natgillin/translations-raw huggingface dataset:
Interactions between entacapone and imipramine and between entacapone and moclobemide have been investigated in single dose studies in healthy volunteers.
Interakcije između entakapona i imipramina te između entakapona i moklobemida ispitivane su u studijama s jednokratnom dozom u zdravih dobrovoljaca.
Suicidal behaviour, Dopamine dysregulation syndrome
Suicidalno ponašanje, sindrom poremećene regulacije dopamina
- Allergic reaction, the signs may include hives (nettle rash), itching, rash, swelling of your face, lips, tongue or throat.
- Alergijska reakcija, čiji znakovi mogu uključivati urtikariju (koprivnjaču), svrbež, osip, oticanje lica, usana, jezika ili grla.
These behaviours are called impulse control disorders and can include addictive gambling, excessive eating or spending, an abnormally high sex drive or a preoccupation with an increase in sexual thoughts or feelings.
Ta se ponašanja zovu poremećaji kontrole impulsa i mogu uključivati ovisnost o kockanju, prekomjerno jedenje ili trošenje, nenormalnu potrebu za seksom ili zaokupljenost sve jačim seksualnim mislima i osjećajima.
Entacapone slows the clearance of levodopa from the bloodstream resulting in an increased area under the curve (AUC) in the pharmacokinetic profile of levodopa.
Entakapon usporava klirens levodope iz krvotoka čime se postiže povećanje površine ispod krivulje (AUC) u farmakokinetičkom profilu 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 distribucije za levodopu (Vd 0,36-1,6 l/kg) i za entakapon (VdSS 0,27 l/kg) je relativno malen, dok za karbidopu nema podataka.
- For patients who experience progressive anorexia, asthenia and weight decrease within a relatively short period of time, a general medical evaluation including liver function should be considered.
- U bolesnika s progresivnom anoreksijom, astenijom i smanjenjem tjelesne težine unutar relativno kratkog vremenskog perioda, potrebno je razmisliti o općem liječničkom pregledu, uključujući pretragu funkcije jetre.
If this happens, your doctor may need to change the dose of your antiparkinson medicine - experience diarrhoea: monitoring of your weight is recommended in order to avoid potentially excessive weight loss - experience progressive anorexia, asthenia (weakness, exhaustion) and weight decrease within a relatively short period of time.
Ako se to dogodi, liječnik će možda trebati promijeniti dozu Vašeg antiparkinsonika, - dobijete proljev: preporučuje se praćenje Vaše tjelesne težine kako bi se izbjegla mogućnost pojačanog gubitka težine, - doživite napredujući gubitak apetita, opću slabost (iscrpljenost) i pad tjelesne težine u relativno kratkom vremenskom razdoblju.
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.
Neklinički podaci o levodopi, karbidopi i entakaponu, pojedinačno ili u kombinaciji, ne ukazuju na poseban rizik za ljude na temelju konvencionalnih ispitivanja sigurnosne farmakologije, toksičnosti ponovljenih doza, genotoksičnosti i kancerogenog potencijala.
Therefore, caution should be exercised when driving or using machines.
Stoga je potreban oprez pri upravljanju vozilima ili radu sa strojevima.
Other active substances: Dopamine receptor antagonists (e.g. some antipsychotics and antiemetics), phenytoin and papaverine may reduce the therapeutic effect of levodopa.
Ostale djelatne tvari: antagonisti dopaminskih receptora (npr. neki antipsihotici i antiemetici), fenitoin i papaverin mogu smanjiti terapijski učinak levodope.
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 i benzerazid su periferni DDC-inhibitori koji smanjuju periferni metabolizam levodope u dopamin i time je više levodope raspoloživo za mozak.
According to in vitro studies, significant displacement is not anticipated at therapeutic concentrations of the medicinal products.
Prema in vitro ispitivanjima ne očekuje se značajno istiskivanje u terapijskim koncentracijama lijekova.
Entacapone is a reversible, specific and mainly peripherally acting COMT inhibitor designed for concomitant administration with levodopa.
Entakapon je reverzibilan, specifičan i uglavnom periferno aktivan COMT inhibitor namijenjen za istodobnu primjenu s levodopom.
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.
U prvom ispitivanju entakapon je povisio srednje trajanje "ON" faze za 1 h 20 min (CI 95% 45 min, 1 h 56 min) u odnosu na početnu vrijednost.
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.
Poluvrijeme eliminacije (t1/2) je 0,6-1,3 sati za levodopu, 2-3 sata za karbidopu i 0,4-0,7 sati za entakapon, kada se primijenjuju odvojeno.
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.
Kako se levodopa ekstenzivno metabolizira u periferiji, samo mali dio primijenjene doze dospijeva u središnji živčani sustav kada se levodopa primijeni bez inhibitora metaboličkih enzima.
Carbidopa and entacapone were excreted in milk in animals but is not known whether they are excreted in human breast milk.
Kod životinja se karbidopa i entakapon izlučuju u mlijeko, ali nije poznato da li se izlučuju u majčino mlijeko u ljudi.
Entacapone in association with levodopa has been associated with isolated cases of excessive daytime somnolence and sudden sleep onset episodes.
Entakapon udružen s levodopom bio je povezan s izoliranim slučajevima pretjerane somnolencije tijekom dana i epizodama iznenadnog nastupa sna.
Do not use this medicine after the expiry date which is stated on the bottle and the carton after EXP.
Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na bočici i kutiji iza oznake „Rok valjanosti“.
Hospitalisation is advised and general supportive measures should be employed with immediate gastric lavage and repeated doses of charcoal over time.
Savjetuje se hospitalizacija, a moraju se poduzeti opće suportivne mjere s hitnim ispiranjem želuca i ponavljanom primjenom aktivnog ugljena kroz određeno vrijeme.
Absorption/distribution: There are substantial inter- and intra-individual variations in the absorption of levodopa, carbidopa and entacapone.
Apsorpcija/distribucija: postoje značajne inter- i intraindividualne razlike u apsorpciji levodope, karbidope i entakapona.
Characteristics in patients
Karakteristike bolesnika
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.
Otkada se entakapon nalazi na tržištu objavljeni su rijetki slučajevi NMS-a, posebno nakon naglog smanjenja ili ukidanja entakapona i drugih istovremeno primijenjenih dopaminergičkih lijekova.
Parkinson's disease is caused by low levels of a substance called dopamine in the brain.
Parkinsonovu bolest uzrokuju niske razine tvari u mozgu zvane dopamin.
Patients with past or current psychosis should be treated with caution.
Bolesnike s trenutnom psihozom, ili s psihozom u anamnezi, treba oprezno liječiti.
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.
Kada se daje samostalno bez druge dvije djelatne tvari, bioraspoloživost levodope je 15-33%, karbidope 40-70%, a entakapona 35% nakon oralne doze od 200 mg.
Carbidopa is metabolized to two main metabolites which are excreted in the urine as glucuronides and unconjugated compounds.
Karbidopa se metabolizira u dva glavna metabolita koji se izlučuju mokraćom kao glukuronidi i nekonjugirani spojevi.
Ischemic heart disease events other than myocardial infarction (e.g. angina pectoris)**, irregular heart rhythm
Događaji vezani uz ishemičku srčanu bolest osim infarkta miokarda (npr. angina pektoris)**, nepravilan srčani ritam
Hepatic impairment: 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).
Oštećenje jetre: metabolizam entakapona je usporen kod bolesnika s blagim do umjerenim jetrenim oštećenjem (Child-Pugh stadij A i B) dovodeći do povišene koncentracije entakapona u plazmi u fazi apsorpcije, kao i u fazi eliminacije (vidjeti dijelove 4.2 i 4.3).
Rhabdomyolysis*
Rabdomioliza*
Before initiation of treatment, patients and caregivers should be warned of the potential risk of developing DDS (see also section 4.8).
Prije uvođenja liječenja bolesnike i njihove njegovatelje potrebno je upozoriti na mogući rizik od razvoja sindroma poremećene regulacije dopamina (vidjeti i dio 4.8).
Fertility studies in animals have not been conducted with the combination of entacapone, levodopa and carbidopa.
Ispitivanja plodnosti u životinja nisu provedena s kombinacijom entakapona, levodope i karbidope.
General characteristics of the active substances
Opća svojstva djelatnih tvari
Some of these adverse reactions relate to the increased dopaminergic activity (e.g. dyskinesia, nausea and vomiting) and occur most commonly at the beginning of the treatment.
Neke od tih nuspojava povezane su s povišenom dopaminergičkom aktivnosti (npr. diskinezija, mučnina i povraćanje) i najčešće se javljaju na početku liječenja.
Cumulatively, dopamine dysregulation syndrome has been included in 10 reports.
Kumulativno je sindrom poremećene regulacije dopamina uključen u 10 prijava.
These can be symptoms of neuroleptic malignant syndrome (NMS, a rare severe reaction to medicines used to treat disorders of the central nervous system) or rhabdomyolysis (a rare severe muscle disorder).
To mogu biti simptomi neuroleptičkog malignog sindroma (NMS, rijetke teške reakcije na lijekove koji se koriste za liječenje poremećaja središnjeg živčanog sustava) ili rabdomiolize (rijedak teški mišićni poremećaj).
- In patients with a history of myocardial infarction who have residual atrial nodal or ventricular arrhythmias; cardiac function should be monitored with particular care during the period of initial dose adjustments.
- U bolesnika s anamnezom infarkta miokarda koji imaju rezidualne atrijske nodalne ili ventrikularne aritmije, posebno pažljivo treba pratiti srčanu funkciju tijekom perioda početnog prilagođavanja doziranja.
Caution should be exercised when the following active substances are administered concomitantly with levodopa therapy.
Potreban je oprez kada se sljedeće djelatne tvari istodobno primijenjuju s levodopom:
The CHMP recommends that the terms of the Marketing Authorisations should be varied.
CHMP predlaže izmjenu uvjeta odobrenja za stavljanje lijeka u promet.
Carbidopa and entacapone improve the antiparkinson effects of levodopa.
Karbidopa i entakapon poboljšavaju antiparkinsonske učinke levodope.
Dopamine dysregulation syndrome is mentioned in the product information of other dopaminergic medication used in Parkinson's disease such as levodopa/carbidopa, apomorphine, levodopa/benserazide, rotigotine and ropinirole.
Sindrom poremećene regulacije dopamina se spominje u informacijama o lijeku drugih dopaminergičkih lijekova koji se koriste u terapiji Parkinsonove bolesti kao što su levodopa/kardiodopa, apomorfin, levodopa/benzerazid, rotigotin i ropinirol.
Dopamine dysregulation syndrome (DDS) is described as a compulsive pattern of dopaminergic misuse above doses adequate to control motor symptoms.
Dopamine dysregulation syndrome DDS) opisan je kao kompulzivni obrazac pogrešne primjene dopaminergičkih lijekova iznad doza dovoljnih za kontrolu motoričkih simptoma.
Review of treatment is recommended if such symptoms develop.
Ako se razviju takvi simptomi, preporučuje se preispitivanje liječenja.
With inhibition of the decarboxylase by a DDC inhibitor, catechol-O-methyltransferase (COMT) becomes the major peripheral metabolic pathway catalyzing the conversion of levodopa to 3-Omethyldopa (3-OMD), a potentially harmful metabolite of levodopa.
Inhibiranjem dekarboksilaze pomoću DDC-inhibitora katehol-O-metiltransferaze (COMT) postaje glavni periferni metabolički put kojim se katalizira konverzija levodope u 3-O-metildopu (3-OMD), potencijalno štetan metabolit levodope.
Affected patients show a compulsive pattern of dopaminergic drug misuse above doses adequate to control motor symptoms, which may in some cases result in severe dyskinesias (see also section 4.4).
Pogođeni bolesnici pokazuju kompulzivni obrazac pogrešne primjene dopaminergičkih lijekova u dozama većima od onih dovoljnih za kontrolu motoričkih simptoma, što u nekim slučajevima može dovesti do teških diskinezija (vidjeti i dio 4.4).
In case of an overdose you may feel confused or agitated, your heart rate may be slower or faster than normal or the colour of your skin, tongue, eyes or urine may change.
U slučaju predoziranja možete se osjećati smeteno ili uznemireno, puls može biti sporiji ili brži od normalnog ili se boja
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 i znakovi u ovim slučajevima predoziranja uključivali su agitaciju, konfuzno stanje, komu, bradikardiju, ventrikularnu tahikardiju, Cheyne-Stokesovo disanje, diskoloraciju kože, jezika i konjunktive, te kromaturiju.
- Entacapone in association with levodopa has been associated with somnolence and episodes of sudden sleep onset in patients with Parkinson's disease and caution should therefore be exercised when driving or operating machines (see section 4.7).
- Entakapon udružen s levodopom povezan je s pospanošću i epizodama iznenadnog nastupa sna u bolesnika s Parkinsonovom bolešću, pa se preporučuje oprez prilikom upravljanja vozilima i rukovanja strojevima (vidjeti dio 4.7).
Renal impairment: Renal impairment does not affect the pharmacokinetics of entacapone.
Oštećenje bubrega: oštećenje bubrega ne utječe na farmakokinetiku entakapona.
Chromaturia*
Kromaturija*
In the pharmacokinetic studies with Levodopa/Carbidopa/Entacapone Orion 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.
U farmakokinetičkim ispitivanjima Levodopa/Carbidopa/Entacapone Oriona, bioraspoloživost levodope je viša u žena nego u muškaraca, u prvom redu zbog razlike u tjelesnoj težini, dok kod karbidope i entakapona ne postoje razlike među spolovima.
Taking into account the PRAC Assessment Report on the PSUR for carbidopa/entacapone/levodopa, the scientific conclusions of the CHMP are as follows:
Uzimajući u obzir PRAC-ovo izvješće o ocjeni periodičkog izvješća o neškodljivosti lijeka (PSUR) za karbidopu/entakapon/levodopu, znanstveni zaključci CHMP-a su sljedeći:
These include: - medicines used to treat depression such as moclobemide, amitriptyline, desipramine,
Među njih se ubrajaju: - lijekovi koji se koriste za liječenje depresije kao što su moklobemid, amitriptilin, dezipramin,
The safety of levodopa, carbidopa or entacapone in the infant is not known.
Sigurnost levodope, karbidope ili entakapona za dojenče nije poznata.
- 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 mogu dati lažno pozitivan rezultat za određivanje ketonskih tijela u mokraći test-trakicom, a ta se reakcija ne mijenja vrenjem uzorka mokraće.
Paediatric population: The safety and efficacy of Levodopa/Carbidopa/Entacapone Orion in children aged below 18 years have not been established.
Pedijatrijska populacija: sigurnost i djelotvornost Levodopa/Carbidopa/Entacapone Oriona u djece mlađe od 18 godina nisu ustanovljene.
Reduction of levodopa dose decreases the severity and frequency of these dopaminergic reactions.
Sniženje doze levodope smanjuje težinu i učestalost tih dopaminergičkih reakcija.
In repeated dose toxicity studies with entacapone, anaemia most likely due to iron chelating properties of entacapone was observed.
U ispitivanjima toksičnosti ponovljenih doza s entakaponom opažena je anemija, najvjerojatnije zbog svojstva entakapona da stvara kelate sa željezom.
On the basis of the scientific conclusions for carbidopa/entacapone/levodopa the CHMP is of the opinion that the benefit-risk balance of the medicinal products containing carbidopa/entacapone/levodopa is unchanged subject to the proposed changes to the product information.
Na temelju znanstvenih zaključaka za karbidopu/entakapon/levodopu, CHMP smatra da je omjer koristi i rizika lijekova koji sadrže karbidopu/entakapon/levodopu nepromijenjen, uz predložene izmjene informacija o lijeku.
Entacapone enhances the effects of levodopa.
Entakapon povećava učinke levodope.
*Adverse reactions that are mainly attributable to entacapone or are more frequent (by the frequency difference of at least 1% in the clinical trial data) with entacapone than levodopa/DDC inhibitor alone.
* Nuspojave koje su uglavnom pripisive entakaponu ili su češće (uz razliku u učestalosti od najmanje 1% u podacima iz kliničkih ispitivanja) uz entakapon nego uz samo levodopu/DDC-inhibitor.
Adverse reactions that are mainly attributable to entacapone or are more frequent with entacapone than levodopa/DDC inhibitor alone are indicated with an asterisk in Table 1, section 4.8b.
Nuspojave koje su uglavnom pripisive entakaponu ili su češće uz entakapon nego uz samo levodopu/DDC-inhibitor označene su zvjezdicom u Tablici 1, dio 4.8b.
When used with Levodopa/Carbidopa/Entacapone Orion, the daily dose of selegiline should not exceed 10 mg.
Kada se primijenjuje sa Levodopa/Carbidopa/Entacapone Orionom, dnevna doza selegilina ne smije prijeći 10 mg.
In such patients it is advisable to introduce entacapone treatment as a separate treatment (entacapone tablets) and adjust the levodopa dose if necessary, before switching to Levodopa/Carbidopa/Entacapone Orion.
Kod takvih bolesnika je preporučljivo uvesti entakapon kao odvojeni lijek (entakapon tablete) i po potrebi prilagoditi dozu levodope, prije prelaska na Levodopa/Carbidopa/Entacapone
Dopamine dysregulation syndrome is a well-recognised risk for dopaminergic medication used in Parkinson's disease.
Sindrom poremećene regulacije dopamina dobro je prepoznat rizik za dopaminergičke lijekove koji se koriste u terapiji Parkinsonove bolesti.
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.
U terapijskim koncentracijama, entakapon ne istiskuje druge djelatne tvari koje se vežu u velikoj mjeri (npr. varfarin, salicilna kiselina, fenilbutazon ili diazepam), niti ove tvari u terapijskim ili višim koncentracijama istiskuju entakapon u značajnijoj mjeri.
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, uključujući rabdomiolizu i hipertermiju, karakteristični su motorički simptomi (rigidnost, mioklonus, tremor), promjene mentalnog stanja (npr. agitacija, konfuzija, koma), hipertermija, autonomna disfunkcija (tahikardija, varijabilni krvni tlak) i povišena kreatin fosfokinaza u serumu.
Levodopa, the precursor of dopamine, crosses the blood brain barrier and relieves the symptoms of the disease.
Levodopa, prekursor dopamina, prelazi krvnomoždanu barijeru i olakšava simptome bolesti.
Detailed information on this medicine is available on the European Medicine's Agency web site: http://www.ema.europa.eu.
Detaljnije informacije o ovom lijeku dostupne su na internetskoj stranici Europske agencije za lijekove: http://www.ema.europa.eu.
When more levodopa is required, an increase in the frequency of doses and/or the use of an alternative strength of Levodopa/Carbidopa/Entacapone Orion should be considered, within the dose recommendations.
Kada je potrebno više levodope, treba razmotriti češće uzimanje doza i/ili korištenje alternativne jačine Levodopa/Carbidopa/Entacapone Oriona, u okviru preporuka za doziranje.
Levodopa/Carbidopa/Entacapone Orion should not be used during pregnancy unless the benefits for the mother outweigh the possible risks to the foetus.
Orion se ne smije primjenjivati tijekom trudnoće, osim ako je korist za majku veća od mogućih rizika za fetus.
Muscle, musculoskeletal and connective tissue pain*
Bol u mišićima, mišićnokoštana bol i bol vezivnog tkiva*
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).
Značajan broj bolesnika s Parkinsonovom bolešću liječen je kombinacijom levodope, karbidope i entakapona s nekoliko djelatnih tvari uključujući MAO-A inhibitore, tricikličke antidepresive, inhibitore ponovne pohrane noradrenalina kao što su dezipramin, maprotilin i venlafaksin, te lijekove koji se metaboliziraju putem COMT-a (npr. spojevi s kateholskom strukturom, paroksetin).
Experience with Levodopa/Carbidopa/Entacapone Orion in patients under 18 years is limited.
Iskustvo sa Levodopa/Carbidopa/Entacapone Orionom u bolesnika mlađih od 18 godina je ograničeno.
Dopamine dysregulation syndrome was included in five adverse drug reaction reports during this PSUR reporting period.
Sindrom poremećene regulacije dopamina bio je uključen u 5 prijava nuspojava tijekom ovog perioda koji pokriva PSUR.
Biotransformation and elimination: 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.
Biotransformacija i eliminacija: levodopa se ekstenzivno metabolizira u različite metabolite, a najvažniji putovi su dekarboksilacija pomoću dopa dekarboksilaze (DDC) i O-metilacija pomoću katehol-O-metiltransferaze (COMT).
There are no adequate data from the use of the combination of levodopa/carbidopa/entacapone in pregnant women.
Nema odgovarajućih podataka o primjeni kombinacije levodope/karbidope/entakapona u trudnica.
- In clinical studies, dopaminergic adverse reactions, e.g. dyskinesia, were more common in patients who received entacapone and dopamine agonists (such as bromocriptine), selegiline or amantadine compared to those who received placebo with this combination.
- U kliničkim su studijama neželjeni dopaminergički učinci, npr. diskinezija, bili češći u bolesnika koji su primali entakapon i agoniste dopamina (kao što je bromokriptin), selegilin ili amantadin, u usporedbi s onima koji su primali placebo s tom kombinacijom.
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.
Vezano uz reproduktivnu toksičnost entakapona, zabilježeno je smanjenje težine ploda i blago usporen razvoj kostiju u kunića tretiranih dozama kojima se postižu sistemske razine izloženosti u terapijskom rasponu.