FrancophonIA/ELRC3.0 huggingface dataset:
English: Human Coagulation Factor VIII 500IU/Vial, Human Von Willebrand Factor 38 I.U.
Croatian: Humani koagulacijski faktor VIII 500IU/Bočica, humani von Willebrandov faktor 38 IU / ml
English: Human Coagulation Factor VIII 500 I.E., Human Von Willebrand Factor 1200 I.E.
Croatian: Humani koagulacijski faktor VIII 500 IU, humani von Willebrandov faktor 1200 IU
English: Octanate 500 Octapharma Gmbh Human Coagulation Factor VIII
Croatian: Octanate 500 Octapharma Gmbh Humani koagulacijski faktor VIII
English: Wilate 1000 Octapharma Gmbh Human Coagulation Factor VIII, Human Von
Croatian: Wilate 1000 Octapharma Gmbh Humani koagulacijski faktor VIII, humani von
English: Human Coagulation Factor VIII 250 I.E., Human Von Willebrand Factor 600 I.E.
Croatian: Humani koagulacijski faktor VIII 250 IU, humani von Willebrandov faktor 600 IU
English: Beriate 500 Csl Behring Gmbh Human Coagulation Factor VIII
Croatian: Beriate 500 Csl Behring Gmbh Humani koagulacijski faktor VIII
English: Beriate 2000 Csl Behring Gmbh Human Coagulation Factor VIII
Croatian: Beriate 2000 Csl Behring Gmbh Humani koagulacijski faktor VIII
English: Human Coagulation Factor VIII 1500 I.E.
Croatian: Humani koagulacijski faktor VIII 1500 IU
English: Human Coagulation Factor VIII (Rdna) 250IU/Vial
Croatian: Humani koagulacijski faktor VIII (rDNK) 250IU/Bočica
English: Czech Republic Haemate P Csl Behring Gmbh Human Coagulation Factor VIII (Rdna),
Croatian: Češka Republika Haemate P Csl Behring Gmbh Humani koagulacijski faktor VIII (rDNK), humani von
English: Human Coagulation Factor VIII, Human Von Willebrand FactorVIII
Croatian: Humani koagulacijski faktor VIII, humani von Willebrandov faktor
English: Beriate 250 Csl Behring Gmbh Human Coagulation Factor VIII
Croatian: Beriate 250 Csl Behring Gmbh Humani koagulacijski faktor VIII
English: Human Coagulation Factor VIII 250 I.E. Human Von Willebrand Factor 150 I.E.
Croatian: Humani koagulacijski faktor VIII 250 IU, humani von Willebrandov faktor 150 IU
English: Human Coagulation Factor VIII 1000 I.E./ Human Von Willebrand Factor 600 I.E.
Croatian: Humani koagulacijski faktor VIII 1000 IU, humani von Willebrandov faktor 600 IU
English: Human Coagulation Factor VIII 200 IU/ml
Croatian: Humani koagulacijski faktor VIII (rDNK) 200 IU / ml
English: Wilate 900 Octapharma Gmbh Human Coagulation Factor VIII, Human Von
Croatian: Wilate 900 Octapharma Gmbh Humani koagulacijski faktor VIII, humani von
English: Wilate 500 Octapharma Gmbh Human Coagulation Factor VIII, Human Von
Croatian: Wilate 500 Octapharma Gmbh Humani koagulacijski faktor VIII, humani von
English: Luxembourg Recombinate Baxalta Innovations Gmbh
Croatian: Luksemburg Recombinate Baxalta Innovations Gmbh
English: CSL Behring Gmbh Human Coagulation Factor VIII
Croatian: Csl Behring Gmbh Humani koagulacijski faktor VIII
English: Csl Behring Gmbh Human Coagulation Factor VIII
Croatian: CSL Behring Gmbh Humani koagulacijski faktor VIII
English: Beriate 1000 Csl Behring Gmbh Human Coagulation Factor VIII
Croatian: Beriate 1000 Csl Behring Gmbh Humani koagulacijski faktor VIII
English: Human Coagulation Factor VIII 500IU/Vial, Human Von Willebrand Factor 120 I.U.
Croatian: Humani koagulacijski faktor VIII 500IU/Bočica, humani von Willebrandov faktor 120 IU / ml
English: Human Coagulation Factor VIII (Rdna) 1000IU/Vial
Croatian: Humani koagulacijski faktor VIII (rDNK) 1000 IU / 10 ml
English: Human Coagulation Factor VIII 500 I.E., Human Von Willebrand Factor 300 I.E.
Croatian: Humani koagulacijski faktor VIII 500 IU, humani von Willebrandov faktor 300 IU
English: Human Coagulation Factor VIII 100 IU/ml
Croatian: Humani koagulacijski faktor VIII (rDNK) 100 IU / ml
English: Luxembourg Haemate P Csl Behring Gmbh Human Coagulation Factor VIII, Human Von
Croatian: Luksemburg Haemate P Csl Behring Gmbh Humani koagulacijski faktor VIII, humani von
English: Haemate P Csl Behring Mepe Human Coagulation Factor VIII, Human Von
Croatian: Haemate P Csl Behring Mepe Humani koagulacijski faktor VIII, humani von
English: Human Coagulation Factor VIII (Rdna) 500IU/Vial
Croatian: Humani koagulacijski faktor VIII (rDNK) 500 IU / 5 ml
English: Human Coagulation Factor VIII 500 I.U.
Croatian: Humani koagulacijski faktor VIII 500 I.U. Bočica
English: Human Coagulation Factor VIII 100 I.U./ml, Human Von Willebrand Factor 100 I.U./ml VIII
Croatian: Humani koagulacijski faktor VIII 100 IU/ml, humani von Willebrandov faktor 100 IU/ml VIII
English: Octanate Lv Octapharma Gmbh Human Coagulation Factor VIII
Croatian: Octanate Lv Octapharma Gmbh Humani koagulacijski faktor VIII
English: Csl Behring Gmbh Human Coagulation Factor VIII (Rdna),
Croatian: Csl Behring Gmbh Humani koagulacijski faktor VIII (rDNK), humani von
English: Human Coagulation Factor VIII (Rdna) 50 I.U.
Croatian: Humani koagulacijski faktor VIII (rDNK) 50 IU / ml
English: Human Coagulation Factor VIII (Rdna) 25 I.U.
Croatian: Humani koagulacijski faktor VIII (rDNK) 25 IU / ml
English: Haemate P CSL Behring Gmbh Human Coagulation Factor VIII, Human Von
Croatian: Haemate P Csl Behring Gmbh Humani koagulacijski faktor VIII, humani von
English: Haemate P Csl Behring Gmbh Human Coagulation Factor VIII, Human Von
Croatian: Haemate P CSL Behring Gmbh Humani koagulacijski faktor VIII, humani von
English: Haemoctin Biotest Hungaria Kft. Human Coagulation Factor VIII
Croatian: Haemoctin Biotest Hungaria Kft.
English: Haemate P Csl Behring Gmbh Human Coagulation Factor VIII (Rdna),
Croatian: Haemate P Csl Behring Gmbh Humani koagulacijski faktor VIII (rDNK), humani von
English: Human Coagulation Factor VIII (Rdna) 250 I.U.
Croatian: Humani koagulacijski faktor VIII (rDNK) 250 IU / 5 ml
English: Human Coagulation Factor VIII 100 I.U./ml, Human Von Willebrand Factor 100 I.U./mlVIII
Croatian: Humani koagulacijski faktor VIII 100 IU / ml, von Willebrandov faktor 25 IU / ml
English: Date of first authorisation: 24 June 2016
Croatian: Datum prvog odobrenja: 24. lipnja 2016.
English: There is no known specific antidote.
Croatian: Nema poznatog specifičnog antidota.
English: Always take this medicine exactly as your doctor has told you.
Croatian: Uvijek uzmite ovaj lijek točno onako kako je Vam je rekao Vaš liječnik.
English: HDPE bottles: 3 years Blisters: 5 years
Croatian: Boce od HDPE: 3 godine Blisteri: 5 godine
English: Follow the instructions that your doctor has given you.
Croatian: Slijedite upute koje Vam je dao Vaš liječnik.
English: Elderly (≥ 65 years old)
Croatian: Starije osobe (u dobi ≥ 65 godina)
English: Children and adolescents under the age of 18 years must not take this medicine as it has not been studied in these age groups.
Croatian: Djeca i adolescenti mlađi od 18 godina ne smiju uzimati ovaj lijek jer on nije ispitan u tim dobnim skupinama.
English: The capsules are packaged in bottles or blisters.
Croatian: Kapsule su pakirane u bocama ili blisterima.
English: Do not stop taking Ongentys unless your doctor tells you to as your symptoms may get worse.
Croatian: Nemojte prestati uzimati Ongentys, osim ako Vam to nije odredio liječnik, jer bi Vam se simptomi mogli pogoršati.
English: This will help the doctor identify what you have taken.
Croatian: To će liječniku pomoći prepoznati lijek koji ste uzeli.
English: Overall, it can be concluded that the kidney is not the primary route of excretion.
Croatian: Uglavnom, može se zaključiti da bubrezi nisu primarni put izlučivanja.
English: The magnitude of this effect is not considered to be of clinical relevance.
Croatian: Vrijednost ovog učinka ne smatra se klinički značajnom.
English: If you take more Ongentys than you should
Croatian: Ako uzmete više Ongentysa nego što ste trebali
English: Other medicines and Ongentys
Croatian: Drugi lijekovi i Ongentys
English: Opicapone presents a low absorption (~20%).
Croatian: Opikapon ima nisku apsorpciju (~20%).
English: At screening, the mean age was similar in all treatment groups in both studies, ranging between 61.5 and 65.3 years.
Croatian: Na probiru, srednja dob bila je slična u svim skupinama u oba ispitivanja, krećući se u rasponu od 61,5 do 65,3 godine.
English: Very common: may affect more than 1 in 10 people - involuntary and uncontrollable, or difficult or painful body movements
Croatian: Vrlo često: mogu se javiti kod više od 1 na 10 osoba: - nehotični i nekontrolirani, ili otežani i bolni pokreti
English: Non-clinical data revealed no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity and carcinogenic potential.
Croatian: Neklinički podaci nisu ukazali na poseban rizik za ljude na temelju konvencionalnih ispitivanja sigurnosne farmakologije, toksičnosti ponovljenih doza, genotoksičnosti i kancerogenog potencijala.
English: What Ongentys is and what it is used for
Croatian: Što je Ongentys i za što se koristi
English: The most common adverse reactions reported were nervous system disorders.
Croatian: Najčešće zabilježene nuspojave bili su poremećaji živčanog sustava.
English: Note: A responder was a patient who had a reduction of at least 1 hour in absolute OFF-time (OFF-time responder)
Croatian: Napomena: Responder je bolesnik koji je imao smanjenje od najmanje 1 sata u apsolutnom OFF-vremenu (responder s obzirom na OFF-vrijeme).
English: Therefore, their concomitant use should be considered with appropriate caution.
Croatian: Stoga se njihova istodobna primjena mora razmotriti s odgovarajućim oprezom.
English: Patients should be monitored regularly for the development of impulse control disorders and review of treatment is recommended if such symptoms develop.
Croatian: Bolesnike je potrebno redovito nadzirati zbog mogućeg razvoja poremećaja kontrole poriva i preporučuje se revidirati terapiju ako se razviju takvi simptomi.
English: Contents of the pack and other information What Ongentys contains
Croatian: Sadržaj pakiranja i druge informacije Što Ongentys sadrži
English: The recommended dose is 50 mg once daily.
Croatian: Preporučena doza je 50 mg jedanput na dan.
English: - if you are allergic to opicapone or any of the other ingredients of this medicine (listed in section
Croatian: - ako ste alergični na opikapon ili neki drugi sastojak ovog lijeka (naveden u dijelu 6);
English: Taking Ongentys and quinidine together, i.e. at the same time, may decrease the effect of Ongentys.
Croatian: Uzimanje Ongentysa i kinidina zajedno, tj. istodobno, može umanjiti učinak Ongentysa.
English: Take the medicine package and this leaflet with you.
Croatian: Uzmite sa sobom pakiranje lijeka i ovu uputu.
English: Other metabolic pathways include glucuronidation, methylation and reduction.
Croatian: Ostali metabolički putevi uključuju glukuronidaciju, metilaciju i redukciju.
English: Tell your doctor as soon as possible if you notice any of the following side effects:
Croatian: Obratite se svom liječniku što je prije moguće ako primijetite bilo koju od sljedećih nuspojava:
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.
Croatian: Ako ste trudni ili dojite, mislite da biste mogli biti trudni ili planirate imati dijete, obratite se svom liječniku ili ljekarniku za savjet prije nego uzmete ovaj lijek.
English: The capsules should be swallowed whole with water.
Croatian: Kapsule je potrebno progutati cijele s vodom.
English: Swallow the capsule whole with a glass of water.
Croatian: Kapsule progutajte cijele s čašom vode.
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.
Croatian: Iako nema dokaza da bi na učinkovitost i sigurnost opikapona mogla djelovati primjena pripravaka levodope s kontroliranim oslobađanjem, iskustvo s primjenom tih pripravaka je ograničeno.
English: Contact your doctor straight away if you experience any side effects at the start of treatment.
Croatian: Odmah se obratite svom liječniku ako osjetite bilo koju nuspojavu na početku liječenja.
English: Parkinson's disease is a progressive disease of the nervous system that causes shaking and affects your movement.
Croatian: Parkinsonova bolest je napredujuća bolest živčanog sustava koja uzrokuje tresenje i utječe na Vaše kretnje.
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).
Croatian: Stoga je često potrebno prilagoditi doziranje levodope tijekom prvih dana ili prvih tjedana nakon započinjanja liječenja opikaponom (vidjeti dio 4.4).
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.
Croatian: Takvo ponašanje naziva se „poremećaj kontrole poriva” i može uključivati: ovisničko kockanje, neuobičajeno jak spolni nagon ili pojačanu zaokupljenost seksualnim mislima ili osjećajima.
English: The SCOMT activity inhibition was significantly increased in elderly subjects.
Croatian: Inhibicija aktivnosti S-COMT bila je značajno povećana u starijih ispitanika.
English: Dyskinesia was the most frequently reported treatment-emergent adverse reaction (17.7%).
Croatian: Diskinezija je bila najčešća prijavljena nuspojava nastala tijekom primjene lijeka (17,7%).
English: Ask your doctor or pharmacist if you can take your antidepressant together with Ongentys.
Croatian: Upitajte svog liječnika ili ljekarnika smijete li uzimati Vaš antidepresiv i Ongentys.
English: Do not use this medicine after the expiry date which is stated on the bottle/blister/carton after EXP.
Croatian: Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na boci/blisteru/kutiji iza oznake EXP.
English: Difference to placebo p-value (95% CI)
Croatian: Razlika u odnosu na placebo p-vrijednost (95% CI)
English: Talk to your doctor or pharmacist if you or your family/carer notices you are developing urges or cravings to behave in ways that are unusual for you or you cannot resist the impulse, drive or temptation to carry out certain activities that could harm you or others.
Croatian: Obratite se svom liječniku ili ljekarniku ako ste Vi ili netko od Vaše obitelji/njegovatelja primijetili da ste razvili poriv ili jaku potrebu da se ponašate na način koji za Vas nije uobičajen ili se ne možete oduprijeti porivu, nagonu ili iskušenju da se upustite u neke radnje koje mogu naštetiti Vama osobno ili drugima.
English: What Ongentys looks like and contents of the pack
Croatian: Kako Ongentys izgleda i sadržaj pakiranja
English: The remainder of the radioactivity was excreted in urine (mean 12.8%) and via expired air (mean 15.9%).
Croatian: Preostali dio radioaktivnosti izlučio se mokraćom (srednja vrijednost 12,8%) i izdahnutim zrakom (srednja vrijednost 15,9%).
English: The majority of patients treated in both pivotal studies were treated with immediate-release levodopa/DDCI.
Croatian: Većina bolesnika liječenih u oba ključna ispitivanja bila je liječena formulacijom s trenutnim oslobađanjem levodope/DDCI.
English: The patient should not take an extra dose to make up for the missed dose.
Croatian: Bolesnik ne smije uzeti dodatnu dozu kako bi nadoknadio propuštenu.
English: Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take Ongentys.
Croatian: Bolesnici s rijetkim nasljednim problemima intolerancije na galaktozu, deficitom Lapp-laktaze ili malapsorpcijom glukoze-galaktoze, ne smiju uzimati Ongentys.
English: Pharmacotherapeutic group: Anti-parkinson drugs, other dopaminergic agents, ATC code: [not yet assigned]
Croatian: Farmakoterapijska skupina: Antiparkinsonici, ostali dopaminergici, ATK oznaka: [nije još dodijeljena]
English: It increases the effects of levodopa and helps to relieve the symptoms of Parkinson's disease and movement problems.
Croatian: On pojačava učinak levodope i pomaže ublažiti simptome Parkinsonove bolesti i teškoće s pokretima.
English: All reductions in activity essentially occurred at the highest concentration of opicapone (10 mcg/mL).
Croatian: Sva smanjenja aktivnosti u biti su se događala pri najvišoj koncentraciji opikapona (10 µg/ml).
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.
Croatian: Stoga je potreban poseban oprez u slučajevima kada se kinidin mora primjenjivati zajedno s opikaponom, jer se njihova istodobna primjena mora izbjegavati.
English: Side effects caused by Ongentys are usually mild to moderate and occur mostly within the first weeks of treatment.
Croatian: Nuspojave uzrokovane Ongentysom obično su blage do umjerene i javljaju se većinom unutar prvih tjedana liječenja.
English: Symptomatic and supportive treatment should be administered as appropriate.
Croatian: Potrebno je provesti simptomatsko i potporno liječenje ako se to smatra prikladnim.
English: Dry eye
Croatian: - suhe oči
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.
Croatian: U bolesnika koji uzimaju levodopu i periferni DDCI, poput karbidope ili benzerazida, opikapon povisuje razinu levodope u plazmi i tako poboljšava klinički odgovor na levodopu.
English: Opicapone reduced CYP2C9 activity through competitive / mixed type mode of inhibition.
Croatian: Opikapon je smanjio aktivnost CYP2C9 kompetitivnim/miješanim modusom inhibicije.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING BOX (BLISTER OPA/Al/PVC//Al)
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU KUTIJA (BLISTER OPA/Al/PVC//Al)
English: Combination of opicapone and MAO inhibitors could result in inhibition of the majority of the pathways responsible for the metabolism of catecholamines.
Croatian: Kombinacija opikapona i inhibitora MAO može imati za posljedicu inhibiciju većine metaboličkih puteva odgovornih za metabolizam katekolamina.
English: What you need to know before you take Ongentys 3.
Croatian: Što morate znati prije nego počnete uzimati Ongentys
English: Take Ongentys at least one hour before or after taking your levodopa medicine.
Croatian: Uzmite Ongentys najmanje jedan sat prije ili nakon što uzmete lijek koji sadrži levodopu.
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.
Croatian: Međutim, budući da je opikapon predviđen kao dodatak terapiji levodopom, može se razmotriti prilagođavanje doze na temelju mogućeg pojačanog dopaminergičkog odgovora na levodopu i s time povezane podnošljivosti.
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.
Croatian: Bilo je 60 bolesnika iz kombinirane faze 3 ispitivanja koji su pretežno koristili levodopu s kontroliranim oslobađanjem (tj. >50% njihovih formulacija levodope/DDCI), 48 ih je bilo liječeno samo formulacijama levodope s kontroliranim otpuštanjem.
English: Other metabolites were not found in quantifiable concentrations in the majority of plasma samples collected during a clinical mass balance study.
Croatian: Drugi metaboliti nisu pronađeni u mjerljivim koncentaracijama u većini uzoraka plazme prikupljenih tijekom kliničkog ispitivanja masene bilance.
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.
Croatian: U prisutnosti inhibitora DOPA-dekarboksilaze (DDCI), COMT postaje glavni enzim koji metabolizira levodopu, katalizirajući njezinu konverziju u 3-O-metildopu (3-OMD) u mozgu i na periferiji.
English: Frequency categories are defined as follows: very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100), rare (≥ 1/10,000 to < 1/1,000), very rare (< 1/10,000), not known (cannot be estimated from the available data).
Croatian: (≥ 1/1000 i < 1/100), rijetko (≥ 1/10 000 i < 1/1000), vrlo rijetko (< 1/10 000), nije poznato (ne može se procijeniti iz dostupnih podataka).
English: If you forget to take one dose, you should continue the treatment and take the next dose as scheduled.
Croatian: Ako ste zaboravili uzeti jednu dozu lijeka, trebate nastaviti s liječenjem tako što ćete sljedeću dozu uzeti prema uobičajenom rasporedu.
English: The reduced metabolite of opicapone (found to be active in non-clinical studies) is a minor metabolite in human plasma, and represented less than 10% of total systemic exposure to opicapone.
Croatian: Metabolit nastao redukcijom opikapona (za kojeg je utvrđeno da je aktivni metabolit u nekliničkim ispitivanjima) sporedni je metabolit u ljudskoj plazmi i predstavlja manje od 10% ukupne sistemske izloženosti opikaponu.
English: Ongentys should be taken once-daily at bedtime at least one hour before or after levodopa combinations.
Croatian: Ongentys se treba uzimati jedanput na dan prije spavanja i najmanje jedan sat prije ili nakon uzimanja kombinacije koja sadrži levodopu.
English: However, clinical interaction studies conducted with warfarin showed no effect of opicapone on the pharmacodynamics of warfarin, a substrate of CYP2C9.
Croatian: Međutim, klinička ispitivanja interakcije provedena s varfarinom nisu pokazala učinak opikapona na farmakodinamiku varfarina, supstrata za CYP2C9.
English: CI = confidence interval; N = total number of patients; n = number of patients with available information; NA = not applicable; OPC = opicapone
Croatian: CI = interval pouzdanosti; N = ukupni broj bolesnika; n = broj bolesnika s dostupnim podacima; NP = nije primjenjivo; OPC = opikapon
English: Effect of transporters on opicapone
Croatian: Učinak transportera na opikapon
English: If you stop taking Ongentys
Croatian: Ako prestanete uzimati Ongentys
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.
Croatian: Na vezivanje 14Copikapona za proteine plazme nije utjecala prisutnost varfarina, diazepama, digoksina i tolbutamida, a na vezivanje 14C-varfarina, 2-14C-diazepama, 3H-digoksina i 14C-tolbutamida nije utjecala prisutnost opikapona i opikaponsulfata, glavnog metabolita u ljudi.
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).
Croatian: Ispitivanje provedeno na zdravim dobrovoljcima pokazalo je da, kada se jednokratna doza od 50 mg opikapona istodobno primjenjivala (unutar jednog sata) s jednokratnom dozom kinidina (600 mg), sistemska izloženost opikaponu smanjila se za 37 % (AUC0-tlast).
English: As Ongentys will be used with other levodopa medicines, please also read the package leaflets of these medicines carefully.
Croatian: Budući da ćete Ongentys uzimati s drugim lijekovima koji sadrže levodopu, molimo da pažljivo pročitate uputu o lijeku za te lijekove.
English: If you take more Ongentys than you should, tell your doctor or pharmacist, or go to a hospital immediately.
Croatian: Ako uzmete više Ongentysa nego što ste trebali, odmah se obratite svom liječniku ili ljekarniku ili otiđite u bolnicu.
English: Since the risk to the baby/infant cannot be excluded, you should stop breast-feeding during treatment with Ongentys.
Croatian: Budući da se rizik za novorođenče/dojenče ne može isključiti, za vrijeme liječenja Ongentysom trebate prekinuti s dojenjem.