natgillin/translations-raw huggingface dataset:
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.
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.
Influence of brivaracetam on AED plasma concentration
Učinek brivaracetama na plazemsko koncentracijo antiepileptikov karbamazepin
OUTER CARTON / BOTTLE
ŠKATLA/ STEKLENICA
Oral solution Slightly viscous, clear colourless to yellowish liquid.
peroralna raztopina Rahlo viskozna, bistra, brezbarvna do rumenkasta tekočina.
What you need to know before you take Briviact
Kaj morate vedeti, preden boste vzeli zdravilo Briviact
The active substance is brivaracetam.
Zdravilna učinkovina je brivaracetam.
Each ml of solution for injection/infusion contains 10 mg brivaracetam.
En ml raztopine za injiciranje/infundiranje vsebuje 10 mg brivaracetama.
Seek advice immediately from your doctor if you are pregnant or are planning to become pregnant.
Če ste noseči ali načrtujete nosečnost, se takoj posvetujte z zdravnikom.
Based on individual patient response and tolerability, the dose may be adjusted in the dose range of 50 mg/day to 200 mg/day.
Glede na odziv posameznega bolnika in prenašanje se lahko odmerek prilagaja v razponu od 50 mg/dan do 200 mg/dan.
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
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
Your doctor will work out the right dose for you, depending on your weight.
Zdravnik bo na podlagi vaše telesne mase določil pravilen odmerek za vas.
Valproic acid
Nič valprojska kislina
What Briviact looks like and contents of the pack Briviact 10 mg/ml oral solution is slightly viscous, clear, colourless to yellowish liquid.
Zdravilo Briviact 10 mg/ml peroralna raztopina je rahlo viskozna, bistra, brezbarvna do rumenkasta tekočina.
One full 10 ml oral dosing syringe corresponds to 100 mg of brivaracetam.
Ena polna 10-ml peroralna odmerna brizga ustreza 100 mg brivaracetama.
If you have taken more Briviact than you should, talk to your doctor.
Če ste vzeli večji odmerek zdravila Briviact, kot bi smeli Če ste vzeli večji odmerek zdravila Briviact, kot bi smeli, se posvetujte z zdravnikom.
Clonazepam
Nič klonazepam
What Briviact contains
Kaj vsebuje navodilo
In children and adolescents weighing 50 kg or greater, a 50 mg/day starting dose is recommended.
Pri otrocih in mladostnikih, ki tehtajo 50 kg ali več, se priporoča začetni odmerek 50 mg/dan.
In children and adolescents weighing less than 50 kg, a 1 mg/kg/day starting dose is recommended.
Pri otrocih in mladostnikih, ki tehtajo manj kot 50 kg, se priporoča začetni odmerek 1 mg/kg/dan.
What Briviact looks like and contents of the pack Briviact 10 mg/ml solution for injection/infusion is a clear, colourless, sterile solution.
Zdravilo Briviact 10 mg/ml raztopina za injiciranje/infundiranje je bistra, brezbarvna, sterilna raztopina.
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.
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.
You will take Briviact together with other medicines for epilepsy.
Zdravilo Briviact boste jemali skupaj z drugimi zdravili proti epilepsiji.
It belongs to a group of medicines called ‘anti-epileptics'.
To je zdravilo iz skupine antiepileptikov.
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.
Ob upoštevanju koristi zdravila za mater se je treba odločiti, ali naj se prekine dojenje ali jemanje brivaracetama.
Briviact 10 mg film-coated tablets Each 10 mg film-coated tablet contains 88 mg lactose.
Briviact 10 mg filmsko obložene tablete Ena 10 mg filmsko obložena tableta vsebuje 88 mg laktoze.
Briviact 100 mg film-coated tablets Each 100 mg film-coated tablet contains 377 mg lactose.
Briviact 100 mg filmsko obložene tablete Ena 100 mg filmsko obložena tableta vsebuje 377 mg laktoze.
Concomitant treatment with levetiracetam
Sočasno zdravljenje z levetiracetamom
- Open the bottle: press the cap and turn it anti-clockwise (figure 1).
Pritisnite zaporko in jo obrnite v nasprotni smeri urinega kazalca (slika 1)
Briviact is used together with other medicines for epilepsy.
- Zdravilo Briviact se uporablja skupaj z drugimi zdravili proti epilepsiji.
Children (from 4 years of age) and adolescents weighing less than 50 kg The recommended starting dose is 1 mg/kg/day.
Otroci (od 4. leta starosti) in mladostniki, ki tehtajo manj kot 50 kg Priporočeni začetni odmerek je 1 mg/kg/dan.
UNIQUE IDENTIFIER - 2D BARCODE Not Applicable.
EDINSTVENA OZNAKA - DVODIMENZIONALNA ČRTNA KODA Navedba smiselno ni potrebna
Briviact oral solution contains methyl parahydroxybenzoate, sodium and sorbitol Briviact oral solution contains: - methyl parahydroxybenzoate (E218) - this may cause allergic reactions (possibly delayed).
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.
No adverse liver changes were seen in rats and monkeys following chronic administration of brivaracetam at 5- and 42fold the clinical AUC exposure.
Pri podganah in opicah po kroničnem dajanju brivaracetama pri od 5- do 42-kratni klinični izpostavljenosti AUC niso opazili neželenih učinkov na jetra.
Briviact 75 mg film-coated tablets Each 75 mg film-coated tablet contains 283 mg lactose.
Briviact 75 mg filmsko obložene tablete Ena 75 mg filmsko obložena tableta vsebuje 283 mg laktoze.
Briviact 50 mg film-coated tablets Each 50 mg film-coated tablet contains 189 mg lactose.
Briviact 50 mg filmsko obložene tablete Ena 50 mg filmsko obložena tableta vsebuje 189 mg laktoze.
One full 5 ml oral dosing syringe corresponds to 50 mg of brivaracetam.
Ena polna 5-ml peroralna odmerna brizga ustreza 50 mg brivaracetama.
1 - 4 mg/kg/day
1-4 mg/kg/dan
CYP1A, 2C8, 2C9, 2D6 and 3A4) inhibitors.
Testi in vitro so pokazali, da naj zaviralci CYP (npr. CYP1A, 2C8, 2C9, 2D6 in 3A4) ne bi pomembno vplivali na presnovno pot brivaracetama.
Exposure to brivaracetam was increased in adult patients with chronic liver disease.
Pri odraslih bolnikih s kronično okvaro jeter je bila izpostavljenost brivaracetamu povečana.
Briviact 25 mg film-coated tablets Each 25 mg film-coated tablet contains 94 mg lactose.
Briviact 25 mg filmsko obložene tablete Ena 25 mg filmsko obložena tableta vsebuje 94 mg laktoze.
How to take Briviact
Kako jemati zdravilo Briviact
Suicidal ideation and behaviour have been reported in patients treated with anti-epileptic drugs (AEDs), including brivaracetam, in several indications.
Pri bolnikih, ki so se zdravili z antiepileptiki, vključno z brivaracetamom, so pri večih indikacijah poročali o samomorilnem razmišljanju in vedenju.
Brivaracetam is not recommended in end-stage renal disease patients undergoing dialysis due to lack of data.
Zaradi pomanjkanje podatkov brivaracetam ni priporočen za bolnike s končno ledvično odpovedjo na dializi.
Elderly (65 years of age and above) No dose adjustment is needed in elderly patients (see section 5.2).
Pri starejših bolnikih prilagoditev odmerka ni potrebna (glejte poglavje 5.2).
Do not use this medicine after the expiry date which is stated on the cardboard box and bottle after EXP.
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.
(corresponding to 1.5 mg/kg/intake)
(ustreza 1,5 mg/kg/vnos)
5 ml oral dosing syringe
5-ml peroralna odmerna brizga
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.
Absorbira se v celoti, vezava na plazemske beljakovine je zelo nizka, ledvično izločanje sledi obsežni biotransformaciji in presnovki so farmakološko neaktivni.
Sodium acetate (trihydrate) Acetic acid, glacial (for pH-adjustment) Sodium chloride
6.1 Seznam pomožnih snovi natrijev acetat (trihidrat) koncentrirana ocetna kislina (ledocet) (za uravnavanje pH) natrijev klorid voda za injekcije
Coating - 10 mg film-coated tablets: polyvinyl alcohol, titanium dioxide (E171), macrogol 3350, talc.
Obloga - 10 mg filmsko obložene tablete: polivinilalkohol, titanov dioksid (E171), makrogol 3350, smukec.
Each ml contains 10 mg brivaracetam.
- En ml vsebuje 10 mg brivaracetama.
Briviact is administered as an injection or infusion into a vein by a doctor or a nurse.
Zdravilo Briviact vam bosta zdravnik ali sestra dala z injiciranjem ali infundiranjem v žilo.
(corresponding to 0.5 mg/kg/intake)
(ustreza 0,5 mg/kg/vnos)
Treatment with levetiracetam
Zdravljenje z levetiracetamom
Children (from 4 years of age) and adolescents weighing 50 kg or more The recommended starting dose is 50mg/day.
Otroci (od 4. leta starosti) in mladostniki, ki tehtajo več kot 50 kg Priporočeni začetni odmerek je 50 mg/dan.
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.
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.
- Briviact solution for injection/infusion is used for a short amount of time when you cannot take Briviact orally.
- Zdravilo Briviact raztopina za injiciranje/infundiranje se uporablja kratek čas, kadar zdravila
Brivaracetam is not recommended for use in monotherapy.
Uporaba brivaracetama pri samostojnem zdravljenju ni priporočena.
Briviact 10 mg/ml injection/infusion brivaracetam
Briviact 10 mg/ml injiciranje/infundiranje brivaracetam
One vial of 5 ml contains 50 mg brivaracetam.
Ena viala po 5 ml vsebuje 50 mg brivaracetama.
10 ml oral dosing syringe
10-ml peroralna odmerna brizga
Children (≥4 years) and adolescents <50 kg
Otroci (≥ 4 leta) in mladostniki < 50 kg odmerja se razdeljen na 2 enaka odmerka
What Briviact contains The active substance is brivaracetam.
Kaj vsebuje zdravilo Briviact Zdravilna učinkovina je brivaracetam.
Briviact 75 mg are purple, oval, film-coated tablets of 13.0 mm x 7.3 mm and debossed with ‘u75' on one side.
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.
Do not use this medicine after the expiry date which is stated on the carton and vial after EXP.
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.
Green-grey, oval film-coated tablets with dimensions of 14.5 mm x 8.1 mm and debossed with ‘u100' on one side.
Zelenosive, ovalne, filmsko obložene tablete z dimenzijami 14,5 mm x 8,1 mm in vtisnjeno oznako u100 na eni strani.
Briviact 75 mg film-coated tablets Each film-coated tablet contains 75 mg brivaracetam.
Briviact 75 mg filmsko obložene tablete Ena filmsko obložena tableta vsebuje 75 mg brivaracetama.
White to off-white, round film-coated tablets of 6.5 mm in diameter and debossed with ‘u10' on one side.
Bele do umazano bele, okrogle, filmsko obložene tablete s premerom 6,5 mm in vtisnjeno oznako u10
Grey, oval film-coated tablets with dimensions of 8.9 mm x 5.0 mm and debossed with ‘u25' on one side.
Sive, ovalne, filmsko obložene tablete z dimenzijami 8,9 mm x 5,0 mm in vtisnjeno oznako u25 na eni strani.
Children (from 4 years of age) and adolescents weighing 50 kg or more
Odrasli, mladostniki in otroci, ki tehtajo 50 kg ali več
Briviact 25 mg are grey, oval, film-coated tablets of 8.9 mm x 5.0 mm and debossed with ‘u25' on one side.
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.
Briviact 10 mg/ml solution for injection/infusion
Briviact 10 mg/ml raztopina za injiciranje/infundiranje
(corresponding to 2 mg/kg/intake)
(ustreza 2 mg/kg/vnos)
Briviact 75 mg film-coated tablets
Briviact 75 mg filmsko obložene tablete
Croscarmellose Sodium, Lactose monohydrate Betadex
6.1 Seznam pomožnih snovi Jedro premrežen natrijev karmelozat laktoza monohidrat betadeks brezvodna laktoza magnezijev stearat
0.05 ml/kg/intake
0,05 ml/kg/vnos
Brivaracetam oral solution contains sodium.
Peroralna raztopina brivaracetama vsebuje natrij.
Zonisamide
Nič zonisamid
Yellow, oval film-coated tablets with dimensions of 11.7 mm x 6.6 mm and debossed with ‘u50' on one side.
Rumene, ovalne, filmsko obložene tablete z dimenzijami 11,7 mm x 6,6 mm in vtisnjeno oznako u50 na eni strani.
Briviact 50 mg are yellow, oval, film-coated tablets of 11.7 mm x 6.6 mm and debossed with ‘u50' on one side.
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.
0.1 ml/kg/intake
0,1 ml/kg/vnos
Briviact 100 mg film-coated tablets Each film-coated tablet contains 100 mg brivaracetam.
Briviact 100 mg filmsko obložene tablete Ena filmsko obložena tableta vsebuje 100 mg brivaracetama.
Not Applicable.
Navedba smiselno ni potrebna.
Briviact contains the active substance brivaracetam.
Zdravilo Briviact vsebuje zdravilno učinkovino brivaracetam.
Volume per administration (ml) = [weight (kg) x daily dose (mg/kg/day) ] x 0.05
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.
Somnolence and dizziness have been reported in a healthy subject taking a single dose of 1,400 mg of brivaracetam.
Pri zdravih preskušancih, ki so vzeli enojni odmerek 1400 mg brivaracetama, so poročali o somnolenci in omotici.
nervous excitement (agitation) - thoughts or attempts of harming or killing yourself: tell your doctor straight away - a decrease in white blood cells (called ‘neutropenia') - shown in blood tests
Občasni: pojavijo se lahko pri največ 1 od 100 bolnikov - alergijske reakcije - nenormalne misli in/ali izguba stika z realnostjo (psihotične motnje), agresivnost, motorični nemir (agitacija) - misli ali poskusi o samopoškodovanju ali samomoru: to takoj povejte zdravniku - zmanjšanje števila belih krvnih celic (nevtropenija), ki ga pokažejo krvni testi
Briviact 10 mg film-coated tablets Polyvinyl alcohol Titanium dioxide (E171) Macrogol 3350
Briviact 10 mg filmsko obložene tablete polivinilalkohol titanov dioksid (E171) makrogol 3350 smukec
In all controlled and uncontrolled trials in patients with epilepsy, 2,388 subjects have received brivaracetam, of whom 1,740 have been treated for ≥ 6 months,1,363 for ≥ 12 months, 923 for ≥ 24 months and 569 for ≥ 60 months (5 years).
Od teh je bilo 1740 zdravljenih ≥ 6 mesecev, 1363 ≥ 12 mesecev, 923 ≥ 24 mesecev in 569 ≥ 60 mesecev (5 let).
Do not use this medicine after the expiry date which is stated on the carton and blister after EXP.
Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli ali pretisnem omotu poleg oznake EXP. Rok uporabnosti zdravila se izteče na zadnji dan navedenega meseca.
A meta-analysis of randomized placebocontrolled trials of AEDs has also shown a small increased risk of suicidal ideation and behaviour.
Majhno povečanje tveganja za pojav samomorilnega razmišljanja in vedenja je pokazala tudi metaanaliza randomiziranih, s placebom nadzorovanih preskušanj antiepileptikov.
Each film-coated tablet contains 75 mg brivaracetam.
Ena filmsko obložena tableta vsebuje 75 mg brivaracetama.
Briviact 25 mg film-coated tablets Each film-coated tablet contains 25 mg brivaracetam.
Briviact 25 mg filmsko obložene tablete Ena filmsko obložena tableta vsebuje 25 mg brivaracetama.
Purple, oval film-coated tablets with dimensions of 13.0 mm x 7.3 mm debossed with ‘u75' on one side.
Škrlatne, ovalne, filmsko obložene tablete z dimenzijami 13,0 mm x 7,3 mm in vtisnjeno oznako u75 na eni strani.
Dose adjustments are recommended for patients with hepatic impairment (see section
Za bolnike z okvaro jeter je priporočena prilagoditev odmerka (glejte poglavje 4.2).
(corresponding to 1 mg/kg/intake)
(ustreza 1 mg/kg/vnos)
Briviact 25 mg film-coated tablets
Briviact 25 mg filmsko obložene tablete
For a dose of 1 mg/kg/day
Za odmerek 1 mg/kg/dan
0.5 mg/kg = 0.05 ml/kg
Telesna masa 0,5 mg/kg = 0,05 ml/kg
0.15 ml/kg/intake
0,15 ml/kg/vnos
Briviact 10 mg/ml solution for injection/infusion brivaracetam
Briviact 10 mg/ml raztopina za injiciranje/infundiranje brivaracetam
Briviact 100 mg film-coated tablets
Briviact 100 mg filmsko obložene tablete
Briviact 10 mg film-coated tablets
Briviact 10 mg filmsko obložene tablete
For a dose of 4 mg/kg/day
Za odmerek 4 mg/kg/dan
Lamotrigine
Obloga
Briviact 50 mg film-coated tablets Each film-coated tablet contains 50 mg brivaracetam.
Briviact 50 mg filmsko obložene tablete Ena filmsko obložena tableta vsebuje 50 mg brivaracetama.
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.
Modeliranje populacijske farmakokinetike je pokazalo, da je odmerek 2,0 mg/kg dvakrat na dan povzročil enako povprečno plazemsko koncentracijo v dinamičnem ravnovesju kot pri odraslih, ki so prejemali 100 mg dvakrat na dan. Ocenjeni plazemski očistek je bil 1,61 l/uro za otroke, ki so tehtali 20 kg, 2,18 l/uro za otroke, ki so tehtali 30 kg in 3,19 l/uro za otroke, ki so tehtali 50 kg. Za primerjavo je bil ocenjeni plazemski očistek za odrasle bolnike 3,58 l/uro (70 kg telesne mase).
Each film-coated tablet contains 25 mg brivaracetam.
Ena filmsko obložena tableta vsebuje 25 mg brivaracetama.
- If you are not sure what to do, ask your doctor or pharmacist.
- Če ste negotovi, se posvetujte z zdravnikom ali farmacevtom.
Each film-coated tablet contains 10 mg brivaracetam.
Ena filmsko obložena tableta vsebuje 10 mg brivaracetama.
Each film-coated tablet contains 100 mg brivaracetam.
Ena filmsko obložena tableta vsebuje 100 mg brivaracetama.
Briviact 50 mg film-coated tablets
Briviact 50 mg filmsko obložene tablete
0.2 ml/kg/intake
0,2 ml/kg/vnos
Briviact 10 mg/ml oral solution brivaracetam
Briviact 10 mg/ml peroralna raztopina brivaracetam
For a dose of 2 mg/kg/day
Za odmerek 2 mg/kg/dan
Briviact 75 mg film-coated tablets brivaracetam
Briviact 75 mg filmsko obložene tablete brivaracetam
Strong enzyme inducing AEDs
Antiepileptiki, ki močno inducirajo encime
For a dose of 3 mg/kg/day
Za odmerek 3 mg/kg/dan
Each film-coated tablet contains 50 mg brivaracetam.
Ena filmsko obložena tableta vsebuje 50 mg brivaracetama.
PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND IMMEDIATE PACKAGING
Izgled zdravila Briviact in vsebina pakiranja
Briviact 100 mg film-coated tablets brivaracetam
Briviact 100 mg filmsko obložene tablete brivaracetam
Briviact 10 mg film-coated tablets brivaracetam
Briviact 10 mg filmsko obložene tablete brivaracetam
Briviact 25 mg film-coated tablets brivaracetam
Briviact 25 mg filmsko obložene tablete brivaracetam
EU/1/15/1073/017 14 film-coated tablets EU/1/15/1073/018 56 film-coated tablets EU/1/15/1073/019 100 x 1 film-coated tablet EU/1/15/1073/027 14 x 1 film-coated tablet
EU/1/15/1073/017 14 filmsko obloženih tablet EU/1/15/1073/018 56 filmsko obloženih tablet EU/1/15/1073/019 100 x 1 filmsko obložena tableta EU/1/15/1073/027 14 x 1 filmsko obložena tableta
Briviact is a long term treatment - keep taking Briviact until your doctor tells you to stop.
Jemljite ga, dokler vam zdravnik ne naroči, da prenehajte.
Clobazam
klobazam
Phenytoin
Nič fenitoin
Briviact 50 mg film-coated tablets brivaracetam
Briviact 50 mg filmsko obložene tablete brivaracetam
EU/1/15/1073/004 168 (3 packs of 56) film-coated tablets
EU/1/15/1073/004 168 (3 pakiranja po 56) filmsko obloženih tablet
EU/1/15/1073/013 14 film-coated tablets EU/1/15/1073/014 56 film-coated tablets EU/1/15/1073/015 100 x 1 film-coated tablet EU/1/15/1073/026 14 x 1 film-coated tablet
EU/1/15/1073/013 14 filmsko obloženih tablet EU/1/15/1073/014 56 filmsko obloženih tablet EU/1/15/1073/015 100 x 1 filmsko obložena tableta EU/1/15/1073/026 14 x 1 filmsko obložena tableta
Citric acid anhydrous (for pH-adjustment) Methyl parahydroxybenzoate (E218) Carmellose sodium
6.1 Seznam pomožnih snovi natrijev citrat brezvodna citronska kislina (za uravnavanje pH) metilparahidroksibenzoat (E218) natrijev karmelozat sukraloza tekoči sorbitol glicerol (E422) aroma maline (propilenglikol 90 % - 98 %) prečiščena voda
Each ml of oral solution contains 10 mg brivaracetam.
En ml peroralne raztopine vsebuje 10 mg brivaracetama.
In controlled studies, the carbamazepine epoxide plasma concentration increased by a mean of 37 %, 62 % and 98 % with little variability at brivaracetam doses of 50 mg/day, 100 mg/day and 200 mg/day respectively.
62 % in 98 % pri odmerkih brivaracetama 50 mg/dan, 100 mg/dan in 200 mg/dan.
EU/1/15/1073/008 168 (3 packs of 56) film-coated tablets
EU/1/15/1073/008 168 (3 pakiranja po 56) filmsko obloženih tablet
- 100 mg film-coated tablets: polyvinyl alcohol, titanium dioxide (E171), macrogol 3350, talc, iron oxide yellow (E172), iron oxide black (E172).
- 100 mg filmsko obložene tablete: polivinilalkohol, titanov dioksid (E171), makrogol 3350, smukec, rumeni železov oksid (E172), črni železov oksid (E172).
- 75 mg film-coated tablets: polyvinyl alcohol, titanium dioxide (E171), macrogol 3350, talc, iron oxide yellow (E172), iron oxide red (E172), iron oxide black (E172).
- 75 mg filmsko obložene tablete: polivinilalkohol, titanov dioksid (E171), makrogol 3350, smukec, rumeni železov oksid (E172), rdeči železov oksid (E172), črni železov oksid (E172).
Briviact 10 mg film-coated tablets Each film-coated tablet contains 10 mg brivaracetam.
KAKOVOSTNA IN KOLIČINSKA SESTAVA Briviact 10 mg filmsko obložene tablete Ena filmsko obložena tableta vsebuje 10 mg brivaracetama.
EU/1/15/1073/009 14 film-coated tablets EU/1/15/1073/010 56 film-coated tablets EU/1/15/1073/011 100 x 1 film-coated tablet EU/1/15/1073/025 14 x 1 film-coated tablet
EU/1/15/1073/009 14 filmsko obloženih tablet EU/1/15/1073/010 56 filmsko obloženih tablet EU/1/15/1073/011 100 x 1 filmsko obložena tableta EU/1/15/1073/025 14 x 1 filmsko obložena tableta
EU/1/15/1073/005 14 film-coated tablets EU/1/15/1073/006 56 film-coated tablets EU/1/15/1073/007 100 x 1 film-coated tablet EU/1/15/1073/024 14 x 1 film-coated tablet
EU/1/15/1073/005 14 filmsko obloženih tablet EU/1/15/1073/006 56 filmsko obloženih tablet EU/1/15/1073/007 100 x 1 filmsko obložena tableta EU/1/15/1073/024 14 x 1 filmsko obložena tableta
EU/1/15/1073/020 168 (3 packs of 56) film-coated tablets
EU/1/15/1073/020 168 (3 pakiranja po 56) filmsko obloženih tablet
EU/1/15/1073/001 14 film-coated tablets EU/1/15/1073/002 56 film-coated tablets EU/1/15/1073/003 100 x 1 film-coated tablet EU/1/15/1073/023 14 x 1 film-coated tablet
EU/1/15/1073/001 14 filmsko obloženih tablet EU/1/15/1073/002 56 filmsko obloženih tablet EU/1/15/1073/003 100 x 1 filmsko obložena tableta EU/1/15/1073/023 14 x 1 filmsko obložena tableta
EU/1/15/1073/012 168 (3 packs of 56) film-coated tablets
EU/1/15/1073/012 168 (3 pakiranja po 56) filmsko obloženih tablet
EU/1/15/1073/016 168 (3 packs of 56) film-coated tablets
EU/1/15/1073/016 168 (3 pakiranja po 56) filmsko obloženih tablet