FrancophonIA/ELRC3.0 huggingface dataset:
English: - Concomitant administration of antipsychotics with dopamine receptor-blocking properties, 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.
Croatian: - Istovremenu primjenu antipsihotika sa svojstvima blokiranja dopaminskih receptora, posebno antagonista D2 receptora, treba provoditi s oprezom, a bolesnika treba pažljivo promatrati radi gubitka antiparkinsonskog učinka ili pogoršanja simptoma parkinsonizma.
English: However, after combination of carbidopa with levodopa, the absorption of levodopa is similar between the elderly and the young people, but the AUC is still 1.5 fold greater in the elderly due to decreased DDC activity and lower clearance by aging.
Croatian: Međutim, nakon kombinacije karbidope s levodopom, apsorpcija levodope je slična kod starijih i mlađih osoba, ali je AUC još uvijek 1,5 puta veći u starijih zbog smanjene aktivnosti DDC-a i nižeg klirensa sa starenjem.
English: Dose adjustment of the antihypertensive agent may be required.
Croatian: Može biti potrebno prilagođavanje doze antihipertenziva.
English: - Severe hepatic impairment.
Croatian: - Teško oštećenje jetre.
English: The following side effects have also been reported: - hepatitis (inflammation of the liver) - itching
Croatian: Sljedeće nuspojave su također zabilježene: - hepatitis (upala jetre) - svrbež
English: You may experience the following side effects: - Inability to resist the impulse to perform an action that could be harmful, which may include: - strong impulse to gamble excessively despite serious personal or family consequences - altered or increased sexual interest and behaviour of significant concern to you or to others, for example, an increased sexual drive - uncontrollable excessive shopping or spending - binge eating (eating large amounts of food in a short time period) or compulsive eating (eating more food than normal and more than is needed to satisfy your hunger).
Croatian: Možda ćete osjetiti slijedeće nuspojave: - Nemogućnost odupiranja impulsu za neki postupak koji može biti štetan, što može uključivati: - snažan impuls za prekomjerno kockanje usprkos teškim osobnim ili obiteljskim posljedicama - promijenjeno ili povećano zanimanje za seks i ponašanje koje značajno zabrinjava Vas i druge, na primjer, pojačani seksualni nagon - nekontrolirano prekomjerno kupovanje ili trošenje - prejedanje (jedenje velikih količina hrane u kratkom vremenskom razdoblju) ili kompulzivno jedenje (jedenje više hrane nego obično i više nego je potrebno za utoliti glad).
English: This corresponded to an 8.3% increase in the proportion of daily ON time.
Croatian: To je odgovaralo porastu dnevnog trajanja "ON" faze od 8,3%.
English: - Pheochromocytoma.
Croatian: - Feokromocitom.
English: Both levodopa and entacapone are rapidly absorbed and eliminated.
Croatian: Levodopa i entakapon se brzo apsorbiraju i eliminiraju.
English: Correspondingly, the daily OFF time decreased by 18% on entacapone and by 5% on placebo.
Croatian: U skladu s time, dnevno trajanje "OFF" faze smanjilo se za 18% s entakaponom i 5% s placebom.
English: Elderly: When given without carbidopa and entacapone, the absorption of levodopa is greater and elimination is slower in elderly than in young people.
Croatian: Starije osobe: kada se daje bez karbidope i entakapona, apsorpcija levodope je veća i izlučivanje polaganije u starijih nego u mlađih osoba.
English: It may therefore be necessary, particularly in patients with dyskinesia, to reduce levodopa dose by 10-30% within the first days to first weeks after initiating Levodopa/Carbidopa/Entacapone Orion treatment.
Croatian: Stoga može biti potrebno, posebno kod bolesnika s diskinezijom, smanjiti dozu levodope za 10-30% unutar prvih nekoliko dana ili tjedana po započinjanju liječenja Levodopa/Carbidopa/Entacapone Orionom.
English: Dopamine does not cross the blood-brain barrier.
Croatian: Dopamin ne prolazi krvnomoždanu barijeru.
English: Prolonged or persistent diarrhoea appearing during use of entacapone may be a sign of colitis.
Croatian: Pojava dugotrajne ili ustrajne dijareje tijekom primjene entakapona može biti znak za kolitis.
English: According to the current understanding, the symptoms of Parkinson's disease are related to depletion of dopamine in the corpus striatum.
Croatian: Prema sadašnjem shvaćanju, simptomi Parkinsonove bolesti su povezani s pražnjenjem dopamina u corpusu striatumu.
English: - For patients experiencing diarrhoea, a follow-up of weight is recommended in order to avoid potential excessive weight decrease.
Croatian: - Kod bolesnika koji imaju proljev, preporučuje se praćenje tjelesne težine kako bi se izbjegla mogućnost prekomjernog smanjenja tjelesne težine.
English: Levodopa increases the amount of dopamine and hence reduces the symptoms of Parkinson's disease.
Croatian: Levodopa povećava količinu dopamina i na taj način smanjuje simptome Parkinsonove bolesti.
English: There is evidence that breast-feeding is suppressed during treatment with levodopa.
Croatian: Postoje dokazi da je laktacija suprimirana tijekom liječenja levodopom.
English: The daily dose of levodopa can be reduced by extending the dosing intervals and/or by reducing the amount of levodopa per dose, according to the clinical condition of the patient.
Croatian: Dnevna doza levodope može biti smanjena produljenjem intervala doziranja i/ili smanjenjem količine levodope po dozi, u skladu s kliničkim stanjem bolesnika.
English: The adequacy of the respiratory, circulatory and renal systems should be carefully monitored and appropriate supportive measures employed.
Croatian: Stanje respiratornog, cirkulatornog i bubrežnog sustava mora se pažljivo pratiti te se moraju poduzeti odgovarajuće suportivne mjere.
English: Contains sucrose.
Croatian: Sadrži saharozu.
English: In the second study, the mean proportion of daily ON time increased by 4.5% (CI95% 0.93%, 7.97%) from baseline.
Croatian: U drugom ispitivanju, srednja vrijednost udjela dnevnog trajanja "ON" faze bila je povišena za 4,5% (CI 95% 0,93%, 7,97%) u odnosu na početnu vrijednost.
English: Data from in vitro studies using human liver microsomal preparations indicate that entacapone inhibits cytochrome P450 2C9 (IC50 ~ 4 µM).
Croatian: Podaci iz in vitro ispitivanja uz korištenje humanih jetrenih mikrosomalnih preparata ukazuju da entakapon inhibira citokrom P450 2C9 (IC50 ~ 4 μM).
English: If you have been told by your doctor that you have intolerance to some sugars, contact your doctor before taking this medicinal product.
Croatian: Ako Vam je liječnik rekao da ne podnosite neke šećere, savjetujte se s liječnikom prije uzimanja ovog lijeka.
English: If this happens, you should not drive or use any tools or machines (see also section 'Driving and using machines') - notice that uncontrolled movements begin or get worse after you started to take Levodopa/Carbidopa/Entacapone Orion.
Croatian: Ako se to dogodi, ne smijete voziti niti rukovati alatima ili strojevima (vidjeti također dio "Upravljanje vozilima i strojevima"), - primijetite pojavu nekontroliranih pokreta ili se oni pogoršaju nakon što počnete uzimati Levodopa/Carbidopa/Entacapone Orion.
English: Levodopa/Carbidopa/Entacapone Orion and iron preparations should be taken at least 2-3 hours apart (see section 4.8).
Croatian: Oriona i preparata željeza mora iznositi najmanje 2-3 sata (vidjeti dio 4.8).
English: 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.
Croatian: Levodopa se veže na bjelančevine plazme samo malim udjelom od oko 10-30%, karbidopa se veže otprilike 36%, dok se entakapon ekstenzivno veže na bjelančevine plazme (oko 98%), uglavnom na serumski albumin.
English: 2D barcode carrying the unique identifier included [carton only]
Croatian: Sadrži 2D barkod s jedinstvenim identifikatorom. [samo kutija]
English: For severe hepatic impairment see section 4.3.
Croatian: Za teško oštećenje jetre vidjeti dio 4.3.
English: Interactions between entacapone and imipramine and between entacapone and moclobemide have been investigated in single dose studies in healthy volunteers.
Croatian: Interakcije između entakapona i imipramina te između entakapona i moklobemida ispitivane su u studijama s jednokratnom dozom u zdravih dobrovoljaca.
English: Suicidal behaviour, Dopamine dysregulation syndrome
Croatian: Suicidalno ponašanje, sindrom poremećene regulacije dopamina
English: - Allergic reaction, the signs may include hives (nettle rash), itching, rash, swelling of your face, lips, tongue or throat.
Croatian: - Alergijska reakcija, čiji znakovi mogu uključivati urtikariju (koprivnjaču), svrbež, osip, oticanje lica, usana, jezika ili grla.
English: ANNEX IV
Croatian: PRILOG IV
English: 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.
Croatian: 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.
English: Entacapone slows the clearance of levodopa from the bloodstream resulting in an increased area under the curve (AUC) in the pharmacokinetic profile of levodopa.
Croatian: Entakapon usporava klirens levodope iz krvotoka čime se postiže povećanje površine ispod krivulje (AUC) u farmakokinetičkom profilu levodope.
English: 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.
Croatian: 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.
English: - 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.
Croatian: - 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.
English: 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.
Croatian: 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.
English: 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.
Croatian: 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.
English: Therefore, caution should be exercised when driving or using machines.
Croatian: Stoga je potreban oprez pri upravljanju vozilima ili radu sa strojevima.
English: Other active substances: Dopamine receptor antagonists (e.g. some antipsychotics and antiemetics), phenytoin and papaverine may reduce the therapeutic effect of levodopa.
Croatian: Ostale djelatne tvari: antagonisti dopaminskih receptora (npr. neki antipsihotici i antiemetici), fenitoin i papaverin mogu smanjiti terapijski učinak levodope.
English: 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.
Croatian: Karbidopa i benzerazid su periferni DDC-inhibitori koji smanjuju periferni metabolizam levodope u dopamin i time je više levodope raspoloživo za mozak.
English: According to in vitro studies, significant displacement is not anticipated at therapeutic concentrations of the medicinal products.
Croatian: Prema in vitro ispitivanjima ne očekuje se značajno istiskivanje u terapijskim koncentracijama lijekova.
English: Entacapone is a reversible, specific and mainly peripherally acting COMT inhibitor designed for concomitant administration with levodopa.
Croatian: Entakapon je reverzibilan, specifičan i uglavnom periferno aktivan COMT inhibitor namijenjen za istodobnu primjenu s levodopom.
English: 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.
Croatian: 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.
English: 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.
Croatian: 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.
English: 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.
Croatian: 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.
English: Carbidopa and entacapone were excreted in milk in animals but is not known whether they are excreted in human breast milk.
Croatian: Kod životinja se karbidopa i entakapon izlučuju u mlijeko, ali nije poznato da li se izlučuju u majčino mlijeko u ljudi.
English: Entacapone in association with levodopa has been associated with isolated cases of excessive daytime somnolence and sudden sleep onset episodes.
Croatian: Entakapon udružen s levodopom bio je povezan s izoliranim slučajevima pretjerane somnolencije tijekom dana i epizodama iznenadnog nastupa sna.
English: Do not use this medicine after the expiry date which is stated on the bottle and the carton after EXP.
Croatian: Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na bočici i kutiji iza oznake „Rok valjanosti“.
English: Hospitalisation is advised and general supportive measures should be employed with immediate gastric lavage and repeated doses of charcoal over time.
Croatian: Savjetuje se hospitalizacija, a moraju se poduzeti opće suportivne mjere s hitnim ispiranjem želuca i ponavljanom primjenom aktivnog ugljena kroz određeno vrijeme.
English: Absorption/distribution: There are substantial inter- and intra-individual variations in the absorption of levodopa, carbidopa and entacapone.
Croatian: Apsorpcija/distribucija: postoje značajne inter- i intraindividualne razlike u apsorpciji levodope, karbidope i entakapona.
English: Characteristics in patients
Croatian: Karakteristike bolesnika
English: 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.
Croatian: 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.
English: Parkinson's disease is caused by low levels of a substance called dopamine in the brain.
Croatian: Parkinsonovu bolest uzrokuju niske razine tvari u mozgu zvane dopamin.
English: Patients with past or current psychosis should be treated with caution.
Croatian: Bolesnike s trenutnom psihozom, ili s psihozom u anamnezi, treba oprezno liječiti.
English: 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.
Croatian: 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.
English: Carbidopa is metabolized to two main metabolites which are excreted in the urine as glucuronides and unconjugated compounds.
Croatian: Karbidopa se metabolizira u dva glavna metabolita koji se izlučuju mokraćom kao glukuronidi i nekonjugirani spojevi.
English: Ischemic heart disease events other than myocardial infarction (e.g. angina pectoris)**, irregular heart rhythm
Croatian: Događaji vezani uz ishemičku srčanu bolest osim infarkta miokarda (npr. angina pektoris)**, nepravilan srčani ritam
English: 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).
Croatian: 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).
English: Rhabdomyolysis*
Croatian: Rabdomioliza*
English: Before initiation of treatment, patients and caregivers should be warned of the potential risk of developing DDS (see also section 4.8).
Croatian: Prije uvođenja liječenja bolesnike i njihove njegovatelje potrebno je upozoriti na mogući rizik od razvoja sindroma poremećene regulacije dopamina (vidjeti i dio 4.8).
English: Fertility studies in animals have not been conducted with the combination of entacapone, levodopa and carbidopa.
Croatian: Ispitivanja plodnosti u životinja nisu provedena s kombinacijom entakapona, levodope i karbidope.
English: General characteristics of the active substances
Croatian: Opća svojstva djelatnih tvari
English: 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.
Croatian: Neke od tih nuspojava povezane su s povišenom dopaminergičkom aktivnosti (npr. diskinezija, mučnina i povraćanje) i najčešće se javljaju na početku liječenja.
English: Cumulatively, dopamine dysregulation syndrome has been included in 10 reports.
Croatian: Kumulativno je sindrom poremećene regulacije dopamina uključen u 10 prijava.
English: 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).
Croatian: 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).
English: - 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.
Croatian: - 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.
English: Caution should be exercised when the following active substances are administered concomitantly with levodopa therapy.
Croatian: Potreban je oprez kada se sljedeće djelatne tvari istodobno primijenjuju s levodopom:
English: The CHMP recommends that the terms of the Marketing Authorisations should be varied.
Croatian: CHMP predlaže izmjenu uvjeta odobrenja za stavljanje lijeka u promet.
English: Carbidopa and entacapone improve the antiparkinson effects of levodopa.
Croatian: Karbidopa i entakapon poboljšavaju antiparkinsonske učinke levodope.
English: 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.
Croatian: 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.
English: Dopamine dysregulation syndrome (DDS) is described as a compulsive pattern of dopaminergic misuse above doses adequate to control motor symptoms.
Croatian: Dopamine dysregulation syndrome DDS) opisan je kao kompulzivni obrazac pogrešne primjene dopaminergičkih lijekova iznad doza dovoljnih za kontrolu motoričkih simptoma.
English: Review of treatment is recommended if such symptoms develop.
Croatian: Ako se razviju takvi simptomi, preporučuje se preispitivanje liječenja.
English: 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.
Croatian: 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.
English: 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).
Croatian: 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).
English: 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.
Croatian: U slučaju predoziranja možete se osjećati smeteno ili uznemireno, puls može biti sporiji ili brži od normalnog ili se boja
English: 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.
Croatian: 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.
English: - 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).
Croatian: - 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).
English: Renal impairment: Renal impairment does not affect the pharmacokinetics of entacapone.
Croatian: Oštećenje bubrega: oštećenje bubrega ne utječe na farmakokinetiku entakapona.
English: Chromaturia*
Croatian: Kromaturija*
English: 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.
Croatian: 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.