FrancophonIA/ELRC3.0 huggingface dataset:
English: The 300 ml glass bottle of Briviact is packed in a cardboard box containing a 10 ml oral syringe and a 5 ml oral syringe and an adaptor for the syringe.
Slovenian: 300 ml steklenica zdravila Briviact je na voljo v škatli, ki vsebuje 10-ml peroralno brizgo in 5-ml peroralno brizgo in adapter za brizgo.
English: In the table below, adverse reactions, which were identified based on review of the three placebocontrolled, fixed-dose studies safety database in subjects ≥ 16 years of age, are listed by System Organ Class and frequency.
Slovenian: Spodnja preglednica prikazuje neželene učinke, ki so bili ugotovljeni po pregledu baze podatkov o varnosti iz treh s placebom nadzorovanih kliničnih študij s stalnim odmerkom pri preskušancih, starih ≥ 16 let.
English: For children weighing 50 kg or greater the brivaracetam starting dose was 50 mg/day and depending on response and tolerability, the dose was increased up to a maximum of 200 mg/day by weekly increments of 50 mg/day.
Slovenian: Za otroke, ki so tehtali 50 kg ali več, je bil začetni odmerek brivaracetama 50 mg/dan, ki so ga glede na odziv in prenašanje povečali do največ 200 mg/dan v tedenskih korakih po 50 mg/dan.
English: 10 mg/ml solution for injection/infusion is packed in 6 ml nominal capacity glass vials (type I) with siliconized bromobutyl rubber stoppers and sealed with an aluminium/polypropylene tear off cap. Each single use vial contains an extractable volume of not less than 5.0 ml of solution for injection/infusion.
Slovenian: Raztopina za injiciranje/infundiranje, 10 mg/ml, je na voljo v stekleni viali (tip I) z nominalno prostornino 6 ml, z zamaškom iz silikonizirane brombutilne gume, zaprtim z zaporko na poteg iz aluminij/polipropilena.
English: The dose should be administered in two equally divided doses, once in the morning and once in the evening.
Slovenian: Odmerek je treba dajati razdeljen na dva enaka odmerka, enkrat zjutraj in enkrat zvečer.
English: Children and adolescents weighing less than 50 kg - The recommended dose is from 0.5 mg to 2 mg for each kg of bodyweight, taken twice a day.
Slovenian: Otroci in mladostniki, ki tehtajo manj kot 50 kg - Priporočeni odmerek je od 0,5 mg do 2 mg za vsak kg telesne mase dvakrat na dan.
English: Adults, adolescents and children weighing 50 kg or more - The recommended dose is from 25 mg to 100 mg taken twice a day.
Slovenian: Odrasli, mladostniki in otroci, ki tehtajo 50 kg ali več - Priporočeni odmerek je od 25 mg do 100 mg dvakrat na dan.
English: - Briviact may be diluted before it is injected by your doctor or nurse.
Slovenian: - Zdravilo Briviact lahko zdravnik ali medicinska sestra razredči pred injiciranjem.
English: Suicidal ideation, psychotic disorder, aggression, agitation Nervous system disorders Very common Dizziness, somnolence Common
Slovenian: Samomorilno razmišljanje, psihotične motnje, agresija, agitacija
English: n = 252 n = 249
Slovenian: n = 252
English: Briviact is used in adults, adolescents and children from 4 years of age.
Slovenian: Za kaj uporabljamo zdravilo Briviact - Zdravilo Briviact se uporablja pri odraslih, mladostnikih in otrocih od 4. leta starosti.
English: - You have liver problems - your doctor may need to adjust your dose.
Slovenian: Če imate kadar koli take misli, se takoj posvetujte z zdravnikom; - imate težave z jetri vam bo zdravnik morda moral prilagoditi odmerek.
English: Pharmacokinetic/pharmacodynamics relationship
Slovenian: Povezava med farmakokinetiko/farmakodinamiko
English: Suicidal ideation has been reported in 0.3 % (3/1099) brivaracetam patients and 0.7 % (3/459) placebo patients.
Slovenian: O samomorilnem razmišljanju so poročali pri 0,3 % (3/1099) bolnikov, ki so jemali brivaracetam, in pri 0,7 % (3/459) bolnikov, ki so jemali placebo.
English: Table 1: Pharmacokinetic interactions between brivaracetam and other AEDs AED coadministered Influence of AED on brivaracetam plasma concentration
Slovenian: Preglednica 1: Farmakokinetične interakcije med brivaracetamom in drugimi antiepileptiki Sočasno uporabljeni antiepileptiki
English: Briviact oral solution is provided with a 5 ml and a 10 ml oral dosing syringe with their adaptor.
Slovenian: Peroralna raztopina zdravila Briviact je na voljo s peroralno odmerno brizgo 5 ml in 10 ml z adapterjem.
English: The efficacy of brivaracetam in monotherapy has not been established.
Slovenian: Učinkovitost brivaracetama pri samostojnem zdravljenju ni bila ugotovljena.
English: - Then take your next dose at the time you would normally take it. - Do not take a double dose to make up for a forgotten dose.
Slovenian: - Ne vzemite dvojnega odmerka, če ste pozabili vzeti prejšnji odmerek.
English: Neutropenia has been reported in 0.5 % (6/1099) brivaracetam patients and 0 % (0/459) placebo patients.
Slovenian: O nevtropeniji so poročali pri 0,5 % (6/1099) bolnikov, ki so jemali brivaracetam, in pri 0 % (0/459) bolnikov, ki so jemali placebo.
English: No dose adjustment is needed in patients with impaired renal function (see section 5.2).
Slovenian: Za bolnike z okvarjenim delovanjem ledvic prilagoditev odmerka ni potrebna (glejte poglavje 5.2).
English: The discontinuation rate due to adverse reactions was 3.5 %, 3.4 % and 4.0 % for patients randomized to brivaracetam at respectively the dose of 50 mg/day, 100 mg/day and 200 mg/day and 1.7% for patients randomized to placebo.
Slovenian: Stopnja prekinitve zdravljenja zaradi neželenih učinkov je bila 3,5 %, 3,4 % in 4,0 % pri bolnikih, randomiziranih na brivaracetam z odmerki 50 mg/dan, 100 mg/dan in 200 mg/dan, in 1,7 % pri bolnikih, ki so bili randomizirani na zdravljenje s placebom.
English: Based on individual patient response, the dose may be adjusted in the effective dose range of 50 mg/day and 200 mg/day.
Slovenian: Na podlagi odziva posameznega bolnika je mogoče odmerek prilagajati v razponu učinkovitega odmerka 50 mg/dan in 200 mg/dan.
English: How to use Briviact
Slovenian: Kako uporabljati zdravilo Briviact
English: In rats, there was no effect on fertility with brivaracetam (see section 5.3).
Slovenian: Pri podganah brivaracetam ni vplival na plodnost (glejte poglavje 5.3).
English: What you need to know before you take Briviact 3.
Slovenian: Kaj morate vedeti, preden boste vzeli zdravilo Briviact 3.
English: A nasogastric tube or a gastrostomy tube may be used when administering brivaracetam oral solution.
Slovenian: Za dajanje peroralne raztopine brivaracetama se lahko uporablja nazogastrična sonda ali sonda za gastrostomijo.
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 - depression, anxiety, not being able to sleep (insomnia), irritability - infections of the nose and throat (such as the ‘common cold'), cough - decreased 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 - depresija, tesnoba, nespečnost (insomnija), razdražljivost - okužbe nosu in grla (npr. prehlad), kašelj
English: Briviact contains sodium
Slovenian: Zdravilo Briviact vsebuje natrij
English: In clinical studies, brivaracetam was used as adjunctive therapy and when it was used with carbamazepine, it induced a dose-related increase in the concentration of the active metabolite, carbamazepine-epoxide (see section 4.5).
Slovenian: Če so ga uporabili skupaj s karbamazepinom, je sprožil z odmerkom povezano povečanje koncentracije aktivnega presnovka, karbamazepin epoksida (glejte poglavje 4.5).
English: Briviact 10 mg film-coated tablets Briviact 25 mg film-coated tablets Briviact 50 mg film-coated tablets Briviact 75 mg film-coated tablets Briviact 100 mg film-coated tablets
Slovenian: Briviact 10 mg filmsko obložene tablete Briviact 25 mg filmsko obložene tablete Briviact 50 mg filmsko obložene tablete Briviact 75 mg filmsko obložene tablete Briviact 100 mg filmsko obložene tablete
English: In clinical studies 2.5 % (4/161), 5.1 % (17/332) and 4.0% (10/249) of the patients on brivaracetam 50 mg/day, 100 mg/day and 200 mg/day respectively became seizure free during the 12-week treatment period compared with 0.5 % (2/418) on placebo.
Slovenian: V kliničnih študijah so bili pri 2,5 % (4/161), 5,1 % (17/332) in 4,0% (10/249) bolnikov, ki so prejemali brivaracetam v odmerkih po 50 mg/dan, 100 mg/dan in 200 mg/dan, napadi odpravljeni med 12-tedenskim zdravljenjem, v primerjavi z 0,5 % (2/418) pri bolnikih, ki so prejemali placebo.
English: Influence of brivaracetam on AED plasma concentration
Slovenian: Učinek brivaracetama na plazemsko koncentracijo antiepileptikov karbamazepin
English: OUTER CARTON / BOTTLE
Slovenian: ŠKATLA/ STEKLENICA
English: Oral solution Slightly viscous, clear colourless to yellowish liquid.
Slovenian: peroralna raztopina Rahlo viskozna, bistra, brezbarvna do rumenkasta tekočina.
English: What you need to know before you take Briviact
Slovenian: Kaj morate vedeti, preden boste vzeli zdravilo Briviact
English: The active substance is brivaracetam.
Slovenian: Zdravilna učinkovina je brivaracetam.
English: Each ml of solution for injection/infusion contains 10 mg brivaracetam.
Slovenian: En ml raztopine za injiciranje/infundiranje vsebuje 10 mg brivaracetama.
English: Seek advice immediately from your doctor if you are pregnant or are planning to become pregnant.
Slovenian: Če ste noseči ali načrtujete nosečnost, se takoj posvetujte z zdravnikom.
English: Based on individual patient response and tolerability, the dose may be adjusted in the dose range of 50 mg/day to 200 mg/day.
Slovenian: Glede na odziv posameznega bolnika in prenašanje se lahko odmerek prilagaja v razponu od 50 mg/dan do 200 mg/dan.
English: Briviact 10 mg film-coated tablets Briviact 25 mg film-coated tablets Briviact 50 mg film-coated tablets Briviact 75 mg film-coated tablets Briviact 100 mg film-coated tablets brivaracetam
Slovenian: Briviact 10 mg filmsko obložene tablete Briviact 25 mg filmsko obložene tablete Briviact 50 mg filmsko obložene tablete Briviact 75 mg filmsko obložene tablete Briviact 100 mg filmsko obložene tablete brivaracetam
English: Your doctor will work out the right dose for you, depending on your weight.
Slovenian: Zdravnik bo na podlagi vaše telesne mase določil pravilen odmerek za vas.
English: Valproic acid
Slovenian: Nič valprojska kislina
English: What Briviact looks like and contents of the pack Briviact 10 mg/ml oral solution is slightly viscous, clear, colourless to yellowish liquid.
Slovenian: Zdravilo Briviact 10 mg/ml peroralna raztopina je rahlo viskozna, bistra, brezbarvna do rumenkasta tekočina.
English: One full 10 ml oral dosing syringe corresponds to 100 mg of brivaracetam.
Slovenian: Ena polna 10-ml peroralna odmerna brizga ustreza 100 mg brivaracetama.
English: If you have taken more Briviact than you should, talk to your doctor.
Slovenian: Če ste vzeli večji odmerek zdravila Briviact, kot bi smeli Če ste vzeli večji odmerek zdravila Briviact, kot bi smeli, se posvetujte z zdravnikom.
English: Clonazepam
Slovenian: Nič klonazepam
English: What Briviact contains
Slovenian: Kaj vsebuje navodilo
English: In children and adolescents weighing 50 kg or greater, a 50 mg/day starting dose is recommended.
Slovenian: Pri otrocih in mladostnikih, ki tehtajo 50 kg ali več, se priporoča začetni odmerek 50 mg/dan.
English: In children and adolescents weighing less than 50 kg, a 1 mg/kg/day starting dose is recommended.
Slovenian: Pri otrocih in mladostnikih, ki tehtajo manj kot 50 kg, se priporoča začetni odmerek 1 mg/kg/dan.
English: What Briviact looks like and contents of the pack Briviact 10 mg/ml solution for injection/infusion is a clear, colourless, sterile solution.
Slovenian: Zdravilo Briviact 10 mg/ml raztopina za injiciranje/infundiranje je bistra, brezbarvna, sterilna raztopina.
English: From the pooled open-label safety and PK studies in adjunctive therapy, 149 children with POS have received brivaracetam, of whom 116 have been treated for ≥6 months, 107 for ≥12 months, 58 for ≥24 months, and 28 for ≥36 months.
Slovenian: V odprti, združeni varnostni in farmakokinetični študiji pri dopolnilnem zdravljenju, je 149 otrok s parcialnimi napadi prejelo brivaracetam, pri čemer se jih je 116 zdravilo ≥ 6 mesecev, 107 ≥ 12 mesecev, 58 ≥ 24 mesecev in 28 ≥ 36 mesecev.
English: You will take Briviact together with other medicines for epilepsy.
Slovenian: Zdravilo Briviact boste jemali skupaj z drugimi zdravili proti epilepsiji.
English: It belongs to a group of medicines called ‘anti-epileptics'.
Slovenian: To je zdravilo iz skupine antiepileptikov.
English: A decision should be made whether to discontinue breastfeeding or to discontinue brivaracetam, taking into account the benefit of the medicinal product to the mother.
Slovenian: Ob upoštevanju koristi zdravila za mater se je treba odločiti, ali naj se prekine dojenje ali jemanje brivaracetama.
English: Briviact 10 mg film-coated tablets Each 10 mg film-coated tablet contains 88 mg lactose.
Slovenian: Briviact 10 mg filmsko obložene tablete Ena 10 mg filmsko obložena tableta vsebuje 88 mg laktoze.
English: Briviact 100 mg film-coated tablets Each 100 mg film-coated tablet contains 377 mg lactose.
Slovenian: Briviact 100 mg filmsko obložene tablete Ena 100 mg filmsko obložena tableta vsebuje 377 mg laktoze.
English: Concomitant treatment with levetiracetam
Slovenian: Sočasno zdravljenje z levetiracetamom
English: - Open the bottle: press the cap and turn it anti-clockwise (figure 1).
Slovenian: Pritisnite zaporko in jo obrnite v nasprotni smeri urinega kazalca (slika 1)
English: Briviact is used together with other medicines for epilepsy.
Slovenian: - Zdravilo Briviact se uporablja skupaj z drugimi zdravili proti epilepsiji.
English: Children (from 4 years of age) and adolescents weighing less than 50 kg The recommended starting dose is 1 mg/kg/day.
Slovenian: Otroci (od 4. leta starosti) in mladostniki, ki tehtajo manj kot 50 kg Priporočeni začetni odmerek je 1 mg/kg/dan.
English: UNIQUE IDENTIFIER - 2D BARCODE Not Applicable.
Slovenian: EDINSTVENA OZNAKA - DVODIMENZIONALNA ČRTNA KODA Navedba smiselno ni potrebna
English: Briviact oral solution contains methyl parahydroxybenzoate, sodium and sorbitol Briviact oral solution contains: - methyl parahydroxybenzoate (E218) - this may cause allergic reactions (possibly delayed).
Slovenian: Zdravilo Briviact peroralna raztopina vsebuje metilparahidroksibenzoat, natrij in sorbitol Zdravilo Briviact peroralna raztopina vsebuje: - metilparahidroksibenzoat (E218) - lahko povzroči alergijske reakcije (lahko zapoznele); - 1,16 mg natrija na mililiter.
English: No adverse liver changes were seen in rats and monkeys following chronic administration of brivaracetam at 5- and 42fold the clinical AUC exposure.
Slovenian: Pri podganah in opicah po kroničnem dajanju brivaracetama pri od 5- do 42-kratni klinični izpostavljenosti AUC niso opazili neželenih učinkov na jetra.
English: Briviact 75 mg film-coated tablets Each 75 mg film-coated tablet contains 283 mg lactose.
Slovenian: Briviact 75 mg filmsko obložene tablete Ena 75 mg filmsko obložena tableta vsebuje 283 mg laktoze.
English: Briviact 50 mg film-coated tablets Each 50 mg film-coated tablet contains 189 mg lactose.
Slovenian: Briviact 50 mg filmsko obložene tablete Ena 50 mg filmsko obložena tableta vsebuje 189 mg laktoze.
English: One full 5 ml oral dosing syringe corresponds to 50 mg of brivaracetam.
Slovenian: Ena polna 5-ml peroralna odmerna brizga ustreza 50 mg brivaracetama.
English: 1 - 4 mg/kg/day
Slovenian: 1-4 mg/kg/dan
English: CYP1A, 2C8, 2C9, 2D6 and 3A4) inhibitors.
Slovenian: Testi in vitro so pokazali, da naj zaviralci CYP (npr. CYP1A, 2C8, 2C9, 2D6 in 3A4) ne bi pomembno vplivali na presnovno pot brivaracetama.
English: Exposure to brivaracetam was increased in adult patients with chronic liver disease.
Slovenian: Pri odraslih bolnikih s kronično okvaro jeter je bila izpostavljenost brivaracetamu povečana.
English: Briviact 25 mg film-coated tablets Each 25 mg film-coated tablet contains 94 mg lactose.
Slovenian: Briviact 25 mg filmsko obložene tablete Ena 25 mg filmsko obložena tableta vsebuje 94 mg laktoze.
English: How to take Briviact
Slovenian: Kako jemati zdravilo Briviact
English: Suicidal ideation and behaviour have been reported in patients treated with anti-epileptic drugs (AEDs), including brivaracetam, in several indications.
Slovenian: Pri bolnikih, ki so se zdravili z antiepileptiki, vključno z brivaracetamom, so pri večih indikacijah poročali o samomorilnem razmišljanju in vedenju.
English: Brivaracetam is not recommended in end-stage renal disease patients undergoing dialysis due to lack of data.
Slovenian: Zaradi pomanjkanje podatkov brivaracetam ni priporočen za bolnike s končno ledvično odpovedjo na dializi.
English: Elderly (65 years of age and above) No dose adjustment is needed in elderly patients (see section 5.2).
Slovenian: Pri starejših bolnikih prilagoditev odmerka ni potrebna (glejte poglavje 5.2).
English: Do not use this medicine after the expiry date which is stated on the cardboard box and bottle after EXP.
Slovenian: Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli in steklenici poleg oznake EXP. Rok uporabnosti zdravila se izteče na zadnji dan navedenega meseca.
English: (corresponding to 1.5 mg/kg/intake)
Slovenian: (ustreza 1,5 mg/kg/vnos)
English: 5 ml oral dosing syringe
Slovenian: 5-ml peroralna odmerna brizga
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.
Slovenian: Absorbira se v celoti, vezava na plazemske beljakovine je zelo nizka, ledvično izločanje sledi obsežni biotransformaciji in presnovki so farmakološko neaktivni.
English: Sodium acetate (trihydrate) Acetic acid, glacial (for pH-adjustment) Sodium chloride
Slovenian: 6.1 Seznam pomožnih snovi natrijev acetat (trihidrat) koncentrirana ocetna kislina (ledocet) (za uravnavanje pH) natrijev klorid voda za injekcije
English: Coating - 10 mg film-coated tablets: polyvinyl alcohol, titanium dioxide (E171), macrogol 3350, talc.
Slovenian: Obloga - 10 mg filmsko obložene tablete: polivinilalkohol, titanov dioksid (E171), makrogol 3350, smukec.
English: Each ml contains 10 mg brivaracetam.
Slovenian: - En ml vsebuje 10 mg brivaracetama.
English: Briviact is administered as an injection or infusion into a vein by a doctor or a nurse.
Slovenian: Zdravilo Briviact vam bosta zdravnik ali sestra dala z injiciranjem ali infundiranjem v žilo.
English: (corresponding to 0.5 mg/kg/intake)
Slovenian: (ustreza 0,5 mg/kg/vnos)
English: Treatment with levetiracetam
Slovenian: Zdravljenje z levetiracetamom
English: Children (from 4 years of age) and adolescents weighing 50 kg or more The recommended starting dose is 50mg/day.
Slovenian: Otroci (od 4. leta starosti) in mladostniki, ki tehtajo več kot 50 kg Priporočeni začetni odmerek je 50 mg/dan.
English: Briviact 100 mg are green-grey, oval, film-coated tablets of 14.5 mm x 8.1 mm and debossed with ‘u100' on one side.
Slovenian: Tablete zdravila Briviact 100 mg so zelenosive, ovalne, filmsko obložene tablete z dimenzijami 14,5 mm x 8,1 mm in vtisnjeno oznako u100 na eni strani.
English: - Briviact solution for injection/infusion is used for a short amount of time when you cannot take Briviact orally.
Slovenian: - Zdravilo Briviact raztopina za injiciranje/infundiranje se uporablja kratek čas, kadar zdravila
English: Brivaracetam is not recommended for use in monotherapy.
Slovenian: Uporaba brivaracetama pri samostojnem zdravljenju ni priporočena.
English: Briviact 10 mg/ml injection/infusion brivaracetam
Slovenian: Briviact 10 mg/ml injiciranje/infundiranje brivaracetam
English: One vial of 5 ml contains 50 mg brivaracetam.
Slovenian: Ena viala po 5 ml vsebuje 50 mg brivaracetama.
English: 10 ml oral dosing syringe
Slovenian: 10-ml peroralna odmerna brizga
English: Children (≥4 years) and adolescents <50 kg
Slovenian: Otroci (≥ 4 leta) in mladostniki < 50 kg odmerja se razdeljen na 2 enaka odmerka
English: What Briviact contains The active substance is brivaracetam.
Slovenian: Kaj vsebuje zdravilo Briviact Zdravilna učinkovina je brivaracetam.
English: Briviact 75 mg are purple, oval, film-coated tablets of 13.0 mm x 7.3 mm and debossed with ‘u75' on one side.
Slovenian: Tablete zdravila Briviact 75 mg so škrlatne, ovalne, filmsko obložene tablete z dimenzijami 13,0 mm x 7,3 mm in vtisnjeno oznako u75 na eni strani.
English: Do not use this medicine after the expiry date which is stated on the carton and vial after EXP.
Slovenian: Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli ali viali poleg oznake EXP. Rok uporabnosti zdravila se izteče na zadnji dan navedenega meseca.
English: Green-grey, oval film-coated tablets with dimensions of 14.5 mm x 8.1 mm and debossed with ‘u100' on one side.
Slovenian: Zelenosive, ovalne, filmsko obložene tablete z dimenzijami 14,5 mm x 8,1 mm in vtisnjeno oznako u100 na eni strani.
English: Briviact 75 mg film-coated tablets Each film-coated tablet contains 75 mg brivaracetam.
Slovenian: Briviact 75 mg filmsko obložene tablete Ena filmsko obložena tableta vsebuje 75 mg brivaracetama.
English: White to off-white, round film-coated tablets of 6.5 mm in diameter and debossed with ‘u10' on one side.
Slovenian: Bele do umazano bele, okrogle, filmsko obložene tablete s premerom 6,5 mm in vtisnjeno oznako u10
English: Grey, oval film-coated tablets with dimensions of 8.9 mm x 5.0 mm and debossed with ‘u25' on one side.
Slovenian: Sive, ovalne, filmsko obložene tablete z dimenzijami 8,9 mm x 5,0 mm in vtisnjeno oznako u25 na eni strani.
English: Children (from 4 years of age) and adolescents weighing 50 kg or more
Slovenian: Odrasli, mladostniki in otroci, ki tehtajo 50 kg ali več
English: Briviact 25 mg are grey, oval, film-coated tablets of 8.9 mm x 5.0 mm and debossed with ‘u25' on one side.
Slovenian: Tablete zdravila Briviact 25 mg so sive, ovalne, filmsko obložene tablete z dimenzijami 8,9 mm x 5,0 mm in vtisnjeno oznako u25 na eni strani.
English: Briviact 10 mg/ml solution for injection/infusion
Slovenian: Briviact 10 mg/ml raztopina za injiciranje/infundiranje
English: (corresponding to 2 mg/kg/intake)
Slovenian: (ustreza 2 mg/kg/vnos)
English: Briviact 75 mg film-coated tablets
Slovenian: Briviact 75 mg filmsko obložene tablete
English: n = 100 n = 99 n = 100
Slovenian: n = 100
English: Croscarmellose Sodium, Lactose monohydrate Betadex
Slovenian: 6.1 Seznam pomožnih snovi Jedro premrežen natrijev karmelozat laktoza monohidrat betadeks brezvodna laktoza magnezijev stearat
English: 0.05 ml/kg/intake
Slovenian: 0,05 ml/kg/vnos
English: Brivaracetam oral solution contains sodium.
Slovenian: Peroralna raztopina brivaracetama vsebuje natrij.
English: Zonisamide
Slovenian: Nič zonisamid
English: Yellow, oval film-coated tablets with dimensions of 11.7 mm x 6.6 mm and debossed with ‘u50' on one side.
Slovenian: Rumene, ovalne, filmsko obložene tablete z dimenzijami 11,7 mm x 6,6 mm in vtisnjeno oznako u50 na eni strani.
English: Briviact 50 mg are yellow, oval, film-coated tablets of 11.7 mm x 6.6 mm and debossed with ‘u50' on one side.
Slovenian: Tablete zdravila Briviact 50 mg so rumene, ovalne, filmsko obložene tablete z dimenzijami 11,7 mm x 6,6 mm in vtisnjeno oznako u50 na eni strani.
English: 0.1 ml/kg/intake
Slovenian: 0,1 ml/kg/vnos
English: Briviact 100 mg film-coated tablets Each film-coated tablet contains 100 mg brivaracetam.
Slovenian: Briviact 100 mg filmsko obložene tablete Ena filmsko obložena tableta vsebuje 100 mg brivaracetama.
English: Not Applicable.
Slovenian: Navedba smiselno ni potrebna.
English: Briviact contains the active substance brivaracetam.
Slovenian: Zdravilo Briviact vsebuje zdravilno učinkovino brivaracetam.
English: Volume per administration (ml) = [weight (kg) x daily dose (mg/kg/day) ] x 0.05
Slovenian: Količina na dajanje (ml) = [telesna masa (kg) x dnevni odmerek (mg/kg/dan)] x 0,05 V spodnji preglednici so količine za peroralno raztopino na vnos, odvisne od predpisanega odmerka in telesne mase.