natgillin/translations-raw huggingface dataset:
Pramipexole was not genotoxic.
Pramipeksol ni bil genotoksič V š
In a carcinogenicity study, male rats developed Leydig cell hyperplasia and adenomas, explained by the prolactin-inhibiting effect of pramipexole.
Leydigovih celic in adenome, kar so razlož z dejstvom, da pramipeksol zavira sintezo prolaktina.
This finding is not clinically relevant to man.
Ista š
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.
odmerkih 2 mg/ kg (soli) ali več povezan z degeneracijo mrež pri albino podganah.
The latter finding was not observed in pigmented rats, nor in a 2-year albino mouse carcinogenicity study or in any other species investigated.
Tega niso nice opazili niti pri pigmentiranih podganah niti v raziskavi kancerogenosti pri 2- letnih albino miš ali katerikoli drugi raziskovani vrsti. ih
6.1 List of excipients
6. 1 Seznam pomož snovi nih
Mannitol Maize starch Pregelatinised maize starch Povidone K25 Colloidal anhydrous silica Magnesium stearate
manitol koruzni škrob predgelirani koruzni škrob povidon K25 brezvodni koloidni silicijev dioksid magnezijev stearat
Store in the original package in order to protect from light.
Shranjujte v originalni ovojnini za zagotovitev zašite pred svetlobo. č
Blister pack (Al/ Al foil):
Pretisni omot (Al/ Al- folija):
20, 30, 60, 90 or 100 tablets.
20, 30, 60, 90 ali 100 tablet.
20 tablets:
8 20 tablet:
EU/ 1/ 08/ 469/ 001 30 tablets:
EU/ 1/ 08/ 469/ 001 30 tablet:
EU/ 1/ 08/ 469/ 002 60 tablets:
EU/ 1/ 08/ 469/ 002 60 tablet:
EU/ 1/ 08/ 469/ 003 90 tablets:
EU/ 1/ 08/ 469/ 003 90 tablet:
EU/ 1/ 08/ 469/ 004 100 tablets:
EU/ 1/ 08/ 469/ 004 100 tablet:
Oprymea 0.18 mg tablets
Oprymea 0, 18 mg tablete
Each tablet contains 0.18 mg pramipexole base (as 0.25 mg pramipexole dihydrochloride monohydrate).
1 tableta vsebuje 0, 18 mg pramipeksola v obliki 0, 25 mg pramipeksolijevega dihidroklorid monohidrata.
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: bele, ovalne, s posnetimi robovi in z zarezo na obeh straneh ter oznako P7 na obeh polovicah ene strani tablete.
10 However, it should be noted that the incidence of somnolence is increased at doses higher than 1.5 mg/ day (see section 4.8).
zaspanost pogostejš pri dnevnih odmerkih, ki so več od 1, 5 mg (glejte poglavje 4. 8).
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.
od 1, 1 mg (1, 5 mg soli). imi
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.
Dnevni odmerki, več od 1, 1 mg (1, 5 mg soli), so lahko koristni pri bolnikih z napredovalo ji Parkinsonovo boleznijo, pri katerih je predvideno zdravljenje z manjš odmerki levodope.
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).
ljivo, da se odmerek levodope zmanjš tako med a
Thereafter the dose should be reduced by 0.264 mg of base (0.375 mg of salt) per day (see section 4.4).
poveč evanjem odmerka zdravila Oprymea kot med vzdrž
Dosing in patients with renal impairment The elimination of pramipexole is dependent on renal function.
evalnim zdravljenjem s tem zdravilom.
The following dosage schedule is suggested for initiation of therapy:
Nagla prekinitev zdravljenja z dopaminskimi agonisti lahko
Patients with a creatinine clearance above 50 ml/ min require no reduction in daily dose.
izzove nevroleptič maligni sindrom. ni
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).
Zdravljenje s pramipeksolom zato ukinjamo postopoma, in sicer po 0, 54 mg (0, 75 mg soli) na dan, dokler dnevnega odmerka ne zmanjš na 0, 54 mg pramipeksola (0, 75 mg soli).
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.
Nato odmerek amo zmanjš ujemo po 0, 264 mg pramipeksola (0, 375 mg soli) na dan (glejte poglavje 4. 4).
The daily dose can be administered in two divided doses if creatinine clearance is between 20 and 50 ml/ min, and as a single daily dose if creatinine clearance is less than 20 ml/ min.
Odmerjanje pri bolnikih z ledvič okvaro no Izloč pramipeksola je odvisno od ledvič ki je
Dosing in patients with hepatic impairment Dose adjustment in patients with hepatic failure is probably not necessary, as approx.
anje priporoč za zač zdravljenja. ljivo etek
90% of absorbed active substance is excreted through the kidneys.
nega delovanja.
However, the potential influence of hepatic insufficiency on Oprymea pharmacokinetics has not been investigated.
V nadaljevanju je navedeno odmerjanje,
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.
Pri bolnikih s kreatininskim oč istkom več 50 ml/ min ni treba zmanjš dnevnega odmerka.
4.3 Contraindications
kot
Hypersensitivity to the active substance or to any of the excipients.
ati
4.4 Special warnings and precautions for use
Pri bolnikih s kreatininskim oč
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.
istkom med 20 in 50 ml/ min zač dnevni odmerek zdravila Oprymea etni razdelimo na dva odmerka.
Hallucinations are known as a side-effect of treatment with dopamine agonists and levodopa.
Zač nemo z dajanjem 0, 088 mg pramipeksola (0, 125 mg soli) dvakrat na dan (tj.
Patients should be informed that (mostly visual) hallucinations can occur.
0, 25 mg soli).
In advanced Parkinson’ s disease, in combination treatment with levodopa, dyskinesias can occur during the initial titration of Oprymea.
Bolnikom s kreatininskim očistkom manj kot 20 ml/ min damo dnevni odmerek zdravila Oprymea v enkratnem odmerku.
If they occur, the dose of levodopa should be decreased.
Zač nemo z 0, 088 mg pramipeksola (0, 125 mg soli).
Furthermore a reduction of dosage or termination of therapy may be considered.
Č ledvič delovanje med vzdrž
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).
no
Furthermore, patients and caregivers should be aware of the fact that behavioural changes can occur.
evalnim zdravljenjem oslabi, dnevni odmerek zdravila Oprymea
Dose reduction/ taper or discontinuation should be considered.
zmanjš za enak odstotek, za kakrš
Patients with psychotic disorders should only be treated with dopamine agonists if the potential benefits outweigh the risks.
amo
Coadministration of antipsychotic medicinal products with pramipexole should be avoided (see section 4.5).
Č se na primer e
Ophthalmologic monitoring is recommended at regular intervals or if vision abnormalities occur.
Dnevni
In case of severe cardiovascular disease, care should be taken.
odmerek lahko razdelimo na dva odmerka, č je kreatininski oč
Symptoms suggestive of neuroleptic malignant syndrome have been reported with abrupt withdrawal of dopaminergic therapy (see section 4.2)
e
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.
istek med 20 in 50 ml/ min, oziroma ga
4.5 Interaction with other medicinal products and other forms of interaction
damo v enkratnem odmerku, č je kreatininski oč
Pramipexole is bound to plasma proteins to a very low (< 20%) extent, and little biotransformation is seen in man.
istek manjšod 20 ml/ min. i
As anticholinergics are mainly eliminated by biotransformation, the potential for an interaction is limited, although an interaction with anticholinergics has not been investigated.
Odmerjanje pri bolnikih z jetrno okvaro Pri bolnikih z jetrnim odpovedovanjem prilagoditev odmerka verjetno ni potrebna, saj se približ no 90% absorbirane zdravilne uč inkovine izločskozi ledvice.
There is no pharmacokinetic interaction with selegiline and levodopa.
Morebitnega vpliva jetrnega i odpovedovanja na farmakokinetiko pramipeksola niso raziskovali.
Cimetidine reduced the renal clearance of pramipexole by approximately 34%, presumably by inhibition of the cationic secretory transport system of the renal tubules.
Odmerjanje za otroke in mladostnike Zaradi pomanjkanja podatkov o varnosti in uč inkovitosti uporaba zdravila Oprymea pri otrocih, mlajš od 18 let, ni priporoč
Therefore, medicinal products
Kontraindikacije
Reduction of the pramipexole dose should be considered when these medicinal products are administered concomitantly.
Preobč utljivost za zdravilno uč inkovino ali katerokoli pomož snov. no
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.
4. 4 Posebna opozorila in previdnostni ukrepi
Because of possible additive effects, caution should be advised when patients are taking other sedating medicinal products or alcohol in combination with pramipexole.
Bolnikom s Parkinsonovo boleznijo in ledvič okvaro predpisujemo manjš odmerke, kar je opisano v poglavju 4. 2.
Coadministration of antipsychotic medicinal products with pramipexole should be avoided (see section 4.4), e. g. if antagonistic effects can be expected.
e
4.6 Pregnancy and lactation
Halucinacije so znani než
The effect on pregnancy and lactation has not been investigated in humans.
eleni uč zdravljenja z dopaminskimi agonisti in levodopo.
Pramipexole was not teratogenic in rats and rabbits, but was embryotoxic in the rat at maternotoxic doses (see section 5.3).
Bolnike inek moramo opozoriti, da lahko pride do halucinacij (več inoma vidnih).
Oprymea should not be used during pregnancy unless clearly necessary, i. e. if the potential benefit justifies the potential risk to the foetus.
Č se to zgodi, e zmanjš tudi odmerek levodope. amo
As pramipexole treatment inhibits secretion of prolactin in humans, inhibition of lactation is expected.
Pramipeksol povezujejo z zaspanostjo in nenadnimi epizodami spanja, zlasti pri bolnikih s Parkinsonovo boleznijo.
In rats, the concentration of active substance-related radioactivity was higher in breast milk than in plasma.
O nenadnih epizodah spanja med dnevnimi dejavnostmi, ki se pri nekaterih bolnikih pojavijo, ne da bi se jih zavedali ali brez opozorilnih znakov, ne poroč pogosto.
In the absence of human data, Oprymea should not be used during breast-feeding.
Bolnike je ajo treba nanje opozoriti in jim in upravljanju strojev.
However, if its use is unavoidable, breast-feeding should be discontinued.
svetovati, naj bodo med zdravljenjem s pramipeksolom previdni pri vož
4.7 Effects on ability to drive and use machines
Bolniki, pri katerih se je ž
Oprymea can have a major influence on the ability to drive and use machines.
pojavila zaspanost in/ ali nenadna epizoda spanja, ne smejo voziti ali e
Hallucinations or somnolence can occur.
upravljati strojev.
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).
nih
4.8 Undesirable effects
inkov je treba bolnikom svetovati, naj bodo previdni,
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.
č hkrati s e
63% of patients on pramipexole and 52% of patients on placebo reported at least one adverse drug reaction.
pramipeksolom jemljejo š druga zdravila s sedativnim uč poglavji 4. 7 in 4. 8).
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.
Pri bolnikih, pri katerih so Parkinsonovo bolezen zdravili z dopaminskimi agonisti, tudi s pramipeksolom, so poroč o patološ hazardiranju, poveč
The incidence of somnolence is increased at doses higher than 1.5 mg/ day (see section 4.2).
anem libidu in hiperseksualnosti.
13 reaction in combination with levodopa was dyskinesia.
Bolniki in negovalci morajo vedeti, da se lahko pojavijo vedenjske spremembe.
Hypotension may occur at the beginning of treatment, especially if pramipexole is titrated too fast.
Presoditi moramo o zmanjš odmerka ali postopni ukinitvi zdravila. anju
The most commonly (≥
Bolnike s psihotičnimi motnjami zdravimo z dopaminskimi agonisti samo takrat, kadar morebitna korist opravič tveganje. uje
5%) reported adverse drug reactions in patients with other indication treated
Soč asnemu jemanju antipsihotič zdravil in pramipeksola se je treba izogibati (glejte poglavje 4. 5). nih
with pramipexole were nausea, headache, dizziness and fatigue.
Priporoč so redni oftalmološ pregledi, š posebno, č se pojavijo motnje vida.
Tables 1 and 2 display the frequency of adverse reactions from placebo-controlled clinical trials.
ljivi
Table 1:
ki
Very common Adverse Reactions (≥ 1/ 10) System organ class
Priporoč
Adverse reaction
no- ž
Pramipexole N= 1,923 (%)
ljivo je spremljati krvni tlak, zlasti na
Nervous system disorders
zač zdravljenja, saj je z dopaminergič zdravljenjem povezano sploš tveganje za posturalno
Dizziness Dyskinesia
etku
15.5 12.9
nim
Gastrointestinal disorders Vascular disorders
no
Nausea Hypotension
hipotenzijo.
17.2 12.6
Pri nagli prekinitvi zdravljenja z dopaminskimi agonisti so poroč o simptomih, ki kaž na nevroleptič
Common Adverse Reactions (≥ 1/ 100 to < 1/ 10) System organ class
maligni sindrom (glejte poglavje 4. 2). ni
Adverse reaction
ali
Pramipexole N= 1,923 (%)
ejo
Abnormal dreams Confusional state Hallucinations Insomnia
Iz literature je razvidno, da je okrepitev simptomov pri zdravljenju druge indikacije lahko posledica zdravljenja z dopaminergič
3.5 3.0 6.6 8.2
nimi zdravili.
Nervous system disorders
ih
Somnolence Headache
več ernih urah (ali celo popoldne), njihovo več intenzivnost in razš
8.6 6.5
jo
Gastrointestinal disorders
iritev na druge okončine.
Constipation
Pogostosti okrepitve simptomov po dolgotrajnejš jemanju pramipeksola in ustreznem zdravljenju em teh simptomov v nadzorovanih klinič preizkuš
5.5
nih
General disorders and administration site conditions
4. 5 Medsebojno delovanje z drugimi zdravili in druge oblike interakcij
Fatigue
Na plazemske beljakovine se vež zelo malo pramipeksola (< 20%) in pri č
6.1
e
Peripheral oedema
loveku je opaž le ena
See also section 4.4.
eprav interakcij z
Pramipexole may be associated with libido disorders (increased (0.1%) or decreased (0.4%)).
antiholinergiki niso raziskovali, je mož nost, da bi do njih priš majhna, saj se antiholinergiki izloč
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.
lo,
4.9 Overdose
ajo
There is no clinical experience with massive overdose.
v glavnem z biotransformacijo.
There is no established antidote for overdose 14 of a dopamine agonist.
Farmakokinetič interakcij s selegilinom in levodopo ni. nih
If signs of central nervous system stimulation are present, a neuroleptic agent may be indicated.
Cimetidin je zmanjš ledvič oč
5.
al
5.1 Pharmacodynamic properties
ni istek pramipeksola za približ
N04BC05.
34%, verjetno z zaviranjem no
Pramipexole alleviates Parkinsonian motor deficits by stimulation of dopamine receptors in the striatum.
kationskega sekretornega transportnega sistema v ledvič tubulih.
Animal studies have shown that pramipexole inhibits dopamine synthesis, release, and turnover.
Zato so mož interakcije med
In human volunteers, a dose-dependent decrease in prolactin was observed.
nih
Clinical trials in Parkinson’ s disease
ne
Out of these, approximately 900 were in more advanced stages, received concomitant levodopa therapy, and suffered from motor complications.
pramipeksolom in zdravili, ki to aktivno ledvič pot izloč zavirajo ali se po njej izloč kot sta
In early and advanced Parkinson’ s disease, efficacy of pramipexole in the controlled clinical trials was maintained for approximately six months.
anja
5.2 Pharmacokinetic properties
ajo,
Pramipexole is rapidly and completely absorbed following oral administration.
npr. cimetidin in amantadin.
Pramipexole shows linear kinetics and a small inter-patient variation of plasma levels.
Posledica je zmanjš oč an istek enega ali obeh zdravil.
In humans, the protein binding of pramipexole is very low (< 20%) and the volume of distribution is large (400 l).
Kadar omenjeni zdravili predpiš skupaj s pramipeksolom, moramo upoš pramipeksola.
High brain tissue concentrations were observed in the rat (approx.
emo
Pramipexole is metabolised in man only to a small extent.
tevati, da je treba zmanjš odmerek ati
The elimination half-life (t½) varies from 8 hours in the young to 12 hours in the elderly.
12
15 5.3 Preclinical safety data
Odmerki drugih antiparkinsonikov naj ostanejo nespremenjeni.
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.
Bolnikom, ki jemljejo pramipeksol, zaradi mož aditivnih uč drugih sedativnih zdravil in pri soč
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.
nih
The potential effects of pramipexole on reproductive function have been investigated in rats and rabbits.
inkov svetujemo previdnost pri jemanju
Pramipexole was not genotoxic.
asnem pitju alkoholnih pijač.
In a carcinogenicity study, male rats developed Leydig cell hyperplasia and adenomas, explained by the prolactin-inhibiting effect of pramipexole.
Soč asnemu jemanju antipsihotič zdravil in pramipeksola se je treba izogibati (glejte poglavje 4. 4), nih npr. kadar je prič akovan antagonistič uč ni inek.
This finding is not clinically relevant to man.
4. 6 Noseč in dojenje nost
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.
Pri ženskah vpliva pramipeksola na noseč in dojenje niso raziskovali.
The latter finding was not observed in pigmented rats, nor in a 2-year albino mouse carcinogenicity study or in any other species investigated.
Zdravilo Oprymea predpiš med noseč
6.
en
6.1 List of excipients
nih
Mannitol Maize starch Pregelatinised maize starch Povidone K25 Colloidal anhydrous silica Magnesium stearate
emo
6.2 Incompatibilities
nostjo le,
Not applicable.
morebitno tveganje za plod.
6.3 Shelf life
Zdravljenje s pramipeksolom zavira izloč prolaktina pri č pričakovano.
2 years.
anje
6.4 Special precautions for storage
loveku, zato je zaviranje laktacije
Store in the original package in order to protect from light.
Izloč pramipeksola v materino mleko, niso raziskovali.
6.5 Nature and contents of container
ene
Blister pack (Al/ Al foil):
inkovine več v mleku kot v plazmi.
20, 30, 60, 90 or 100 tablets.
Zaradi pomanjkanja podatkov ja
Not all pack sizes may be marketed.
pramipeksola ne dajemo materam, ki dojijo.
6.6 Special precautions for disposal
4. 7 Vpliv na sposobnost vož in upravljanja s stroji nje
Any unused product or waste material should be disposed of in accordance with local requirements.
Zdravilo Oprymea pomembno vpliva na sposobnost za vož in upravljanje strojev. njo
MARKETING AUTHORISATION HOLDER
Pojavijo se lahko halucinacije in zaspanost.
KRKA, d. d., Novo mesto, Š marješ cesta 6, 8501 Novo mesto, Slovenia ka
Bolnikom, pri katerih se med zdravljenjem s pramipeksolom pojavlja zaspanost in/ ali imajo nenadne epizode spanja, je treba svetovati, naj ne vozijo in naj se ne ukvarjajo z dejavnostmi, pri katerih se zaradi poslabš budnosti poveč nevarnost resnih poš
8.
ane a
MARKETING AUTHORISATION NUMBER(S)
kodb ali smrti (npr. pri upravljanju strojev),
EU/ 1/ 08/ 469/ 009 100 tablets:
dokler ponavljajoč se epizode nenadnega spanja in zaspanost ne minejo (glejte poglavja 4. 4, 4. 5 in e 4. 8).
EU/ 1/ 08/ 469/ 010
4. 8 Než eleni uč inki
9.
ano
DATE OF FIRST AUTHORISATION/ RENEWAL OF THE AUTHORISATION
nost, motnje libida, slabost,
12/ 9/ 2008
anje
10.
č
DATE OF REVISION OF THE TEXT
Analiza podatkov s placebom
Detailed information on this medicinal product is available on the website of the European Medicines Agency (EMEA) http: / /www. emea. europa. eu/.
Vsaj o enem než
17 1.
ali
NAME OF THE MEDICINAL PRODUCT
elenem uč
Oprymea 0.35 mg tablets
je poroč 63% inku alo
QUALITATIVE AND QUANTITATIVE COMPOSITION
bolnikov, ki so se zdravili s pramipeksolom, in 52% bolnikov, ki so jemali placebo.
Each tablet contains 0.35 mg pramipexole base (as 0.5 mg pramipexole dihydrochloride monohydrate).
Než eleni uč o katerih so pri bolnikih s Parkinsonovo boleznijo najpogosteje poroč (≥5%) in so
Please note:
inki,
Pramipexole doses as published in the literature refer to the salt form.
bili med zdravljenjem s pramipeksolom pogostejškot med jemanjem placeba, so bili slabost, i diskinezija, hipotenzija, omotica, zaspanost, nespečnost, zaprtost, halucinacije, glavobol in utrujenost.
Therefore, doses will be expressed in terms of both pramipexole base and pramipexole salt (in brackets).
Pri bolnikih,
For a full list of excipients, see section 6.1.
ki so jemali pramipeksol in levodopo, je bil pogostejšnež
PHARMACEUTICAL FORM
eleni uč diskinezija. inek
Tablet.
ujemo.
0.35 mg: white, oval, with bevelled edges, both sides scored, with imprint "P8" on both halves of one side of the tablet.
O slabosti in utrujenosti so med zdravljenjem s pramipeksolom pogosteje poroč pri ž in 10, 5%) kot pri moš (6, 7% in 7, 3%). kih
The tablet can be divided into equal halves.
Preglednici 1 in 2 kaž pogostost než
4.
eta
CLINICAL PARTICULARS
elenih uč
4.1 Therapeutic indications
inkov v s placebom nadzorovanih klinič
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).
Pogosti než eleni uč so bili več
4.2 Posology and method of administration
inoma blagi do zmerni, obič so se pojavljali v ajno
The daily dosage is administered in equally divided doses 3 times a day.
zgodnjem obdobju zdravljenja in več jih je minila, č
Providing patients do not experience intolerable side-effects, the dosage should be titrated to achieve a maximal therapeutic effect.
etudi so bolniki zdravljenje nadaljevali.
Ascending – Dose Schedule of OPRYMEA Week
Zelo pogosti neželeni
Dosage (mg of base)
uč (≥1/ 10) inki
Total Daily Dose (mg of base)
Organski sistem bolezni ž evja
Dosage (mg of salt)
Neželeni uč inek
Total Daily Dose (mg of salt)
Pramipeksol N = 1. 923 (%)
1 2 3
ivč
3 x 0.088 3 x 0.18 3 x 0.35
omotica diskinezija
0.264 0.54 1.1
15, 5 12, 9
3 x 0.125 3 x 0.25 3 x 0.5
bolezni prebavil ž bolezni
0.375 0.75 1.50
Preglednica 2: