir lineā kinē un
Each tablet contains 0.088 mg pramipexole equivalent to 0.125 mg pramipexole dihydrochloride monohydrate.
Cilvē
LIST OF EXCIPIENTS
Cilvē organismā
PHARMACEUTICAL FORM AND CONTENTS
tikai neliels daudzums pramipeksola metabolizē jas.
90 tablets
caur nierē Apmē 90% no C m. ram
5.
5. 3
METHOD AND ROUTE(S) OF ADMINISTRATION
jams, ka š iedarbī pamatā izteikts īs bas ir
Read the package leaflet before use.
pramipeksola farmakodinamiskais efekts.
Oral use
roja
6.
un
SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF THE REACH AND SIGHT OF CHILDREN
asinsspiediena pazemināanos un sirdsdarbī š bas
Keep out of the reach and sight of children.
nināanos, pē iem konstatē tendenci uz hipotensiju.
7.
vo
OTHER SPECIAL WARNING(S), IF NECESSARY
teratogē ž m un truš tač bija embriotoksisks ž m, ja to lietoja mā toksiskā
8.
ns
EXPIRY DATE
iem, u urkā
EXP
tei
9.
ā
SPECIAL STORAGE CONDITIONS
pramipeksola nevē m,
Store in the original package in order to protect from light.
Kanceroģ zes pējumā urku tē iem attī jā Leidiga šnu
10.
tī
SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE
hiperplā un adenomas, ko var izskaidrot ar pramipeksola prolaktī inhibē o iedarbī Cilvē š atradne
11.
nā
NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER
m, arī m tīm vnieku sugā kanceroģ zes pējumos šdu
52 12.
2 gadi.
MARKETING AUTHORISATION NUMBER(S)
20, 30, 60, 90 vai 100 tabletes.
EU/ 1/ 08/ 469/ 004
32 6. 6 Ī i norā jumi atkritumu likvidēanai
13.
lus
BATCH NUMBER
iznī i
Batch
jā
14.
bā
GENERAL CLASSIFICATION FOR SUPPLY
REĢISTRĀCIJAS APLIECĪ BAS Ī NIEKS PAŠ
Medicinal product subject to medical prescription.
KRKA, d. d., Novo mesto, Šmarješ cesta 6, 8501 Novo mesto, Slovē
INSTRUCTIONS ON USE
EU/ 1/ 08/ 469/ 020
INFORMATION IN BRAILLE
REĢISTRĀCIJAS/ PĀRREĢISTRĀCIJAS DATUMS
Oprymea 0.088 mg
12/ 9/ 2008
53 PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND IMMEDIATE PACKAGING
Sī ka informā par š zā m ir pieejama Eiropas zā aģ ras (EMEA) mā lapā
BOX for blisters
ļ entū
1.
jas
Oprymea 0.088 mg tablets Pramipexole
Oprymea 1, 1 mg tabletes
STATEMENT OF ACTIVE SUBSTANCE(S)
KVALITATĪ VAIS UN KVANTITATĪ VAIS SASTĀVS
Each tablet contains 0.088 mg pramipexole equivalent to 0.125 mg pramipexole dihydrochloride monohydrate.
Katra tablete satur 1, 1 mg pramipeksola (pramipexole) bā (1, 5 mg pramipeksola dihidrohlor ī monohidrā veidā
LIST OF EXCIPIENTS
Uzmanī bu:
4.
ls
PHARMACEUTICAL FORM AND CONTENTS
Pilnu palī gvielu sarakstu skatīapakš
100 tablets
punktā6. 1.
METHOD AND ROUTE(S) OF ADMINISTRATION
1, 1 mg: baltas, apaļ ar nošeltā malā un dalī vienā s daļ
Read the package leaflet before use.
juma lī abā pusē Tableti var sadalīdivā niju s s. t s
Oral use
KLĪ
SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF THE REACH AND SIGHT OF CHILDREN
tiskas Parkinsona slimī simptomu ā š monoterapijā bas rstēanai
Keep out of the reach and sight of children.
vai kombinē terapijā levodopu, visā
OTHER SPECIAL WARNING(S), IF NECESSARY
slimī laikāieskaitot vēno stadiju, kad levodopas iedarbī bas, lī ba
8.
kas
EXPIRY DATE
s ūst vī kas s
EXP
bas
9.
rstī
SPECIAL STORAGE CONDITIONS
4. 2 Devas un lietoš anas veids
Store in the original package in order to protect from light.
li, s norij, uzdzerot ūdeni, tā var lietot ēanas laikā tukš dūāDiennakts s š vai ā š.
10.
kot
SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE
palielinot to ik pē 5- 7 dienā Ja pacientam nav nepanesamu blakusparā bu, devu pakā jā
11.
dī
NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER
Pieaugoš kā bā Oprymea dozēanas shē Nedē
KRKA, d. d., Novo mesto, Š marješ cesta 6, 8501 Novo mesto, Slovenia ka
Ja nepiecieš tā ka devas palielināana, dienas devu ar nedē intervā jā
54 12.
lu palielina par 0, 54 mg bā zes
MARKETING AUTHORISATION NUMBER(S)
(0, 75 mg sā lī maksimā devai 3, 3 mg bā (4, 5 mg sā dienā
EU/ 1/ 08/ 469/ 005
ls) dz
13.
ls)
BATCH NUMBER
r, ņ rā
Batch
bas
14.
ums
GENERAL CLASSIFICATION FOR SUPPLY
rsniedz 1, 5 mg/ dienā( skatīapakš t punktu
Medicinal product subject to medical prescription.
Uzturoš terapija ā Individuā m devā jā t robežs no 0, 264 mg bā (0, 375 mg sā lī maksimā devai 3, 3 mg bā
INSTRUCTIONS ON USE
m bū ā zes ls) dz lai
16.
ls)
INFORMATION IN BRAILLE
istrā
Oprymea 0.088 mg
roja kot
55 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
devu 1, 1 mg bā (1, 5 mg sā Turpmā devas pielā ana jā pamatojoties uz klī
BLISTER/ (Al/ Al)
ls).
NAME OF THE MEDICINAL PRODUCT
nisko atbildes
Oprymea 0.088 mg tablets Pramipexole
reakciju un blakusparā bu raš
2.
dī
NAME OF THE MARKETING AUTHORISATION HOLDER
Klī niskos pējumos apmē 5% pacientu tika ā tī ram
KRKA
kas
3.
zes
EXPIRY DATE
još
4.
ta
BATCH NUMBER
š t ama
Batch
ta š t
OTHER
š š
56 PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND IMMEDIATE PACKAGING
terapijas laikā atkarī no individuā pacienta atbildes reakcijas.
BOX for blisters
neiroleptiskā gā
1.
zes
NAME OF THE MEDICINAL PRODUCT
Devas pacientiem ar nieru darbī traucē
Oprymea 0.18 mg tablets Pramipexole
Pacientiem ar kreatinī klī na rensu no 20 lī 50 ml/ min, Oprymea sā
Each tablet contains 0.18 mg pramipexole equivalent to 0.25 mg pramipexole dihydrochloride monohydrate.
Pacientiem ar kreatinī klī na rensu zem 20 ml/ min, Oprymea dienas deva jā mē nozī vienāreizējā k ar, sā 0, 088 mg bā (0, 125 mg sā dienā
Oral use
Devas bē
6.
iem
SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF THE REACH AND SIGHT OF CHILDREN
Oprymea nav ieteicams lietoš bē anai rniem un pusaudž lī 18 gadu vecumam, jo nav informā droš un efektivitā
Keep out of the reach and sight of children.
4. 4 Ī i brī jumi un piesardzī lietoš
7.
35
OTHER SPECIAL WARNING(S), IF NECESSARY
jumiem, nepiecieš devas ama
8.
dī
EXPIRY DATE
punktā4. 2.
EXP
ma
9.
dī
SPECIAL STORAGE CONDITIONS
kotnē s Oprymea devas jā
Store in the original package in order to protect from light.
palielināanas laikā novē diskinē Šdā jumā samazina levodopas deva.
10.
jā
SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE
Pramipeksola lietoš ir saistī ar miegainī un pē ņ iemigš epizodē galvenokā pacientiem
11.
bu.
NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER
Pacientus jā dina par šdu iespē jā
KRKA, d. d., Novo mesto, Š marješ cesta 6, 8501 Novo mesto, Slovenia ka
Pacientiem, kuriem bijusi miegainī un/ vai pē ņ iemigš epizodes, jā vadīš vai mehā
57 12.
kšas
MARKETING AUTHORISATION NUMBER(S)
atturas no transportlī u dzekļ
EU/ 1/ 08/ 469/ 006
nismu apkalpoš
13.
anas.
BATCH NUMBER
ja. ievē
Batch
ba,
14.
as les
GENERAL CLASSIFICATION FOR SUPPLY
iespējama aditī iedarbī (skatī
Medicinal product subject to medical prescription.
t apakš punktu 4. 7 un 4. 8).
15.
ti.
INSTRUCTIONS ON USE
aprū speciā bū jā
16.
pes
INFORMATION IN BRAILLE
samazināana/ pā
Oprymea 0.18 mg
rtraukš ana.
58 PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND IMMEDIATE PACKAGING
Pacienti ar psihozē jārstē dopamī agonistiem tikai tajos gadī
BOX for blisters
m ā ar
NAME OF THE MEDICINAL PRODUCT
jumos, kad gaidā mais ieguvums
Oprymea 0.18 mg tablets Pramipexole
pārsniedz iespē jamo risku.
2.
ro
STATEMENT OF ACTIVE SUBSTANCE(S)
Nopietnu kardiovaskulā slimī gadī
Each tablet contains 0.18 mg pramipexole equivalent to 0.25 mg pramipexole dihydrochloride monohydrate.
risks, kas saistī ar dopamī isko zā lietoš ieteicams kontrolēasinsspiedienu, ī i terapijas sā kumā.
3.
da
LIST OF EXCIPIENTS
aundabī go
4.
punktu 4. 2).
PHARMACEUTICAL FORM AND CONTENTS
Literatū pieejamie ziņ
30 tablets
vokļ
5.
ku
METHOD AND ROUTE(S) OF ADMINISTRATION
(vai pat pē cpusdienā),
Read the package leaflet before use.
š uz citā ekstermitā m.
Oral use
anas
6.
as o
SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF THE REACH AND SIGHT OF CHILDREN
ā š kontrolē klī rstēanas tos niskos pējumos tī
Keep out of the reach and sight of children.
4. 5 Mijiedarbī ar citā zā m un citi mijiedarbī veidi
7.
ba
OTHER SPECIAL WARNING(S), IF NECESSARY
Pramipeksols saistā ar plazmas olbaltumvielā ļ vā (< 20%), biotransformā cilvē ir vā
8.
ji
EXPIRY DATE
izteikta.
9.
ba
SPECIAL STORAGE CONDITIONS
saistī ar olbaltumvielā vai eliminā bu m ciju
Store in the original package in order to protect from light.
Tā antiholī iskie lī i galvenokā eliminē
SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE
biotransformācijas ceļ mijiedarbī iespē ir ierobež lai gan mijiedarbī ar antiholī iskiem
11.
tī
NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER
tisku mijiedarbī ar selegilī un levodopu nenovē bu nu ro.
KRKA, d. d., Novo mesto, Š marješ cesta 6, 8501 Novo mesto, Slovenia ka
rensu apmē par 34%, domā ram jams, inhibē nieru kanā u jot liņ
59 12.
lā
MARKETING AUTHORISATION NUMBER(S)
cijas ceļ vai tiek u
EU/ 1/ 08/ 469/ 007
, abu š zā klī
13.
tā
BATCH NUMBER
o ļ rensu.
Batch
ā
14.
les
GENERAL CLASSIFICATION FOR SUPPLY
vienlaikus ar pramipeksolu, jā apsver
Medicinal product subject to medical prescription.
pramipeksola devas samazināanas nepiecieš ba.
16.
amī
Oprymea 0.18 mg
Ja Oprymea ordinē
60 PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND IMMEDIATE PACKAGING
cita pretparkinsonisma zā devu, kamēOprymea deva tiek paaugstinā
BOX for blisters
Tā iespē
1.
va
NAME OF THE MEDICINAL PRODUCT
nomierinoš zā vai alkoholu. as les
Oprymea 0.18 mg tablets Pramipexole
Jāizvairā no antipsihotisko zā un pramipeksola vienlaikus lietoš (skatīapakš
2.
ļu
STATEMENT OF ACTIVE SUBSTANCE(S)
punktu 4. 4),
Each tablet contains 0.18 mg pramipexole equivalent to 0.25 mg pramipexole dihydrochloride monohydrate.
piemē ram, ja ir sagaidā antagonistiska darbī
LIST OF EXCIPIENTS
4. 6 Grūtniecī un zī š
4.
ba
PHARMACEUTICAL FORM AND CONTENTS
Pramipeksols nebija teratogē ž m un
60 tablets
ns urkā
5.
tei
METHOD AND ROUTE(S) OF ADMINISTRATION
(skatīapakš t punktu 5. 3).
Read the package leaflet before use.
jamo risku auglim.
Oral use
cija tes
6.
gas
SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF THE REACH AND SIGHT OF CHILDREN
radioaktivitā koncentrā mā pienā augstā nekā
Keep out of the reach and sight of children.
plazmāTā pējumi ar cilvē. kā tī
7.
tu
OTHER SPECIAL WARNING(S), IF NECESSARY
jā rtrauc anu, pā
8.
rna
EXPIRY DATE
ana
EXP
ti.
9.
ju
SPECIAL STORAGE CONDITIONS
dzekļ un apkalpot mehā us nismus
Store in the original package in order to protect from light.
Oprymea var bū ietekmēspē vadītransportlī us un apkalpot mehā
10.
ju t
SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE
Pacientiem, kuriem Oprymea terapijas laikā miegainī un/ vai pē ņ iemigš epizodes, lī š simptomu izzuš jā
11.
dz o
NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER
anai iesaka atturē no transportlī u vadī
61 KRKA, d. d., Novo mesto, Š marješ cesta 6, 8501 Novo mesto, Slovenia ka
mehā nismu apkalpoš anas), kuru laikā modrī traucē smagu traumu vai nā riskam (skatīapakš
12.
ves
MARKETING AUTHORISATION NUMBER(S)
punktu 4. 4, 4. 5, un 4. 8).
EU/ 1/ 08/ 469/ 008
lamā blakusparā bas
13.
dī
BATCH NUMBER
Oprymea lietoš laikā
Batch
anas
14.
sagaidā