FrancophonIA/ELRC3.0 huggingface dataset:
English: EU/1/07/427/056 - 70 tablets, per box
Slovenian: EU/1/07/427/056 - 70 tablet v škatli
English: EU/1/07/427/003 - 56 tablets, per box
Slovenian: EU/1/07/427/003 - 56 tablet v škatli
English: EU/1/07/427/054 - 70 tablets, per box
Slovenian: EU/1/07/427/054 - 70 tablet v škatli
English: 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.
Slovenian: se lahko pojavijo naslednji simptomi: tresenje, okornost ali šibkost mišic, zaspanost, nemir, težave z dihanjem in motnje hranjenja.
English: EU/1/07/427/024 - 30 tablets, per box
Slovenian: EU/1/07/427/024 - 30 tablet v škatli
English: 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.
Slovenian: 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.
English: 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.
Slovenian: 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.
English: EU/1/07/427/043 - 35 tablets, per box
Slovenian: EU/1/07/427/043 - 35 tablet v škatli
English: EU/1/07/427/037 - 56 tablets, per box
Slovenian: EU/1/07/427/037 - 56 tablet v škatli
English: NAME OF THE MEDICINAL PRODUCT Olanzapine Teva 2.5 mg film-coated tablets Olanzapine
Slovenian: Olanzapin Teva 2,5 mg filmsko obložene tablete olanzapin
English: Weight should be monitored regularly, e.g. at baseline, 4, 8 and 12 weeks after starting olanzapine treatment and quarterly thereafter.
Slovenian: Redno moramo spremljati telesno maso, npr. na začetku, 4, 8 in
English: 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.
Slovenian: 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.
English: EU/1/07/427/034 - 56 tablets, per box
Slovenian: EU/1/07/427/034 - 56 tablet v škatli
English: (≥5.17-<6.2 mmol/l) to high (≥6.2 mmol/l) were very common.
Slovenian: - < 5,17 mmol/l) na visoke (≥ 5,17 mmol/l).
English: 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.
Slovenian: 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.
English: EU/1/07/427/065 - 98 tablets, per box
Slovenian: EU/1/07/427/065 - 98 tablet v škatli
English: EU/1/07/427/046 - 35 tablets, per box
Slovenian: EU/1/07/427/046 - 35 tablet v škatli
English: EU/1/07/427/067 - 98 tablets, per box
Slovenian: EU/1/07/427/067 - 98 tablet v škatli
English: NAME OF THE MEDICINAL PRODUCT Olanzapine Teva 20 mg film-coated tablets Olanzapine
Slovenian: Olanzapin Teva 20 mg filmsko obložene tablete olanzapin
English: EU/1/07/427/064 - 98 tablets, per box
Slovenian: EU/1/07/427/064 - 98 tablet v škatli
English: EU/1/07/427/057 - 70 tablets, per box
Slovenian: EU/1/07/427/057 - 70 tablet v škatli
English: EU/1/07/427/066 - 98 tablets, per box
Slovenian: EU/1/07/427/066 - 98 tablet v škatli
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each film-coated tablet contains: 20 mg Olanzapine.
Slovenian: Ena filmsko obložena tableta vsebuje: 20 mg olanzapina.
English: EU/1/07/427/045 - 35 tablets, per box
Slovenian: EU/1/07/427/045 - 35 tablet v škatli
English: EU/1/07/427/063 - 98 tablets, per box
Slovenian: EU/1/07/427/063 - 98 tablet v škatli
English: EU/1/07/427/047 - 35 tablets, per box
Slovenian: EU/1/07/427/047 - 35 tablet v škatli
English: Musculoskeletal and connective tissue disorders Arthralgia9
Slovenian: Bolezni mišično-skeletnega sistema in vezivnega tkiva
English: Respiratory, thoracic and mediastinal disorders Epistaxis9
Slovenian: Bolezni dihal, prsnega koša in mediastinalnega prostora
English: 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.
Slovenian: OPA/aluminij/PVC aluminij pretisni omoti v škatlah po 28, 30, 35, 56, 70 ali 98 filmsko obloženih tablet.
English: EU/1/07/427/044 - 35 tablets, per box
Slovenian: EU/1/07/427/044 - 35 tablet v škatli
English: Olanzapine Teva 20 mg film-coated tablets Pink, biconvex, oval film-coated tablets, debossed ”OL 20” on one side and plain on the other.
Slovenian: Roza, bikonveksne, ovalne filmsko obložene tablete z vtisnjenim napisom »OL 20« na eni strani in ravne na drugi strani.
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each film-coated tablet contains: 10 mg Olanzapine.
Slovenian: Ena filmsko obložena tableta vsebuje: 10 mg olanzapina.
English: 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.
Slovenian: Bele, bikonveksne, okrogle filmsko obložene tablete z vtisnjenim napisom »OL 7,5« na eni strani in ravne na drugi strani.
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each film-coated tablet contains: 5 mg Olanzapine.
Slovenian: Ena filmsko obložena tableta vsebuje: 5 mg olanzapina.
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each film-coated tablet contains: 15 mg Olanzapine.
Slovenian: Ena filmsko obložena tableta vsebuje: 15 mg olanzapina.
English: Fatigue
Slovenian: Zaspanost
English: Czech Republic Immunate Stim Plus
Slovenian: Immunate Stim Plus
English: Luxembourg Factane
Slovenian: Luksemburg Factane
English: Recombinant coagulation factor VIII (octocog alfa)
Slovenian: Rekombinantni koagulacijski faktor VIII (oktokog alfa)
English: Willebrand Factor
Slovenian: Willebrandov faktor
English: Germany Faktor VIII Sdh Intersero
Slovenian: Faktor VIII Sdh Intersero
English: Belgium Haemate P2400-1000
Slovenian: Haemate P2400-1000
English: Belgium Haemate P1200-500
Slovenian: Haemate P1200-500
English: Luxembourg Wilate
Slovenian: Luksemburg Wilate
English: Belgium Factane 1000 IU/10 ml
Slovenian: Factane 1000 i.e./10 ml
English: Belgium Haemate P600-250
Slovenian: Haemate P600-250
English: Luxembourg Octanate
Slovenian: Luksemburg Octanate
English: Belgium Factane 500 IU - 5 ml
Slovenian: Factane 500 i.e. - 5 ml
English: Powder For Solution For Injection
Slovenian: Prašek za injekcijo
English: Grifols Italia S.P.A Human Coagulation Factor VIII, Human Von Willebrand Factor
Slovenian: Grifols Italia S.P.A Humani koagulacijski faktor VIII, humani von Willebrandov faktor
English: LFB Biomedicaments Human Coagulation Factor VIII
Slovenian: LFB Biomedicaments Humani koagulacijski faktor VIII
English: Octapharma-Ltd Human Coagulation Factor VIII
Slovenian: Octapharma-Ltd Humani koagulacijski faktor VIII
English: Human Coagulation Factor VIII 250 I.E.
Slovenian: Humani koagulacijski faktor VIII 250 i.e.
English: Human Coagulation Factor VIII 1000 I.E.
Slovenian: Humani koagulacijski faktor VIII 1000 i.e.
English: Csl Behring Gmbh Human Coagulation Factor VIII, Human Von Willebrand Factor
Slovenian: Csl Behring Gmbh Humani koagulacijski faktor VIII, humani von Willebrandov faktor
English: Octapharma France Human Coagulation Factor VIII
Slovenian: Octapharma France Humani koagulacijski faktor VIII
English: Human Coagulation Factor VIII 1500 I.E.
Slovenian: Humani koagulacijski faktor VIII 1500 i.e.
English: Octapharma Ab Human Coagulation Factor VIII
Slovenian: Octapharma Ab Humani koagulacijski faktor VIII
English: Haemate P Csl Behring, S.A Human Coagulation Factor VIII, Von
Slovenian: Haemate P Csl Behring, S.A Humani koagulacijski faktor VIII, von
English: Human Coagulation Factor VIII 2000 IU
Slovenian: Humani koagulacijski faktor VIII 2000 i.e.
English: Octapharma Ab Human Coagulation Factor VIII, Human Von Willebrand Factor
Slovenian: Octapharma Ab Humani koagulacijski faktor VIII, humani von Willebrandov faktor
English: Octanate Lv Octapharma Ab Human Coagulation Factor VIII
Slovenian: Octanate Lv Octapharma Ab Humani koagulacijski faktor VIII
English: Human Coagulation Factor VIII 1000 I.E. Human Von Willebrand Factor 2400 I.E.
Slovenian: Humani koagulacijski faktor VIII 1000 i.e. humani von Willebrandov faktor 2400 i.e. VIII
English: Octanate LV Octapharma France Human Coagulation Factor VIII
Slovenian: Octanate LV Octapharma France Humani koagulacijski faktor VIII
English: Intersero Gmbh Human Coagulation Factor VIII
Slovenian: Intersero Gmbh Humani koagulacijski faktor VIII
English: Octapharma-Ltd Human Coagulation Factor VIII, Human Von Willebrand Factor
Slovenian: Octapharma-Ltd Humani koagulacijski faktor VIII, humani von Willebrandov faktor
English: Octanate 1000 Octapharma Gmbh Human Coagulation Factor VIII
Slovenian: Octanate 1000 Octapharma Gmbh Humani koagulacijski faktor VIII
English: Octanate 250 Octapharma Gmbh Human Coagulation Factor VIII
Slovenian: Octanate 250 Octapharma Gmbh Humani koagulacijski faktor VIII
English: Octapharma Gmbh Human Coagulation Factor VIII
Slovenian: Octapharma Gmbh Humani koagulacijski faktor VIII
English: Octapharma Gmbh Human Coagulation Factor VIII, Human Von Willebrand Factor
Slovenian: Octapharma Gmbh Humani koagulacijski faktor VIII, humani von Willebrandov faktor
English: Human Coagulation Factor VIII 500 I.E.
Slovenian: Humani koagulacijski faktor VIII 500 i.e.
English: Human Coagulation Factor VIII 1000IU/Vial, Human Von Willebrand Factor 75 I.U.
Slovenian: Humani koagulacijski faktor VIII 1000 i.e./viala, humani von Willebrandov faktor 75 i.e. /ml
English: United Kingdom Octanate Lv Octapharma-Ltd Human Coagulation Factor VIII
Slovenian: Octanate Lv Octapharma-Ltd Humani koagulacijski faktor VIII
English: Human Coagulation Factor VIII 500 I.E., Human Von Willebrand Factor 1200 I.E.
Slovenian: Humani koagulacijski faktor VIII 500 i.e., humani von Willebrandov faktor 1200 i.e.
English: Human Coagulation Factor VIII 250 I.E. Human Von Willebrand Factor 150 I.E.
Slovenian: Humani koagulacijski faktor VIII 250 i.e., humani von Willebrandov faktor 150 i.e.
English: Wilate 450 Octapharma Gmbh Human Coagulation Factor VIII, Human Von
Slovenian: Wilate 450 Octapharma Gmbh Humani koagulacijski faktor VIII, humani von
English: Luxembourg Recombinate Baxalta Innovations Gmbh
Slovenian: Luksemburg Recombinate Baxalta Innovations Gmbh
English: Human Coagulation Factor VIII 500 I.E., Human Von Willebrand Factor 300 I.E.
Slovenian: Humani koagulacijski faktor VIII 500 i.e., humani von Willebrandov faktor 300 i.e.
English: Human Coagulation Factor VIII 250 I.E., Human Von Willebrand Factor 600 I.E.
Slovenian: Humani koagulacijski faktor VIII 250 i.e., humani von Willebrandov faktor 600 i.e.
English: Octanate 500 Octapharma Gmbh Human Coagulation Factor VIII
Slovenian: Octanate 500 Octapharma Gmbh Humani koagulacijski faktor VIII
English: Wilate 1000 Octapharma Gmbh Human Coagulation Factor VIII, Human Von
Slovenian: Wilate 1000 Octapharma Gmbh Humani koagulacijski faktor VIII, humani von
English: Beriate 500 Csl Behring Gmbh Human Coagulation Factor VIII
Slovenian: Beriate 500 Csl Behring Gmbh Humani koagulacijski faktor VIII
English: Beriate 2000 Csl Behring Gmbh Human Coagulation Factor VIII
Slovenian: Beriate 2000 Csl Behring Gmbh Humani koagulacijski faktor VIII
English: Human Coagulation Factor VIII (Rdna) 200 I.U.
Slovenian: Humani koagulacijski faktor VIII (rDNA) 200 i.e. /ml
English: Human Coagulation Factor VIII, Human Von Willebrand FactorVIII
Slovenian: Humani koagulacijski faktor VIII, humani von Willebrandov faktor
English: Beriate 250 Csl Behring Gmbh Human Coagulation Factor VIII
Slovenian: Beriate 250 Csl Behring Gmbh Humani koagulacijski faktor VIII
English: Wilate 900 Octapharma Gmbh Human Coagulation Factor VIII, Human Von
Slovenian: Wilate 900 Octapharma Gmbh Humani koagulacijski faktor VIII, humani von
English: Wilate 500 Octapharma Gmbh Human Coagulation Factor VIII, Human Von
Slovenian: Wilate 500 Octapharma Gmbh Humani koagulacijski faktor VIII, humani von
English: Human Coagulation Factor VIII 1000 I.E./ Human Von Willebrand Factor 600 I.E.
Slovenian: Humani koagulacijski faktor VIII 1000 i.e., humani von Willebrandov faktor 600 i.e. VIII
English: Csl Behring Gmbh Human Coagulation Factor VIII
Slovenian: CSL Behring Gmbh Humani koagulacijski faktor VIII
English: CSL Behring Gmbh Human Coagulation Factor VIII
Slovenian: Csl Behring Gmbh Humani koagulacijski faktor VIII
English: Human Coagulation Factor VIII (Rdna) 500IU/Vial
Slovenian: Humani koagulacijski faktor VIII (rDNA) 500 i.e./viala
English: Beriate 1000 Csl Behring Gmbh Human Coagulation Factor VIII
Slovenian: Beriate 1000 Csl Behring Gmbh Humani koagulacijski faktor VIII
English: Powder And Solvent For Solution For Infusion
Slovenian: Prašek in vehikel za raztopino za infundiranje
English: Human Coagulation Factor VIII (Rdna) 1000IU/Vial
Slovenian: Humani koagulacijski faktor VIII (rDNA) 1000 i.e./viala
English: Haemate P Csl Behring Mepe Human Coagulation Factor VIII, Human Von
Slovenian: Haemate P Csl Behring Mepe Humani koagulacijski faktor VIII, humani von
English: Csl Behring Gmbh Human Coagulation Factor VIII (Rdna),
Slovenian: Csl Behring Gmbh Humani koagulacijski faktor VIII (rDNA), humani von
English: Luxembourg Haemate P Csl Behring Gmbh Human Coagulation Factor VIII, Human Von
Slovenian: Luksemburg Haemate P Csl Behring Gmbh Humani koagulacijski faktor VIII, humani von
English: United Kingdom Optivate
Slovenian: Združeno kraljestvo
English: Human Coagulation Factor VIII (Rdna) 100 I.U.
Slovenian: Humani koagulacijski faktor VIII (rDNA) 100 i.e. /ml
English: Octanate Lv Octapharma Gmbh Human Coagulation Factor VIII
Slovenian: Octanate Lv Octapharma Gmbh Humani koagulacijski faktor VIII
English: Human Coagulation Factor VIII (Rdna) 50 I.U.
Slovenian: Humani koagulacijski faktor VIII (rDNA) 50 i.e. /ml
English: Human Coagulation Factor VIII (Rdna) 1000 I.U.
Slovenian: Humani koagulacijski faktor VIII (rDNA) 1000 i.e. Viala
English: Haemate P Csl Behring Gmbh Human Coagulation Factor VIII (Rdna),
Slovenian: Haemate P Csl Behring Gmbh Humani koagulacijski faktor VIII (rDNA), humani von
English: Human Coagulation Factor VIII (Rdna) 250IU/Vial
Slovenian: Humani koagulacijski faktor VIII (rDNA) 250 i.e./viala
English: Human Coagulation Factor VIII (Rdna) 25 I.U.
Slovenian: Humani koagulacijski faktor VIII (rDNA) 25 i.e. /ml
English: Human Coagulation Factor VIII (Rdna) 500 I.U.
Slovenian: Humani koagulacijski faktor VIII (rDNA) 500 i.e. Viala
English: Human Coagulation Factor VIII (Rdna) 250 I.U.
Slovenian: Humani koagulacijski faktor VIII (rDNA) 250 i.e. Viala
English: Human Coagulation Factor VIII 100 I.U./ml, Human Von Willebrand Factor 100 I.U./mlVIII
Slovenian: Humani koagulacijski faktor VIII (rDNA) 50 i.e. /ml, humani von Willebrandov faktor 120 i.e. /ml
English: Haemoctin Biotest Hungaria Kft. Human Coagulation Factor VIII
Slovenian: Haemoctin Biotest Hungaria Kft.
English: Haemate P Csl Behring Gmbh Human Coagulation Factor VIII, Human Von
Slovenian: Haemate P Csl Behring Gmbh Humani koagulacijski faktor VIII, humani von
English: Human Coagulation Factor VIII 100 I.U./ml, Human Von Willebrand Factor 100 I.U./ml VIII
Slovenian: Humani koagulacijski faktor VIII 100 i.e. /ml, von Willebrandov faktor 25 i.e. /ml
English: Human Coagulation Factor VIII 500IU/Vial, Human Von Willebrand Factor 120 I.U.
Slovenian: Humani koagulacijski faktor VIII 50 i.e. /ml, von Willebrandov faktor 120 i.e. /ml
English: Cardboard box 1 vial of freezedried antigen and 1 vial of aqueous adjuvant
Slovenian: Velikost pakiranja zloženka 1 viala liofiliziranega antigena in 1 viala vodnega dodatka
English: There is no known specific antidote.
Slovenian: Specifičnega znanega antidota ni.
English: This will help the doctor identify what you have taken.
Slovenian: Tako boste zdravniku pomagali ugotoviti, kaj ste vzeli.
English: The magnitude of this effect is not considered to be of clinical relevance.
Slovenian: Razsežnost tega učinka ne velja za klinično pomembno.
English: Overall, it can be concluded that the kidney is not the primary route of excretion.
Slovenian: Na splošno je možno sklepati, da ledvice niso glavna pot izločanja.
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.
Slovenian: Otroci in mladostniki, stari manj kot 18 let, tega zdravila ne smejo jemati, saj ga v teh starostnih skupinah niso preučili.
English: Elderly (≥ 65 years old)
Slovenian: Starejše osebe (≥65 let)
English: Symptomatic and supportive treatment should be administered as appropriate.
Slovenian: Uvesti je treba simptomatsko in podporno zdravljenje, kot je ustrezno.
English: A risk to the newborns/infants cannot be excluded.
Slovenian: Tveganja za novorojence/dojenčke ne moremo izključiti.
English: Follow the instructions that your doctor has given you.
Slovenian: Upoštevajte navodila, ki ste jih prejeli od zdravnika.
English: At screening, the mean age was similar in all treatment groups in both studies, ranging between 61.5 and 65.3 years.
Slovenian: Pri presejanju je bila povprečna starost podobna v vseh skupinah zdravljenja v obeh študijah z razponom od 61,5 do 65,3 leta.
English: Caution must be exercised in patients ≥ 85 years of age as there is limited experience in this age group.
Slovenian: Previdnost je potrebna pri bolnikih, starih ≥ 85 let, saj so izkušnje pri tej starostni skupini omejene.
English: Date of first authorisation: 24 June 2016
Slovenian: DATUM PRIDOBITVE/PODALJŠANJA DOVOLJENJA ZA PROMET Z ZDRAVILOM Datum prve odobritve: 24. junij 2016
English: Opicapone presents a low absorption (~20%).
Slovenian: Opikapon ima nizko absorpcijo (~20 %).
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).
Slovenian: 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).
English: Tell your doctor as soon as possible if you notice any of the following side effects:
Slovenian: Zdravnika čim prej obvestite, če opazite katerega od naslednjih neželenih učinkov:
English: The majority of patients treated in both pivotal studies were treated with immediate-release levodopa/DDCI.
Slovenian: Večina bolnikov, zdravljenih v obeh ključnih študijah, je bilo zdravljenih z levodopo/DDCI s takojšnjim sproščanjem.
English: Responders, n (%) 65 (47.8)
Slovenian: Odzivne osebe, n (%) 65 (47,8)
English: (only for outer packaging)
Slovenian: (samo za zunanjo ovojnino)
English: Swallow the capsule whole with a glass of water.
Slovenian: Kapsulo pogoltnite celo s kozarcem vode.
English: The remainder of the radioactivity was excreted in urine (mean 12.8%) and via expired air (mean 15.9%).
Slovenian: Preostanek radioaktivnosti se je izločil v urinu (povprečje 12,8 %) in z izdihanim zrakom (povprečje 15,9 %).
English: Patients should be monitored regularly for the development of impulse control disorders and review of treatment is recommended if such symptoms develop.
Slovenian: Bolnike je treba redno spremljati glede razvoja motenj nadzora impulzov; če se razvijejo ti simptomi, se priporoča ponovna ocena zdravljenja.
English: The recommended dose is 50 mg once daily.
Slovenian: Priporočeni odmerek je 50 mg enkrat na dan.
English: All reductions in activity essentially occurred at the highest concentration of opicapone (10 mcg/mL).
Slovenian: Vsa zmanjšanja aktivnosti so se načeloma pojavila pri največji koncentraciji opikapona (10 µg/ml).
English: CI = confidence interval; N = total number of patients; n = number of patients with available information; NA = not applicable; OPC = opicapone
Slovenian: IZ = interval zaupanja; N = skupno število bolnikov; n = število bolnikov z razpoložljivimi informacijami; n.s. = ni smiselno; OPC = opikapon
English: The most common adverse reactions reported were nervous system disorders.
Slovenian: Neželeni učinki, o katerih so najpogosteje poročali, so bile motnje živčnega sistema.
English: 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.
Slovenian: 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.
English: Dyskinesia was the most frequently reported treatment-emergent adverse reaction (17.7%).
Slovenian: Diskinezija je bila najpogosteje poročan neželeni učinek, ki se je pojavil med zdravljenjem (17,7 %).
English: Parkinson's disease is a progressive disease of the nervous system that causes shaking and affects your movement.
Slovenian: Parkinsonova bolezen je napredujoča bolezen živčnega sistema, ki povzroča tresenje vpliva na vaše gibanje.
English: Therefore, caution should be exercised when driving or using machines.
Slovenian: Zato je pri vožnji in upravljanju s stroji potrebna previdnost.
English: Opicapone enhances the effects of levodopa.
Slovenian: Opikapon okrepi učinke levodope.
English: Take the medicine package and this leaflet with you.
Slovenian: Pakiranje zdravila in to navodilo vzemite s seboj.
English: Ask your doctor or pharmacist if you can take your antidepressant together with Ongentys.
Slovenian: Posvetujte se z zdravnikom ali farmacevtom, ali lahko svoj antidepresiv jemljete skupaj z zdravilom Ongentys.
English: In both studies, 783 patients were treated with 25 mg or 50 mg of opicapone or placebo.
Slovenian: V obeh študijah je bilo 783 bolnikov zdravljenih s 25 mg ali 50 mg opikapona ali s placebom.
English: Other metabolic pathways include glucuronidation, methylation and reduction.
Slovenian: Druge presnovne poti vključujejo glukuronidacijo, metilacijo in redukcijo.
English: Not all packs may be marketed.
Slovenian: Na trgu morda ni vseh navedenih pakiranj.
English: Do not stop taking Ongentys unless your doctor tells you to as your symptoms may get worse.
Slovenian: Ne prenehajte jemati zdravila Ongentys, razen če vam tako naroči zdravnik, saj se lahko simptomi poslabšajo.
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.
Slovenian: 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.
English: Behaviours such as these have been reported in patients using other medicines for Parkinsons´s disease.
Slovenian: O takšnih vedenjih so poročali pri bolnikih, ki uporabljajo druga zdravila za Parkinsonovo bolezen.
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.
Slovenian: 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.
English: Although embryo-foetal development was not negatively influenced in rabbits, the study is not considered predictive for human risk assessment.
Slovenian: Čeprav ni bilo negativnega vpliva na embrio-fetalni razvoj pri kuncih, študija ne velja za napovedno za oceno tveganja pri ljudeh.