natgillin/translations-raw huggingface dataset:
sudden sleep onset in patients with Parkinson’ s disease and caution should therefore be exercised when driving or operating machines (see section 4.7).
bolnikih s Parkinsonovo boleznijo, zaradi česar je potrebna previdnost pri vožnji in upravljanju s stroji (glejte poglavje 4. 7).
- In clinical studies, undesirable dopaminergic effects, e. g. dyskinesia, were more common in
- V kliničnih raziskavah so bili neželeni dopaminergični učinki (npr. diskinezija) pogostejši pri
patients who received entacapone and dopamine agonists (such as bromocriptine), selegiline or amantadine compared to those who received placebo with this combination.
bolnikih, ki so prejemali entakapon in agoniste dopamina (kot je bromokriptin), selegilin ali amantadin, kot pa pri tistih, ki so prejemali to kombinacijo s placebom.
- Rhabdomyolysis secondary to severe dyskinesias or neuroleptic malignant syndrome (NMS) has
- Pri bolnikih s Parkinsonovo boleznijo redko opažajo pojav rabdomiolize, ki bi bila posledica
been observed rarely in patients with Parkinson’ s disease.
hude diskinezije ali malignega nevroleptičnega sindroma (NMS).
Therefore, any abrupt dosage reduction or withdrawal of levodopa should be carefully observed, particularly in patients who are also receiving neuroleptics.
Zato je treba vsako nenadno zmanjšanje odmerka ali ukinitev levodope skrbno spremljati, zlasti pri bolnikih, ki prejemajo tudi nevroleptike.
NMS, including rhabdomyolysis and hyperthermia, is characterised by motor symptoms (rigidity, myoclonus, tremor), mental status changes (e. g., agitation, confusion, coma), hyperthermia, autonomic dysfunction (tachycardia, labile blood pressure) and elevated serum creatine phosphokinase.
Za NMS, vključno z rabdomiolizo in hipertermijo, so značilni motorični simptomi (otrplost, mioklonus, tresenje), spremembe duševnega stanja (npr. vznemirjenost, zmedenost, koma) hipertermija, disfunkcija avtonomnega živčevja (tahikardija, labilen krvni tlak) in povišana vrednost serumske kreatin fosfokinaze.
In individual cases, only some of these symptoms and/ or findings may be evident.
V posameznih primerih so lahko prisotni le nekateri od teh simptomov in/ ali izsledkov preiskav.
A syndrome resembling the neuroleptic malignant syndrome including muscular rigidity, elevated body temperature, mental changes and increased serum creatine
Ob nenadni ukinitvi antiparkinsonikov poročajo o pojavu sindroma podobnega malignemu nevroleptičnemu sindromu, ki vključuje otrplost mišic,
4 phosphokinase has been reported with the abrupt withdrawal of antiparkinsonian agents.
4 povišano telesno temperaturo, duševne spremembe in povišane vrednosti serumske kreatin fosfokinaze.
Neither NMS nor rhabdomyolysis have been reported in association with entacapone treatment from controlled trials in which entacapone was discontinued abruptly.
V kontroliranih raziskavah z nenadno ukinitvijo entakapona ne poročajo o pojavu NMS ali rabdomiolize v povezavi z entakaponskim zdravljenjem.
Since the introduction of entacapone into the market, isolated cases of NMS have been reported, especially following abrupt reduction or discontinuation of entacapone and other concomitant dopaminergic medicinal products.
Zdravnik, ki predpisuje zdravilo, mora biti previden, kadar bolniku, ki se je do nedavnega zdravil z zdravilom Stalevo, to terapijo nadomešča z levodopo/ zaviralci DDK brez etakapona ali z drugo dopaminergično terapijo.
When considered necessary, the replacement of Stalevo with levodopa and DDC inhibitor without entacapone or other dopaminergic treatment should proceed slowly and an increase in levodopa dosage may be necessary.
Kadar je to potrebno, naj se zdravilo Stalevo nadomesti z levodopo in zaviralcem DDK brez entakapona postopoma, morda bo treba povečati odmerek levodope.
- If general anaesthesia is required, therapy with Stalevo may be continued for as long as the
- Če je potrebna splošna anestezija, se lahko terapija z zdravilom Stalevo nadaljuje vse dokler sme
patient is permitted to take fluids and medicinal products by mouth.
bolnik jemati tekočine in zdravila peroralno.
If therapy has to be stopped temporarily, Stalevo may be restarted as soon as oral medicinal products can be taken at the same daily dosage as before.
Če je treba terapijo začasno prekiniti, se lahko zdravljenje z zdravilom Stalevo nadaljuje z enakim režimom odmerjanja kot pred prekinitvijo takoj, ko je možna peroralna aplikacija.
- Periodic evaluation of hepatic, haematopoietic, cardiovascular and renal function is
- Med dolgotrajnejšim zdravljenjem z zdravilom Stalevo je priporočljivo občasno testirati
recommended during extended therapy with Stalevo.
delovanje jeter, srčno- žilnega sistema in ledvic.
- For patients experiencing diarrhoea, a follow-up of weight is recommended in order to avoid
- Pri bolnikih z drisko je priporočljivo spremljati telesno težo, da se prepreči morebitna prevelika
potential excessive weight decrease.
izguba telesne teže.
- Pathological gambling, increased libido and hypersexuality have been reported in Parkinson’ s
- Pri bolnikih s Parkinsonovo boleznijo, zdravljenih z zaviralci dopaminskih receptorjev ter
disease patients treated with dopamine agonists and other dopaminergic treatments such as Stalevo.
drugimi dopaminergičnimi zdravili, kot je zdravilo Stalevo, poročajo o pojavu patološke nagnjenosti k hazarderstvu, povečanem libidu in hiperseksualnosti.
- For patients who experience progressive anorexia, asthenia and weight decrease within a
- Za bolnike, ki izkusijo progresivno anoreksijo, astenijo ali zmanjšanje telesne teže v relativno
relatively short period of time, a general medical evaluation including liver function should be considered.
kratkem obdobju je treba razmisliti o splošnem zdravniškem pregledu, vključno z delovanjem jeter.
- Stalevo contains sucrose, and therefore patients with rare hereditary problems of fructose
- Zdravilo Stalevo vsebuje saharozo, zato bolniki z redkimi prirojenimi motnjami, kot so
intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine.
intoleranca za fruktozo, malabsorpcija glukoze- galaktoze ali pomanjkanje saharaze- izomaltaze, ne smejo jemati tega zdravila.
Other antiparkinsonian medicinal products:
Drugi antiparkinsoniki:
To date there has been no indication of interactions that would preclude concurrent use of standard antiparkinsonian medicinal products with Stalevo therapy.
Do sedaj niso znane nobene interakcije, ki bi omejevale sočasno uporabo standardnih antiparkinsonikov in zdravila Stalevo.
However, no interaction with carbidopa has been observed with the recommended treatment schedule (200 mg of entacapone up to 10 times daily).
Vendar pa ob priporočenem terapevtskem režimu (200 mg etakapona do 10- krat dnevno) niso opazili nobenih interakcij s karbidopo.
Interactions between entacapone and selegiline have been investigated in repeated dose studies in Parkinson's disease patients treated with levodopa/ DDC inhibitor and no interaction was observed.
Interakcije med entakaponom in selegilinom so proučevali v raziskavah z večkratnimi odmerki pri bolnikih s Parkinsonovo boleznijo, ki so bili zdravljeni z levodopo/ zaviralci DDK in niso ugotovili nobenih interakcij.
Antihypertensives:
Antihipertenzivi:
Symptomatic postural hypotension may occur when levodopa is added to the treatment of patients already receiving antihypertensives.
Kadar se levodopa uvede v zdravljenje bolnikov, ki že prejemajo antihipertenzive, lahko pride do simptomatske posturalne hipotenzije.
Dosage adjustment of the antihypertensive agent may be required.
Morda bo potrebno prilagoditi odmerek antihipertenziva.
Rarely, reactions including hypertension and dyskinesia have been reported with the concomitant use of tricyclic antidepressants and levodopa/ carbidopa.
Redka poročila navajajo reakcije, ki vključujejo hipertenzijo in diskinezijo v povezavi s sočasno uporabo tricikličnih antidepresivov in levodope/ karbidope.
A significant number of Parkinson's disease patients have been treated with the combination of levodopa, carbidopa and entacapone with several active substances including MAO-A inhibitors, tricyclic antidepressants, noradrenaline reuptake inhibitors such as desipramine, maprotiline and venlafaxine and medicinal products that are metabolised by COMT (e. g. catechol-structured compounds, paroxetine).
Znatno število bolnikov s Parkinsonovo boleznijo so zdravili s kombinacijo levodope, karbidope in entakapona ter mnogimi zdravilnimi učinkovinami, vključno z zaviralci MAO- A, tricikličnimi antidepresivi, zaviralci ponovnega privzema noradrenalina, kot so dezipramin, maprotilin in venlafaksin ter zdravila, ki se presnavljajo preko COMT (npr. učinkovine, ki imajo v svoji strukturi katehol, paroksetin).
However, caution should be exercised when these medicinal products are used concomitantly with Stalevo (see sections 4.3 and 4.4).
Vseeno pa je potrebna previdnost, kadar se ta zdravila uporabljajo sočasno z zdravilom Stalevo (glejte poglavji 4. 3 in 4. 4).
Other active substances:
Druge zdravilne učinkovine:
Dopamine receptor antagonists (e. g. some antipsychotics and antiemetics), phenytoin and papaverine may reduce the therapeutic effect of levodopa.
Antagonisti dopaminskih receptorjev (npr. nekateri antipsihotiki in antiemetiki), fenitoin in papaverin lahko zmanjšajo terapevtski učinek levodope.
Patients taking these
Bolnike, ki jemljejo
5 medicinal products with Stalevo should be carefully observed for loss of therapeutic response.
5 ta zdravila poleg zdravila Stalevo, je treba skrbno spremljati zaradi morebitnega zmanjšanja terapevtskega odgovora.
Due to entacapone's affinity to cytochrome P450 2C9 in vitro (see section 5.2), Stalevo may potentially interfere with active substances whose metabolism is dependent on this isoenzyme, such as S-warfarin.
Ker ima entakapon afiniteto za citokrom P450 2C9 in vitro (glejte poglavje 5. 2), lahko zdravilo Stalevo potencialno vpliva na delovanje učinkovin katerih presnova je odvisna od tega izoencima, kot je to S- varfarin.
However, in an interaction study with healthy volunteers, entacapone did not change the plasma levels of S-warfarin, while the AUC for R-warfarin increased on average by 18% [CI90 11- 26%].
Vendar pa v raziskavi interakcij pri zdravih prostovoljcih entakapon ni povzročil spremembe plazemskih koncentracij S- vafarina, med tem, ko so se vrednosti AUC R- varfarina povečale v povprečju za 18% [CI90 11- 26%].
The INR values increased on average by 13% [CI90 6-19%].
Vrednosti INR so se povečale v povprečju za 13% [CI90 6- 19%].
Other forms of interactions:
Druge oblike interakcij:
Since levodopa competes with certain amino acids, the absorption of Stalevo may be impaired in some patients on high protein diet.
Ker levodopa tekmuje (kompetitira) z nekaterimi amino kislinami, je lahko pri nekaterih bolnikih, ki uživajo visoko proteinsko dieto, absorpcija zdravila Stalevo motena.
Therefore, Stalevo and iron preparations should be taken at least 2-3 hours apart (see section 4.8).
Zato je treba pri jemanju zdravila Stalevo in železovih pripravkov upoštevati najmanj 2- 3 urni razmak med obema zdraviloma (glejte poglavje 4. 8).
In vitro data:
Podatki in vitro:
Entacapone binds to human albumin binding site II which also binds several other medicinal products, including diazepam and ibuprofen.
Entakapon se veže na vezavno mesto II v humanem albuminu, kamor se vežejo še mnoga druga zdravila, vključno diazepam in ibuprofen.
There are no adequate data from the use of the combination of levodopa/ carbidopa/ entacapone in pregnant women.
Ni ustreznih podatkov o uporabi kombinacije levodope/ karbidope/ entakapona pri nosečnicah.
Studies in animals have shown reproductive toxicity of the separate compounds (see section 5.3).
V raziskavah na živalih je bila ugotovljena reproduktivna toksičnost posameznih učinkovin (glejte poglavje 5. 3).
Stalevo should not be used during pregnancy unless the benefits for the mother outweigh the possible risks to the foetus.
Zdravilo Stalevo naj se med nosečnostjo ne uporablja, razen če koristi za mater ne odtehtajo morebitnega tveganja za plod.
Levodopa is excreted in human breast milk.
Levodopa se izloča v humanem mleku.
There is evidence that lactation is suppressed during treatment with levodopa.
Zdravljenje z levodopo dokazano suprimira laktacijo.
Carbidopa and entacapone were excreted in milk in animals but is not known whether they are excreted in human breast milk.
Karbidopa in entakapon sta se izločala v mleku živali, ni pa znano, če se izločata tudi v humanem mleku.
The safety of levodopa, carbidopa or entacapone in the infant is not known.
Varnost levodope, karbidope ali entakapona za dojenčka ni znana.
Women should not breast-feed during treatment with Stalevo.
Ženske naj med zdravljenjem z zdravilom Stalevo ne dojijo.
Stalevo may have major influence on the ability to drive and use machines.
Zdravilo Stalevo ima lahko pomemben vpliv na sposobnost vožnje in upravljanja s stroji.
Patients being treated with Stalevo and presenting with somnolence and/ or sudden sleep onset episodes must be instructed 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 have resolved (see section 4.4).
Bolnikom, ki se zdravijo z zdravilom Stalevo in navajajo pojav zaspanosti in nenadnega spanca, je treba odsvetovati da vozijo ali se udejstvujejo v dejavnostih, pri katerih lahko zaradi zmanjšane pozornosti sebe ali druge izpostavljajo nevarnosti resne poškodbe ali smrti (npr. upravljanje s stroji), vse dokler te epizode ne minejo (glejte poglavje 4. 4).
The following section describes the undesirable effects reported for levodopa/ carbidopa and for entacapone used in combination with levodopa/ DDC inhibitor.
V naslednjem poglavju so opisani neželeni učinki, o katerih poročajo v zvezi z uporabo levodope/ karbidope ter pri uporabi entakapona v kombinaciji z levodopo/ zaviralci DDK.
Adverse reactions that occur frequently with levodopa/ carbidopa are those due to central neuropharmacological activity of dopamine.
Do neželenih učinkov, ki se pogosto pojavljajo pri uporabi levodope/ karbodope, prihaja zaradi farmakoloških učinkov dopamina na centralni živčni sistem.
These reactions can usually be diminished by levodopa dosage reduction.
Te reakcije se da običajno ublažiti z zmanjšanjem odmerka levodope.
The most common adverse reactions are dyskinesias including choreiform, dystonic and other involuntary movements.
Najpogostejši neželeni učinki so diskinezije vključno s horeatičnimi, distoničnimi in drugimi nehotenimi gibi.
Muscle twitching and blepharospasm may be taken as early signs to consider levodopa dosage reduction.
6 nakazuje, da je treba zmanjšati odmerek levodope.
Nausea, also related to enhanced central dopaminergic activity, is a common adverse reaction of levodopa/ carbidopa.
Slabost, ki je tudi povezana s povečanim osrednjim dopaminergičnim delovanjem, je pogost neželeni učinek levodope/ karbidope.
6 Other adverse reactions associated with levodopa/ carbidopa therapy are mental changes, including paranoid ideation and psychotic episodes; depression, with or without development of suicidal tendencies; and cognitive dysfunction.
Drugi neželeni učinki povezani s terapijo z levodopo/ karbidopo so še duševne spremembe, vključno s paranoidnimi mislimi in psihotičnimi stanji, depresijo z ali brez razvoja samomorilnih tendenc, ter kognitivne motnje.
Adding of entacapone to levodopa/ DDC inhibitor therapy (carbidopa or benserazide), i. e. initiation of Stalevo treatment in an entacapone naive patient, may aggravate some of these mental changes.
Dodajanje entakapona terapiji z levodopo/ zaviralci DDK (karbidopo ali benzerazidom), tj. uvedba zdravljenja z zdravilom Stalevo pri bolnikih, ki še niso prejemali entakapona, lahko še poslabša nekatere od teh duševnih sprememb.
Less frequent adverse reactions of levodopa/ carbidopa therapy are irregular heart rhythm and/ or palpitations, orthostatic hypotensive episodes, bradykinetic episodes (the'on-off 'phenomenon), anorexia, vomiting, dizziness, and somnolence.
Manj pogosti neželeni učinki terapije z levodopo / karbidopo so: neenakomeren srčni utrip in/ ali palpitacije, ortostatska hipotenzija, bradikinezija (občasne motnje ravnotežja), anoreksija, bruhanje, vrtoglavica in zaspanost.
Gastrointestinal bleeding, development of duodenal ulcer, hypertension, phlebitis, leucopenia, haemolytic and non-haemolytic anaemia, thrombocytopenia, agranulocytosis, chest pain, dyspnoea and paraesthesia have occurred rarely with levodopa/ carbidopa.
Ob zdravljenju z levodopo/ karbidopo so se redko pojavili: gastrointestinalne krvavitve, razjeda dvanajstnika, hipertenzija, flebitis, levkopenija, hemolitična in nehemolitična anemija, trombocitopenija, agranulocitoza, bolečine v prsnem košu, oteženo dihanje in parestezije.
Convulsions have occurred rarely with levodopa/ carbidopa; however a causal relationship to levodopa/ carbidopa therapy has not been established.
Redko so se ob levodopi/ karbodopi pojavile konvulzije, vendar pa vzročna zveza z levodopo/ karbidopo ni bila potrjena.
Parkinson’ s disease patients treated with dopamine agonists and other dopaminergic treatments such as Stalevo, especially at high doses, have been reported as exhibiting signs of pathological gambling, increased libido and hypersexuality, generally reversible upon reduction of the dose or treatment discontinuation.
Poročajo, da pri bolnikih s Parkinsonovo boleznijo, zdravljenih z zaviralci dopaminskih receptorjev in drugimi dopaminergičnimi zdravili, kot je zdravilo Stalevo, zlasti še pri velikih odmerkih, opažajo znake patološke nagnjenosti k hazardiranju, povečan libido in hiperseksulanost, ki pa ob zmanjšanju odmerka ali prekinitvi zdravljenja običajno izginejo.
Other adverse reactions that have been reported with levodopa and may, therefore, be potential adverse reactions of Stalevo as well, include:
Drugi neželeni učinki, ki jih navajajo v zvezi z uporabo levodope in bi zato lahko bili tudi potencialni neželeni učinki zdravila Stalevo, so še:
Nervous system disorders:
Motnje živčnega sistema:
Ataxia, numbness, increased hand tremor, muscle twitching, muscle cramp, trismus, activation of latent Horner's syndrome.
Ataksija, otrplost, povečano tresenje rok, trzanje mišic, mišični krči, krč čeljustnih mišic, aktivacija pritajenega Hornerjeveg sindroma.
Also falling and gait abnormalities are potential undesirable effects.
Potencialni neželeni učinki so še padanje in zanašanje pri hoji.
Diplopia, blurred vision, dilated pupils, oculogyric crises.
Očesne bolezni: dvojni vid, zamegljen vid, razširjeni zenici, okulogirna kriza.
Dry mouth, bitter taste, sialorrhoea, dysphagia, bruxism, hiccups, abdominal pain and distress, constipation, diarrhoea, flatulence, burning sensation of the tongue.
Bolezni prebavil: suha usta, grenak okus, sialoreja, disfagija, bruksizem (škrtanje z zobmi), kolcanje, bolečine v trebuhu, zaprtje, driska, vetrovi, žgoč občutek na jeziku.
Urinary retention, urinary incontinence, dark urine, priapism.
Bolezni sečil: zastajanje urina, urinska inkontinenca, temen urin, priapizem.
Flushing, increased sweating, dark sweat, rash, hair loss.
Zardevanje, prekomerno znojenje, temen znoj, izpuščaj, izpadanje las
Weight gain or loss, oedema.
Presnovne in prehranske motnje: povečanje ali izguba telesne teže, edem
Confusion, insomnia, nightmares, hallucinations, delusions, agitation, anxiety, euphoria.
Psihiatrične motnje: zmedenost, nespečnost, nočne more, halucinacije, deluzije, nemir, tesnoba, evforija.
Weakness, faintness, fatigue, headache, hoarseness, malaise, hot flushes, sense of stimulation, bizarre breathing patterns, neuroleptic malignant syndrome, malignant melanoma.
Ostalo: oslabelost, izgubljanje zavesti, izčrpanost, glavobol, hripavost, slabost, vročinski valovi, občutek vzburjenosti, neobičajen način dihanja, maligni nevroleptični sindrom, maligni melanom.
The most frequent adverse reactions caused by entacapone relate to the increased dopaminergic activity and occur most commonly at the beginning of the treatment.
Najpogostejši neželeni učinki, ki jih povzroča entakapon, so povezani z močnejšim dopaminergičnim delovanjem in se običajno pojavljajo v začetku zdravljenja.
Reduction of levodopa dosage decreases the severity and frequency of the reactions.
Z zmanjšanjem odmerka levodope se zmanjšata stopnja in pogostnost teh reakcij.
The other major class of adverse reactions are gastrointestinal symptoms, including nausea, vomiting, abdominal pain, constipations and diarrhoea.
Druga glavna skupina neželenih reakcij so gastrointestinalni simptomi, vključno s slabostjo, bruhanjem, bolečinami v trebuhu, zaprtjem in drisko.
Urine may be discoloured reddish-brown by entacapone, but this is a harmless phenomenon.
Urin se lahko zaradi entakapona obarva rdečkasto rjavo, vendar je ta pojav neškodljiv.
The following adverse reactions, listed in Table 1, have been accumulated both from clinical studies
7 Naslednji neželeni učinki, prikazani v tabeli 1, so bili zabeleženi v kliničnih raziskavah z entakaponom in sicer od uvedbe entakapona na tržišče za potrebe kombinirane terapije z levodopo/ zaviralci DDK in entakaponom.
Dyskinesia, Parkinsonism aggravated Dizziness, dystonia, hyperkinesia
diskinezija, poglobljen parkinsonizem vrtoglavica, distonija, hiperkinezija
Nausea Diarrhoea, abdominal pain, dry mouth, constipation, vomiting Anorexia Colitis
slabost driska, bolečine v trebuhu, suha usta, zaprtje, bruhanje anoreksija kolitis
Renal and urinary disorders Very common:
Bolezni sečil Zelo pogosto:
Urine discolouration
obarvanost urina
Skin and subcutaneous tissue disorders Rare:
Zelo redko:
Urticaria Skin, hair, beard and nail discolorations
eritem ali makulopapularni izpuščaj koprivnica sprememba barve kože, las, brade in nohtov
General disorders and administration site conditions Common:
Splošne težave in Pogosto:
Fatigue, sweating increased, fall Weight decrease
spremembe na mestu aplikacije izčrpanost, prekomerno znojenje, padci izguba telesne teže (hujšanje)
Hepatobiliary disorders Rare:
Hepatobiliarne bolezni Redko:
Hepatic function tests abnormal Not known:
Neznano:
Hepatitis with mainly cholestatic features (see section 4.4)
testi jetrne funkcije kažejo nepravilnosti hepatitis s prevladujočimi znaki holestaze (glejte poglavje 4. 4.)
Psychiatric disorders Common:
Psihiatrične motnje Pogosto:
Insomnia, hallucinations, confusion, nightmares, agitation
nespečnost, halucinacije, zmedenost, nočne more, nemir
Very common (≥ 1/ 10); common (1≥ 100 to < 1/ 10); uncommon (≥ 1/ 1,000 to < 1/ 100); rare (≥ 1/ 10,000 to < 1/ 1,000), very rare (< 1/ 10,000), not known (cannot be estimated from the available data, since no valid estimate can be derived from clinical trials or epidemiological studies).
Neželeni učinki so razvrščeni po organskih sistemih in glede na pogostnost pojavljanja v naslednje skupine: zelo pogosti (≥1/ 10); pogosti (1≥100 do < 1/ 10); manj pogosti (≥1/ 1. 000 do < 1/ 100); redki (≥1/ 10. 000 do < 1/ 1. 000); zelo redki (< 1/ 10. 000); niso znani (na osnovi razpoložljivih podatkov ocena ni mogoča, saj iz kliničnih preskušanj ali epidemioloških študij ni možno sklepati veljavnih ocen).
Entacapone in association with levodopa has been associated with isolated cases of excessive daytime somnolence and sudden sleep onset episodes.
Entakapon v kombinaciji z levodopo povezujejo s posameznimi primeri prekomerne zaspanosti čez dan in epizodami nenadnega spanca.
Isolated cases of NMS have been reported following the abrupt reduction or discontinuation of entacapone and other dopaminergic treatments.
Poročila omenjajo posamezne primere NMS po nenadnem zmanjšanju ali ukinitvi entakapona in drugih sočasnih dopaminergičnih zdravljenj.
Isolated cases of rhabdomyolysis have been reported.
Poročila omenjajo posamezne primere rabdomiolize.
The following laboratory abnormalities have been reported with levodopa/ carbidopa treatment and should, therefore, be acknowledged when treating patients with Stalevo:
Pri zdravljenju z levodopo/ karbidopo poročajo o naslednjih odklonih laboratorijskih vrednosti, ki bi jih torej morali upoštevati tudi pri zdravljenju z zdravilom Stalevo: