natgillin/translations-raw huggingface dataset:
Commonly, levels of blood urea nitrogen, creatinine, and uric acid are lower during administration of levodopa/ carbidopa than with levodopa alone.
Običajno so med jemanjem levodope/ karbidope vrednosti sečninskega dušika v krvi, kreatinina in sečne kisline višje kot med jemanjem same levodope.
Transient abnormalities include elevated values of blood urea, AST (SGOT), ALT (SGPT), LDH, bilirubin, and alkaline phosphatase.
Prehodne anomalije zajemajo povišane vrednosti sečninskega dušika v krvi, AST (SGOT), ALT (SGPT), LDH, bilirubina in alkalne fosfataze.
8 Decreased haemoglobin, haematocrit, elevated serum glucose and white blood cells, bacteria and blood in the urine have been reported.
8 Poročajo tudi o znižanih vrednostih hemoglobina in hematokrita, povišanih vrednosti sladkorja v serumu ter večjem številu belih krvničk, bakterij in krvi v urinu.
Positive Coombs' tests have been reported, both for levodopa/ carbidopa and for levodopa alone, but haemolytic anaemia is extremely rare.
O pozitivnih rezultatih Coombovega testa poročajo tako v povezavi z levodopo/ karbidopo kot tudi z levodopo samo, vendar pa se hemolitična anemija pojavlja izjemno redko.
Levodopa/ carbidopa may cause false positive result when a dipstick is used to test for urinary ketone and this reaction is not altered by boiling the urine sample.
Levodopa/ karbidopa lahko daje lažno pozitivne rezultate, kadar se test na ketone v urinu izvaja s pomočjo testnega traku, te reakcije pa ne spremeni niti prekuhavanje urinskega vzorca.
The use of glucose oxidase methods may give false negative results for glycosuria.
Metoda z glukozno oksidazo lahko daje lažno negativne rezultate za prisotnost glukoze v seču (glukozurijo).
The post-marketing data includes isolated cases of overdose in which the reported highest daily doses of levodopa and entacapone have been at least 10,000 mg and 40,000 mg, respectively.
40. 000 mg.
The acute symptoms and signs in these cases of overdose included agitation, confusional state, coma, bradycardia, ventricular tachycardia, Cheyne-Stokes respiration, discolourations of skin, tongue and conjunctiva, and chromaturia.
Akutni simptomi in znaki the primerov prevelikega odmerjanja zajemajo nemir, zmedenost, komo, bradikardijo, ventrilukarno tahikardijo, obliko dihanja Cheyne- Stokes, razbarvanje kože, jezika, očesne veznice in kromaturija.
Management of acute overdosage with Stalevo therapy is similar to acute overdosage with levodopa.
Ukrepi pri akutnem prevelikem odmerjanju zdravila Stalevo so podobni kot pri akutnem prevelikem odmerjanju levodope.
This may hasten the elimination of entacapone in particular by decreasing its absorption/ reabsorption from the GI tract.
To lahko pospeši odstranjevanje entakapona s tem, da zmanjšuje njegovo absorpcijo/ resorpcijo iz prebavnega trakta.
If required, appropriate, anti-arrhythmic therapy should be given.
Po potrebi je treba uvesti zdravljenje z ustreznimi antiaritmiki.
The value of dialysis in the treatment of overdosage is not known.
Koristnost dialize pri zdravljenju prevelikega odmerjanja ni znana.
Pharmacotherapeutic group: dopa and dopa derivatives, ATC code:
Farmakoterapevtska skupina: dopa in derivati dope, oznaka ATC:
According to the current understanding, the symptoms of Parkinson’ s disease are related to depletion of dopamine in the corpus striatum.
V skladu z dosedanjimi ugotovitvami so simptomi Parkinsonove bolezni povezani z izgubo dopamina v progastem telesu (corpus striatum).
Levodopa, the precursor of dopamine, crosses the blood brain barrier and relieves the symptoms of the disease.
Levodopa, prekurzor v sintezi dopamina, prehaja skozi krvnomožgansko pregrado in lajša simptome bolezni.
As levodopa is extensively metabolised in the periphery only a small portion of a given dose reaches the central nervous system when levodopa is administered without metabolic enzyme inhibitors.
Ker se levodopa večinoma presnavlja periferno, le majhen delež odmerka doseže osrednji živčni sistem, kadar se levodopa uporablja brez zaviralcev encimov, ki sodelujejo pri presnovi.
Carbidopa and benserazide are peripheral DDC inhibitors which reduce the peripheral metabolism of levodopa to dopamine and, thus, more levodopa is available to the brain.
Karbidopa in benzerazid so periferni zaviralci DDK, ki zmanjšujejo periferno presnovo levodope v dopamin, zaradi česar je večja količina levodope na razpolago v možganih.
When decarboxylation of levodopa is reduced with the co-administration of a DDC inhibitor, a lower dose of levodopa can be used and the incidence of undesirable effects such as nausea is reduced.
Kadar se dekarboksilacija levodope zmanjša s pomočjo sočasne uporabe zaviralca DDK, se lahko uporabi manjši odmerek levodope, s tem pa se zmanjša incidenca neželenih učinkov, kot je npr. bruhanje.
With inhibition of the decarboxylase by a DDC inhibitor, COMT becomes the major peripheral metabolic pathway catalyzing the conversion of levodopa to 3-O-methyldopa (3-OMD), a potentially harmful metabolite of levodopa.
Po zavrtju dekarboksilaze z zaviralcem DDK postane katehol- O- metiltransferaza glavna periferna pot presnove, ki katalizira pretvorbo levodope v 3- O- metildopo (3- OMD), potencialno škodljiv presnovek levodope.
The evidence of the therapeutic effects of Stalevo is based on two phase III double-blind studies, in which 376 Parkinson’ s disease patients with end-of-dose motor fluctuations received either
Dokazi o terapevtskih učinkih zdravila Stalevo temeljijo na dveh dvojno slepih raziskavah III. faze, v katerih je 376 bolnikov s Parkinsonovo boleznijo in motoričnimi fluktuacijami na koncu odmernega obdobja ob vsakem odmerku levodope/ zaviralca DDK prejemalo bodisi entakapon ali placebo.
9 entacapone or placebo with each levodopa/ DDC inhibitor dose.
Dnevni interval učinkovanja zdravila z ali brez entakapona so bolniki beležili v domači dnevnik.
Daily ON time with and without entacapone was recorded in home-diaries by patients.
V prvi raziskavi je entakapon povečal dnevno trajanje intervala učinkovanja (» ON «) za 1 h 20 min (CI95%
In the first study, entacapone increased the mean daily ON time by 1 h 20 min (CI 95% 45 min, 1 h 56 min) from baseline.
9 45 min, 1 h 56 min) glede na izhodiščne vrednosti.
This corresponded to an 8.3% increase in the proportion of daily ON time.
To je odgovarjalo povečanju razmerja dnevnega trajanja tega intervala za 8, 3%.
Correspondingly, the decrease in daily OFF time was 24% in the entacapone group and 0% in the placebo group.
Skladno s tem se je dnevno trajanje intervala, ko zdravilo ni delovalo (» OFF «) pri skupini z entakaponom skrajšalo za 24%, pri skupini s placebom pa za 0%.
In the second study, the mean proportion of daily ON time increased by 4.5% (CI95% 0.93%, 7.97%) from baseline.
V drugi raziskavi se je srednje razmerje dnevnega trajanja intervala » ON « povečalo za 4, 5% (CI95% 0, 93%, 7, 97%) glede na izhodiščne vrednosti.
This is translated to a mean increase of 35 min in the daily ON time.
To odgovarja srednjemu povečanju dnevnega trajanja intervala » ON « za 35 min.
Correspondingly, the daily OFF time decreased by 18% on entacapone and by 5% on placebo.
Skladno s tem se je dnevno trajanje intervala » OFF « pri skupini z entakaponom skrajšalo za 18%, pri skupini s placebom pa za 5%.
Because the effects of Stalevo tablets are equivalent with entacapone 200 mg tablet administered concomitantly with the commercially available standard release carbidopa/ levodopa preparations in corresponding doses these results are applicable to describe the effects of Stalevo as well.
Ker so učinki tablet zdravila Stalevo enaki kot pri tabletah entakapona 200 mg, uporabljenih sočasno z zdravili karbidope/ levodope s standardnim sproščanjem v odgovarjajočih odmerkih, so ti rezultati uporabni tudi za prikaz učinkov zdravila Stalevo.
General characteristics of the active substances
Glavne značilnosti aktivnih učinkovin
Absorption/ Distribution:
Absorpcija/ distribucija:
There are substantial inter- and intra-individual variations in the absorption of levodopa, carbidopa and entacapone.
Obstajajo znatne interindividualne in intraindividualne razlike v absorpciji levodope, karbidope in entakapona.
When given separately without the two other active substances, the bioavailability for levodopa is 15-33%, for carbidopa 40-70% and for entacapone 35% after a 200 mg oral dose.
Pri samostojni aplikaciji peroralnega odmerka 200 mg brez ostalih dveh aktivnih učinkovin je bila biološka uporabnost levodope 15– 33%, karbidope 40– 70%, entakapona pa 35%.
Meals rich in large neutral amino acids may delay and reduce the absorption of levodopa.
Obroki, ki vsebujejo veliko nevtralnih amino kislin, lahko upočasnijo ali zmanjšajo absorpcijo levodope.
The distribution volume of both levodopa (Vd 0.36-1.6 l/ kg) and entacapone (Vdss 0.27 l/ kg) is moderately small while no data for carbidopa are available.
Volumen porazdelitve tako levodope (Vd 0, 36 – 1, 6 l/ kg) kot entakapona (Vdss 0, 27 l/ kg) je zmerno majhen, med tem ko za karbidopo ni podatkov.
Levodopa is bound to plasma protein only to a minor extent of about 10-30% and carbidopa is bound approximately 36%, while entacapone is extensively bound to plasma proteins (about 98%), mainly to serum albumin.
Levodopa se le v manjši meri veže na proteine v plazmi (približno 10- 30%), karbidopa pa v približno 36%, med tem ko se entakapon veže na proteine v plazmi v veliki meri (približno 98%) in to pretežno na serumski albumin.
At therapeutic concentrations, entacapone does not displace other extensively bound active substances (e. g. warfarin, salicylic acid, phenylbutazone, or diazepam), nor is it displaced to any significant extent by any of these substances at therapeutic or higher concentrations.
V terapevtskih koncentracijah entakapon ne izpodriva drugih zdravilnih učinkovin, ki se vežejo v velikem odstotku (npr. varfarin, salicilna kislina, fenilbutazon ali diazepam), niti ga nobena od teh učinkovin v terapevtskih ali tudi višjih koncentracijah bistveno ne izpodriva.
Metabolism and Elimination:
Presnova in izločanje:
Levodopa is extensively metabolised to various metabolites, decarboxylation by dopa decarboxylase (DDC) and O-methylation by catechol-O-methyltransferase (COMT) being the most important pathways.
Levodopa se v veliki meri presnavlja v različne metabolite, pri čemer sta najpomembnejši presnovni poti dekarboksilacija z dopa dekarboksilazo (DDK) in O- metilacija z katehol- O- metiltransferazo (COMT).
Carbidopa is metabolized to two main metabolites which are excreted in the urine as glucuronides and unconjugated compounds.
Karbidopa se presnavlja v dva glavna metabolita, ki se izločata v urinu v obliki glukoronida in nekonjugiranih spojin.
Unchanged carbidopa accounts for 30% of the total urinary excretion.
Karbidopa v nespremenjeni obliki predstavlja 30% vseh oblik, ki se izločajo v urinu.
Entacapone is almost completely metabolized prior to excretion via urine (10 to 20%) and bile/ feces (80 to 90%).
Entakapon se skoraj v celoti metabolizira, preden se izloči preko urina (10- 20%) in preko žolča/ blata (80- 90%).
The main metabolic pathway is glucuronidation of entacapone and its active metabolite, the cis-isomer, which accounts for about 5% of plasma total amount.
Glavna presnovna pot je glukuronizacija entakapona in njegovega aktivnega metabolita cis- izomera, ki predstavlja približno 5% celotne količine v plazmi.
Total clearance for levodopa is in the range of 0.55-1.38 l/ kg/ h and for entacapone is in the range of 0.70 l/ kg/ h.
Celokupen očistek levodope se giblje v razponu med 0, 55– 1, 38 l/ kg/ h, entakapona pa okrog 0, 70 l/ kg/ h.
The elimination-half life is (t1/ 2) is 0.6-1.3 hours for levodopa, 2-3 hours for carbidopa and 0.4-0.7 hours for entacapone, each given separately.
Razpolovni čas izločanja (t1/ 2) je 0, 6– 1, 3 ure za levodopo, 2– 3 ure za karbidopo in 0, 4- 0, 7 ur za entakapon, ob samostojni aplikaciji vsakega posameznega zdravila.
Entacapone showed little or no inhibition of other types of P450 isoenzymes (CYP1A2, CYP2A6, CYP2D6, CYP2E1, CYP3A and CYP2C19), see section 4.5.
Zaviralni učinek entakapona na druge vrste izoencimov P450 (CYP1A2, CYP2A6, CYP2D6, CYP2E1, CYP3A in CYP2C19) pa je bil majhen ali ga sploh ni bilo (glejte poglavje 4. 5).
10 Characteristics in patients
Značilnosti pri bolnikih
Elderly:
10 Starostniki:
When given without carbidopa and entacapone, the absorption of levodopa is greater and elimination is slower in elderly than in young subjects.
Kadar se levodopa daje brez karbidope in entakapona, je pri starejših osebah njena absorpcija večja, izločanje pa počasnejše kot pri mlajših osebah.
However, after combination of carbidopa with levodopa, the absorption of levodopa is similar between the elderly and the young, but the AUC is still 1.5 fold greater in the elderly due to decreased DDC activity and lower clearance by aging.
Vendar pa je pri kombinaciji karbidope z levodopo absorpcija levodope pri starejših in pri mlajših podobna, med tem ko je vrednost AUC pri starejših še vedno 1, 5- krat večja zaradi starostno pogojenega zmanjšanega delovanja DDK in nižjega očistka.
There are no significant differences in the AUC of carbidopa or entacapone between younger (45– 64 years) and elderly subjects (65– 75 years).
Med mlajšimi (45- 64 let) in starejšimi (65- 75 let) osebami ni značilne razlike v AUC vrednostih karbidope ali entakapona.
Bioavailability of levodopa is significantly higher in women than in men.
Biološka uporabnost levodope je pri ženskah značilno višja kot pri moških.
In the pharmacokinetic studies with Stalevo the bioavailability of levodopa is higher in women than in men, primarily due to the difference in body weight, while there is no gender difference with carbidopa and entacapone.
V raziskavah farmakokinetike zdravila Stalevo je biološka uporabnost levodope pri ženskah večja kot pri moških predvsem zaradi razlike v telesni teži, med tem ko pri karbidopi in entakaponu razlike med spoloma ni bilo.
The metabolism of entacapone is slowed in patients with mild to moderate hepatic impairment (Child-Pugh Class A and B) leading to an increased plasma concentration of entacapone both in the absorption and elimination phases (see sections 4.2 and 4.3).
Pri bolnikih z blago do zmerno okvaro jeter (razred A- B po Child- Pughovi klasifikaciji) je presnova entakapona upočasnjena, zaradi česar pride do povečanih koncentracij entakapona v plazmi tako v fazi absorpcije kot tudi v fazi izločanja (glejte poglavji 4. 2 in 4. 3).
However, a longer dosing interval of Stalevo may be considered for patients who are receiving dialysis therapy (see section 4.2).
Vseeno pa priporočajo, da bi pri bolnikih, ki se zdravijo z dializo, pri odmerjanju zdravila Stalevo upoštevali daljši interval (glejte poglavje 4. 2).
Preclinical data of levodopa, carbidopa and entacapone tested alone or in combination revealed no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity, and carcinogenic potential.
Predklinični podatki testiranja levodope, karbidope in entakapona bodisi samostojno ali v kombinaciji, ki so temeljili na standardnih farmakoloških raziskavah varnosti, toksičnosti ponovnih odmerkov, genotoksičnosti ali karcinogenosti, niso pokazali, da bi uporaba pri človeku predstavljala posebno tveganje.
In repeated dose toxicity studies with entacapone, anaemia most likely due to iron chelating properties of entacapone was observed.
V raziskavah toksičnosti ponovnih odmerkov entakapona poročajo o anemiji, ki nastane verjetno kot posledica lastnosti entakapona, da kelira železo.
Regarding reproduction toxicity of entacapone, decreased foetal weight and a slightly delayed bone development were noticed in rabbits treated at systemic exposure levels in the therapeutic range.
V zvezi z reproduktivno toksičnostjo entakapona poročajo o manjši teži ploda in nekoliko zapoznelem razvoju kosti pri zajcih ob sistemski izpostavljenosti koncentracijam znotraj terapevtskega razpona.
Croscarmellose sodium Magnesium stearate Maize starch Mannitol (E421) Povidone (E1201)
Jedro tablete: premreženi natrijev karmelozat magnezijev stearat koruzni škrob manitol (E421) povidon (E1201)
Glycerol (85 per cent) (E422) Hypromellose Magnesium stearate Polysorbate 80 Red iron oxide (E172) Sucrose
Filmska obloga: glicerol (85 odstotkov) (E422) hipromeloza magnezijev stearat polisorbat 80 rdeči železov oksid (E172) saharoza titanov dioksid (E171) rumeni železov oksid (E172)
11 Titanium dioxide (E171) Yellow iron oxide (E172)
11 Navedba smiselno ni potrebna.
6.2 Incompatibilities
6. 3 Rok uporabnosti
6.6 Special precautions for disposal
6. 6 Posebni varnostni ukrepi za odstranjevnje
17 October 2003 Date of last renewal:
17. oktober 2003 Datum podaljšanja:
Detailed information on this medicine is available on the European Medicine’ s Agency (EMEA) web site: http: / /www. emea. europa. eu
Podrobne informacije o zdravilu so objavljene na spletni strani Evropske agencije za zdravila (EMEA) http: // www. emea. europa. eu /.
Stalevo 100 mg/ 25 mg/ 200 mg film-coated tablets
Stalevo 100 mg/ 25 mg/ 200 mg filmsko obložene tablete
Each tablet contains 100 mg of levodopa, 25 mg of carbidopa and 200 mg of entacapone.
Vsaka tableta vsebuje 100 mg levodope, 25 mg karbidope in 200 mg entakapona.
Each tablet contains 1.6 mg of sucrose.
Pomožna snov: ena tableta vsebuje 1, 6 mg saharoze
Brownish or greyish red, oval, unscored film-coated tablets marked with ‘ LCE 100’ on one side.
Rjavkaste ali sivkasto- rdeče ovalne filmsko obložene tablete brez zareze z oznako » LCE 100 « na eni strani.
The daily dose should be preferably optimised using one of the four available tablet strengths (50 mg/ 12.5 mg/ 200 mg, 100 mg/ 25 mg/ 200 mg, 150 mg/ 37.5 mg/ 200 mg or 200 mg/ 50 mg/ 200 mg levodopa/ carbidopa/ entacapone).
Dnevni odmerek naj se po možnosti optimizira z uporabo tablet ustrezne jakosti – ene od treh, ki so na razpolago (50 mg/ 12, 5 mg/ 200 mg, 100 mg/ 25 mg/ 200 mg, ali 150 mg / 37, 5 mg/ 200 mg ali 200 mg/ 50 mg/ 200 mg levodopa/ karbidopa/ entakapon).
According to this daily carbidopa dose, the maximum recommended daily Stalevo 200 mg/ 50 mg/ 200 mg dose is 7 tablets per day.
V skladu s tem dnevnim odmerkom karbidope je maksimalni priporočeni dnevni odmerek zdravila Stalevo 200 mg/ 50 mg/ 200 mg 7 tablet dnevno.
Usually Stalevo is to be used in patients who are currently treated with corresponding doses of standard release levodopa/ DDC inhibitor and entacapone.
Običajno naj bi se zdravilo Stalevo uporabljalo pri bolnikih, ki trenutno prejemajo ustrezne odmerke zaviralcev DDK s standardnim sproščanjem levodope in entakapon.
13 entacapone 200 mg four times daily can take one 100 mg/ 25 mg/ 200 mg Stalevo tablet four times daily in place of their usual levodopa/ carbidopa and entacapone doses.
Npr.: bolnik, ki prejema po eno tableto 100 mg/ 25 mg levodope/ karbidope z eno tableto entakapona 200 mg 4- krat dnevno, lahko jemlje eno 100 mg/ 25 mg/ 200 mg tableto zdravila Stalevo 4- krat dnevno namesto običajnih odmerkov levodope/ karbidope in entakapona.
When initiating Stalevo therapy for patients currently treated with entacapone and levodopa/ carbidopa in doses not equal to Stalevo 100 mg/ 25 mg/ 200 mg, (or 50 mg/ 12.5 mg/ 200 mg, or 150 mg/ 37.5 mg/ 200 mg or 200 mg/ 50 mg/ 200 mg) tablets, Stalevo dosing should be carefully titrated for optimal clinical response.
Ob uvajanju terapije z zdravilom Stalevo pri bolnikih, ki trenutno prejemajo entakapon in levodopo/ karbidopo v domerkih, ki se razlikujejo od tablet zdravila Stalevo 100 mg/ 25 mg/ 200 mg (ali 50 mg/ 12, 5 mg/ 200 mg ali 150 mg/ 37, 5 mg/ 200 mg), je treba za dosego optimalnega kliničnega odgovora odmerjanje zdravila Stalevo skrbno titrirati.
When initiating Stalevo in patients currently treated with entacapone and levodopa/ benserazide in a standard release formulation, discontinue dosing of levodopa/ benserazide the previous night and start Stalevo the next morning.
Ko se zdravljenje z zdravilom Stalevo uvaja pri bolniki, ki renutno prejemajo entakapon in levodopo/ benzerazid s standardnim sproščanjem, se odmerjanje levodope/ benzerazida ukine eno noč pred uvedbo zdravila Stalevo, ki se začne dajati naslednje jutro.
Dose reduction may be needed (see section 5.2).
(glejte poglavje 5. 2).
For severe hepatic impairment see section 4.3
Za hudo okvaro jeter glejte poglavje 4. 3.
Renal impairment does not affect the pharmacokinetics of entacapone.
14 Ookvara ledvic; Okvara ledvic ne vpliva na farmakokinetiko entakapona.
No particular studies are reported on the pharmacokinetics of levodopa and carbidopa in patients with renal insufficiency, therefore Stalevo therapy should be administered cautiously to patients in severe renal impairment including those receiving dialysis therapy (see section 5.2).
Študije, v katerih bi posebej preučevali farmakokinetiko levodope in karbidope pri bolnikih z ledvično insuficienco niso bile izvedene, zato je potrebna previdnost pri dajanju zdravila Stalevo bolnikom s hudo prizadetostjo ledvic kot tudi tistim, ki se zdravijo z dializo (glejte poglavje 5. 2).
- A previous history of Neuroleptic Malignant Syndrome (NMS) and/ or non-traumatic
- nevroleptični maligni sindrom (NMS) in/ ali neravmatska rabdomioliza v preteklosti,
changes, depression with suicidal tendencies, and other serious antisocial behaviour.
psihičnih sprememb, deresije s samomorilnimi nagibi ter drugih resnih oblik antisocialnega vedenja.
particularly D2 receptor antagonists should be carried out with caution, and the patient carefully observed for loss of antiparkinsonian effect or worsening of parkinsonian symptoms.
antagonistov receptorja D2, zahteva previdnost, bolnika pa je treba skrbno spremljati, če bi prišlo do izgube antiparkinsonskega učinka ali poslabšanja parkinsonskih simptomov.
the intra-ocular pressure is well controlled and the patient is monitored carefully for changes in intra-ocular pressure.
zdravilom Stalevo, pod pogojem, da je intraokularni pritisk dobro obvladovan in da bolnika skrbno spremljamo, če bi se pojavile spremembe v intraokularnem pritisku.
In individual cases, only some of these symptoms and/ or findings may be evident.
V posameznih primerih so lahko prisotni le lekateri od teh simptomov in/ ali izsledkov preiskav.
15 phosphokinase has been reported with the abrupt withdrawal of antiparkinsonian agents.
15 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 bodisi NMS ali rabdomiolize v povezavi z entakaponskim zdravljenjem.
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 pa bo treba tudi povečati odmerek levodope.
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 hiperseksulanosti.
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).