FrancophonIA/ELRC3.0 huggingface dataset:
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 kod kojih se javila progresivna anoreksija, astenija i gubitak tjelesne težine u relativno kratkom vremenu potrebno je razmotriti opću provjeru zdravstvenog stanja uključujući i provjeru funkcije jetre.
English: If unacceptable dopaminergic adverse events were seen, the levodopa dose was to be adjusted.
Croatian: Ako su primijećeni neprihvatljivi dopaminergički štetni događaji, bilo je potrebno prilagoditi dozu levodope.
English: The European Medicines Agency has waived the obligation to submit the results of studies with opicapone in all subsets of the paediatric population with Parkinson's disease and motor fluctuations (see section 4.2 for information on paediatric use).
Croatian: Europska agencija za lijekove je izuzela obvezu podnošenja rezultata ispitivanja opikapona u svim podskupinama pedijatrijske populacije s Parkinsonovom bolesti i motoričkim fluktuacijama (vidjeti dio 4.2 za informacije o pedijatrijskoj primjeni).
English: In both studies, 783 patients were treated with 25 mg or 50 mg of opicapone or placebo.
Croatian: U oba ispitivanja 783 bolesnika liječeno je opikaponom u dozi od 25 mg ili 50 mg ili placebo.
English: a. ON-time without troublesome dyskinesias=ON-time with non-troublesome dyskinesias + ON-time without dyskinesias
Croatian: ON-vrijeme bez problematičnih diskinezija=ON-vrijeme s neproblematičnim diskinezijama + ON-vrijeme bez diskinezija
English: In the OL studies, all patients began at a dose of 25 mg opicapone for the first week (7 days), regardless of their prior treatment in the double-blind period.
Croatian: U otvorenim ispitivanjima svi bolesnici započeli su s uzimanjem doze od 25 mg opikapona u prvom tjednu ispitivanja (7 dana), neovisno o njihovom ranijem liječenju tijekom razdoblja dvostruko slijepog ispitivanja.
English: Hence, the precautions valid for levodopa treatment should also be taken into account for Ongentys.
Croatian: Stoga je potrebno mjere opreza koje vrijede za levodopu uzeti u obzir i za Ongentys.
English: If you stop taking Ongentys your doctor may need to adjust the dose of other medicines that you are taking to treat Parkinson's disease.
Croatian: Ako prestanete uzimati Ongentys, možda će Vaš liječnik morati prilagoditi dozu ostalih lijekova koje uzimate za liječenje Parkinsonove bolesti.
English: Opicapone enhances the effects of levodopa.
Croatian: Opikapon pojačava učinke levodope.
English: To reduce levodopa-related dopaminergic adverse reactions (e.g. dyskinesia, hallucinations, nausea, vomiting and orthostatic hypotension), it is often necessary to adjust the daily dose of levodopa by extending the dosing intervals and/or reducing the amount of levodopa per dose within the first days to first weeks after initiating treatment with Ongentys, according to the clinical condition of the patient (see section 4.2).
Croatian: Da bi se smanjile dopaminergičke nuspojave povezane s levodopom (npr. diskinezija, halucinacije, mučnina, povraćanje i ortostatska hipotenzija), često je potrebno prilagoditi dnevnu dozu levodope produžujući intervale između doza i/ili smanjujući količinu levodope po dozi unutar prvih dana ili tjedana nakon započinjanja liječenja Ongentysom, već prema kliničkom stanju bolesnika (vidjeti dio 4.2).
English: For other adverse events, the levodopa and/or opicapone dose could be adjusted.
Croatian: Za kontrolu ostalih štetnih događaja doza levodope i/ili opikapona mogla se je prilagoditi.
English: In vitro studies over the opicapone concentration range 0.3 to 30 mcg/mL showed that binding of 14C-opicapone to human plasma proteins is high (99.9%) and concentration-independent.
Croatian: In vitro ispitivanja s rasponom koncentracije opikapona od 0,3 do 30 µg/ml pokazala su da je vezivanje 14Copikapona za proteine ljudske plazme visoko (99,9%) i neovisno o koncentraciji.
English: Ongentys is not recommended during pregnancy and in women of childbearing potential not using contraception.
Croatian: Ne preporučuje se koristiti Ongentys tijekom trudnoće niti u žena reproduktivne dobi koje ne koriste kontracepciju.
English: If you have been told by your doctor that you have intolerance to some sugars, contact your doctor before taking this medicine.
Croatian: Ako vam je liječnik rekao da ne podnosite neke vrste šećera, obratite mu se prije nego uzmete ovaj lijek.
English: Some side effects may be caused by the increased effects of using Ongentys together with levodopa.
Croatian: Neke nuspojave mogu biti uzrokovane pojačanim učincima primjene Ongentysa zajedno s levodopom.
English: The efficacy and safety of opicapone has been demonstrated in two Phase 3 double-blind, placebo and active (Study 1 only) controlled studies in 1,027 randomized adult patients with Parkinson's disease treated with levodopa/DDCI (alone or in combination with other antiparkinsonian drugs) and end-ofdose motor fluctuations for up to 15 weeks.
Croatian: Djelotvornost i sigurnost opikapona pokazana je u dva dvostruko slijepa, placebom i aktivno (samo Ispitivanje 1) kontrolirana ispitivanja faze 3 u 1027 randomiziranih odraslih bolesnika s Parkinsonovom bolešću liječenih kombinacijom levodopa/DDCI (samom ili u kombinaciji s drugim antiparkinsonicima) i motoričkim fluktuacijama pri kraju doze sve do 15 tjedana.
English: Caution must be exercised in patients ≥ 85 years of age as there is limited experience in this age group.
Croatian: ≥ 85 godina, jer su iskustva s primjenom u populaciji te starosne dobi ograničena.
English: If one dose is missed, the next dose should be taken as scheduled.
Croatian: Ako se doza propusti, sljedeću dozu potrebno je uzeti prema uobičajenom rasporedu.
English: If Ongentys is discontinued it is necessary to adjust the dosing of the other antiparkinsonian treatments, especially levodopa, to achieve a sufficient level of control of the symptoms.
Croatian: Prekine li se uzimanje Ongentysa potrebno je prilagoditi doziranje ostalih lijekova za liječenje Parkinsonove bolesti, posebice levodope, kako bi se postigla zadovoljavajuća kontrola simptoma.
English: Fax: +351 22 986 61 90 e-mail: info@bial.com
Croatian: Faks: +351 22 986 61 90 e-mail: info@bial.com
English: Opicapone is a peripheral, selective and reversible catechol-O-methyltransferase (COMT) inhibitor endowed with a high binding affinity (sub-picomolar) that translates into a slow complex dissociation rate constant and a long duration of action (>24 hours) in vivo.
Croatian: Opikapon je periferni, selektivni i reverzibilni inhibitor katekol-O-metiltransferaze (COMT) karakteriziran visokim afinitetom vezivanja (subpikomolarno), što in vivo znači nisku konstantu brzine disocijacije kompleksa i dugo trajanje djelovanja (> 24 h).
English: There is no relevant use of Ongentys in the paediatric population with Parkinson's disease and motor fluctuations.
Croatian: Nema relevantne primjene Ongentysa u pedijatrijskoj populaciji s Parkinsonovom bolešću i motoričkim fluktuacijama.
English: In rats, opicapone did not affect male and female fertility or prenatal development at exposure levels 22 times the therapeutic exposure in humans.
Croatian: U štakora opikapon nije imao učinka na plodnost mužjaka i ženki i na prenatalni razvoj pri 22 puta većoj izloženosti od one terapijske u ljudi.
English: In in vitro studies in human hepatic microsomes, minor inhibition of CYP1A2 and CYP2B6 was observed.
Croatian: U in vitro ispitivanjima na mikrosomima ljudske jetre primijećena je manja inhibicija CYP1A2 i CYP2B6.
English: If you forget to take Ongentys
Croatian: Ako ste zaboravili uzeti Ongentys
English: OPA/Al/PVC//Al blisters containing 10 or 30 capsules.
Croatian: Blisteri OPA/Al/PVC//Al koji sadrže 10 ili 30 kapsula.
English: In pregnant rabbits, opicapone was less well tolerated resulting in maximum systemic exposure levels around or below the therapeutic range.
Croatian: U skotnih ženki kunića opikapon je bio manje podnošljiv rezultirajući s maksimalnim razinama sistemske izloženosti približne ili ispod terapijskog raspona.
English: In urine, the primary metabolite was the glucuronide metabolite of opicapone, while parent drug and other metabolites were generally below the limit of quantification.
Croatian: U mokraći je primarni metabolit bio glukuronid opikapona, dok su nepromijenjeni lijek i ostali metaboliti općenito bili ispod granica mjerljivosti.
English: It is not known if Ongentys passes into breast milk in humans.
Croatian: Nije poznato prelazi li Ongentys u majčino mlijeko u ljudi.
English: CYP2C8 and OATP1B1 substrates
Croatian: Supstrati za CYP2C8 i OATP1B1
English: Table 2 - Change in absolute OFF-time and ON-time (minutes) from baseline to endpoint Treatment
Croatian: Tablica 2 - Promjena u apsolutnom OFF- i ON-vremenu (u minutama) od početne vrijednosti do mjerne točke ishoda
English: Each hard capsule contains 171.9 mg of lactose (as monohydrate).
Croatian: Jedna tvrda kapsula sadrži 171,9 mg laktoze (u obliku hidrata).
English: There is no experience taking Ongentys and safinamide together.
Croatian: Nema iskustava s istodobnim uzimanjem Ongentysa i safinamida.
English: Monoamino oxidase (MAO) inhibitors
Croatian: Inhibitori monoaminooksidaze (MAO)
English: The recommended dose of opicapone is 50 mg.
Croatian: Preporučena doza opikapona je 50 mg.
English: Doses of other medicines to treat Parkinson's disease
Croatian: Doze ostalih lijekova za liječenje Parkinsonove bolesti
English: Taking Ongentys with these medicines may increase the risk of side effects.
Croatian: Uzimanje Ongentysa s tim lijekovima može povećati rizik od nuspojava.
English: There are no or limited amount of data from the use of opicapone in pregnant women.
Croatian: Nema podataka ili su podaci o primjeni opikapona u trudnica ograničeni.
English: Phaeochromocytoma, paraganglioma, or other catecholamine secreting neoplasms.
Croatian: Feokromocitom, paragangliom ili druge neoplazme koje izlučuju kateholamine.
English: Although embryo-foetal development was not negatively influenced in rabbits, the study is not considered predictive for human risk assessment.
Croatian: Iako opikapon nije negativno utjecao na embrionalni i fetalni razvoj kunića, rezultati ispitivanja ne smatraju se prediktivnima za ocjenu rizika u ljudi.
English: Opicapone may, together with levodopa, cause dizziness, symptomatic orthostatism and somnolence.
Croatian: Opikapon, zajedno s levodopom, može uzrokovati omaglicu, simptomatsku ortostazu i somnolenciju.
English: History of neuroleptic malignant syndrome and/or non-traumatic rhabdomyolysis.
Croatian: Neuroleptički maligni sindrom i/ili netraumatska rabdomioliza u anamnezi.
English: Medicinal products metabolised by COMT
Croatian: Lijekovi koji se metaboliziraju pomoću COMT-a
English: Table 3 - OFF-time responder rates at endpoint Response type
Croatian: Tablica 3 - omjeri respondera s obzirom na OFF-vrijeme u mjernoj točki ishoda Tip odgovora
English: There is no relationship between exposure of opicapone and body weight over the range of 40-100 kg.
Croatian: Izloženost opikaponu i tjelesna težina u rasponu od 40 do 100 kg međusobno nisu povezane.
English: Table 1 - Frequency of adverse reactions (MedDRA) in placebo-controlled Phase 3 studies System Organ Class
Croatian: Tablica 1 - Učestalost nuspojava (MedDRA) u placebom kontroliranim ispitivanjima faze 3 Klasifikacija organskih sustava
English: Opicapone in association with levodopa may have major influence on the ability to drive and use machines.
Croatian: Opikapon udružen s levodopom može značajno utjecati na sposobnost upravljanja vozilima i rada sa strojevima.
English: Study 1 Change in OFF-time
Croatian: Ispitivanje 1 Promjena u OFF-vremenu
English: Removal of opicapone by gastric lavage and/or inactivation by administering activated charcoal should be considered.
Croatian: Mora se razmotriti potreba uklanjanja opikapona ispiranjem želuca i/ili njegova inaktivacija primjenom aktivnog ugljena.
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS BLISTER OPA/Al/PVC//Al
Croatian: PODACI KOJE MORA NAJMANJE SADRŽAVATI BLISTER ILI STRIP BLISTER OPA/Al/PVC//Al
English: The results of the open-label (OL) extension studies of 1 year duration in 862 patients who continued treatment from the double-blind studies (Study 1-OL and Study 2-OL) indicated maintenance of the effect achieved during DB study periods.
Croatian: Rezultati nastavka otvorenih ispitivanja u trajanju od 1 godine na 862 bolesnika koji su nastavili liječenjem iz dvostruko slijepih ispitivanja (Otvoreno ispitivanje 1 i Otvoreno ispitivanje 2) pokazali su održavanje učinka postignutog tijekom perioda dvostruko slijepih ispitivanja.
English: Change in total ON-time without troublesome dyskinesiasa
Croatian: Promjena u ukupnom ON-vremenu bez problematičnih diskinezijaa
English: Your doctor may need to adjust your treatment; - medicines to treat asthma such as rimiterole or isoprenaline.
Croatian: Vaš će liječnik možda morati prilagoditi Vašu terapiju; - lijekove za liječenje astme poput rimiterola ili izoprenalina.
English: - The active substance is opicapone.
Croatian: - Djelatna tvar je opikapon.
English: A single dose study with opicapone 25 mg showed an average increase of 30 % in the rate, but not the extent, of exposure to repaglinide (a CYP2C8 substrate), when the two drugs were co-administered.
Croatian: Ispitivanje primjene jednokratne doze od 25 mg opikapona pokazalo je prosječni porast stope za 30% ali ne i opsega izloženosti repaglinidu, supstratu za CYP2C8, kada su se oba lijeka primjenjivala istodobno.
English: 10 hard capsules 30 hard capsules
Croatian: 10 tvrdih kapsula 30 tvrdih kapsula
English: If end-of-dose motor fluctuations were not sufficiently controlled and tolerability allowed, the opicapone dose could be increased to 50 mg.
Croatian: Ako motoričke fluktuacije na kraju doze nisu bile dovoljno kontrolirane, a podnošenje lijeka je to dopuštalo, doza opikapona mogla se je povećati na
English: Ongentys is for use in adults who are already taking medicines containing levodopa and DOPA decarboxylase inhibitors.
Croatian: Ongentys se primjenjuje u odraslih koji već uzimaju lijekove koji sadrže levodopu i inhibitore DOPA dekarboksilaze.
English: Opicapone is a weak in vitro inhibitor of CYP2C8 and OATP1B1, whereas repaglinide is a sensitive CYP2C8 and OATP1B1 substrate.
Croatian: Opikapon je slabi in vitro inhibitor CYP2C8 i OATP1B1, dok je repaglinid osjetljiv supstrat za CYP2C8 i OATP1B1.
English: If not sufficient to manage the adverse events, the opicapone dose could then be down titrated.
Croatian: Ako to nije bilo dovoljno za kontrolu štetnih događaja, doza opikapona mogla je postepeno biti smanjivana.
English: Therefore, it can be presumed that opicapone and its metabolites are mainly excreted in the faeces.
Croatian: Stoga se može pretpostaviti da se opikapon i njegovi metaboliti uglavnom izlučuju stolicom.
English: 10 hard capsules 30 hard capsules 90 hard capsules
Croatian: 10 tvrdih kapsula 30 tvrdih kapsula 90 tvrdih kapsula
English: Careful monitoring of patients being treated with these medicinal products is advised when opicapone is used.
Croatian: Savjetuje se pažljivi nadzor bolesnika liječenih opikaponom kada primaju ove lijekove.
English: It is unknown whether opicapone or its metabolites are excreted in human milk.
Croatian: Nije poznato izlučuju li se opikapon ili njegovi metaboliti u majčino mlijeko.
English: At clinically relevant concentrations, opicapone is not expected to inhibit OAT1, OAT3, OATP1B1, OATP1B3, OCT1, OCT2, BCRP, P-gp/MDR1, BSEP, MATE1 and MATE2-K transporters as suggested by in vitro and in vivo studies.
Croatian: U klinički relevantnim koncentracijama ne očekuje se da opikapon inhibira OAT1, OAT3, OATP1B1, OATP1B3, OCT1, OCT2, BCRP, P-gp/MDR1, BSEP, MATE1 i MATE2-K, kako sugeriraju in vitro i in vivo ispitivanja.
English: How to take Ongentys
Croatian: Kako uzimati Ongentys
English: White high density polyethylene (HDPE) bottles with polypropylene (PP) child resistant closures containing 10, 30 or 90 capsules.
Croatian: Bijele boce od polietilena visoke gustoće (HDPE) sa zatvaračem od polipropilena (PP) sigurnim za djecu, koje sadrže 10, 30 ili 90 kapsula.
English: Following once-daily multiple oral doses of opicapone in the dose range of 5 to 50 mg, opicapone sulphate presented a long terminal phase with elimination half-life values ranging from 94 h to 122 h and, as a consequence of this long terminal elimination half-life, opicapone sulphate presented a high accumulation ratio in plasma, with values close of up to 6.6.
Croatian: Nakon višekratne peroralne primjene opikapona, uz doziranjem jedanput na dan u rasponu od 5 do 50 mg, opikaponsulfat je imao dugu terminalnu fazu s vrijednostima poluvijeka eliminacije u rasponu od 94 do 122 h te je, kao posljedicu ovog dugog poluvijeka eliminacije, imao visok omjer akumulacije u plazmi s vrijednostima gotovo do 6,6.
English: In Study 1, 122 patients were treated with opicapone 5 mg and 122 patients were treated with entacapone 200 mg (active comparator).
Croatian: U Ispitivanju1 liječeno je 122 bolesnika opikaponom od 5 mg i 122 bolesnika entakaponom od 200 mg (aktivni komparator).
English: Caution must be exercised in these patients and dose adjustment may be necessary (see section
Croatian: Kod primjene u tih bolesnika potreban je oprez i može biti potrebno prilagođavanje doze (vidjeti dio 5.2).
English: It is used to treat Parkinson's disease and associated movement problems.
Croatian: Primjenjuje se za liječenje Parkinsonove bolesti i s njom povezanih teškoća s pokretima.
English: Ongentys is a medicine that contains the active substance opicapone.
Croatian: Ongentys je lijek koji sadrži djelatnu tvar opikapon.
English: There is no experience with opicapone when used concomitantly with the MAO-B inhibitor safinamide.
Croatian: Nema iskustva s istodobnom primjenom opikapona i MAO-B inhibitora safinamida.
English: In the table below (Table 1) all adverse reactions are presented by System Organ Class and frequency.
Croatian: U tablici u nastavku (Tablica 1) prikazane su sve nuspojave prema klasifikaciji organskih sustava i učestalosti.
English: Each hard capsule contains 148.2 mg of lactose (as monohydrate).
Croatian: Jedna tvrda kapsula sadrži 148,2 mg laktoze (u obliku hidrata).
English: The most abundant peaks in plasma after a single-dose of 100 mg 14C-opicapone are metabolites BIA 9-1103 (sulphate) and BIA 9-1104 (methylated), 67.1 and 20.5% of radioactive AUC respectively.
Croatian: Nakon primjene jednokratne doze od 100 mg 14C-opikapona najveće vršne koncentracije u plazmi imali su metaboliti BIA 9-1103 (sulfat) i BIA 9-1104 (metilirani), 67,1 odnosno 20,5% AUC radioaktivnosti.
English: Animal studies with opicapone do not indicate harmful effects with respect to fertility (see section 5.3).
Croatian: Ispitivanja opikapona na životinjama ne ukazuju na štetne učinke na plodnost (vidjeti dio 5.3).
English: Ongentys contains lactose
Croatian: Ongentys sadrži laktozu
English: Ongentys contains lactose.
Croatian: Ongentys sadrži laktozu.
English: Sulphation of opicapone appears to be the major metabolic pathway in humans, yielding the inactive opicapone sulphate metabolite.
Croatian: Čini se da je sulfatacija opikapona glavni metabolički put u ljudi, kojim nastaje nedjelatni metabolit opikaponsulfat.
English: The effects of opicapone on fertility in humans have not been studied.
Croatian: Učinci opikapona na plodnost u ljudi nisu ispitivani.
English: An in vitro study showed opicapone inhibited CYP2C8 activity.
Croatian: In vitro ispitivanje pokazalo je da opikapon inhibira aktivnost CYP2C8.
English: Following administration of a single oral dose of 14C-opicapone, the main excretion route of opicapone and its metabolites was faeces, accounting for 58.5% to 76.8% of the administered radioactivity (mean 67.2%).
Croatian: Nakon primjene jedne peroralne doze 14C-opikapona, glavni put izlučivanja opikapona i njegovih metabolita bio je putem stolice, na što se odnosilo 58,5% do 76,8% primijenjene radioaktivnosti (srednja vrijednost
English: A study conducted in healthy subjects showed that there were no changes in repaglinide's exposure when repaglinide was administered following multiple once-daily administration of opicapone 50 mg.
Croatian: Ispitivanje provedeno na zdravim ispitanicima pokazalo je da nije bilo promjene u izloženosti repaglinidu kada se repaglinid primjenjivao nakon višekratne primjene 50 mg opikapona jedanput dnevno.
English: Ongentys may increase their effect; - medicines used to treat allergic reactions such as adrenaline.
Croatian: Ongentys može pojačati njihov učinak; - lijekove koji se primjenjuju za liječenje alergijskih reakcija poput adrenalina.
English: Behaviours such as these have been reported in patients using other medicines for Parkinsons´s disease.
Croatian: Ovakvo ponašanje zabilježeno je i u bolesnika koji su uzimali druge lijekove za liječenje Parkinsonove bolesti.
English: A second study conducted showed that, at steady state, opicapone 50 mg had no effect on repaglinide systemic exposure.
Croatian: Drugo provedeno ispitivanje pokazalo je da u stanju dinamičke ravnoteže opikapon u dozi od 50 mg nije imao utjecaja na sistemsku izloženost repaglinidu.
English: Study 2 Change in OFF-time
Croatian: Ispitivanje 2 Promjena u OFF-vremenu
English: There is no clinical experience in patients with severe hepatic impairment (Child-Pugh Class C), therefore, Ongentys is not recommended in these patients (see section 5.2).
Croatian: Nema kliničkog iskustva s primjenom u bolesnika s teškim oštećenjem jetre (stupanj C prema ChildPughovoj klasifikaciji), stoga se Ongentys ne preporučuje u tih bolesnika (vidjeti dio 5.2).
English: No dose adjustment is needed for elderly patients (see section 5.2).
Croatian: Nije potrebno prilagođavanje doze u bolesnika starije dobi (vidjeti dio 5.2).
English: Your doctor may need to reconsider your treatment.
Croatian: Vaš liječnik će možda trebati razmotriti promjenu u liječenju.
English: However, an evaluation with 50 mg opicapone was performed in subjects included in both phase 3 studies with GFR/1.73 m2 <60 mL/min (i.e. moderately decreased renal elimination capacity), and using pooled BIA 9-1103 data (major metabolite of opicapone).
Croatian: Međutim, napravljena je procijena primjene 50 mg opikapona u ispitanika uključenih u oba ispitivanja faze 3 s brzinom glomerularne filtracije od < 60 ml/min/1,73 m2 (tj. umjereno oslabljene sposobnosti bubrežne eliminacije), korištenjem objedinjenih podataka za BIA 9-1103 (glavni metabolit opikapona).
English: At steady state, opicapone 50 mg significantly increased the extent of levodopa systemic exposure approximately 2 fold compared to placebo following a single oral administration of either 100/25 mg levodopa/carbidopa or 100/25 mg levodopa/benserazide administered 12 h after the opicapone dose.
Croatian: otprilike za 2 puta u usporedbi s placebom nakon jednokratne peroralne primjene 100/25 mg levodope/karbidope ili 100/25 mg levodope/benzerazida primijenjenih 12 sati nakon doze opikapona.
English: Breast-feeding should be discontinued during treatment with Ongentys.
Croatian: Dojenje treba prekinuti za vrijeme liječenja lijekom Ongentys.
English: The pharmacokinetics of opicapone was evaluated in healthy subjects and moderate chronic hepatic impaired patients after administration of a single-dose of 50 mg.
Croatian: Farmakokinetika opikapona procjenjivana je u zdravih ispitanika i u bolesnika s umjerenim kroničnim oštećenjem funkcije jetre nakon primjene jedne doze od 50 mg.
English: The difference in LS mean change in OFF-time of opicapone 50 mg to entacapone was -24.8 minutes and non-inferiority of opicapone 50 mg to entacapone was demonstrated (95% confidence interval: -61.4, 11.8).
Croatian: Razlika u LS srednjoj vrijednosti promjene OFFvremena između skupine koja je primala opikapon 50 mg i skupine koja je primala entakapon iznosila je24,8 minuta, te je pokazana neinferiornost opikapona 50 mg prema entakaponu (95% CI: -61,4; 11,8).
English: Effect of opicapone on transporters
Croatian: Učinak opikapona na transportere