natgillin/translations-raw huggingface dataset:
Reactions suggestive of immediate (Type I) hypersensitivity have been reported in a small number of brivaracetam patients (9/3022) during clinical development.
Reakcije koje ukazuju na ranu preosjetljivost (tipa I) prijavljene su kod malog broja bolesnika liječenih brivaracetamom (9/3022) tijekom kliničkog razvoja lijeka.
Your doctor will work out the right dose for you, depending on your weight.
Vaš liječnik će odlučiti koja je odgovarajuća doza za Vas, ovisno o Vašoj tjelesnoj težini.
Study N01358
Ispitivanje br. 1358
At the end of the evaluation period, subjects may have been eligible for entry into a long-term follow-up study continuing on their last received dose (see section 4.8).
Na kraju razdoblja procjene, ispitanici su mogli biti podobni za uključivanje u dugoročno ispitivanje praćenja, u kojem su nastavili primati zadnju primijenjenu dozu (vidjeti dio 4.8).
This is because stopping treatment could increase the number of fits you have.
Naime, prekid liječenja može povećati broj napadaja koje imate.
The safety and efficacy of brivaracetam in children aged less than 4 years have not yet been established.
Sigurnost i djelotvornost brivaracetama u djece mlađe od 4 godine još nisu ustanovljene.
This medicinal product is for single use only, any unused solution should be discarded.
Ovaj je lijek namijenjen isključivo za jednokratnu uporabu i svu neiskorištenu otopinu treba baciti.
Table 2: Key Efficacy Outcomes for Partial Onset Seizure Frequency per 28 Days Study
Tablica 2: Ključni ishodi djelotvornosti s obzirom na učestalost parcijalnih nastupa napadaja tijekom 28 dana
All doses were adjusted by body weight, and did not exceed a maximum of 50 mg/day, 100 mg/day, and 200 mg/day.
Sve doze su prilagođavane prema tjelesnoj težini i nisu prekoračivale maksimum od 50 mg/dan, 100 mg/dan i 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.
Hidrolizi amidne skupine kojom nastaje metabolit u obliku karboksilne kiseline (34% doze u urinu) pridonose hepatična i ekstrahepatična amidaza.
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).
Maksimalna dnevna doza od 150 mg, podijeljena na 2 doze, preporučuje se za sve stupnjeve oštećenja jetrene funkcije (vidjeti dijelove 4.4 i
Brivaracetam film-coated tablets, oral solution and solution for intravenous injection show the same AUC, while the maximum plasma concentration is slightly higher after intravenous administration.
Brivaracetam filmom obložene tablete, oralna otopina i otopina za intravensku injekciju pokazuju isti AUC, dok je maksimalna plazmatska koncentracija nešto viša nakon intravenske primjene.
Brivaracetam bolus injection or intravenous infusion has not been studied in acute conditions; e.g. status epilepticus and is therefore not recommended for such conditions.
Bolusna injekcija ili intravenska infuzija brivaracetama nisu ispitane u akutnim stanjima (npr. kod epileptičkog statusa) i stoga se njihova primjena u takvim stanjima ne preporučuje.
Since less than 10 % of brivaracetam is excreted in urine, haemodialysis is not expected to significantly enhance brivaracetam clearance (see section 5.2).
Budući da se manje od 10% brivaracetama izluči putem urina, ne očekuje se da će hemodijaliza značajno pospješiti klirens brivaracetama (vidjeti dio 5.2).
The effect of the interactions on the plasma concentration is summarised in table 1 (increase is indicated as “↑” and decrease as “↓”, area under the plasma concentration versus time curve as “AUC”, maximum observed concentration as Cmax).
Učinci interakcija na plazmatsku koncentraciju sažeto su prikazani u tablici 1 (povećanje je označeno kao “↑”, smanjenje kao “↓”, površina ispod krivulje plazmatske koncentracije u odnosu na vrijeme kao “AUC”, a maksimalna zabilježena koncentracija kao “Cmax”).
If you are not sure, talk to your doctor or pharmacist before taking Briviact.
Ako niste sigurni, obratite se svom liječniku ili ljekarniku prije nego uzmete Briviact.
- Pull the plunger down to the millilitre (ml) dose marker on the oral syringe prescribed by your doctor (figure 8).
- Povucite klip do oznake na štrcaljki za usta koja označava mililitarsku (ml) dozu koju Vam je propisao Vaš liječnik (slika 8)
Brivaracetam solution for injection/infusion is physically compatible and chemically stable when mixed with the following diluents
Brivaracetam otopina za injekciju/infuziju fizički je kompatibilna i kemijski stabilna ako se miješa sa sljedećim sredstvima za razrjeđivanje
Brivaracetam has minor or moderate influence on the ability to drive and use machines.
Brivaracetam malo ili umjereno utječe na sposobnost upravljanja vozilima i rada sa strojevima.
The efficacy and tolerability of brivaracetam in paediatric patients less than 4 years of age have not been established (see section 4.2).
Djelotvornost i podnošljivost brivaracetama u pedijatrijskih bolesnika mlađih od 4 godine nisu ustanovljene (vidjeti dio 4.2).
In two phase 3 randomised placebo-controlled studies, levetiracetam was administered as concomitant AED in about 20 % of the patients.
U dvama randomiziranim, placebom kontroliranim ispitivanjima faze 3, levetiracetam se primjenjivao kao istodobni antiepileptik u približno 20% bolesnika.
In a pharmacokinetic study with a 3-week evaluation period and weekly fixed 3-step up-titration using the brivaracetam oral solution, 99 subjects aged 1 month to <16 years were evaluated.
U farmakokinetičkom ispitivanju s razdobljem procjene od 3 tjedna i tjednim fiksnim povišenjem titracije u 3 koraka uz primjenu oralne otopine brivaracetama, procijenjeno je 99 ispitanika u dobi od 1 mjeseca do <16 godina.
People with liver problems
Osobe s jetrenim tegobama
- Intravenous infusion: brivaracetam may be diluted in a compatible diluent and administered as a 15-minute intravenous infusion (see section 6.6).
- Intravenska infuzija: brivaracetam se može razrijediti u kompatibilnom sredstvu za razrjeđivanje i primijeniti u obliku 15-minutne intravenske infuzije (vidjeti dio 6.6).
- Put the adaptor into the top of the bottle (figure 3).
- Stavite nastavak na vrh boce (slika 3).
Carcinogenicity studies did not indicate any oncogenic potential in rats, whereas increased incidences of hepatocellular tumors in male mice are considered to result of a non-genotoxic, mode of action linked to a phenobarbitonelike liver enzyme induction, which is a known rodent specific phenomenon.
Ispitivanja kancerogenosti nisu ukazala na onkogeni potencijal u štakora, a povećane incidencije hepatocelularnih tumora u mužjaka miševa smatrale su se posljedicom negenotoksičnog mehanizma djelovanja povezanog s indukcijom jetrenih enzima nalik onoj koju uzrokuje fenobarbiton, za koju se zna da je fenomen specifičan za glodavce.
In comparison, plasma clearance was estimated at 3.58 L/h in adult patients (70 kg body weight).
U usporedbi s tim, klirens plazme bio je procijenjen na 3,58 l/h u odraslih bolesnika (70 kg tjelesne težine).
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.
Od 130 starijih ispitanika uključenih u program razvoja brivaracetama faze 2/3 (44 bolesnika s epilepsijom), njih 100 bilo je u dobi od 65 do 74 godine, a njih 30 u dobi od 75 do 84 godine.
If you have any of these thoughts at any time, contact your doctor immediately.
Ako u bilo kojem trenutku počnete razmišljati o tome, odmah se javite svom liječniku.
This plasma concentration is slightly above the median exposure obtained after brivaracetam doses of 50 mg/day.
Ta je plazmatska koncentracija nešto viša od medijana izloženosti koji se postiže nakon primjene brivaracetama u dozama od 50 mg/dan.
In safety pharmacology studies, the predominant effects were CNS related (mainly transient CNS depression and decreased spontaneous locomotor activity) seen at multiples (greater than 50 fold) of the pharmacologically active dose of brivaracetam, 2 mg/kg.
Sigurnosna farmakološka ispitivanja pokazala su da su predominantni učinci bili povezani sa SŽS-om (uglavnom prolazna depresija SŽS-a i smanjena spontana lokomotorna aktivnost), primijećeni kod primjene doza višestruko većih (više od 50 puta) od farmakološki aktivne doze brivaracetama od 2 mg/kg.
A 40 % decrease in steady-state plasma concentration has been estimated across a body weight range from 46 kg to 115 kg.
Procjenjuje se da plazmatska koncentracija u stanju dinamičke ravnoteže opada za 40% kroz raspon tjelesne težine od 46 kg do 115 kg.
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.
Osim o dozi ovisnih povećanja incidencije somnolencije i umora, doze brivaracetama od 50 mg/dan i 100 mg/dan imale su sličan sigurnosni profil, uključujući nuspojave povezane sa SŽS-om i one kod dugoročne primjene.
The European Medicines Agency has deferred the obligation to submit the results of studies with brivaracetam in one or more subsets of the paediatric population in epilepsy with partial onset seizures.
Europska agencija za lijekove izuzela je obvezu podnošenja rezultata ispitivanja brivaracetama u jednoj ili više podskupina pedijatrijske populacije za liječenje epilepsije s parcijalnim nastupima napadaj.
Briviact is indicated as adjunctive therapy in the treatment of partial onset seizures with or without secondary generalisation in adults, adolescents and children from 4 years of age with epilepsy.
Briviact je indiciran kao dodatna terapija u liječenju parcijalnih nastupa napadaja sa sekundarnom generalizacijom ili bez nje u odraslih bolesnika, adolescenata i djece od navršene 4 godine života koji boluju od epilepsije.
Therefore, starting or ending treatment with St John's wort should be done with caution.
Stoga uvođenje ili prekid liječenja gospinom travom treba provoditi uz oprez.
Patients with rare heriditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.
Bolesnici s rijetkim nasljednim poremećajem nepodnošenja galaktoze, potpunim nedostatkom laktaze ili malapsorpcijom glukoze i galaktoze ne bi smjeli uzimati ovaj lijek.
It is used to treat a type of epilepsy that has partial seizures with or without a secondary generalisation.
- Koristi se za liječenje jedne vrste epilepsije s djelomičnim napadajima uz sekundarnu generalizaciju ili bez nje.
How much you will be given
Koliko ćete lijeka primiti
Doses in patients from 4 years of age were defined by weight-based dose adaptations which have been established to achieve similar plasma concentrations to the ones observed in adults taking efficacious doses (section 5.2).
Doze u bolesnika od 4 godine starosti definirane su prema prilagodbama doze prema tjelesnoj težini koje su utvrđene u svrhu postizanja sličnih koncentracija u plazmi onima zabilježenima u odraslih koji uzimaju djelotvorne doze (dio 5.2).
If you stop taking Briviact
Ako prestanete uzimati Briviact
Hypersensitivity to the active substance or other pyrrolidone derivatives or to any of the excipients listed in section 6.1.
Preosjetljivost na djelatnu tvar, druge pirolidonske derivate ili neku od pomoćnih tvari navedenih u dijelu 6.1.
Brivaracetam is weakly bound (≤ 20 %) to plasma proteins.
Brivaracetam se u maloj mjeri veže za proteine u plazmi (≤ 20%).
There was no additive effect of brivaracetam and valproate on the AUC of carbamazepine epoxide.
Nije primijećen aditivan učinak brivaracetama i valproata na AUC karbamazepin epoksida.
Figure 1: Proportion of patients by category of seizure response for brivaracetam and placebo over 12 weeks across all three double-blind pivotal trials
Slika 1: Udio bolesnika prema kategoriji odgovora s obzirom na napadaje uz brivaracetam i placebo tijekom 12 tjedana u sva tri dvostruko slijepa pivotalna ispitivanja
Each ml of oral solution contains 239.8 mg sorbitol (E420), 1mg methyl parahydroxybenzoate (E218) and 1.16 mg sodium.
Jedan ml oralne otopine sadrži 239,8 mg sorbitola (E420), 1 mg metilparahidroksibenzoata (E218) i 1,16 mg natrija.
Study enrollment criteria required that patients have uncontrolled POS despite treatment with either 1 or 2 concomitant AEDs.
Kriteriji za uključivanje u ispitivanje zahtijevali su da bolesnici imaju nekontrolirane parcijalne napadaje unatoč liječenju jednim ili dvama antiepilepticima istodobno.
Both metabolites, are further metabolised forming a common hydroxylated acid formed predominantly by hydroxylation of the propyl side chain on the carboxylic acid metabolite (mainly by CYP2C9).
Oba metabolita dalje se metaboliziraju i tvore zajedničku hidroksilnu kiselinu koja prvenstveno nastaje hidroksilacijom propilnog bočnog lanca na metabolitu karboksilne kiseline (pretežno djelovanjem enzima CYP2C9).
Follow these steps each time you take Briviact: - Put the oral syringe into the adaptor opening (figure 4).
Slijedite ove upute svaki put kada uzimate Briviact: - Stavite štrcaljku za usta na otvor na nastavku (slika 4).
Each film-coated tablet contains 10 mg, 25 mg, 50mg, 75 mg, or 100 mg brivaracetam.
Jedna filmom obložena tableta sadrži 10 mg, 25 mg, 50 mg, 75 mg ili 100 mg brivaracetama.
If brivaracetam has to be discontinued it is recommended to withdraw it gradually by 50 mg/day on a weekly basis.
Ako se liječenje brivaracetamom mora prekinuti, preporučuje se postupno smanjivanje doze za 50 mg/dan svaki tjedan.
The 5 ml oral syringe must be used in patients weighing less than 20 kg to ensure accurate dosing as the 10 ml oral syringe does not allow accurate measurements of volumes <1 ml.
Štrcaljka za oralnu primjenu od 5 ml mora se koristiti u bolesnika s tjelesnom težinom manjom od 20 kg, kako bi se osiguralo točno doziranje, budući da štrcaljka za oralnu primjenu od 10 ml ne omogućuje točno mjerenje volumena <1 ml.
Brivaracetam oral solution can be diluted in water or juice shortly before swallowing and may be taken with or without food (see section 5.2).
Brivaracetam oralna otopina može se razrijediti u vodi ili voćnom soku neposredno prije uzimanja, a može se uzimati s hranom ili bez nje (vidjeti dio 5.2).
Intravenous bolus: may be administered directly without dilution Intravenous infusion: may be administered over 15 minutes in a compatible diluent
Intravenska bolusna injekcija: može se primijeniti izravno, bez razrjeđivanja Intravenska infuzija: može se primijeniti tijekom razdoblja od 15 minuta u kompatibilnom sredstvu za razrjeđivanje
Population pharmacokinetics modeling indicated that the dose of 2.0 mg/kg twice a day provides the same steady-state average plasma concentration as in adults receiving 100 mg twice daily.
Populacijsko farmakokinetičko modeliranje pokazalo je da doza od 2,0 mg/kg dvaput na dan daje iste prosječne plazmatske koncentracije u stanju dinamičke ravnoteže kao i doza od 100 mg dvaput na dan u odraslih.
Very common: may affect more than 1 in 10 people - feeling sleepy or dizzy
Vrlo česte: mogu se javiti u više od 1 na 10 osoba - pospanost ili omaglica
Administered in 2 equally divided doses
Primjena u 2 jednake doze
Brivaracetam did not affect male or female fertility and has demonstrated no teratogenic potential in either rat or rabbit.
Brivaracetam nije utjecao na plodnost mužjaka ni ženki te nije pokazao teratogeni potencijal ni u štakora ni u kunića.
The three pivotal double-blind placebo-controlled studies included 38 elderly patients aged between 65 and 80 years.
Tri pivotalna, dvostruko slijepa, placebom kontrolirana ispitivanja uključivala su 38 starijih bolesnika u dobi od 65 do 80 godina.
Based on data in adults, no dose adjustment is necessary in paediatric patients with impaired renal function.
Na osnovi podataka u odraslih, nije potrebno prilagođavati dozu u pedijatrijskih bolesnika s oštećenjem bubrežne funkcije.
Brivaracetam was evaluated in these patients in a short term openlabel pharmacokinetic study and an ongoing open-label extension study, in 16 subjects from 1 month to <4 years of age (see section 5.2).
Primjena brivaracetama u tih bolesnika ocjenjivala se u kratkoročnom otvorenom farmakokinetičkom ispitivanju i otvorenom nastavku ispitivanja koje je još u tijeku, u 16 ispitanika u dobi od 1 mjeseca do <4 godine (vidjeti dio 5.2).
Briviact film-coated tablets contain lactose (a type of sugar).
Briviact filmom obložene tablete sadrže laktozu (jednu vrstu šećera).
Brivaracetam is a moderate reversible inhibitor of epoxide hydrolase resulting in an increased concentration of carbamazepine epoxide, an active metabolite of carbamazepine.
Brivaracetam je umjereno reverzibilan inhibitor epoksid hidrolaze koji povećava koncentraciju karbamazepin epoksida, aktivnog metabolita karbamazepina.
Findings not observed in clinical studies, but seen in the repeated-dose toxicology dog studies at exposure similar to the clinical plasma AUC, were hepatotoxic effects (mainly porphyria).
Nalazi koji nisu primijećeni u kliničkim ispitivanjima, ali su opaženi u ispitivanjima toksičnosti ponovljenih doza na psima pri razinama izloženosti sličnima onima koje se postižu uz klinički plazmatski AUC, bili su hepatotoksični učinci (prvenstveno porfirija).
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 prvenstveno metabolizira hidrolizom amidne skupine, pri čemu nastaje odgovarajuća karboksilna kiselina (približno 60% eliminacije), te sekundarno putem hidroksilacije na propilnom bočnom lancu (približno 30% eliminacije).
In vitro, brivaracetam was not an inhibitor of the CYP1A2, 2A6, 2B6, 2C8, 2C9, 2D6, 3A4, or the transporters P-gp, BCRP, BSEP MRP2, MATE-K, MATE-1, OATP1B1, OATP1B3, OAT1 and OCT1 at clinically relevant concentrations.
In vitro, brivaracetam nije inhibitor enzima CYP1A2, 2A6, 2B6, 2C8, 2C9, 2D6, 3A4 ili prijenosnika P-gp, BCRP, BSEP MRP2, MATE-K, MATE-1, OATP1B1, OATP1B3, OAT1 i OCT1 u klinički značajnim koncentracijama.
Infections and infestations
Infekcije i infestacije često
Gender There are no clinically relevant differences in the pharmacokinetics of brivaracetam by gender.
Spol Nema klinički značajnih razlika u farmakokinetici brivaracetama s obzirom na spol.
After first opening of the bottle, use within 5 months.
Primijenite unutar 5 mjeseci nakon prvog otvaranja boce.
The estimated plasma clearance was 1.61 L/h, 2.18 L/h and 3.19 L/h for children weighing 20 kg, 30 kg and 50 kg, respectively.
Procijenjeni klirens plazme bio je 1,61 l/h, 2,18 l/h i 3,19 l/h za djecu s tjelesnom težinom od 20 kg, 30 kg, odnosno 50 kg.
- Then push the plunger up to remove any possible air bubbles (figure 7).
- Zatim pritisnite klip prema gore da biste uklonili sve zračne mjehuriće koji bi mogli biti u štrcaljki (slika 7).
In a pharmacokinetic and pharmacodynamic interaction study between brivaracetam 200 mg single dose and ethanol 0.6 g/L continuous infusion in healthy subjects, there was no pharmacokinetic interaction but brivaracetam approximately doubled the effect of alcohol on psychomotor function, attention and memory.
U ispitivanju farmakokinetičkih i farmakodinamičkih interakcija između brivaracetama primijenjenog u jednokratnoj dozi od 200 mg i kontinuirane infuzije etanola u dozi od 0,6 g/l u zdravih ispitanika nije primijećena nikakva farmakokinetička interakcija, ali je brivaracetam približno udvostručio učinak alkohola na psihomotoričku funkciju, pažnju i pamćenje.
Syringe 10 ml and 5ml (as symbols - only for the outer carton)
Štrcaljka od 10 ml i 5 ml (kao simboli - samo za kutiju)
Brivaracetam did not show any dependence potential in rats.
Brivaracetam nije pokazao potencijal izazivanja ovisnosti u štakora.
These medicines are used to treat epilepsy.
Ti se lijekovi koriste za liječenje epilepsije.
Brivaracetam was administered at weekly increasing doses of approximately 1 mg/kg/day, 2 mg/kg/day, and 4 mg/kg/day.
Brivaracetam je primjenivan u dozama koje su se povećavale tjedno, od približno 1 mg/kg/dan, 2 mg/kg/dan i 4 mg/kg/dan.
- Briviact solution for injection/infusion is used for a short amount of time when you cannot take Briviact orally.
- Briviact otopina za injekciju/infuziju koristi se tijekom kraćih vremenskih razdoblja kada ne možete uzimati Briviact kroz usta.
Brivaracetam film-coated tablets must be taken orally swallowed in whole with liquid and may be taken with or without food (see section 5.2).
Filmom obložene tablete brivaracetama moraju se uzeti peroralno i progutati cijele s tekućinom, a mogu se uzimati s hranom ili bez nje (vidjeti dio 5.2).
Excipient(s) with known effect: Each ml of solution for injection/infusion contains 3.8 mg sodium.
Pomoćne tvari s poznatim učinkom: Jedan ml otopine za injekciju/infuziju sadrži 3,8 mg natrija.
There is a limited amount of data from the use of brivaracetam in pregnant women.
Postoji ograničena količina podataka o primjeni brivaracetama u trudnica.
Briviact contains lactose
Briviact sadrži laktozu
- Turn the bottle the right way up (figure 9).
- Okrenite bocu tako da stoji uspravno (slika 9).
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 %).
Najčešći antiepileptici koje su bolesnici uzimali u trenutku uključivanja u ispitivanje bili su karbamazepin (40,6%), lamotrigin (25,2%), valproat (20,5%), okskarbazepin (16,0%), topiramat (13,5%), fenitoin (10,2%) i levetiracetam (9,8%).
Allée de la Recherche 60 (address only for outer carton) B-1070 Brussels
Allée de la Recherche 60 (adresa samo za kutiju) B-1070 Bruxelles
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.
U trećem ispitivanju, unaprijed specificirana analiza dokazala je djelotvornost u odnosu na placebo za 100 mg/dan i 200 mg/dan u bolesnika koji su prethodno bili izloženi levetiracetamu.
When converting from oral to intravenous administration or vice versa, the total daily dose and frequency of administration should be maintained.
Kod prelaska s peroralne na intravensku primjenu ili obratno, treba zadržati ukupnu dnevnu dozu i učestalost primjene.
In the short-term clinical studies of brivaracetam in epilepsy patients, there were no cases of completed suicide and suicide attempt, however both have been reported in open-label extension studies(see section 4.4).
U kratkoročnim kliničkim ispitivanjima brivaracetama provedenima u bolesnika s epilepsijom, nisu zabilježeni slučajevi izvršenih samoubojstava ni pokušaja samoubojstva, ali je oboje prijavljeno u otvorenim nastavcima ispitivanja (vidjeti dio 4.4).
• Packs of 14 x 1 and 100 x 1 film-coated tablet in PVC/PCTFE - Aluminium blisters
• Pakiranja od 14 x 1 i 100 x 1 filmom obložene tablete u PVC/PCTFE-aluminij blisterima
In adults, a 50 mg/day starting dose should be considered.
U odraslih treba razmotriti početnu dozu od 50 mg/dan.
A second disposition pathway involves hydroxylation mediated by CYP2C19 (see section 5.2).
Drugi put biotransformacije uključuje hidroksilaciju posredstvom enzima CYP2C19 (vidjeti dio 5.2).
Take the daily dose in two equal divided doses - one in the morning and one in the evening at about the same time each day.
Uzmite dnevnu dozu u dvije jednako podijeljene doze - jednu ujutro, a drugu navečer, otprilike u isto vrijeme svaki dan.
The recommended starting dose is either 50 mg/day or 100 mg/day based on physician assessment of required seizure reduction versus potential side effects.
Preporučena početna doza je 50 mg/dan ili 100 mg/dan, ovisno o liječnikovoj ocjeni potrebnog smanjenja napadaja u odnosu na moguće nuspojave.