qanastek/EMEA-V3 huggingface dataset:
90% of absorbed active substance is excreted through the kidneys.
jumu teorē nav nepiecieš tiski ama, tā 90% no absorbē s kā tā
However, the potential influence of hepatic insufficiency on Oprymea pharmacokinetics has not been investigated.
aktī s vielas izdalā caur nierē Tomē aknu mazspē potenciā ietekme uz Oprymea
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 nav ieteicams lietoš bē anai rniem un pusaudž lī 18 gadu vecumam, jo nav informā droš un efektivitā
4.3 Contraindications
cijas par
Hypersensitivity to the active substance or to any of the excipients.
ību
4.4 Special warnings and precautions for use
ti.
3 When prescribing Oprymea in a patient with Parkinson’ s disease with renal impairment a reduced dose is suggested in line with section 4.2.
4. 3 Kontrindikācijas
Hallucinations are known as a side-effect of treatment with dopamine agonists and levodopa.
Pacienti
Patients should be informed that (mostly visual) hallucinations can occur.
jā dina, ka var rasties halucinā brī cijas (parasti vizuā las).
In advanced Parkinson’ s disease, in combination treatment with levodopa, dyskinesias can occur during the initial titration of Oprymea.
Progresē as Parkinsona slimī gadī, lietojot vienlaikus ar levodopu, sā
If they occur, the dose of levodopa should be decreased.
palielināanas laikā novē diskinē Šdā jumā samazina levodopas deva.
Pramipexole has been associated with somnolence and episodes of sudden sleep onset, particularly in patients with Parkinson’ s disease.
Pramipeksola lietoš ir saistī ar miegainī un pē ņ iemigš epizodē galvenokā pacientiem
Sudden onset of sleep during daily activities, in some cases without awareness or warning signs, has been reported uncommonly.
ar Parkinsona slimī Retā novē pē ņ iemigš dienas aktivitāu laikādaž gadī
Patients must be informed of this and advised to exercise caution while driving or operating machines during treatment with Oprymea.
piesardzī terapijas laikā Oprymea, vadot transportlī us vai apkalpojot mehā
Patients who have experienced somnolence and/ or an episode of sudden sleep onset must refrain from driving or operating machines.
Pacientiem, kuriem bijusi miegainī un/ vai pē ņ iemigš epizodes, jā vadīš vai mehā
Furthermore a reduction of dosage or termination of therapy may be considered.
Bez tam jāapsver devas samazināanas vai terapijas pā š
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).
iespē Jā ro piesardzī vienlaikus ar pramipeksolu lietojot citas nomierinoš zā vai alkoholu, jo
Pathological gambling, increased libido and hypersexuality have been reported in patients treated with dopamine agonists for Parkinson’ s disease, including pramipexole.
Pacientiem ar Parkinsona slimī kuri lietoja dopamī agonistus, tai skaitā
Furthermore, patients and caregivers should be aware of the fact that behavioural changes can occur.
patoloģ tieksmi uz azartspē m, paaugstinā dzimumtieksmi, hiperseksualitā Bez tam, pacienti un
Dose reduction/ taper or discontinuation should be considered.
Bū jā
Patients with psychotic disorders should only be treated with dopamine agonists if the potential benefits outweigh the risks.
Pacienti ar psihozē jārstē dopamī agonistiem tikai tajos gadī
Coadministration of antipsychotic medicinal products with pramipexole should be avoided (see section 4.5).
Jā izvairā no antipsihotisko zā un pramipeksola vienlaikus lietoš (skatīapakš
Ophthalmologic monitoring is recommended at regular intervals or if vision abnormalities occur.
jumos jā ro piesardzī Tā pastā posturā hipotensijas ievē ba. kā v las
In case of severe cardiovascular disease, care shou ld be taken.
risks, kas saistī ar dopamī isko zā lietoš ieteicams kontrolēasinsspiedienu, ī i terapijas sā kumā.
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.
kši rtraucot lietot dopamī isko terapiju, ziņ par simptomiem, kas norā uz ļ
Symptoms suggestive of neuroleptic malignant syndrome have been reported with abrupt withdrawal of dopaminergic therapy (see section 4.2)
neiroleptisko sindromu (skatīapakš
Reports in the literature indicate that treatment of another indication with dopaminergic medicinal products can result in augmentation.
ojumi liecina, ka citu indikā ā š ar dopamī iskā zā m var izraisī ciju rstēana nerģ m lē
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.
Pasliktināanā ietver agrā simptomu sā anos vakarā
The frequency of augmentation after longer use of pramipexole and the appropriate management of these events have not been evaluated in controlled clinical trials.
Pasliktināanā biež pē anos m tē šs ums c
4.5 Interaction with other medicinal products and other forms of interaction
jumu ā š kontrolē klī rstēana tos niskos pējumos nav tī
Pramipexole is bound to plasma proteins to a very low (< 20%) extent, and little biotransformation is seen in man.
Pramipeksols saistā ar plazmas olbaltumvielā ļ vā (< 20%), biotransformā cilvē ir vā
Therefore, interactions with other medicinal products affecting plasma protein binding or elimination by biotransformation are unlikely.
Tā c mijiedarbī ar citā zā m, kas ietekmē
As anticholinergics are mainly eliminated by biotransformation, the potential for an interaction is limited, although an interaction with anticholinergics has not been investigated.
biotransformācijas ceļ mijiedarbī iespē ir ierobež lai gan mijiedarbī ar antiholī iskiem
There is no pharmacokinetic interaction with selegiline and levodopa.
tisku mijiedarbī ar selegilī un levodopu nenovē bu nu ro.
Cimetidine reduced the renal clearance of pramipexole by approximately 34%, presumably by inhibition of the cationic secretory transport system of the renal tubules.
rensu apmē par 34%, domā ram
Therefore, medicinal products
jams, inhibē nieru kanā u jot
4 that are inhibitors of this active renal elimination pathway or are eliminated by this pathway, such as cimetidine and amantadine, may interact with pramipexole resulting in reduced clearance of either or both medicinal products.
4 eliminē šdā ākā tas ā ceļ cimetidī vai amantadī var mijiedarboties ar pramipeksolu, rezultā
Reduction of the pramipexole dose should be considered when these medicinal products are administered concomitantly.
pramipeksola devas samazināanas nepiecieš ba.
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.
kombinā ar levodopu, ieteicams levodopas devu samazinā saglabā konstantu cijā t, jot
Because of possible additive effects, caution should be advised when patients are taking other sedating medicinal products or alcohol in combination with pramipexole.
cita pretparkinsonisma zā devu, kamēOprymea deva tiek paaugstinā
Coadministration of antipsychotic medicinal products with pramipexole should be avoided (see section 4.4), e. g. if antagonistic effects can be expected.
Jāizvairā no antipsihotisko zā un pramipeksola vienlaikus lietoš (skatīapakš
4.6 Pregnancy and lactation
4. 6 Grūtniecī un zī š
The effect on pregnancy and lactation has not been investigated in humans.
Pramipeksols nebija teratogē ž m un
Pramipexole was not teratogenic in rats and rabbits, but was embryotoxic in the rat at maternotoxic doses (see section 5.3).
(skatīapakš t punktu 5. 3).
Oprymea should not be used during pregnancy unless clearly necessary, i. e. if the potential benefit justifies the potential risk to the foetus.
Oprymea nedrī lietot grū attaisno iespē
As pramipexole treatment inhibits secretion of prolactin in humans, inhibition of lactation is expected.
tniecī laikāja vien nav pamatotu indikā tas ir, ja gaidā bas, ciju, mais ieguvums
The excretion of pramipexole into breast milk has not been studied in women.
jamo risku auglim.
In rats, the concentration of active substance-related radioactivity was higher in breast milk than in plasma.
Tā terapija ar pramipeksolu inhibē kā prolaktī sekrē cilvē Pramipeksola ekskrē mā pienā
In the absence of human data, Oprymea should not be used during breast-feeding.
plazmāTā pējumi ar cilvē. kā tī
However, if its use is unavoidable, breast-feeding should be discontinued.
pieejami, Oprymea, nevajadzē lietot zīš laikāJa nav iespē bē baroš ar
4.7 Effects on ability to drive and use machines
4. 7 Ietekme uz spē vadītransportlī
Oprymea can have a major influence on the ability to drive and use machines.
Oprymea var bū ietekmēspē vadītransportlī us un apkalpot mehā
Hallucinations or somnolence can occur.
Var rasties halucinā cijas vai miegainī ba.
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).
Pacientiem, kuriem Oprymea terapijas laikā miegainī un/ vai pē ņ iemigš epizodes, lī š simptomu izzuš jā
4.8 Undesirable effects
š vai aktivitā m (piemē anas tē
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.
mehā nismu apkalpoš anas), kuru laikā modrī traucē smagu traumu vai nā riskam (skatīapakš
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.
Analizē apkopotu placebo kontrolē pējumu datus, kas ietvē pavisam 1923 pacientus, kuri lietoja
63% of patients on pramipexole and 52% of patients on placebo reported at least one adverse drug reaction.
abā grupā Par vismaz vienu blakusparā bu ziņ 63% pacientu pramipeksola grupā 52% pacientu
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.
Pacientiem ar Parkinsona slimī visbiežk (≥ ziņ par sliktu dūu, diskinē hipotensiju, reiboni, miegainī bezmiegu, aizcietē
The incidence of somnolence is increased at doses higher than 1.5 mg/ day (see section 4.2).
jumiem, halucinā m, galvassā m un nogurumu (daudz biežk cijā pē ā
Hypotension may occur at the beginning of treatment, especially if pramipexole is titrated too fast.
Miegainī incidence palielinā lietojot devas, kas pā 1, 5 mg/ dienā (skatīapakš
The most commonly (≥
Pacientiem ar citu indikā kurus ā ja ar pramipeksolu, visbiežk (≥ ziņ par sliktu dūu,
5%) reported adverse drug reactions in patients with other indication treated
ā 5%) ots
with pramipexole were nausea, headache, dizziness and fatigue.
Par sliktu dūu un nogurumu biežk ziņ sievietē (20, 8% un
Nausea and fatigue were more often reported in female patients (20.8% and 10.5%, respectively) compared to males (6.7% and 7.3%, respectively).
attiecī 10, 5%), nekā rieš (6, 7% un attiecī 7, 3%).
Tables 1 and 2 display the frequency of adverse reactions from placebo-controlled clinical trials.
1. un 2. tabulā apkopoti ziņ ojumi par zā blakusparā bā kas saņ
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.
rotas 1% un vairā
However, the majority of common adverse reactions were mild to moderate, they usually start early in therapy, and most tended to disappear even as therapy was continued.
pramipeksolu, un ziņ daudz biežk pacientiem, kuri lietoja pramipeksolu, salī
Very common Adverse Reactions (≥ 1/ 10) System organ class
i 1/ 10)
Adverse reaction
Blakusparā bas dī
Pramipexole N= 1,923 (%)
Pramipeksols N = 1923 (%)
Nervous system disorders
Nervu sistē traucē
Dizziness Dyskinesia
Reibonis Diskinēzija
Gastrointestinal disorders Vascular disorders
alKuņa un zarnu trakta traucē
Nausea Hypotension
jumi
17.2 12.6
Slikta dūa š
Common Adverse Reactions (≥ 1/ 100 to < 1/ 10) System organ class
i 1/ 100 lī < 1/ 10) dz
Adverse reaction
Pramipeksols N =
Pramipexole N= 1,923 (%)
1923 (%)
Psychiatric disorders
Psihiskie traucē
Abnormal dreams Confusional state Hallucinations Insomnia
Neparasti sapņi Apjukums Halucinācijas Bezmiegs
Somnolence Headache
Galvassā pes Miegainī ba
8.6 6.5
6, 5 8, 6
Gastrointestinal disorders
Kuņa un zarnu trakta traucē
Constipation
Aizcietējumi
5.5
rē
General disorders and administration site conditions
jumi un reakcijas
Fatigue
Nogurums
Peripheral oedema
Perifē tū ra ska
Pramipexole is associated with somnolence (8.6%) and has been associated uncommonly with excessive daytime somnolence and sudden sleep onset episodes (0.1%).
Pramipeksola lietoš ir saistī ar miegainī (8, 6%), nereti tā
See also section 4.4.
punktu 4. 4.
Pramipexole may be associated with libido disorders (increased (0.1%) or decreased (0.4%)).
Pramipeksols var būsaistī ar dzimumtieksmes traucē 0, 4%).
Patients treated with dopamine agonists for Parkinson’ s disease, including pramipexole, especially at high doses, have been reported as exhibiting signs of pathological gambling, increase libido and hypersexuality, generally reversible upon treatment discontinuation.
augstā devā ziņ par patoloģ tieksmi uz azartspē m, paaugstinā dzimumtieksmi un
4.9 Overdose
isku
There is no clinical experience with massive overdose.
rtraukš parasti ir atgriezeniska. anas
The expected adverse events would be those related to the pharmacodynamic profile of a dopamine agonist, including nausea, vomiting, hyperkinesia, hallucinations, agitation and hypotension.
Sagaidā s blakusparā bas saistī ar dopamī š mā dī tas na
There is no established antidote for overdose 6 of a dopamine agonist.
6
If signs of central nervous system stimulation are present, a neuroleptic agent may be indicated.
Dopamī agonistu pā
Management of the overdose may require general supportive measures, along with gastric lavage, intravenous fluids, administration of activated charcoal and electrocardiogram monitoring.
Pā ti dzekļ rdozēanas gadī š jumā
5.
ic
PHARMACOLOGICAL PROPERTIES
kumi līdztekus ar kuņa skaloš ģ
5.1 Pharmacodynamic properties
FARMAKOLOĢISKĀ Ī Ī S PAŠBAS
Pharmacotherapeutic group: dopamine agonists, ATC code:
Farmakoterapeitiskāgrupa: dopamī agonists, ATĶkods:
N04BC05.
N04BC05 na
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.
Pramipeksols ir dopamī agonists, kas izteikti selektī un specifiski saistā ar dopamī receptoru D2
Pramipexole alleviates Parkinsonian motor deficits by stimulation of dopamine receptors in the striatum.
Pējumos ar dzī
Animal studies have shown that pramipexole inhibits dopamine synthesis, release, and turnover.
vniekiem konstatē ka pramipeksols nomā ja,
In human volunteers, a dose-dependent decrease in prolactin was observed.
Pējumos ar brī tī tī vprāgajiem novē devas atkarī prolaktī samazināanos.
Clinical trials in Parkinson’ s disease
niskie pējumi Parkinsona
In patients pramipexole alleviates signs and symptoms of idiopathic Parkinson 's disease.
Kontrolē klī
Controlled clinical trials included approximately 2100 patients of Hoehn and Yahr stages I – IV.
pējumos tika iesaistī apmē 2100 pacienti (I – IV pakā pē Hoehn un Yahr klasifikā
Out of these, approximately 900 were in more advanced stages, received concomitant levodopa therapy, and suffered from motor complications.
tiem apmē 900 smagā pakā pacientu ar motorā komplikā m vienlaikus saņma levodopu.
In early and advanced Parkinson’ s disease, efficacy of pramipexole in the controlled clinical trials was maintained for approximately six months.
Atklā pējumos, kuros izvē ja ilgstoš zā lietoš un
In open continuation trials lasting for more than three years there were no signs of decreasing efficacy.
kas ilga vairā nekā s gadus, pazī kas liecinā par efektivitā samazināanos, nenovē
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.
Kontrolē dubultaklos pējumos, kas ilga 2 gadus, sā
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).
(nosakot vidē s izmaiņ UPDRS punktu jā as
The overall incidence of hallucinations and somnolence was generally higher in the escalation phase with the pramipexole group.
rā tā Vispā jais halucinā un miegainī biež pramipeksola grupā lielā devas
However there was no significant difference during the maintenance phase.
Tomē uzturoš fā bū
These points should be considered when initiating pramipexole treatment in patients with Parkinson´s disease.
Tas jāem ķ bu
5.2 Pharmacokinetic properties
vē, uzsā pramipeksola ņ rā kot
Pramipexole is rapidly and completely absorbed following oral administration.
terapiju pacientiem ar Parkinsona slimī bu.
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
Concomitant administration with food did not reduce the extent of pramipexole absorption, but the rate of absorption was reduced.
Pramipeksolam ir lineā kinē un
Pramipexole shows linear kinetics and a small inter-patient variation of plasma levels.
Cilvē
In humans, the protein binding of pramipexole is very low (< 20%) and the volume of distribution is large (400 l).
plazmas olbaltumvielā (< 20%), izkliedes tilpums ir liels (400 l).
High brain tissue concentrations were observed in the rat (approx.
Ž m novē augstu koncentrā smadzeņ audos (apmē 8
8-fold compared to plasma).
m reizes augstā nekā
Pramipexole is metabolised in man only to a small extent.
Cilvē organismā
Renal excretion of unchanged pramipexole is the major route of elimination.
tikai neliels daudzums pramipeksola metabolizē jas.
Approximately 90% of 14 C-labelled dose is excreted through the kidneys while less than 2% is found in the faeces.
14
The total clearance of pramipexole is approximately 500 ml/ min and the renal clearance is approximately 400 ml/ min.
Eliminā ram
The elimination half-life (t½) varies from 8 hours in the young to 12 hours in the elderly.
cijas pusperiods (t½) svā s no 8 rstā
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.
niskie dati par droš ību
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.
Atkā rtotu devu toksicitā pējumi pierā ja, ka pramipeksols funkcionā ietekmē
The potential effects of pramipexole on reproductive function have been investigated in rats and rabbits.
nervu sistē un sievietes reproduktī sistē iespē
Pramipexole was not teratogenic in rats and rabbits but was embryotoxic in the rat at maternally toxic doses.
jams, ka š iedarbī pamatā izteikts īs bas ir
Pramipexole was not genotoxic.
pramipeksola farmakodinamiskais efekts.
In a carcinogenicity study, male rats developed Leydig cell hyperplasia and adenomas, explained by the prolactin-inhibiting effect of pramipexole.
asinsspiediena pazemināanos un sirdsdarbī š bas
This finding is not clinically relevant to man.
nināanos, pē iem konstatē tendenci uz hipotensiju.
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.
Potenciā pramipeksola ietekmi uz reproduktī funkciju pēja ž m un truš Pramipeksols nebija
The latter finding was not observed in pigmented rats, nor in a 2-year albino mouse carcinogenicity study or in any other species investigated.
teratogē ž m un truš tač bija embriotoksisks ž m, ja to lietoja mā toksiskā
6.
ns
PHARMACEUTICAL PARTICULARS
tika izmeklē tikai atseviši rā tā dažm dzī
6.1 List of excipients
pramipeksola nevē m,
Mannitol Maize starch Pregelatinised maize starch Povidone K25 Colloidal anhydrous silica Magnesium stearate
hiperplā un adenomas, ko var izskaidrot ar pramipeksola prolaktī inhibē o iedarbī Cilvē š atradne
6.2 Incompatibilities
zija nebija klī nozī ga.
Not applicable.
bu.
6.3 Shelf life
lielā devā
2 years.
m 2 mg/ kg (sā un ja, nā urkā
6.4 Special precautions for storage
ls)
Store in the original package in order to protect from light.
kā
6.5 Nature and contents of container
pramipeksols bija saistī ar tī ts klenes deģenerā Pigmentē m ž m un divgadī m
20, 30, 60, 90 or 100 tablets.
ciju. tā urkā
Not all pack sizes may be marketed.
albī m pelē kā citā pētā dzī
6.6 Special precautions for disposal
m, arī m tīm vnieku sugā kanceroģ zes pējumos šdu
Any unused product or waste material should be disposed of in accordance with local requirements.
ā
8 7.
iju
MARKETING AUTHORISATION HOLDER
nekonstatē ja.
KRKA, d. d., Novo mesto, Š marješ cesta 6, 8501 Novo mesto, Slovenia ka
FARMACEITISKĀ Ī Ī S PAŠBAS
8.
ta
MARKETING AUTHORISATION NUMBER(S)
6. 4 pašuzglabāanas nosacī
20 tablets:
Blisteri (Al/ Al folija):
EU/ 1/ 08/ 469/ 001 30 tablets:
EU/ 1/ 08/ 469/ 001 30 tabletes:
EU/ 1/ 08/ 469/ 002 60 tablets:
EU/ 1/ 08/ 469/ 002 60 tabletes:
EU/ 1/ 08/ 469/ 003 90 tablets:
EU/ 1/ 08/ 469/ 003 90 tabletes:
EU/ 1/ 08/ 469/ 004 100 tablets:
EU/ 1/ 08/ 469/ 004 100 tabletes:
DATE OF FIRST AUTHORISATION/ RENEWAL OF THE AUTHORISATION
EĢISTRĀCIJAS/ PĀRREĢISTRĀCIJAS DATUMS
DATE OF REVISION OF THE TEXT
TEKSTA PĒ JĀ PĀ DĒ S RSKATĪANAS DATUMS Š
Detailed information on this medicinal product is available on the website of the European Medicines Agency (EMEA) http: / /www. emea. europa. eu/.
Sī ka informā par š zā m ir pieejama Eiropas zā aģ ras (EMEA) mā lapā
NAME OF THE MEDICINAL PRODUCT
ZĀ U NOSAUKUMS Ļ
Oprymea 0.18 mg tablets
Oprymea 0, 18 mg tabletes
QUALITATIVE AND QUANTITATIVE COMPOSITION
KVALITATĪ VAIS UN KVANTITATĪ VAIS SASTĀVS
Each tablet contains 0.18 mg pramipexole base (as 0.25 mg pramipexole dihydrochloride monohydrate).
Katra tablete satur 0, 18 mg pramipeksola (pramipexole) bā (0, 25 mg pramipeksola dihidrohlorī monohidrā veidā
Please note:
Uzmanī bu:
Pramipexole doses as published in the literature refer to the salt form.
literatū publicē s pramipeksola devas atbilst sā formai.
Therefore, doses will be expressed in terms of both pramipexole base and pramipexole salt (in brackets).
Tā c devas tiek norā tas pramipeksola bā un sā formai (iekavā
For a full list of excipients, see section 6.1.
punktā6. 1.
PHARMACEUTICAL FORM
Ā U FORMA Ļ
0.18 mg: white, oval, with bevelled edges, both sides scored, with imprint "P7" on both halves of one side of the tablet.
0, 18 mg: baltas, ovā ar nošeltā malā un dalī
The tablet can be divided into equal halves.
dalījuma daļ ir uzdruka „ P7 ”.
CLINICAL PARTICULARS
NISKĀINFORMĀCIJA
4.1 Therapeutic indications
4. 1 Terapeitiskā indikā
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).
samazinā vai kļ nepastā ga un sā terapeitiskā iedarbī svā bas (devas beigu vai “ on- off ”
4.2 Posology and method of administration
Parkinsona slimī ba Tabletes jā perorā tā jā
Parkinson’ s disease The tablets should be taken orally, swallowed with water, and can be taken either with or without food.
li, s norij, uzdzerot ūdeni, tā var lietot ēanas laikā tukš dūāDiennakts s š vai ā š.
The daily dosage is administered in equally divided doses 3 times a day.
Terapijas uzsā ana kš Deva jā palielina pakāpeniski, sā ar sā
Initial treatment Dosages should be increased gradually from a starting-dose of 0.264 mg of base (0.375 mg of salt) per day and then increased every 5 - 7 days.
kuma devu 0, 264 mg bā (0, 375 mg sā dienā tad zes ls) un
Total Daily Dose (mg of base)
Deva (mg sā
Dosage (mg of salt)
(mg bā
Total Daily Dose (mg of salt)
(mg sā ls)
During dose escalation in three pivotal studies, efficacy was observed starting at a daily dose of 1.1 mg of base (1.5 mg of salt).
Tomē jāem vē, ka miegainī biež palielinā ja deva pā 4. 8).
Further dose adjustments should be done based on the clinical response and the occurrence of adverse reactions.
s,
In clinical trials approximately 5% of patients were treated at doses below 1.1 mg (1.5 mg of salt).
rsniedz 1, 5 mg/ dienā( skatīapakš t punktu
In advanced Parkinson’ s disease, doses higher than 1.1 mg (1.5 mg of salt) per day can be useful in patients where a reduction of the levodopa therapy is intended.
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
It is recommended that the dosage of levodopa is reduced during both the dose escalation and the maintenance treatment with Oprymea, depending on reactions in individual patients.
zes
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).
(4, 5 mg sā dienāTrijos reģ cijas pējumos, palielinot devu, efektivitā novē sā ar dienas
Thereafter the dose should be reduced by 0.264 mg of base (0.375 mg of salt) per day (see section 4.4).
devu 1, 1 mg bā (1, 5 mg sā Turpmā devas pielā ana jā pamatojoties uz klī
The following dosage schedule is suggested for initiation of therapy:
reakciju un blakusparā bu raš
Patients with a creatinine clearance above 50 ml/ min require no reduction in daily dose.
Klī niskos pējumos apmē 5% pacientu tika ā tī ram
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).
bija zemā par 1, 1 mg bā (1, 5 mg sā Pacientiem ar progresē u Parkinsona slimī kuriem
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.
paredzē levodopas devas mazināana, var būnepiecieš deva, kas augstā par 1, 1 mg bā (1, 5 mg
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%.
zes
Dosing in patients with hepatic impairment Dose adjustment in patients with hepatic failure is probably not necessary, as approx.
sā dienāLevodopas devas mazināanu iesaka veikt OPRYMEA devas palielināanas laikā uzturošs
90% of absorbed active substance is excreted through the kidneys.
terapijas laikā atkarī no individuā pacienta atbildes reakcijas.
However, the potential influence of hepatic insufficiency on Oprymea pharmacokinetics has not been investigated.
Terapijas pārtraukš ana Pē ņ dopamī iskā terapijas pā
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.
kša
4.3 Contraindications
nerģ s
Hypersensitivity to the active substance or to any of the excipients.
rtraukš var izraisīļ ana t aundabī
4.4 Special warnings and precautions for use
sindroma attī bu. stī
11 When prescribing Oprymea in a patient with Parkinson’ s disease with renal impairment a reduced dose is suggested in line with section 4.2.
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
Hallucinations are known as a side-effect of treatment with dopamine agonists and levodopa.
samazina par 0, 264 mg bā (0, 375 mg sā dienā zes ls)
Patients should be informed that (mostly visual) hallucinations can occur.
apakšpunktu 4. 4).
If they occur, the dose of levodopa should be decreased.
Devas pacientiem ar nieru darbī traucē
Pramipexole has been associated with somnolence and episodes of sudden sleep onset, particularly in patients with Parkinson’ s disease.
Pramipeksola eliminā ir atkarī no nieru funkcijas.
Sudden onset of sleep during daily activities, in some cases without awareness or warning signs, has been reported uncommonly.
Terapijas sā anai ieteicama šda dozēanas shēma:
Patients must be informed of this and advised to exercise caution while driving or operating machines during treatment with Oprymea.
Pacientiem ar kreatinī klī na rensu virs 50 ml/ min nav jā samazina dienas deva.
Patients who have experienced somnolence and/ or an episode of sudden sleep onset must refrain from driving or operating machines.
Pacientiem ar kreatinī klī na rensu no 20 lī 50 ml/ min, Oprymea sā
Furthermore a reduction of dosage or termination of therapy may be considered.
kotnē dienas deva jā jā sadala divās
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).
reizes devā jā k ar 0, 088 mg bā (0, 125 mg sā divas reizes dienā dienā).
Pathological gambling, increased libido and hypersexuality have been reported in patients treated with dopamine agonists for Parkinson’ s disease, including pramipexole.
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
Furthermore, patients and caregivers should be aware of the fact that behavioural changes can occur.
nieru funkcija pasliktinā Oprymea dienas deva jā s,
Dose reduction/ taper or discontinuation should be considered.
samazina tiešpar tik i
Patients with psychotic disorders should only be treated with dopamine agonists if the potential benefits outweigh the risks.
procentiem, par cik procentiem samazinā kreatinī klī
Ophthalmologic monitoring is recommended at regular intervals or if vision abnormalities occur.
na renss, tas ir, ja kreatinī klī na renss samazinā par s
In case of severe cardiovascular disease, care should be taken.
30%, Oprymea dienas deva arī samazina par 30%.
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.
Diennakts devu var dalīdivā reizes devā ja kreatinī klī
Symptoms suggestive of neuroleptic malignant syndrome have been reported with abrupt withdrawal of dopaminergic therapy (see section 4.2)
s,
Reports in the literature indicate that treatment of another indication with dopaminergic medicinal products can result in augmentation.
na renss ir no 20 lī 50
4.5 Interaction with other medicinal products and other forms of interaction
ml/ min, dienas deva jā mē
Pramipexole is bound to plasma proteins to a very low (< 20%) extent, and little biotransformation is seen in man.
20 ml/ min.
Therefore, interactions with other medicinal products affecting plasma protein binding or elimination by biotransformation are unlikely.
nozī vienā
Therefore, medicinal products
reizēja kreatinī klī, na renss ir zem
Reduction of the pramipexole dose should be considered when these medicinal products are administered concomitantly.
Devas pacientiem ar aknu darbī traucē
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.
bas
Because of possible additive effects, caution should be advised when patients are taking other sedating medicinal products or alcohol in combination with pramipexole.
jumiem
Coadministration of antipsychotic medicinal products with pramipexole should be avoided (see section 4.4), e. g. if antagonistic effects can be expected.
Devas pielā ana pacientiem ar aknu bojā
4.6 Pregnancy and lactation
goš
The effect on pregnancy and lactation has not been investigated in humans.
jumu teorē nav nepiecieš tiski ama, tā 90% no absorbē s kā tā
In the absence of human data, Oprymea should not be used during breast-feeding.
aktī s vielas izdalā caur nierē Tomē aknu mazspē potenciā ietekme uz Oprymea
However, if its use is unavoidable, breast-feeding should be discontinued.
r,
4.7 Effects on ability to drive and use machines
jas
Oprymea can have a major influence on the ability to drive and use machines.
lā
Hallucinations or somnolence can occur.
farmakokinē nav pēta.
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).
tiku
4.8 Undesirable effects
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.
Devas bē
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.
rniem un pusaudž iem Oprymea nav ieteicams lietoš bē anai rniem un pusaudž lī 18 gadu vecumam, jo nav iem dz informā cijas par droš un efektivitā
63% of patients on pramipexole and 52% of patients on placebo reported at least one adverse drug reaction.
ti.
More frequent adverse drug
4. 3 Kontrindikācijas
13 reaction in combination with levodopa was dyskinesia.
Paaugstinā jutī pret aktī vielu vai kā no palī
Hypotension may occur at the beginning of treatment, especially if pramipexole is titrated too fast.
du
The most commonly (≥
gvielā m.
5%) reported adverse drug reactions in patients with other indication treated
4. 4 Ī i brī jumi un piesardzī lietoš
with pramipexole were nausea, headache, dizziness and fatigue.
paš dinā
Tables 1 and 2 display the frequency of adverse reactions from placebo-controlled clinical trials.
ba
Table 1:
anā
Very common Adverse Reactions (≥ 1/ 10) System organ class
11 Ordinē Oprymea Parkinsona slimī pacientiem ar nieru darbī traucē
Adverse reaction
bas bas
Pramipexole N= 1,923 (%)
jumiem, nepiecieš devas ama
Nervous system disorders
pielā
Dizziness Dyskinesia
ana atbilstošnorā jumiem
15.5 12.9
apakš
Gastrointestinal disorders Vascular disorders
goš
Nausea Hypotension
i
17.2 12.6
dī
Table 2:
punktā4. 2.
Common Adverse Reactions (≥ 1/ 100 to < 1/ 10) System organ class
Pacienti
Adverse reaction
ar na
Pramipexole N= 1,923 (%)
jā dina, ka var rasties halucinā brī cijas (parasti vizuā las).
Psychiatric disorders
Progresē as Parkinsona slimī gadī, lietojot vienlaikus ar levodopu, sā
Abnormal dreams Confusional state Hallucinations Insomnia
još
3.5 3.0 6.6 8.2
bas jumā
Nervous system disorders
kotnē s Oprymea devas jā
Somnolence Headache
palielināanas laikā novē diskinē Šdā jumā samazina levodopas deva.
8.6 6.5
var
Gastrointestinal disorders
rot
Constipation
ziju. ā gadī
5.5
jā
General disorders and administration site conditions
Pramipeksola lietoš ir saistī ar miegainī un pē ņ iemigš epizodē galvenokā pacientiem
Fatigue
ana
6.1
bu
Peripheral oedema
kšas
1.9
anas
Pramipexole is associated with somnolence (8.6%) and has been associated uncommonly with excessive daytime somnolence and sudden sleep onset episodes (0.1%).
ar Parkinsona slimī Retā novē pē ņ iemigš dienas aktivitāu laikādaž gadī
See also section 4.4.
bu.
Pramipexole may be associated with libido disorders (increased (0.1%) or decreased (0.4%)).
rota kša
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.
ana š,
4.9 Overdose
ša ana š
There is no clinical experience with massive overdose.
neapzinā vai bez brī juma simptomiem.
There is no established antidote for overdose 14 of a dopamine agonist.
Pacientus jā dina par šdu iespē jā
5.
ti
PHARMACOLOGICAL PROPERTIES
ā brī ā
5.1 Pharmacodynamic properties
ju, iesaka bū
Pharmacotherapeutic group: dopamine agonists, ATC code:
piesardzī terapijas laikā Oprymea, vadot transportlī us vai apkalpojot mehā
N04BC05.
nismus.
Animal studies have shown that pramipexole inhibits dopamine synthesis, release, and turnover.
Pacientiem, kuriem bijusi miegainī un/ vai pē ņ iemigš epizodes, jā vadīš vai mehā
In human volunteers, a dose-dependent decrease in prolactin was observed.
atturas no transportlī u dzekļ
Clinical trials in Parkinson’ s disease
nismu apkalpoš
In patients pramipexole alleviates signs and symptoms of idiopathic Parkinson 's disease.
Bez tam jāapsver devas samazināanas vai terapijas pā š rtraukšanas
Out of these, approximately 900 were in more advanced stages, received concomitant levodopa therapy, and suffered from motor complications.
iespē Jā ro piesardzī vienlaikus ar pramipeksolu lietojot citas nomierinoš zā vai alkoholu, jo
In early and advanced Parkinson’ s disease, efficacy of pramipexole in the controlled clinical trials was maintained for approximately six months.
as les
5.2 Pharmacokinetic properties
iespējama aditī iedarbī (skatī
Pramipexole is rapidly and completely absorbed following oral administration.
t apakš punktu 4. 7 un 4. 8).
Concomitant administration with food did not reduce the extent of pramipexole absorption, but the rate of absorption was reduced.
Pacientiem ar Parkinsona slimī kuri lietoja dopamī agonistus, tai skaitā
Pramipexole shows linear kinetics and a small inter-patient variation of plasma levels.
pramipeksolu, ziņ par ots
In humans, the protein binding of pramipexole is very low (< 20%) and the volume of distribution is large (400 l).
patoloģ tieksmi uz azartspē m, paaugstinā dzimumtieksmi, hiperseksualitā Bez tam, pacienti un
High brain tissue concentrations were observed in the rat (approx.
Bū jā
8-fold compared to plasma).
rtraukš ana.
Pramipexole is metabolised in man only to a small extent.
Pacienti ar psihozē jārstē dopamī agonistiem tikai tajos gadī
Renal excretion of unchanged pramipexole is the major route of elimination.
jumos, kad gaidā mais ieguvums
Approximately 90% of 14 C-labelled dose is excreted through the kidneys while less than 2% is found in the faeces.
pārsniedz iespē jamo risku.
The elimination half-life (t½) varies from 8 hours in the young to 12 hours in the elderly.
Jā izvairā no antipsihotisko zā un pramipeksola vienlaikus lietoš (skatīapakš
15 5.3 Preclinical safety data
punktu 4. 5).
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.
Oftalmoloģ kontrole jā regulā vai gadī, ja novē redzes traucē
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.
jumā
The potential effects of pramipexole on reproductive function have been investigated in rats and rabbits.
ro
Pramipexole was not genotoxic.
jumus.
This finding is not clinically relevant to man.
Nopietnu kardiovaskulā slimī gadī
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.
jumos jā ro piesardzī Tā pastā posturā hipotensijas ievē ba. kā v las
The latter finding was not observed in pigmented rats, nor in a 2-year albino mouse carcinogenicity study or in any other species investigated.
risks, kas saistī ar dopamī isko zā lietoš ieteicams kontrolēasinsspiedienu, ī i terapijas sā kumā.
6.
ts
PHARMACEUTICAL PARTICULARS
paš
6.1 List of excipients
Pē ņpā
Mannitol Maize starch Pregelatinised maize starch Povidone K25 Colloidal anhydrous silica Magnesium stearate
kši rtraucot lietot dopamī isko terapiju, ziņ par simptomiem, kas norā uz ļ
6.2 Incompatibilities
nerģ
Not applicable.
aundabī go
6.3 Shelf life
neiroleptisko sindromu (skatīapakš
2 years.
punktu 4. 2).
6.4 Special precautions for storage
Literatū pieejamie ziņ
Store in the original package in order to protect from light.
ojumi liecina, ka citu indikā ā š ar dopamī iskā zā m var izraisī ciju rstēana nerģ m lē
6.5 Nature and contents of container
stā a pasliktināanos.
Blister pack (Al/ Al foil):
(vai pat pē cpusdienā),
20, 30, 60, 90 or 100 tablets.
simptomu pastiprināanos un simptomu izplatī
Not all pack sizes may be marketed.
š uz citā ekstermitā m.
6.6 Special precautions for disposal
ilgā pramipeksola lietoš un atbilstoš š traucē
Any unused product or waste material should be disposed of in accordance with local requirements.
as o
16 7.
jumu
KRKA, d. d., Novo mesto, Š marješ cesta 6, 8501 Novo mesto, Slovenia ka
ā š kontrolē klī rstēanas tos niskos pējumos tī
8.
nav
MARKETING AUTHORISATION NUMBER(S)
4. 5 Mijiedarbī ar citā zā m un citi mijiedarbī veidi
20 tablets:
Pramipeksols saistā ar plazmas olbaltumvielā ļ vā (< 20%), biotransformā cilvē ir vā
EU/ 1/ 08/ 469/ 006 30 tablets:
Tā c mijiedarbī ar citā zā m, kas ietekmē
EU/ 1/ 08/ 469/ 007 60 tablets:
saistī ar olbaltumvielā vai eliminā bu m ciju
EU/ 1/ 08/ 469/ 008 90 tablets:
biotransformācijas ceļ ir maz ticama.
EU/ 1/ 08/ 469/ 009 100 tablets:
Tā antiholī iskie lī i galvenokā eliminē
EU/ 1/ 08/ 469/ 010
dzekļ
9.
rt
DATE OF FIRST AUTHORISATION/ RENEWAL OF THE AUTHORISATION
biotransformācijas ceļ mijiedarbī iespē ir ierobež lai gan mijiedarbī ar antiholī iskiem
12/ 9/ 2008
bas ja ota, ba
10.
nerģ
DATE OF REVISION OF THE TEXT
Farmakokinē
Detailed information on this medicinal product is available on the website of the European Medicines Agency (EMEA) http: / /www. emea. europa. eu/.
tisku mijiedarbī ar selegilī un levodopu nenovē bu nu ro.
17 1.
ns
NAME OF THE MEDICINAL PRODUCT
rensu apmē par 34%, domā ram
Oprymea 0.35 mg tablets
jams, inhibē nieru kanā u jot
2.
vo
QUALITATIVE AND QUANTITATIVE COMPOSITION
cijas ceļ vai tiek u
Each tablet contains 0.35 mg pramipexole base (as 0.5 mg pramipexole dihydrochloride monohydrate).
12 eliminē šdā ākā tas ā ceļ cimetidī vai amantadī var mijiedarboties ar pramipeksolu, rezultā
Please note:
tā
Pramipexole doses as published in the literature refer to the salt form.
Ja šdas zā ordinē
Therefore, doses will be expressed in terms of both pramipexole base and pramipexole salt (in brackets).
vienlaikus ar pramipeksolu, jā apsver
For a full list of excipients, see section 6.1.
pramipeksola devas samazināanas nepiecieš ba.
PHARMACEUTICAL FORM
Ja Oprymea ordinē
Tablet.
ta.
0.35 mg: white, oval, with bevelled edges, both sides scored, with imprint "P8" on both halves of one side of the tablet.
kā jama aditī iedarbī jā ro piesardzī vienlaikus ar pramipeksolu lietojot citas
The tablet can be divided into equal halves.
nomierinoš zā vai alkoholu. as les
4.
punktu 4. 4),
CLINICAL PARTICULARS
piemē ram, ja ir sagaidā antagonistiska darbī
4.1 Therapeutic indications
4. 6 Grūtniecī un zī š
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).
dīana
4.2 Posology and method of administration
Pramipeksols nebija teratogē ž m un
Parkinson’ s disease The tablets should be taken orally, swallowed with water, and can be taken either with or without food.
truš tač bija embriotoksisks ž m, ja to lietoja mā toksiskā
The daily dosage is administered in equally divided doses 3 times a day.
(skatīapakš t punktu 5. 3).
Initial treatment Dosages should be increased gradually from a starting-dose of 0.264 mg of base (0.375 mg of salt) per day and then increased every 5 - 7 days.
tniecī laikāja vien nav pamatotu indikā tas ir, ja gaidā bas, ciju, mais ieguvums
Providing patients do not experience intolerable side-effects, the dosage should be titrated to achieve a maximal therapeutic effect.
Tā terapija ar pramipeksolu inhibē kā prolaktī sekrē cilvē Pramipeksola ekskrē mā pienā
Ascending – Dose Schedule of OPRYMEA Week
kam, gaidā laktā ma
Dosage (mg of base)
cijas nomā
Total Daily Dose (mg of base)
ana. kš
Dosage (mg of salt)
cija tes
Total Daily Dose (mg of salt)
sievietē nav pēta.
1 2 3
gas
3 x 0.088 3 x 0.18 3 x 0.35
radioaktivitā koncentrā mā pienā augstā nekā
0.264 0.54 1.1
tes
3 x 0.125 3 x 0.25 3 x 0.5
cija tes
0.375 0.75 1.50
bija
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.
ka
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).
plazmāTā pējumi ar cilvē. kā tī
It is recommended that the dosage of levodopa is reduced during both the dose escalation and the maintenance treatment with Oprymea, depending on reactions in individual patients.
pieejami, Oprymea, nevajadzē lietot zīš laikāJa nav iespē bē baroš ar
Treatment discontinuation Abrupt discontinuation of dopaminergic therapy can lead to the development of a neuroleptic malignant syndrome.
.
The following dosage schedule is suggested for initiation of therapy:
jams pārtraukt zā lietoš ļu
Patients with a creatinine clearance above 50 ml/ min require no reduction in daily dose.
jā rtrauc anu, pā
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).
rna
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.
ana
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%.
ti.
90% of absorbed active substance is excreted through the kidneys.
4. 7 Ietekme uz spē vadītransportlī
However, the potential influence of hepatic insufficiency on Oprymea pharmacokinetics has not been investigated.
ju
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.
t
4.3 Contraindications
dzekļ un apkalpot mehā us nismus
Hypersensitivity to the active substance or to any of the excipients.
Oprymea var bū ietekmēspē vadītransportlī us un apkalpot mehā
4.4 Special warnings and precautions for use
dzekļ
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.
nismus.
Patients should be informed that (mostly visual) hallucinations can occur.
Var rasties halucinā cijas vai miegainī ba.
In advanced Parkinson’ s disease, in combination treatment with levodopa, dyskinesias can occur during the initial titration of Oprymea.
Pacientiem, kuriem Oprymea terapijas laikā miegainī un/ vai pē ņ iemigš epizodes, lī š simptomu izzuš jā
If they occur, the dose of levodopa should be decreased.
anai iesaka atturē no transportlī u vadī