FrancophonIA/ELRC3.0 huggingface dataset:
English: Patients with rare heriditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.
Croatian: Bolesnici s rijetkim nasljednim poremećajem nepodnošenja galaktoze, potpunim nedostatkom laktaze ili malapsorpcijom glukoze i galaktoze ne bi smjeli uzimati ovaj lijek.
English: It is used to treat a type of epilepsy that has partial seizures with or without a secondary generalisation.
Croatian: - Koristi se za liječenje jedne vrste epilepsije s djelomičnim napadajima uz sekundarnu generalizaciju ili bez nje.
English: How much you will be given
Croatian: Koliko ćete lijeka primiti
English: 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).
Croatian: 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).
English: If you stop taking Briviact
Croatian: Ako prestanete uzimati Briviact
English: Hypersensitivity to the active substance or other pyrrolidone derivatives or to any of the excipients listed in section 6.1.
Croatian: Preosjetljivost na djelatnu tvar, druge pirolidonske derivate ili neku od pomoćnih tvari navedenih u dijelu 6.1.
English: Brivaracetam is weakly bound (≤ 20 %) to plasma proteins.
Croatian: Brivaracetam se u maloj mjeri veže za proteine u plazmi (≤ 20%).
English: There was no additive effect of brivaracetam and valproate on the AUC of carbamazepine epoxide.
Croatian: Nije primijećen aditivan učinak brivaracetama i valproata na AUC karbamazepin epoksida.
English: Figure 1: Proportion of patients by category of seizure response for brivaracetam and placebo over 12 weeks across all three double-blind pivotal trials
Croatian: 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
English: Each ml of oral solution contains 239.8 mg sorbitol (E420), 1mg methyl parahydroxybenzoate (E218) and 1.16 mg sodium.
Croatian: Jedan ml oralne otopine sadrži 239,8 mg sorbitola (E420), 1 mg metilparahidroksibenzoata (E218) i 1,16 mg natrija.
English: Study enrollment criteria required that patients have uncontrolled POS despite treatment with either 1 or 2 concomitant AEDs.
Croatian: Kriteriji za uključivanje u ispitivanje zahtijevali su da bolesnici imaju nekontrolirane parcijalne napadaje unatoč liječenju jednim ili dvama antiepilepticima istodobno.
English: 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).
Croatian: 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).
English: Follow these steps each time you take Briviact: - Put the oral syringe into the adaptor opening (figure 4).
Croatian: Slijedite ove upute svaki put kada uzimate Briviact: - Stavite štrcaljku za usta na otvor na nastavku (slika 4).
English: Each film-coated tablet contains 10 mg, 25 mg, 50mg, 75 mg, or 100 mg brivaracetam.
Croatian: Jedna filmom obložena tableta sadrži 10 mg, 25 mg, 50 mg, 75 mg ili 100 mg brivaracetama.
English: If brivaracetam has to be discontinued it is recommended to withdraw it gradually by 50 mg/day on a weekly basis.
Croatian: Ako se liječenje brivaracetamom mora prekinuti, preporučuje se postupno smanjivanje doze za 50 mg/dan svaki tjedan.
English: 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.
Croatian: 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.
English: 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).
Croatian: 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).
English: Intravenous bolus: may be administered directly without dilution Intravenous infusion: may be administered over 15 minutes in a compatible diluent
Croatian: Intravenska bolusna injekcija: može se primijeniti izravno, bez razrjeđivanja Intravenska infuzija: može se primijeniti tijekom razdoblja od 15 minuta u kompatibilnom sredstvu za razrjeđivanje
English: 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.
Croatian: 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.
English: Very common: may affect more than 1 in 10 people - feeling sleepy or dizzy
Croatian: Vrlo česte: mogu se javiti u više od 1 na 10 osoba - pospanost ili omaglica
English: Administered in 2 equally divided doses
Croatian: Primjena u 2 jednake doze
English: Brivaracetam did not affect male or female fertility and has demonstrated no teratogenic potential in either rat or rabbit.
Croatian: Brivaracetam nije utjecao na plodnost mužjaka ni ženki te nije pokazao teratogeni potencijal ni u štakora ni u kunića.
English: The three pivotal double-blind placebo-controlled studies included 38 elderly patients aged between 65 and 80 years.
Croatian: Tri pivotalna, dvostruko slijepa, placebom kontrolirana ispitivanja uključivala su 38 starijih bolesnika u dobi od 65 do 80 godina.
English: Based on data in adults, no dose adjustment is necessary in paediatric patients with impaired renal function.
Croatian: Na osnovi podataka u odraslih, nije potrebno prilagođavati dozu u pedijatrijskih bolesnika s oštećenjem bubrežne funkcije.
English: 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).
Croatian: 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).
English: Briviact film-coated tablets contain lactose (a type of sugar).
Croatian: Briviact filmom obložene tablete sadrže laktozu (jednu vrstu šećera).
English: Brivaracetam is a moderate reversible inhibitor of epoxide hydrolase resulting in an increased concentration of carbamazepine epoxide, an active metabolite of carbamazepine.
Croatian: Brivaracetam je umjereno reverzibilan inhibitor epoksid hidrolaze koji povećava koncentraciju karbamazepin epoksida, aktivnog metabolita karbamazepina.
English: 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).
Croatian: 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).
English: 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).
Croatian: 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).
English: 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.
Croatian: 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.
English: Infections and infestations
Croatian: Infekcije i infestacije često
English: Gender There are no clinically relevant differences in the pharmacokinetics of brivaracetam by gender.
Croatian: Spol Nema klinički značajnih razlika u farmakokinetici brivaracetama s obzirom na spol.
English: After first opening of the bottle, use within 5 months.
Croatian: Primijenite unutar 5 mjeseci nakon prvog otvaranja boce.
English: 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.
Croatian: 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.
English: - Then push the plunger up to remove any possible air bubbles (figure 7).
Croatian: - Zatim pritisnite klip prema gore da biste uklonili sve zračne mjehuriće koji bi mogli biti u štrcaljki (slika 7).
English: 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.
Croatian: 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.
English: Syringe 10 ml and 5ml (as symbols - only for the outer carton)
Croatian: Štrcaljka od 10 ml i 5 ml (kao simboli - samo za kutiju)
English: Brivaracetam did not show any dependence potential in rats.
Croatian: Brivaracetam nije pokazao potencijal izazivanja ovisnosti u štakora.
English: These medicines are used to treat epilepsy.
Croatian: Ti se lijekovi koriste za liječenje epilepsije.
English: Brivaracetam was administered at weekly increasing doses of approximately 1 mg/kg/day, 2 mg/kg/day, and 4 mg/kg/day.
Croatian: 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.
English: - Briviact solution for injection/infusion is used for a short amount of time when you cannot take Briviact orally.
Croatian: - Briviact otopina za injekciju/infuziju koristi se tijekom kraćih vremenskih razdoblja kada ne možete uzimati Briviact kroz usta.
English: 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).
Croatian: 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).
English: Excipient(s) with known effect: Each ml of solution for injection/infusion contains 3.8 mg sodium.
Croatian: Pomoćne tvari s poznatim učinkom: Jedan ml otopine za injekciju/infuziju sadrži 3,8 mg natrija.
English: There is a limited amount of data from the use of brivaracetam in pregnant women.
Croatian: Postoji ograničena količina podataka o primjeni brivaracetama u trudnica.
English: Briviact contains lactose
Croatian: Briviact sadrži laktozu
English: - Turn the bottle the right way up (figure 9).
Croatian: - Okrenite bocu tako da stoji uspravno (slika 9).
English: 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 %).
Croatian: 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%).
English: Allée de la Recherche 60 (address only for outer carton) B-1070 Brussels
Croatian: Allée de la Recherche 60 (adresa samo za kutiju) B-1070 Bruxelles
English: 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.
Croatian: 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.
English: When converting from oral to intravenous administration or vice versa, the total daily dose and frequency of administration should be maintained.
Croatian: Kod prelaska s peroralne na intravensku primjenu ili obratno, treba zadržati ukupnu dnevnu dozu i učestalost primjene.
English: 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).
Croatian: 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).
English: • Packs of 14 x 1 and 100 x 1 film-coated tablet in PVC/PCTFE - Aluminium blisters
Croatian: • Pakiranja od 14 x 1 i 100 x 1 filmom obložene tablete u PVC/PCTFE-aluminij blisterima
English: In adults, a 50 mg/day starting dose should be considered.
Croatian: U odraslih treba razmotriti početnu dozu od 50 mg/dan.
English: A second disposition pathway involves hydroxylation mediated by CYP2C19 (see section 5.2).
Croatian: Drugi put biotransformacije uključuje hidroksilaciju posredstvom enzima CYP2C19 (vidjeti dio 5.2).
English: 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.
Croatian: Uzmite dnevnu dozu u dvije jednako podijeljene doze - jednu ujutro, a drugu navečer, otprilike u isto vrijeme svaki dan.
English: 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.
Croatian: Preporučena početna doza je 50 mg/dan ili 100 mg/dan, ovisno o liječnikovoj ocjeni potrebnog smanjenja napadaja u odnosu na moguće nuspojave.
English: 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.
Croatian: 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.
English: Adverse reactions from clinical trials
Croatian: Nuspojave u kliničkim ispitivanjima
English: Physicians should discuss family planning and contraception with women of childbearing potential taking brivaracetam (see Pregnancy).
Croatian: Liječnici moraju razgovarati sa ženama reproduktivne dobi koje uzimaju brivaracetam o planiranju obitelji i kontracepciji (vidjeti odlomak „Trudnoća“).
English: 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.
Croatian: 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.
English: 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.
Croatian: 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.
English: The following table summarises the recommended posology for children from 4 years of age and adolescents.
Croatian: Sljedeća tablica daje sažetak preporučenog doziranja za djecu od navršenih 4 godina života i adolescente.
English: Follow these steps the first time you take Briviact: - Take off the adaptor from the oral syringe (figure 2).
Croatian: Slijedite ove upute kada prvi put uzimate Briviact: - Skinite nastavak sa štrcaljke za usta (slika 2).
English: Brivaracetam 200mg/day may increase plasma concentrations of medicinal products transported by OAT3.
Croatian: Brivaracetam u dozi od 200 mg/dan može povisiti plazmatsku koncentraciju lijekova koje prenosi OAT3.
English: AUC 19 % ↓ No dose adjustment required
Croatian: AUC 19 % ↓ Nije potrebno prilagođavati dozu
English: Therapeutic dose range
Croatian: Raspon terapijskih doza
English: AUC 21 % ↓ No dose adjustment required
Croatian: AUC 21 % ↓ Nije potrebno prilagođavati dozu
English: In vitro, Brivaracetam inhibits OAT3 with a half maximal inhibitory concentration 42-fold higher than the Cmax at the highest clinical dose.
Croatian: In vitro, brivaracetam inhibira OAT3 s polovicom maksimalne inhibitorne koncentracije 42 puta većom od Cmax pri najvećoj kliničkoj dozi.
English: 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).
Croatian: Nemojte primjenjivati Briviact: - ako ste alergični na brivaracetam, druge pirolidonske derivate ili neki drugi sastojak ovog lijeka (naveden u dijelu 6.).
English: What Briviact contains
Croatian: Što Briviact sadrži
English: 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.
Croatian: 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.
English: - The recommended dose is from 0.5 mg to 2 mg for each kg of bodyweight, taken twice a day.
Croatian: - Preporučena doza iznosi od 0,5 mg do 2 mg po kilogramu tjelesne težine, uzimana dvaput dnevno.
English: In monkeys, CNS signs (prostrate, loss of balance, clumsy movements) occurred at 64 fold the clinical Cmax, these effects being less apparent over time.
Croatian: 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.
English: The adverse reactions most frequently resulting in discontinuation of brivaracetam therapy were dizziness (0.8 %) and convulsion (0.8 %).
Croatian: Nuspojave koje su najčešće uzrokovale prekid liječenja brivaracetamom bile su omaglica (0,8%) i konvulzija (0,8%).
English: 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.
Croatian: 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.
English: There is no specific antidote for overdose with brivaracetam.
Croatian: Nema specifičnog protulijeka za predoziranje brivaracetamom.
English: Additional graduations at 0.25 ml and 0.75 ml starting at 0.25 ml up to 5 ml are shown.
Croatian: Prikazani su dodatni gradusi od 0,25 ml i 0,75 ml, počevši od 0,25 ml do 5 ml.
English: 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.
Croatian: 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.
English: Brivaracetam is rapidly and completely absorbed after oral administration and the absolute bioavailablity is approximately 100 %.
Croatian: Brivaracetam se nakon peroralne primjene brzo i potpuno apsorbira, uz apsolutnu bioraspoloživost od približno 100%.
English: 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).
Croatian: 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).
English: The oral solution contains methyl parahydroxybenzoate (E218), which may cause allergic reactions (possibly delayed).
Croatian: Oralna otopina sadrži metilparahidroksibenzoat (E218), koji može uzrokovati alergijske reakcije (koje mogu biti odgođene).
English: 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.
Croatian: 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.
English: Solution for injection/infusion (injection/infusion) Clear, colourless, solution.
Croatian: Otopina za injekciju/infuziju (injekcija/infuzija) Bistra, bezbojna otopina.
English: Any unused medicinal product, neat or diluted, or waste material should be disposed of in accordance with local requirements.
Croatian: Neiskorišteni lijek, čist ili razrijeđen, ili otpadni materijal potrebno je zbrinuti sukladno nacionalnim propisima.
English: 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.
Croatian: 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.
English: 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.
Croatian: 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.
English: Ireland UCB (Pharma) Ireland Ltd.
Croatian: UCB (Pharma) Ireland Ltd.
English: 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.
Croatian: 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.
English: Recommended maintenance dose
Croatian: Preporučena početna doza