natgillin/translations-raw huggingface dataset:
Although the exact role of this protein remains to be elucidated it has been shown to modulate exocytosis of neurotransmitters.
Čeprav natančna vloga tega proteina še ni znana, pa je ugotovljeno, da modulira eksocitozo nevrotransmiterjev.
If a woman decides to become pregnant, the use of brivaracetam should be carefully re-evaluated.
Če se ženska odloči, da bo zanosila, je treba uporabo brivaracetama ponovno ovrednotiti.
Patients with more than a 25 % increase in POS are shown at left as “worse”.
Bolniki z več kot 25 % povečanjem parcialnih napadov so prikazani na levi kot »poslabšanje«.
Currently available data are described in section 4.8, 5.1, and 5.2 but no recommendation on a posology can be made.
Trenutno razpoložljivi podatki so opisani v poglavjih 4.8, 5.1 in 5.2, vendar priporočil o odmerjanju ni mogoče dati.
- If you drink alcohol while taking Briviact the negative effects of alcohol may be increased.
- Če pijete alkohol, ko jemljete zdravilo Briviact, se lahko negativni učinki alkohola povečajo.
You may feel dizzy and sleepy.
Morda boste omotični ali zaspani.
The clinical experience in patients ≥ 65 years is limited.
Klinične izkušnje pri bolnikih starih ≥ 65 let so omejene.
More details are provided below the table.
Več podrobnosti je navedenih pod preglednico.
The risk of clinically relevant CYP3A4 interactions is considered to be low.
Tveganje klinično pomembnih interakcij s CYP3A4 se smatra za nizko.
The mechanism of this risk is not known and the available data do not exclude the possibility of an increased risk for brivaracetam.
Mehanizem tveganja ni poznan, razpoložljivi podatki pa ne izključujejo možnosti povečanja tveganja pri zdravljenju z brivaracetamom.
Do not stop treatment without talking to your doctor first.
Ne prekinite zdravljenja, ne da bi se pred tem posvetovali s svojim zdravnikom.
However, as a high proportion of subjects (26%) discontinued from the open-label studies due to lack of efficacy, a selection bias may have occurred, as the subjects who stayed in the study responded better than those who have terminated prematurely.
Vendar pa, ker je visok delež preskušancev (26 %) prekinilo sodelovanje v odprtih študijah zaradi pomanjkanja učinkovitosti, se je lahko pri selekciji pojavila pristranskost, saj so se preskušanci, ki so ostali v študiji odzvali boljše od tistih, ki so jo predčasno zaključili.
Pharmacokinetics is dose-proportional from 10 to at least 600 mg.
Farmakokinetika je sorazmerna z odmerkom od 10 do vsaj 600 mg.
Due to possible differences in individual sensitivity some patients might experience somnolence, dizziness, and other central nervous system (CNS) related symptoms.
Zaradi morebitnih razlik v občutljivosti posameznikov lahko nekateri bolniki izkusijo somnolenco, omotičnost in druge simptome, povezane s centralnim živčnim sistemom.
Interaction with alcohol
Interakcije z alkoholom
You do not need to remove the adaptor after use.
Po uporabi adapterja ni potrebno odstraniti.
- Whenever the risk management system is modified, especially as the result of new information being received that may lead to a significant change to the benefit/risk profile or as the result of an important (pharmacovigilance or risk minimisation) milestone being reached.
• ob vsakršni spremembi sistema za obvladovanje tveganj, zlasti kadar je tovrstna sprememba posledica prejema novih informacij, ki lahko privedejo do znatne spremembe razmerja med koristmi in tveganji, ali kadar je ta sprememba posledica tega, da je bil dosežen pomemben mejnik (farmakovigilančni ali povezan z zmanjševanjem tveganja).
The 100 mg/day dose was nominally significant.
Odmerek 100 mg/dan je bil nominalno pomemben.
Although data are limited, the efficacy was comparable to younger subjects.
Podatkov sicer ni veliko, vendar je bila učinkovitost primerljiva z učinkovitostjo pri mlajših preskušancih.
If not used immediately, in-use storage time and conditions prior to use are the responsibility of the user.
Če se ne uporabi takoj, je za čas in pogoje shranjevanja odgovoren uporabnik.
You have been given this medicine to lower the number of fits (seizures) you have.
- To zdravilo vam je bilo predpisano, da bi zmanjšali število krčev (epileptičnih napadov), ki jih imate.
More than 95 % of the dose, including metabolites, is excreted in the urine within 72 hours after intake.
Več kot 95 % odmerka, vključno s presnovki, se izloči z urinom v 72 urah po zaužitju.
If your doctor asks you to stop taking this medicine they will lower your dose gradually.
Če vam bo zdravnik naročil, da nehate jemati to zdravilo, bo odmerek zmanjševal postopoma.
All studies had an 8-week baseline period followed by a 12-week treatment period with no uptitration.
Vse študije so imele 8-tedensko izhodiščno obdobje, ki mu je sledilo 12-tedensko obdobje zdravljenja brez povečevanja odmerka.
- Put the adaptor into the top of the bottle (figure 3).
- Vstavite adapter v vrh steklenice (slika 3).
In particular, tell your doctor if you are taking any of the following medicines - this is because your doctor may need to adjust your Briviact dose: - Rifampicin - a medicine used to treat bacterial infections.
Zdravniku povejte zlasti, če jemljete katero od naslednjih zdravil, ker vam bo morda moral prilagoditi odmerek zdravila Briviact: rifampicin - zdravilo, ki se uporablja za zdravljenje bakterijskih okužb.
These partial seizures can spread and extend to larger areas on both sides of the brain - this is called a ‘secondary generalisation'.
Ti parcialni napadi se lahko razširijo na večja območja na obeh straneh možganov, kar imenujemo
In such cases, it should be used straight after dilution.
V tem primeru ga je treba porabiti takoj po razredčenju.
If patients missed one dose or more, it is recommended that they take a single dose as soon as they remember and take the following dose at the usual morning or evening time.
Če bolnik izpusti enega ali več odmerkov, je priporočeno, da vzame en odmerek takoj, ko se spomni, naslednji odmerek pa ob običajnem jutranjem ali večernem času.
- Close the bottle with the plastic screw cap (you do not need to remove the adaptor).
- Zaprite steklenico s plastično navojno zaporko (adapterja ni treba odstraniti).
Risk related to epilepsy and antiepileptic medicinal products in general For all anti-epileptic drugs, it has been shown that in the offspring of treated women with epilepsy, the prevalence of malformations is two to three times greater than the rate of approximately 3 % in the general population.
Tveganja, povezana z epilepsijo in antiepileptiki na splošno Za vse antiepileptike so dokazali, da je pri potomcih zdravljenih žensk z epilepsijo prevalenca malformacij od dva- do trikrat višja kot stopnja v splošni populaciji, ki je približno 3 %.
The safety profile in elderly patients appears to be similar to that observed in younger adult patients.
Varnostni profil pri starejših bolnikih je podoben tistemu pri mlajših odraslih bolnikih.
The renal clearance of these non active metabolites was decreased 10-fold.
Ledvični očistek teh neaktivnih presnovkov se je zmanjšal za 10-krat.
Check with your doctor which one you should use.
Posvetujte se z zdravnikom, katero naj uporabite.
The efficacy outcomes are summarized in Table 2.
Rezultati učinkovitosti so zbrani v preglednici 2.
An additional adverse reaction reported in children was psychomotor hyperactivity
Dodatni neželeni učinek, o katerem so poročali pri otrocih, je bila psihomotorična hiperaktivnost
Patients should be monitored for signs of suicidal ideation and behaviours and appropriate treatment should be considered.
Bolnike je treba spremljati zaradi znakov samomorilnega razmišljanja in vedenja ter razmisliti o ustreznem zdravljenju.
Discontinuation of anti-epileptic treatments may result in exacerbation of the disease which could be harmful to the mother and the foetus.
Prekinitev zdravljenja z antiepileptiki lahko povzroči poslabšanje bolezni, kar bi lahko škodovalo materi in plodu.
In patients who were followed up in the open-label extension studies for up to 8 years, the safety profile was similar to that observed in the short-term, placebo-controlled studies.
Pri bolnikih, ki so jih spremljali v podaljšanih odprtih študijah za obdobje do 8 let, je bil varnostni profil podoben tistemu, ki so ga opazili v kratkotrajnih študijah, nadzorovanih s placebom.
Briviact with alcohol - Combining this medicine with alcohol is not recommended.
Zdravilo Briviact skupaj z alkoholom - Jemanje tega zdravila skupaj z alkoholom ni priporočljivo.
Patients should be advised not to drive a car or to operate other potentially hazardous machines until they are familiar with the effects of brivaracetam on their ability to perform such activities.
Bolnikom je treba svetovati, da ne vozijo avta ali uporabljajo drugih potencialno nevarnih strojev, dokler niso seznanjeni z učinki brivaracetama na njihovo sposobnost opravljanja takih dejavnosti.
Genotoxicity studies have not detected any mutagenic or clastogenic activity.
Študije genotoksičnosti niso ugotovile mutagene ali klastogene aktivnosti.
The median baseline seizure frequency across the 3 studies was 9 seizures per 28 days.
Mediana izhodiščne pogostnosti napadov v 3 študijah je bila 9 napadov v 28 dneh.
There are limited safety data from open-label studies in children from 1 month to <4 years of age.
Na voljo je omejeno število podatkov o varnosti iz odprtih študij pri otrocih, starih od 1 meseca do < 4 leta.
Patients with rare hereditary problems of fructose intolerance should not take this medicine.
Bolniki z redko dedno intoleranco na fruktozo ne smejo jemati tega zdravila.
Pharmacotherapeutic group: antiepileptics, other antiepileptics, ATC code: N03AX23
Farmakoterapevtska skupina: antiepileptiki, drugi antiepileptiki; oznaka ATC: N03AX23
At the end of the evaluation period, subjects may have been eligible for entry into a long-term follow-up study continuing on their last received dose (see section 4.8).
Ob koncu obdobja ocenjevanja so bili lahko preskušanci primerni za vstop v dolgotrajno študijo sledenja, v kateri so še naprej jemali zadnji prejeti odmerek (glejte poglavje 4.8).
Open-label extension studies
Podaljšane odprte študije
Opening date (Only for outer carton)
Datum odprtja (Samo za škatlo.)
Depression, anxiety, insomnia, irritability
Depresija, anksioznost, insomnija, razdražljivost
Calendar days: Mon., Tue.,Wed., Thu., Fri., Sat., Sun.
Koledarski dnevi: pon., tor., sre., čet., pet., sob., ned.
There is insufficient data to determine the clinical significance of this effect in pregnancy.
Ni dovolj podatkov, da bi lahko določili klinični pomen tega učinka med nosečnostjo.
Table 2: Key Efficacy Outcomes for Partial Onset Seizure Frequency per 28 Days Study
Preglednica 2: Ključni rezultati učinkovitosti za pogostnost parcialnih napadov na 28 dni Študija
- Hold the bottle upside down in one hand and use the other hand to fill the oral syringe.
- Z eno roko držite steklenico navzdol, z drugo pa napolnite peroralno brizgo.
The European Medicines Agency has deferred the obligation to submit the results of studies with brivaracetam in one or more subsets of the paediatric population in epilepsy with partial onset seizures.
Evropska agencija za zdravila je začasno odložila zahtevo za predložitev rezultatov študij z brivaracetamom iz ene ali več podskupin pediatrične populacije z epilepsijo s parcialnimi napadi.
The table below only shows examples of doses to take.
Spodnja preglednica prikazuje primere odmerkov, ki se jemljejo.
Less than 1 % of the dose is excreted in faeces and less than 10 % of brivaracetam is excreted unchanged in urine.
Manj kot 1 % odmerka se izloči z blatom in manj kot 10 % brivaracetama se v nespremenjeni obliki izloči z urinom.
The oral solution contains sorbitol (E420).
Peroralna raztopina vsebuje sorbitol (E420).
The lower efficacy observed in these patients compared to the leveticacetam-naïve patients was likely due to the higher number of prior AEDs used and higher baseline seizure frequency.
Nižja učinkovitost, ki so jo opazili pri teh bolnikih v primerjavi z levetiracetam naivnimi bolniki, je bila verjetno zaradi večjega števila prej uporabljenih antiepileptikov in večje pogostnosti napadov v izhodišču.
Patients (and caregivers of patients) should be advised to seek medical advice should any signs of suicidal ideation or behaviour emerge.
Bolnikom (in skrbnikom bolnikov) je treba svetovati, naj poiščejo zdravniško pomoč, če se pojavijo znaki samomorilnega vedenja ali razmišljanja.
Your doctor will work out the right daily dose for you.
Zdravnik bo izračunal pravilen dnevni odmerek za vas.
How long to use Briviact for - Your doctor will decide for how many days you will be given the injections or infusion.
Kako dolgo boste prejemali zdravilo Briviact - Vaš zdravnik bo presodil, koliko dni boste prejemali injekcije ali infuzijo.
- Then push the plunger up to remove any possible air bubbles (figure 7).
- Nato potisnite bat navzgor, da odstranite morebitne zračne mehurčke (slika 7).
Plasma concentrations were shown to be dose-proportional in all age groups.
Koncentracije v plazmi so bile sorazmerne z odmerkom v vseh starostnih skupinah.
No data available
Podatki niso na voljo
It is not recommended to take Briviact if you are pregnant or breast-feeding, as the effects of Briviact on pregnancy and the unborn baby or the new-born child are not known.
Če ste noseči ali dojite, jemanje zdravila Briviact ni priporočljivo, saj učinki zdravila Briviact na nosečnost in še nerojenega otroka ali novorojenčka niso znani.
The total plasma clearance in patients was estimated to 3.6 L/h.
Skupni plazemski očistek pri bolnikih je bil ocenjen na 3,6 l/h.
Patients had a mean duration of epilepsy of approximately 23 years.
Bolniki so v povprečju imeli epilepsijo 23 let.
From a microbiological point of view, the product should be used immediately after dilution.
Z mikrobiološkega vidika je treba zdravilo uporabiti takoj po redčenju.
The number of patients with other ethnic background was limited.
Število bolnikov drugih ras je bilo majhno.
No child received a dose greater than 200 mg/day.
Noben otrok ni prejel odmerka, večjega kot 200 mg/dan.
The frequencies are defined as follows: very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥ 1/1,000 to < 1/100).
Pogostnosti so opredeljene takole: zelo pogosti (≥ 1/10), pogosti (≥ 1/100 do < 1/10), občasni (≥ 1/1.000 do < 1/100).
Stopping treatment could increase your seizures and harm your baby.
Prekinitev zdravljenja bi lahko povečala število napadov in škodila vašemu otroku.
If you forget to take Briviact - If you miss a dose take it as soon as you remember.
Če ste pozabili vzeti zdravilo Briviact - Če ste pozabili vzeti odmerek zdravila, ga vzemite takoj, ko se spomnite.
However, toxicological data accumulated on brivaracetam and on a structurally-related compound indicate that the dog liver changes have developed through mechanisms not relevant for humans.
Kljub temu pa toksikološki podatki, zbrani o brivaracetamu in strukturno povezanih spojinah, kažejo, da so se spremembe v pasjih jetrih razvile z mehanizmi, ki niso relevantni za ljudi.
It is used to treat a type of epilepsy that has partial seizures with or without a secondary generalisation.
- Uporablja se za zdravljenje vrste epilepsije s parcialnimi napadi s sekundarno generalizacijo ali brez nje.
Patients were required to have at least 8 POS during the baseline period.
Bolniki so med izhodiščnim obdobjem morali imeti vsaj 8 parcialnih napadov.
The following table summarises the recommended posology for children from 4 years of age and adolescents.
Naslednja preglednica vsebuje povzetek priporočenega odmerjanja za otroke od 4. leta starosti in mladostnike.
They were usually mild to moderate in intensity.
Navadno sta bila blaga do zmerna.
Brivaracetam bolus injection or intravenous infusion has not been studied in acute conditions; e.g. status epilepticus and is therefore not recommended for such conditions.
Injiciranja bolusa brivaracetama ali intravenske infuzije niso preučevali pri akutnih stanjih, kot je status epilepticus, zato za taka stanja ni priporočen.
Carbamazepine - None Carbamazepine-epoxide ↑ (See below)
karbamazepin - nič karbamazepin epoksid ↑ (glejte spodaj)
Intravenous administration was associated with infusion site pain in 2.8 % of the patients.
Intravenska uporaba je bila pri 2,8 % bolnikov povezana z bolečino na mestu infundiranja.
Brivaracetam has minor or moderate influence on the ability to drive and use machines.
Brivaracetam ima blag ali zmeren učinek na sposobnost vožnje in upravljanja s stroji.
Adverse reactions from clinical trials
Neželeni učinki iz kliničnih preskušanj
The EC50 (brivaracetam plasma concentration corresponding to 50 % of the maximum effect) was estimated to be 0.57 mg/L.
EC50 (plazemska koncentracija brivaracetama, ki ustreza 50 % največjega učinka) je bila ocenjena na 0,57 mg/l.
- When you start taking this medicine you will take Briviact orally (as tablets or an oral solution) or be given it as an injection or infusion.
- Ko boste začeli z jemanjem tega zdravila, boste zdravilo Briviact vzeli peroralno (kot tablete ali peroralno raztopino) ali pa ga boste prejeli v obliki injekcije/infuzije.
Limited data are available on neurodevelopment in children <4 years of age.
O nevrološkem razvoju pri otrocih starih < 4 leta, so na voljo omejeni podatki.
What Briviact is and what it is used for 2.
Kaj je zdravilo Briviact in za kaj ga uporabljamo 2.
As a precautionary measure, brivaracetam should not be used during pregnancy unless clinically necessary i.e. (if the benefit to the mother clearly outweighs the potential risk to the foetus).
Kot varnostni ukrep se brivaracetam med nosečnostjo ne sme uporabljati, razen če to ni klinično potrebno, tj. če korist za mater jasno upravičuje potencialno tveganje za plod.
A second disposition pathway involves hydroxylation mediated by CYP2C19 (see section 5.2).
Druga presnovna pot vključuje hidroksilacijo, posredovano s CYP2C19 (glejte poglavje 5.2).
Recommended maintenance dose
Priporočeni vzdrževalni odmerek
(not for packsizes 14 x1 and 100 x 1 film-coated tablet)
(ne za pakiranji po 14 x 1 in 100 x 1 filmsko obložena tableta)
Prescribers should consider adjusting the brivaracetam dose in patients starting or ending treatment with rifampicin.
Zdravniki, ki predpisujejo zdravilo, morajo razmisliti o prilagoditvi odmerka brivaracetama pri bolnikih, ki začenjajo ali zaključujejo zdravljenje z rifampicinom.
Children and adolescents weighing less than 50 kg - Your doctor may prescribe the injection only for a few days if you cannot take your medicine by mouth.
Otroci in mladostniki, ki tehtajo manj kot 50 kg - Zdravnik vam lahko predpiše injekcijo le za nekaj dni, če zdravila ne morete jemati peroralno
Each carton contains 10 vials.
Ena škatla vsebuje 10 vial.
Study enrollment criteria required that patients have uncontrolled POS despite treatment with either 1 or 2 concomitant AEDs.
Kriteriji za vključitev v študijo so zahtevali, da imajo bolniki nenadzorovane parcialne napade navkljub zdravljenju z 1 ali 2 sočasnima antiepileptikoma.
There was generally no change in the concentration-time profiles of the endogenous markers estradiol, progesterone, luteinizing hormone (LH), follicle stimulating hormone (FSH), and sex hormone binding globulin (SHBG).
V splošnem ni bilo sprememb v profilih koncentracijačas za endogene označevalce estradiol, progesteron, luteinizirajoči hormon (LH), folikle stimulirajoči hormon (FSH), in globulin, ki se veže na spolne hormone (SHBG).
Other strong enzyme inducers (such as St John´s wort (Hypericum perforatum)) may also decrease the systemic exposure of brivaracetam.
Tudi drugi močni induktorji encimov (npr. šentjanževka (Hypericum perforatum)) lahko zmanjšajo sistemsko izpostavljenost brivaracetama.
The precise volume of oral solution is to be calculated according to the exact body weight of the child.
Natančna količina peroralne raztopine se izračuna s podatkom o natančni telesni masi otroka.
Each vial of Briviact solution for injection/infusion must be used only once (single use).
Vsaka viala zdravila Briviact raztopina za injiciranje/infundiranje se lahko uporabi le enkrat (enkratna uporaba).
Children Briviact is not recommended for use in children under 4 years of age.
Otroci Zdravila Briviact ne priporočamo za uporabo pri otrocih, mlajših od 4 let.
Brivaracetam is weakly bound (≤ 20 %) to plasma proteins.
Brivaracetam se šibko veže (≤ 20 %) na plazemske beljakovine.
In two phase 3 randomised placebo-controlled studies, levetiracetam was administered as concomitant AED in about 20 % of the patients.
V dveh randomiziranih študijah faze 3, nadzorovanih s placebom, je bil levetiracetam uporabljen kot sočasni antiepileptik pri približno 20 % bolnikov.
A long-term, uncontrolled, open-label safety study included children (from 4 years to less than 16 years) who continued treatment after completing the PK study (see section 5.2) and children directly enrolled into the safety study.
V dolgoročni, nenadzorovani, odprti študiji varnosti so bili vključeni otroci (stari od 4 do manj kot 16 let), ki so po koncu farmakokinetične študije zdravljenje nadaljevali (glejte poglavje 5.2), in otroci, ki so bili vključeni neposredno v študijo varnosti.
The median tmax for tablets taken without food is 1 hour (tmax range is 0.25 to 3 h).
Mediana čas tmax za tablete, zaužite s hrano, je 1 ura (razpon tmax je od 0,25 do 3 h).
There is insufficient data to determine the clinical significance.
Ni dovolj podatkov, da bi določili klinični pomen tega učinka.
The safety and efficacy of brivaracetam in children aged less than 4 years have not yet been established.
Varnost in učinkovitost brivaracetama pri otrocih, mlajših od 4 let, nista bili dokazani.
Study N01358
Študija N01358
Since less than 10 % of brivaracetam is excreted in urine, haemodialysis is not expected to significantly enhance brivaracetam clearance (see section 5.2).
Ker se v urin izloči manj kot 10 % brivaracetama, ne gre pričakovati, da bo hemodializa pomembno izboljšala očistek brivaracetama (glejte poglavje 5.2).
The three pivotal double-blind placebo-controlled studies included 38 elderly patients aged between 65 and 80 years.
V treh ključnih dvojno slepih, s placebom nadzorovanih študijah je bilo udeleženih 38 starejših bolnikov, starih med 65 in 80 let.
None of the 6 cases of neutropenia were severe, required any specific treatment or led to discontinuation of brivaracetam and none had associated infections.
Noben od teh 6 primerov nevtropenije ni bil resen, ni zahteval specifičnega zdravljenja ali povzročil prekinitve zdravljenja z brivaracetamom, poleg tega pa v povezavi z nobenim od teh primerov ni prišlo do okužb.
Patients with an improvement in percent reduction in baseline POS frequency are shown in the 4 right-most categories.
Bolniki z izboljšanjem v odstotnem zmanjšanju osnovne pogostnosti parcialnih napadov so prikazani v 4 kategorijah na desni.
1,558 patients received study drug of which 1,099 received brivaracetam.
Preiskovano zdravilo je prejelo 1558 bolnikov, od teh jih je 1099 prejelo brivaracetam.
The volume of distribution is 0.5 L/kg, a value close to that of the total body water.
Volumen porazdelitve je 0,5 l/kg, kar je blizu celotni količini vode v telesu.
- If you weigh 20 kg or more, your doctor will recommend the use of the 5 ml oral syringe or the
- Če tehtate 20 kg ali več, vam bo zdravnik svetoval, da uporabljate 5-ml peroralno brizgo ali
The maximum dose should not exceed 3 mg/kg/day.
Največji odmerek ne sme preseči 3 mg/kg/dan.
Instructions for use are provided in the package leaflet.
Navodila za uporabo so navedena v Navodilih za uporabo.
Intake of brivaracetam with alcohol is not recommended.
Jemanje brivaracetama z alkoholom ni priporočljivo.
How to take Briviact tablets - Swallow the tablets whole with a glass of liquid.
Kako jemati tablete zdravila Briviact - Tablete zaužijte cele s kozarcem tekočine.