natgillin/translations-raw huggingface dataset:
Briviact tablets are packaged in blister packs supplied in cardboard boxes containing either 14, 56, 14 x 1 or 100 x 1 film-coated tablets or in multipacks containing 168 (3 packs of 56) film-coated tablets.
Briviact tablete zapakirane su u blister pakiranja uložena u kutije koje sadrže 14, 56, 14 x 1 ili 100 x 1 filmom obloženu tabletu ili višestruka pakiranja koja sadrže 168 (3 pakiranja od 56) filmom obloženih tableta.
Adverse reactions from clinical trials
Nuspojave u kliničkim ispitivanjima
Physicians should discuss family planning and contraception with women of childbearing potential taking brivaracetam (see Pregnancy).
Liječnici moraju razgovarati sa ženama reproduktivne dobi koje uzimaju brivaracetam o planiranju obitelji i kontracepciji (vidjeti odlomak „Trudnoća“).
In rats, brivaracetam was shown to readily cross the placenta and to be excreted in milk of lactating rats with concentrations similar to maternal plasma levels.
U štakora se pokazalo da brivaracetam prolazi kroz posteljicu i da se izlučuje u mlijeko ženki štakora u laktaciji u koncentracijama sličnima majčinim plazmatskim vrijednostima.
Brivaracetam displays a high and selective affinity for synaptic vesicle protein 2A (SV2A), a transmembrane glycoprotein found at presynaptic level in neurons and in endocrine cells.
Brivaracetam pokazuje visok i selektivan afinitet za protein sinaptičkih vezikula 2A (engl. synaptic vesicle protein 2A, SV2A), transmembranski glikoprotein koji se nalazi na presinaptičkoj razini u neuronima i endokrinim stanicama.
The following table summarises the recommended posology for children from 4 years of age and adolescents.
Sljedeća tablica daje sažetak preporučenog doziranja za djecu od navršenih 4 godina života i adolescente.
Follow these steps the first time you take Briviact: - Take off the adaptor from the oral syringe (figure 2).
Slijedite ove upute kada prvi put uzimate Briviact: - Skinite nastavak sa štrcaljke za usta (slika 2).
Brivaracetam 200mg/day may increase plasma concentrations of medicinal products transported by OAT3.
Brivaracetam u dozi od 200 mg/dan može povisiti plazmatsku koncentraciju lijekova koje prenosi OAT3.
AUC 19 % ↓ No dose adjustment required
AUC 19 % ↓ Nije potrebno prilagođavati dozu
Therapeutic dose range
Raspon terapijskih doza
AUC 21 % ↓ No dose adjustment required
AUC 21 % ↓ Nije potrebno prilagođavati dozu
In vitro, Brivaracetam inhibits OAT3 with a half maximal inhibitory concentration 42-fold higher than the Cmax at the highest clinical dose.
In vitro, brivaracetam inhibira OAT3 s polovicom maksimalne inhibitorne koncentracije 42 puta većom od Cmax pri najvećoj kliničkoj dozi.
Do not use Briviact if: - you are allergic to brivaracetam, other pyrrolidone derivatives or any of the other ingredients of this medicine (listed in section 6).
Nemojte primjenjivati Briviact: - ako ste alergični na brivaracetam, druge pirolidonske derivate ili neki drugi sastojak ovog lijeka (naveden u dijelu 6.).
What Briviact contains
Što Briviact sadrži
Figure 1 shows the percentage of patients (excluding patients with concomitant levetiracetam) by category of reduction from baseline in POS frequency per 28 days in all 3 studies.
Slika 1 prikazuje postotak bolesnika (osim onih istodobno liječenih levetiracetamom) prema kategoriji smanjenja učestalosti parcijalnih napadaja tijekom 28 dana u odnosu na početnu vrijednost u sva 3 ispitivanja.
- The recommended dose is from 0.5 mg to 2 mg for each kg of bodyweight, taken twice a day.
- Preporučena doza iznosi od 0,5 mg do 2 mg po kilogramu tjelesne težine, uzimana dvaput dnevno.
In monkeys, CNS signs (prostrate, loss of balance, clumsy movements) occurred at 64 fold the clinical Cmax, these effects being less apparent over time.
U majmuna su znakovi u SŽS-u (prostracija, gubitak ravnoteže, nespretni pokreti) primijećeni kod primjene doze 64 puta veće od kliničke vrijednosti Cmax, ali su oni s vremenom postajali manje primjetni.
The adverse reactions most frequently resulting in discontinuation of brivaracetam therapy were dizziness (0.8 %) and convulsion (0.8 %).
Nuspojave koje su najčešće uzrokovale prekid liječenja brivaracetamom bile su omaglica (0,8%) i konvulzija (0,8%).
Brivaracetam exhibits linear and time-independent pharmacokinetics with low intra- and inter-subject variability, and features complete absorption, very low protein binding, renal excretion following extensive biotransformation, and pharmacologically inactive metabolites.
Brivaracetam pokazuje linearnu farmakokinetiku neovisnu o vremenu, uz malu intraindividualnu i interindividualnu varijabilnost, a karakterizira je potpuna apsorpcija, vrlo nizak stupanj vezanja za proteine, izlučivanje putem bubrega nakon opsežne biotransformacije te farmakološki neaktivni metaboliti.
There is no specific antidote for overdose with brivaracetam.
Nema specifičnog protulijeka za predoziranje brivaracetamom.
Additional graduations at 0.25 ml and 0.75 ml starting at 0.25 ml up to 5 ml are shown.
Prikazani su dodatni gradusi od 0,25 ml i 0,75 ml, počevši od 0,25 ml do 5 ml.
Following dilution, brivaracetam solution for injection/infusion was found to be physically compatible and chemically stable when mixed with the diluents listed in the section 6.6 for 24 hours and stored in PVC or polyolefin bags at temperature up to 25°C.
Nakon razrjeđivanja, otopina brivaracetama za injekciju/infuziju pomiješana sa sredstvima za razrjeđivanje navedenima u dijelu 6.6 fizički je kompatibilna i kemijski stabilna 24 sata kada se čuva u PVC ili poliolefinskim vrećicama na temperaturi do 25°C.
Brivaracetam is rapidly and completely absorbed after oral administration and the absolute bioavailablity is approximately 100 %.
Brivaracetam se nakon peroralne primjene brzo i potpuno apsorbira, uz apsolutnu bioraspoloživost od približno 100%.
The steady-state plasma clearance of brivaracetam was similar (0.76 ml/min/kg) to young healthy male subjects (0.83 ml/min/kg) (see section 4.2).
Plazmatski klirens brivaracetama u stanju dinamičke ravnoteže bio je sličan (0,76 ml/min/kg) onom u mladih, zdravih ispitanika muškog spola (0,83 ml/min/kg) (vidjeti dio 4.2).
The oral solution contains methyl parahydroxybenzoate (E218), which may cause allergic reactions (possibly delayed).
Oralna otopina sadrži metilparahidroksibenzoat (E218), koji može uzrokovati alergijske reakcije (koje mogu biti odgođene).
Children who directly enrolled received a brivaracetam starting dose of 1 mg/kg/day and depending on response and tolerability, the dose was increased up to 5 mg/kg/day by doubling the dose at weekly intervals.
Djeca koja su se izravno uključila primala su početnu dozu brivaracetama od 1 mg/kg/dan i, ovisno o odgovoru i podnošljivosti, doza se povećavala do 5 mg/kg/dan udvostručavanjem doze u tjednim intervalima.
Solution for injection/infusion (injection/infusion) Clear, colourless, solution.
Otopina za injekciju/infuziju (injekcija/infuzija) Bistra, bezbojna otopina.
Any unused medicinal product, neat or diluted, or waste material should be disposed of in accordance with local requirements.
Neiskorišteni lijek, čist ili razrijeđen, ili otpadni materijal potrebno je zbrinuti sukladno nacionalnim propisima.
It is recommended to parent and care giver to administer Briviact oral solution with the measuring device (10 ml or 5 ml oral dosing syringe) provided in the carton box.
Preporuča se roditelju i davatelju skrbi primjenjivati oralnu otopinu Briviacta s mjernim pomagalom (štrcaljka s dozatorom od 10 ml ili 5 ml), priloženim u kartonskoj kutiji.
A study in subjects with severe renal impairment (creatinine clearance <30 ml/min/1.73 m² and not requiring dialysis) revealed that the plasma AUC of brivaracetam was moderately increased (+21 %) relative to healthy controls, while the AUC of the acid, hydroxy and hydroxyacid metabolites were increased 3-, 4-, and 21-fold, respectively.
Ispitivanje provedeno u ispitanika s teškim oštećenjem bubrežne funkcije (klirens kreatinina < 30 ml/min/1,73 m bez potrebe za dijalizom) pokazalo je da je plazmatski AUC brivaracetama bio umjereno povišen (+21%) u odnosu na zdrave kontrolne ispitanike, dok je AUC kiselog, hidroksi i hidroksikiselog metabolita bio povećan 3, 4 odnosno 21 puta.
Ireland UCB (Pharma) Ireland Ltd.
UCB (Pharma) Ireland Ltd.
Coadministration with a high-fat meal slowed down the absorption rate (median tmax 3 h) and decreased the maximum plasma concentration (37 % lower) of brivaracetam, while the extent of absorption remained unchanged.
Primjena uz obrok s visokim udjelom masnoća usporila je brzinu apsorpcije (medijan tmax iznosio je 3 sata) i snizila maksimalnu plazmatsku koncentraciju brivaracetama (za 37%), dok je opseg apsorpcije ostao nepromijenjen.
Recommended maintenance dose
Preporučena početna doza
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.
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.
What you need to know before you take Briviact 3.
Što morate znati prije nego počnete uzimati Briviact 3.
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).
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).
How long to take Briviact for
Koliko dugo uzimati Briviact
Children (≥4 years) and adolescents <50 kg
Djeca (≥4 godine) i adolescenti <50 kg
No CYP3A4 induction was found in vivo (see midazolam above).
Nije utvrđena indukcija enzima CYP3A4 in vivo (vidjeti prethodno navedene informacije za midazolam).
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.
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.
In case of co-administration of brivaracetam and carbamazepine, the amount of carbamazepine-epoxide excreted in breast milk could increase.
U slučaju istodobne primjene brivaracetama i karbamazepina, može se povećati količina karbamazepin-epoksida koja se izlučuje u majčino mlijeko.
In vitro interaction studies to determine the potential inhibitory effects on transporters concluded that there were no clinically relevant effects, except for OAT3.
Ispitivanja interakcija provedena radi utvrđivanja potencijalnih inhibitornih učinaka na prijenosnike zaključila su da nema klinički značajnih učinaka, osim za OAT3.
Brivaracetam has not been studied in patients undergoing hemodialysis (see section 4.2).
Brivaracetam se nije ispitivao u bolesnika na hemodijalizi (vidjeti dio 4.2).
In vitro studies have shown that brivaracetam exhibits little or no inhibition of CYP450 isoforms except for CYP2C19.
Ispitivanja in vitro pokazala su da brivaracetam ostvaruje neznatnu ili nikakvu inhibiciju izooblika enzima CYP450 osim za enzim CYP2C19.
Brivaracetam plasma concentrations are decreased when coadministered with strong enzyme inducing AEDs (carbamazepine, phenobarbital, phenytoin) but no dose adjustment is required (see table 1).
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).
Currently, no clinical data are available in neonates.
Trenutno, nema dostupnih kliničkih podataka za novorođenčad.
OUTER CARTON / BOTTLE
KUTIJA / BOCA
What you need to know before you take Briviact
Što morate znati prije nego počnete primjenjivati Briviact
To be taken into consideration for patients on a controlled sodium diet.
To treba uzeti u obzir u bolesnika koji su na dijeti s kontroliranim unosom natrija.
No dose adjustment required
Nije potrebno prilagođavati dozu
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.
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.
Four of these subjects had decreased neutrophil counts at baseline, and experienced additional decrease in neutrophil counts after initiation of brivaracetam treatment.
Četiri od tih ispitanika imala su smanjen broj neutrofila već na početku ispitivanja, koji se zatim dodatno smanjio nakon početka liječenja brivaracetamom.
If you have been told by your doctor that you cannot tolerate or digest some sugars, contact your doctor before taking this medicine.
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.
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.
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.
14 film-coated tablets 56 film-coated tablets 100 x 1 film-coated tablet 14 x 1 film-coated tablet
14 filmom obloženih tableta 56 filmom obloženih tableta 100 x 1 filmom obložena tableta 14 x 1 filmom obložena tableta
The total plasma clearance in patients was estimated to 3.6 L/h.
Procjenjuje se da ukupan plazmatski klirens u bolesnika iznosi 3,6 l/h.
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.
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.
- If you weigh less than 20 kg, you should use the 5 ml oral syringe provided in the carton to ensure accurate dosing.
- 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.
In vitro, interaction studies to determine the potential inhibitory effects on transporters concluded that there were no clinically relevant effects, except for OAT3.
Ispitivanja interakcija in vitro provedena radi utvrđivanja potencijalnih inhibitornih učinaka na prijenosnike zaključila su da nema klinički značajnih učinaka, osim za OAT3.
Study N01252
Ispitivanje br. 1252
OUTER CARTON OF MULTIPACK (WITH BLUE BOX)
KUTIJA VIŠESTRUKOG PAKIRANJA (S PLAVIM OKVIROM)
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.
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).
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 %.
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%.
Patients with an improvement in percent reduction in baseline POS frequency are shown in the 4 right-most categories.
Bolesnici koji su ostvarili poboljšanje u vidu smanjenja početne učestalosti parcijalnih napadaja prikazani su u 4 kategorije posve zdesna.
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).
(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).
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.
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.
No clinical data are available in paediatric patients with hepatic impairment.
Nisu dostupni klinički podaci za pedijatrijske bolesnike s oštećenjem jetre.
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).
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).
Brivaracetam may also be initiated at 2 mg/kg/day based on physician assessment of need for seizure control.
Brivaracetam se također može uvesti u dozi od 2 mg/kg/dan na osnovi procjene liječnika o potrebi za kontrolom napadaja.
In clinical studies, a reduction in seizure frequency over placebo was higher with the dose of 100 mg/day than with 50 mg/day.
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.
1 mg/kg/day (or 2 mg/kg/day)*
1 mg/kg/dan (ili 2 mg/kg/dan)*
The other ingredients are: sodium acetate (trihydrate), acetic acid, glacial, sodium chloride, water for injection.
Drugi sastojci su: natrijev acetat (trihidrat), ledena acetatna kiselina, natrijev klorid, voda za injekcije.
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).
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).
In juvenile dogs, the brivaracetam-induced changes at the exposure level 6- fold the clinical AUC were similar to those observed in adult animals.
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.
Further seizure frequency reduction is obtained by increasing the dose to 100 mg/day and reaches a plateau at 200 mg/day.
Daljnje smanjenje učestalosti napadaja postiže se povećanjem doze na 100 mg/dan, te dostiže plato pri dozi od 200 mg/dan.
Briviact with alcohol - Combining this medicine with alcohol is not recommended.
Ne preporučuje se kombinirati ovaj lijek s alkoholom.
Animal studies did not detect any teratogenic potential of brivaracetam (see section 5.3).
Ispitivanja na životinjama nisu utvrdila teratogeni potencijal brivaracetama (vidjeti dio 5.3).
The 10 ml oral syringe has only one graduation in steps of 0.25 ml.
Štrcaljka za usta zapremnine 10 ml ima samo jedno graduiranje u koracima od 0,25 ml.
The dose should be administered in two equally divided doses, once in the morning and once in the evening.
Dozu treba davati u dvije jednako podijeljene doze, jednu ujutro i jednu navečer.
Brivaracetam may also be initiated at 100 mg/day based on physician assessment of need for seizure control.
Brivaracetam se također može uvesti u dozi od 100 mg/dan na osnovi procjene liječnika o potrebi za kontrolom napadaja.
When tested in vitro brivaracetam did not induce CYP1A1/2 but induced CYP3A4 and CYP2B6.
Kada se ispitivao in vitro, brivaracetam nije inducirao CYP1A1/2, ali je inducirao CYP3A4 i CYP2B6.
Study N01253
Ispitivanje br. 1253
- 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.
- Nemojte uzeti dvostruku dozu kako biste nadoknadili zaboravljenu dozu.
The 5 ml oral syringe has 2 overlapping graduations: in steps of 0.25 ml and in steps of 0.1 ml.
Štrcaljka za usta zapremnine 5 ml ima 2 preklapajuća graduiranja: u koracima od 0,25 ml i u koracima od 0,1 ml.
Two oral syringes (5 ml and 10 ml) are included in the carton.
Dvije štrcaljke za usta (5 ml i 10 ml) priložene su u kutiju.
Brivaracetam is cleared by multiple pathways including renal excretion, non-CYP-mediated hydrolysis and CYP-mediated oxidations.
Brivaracetam se eliminira kroz nekoliko različitih putova, koji uključuju izlučivanje putem bubrega, hidrolizu koja nije posredovana CYP enzimima te oksidacije posredovane CYP enzimima.
- Intravenous bolus: brivaracetam may be administered as an intravenous bolus without dilution.
- Intravenska bolusna injekcija: brivaracetam se može primijeniti kao intravenska bolusna injekcija bez razrjeđivanja.
The most frequently reported adverse reactions (>10%) with brivaracetam treatment were: somnolence (14.3 %) and dizziness (11.0 %).
Najčešće prijavljene nuspojave (> 10%) kod liječenja brivaracetamom bile su somnolencija (14,3%) i omaglica (11,0%).
Effects of brivaracetam on other medicinal products Brivaracetam given 50 or 150 mg/day did not affect the AUC of midazolam (metabolised by CYP3A4).
Brivaracetam u dozi od 50 ili 150 mg/dan nije utjecao na AUC midazolama (koji se metabolizira putem enzima CYP3A4).
• Packs of 14, 56 film-coated tablets and in multipacks containing 168 (3 packs of 56) filmcoated tablets in PVC/PCTFE - Aluminium blisters
• 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
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.
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.