natgillin/translations-raw huggingface dataset:
Common Adverse Reactions (≥ 1/ 100 to < 1/ 10) System organ class
Iz literature je razvidno, da je okrepitev simptomov pri zdravljenju druge indikacije lahko posledica zdravljenja z dopaminergič
Adverse reaction
nimi zdravili.
Pramipexole N= 1,923 (%)
več ernih urah (ali celo popoldne), njihovo več intenzivnost in razš
Psychiatric disorders
anjih niso ovrednotili.
Abnormal dreams Confusional state Hallucinations Insomnia
Na plazemske beljakovine se vež zelo malo pramipeksola (< 20%) in pri č
3.5 3.0 6.6 8.2
loveku je opaž le ena
Nervous system disorders
manjš biotransformacija.
Somnolence Headache
eprav interakcij z
8.6 6.5
ajo
Gastrointestinal disorders
v glavnem z biotransformacijo.
Constipation
Cimetidin je zmanjš ledvič oč
5.5
al
General disorders and administration site conditions
ni istek pramipeksola za približ 34%, verjetno z zaviranjem no
Fatigue
nih
6.1
no
Peripheral oedema
anja
1.9
ajo,
Pramipexole is associated with somnolence (8.6%) and has been associated uncommonly with excessive daytime somnolence and sudden sleep onset episodes (0.1%).
Posledica je zmanjš oč an istek enega ali obeh zdravil.
See also section 4.4.
Kadar omenjeni
Pramipexole may be associated with libido disorders (increased (0.1%) or decreased (0.4%)).
28 zdravili predpiš skupaj s pramipeksolom, moramo upoš pramipeksola.
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.
Odmerki drugih antiparkinsonikov naj ostanejo nespremenjeni.
4.9 Overdose
inkov svetujemo previdnost pri jemanju
There is no clinical experience with massive overdose.
asnem pitju alkoholnih pijač.
The expected adverse events would be those related to the pharmacodynamic profile of a dopamine agonist, including nausea, vomiting, hyperkinesia, hallucinations, agitation and hypotension.
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.
There is no established antidote for overdose 38 of a dopamine agonist.
4. 6 Noseč in dojenje nost
If signs of central nervous system stimulation are present, a neuroleptic agent may be indicated.
Pri ženskah vpliva pramipeksola na noseč in dojenje niso raziskovali.
Management of the overdose may require general supportive measures, along with gastric lavage, intravenous fluids, administration of activated charcoal and electrocardiogram monitoring.
Zdravilo Oprymea predpiš med noseč
5.
en
PHARMACOLOGICAL PROPERTIES
č prič e akovane koristi zdravljenja opravič ujejo
5.1 Pharmacodynamic properties
morebitno tveganje za plod.
Pharmacotherapeutic group: dopamine agonists, ATC code:
Zdravljenje s pramipeksolom zavira izloč prolaktina pri č pričakovano.
N04BC05.
anje
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.
Izloč pramipeksola v materino mleko, niso raziskovali.
Pramipexole alleviates Parkinsonian motor deficits by stimulation of dopamine receptors in the striatum.
Pri podganah je bila koncentracija anja radioaktivo označ zdravilne uč
Animal studies have shown that pramipexole inhibits dopamine synthesis, release, and turnover.
Zaradi pomanjkanja podatkov ja
In human volunteers, a dose-dependent decrease in prolactin was observed.
Č se uporabi ne moremo izogniti, mora mati prenehati e dojiti.
Clinical trials in Parkinson’ s disease
4. 7 Vpliv na sposobnost vož in upravljanja s stroji nje
In patients pramipexole alleviates signs and symptoms of idiopathic Parkinson 's disease.
Zdravilo Oprymea pomembno vpliva na sposobnost za vož in upravljanje strojev. njo
Controlled clinical trials included approximately 2100 patients of Hoehn and Yahr stages I – IV.
Pojavijo se lahko halucinacije in zaspanost.
Out of these, approximately 900 were in more advanced stages, received concomitant levodopa therapy, and suffered from motor complications.
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
In early and advanced Parkinson’ s disease, efficacy of pramipexole in the controlled clinical trials was maintained for approximately six months.
kodb ali smrti (npr. pri upravljanju strojev),
In open continuation trials lasting for more than three years there were no signs of decreasing efficacy.
dokler ponavljajoč se epizode nenadnega spanja in zaspanost ne minejo (glejte poglavja 4. 4, 4. 5 in e 4. 8).
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.
Pričakovani než eleni uč med zdravljenjem s pramipeksolom so nenavadne sanje, zmedenost, inki zaprtost, blodnje, omotica, diskinezija, utrujenost, halucinacije, glavobol, hiperkinezija, hipotenzija, poveč hranjenje (kompulzivno prenajedanje, hiperfagija), nespeč
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).
periferni edem, paranoja, patološ hazardiranje, hiperseksualnost in druge oblike nenormalnega ko vedenja, zaspanost, poveč telesne mase, nenaden pojav spanca, pruritus in izpušaj ter druge oblike preobč utljivosti.
The overall incidence of hallucinations and somnolence was generally higher in the escalation phase with the pramipexole group.
Analiza podatkov s placebom
However there was no significant difference during the maintenance phase.
nadzorovanih klinič preizkuš v katerih je sodelovalo 1. 923 nih anj,
These points should be considered when initiating pramipexole treatment in patients with Parkinson´s disease.
Vsaj o enem než
5.2 Pharmacokinetic properties
je poroč 63% inku alo
Pramipexole is rapidly and completely absorbed following oral administration.
bolnikov, ki so se zdravili s pramipeksolom, in 52% bolnikov, ki so jemali placebo.
The absolute bioavailability is greater than 90% and the maximum plasma concentrations occur between 1 and 3 hours.
Než eleni uč o katerih so pri bolnikih s Parkinsonovo boleznijo najpogosteje poroč (≥5%) in so
Pramipexole shows linear kinetics and a small inter-patient variation of plasma levels.
bili med zdravljenjem s pramipeksolom pogostejškot med jemanjem placeba, so bili slabost, i diskinezija, hipotenzija, omotica, zaspanost, nespečnost, zaprtost, halucinacije, glavobol in utrujenost.
In humans, the protein binding of pramipexole is very low (< 20%) and the volume of distribution is large (400 l).
Pri bolnikih,
High brain tissue concentrations were observed in the rat (approx.
ki so jemali pramipeksol in levodopo, je bil pogostejšnež
8-fold compared to plasma).
eleni uč diskinezija. inek
Pramipexole is metabolised in man only to a small extent.
Hipotenzija se lahko pojavi na zač zdravljenja, zlasti č odmerek pramipeksola prehitro poveč
Renal excretion of unchanged pramipexole is the major route of elimination.
eleni uč (≥5%), o katerih so poroč pri bolnikih z drugo indikacijo, ki so se inki ali
Approximately 90% of 14 C-labelled dose is excreted through the kidneys while less than 2% is found in the faeces.
zdravili s pramipeksolom, so bili slabost, glavobol, omotica in utrujenost.
The elimination half-life (t½) varies from 8 hours in the young to 12 hours in the elderly.
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
39 5.3 Preclinical safety data
Preglednici 1 in 2 kaž pogostost než
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.
eta
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.
elenih uč
The potential effects of pramipexole on reproductive function have been investigated in rats and rabbits.
inkov v s placebom nadzorovanih klinič
Pramipexole was not teratogenic in rats and rabbits but was embryotoxic in the rat at maternally toxic doses.
nih
Pramipexole was not genotoxic.
preizkušanjih.
In a carcinogenicity study, male rats developed Leydig cell hyperplasia and adenomas, explained by the prolactin-inhibiting effect of pramipexole.
Navedeni so než eleni učinki, ki so se pojavili pri 1% ali večbolnikov zdravljenih s pramipeksolom, in o katerih so poroč pomembno pogosteje pri bolnikih, ki so jemali ali pramipeksolom, kot pri bolnikih, ki so jemali placebo, ali pa je bil dogodek ocenjen kot klinič no pomemben.
This finding is not clinically relevant to man.
Pogosti než eleni uč so bili več
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.
inoma blagi do zmerni, obič so se pojavljali v ajno
The latter finding was not observed in pigmented rats, nor in a 2-year albino mouse carcinogenicity study or in any other species investigated.
zgodnjem obdobju zdravljenja in več jih je minila, č
6.
ina
PHARMACEUTICAL PARTICULARS
Zelo pogosti neželeni
6.1 List of excipients
uč (≥1/ 10) inki
Mannitol Maize starch Pregelatinised maize starch Povidone K25 Colloidal anhydrous silica Magnesium stearate
Organski sistem bolezni ž evja
6.2 Incompatibilities
Pramipeksol N = 1. 923 (%)
Not applicable.
omotica diskinezija
6.3 Shelf life
15, 5 12, 9
2 years.
17, 2
6.4 Special precautions for storage
Pogosti než
Store in the original package in order to protect from light.
eleni uč (≥1/ 100 do < 1/ 10) inki Organski sistem psihiatrič motnje
6.5 Nature and contents of container
Neželeni uč inek
Blister pack (Al/ Al foil):
Pramipeksol N = 1. 923 (%)
20, 30, 60, 90 or 100 tablets.
ne bolezni ž evja
Not all pack sizes may be marketed.
nenormalne sanje zmedenost halucinacije nespeč nost
6.6 Special precautions for disposal
zaspanost glavobol
Any unused product or waste material should be disposed of in accordance with local requirements.
bolezni prebavil sploš tež in spremembe na
40 7.
5, 5
MARKETING AUTHORISATION HOLDER
utrujenost periferni edem
KRKA, d. d., Novo mesto, Š marješ cesta 6, 8501 Novo mesto, Slovenia ka
Pri bolnikih, ki so se z dopaminskimi agonisti zdravili zaradi Parkinsonove bolezni, so poroč o ali patološ hazardiranju, poveč
8.
kem
MARKETING AUTHORISATION NUMBER(S)
anem libidu in hiperseksualnosti.
20 tablets:
odmerka anju
EU/ 1/ 08/ 469/ 021 30 tablets:
ali ukinitvi zdravila izginili.
EU/ 1/ 08/ 469/ 022 60 tablets:
4. 9 Preveliko odmerjanje
EU/ 1/ 08/ 469/ 023 90 tablets:
Z zdravljenjem z zelo velikimi odmerki ni klinič izkuš Prič
EU/ 1/ 08/ 469/ 024 100 tablets:
akovani než
EU/ 1/ 08/ 469/ 025
eleni učinki, vključ s no
DATE OF FIRST AUTHORISATION/ RENEWAL OF THE AUTHORISATION
Č so prisotni znaki stimulacije osrednjega ž evja, je lahko
12/ 9/ 2008
ivč
10.
30
DATE OF REVISION OF THE TEXT
indicirano nevroleptič zdravilo.
Detailed information on this medicinal product is available on the website of the European Medicines Agency (EMEA) http: / /www. emea. europa. eu/.
dajanju intravenskih tekoč in aktivnega oglja ter spremljanju elektrokardiograma zahteva sploš podporne ukrepe.
41 ANNEX II
ne
A.
5.
MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE
N04BC05.
B.
ne
CONDITIONS OF THE MARKETING AUTHORISATION
Klinič preizkuš pri Parkinsonovi bolezni
42 A.
anja
MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE
Pramipeksol ublažznake in simptome idiopatske Parkinsonove bolezni.
Name and address of the manufacturer responsible for batch release
Približ
Krka, d. d., Novo mesto Š marješ cesta 6 ka 8501 Novo mesto Slovenia
900 z bolj napredovalimi stadiji jih je soč jemalo levodopo in so trpeli zaradi motori č zapletov.
B.
nih
CONDITIONS OF THE MARKETING AUTHORISATION
V kontroliranih klinič preizkuš
 CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE IMPOSED ON THE MARKETING AUTHORISATION HOLDER
anjih je uč pramipeksola pri bolnikih z zgodnjo in napredovalo inek
Medicinal product subject to medical prescription.
Parkinsonovo boleznijo trajal približ š mesecev.
 CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
no est
Not aplicable.
anjih, ki so
 OTHER CONDITIONS
trajala več
Pharmacovigilance system
tri leta, se uč zdravila kot inek
The MAH must ensure that the system of pharmacovigilance, as described in version DescPhSys 000001/ 15 (13 October 2008) presented in Module 1.8.1. of the Marketing Authorisation Application, is in place and functioning before and whilst the product is on the market.
ni zmanjš
PSURs
al.
The PSUR submission schedule for Oprymea tablets should follow PSURs submission schedule for the reference medicinal product.
V kontroliranem dvojno slepem dve leti trajajoč klinič preizkuš je bilo po zač
43 ANNEX III
etnem
LABELLING AND PACKAGE LEAFLET
Presoditi je treba, ali so zakasneli motorič
44 A.
anje
LABELLING
anja
45 PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND IMMEDIATE PACKAGING
levodopo (izmerjeno s srednjo spremembo pri klinič nevrološ preiskavi za bolnike s Parkinsonovo
BOX for blisters
V vzdrž
NAME OF THE MEDICINAL PRODUCT
evalni fazi med zdraviloma ni
Oprymea 0.088 mg tablets Pramipexole
Omenjene ugotovitve je treba upoš
2.
ilne
STATEMENT OF ACTIVE SUBSTANCE(S)
5. 2 Farmakokinetič lastnosti ne
Each tablet contains 0.088 mg pramipexole equivalent to 0.125 mg pramipexole dihydrochloride monohydrate.
Soč
LIST OF EXCIPIENTS
Pramipeksol kaž
4.
je
PHARMACEUTICAL FORM AND CONTENTS
Približ 90% odmerka, označ 14
20 tablets
Skupni oč
METHOD AND ROUTE(S) OF ADMINISTRATION
(t 1/ 2) izloč se giblje anja
Read the package leaflet before use.
12 ur pri starejš ljudeh. ih
Oral use
inke,
6.
ivč
SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF THE REACH AND SIGHT OF CHILDREN
enska rodila, ki so verjetno posledica povečanega
Keep out of the reach and sight of children.
farmakodinamič nega uč pramipeksola. inka
7.
ič
OTHER SPECIAL WARNING(S), IF NECESSARY
utripa, pri opicah pa tež k hipotenzivnemu uč
8.
njo
EXPIRY DATE
inku.
EXP
en.
SPECIAL STORAGE CONDITIONS
ivalskih vrst in omejenih raziskovanih parametrov než eleni učinki
Store in the original package in order to protect from light.
pramipeksola na noseč in na plodnost samcev niso bili v celoti pojasnjeni. nost
10.
en.
SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE
Ista š
11.
no
NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER
tudija je tudi pokazala, da je bil pramipeksol v
KRKA, d. d., Novo mesto, Š marješ cesta 6, 8501 Novo mesto, Slovenia ka
FARMACEVTSKI PODATKI
MARKETING AUTHORISATION NUMBER(S)
6. 1 Seznam pomož snovi nih
EU/ 1/ 08/ 469/ 001
6. 2 Inkompatibilnosti
BATCH NUMBER
6. 3 Rok uporabnosti
Batch
2 leti.
GENERAL CLASSIFICATION FOR SUPPLY
6. 4 Posebna navodila za shranjevanje
Medicinal product subject to medical prescription.
Shranjujte v originalni ovojnini za zagotovitev zašite pred svetlobo. č
INSTRUCTIONS ON USE
6. 5 Vrsta ovojnine in vsebina
INFORMATION IN BRAILLE
20, 30, 60, 90 ali 100 tablet.
Oprymea 0.088 mg
Na trgu ni vseh navedenih pakiranj.
47 PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND IMMEDIATE PACKAGING
6. 6 Posebni varnostni ukrepi za odstranjevanje
BOX for blisters
Neuporabljeno zdravilo ali odpadni material zavrzite v skladu z lokalnimi predpisi.
1.
32 7.
NAME OF THE MEDICINAL PRODUCT
IMETNIK DOVOLJENJA ZA PROMET
Oprymea 0.088 mg tablets Pramipexole
KRKA, tovarna zdravil, d. d., Novo mesto, Šmarješ cesta 6, 8501 Novo mesto, Slovenija ka
STATEMENT OF ACTIVE SUBSTANCE(S)
ŠTEVILKA (ŠTEVILKE) DOVOLJENJA (DOVOLJENJ) ZA PROMET
Each tablet contains 0.088 mg pramipexole equivalent to 0.125 mg pramipexole dihydrochloride monohydrate.
EU/ 1/ 08/ 469/ 020
LIST OF EXCIPIENTS
12/ 9/ 2008
PHARMACEUTICAL FORM AND CONTENTS
DATUM ZADNJE REVIZIJE BESEDILA
30 tablets
IME ZDRAVILA
METHOD AND ROUTE(S) OF ADMINISTRATION
KAKOVOSTNA IN KOLIČINSKA SESTAVA
Read the package leaflet before use.
1 tableta vsebuje 1, 1 mg pramipeksola v obliki 1, 5 mg pramipeksolijevega dihidroklorida monohidrata.
Oral use
Opomba:
6.
eni
SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF THE REACH AND SIGHT OF CHILDREN
obe obliki, pramipeksol in pramipeksolijevo sol (v oklepaju).
Keep out of the reach and sight of children.
Za celoten seznam pomož snovi glejte poglavje 6. 1. nih
OTHER SPECIAL WARNING(S), IF NECESSARY
1, 1 mg: bele, okrogle, s posnetimi robovi in z zarezo na obeh straneh.
EXPIRY DATE
KLINIČ PODATKI NI
EXP
inka
9.
inka
SPECIAL STORAGE CONDITIONS
ali vklopno- izklopni pojavi).
Store in the original package in order to protect from light.
4. 2 Odmerjanje in nač uporabe in
SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE
Dnevni odmerek damo razdeljen v tri enake odmerke.
11.
nih
NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER
elenih uč inkov, odmerek
KRKA, d. d., Novo mesto, Š marješ cesta 6, 8501 Novo mesto, Slovenia ka
prilagajamo, dokler ne dosež maksimalnega terapevtskega uč
48 12.
inka.
EU/ 1/ 08/ 469/ 002
Shema poveč
BATCH NUMBER
evanja odmerka Oprymee Teden
Batch
Odmerek (mg)
GENERAL CLASSIFICATION FOR SUPPLY
Skupni dnevni odmerek (mg)
Medicinal product subject to medical prescription.
Odmerek soli (mg)
INSTRUCTIONS ON USE
Skupni dnevni odmerek soli (mg)
16.
1 2 3
INFORMATION IN BRAILLE
3 x 0, 088 3 x 0, 18 3 x 0, 35
Oprymea 0.088 mg
0, 264 0, 54 1, 1
49 PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND IMMEDIATE PACKAGING
3 x 0, 125 3 x 0, 25 3 x 0, 5
1.
e e
NAME OF THE MEDICINAL PRODUCT
ujemo po 0, 54 mg (0, 75 mg soli)
Oprymea 0.088 mg tablets Pramipexole
do največ odmerka, to je 3, 3 mg pramipeksola (4, 5 mg soli).
2.
jega
STATEMENT OF ACTIVE SUBSTANCE(S)
zaspanost pogostejš pri dnevnih odmerkih, ki so več od 1, 5 mg (glejte poglavje 4. 8).
Each tablet contains 0.088 mg pramipexole equivalent to 0.125 mg pramipexole dihydrochloride monohydrate.
Vzdrž evalno zdravljenje Individualni dnevni odmerek je lahko od 0, 264 mg (0, 375 mg soli) do največ mg pramipeksola 3, 3 (4, 5 mg soli).
LIST OF EXCIPIENTS
V klinič preizkuš
4.
nih
PHARMACEUTICAL FORM AND CONTENTS
anjih so približ 5% bolnikov no
60 tablets
zdravili z dnevnimi odmerki, manjš
METHOD AND ROUTE(S) OF ADMINISTRATION
od 1, 1 mg (1, 5 mg soli). imi
Oral use
Glede na imi odziv posameznega bolnika je priporoč
SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF THE REACH AND SIGHT OF CHILDREN
ljivo, da se odmerek levodope zmanjš tako med a
Keep out of the reach and sight of children.
poveč evanjem odmerka zdravila Oprymea kot med vzdrž
OTHER SPECIAL WARNING(S), IF NECESSARY
evalnim zdravljenjem s tem zdravilom.
EXPIRY DATE
Prekinitev zdravljenja
EXP
Nagla prekinitev zdravljenja z dopaminskimi agonisti lahko
SPECIAL STORAGE CONDITIONS
izzove nevroleptič maligni sindrom. ni
Store in the original package in order to protect from light.
Nato odmerek amo zmanjš ujemo po 0, 264 mg pramipeksola (0, 375 mg soli) na dan (glejte poglavje 4. 4).
SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE
Odmerjanje pri bolnikih z ledvič okvaro no Izloč pramipeksola je odvisno od ledvič ki je
NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER
anje priporoč ljivo za zač zdravljenja. etek
KRKA, d. d., Novo mesto, Š marješ cesta 6, 8501 Novo mesto, Slovenia ka
V nadaljevanju je navedeno odmerjanje,
50 12.
Pri bolnikih s kreatininskim oč istkom več 50 ml/ min ni treba zmanjš dnevnega odmerka.
MARKETING AUTHORISATION NUMBER(S)
Pri bolnikih s kreatininskim oč
EU/ 1/ 08/ 469/ 003
0, 25 mg soli).
BATCH NUMBER
Č ledvič delovanje med vzdrž
Batch
e
14.
no
Medicinal product subject to medical prescription.
evalnim zdravljenjem oslabi, dnevni odmerek zdravila Oprymea
INSTRUCTIONS ON USE
zmanjš za enak odstotek, za kakrš
16.
amo
Oprymea 0.088 mg
Č se na primer e
51 PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND IMMEDIATE PACKAGING
Dnevni
BOX for blisters
a
1.
amo
Oprymea 0.088 mg tablets Pramipexole
odmerek lahko razdelimo na dva odmerka, č je kreatininski oč
STATEMENT OF ACTIVE SUBSTANCE(S)
istek med 20 in 50 ml/ min, oziroma ga
Each tablet contains 0.088 mg pramipexole equivalent to 0.125 mg pramipexole dihydrochloride monohydrate.
damo v enkratnem odmerku, č je kreatininski oč
PHARMACEUTICAL FORM AND CONTENTS
istek manjšod 20 ml/ min. i
90 tablets
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.
5.
35
METHOD AND ROUTE(S) OF ADMINISTRATION
Bolnike inek moramo opozoriti, da lahko pride do halucinacij (več inoma vidnih).
Read the package leaflet before use.
Č se to zgodi, e zmanjš tudi odmerek levodope. amo
Oral use
svetovati, naj bodo med zdravljenjem s pramipeksolom previdni pri vož
6.
nji
SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF THE REACH AND SIGHT OF CHILDREN
pojavila zaspanost in/ ali nenadna epizoda spanja, ne smejo voziti ali e
Keep out of the reach and sight of children.
upravljati strojev.
7.
nih
OTHER SPECIAL WARNING(S), IF NECESSARY
inkov je treba bolnikom svetovati, naj bodo previdni, č hkrati s e
8.
e
EXPIRY DATE
inkom ali č
EXP
ali
9.
kem
SPECIAL STORAGE CONDITIONS
anem libidu in hiperseksualnosti.
Store in the original package in order to protect from light.
Bolniki in negovalci morajo vedeti, da se lahko pojavijo vedenjske spremembe.
SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE
Bolnike s psihotičnimi motnjami zdravimo z dopaminskimi agonisti samo takrat, kadar morebitna korist opravič tveganje. uje
NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER
Soč asnemu jemanju antipsihotič zdravil in pramipeksola se je treba izogibati (glejte poglavje 4. 5). nih
KRKA, d. d., Novo mesto, Š marješ cesta 6, 8501 Novo mesto, Slovenia ka
Priporoč so redni oftalmološ pregledi, š posebno, č se pojavijo motnje vida.
52 12.
ljivi
MARKETING AUTHORISATION NUMBER(S)
Priporoč
EU/ 1/ 08/ 469/ 004
ljivo je spremljati krvni tlak, zlasti na
13.
etku
Batch
nim
GENERAL CLASSIFICATION FOR SUPPLY
hipotenzijo.
Medicinal product subject to medical prescription.
maligni sindrom (glejte poglavje 4. 2). ni
15.
ali
16.
ejo
INFORMATION IN BRAILLE
Iz literature je razvidno, da je okrepitev simptomov pri zdravljenju druge indikacije lahko posledica zdravljenja z dopaminergič
Oprymea 0.088 mg
nimi zdravili.
53 PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND IMMEDIATE PACKAGING
več ernih urah (ali celo popoldne), njihovo več intenzivnost in razš
BOX for blisters
iritev na druge okončine.
1.
nih
NAME OF THE MEDICINAL PRODUCT
anjih niso ovrednotili.
Oprymea 0.088 mg tablets Pramipexole
Na plazemske beljakovine se vež zelo malo pramipeksola (< 20%) in pri č
STATEMENT OF ACTIVE SUBSTANCE(S)
loveku je opaž le ena
Each tablet contains 0.088 mg pramipexole equivalent to 0.125 mg pramipexole dihydrochloride monohydrate.
Č
3.
anje
LIST OF EXCIPIENTS
eprav interakcij z
PHARMACEUTICAL FORM AND CONTENTS
antiholinergiki niso raziskovali, je mož nost, da bi do njih priš majhna, saj se antiholinergiki izloč
100 tablets
lo,
5.
ajo
METHOD AND ROUTE(S) OF ADMINISTRATION
v glavnem z biotransformacijo.
Read the package leaflet before use.
Cimetidin je zmanjš ledvič oč
6.
al
SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF THE REACH AND SIGHT OF CHILDREN
ni istek pramipeksola za približ 34%, verjetno z zaviranjem no
Keep out of the reach and sight of children.
kationskega sekretornega transportnega sistema v ledvič tubulih.
7.
ne
OTHER SPECIAL WARNING(S), IF NECESSARY
pramipeksolom in zdravili, ki to aktivno ledvič pot izloč zavirajo ali se po njej izloč kot sta
8.
no
EXP
anja
9.
ajo,