natgillin/translations-raw huggingface dataset:
NAME OF THE MEDICINAL PRODUCT Olanzapine Teva 20 mg film-coated tablets Olanzapine 
Olanzapin Teva 20 mg filmom obložene tablete olanzapin
Olanzapine Teva 15 mg film-coated tablets Light blue, biconvex, oval film-coated tablets, debossed ”OL 15” on one side and plain on the other. 
Olanzapin Teva 15 mg filmom obložene tablete Svijetloplave, bikonveksne, ovalne, filmom obložene tablete s utisnutom oznakom "OL 15" na jednoj strani i bez oznake na drugoj strani.
EU/1/07/427/030 - 56 tablets, per box 
EU/1/07/427/030 - 56 tableta u kutiji
EU/1/07/427/053 - 70 tablets, per box 
EU/1/07/427/053 - 70 tableta u kutiji
STATEMENT OF ACTIVE SUBSTANCE(S) Each film-coated tablet contains: 10 mg Olanzapine. 
Svaka filmom obložena tableta sadrži: 10 mg olanzapina.
EU/1/07/427/063 - 98 tablets, per box 
EU/1/07/427/063 - 98 tableta u kutiji
Olanzapine Teva 20 mg film-coated tablets OPA/alu/PVC-alu blisters in cartons of 28, 30, 35, 56, 70 or 98 film-coated tablets per carton. 
Olanzapin Teva 20 mg raspadljive tablete za usta OPA-Al-PVC/Al blisteri u kutijama s 28, 30, 35, 56, 70 ili 98 raspadljivih tableta za usta.
EU/1/07/427/056 - 70 tablets, per box 
EU/1/07/427/056 - 70 tableta u kutiji
Olanzapine Teva coated tablets are for oral use. 
Olanzapin Teva obložene tablete uzimaju se kroz usta.
EU/1/07/427/034 - 56 tablets, per box 
EU/1/07/427/034 - 56 tableta u kutiji
Olanzapine Teva 7.5 mg film-coated tablets are available in cartons of 28, 28 x 1, 30, 30 x 1, 35, 35 x 1, 56, 56 x 1, 60, 70, 70 x 1, 98 or 98 x 1 film-coated tablets. 
Olanzapin Teva 7,5 mg filmom obložene tablete su dostupne u kutijama s 28, 28 x 1, 30, 30 x 1, 35, 35 x 1, 56, 56 x 1, 60, 70, 70 x 1, 98 ili 98 x 1 filmom obloženih tableta.
EU/1/07/427/066 - 98 tablets, per box 
EU/1/07/427/066 - 98 tableta u kutiji
NAME OF THE MEDICINAL PRODUCT Olanzapine Teva 10 mg orodispersible tablets Olanzapine 
Olanzapin Teva 10 mg raspadljive tablete za usta olanzapin
EU/1/07/427/046 - 35 tablets, per box 
EU/1/07/427/046 - 35 tableta u kutiji
There is a risk of feeling drowsy when you are given Olanzapine Teva. 
Tijekom uzimanja Olanzapina Teva postoji rizik da se osjećate pospano.
NAME OF THE MEDICINAL PRODUCT Olanzapine Teva 15 mg orodispersible tablets Olanzapine 
Olanzapin Teva 15 mg raspadljive tablete za usta olanzapin
EU/1/07/427/045 - 35 tablets, per box 
EU/1/07/427/045 - 35 tableta u kutiji
EU/1/07/427/057 - 70 tablets, per box 
EU/1/07/427/057 - 70 tableta u kutiji
EU/1/07/427/047 - 35 tablets, per box 
EU/1/07/427/047 - 35 tableta u kutiji
High uric acid10 
Ortostatska hipotenzija10
EU/1/07/427/043 - 35 tablets, per box 
EU/1/07/427/043 - 35 tableta u kutiji
Olanzapine Teva 15 mg film-coated tablet is a light blue, biconvex, oval film-coated tablet, debossed ”OL 15” on one side and plain on the other. 
Olanzapin Teva 15 mg filmom obložena tableta je svijetloplava, bikonveksna, ovalna, filmom obložena tableta s utisnutom oznakom "OL 15" na jednoj strani i bez oznake na drugoj strani.
EU/1/07/427/067 - 98 tablets, per box 
EU/1/07/427/067 - 98 tableta u kutiji
EU/1/07/427/037 - 56 tablets, per box 
EU/1/07/427/037 - 56 tableta u kutiji
EU/1/07/427/065 - 98 tablets, per box 
EU/1/07/427/065 - 98 tableta u kutiji
STATEMENT OF ACTIVE SUBSTANCE(S) Each film-coated tablet contains: 5 mg Olanzapine. 
Svaka filmom obložena tableta sadrži: 5 mg olanzapina.
NAME OF THE MEDICINAL PRODUCT Olanzapine Teva 10 mg film-coated tablets Olanzapine 
Olanzapin Teva 10 mg filmom obložene tablete olanzapin
NAME OF THE MEDICINAL PRODUCT Olanzapine Teva 5 mg orodispersible tablets Olanzapine 
Olanzapin Teva 5 mg raspadljive tablete za usta olanzapin
STATEMENT OF ACTIVE SUBSTANCE(S) Each film-coated tablet contains: 15 mg Olanzapine. 
Svaka filmom obložena tableta sadrži: 15 mg olanzapina.
NAME OF THE MEDICINAL PRODUCT Olanzapine Teva 15 mg film-coated tablets Olanzapine 
Olanzapin Teva 15 mg filmom obložene tablete olanzapin
Olanzapine Teva 20 mg film-coated tablets Pink, biconvex, oval film-coated tablets, debossed ”OL 20” on one side and plain on the other. 
Ružičaste, bikonveksne, ovalne, filmom obložene tablete s utisnutom oznakom "OL 20" na jednoj strani i bez oznake na drugoj strani.
Tablet core 
Funkcija jetre
Sími: +354 5503300 
Actavis Pharmaceuticals Iceland ehf. Sími: +354 5503300
Czech Republic Immunate Stim Plus 
Češka Republika Immunate Stim Plus
Czech Republic Optivate 
Češka Republika Optivate
Germany Faktor VIII Sdh Intersero 
Njemačka Faktor VIII Sdh Intersero
Belgium Factane 1000 IU/10 ml 
Factane 1000 IU/10 ml
Recombinant coagulation factor VIII (octocog alfa) 
Rekombinantni koagulacijski faktor VIII (oktokog alfa)
Willebrand Factor 
Willebrandov faktor
Czech Republic Fanhdi 
Češka Republika Fanhdi
Czech Republic Octanate 
Češka Republika Octanate
Czech Republic Wilate 
Češka Republika Wilate
Czech Republic Beriate 
Češka Republika Beriate
Wilate 1000 Octapharma Produtos 
Wilate 1000 Octapharma
Annex I List of medicinal products and presentations 
Popis lijekova, jačina i farmaceutskih oblika
Czech Republic Haemoctin Sdh 
Češka Republika Haemoctin Sdh
Human Coagulation Factor VIII 2000 IU 
Humani koagulacijski faktor VIII 2000 IU
Grifols Italia S.P.A Human Coagulation Factor VIII, Human Von Willebrand Factor 
Grifols Italia S.P.A Humani koagulacijski faktor VIII, humani von Willebrandov faktor
Wilate 500 Octapharma Produtos 
Wilate 500 Octapharma
Lfb Biomedicaments Human Coagulation Factor VIII 
LFB Biomedicaments Humani koagulacijski faktor VIII
LFB Biomedicaments Human Coagulation Factor VIII 
Lfb Biomedicaments Humani koagulacijski faktor VIII
Octapharma-Ltd Human Coagulation Factor VIII 
Octapharma-Ltd Humani koagulacijski faktor VIII
Powder For Injection Intravenous Use 
Prašak za injekciju U venu
Human Coagulation Factor VIII 1000 IU 
Humani koagulacijski faktor VIII 1000 IU
Powder And Solvent For Solution For Infusion 
Prašak i otapalo za otopinu za infuziju
Human Coagulation Factor VIII 250 IU 
Humani koagulacijski faktor VIII 250 IU
United Kingdom 8y 
Ujedinjeno Kraljevstvo
Csl Behring Gmbh Human Coagulation Factor VIII, Human Von Willebrand Factor 
Csl Behring Gmbh Humani koagulacijski faktor VIII, humani von Willebrandov faktor
Octapharma France Human Coagulation Factor VIII 
Octapharma France Humani koagulacijski faktor VIII
Human Coagulation Factor VIII 500 IU 
Humani koagulacijski faktor VIII 500 IU
Octapharma Ab Human Coagulation Factor VIII 
Octapharma Ab Humani koagulacijski faktor VIII
Haemate P Csl Behring, S.A Human Coagulation Factor VIII, Von 
Haemate P Csl Behring, S.A Humani koagulacijski faktor VIII, von
Octapharma Ab Human Coagulation Factor VIII, Human Von Willebrand Factor 
Octapharma Ab Humani koagulacijski faktor VIII, humani von Willebrandov faktor
Octanate Lv Octapharma Ab Human Coagulation Factor VIII 
Octanate Lv Octapharma Ab Humani koagulacijski faktor VIII
Czech Republic Recombinate Baxalta Innovations GmbH 
Češka Republika Recombinate Baxalta Innovations GmbH
Octanate LV Octapharma France Human Coagulation Factor VIII 
Octanate LV Octapharma France Humani koagulacijski faktor VIII
Intersero Gmbh Human Coagulation Factor VIII 
Intersero Gmbh Humani koagulacijski faktor VIII
Octapharma-Ltd Human Coagulation Factor VIII, Human Von Willebrand Factor 
Octapharma-Ltd Humani koagulacijski faktor VIII, humani von Willebrandov faktor
Octanate 1000 Octapharma Gmbh Human Coagulation Factor VIII 
Octanate 1000 Octapharma Gmbh Humani koagulacijski faktor VIII
Octanate 250 Octapharma Gmbh Human Coagulation Factor VIII 
Octanate 250 Octapharma Gmbh Humani koagulacijski faktor VIII
Octapharma Gmbh Human Coagulation Factor VIII 
Octapharma Gmbh Humani koagulacijski faktor VIII
Octapharma Gmbh Human Coagulation Factor VIII, Human Von Willebrand Factor 
Octapharma Gmbh Humani koagulacijski faktor VIII, humani von Willebrandov faktor
Human Coagulation Factor VIII 1000 I.E. Human Von Willebrand Factor 2400 I.E. 
Humani koagulacijski faktor VIII 1000 IU humani von Willebrandov faktor 2400 IU
United Kingdom Octanate Lv Octapharma-Ltd Human Coagulation Factor VIII 
Octanate Lv Octapharma-Ltd Humani koagulacijski faktor VIII
Wilate 450 Octapharma Gmbh Human Coagulation Factor VIII, Human Von 
Wilate 450 Octapharma Gmbh Humani koagulacijski faktor VIII, humani von
Human Coagulation Factor VIII 1000IU/Vial, Human Von Willebrand Factor 75 I.U. 
Humani koagulacijski faktor VIII 1000IU/Bočica, humani von Willebrandov faktor 75 IU / ml
Human Coagulation Factor VIII 500IU/Vial, Human Von Willebrand Factor 38 I.U. 
Humani koagulacijski faktor VIII 500IU/Bočica, humani von Willebrandov faktor 38 IU / ml
Human Coagulation Factor VIII 500 I.E., Human Von Willebrand Factor 1200 I.E. 
Humani koagulacijski faktor VIII 500 IU, humani von Willebrandov faktor 1200 IU
Octanate 500 Octapharma Gmbh Human Coagulation Factor VIII 
Octanate 500 Octapharma Gmbh Humani koagulacijski faktor VIII
Wilate 1000 Octapharma Gmbh Human Coagulation Factor VIII, Human Von 
Wilate 1000 Octapharma Gmbh Humani koagulacijski faktor VIII, humani von
Human Coagulation Factor VIII 250 I.E., Human Von Willebrand Factor 600 I.E. 
Humani koagulacijski faktor VIII 250 IU, humani von Willebrandov faktor 600 IU
Beriate 500 Csl Behring Gmbh Human Coagulation Factor VIII 
Beriate 500 Csl Behring Gmbh Humani koagulacijski faktor VIII
Beriate 2000 Csl Behring Gmbh Human Coagulation Factor VIII 
Beriate 2000 Csl Behring Gmbh Humani koagulacijski faktor VIII
Human Coagulation Factor VIII 1500 I.E. 
Humani koagulacijski faktor VIII 1500 IU
Human Coagulation Factor VIII (Rdna) 250IU/Vial 
Humani koagulacijski faktor VIII (rDNK) 250IU/Bočica
Czech Republic Haemate P Csl Behring Gmbh Human Coagulation Factor VIII (Rdna), 
Češka Republika Haemate P Csl Behring Gmbh Humani koagulacijski faktor VIII (rDNK), humani von
Human Coagulation Factor VIII, Human Von Willebrand FactorVIII 
Humani koagulacijski faktor VIII, humani von Willebrandov faktor
Beriate 250 Csl Behring Gmbh Human Coagulation Factor VIII 
Beriate 250 Csl Behring Gmbh Humani koagulacijski faktor VIII
Human Coagulation Factor VIII 250 I.E. Human Von Willebrand Factor 150 I.E. 
Humani koagulacijski faktor VIII 250 IU, humani von Willebrandov faktor 150 IU
Human Coagulation Factor VIII 1000 I.E./ Human Von Willebrand Factor 600 I.E. 
Humani koagulacijski faktor VIII 1000 IU, humani von Willebrandov faktor 600 IU
Human Coagulation Factor VIII 200 IU/ml 
Humani koagulacijski faktor VIII (rDNK) 200 IU / ml
Wilate 900 Octapharma Gmbh Human Coagulation Factor VIII, Human Von 
Wilate 900 Octapharma Gmbh Humani koagulacijski faktor VIII, humani von
Wilate 500 Octapharma Gmbh Human Coagulation Factor VIII, Human Von 
Wilate 500 Octapharma Gmbh Humani koagulacijski faktor VIII, humani von
CSL Behring Gmbh Human Coagulation Factor VIII 
Csl Behring Gmbh Humani koagulacijski faktor VIII
Csl Behring Gmbh Human Coagulation Factor VIII 
CSL Behring Gmbh Humani koagulacijski faktor VIII
Beriate 1000 Csl Behring Gmbh Human Coagulation Factor VIII 
Beriate 1000 Csl Behring Gmbh Humani koagulacijski faktor VIII
Human Coagulation Factor VIII 500IU/Vial, Human Von Willebrand Factor 120 I.U. 
Humani koagulacijski faktor VIII 500IU/Bočica, humani von Willebrandov faktor 120 IU / ml
Human Coagulation Factor VIII (Rdna) 1000IU/Vial 
Humani koagulacijski faktor VIII (rDNK) 1000 IU / 10 ml
Human Coagulation Factor VIII 500 I.E., Human Von Willebrand Factor 300 I.E. 
Humani koagulacijski faktor VIII 500 IU, humani von Willebrandov faktor 300 IU
Human Coagulation Factor VIII 100 IU/ml 
Humani koagulacijski faktor VIII (rDNK) 100 IU / ml
Luxembourg Haemate P Csl Behring Gmbh Human Coagulation Factor VIII, Human Von 
Luksemburg Haemate P Csl Behring Gmbh Humani koagulacijski faktor VIII, humani von
Haemate P Csl Behring Mepe Human Coagulation Factor VIII, Human Von 
Haemate P Csl Behring Mepe Humani koagulacijski faktor VIII, humani von
Human Coagulation Factor VIII (Rdna) 500IU/Vial 
Humani koagulacijski faktor VIII (rDNK) 500 IU / 5 ml
Human Coagulation Factor VIII 500 I.U. 
Humani koagulacijski faktor VIII 500 I.U. Bočica
Human Coagulation Factor VIII 100 I.U./ml, Human Von Willebrand Factor 100 I.U./ml VIII 
Humani koagulacijski faktor VIII 100 IU/ml, humani von Willebrandov faktor 100 IU/ml VIII
Octanate Lv Octapharma Gmbh Human Coagulation Factor VIII 
Octanate Lv Octapharma Gmbh Humani koagulacijski faktor VIII
Csl Behring Gmbh Human Coagulation Factor VIII (Rdna), 
Csl Behring Gmbh Humani koagulacijski faktor VIII (rDNK), humani von
Human Coagulation Factor VIII (Rdna) 50 I.U. 
Humani koagulacijski faktor VIII (rDNK) 50 IU / ml
Human Coagulation Factor VIII (Rdna) 25 I.U. 
Humani koagulacijski faktor VIII (rDNK) 25 IU / ml
Haemate P CSL Behring Gmbh Human Coagulation Factor VIII, Human Von 
Haemate P Csl Behring Gmbh Humani koagulacijski faktor VIII, humani von
Haemate P Csl Behring Gmbh Human Coagulation Factor VIII, Human Von 
Haemate P CSL Behring Gmbh Humani koagulacijski faktor VIII, humani von
Haemoctin Biotest Hungaria Kft. Human Coagulation Factor VIII 
Haemoctin Biotest Hungaria Kft.
Haemate P Csl Behring Gmbh Human Coagulation Factor VIII (Rdna), 
Haemate P Csl Behring Gmbh Humani koagulacijski faktor VIII (rDNK), humani von
Human Coagulation Factor VIII (Rdna) 250 I.U. 
Humani koagulacijski faktor VIII (rDNK) 250 IU / 5 ml
Human Coagulation Factor VIII 100 I.U./ml, Human Von Willebrand Factor 100 I.U./mlVIII 
Humani koagulacijski faktor VIII 100 IU / ml, von Willebrandov faktor 25 IU / ml
Date of first authorisation: 24 June 2016 
Datum prvog odobrenja: 24. lipnja 2016.
There is no known specific antidote. 
Nema poznatog specifičnog antidota.
Always take this medicine exactly as your doctor has told you. 
Uvijek uzmite ovaj lijek točno onako kako je Vam je rekao Vaš liječnik.
HDPE bottles: 3 years Blisters: 5 years 
Boce od HDPE: 3 godine Blisteri: 5 godine
Follow the instructions that your doctor has given you. 
Slijedite upute koje Vam je dao Vaš liječnik.
Elderly (≥ 65 years old) 
Starije osobe (u dobi ≥ 65 godina)
Children and adolescents under the age of 18 years must not take this medicine as it has not been studied in these age groups. 
Djeca i adolescenti mlađi od 18 godina ne smiju uzimati ovaj lijek jer on nije ispitan u tim dobnim skupinama.
The capsules are packaged in bottles or blisters. 
Kapsule su pakirane u bocama ili blisterima.
Do not stop taking Ongentys unless your doctor tells you to as your symptoms may get worse. 
Nemojte prestati uzimati Ongentys, osim ako Vam to nije odredio liječnik, jer bi Vam se simptomi mogli pogoršati.
This will help the doctor identify what you have taken. 
To će liječniku pomoći prepoznati lijek koji ste uzeli.
Overall, it can be concluded that the kidney is not the primary route of excretion. 
Uglavnom, može se zaključiti da bubrezi nisu primarni put izlučivanja.
The magnitude of this effect is not considered to be of clinical relevance. 
Vrijednost ovog učinka ne smatra se klinički značajnom.
If you take more Ongentys than you should 
Ako uzmete više Ongentysa nego što ste trebali
Other medicines and Ongentys 
Drugi lijekovi i Ongentys
Opicapone presents a low absorption (~20%). 
Opikapon ima nisku apsorpciju (~20%).
At screening, the mean age was similar in all treatment groups in both studies, ranging between 61.5 and 65.3 years. 
Na probiru, srednja dob bila je slična u svim skupinama u oba ispitivanja, krećući se u rasponu od 61,5 do 65,3 godine.
Very common: may affect more than 1 in 10 people - involuntary and uncontrollable, or difficult or painful body movements 
Vrlo često: mogu se javiti kod više od 1 na 10 osoba: - nehotični i nekontrolirani, ili otežani i bolni pokreti
Non-clinical data revealed no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity and carcinogenic potential. 
Neklinički podaci nisu ukazali na poseban rizik za ljude na temelju konvencionalnih ispitivanja sigurnosne farmakologije, toksičnosti ponovljenih doza, genotoksičnosti i kancerogenog potencijala.
What Ongentys is and what it is used for 
Što je Ongentys i za što se koristi
The most common adverse reactions reported were nervous system disorders. 
Najčešće zabilježene nuspojave bili su poremećaji živčanog sustava.
Note: A responder was a patient who had a reduction of at least 1 hour in absolute OFF-time (OFF-time responder) 
Napomena: Responder je bolesnik koji je imao smanjenje od najmanje 1 sata u apsolutnom OFF-vremenu (responder s obzirom na OFF-vrijeme).
Therefore, their concomitant use should be considered with appropriate caution. 
Stoga se njihova istodobna primjena mora razmotriti s odgovarajućim oprezom.
Patients should be monitored regularly for the development of impulse control disorders and review of treatment is recommended if such symptoms develop. 
Bolesnike je potrebno redovito nadzirati zbog mogućeg razvoja poremećaja kontrole poriva i preporučuje se revidirati terapiju ako se razviju takvi simptomi.
Contents of the pack and other information What Ongentys contains 
Sadržaj pakiranja i druge informacije Što Ongentys sadrži
The recommended dose is 50 mg once daily. 
Preporučena doza je 50 mg jedanput na dan.
- if you are allergic to opicapone or any of the other ingredients of this medicine (listed in section 
- ako ste alergični na opikapon ili neki drugi sastojak ovog lijeka (naveden u dijelu 6);
Taking Ongentys and quinidine together, i.e. at the same time, may decrease the effect of Ongentys. 
Uzimanje Ongentysa i kinidina zajedno, tj. istodobno, može umanjiti učinak Ongentysa.
Take the medicine package and this leaflet with you. 
Uzmite sa sobom pakiranje lijeka i ovu uputu.
Other metabolic pathways include glucuronidation, methylation and reduction. 
Ostali metabolički putevi uključuju glukuronidaciju, metilaciju i redukciju.
Tell your doctor as soon as possible if you notice any of the following side effects: 
Obratite se svom liječniku što je prije moguće ako primijetite bilo koju od sljedećih nuspojava:
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. 
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.
The capsules should be swallowed whole with water. 
Kapsule je potrebno progutati cijele s vodom.
Swallow the capsule whole with a glass of water. 
Kapsule progutajte cijele s čašom vode.
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. 
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.
Contact your doctor straight away if you experience any side effects at the start of treatment. 
Odmah se obratite svom liječniku ako osjetite bilo koju nuspojavu na početku liječenja.
Parkinson's disease is a progressive disease of the nervous system that causes shaking and affects your movement. 
Parkinsonova bolest je napredujuća bolest živčanog sustava koja uzrokuje tresenje i utječe na Vaše kretnje.
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). 
Stoga je često potrebno prilagoditi doziranje levodope tijekom prvih dana ili prvih tjedana nakon započinjanja liječenja opikaponom (vidjeti dio 4.4).
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. 
Takvo ponašanje naziva se „poremećaj kontrole poriva” i može uključivati: ovisničko kockanje, neuobičajeno jak spolni nagon ili pojačanu zaokupljenost seksualnim mislima ili osjećajima.
The SCOMT activity inhibition was significantly increased in elderly subjects. 
Inhibicija aktivnosti S-COMT bila je značajno povećana u starijih ispitanika.
Dyskinesia was the most frequently reported treatment-emergent adverse reaction (17.7%). 
Diskinezija je bila najčešća prijavljena nuspojava nastala tijekom primjene lijeka (17,7%).
Ask your doctor or pharmacist if you can take your antidepressant together with Ongentys. 
Upitajte svog liječnika ili ljekarnika smijete li uzimati Vaš antidepresiv i Ongentys.
Do not use this medicine after the expiry date which is stated on the bottle/blister/carton after EXP. 
Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na boci/blisteru/kutiji iza oznake EXP.
Difference to placebo p-value (95% CI) 
Razlika u odnosu na placebo p-vrijednost (95% CI)
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. 
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.
What Ongentys looks like and contents of the pack 
Kako Ongentys izgleda i sadržaj pakiranja
The remainder of the radioactivity was excreted in urine (mean 12.8%) and via expired air (mean 15.9%). 
Preostali dio radioaktivnosti izlučio se mokraćom (srednja vrijednost 12,8%) i izdahnutim zrakom (srednja vrijednost 15,9%).
The majority of patients treated in both pivotal studies were treated with immediate-release levodopa/DDCI. 
Većina bolesnika liječenih u oba ključna ispitivanja bila je liječena formulacijom s trenutnim oslobađanjem levodope/DDCI.
The patient should not take an extra dose to make up for the missed dose. 
Bolesnik ne smije uzeti dodatnu dozu kako bi nadoknadio propuštenu.
Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take Ongentys. 
Bolesnici s rijetkim nasljednim problemima intolerancije na galaktozu, deficitom Lapp-laktaze ili malapsorpcijom glukoze-galaktoze, ne smiju uzimati Ongentys.
Pharmacotherapeutic group: Anti-parkinson drugs, other dopaminergic agents, ATC code: [not yet assigned] 
Farmakoterapijska skupina: Antiparkinsonici, ostali dopaminergici, ATK oznaka: [nije još dodijeljena]
It increases the effects of levodopa and helps to relieve the symptoms of Parkinson's disease and movement problems. 
On pojačava učinak levodope i pomaže ublažiti simptome Parkinsonove bolesti i teškoće s pokretima.
All reductions in activity essentially occurred at the highest concentration of opicapone (10 mcg/mL). 
Sva smanjenja aktivnosti u biti su se događala pri najvišoj koncentraciji opikapona (10 µg/ml).
Thus, particular consideration should be given to cases where quinidine needs to be administered together with opicapone as their co-administration should be avoided. 
Stoga je potreban poseban oprez u slučajevima kada se kinidin mora primjenjivati zajedno s opikaponom, jer se njihova istodobna primjena mora izbjegavati.
Side effects caused by Ongentys are usually mild to moderate and occur mostly within the first weeks of treatment. 
Nuspojave uzrokovane Ongentysom obično su blage do umjerene i javljaju se većinom unutar prvih tjedana liječenja.
Symptomatic and supportive treatment should be administered as appropriate. 
Potrebno je provesti simptomatsko i potporno liječenje ako se to smatra prikladnim.
Dry eye 
- suhe oči
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. 
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.
Opicapone reduced CYP2C9 activity through competitive / mixed type mode of inhibition. 
Opikapon je smanjio aktivnost CYP2C9 kompetitivnim/miješanim modusom inhibicije.