natgillin/translations-raw huggingface dataset:
All doses were adjusted by body weight, and did not exceed a maximum of 50 mg/day, 100 mg/day, and 200 mg/day.
Vsi odmerki so bili prilagojeni na telesno maso in niso presegli največjega odmerka 50 mg/dan, 100 mg/dan in 200 mg/dan.
This may avoid the brivaracetam plasma concentration falling below the efficacy level and prevent breakthrough seizures from occurring.
S tem se je mogoče izogniti padcu plazemske koncentracije brivaracetama pod raven učinkovitosti in preprečiti pojav prebojnih epileptičnih napadov.
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.
Brivaracetam in vitro ni substrat za človeški P-glikoprotein (P-gp), proteine odporne proti večim učinkovinam 1 in 2 in verjetno ne za organski anionski prenašalni polipeptid 1B1 (OATP1B1) in OATP1B3.
Brivaracetam did not affect male or female fertility and has demonstrated no teratogenic potential in either rat or rabbit.
Brivaracetam ni vplival na plodnost samcev ali samic ter pri podganah in kuncih ni kazal teratogenega potenciala.
Very common: may affect more than 1 in 10 people - feeling sleepy or dizzy
Zelo pogosti: pojavijo se lahko pri več kot 1 od 10 bolnikov - občutek zaspanosti ali omotice
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.
Embriotoksičnost so opazili pri kuncih pri za mater toksičnem odmerku brivaracetama, pri čemer je bila raven izpostavljenosti 8-kratnik klinične izpostavljenosti AUC pri največjem priporočenem odmerku.
Excipient(s) with known effect: Each ml of solution for injection/infusion contains 3.8 mg sodium.
Pomožne snovi z znanim učinkom: En ml raztopine za injiciranje/infundiranje vsebuje 3,8 mg natrija.
It is unknown whether brivaracetam is excreted in human breast milk.
Ni znano, ali se brivaracetam izloča v materino mleko.
10 ml oral syringe provided in the carton to ensure accurate dosing.
10-ml peroralno brizgo, priloženo v škatli, da zagotovite natančno odmerjanje.
Study N01252
Študija N01252
No additional safety or tolerability concern was observed (see section 5.1).
Prav tako niso ugotovili dodatnih zadržkov glede varnosti in prenašanja zdravila (glejte poglavje 5.1).
A maximum daily dose of 150 mg administered in 2 divided doses is recommended for all stages of hepatic impairment (see section 4.4 and 5.2).
Za vse stopnje okvare jeter je priporočen največji dnevni odmerek 150 mg, razdeljen v 2 enaka odmerka (glejte poglavji 4.4 in 5.2).
This helps to stop your fits coming back or getting worse.
Tako boste preprečili, da bi se epileptični napadi vrnili ali poslabšali.
The most commonly taken AEDs at the time of study entry were carbamazepine (40.6 %), lamotrigine (25.2 %), valproate (20.5 %), oxcarbazepine (16.0 %), topiramate (13.5 %), phenytoin (10.2 %) and levetiracetam (9.8 %).
V času študije so najpogosteje jemali karbamazepin (40,6 %), lamotrigin (25,2 %), valproat (20,5 %), okskarbazepin (16,0 %), topiramat (13,5 %), fenitoin (10,2 %) in levetiracetam (9,8 %).
Based on data in adults, no dose adjustment is necessary in paediatric patients with impaired renal function.
Na podlagi podatkov pri odraslih prilagajanje odmerka pri pediatričnih bolnikih z okvarjenim delovanjem ledvic ni potrebno.
(Omitted from cartons of 14 film-coated tablets)
(Izpuščeno na zloženkah s 14 filmsko obloženimi tabletami)
Each ml of oral solution contains 239.8 mg sorbitol (E420), 1mg methyl parahydroxybenzoate (E218) and 1.16 mg sodium.
En ml peroralne raztopine vsebuje 239,8 mg sorbitola (E420), 1 mg metilparahidroksibenzoata (E218) in 1,16 mg natrija.
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.
Farmakokinetična študija pri preskušancih s cirozo jeter (stopnja Child-Pugh A, B in C) je pokazala podobna povečanja izpostavljenosti brivaracetamu ne glede na resnost bolezni (50 %, 57 % in 59 %) v primerjavi z ustreznimi zdravimi kontroliranimi preskušanci (glejte poglavje 4.2).
14 film-coated tablets 56 film-coated tablets 100 x 1 film-coated tablet 14 x 1 film-coated tablet
14 filmsko obloženih tablet 56 filmsko obloženih tablet 100 x 1 filmsko obložena tableta 14 x 1 filmsko obložena tableta
There were no adverse effects in any of the standard developmental or maturation endpoints.
Pri standardnih razvojnih in zrelostnih opazovanih dogodkih ni bilo neželenih učinkov.
Briviact solution for injection/infusion can be administered as a bolus injection or as an infusion:
Briviact raztopino za injiciranje lahko dajete kot bolus ali kot infuzijo:
(Only for outer carton)
(Samo za škatlo.)
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.
V splošnem je bil brivaracetam učinkovit za dopolnilno zdravljenje parcialnih napadov pri bolnikih, starih 16 let ali več, in pri odmerkih med 50 mg/dan in 200 mg/dan.
The hydrolysis of the amide moiety leading to the carboxylic acid metabolite (34 % of the dose in urine) is supported by hepatic and extra-hepatic amidase.
Hidrolizo amidnega dela, ki vodi do presnovka v obliki karboksilne kisline (34 % odmerka v urinu), omogoča amidaza v jetrih in izven njih.
- Intravenous bolus: brivaracetam may be administered as an intravenous bolus without dilution.
- Intravenski bolus: brivaracetam lahko dajete kot intravenski bolus brez razredčenja.
When tested in vitro brivaracetam did not induce CYP1A1/2 but induced CYP3A4 and CYP2B6.
Pri testiranju in vitro brivaracetam ni induciral CYP1A1/2, ampak je induciral CYP3A4 in CYP2B6.
The adverse reactions most frequently resulting in discontinuation of brivaracetam therapy were dizziness (0.8 %) and convulsion (0.8 %).
Neželena učinka, o katerih so najpogosteje poročali pri prekinitvi zdravljenja z brivaracetamom, sta bila omotica (0,8 %) in konvulzije (0,8 %).
In case of co-administration of brivaracetam and carbamazepine, the amount of carbamazepine-epoxide excreted in breast milk could increase.
V primeru sočasnega dajanja brivaracetama in karbamazepina se lahko poveča količina karbamazepin epoksida, ki se izloča v materino mleko.
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.
Ugotovili so, da je raztopina brivaracetama za injiciranje/infundiranje po redčenju fizikalno kompatibilna in kemijsko stabilna 24 ur, če je zmešana s topili, naštetimi v poglavju 6.6, in shranjena v vrečah iz PVC-ja ali poliolefina pri temperaturi do 25 °C.
Brivaracetam is cleared by multiple pathways including renal excretion, non-CYP-mediated hydrolysis and CYP-mediated oxidations.
Brivaracetam se iz telesa čisti po več poteh, vključno z ledvičnim izločanjem, hidrolizo, ki ni posredovana s CYP, in z oksidacijami, posredovanimi s CYP.
The three metabolites are not pharmacologically active.
Noben od treh presnovkov ni farmakološko aktiven.
Binding to SV2A is believed to be the primary mechanism for brivaracetam anticonvulsant activity.
Predvideva se, da je vezava na SV2A primarni mehanizem za antikonvulzijsko aktivnost brivaracetama.
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.
Učinkovitost brivaracetama kot dopolnilnega zdravljenja parcialnih napadov so ugotovili v 3 randomiziranih, dvojno slepih s placebom nadzorovanih multicentričnih študijah s fiksnimi odmerki pri preskušancih, starih 16 let in več.
Briviact film-coated tablets contain lactose (a type of sugar).
Filmsko obložene tablete Briviact vsebujejo laktozo (vrsto sladkorja).
Upper respiratory tract infections, cough
Okužbe zgornjih dihal, kašelj
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).
Potencialne interakcije brivaracetama (od 50 mg/dan do 200 mg/dan) z drugimi antiepileptiki so preiskovali v združeni analizi plazemskih koncentracij zdravil iz vseh študij faze 2-3 v populacijski farmakokinetični analizi s placebom nadzorovanih študij faze 2-3 in v namenskih študijah interakcij med dvema zdraviloma (za naslednje antiepileptike: karbamazepin, lamotrigin, fentoin in topiramat).
Apart from dose-dependent increases in incidences of somnolence and fatigue brivaracetam 50 mg/day and 100 mg/day had a similar safety profile including CNSrelated AEs and with long-term use.
Razen povečanj incidence somnolence in utrujenosti, odvisnih od odmerka, je brivaracetam v odmerku 50 mg/dan in 100 mg/dan imel podoben varnostni profil, vključno z neželenimi učinki, povezanimi s centralnim živčnim sistemom, in dolgotrajno uporabo.
Brivaracetam is primarily metabolized by hydrolysis of the amide moiety to form the corresponding carboxylic acid (approximately 60 % the elimination), and secondarily by hydroxylation on the propyl side chain (approximately 30 % the elimination).
Brivaracetam se primarno presnavlja s hidrolizo amidnega dela, tako da tvori ustrezno karboksilno kislino (približno 60 % izločene učinkovine), in sekundarno s hidroksilacijo propilne stranske verige (približno 30 % izločene učinkovine).
Additional graduations at 0.25 ml and 0.75 ml starting at 0.25 ml up to 5 ml are shown.
Prikazane so dodatne graduacijske oznake za 0,25 ml in 0,75 ml, ki se začnejo pri 0,25 ml do 5 ml.
If you have been told by your doctor that you cannot tolerate or digest some sugars, contact your doctor before taking this medicine.
Če vam je zdravnik povedal, da ne prenašate ali prebavljate nekaterih sladkorjev, se pred uporabo tega zdravila posvetujte s svojim zdravnikom.
In juvenile dogs, the brivaracetam-induced changes at the exposure level 6- fold the clinical AUC were similar to those observed in adult animals.
Pri mladičih psov so bile spremembe, ki jih je povzročil brivaracetam s stopnjo izpostavljenosti, ki je bila 6-krat višja od klinične AUC, podobne spremembam, opaženim pri odraslih živalih.
Studies in rats have shown excretion of brivaracetam in breast milk (see section 5.3).
Študije na podganah so pokazale izločanje brivaracetama v materino mleko (glejte poglavje 5.3).
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Brivaracetam may increase plasma concentrations of medicinal products metabolised by CYP2C19 (e.g. lanzoprazole, omeprazole, diazepam).
Brivaracetam lahko poveča plazemske koncentracije učinkovin, ki se presnavljajo s CYP2C19 (npr. lansoprazol, omeprazol, diazepam).
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).
Ne jemljite zdravila Briviact: - če ste alergični na brivaracetam, druge derivate pirolidona ali katero koli sestavino tega zdravila (navedeno v poglavju 6).
The hydroxyacid metabolite did not reveal any safety concerns in non clinical studies.
Hidroksikislinski presnovek v predkliničnih študijah ni pokazal nobenih varnostnih zadržkov.
Brivaracetam was administered at weekly increasing doses of approximately 1 mg/kg/day, 2 mg/kg/day, and 4 mg/kg/day.
Brivaracetam so dajali v tedensko naraščajočih odmerkih približno 1 mg/kg/dan, 2 mg/kg/dan in 4 mg/kg/dan.
In clinical studies, a reduction in seizure frequency over placebo was higher with the dose of 100 mg/day than with 50 mg/day.
V kliničnih študijah je bilo zmanjšanje pogostnosti napadov v primerjavi s placebom večje pri odmerku 100 mg/dan kot pri odmerku 50 mg/dan.
OUTER CARTON OF MULTIPACK (WITH BLUE BOX)
ŠKATLA VEČKRATNEGA PAKIRANJA (Z MODRIM OKENCEM)
None a
Nič a
Brivaracetam may also be initiated at 2 mg/kg/day based on physician assessment of need for seizure control.
Brivaracetam je možno uvesti tudi z 2 mg/kg/dan na podlagi zdravnikove ocene potrebe po obvladovanju epileptičnih napadov.
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.
Otroci, ki so bili vključeni neposredno, so prejemali začetni odmerek brivaracetama 1 mg/kg/dan; odvisno od odziva in prenašanja so odmerek povečali do 5 mg/kg/dan s podvajanjem odmerka v tedenskih intervalih.
Two oral syringes will be provided in the carton.
V škatli sta priloženi dve peroralni brizgi.
Brivaracetam is eliminated primarily by metabolism and by excretion in the urine.
Brivaracetam se primarno izloča s presnovo in izločanjem z urinom.
AUC 19 % ↓ No dose adjustment required
AUC 19 % ↓ Prilagoditev odmerka ni potrebna.
Multipack: 168 (3 packs of 56) film-coated tablets
Večkratno pakiranje: 168 (3 pakiranja po 56) filmsko obloženih tablet
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).
Plazemski očistek brivaracetama v stanju dinamičnega ravnovesja je bil podoben (0,76 ml/min/kg) kot pri mladih zdravih moških preskušancih (0,83 ml/min/kg) (glejte poglavje 4.2).
Contains sodium acetate (trihydrate), sodium chloride.
Vsebuje natrijev acetat (trihidrat), natrijev klorid.
INTERMEDIATE CARTON WITHIN MULTIPACK (3 PACKS OF 56 FILM-COATED TABLETS) (WITHOUT BLUE BOX)
VMESNA ŠKATLA ZNOTRAJ VEČKRATNEGA PAKIRANJA (3 PAKIRANJA PO 56 FILMSKO OBLOŽENIH TABLET) (BREZ MODREGA OKENCA)
Syringe 10 ml and 5ml (as symbols - only for the outer carton)
Brizga 10 ml in 5 ml (v obliki simbola - samo za škatlo)
- At the request of the European Medicines Agency;
Posodobljen RMP je treba predložiti: • na zahtevo Evropske agencije za zdravila;
The most frequently reported adverse reactions (>10 %) with brivaracetam treatment were: somnolence (14.3 %) and dizziness (11.0 %).
Najpogosteje poročana neželena učinka (> 10 %) pri zdravljenju z brivaracetamom sta bila somnolenca (14,3 %) in omotica (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 v odmerku 50 ali 150 mg/dan ni vplival na AUC midazolama (ki ga presnavlja CYP3A4).
Brivaracetam may also be initiated at 100 mg/day based on physician assessment of need for seizure control.
Brivaracetam je možno uvesti tudi s 100 mg/dan na podlagi zdravnikove ocene potrebe po obvladovanju epileptičnih napadov.
The 5 ml oral syringe has 2 overlapping graduations: in steps of 0.25 ml and in steps of 0.1 ml.
5-ml peroralna odmerna brizga ima 2 prekrivajoči se graduaciji: v korakih po 0,25-ml in v korakih po 0,1 ml.
In adults, a 50 mg/day starting dose should be considered.
Pri odraslih je treba razmisliti o začetnem odmerku 50 mg/dan.
Two oral syringes (5 ml and 10 ml) are included in the carton.
V škatli sta priloženi dve peroralni brizgi (5 ml in 10 ml).
- Periodic safety update reports
• Redno posodobljena poročila o varnosti zdravila (PSUR)
- You can switch between taking Briviact orally to the solution for injection/infusion, and the other way around.
- Lahko prehajate iz peroralnega jemanja zdravila Briviact na raztopino za injiciranje in obratno.
Any unused medicinal product, neat or diluted, or waste material should be disposed of in accordance with local requirements.
Neuporabljeno zdravilo (nerazredčeno ali razredčeno) ali odpadni material zavrzite v skladu z lokalnimi predpisi.
Therapeutic dose range
Razpon terapevtskega odmerka
- The recommended dose is from 0.5 mg to 2 mg for each kg of bodyweight, taken twice a day.
- Priporočeni odmerek je od 0,5 mg do 2 mg za vsak kg telesne mase dvakrat na dan.
Talk to your doctor or pharmacist before taking Briviact if: - You have thoughts of harming or killing yourself.
Pred jemanjem zdravila Briviact se posvetujte z zdravnikom ali farmacevtom če: - razmišljate o samopoškodovanju ali samomoru.
In a third study, a pre-specified analysis demonstrated efficacy over placebo for 100 mg/day and 200 mg/day in patients with prior exposure to levetiracetam.
V tretji študiji, je vnaprej specificirana analiza pokazala učinkovitost v primerjavi s placebom za 100 mg/dan in 200 mg/dan pri bolnikih, ki so bili prej izpostavljeni levetiracetamu.
Brivaracetam did not show any dependence potential in rats.
Brivaracetam pri podganah ni kazal potenciala za razvoj odvisnosti.
AUC 21 % ↓ No dose adjustment required
AUC 21 % ↓ Prilagoditev odmerka ni potrebna.
The recommended maintenance dose is 2 mg/kg/day.
Priporočeni vzdrževalni odmerek je 2 mg/kg/dan.
Solution for injection/infusion (injection/infusion) Clear, colourless, solution.
raztopina za injiciranje/infundiranje (injekcija/infuzija) Bistra, brezbarvna raztopina.
Although the number of subjects is limited, there was no observed benefit of brivaracetam versus placebo in patients taking levetiracetam concurrently which may reflect competition at the SV2A binding site.
Čeprav je bilo število preskušancev omejeno, niso opazili prednosti brivaracetama v primerjavi s placebom pri bolnikih, ki so sočasno jemali levetiracetam, kar lahko odraža konkurenco na mestu vezave SV2A.
Follow these steps the first time you take Briviact: - Take off the adaptor from the oral syringe (figure 2).
Ko prvič vzamete zdravilo Briviact, upoštevajte naslednje korake: - Snemite adapter s peroralne brizge (slika 2).
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.
V študiji pri starejših preiskovancih (starih od 65 do 79 let, očistek kreatinina od 53 do 98 ml/min/1,73 m²), ki so prejemali brivaracetam v odmerku 400 mg/dan dvakrat na dan, je bil plazemski razpolovni čas brivaracetama 7,9 oziroma 9,3 ure v skupinah od 65 do 75 oziroma > 75 let.
The 10 ml oral syringe has only one graduation in steps of 0.25 ml.
10-ml peroralna odmerna brizga ima samo eno graduacijo v korakih po 0,25 ml.
The main disposition pathway of brivaracetam is by CYP-independent hydrolysis.
Glavna presnovna pot brivaracetama je od CYP neodvisna hidroliza.
The percentages of patients with at least a 50 % reduction in seizure frequency were 20.3 %, 34.2 %, 39.5 %, and 37.8 % for placebo, 50 mg/day, 100 mg/day, and 200 mg/day, respectively.
Odstotek bolnikov z vsaj 50 % zmanjšanjem pogostnosti napadov je bil 20,3 %, 34,2 %, 39,5 % in 37,8 % za placebo, 50 mg/dan, 100 mg/dan in 200 mg/dan.
Of the 130 elderly subjects enrolled in the brivaracetam phase 2/3 development program (44 with epilepsy), 100 were 65-74 years of age and 30 were 75-84 years of age.
faze (44 od teh z epilepsijo), je bilo 100 starih 65-74 let, 30 pa 75-84 let.
How long to take Briviact for
Kako dolgo jemati zdravilo Briviact
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.
V združeni analizi treh ključnih preskušanj niso opazili sprememb učinkovitosti (merjeno kot 50 % stopnja odzivnosti) v razponu odmerkov od 50 mg/dan do 200 mg/dan, če je bil brivaracetam kombiniran z antiepileptiki, ki inducirajo ali ne inducirajo encimov.
In vitro, brivaracetam did ot induce CYP1A2.
In vitro brivaracetam ni induciral CYP1A2.
Animal studies did not detect any teratogenic potential of brivaracetam (see section 5.3).
V študijah na živalih niso zaznali teratogenega potenciala brivaracetama (glejte poglavje 5.3).
Intravenous bolus: may be administered directly without dilution Intravenous infusion: may be administered over 15 minutes in a compatible diluent
intravenski bolus: lahko dajete neposredno brez redčenja; intravenska infuzija: lahko razredčite s kompatibilnim topilom in dajete kot 15-minutno intravensko infuzijo.
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).
300 ml steklenica (tip III) jantarne barve z belo zaporko, varno za otroke (polipropilen) v škatli, ki vsebuje še 5 ml in 10 ml graduirano brizgo za peroralno odmerjanje (polipropilen, polietilen) in adapter za brizgo (polietilen).
There is no data on placental transfer in humans, but brivaracetam was shown to readily cross the placenta in rats (see section 5.3).
Ni podatkov o prehajanju skozi placento pri ljudeh, vendar je bilo pri podganah dokazano, da brivaracetam zlahka prehaja skozi placento (glejte poglavje 5.3).
CYP2B6 induction has not been investigated in vivo and brivaracetam may decrease plasma concentrations of medicinal products metabolised by CYP2B6 (e.g. efavirenz).
In vivo indukcije CYP2B6 niso preučevali in brivaracetam lahko zmanjša plazemske koncentracije učinkovin, ki se presnavljajo s CYP2B6 (npr. efavirenz).
As from the 0.1 ml graduation mark, each graduation corresponds to 0.1 ml which is 1 mg of brivaracetam.
Od graduacijske oznake 0,1 ml naprej vsaka graduacijska oznaka ustreza 0,1 ml, kar je 1 mg brivaracetama.
Brivaracetam may be initiated with either intravenous or oral administration.
Zdravljenje z brivaracetamom lahko začnemo z intravensko ali peroralno uporabo.
No clinical data are available in paediatric patients with hepatic impairment.
Klinični podatki za pediatrične bolnike z okvaro jeter niso na voljo.
• Packs of 14, 56 film-coated tablets and in multipacks containing 168 (3 packs of 56) filmcoated tablets in PVC/PCTFE - Aluminium blisters
• Pakiranje po 14, 56 filmsko obloženih tablet in v večkratnem pakiranju, ki vsebuje 168 (3 pakiranja po 56) filmsko obloženih tablet v pretisnih omotih PVC/PCTFE-aluminij.
In vitro, the hydroxylation of brivaracetam is mediated primarily by CYP2C19.
Hidroksilacija brivaracetama in vitro je primarno posredovana s CYP2C19.
There were no adverse effects on CNS function, neuropathological and brain histopathological examination.
Neželenih učinkov na delovanje centralnega živčnega sistema ni bilo, prav tako niso bili opaženi pri nevropatoloških in histopatoloških preiskavah možganov.
Further seizure frequency reduction is obtained by increasing the dose to 100 mg/day and reaches a plateau at 200 mg/day.
Nadaljnje zmanjšanje pogostnosti epileptičnih napadov je bilo doseženo s povečanjem odmerka na 100 mg/dan in doseže konstantno raven pri 200 mg/dan.
Adverse reactions with intravenous administration generally appeared to be similar to those observed with oral administration.
Neželeni učinki pri intravenski uporabi so bili v splošnem podobni tistim, ki so jih opazili pri peroralni uporabi.