natgillin/translations-raw huggingface dataset:
- Take the oral syringe out of the adaptor (figure 10).
- Izvadite štrcaljku za usta iz nastavka (slika 10).
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.
U kontroliranim se ispitivanjima plazmatska koncentracija karbamazepin epoksida povećala za srednju vrijednost od 37%, 62% i 98% uz primjenu brivaracetama u dozi od 50 mg/dan, 100 mg/dan odnosno 200 mg/dan, uz malu varijabilnost.
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)).
Poboljšanje medijana postotnog smanjenja učestalosti napadaja tijekom 28 dana među bolesnicima koji su na početku ispitivanja imali napadaje tipa IC (sekundarno generalizirani toničko-klonički napadaji) primijećeno je u (66,6% (n=62), 61,2% (n=100) i 82,1% (n=75) bolesnika liječenih brivaracetamom u dozi od 50 mg/dan, 100 mg/dan odnosno 200 mg/dan, u odnosu na 33,3% (n=115)) bolesnika koji su primali placebo.
Pharmacokinetic/pharmacodynamics relationship
Farmakokinetički/farmakodinamički odnos
Carbamazepine - None Carbamazepine-epoxide ↑ (See below)
Karbamazepin - nema Karbamazepin-epoksid ↑ (Vidjeti u nastavku) Nije potrebno prilagođavati dozu.
- Open the bottle: press the cap and turn it anti-clockwise (figure 1).
- Otvorite bocu: pritisnite zatvarač i okrenite ga u smjeru suprotnom od kazaljke na satu (slika
Influence of brivaracetam on AED plasma concentration
Utjecaj brivaracetama na plazmatsku koncentraciju antiepileptika
n = randomised patients who received at least 1 dose of study medication ~ Dose not studied
= randomizirani bolesnici koji su primili najmanje 1 dozu ispitivanog lijeka ~ Doza na kojoj nije provedeno ispitivanje * Statistički značajno
Effects of other agents on the pharmacokinetics of brivaracetam In vitro data suggest that brivaracetam has a low interaction potential.
In vitro podaci ukazuju na to da brivaracetam ima nizak interakcijski potencijal.
Overall, brivaracetam was efficacious for the adjunctive treatment of partial onset seizures in patients 16 years of age and older between 50 mg/day and 200 mg/day.
Sveukupno se brivaracetam pokazao djelotvornim kao dodatna terapija u liječenju parcijalnih nastupa napadaja u bolesnika u dobi od 16 ili više godina u dozama od 50 mg/dan do 200 mg/dan.
Embryotoxicity was observed in rabbits at a maternal toxic dose of brivaracetam with an exposure level 8-fold the clinical AUC exposure at the maximum recommended dose.
U kunića je primijećena embriotoksičnost pri dozama brivaracetama koje su bile toksične za majku i kojima se postizala izloženost 8 puta veća od izloženosti koja se postiže uz klinički AUC nakon primjene maksimalne preporučene doze.
The recommended maintenance dose is 2 mg/kg/day.
Preporučena doza održavanja je 2 mg/kg/dan.
UNIQUE IDENTIFIER - 2D BARCODE Not Applicable.
JEDINSTVENI IDENTIFIKATOR - 2D BARKOD Nije primjenjivo.
Statistically significant Approximately 20 % of the patients were on concomitant levetiracetam The primary outcome for N01252 did not achieve statistical significance based on the sequential testing procedure .
Primarni ishod za ispitivanje br. 1252 nije postigao statističku značajnost prema sekvencijalnom testu.
briviact 10 mg/ml (Only for outer carton)
briviact 10 mg/ml (samo za kutiju)
As in adults, brivaracetam solution for injection/infusion is an alternative route of administration for patients when oral administration is temporarily not feasible.
Kao u odraslih, brivaracetam otopina za injekciju/infuziju predstavlja zamjensku opciju za primjenu u bolesnika u kojih peroralna primjena privremeno nije moguća.
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.
Kada se brivaracetam u dozi od 400 mg/dan (doza dvostruko veća od preporučene maksimalne dnevne doze) primjenjivao istodobno s oralnim kontraceptivom koji je sadržavao etinilestradiol (0,03 mg) i levonorgestrel (0,15 mg), primijećeno je smanjenje AUC-a estrogena za 27% i AUC-a progestagena za 23%, ali to nije utjecalo na supresiju ovulacije.
None a based on a study involving the administration of a supratherapeutic dose of 400 mg/day brivaracetam.
Temeljeno na ispitivanju koje uključuje primjenu supraterapijske doze od 400 mg/dan brivaracetama.
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.
U analizi objedinjenih podataka iz triju pivotalnih ispitivanja nisu primijećene razlike u djelotvornosti (koja se određivala kao stopa bolesnika s odgovorom od 50%) unutar raspona doza od 50 mg/dan do 200 mg/dan kada se brivaracetam kombinirao s inducirajućim ili neinducirajućim antiepilepticima.
There is limited clinical experience with brivaracetam overdose in humans.
Kliničko iskustvo s predoziranjem brivaracetamom u ljudi je ograničeno.
50 - 200 mg/day
50 - 200 mg/dan
Brivaracetam may be initiated with either intravenous or oral administration.
Liječenje brivaracetamom može se započeti intravenskom ili peroralnom primjenom.
No human data on the effect of brivaracetam on fertility are available.
Nema dostupnih podataka o utjecaju brivaracetama na plodnost ljudi.
Brivaracetam may increase plasma concentrations of medicinal products metabolised by CYP2C19 (e.g. lanzoprazole, omeprazole, diazepam).
Brivaracetam može povisiti plazmatsku koncentraciju lijekova metaboliziranih enzimom CYP2C19 (npr. lanzoprazola, omeprazola, diazepama).
The recommended maintenance dose is 100 mg/day.
Preporučena doza održavanja je 100 mg/dan.
The daily dose of brivaracetam ranged from 5 to 200 mg/day across these studies.
Dnevna doza brivaracetama u tim se ispitivanjima kretala u rasponu od 5 do 200 mg/dan.
Briviact solution for injection/infusion contains 0.83 mmol (or 19.14 mg) sodium per vial.
Briviact otopina za injekciju/infuziju sadrži 0,83 mmol (ili 19,14 mg) natrija po bočici.
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).
Smeđa staklena boca od 300 ml (staklo tipa III) s bijelim zatvaračem sigurnim za djecu (polipropilen), u kutiji koja sadrži i graduiranu štrcaljku za usta od 5 ml i 10 ml (polipropilen, polietilen) te nastavak za štrcaljku (polietilen).
- You can switch between taking Briviact orally to the solution for injection/infusion, and the other way around.
- Briviact za primjenu kroz usta možete zamijeniti otopinom za injekciju/infuziju i obratno.
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.
U kliničkim je ispitivanjima 2,5% (4/161), 5,1% (17/332) i 4,0% (10/249) bolesnika liječenih dozom od 50 mg/dan, 100 mg/dan odnosno 200 mg/dan bilo bez napadaja tijekom 12-tjednog razdoblja liječenja, u usporedbi s 0,5% (2/418) bolesnika koji su primali placebo.
Children Briviact is not recommended for use in children under 4 years of age.
Djeca Primjena lijeka Briviact ne preporučuje se u djece mlađe od 4 godine.
Although the number of subjects is limited, there was no observed benefit of brivaracetam versus placebo in patients taking levetiracetam concurrently which may reflect competition at the SV2A binding site.
Iako je broj ispitanika ograničen, u bolesnika koji su istodobno uzimali levetiracetam nije primijećena korist od primjene brivaracetama u odnosu na placebo što može biti odraz natjecanja za SV2A vezno mjesto.
Studies in rats have shown excretion of brivaracetam in breast milk (see section 5.3).
Ispitivanja na štakorima pokazala su da se brivaracetam izlučuje u mlijeko (vidjeti dio 5.3).
There is no data on placental transfer in humans, but brivaracetam was shown to readily cross the placenta in rats (see section 5.3).
Nema podataka o prijenosu kroz posteljicu u ljudi, ali pokazalo se da brivaracetam prolazi kroz posteljicu u štakora (vidjeti dio 5.3).
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.
U tih bolesnika opažena je niža djelotvornost u usporedbi s bolesnicima koji prethodno nisu bili liječeni levetiracetamom vjerojatno zbog većeg broja prethodno primijenjenih antiepileptika i veće početne učestalosti napadaja.
Antiepileptic drugs
Antiepileptici
Contains sodium acetate (trihydrate), sodium chloride.
Sadrži natrijev acetat (trihidrat) i natrijev klorid.
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.
Za djecu s tjelesnom težinom od 50 kg ili više, početna doza brivaracetama bila je 50 mg/dan, a ovisno o odgovoru i podnošljivosti, doza se povećavala do najviše 200 mg/dan u tjednim prirastima od 50 mg/dan.
As from the 0.1 ml graduation mark, each graduation corresponds to 0.1 ml which is 1 mg of brivaracetam.
Od oznake gradusa od 0,1 ml, svaki gradus odgovara 0,1 ml, što je 1 mg brivaracetama.
Briviact oral solution contains methyl parahydroxybenzoate, sodium and sorbitol Briviact oral solution contains: - methyl parahydroxybenzoate (E218) - this may cause allergic reactions (possibly delayed).
Briviact oralna otopina sadrži metilparahidroksibenzoat, natrij i sorbitol Briviact oralna otopina sadrži: - metilparahidroksibenzoat (E218) - može uzrokovati alergijske reakcije (koje mogu biti odgođene).
In vitro, the hydroxylation of brivaracetam is mediated primarily by CYP2C19.
U hidroksilaciji brivaracetama in vitro posreduje prvenstveno CYP2C19.
Learning and memory function were not affected.
Brivaracetam nije utjecao na funkciju učenja ni pamćenja.
There are limited clinical data on the use of brivaracetam in patients with pre-existing hepatic impairment.
Ograničeni su klinički podaci o primjeni brivaracetama u bolesnika s otprije postojećim oštećenjem jetrene funkcije.
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.
Od trenutka uključivanja u randomizirana ispitivanja, 5,3% ispitanika izloženih brivaracetamu tijekom 6 mjeseci (n=1500) bilo je bez napadaja, a isto je zabilježeno i u 4,6% ispitanika izloženih lijeku tijekom 12 mjeseci (n=1188) te 3,7% onih koji su mu bili izloženi tijekom 24 mjeseca (n=847).
No dose adjustment is needed in patients with impaired renal function (see section 5.2).
Nije potrebno prilagođavati dozu u bolesnika s oštećenjem bubrežne funkcije (vidjeti dio 5.2).
50 mg/day 100 mg/day 200 mg/day
50 mg/dan 100 mg/dan 200 mg/dan
The solution for injection/infusion contains 0.83 mmol (or 19.14 mg) sodium per vial.
Otopina za injekciju/infuziju sadrži 0,83 mmol (ili 19,14 mg) natrija po bočici.
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.
Štrcaljka za oralno doziranje (10 ml graduirano na svakih 0,25 ml) s nastavkom, preporučena je za primjenu u bolesnika s tjelesnom težinom većom od 20 kg ili kojima je potrebna doza između 50 mg i 100 mg (5 ml do 10 ml) brivaracetama po primjeni.
- Periodic safety update reports
• Periodička izvješća o neškodljivosti
- Pull the plunger down to fill the oral syringe with a small amount of solution (figure 6).
- Povlačite klip prema dolje kako biste uvukli malu količinu otopine u štrcaljku za usta (slika 6).
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.
Briviact se može razrijediti sljedećim otopinama: otopinom natrijeva klorida za injekcije od 9 mg/ml (0,9%), otopinom glukoze za injekcije od 50 mg/ml (5%) ili otopinom Ringerova laktata.
The other ingredients are: sodium citrate, citric acid anhydrous, methyl parahydroxybenzoate (E218), carmellose sodium, sucralose, sorbitol liquid, glycerol (E422), raspberry flavour, water, purified.
Drugi sastojci su: natrijev citrat, bezvodna citratna kiselina, metilparahidroksibenzoat (E218), karmelozanatrij, sukraloza, tekući sorbitol, glicerol (E422), aroma maline, pročišćena voda.
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.
Iz združenih otvorenih ispitivanja sigurnosti i FK s adjunktivnom terapijom, 149 djece s parcijalnim nastupom napadaja (POS) primalo je brivaracetam, od kojih je 116 liječeno ≥6 mjeseci, 107 ≥12 mjeseci, 58 ≥24 mjeseca, a 28 ≥36 mjeseci.
The efficacy outcomes are summarized in Table 2.
Ishodi djelotvornosti sažeto su prikazani u Tablici
In vitro, brivaracetam did ot induce CYP1A2.
In vitro, brivaracetam nije inducirao CYP1A2.
n= 96 n= 101
n=101
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
Ako Vam je liječnik rekao da ne podnosite neke šećere, savjetujte se sa svojim liječnikom prije uzimanja ovog lijeka.
- Turn the bottle upside down (figure 5).
- Preokrenite bocu (slika 5).
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.
Nuspojave identificirane na temelju pregleda tri placebom kontrolirana klinička ispitivanja s fiksnom dozom u ispitanika ≥ 16 godina starosti, navedene su u tablici u nastavku prema klasifikaciji organskih sustava i učestalosti.
The minimum extractible volume is 0.25 ml which is 2.5 mg of brivaracetam.
Najmanji volumen koji se može ekstrahirati je 0,25 ml, što odgovara 2,5 mg brivaracetama.
CYP2B6 induction has not been investigated in vivo and brivaracetam may decrease plasma concentrations of medicinal products metabolised by CYP2B6 (e.g. efavirenz).
Indukcija enzima CYP2B6 nije se ispitivala in vivo i brivaracetam može smanjiti plazmatske koncentracije lijekova metaboliziranih enzimom CYP2B6 (npr. efavirenza).
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.
Štrcaljka za oralno doziranje (5 ml graduirano na svakih 0,1 ml) s nastavkom, preporučena je za primjenu u bolesnika s tjelesnom težinom manjom od 20 kg ili kojima je potrebno najviše 50 mg (5 ml) brivaracetama po primjeni.
The main disposition pathway of brivaracetam is by CYP-independent hydrolysis.
Glavni put biotransformacije brivaracetama je hidroliza neovisna o CYP enzimima.
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.
Posebno, obavijestite svog liječnika ako uzimate bilo koji od sljedećih lijekova - to je stoga što će Vaš liječnik možda trebati prilagoditi Vašu dozu Briviacta: rifampicin, lijek koji se koristi za liječenje bakterijskih infekcija. gospinu travu, (također poznatu kao Hypericum perforatum) biljni lijek koji se koristi za liječenje depresije i tjeskobe, kao i drugih stanja.
Children (≥4 years) and adolescents ≥50 kg Administered in 2 equally divided doses
Djeca (≥4 godine) i adolescenti ≥50 kg Primjena u 2 jednake doze
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.
Na osnovi pojedinačnog odgovora bolesnika, doza se može prilagođavati u djelotvornom rasponu doze od 1 mg/kg/dan i 4 mg/kg/dan.
Table 1: Pharmacokinetic interactions between brivaracetam and other AEDs AED coadministered Influence of AED on brivaracetam plasma concentration
Tablica 1: Farmakokinetičke interakcije između brivaracetama i drugih antiepileptika Istodobno primijenjen antiepileptik
The primary endpoints in the phase 3 studies were the percent reduction in POS frequency over placebo and the 50 % responder rate based on 50 % reduction in POS frequency from baseline.
Primarne mjere ishoda u ispitivanjima faze 3 bile su postotno smanjenje učestalosti parcijalnih napadaja u odnosu na placebo i stopa bolesnika s odgovorom od 50%, određenim na temelju smanjenja učestalosti parcijalnih napadaja za 50% u odnosu na početak ispitivanja.
Brivaracetam solution for injection/infusion is an alternative for patients when oral administration is temporarily not feasible.
Brivaracetam otopina za injekciju/infuziju predstavlja zamjensku opciju za bolesnike u kojih peroralna primjena privremeno nije moguća.
INTERMEDIATE CARTON WITHIN MULTIPACK (3 PACKS OF 56 FILM-COATED TABLETS) (WITHOUT BLUEBOX)
UNUTARNJE PAKIRANJE KAO DIO VIŠESTRUKOG PAKIRANJA (3 PAKIRANJA OD 56 FILMOM OBLOŽENIH TABLETA) (BEZ PLAVOG OKVIRA)
No adverse liver changes were seen in rats and monkeys following chronic administration of brivaracetam at 5- and 42fold the clinical AUC exposure.
Štetne promjene na jetri nisu primijećene u štakora ni majmuna nakon kronične primjene brivaracetama u dozama kojima se postiže izloženost 5 odnosno 42 puta veća od one koja se postiže uz klinički AUC.
Contains sodium citrate, carmellose sodium, methyl parahydroxybenzoate (E218), sorbitol liquid and glycerol (E422).
Sadrži natrijev citrat, karmelozunatrij, metilparahidroksibenzoat (E218), tekući sorbitol i glicerol (E422).
The minimum extractible volume is 1 ml which is 10 mg of brivaracetam.
Najmanji volumen koji se može ekstrahirati je 1 ml, što odgovara 10 mg brivaracetama.
Croscarmellose sodium, lactose monohydrate, betadex, lactose anhydrous, magnesium stearate
Jezgra umrežena karmelozanatrij, laktoza hidrat, betadeks, bezvodna laktoza, magnezijev stearat
PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND IMMEDIATE PACKAGING
PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM I UNUTARNJEM PAKIRANJU
Binding to SV2A is believed to be the primary mechanism for brivaracetam anticonvulsant activity.
Vjeruje se da je vezivanje za SV2A primarni mehanizam kojim brivaracetam ostvaruje svoje antikonvulzivno djelovanje.
The active substance is brivaracetam.
Djelatna tvar je brivaracetam.
Suicidal ideation has been reported in 0.3 % (3/1099) brivaracetam patients and 0.7 % (3/459) placebo patients.
Suicidalne ideje prijavljene su u 0,3% (3/1099) bolesnika liječenih brivaracetamom i 0,7% (3/459) bolesnika koji su primali placebo.
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).
U svim kontroliranim i nekontroliranim ispitivanjima provedenima u bolesnika s epilepsijom, brivaracetam je primalo 2388 ispitanika; 1740 njih liječeno je ≥ 6 mjeseci, 1363 ≥ 12 mjeseci, 923 ≥ 24 mjeseca, a njih 569 ≥ 60 mjeseci (5 godina).
As from the 1 ml graduation mark, each graduation corresponds to 0.25 ml which is 2.5 mg of brivaracetam.
Od oznake gradusa od 1 ml, svaki gradus odgovara 0,25 ml, što je 2,5 mg brivaracetama.
Each millilitre (ml) contains 10 milligrams (mg) brivaracetam.
Jedan mililitar (ml) sadrži 10 miligrama (mg) brivaracetama.
n = 252 n = 249
n=252
Brivaracetam film-coated tablets contain lactose.
Filmom obložene tablete brivaracetama sadrže laktozu.
Neutropenia has been reported in 0.5 % (6/1099) brivaracetam patients and 0 % (0/459) placebo patients.
Neutropenija je prijavljena u 0,5% (6/1099) bolesnika liječenih brivaracetamom i 0% (0/459) bolesnika koji su primali placebo.
Instructions for use are provided in the package leaflet.
Upute za primjenu navedene su u uputi za lijek.
1 - 4 mg/kg/day
1 - 4 mg/kg/dan
The efficacy of brivaracetam in monotherapy has not been established.
Nije utvrđena djelotvornost brivaracetama u monoterapiji.
Oral solution Slightly viscous, clear colourless to yellowish liquid.
Oralna otopina Blago viskozna, bistra, bezbojna do žućkasta tekućina.
An additional adverse reaction reported in children was psychomotor hyperactivity
Dodatna nuspojava prijavljena u djece bila je psihomotorička hiperaktivnost (4,7%).
Talk to your doctor or pharmacist before taking Briviact if: - You have thoughts of harming or killing yourself.
Upozorenja i mjere opreza Obratite se svom liječniku ili ljekarniku prije nego uzmete Briviact: - ako razmišljate o samoozljeđivanju ili samoubojstvu.
Based on individual patient response, the dose may be adjusted in the effective dose range of 50 mg/day and 200 mg/day.
Na osnovi pojedinačnog odgovora bolesnika, doza se može prilagođavati u djelotvornom rasponu doze od 50 mg/dan i 200 mg/dan.
Briviact is administered as an injection or infusion into a vein by a doctor or a nurse.
Briviact će Vam dati liječnik ili medicinska sestra u obliku injekcije ili infuzije u venu.
Check with your doctor which one you should use.
Provjerite sa svojim liječnikom koristite li odgovarajuću štrcaljku.
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.
Sredstva za razrjeđivanje - otopina natrijeva klorida za injekciju od 9 mg/ml (0,9%) - otopina glukoze za injekciju od 50 mg/ml (5%) - otopina Ringerova laktata za injekciju
Briviact contains sodium
Briviact sadrži natrij
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
Česte: mogu se javiti u do 1 na 10 osoba - gripa - izrazit umor - konvulzija, vrtoglavica (osjećaj da se sve oko Vas vrti) - mučnina, povraćanje, zatvor - depresija, tjeskoba, nesanica, razdražljivost - infekcije nosa i grla (poput prehlade), kašalj - smanjen apetit
Brivaracetam oral solution contains sodium.
Brivaracetam oralna otopina sadrži natrij.
How to take Briviact
Kako uzimati Briviact
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.
Stopa prekida liječenja zbog nuspojava iznosila je 3,5%, 3,4% i 4,0% u bolesnika randomiziranih za primanje brivaracetama u dozi od 50 mg/dan, 100 mg/dan odnosno 200 mg/dan te 1,7% u bolesnika randomiziranih za primanje placeba.
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.
Postotak bolesnika u kojih se učestalost parcijalnih napadaja smanjila za najmanje 50% iznosio je 20,3% uz placebo, 34,2% uz dozu od 50 mg/dan, 39,5% uz dozu od 100 mg/dan i 37,8% uz dozu od 200 mg/dan.
Briviact 10 mg/ml solution for injection/infusion 5 ml vial is packed in a carton box of 10 vials.
Bočica s 5 ml lijeka Briviact 10 mg/ml otopina za injekciju/infuziju pakirana je u kutiju koja sadrži 10 bočica.
Briviact contains the active substance brivaracetam.
Briviact sadrži djelatnu tvar brivaracetam.