FrancophonIA/ELRC3.0 huggingface dataset:
English: In pregnant rabbits, opicapone was less well tolerated resulting in maximum systemic exposure levels around or below the therapeutic range.
Slovenian: Breje samice kuncev so opikapon slabše prenašale, zaradi česar so bile pri njih največje sistemske ravni izpostavljenosti okoli terapevtskega razpona ali pod njim.
English: HDPE bottles: 3 years Blisters: 5 years
Slovenian: Pretisni omoti: 5 let
English: If you forget to take Ongentys
Slovenian: Če ste pozabili vzeti zdravilo Ongentys
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).
Slovenian: Za zmanjšanje z levodopo povezanih dopaminergičnih neželenih učinkov (npr. diskinezija, halucinacije, navzea, bruhanje in ortostatska hipotenzija) je pogosto treba prilagoditi dnevni odmerek levodope s podaljšanjem intervalov odmerjanja in/ali zmanjšanjem količine levodope na odmerek v prvih dneh ali tednih po začetku zdravljenja z zdravilom Ongentys, v skladu s kliničnim stanjem bolnika (glejte poglavje 4.2).
English: Phaeochromocytoma, paraganglioma, or other catecholamine secreting neoplasms.
Slovenian: Feokromocitom, paragangliom ali druge novotvorbe, ki izločajo kateholamin.
English: There is no experience with opicapone when used concomitantly with the MAO-B inhibitor safinamide.
Slovenian: Izkušenj s sočasno uporabo opikapona in zaviralca MAO-B safinamida ni.
English: The dose of other medicines to treat Parkinson's disease may need to be adjusted when you start taking Ongentys.
Slovenian: Odmerek drugih zdravil za zdravljenje Parkinsonove bolezni Odmerek zdravil za zdravljenje Parkinsonove bolezni bo morda treba prilagoditi, ko boste začeli jemati zdravilo Ongentys.
English: Your doctor may need to adjust your treatment; - medicines to treat asthma such as rimiterole or isoprenaline.
Slovenian: Vaš zdravnik bo morda moral prilagoditi vaše zdravljenje; - zdravila za zdravljenje astme, kot sta rimiterol ali izoprenalin.
English: Difference to placebo p-value
Slovenian: Razlika glede na placebo vrednost p
English: Titanium dioxide (E171)
Slovenian: eritrozin (E127) titanov dioksid (E171)
English: If you stop taking Ongentys
Slovenian: Če ste prenehali jemati zdravilo Ongentys
English: Each hard capsule contains 148.2 mg of lactose (as monohydrate).
Slovenian: Ena trda kapsula vsebuje približno 148,2 mg laktoze (v obliki monohidrata).
English: Sulphation of opicapone appears to be the major metabolic pathway in humans, yielding the inactive opicapone sulphate metabolite.
Slovenian: Kaže, da je pri ljudeh glavna presnovna pot sulfacija opikapona, pri kateri nastane neaktivni presnovek opikaponijev sulfat.
English: - if you have a tumour of the adrenal gland (known as phaeochromocytoma), or of the nervous system (known as paraganglioma), or any other tumour which increase the risk of severe high blood pressure; - if you have ever suffered from neuroleptic malignant syndrome which is a rare reaction to antipsychotic medicines; - if you have ever suffered from a rare muscle disorder called rhabdomyolysis which was not caused by injury; - if you are taking certain antidepressants called monoamine-oxidase (MAO) inhibitors (e.g. phenelzine, tranylcypromine or moclobemide).
Slovenian: - če imate tumor nadledvične žleze (znan kot feokromocitom) ali živčnega sistema (znan kot paragangliom) ali kateri drugi tumor, ki poveča tveganje resno zvišanega krvnega tlaka; - če ste kadar koli doživeli nevroleptični maligni sindrom, ki je redka reakcija na antipsihotike; - če ste kadar koli imeli redno mišično motnjo, imenovano rabdomiolizo, ki je ni povzročila poškodba; - če jemljete nekatere antidepresive, imenovane zaviralci monoaminooksidaze (MAO) (npr. fenelzin,
English: Ongentys is a medicine that contains the active substance opicapone.
Slovenian: Zdravilo Ongentys je zdravilo, ki vsebuje učinkovino opikapon.
English: If not sufficient to manage the adverse events, the opicapone dose could then be down titrated.
Slovenian: Če to ni bilo dovolj za obvladovanje neželenih učinkov, je bilo možno odmerek opikapona titrirati navzdol.
English: Patients and care-givers should be made aware that 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.
Slovenian: Bolniki in negovalci morajo vedeti, da se pri bolnikih, zdravljenih z dopaminskimi agonisti in/ali drugimi dopaminergičnimi zdravili, lahko pojavijo motnje nadzora impulzov, vključno s patološkim igranjem iger na srečo, povečanim libidom, hiperseksualnostjo, kompulzivnim zapravljanjem ali nakupovanjem, prenajedanjem in kompulzivnim hranjenjem.
English: There is no relevant use of Ongentys in the paediatric population with Parkinson's disease and motor fluctuations.
Slovenian: Zdravilo Ongentys ni namenjeno za uporabo pri pediatrični populaciji s Parkinsonovo boleznijo in motoričnimi fluktuacijami.
English: Ongentys should be taken once-daily at bedtime at least one hour before or after levodopa combinations.
Slovenian: Zdravilo Ongentys se jemlje enkrat na dan pred spanjem vsaj eno uro pred zdravilom s kombinacijo levodope ali po njem.
English: Ongentys is indicated as adjunctive therapy to preparations of levodopa/ DOPA decarboxylase inhibitors (DDCI) in adult patients with Parkinson's disease and end-of-dose motor fluctuations who cannot be stabilised on those combinations.
Slovenian: Zdravilo Ongentys je indicirano kot dodatno zdravljenje k zdravilom z levodopo/zaviralci dopa dekarboksilaze (DDK) pri odraslih bolnikih s Parkinsonovo boleznijo in motoričnimi fluktuacijami na koncu odmernega obdobja, ki jih zdravljenje s temi kombinacijami ne stabilizira.
English: In the table below (Table 1) all adverse reactions are presented by System Organ Class and frequency.
Slovenian: Preglednica neželenih učinkov V spodnji preglednici (preglednica 1) so vsi neželeni učinki predstavljeni po organskih sistemih in pogostnosti.
English: OPA/Al/PVC//Al blisters containing 10 or 30 capsules.
Slovenian: Pretisni omoti iz OPA/Al/PVC//Al vsebujejo 10 ali 30 kapsul.
English: Opicapone is a weak in vitro inhibitor of CYP2C8 and OATP1B1, whereas repaglinide is a sensitive CYP2C8 and OATP1B1 substrate.
Slovenian: Opikapon je šibak in vitro zaviralec CYP2C8 in OATP1B1, medtem ko je repaglinid občutljiv substrat CYP2C8 in OATP1B1.
English: After oral administration, the apparent volume of distribution of opicapone at a dose of 50 mg was 29 L with an inter-subject variability of 36%.
Slovenian: Po peroralni uporabi je bil navidezni volumen porazdelitve opikapona v odmerku 50 mg 29 l, pri čemer je bila variabilnost med posamezniki 36 %.
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.
Slovenian: V urinu je bil glavni presnovek glukuronidni presnovek opikapona, medtem ko so bili izhodiščna učinkovina in drugi presnovki običajno pod mejo merljivosti.
English: The recommended dose of opicapone is 50 mg.
Slovenian: Priporočeni odmerek opikapona je 50 mg.
English: Effect of transporters on opicapone
Slovenian: Vpliv prenašalcev na opikapon
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.
Slovenian: Z največjo koncentracijo v plazmi po enkratnem odmerku 100 mg 14C-opikapona sta zastopana presnovka BIA 9-1103 (sulfat) in BIA 9-1104 (metiliran), ki predstavljata 67,1 oz. 20,5 % radioaktivne vrednosti AUC.
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).
Slovenian: Kliničnih izkušenj z bolniki s hudo okvaro jeter (stopnje C po Child-Pughu) ni, zato se zdravila Ongentys pri teh bolnikih ne priporoča (glejte poglavje 5.2).
English: À Av. da Siderurgia Nacional 4745-457 S. Mamede do Coronado Portugal tel: +351 22 986 61 00 fax: +351 22 986 61 90 e-mail: info@bial.com
Slovenian: À Av. da Siderurgia Nacional 4745-457 S. Mamede do Coronado Portugalska tel: +351 22.986 61 00 faks: +351 22 986 61 90
English: À Av. da Siderurgia Nacional 4745-457 S. Mamede do Coronado Portugal (only for outer packaging)
Slovenian: À Av. da Siderurgia Nacional 4745-457 S. Mamede do Coronado Portugalska (samo za zunanjo ovojnino)
English: Take Ongentys at least one hour before or after taking your levodopa medicine.
Slovenian: Zdravilo Ongentys vzemite vsaj eno uro, preden vzamete zdravilo z levodopo, ali eno uro kasneje.
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).
Slovenian: Vendar pa so opravili ovrednotenje s 50 mg opikapona pri osebah, vključenih v obe študiji 3. faze, z GFR/1,73 m2 < 60 ml/min (tj. zmerno zmanjšana zmožnost ledvičnega izločanja), in z uporabo združenih podatkov
English: The binding of 14C-opicapone to plasma proteins was unaffected by the presence of warfarin, diazepam, digoxin and tolbutamide, and the binding of 14C-warfarin, 2-14C-diazepam, 3H-digoxin and 14C-tolbutamide was unaffected by the presence of opicapone and opicapone sulphate, the major human metabolite.
Slovenian: in na vezavo 14C-varfarina, 2-14C-diazepama, 3H-digoksina in 14C-tolbutamida ni vplivala prisotnost opikapona in opikaponijevega sulfata, glavnega presnovka pri človeku.
English: An in vitro study showed opicapone inhibited CYP2C8 activity.
Slovenian: Študija in vitro je pokazala, da opikapon zavira 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%).
Slovenian: Po dajanju enkratnega peroralnega odmerka 14C-opikapona je bila glavna pot izločanja opikapona in njegovih presnovkov blato, kar predstavlja 58,5 % do 76,8 % uporabljene radioaktivnosti (povprečje
English: Taking Ongentys and quinidine together, i.e. at the same time, may decrease the effect of Ongentys.
Slovenian: Sočasno jemanje zdravila Ongentys in kinidina lahko zmanjša učinek zdravila Ongentys.
English: Do not use this medicine after the expiry date which is stated on the bottle/blister/carton after EXP.
Slovenian: Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na plastenki/pretisnem omotu/škatli poleg oznake EXP. Rok uporabnosti zdravila se izteče na zadnji dan navedenega meseca.
English: No dose adjustment is needed for elderly patients (see section 5.2).
Slovenian: Pri starejših bolnikih odmerka ni treba prilagajati (glejte poglavje 5.2).
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.
Slovenian: Na podlagi in vitro in in vivo študij se ne pričakuje, da bo opikapon v klinično pomembnih koncentracijah zaviral prenašalce OAT1, OAT3, OATP1B1, OATP1B3, OCT1, OCT2, BCRP, P-gp/MDR1, BSEP, MATE1 in MATE2-K.
English: What Ongentys looks like and contents of the pack
Slovenian: Izgled zdravila Ongentys in vsebina pakiranja
English: How to store Ongentys 6.
Slovenian: Shranjevanje zdravila Ongentys 6.
English: Concomitant use with monoamine oxidase (MAO-A and MAO-B) inhibitors (e.g. phenelzine, tranylcypromine and moclobemide) other than those for the treatment of Parkinson's disease (see section 4.5).
Slovenian: Sočasna uporaba z zaviralci monoaminoksidaze (MAO-A in MAO-B) (npr. fenelzin, tranilcipromin in moklobemid), razen tistih za zdravljenje Parkinsonove bolezni (glejte poglavje 4.5).
English: Effect of opicapone on transporters
Slovenian: Vpliv opikapona na prenašalce
English: Because of this, concomitant use of opicapone with MAO inhibitors (e.g. phenelzine, tranylcypromine and moclobemide) other than those for the treatment of Parkinson's disease is contraindicated.
Slovenian: Zato je sočasna uporaba opikapona z zaviralci MAO (npr. fenelzin, tranilcipromin in moklobemid), razen tistimi za zdravljenje Parkinsonove bolezni, kontraindicirana.
English: After oral administration, the apparent total body clearance of opicapone at a dose of 50 mg was 22 L/h, with an inter-subject variability of 45%.
Slovenian: Po peroralni uporabi je bil navidezni celotni telesni očistek opikapona v odmerku 50 mg 22 l, pri čemer je bila variabilnost med posamezniki 45 %.
English: No dose adjustment is necessary in patients with renal impairment, as opicapone is not excreted by the kidney (see section 5.2).
Slovenian: Pri bolnikih z okvaro ledvic odmerka ni treba prilagajati, saj se opikapon ne izloča skozi ledvice (glejte poglavje 5.2).
English: Dyspnoea
Slovenian: dispepsija
English: Non-clinical data revealed no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity and carcinogenic potential.
Slovenian: Predklinični podatki na osnovi običajnih študij farmakološke varnosti, toksičnosti pri ponavljajočih odmerkih, genotoksičnosti in kancerogenega potenciala ne kažejo posebnega tveganja za človeka.
English: In healthy subjects, the opicapone elimination half-life (t1/2) was 0.7 h to 3.2 h following once-daily multiple-dose administration up to 50 mg opicapone.
Slovenian: Pri zdravih osebah je bil razpolovni čas (t1/2) izločanja opikapona 0,7 ure do 3,2 ure po večkratnem odmerjanju do 50 mg opikapona enkrat na dan.
English: White high density polyethylene (HDPE) bottles with polypropylene (PP) child resistant closures containing 10, 30 or 90 capsules.
Slovenian: Bele plastenke iz polietilena visoke gostote (HDPE, high density polyethylene) s polipropilensko (PP) za otroke varno zaporko vsebujejo 10, 30 ali 90 kapsul.
English: Careful monitoring of patients being treated with these medicinal products is advised when opicapone is used.
Slovenian: Pri uporabi opikapona se priporoča skrbno spremljanje bolnikov, ki se zdravijo s temi zdravili.
English: Opicapone in association with levodopa may have major influence on the ability to drive and use machines.
Slovenian: 4.7 Vpliv na sposobnost vožnje in upravljanja s stroji Opikapon v povezavi z levodopo ima lahko pomemben vpliv na sposobnost vožnje in upravljanja s stroji.
English: White high density polyethylene (HDPE) bottles with polypropylene (PP) child resistant closures containing 10 or 30 capsules.
Slovenian: Bele plastenke iz polietilena visoke gostote (HDPE, high density polyethylene) s polipropilensko (PP) za otroke varno zaporko vsebujejo 10 ali 30 kapsul.
English: Blood creatine phosphokinase increased
Slovenian: Preiskave zvišanje kreatin fosfokinaze v krvi zmanjšanje telesne mase
English: Your doctor may need to review your treatments.
Slovenian: Morda bo moral zdravnik vaše zdravljenje spremeniti.
English: Study 1 Change in OFF-time
Slovenian: Študija 1 Sprememba v času izklopa
English: Animal studies with opicapone do not indicate harmful effects with respect to fertility (see section 5.3).
Slovenian: Študije na živalih z opikaponom ne kažejo škodljivih učinkov na sposobnost razmnoževanja (glejte poglavje 5.3).
English: In vitro studies have shown that opicapone is not transported by OATP1B1, but is transported by OATP1B3, and efflux transported by P-gp and BCRP.
Slovenian: Študije in vitro so pokazale, da OATP1B1 ne prenaša opikapona, temveč ga prenaša OATP1B3, efluksna prenašalca pa sta P-gp in BCRP.
English: There is limited clinical experience in patients with moderate hepatic impairment (Child-Pugh Class B).
Slovenian: Klinične izkušnje pri bolnikih z zmerno okvaro jeter (stopnje B po Child-Pughu) so omejene.
English: Ongentys contains lactose
Slovenian: Zdravilo Ongentys vsebuje laktozo
English: BIA 9-1103, its major metabolite, was transported by OATP1B1 and OATP1B3, and efflux transported by BCRP, but is not a substrate for the P-gp/MDR1 efflux transporter.
Slovenian: Njegov glavni presnovek BIA 9-1103 prenašata OATP1B1 in OATP1B3, efluksni prenašalec pa je BCRP, vendar ni substrat za efluksni prenašalec P-gp/MDR1.
English: Talk to your doctor or pharmacist before taking Ongentys: - if you have severe liver problems and suffered from loss of appetite, weight loss, weakness, or exhaustion within a short period of time.
Slovenian: Pred začetkom jemanja zdravila Ongentys se posvetujte z zdravnikom ali farmacevtom: - če imate resne težave z jetri in so se vam v kratkem času pojavili izguba apetita, izguba telesne mase,
English: - The other ingredients are: o capsule content: lactose monohydrate, sodium starch glycolate (Type A), pregelatinized maize starch and magnesium stearate o capsule shell: gelatine, indigo carmine aluminium lake (E132), erythrosine (E127) and titanium dioxide (E171) o printing ink: shellac, titanium dioxide (E171), propylene glycol, ammonia, simethicone
Slovenian: o vsebina kapsule: laktoza monohidrat, natrijev karboksimetilškrob (vrsta A), predgeliran koruzni škrob in magnezijev stearat o ovojnica kapsule: želatina, indigotin (E132), eritrozin (E127) in titanov dioksid (E171) o tiskarsko črnilo: šelak, titanov dioksid (E171), propilenglikol, amoniak, simetikon
English: There is limited experience with opicapone when used concomitantly with tricyclic antidepressants and noradrenaline re-uptake inhibitors (e.g. venlafaxine, maprotiline and desipramine).
Slovenian: Izkušnje z opikaponom, uporabljenim sočasno s tricikličnimi antidepresivi in zaviralci ponovnega privzema noradrenalina (npr. venlafaksin, maprotilin in dezipramin), so omejene.
English: Caution must be exercised in these patients and dose adjustment may be necessary (see section
Slovenian: Pri teh bolnikih je potrebna previdnost in morebitna prilagoditev odmerka (glejte poglavje 5.2).
English: Pharmacokinetic results showed that opicapone is rapidly absorbed, with a tmax of 1.0 h to 2.5 h following once-daily multiple-dose administration up to 50 mg opicapone.
Slovenian: Farmakokinetični rezultati kažejo, da se opikapon hitro absorbira, s tmax 1,0 ure do 2,5 ure po večkratnem odmerjanju do 50 mg opikapona enkrat na dan.
English: Ongentys contains lactose.
Slovenian: Zdravilo Ongentys vsebuje laktozo.
English: It is unknown whether opicapone or its metabolites are excreted in human milk.
Slovenian: Ni znano, ali se opikapon ali njegovi presnovki izločajo v materino mleko.
English: A study conducted in healthy volunteers showed that when a single dose of 50 mg opicapone was coadministered (within 1 hour) with a single dose of quinidine (600 mg), systemic exposure of opicapone decreased by 37% (AUC0-tlast).
Slovenian: Študija z zdravimi prostovoljci je pokazala zmanjšanje sistemske izpostavljenosti opikaponu za 37 % (AUC0-tlast) pri sočasnem dajanju (z razmikom do 1 ure) enkratnega odmerka 50 mg opikapona z enkratnim odmerkom kinidina (600 mg).
English: - muscle spasm - dizziness - headache - sleepiness - difficulty falling or staying asleep - strange dreams - experiencing or seeing things which do not exist (hallucinations) - a fall in blood pressure on standing up which causes dizziness, light-headedness or fainting
Slovenian: - težave zaspati ali zbujanje ponoči - čudne sanje - doživljanje ali videnje neobstoječih stvari (halucinacije) - padec krvnega tlaka pri vstajanju, ki lahko povzroči omotico, vrtoglavost ali omedlevico
English: Breast-feeding should be discontinued during treatment with Ongentys.
Slovenian: Med zdravljenjem z zdravilom Ongentys je treba prenehati z dojenjem.
English: Increases in liver enzymes were reported in studies with nitrocatechol inhibitors of catechol-Omethyltransferase (COMT).
Slovenian: Drugo V študijah z nitrokateholnimi zaviralci katehol-O-metil transferaze (COMT) so poročali o zvišanju ravni jetrnih encimov.
English: Hence, the precautions valid for levodopa treatment should also be taken into account for Ongentys.
Slovenian: Zato je treba pri zdravilu Ongentys upoštevati vse previdnostne ukrepe, ki veljajo za zdravljenje z levodopo.
English: Opicapone demonstrated clinical efficacy superior to placebo during the double-blind treatment, both for the primary efficacy variable used in both pivotal studies, i.e. reduction in OFF-time (Table 2), the proportion of OFF-time responders (i.e. a subject who had a reduction in OFF-time of at least 1 hour from baseline to endpoint) (Table 3) and for most diary-derived secondary endpoints.
Slovenian: V dvojno slepem zdravljenju je bilo dokazano, da je klinična učinkovitost opikapona boljša kot pri placebu, tako za primarno spremenljivko učinkovitosti, uporabljeno v obeh osrednjih študijah, tj. skrajšanje časa izklopa (preglednica 2), delež odzivnih oseb glede čas izklopa (tj. oseb, ki so imele zmanjšanje časa izklopa za vsaj 1 uro od izhodišča do končne točke) (preglednica 3), in za večino sekundarnih opazovanih dogodkov,
English: A second study conducted showed that, at steady state, opicapone 50 mg had no effect on repaglinide systemic exposure.
Slovenian: Druga študija je pokazala, da odmerek 50 mg opikapona ni vplival na sistemsko izpostavljenost repaglinidu v stanju dinamičnega ravnovesja.
English: How to take Ongentys
Slovenian: Kako jemati zdravilo Ongentys
English: Shellac, propylene glycol, ammonia, indigo carmine aluminium (E132)
Slovenian: Tiskarsko črnilo šelak, propilenglikol, amoniak, indigotin (E132)
English: The pharmacokinetics of opicapone was evaluated in elderly subjects (aged 65-78 years old) after 7day multiple-dose administration of 30 mg. An increase in both the rate and extent of systemic exposure was observed for the elderly population when compared to the young population.
Slovenian: Farmakokinetiko opikapona so ovrednotili pri starejših osebah (starih od 65 do 78 let) po 7-dnevnem večkratnem odmerjanju 30 mg.
English: ongentys 25 mg (only on the outer packaging)
Slovenian: ongentys 25 mg (samo za zunanjo ovojnino)
English: ongentys 50 mg (only on the outer packaging)
Slovenian: ongentys 50 mg (samo za zunanjo ovojnino)
English: HDPE bottles: Keep the bottle tightly closed in order to protect from moisture.
Slovenian: Plastenke HDPE: Plastenko shranjujte tesno zaprto za zagotovitev zaščite pred vlago.
English: Do not drive or operate machinery if you experience any of these side effects.
Slovenian: Če imate katerega od teh neželenih učinkov, ne vozite in ne upravljajte strojev.
English: Package leaflet: Information for the patient Ongentys 50 mg hard capsules opicapone This medicine is subject to additional monitoring.
Slovenian: Navodilo za uporabo Ongentys 50 mg trde kapsule opikapon Za to zdravilo se izvaja dodatno spremljanje varnosti.
English: There is no clinical experience in patients with severe hepatic impairment (Child-Pugh Class C) (see section 4.2).
Slovenian: Pri bolnikih s hudo okvaro jeter (razred C po Child-Pughu) ni kliničnih izkušenj (glejte poglavje 4.2).
English: Package leaflet: Information for the patient Ongentys 25 mg hard capsules opicapone This medicine is subject to additional monitoring.
Slovenian: Navodilo za uporabo Ongentys 25 mg trde kapsule opikapon Za to zdravilo se izvaja dodatno spremljanje varnosti.
English: The pharmacokinetics of opicapone was not directly evaluated in subjects with chronic renal impairment.
Slovenian: Farmakokinetike opikapona pri osebah s kronično okvaro ledvic niso ovrednotili neposredno.
English: Other metabolites were not found in quantifiable concentrations in the majority of plasma samples collected during a clinical mass balance study.
Slovenian: V večini vzorcev plazme, zbranih med klinično študijo masnega ravnovesja, niso našli drugih presnovkov v merljivih koncentracijah.