FrancophonIA/ELRC3.0 huggingface dataset:
English: Do not use this medicine after the expiry date which is stated on the carton and blister after EXP.
Croatian: Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na kutiji i blisteru iza oznake „Rok valjanosti“ / „EXP“.
English: Sodium acetate (trihydrate) Acetic acid, glacial (for pH-adjustment) Sodium chloride
Croatian: 6.1 Popis pomoćnih tvari natrijev acetat (trihidrat) acetatna kiselina, ledena (za podešavanje pH) natrijev klorid voda za injekcije
English: A decision should be made whether to discontinue breastfeeding or to discontinue brivaracetam, taking into account the benefit of the medicinal product to the mother.
Croatian: Uzimajući u obzir korist lijeka za majku, treba donijeti odluku o tome hoće li se prekinuti dojenje ili obustaviti liječenje brivaracetamom.
English: Briviact 10 mg/ml solution for injection/infusion
Croatian: Briviact 10 mg/ml otopina za injekciju/infuziju
English: Children (from 4 years of age) and adolescents weighing 50 kg or more The recommended starting dose is 50mg/day.
Croatian: Djeca (od navršene 4 godine) i adolescenti s tjelesnom težinom od 50 kg ili više Preporučena početna doza je 50 mg/dan.
English: Do not use this medicine after the expiry date which is stated on the cardboard box and bottle after EXP.
Croatian: Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na kutiji i bočici iza oznake „Rok valjanosti“ / „EXP“.
English: - As a child or adolescent weighing less than 50 kg, the maximum dose you will take is 1.5 mg for each kg of bodyweight twice a day.
Croatian: - kao dijete ili adolescent s tjelesnom težinom manjom od 50 kg, najveća doza koju ćete uzimati je 1,5 mg za svaki kg tjelesne težine, uzimana dvaput dnevno.
English: In children and adolescents weighing less than 50 kg, a 1 mg/kg/day starting dose is recommended.
Croatian: U djece i adolescenata koji teže manje od 50 kg, preporučuje se početna doza od 1 mg/kg/dan.
English: Based on individual patient response and tolerability, the dose may be adjusted in the dose range of 50 mg/day to 200 mg/day.
Croatian: Ovisno o odgovoru i podnošljivosti lijeka u pojedinog bolesnika, doza se može prilagođavati unutar raspona od 50 mg/dan do 200 mg/dan.
English: As a child or adolescent weighing less than 50 kg, the maximum dose you will take is 1.5 mg for each kg of bodyweight twice a day.
Croatian: Kao dijete ili adolescent s tjelesnom težinom manjom od 50 kg, najveća doza koju ćete uzimati je 1,5 mg za svaki kg tjelesne težine, uzimana dvaput dnevno.
English: What Briviact is
Croatian: Što je Briviact
English: 10 mg/ml solution for injection/infusion is packed in 6 ml nominal capacity glass vials (type I) with siliconized bromobutyl rubber stoppers and sealed with an aluminium/polypropylene tear off cap. Each single use vial contains an extractable volume of not less than 5.0 ml of solution for injection/infusion.
Croatian: Otopina za injekciju/infuziju od 10 mg/ml pakirana je u staklene bočice (staklo tipa I) deklariranog volumena 6 ml s čepovima od silikonizirane brombutilne gume i aluminijskim/polipropilenskim zaštitnim zatvaračem koji se otkida.
English: Volumes of oral solution to be taken per administration
Croatian: Volumeni oralne otopine koji se uzimaju po primjeni
English: You will take Briviact together with other medicines for epilepsy.
Croatian: Briviact ćete uzimati zajedno s drugim lijekovima za epilepsiju.
English: Briviact 10 mg film-coated tablets Each 10 mg film-coated tablet contains 88 mg lactose.
Croatian: Briviact 10 mg filmom obložene tablete Jedna filmom obložena tableta od 10 mg sadrži 88 mg laktoze.
English: Briviact 50 mg film-coated tablets Each 50 mg film-coated tablet contains 189 mg lactose.
Croatian: Briviact 50 mg filmom obložene tablete Jedna filmom obložena tableta od 50 mg sadrži 189 mg laktoze.
English: Open label extension studies
Croatian: Otvoreni nastavci ispitivanja
English: Briviact 75 mg film-coated tablets Each 75 mg film-coated tablet contains 283 mg lactose.
Croatian: Briviact 75 mg filmom obložene tablete Jedna filmom obložena tableta od 75 mg sadrži 283 mg laktoze.
English: A nasogastric tube or a gastrostomy tube may be used when administering brivaracetam oral solution.
Croatian: Za primjenu brivaracetam oralne otopine može se koristiti nazogastrična ili gastrostomska sonda.
English: Briviact oral solution is provided with a 5 ml and a 10 ml oral dosing syringe with their adaptor.
Croatian: Briviact oralna otopina izdaje se sa štrcaljkom za oralno doziranje od 5 ml i 10 ml i njihovim nastavkom.
English: Raspberry flavour (propylene glycol 90 % - 98 %) Purified water.
Croatian: karmelozanatrij sukraloza sorbitol, tekući glicerol (E422) aroma maline (propilenglikol 90% - 98%) pročišćena voda
English: Recommended starting dose 50 mg/day (or 100 mg/day)*
Croatian: 50 mg/dan (ili 100 mg/dan)*
English: Briviact 100 mg film-coated tablets Each 100 mg film-coated tablet contains 377 mg lactose.
Croatian: Briviact 100 mg filmom obložene tablete Jedna filmom obložena tableta od 100 mg sadrži 377 mg laktoze.
English: You will use Briviact together with other medicines for epilepsy.
Croatian: Briviact ćete primjenjivati zajedno s drugim lijekovima za epilepsiju.
English: Common: may affect up to 1 in 10 people - flu - feeling very tired (fatigue) - convulsion, a feeling of ‘spinning' (vertigo) - feeling and being sick, constipation - pain or discomfort at the injection or infusion site - depression, anxiety, not being able to sleep (insomnia), irritability - infections of the nose and throat (such as the ‘common cold'), cough - decrease appetite
Croatian: Česte: mogu se javiti u do 1 na 10 osoba - gripa - izrazit umor - konvulzija, vrtoglavica (osjećaj da se sve oko Vas vrti) - mučnina, povraćanje, zatvor - bol ili nelagoda na mjestu primjene injekcije ili infuzije - depresija, tjeskoba, nesanica, razdražljivost
English: Brivaracetam is not recommended for use in monotherapy.
Croatian: Ne preporučuje se primjena brivaracetama u monoterapiji.
English: In children and adolescents weighing 50 kg or greater, a 50 mg/day starting dose is recommended.
Croatian: U djece i adolescenata s tjelesnom težinom od 50 kg ili većom, preporučuje se početna doza od 50 mg/dan.
English: Children (from 4 years of age) and adolescents weighing less than 50 kg The recommended starting dose is 1 mg/kg/day.
Croatian: Djeca (od navršene 4 godine) i adolescenti s tjelesnom težinom manjom od 50 kg Preporučena početna doza je 1 mg/kg/dan.
English: 5 ml oral dosing syringe
Croatian: 5 ml štrcaljka za usta
English: Briviact 10 mg/ml injection/infusion brivaracetam
Croatian: Briviact 10 mg/ml injekcija/infuzija brivaracetam i.v.
English: Briviact 25 mg film-coated tablets Each 25 mg film-coated tablet contains 94 mg lactose.
Croatian: Briviact 25 mg filmom obložene tablete Jedna filmom obložena tableta od 25 mg sadrži 94 mg laktoze.
English: What Briviact contains The active substance is brivaracetam.
Croatian: Sadržaj pakiranja i druge informacije Što Briviact sadrži Djelatna tvar je brivaracetam.
English: One vial of 5 ml contains 50 mg brivaracetam.
Croatian: Jedna bočica od 5 ml sadrži 50 mg brivaracetama.
English: Valproic acid
Croatian: Valproatna kiselina Nema
English: White to off-white, round film-coated tablets of 6.5 mm in diameter and debossed with ‘u10' on one side.
Croatian: Bijele do bjelkaste, okrugle, filmom obložene tablete promjera 6,5 mm, s utisnutom oznakom „u10“ na jednoj strani.
English: 10 ml oral dosing syringe
Croatian: 10 ml štrcaljka za usta
English: Seek advice immediately from your doctor if you are pregnant or are planning to become pregnant.
Croatian: Ako zatrudnite ili planirate trudnoću, odmah se posavjetujte sa svojim liječnikom.
English: (corresponding to 1.5 mg/kg/intake)
Croatian: (odgovara 1,5 mg/kg/unos)
English: In rats, there was no effect on fertility with brivaracetam (see section 5.3).
Croatian: Brivaracetam nije utjecao na plodnost štakora (vidjeti dio 5.3).
English: Volume per administration (ml) = [weight (kg) x daily dose (mg/kg/day) ] x 0.05
Croatian: Volumen po primjeni (ml) = [tjelesna težina (kg) x dnevna doza (mg/kg/dan) ] x 0,05 Tablica u nastavku navodi primjere volumena oralne otopine po unosu, ovisno o propisanoj dozi i tjelesnoj težini.
English: - Keep the bottle, the oral syringe, and the leaflet in the carton.
Croatian: - Operite štrcaljku za usta samo vodom (slika 13) - Bočicu, štrcaljku za usta i uputu za lijek držite u kutiji.
English: Briviact 100 mg are green-grey, oval, film-coated tablets of 14.5 mm x 8.1 mm and debossed with ‘u100' on one side.
Croatian: Briviact 100 mg su zeleno-sive, ovalne, filmom obložene tablete dimenzija 14,5 mm x 8,1 mm, s utisnutom oznakom „u 100“ na jednoj strani.
English: Yellow, oval film-coated tablets with dimensions of 11.7 mm x 6.6 mm and debossed with ‘u50' on one side.
Croatian: Žute, ovalne, filmom obložene tablete dimenzija 11,7 mm x 6,6 mm, s utisnutom oznakom „u50“ na jednoj strani.
English: Each ml contains 10 mg brivaracetam.
Croatian: Jedan ml sadrži 10 mg brivaracetama.
English: Brivaracetam is not recommended in end-stage renal disease patients undergoing dialysis due to lack of data.
Croatian: Zbog nedostatka podataka, ne preporučuje se primjena brivaracetama u bolesnika u završnom stadiju bubrežne bolesti na dijalizi.
English: Somnolence and dizziness have been reported in a healthy subject taking a single dose of 1,400 mg of brivaracetam.
Croatian: U zdravog ispitanika koji je uzeo jednokratnu dozu brivaracetama od 1400 mg prijavljene su somnolencija i omaglica.
English: Briviact 25 mg are grey, oval, film-coated tablets of 8.9 mm x 5.0 mm and debossed with ‘u25' on one side.
Croatian: Briviact 25 mg su sive, ovalne, filmom obložene tablete dimenzija 8,9 mm x 5,0 mm, s utisnutom oznakom „u 25“ na jednoj strani.
English: Adults, adolescents and children weighing 50 kg or more - The recommended dose is from 25 mg to 100 mg taken twice a day.
Croatian: Odrasli, adolescenti i djeca s tjelesnom težinom od 50 kg ili više - Preporučena doza iznosi od 25 mg do 100 mg uzimana dvaput dnevno.
English: Concomitant treatment with levetiracetam
Croatian: Istodobno liječenje levetiracetamom
English: Briviact is used together with other medicines for epilepsy.
Croatian: Briviact se primjenjuje zajedno s drugim lijekovima za liječenje epilepsije.
English: (corresponding to 2 mg/kg/intake)
Croatian: (odgovara 2 mg/kg/unos)
English: Nausea, vomiting, constipation
Croatian: Poremećaji probavnog sustava često mučnina, povraćanje, konstipacija
English: (corresponding to 0.5 mg/kg/intake)
Croatian: (odgovara 0,5 mg/kg/unos)
English: Green-grey, oval film-coated tablets with dimensions of 14.5 mm x 8.1 mm and debossed with ‘u100' on one side.
Croatian: Zeleno-sive, ovalne, filmom obložene tablete dimenzija 14,5 mm x 8,1 mm, s utisnutom oznakom „u100“ na jednoj strani.
English: Dose adjustments are recommended for patients with hepatic impairment (see section
Croatian: Preporučuje se prilagoditi dozu u bolesnika s oštećenjem jetrene funkcije (vidjeti dio 4.2).
English: Briviact 50 mg are yellow, oval, film-coated tablets of 11.7 mm x 6.6 mm and debossed with ‘u50' on one side.
Croatian: Briviact 50 mg su žute, ovalne, filmom obložene tablete dimenzija 11,7 mm x 6,6 mm, s utisnutom oznakom „u 50“ na jednoj strani.
English: Briviact 75 mg film-coated tablets Each film-coated tablet contains 75 mg brivaracetam.
Croatian: Briviact 75 mg filmom obložene tablete Jedna filmom obložena tableta sadrži 75 mg brivaracetama.
English: How to store Briviact 6.
Croatian: Kako primjenjivati Briviact 4. Moguće nuspojave
English: Briviact 10 mg/ml solution for injection/infusion brivaracetam
Croatian: Briviact 10 mg/ml otopina za injekciju/infuziju brivaracetam
English: n = 100 n = 99 n = 100
Croatian: n = 100
English: How to store Briviact
Croatian: Kako primjenjivati Briviact
English: Briviact 10 mg/ml oral solution brivaracetam
Croatian: Briviact 10 mg/ml oralna otopina brivaracetam
English: Immune system disorders Uncommon
Croatian: Poremećaji imunološkog sustava manje često preosjetljivost tipa
English: (corresponding to 1 mg/kg/intake)
Croatian: (odgovara 1 mg/kg/unos)
English: Grey, oval film-coated tablets with dimensions of 8.9 mm x 5.0 mm and debossed with ‘u25' on one side.
Croatian: Sive, ovalne, filmom obložene tablete dimenzija 8,9 mm x 5,0 mm, s utisnutom oznakom „u25“ na jednoj strani.
English: In the clinical studies, although the numbers were limited, there was no observed benefit of brivaracetam versus placebo in patients taking levetiracetam concurrently.
Croatian: U kliničkim ispitivanjima nije primijećena korist od primjene brivaracetama u odnosu na placebo, u bolesnika koji su istodobno uzimali levetiracetam, iako je njihov broj bio ograničen.
English: Briviact 75 mg film-coated tablets
Croatian: Briviact 75 mg filmom obložene tablete
English: Citric acid anhydrous (for pH-adjustment) Methyl parahydroxybenzoate (E218) Carmellose sodium
Croatian: 6.1 Popis pomoćnih tvari natrijev citrat citratna kiselina, bezvodna (za podešavanje pH) metilparahidroksibenzoat (E218)
English: Briviact 10 mg film-coated tablets Polyvinyl alcohol Titanium dioxide (E171) Macrogol 3350
Croatian: Briviact 10 mg filmom obložene tablete poli(vinilni) alkohol titanijev dioksid (E171) makrogol 3350 talk
English: Briviact 75 mg are purple, oval, film-coated tablets of 13.0 mm x 7.3 mm and debossed with ‘u75' on one side.
Croatian: Briviact 75 mg su ljubičaste, ovalne, filmom obložene tablete dimenzija 13,0 mm x 7,3 mm, s utisnutom oznakom „u 75“ na jednoj strani.
English: (Omitted from cartons of 14 film-coated tablets)
Croatian: Za dodatne informacije pročitajte uputu o lijeku. (izostavljeno s kutije za pakiranje od 14 filmom obloženih tableta)
English: UCB Pharma S.A., Chemin du Foriest, B-1420 Braine-l'Alleud, Belgium.
Croatian: UCB Pharma S.A., Chemin du Foriest, B-1420 Braine-l'Alleud, Belgija Za sve informacije o ovom lijeku obratite se lokalnom predstavniku nositelja odobrenja za stavljanje lijeka u promet:
English: nervous excitement (agitation) - thoughts or attempts of harming or killing yourself: tell your doctor straight away - a decrease in white blood cells (called ‘neutropenia') - shown in blood tests
Croatian: Manje česte: mogu se javiti u do 1 na 100 osoba - alergijske reakcije - abnormalne misli i/ili gubitak dodira sa stvarnošću (psihotični poremećaj), agresivno ponašanje, nervozna uzbuđenost (agitacija) - razmišljanje o samoozljeđivanju ili samoubojstvu; odmah to priopćite svojem liječniku - smanjen broj bijelih krvnih stanica (što se naziva „neutropenijom“) - vidljivo u nalazima krvnih pretraga
English: - Briviact may be diluted before it is injected by your doctor or nurse.
Croatian: Prije injekcije, liječnik ili medicinska sestra mogu razrijediti Briviact.
English: Purple, oval film-coated tablets with dimensions of 13.0 mm x 7.3 mm debossed with ‘u75' on one side.
Croatian: Ljubičaste, ovalne, filmom obložene tablete dimenzija 13,0 mm x 7,3 mm, s utisnutom oznakom „u75“ na jednoj strani.
English: Each film-coated tablet contains 75 mg brivaracetam.
Croatian: Jedna filmom obložena tableta sadrži 75 mg brivaracetama.
English: What Briviact is used for
Croatian: Za što se Briviact koristi
English: For a dose of 1 mg/kg/day
Croatian: Za dozu od 1 mg/kg/dan
English: Briviact 25 mg film-coated tablets Each film-coated tablet contains 25 mg brivaracetam.
Croatian: Briviact 25 mg filmom obložene tablete Jedna filmom obložena tableta sadrži 25 mg brivaracetama.
English: Briviact 75 mg tablets brivaracetam
Croatian: Briviact 75 mg tablete brivaracetam
English: Briviact 25 mg film-coated tablets
Croatian: Briviact 25 mg filmom obložene tablete
English: Each ml of oral solution contains 10 mg brivaracetam.
Croatian: Jedan ml oralne otopine sadrži 10 mg brivaracetama.
English: Briviact 100 mg film-coated tablets Each film-coated tablet contains 100 mg brivaracetam.
Croatian: Briviact 100 mg filmom obložene tablete Jedna filmom obložena tableta sadrži 100 mg brivaracetama.
English: What Briviact looks like and contents of the pack Briviact 10 mg are white to off-white, round, film-coated tablets of 6.5 mm in diameter and debossed with ‘u10' on one side.
Croatian: Briviact 10 mg su bijele do bjelkaste, okrugle, filmom obložene tablete promjera 6,5 mm, s utisnutom oznakom „u 10“ na jednoj strani.
English: Briviact 100 mg tablets brivaracetam
Croatian: Briviact 100 mg tablete brivaracetam
English: Briviact 10 mg film-coated tablets Each film-coated tablet contains 10 mg brivaracetam.
Croatian: Briviact 10 mg filmom obložene tablete Jedna filmom obložena tableta sadrži 10 mg brivaracetama.
English: Briviact 100 mg film-coated tablets
Croatian: Briviact 100 mg filmom obložene tablete
English: Each film-coated tablet contains 100 mg brivaracetam.
Croatian: Jedna filmom obložena tableta sadrži 100 mg brivaracetama.
English: Each film-coated tablet contains 25 mg brivaracetam.
Croatian: Jedna filmom obložena tableta sadrži 25 mg brivaracetama.
English: For a dose of 4 mg/kg/day
Croatian: Za dozu od 4 mg/kg/dan
English: Briviact 10 mg tablets brivaracetam
Croatian: Briviact 10 mg tablete brivaracetam
English: Briviact 10 mg film-coated tablets
Croatian: Briviact 10 mg filmom obložene tablete
English: Each film-coated tablet contains 10 mg brivaracetam.
Croatian: Jedna filmom obložena tableta sadrži 10 mg brivaracetama.
English: Briviact 50 mg film-coated tablets Each film-coated tablet contains 50 mg brivaracetam.
Croatian: Briviact 50 mg filmom obložene tablete Jedna filmom obložena tableta sadrži 50 mg brivaracetama.
English: Briviact 25 mg tablets brivaracetam
Croatian: Briviact 25 mg tablete brivaracetam
English: Briviact 50 mg film-coated tablets
Croatian: Briviact 50 mg filmom obložene tablete
English: - If you weigh 20 kg or more, your doctor will recommend the use of the 5 ml oral syringe or the
Croatian: - Ako je Vaša tjelesna težina 20 kg ili više, trebate koristiti štrcaljku za usta od 5 ml ili od 10 ml priloženu u kutiju, kako biste osigurali točno doziranje.
English: Only clear solution free from particles and discoloration should be used.
Croatian: Smije se primijeniti samo bistra otopina koja ne sadrži vidljive čestice i koja nije promijenila boju.
English: Strong enzyme inducing AEDs
Croatian: Antiepileptici koji su snažni enzimski induktori
English: Depression, anxiety, insomnia, irritability
Croatian: Psihijatrijski poremećaji često depresija, anksioznost, nesanica, razdražljivost manje često suicidalne ideje, psihotični poremećaj, agresivnost, agitacija
English: For a dose of 3 mg/kg/day
Croatian: Za dozu od 3 mg/kg/dan
English: - As an adult, adolescent or child weighing 50 kg or more, the maximum dose you will take is
Croatian: - kao odrasla osoba, adolescent ili dijete s tjelesnom težinom od 50 kg ili više, najveća doza koju ćete dobiti bit će 75 mg dvaput dnevno.
English: For a dose of 2 mg/kg/day
Croatian: Za dozu od 2 mg/kg/dan
English: Briviact 50 mg tablets brivaracetam
Croatian: Briviact 50 mg tablete brivaracetam
English: Each film-coated tablet contains 50 mg brivaracetam.
Croatian: Jedna filmom obložena tableta sadrži 50 mg brivaracetama.
English: Briviact 75 mg film-coated tablets brivaracetam
Croatian: Briviact 75 mg filmom obložene tablete brivaracetam
English: Children (from 4 years of age) and adolescents weighing 50 kg or more
Croatian: Djeca (≥4 godine) i adolescenti ≥50 kg
English: 0.05 ml/kg/intake
Croatian: 0,05 ml/kg/unos
English: EU/1/15/1073/017 14 film-coated tablets EU/1/15/1073/018 56 film-coated tablets EU/1/15/1073/019 100 x 1 film-coated tablet EU/1/15/1073/027 14 x 1 film-coated tablet
Croatian: EU/1/15/1073/017 14 filmom obloženih tableta EU/1/15/1073/018 56 filmom obloženih tableta EU/1/15/1073/019 100 x 1 filmom obložena tableta EU/1/15/1073/027 14 x 1 filmom obložena tableta
English: 0.5 mg/kg = 0.05 ml/kg
Croatian: Tjelesna težina 0,5 mg/kg = 0,05 ml/kg
English: Briviact 100 mg film-coated tablets brivaracetam
Croatian: Briviact 100 mg filmom obložene tablete brivaracetam
English: Briviact 10 mg film-coated tablets brivaracetam
Croatian: Briviact 10 mg filmom obložene tablete brivaracetam
English: Briviact 25 mg film-coated tablets brivaracetam
Croatian: Briviact 25 mg filmom obložene tablete brivaracetam
English: EU/1/15/1073/013 14 film-coated tablets EU/1/15/1073/014 56 film-coated tablets EU/1/15/1073/015 100 x 1 film-coated tablet EU/1/15/1073/026 14 x 1 film-coated tablet
Croatian: EU/1/15/1073/013 14 filmom obloženih tableta EU/1/15/1073/014 56 filmom obloženih tableta EU/1/15/1073/015 100 x 1 filmom obložena tableta EU/1/15/1073/026 14 x 1 filmom obložena tableta
English: EU/1/15/1073/004 168 (3 packs of 56) film-coated tablets
Croatian: EU/1/15/1073/004 168 (3 pakiranja od 56) filmom obloženih tableta
English: Croscarmellose Sodium, Lactose monohydrate Betadex
Croatian: 6.1 Popis pomoćnih tvari Jezgra karmelozanatrij, umrežena laktoza hidrat betadeks laktoza, bezvodna magnezijev stearat
English: Briviact 50 mg film-coated tablets brivaracetam
Croatian: Briviact 50 mg filmom obložene tablete brivaracetam
English: - 75 mg film-coated tablets: polyvinyl alcohol, titanium dioxide (E171), macrogol 3350, talc, iron oxide yellow (E172), iron oxide red (E172), iron oxide black (E172).
Croatian: Briviact 75 mg filmom obložene tablete poli(vinilni) alkohol titanijev dioksid (E171) makrogol 3350 talk željezov oksid, žuti (E172) željezov oksid, crveni (E172) željezov oksid, crni (E172)
English: Briviact 10 mg/ml oral solution
Croatian: Briviact 10 mg/ml oralna otopina
English: EU/1/15/1073/008 168 (3 packs of 56) film-coated tablets
Croatian: EU/1/15/1073/008 168 (3 pakiranja od 56) filmom obloženih tableta
English: EU/1/15/1073/009 14 film-coated tablets EU/1/15/1073/010 56 film-coated tablets EU/1/15/1073/011 100 x 1 film-coated tablet EU/1/15/1073/025 14 x 1 film-coated tablet
Croatian: EU/1/15/1073/009 14 filmom obloženih tableta EU/1/15/1073/010 56 filmom obloženih tableta EU/1/15/1073/011 100 x 1 filmom obložena tableta EU/1/15/1073/025 14 x 1 filmom obložena tableta
English: EU/1/15/1073/020 168 (3 packs of 56) film-coated tablets
Croatian: EU/1/15/1073/020 168 (3 pakiranja od 56) filmom obloženih tableta
English: EU/1/15/1073/005 14 film-coated tablets EU/1/15/1073/006 56 film-coated tablets EU/1/15/1073/007 100 x 1 film-coated tablet EU/1/15/1073/024 14 x 1 film-coated tablet
Croatian: EU/1/15/1073/005 14 filmom obloženih tableta EU/1/15/1073/006 56 filmom obloženih tableta EU/1/15/1073/007 100 x 1 filmom obložena tableta EU/1/15/1073/024 14 x 1 filmom obložena tableta
English: Two oral syringes will be provided in the carton.
Croatian: Upute za uporabu za bolesnike ili njegovatelje: Dvije štrcaljke za usta bit će priložene u kutiju.
English: EU/1/15/1073/001 14 film-coated tablets EU/1/15/1073/002 56 film-coated tablets EU/1/15/1073/003 100 x 1 film-coated tablet EU/1/15/1073/023 14 x 1 film-coated tablet
Croatian: EU/1/15/1073/001 14 filmom obloženih tableta EU/1/15/1073/002 56 filmom obloženih tableta EU/1/15/1073/003 100 x 1 filmom obložena tableta EU/1/15/1073/023 14 x 1 filmom obložena tableta
English: EU/1/15/1073/012 168 (3 packs of 56) film-coated tablets
Croatian: EU/1/15/1073/012 168 (3 pakiranja od 56) filmom obloženih tableta
English: - 100 mg film-coated tablets: polyvinyl alcohol, titanium dioxide (E171), macrogol 3350, talc, iron oxide yellow (E172), iron oxide black (E172).
Croatian: Briviact 100 mg filmom obložene tablete poli(vinilni) alkohol titanijev dioksid (E171) makrogol 3350 talk željezov oksid, žuti (E172) željezov oksid, crni (E172)
English: EU/1/15/1073/016 168 (3 packs of 56) film-coated tablets
Croatian: EU/1/15/1073/016 168 (3 pakiranja od 56) filmom obloženih tableta
English: Treatment with levetiracetam
Croatian: Liječenje levetiracetamom
English: Coating
Croatian: Dojenje
English: 0.1 ml/kg/intake
Croatian: 0,1 ml/kg/unos
English: The table below provides examples of volumes of oral solution per intake depending on prescribed dose and body weight.
Croatian: Pedijatrijska populacija Liječnik treba propisati najprimjereniju formulaciju i jačinu u skladu s tjelesnom težinom i dozom.
English: Clobazam
Croatian: Klobazam