FrancophonIA/ELRC3.0 huggingface dataset:
English: Taking into account the PRAC Assessment Report on the PSUR for carbidopa/entacapone/levodopa, the scientific conclusions of the CHMP are as follows:
Croatian: Uzimajući u obzir PRAC-ovo izvješće o ocjeni periodičkog izvješća o neškodljivosti lijeka (PSUR) za karbidopu/entakapon/levodopu, znanstveni zaključci CHMP-a su sljedeći:
English: These include: - medicines used to treat depression such as moclobemide, amitriptyline, desipramine,
Croatian: Među njih se ubrajaju: - lijekovi koji se koriste za liječenje depresije kao što su moklobemid, amitriptilin, dezipramin,
English: The safety of levodopa, carbidopa or entacapone in the infant is not known.
Croatian: Sigurnost levodope, karbidope ili entakapona za dojenče nije poznata.
English: - 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.
Croatian: - Levodopa/karbidopa mogu dati lažno pozitivan rezultat za određivanje ketonskih tijela u mokraći test-trakicom, a ta se reakcija ne mijenja vrenjem uzorka mokraće.
English: Paediatric population: The safety and efficacy of Levodopa/Carbidopa/Entacapone Orion in children aged below 18 years have not been established.
Croatian: Pedijatrijska populacija: sigurnost i djelotvornost Levodopa/Carbidopa/Entacapone Oriona u djece mlađe od 18 godina nisu ustanovljene.
English: Reduction of levodopa dose decreases the severity and frequency of these dopaminergic reactions.
Croatian: Sniženje doze levodope smanjuje težinu i učestalost tih dopaminergičkih reakcija.
English: In repeated dose toxicity studies with entacapone, anaemia most likely due to iron chelating properties of entacapone was observed.
Croatian: U ispitivanjima toksičnosti ponovljenih doza s entakaponom opažena je anemija, najvjerojatnije zbog svojstva entakapona da stvara kelate sa željezom.
English: 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.
Croatian: 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.
English: Entacapone enhances the effects of levodopa.
Croatian: Entakapon povećava učinke levodope.
English: *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.
Croatian: * 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.
English: 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.
Croatian: 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.
English: When used with Levodopa/Carbidopa/Entacapone Orion, the daily dose of selegiline should not exceed 10 mg.
Croatian: Kada se primijenjuje sa Levodopa/Carbidopa/Entacapone Orionom, dnevna doza selegilina ne smije prijeći 10 mg.
English: 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.
Croatian: Kod takvih bolesnika je preporučljivo uvesti entakapon kao odvojeni lijek (entakapon tablete) i po potrebi prilagoditi dozu levodope, prije prelaska na Levodopa/Carbidopa/Entacapone
English: Dopamine dysregulation syndrome is a well-recognised risk for dopaminergic medication used in Parkinson's disease.
Croatian: Sindrom poremećene regulacije dopamina dobro je prepoznat rizik za dopaminergičke lijekove koji se koriste u terapiji Parkinsonove bolesti.
English: 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.
Croatian: 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.
English: 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.
Croatian: 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.
English: Levodopa, the precursor of dopamine, crosses the blood brain barrier and relieves the symptoms of the disease.
Croatian: Levodopa, prekursor dopamina, prelazi krvnomoždanu barijeru i olakšava simptome bolesti.
English: Detailed information on this medicine is available on the European Medicine's Agency web site: http://www.ema.europa.eu.
Croatian: Detaljnije informacije o ovom lijeku dostupne su na internetskoj stranici Europske agencije za lijekove: http://www.ema.europa.eu.
English: 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.
Croatian: Kada je potrebno više levodope, treba razmotriti češće uzimanje doza i/ili korištenje alternativne jačine Levodopa/Carbidopa/Entacapone Oriona, u okviru preporuka za doziranje.
English: Levodopa/Carbidopa/Entacapone Orion should not be used during pregnancy unless the benefits for the mother outweigh the possible risks to the foetus.
Croatian: Orion se ne smije primjenjivati tijekom trudnoće, osim ako je korist za majku veća od mogućih rizika za fetus.
English: Muscle, musculoskeletal and connective tissue pain*
Croatian: Bol u mišićima, mišićnokoštana bol i bol vezivnog tkiva*
English: 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).
Croatian: 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).
English: Experience with Levodopa/Carbidopa/Entacapone Orion in patients under 18 years is limited.
Croatian: Iskustvo sa Levodopa/Carbidopa/Entacapone Orionom u bolesnika mlađih od 18 godina je ograničeno.
English: Dopamine dysregulation syndrome was included in five adverse drug reaction reports during this PSUR reporting period.
Croatian: Sindrom poremećene regulacije dopamina bio je uključen u 5 prijava nuspojava tijekom ovog perioda koji pokriva PSUR.
English: 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.
Croatian: 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).
English: There are no adequate data from the use of the combination of levodopa/carbidopa/entacapone in pregnant women.
Croatian: Nema odgovarajućih podataka o primjeni kombinacije levodope/karbidope/entakapona u trudnica.
English: - 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.
Croatian: - 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.
English: 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.
Croatian: 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.
English: Both levodopa and combinations of carbidopa and levodopa have caused visceral and skeletal malformations in rabbits.
Croatian: Levodopa, kao i kombinacija karbidope i levodope, izazvale su visceralne i koštane malformacije u kunića.
English: Due to short elimination half-lives, no true accumulation of levodopa or entacapone occurs on repeated administration.
Croatian: Zbog kratkog poluvremena eliminacije, prilikom ponovljene primjene zapravo ne dolazi do akumulacije levodope niti entakapona.
English: These include: - dopamine antagonists used to treat mental disorders, nausea and vomiting - phenytoin, used to prevent convulsions - papaverine used to relax the muscles.
Croatian: Među njih se ubrajaju: - antagonisti dopamina, koji se koriste za liječenje duševnih poremećaja, mučnine i povraćanja, - fenitoin, koji se koristi za sprječavanje konvulzija, - papaverin, koji se koristi za opuštanje mišića.
English: The most frequently reported adverse reactions with Levodopa/Carbidopa/Entacapone Orion are dyskinesias occurring in approximately 19% of patients; gastrointestinal symptoms including nausea and diarrhoea occurring in approximately 15% and 12% of patients, respectively; muscle, musculoskeletal and connective tissue pain occurring in approximately 12% of patients; and harmless reddish-brown discolouration of urine (chromaturia) occurring in approximately 10% of patients.
Croatian: Oriona su diskinezije koje se javljaju u otprilike 19% bolesnika; gastrointestinalni simptomi uključujući mučninu i proljev javljaju se u otprilike 15%, odnosno 12% bolesnika; bol u mišićima, mišićnokoštana bol i bol vezivnog tkiva javlja se u otprilike 12% bolesnika; te bezopasna crvenkasto-smeđa diskoloracija mokraće (kromaturija) javlja se u otprilike 10% bolesnika.
English: Myocardial infarction**
Croatian: Manje često: Infarkt miokarda**
English: Depression, hallucination, confusional state*, abnormal dreams*, anxiety, insomnia
Croatian: Depresija, halucinacija, konfuzno stanje *, poremećeni snovi*, anksioznost, nesanica Manje često: Psihoza, agitacija*
English: Levodopa is excreted in human breast milk.
Croatian: Levodopa se izlučuje u majčino mlijeko u ljudi.
English: Other adverse reactions with an asterisk in Table 1, section 4.8b are marked based on either their more frequent occurring (by the frequency difference of at least 1%) in the clinical trial data with entacapone than levodopa/DDCI alone or the individual case safety reports received after the introduction of entacapone into the market.
Croatian: Ostale nuspojave sa zvjezdicom u Tablici 1., dijelu 4.8b su označene ili zbog veće učestalosti javljanja (uz razliku u učestalosti od najmanje 1%) u podacima iz kliničkih ispitivanja uz entakapon nego uz samo levodopu/DDC-inhibitor ili zbog sigurnosnih izvješća o pojedinačnom slučaju zaprimljenih nakon uvođenja entakapona na tržište.
English: Patients being treated with Levodopa/Carbidopa/Entacapone Orion 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).
Croatian: Bolesnike, koji su liječeni Levodopa/Carbidopa/Entacapone Orionom i u kojih se javlja somnolencija i/ili imaju epizode iznenadnog nastupa sna, mora se uputiti da se suzdrže od upravljanja vozilima ili od aktivnosti u kojima zbog poremećene budnosti oni ili druge osobe mogu biti pod rizikom od ozbiljne ozljede ili smrti (npr. rad sa strojevima), sve dok takve ponavljajuće epizode ne prestanu (vidjeti dio
English: Other antiparkinsonian medicinal products: To date there has been no indication of interactions that would preclude concurrent use of standard antiparkinsonian medicinal products with Levodopa/Carbidopa/Entacapone Orion therapy.
Croatian: Drugi antiparkinsonici: do sada nema naznaka interakcija koje bi isključivale istodobnu primjenu standardnih antiparkinsonika uz liječenje Levodopa/Carbidopa/Entacapone Orionom.
English: Your doctor may take some regular laboratory tests during a long term treatment with Levodopa/Carbidopa/Entacapone Orion.
Croatian: Vaš će Vam liječnik možda napraviti neke redovite laboratorijske pretrage tijekom dugotrajnog liječenja Levodopa/Carbidopa/Entacapone Orionom.
English: - a liver problem, because your dose may need to be adjusted - kidney or hormone-related diseases - stomach ulcers or convulsions - if you experience prolonged diarrhoea consult your doctor as it may be a sign of inflammation of the colon - any form of severe mental disorder like psychosis - chronic wide-angle glaucoma, because your dose may need to be adjusted and the pressure in your eyes may need to be monitored.
Croatian: - probleme s jetrom, jer tada Vašu dozu možda treba prilagoditi, - bolesti povezane s bubrezima ili hormonima, - čireve želuca ili konvulzije, - ako dobijete dugotrajan proljev posavjetujte se sa svojim liječnikom, jer to može biti znak upale debelog crijeva, - bilo kakav oblik teškog duševnog poremećaja poput psihoze, - kronični glaukom otvorenog kuta, jer tada Vašu dozu možda treba prilagoditi i pratiti očni tlak.
English: 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.
Croatian: Interakcije između entakapona i selegilina ispitivane su u studijama ponovljenih doza u bolesnika s Parkinsonovom bolešću liječenih levodopom/DDC-inhibitorom te nisu opažene nikakve interakcije.
English: If any of this happens, contact your doctor immediately - feel depressed, have suicidal thoughts, or notice unusual changes in your behaviour - find yourself suddenly falling asleep, or if you feel very drowsy.
Croatian: - osjetite depresiju, ako imate samoubilačke misli ili primjećujete neobične promjene u svome ponašanju, - ustanovite da iznenada zapadate u san ili osjećate jaku pospanost.
English: Very common (may affect more than 1 in 10 people) - uncontrolled movements (dyskinesias) - feeling sick (nausea) - harmless reddish-brown discolouration of urine - muscle pain - diarrhoea
Croatian: Vrlo često (može se javiti kod više od 1 na 10 osoba) - nekontrolirani pokreti (diskinezije) - mučnina - bezopasna crvenkasto-smeđa promjena boje mokraće - bol u mišićima - proljev.
English: Patients and carers should be made aware that behavioural symptoms of impulse control disorders including pathological gambling, increased libido, hypersexuality, compulsive spending or buying, binge eating and compulsive eating can occur in patients treated with dopamine agonists and/or other dopaminergic treatments containing levodopa including Levodopa/Carbidopa/Entacapone Orion.
Croatian: Bolesnici i skrbnici trebaju znati da se simptomi u ponašanju kod poremećaja kontrole impulsa uključujući patološko kockanje, pojačani libido, hiperseksualnost, kompulzivno trošenje ili kupovanje, prejedanje i kompulzivno jedenje mogu javiti u bolesnika liječenih agonistima dopamina i/ili drugim dopaminergičkim lijekovima koji sadrže levodopu, uključujući Levodopa/Carbidopa/Entacapone Orion.
English: Impulse control disorders: Pathological gambling, increased libido, hypersexuality, compulsive spending or buying, binge eating and compulsive eating can occur in patients treated with dopamine agonists and/or other dopaminergic treatments containing levodopa including Levodopa/Carbidopa/Entacapone Orion (see section 4.4).
Croatian: Poremećaji kontrole impulsa: Patološko kockanje, pojačani libido, hiperseksualnost, kompulzivno trošenje ili kupovanje, prejedanje i kompulzivno jedenje mogu se javiti u bolesnika liječenih agonistima dopamina i/ili drugim dopaminergičkim lijekovima koji sadrže levodopu, uključujući Levodopa/Carbidopa/Entacapone Orion (vidjeti dio 4.4).
English: Convulsions have occurred rarely with levodopa/carbidopa; however a causal relationship to levodopa/carbidopa therapy has not been established.
Croatian: Konvulzije su se rijetko javile uz levodopu/karbidopu; međutim uzročna veza s liječenjem levodopom/karbidopom nije utvrđena.
English: Levodopa and entacapone may form chelates with iron in the gastrointestinal tract.
Croatian: Levodopa i entakapon mogu stvarati kelate sa željezom u probavnom traktu.
English: For adults and elderly: - Your doctor will tell you exactly how many tablets of Levodopa/Carbidopa/Entacapone Orion to take each day.
Croatian: Odrasli i starije osobe: - Vaš liječnik će odrediti točno koliko tableta Levodopa/Carbidopa/Entacapone
English: Few adverse reactions are known to be directly attributable to the active substance entacapone including diarrhoea and reddish-brown discolouration of urine.
Croatian: Mali broj nuspojava za koje se zna da su direktno pripisive djelatnoj tvari entakaponu obuhvaća proljev i crvenkasto-smeđu diskoloraciju mokraće.
English: - Coadministration of Levodopa/Carbidopa/Entacapone Orion with non-selective monoamine oxidase (MAO-A and MAO-B) inhibitors (e.g. phenelzine, tranylcypromine).
Croatian: - Istodobna primjena Levodopa/Carbidopa/Entacapone Oriona s neselektivnim inhibitorima monoaminooksidaze (MAO-A i MAO-B) (npr. fenelzin, tranilcipromin).
English: The Package leaflet is updated accordingly.
Croatian: Uputa o lijeku je ažurirana u skladu s tim.
English: Therefore, the use of Levodopa/Carbidopa/Entacapone Orion in children or adolescents is not recommended.
Croatian: Stoga se primjena Levodopa/Carbidopa/Entacapone Oriona u djece ili adolescenata ne preporučuje.
English: Diarrhoea*, nausea*
Croatian: Proljev*, mučnina*
English: - A previous history of Neuroleptic Malignant Syndrome (NMS) and/or non-traumatic rhabdomyolysis.
Croatian: - Neuroleptički maligni sindrom (NMS) i/ili netraumatska rabdomioliza u anamnezi.
English: If you must undergo surgery, please tell your doctor that you are using Levodopa/Carbidopa/Entacapone Orion.
Croatian: Ako morate na kirurški zahvat, obavijestite svog liječnika da uzimate Levodopa/Carbidopa/Entacapone
English: - Levodopa/Carbidopa/Entacapone Orion contains sucrose, and therefore patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucraseisomaltase insufficiency should not take this medicine.
Croatian: Orion sadržava saharozu te stoga bolesnici s rijetkim nasljednim problemima nepodnošenja fruktoze, malapsorpcije glukoze-galaktoze ili nedostatka saharaza-izomaltaze ne bi smjeli uzimati ovaj lijek.
English: Pyridoxine, however, is not effective in reversing the actions of Levodopa/Carbidopa/Entacapone Orion.
Croatian: Piridoksin, međutim, nije učinkovit u suzbijanju djelovanja Levodopa/Carbidopa/Entacapone Oriona.
English: maprotiline, venlafaxine and paroxetine, - rimiterole and isoprenaline, used to treat respiratory diseases - adrenaline, used for severe allergic reactions - noradrenaline, dopamine and dobutamine, used to treat heart diseases and low blood pressure - alpha-methyldopa, used to treat high blood pressure - apomorphine, which is used to treat Parkinson's disease.
Croatian: maprotilin, venlafaksin i paroksetin, - rimiterol i izoprenalin, koji se koriste za liječenje respiratornih bolesti, - adrenalin, koji se koristi za teške alergijske reakcije, - noradrenalin, dopamin i dobutamin, koji se koriste za liječenje srčanih bolesti i niskog krvnog tlaka, - alfa-metildopu, koja se koristi za liječenje visokog krvnog tlaka, - apomorfin, koji se koristi za liječenje Parkinsonove bolesti.
English: For some patients, Levodopa/Carbidopa/Entacapone Orion may not be well absorbed if it is taken with, or shortly after eating protein-rich food (such as meats, fish, dairy products, seeds and nuts).
Croatian: Orion možda neće dobro apsorbirati ako se uzme tijekom ili kratko nakon obroka bogatog bjelančevinama (npr. meso, riba, mliječni proizvodi, sjemenke i orašasti plodovi).
English: 150 mg/37.5 mg/200 mg tablets, do not take more than 10 tablets per day.
Croatian: 150 mg/37,5 mg/200 mg tablete ne smijete uzeti više od 10 tableta na dan.
English: - are allergic to levodopa, carbidopa or entacapone, or any of the other ingredients of this medicine (listed in section 6) - have narrow-angle glaucoma (an eye disorder) - have a tumour of the adrenal gland - are taking certain medicines for treating depression (combinations of selective MAO-A and
Croatian: - ako ste alergični na levodopu, karbidopu ili entakapon, ili neki drugi sastojak ovog lijeka (naveden u dijelu 6.), - ako imate glaukom zatvorenog kuta (očni poremećaj), - ako imate tumor nadbubrežne žlijezde, - ako uzimate određene lijekove za liječenje depresije (kombinaciju selektivnih MAO-A i MAO-B
English: Discontinuation of Levodopa/Carbidopa/Entacapone Orion therapy: If Levodopa/Carbidopa/Entacapone Orion treatment (levodopa/carbidopa/entacapone) is discontinued and the patient is transferred to levodopa/DDC inhibitor therapy without entacapone, it is necessary to adjust the dosing of other antiparkinsonian treatments, especially levodopa, to achieve a sufficient level of control of the parkinsonian symptoms.
Croatian: Orionom: ako se liječenje Levodopa/Carbidopa/Entacapone Orionom (levodopa/karbidopa/entakapon) prekida i bolesnici prelaze na terapiju levodopom/DDC-inhibitorom bez entakapona, potrebno je prilagoditi doziranje drugog antiparkinsonika, osobito levodope, da bi se postigla dovoljna razina kontrole simptoma parkinsonizma.
English: 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 adverse reactions such as nausea is reduced.
Croatian: Kada se istodobnom primjenom DDCinhibitora smanji dekarboksilacija levodope, može se koristiti niža doza levodope, čime se smanjuje učestalost nuspojava kao što je mučnina.
English: time with and without entacapone was recorded in home-diaries by patients.
Croatian: Dnevno trajanje "ON" faze sa ili bez entakapona bolesnici su bilježili u dnevnik.
English: Consult your doctor if during the treatment with Levodopa/Carbidopa/Entacapone Orion you: - notice that your muscles get very rigid or jerk violently, or if you get tremors, agitation, confusion, fever, rapid pulse, or wide fluctuations in your blood pressure.
Croatian: Savjetujte se sa svojim liječnikom ako tijekom liječenja Levodopa/Carbidopa/Entacapone Orionom: - primijetite da Vam mišići postaju jako ukočeni ili se snažno trzaju, ako se pojavi drhtanje, uznemirenost, smetenost, vrućica, ubrzani puls ili izrazite promjene krvnoga tlaka.
English: The starting dose of Levodopa/Carbidopa/Entacapone Orion should provide either the same amount of levodopa or slightly (5-10%) more.
Croatian: Oriona koje osigurava istu količinu levodope ili malo (5-10%) veću.