natgillin/translations-raw huggingface dataset:
Talk to your doctor or pharmacist before using Briviact if: - You have thoughts of harming or killing yourself.
Upozorenja i mjere opreza Obratite se svom liječniku ili ljekarniku prije nego primjenite Briviact: - ako razmišljate o samoozljeđivanju ili samoubojstvu.
Contains croscarmellose sodium, lactose monohydrate and lactose anhydrous.
Sadrži umreženu karmelozunatrij, laktozu hidrat i bezvodnu laktozu.
The 300 ml glass bottle of Briviact is packed in a cardboard box containing a 10 ml oral syringe and a 5 ml oral syringe and an adaptor for the syringe.
Staklena boca lijeka Briviact od 300 ml pakirana je u kutiju koja sadrži štrcaljku za usta od 10 ml i od 5 ml i nastavak za štrcaljku.
Suicidal ideation, psychotic disorder, aggression, agitation Nervous system disorders Very common Dizziness, somnolence Common
Psihijatrijski poremećaji često depresija, anksioznost, nesanica, razdražljivost manje često suicidalne ideje, psihotični poremećaj, agresivnost, agitacija Poremećaji živčanog sustava vrlo često omaglica, somnolencija često konvulzija, vrtoglavica
n = randomised patients who received at least 1 dose of study medication ~ Dose not studied Statistically significant Approximately 20 % of the patients were on concomitant levetiracetam The primary outcome for N01252 did not achieve statistical significance based on the sequential testing procedure.
= randomizirani bolesnici koji su primili najmanje 1 dozu ispitivanog lijeka ~ Doza na kojoj nije provedeno ispitivanje Statistički značajno Približno 20% bolesnika istodobno se liječilo levetiracetamom
The pharmacokinetics of brivaracetam was not significantly affected by race (Caucasian, , Asian) in a population pharmacokinetic modeling from epilepsy patients.
Populacijsko farmakokinetičko modeliranje provedeno u bolesnika s epilepsijom pokazalo je da rasa (bijela, azijska) nije značajno utjecala na farmakokinetiku brivaracetama.
One full 10 ml oral dosing syringe corresponds to 100 mg of brivaracetam.
Jedna puna štrcaljka za oralno doziranje od 10 ml odgovara 100 mg brivaracetama.
It is unknown whether brivaracetam is excreted in human breast milk.
Nije poznato izlučuje li se brivaracetam u majčino mlijeko u ljudi.
Driving and using machines - You may feel sleepy, dizzy or tired while taking Briviact.
Upravljanje vozilima i strojevima - Tijekom liječenja lijekom Briviact možete osjećati pospanost, omaglicu ili umor.
50 mg/5 ml 10 vials solution for injection/infusion
50 mg/5 ml 10 bočica s otopinom za injekciju/infuziju
UNIQUE IDENTIFIER - 2D BARCODE <2D barcode carrying the unique identifier included.>
JEDINSTVENI IDENTIFIKATOR - 2D BARKOD <Sadrži 2D barkod s jedinstvenim identifikatorom.>
People with liver problems If you have problems with your liver: - As an adult, adolescent or child weighing 50 kg or more, the maximum dose you will take is 75 mg twice a day.
Ako imate jetrenih tegoba: - kao odrasla osoba, adolescent ili dijete s tjelesnom težinom od 50 kg ili više, najveća doza koju ćete uzimati bit će 75 mg dvaput dnevno.
Briviact 10 mg film-coated tablets Briviact 25 mg film-coated tablets Briviact 50 mg film-coated tablets Briviact 75 mg film-coated tablets Briviact 100 mg film-coated tablets
Briviact 10 mg filmom obložene tablete Briviact 25 mg filmom obložene tablete Briviact 50 mg filmom obložene tablete Briviact 75 mg filmom obložene tablete Briviact 100 mg filmom obložene tablete
What Briviact looks like and contents of the pack Briviact 10 mg/ml oral solution is slightly viscous, clear, colourless to yellowish liquid.
Briviact 10 mg/ml oralna otopina je blago viskozna, bistra, bezbojna do žućkasta tekućina.
One full 5 ml oral dosing syringe corresponds to 50 mg of brivaracetam.
Jedna puna štrcaljka od 5 ml za oralno doziranje odgovara 50 mg brivaracetama.
Adverse reactions with intravenous administration generally appeared to be similar to those observed with oral administration.
Nuspojave koje su se javljale kod intravenske primjene načelno su bile slične onima primijećenima kod peroralne primjene.
Briviact 10 mg film-coated tablets Briviact 25 mg film-coated tablets Briviact 50 mg film-coated tablets Briviact 75 mg film-coated tablets Briviact 100 mg film-coated tablets brivaracetam
Briviact 10 mg filmom obložene tablete Briviact 25 mg filmom obložene tablete Briviact 50 mg filmom obložene tablete Briviact 75 mg filmom obložene tablete Briviact 100 mg filmom obložene tablete brivaracetam
Each ml of solution for injection/infusion contains 10 mg brivaracetam.
Jedan ml oralne otopine za injekciju/infuziju sadrži 10 mg brivaracetama.
Blood and lymphatic system disorders
Poremećaji krvi i limfnog sustava manje često Neutropenija
Children and adolescents weighing less than 50 kg - The recommended dose is from 0.5 mg to 2 mg for each kg of bodyweight, taken twice a day.
Djeca i adolescenti s tjelesnom težinom manjom od 50 kg - Preporučena doza iznosi od 0,5 mg do 2 mg po kilogramu tjelesne težine, uzimana dvaput dnevno.
What Briviact looks like and contents of the pack Briviact 10 mg/ml solution for injection/infusion is a clear, colourless, sterile solution.
Briviact 10 mg/ml otopina za injekciju/infuziju je bistra, bezbojna, sterilna otopina.
Do not use this medicine after the expiry date which is stated on the carton and blister after EXP.
Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na kutiji i blisteru iza oznake „Rok valjanosti“ / „EXP“.
Sodium acetate (trihydrate) Acetic acid, glacial (for pH-adjustment) Sodium chloride
6.1 Popis pomoćnih tvari natrijev acetat (trihidrat) acetatna kiselina, ledena (za podešavanje pH) natrijev klorid voda za injekcije
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.
Uzimajući u obzir korist lijeka za majku, treba donijeti odluku o tome hoće li se prekinuti dojenje ili obustaviti liječenje brivaracetamom.
Briviact 10 mg/ml solution for injection/infusion
Briviact 10 mg/ml otopina za injekciju/infuziju
Children (from 4 years of age) and adolescents weighing 50 kg or more The recommended starting dose is 50mg/day.
Djeca (od navršene 4 godine) i adolescenti s tjelesnom težinom od 50 kg ili više Preporučena početna doza je 50 mg/dan.
Do not use this medicine after the expiry date which is stated on the cardboard box and bottle after EXP.
Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na kutiji i bočici iza oznake „Rok valjanosti“ / „EXP“.
- 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.
- 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.
In children and adolescents weighing less than 50 kg, a 1 mg/kg/day starting dose is recommended.
U djece i adolescenata koji teže manje od 50 kg, preporučuje se početna doza od 1 mg/kg/dan.
Based on individual patient response and tolerability, the dose may be adjusted in the dose range of 50 mg/day to 200 mg/day.
Ovisno o odgovoru i podnošljivosti lijeka u pojedinog bolesnika, doza se može prilagođavati unutar raspona od 50 mg/dan do 200 mg/dan.
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.
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.
What Briviact is
Što je Briviact
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.
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.
Volumes of oral solution to be taken per administration
Volumeni oralne otopine koji se uzimaju po primjeni
You will take Briviact together with other medicines for epilepsy.
Briviact ćete uzimati zajedno s drugim lijekovima za epilepsiju.
Briviact 10 mg film-coated tablets Each 10 mg film-coated tablet contains 88 mg lactose.
Briviact 10 mg filmom obložene tablete Jedna filmom obložena tableta od 10 mg sadrži 88 mg laktoze.
Briviact 50 mg film-coated tablets Each 50 mg film-coated tablet contains 189 mg lactose.
Briviact 50 mg filmom obložene tablete Jedna filmom obložena tableta od 50 mg sadrži 189 mg laktoze.
Open label extension studies
Otvoreni nastavci ispitivanja
Briviact 75 mg film-coated tablets Each 75 mg film-coated tablet contains 283 mg lactose.
Briviact 75 mg filmom obložene tablete Jedna filmom obložena tableta od 75 mg sadrži 283 mg laktoze.
A nasogastric tube or a gastrostomy tube may be used when administering brivaracetam oral solution.
Za primjenu brivaracetam oralne otopine može se koristiti nazogastrična ili gastrostomska sonda.
Briviact oral solution is provided with a 5 ml and a 10 ml oral dosing syringe with their adaptor.
Briviact oralna otopina izdaje se sa štrcaljkom za oralno doziranje od 5 ml i 10 ml i njihovim nastavkom.
Raspberry flavour (propylene glycol 90 % - 98 %) Purified water.
karmelozanatrij sukraloza sorbitol, tekući glicerol (E422) aroma maline (propilenglikol 90% - 98%) pročišćena voda
Recommended starting dose 50 mg/day (or 100 mg/day)*
50 mg/dan (ili 100 mg/dan)*
Briviact 100 mg film-coated tablets Each 100 mg film-coated tablet contains 377 mg lactose.
Briviact 100 mg filmom obložene tablete Jedna filmom obložena tableta od 100 mg sadrži 377 mg laktoze.
You will use Briviact together with other medicines for epilepsy.
Briviact ćete primjenjivati zajedno s drugim lijekovima za epilepsiju.
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
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
Brivaracetam is not recommended for use in monotherapy.
Ne preporučuje se primjena brivaracetama u monoterapiji.
In children and adolescents weighing 50 kg or greater, a 50 mg/day starting dose is recommended.
U djece i adolescenata s tjelesnom težinom od 50 kg ili većom, preporučuje se početna doza od 50 mg/dan.
Children (from 4 years of age) and adolescents weighing less than 50 kg The recommended starting dose is 1 mg/kg/day.
Djeca (od navršene 4 godine) i adolescenti s tjelesnom težinom manjom od 50 kg Preporučena početna doza je 1 mg/kg/dan.
5 ml oral dosing syringe
5 ml štrcaljka za usta
Briviact 10 mg/ml injection/infusion brivaracetam
Briviact 10 mg/ml injekcija/infuzija brivaracetam i.v.
Briviact 25 mg film-coated tablets Each 25 mg film-coated tablet contains 94 mg lactose.
Briviact 25 mg filmom obložene tablete Jedna filmom obložena tableta od 25 mg sadrži 94 mg laktoze.
What Briviact contains The active substance is brivaracetam.
Sadržaj pakiranja i druge informacije Što Briviact sadrži Djelatna tvar je brivaracetam.
One vial of 5 ml contains 50 mg brivaracetam.
Jedna bočica od 5 ml sadrži 50 mg brivaracetama.
Valproic acid
Valproatna kiselina Nema
White to off-white, round film-coated tablets of 6.5 mm in diameter and debossed with ‘u10' on one side.
Bijele do bjelkaste, okrugle, filmom obložene tablete promjera 6,5 mm, s utisnutom oznakom „u10“ na jednoj strani.
10 ml oral dosing syringe
10 ml štrcaljka za usta
Seek advice immediately from your doctor if you are pregnant or are planning to become pregnant.
Ako zatrudnite ili planirate trudnoću, odmah se posavjetujte sa svojim liječnikom.
(corresponding to 1.5 mg/kg/intake)
(odgovara 1,5 mg/kg/unos)
In rats, there was no effect on fertility with brivaracetam (see section 5.3).
Brivaracetam nije utjecao na plodnost štakora (vidjeti dio 5.3).
Volume per administration (ml) = [weight (kg) x daily dose (mg/kg/day) ] x 0.05
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.
- Keep the bottle, the oral syringe, and the leaflet in the carton.
- Operite štrcaljku za usta samo vodom (slika 13) - Bočicu, štrcaljku za usta i uputu za lijek držite u kutiji.
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.
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.
Yellow, oval film-coated tablets with dimensions of 11.7 mm x 6.6 mm and debossed with ‘u50' on one side.
Žute, ovalne, filmom obložene tablete dimenzija 11,7 mm x 6,6 mm, s utisnutom oznakom „u50“ na jednoj strani.
Each ml contains 10 mg brivaracetam.
Jedan ml sadrži 10 mg brivaracetama.
Brivaracetam is not recommended in end-stage renal disease patients undergoing dialysis due to lack of data.
Zbog nedostatka podataka, ne preporučuje se primjena brivaracetama u bolesnika u završnom stadiju bubrežne bolesti na dijalizi.
Somnolence and dizziness have been reported in a healthy subject taking a single dose of 1,400 mg of brivaracetam.
U zdravog ispitanika koji je uzeo jednokratnu dozu brivaracetama od 1400 mg prijavljene su somnolencija i omaglica.
Briviact 25 mg are grey, oval, film-coated tablets of 8.9 mm x 5.0 mm and debossed with ‘u25' on one side.
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.
Adults, adolescents and children weighing 50 kg or more - The recommended dose is from 25 mg to 100 mg taken twice a day.
Odrasli, adolescenti i djeca s tjelesnom težinom od 50 kg ili više - Preporučena doza iznosi od 25 mg do 100 mg uzimana dvaput dnevno.
Concomitant treatment with levetiracetam
Istodobno liječenje levetiracetamom
Briviact is used together with other medicines for epilepsy.
Briviact se primjenjuje zajedno s drugim lijekovima za liječenje epilepsije.
(corresponding to 2 mg/kg/intake)
(odgovara 2 mg/kg/unos)
Nausea, vomiting, constipation
Poremećaji probavnog sustava često mučnina, povraćanje, konstipacija
(corresponding to 0.5 mg/kg/intake)
(odgovara 0,5 mg/kg/unos)
Green-grey, oval film-coated tablets with dimensions of 14.5 mm x 8.1 mm and debossed with ‘u100' on one side.
Zeleno-sive, ovalne, filmom obložene tablete dimenzija 14,5 mm x 8,1 mm, s utisnutom oznakom „u100“ na jednoj strani.
Dose adjustments are recommended for patients with hepatic impairment (see section
Preporučuje se prilagoditi dozu u bolesnika s oštećenjem jetrene funkcije (vidjeti dio 4.2).
Briviact 50 mg are yellow, oval, film-coated tablets of 11.7 mm x 6.6 mm and debossed with ‘u50' on one side.
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.
Briviact 75 mg film-coated tablets Each film-coated tablet contains 75 mg brivaracetam.
Briviact 75 mg filmom obložene tablete Jedna filmom obložena tableta sadrži 75 mg brivaracetama.
How to store Briviact 6.
Kako primjenjivati Briviact 4. Moguće nuspojave
Briviact 10 mg/ml solution for injection/infusion brivaracetam
Briviact 10 mg/ml otopina za injekciju/infuziju brivaracetam
n = 100 n = 99 n = 100
n = 100
How to store Briviact
Kako primjenjivati Briviact
Briviact 10 mg/ml oral solution brivaracetam
Briviact 10 mg/ml oralna otopina brivaracetam
Immune system disorders Uncommon
Poremećaji imunološkog sustava manje često preosjetljivost tipa
(corresponding to 1 mg/kg/intake)
(odgovara 1 mg/kg/unos)
Grey, oval film-coated tablets with dimensions of 8.9 mm x 5.0 mm and debossed with ‘u25' on one side.
Sive, ovalne, filmom obložene tablete dimenzija 8,9 mm x 5,0 mm, s utisnutom oznakom „u25“ na jednoj strani.
In the clinical studies, although the numbers were limited, there was no observed benefit of brivaracetam versus placebo in patients taking levetiracetam concurrently.
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.
Briviact 75 mg film-coated tablets
Briviact 75 mg filmom obložene tablete
Citric acid anhydrous (for pH-adjustment) Methyl parahydroxybenzoate (E218) Carmellose sodium
6.1 Popis pomoćnih tvari natrijev citrat citratna kiselina, bezvodna (za podešavanje pH) metilparahidroksibenzoat (E218)
Briviact 10 mg film-coated tablets Polyvinyl alcohol Titanium dioxide (E171) Macrogol 3350
Briviact 10 mg filmom obložene tablete poli(vinilni) alkohol titanijev dioksid (E171) makrogol 3350 talk
Briviact 75 mg are purple, oval, film-coated tablets of 13.0 mm x 7.3 mm and debossed with ‘u75' on one side.
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.
(Omitted from cartons of 14 film-coated tablets)
Za dodatne informacije pročitajte uputu o lijeku. (izostavljeno s kutije za pakiranje od 14 filmom obloženih tableta)
UCB Pharma S.A., Chemin du Foriest, B-1420 Braine-l'Alleud, Belgium.
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:
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
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
- Briviact may be diluted before it is injected by your doctor or nurse.
Prije injekcije, liječnik ili medicinska sestra mogu razrijediti Briviact.
Purple, oval film-coated tablets with dimensions of 13.0 mm x 7.3 mm debossed with ‘u75' on one side.
Ljubičaste, ovalne, filmom obložene tablete dimenzija 13,0 mm x 7,3 mm, s utisnutom oznakom „u75“ na jednoj strani.
Each film-coated tablet contains 75 mg brivaracetam.
Jedna filmom obložena tableta sadrži 75 mg brivaracetama.
What Briviact is used for
Za što se Briviact koristi
For a dose of 1 mg/kg/day
Za dozu od 1 mg/kg/dan
Briviact 25 mg film-coated tablets Each film-coated tablet contains 25 mg brivaracetam.
Briviact 25 mg filmom obložene tablete Jedna filmom obložena tableta sadrži 25 mg brivaracetama.
Briviact 75 mg tablets brivaracetam
Briviact 75 mg tablete brivaracetam
Briviact 25 mg film-coated tablets
Briviact 25 mg filmom obložene tablete
Each ml of oral solution contains 10 mg brivaracetam.
Jedan ml oralne otopine sadrži 10 mg brivaracetama.
Briviact 100 mg film-coated tablets Each film-coated tablet contains 100 mg brivaracetam.
Briviact 100 mg filmom obložene tablete Jedna filmom obložena tableta sadrži 100 mg brivaracetama.
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.
Briviact 10 mg su bijele do bjelkaste, okrugle, filmom obložene tablete promjera 6,5 mm, s utisnutom oznakom „u 10“ na jednoj strani.
Briviact 100 mg tablets brivaracetam
Briviact 100 mg tablete brivaracetam
Briviact 10 mg film-coated tablets Each film-coated tablet contains 10 mg brivaracetam.
Briviact 10 mg filmom obložene tablete Jedna filmom obložena tableta sadrži 10 mg brivaracetama.
Briviact 100 mg film-coated tablets
Briviact 100 mg filmom obložene tablete
Each film-coated tablet contains 100 mg brivaracetam.
Jedna filmom obložena tableta sadrži 100 mg brivaracetama.
Each film-coated tablet contains 25 mg brivaracetam.
Jedna filmom obložena tableta sadrži 25 mg brivaracetama.
For a dose of 4 mg/kg/day
Za dozu od 4 mg/kg/dan
Briviact 10 mg tablets brivaracetam
Briviact 10 mg tablete brivaracetam
Briviact 10 mg film-coated tablets
Briviact 10 mg filmom obložene tablete
Each film-coated tablet contains 10 mg brivaracetam.
Jedna filmom obložena tableta sadrži 10 mg brivaracetama.
Briviact 50 mg film-coated tablets Each film-coated tablet contains 50 mg brivaracetam.
Briviact 50 mg filmom obložene tablete Jedna filmom obložena tableta sadrži 50 mg brivaracetama.
Briviact 25 mg tablets brivaracetam
Briviact 25 mg tablete brivaracetam
Briviact 50 mg film-coated tablets
Briviact 50 mg filmom obložene tablete
- If you weigh 20 kg or more, your doctor will recommend the use of the 5 ml oral syringe or the
- 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.
Only clear solution free from particles and discoloration should be used.
Smije se primijeniti samo bistra otopina koja ne sadrži vidljive čestice i koja nije promijenila boju.
Strong enzyme inducing AEDs
Antiepileptici koji su snažni enzimski induktori
Depression, anxiety, insomnia, irritability
Psihijatrijski poremećaji često depresija, anksioznost, nesanica, razdražljivost manje često suicidalne ideje, psihotični poremećaj, agresivnost, agitacija
For a dose of 3 mg/kg/day
Za dozu od 3 mg/kg/dan
- As an adult, adolescent or child weighing 50 kg or more, the maximum dose you will take is
- 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.
For a dose of 2 mg/kg/day
Za dozu od 2 mg/kg/dan
Briviact 50 mg tablets brivaracetam
Briviact 50 mg tablete brivaracetam
Each film-coated tablet contains 50 mg brivaracetam.
Jedna filmom obložena tableta sadrži 50 mg brivaracetama.
Briviact 75 mg film-coated tablets brivaracetam
Briviact 75 mg filmom obložene tablete brivaracetam
Children (from 4 years of age) and adolescents weighing 50 kg or more
Djeca (≥4 godine) i adolescenti ≥50 kg
0.05 ml/kg/intake
0,05 ml/kg/unos
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
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
0.5 mg/kg = 0.05 ml/kg
Tjelesna težina 0,5 mg/kg = 0,05 ml/kg
Briviact 100 mg film-coated tablets brivaracetam
Briviact 100 mg filmom obložene tablete brivaracetam
Briviact 10 mg film-coated tablets brivaracetam
Briviact 10 mg filmom obložene tablete brivaracetam
Briviact 25 mg film-coated tablets brivaracetam
Briviact 25 mg filmom obložene tablete brivaracetam
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
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
EU/1/15/1073/004 168 (3 packs of 56) film-coated tablets
EU/1/15/1073/004 168 (3 pakiranja od 56) filmom obloženih tableta
Croscarmellose Sodium, Lactose monohydrate Betadex
6.1 Popis pomoćnih tvari Jezgra karmelozanatrij, umrežena laktoza hidrat betadeks laktoza, bezvodna magnezijev stearat
Briviact 50 mg film-coated tablets brivaracetam
Briviact 50 mg filmom obložene tablete brivaracetam