natgillin/translations-raw huggingface dataset:
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.
eleni uč (≥1/ 100 do < 1/ 10) inki Organski sistem psihiatrič motnje
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).
Pramipeksol N = 1. 923 (%)
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.
nenormalne sanje zmedenost halucinacije nespeč nost
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).
bolezni prebavil sploš tež in spremembe na
Further dose adjustments should be done based on the clinical response and the occurrence of adverse reactions.
zaprtost
In clinical trials approximately 5% of patients were treated at doses below 1.1 mg (1.5 mg of salt).
5, 5
Treatment discontinuation Abrupt discontinuation of dopaminergic therapy can lead to the development of a neuroleptic malignant syndrome.
ne ave mestu dajanja
The following dosage schedule is suggested for initiation of therapy:
utrujenost periferni edem
Patients with a creatinine clearance above 50 ml/ min require no reduction in daily dose.
6, 1 1, 9
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 povezujejo z zaspanostjo (8, 6%), obč asno tudi s preveliko zaspanostjo č dan in z epizodami nenadnega spanca (0, 1%) (glejte tudi poglavje 4. 4). ez
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.
Pramipeksol lahko povzročmotnje libida (poveč pri 0, 1% bolnikov ali zmanjš pri 0, 4% bolnikov).
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%.
anje
However, the potential influence of hepatic insufficiency on Oprymea pharmacokinetics has not been investigated.
Pri bolnikih, ki so se z dopaminskimi agonisti zdravili zaradi Parkinsonove bolezni, so poroč o ali patološ hazardiranju, poveč
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.
Ti znaki so po zmanjš
4.3 Contraindications
odmerka anju
Hypersensitivity to the active substance or to any of the excipients.
ali ukinitvi zdravila izginili.
4.4 Special warnings and precautions for use
4. 9 Preveliko odmerjanje
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.
Z zdravljenjem z zelo velikimi odmerki ni klinič izkuš Prič
Hallucinations are known as a side-effect of treatment with dopamine agonists and levodopa.
enj.
If they occur, the dose of levodopa should be decreased.
akovani než eleni učinki, vključ s no
Pramipexole has been associated with somnolence and episodes of sudden sleep onset, particularly in patients with Parkinson’ s disease.
slabostjo, bruhanjem, hiperkinezijo, halucinacijami, agitacijo in hipotenzijo, bi morali biti povezani s farmakodinamič nimi lastnostmi dopaminskih agonistov.
Sudden onset of sleep during daily activities, in some cases without awareness or warning signs, has been reported uncommonly.
Za preveliko odmerjanje dopaminskih agonistov ni uveljavljenega antidota.
Furthermore a reduction of dosage or termination of therapy may be considered.
Č so prisotni znaki stimulacije osrednjega ž evja, je lahko
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).
ivč
Furthermore, patients and caregivers should be aware of the fact that behavioural changes can occur.
indicirano nevroleptič zdravilo.
Dose reduction/ taper or discontinuation should be considered.
Zdravljenje prevelikega odmerjanja lahko ob izpiranju ž
Patients with psychotic disorders should only be treated with dopamine agonists if the potential benefits outweigh the risks.
dajanju intravenskih tekoč in aktivnega oglja ter spremljanju elektrokardiograma zahteva sploš podporne ukrepe.
Coadministration of antipsychotic medicinal products with pramipexole should be avoided (see section 4.5).
ne
Ophthalmologic monitoring is recommended at regular intervals or if vision abnormalities occur.
FARMAKOLOŠ LASTNOSTI KE
In case of severe cardiovascular disease, care should be taken.
14 5. 1 Farmakodinamič lastnosti ne
Symptoms suggestive of neuroleptic malignant syndrome have been reported with abrupt withdrawal of dopaminergic therapy (see section 4.2)
N04BC05.
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.
Pramipeksol je dopaminski agonist s polno intrinzič aktivnostjo, katerega vezava na podskupino no dopaminskih receptorjev D 2, med katerimi ima preferenč afiniteto za receptorje D3, je visoko no selektivna in specifična.
The frequency of augmentation after longer use of pramipexole and the appropriate management of these events have not been evaluated in controlled clinical trials.
Pramipeksol spodbuja dopaminske receptorje v striatumu in s tem bla žmotorič motnje pri
4.5 Interaction with other medicinal products and other forms of interaction
ne
Pramipexole is bound to plasma proteins to a very low (< 20%) extent, and little biotransformation is seen in man.
Parkinsonovi bolezni.
Therefore, interactions with other medicinal products affecting plasma protein binding or elimination by biotransformation are unlikely.
Poskusi na ž ivalih so pokazali, da pramipeksol zavira sintezo, sprošanje in č hitrost izrabe ("turnover") dopamina.
There is no pharmacokinetic interaction with selegiline and levodopa.
Pri prostovoljcih so opazili od odmerka odvisno zmanjš vrednosti prolaktina. ane
Reduction of the pramipexole dose should be considered when these medicinal products are administered concomitantly.
Klinič preizkuš pri Parkinsonovi bolezni
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.
anja
Because of possible additive effects, caution should be advised when patients are taking other sedating medicinal products or alcohol in combination with pramipexole.
V kontrolirana klinič
Coadministration of antipsychotic medicinal products with pramipexole should be avoided (see section 4.4), e. g. if antagonistic effects can be expected.
i
4.6 Pregnancy and lactation
na
The effect on pregnancy and lactation has not been investigated in humans.
Približ
Pramipexole was not teratogenic in rats and rabbits, but was embryotoxic in the rat at maternotoxic doses (see section 5.3).
no
As pramipexole treatment inhibits secretion of prolactin in humans, inhibition of lactation is expected.
900 z bolj napredovalimi stadiji jih je soč jemalo levodopo in so trpeli zaradi motori č zapletov.
The excretion of pramipexole into breast milk has not been studied in women.
V kontroliranih klinič preizkuš
In rats, the concentration of active substance-related radioactivity was higher in breast milk than in plasma.
anjih je uč pramipeksola pri bolnikih z zgodnjo in napredovalo inek
In the absence of human data, Oprymea should not be used during breast-feeding.
Parkinsonovo boleznijo trajal približ š mesecev.
However, if its use is unavoidable, breast-feeding should be discontinued.
Tudi v odprtih nadaljevalnih preizkuš
4.7 Effects on ability to drive and use machines
no est
Oprymea can have a major influence on the ability to drive and use machines.
anjih, ki so
Hallucinations or somnolence can occur.
trajala več
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).
tri leta, se uč zdravila kot inek
4.8 Undesirable effects
ni zmanjš
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.
al.
63% of patients on pramipexole and 52% of patients on placebo reported at least one adverse drug reaction.
V kontroliranem dvojno slepem dve leti trajajoč klinič preizkuš je bilo po zač
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,
etnem
More frequent adverse drug reaction in combination with levodopa was dyskinesia.
zdravljenju s pramipeksolom v primerjavi z zač etnim zdravljenjem z levodopo ugotovljeno pomembno zmanjš pojavljanja motorič zapletov.
Hypotension may occur at the beginning of treatment, especially if pramipexole is titrated too fast.
Presoditi je treba, ali so zakasneli motorič
The most commonly (≥
anje
5%) reported adverse drug reactions in patients with other indication treated
nih
with pramipexole were nausea, headache, dizziness and fatigue.
ni
Tables 1 and 2 display the frequency of adverse reactions from placebo-controlled clinical trials.
zapleti pri zdravljenju s pramipeksolom koristnejšod izboljš motorič funkcije pri zdravljenju z
Table 1:
anja
Very common Adverse Reactions (≥ 1/ 10) System organ class
levodopo (izmerjeno s srednjo spremembo pri klinič nevrološ preiskavi za bolnike s Parkinsonovo
Adverse reaction
ki
Pramipexole N= 1,923 (%)
boleznijo – po lestvici UPDRS).
Nervous system disorders
evalni fazi med zdraviloma ni
Dizziness Dyskinesia
bilo znač razlike.
15.5 12.9
ilne
Gastrointestinal disorders Vascular disorders
tevati ob uvajanju zdravljenja s
Nausea Hypotension
pramipeksolom pri bolnikih s Parkinsonovo boleznijo.
Table 2:
5. 2 Farmakokinetič lastnosti ne
Common Adverse Reactions (≥ 1/ 100 to < 1/ 10) System organ class
Pramipeksol se po peroralnem jemanju hitro in popolnoma absorbira.
Adverse reaction
a
Pramipexole N= 1,923 (%)
kot
Psychiatric disorders
ja
Abnormal dreams Confusional state Hallucinations Insomnia
ena
3.5 3.0 6.6 8.2
asno
Nervous system disorders
Pramipeksol kaž
Somnolence Headache
a, a
Gastrointestinal disorders
linearno kinetiko in majhna odstopanja vrednosti plazemskih koncentracij med bolniki.
Constipation
no
5.5
je
General disorders and administration site conditions
Pramipeksol se pri ljudeh presnavlja le v manjšmeri. i
Fatigue
Približ 90% odmerka, označ 14
Peripheral oedema
no
1.9
enega s
Pramipexole is associated with somnolence (8.6%) and has been associated uncommonly with excessive daytime somnolence and sudden sleep onset episodes (0.1%).
C, se izločskozi ledvice, medtem ko v blatu najdemo manj kot 2% odmerka.
See also section 4.4.
Skupni oč
Pramipexole may be associated with libido disorders (increased (0.1%) or decreased (0.4%)).
i
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.
istek
4.9 Overdose
pramipeksola je približ 500 ml/ min, ledvič oč
22 There is no clinical experience with massive overdose.
ni istek pa je približ 400 ml/ min.
There is no established antidote for overdose of a dopamine agonist.
Razpolovni č no
PHARMACOLOGICAL PROPERTIES
(t 1/ 2) izloč se giblje anja
5.1 Pharmacodynamic properties
od 8 ur pri mladih do
N04BC05.
12 ur pri starejš ljudeh. ih
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.
5. 3 Predklinič podatki o varnosti ni
Pramipexole alleviates Parkinsonian motor deficits by stimulation of dopamine receptors in the striatum.
Š tudije toksič nosti po več kratnih odmerkih so pokazale, da pramipeksol kaž funkcionalne uč več inoma na osrednje ž evje in ž
Animal studies have shown that pramipexole inhibits dopamine synthesis, release, and turnover.
enska rodila, ki so verjetno posledica povečanega
In human volunteers, a dose-dependent decrease in prolactin was observed.
farmakodinamič nega uč pramipeksola. inka
Clinical trials in Parkinson’ s disease
Pri pritlikavih praš ih so opazili zniž diastolič
In patients pramipexole alleviates signs and symptoms of idiopathic Parkinson 's disease.
anje
These points should be considered when initiating pramipexole treatment in patients with Parkinson´s disease.
nega in sistolič nega tlaka ter zmanjš srč anje nega
5.2 Pharmacokinetic properties
utripa, pri opicah pa tež k hipotenzivnemu uč
8-fold compared to plasma).
inku.
Pramipexole is metabolised in man only to a small extent.
15
Renal excretion of unchanged pramipexole is the major route of elimination.
Morebitne uč pramipeksola na rodila so raziskovali pri podganah in zajcih.
Approximately 90% of 14 C-labelled dose is excreted through the kidneys while less than 2% is found in the faeces.
Pramipeksol ni bil inke teratogen pri podganah in zajcih, vendar je bil pri podganah v odmerkih, toksič za samico, nih embriotoksič Zaradi izbire ž
The total
en.
23 clearance of pramipexole is approximately 500 ml/ min and the renal clearance is approximately 400 ml/ min.
ivalskih vrst in omejenih raziskovanih parametrov než eleni učinki
The elimination half-life (t½) varies from 8 hours in the young to 12 hours in the elderly.
pramipeksola na noseč in na plodnost samcev niso bili v celoti pojasnjeni. nost
5.3 Preclinical safety data
Pramipeksol ni bil genotoksič V š
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.
en.
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.
tudiji kancerogenosti so pri podganjih samcih odkrili hiperplazijo
The potential effects of pramipexole on reproductive function have been investigated in rats and rabbits.
Leydigovih celic in adenome, kar so razlož z dejstvom, da pramipeksol zavira sintezo prolaktina.
Pramipexole was not teratogenic in rats and rabbits but was embryotoxic in the rat at maternally toxic doses.
Ista š
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.
no
This finding is not clinically relevant to man.
tudija je tudi pokazala, da je bil pramipeksol v
KRKA, d. d., Novo mesto, Š marješ cesta 6, 8501 Novo mesto, Slovenia ka
KRKA, tovarna zdravil, d. d., Novo mesto, Šmarješ cesta 6, 8501 Novo mesto, Slovenija ka
20 tablets:
20 tablet:
EU/ 1/ 08/ 469/ 011 30 tablets:
EU/ 1/ 08/ 469/ 006 30 tablet:
EU/ 1/ 08/ 469/ 012 60 tablets:
EU/ 1/ 08/ 469/ 007
EU/ 1/ 08/ 469/ 013 90 tablets:
EU/ 1/ 08/ 469/ 008 90 tablet:
EU/ 1/ 08/ 469/ 014 100 tablets:
EU/ 1/ 08/ 469/ 009 100 tablet:
Oprymea 0.7 mg tablets
Oprymea 0, 35 mg tablete
Each tablet contains 0.7 mg pramipexole base (as 1 mg pramipexole dihydrochloride monohydrate).
1 tableta vsebuje 0, 35 mg pramipeksola v obliki 0, 5 mg pramipeksolijevega dihidroklorid monohidrata.
0.70 mg: white, round, with bevelled edges, both sides scored, with imprint "P9" on both halves of one side of the tablet.
0, 35 mg: bele, ovalne, s posnetimi robovi in z zarezo na obeh straneh ter oznako P8 na obeh polovicah ene strani tablete.
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).
zaspanost pogostejš pri dnevnih odmerkih, ki so več od 1, 5 mg (glejte poglavje 4. 8).
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.
Zač nemo z 0, 088 mg pramipeksola (0, 125 mg soli).
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.
Bolnikom s Parkinsonovo boleznijo in ledvič okvaro predpisujemo manjš odmerke, kar je opisano v poglavju 4. 2.
In advanced Parkinson’ s disease, in combination treatment with levodopa, dyskinesias can occur during the initial titration of Oprymea.
Pri bolnikih z napredovalo Parkinsonovo boleznijo, ki jemljejo zdravilo v kombinaciji z levodopo, se lahko med zač etnim povečevanjem odmerka pramipeksola pojavijo diskinezije.
Sudden onset of sleep during daily activities, in some cases without awareness or warning signs, has been reported uncommonly.
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 case of severe cardiovascular disease, care should be taken.
Priporoč
Cimetidine reduced the renal clearance of pramipexole by approximately 34%, presumably by inhibition of the cationic secretory transport system of the renal tubules.
ni istek pramipeksola za približ 34%, verjetno z zaviranjem no
Therefore, medicinal products
Zato so mož interakcije med
28 that are inhibitors of this active renal elimination pathway or are eliminated by this pathway, such as cimetidine and amantadine, may interact with pramipex ole resulting in reduced clearance of either or both medicinal products.
pramipeksolom in zdravili, ki to aktivno ledvič pot izloč zavirajo ali se po njej izloč kot sta
Reduction of the pramipexole dose should be considered when these medicinal products are administered concomitantly.
Kadar omenjeni
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.
Odmerki drugih antiparkinsonikov naj ostanejo nespremenjeni.
Because of possible additive effects, caution should be advised when patients are taking other sedating medicinal products or alcohol in combination with pramipexole.
Bolnikom, ki jemljejo pramipeksol, zaradi mož aditivnih uč drugih sedativnih zdravil in pri soč
The incidence of somnolence is increased at doses higher than 1.5 mg/ day (see section 4.2).
21 Zaspanost je pogostejš pri dnevnih odmerkih, ki so več od 1, 5 mg (glejte poglavje 4. 2).
More frequent adverse drug
Pri bolnikih,
29 reaction in combination with levodopa was dyskinesia.
ki so jemali pramipeksol in levodopo, je bil pogostejšnež
Hypotension may occur at the beginning of treatment, especially if pramipexole is titrated too fast.
Hipotenzija se lahko pojavi na zač zdravljenja, zlasti č odmerek pramipeksola prehitro poveč
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.
enj.
4.9 Overdose
akovani než
There is no clinical experience with massive overdose.
eleni učinki, vključ s no
There is no established antidote for overdose 30 of a dopamine agonist.
Za preveliko odmerjanje dopaminskih agonistov ni uveljavljenega antidota.
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.
Pramipeksol je dopaminski agonist s polno intrinzič aktivnostjo, katerega vezava na podskupino no dopaminskih receptorjev D 2, med katerimi ima preferenč afiniteto za receptorje D3, je visoko no selektivna in specifična.
The total clearance of pramipexole is approximately 500 ml/ min and the renal clearance is approximat ely 400 ml/ min.
Razpolovni č no
The elimination half-life (t½) varies from 8 hours in the young to 12 hours in the elderly.
12 ur pri starejš ljudeh. ih
31 5.3 Preclinical safety data
23 5. 3 Predklinič podatki o varnosti ni
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.
Š tudije toksič nosti po več kratnih odmerkih so pokazale, da pramipeksol kaž funkcionalne uč več inoma na osrednje ž evje in ž
Decreases in diastolic and systolic pressure and heart rate were noted in the mini pig, and a tendency to an hypotensive effect was discerned in the monkey.
enska rodila, ki so verjetno posledica povečanega
The potential effects of pramipexole on reproductive function have been investigated in rats and rabbits.
farmakodinamič nega uč pramipeksola. inka
Pramipexole was not teratogenic in rats and rabbits but was embryotoxic in the rat at maternally toxic doses.
Morebitne uč pramipeksola na rodila so raziskovali pri podganah in zajcih.
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.
Pramipeksol ni bil inke teratogen pri podganah in zajcih, vendar je bil pri podganah v odmerkih, toksič za samico, nih embriotoksič Zaradi izbire ž
Pramipexole was not genotoxic.
pramipeksola na noseč in na plodnost samcev niso bili v celoti pojasnjeni. nost
EU/ 1/ 08/ 469/ 016 30 tablets:
EU/ 1/ 08/ 469/ 011 30 tablet:
EU/ 1/ 08/ 469/ 017 60 tablets:
EU/ 1/ 08/ 469/ 012 60 tablet:
EU/ 1/ 08/ 469/ 018 90 tablets:
EU/ 1/ 08/ 469/ 013 90 tablet:
EU/ 1/ 08/ 469/ 019 100 tablets:
EU/ 1/ 08/ 469/ 014 100 tablet:
Oprymea 1.1 mg tablets
Oprymea 0, 7 mg tablete
Each tablet contains 1.1 mg pramipexole base (as 1.5 mg pramipexole dihydrochloride monohydrate).
1 tableta vsebuje 0, 7 mg pramipeksola v obliki 1 mg pramipeksolijevega dihidroklorida monohidrata.
1.1 mg: white, round, with bevelled edges, both sides scored.
0, 70 mg: bele, okrogle, s posnetimi robovi in z zarezo na obeh straneh ter oznako P9 na obeh polovicah ene strani tablete.
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).
zaspanost pogostejš pri dnevnih odmerkih, ki so več od 1, 5 mg (glejte poglavje 4. 8).
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.
Nato odmerek amo zmanjš ujemo po 0, 264 mg pramipeksola (0, 375 mg soli) na dan (glejte poglavje 4. 4).
Dosing in patients with hepatic impairment Dose adjustment in patients with hepatic failure is probably not necessary, as approx.
anje priporoč ljivo za zač zdravljenja. etek
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.
istkom med 20 in 50 ml/ min zač dnevni odmerek zdravila Oprymea etni razdelimo na dva odmerka.
37 reaction in combination with levodopa was dyskinesia.
Bolniki in negovalci morajo vedeti, da se lahko pojavijo vedenjske spremembe.
Table 2:
maligni sindrom (glejte poglavje 4. 2). ni