FrancophonIA/ELRC3.0 huggingface dataset:
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.
Croatian: 1103 u plazmi nisu bile promijenjene u bolesnika s kroničnim oštećenjem funkcije bubrega te stoga nema potrebe prilagođavati dozu.
English: The LS mean reduction in absolute OFF-time from baseline to endpoint in the entacapone group was -78.7 minutes.
Croatian: dobivena metodom najmanjih kvadrata (LS mean), u skupini entakapona iznosila je -78,7 minuta.
English: ongentys 50 mg (only on the outer packaging)
Croatian: ongentys 50 mg (samo na vanjskom pakiranju)
English: ongentys 25 mg (only on the outer packaging)
Croatian: ongentys 25 mg (samo na vanjskom pakiranju)
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.
Croatian: Rezultati farmakokinetičkog ispitivanja pokazali su da se opikapon brzo apsorbira uz tmax od 1,0 h do 2,5 h nakon višekratnih primjena opikapona u dozi do 50 mg jedanput na dan.
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%.
Croatian: Nakon peroralne primjene, prividni volumen distribucije opikapona pri dozi od 50 mg iznosio je 29 l, s varijabilnošću među ispitanicima od 36%.
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.
Croatian: Opikapon može interferirati s metabolizmom lijekova koji sadrže katekolnu skupinu a metaboliziraju se pomoću COMT-a, npr. rimiterolom, izoprenalinom, adrenalinom, noradrenalinom, dopaminom,
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).
Croatian: npr. razagilina (do 1 mg/dan) i selegilina (do 10 mg/dan u formulaciji za peroralnu primjenu ili 1,25 mg/dan u formulaciji za bukalnu apsorpciju) (vidjeti dio 4.3).
English: Shellac, propylene glycol, ammonia, indigo carmine aluminium (E132)
Croatian: Tinta za označivanje šelak, propilenglikol, amonijak, boja indigo carmine aluminium (E132)
English: HDPE bottles: Keep the bottle tightly closed in order to protect from moisture.
Croatian: Boce od HDPE: Bocu čuvati čvrsto zatvorenu radi zaštite od vlage.
English: Lactose monohydrate Sodium starch glycolate, Type A Maize starch, pregelatinized Magnesium stearate
Croatian: Sadržaj kapsule laktoza hidrat natrijev škroboglikolat, vrsta A kukuruzni škrob, prethodno geliran magnezijev stearat
English: Abdominal distention, Abdominal pain, Abdominal pain upper, Dyspepsia
Croatian: povraćanje distenzija abdomena, bol u abdomenu, bol u gornjem abdomenu, dispepsija
English: Many of the side effects can be managed by your doctor adjusting your levodopa medicine.
Croatian: Mnoge nuspojave mogu se ukloniti tako da Vam liječnik prilagodi dozu lijeka koji sadrži levodopu.
English: Indigo carmine aluminium lake (E132) Erythrosine (E127)
Croatian: Ovojnica kapsule želatina boja indigo carmine aluminium lake (E132) eritrozin (E127) titanijev dioksid (E171)
English: CI = confidence interval; LS mean = least square mean; N = number of non-missing values; OPC = opicapone.
Croatian: CI = interval pouzdanosti; LS srednja vrijednost = srednja vrijednost dobivena metodom najmanjeg kvadrata; N = broj postojećih vrijednosti; OPC = opikapon; a.
English: Danmark/Deutschland/Eesti/Ελλάδα/France/ Hrvatska/Ireland/Ísland/Italia/Κύπρος/Latvija/
Croatian: 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
English: The bioavailability of opicapone was significantly higher in patients with moderate chronic hepatic impairment and no safety concerns were observed.
Croatian: Bioraspoloživost opikapona bila je značajno viša u bolesnika s umjerenim kroničnim oštećenjem funkcije jetre, ali pojave koje bi mogle utjecati na sigurnost primjene nisu primjećene.
English: Shellac, titanium dioxide (E171), propylene glycol, ammonia, simethicone
Croatian: Tinta za označivanje šelak, titanijev dioksid (E171), propilenglikol, amonijak, simetikon
English: The pharmacokinetics of opicapone was not directly evaluated in subjects with chronic renal impairment.
Croatian: Farmakokinetika opikapona nije izravno procjenjivana u ispitanika s kroničnim oštećenjem funkcije bubrega.
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
Croatian: Mamede do Coronado Portugal tel: +351 22 986 61 00 faks: +351 22 986 61 90 e-mail: info@bial.com
English: No dose adjustment is necessary in patients with renal impairment, as opicapone is not excreted by the kidney (see section 5.2).
Croatian: Nije potrebno prilagođavanje doze u bolesnika s oštećenjem funkcije bubrega, jer se opikapon ne izlučuje bubrezima (vidjeti dio 5.2).
English: Responders, n (%) 65 (47.8)
Croatian: Responderi, n (%)
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.
Croatian: BIA 9-1103, njegov glavni metabolit, transportiran je pomoću OATP1B1 i OATP1B3, a efluks transporter mu je bio BCRP.
English: Intolerance to excipients
Croatian: Intolerancija na pomoćne tvari
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
Croatian: - Drugi sastojci su: o sadržaj kapsule: laktoza hidrat, natrijev škroboglikolat (vrsta A), prethodno gelirani kukuruzni škrob i magnezijev stearat o ovojnica kapsule: želatina, boja indigo carmine aluminium lake (E132), eritrozin (E127) i titanijev dioksid (E171) o tinta za označivanje: šelak, titanijev dioksid (E171), propilenglikol, amonijak, simetikon
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.
Croatian: dekarboksilaze (DDCI) u odraslih bolesnika s Parkinsonovom bolešću i motoričkim fluktuacijama pri kraju doze koji se ne mogu stabilizirati primjenom te kombinacije.
English: Blood creatine phosphokinase increased
Croatian: Pretrage povišena razina kreatin-fosfokinaze u krvi smanjenje tjelesne težine
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%.
Croatian: Nakon peroralne primjene, prividni ukupni klirens opikapona iz tijela pri dozi od 50 mg iznosio je 22 l/h, s varijabilnošću među ispitanicima od 45%.
English: Ongentys may increase its effect; - medicines containing quinidine, a medicine used to treat abnormal heart rhythms or malaria.
Croatian: Ongentys može pojačati njihov učinak; - lijekove koji sadrže kinidin, lijek koji se koristi za liječenje nenormalnih srčanih ritmova ili malarije.
English: Ongentys should be taken preferably at bedtime.
Croatian: Ongentys je najbolje uzeti prije spavanja.
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.
Croatian: - ako imate teške probleme s jetrom i izgubili ste apetit, tjelesnu težinu, pojavila Vam se slabosti ili iscrpljenosti unutar kratkog vremena.
English: Ongentys taken with levodopa may make you feel light-headed, dizzy, or sleepy.
Croatian: Ongentys, kad se uzima s levodopom, može uzrokovati da osjećate ošamućenost, omaglicu, ili pospanost.
English: Keep the bottle tightly closed in order to protect from moisture
Croatian: Bocu čuvati čvrsto zatvorenu radi zaštite od vlage.
English: There is limited experience with opicapone when used concomitantly with tricyclic antidepressants and noradrenaline re-uptake inhibitors (e.g. venlafaxine, maprotiline and desipramine).
Croatian: Triciklički antidepresivi i inhibitori ponovne pohrane noradrenalina Iskustva s opikaponom kada se on istodobno primjenjuje s tricikličkim antidepresivima i inhibitorima ponovne pohrane noradrenalina (npr. venlafaksinom, maprotilinom i dezipraminom) su ograničena.
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.
Croatian: U zdravih ispitanika poluvijek eliminacije (t1/2) opikapona, nakon njegove višekratne primjene u dozi do 50 mg jedanput na dan, iznosio je 0,7 h do 3,2 h.
English: Your doctor may need to review your treatments.
Croatian: Vaš će liječnik možda trebati preispitati je li Vaše liječenje odgovarajuće.
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.
Croatian: Zbog toga je kontraindicirana istodobna primjena opikapona i inhibitora MAO (npr. fenelzina, tranilcipromina i moklobemida), osim onih namijenjenih liječenju Parkinsonove bolesti.
English: The difference in LS mean change in OFF-time of entacapone to placebo in Study 1 was -30.5 minutes.
Croatian: Razlika u LS srednjoj vrijednosti promjene OFF-vremena između skupine koja je primala entakapon i skupine koja je primala placebo u Ispitivanju 1 iznosila je -30,5 minuta.
English: Ear and labyrinth disorders
Croatian: Poremećaji uha i labirinta kongestija uha
English: Ongentys is to be administered as an adjunct to levodopa treatment.
Croatian: Ongentys se primjenjuje kao dodatak liječenju levodopom.
English: Blisters: Store in the original blister in order to protect from moisture.
Croatian: Blisteri: Čuvati u originalnom blisteru radi zaštite od vlage.
English: Anxiety, Depression, Hallucination auditory, Nightmare, Sleep disorder.,
Croatian: halucinacije, vidne halucinacije, nesanica anksioznost, depresija, slušne halucinacije,
English: Bottles: Keep the bottle tightly closed in order to protect from moisture.
Croatian: Boce: Bocu čuvati čvrsto zatvorenu radi zaštite od vlage.
English: Ongentys may increase their effects; - medicines for high cholesterol such as rosuvastatin, simvastatin, atorvastatin or pravastatin Ongentys may increase their effects; - medicines that affect the immune system such as methotrexate.
Croatian: Ongentys može pojačati njihov učinak; - lijekove koji se primjenjuju za liječenje zatajivanja srca poput dobutamina, dopamina ili dopeksamina; Ongentys može pojačati njihov učinak; - lijekove za liječenje povišene razine kolesterola poput rosuvastatina, simvastatina, atorvastatina ili pravastatina.
English: Increases in liver enzymes were reported in studies with nitrocatechol inhibitors of catechol-Omethyltransferase (COMT).
Croatian: U ispitivanjima s nitrokatekolskim inhibitorima katekol-O-metiltransferaze (COMT) zabilježen je porast razine jetrenih enzima.
English: Blisters: 10, 30 or 90 capsules.
Croatian: Blisteri: 10, 30 ili 90 kapsula.
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, propylene glycol, ammonia, indigo carmine aluminium (E132)
Croatian: o sadržaj kapsule: laktoza hidrat, natrijev škroboglikolat (vrsta A), prethodno gelirani kukuruzni škrob i magnezijev stearat o ovojnica kapsule: želatina, boja indigo carmine aluminium lake (E132), eritrozin (E127) i titanijev dioksid (E171) o tinta za označivanje: šelak, propilenglikol, amonijak, boja indigo carmine aluminium (E132)
English: Blisters: 10 or 30 capsules.
Croatian: Blisteri: 10 ili 30 kapsula.
English: Tell your doctor if you are taking: - medicines for depression or anxiety such as venlafaxine, maprotiline and desipramine.
Croatian: - lijekove za depresiju ili tjeskobu poput venlafaksina, maprotilina i dezipramina.
English: Bottles: 10, 30 or 90 capsules.
Croatian: Boce: 10, 30 ili 90 kapsula.
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).
Croatian: - ako ste ikad imali maligni neuroleptički sindrom, rijetku reakciju na antipsihotičke lijekove - ako ste ikad imali rijetki mišićni poremećaj koji se naziva rabdomioliza koji nije bio uzrokovan ozljedom;
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.
Croatian: Farmakokinetika opikapona procjenjivana je u starijih ispitanika (u dobi 65-78 godina) nakon višekratne primjene doze od 30 mg tijekom 7 dana.
English: Do not drive or operate machinery if you experience any of these side effects.
Croatian: Ako osjetite ove nuspojave, nemojte upravljati vozilima ili raditi sa strojevima.
English: Bottles: 10 or 30 capsules.
Croatian: Boce: 10 ili 30 kapsula.
English: Other levodopa medicines
Croatian: Drugi lijekovi koji sadrže levodopu
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.
Croatian: In vitro ispitivanja pokazala su da se opikapon ne transportira pomoću OATP1B1, ali se transportira pomoću
English: Entacapone (N=122)
Croatian: Entakapon (N=122)
English: INSTRUCTIONS ON USE
Croatian: Ne preporučuje se koristiti
English: Dose adjustments of antiparkinsonian therapy
Croatian: Prilagođavanje doze lijekova za liječenje Parkinsonove bolesti
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.
Croatian: Opikapon je pokazao bolju kliničku djelotvornost u usporedbi s placebom tijekom dvostruko slijepog ispitivanja, kako za varijablu primarne djelotvornosti korištene u oba ključna ispitivanja, tj. smanjenje OFFvremena (Tablica 2), udio respondera (bolesnika s postignutim odgovorom) s obzirom na OFF-vrijeme (npr.
English: Hypertension, Hypotension
Croatian: Krvožilni poremećaji ortostatska hipotenzija hipertenzija, hipotenzija
English: There is limited clinical experience in patients with moderate hepatic impairment (Child-Pugh Class B).
Croatian: Klinička iskustva s primjenom u bolesnika s umjerenim oštećenjem funkcije jetre (stupanj B prema ChildPughovoj klasifikaciji) su ograničena.
English: Common: may affect up to 1 in 10 people - constipation - dry mouth - vomiting (being sick) - increased levels of the enzyme (creatine kinase) in your blood - muscle spasm
Croatian: - povraćanje - povećane razine enzima (kreatin kinaze) u krvi - mišićni grčevi
English: Ongentys 50 mg hard capsules are dark blue, approximately 19 mm length, with “OPC 50” and “Bial” printed on the capsules.
Croatian: Ongentys 50 mg tvrde kapsule su tamnoplave boje, duge oko 19 mm, s otisnutim „OPC 50” i „Bial” na kapsuli.
English: Weight decreased
Croatian: Tjelesna težina
English: Dysgeusia, Hyperkinesia, Syncope
Croatian: Poremećaji živčanog sustava diskinezija omaglica, glavobolja, somnolencija disgeuzija, hiperkinezija, sinkopa
English: OPA/Al/PVC//Al blisters containing 10, 30 or 90 capsules Not all pack sizes may be marketed.
Croatian: Blisteri OPA/Al/PVC//Al koji sadrže 10, 30 ili 90 kapsula.
English: Ongentys 25 mg hard capsules are light blue, approximately 19 mm length, with “OPC 25” and “Bial” printed on the capsules.
Croatian: Ongentys 25 mg tvrde kapsule su svijetloplave boje, duge oko 19 mm, s otisnutim „OPC 25” i „Bial” na kapsuli.
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.
Croatian: Bolesnici su imali stupanj težine bolesti 1 do 3 (prema modificiranoj ljestvici Hoehn-Yahr) u dijelu dana kad su simptomi bolesti bili dobro kontrolirani lijekovima (engl.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE PACKAGING
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM I UNUTARNJEM PAKIRANJU BOCA OD HDPE
English: Muscle twitching, Musculoskeletal stiffness, Myalgia, Pain in extremity
Croatian: mišićno-koštana ukočenost, mialgija,
English: Decreased appetite, Hypertriglyceridaemia
Croatian: Poremećaji metabolizma i prehrane oslabljeni apetit, hipertrigliceridemija
English: No dose adjustment is necessary in patients with mild hepatic impairment (Child-Pugh Class A).
Croatian: Nije potrebno prilagođavanje doze u bolesnika s blagim oštećenjem funkcije jetre (stupanj A prema Child
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.
Croatian: Bolesnike i osobe koje se o njima brinu potrebno je uputiti da bolesnici koji se liječe agonistima dopamina i/ili drugim dopaminergicima mogu razviti poremećaje kontrole poriva, uključujući patološko kockanje,
English: Ongentys is for oral use.
Croatian: Ongentys se primjenjuje kroz usta.
English: N LS mean
Croatian: N LS srednja vrijednost
English: See leaflet for further information.
Croatian: Za više informacija pogledati u uputi o lijeku.
English: Ongentys 25 mg hard capsules
Croatian: Ongentys 25 mg tvrde kapsule
English: Each hard capsule contains 25 mg of opicapone.
Croatian: Jedna tvrda kapsula sadrži 25 mg opikapona.
English: There is no clinical experience in patients with severe hepatic impairment (Child-Pugh Class C) (see section 4.2).
Croatian: Nema kliničkog iskustva o primjeni u bolesnika s teškim oštećenjem funkcije jetre (stupanj C prema Child
English: Each hard capsule contains 50 mg of opicapone.
Croatian: Jedna tvrda kapsula sadrži 50 mg opikapona.
English: Eye disorders
Croatian: - začepljenost uha
English: Ongentys 50 mg hard capsules
Croatian: Ongentys 50 mg tvrde kapsule
English: EU/1/15/1066/001 10 hard capsules EU/1/15/1066/008 30 hard capsules
Croatian: EU/1/15/1066/001 10 tvrdih kapsula EU/1/15/1066/008 30 tvrdih kapsula
English: EU/1/15/1066/005 10 hard capsules EU/1/15/1066/006 30 hard capsules EU/1/15/1066/007 90 hard capsules
Croatian: EU/1/15/1066/005 10 tvrdih kapsula EU/1/15/1066/006 30 tvrdih kapsula EU/1/15/1066/007 90 tvrdih kapsula
English: Opicapone showed a marked (>90%) and long-lasting (>24 hours) COMT inhibition in healthy subjects after administration of 50 mg opicapone.
Croatian: Nakon primjene 50 mg opikapona u zdravih ispitanika, opikapon je pokazao izrazitu (>90%) i dugotrajnu inhibiciju COMT-a (> 24 h).
English: Ongentys 25 mg capsules opicapone
Croatian: Ongentys 25 mg kapsule opikapon
English: EU/1/15/1066/009 10 hard capsules EU/1/15/1066/010 30 hard capsules
Croatian: EU/1/15/1066/009 10 tvrdih kapsula EU/1/15/1066/010 30 tvrdih kapsula
English: White high density polyethylene (HDPE) bottles with polypropylene (PP) child resistant closures containing 10 or 30 capsules.
Croatian: Bijele boce od polietilena visoke gustoće (HDPE) sa zatvaračem od polipropilena (PP) sigurnim za djecu,
English: Package leaflet: Information for the patient Ongentys 25 mg hard capsules opicapone This medicine is subject to additional monitoring.
Croatian: Uputa o lijeku: Informacije za bolesnika Ongentys 25 mg tvrde kapsule opikapon
English: EU/1/15/1066/002 10 hard capsules EU/1/15/1066/003 30 hard capsules EU/1/15/1066/004 90 hard capsules
Croatian: EU/1/15/1066/002 10 tvrdih kapsula EU/1/15/1066/003 30 tvrdih kapsula EU/1/15/1066/004 90 tvrdih kapsula
English: Hepatic impairment
Croatian: - omaglica - glavobolja
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).
Croatian: tranilciprominom i moklobemidom) osim onih namijenjenih liječenju Parkinsonove bolesti (vidjeti dio 4.5).
English: Light blue capsules, size 1, approximately 19 mm, imprinted “OPC 25” on the cap and “Bial” on the body.
Croatian: Kapsule svijetloplave boje, veličine 1, duge oko 19 mm, s otisnutim „OPC 25” na kapici i „Bial” na tijelu kapsule.
English: Each capsule contains 25 mg of opicapone.
Croatian: Jedna kapsula sadrži 25 mg opikapona.
English: Ongentys 50 mg capsules opicapone
Croatian: Ongentys 50 mg kapsule opikapon
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.
Croatian: Opikapon je pokazao bolju kliničku djelotvornost u usporedbi s placebom tijekom dvostruko slijepog ispitivanja, kako za varijablu primarne djelotvornosti korištene u oba ključna ispitivanja, tj. smanjenje OFF
English: Dark blue capsules, size 1, approximately 19 mm, imprinted “OPC 50” on the cap and “Bial” on the body.
Croatian: Kapsule tamnoplave boje, veličine 1, duge oko 19 mm, s otisnutim „OPC 50” na kapici i „Bial” na tijelu kapsule.
English: Opicapone exposure increased in a dose proportional manner following once-daily multiple dose administration up to 50 mg opicapone.
Croatian: Nakon višekratne primjene opikapona u dozi do 50 mg jedanput na dan, izloženost opikaponu povećavala se proporcionalno dozi.
English: Package leaflet: Information for the patient Ongentys 50 mg hard capsules opicapone This medicine is subject to additional monitoring.
Croatian: Uputa o lijeku: Informacije za bolesnika Ongentys 50 mg tvrde kapsule opikapon
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
Croatian: - pad krvnog tlaka pri ustajanju koji uzrokuje omaglicu, ošamućenost ili nesvjesticu Manje često: mogu se javiti u do 1 na 100 osoba: - osjećaj lupanja srca ili nepravilni otkucaji srca
English: How to store Ongentys
Croatian: Moguće nuspojave Kako čuvati Ongentys
English: Each capsule contains 50 mg of opicapone.
Croatian: Jedna kapsula sadrži 50 mg opikapona.
English: Musculoskeletal and connective tissue disorders
Croatian: Poremećaji mišićno koštanog sustava i vezivnog tkiva mišićni spazmi trzanje mišića,
English: Constipation, Dry mouth, Vomiting
Croatian: - mišićni trzaji, ukočenost ili bol