FrancophonIA/ELRC3.0 huggingface dataset:
English: Side effects caused by Ongentys are usually mild to moderate and occur mostly within the first weeks of treatment.
Slovenian: Neželeni učinki, ki jih povzroča zdravilo Ongentys, so običajno blagi do zmerni in se najpogosteje pojavijo v prvih tednih zdravljenja.
English: The capsules are packaged in bottles or blisters.
Slovenian: Kapsule so pakirane v plastenke ali pretisne omote.
English: If you are pregnant, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Slovenian: Če ste noseči ali dojite, menite, da bi lahko bili noseči, ali načrtujete zanositev, se posvetujte z zdravnikom ali farmacevtom, preden vzamete to zdravilo.
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).
Slovenian: Evropska agencija za zdravila je odstopila od zahteve za predložitev rezultatov študij z opikaponom za vse podskupine pediatrične populacije s Parkinsonovo boleznijo in motoričnimi fluktuacijami (za podatke o uporabi pri pediatrični populaciji glejte poglavje 4.2).
English: These behaviours are called ‘impulse control disorders' and can include: addictive gambling, an abnormally high sex drive or an increased preoccupation with sexual thoughts or feelings.
Slovenian: Ta vedenja se imenujejo motnja nadzora impulzov in vključujejo: zasvojenost z igrami na srečo, nenormalno velik spolni nagon ali prevzetost s seksualnimi mislimi ali občutki.
English: In patients taking levodopa and a peripheral DDCI, such as carbidopa or benserazide, opicapone increases levodopa plasma levels thereby improving the clinical response to levodopa.
Slovenian: Pri bolnikih, ki jemljejo levodopo in periferni DDCI, kot sta karbidopa ali benserazid, opikapon poveča ravni levodope v plazmi ter tako izboljša klinični odziv na levodopo.
English: In Study 1, 122 patients were treated with opicapone 5 mg and 122 patients were treated with entacapone 200 mg (active comparator).
Slovenian: V 1. študiji je bilo 122 bolnikov zdravljenih z opikaponom 5 mg in 122 bolnikov je bilo zdravljenih z entakaponom 200 mg (aktivna primerjana učinkovina).
English: It increases the effects of levodopa and helps to relieve the symptoms of Parkinson's disease and movement problems.
Slovenian: Poveča učinke levodope in pomaga ublažiti simptome Parkinsonove bolezni in težave z gibanjem.
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.
Slovenian: Pri bolnikih, pri katerih nastopijo progresivna anoreksija, astenija ali zmanjšanje telesne mase v relativno kratkem obdobju, je treba razmisliti o splošnem zdravniškem pregledu, vključno z delovanjem jeter.
English: Although there is no evidence that either the efficacy or safety of opicapone would be affected by use of controlled-release levodopa preparations, the experience with such preparations is limited.
Slovenian: Čeprav ni dokazov, da uporaba formulacij z levodopo z nadzorovanim sproščanjem vpliva na učinkovitost ali varnost opikapona, so izkušnje s takimi formulacijami omejene.
English: Pharmacotherapeutic group: Anti-parkinson drugs, other dopaminergic agents, ATC code: [not yet assigned]
Slovenian: Farmakoterapevtska skupina: antiparkinsoniki, druga dopaminergična zdravila, oznaka ATC: (še ni bila dodeljena)
English: The SCOMT activity inhibition was significantly increased in elderly subjects.
Slovenian: Zaviranje aktivnosti S-COMT je bilo pri starejših osebah občutno povečano.
English: The LS mean reduction in absolute OFF-time from baseline to endpoint in the entacapone group was -78.7 minutes.
Slovenian: Zmanjšanje povprečja LS absolutnega časa izklopa od izhodišča do končne točke v skupini z entakaponom je znašalo -78,7 minut.
English: If one dose is missed, the next dose should be taken as scheduled.
Slovenian: Če se odmerek izpusti, je treba naslednji odmerek vzeti, kot je načrtovano.
English: The patient should not take an extra dose to make up for the missed dose.
Slovenian: Bolnik naj ne vzame dodatnega odmerka, da nadomesti izpuščenega.
English: - if you are allergic to opicapone or any of the other ingredients of this medicine (listed in section
Slovenian: - če ste alergični na opikapon ali katero koli sestavino tega zdravila (navedeno v poglavju 6).
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.
Slovenian: Rezultati enoletnih odprtih podaljškov študij z 862 bolniki, ki so nadaljevali zdravljenje iz dvojno slepih študij (študija 1-OL in študija 2-OL) kažejo, da se je učinek, ki je bil dosežen v dvojno slepem obdobju študije, ohranil.
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.
Slovenian: Pri prekinitvi zdravljenja z zdravilom Ongentys je treba prilagoditi odmerek drugih antiparkinsonikov, zlasti levodope, da se doseže zadostna raven nadzorovanja simptomov.
English: Your doctor may need to adjust your treatment; - safinamide used for Parkinson's disease.
Slovenian: Morda bo moral zdravnik vaše zdravljenje prilagoditi; - safinamid, ki se uporablja za Parkinsonovo bolezen.
English: Very common: may affect more than 1 in 10 people - involuntary and uncontrollable, or difficult or painful body movements
Slovenian: Zelo pogosti: pojavijo se lahko pri več kot 1 od 10 bolnikov - neprostovoljni in neobvladljivi oziroma težavni ali boleči telesni gibi
English: Table 1 - Frequency of adverse reactions (MedDRA) in placebo-controlled Phase 3 studies System Organ Class
Slovenian: Preglednica 1 - Pogostnost neželenih učinkov (MedDRA) v študijah 3. faze, nadzorovanih s placebom Organski sistem Zelo pogosti
English: Doses of other medicines to treat Parkinson's disease
Slovenian: Odmerek drugih zdravil za zdravljenje Parkinsonove bolezni
English: What Ongentys is and what it is used for 2.
Slovenian: Kaj je zdravilo Ongentys in za kaj ga uporabljamo 2.
English: Opicapone reduced CYP2C9 activity through competitive / mixed type mode of inhibition.
Slovenian: Opikapon je zmanjšal aktivnost CYP2C9 s kompetitivnim/mešanim načinom zaviranja.
English: In rats, opicapone did not affect male and female fertility or prenatal development at exposure levels 22 times the therapeutic exposure in humans.
Slovenian: Pri podganah opikapon ni vplival na plodnost samcev in samic ali na prenatalni razvoj pri ravneh izpostavljenosti, ki so bile 22-krat večje od terapevtske izpostavljenosti pri ljudeh.
English: If you forget to take one dose, you should continue the treatment and take the next dose as scheduled.
Slovenian: Če pozabite vzeti en odmerek, nadaljujte z zdravljenjem in vzemite naslednji odmerek, kot je načrtovano.
English: The effects of opicapone on fertility in humans have not been studied.
Slovenian: Učinkov opikapona na plodnost pri ljudeh niso preučili.
English: Your doctor may need to reconsider your treatment.
Slovenian: Morda bo moral zdravnik ponovno premisliti o vašem zdravljenju.
English: In the presence of a DOPA decarboxylase inhibitor (DDCI), COMT becomes the major metabolising enzyme for levodopa, catalysing its conversion to 3-O-methyldopa (3-OMD) in the brain and periphery.
Slovenian: V prisotnosti zaviralca dopa-dekarboksilaze (DDCI, DOPA decarboxylase inhibitor) postane COMT glavni presnovni encim za levodopo, ki katalizira njeno pretvorbo v 3-O-metildopo (3-OMD) v možganih in periferiji.
English: As Ongentys will be used with other levodopa medicines, please also read the package leaflets of these medicines carefully.
Slovenian: Ker se zdravilo Ongentys uporablja z drugimi zdravili z levodopo, natančno preberite tudi navodila za uporabo teh zdravil.
English: The difference in LS mean change in OFF-time of entacapone to placebo in Study 1 was -30.5 minutes.
Slovenian: Razlika v spremembi povprečja LS v času izklopa med entakaponom in placebom v študiji 1 je bila -30,5 minut.
English: Ongentys is for use in adults who are already taking medicines containing levodopa and DOPA decarboxylase inhibitors.
Slovenian: Zdravilo Ongentys se uporablja pri odraslih, ki že jemljejo zdravila, ki vsebujejo levodopo in zaviralce dopa dekarboksilaze.
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).
Slovenian: Razlika v spremembi povprečja LS v času izklopa za opikapon 50 mg glede na entakapon je bila -24,8 minut in neinferiornost opikapona 50 mg v primerjavi z entakaponom je bila dokazana (95-% interval zaupanja: -61,4; 11,8).
English: Since the risk to the baby/infant cannot be excluded, you should stop breast-feeding during treatment with Ongentys.
Slovenian: Ker tveganja za dojenega novorojenca/otroka ne moremo izključiti, je treba med zdravljenjem z zdravilom Ongentys prenehati dojiti.
English: Combination of opicapone and MAO inhibitors could result in inhibition of the majority of the pathways responsible for the metabolism of catecholamines.
Slovenian: Kombinacija opikapona in zaviralcev MAO lahko povzroči zaviranje večine poti, odgovornih za presnovo kateholaminov.
English: It is used to treat Parkinson's disease and associated movement problems.
Slovenian: Uporablja se za zdravljenje Parkinsonove bolezni in povezanih težav z gibanjem.
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.
Slovenian: Če prenehate jemati zdravilo Ongentys, bo morda moral zdravnik prilagoditi odmerek drugih zdravil, ki jih jemljete za zdravljenje Parkinsonove bolezni.
English: History of neuroleptic malignant syndrome and/or non-traumatic rhabdomyolysis.
Slovenian: Anamneza malignega nevroleptičnega sindroma in/ali netravmatske rabdomiolize.
English: There were 60 patients in the combined Phase 3 studies who were predominantly using controlled-release levodopa (i.e. >50% of their levodopa/DDCI formulations), 48 of whom were treated solely with controlled-release formulations of levodopa.
Slovenian: V obeh študijah 3. faze skupaj je bilo 60 bolnikov, ki so pretežno uporabljali levodopo z nadzorovanim sproščanjem (tj. > 50 % njihove formulacije levodope/DDCI), od teh se jih je 48 zdravilo samo s formulacijo levodope z nadzorovanim sproščanjem.
English: Some side effects may be caused by the increased effects of using Ongentys together with levodopa.
Slovenian: Nekateri neželeni učinki so morda posledica večjih učinkov uporabe zdravila Ongentys skupaj z levodopo.
English: However, clinical interaction studies conducted with warfarin showed no effect of opicapone on the pharmacodynamics of warfarin, a substrate of CYP2C9.
Slovenian: Vendar pa klinične študije medsebojnega delovanja z varfarinom niso pokazale učinka opikapona na farmakodinamiko varfarina, ki je substrat CYP2C9.
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.
Slovenian: Opikapon je periferni, selektivni in reverzibilni zaviralec katehol-O-metiltransferaze (COMT) z visoko vezavno afiniteto (sub-pikomolarno), kar pomeni počasno konstanto hitrosti disociacije kompleksa in dolgo trajanje delovanja (> 24 ur) in vivo.
English: If you take more Ongentys than you should, tell your doctor or pharmacist, or go to a hospital immediately.
Slovenian: Če ste vzeli večji odmerek zdravila Ongentys, kot bi smeli, povejte zdravniku ali farmacevtu ali pojdite takoj v bolnišnico.
English: For other adverse events, the levodopa and/or opicapone dose could be adjusted.
Slovenian: Za druge neželene učinke je bilo možno odmerek levodope in/ali opikapona prilagoditi.
English: What you need to know before you take Ongentys 3.
Slovenian: Kaj morate vedeti, preden boste vzeli zdravilo Ongentys 3.
English: Hence, it is often necessary to adjust levodopa dosage within the first days to first weeks after initiating the treatment with opicapone (see section 4.4).
Slovenian: Zato je v prvih dneh ali tednih pogosto treba prilagoditi odmerek levodope po uvedbi zdravljenja z opikaponom (glejte poglavje 4.4).
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.
Slovenian: Študije in vitro za razpon koncentracij opikapona od 0,3 do 30 µg/ml kažejo, da je vezavnost 14C-opikapona na beljakovine v človeški plazmi visoka (99,9 %) in neodvisna od koncentracije.
English: Dose adjustments of antiparkinsonian therapy
Slovenian: Prilagajanje odmerka antiparkinsonikov
English: Taking Ongentys with these medicines may increase the risk of side effects.
Slovenian: Ongentys s temi zdravili lahko poveča tveganje za neželene učinke.
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.
Slovenian: V stanju dinamičnega ravnovesja je opikapon 50 mg značilno povečal obseg sistemske izpostavljenosti levodopi za približno 2-krat v primerjavi s placebom po enem peroralnem dajanju bodisi 100/25 mg levodope/karbidope ali 100/25 mg levodope/benserazida, danih 12 ur po odmerku opikapona.
English: Therefore, their concomitant use should be considered with appropriate caution.
Slovenian: Zato je pri razmisleku o sočasni uporabi potrebna ustrezna previdnost.
English: Note: A responder was a patient who had a reduction of at least 1 hour in absolute OFF-time (OFF-time responder)
Slovenian: Opomba: Odzivna oseba je bil bolnik, pri katerem se je absolutni čas izklopa (odzivna oseba za čas izklopa)
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.
Slovenian: Študija z enkratnim odmerkom 25 mg opikapona je pokazala povprečno 30-odstotno povečanje hitrosti, vendar ne obsega, izpostavljenosti repaglinidu (substratu CYP2C8) pri sočasnem dajanju teh zdravil.
English: Table 2 - Change in absolute OFF-time and ON-time (minutes) from baseline to endpoint Treatment
Slovenian: Preglednica 2 - sprememba absolutnega časa izklopa in časa vklopa (v minutah) od izhodišča do končne točke
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING BOX (BLISTER OPA/Al/PVC//Al)
Slovenian: PODATKI NA ZUNANJI OVOJNINI ŠKATLA (PRETISNI OMOT OPA/Al/PVC//Al)
English: If you have been told by your doctor that you have intolerance to some sugars, contact your doctor before taking this medicine.
Slovenian: Če vam je zdravnik povedal, da ne prenašate nekaterih sladkorjev, se pred začetkom jemanja tega zdravila posvetujte z zdravnikom.
English: There is no relationship between exposure of opicapone and body weight over the range of 40-100 kg.
Slovenian: Med izpostavljenostjo opikaponu in telesno maso v razponu od 40 do 100 kg ni razmerja.
English: If end-of-dose motor fluctuations were not sufficiently controlled and tolerability allowed, the opicapone dose could be increased to 50 mg.
Slovenian: Če motorične fluktuacije na koncu odmernega obdobja niso bile ustrezno nadzorovane in je bilo na podlagi prenašanja zdravila to možno, je bilo možno odmerek opikapona dvigniti na 50 mg.
English: Other medicines and Ongentys
Slovenian: Druga zdravila in zdravilo Ongentys
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.
Slovenian: Učinkovitost in varnost opikapona je bila pokazana v dveh s placebom in učinkovino (le študija 1) nadzorovanih, dvojno slepih študijah 3. faze s 1.027 randomiziranimi odraslimi bolniki s Parkinsonovo boleznijo, do 15 tednov zdravljenih z levodopo/DDCI (samo ali v kombinaciji z drugimi antiparkinsoniki) in motoričnimi fluktuacijami na koncu odmernega obdobja.
English: Monoamino oxidase (MAO) inhibitors
Slovenian: Zaviralci monoaminooksidaze (MAO)
English: Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take Ongentys.
Slovenian: Bolniki z redkimi dednimi težavami neprenašanja galaktoze, laponsko obliko zmanjšane aktivnosti laktaze ali malabsorpcijo glukoze-galaktoze ne smejo jemati zdravila Ongentys.
English: Table 3 - OFF-time responder rates at endpoint Response type
Slovenian: Preglednica 3 - Deleži časa izklopa pri odzivnih osebah ob izhodišču Vrsta odziva
English: Each hard capsule contains 171.9 mg of lactose (as monohydrate).
Slovenian: Ena trda kapsula vsebuje 171,9 mg laktoze (v obliki monohidrata).
English: In in vitro studies in human hepatic microsomes, minor inhibition of CYP1A2 and CYP2B6 was observed.
Slovenian: V študijah in vitro na človeških jetrnih mikrosomih so opazili manjše zaviranje CYP1A2 in CYP2B6.
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.
Slovenian: Po večkratnem peroralnem odmerjanju opikapona enkrat na dan v razponu odmerkov od 5 do 50 mg je imel opikaponijev sulfat dolgo končno fazo z vrednostmi razpolovnega časa izločanja od 94 ur do 122 ur; posledično je zaradi tega dolgega končnega razpolovnega časa izločanja opikaponijev sulfat v plazmi prisoten v veliki stopnji akumulacije z vrednostmi blizu 6,6.
English: Therefore, it can be presumed that opicapone and its metabolites are mainly excreted in the faeces.
Slovenian: Zato se lahko predvideva, da se opikapon in njegovi presnovki izločajo pretežno z blatom.
English: Dysgeusia, Hyperkinesia, Syncope
Slovenian: zaspanost disgevzija, hiperkinezija, sinkopa
English: Tricyclic antidepressants and noradrenaline re-uptake inhibitors
Slovenian: Triciklični antidepresivi in zaviralci ponovnega privzema noradrenalina
English: There are no or limited amount of data from the use of opicapone in pregnant women.
Slovenian: Podatkov o uporabi opikapona pri nosečnicah ni ali so omejeni.
English: Removal of opicapone by gastric lavage and/or inactivation by administering activated charcoal should be considered.
Slovenian: Razmisliti je treba o odstranitvi opikapona z izpiranjem želodca in/ali inaktivacijo z dajanjem aktivnega oglja.
English: Opicapone may interfere with the metabolism of medicinal products containing a catechol group that are metabolised by COMT, e.g. rimiterole, isoprenaline, adrenaline, noradrenaline, dopamine, dopexamine or dobutamine, leading to potentiated effects of these medicinal products.
Slovenian: Opikapon lahko vpliva na presnovo zdravil, ki vsebujejo kateholno skupino, ki se presnavljajo s COMT, npr. rimiterol, izoprenalin, adrenalin, noradrenalin, dopamin, dopeksamin ali dobutamin, kar okrepi učinke teh zdravil.
English: If unacceptable dopaminergic adverse events were seen, the levodopa dose was to be adjusted.
Slovenian: Če so opazili nesprejemljive dopaminergične neželene učinke, je bilo treba odmerek levodope prilagoditi.
English: What Ongentys is and what it is used for
Slovenian: Kaj je zdravilo Ongentys in za kaj ga uporabljamo
English: However, as opicapone is to be used as adjunctive levodopa-therapy, dose adjustments may be considered based on a potentially enhanced levodopa dopaminergic response and associated tolerability.
Slovenian: Vendar pa se opikapon uporablja kot dodatno zdravljenje k levodopi, zato je treba razmisliti o prilagajanjih odmerka na podlagi možnega povečanega dopaminergičnega odziva na levodopo in s tem povezanim prenašanjem.
English: Patients had disease severity stages 1 to 3 (modified Hoehn and Yahr) at ON, were treated with 3 to 8 daily doses of levodopa/DDCI and had a daily average OFF-time of at least 1.5 hours.
Slovenian: Bolniki z resnostjo bolezni 1. do 3. stopnje (modificirana lestvica Hoehn in Yahr) v fazi vklopa so bili zdravljeni s 3 do 8 dnevnimi odmerki levodope/DDCI in so imeli dnevni povprečni čas izklopa vsaj 1,5 ure.
English: If you take more Ongentys than you should
Slovenian: Če ste vzeli večji odmerek zdravila Ongentys, kot bi smeli
English: Medicinal products metabolised by COMT
Slovenian: Zdravila, ki se presnavljajo s COMT
English: Concomitant use of opicapone and MAO inhibitors for the treatment of Parkinson's disease, e.g. rasagiline (up to 1 mg/day) and selegiline (up to 10 mg/day in oral formulation or 1.25 mg/day in buccal absorption formulation), is permissible (see section 4.3).
Slovenian: Sočasna uporaba opikapona in zaviralcev MAO za zdravljenje Parkinsonove bolezni, npr. razagilina (do 1 mg/dan) in selegilina (do 10 mg/dan v peroralni obliki ali 1,25 mg/dan v obliki za bukalno absorpcijo) je dovoljena (glejte poglavje 4.3).
English: There is no experience taking Ongentys and safinamide together.
Slovenian: Izkušenj z jemanjem zdravila Ongentys in safinamida skupaj ni.
English: Ongentys is not recommended during pregnancy and in women of childbearing potential not using contraception.
Slovenian: Zdravila Ongentys ne uporabljajte pri nosečnicah in pri ženskah v rodni dobi, ki ne uporabljajo učinkovite kontracepcije.
English: CYP2C8 and OATP1B1 substrates
Slovenian: Substrati CYP2C8 in OATP1B1
English: Other levodopa medicines
Slovenian: Druga zdravila z levodopo
English: België/Belgique/Belgien/България/Česká republika/ Danmark/Deutschland/Eesti/Ελλάδα/France/
Slovenian: België/Belgique/Belgien/България/Česká republika/ Danmark/Deutschland/Eesti/Ελλάδα/France/ Hrvatska/Ireland/Ísland/Italia/Κύπρος/Latvija/ Lietuva/Luxembourg/Luxemburg/Magyarország/ Malta/Nederland/Norge/Österreich/Polska/Portugal/ România/Slovenija/Slovenská republika/ Suomi/Finland/Sverige/United Kingdom BIAL - Portela & Cª, S.A.
English: Thus, particular consideration should be given to cases where quinidine needs to be administered together with opicapone as their co-administration should be avoided.
Slovenian: Zato je potrebna posebna pozornost, če je treba kinidin dati skupaj z opikaponom, saj se je treba sočasnemu dajanju teh zdravil izogibati.
English: Many of the side effects can be managed by your doctor adjusting your levodopa medicine.
Slovenian: Mnoge od teh neželenih učinkov lahko zdravnik obvladuje s prilagajanjem odmerka zdravila z levodopo.
English: What you need to know before you take Ongentys Do not take Ongentys:
Slovenian: Kaj morate vedeti, preden boste vzeli zdravilo Ongentys Ne jemljite zdravila Ongentys:
English: Opicapone may, together with levodopa, cause dizziness, symptomatic orthostatism and somnolence.
Slovenian: Opikapon lahko skupaj z levodopo povzroči omotičnost, simptomatski ortostatizem in somnolenco.
English: BIAL - Portela & Cª, S.A. Tél/Tel/Teл./Tlf/Τηλ/Sími/Puh: + 351 22 986 61 00
Slovenian: Tél/Tel/Teл./Tlf/Τηλ/Sími/Puh: + 351 22 986 61 00
English: BIA 9-1103 plasma levels were not affected in patients with chronic renal impairment, and as such, no dose adjustment needs to be considered.
Slovenian: Pri bolnikih s kronično okvaro ledvic ravni BIA 9-1103 v plazmi niso bile spremenjene, zato odmerka ni treba prilagajati.