FrancophonIA/ELRC3.0 huggingface dataset:
English: Physicians should discuss family planning and contraception with women of childbearing potential taking brivaracetam (see Pregnancy).
Slovenian: Zdravniki se morajo z ženskami v rodni dobi, ki jemljejo brivaracetam, pogovoriti o načrtovanju družine in kontracepciji (glejte Nosečnost).
English: Four of these subjects had decreased neutrophil counts at baseline, and experienced additional decrease in neutrophil counts after initiation of brivaracetam treatment.
Slovenian: Štirje od teh preskušancev so imeli že ob izhodišču zmanjšano število nevtrofilcev, po začetku zdravljenja z brivaracetamom pa je prišlo do dodatnega zmanjšanja števila nevtrofilcev.
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.
Slovenian: Tablete zdravila Briviact so pakirane v pretisne omote, ki se nahajajo v škatlah, ki vsebujejo po 14, 56, 14 x 1 ali 100 x 1 filmsko obloženo tableto, ali v večkratnih pakiranjih, ki vsebujejo 168 (3 pakiranja po 56) filmsko obloženih tablet.
English: Recommended starting dose 50 mg/day (or 100 mg/day)*
Slovenian: Priporočeni začetni odmerek 50 mg/dan (ali 100 mg/dan)*
English: - Turn the bottle the right way up (figure 9).
Slovenian: - Obrnite steklenico pokonci (slika 9).
English: In juvenile rats, brivaracetam exposure levels 6- to 15-fold the clinical AUC exposure at the maximum recommended dose induced developmental adverse effects (i.e. mortality, clinical signs, decreased body weight and lower brain weight).
Slovenian: Pri mladičih podgan je brivaracetam z ravnjo izpostavljenosti, ki je od 6- do 15-krat višja od klinične izpostavljenosti AUC pri največjem priporočenem odmerku, povzročal neželene razvojne učinke (tj. smrtnost, klinični znaki, manjša telesna masa in manjša masa možganov).
English: What Briviact is and what it is used for
Slovenian: Kaj je zdravilo Briviact in za kaj ga uporabljamo
English: Study N01253
Slovenian: Študija N01253
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.
Slovenian: Študija preskušancev s hudo okvaro ledvic (očistek kreatinina < 30 ml/min/1,73 m², niso potrebovali dialize) je pokazala, da je bil plazemski AUC brivaracetama zmerno povišan (+ 21 %) v primerjavi z zdravimi kontroliranimi preskušanci, medtem ko se je AUC kislinskih, hidroksi in hidroksikislinskih presnovkov povečal 3-, 4- oziroma 21-krat.
English: How to take Briviact oral solution - You can take Briviact oral solution on its own, or dilute it in water or juice shortly before swallowing.
Slovenian: Kako jemati zdravilo Briviact peroralna raztopina - Zdravilo Briviact peroralna raztopina lahko jemljete samo, ali pa jo razredčite z vodo ali sokom neposredno pred zaužitjem.
English: Brivaracetam plasma concentrations are decreased when coadministered with strong enzyme inducing AEDs (carbamazepine, phenobarbital, phenytoin) but no dose adjustment is required (see table 1).
Slovenian: Plazemske koncentracije brivaracetama se zmanjšajo pri sočasnem jemanju antiepileptikov, ki močno inducirajo encime (karbamazepin, fenobarbital, fentoin), vendar prilagoditev odmerka ni potrebna (glejte preglednico 1).
English: The oral solution contains methyl parahydroxybenzoate (E218), which may cause allergic reactions (possibly delayed).
Slovenian: Peroralna raztopina vsebuje metilparahidroksibenzoat (E218), ki lahko povzroči alergijske reakcije, (lahko zapoznele).
English: Follow these steps each time you take Briviact: - Put the oral syringe into the adaptor opening (figure 4).
Slovenian: Vsakič ko vzamete zdravilo Briviact, upoštevajte naslednje korake: - Vstavite peroralno brizgo v odprtino adapterja (slika 4).
English: All doses were adjusted by body weight, and did not exceed a maximum of 50 mg/day, 100 mg/day, and 200 mg/day.
Slovenian: Vsi odmerki so bili prilagojeni na telesno maso in niso presegli največjega odmerka 50 mg/dan, 100 mg/dan in 200 mg/dan.
English: This may avoid the brivaracetam plasma concentration falling below the efficacy level and prevent breakthrough seizures from occurring.
Slovenian: S tem se je mogoče izogniti padcu plazemske koncentracije brivaracetama pod raven učinkovitosti in preprečiti pojav prebojnih epileptičnih napadov.
English: In vitro, brivaracetam is not a substrate of human Pglycoprotein (P-gp), multidrug resistance proteins (MRP) 1 and 2, and likely not organic anion transporter polypeptide 1B1 (OATP1B1) and OATP1B3.
Slovenian: 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.
English: Brivaracetam did not affect male or female fertility and has demonstrated no teratogenic potential in either rat or rabbit.
Slovenian: Brivaracetam ni vplival na plodnost samcev ali samic ter pri podganah in kuncih ni kazal teratogenega potenciala.
English: Very common: may affect more than 1 in 10 people - feeling sleepy or dizzy
Slovenian: Zelo pogosti: pojavijo se lahko pri več kot 1 od 10 bolnikov - občutek zaspanosti ali omotice
English: Embryotoxicity was observed in rabbits at a maternal toxic dose of brivaracetam with an exposure level 8-fold the clinical AUC exposure at the maximum recommended dose.
Slovenian: 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.
English: Excipient(s) with known effect: Each ml of solution for injection/infusion contains 3.8 mg sodium.
Slovenian: Pomožne snovi z znanim učinkom: En ml raztopine za injiciranje/infundiranje vsebuje 3,8 mg natrija.
English: It is unknown whether brivaracetam is excreted in human breast milk.
Slovenian: Ni znano, ali se brivaracetam izloča v materino mleko.
English: 10 ml oral syringe provided in the carton to ensure accurate dosing.
Slovenian: 10-ml peroralno brizgo, priloženo v škatli, da zagotovite natančno odmerjanje.
English: Study N01252
Slovenian: Študija N01252
English: No additional safety or tolerability concern was observed (see section 5.1).
Slovenian: Prav tako niso ugotovili dodatnih zadržkov glede varnosti in prenašanja zdravila (glejte poglavje 5.1).
English: 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).
Slovenian: Za vse stopnje okvare jeter je priporočen največji dnevni odmerek 150 mg, razdeljen v 2 enaka odmerka (glejte poglavji 4.4 in 5.2).
English: This helps to stop your fits coming back or getting worse.
Slovenian: Tako boste preprečili, da bi se epileptični napadi vrnili ali poslabšali.
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 %).
Slovenian: 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 %).
English: Based on data in adults, no dose adjustment is necessary in paediatric patients with impaired renal function.
Slovenian: Na podlagi podatkov pri odraslih prilagajanje odmerka pri pediatričnih bolnikih z okvarjenim delovanjem ledvic ni potrebno.
English: (Omitted from cartons of 14 film-coated tablets)
Slovenian: (Izpuščeno na zloženkah s 14 filmsko obloženimi tabletami)
English: Each ml of oral solution contains 239.8 mg sorbitol (E420), 1mg methyl parahydroxybenzoate (E218) and 1.16 mg sodium.
Slovenian: En ml peroralne raztopine vsebuje 239,8 mg sorbitola (E420), 1 mg metilparahidroksibenzoata (E218) in 1,16 mg natrija.
English: A pharmacokinetic study in subjects with hepatic cirrhosis (Child-Pugh grades A, B, and C) showed similar increases in exposure to brivaracetam irrespective of disease severity (50 %, 57 % and 59 %), relative to matched healthy controls.
Slovenian: 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).
English: 14 film-coated tablets 56 film-coated tablets 100 x 1 film-coated tablet 14 x 1 film-coated tablet
Slovenian: 14 filmsko obloženih tablet 56 filmsko obloženih tablet 100 x 1 filmsko obložena tableta 14 x 1 filmsko obložena tableta
English: There were no adverse effects in any of the standard developmental or maturation endpoints.
Slovenian: Pri standardnih razvojnih in zrelostnih opazovanih dogodkih ni bilo neželenih učinkov.
English: Briviact solution for injection/infusion can be administered as a bolus injection or as an infusion:
Slovenian: Briviact raztopino za injiciranje lahko dajete kot bolus ali kot infuzijo:
English: (Only for outer carton)
Slovenian: (Samo za škatlo.)
English: Overall, brivaracetam was efficacious for the adjunctive treatment of partial onset seizures in patients 16 years of age and older between 50 mg/day and 200 mg/day.
Slovenian: 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.
English: 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.
Slovenian: Hidrolizo amidnega dela, ki vodi do presnovka v obliki karboksilne kisline (34 % odmerka v urinu), omogoča amidaza v jetrih in izven njih.
English: - Intravenous bolus: brivaracetam may be administered as an intravenous bolus without dilution.
Slovenian: - Intravenski bolus: brivaracetam lahko dajete kot intravenski bolus brez razredčenja.
English: When tested in vitro brivaracetam did not induce CYP1A1/2 but induced CYP3A4 and CYP2B6.
Slovenian: Pri testiranju in vitro brivaracetam ni induciral CYP1A1/2, ampak je induciral CYP3A4 in CYP2B6.
English: The adverse reactions most frequently resulting in discontinuation of brivaracetam therapy were dizziness (0.8 %) and convulsion (0.8 %).
Slovenian: Neželena učinka, o katerih so najpogosteje poročali pri prekinitvi zdravljenja z brivaracetamom, sta bila omotica (0,8 %) in konvulzije (0,8 %).
English: In case of co-administration of brivaracetam and carbamazepine, the amount of carbamazepine-epoxide excreted in breast milk could increase.
Slovenian: V primeru sočasnega dajanja brivaracetama in karbamazepina se lahko poveča količina karbamazepin epoksida, ki se izloča v materino mleko.
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.
Slovenian: 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.
English: Brivaracetam is cleared by multiple pathways including renal excretion, non-CYP-mediated hydrolysis and CYP-mediated oxidations.
Slovenian: Brivaracetam se iz telesa čisti po več poteh, vključno z ledvičnim izločanjem, hidrolizo, ki ni posredovana s CYP, in z oksidacijami, posredovanimi s CYP.
English: The three metabolites are not pharmacologically active.
Slovenian: Noben od treh presnovkov ni farmakološko aktiven.
English: Binding to SV2A is believed to be the primary mechanism for brivaracetam anticonvulsant activity.
Slovenian: Predvideva se, da je vezava na SV2A primarni mehanizem za antikonvulzijsko aktivnost brivaracetama.
English: The efficacy of brivaracetam for the adjunctive therapy of partial onset seizures (POS) was established in 3 randomized, double-blind, placebo-controlled, fixed-dose, multi-center studies in subjects 16 years of age and older.
Slovenian: 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.
English: Briviact film-coated tablets contain lactose (a type of sugar).
Slovenian: Filmsko obložene tablete Briviact vsebujejo laktozo (vrsto sladkorja).
English: Upper respiratory tract infections, cough
Slovenian: Okužbe zgornjih dihal, kašelj
English: Potential interactions between brivaracetam (50 mg/day to 200 mg/day) and other AEDs were investigated in a pooled analysis of plasma drug concentrations from all phase 2-3 studies in a population pharmacokinetic analysis of placebo-controlled phase 2-3 studies, and in dedicated drugdrug interaction studies (for the following AEDs: carbamazepine, lamotrigine, phenytoin and topiramate).
Slovenian: 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).
English: 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.
Slovenian: 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.
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).
Slovenian: 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).
English: Additional graduations at 0.25 ml and 0.75 ml starting at 0.25 ml up to 5 ml are shown.
Slovenian: Prikazane so dodatne graduacijske oznake za 0,25 ml in 0,75 ml, ki se začnejo pri 0,25 ml do 5 ml.
English: If you have been told by your doctor that you cannot tolerate or digest some sugars, contact your doctor before taking this medicine.
Slovenian: Če vam je zdravnik povedal, da ne prenašate ali prebavljate nekaterih sladkorjev, se pred uporabo tega zdravila posvetujte s svojim zdravnikom.
English: In juvenile dogs, the brivaracetam-induced changes at the exposure level 6- fold the clinical AUC were similar to those observed in adult animals.
Slovenian: 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.
English: Studies in rats have shown excretion of brivaracetam in breast milk (see section 5.3).
Slovenian: Študije na podganah so pokazale izločanje brivaracetama v materino mleko (glejte poglavje 5.3).
English: EU/1/15/1073/001 EU/1/15/1073/002 EU/1/15/1073/003 EU/1/15/1073/004 EU/1/15/1073/005 EU/1/15/1073/006 EU/1/15/1073/007 EU/1/15/1073/008 EU/1/15/1073/009 EU/1/15/1073/010 EU/1/15/1073/011 EU/1/15/1073/012 EU/1/15/1073/013 EU/1/15/1073/014 EU/1/15/1073/015 EU/1/15/1073/016 EU/1/15/1073/017 EU/1/15/1073/018 EU/1/15/1073/019 EU/1/15/1073/020 EU/1/15/1073/023 EU/1/15/1073/024 EU/1/15/1073/025 EU/1/15/1073/026 EU/1/15/1073/027
Slovenian: EU/1/15/1073/001 EU/1/15/1073/002 EU/1/15/1073/003 EU/1/15/1073/004 EU/1/15/1073/005 EU/1/15/1073/006 EU/1/15/1073/007 EU/1/15/1073/008 EU/1/15/1073/009 EU/1/15/1073/010 EU/1/15/1073/011 EU/1/15/1073/012 EU/1/15/1073/013 EU/1/15/1073/014 EU/1/15/1073/015 EU/1/15/1073/016 EU/1/15/1073/017 EU/1/15/1073/018 EU/1/15/1073/019 EU/1/15/1073/020 EU/1/15/1073/023 EU/1/15/1073/024 EU/1/15/1073/025 EU/1/15/1073/026
English: Brivaracetam may increase plasma concentrations of medicinal products metabolised by CYP2C19 (e.g. lanzoprazole, omeprazole, diazepam).
Slovenian: Brivaracetam lahko poveča plazemske koncentracije učinkovin, ki se presnavljajo s CYP2C19 (npr. lansoprazol, omeprazol, diazepam).
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).
Slovenian: Ne jemljite zdravila Briviact: - če ste alergični na brivaracetam, druge derivate pirolidona ali katero koli sestavino tega zdravila (navedeno v poglavju 6).
English: The hydroxyacid metabolite did not reveal any safety concerns in non clinical studies.
Slovenian: Hidroksikislinski presnovek v predkliničnih študijah ni pokazal nobenih varnostnih zadržkov.
English: Brivaracetam was administered at weekly increasing doses of approximately 1 mg/kg/day, 2 mg/kg/day, and 4 mg/kg/day.
Slovenian: Brivaracetam so dajali v tedensko naraščajočih odmerkih približno 1 mg/kg/dan, 2 mg/kg/dan in 4 mg/kg/dan.
English: In clinical studies, a reduction in seizure frequency over placebo was higher with the dose of 100 mg/day than with 50 mg/day.
Slovenian: V kliničnih študijah je bilo zmanjšanje pogostnosti napadov v primerjavi s placebom večje pri odmerku 100 mg/dan kot pri odmerku 50 mg/dan.
English: OUTER CARTON OF MULTIPACK (WITH BLUE BOX)
Slovenian: ŠKATLA VEČKRATNEGA PAKIRANJA (Z MODRIM OKENCEM)
English: None a
Slovenian: Nič a
English: Brivaracetam may also be initiated at 2 mg/kg/day based on physician assessment of need for seizure control.
Slovenian: Brivaracetam je možno uvesti tudi z 2 mg/kg/dan na podlagi zdravnikove ocene potrebe po obvladovanju epileptičnih napadov.
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.
Slovenian: 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.
English: Two oral syringes will be provided in the carton.
Slovenian: V škatli sta priloženi dve peroralni brizgi.
English: Brivaracetam is eliminated primarily by metabolism and by excretion in the urine.
Slovenian: Brivaracetam se primarno izloča s presnovo in izločanjem z urinom.
English: AUC 19 % ↓ No dose adjustment required
Slovenian: AUC 19 % ↓ Prilagoditev odmerka ni potrebna.
English: Multipack: 168 (3 packs of 56) film-coated tablets
Slovenian: Večkratno pakiranje: 168 (3 pakiranja po 56) filmsko obloženih tablet
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).
Slovenian: 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).
English: Contains sodium acetate (trihydrate), sodium chloride.
Slovenian: Vsebuje natrijev acetat (trihidrat), natrijev klorid.
English: INTERMEDIATE CARTON WITHIN MULTIPACK (3 PACKS OF 56 FILM-COATED TABLETS) (WITHOUT BLUE BOX)
Slovenian: VMESNA ŠKATLA ZNOTRAJ VEČKRATNEGA PAKIRANJA (3 PAKIRANJA PO 56 FILMSKO OBLOŽENIH TABLET) (BREZ MODREGA OKENCA)
English: Syringe 10 ml and 5ml (as symbols - only for the outer carton)
Slovenian: Brizga 10 ml in 5 ml (v obliki simbola - samo za škatlo)
English: - At the request of the European Medicines Agency;
Slovenian: Posodobljen RMP je treba predložiti: • na zahtevo Evropske agencije za zdravila;
English: The most frequently reported adverse reactions (>10 %) with brivaracetam treatment were: somnolence (14.3 %) and dizziness (11.0 %).
Slovenian: Najpogosteje poročana neželena učinka (> 10 %) pri zdravljenju z brivaracetamom sta bila somnolenca (14,3 %) in omotica (11,0 %).
English: Effects of brivaracetam on other medicinal products Brivaracetam given 50 or 150 mg/day did not affect the AUC of midazolam (metabolised by CYP3A4).
Slovenian: Brivaracetam v odmerku 50 ali 150 mg/dan ni vplival na AUC midazolama (ki ga presnavlja CYP3A4).
English: Brivaracetam may also be initiated at 100 mg/day based on physician assessment of need for seizure control.
Slovenian: Brivaracetam je možno uvesti tudi s 100 mg/dan na podlagi zdravnikove ocene potrebe po obvladovanju epileptičnih napadov.
English: The 5 ml oral syringe has 2 overlapping graduations: in steps of 0.25 ml and in steps of 0.1 ml.
Slovenian: 5-ml peroralna odmerna brizga ima 2 prekrivajoči se graduaciji: v korakih po 0,25-ml in v korakih po 0,1 ml.
English: In adults, a 50 mg/day starting dose should be considered.
Slovenian: Pri odraslih je treba razmisliti o začetnem odmerku 50 mg/dan.
English: Two oral syringes (5 ml and 10 ml) are included in the carton.
Slovenian: V škatli sta priloženi dve peroralni brizgi (5 ml in 10 ml).
English: - Periodic safety update reports
Slovenian: • Redno posodobljena poročila o varnosti zdravila (PSUR)
English: - You can switch between taking Briviact orally to the solution for injection/infusion, and the other way around.
Slovenian: - Lahko prehajate iz peroralnega jemanja zdravila Briviact na raztopino za injiciranje in obratno.
English: Any unused medicinal product, neat or diluted, or waste material should be disposed of in accordance with local requirements.
Slovenian: Neuporabljeno zdravilo (nerazredčeno ali razredčeno) ali odpadni material zavrzite v skladu z lokalnimi predpisi.
English: Therapeutic dose range
Slovenian: Razpon terapevtskega odmerka
English: - The recommended dose is from 0.5 mg to 2 mg for each kg of bodyweight, taken twice a day.
Slovenian: - Priporočeni odmerek je od 0,5 mg do 2 mg za vsak kg telesne mase dvakrat na dan.
English: Talk to your doctor or pharmacist before taking Briviact if: - You have thoughts of harming or killing yourself.
Slovenian: Pred jemanjem zdravila Briviact se posvetujte z zdravnikom ali farmacevtom če: - razmišljate o samopoškodovanju ali samomoru.
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.
Slovenian: 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.
English: Brivaracetam did not show any dependence potential in rats.
Slovenian: Brivaracetam pri podganah ni kazal potenciala za razvoj odvisnosti.
English: AUC 21 % ↓ No dose adjustment required
Slovenian: AUC 21 % ↓ Prilagoditev odmerka ni potrebna.
English: The recommended maintenance dose is 2 mg/kg/day.
Slovenian: Priporočeni vzdrževalni odmerek je 2 mg/kg/dan.
English: Solution for injection/infusion (injection/infusion) Clear, colourless, solution.
Slovenian: raztopina za injiciranje/infundiranje (injekcija/infuzija) Bistra, brezbarvna raztopina.
English: 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.
Slovenian: 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.
English: Follow these steps the first time you take Briviact: - Take off the adaptor from the oral syringe (figure 2).
Slovenian: Ko prvič vzamete zdravilo Briviact, upoštevajte naslednje korake: - Snemite adapter s peroralne brizge (slika 2).