natgillin/translations-raw huggingface dataset:
EU/1/07/427/026 - 56 tablets, per box 
EU/1/07/427/026 - 56 tablet v škatli
EU/1/07/427/036 - 30 tablets, per box 
EU/1/07/427/036 - 30 tablet v škatli
EU/1/07/427/038 - 35 tablets, per box 
EU/1/07/427/038 - 35 tablet v škatli
EU/1/07/427/019 - 56 tablets, per box 
EU/1/07/427/019 - 56 tablet v škatli
(≥1.69 mmol/l-<2.26 mmol/l) to high (≥2.26 mmol/l) were very common. 
Zelo pogoste so bile spremembe v ravneh trigliceridov na tešče z mejnih osnovnih vrednosti (≥ 1,69 mmol/l - < 2,26 mmol/l) na visoke (≥ 2,26 mmol/l).
EU/1/07/427/033 - 50 tablets, per box 
EU/1/07/427/033 - 50 tablet v škatli
Glutamyltransfera se10 
Visoka raven gamaglutamiltransferaze10
EU/1/07/427/032 - 30 tablets, per box 
EU/1/07/427/032 - 30 tablet v škatli
EU/1/07/427/021 - 30 tablets, per box 
EU/1/07/427/021 - 30 tablet v škatli
Olanzapine Teva 5 mg film-coated tablets are available in cartons of 28, 28 x 1, 30, 30 x 1, 35, 35 x 1, 50, 50 x 1, 56, 56 x 1, 70, 70 x 1, 98 or 98 x 1 film-coated tablets. 
Olanzapin Teva 5 mg filmsko obložene tablete so na voljo v pakiranjih po 28, 28 x 1, 30, 30 x 1, 35, 35 x 1, 50, 50 x 1, 56, 56 x 1, 70, 70 x 1, 98 ali 98 x 1 filmsko obložena tableta.
EU/1/07/427/055 - 70 tablets, per box 
EU/1/07/427/055 - 70 tablet v škatli
Olanzapine Teva 10 mg film-coated tablets are available in cartons of 7, 7 x 1, 28, 28 x 1, 30, 30 x 1, 35, 35 x 1, 50, 50 x 1, 56, 56 x 1, 60, 70, 70 x 1, 98 or 98 x1 film-coated tablets. 
Olanzapin Teva 10 mg filmsko obložene tablete so na voljo v pakiranjih po 7, 7 x 1, 28, 28 x 1, 30, 30 x 1, 35, 35 x 1, 50, 50 x 1, 56, 56 x 1, 60, 70, 70 x 1, 98 ali 98 x 1 filmsko obložena tableta.
NAME OF THE MEDICINAL PRODUCT Olanzapine Teva 7.5 mg film-coated tablets Olanzapine 
Olanzapin Teva 7,5 mg filmsko obložene tablete olanzapin
EU/1/07/427/042 - 35 tablets, per box 
EU/1/07/427/042 - 35 tablet v škatli
High uric acid10 
Visoka raven sečne kisline10
EU/1/07/427/025 - 50 tablets, per box 
EU/1/07/427/025 - 50 tablet v škatli
EU/1/07/427/002 - 30 tablets, per box 
EU/1/07/427/002 - 30 tablet v škatli
14 Observed for fasting normal levels at baseline (<1.016 mmol/l) which increased to high 
14 Opazovano pri osnovnih normalnih ravneh na tešče (< 1,016 mmol/l), ki so se povišale na visoke (≥ 1,467 mmol/l) in spremembe v ravneh trigliceridov na tešče z mejnih osnovnih vrednosti
EU/1/07/427/053 - 70 tablets, per box 
EU/1/07/427/053 - 70 tablet v škatli
EU/1/07/427/030 - 56 tablets, per box 
EU/1/07/427/030 - 56 tablet v škatli
EU/1/07/427/056 - 70 tablets, per box 
EU/1/07/427/056 - 70 tablet v škatli
EU/1/07/427/003 - 56 tablets, per box 
EU/1/07/427/003 - 56 tablet v škatli
EU/1/07/427/054 - 70 tablets, per box 
EU/1/07/427/054 - 70 tablet v škatli
The following symptoms may occur in newborn babies, of mothers that have used Olanzapine Teva in the last trimester (last three months of their pregnancy): shaking, muscle stiffness and/or weakness, sleepiness, agitation, breathing problems, and difficulty in feeding. 
se lahko pojavijo naslednji simptomi: tresenje, okornost ali šibkost mišic, zaspanost, nemir, težave z dihanjem in motnje hranjenja.
EU/1/07/427/024 - 30 tablets, per box 
EU/1/07/427/024 - 30 tablet v škatli
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 filmsko obložene tablete so na voljo v pakiranjih po 28, 28 x 1, 30, 30 x 1, 35, 35 x 1, 56, 56 x 1, 60, 70, 70 x 1, 98 ali 98 x 1 filmsko obložena tableta.
OPA/alu/PVC-alu blisters in cartons of 7, 7 x 1, 28, 28 x 1, 30, 30 x 1, 35, 35 x 1, 50, 50 x 1, 56, 56 x 1, 60, 70, 70 x 1, 98 or 98 x 1 film-coated tablets per carton. 
OPA/aluminij/PVC aluminij pretisni omoti v škatlah po 7, 7 x 1, 28, 28 x 1, 30, 30 x 1, 35, 35 x 1, 50, 50 x 1, 56, 56 x 1, 60, 70, 70 x 1, 98 ali 98 x 1 filmsko obložena tableta.
EU/1/07/427/043 - 35 tablets, per box 
EU/1/07/427/043 - 35 tablet v škatli
EU/1/07/427/037 - 56 tablets, per box 
EU/1/07/427/037 - 56 tablet v škatli
NAME OF THE MEDICINAL PRODUCT Olanzapine Teva 2.5 mg film-coated tablets Olanzapine 
Olanzapin Teva 2,5 mg filmsko obložene tablete olanzapin
Weight should be monitored regularly, e.g. at baseline, 4, 8 and 12 weeks after starting olanzapine treatment and quarterly thereafter. 
Redno moramo spremljati telesno maso, npr. na začetku, 4, 8 in
OPA/alu/PVC-alu blisters in cartons of 28, 28 x 1, 30, 30 x 1, 35, 35 x 1, 50, 50 x 1, 56, 56 x 1, 70, 70 x 1, 98 or 98 x 1 film-coated tablets per carton. 
OPA/aluminij/PVC aluminij pretisni omoti v škatlah po 28, 28 x 1, 30, 30 x 1, 35, 35 x 1, 50, 50 x 1, 56, 56 x 1, 70, 70 x 1, 98 ali 98 x 1 filmsko obložena tableta.
EU/1/07/427/034 - 56 tablets, per box 
EU/1/07/427/034 - 56 tablet v škatli
(≥5.17-<6.2 mmol/l) to high (≥6.2 mmol/l) were very common. 
- < 5,17 mmol/l) na visoke (≥ 5,17 mmol/l).
OPA/alu/PVC-alu blisters 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 per carton. 
OPA/aluminij/PVC aluminij pretisni omoti v škatlah po 28, 28 x 1, 30, 30 x 1, 35, 35 x 1, 56, 56 x 1, 60, 70, 70 x 1, 98 ali 98 x 1 filmsko obložena tableta.
EU/1/07/427/065 - 98 tablets, per box 
EU/1/07/427/065 - 98 tablet v škatli
EU/1/07/427/046 - 35 tablets, per box 
EU/1/07/427/046 - 35 tablet v škatli
EU/1/07/427/067 - 98 tablets, per box 
EU/1/07/427/067 - 98 tablet v škatli
NAME OF THE MEDICINAL PRODUCT Olanzapine Teva 20 mg film-coated tablets Olanzapine 
Olanzapin Teva 20 mg filmsko obložene tablete olanzapin
EU/1/07/427/064 - 98 tablets, per box 
EU/1/07/427/064 - 98 tablet v škatli
EU/1/07/427/057 - 70 tablets, per box 
EU/1/07/427/057 - 70 tablet v škatli
EU/1/07/427/066 - 98 tablets, per box 
EU/1/07/427/066 - 98 tablet v škatli
STATEMENT OF ACTIVE SUBSTANCE(S) Each film-coated tablet contains: 20 mg Olanzapine. 
Ena filmsko obložena tableta vsebuje: 20 mg olanzapina.
EU/1/07/427/045 - 35 tablets, per box 
EU/1/07/427/045 - 35 tablet v škatli
EU/1/07/427/063 - 98 tablets, per box 
EU/1/07/427/063 - 98 tablet v škatli
EU/1/07/427/047 - 35 tablets, per box 
EU/1/07/427/047 - 35 tablet v škatli
Musculoskeletal and connective tissue disorders Arthralgia9 
Bolezni mišično-skeletnega sistema in vezivnega tkiva
Respiratory, thoracic and mediastinal disorders Epistaxis9 
Bolezni dihal, prsnega koša in mediastinalnega prostora
Olanzapine Teva 15 mg film-coated tablets OPA/alu/PVC-alu blisters in cartons of 28, 30, 35, 50, 56, 70 or 98 film-coated tablets per carton. 
OPA/aluminij/PVC aluminij pretisni omoti v škatlah po 28, 30, 35, 56, 70 ali 98 filmsko obloženih tablet.
EU/1/07/427/044 - 35 tablets, per box 
EU/1/07/427/044 - 35 tablet v škatli
Olanzapine Teva 20 mg film-coated tablets Pink, biconvex, oval film-coated tablets, debossed ”OL 20” on one side and plain on the other. 
Roza, bikonveksne, ovalne filmsko obložene tablete z vtisnjenim napisom »OL 20« na eni strani in ravne na drugi strani.
STATEMENT OF ACTIVE SUBSTANCE(S) Each film-coated tablet contains: 10 mg Olanzapine. 
Ena filmsko obložena tableta vsebuje: 10 mg olanzapina.
Olanzapine Teva 7.5 mg film-coated tablets White, biconvex, round film-coated tablets, debossed ”OL 7.5” on one side and plain on the other. 
Bele, bikonveksne, okrogle filmsko obložene tablete z vtisnjenim napisom »OL 7,5« na eni strani in ravne na drugi strani.
STATEMENT OF ACTIVE SUBSTANCE(S) Each film-coated tablet contains: 5 mg Olanzapine. 
Ena filmsko obložena tableta vsebuje: 5 mg olanzapina.
STATEMENT OF ACTIVE SUBSTANCE(S) Each film-coated tablet contains: 15 mg Olanzapine. 
Ena filmsko obložena tableta vsebuje: 15 mg olanzapina.
Fatigue 
Zaspanost
Belgium Factane 1000 IU/10 ml 
Factane 1000 i.e./10 ml
Belgium Factane 500 IU - 5 ml 
Factane 500 i.e. - 5 ml
Powder For Solution For Injection 
Prašek za injekcijo
LFB Biomedicaments Human Coagulation Factor VIII 
LFB Biomedicaments Humani koagulacijski faktor VIII
Human Coagulation Factor VIII 250 I.E. 
Humani koagulacijski faktor VIII 250 i.e.
Human Coagulation Factor VIII 1000 I.E. 
Humani koagulacijski faktor VIII 1000 i.e.
Human Coagulation Factor VIII 1500 I.E. 
Humani koagulacijski faktor VIII 1500 i.e.
Human Coagulation Factor VIII 2000 IU 
Humani koagulacijski faktor VIII 2000 i.e.
Human Coagulation Factor VIII 1000 I.E. Human Von Willebrand Factor 2400 I.E. 
Humani koagulacijski faktor VIII 1000 i.e. humani von Willebrandov faktor 2400 i.e. VIII
Human Coagulation Factor VIII 500 I.E. 
Humani koagulacijski faktor VIII 500 i.e.
Human Coagulation Factor VIII 1000IU/Vial, Human Von Willebrand Factor 75 I.U. 
Humani koagulacijski faktor VIII 1000 i.e./viala, humani von Willebrandov faktor 75 i.e. /ml
Human Coagulation Factor VIII 500 I.E., Human Von Willebrand Factor 1200 I.E. 
Humani koagulacijski faktor VIII 500 i.e., humani von Willebrandov faktor 1200 i.e.
Human Coagulation Factor VIII 250 I.E. Human Von Willebrand Factor 150 I.E. 
Humani koagulacijski faktor VIII 250 i.e., humani von Willebrandov faktor 150 i.e.
Human Coagulation Factor VIII 500 I.E., Human Von Willebrand Factor 300 I.E. 
Humani koagulacijski faktor VIII 500 i.e., humani von Willebrandov faktor 300 i.e.
Human Coagulation Factor VIII 250 I.E., Human Von Willebrand Factor 600 I.E. 
Humani koagulacijski faktor VIII 250 i.e., humani von Willebrandov faktor 600 i.e.
Human Coagulation Factor VIII (Rdna) 200 I.U. 
Humani koagulacijski faktor VIII (rDNA) 200 i.e. /ml
Human Coagulation Factor VIII 1000 I.E./ Human Von Willebrand Factor 600 I.E. 
Humani koagulacijski faktor VIII 1000 i.e., humani von Willebrandov faktor 600 i.e. VIII
Human Coagulation Factor VIII (Rdna) 500IU/Vial 
Humani koagulacijski faktor VIII (rDNA) 500 i.e./viala
Powder And Solvent For Solution For Infusion 
Prašek in vehikel za raztopino za infundiranje
Human Coagulation Factor VIII (Rdna) 1000IU/Vial 
Humani koagulacijski faktor VIII (rDNA) 1000 i.e./viala
Csl Behring Gmbh Human Coagulation Factor VIII (Rdna), 
Csl Behring Gmbh Humani koagulacijski faktor VIII (rDNA), humani von
United Kingdom Optivate 
Združeno kraljestvo
Human Coagulation Factor VIII (Rdna) 100 I.U. 
Humani koagulacijski faktor VIII (rDNA) 100 i.e. /ml
Human Coagulation Factor VIII (Rdna) 50 I.U. 
Humani koagulacijski faktor VIII (rDNA) 50 i.e. /ml
Human Coagulation Factor VIII (Rdna) 1000 I.U. 
Humani koagulacijski faktor VIII (rDNA) 1000 i.e. Viala
Haemate P Csl Behring Gmbh Human Coagulation Factor VIII (Rdna), 
Haemate P Csl Behring Gmbh Humani koagulacijski faktor VIII (rDNA), humani von
Human Coagulation Factor VIII (Rdna) 250IU/Vial 
Humani koagulacijski faktor VIII (rDNA) 250 i.e./viala
Human Coagulation Factor VIII (Rdna) 25 I.U. 
Humani koagulacijski faktor VIII (rDNA) 25 i.e. /ml
Human Coagulation Factor VIII (Rdna) 500 I.U. 
Humani koagulacijski faktor VIII (rDNA) 500 i.e. Viala
Human Coagulation Factor VIII (Rdna) 250 I.U. 
Humani koagulacijski faktor VIII (rDNA) 250 i.e. Viala
Human Coagulation Factor VIII 100 I.U./ml, Human Von Willebrand Factor 100 I.U./mlVIII 
Humani koagulacijski faktor VIII (rDNA) 50 i.e. /ml, humani von Willebrandov faktor 120 i.e. /ml
Haemate P Csl Behring Gmbh Human Coagulation Factor VIII, Human Von 
Haemate P Csl Behring Gmbh Humani koagulacijski faktor VIII, humani von
Human Coagulation Factor VIII 100 I.U./ml, Human Von Willebrand Factor 100 I.U./ml VIII 
Humani koagulacijski faktor VIII 100 i.e. /ml, von Willebrandov faktor 25 i.e. /ml
Human Coagulation Factor VIII 500IU/Vial, Human Von Willebrand Factor 120 I.U. 
Humani koagulacijski faktor VIII 50 i.e. /ml, von Willebrandov faktor 120 i.e. /ml
Cardboard box 1 vial of freezedried antigen and 1 vial of aqueous adjuvant 
Velikost pakiranja zloženka 1 viala liofiliziranega antigena in 1 viala vodnega dodatka
There is no known specific antidote. 
Specifičnega znanega antidota ni.
This will help the doctor identify what you have taken. 
Tako boste zdravniku pomagali ugotoviti, kaj ste vzeli.
The magnitude of this effect is not considered to be of clinical relevance. 
Razsežnost tega učinka ne velja za klinično pomembno.
Overall, it can be concluded that the kidney is not the primary route of excretion. 
Na splošno je možno sklepati, da ledvice niso glavna pot izločanja.
Children and adolescents under the age of 18 years must not take this medicine as it has not been studied in these age groups. 
Otroci in mladostniki, stari manj kot 18 let, tega zdravila ne smejo jemati, saj ga v teh starostnih skupinah niso preučili.
Elderly (≥ 65 years old) 
Starejše osebe (≥65 let)
Symptomatic and supportive treatment should be administered as appropriate. 
Uvesti je treba simptomatsko in podporno zdravljenje, kot je ustrezno.
A risk to the newborns/infants cannot be excluded. 
Tveganja za novorojence/dojenčke ne moremo izključiti.
Follow the instructions that your doctor has given you. 
Upoštevajte navodila, ki ste jih prejeli od zdravnika.
At screening, the mean age was similar in all treatment groups in both studies, ranging between 61.5 and 65.3 years. 
Pri presejanju je bila povprečna starost podobna v vseh skupinah zdravljenja v obeh študijah z razponom od 61,5 do 65,3 leta.
Caution must be exercised in patients ≥ 85 years of age as there is limited experience in this age group. 
Previdnost je potrebna pri bolnikih, starih ≥ 85 let, saj so izkušnje pri tej starostni skupini omejene.
Date of first authorisation: 24 June 2016 
DATUM PRIDOBITVE/PODALJŠANJA DOVOLJENJA ZA PROMET Z ZDRAVILOM Datum prve odobritve: 24. junij 2016
Opicapone presents a low absorption (~20%). 
Opikapon ima nizko absorpcijo (~20 %).
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). 
Kategorije pogostnosti so opredeljene, kot sledi: zelo pogosti (≥ 1/10), pogosti (≥ 1/100 do < 1/10), občasni (≥ 1/1.000 do < 1/100), redki (≥ 1/10.000 do < 1/1.000), zelo redki (< 1/10.000), neznana (ni mogoče oceniti iz razpoložljivih podatkov).
Tell your doctor as soon as possible if you notice any of the following side effects: 
Zdravnika čim prej obvestite, če opazite katerega od naslednjih neželenih učinkov:
The majority of patients treated in both pivotal studies were treated with immediate-release levodopa/DDCI. 
Večina bolnikov, zdravljenih v obeh ključnih študijah, je bilo zdravljenih z levodopo/DDCI s takojšnjim sproščanjem.
Responders, n (%) 65 (47.8) 
Odzivne osebe, n (%) 65 (47,8)
(only for outer packaging) 
(samo za zunanjo ovojnino)
Swallow the capsule whole with a glass of water. 
Kapsulo pogoltnite celo s kozarcem vode.
The remainder of the radioactivity was excreted in urine (mean 12.8%) and via expired air (mean 15.9%). 
Preostanek radioaktivnosti se je izločil v urinu (povprečje 12,8 %) in z izdihanim zrakom (povprečje 15,9 %).
Patients should be monitored regularly for the development of impulse control disorders and review of treatment is recommended if such symptoms develop. 
Bolnike je treba redno spremljati glede razvoja motenj nadzora impulzov; če se razvijejo ti simptomi, se priporoča ponovna ocena zdravljenja.
The recommended dose is 50 mg once daily. 
Priporočeni odmerek je 50 mg enkrat na dan.
All reductions in activity essentially occurred at the highest concentration of opicapone (10 mcg/mL). 
Vsa zmanjšanja aktivnosti so se načeloma pojavila pri največji koncentraciji opikapona (10 µg/ml).
CI = confidence interval; N = total number of patients; n = number of patients with available information; NA = not applicable; OPC = opicapone 
IZ = interval zaupanja; N = skupno število bolnikov; n = število bolnikov z razpoložljivimi informacijami; n.s. = ni smiselno; OPC = opikapon
The most common adverse reactions reported were nervous system disorders. 
Neželeni učinki, o katerih so najpogosteje poročali, so bile motnje živčnega sistema.
In the OL studies, all patients began at a dose of 25 mg opicapone for the first week (7 days), regardless of their prior treatment in the double-blind period. 
V odprtih študijah so vsi bolniki začeli z odmerkom 25 mg opikapona v prvem tednu (7 dni), ne glede na njihovo predhodno zdravljenje v dvojno slepem obdobju.
Dyskinesia was the most frequently reported treatment-emergent adverse reaction (17.7%). 
Diskinezija je bila najpogosteje poročan neželeni učinek, ki se je pojavil med zdravljenjem (17,7 %).
Parkinson's disease is a progressive disease of the nervous system that causes shaking and affects your movement. 
Parkinsonova bolezen je napredujoča bolezen živčnega sistema, ki povzroča tresenje vpliva na vaše gibanje.
Therefore, caution should be exercised when driving or using machines. 
Zato je pri vožnji in upravljanju s stroji potrebna previdnost.
Opicapone enhances the effects of levodopa. 
Opikapon okrepi učinke levodope.
Take the medicine package and this leaflet with you. 
Pakiranje zdravila in to navodilo vzemite s seboj.
Ask your doctor or pharmacist if you can take your antidepressant together with Ongentys. 
Posvetujte se z zdravnikom ali farmacevtom, ali lahko svoj antidepresiv jemljete skupaj z zdravilom Ongentys.
In both studies, 783 patients were treated with 25 mg or 50 mg of opicapone or placebo. 
V obeh študijah je bilo 783 bolnikov zdravljenih s 25 mg ali 50 mg opikapona ali s placebom.
Other metabolic pathways include glucuronidation, methylation and reduction. 
Druge presnovne poti vključujejo glukuronidacijo, metilacijo in redukcijo.
Not all packs may be marketed. 
Na trgu morda ni vseh navedenih pakiranj.
Do not stop taking Ongentys unless your doctor tells you to as your symptoms may get worse. 
Ne prenehajte jemati zdravila Ongentys, razen če vam tako naroči zdravnik, saj se lahko simptomi poslabšajo.
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. 
Posvetujte se z zdravnikom ali farmacevtom, če vi sami ali član družine/negovalec opazi, da se pri vas razvijajo nuja ali želje po vedenju, ki je za vas nenavadno, ali če se ne morete upreti nagonom, vzgibom ali skušnjavam za izvajanje nekaterih dejavnosti, ki bi lahko vam ali drugim škodile.
Behaviours such as these have been reported in patients using other medicines for Parkinsons´s disease. 
O takšnih vedenjih so poročali pri bolnikih, ki uporabljajo druga zdravila za Parkinsonovo bolezen.
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. 
Reducirani presnovek opikapona (za katerega so v nekliničnih študijah ugotovili, da je aktiven) je manj zastopan presnovek v plazmi pri človeku in je predstavljal manj kot 10 % skupne sistemske izpostavljenosti opikaponu.
Although embryo-foetal development was not negatively influenced in rabbits, the study is not considered predictive for human risk assessment. 
Čeprav ni bilo negativnega vpliva na embrio-fetalni razvoj pri kuncih, študija ne velja za napovedno za oceno tveganja pri ljudeh.
Side effects caused by Ongentys are usually mild to moderate and occur mostly within the first weeks of treatment. 
Neželeni učinki, ki jih povzroča zdravilo Ongentys, so običajno blagi do zmerni in se najpogosteje pojavijo v prvih tednih zdravljenja.
The capsules are packaged in bottles or blisters. 
Kapsule so pakirane v plastenke ali pretisne omote.
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. 
Če ste noseči ali dojite, menite, da bi lahko bili noseči, ali načrtujete zanositev, se posvetujte z zdravnikom ali farmacevtom, preden vzamete to zdravilo.
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). 
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).
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. 
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.
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. 
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.
In Study 1, 122 patients were treated with opicapone 5 mg and 122 patients were treated with entacapone 200 mg (active comparator). 
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).
It increases the effects of levodopa and helps to relieve the symptoms of Parkinson's disease and movement problems. 
Poveča učinke levodope in pomaga ublažiti simptome Parkinsonove bolezni in težave z gibanjem.
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. 
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.
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. 
Čeprav ni dokazov, da uporaba formulacij z levodopo z nadzorovanim sproščanjem vpliva na učinkovitost ali varnost opikapona, so izkušnje s takimi formulacijami omejene.
Pharmacotherapeutic group: Anti-parkinson drugs, other dopaminergic agents, ATC code: [not yet assigned] 
Farmakoterapevtska skupina: antiparkinsoniki, druga dopaminergična zdravila, oznaka ATC: (še ni bila dodeljena)
The SCOMT activity inhibition was significantly increased in elderly subjects. 
Zaviranje aktivnosti S-COMT je bilo pri starejših osebah občutno povečano.
The LS mean reduction in absolute OFF-time from baseline to endpoint in the entacapone group was -78.7 minutes. 
Zmanjšanje povprečja LS absolutnega časa izklopa od izhodišča do končne točke v skupini z entakaponom je znašalo -78,7 minut.
If one dose is missed, the next dose should be taken as scheduled. 
Če se odmerek izpusti, je treba naslednji odmerek vzeti, kot je načrtovano.
The patient should not take an extra dose to make up for the missed dose. 
Bolnik naj ne vzame dodatnega odmerka, da nadomesti izpuščenega.
- if you are allergic to opicapone or any of the other ingredients of this medicine (listed in section 
- če ste alergični na opikapon ali katero koli sestavino tega zdravila (navedeno v poglavju 6).
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. 
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.
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. 
Pri prekinitvi zdravljenja z zdravilom Ongentys je treba prilagoditi odmerek drugih antiparkinsonikov, zlasti levodope, da se doseže zadostna raven nadzorovanja simptomov.