FrancophonIA/ELRC3.0 huggingface dataset:
English: Brivaracetam plasma concentrations may increase when coadministered with CYP2C19 strong inhibitors (e.g. fluconazole, fluvoxamine), but the risk of a clinically relevant CYP2C19-mediated interaction is considered to be low.
Croatian: Plazmatske koncentracije brivaracetama mogu se povećati pri njegovoj istodobnoj primjeni sa snažnim inhibitorima enzima CYP2C19 (npr. flukonazolom, fluvoksaminom), ali se rizik od klinički značajnih interakcija posredovanih enzimom CYP2C19 smatra niskim.
English: What you need to know before you take Briviact 3.
Croatian: Što morate znati prije nego počnete uzimati Briviact 3.
English: In clinical studies, brivaracetam was used as adjunctive therapy and when it was used with carbamazepine, it induced a dose-related increase in the concentration of the active metabolite, carbamazepine-epoxide (see section 4.5).
Croatian: U kliničkim se ispitivanjima brivaracetam primjenjivao kao dodatna terapija; kada se primjenjivao s karbamazepinom, inducirao je o dozi ovisno povećanje koncentracije aktivnog metabolita, karbamazepin-epoksida (vidjeti dio 4.5).
English: How long to take Briviact for
Croatian: Koliko dugo uzimati Briviact
English: Children (≥4 years) and adolescents <50 kg
Croatian: Djeca (≥4 godine) i adolescenti <50 kg
English: No CYP3A4 induction was found in vivo (see midazolam above).
Croatian: Nije utvrđena indukcija enzima CYP3A4 in vivo (vidjeti prethodno navedene informacije za midazolam).
English: The efficacy of brivaracetam for the adjunctive therapy of partial onset seizures (POS) was established in 3 randomized, double-blind, placebo-controlled, fixed-dose, multi-center studies in subjects 16 years of age and older.
Croatian: Djelotvornost brivaracetama kao dodatne terapije za parcijalne nastupe napadaja utvrđena je u 3 randomizirana, dvostruko slijepa, placebom kontrolirana, multicentrična ispitivanja s primjenom fiksne doze, provedena u ispitanika u dobi od 16 ili više godina.
English: In case of co-administration of brivaracetam and carbamazepine, the amount of carbamazepine-epoxide excreted in breast milk could increase.
Croatian: U slučaju istodobne primjene brivaracetama i karbamazepina, može se povećati količina karbamazepin-epoksida koja se izlučuje u majčino mlijeko.
English: In vitro interaction studies to determine the potential inhibitory effects on transporters concluded that there were no clinically relevant effects, except for OAT3.
Croatian: Ispitivanja interakcija provedena radi utvrđivanja potencijalnih inhibitornih učinaka na prijenosnike zaključila su da nema klinički značajnih učinaka, osim za OAT3.
English: Brivaracetam has not been studied in patients undergoing hemodialysis (see section 4.2).
Croatian: Brivaracetam se nije ispitivao u bolesnika na hemodijalizi (vidjeti dio 4.2).
English: In vitro studies have shown that brivaracetam exhibits little or no inhibition of CYP450 isoforms except for CYP2C19.
Croatian: Ispitivanja in vitro pokazala su da brivaracetam ostvaruje neznatnu ili nikakvu inhibiciju izooblika enzima CYP450 osim za enzim CYP2C19.
English: Brivaracetam plasma concentrations are decreased when coadministered with strong enzyme inducing AEDs (carbamazepine, phenobarbital, phenytoin) but no dose adjustment is required (see table 1).
Croatian: Plazmatske koncentracije brivaracetama smanjuju se pri njegovoj istodobnoj primjeni s antiepilepticima koji su snažni enzimski induktori (karbamazepin, fenobarbital, fenitoin), ali nije potrebno prilagođavati dozu (vidjeti tablicu 1).
English: Currently, no clinical data are available in neonates.
Croatian: Trenutno, nema dostupnih kliničkih podataka za novorođenčad.
English: OUTER CARTON / BOTTLE
Croatian: KUTIJA / BOCA
English: What you need to know before you take Briviact
Croatian: Što morate znati prije nego počnete primjenjivati Briviact
English: To be taken into consideration for patients on a controlled sodium diet.
Croatian: To treba uzeti u obzir u bolesnika koji su na dijeti s kontroliranim unosom natrija.
English: No dose adjustment required
Croatian: Nije potrebno prilagođavati dozu
English: In a study in elderly subjects (65 to79 years old; with creatinine clearance 53 to 98 ml/min/1.73 m²) receiving brivaracetam 400 mg/day in bid administration, the plasma half-life of brivaracetam was 7.9 hours and 9.3 hours in the 65 to 75 and >75 years groups, respectively.
Croatian: U ispitivanju provedenom u starijih ispitanika (u dobi od 65 do 79 godina; s klirensom kreatinina od 53 do 98 ml/min/1,73 m2) koji su primali 400 mg brivaracetama na dan podijeljeno u dvije doze, plazmatski poluvijek brivaracetama u dobnoj skupini od 65 do 75 godina iznosio je 7,9 sati, a u dobnoj skupini > 75 godina 9,3 sata.
English: Four of these subjects had decreased neutrophil counts at baseline, and experienced additional decrease in neutrophil counts after initiation of brivaracetam treatment.
Croatian: Četiri od tih ispitanika imala su smanjen broj neutrofila već na početku ispitivanja, koji se zatim dodatno smanjio nakon početka liječenja brivaracetamom.
English: If you have been told by your doctor that you cannot tolerate or digest some sugars, contact your doctor before taking this medicine.
Croatian: Ako Vam je liječnik rekao da ne podnosite neke vrste šećera ili da ih ne možete probaviti, obratite se svom liječniku prije nego uzmete ovaj lijek.
English: In vivo, in human subjects possessing ineffective mutations of CYP2C19, production of the hydroxy metabolite is decreased 10-fold while brivaracetam itself is increased by 22 % or 42 % in individuals with one or both mutated alleles.
Croatian: In vivo je u ljudskih ispitanika s neutralnim mutacijama enzima CYP2C19 stvaranje hidroksi metabolita deseterostruko smanjeno, dok je koncentracija brivaracetama povećana za 22% odnosno 42% u osoba s jednim odnosno oba mutirana alela.
English: 14 film-coated tablets 56 film-coated tablets 100 x 1 film-coated tablet 14 x 1 film-coated tablet
Croatian: 14 filmom obloženih tableta 56 filmom obloženih tableta 100 x 1 filmom obložena tableta 14 x 1 filmom obložena tableta
English: The total plasma clearance in patients was estimated to 3.6 L/h.
Croatian: Procjenjuje se da ukupan plazmatski klirens u bolesnika iznosi 3,6 l/h.
English: Co-administration of brivaracetam (100 mg/day) with an oral contraceptive containing ethinylestradiol (0.03 mg) and levonorgestrel (0.15 mg) did not influence the pharmacokinetics of either substance.
Croatian: Istodobna primjena brivaracetama (100 mg/dan) s oralnim kontraceptivom koji sadrži etinilestradiol (0,03 mg) i levonorgestrel (0,15 mg) nije utjecala na farmakokinetiku nijedne od tih dviju djelatnih tvari.
English: - If you weigh less than 20 kg, you should use the 5 ml oral syringe provided in the carton to ensure accurate dosing.
Croatian: - Ako je Vaša tjelesna težina manja od 20 kg, trebate koristiti štrcaljku za usta od 5 ml priloženu u kutiju, kako biste osigurali točno doziranje.
English: In vitro, interaction studies to determine the potential inhibitory effects on transporters concluded that there were no clinically relevant effects, except for OAT3.
Croatian: Ispitivanja interakcija in vitro provedena radi utvrđivanja potencijalnih inhibitornih učinaka na prijenosnike zaključila su da nema klinički značajnih učinaka, osim za OAT3.
English: Study N01252
Croatian: Ispitivanje br. 1252
English: OUTER CARTON OF MULTIPACK (WITH BLUE BOX)
Croatian: KUTIJA VIŠESTRUKOG PAKIRANJA (S PLAVIM OKVIROM)
English: A pharmacokinetic study in subjects with hepatic cirrhosis (Child-Pugh grades A, B, and C) showed similar increases in exposure to brivaracetam irrespective of disease severity (50 %, 57 % and 59 %), relative to matched healthy controls.
Croatian: Farmakokinetičko ispitivanje u ispitanika s cirozom jetre (Child-Pugh stadij A, B i C) pokazalo je slična povećanja izloženosti brivaracetamu neovisno o težini bolesti (50%, 57% odnosno 59%) u odnosu na uparene zdrave kontrolne ispitanike (vidjeti dio 4.2).
English: In healthy subjects, coadministration with the strong enzyme inducer rifampicin (600 mg/day for 5 days), decreased brivaracetam area under the plasma concentration curve (AUC) by 45 %.
Croatian: U zdravih je ispitanika istodobna primjena sa snažnim enzimskim induktorom rifampicinom (600 mg/dan tijekom 5 dana) smanjila površinu ispod krivulje plazmatske koncentracije brivaracetama (engl. area under the curve, AUC) za 45%.
English: Patients with an improvement in percent reduction in baseline POS frequency are shown in the 4 right-most categories.
Croatian: Bolesnici koji su ostvarili poboljšanje u vidu smanjenja početne učestalosti parcijalnih napadaja prikazani su u 4 kategorije posve zdesna.
English: There are two ways in which you can choose to drink the medicine: - empty the contents of the syringe into water (or juice) by pushing the plunger to the bottom of the oral syringe (figure 11) - you will then need to drink all of the water (add just enough to make it easy to drink) or - drink the solution directly from the oral syringe without water - drink the whole contents of the syringe (figure 12).
Croatian: (slika 11) - zatim ćete trebati popiti svu vodu (dodajte točno onoliko koliko je dovoljno da se lako popije) ili - popijte otopinu izravno iz štrcaljke za usta bez vode - popijte cijeli sadržaj štrcaljke (slika 12).
English: In the open label, uncontrolled, long-term studies suicidal ideation was reported in 4.7 % of paediatric patients (more common in adolescents) compared with 2.4 % of adults and behavioural disorders were reported in 24.8 % of paediatric patients compared with 15.1 % of adults.
Croatian: U otvorenom, nekontroliranom dugoročnom ispitivanju suicidalna ideacija bila je prijavljena u 4,7 % pedijatrijskih bolesnika (učestalija u adolescenata) u usporedbi s 2,4 % u odraslih bolesnika, a bihevioralni poremećaji bili su prijavljeni u 24,8 % pedijatrijskih bolesnika u usporedbi s 15,1 % odraslih bolesnika.
English: No clinical data are available in paediatric patients with hepatic impairment.
Croatian: Nisu dostupni klinički podaci za pedijatrijske bolesnike s oštećenjem jetre.
English: In juvenile rats, brivaracetam exposure levels 6- to 15-fold the clinical AUC exposure at the maximum recommended dose induced developmental adverse effects (i.e. mortality, clinical signs, decreased body weight and lower brain weight).
Croatian: U juvenilnih štakora, razine izloženosti brivaracetamu koje su 6 do 15 puta veće od izloženosti koja se postiže uz klinički AUC nakon primjene maksimalne preporučene doze inducirale su štetne učinke na razvoj (tj. smrtnost, kliničke znakove, smanjenje tjelesne težine i smanjenje težine mozga).
English: Brivaracetam may also be initiated at 2 mg/kg/day based on physician assessment of need for seizure control.
Croatian: Brivaracetam se također može uvesti u dozi od 2 mg/kg/dan na osnovi procjene liječnika o potrebi za kontrolom napadaja.
English: In clinical studies, a reduction in seizure frequency over placebo was higher with the dose of 100 mg/day than with 50 mg/day.
Croatian: U kliničkim je ispitivanjima smanjenje učestalosti napadaja u odnosu na placebo bilo veće uz dozu od 100 mg/dan nego uz dozu od 50 mg/dan.
English: 1 mg/kg/day (or 2 mg/kg/day)*
Croatian: 1 mg/kg/dan (ili 2 mg/kg/dan)*
English: The other ingredients are: sodium acetate (trihydrate), acetic acid, glacial, sodium chloride, water for injection.
Croatian: Drugi sastojci su: natrijev acetat (trihidrat), ledena acetatna kiselina, natrijev klorid, voda za injekcije.
English: Potential interactions between brivaracetam (50 mg/day to 200 mg/day) and other AEDs were investigated in a pooled analysis of plasma drug concentrations from all phase 2-3 studies, in a population pharmacokinetic analysis of placebo-controlled phase 2-3 studies, and in dedicated drugdrug interaction studies (for the following AEDs: carbamazepine, lamotrigine, phenytoin and topiramate).
Croatian: Moguće interakcije između brivaracetama (50 mg/dan do 200 mg/dan) i drugih antiepileptika ocjenjivale su se u analizi objedinjenih podataka o plazmatskim koncentracijama lijekova iz svih ispitivanja faze 2/3, u populacijskoj farmakokinetičkoj analizi placebom kontroliranih ispitivanja faze 2/3 te u posebnim ispitivanjima interakcija između lijekova (za sljedeće antiepileptike: karbamazepin, lamotrigin, fenitoin i topiramat).
English: In juvenile dogs, the brivaracetam-induced changes at the exposure level 6- fold the clinical AUC were similar to those observed in adult animals.
Croatian: U juvenilnih su pasa promjene inducirane brivaracetamom pri razini izloženosti koja je 6 puta veća od one koja se postiže uz klinički AUC bile slične onima primijećenima u odraslih životinja.
English: Further seizure frequency reduction is obtained by increasing the dose to 100 mg/day and reaches a plateau at 200 mg/day.
Croatian: Daljnje smanjenje učestalosti napadaja postiže se povećanjem doze na 100 mg/dan, te dostiže plato pri dozi od 200 mg/dan.
English: Briviact with alcohol - Combining this medicine with alcohol is not recommended.
Croatian: Ne preporučuje se kombinirati ovaj lijek s alkoholom.
English: Animal studies did not detect any teratogenic potential of brivaracetam (see section 5.3).
Croatian: Ispitivanja na životinjama nisu utvrdila teratogeni potencijal brivaracetama (vidjeti dio 5.3).
English: The 10 ml oral syringe has only one graduation in steps of 0.25 ml.
Croatian: Štrcaljka za usta zapremnine 10 ml ima samo jedno graduiranje u koracima od 0,25 ml.
English: The dose should be administered in two equally divided doses, once in the morning and once in the evening.
Croatian: Dozu treba davati u dvije jednako podijeljene doze, jednu ujutro i jednu navečer.
English: Brivaracetam may also be initiated at 100 mg/day based on physician assessment of need for seizure control.
Croatian: Brivaracetam se također može uvesti u dozi od 100 mg/dan na osnovi procjene liječnika o potrebi za kontrolom napadaja.
English: When tested in vitro brivaracetam did not induce CYP1A1/2 but induced CYP3A4 and CYP2B6.
Croatian: Kada se ispitivao in vitro, brivaracetam nije inducirao CYP1A1/2, ali je inducirao CYP3A4 i CYP2B6.
English: Study N01253
Croatian: Ispitivanje br. 1253
English: - Then take your next dose at the time you would normally take it. - Do not take a double dose to make up for a forgotten dose.
Croatian: - Nemojte uzeti dvostruku dozu kako biste nadoknadili zaboravljenu dozu.
English: The 5 ml oral syringe has 2 overlapping graduations: in steps of 0.25 ml and in steps of 0.1 ml.
Croatian: Štrcaljka za usta zapremnine 5 ml ima 2 preklapajuća graduiranja: u koracima od 0,25 ml i u koracima od 0,1 ml.
English: Two oral syringes (5 ml and 10 ml) are included in the carton.
Croatian: Dvije štrcaljke za usta (5 ml i 10 ml) priložene su u kutiju.
English: Brivaracetam is cleared by multiple pathways including renal excretion, non-CYP-mediated hydrolysis and CYP-mediated oxidations.
Croatian: Brivaracetam se eliminira kroz nekoliko različitih putova, koji uključuju izlučivanje putem bubrega, hidrolizu koja nije posredovana CYP enzimima te oksidacije posredovane CYP enzimima.
English: - Intravenous bolus: brivaracetam may be administered as an intravenous bolus without dilution.
Croatian: - Intravenska bolusna injekcija: brivaracetam se može primijeniti kao intravenska bolusna injekcija bez razrjeđivanja.
English: The most frequently reported adverse reactions (>10%) with brivaracetam treatment were: somnolence (14.3 %) and dizziness (11.0 %).
Croatian: Najčešće prijavljene nuspojave (> 10%) kod liječenja brivaracetamom bile su somnolencija (14,3%) i omaglica (11,0%).
English: Effects of brivaracetam on other medicinal products Brivaracetam given 50 or 150 mg/day did not affect the AUC of midazolam (metabolised by CYP3A4).
Croatian: Brivaracetam u dozi od 50 ili 150 mg/dan nije utjecao na AUC midazolama (koji se metabolizira putem enzima CYP3A4).
English: • Packs of 14, 56 film-coated tablets and in multipacks containing 168 (3 packs of 56) filmcoated tablets in PVC/PCTFE - Aluminium blisters
Croatian: • Pakiranja od 14 i 56 filmom obloženih tableta i višestruka pakiranja koja sadrže 168 (3 pakiranja od 56) filmom obloženih tableta u PVC/PCTFE-aluminij blisterima
English: In vitro, brivaracetam is not a substrate of human Pglycoprotein (P-gp), multidrug resistance proteins (MRP) 1 and 2, and likely not organic anion transporter polypeptide 1B1 (OATP1B1) and OATP1B3.
Croatian: In vitro, brivaracetam nije supstrat ljudskog P-glikoproteina (P-gp) ni proteina rezistencije na više lijekova (engl. multidrug resistance proteins, MRP) 1 i 2, te vjerojatno ni prijenosnog polipeptida organskih aniona 1B1 (OATP1B1) i OATP1B3.
English: - Take the oral syringe out of the adaptor (figure 10).
Croatian: - Izvadite štrcaljku za usta iz nastavka (slika 10).
English: In controlled studies, the carbamazepine epoxide plasma concentration increased by a mean of 37 %, 62 % and 98 % with little variability at brivaracetam doses of 50 mg/day, 100 mg/day and 200 mg/day respectively.
Croatian: U kontroliranim se ispitivanjima plazmatska koncentracija karbamazepin epoksida povećala za srednju vrijednost od 37%, 62% i 98% uz primjenu brivaracetama u dozi od 50 mg/dan, 100 mg/dan odnosno 200 mg/dan, uz malu varijabilnost.
English: Improvement in the median percent reduction in seizure frequency per 28 days has been observed in patients with type IC seizure (secondary generalized tonic-clonic seizures) at baseline treated with brivaracetam (66.6 % (n=62), 61.2 % (n=100) and 82.1 % (n=75) of the patients on brivaracetam 50 mg/day, 100 mg/day and 200 mg/day respectively as compared to placebo 33.3 % (n=115)).
Croatian: Poboljšanje medijana postotnog smanjenja učestalosti napadaja tijekom 28 dana među bolesnicima koji su na početku ispitivanja imali napadaje tipa IC (sekundarno generalizirani toničko-klonički napadaji) primijećeno je u (66,6% (n=62), 61,2% (n=100) i 82,1% (n=75) bolesnika liječenih brivaracetamom u dozi od 50 mg/dan, 100 mg/dan odnosno 200 mg/dan, u odnosu na 33,3% (n=115)) bolesnika koji su primali placebo.
English: Pharmacokinetic/pharmacodynamics relationship
Croatian: Farmakokinetički/farmakodinamički odnos
English: Carbamazepine - None Carbamazepine-epoxide ↑ (See below)
Croatian: Karbamazepin - nema Karbamazepin-epoksid ↑ (Vidjeti u nastavku) Nije potrebno prilagođavati dozu.
English: - Open the bottle: press the cap and turn it anti-clockwise (figure 1).
Croatian: - Otvorite bocu: pritisnite zatvarač i okrenite ga u smjeru suprotnom od kazaljke na satu (slika
English: Influence of brivaracetam on AED plasma concentration
Croatian: Utjecaj brivaracetama na plazmatsku koncentraciju antiepileptika
English: n = randomised patients who received at least 1 dose of study medication ~ Dose not studied
Croatian: = randomizirani bolesnici koji su primili najmanje 1 dozu ispitivanog lijeka ~ Doza na kojoj nije provedeno ispitivanje * Statistički značajno
English: Effects of other agents on the pharmacokinetics of brivaracetam In vitro data suggest that brivaracetam has a low interaction potential.
Croatian: In vitro podaci ukazuju na to da brivaracetam ima nizak interakcijski potencijal.
English: Overall, brivaracetam was efficacious for the adjunctive treatment of partial onset seizures in patients 16 years of age and older between 50 mg/day and 200 mg/day.
Croatian: Sveukupno se brivaracetam pokazao djelotvornim kao dodatna terapija u liječenju parcijalnih nastupa napadaja u bolesnika u dobi od 16 ili više godina u dozama od 50 mg/dan do 200 mg/dan.
English: Embryotoxicity was observed in rabbits at a maternal toxic dose of brivaracetam with an exposure level 8-fold the clinical AUC exposure at the maximum recommended dose.
Croatian: U kunića je primijećena embriotoksičnost pri dozama brivaracetama koje su bile toksične za majku i kojima se postizala izloženost 8 puta veća od izloženosti koja se postiže uz klinički AUC nakon primjene maksimalne preporučene doze.
English: The recommended maintenance dose is 2 mg/kg/day.
Croatian: Preporučena doza održavanja je 2 mg/kg/dan.
English: UNIQUE IDENTIFIER - 2D BARCODE Not Applicable.
Croatian: JEDINSTVENI IDENTIFIKATOR - 2D BARKOD Nije primjenjivo.
English: 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 .
Croatian: Primarni ishod za ispitivanje br. 1252 nije postigao statističku značajnost prema sekvencijalnom testu.
English: briviact 10 mg/ml (Only for outer carton)
Croatian: briviact 10 mg/ml (samo za kutiju)
English: As in adults, brivaracetam solution for injection/infusion is an alternative route of administration for patients when oral administration is temporarily not feasible.
Croatian: Kao u odraslih, brivaracetam otopina za injekciju/infuziju predstavlja zamjensku opciju za primjenu u bolesnika u kojih peroralna primjena privremeno nije moguća.
English: When brivaracetam was coadministered at a dose of 400 mg/day (twice the recommended maximum daily dose) with an oral contraceptive containing ethinylestradiol (0.03 mg) and levonorgestrel (0.15 mg), a reduction in estrogen and progestin AUCs of 27 % and 23 %, respectively, was observed without impact on suppression of ovulation.
Croatian: Kada se brivaracetam u dozi od 400 mg/dan (doza dvostruko veća od preporučene maksimalne dnevne doze) primjenjivao istodobno s oralnim kontraceptivom koji je sadržavao etinilestradiol (0,03 mg) i levonorgestrel (0,15 mg), primijećeno je smanjenje AUC-a estrogena za 27% i AUC-a progestagena za 23%, ali to nije utjecalo na supresiju ovulacije.
English: None a based on a study involving the administration of a supratherapeutic dose of 400 mg/day brivaracetam.
Croatian: Temeljeno na ispitivanju koje uključuje primjenu supraterapijske doze od 400 mg/dan brivaracetama.
English: In a pooled analysis of the three pivotal trials, no differences in efficacy (measured as 50 % responder rate) was observed within the dose range of 50 mg/day to 200 mg/day when brivaracetam is combined with inducing or non-inducing AEDs.
Croatian: U analizi objedinjenih podataka iz triju pivotalnih ispitivanja nisu primijećene razlike u djelotvornosti (koja se određivala kao stopa bolesnika s odgovorom od 50%) unutar raspona doza od 50 mg/dan do 200 mg/dan kada se brivaracetam kombinirao s inducirajućim ili neinducirajućim antiepilepticima.
English: There is limited clinical experience with brivaracetam overdose in humans.
Croatian: Kliničko iskustvo s predoziranjem brivaracetamom u ljudi je ograničeno.
English: 50 - 200 mg/day
Croatian: 50 - 200 mg/dan
English: Brivaracetam may be initiated with either intravenous or oral administration.
Croatian: Liječenje brivaracetamom može se započeti intravenskom ili peroralnom primjenom.
English: No human data on the effect of brivaracetam on fertility are available.
Croatian: Nema dostupnih podataka o utjecaju brivaracetama na plodnost ljudi.
English: Brivaracetam may increase plasma concentrations of medicinal products metabolised by CYP2C19 (e.g. lanzoprazole, omeprazole, diazepam).
Croatian: Brivaracetam može povisiti plazmatsku koncentraciju lijekova metaboliziranih enzimom CYP2C19 (npr. lanzoprazola, omeprazola, diazepama).
English: The recommended maintenance dose is 100 mg/day.
Croatian: Preporučena doza održavanja je 100 mg/dan.
English: The daily dose of brivaracetam ranged from 5 to 200 mg/day across these studies.
Croatian: Dnevna doza brivaracetama u tim se ispitivanjima kretala u rasponu od 5 do 200 mg/dan.
English: Briviact solution for injection/infusion contains 0.83 mmol (or 19.14 mg) sodium per vial.
Croatian: Briviact otopina za injekciju/infuziju sadrži 0,83 mmol (ili 19,14 mg) natrija po bočici.
English: 300 ml amber glass bottle (type III) with a white child resistant closure (polypropylene) in a box also containing a 5 ml and 10 ml graduated oral dosing syringe (polypropylene, polyethylene) and an adaptor for the syringe (polyethylene).
Croatian: Smeđa staklena boca od 300 ml (staklo tipa III) s bijelim zatvaračem sigurnim za djecu (polipropilen), u kutiji koja sadrži i graduiranu štrcaljku za usta od 5 ml i 10 ml (polipropilen, polietilen) te nastavak za štrcaljku (polietilen).