FrancophonIA/ELRC3.0 huggingface dataset:
English: 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.
Slovenian: 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.
English: The 10 ml oral syringe has only one graduation in steps of 0.25 ml.
Slovenian: 10-ml peroralna odmerna brizga ima samo eno graduacijo v korakih po 0,25 ml.
English: The main disposition pathway of brivaracetam is by CYP-independent hydrolysis.
Slovenian: Glavna presnovna pot brivaracetama je od CYP neodvisna hidroliza.
English: 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.
Slovenian: 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.
English: 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.
Slovenian: faze (44 od teh z epilepsijo), je bilo 100 starih 65-74 let, 30 pa 75-84 let.
English: How long to take Briviact for
Slovenian: Kako dolgo jemati zdravilo Briviact
English: 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.
Slovenian: 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.
English: In vitro, brivaracetam did ot induce CYP1A2.
Slovenian: In vitro brivaracetam ni induciral CYP1A2.
English: Animal studies did not detect any teratogenic potential of brivaracetam (see section 5.3).
Slovenian: V študijah na živalih niso zaznali teratogenega potenciala brivaracetama (glejte poglavje 5.3).
English: Intravenous bolus: may be administered directly without dilution Intravenous infusion: may be administered over 15 minutes in a compatible diluent
Slovenian: intravenski bolus: lahko dajete neposredno brez redčenja; intravenska infuzija: lahko razredčite s kompatibilnim topilom in dajete kot 15-minutno intravensko infuzijo.
English: 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).
Slovenian: 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).
English: There is no data on placental transfer in humans, but brivaracetam was shown to readily cross the placenta in rats (see section 5.3).
Slovenian: Ni podatkov o prehajanju skozi placento pri ljudeh, vendar je bilo pri podganah dokazano, da brivaracetam zlahka prehaja skozi placento (glejte poglavje 5.3).
English: CYP2B6 induction has not been investigated in vivo and brivaracetam may decrease plasma concentrations of medicinal products metabolised by CYP2B6 (e.g. efavirenz).
Slovenian: In vivo indukcije CYP2B6 niso preučevali in brivaracetam lahko zmanjša plazemske koncentracije učinkovin, ki se presnavljajo s CYP2B6 (npr. efavirenz).
English: As from the 0.1 ml graduation mark, each graduation corresponds to 0.1 ml which is 1 mg of brivaracetam.
Slovenian: Od graduacijske oznake 0,1 ml naprej vsaka graduacijska oznaka ustreza 0,1 ml, kar je 1 mg brivaracetama.
English: Brivaracetam may be initiated with either intravenous or oral administration.
Slovenian: Zdravljenje z brivaracetamom lahko začnemo z intravensko ali peroralno uporabo.
English: No clinical data are available in paediatric patients with hepatic impairment.
Slovenian: Klinični podatki za pediatrične bolnike z okvaro jeter niso na voljo.
English: • Packs of 14, 56 film-coated tablets and in multipacks containing 168 (3 packs of 56) filmcoated tablets in PVC/PCTFE - Aluminium blisters
Slovenian: • 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.
English: In vitro, the hydroxylation of brivaracetam is mediated primarily by CYP2C19.
Slovenian: Hidroksilacija brivaracetama in vitro je primarno posredovana s CYP2C19.
English: There were no adverse effects on CNS function, neuropathological and brain histopathological examination.
Slovenian: Neželenih učinkov na delovanje centralnega živčnega sistema ni bilo, prav tako niso bili opaženi pri nevropatoloških in histopatoloških preiskavah možganov.
English: Further seizure frequency reduction is obtained by increasing the dose to 100 mg/day and reaches a plateau at 200 mg/day.
Slovenian: Nadaljnje zmanjšanje pogostnosti epileptičnih napadov je bilo doseženo s povečanjem odmerka na 100 mg/dan in doseže konstantno raven pri 200 mg/dan.
English: Adverse reactions with intravenous administration generally appeared to be similar to those observed with oral administration.
Slovenian: Neželeni učinki pri intravenski uporabi so bili v splošnem podobni tistim, ki so jih opazili pri peroralni uporabi.
English: Reactions suggestive of immediate (Type I) hypersensitivity have been reported in a small number of brivaracetam patients (9/3022) during clinical development.
Slovenian: Med kliničnim razvojem zdravila so pri majhnem številu bolnikov, ki so jemali brivaracetam (9/3022) poročali o reakcijah, ki so kazale na takojšnjo preobčutljivost (tip I).
English: As in adults, brivaracetam solution for injection/infusion is an alternative route of administration for patients when oral administration is temporarily not feasible.
Slovenian: Kot pri odraslih je raztopina brivaracetama za injiciranje/infundiranje alternativna pot dajanja bolnikom, ko peroralna uporaba ni izvedljiva.
English: In the clinical studies, although the numbers were limited, there was no observed benefit of brivaracetam versus placebo in patients taking levetiracetam concurrently.
Slovenian: V kliničnih študijah, kljub njihovemu omejenemu številu, niso opazili koristi brivaracetama v primerjavi s placebom pri bolnikih, ki so sočasno jemali levetiracetam.
English: Briviact may be diluted with the following solutions: sodium chloride 9 mg/ml (0.9 %), glucose 50 mg/ml (5 %) solution for injection or lactated Ringer's solution.
Slovenian: Zdravilo Briviact lahko razredčite z naslednjimi raztopinami: natrijev klorid 9 mg/ml (0,9 %), glukoza 50 mg/ml (5 %) raztopina za injiciranje ali Ringerjeva raztopina z laktatom.
English: In vitro, Brivaracetam inhibits OAT3 with a half maximal inhibitory concentration 42-fold higher than the Cmax at the highest clinical dose.
Slovenian: Brivaracetam zavira OAT3 s polovico največje zaviralne koncentracije, ki je 42-krat večja kot Cmax pri največjem kliničnem odmerku.
English: Briviact contains lactose
Slovenian: Zdravilo Briviact vsebuje laktozo
English: briviact 10 mg/ml (Only for outer carton)
Slovenian: briviact 10 mg/ml (Samo za škatlo.)
English: No human data on the effect of brivaracetam on fertility are available.
Slovenian: O vplivu brivaracetama na plodnost pri ljudeh ni podatkov.
English: Contains croscarmellose sodium, lactose monohydrate and lactose anhydrous.
Slovenian: Vsebuje premrežen natrijev karmelozat, laktozo monohidrat in brezvodno laktozo.
English: Co-administration of brivaracetam (100 mg/day) with an oral contraceptive containing ethinylestradiol (0.03 mg) and levonorgestrel (0.15 mg) did not influence the pharmacokinetics of either substance.
Slovenian: Sočasno dajanje brivaracetama (100 mg/dan) in peroralnih kontraceptivov, ki so vsebovali etinilestradiol (0,03 mg) in levonorgestrel (0,15 mg), ni vplivalo na farmakokinetiko nobene od učinkovin.
English: Antiepileptic drugs
Slovenian: Antiepileptiki
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).
Slovenian: Pri študijah toksikologije s ponavljajočimi se odmerki pri psih, z izpostavljenostjo podobno klinični plazemski AUC, so ugotovili hepatotoksične učinke (predvsem porfirijo), vendar tega v kliničnih študijah niso opazili.
English: Brivaracetam solution for injection/infusion is an alternative for patients when oral administration is temporarily not feasible.
Slovenian: Raztopina brivaracetama za injiciranje/infundiranje je alternativa za bolnike, ko peroralno dajanje začasno ni mogoče.
English: There are limited clinical data on the use of brivaracetam in patients with pre-existing hepatic impairment.
Slovenian: Kliničnih podatkov o uporabi brivaracetama pri bolnikih z obstoječo okvaro jeter ni veliko.
English: Currently, no clinical data are available in neonates.
Slovenian: Trenutno kliničnih podatkov za novorojenčke ni na voljo.
English: The recommended maintenance dose is 100 mg/day.
Slovenian: Priporočeni vzdrževalni odmerek je 100 mg/dan.
English: The other ingredients are: sodium acetate (trihydrate), acetic acid, glacial, sodium chloride, water for injection.
Slovenian: Druge sestavine zdravila so: natrijev acetat (trihidrat), koncentrirana ocetna kislina (ledocet), natrijev klorid, voda za injekcije.
English: When brivaracetam was coadministered at a dose of 400 mg/day (twice the recommended maximum daily dose) with an oral contraceptive containing ethinylestradiol (0.03 mg) and levonorgestrel (0.15 mg), a reduction in estrogen and progestin AUCs of 27 % and 23 %, respectively, was observed without impact on suppression of ovulation.
Slovenian: Pri sočasnem dajanju brivaracetama v odmerku 400 mg/dan (dvakratni največji priporočeni dnevni odmerek) s peroralnimi kontraceptivi, ki so vsebovali etinilestradiol (0,03 mg) in levonorgestrel (0,15 mg), so opazili zmanjšanje AUC za estrogen in progestin za 27 % oz. 23 %, vendar to ni vplivalo na zaustavitev ovulacije.
English: The solution for injection/infusion contains 0.83 mmol (or 19.14 mg) sodium per vial.
Slovenian: Raztopina za injiciranje/infundiranje vsebuje 0,83 mmol (ali 19,14 mg) natrija na vialo.
English: Based on individual patient response, the dose may be adjusted in the effective dose range of 1 mg/kg/day and 4 mg/kg/day.
Slovenian: Na podlagi odziva posameznega bolnika je mogoče odmerek prilagajati v razponu učinkovitega odmerka 1 mg/ kg/dan in 4 mg/kg/dan.
English: The minimum extractible volume is 0.25 ml which is 2.5 mg of brivaracetam.
Slovenian: Najmanjša količina, ki jo je mogoče izvleči, je 0,25 ml, kar pomeni 2,5 mg brivaracetama.
English: None a based on a study involving the administration of a supratherapeutic dose of 400 mg/day brivaracetam
Slovenian: Nič a temelji na študiji, ki vključuje dajanje brivaracetama, kot supraterapevtskega odmerka 400 mg/dan Karbamazepin
English: UCB Pharma S.A., Chemin du Foriest, B-1420 Braine-l'Alleud, Belgium.
Slovenian: UCB Pharma S.A., Chemin du Foriest, B-1420 Braine-l'Alleud, Belgija
English: From entry into the randomized studies,5.3 % of the subjects exposed to brivaracetam for 6 months (n=1,500) were seizure free compared to 4.6 % and 3.7 % for subjects exposed for 12 months (n=1,188) and 24 months (n=847), respectively.
Slovenian: Od začetka sodelovanja v randomiziranih študijah je bilo 5,3 % preskušancev, ki so bili izpostavljeni brivaracetamu 6 mesecev (n=1500), brez napadov, v primerjavi s 4,6 % oziroma 3,7 % za preskušance, ki so bili izpostavljeni 12 mesecev (n=1188) oziroma 24 mesecev (n=847).
English: Briviact solution for injection/infusion contains 0.83 mmol (or 19.14 mg) sodium per vial.
Slovenian: Zdravilo Briviact raztopina za injiciranje/infundiranje vsebuje 0,83 mmol (ali 19,14 mg) natrija na vialo.
English: Somnolence and fatigue (8.2 %) were reported at a higher incidence with increasing dose.
Slovenian: Z večanjem odmerka so poročali o povečani incidenci somnolence in utrujenosti (8,2 %).
English: In vitro studies have shown that brivaracetam exhibits little or no inhibition of CYP450 isoforms except for CYP2C19.
Slovenian: Študije in vitro so pokazale, da brivaracetam malo zavira ali ne zavira, izooblike CYP450 razen CYP2C19.
English: Oral dosing syringe (10 ml graduated every 0.25 ml) with an adaptor, recommended for use by patients weighing more than 20 kg or needing a dose between 50 mg and 100 mg (5 ml to 10 ml) brivaracetam per administration.
Slovenian: Peroralna odmerna brizga (10 ml graduirana na vsaki 0,25 ml) z adapterjem se priporoča za uporabo pri bolnikih s telesno maso več kot 20 kg ali bolnikih, ki potrebujejo odmerek med 50 mg in 100 mg (5 ml do 10 ml) brivaracetama na dajanje.
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.
Slovenian: Dnevni odmerek vzemite razdeljen na dva enaka odmerka - enega zjutraj in enega zvečer, vsak dan ob približno enakem času.
English: Allée de la Recherche 60 (address only for outer carton) B-1070 Brussels
Slovenian: Allée de la Recherche 60 (naslov samo za škatlo) B-1070 Brussels
English: 1 mg/kg/day (or 2 mg/kg/day)*
Slovenian: 1 mg/kg/dan (ali 2 mg/kg/dan)*
English: Dose taken twice daily for children from 4 years of age weighing less than 50 kg.
Slovenian: Odmerek se jemlje dvakrat na dan za otroke od 4 leta starosti,
English: A 40 % decrease in steady-state plasma concentration has been estimated across a body weight range from 46 kg to 115 kg.
Slovenian: Pri razponu telesne mase od 46 do 115 kg so ocenili približno 40 % zmanjšanje plazemske koncentracije v dinamičnem ravnovesju.
English: Convulsion, vertigo
Slovenian: Konvulzije, vrtoglavica
English: Contains sodium citrate, carmellose sodium, methyl parahydroxybenzoate (E218), sorbitol liquid and glycerol (E422).
Slovenian: Vsebuje natrijev citrat, natrijev karmelozat, metilparahidroksibenzoat (E218), tekoči sorbitol in glicerol (E422).
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.
Slovenian: Priporoča se, da starš ali negovalec zdravilo Briviact peroralno raztopino aplicira z merilnim pripomočkom, priloženim v škatli (peroralna odmerna brizga z 10 ml ali 5 ml).
English: Treatment of an overdose should include general supportive measures.
Slovenian: Specifičnega antidota za preveliko odmerjanje brivaracetama ni. Zdravljenje prevelikega odmerka naj vključuje splošne podporne ukrepe.
English: Briviact 10 mg/ml solution for injection/infusion 5 ml vial is packed in a carton box of 10 vials.
Slovenian: Zdravilo Briviact 10 mg/ml raztopina za injiciranje/infundiranje je na voljo v 5 ml vialah, v škatli s po 10 vialami.
English: Improvement in the median percent reduction in seizure frequency per 28 days has been observed in patients with type IC seizure (secondary generalized tonic-clonic seizures) at baseline treated with brivaracetam (66.6 % (n=62), 61.2 % (n=100) and 82.1 % (n=75) of the patients on brivaracetam 50 mg/day, 100 mg/day and 200 mg/day respectively as compared to placebo 33.3 % (n=115)).
Slovenian: Pri bolnikih z napadi tipa IC (sekundarni generalizirani tonično-klonični napadi), zdravljenih z brivaracetamom, so v primerjavi z izhodiščem opazili izboljšanje v mediani odstotka zmanjšanja pogostnosti napadov na 28 dni (pri 66,6 % (n=62), 61,2 % (n=100) in 82,1 % (n=75) bolnikov, ki so prejemali 50 mg/dan, 100 mg/dan in 200 mg/dan, v primerjavi s 33,3 % (n=115) bolnikov, ki so prejemali placebo).
English: The medicine is injected slowly into your vein or given as an infusion (drip) over 15 minutes.
Slovenian: Zdravilo boste prejeli s počasnim injiciranjem v žilo ali pa s 15-minutnim infundiranjem (s kapanjem).
English: • Packs of 14 x 1 and 100 x 1 film-coated tablet in PVC/PCTFE - Aluminium blisters
Slovenian: • Pakiranje po 14 x 1 in 100 x 1 filmsko obložena tableta v pretisnih omotih PVC/PCTFEaluminij.
English: There is limited clinical experience with brivaracetam overdose in humans.
Slovenian: Klinične izkušnje s prevelikim odmerjanjem brivaracetama pri ljudeh so omejene.
English: 50 mg/day 100 mg/day 200 mg/day
Slovenian: 50 mg/dan 100 mg/dan 200 mg/dan
English: Brivaracetam film-coated tablets contain lactose.
Slovenian: Filmsko obložene tablete brivaracetama vsebujejo laktozo.
English: Brivaracetam has not been studied in patients undergoing hemodialysis (see section 4.2).
Slovenian: Brivaracetama pri bolnikih, ki so na hemodializi, niso preučevali (glejte poglavje 4.2).
English: If you are not sure, talk to your doctor or pharmacist before taking Briviact.
Slovenian: Če niste prepričani, se pred jemanjem zdravila Briviact posvetujte z zdravnikom ali farmacevtom.
English: - Do not drive, cycle or use any tools or machines until you know how the medicine affects you.
Slovenian: - Dokler ne veste, kako to zdravilo vpliva na vas, ne smete voziti avtomobila ali kolesa oziroma upravljati z orodji ali stroji.
English: Croscarmellose sodium, lactose monohydrate, betadex, lactose anhydrous, magnesium stearate
Slovenian: Jedro premrežen natrijev karmelozat, laktoza monohidrat, betadeks, brezvodna laktoza, magnezijev stearat
English: As from the 1 ml graduation mark, each graduation corresponds to 0.25 ml which is 2.5 mg of brivaracetam.
Slovenian: Od graduacijske oznake 1 ml naprej vsaka graduacijska oznaka ustreza 0,25 ml, kar je 2,5 mg brivaracetama.
English: The minimum extractible volume is 1 ml which is 10 mg of brivaracetam.
Slovenian: Najmanjša količina, ki jo je mogoče izvleči, je 1 ml, kar pomeni 10 mg brivaracetama.
English: What you need to know before you use Briviact 3.
Slovenian: Kaj morate vedeti, preden boste uporabili zdravilo Briviact 3.
English: 50 - 200 mg/day
Slovenian: 50-200 mg/dan
English: Children (≥4 years) and adolescents ≥50 kg Administered in 2 equally divided doses
Slovenian: Otroci (≥ 4 leta) in mladostniki ≥ 50 kg odmerja se razdeljen na 2 enaka odmerka
English: Oral dosing syringe (5 ml graduated every 0.1 ml) with an adaptor, recommended for use by patients weighing less than 20 kg or needing a maximum of 50 mg (5 ml) brivaracetam per administration.
Slovenian: Peroralna odmerna brizga (5 ml graduirana na vsaki 0,1 ml) z adapterjem se priporoča za uporabo pri bolnikih s telesno maso manj kot 20 kg ali bolnikih, ki potrebujejo največ 50 mg (5 ml) brivaracetama na dajanje.
English: Diluents - Sodium chloride 9 mg/ml (0.9 %) solution for injection - Glucose 50 mg/ml (5 %) solution for injection - Lactated Ringer's solution for injection.
Slovenian: Raztopine: - natrijev klorid 9 mg/ml (0,9 %) raztopina za injiciranje - glukoza 50 mg/ml (5 %) raztopina za injiciranje - Ringerjeva raztopina z laktatom za injiciranje
English: n= 96 n= 101
Slovenian: n = 101
English: Allée de la Recherche 60 B-1070 Brussels Belgium
Slovenian: Allée de la Recherche 60 B-1070 Brussels Belgija
English: In the open label, uncontrolled, long-term studies suicidal ideation was reported in 4.7 % of paediatric patients (more common in adolescents) compared with 2.4 % of adults and behavioural disorders were reported in 24.8 % of paediatric patients compared with 15.1 % of adults.
Slovenian: Varnostni profil za brivaracetam, ki so ga opazili pri otrocih, je bil skladen z varnostnim profilom, ki so ga opazili pri odraslih.V odprtih, nenadzorovanih, dolgoročnih študijah so o samomorilnih mislih poročali pri 4,7 % pediatričnih bolnikov (pogosteje pri mladostnikih) v primerjavi z 2,4 % odraslih in o vedenjskih motnjah so poročali pri 24,8 % pediatričnih bolnikov v primerjavi s 15,1 % odraslih.Večina dogodkov je bila po intenzivnosti blagih ali zmernih, dogodki niso bili resni in zaradi njih ni bilo treba prekiniti jemanja študijskega zdravila.
English: Gender There are no clinically relevant differences in the pharmacokinetics of brivaracetam by gender.
Slovenian: Spol Pri farmakokinetiki brivaracetama ni klinično pomembnih razlik med spoloma.
English: No clinical data are available in neonates.
Slovenian: Klinični podatki za novorojenčke niso na voljo.
English: 50 mg/5 ml 10 vials solution for injection/infusion
Slovenian: 50 mg/5 ml 10 vial raztopine za injiciranje/infundiranje
English: Driving and using machines - You may feel sleepy, dizzy or tired while taking Briviact.
Slovenian: Vpliv na sposobnost upravljanja vozil in strojev - Ko jemljete zdravilo Briviact, boste morda zaspani, omotični ali utrujeni.
English: Nausea, vomiting, constipation
Slovenian: Navzeja, bruhanje, zaprtost
English: The other ingredients are: sodium citrate, citric acid anhydrous, methyl parahydroxybenzoate (E218), carmellose sodium, sucralose, sorbitol liquid, glycerol (E422), raspberry flavour, water, purified.
Slovenian: Druge sestavine so: natrijev citrat, brezvodna citronska kislina, metilparahidroksibenzoat (E218), natrijev karmelozat, sukraloza, tekoči sorbitol, glicerol (E422), aroma maline, prečiščena voda.
English: Each millilitre (ml) contains 10 milligrams (mg) brivaracetam.
Slovenian: En mililiter (ml) vsebuje 10 miligramov (mg) brivaracetama.
English: How to store Briviact 6.
Slovenian: Shranjevanje zdravila Briviact 6.
English: Common: may affect up to 1 in 10 people - flu - feeling very tired (fatigue) - convulsion, a feeling of ‘spinning' (vertigo) - feeling and being sick, constipation - pain or discomfort at the injection or infusion site - depression, anxiety, not being able to sleep (insomnia), irritability - infections of the nose and throat (such as the ‘common cold'), cough - decrease appetite
Slovenian: Pogosti: pojavijo se lahko pri največ 1 od 10 bolnikov - gripa - občutek hude utrujenosti - konvulzija, občutek vrtenja (vrtoglavica) - občutek slabosti in bruhanje, zaprtost - bolečina ali nelagodje na mestu injiciranja ali infundiranja - depresija, tesnoba, nespečnost (insomnija), razdražljivost - okužbe nosu in grla (npr. prehlad), kašelj - zmanjšanje apetita
English: People with liver problems If you have problems with your liver: - As an adult, adolescent or child weighing 50 kg or more, the maximum dose you will take is 75 mg twice a day.
Slovenian: Bolniki, ki imajo težave z jetri Če imate težave z jetri: - Kot odrasli, mladostnik ali otrok, ki tehta 50 kg ali več, je največji odmerek, ki ga lahko vzamete, 75 mg dvakrat na dan. - Kot otrok ali mladostnik, ki tehta manj kot 50 kg, je največji odmerek, ki ga lahko vzamete, 1,5 mg za vsak kg telesne mase dvakrat na dan.
English: The pharmacokinetics of brivaracetam was not significantly affected by race (Caucasian, Asian) in a population pharmacokinetic modeling from epilepsy patients.
Slovenian: Rasa (belci, Azijci) ni pomembno vplivala na farmakokinetiko brivaracetama v modeliranju populacijske farmakokinetike pri bolnikih z epilepsijo.
English: Type I hypersensitivity
Slovenian: Preobčutljivost tipa I
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.
Slovenian: Pri opicah so se znaki vpliva na centralni živčni sistem (ležanje, izguba ravnotežja, nerodni gibi) pojavili pri 64-krat višji od kliničnega Cmax.
English: What Briviact looks like and contents of the pack Briviact 10 mg are white to off-white, round, film-coated tablets of 6.5 mm in diameter and debossed with ‘u10' on one side.
Slovenian: Izgled zdravila Briviact in vsebina pakiranja Tablete zdravila Briviact 10 mg so bele do umazano bele, okrogle, filmsko obložene tablete s premerom 6,5 mm in vtisnjeno oznako u10 na eni strani.