FrancophonIA/ELRC3.0 huggingface dataset:
English: The safety profile in elderly patients appears to be similar to that observed in younger adult patients.
Croatian: Čini se da je sigurnosni profil u starijih bolesnika sličan onom primijećenom u mlađih odraslih bolesnika.
English: A small number of people being treated with anti-epileptic medicines such as Briviact have had thoughts of harming or killing themselves.
Croatian: Mali broj ljudi koji se liječe antiepileptičkim lijekovima kao što je Briviact razmišljali su o samoozljeđivanju ili samoubojstvu.
English: Patients with more than a 25 % increase in POS are shown at left as “worse”.
Croatian: Bolesnici s povećanjem učestalosti parcijalnih napadaja za više od 25% prikazani su slijeva i označeni izrazom “pogoršanje”.
English: The precise volume of oral solution is to be calculated according to the exact body weight of the child.
Croatian: Točan volumen oralne otopine izračunava se prema točnoj tjelesnoj težini djeteta.
English: - If you are not sure what to do, ask your doctor or pharmacist.
Croatian: - Ako niste sigurni što učiniti, pitajte svog liječnika ili ljekarnika.
English: In such cases, it should be used straight after dilution.
Croatian: U tom se slučaju on mora primijeniti odmah nakon razrjeđivanja.
English: - For the long term treatment with Briviact, your doctor will ask to you to take Briviact tablets or oral solution.
Croatian: - Za dugoročno liječenje lijekom Briviact, liječnik će od Vas tražiti da uzimate Briviact tablete ili oralnu otopinu.
English: Less than 1 % of the dose is excreted in faeces and less than 10 % of brivaracetam is excreted unchanged in urine.
Croatian: Manje od 1% doze izlučuje se fecesom, a manje od 10% brivaracetama izlučuje se u nepromijenjenom obliku urinom.
English: 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.
Croatian: Dugoročno, nekontrolirano, otvoreno ispitivanje sigurnosti uključivalo je djecu (od 4 godine do nenavršenih 16 godina) koja su nastavila liječenje nakon završenog ispitivanja FK (vidjeti dio 5.2) i djecu koja su se izravno uključivala u ispitivanje sigurnosti.
English: 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.
Croatian: Međutim, kako je visok udio ispitanika (26%) zbog nedostatka djelotvornosti prekinuo s otvorenim ispitivanjima, moguće je da se pojavila pristranost odabira zbog boljeg odgovora bolesnika koji su ostali u ispitivanju od onih koji su prerano prekinuli.
English: Elderly (65 years of age and above) No dose adjustment is needed in elderly patients (see section 5.2).
Croatian: Starije osobe (u dobi od 65 ili više godina) Nije potrebno prilagođavati dozu u starijih bolesnika (vidjeti dio 5.2).
English: 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.
Croatian: Među bolesnicima koji su praćeni u otvorenim nastavcima ispitivanja tijekom razdoblja do 8 godina, sigurnosni profil bio je sličan onom primijećenom u kratkoročnim, placebom kontroliranim ispitivanjima.
English: - 1.16 milligrams sodium per millilitre.
Croatian: - 1,16 miligrama natrija po mililitru otopine.
English: None of the 6 cases of neutropenia were severe, required any specific treatment or led to discontinuation of brivaracetam and none had associated infections.
Croatian: Nijedan od tih 6 slučajeva neutropenije nije bio težak, nije zahtijevao specifično liječenje i nije doveo do prekida liječenja brivaracetamom, te nijedan od njih nije imao pridružene infekcije.
English: Other enzyme inducers
Croatian: Drugi enzimski induktori
English: 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.
Croatian: Ne preporučuje se uzimati Briviact tijekom trudnoće ili dojenja jer učinci lijeka Briviact na trudnoću i nerođeno dijete ili novorođenče nisu poznati.
English: - 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.
Croatian: - Kada započnete liječenje lijekom Briviact, uzimat ćete ga kroz usta (u obliku tableta ili oralne otopine) ili ćete ga primjenjivati u obliku injekcije ili infuzije.
English: The medicine is injected slowly into your vein or given as an infusion (drip) over 15 minutes.
Croatian: Lijek se polako injicira u venu ili primjenjuje u obliku infuzije (kap po kap) tijekom 15 minuta.
English: This medicinal product does not require any special storage conditions.
Croatian: Lijek ne zahtijeva nikakve posebne uvjete čuvanja.
English: If you have taken more Briviact than you should, talk to your doctor.
Croatian: Ako ste uzeli više lijeka Briviact nego što ste trebali, obratite se svom liječniku.
English: This may avoid the brivaracetam plasma concentration falling below the efficacy level and prevent breakthrough seizures from occurring.
Croatian: Na taj će se način možda izbjeći pad plazmatske koncentracije brivaracetama ispod granice djelotvornosti i spriječiti nastup napadaja.
English: If you have more Briviact than you should If you think you have been given too much Briviact, tell your doctor straight away.
Croatian: Ako primite više lijeka Briviact nego što ste trebali Ako mislite da ste primili previše lijeka Briviact, odmah to recite svom liječniku.
English: The hydroxyacid metabolite did not reveal any safety concerns in non clinical studies.
Croatian: Metabolit u obliku hidroksilne kiseline nije uzrokovao nikakve sigurnosne probleme u nekliničkim ispitivanjima.
English: Patients were required to have at least 8 POS during the baseline period.
Croatian: Bolesnici su morali imati najmanje 8 parcijalnih napadaja tijekom početnog razdoblja.
English: Suicidal ideation and behaviour have been reported in patients treated with anti-epileptic drugs (AEDs), including brivaracetam, in several indications.
Croatian: Suicidalne ideje i ponašanje prijavljeni su u bolesnika liječenih antiepilepticima, uključujući brivaracetam, u različitim indikacijama.
English: Briviact is used in adults, adolescents and children from 4 years of age.
Croatian: - Briviact se koristi u odraslih, adolescenata i djece od navršene 4 godine.
English: Intake of brivaracetam with alcohol is not recommended.
Croatian: Ne preporučuje se uzimanje brivaracetama s alkoholom.
English: The EC50 (brivaracetam plasma concentration corresponding to 50 % of the maximum effect) was estimated to be 0.57 mg/L.
Croatian: Procjenjuje se da EC50 (plazmatska koncentracija brivaracetama kojom se ostvaruje 50% maksimalnog učinka) iznosi 0,57 mg/l.
English: The physician should prescribe the most appropriate formulation and strength according to weight and dose.
Croatian: Liječnik treba propisati najprimjereniju formulaciju i jačinu u skladu s tjelesnom težinom i dozom.
English: The frequencies are defined as follows: very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥ 1/1,000 to < 1/100).
Croatian: Učestalost se definira na sljedeći način: vrlo često (≥1/10), često (≥1/100 i <1/10), manje često (≥1/1000 i <1/100).
English: Experience with epilepsy medicines suggests that the results of efficacy studies performed in adults can be extrapolated to children down to the age of 4 years provided the paediatric dose adaptations are established and safety has been demonstrated (see sections 5.2 and 4.8).
Croatian: Iskustvo s lijekovima za liječenje epilepsije upućuje na zaključak da se rezultati ispitivanja djelotvornosti obavljenih na odraslima mogu ekstrapolirati na djecu do 4 godine života, pod uvjetom da su utvrđene prilagodbe pedijatrijskih doza i da je sigurnost dokazana (vidjeti dio 5.2 i 4.8).
English: Exposure to brivaracetam was increased in adult patients with chronic liver disease.
Croatian: Izloženost brivaracetamu bila je povećana u odraslih bolesnika s kroničnom jetrenom bolešću.
English: There is no experience with twice daily intravenous administration of brivaracetam for a period longer than 4 days.
Croatian: Nema iskustva s intravenskom primjenom brivaracetama dvaput dnevno tijekom razdoblja više od 4 dana.
English: 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).
Croatian: Načelno nije bilo promjene u profilima koncentracije kroz vrijeme za endogene biljege estradiol, progesteron, luteinizirajući hormon (LH) folikulostimulirajući hormon (FSH) i globulin koji vezuje spolne hormone (engl. sex hormone binding globulin, SHBG).
English: Prescribers should consider adjusting the brivaracetam dose in patients starting or ending treatment with rifampicin.
Croatian: Liječnici koji propisuju lijek trebali bi razmotriti prilagodbu doze brivaracetama u bolesnika koji započinju ili završavaju liječenje rifampicinom.
English: After 1 week of treatment at 50 mg/day, a final week of treatment at the dose of 20 mg/day is recommended.
Croatian: Nakon tjedan dana liječenja dozom od 50 mg/dan, preporučuje se završni tjedan liječenja dozom od 20 mg/dan.
English: Patients had a mean duration of epilepsy of approximately 23 years.
Croatian: Srednja vrijednost trajanja epilepsije u bolesnika iznosila je približno 23 godine.
English: In the treated population, an increase in malformations has been noted with polytherapy; however, the extent to which the treatment and/or the underlying condition is responsible has not been elucidated.
Croatian: U liječenoj je populaciji primijećen povećan broj malformacija kod primjene politerapije, ali nije razjašnjeno u kojoj je mjeri to posljedica liječenja i/ili podležeće bolesti.
English: Each vial of Briviact solution for injection/infusion must be used only once (single use).
Croatian: Jedna bočica Briviact otopine za injekciju/infuziju smije se upotrijebiti samo jedanput (jednokratna uporaba).
English: Risk related to brivaracetam
Croatian: Rizik povezan s brivaracetamom
English: Somnolence and fatigue (8.2 %) were reported at a higher incidence with increasing dose.
Croatian: Prijavljena incidencija somnolencije i umora (8,2%) rasla je s povećanjem doze.
English: The maximum dose should not exceed 3 mg/kg/day.
Croatian: Maksimalna doza ne smije prekoračivati 3 mg/kg/dan.
English: - You have liver problems - your doctor may need to adjust your dose.
Croatian: - ako imate jetrenih tegoba, Vaš liječnik će možda trebati prilagoditi dozu.
English: Briviact solution for injection/infusion can be administered as a bolus injection or as an infusion:
Croatian: Briviact otopina za injekciju/infuziju može se primijeniti kao bolusna injekcija ili kao infuzija:
English: See also section 4.8, paediatric data.
Croatian: Vidjeti također dio 4.8, za pedijatrijske podatke.
English: The safety profile of brivaracetam observed in children was consistent with the safety profile observed in adults.
Croatian: Sigurnosni profil brivaracetama opažen u djece odgovara poznatom sigurnosnom profilu opaženom u odraslih.
English: What Briviact is and what it is used for
Croatian: Što je Briviact i za što se koristi
English: Stopping treatment could increase your seizures and harm your baby.
Croatian: Prekid liječenja može povećati učestalost napadaja i naškoditi djetetu.
English: Dose taken twice daily for children from 4 years of age weighing less than 50 kg.
Croatian: Doza koja se uzima dvaput dnevno za djecu od navršene 4 godine starosti s tjelesnom težinom manjom od 50 kg.
English: There were no adverse effects on CNS function, neuropathological and brain histopathological examination.
Croatian: Nije bilo štetnih učinaka na funkciju SŽS-a, neuropatoloških promjena ni histopatoloških promjena na mozgu.
English: If you are on a low sodium diet, you need to take this into account.
Croatian: Ako ste na dijeti s niskim unosom natrija, morate to imati na umu. - sorbitol (jednu vrstu šećera).
English: Due to its lipophylicity (Log P) brivaracetam has high cell membrane permeability.
Croatian: Zbog svoje lipofilnosti (log P), brivaracetam ima visoku prolaznost kroz staničnu membranu (permeabilnost).
English: Other strong enzyme inducers (such as St John´s wort (Hypericum perforatum)) may also decrease the systemic exposure of brivaracetam.
Croatian: Drugi snažni enzimski induktori (poput gospine trave [Hypericum perforatum]) također mogu smanjiti sistemsku izloženost brivaracetamu.
English: 1,558 patients received study drug of which 1,099 received brivaracetam.
Croatian: Ispitivani je lijek primalo 1558 bolesnika, od kojih je njih 1099 uzimalo brivaracetam.
English: The volume of distribution is 0.5 L/kg, a value close to that of the total body water.
Croatian: Volumen distribucije iznosi 0,5 l/kg, što je vrijednost približno jednaka ukupnoj količini vode u tijelu.
English: How to take Briviact oral solution - You can take Briviact oral solution on its own, or dilute it in water or juice shortly before swallowing.
Croatian: Kako uzimati Briviact oralnu otopinu - Briviact oralnu otopinu možete uzeti samu ili je možete razrijediti u vodi ili voćnom soku neposredno prije uzimanja.
English: Reactions suggestive of immediate (Type I) hypersensitivity have been reported in a small number of brivaracetam patients (9/3022) during clinical development.
Croatian: Reakcije koje ukazuju na ranu preosjetljivost (tipa I) prijavljene su kod malog broja bolesnika liječenih brivaracetamom (9/3022) tijekom kliničkog razvoja lijeka.
English: Your doctor will work out the right dose for you, depending on your weight.
Croatian: Vaš liječnik će odlučiti koja je odgovarajuća doza za Vas, ovisno o Vašoj tjelesnoj težini.
English: Study N01358
Croatian: Ispitivanje br. 1358
English: 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).
Croatian: Na kraju razdoblja procjene, ispitanici su mogli biti podobni za uključivanje u dugoročno ispitivanje praćenja, u kojem su nastavili primati zadnju primijenjenu dozu (vidjeti dio 4.8).
English: This is because stopping treatment could increase the number of fits you have.
Croatian: Naime, prekid liječenja može povećati broj napadaja koje imate.
English: The safety and efficacy of brivaracetam in children aged less than 4 years have not yet been established.
Croatian: Sigurnost i djelotvornost brivaracetama u djece mlađe od 4 godine još nisu ustanovljene.
English: This medicinal product is for single use only, any unused solution should be discarded.
Croatian: Ovaj je lijek namijenjen isključivo za jednokratnu uporabu i svu neiskorištenu otopinu treba baciti.
English: Table 2: Key Efficacy Outcomes for Partial Onset Seizure Frequency per 28 Days Study
Croatian: Tablica 2: Ključni ishodi djelotvornosti s obzirom na učestalost parcijalnih nastupa napadaja tijekom 28 dana
English: All doses were adjusted by body weight, and did not exceed a maximum of 50 mg/day, 100 mg/day, and 200 mg/day.
Croatian: Sve doze su prilagođavane prema tjelesnoj težini i nisu prekoračivale maksimum od 50 mg/dan, 100 mg/dan i 200 mg/dan.
English: The hydrolysis of the amide moiety leading to the carboxylic acid metabolite (34 % of the dose in urine) is supported by hepatic and extra-hepatic amidase.
Croatian: Hidrolizi amidne skupine kojom nastaje metabolit u obliku karboksilne kiseline (34% doze u urinu) pridonose hepatična i ekstrahepatična amidaza.
English: A maximum daily dose of 150 mg administered in 2 divided doses is recommended for all stages of hepatic impairment (see section 4.4 and 5.2).
Croatian: Maksimalna dnevna doza od 150 mg, podijeljena na 2 doze, preporučuje se za sve stupnjeve oštećenja jetrene funkcije (vidjeti dijelove 4.4 i
English: Brivaracetam film-coated tablets, oral solution and solution for intravenous injection show the same AUC, while the maximum plasma concentration is slightly higher after intravenous administration.
Croatian: Brivaracetam filmom obložene tablete, oralna otopina i otopina za intravensku injekciju pokazuju isti AUC, dok je maksimalna plazmatska koncentracija nešto viša nakon intravenske primjene.
English: 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.
Croatian: Bolusna injekcija ili intravenska infuzija brivaracetama nisu ispitane u akutnim stanjima (npr. kod epileptičkog statusa) i stoga se njihova primjena u takvim stanjima ne preporučuje.
English: Since less than 10 % of brivaracetam is excreted in urine, haemodialysis is not expected to significantly enhance brivaracetam clearance (see section 5.2).
Croatian: Budući da se manje od 10% brivaracetama izluči putem urina, ne očekuje se da će hemodijaliza značajno pospješiti klirens brivaracetama (vidjeti dio 5.2).
English: The effect of the interactions on the plasma concentration is summarised in table 1 (increase is indicated as “↑” and decrease as “↓”, area under the plasma concentration versus time curve as “AUC”, maximum observed concentration as Cmax).
Croatian: Učinci interakcija na plazmatsku koncentraciju sažeto su prikazani u tablici 1 (povećanje je označeno kao “↑”, smanjenje kao “↓”, površina ispod krivulje plazmatske koncentracije u odnosu na vrijeme kao “AUC”, a maksimalna zabilježena koncentracija kao “Cmax”).
English: If you are not sure, talk to your doctor or pharmacist before taking Briviact.
Croatian: Ako niste sigurni, obratite se svom liječniku ili ljekarniku prije nego uzmete Briviact.
English: - Pull the plunger down to the millilitre (ml) dose marker on the oral syringe prescribed by your doctor (figure 8).
Croatian: - Povucite klip do oznake na štrcaljki za usta koja označava mililitarsku (ml) dozu koju Vam je propisao Vaš liječnik (slika 8)
English: Brivaracetam solution for injection/infusion is physically compatible and chemically stable when mixed with the following diluents
Croatian: Brivaracetam otopina za injekciju/infuziju fizički je kompatibilna i kemijski stabilna ako se miješa sa sljedećim sredstvima za razrjeđivanje
English: Brivaracetam has minor or moderate influence on the ability to drive and use machines.
Croatian: Brivaracetam malo ili umjereno utječe na sposobnost upravljanja vozilima i rada sa strojevima.
English: The efficacy and tolerability of brivaracetam in paediatric patients less than 4 years of age have not been established (see section 4.2).
Croatian: Djelotvornost i podnošljivost brivaracetama u pedijatrijskih bolesnika mlađih od 4 godine nisu ustanovljene (vidjeti dio 4.2).
English: In two phase 3 randomised placebo-controlled studies, levetiracetam was administered as concomitant AED in about 20 % of the patients.
Croatian: U dvama randomiziranim, placebom kontroliranim ispitivanjima faze 3, levetiracetam se primjenjivao kao istodobni antiepileptik u približno 20% bolesnika.
English: In a pharmacokinetic study with a 3-week evaluation period and weekly fixed 3-step up-titration using the brivaracetam oral solution, 99 subjects aged 1 month to <16 years were evaluated.
Croatian: U farmakokinetičkom ispitivanju s razdobljem procjene od 3 tjedna i tjednim fiksnim povišenjem titracije u 3 koraka uz primjenu oralne otopine brivaracetama, procijenjeno je 99 ispitanika u dobi od 1 mjeseca do <16 godina.
English: People with liver problems
Croatian: Osobe s jetrenim tegobama
English: - Intravenous infusion: brivaracetam may be diluted in a compatible diluent and administered as a 15-minute intravenous infusion (see section 6.6).
Croatian: - Intravenska infuzija: brivaracetam se može razrijediti u kompatibilnom sredstvu za razrjeđivanje i primijeniti u obliku 15-minutne intravenske infuzije (vidjeti dio 6.6).
English: - Put the adaptor into the top of the bottle (figure 3).
Croatian: - Stavite nastavak na vrh boce (slika 3).
English: Carcinogenicity studies did not indicate any oncogenic potential in rats, whereas increased incidences of hepatocellular tumors in male mice are considered to result of a non-genotoxic, mode of action linked to a phenobarbitonelike liver enzyme induction, which is a known rodent specific phenomenon.
Croatian: Ispitivanja kancerogenosti nisu ukazala na onkogeni potencijal u štakora, a povećane incidencije hepatocelularnih tumora u mužjaka miševa smatrale su se posljedicom negenotoksičnog mehanizma djelovanja povezanog s indukcijom jetrenih enzima nalik onoj koju uzrokuje fenobarbiton, za koju se zna da je fenomen specifičan za glodavce.
English: In comparison, plasma clearance was estimated at 3.58 L/h in adult patients (70 kg body weight).
Croatian: U usporedbi s tim, klirens plazme bio je procijenjen na 3,58 l/h u odraslih bolesnika (70 kg tjelesne težine).
English: Of the 130 elderly subjects enrolled in the brivaracetam phase 2/3 development program (44 with epilepsy), 100 were 65-74 years of age and 30 were 75-84 years of age.
Croatian: Od 130 starijih ispitanika uključenih u program razvoja brivaracetama faze 2/3 (44 bolesnika s epilepsijom), njih 100 bilo je u dobi od 65 do 74 godine, a njih 30 u dobi od 75 do 84 godine.
English: If you have any of these thoughts at any time, contact your doctor immediately.
Croatian: Ako u bilo kojem trenutku počnete razmišljati o tome, odmah se javite svom liječniku.
English: This plasma concentration is slightly above the median exposure obtained after brivaracetam doses of 50 mg/day.
Croatian: Ta je plazmatska koncentracija nešto viša od medijana izloženosti koji se postiže nakon primjene brivaracetama u dozama od 50 mg/dan.
English: In safety pharmacology studies, the predominant effects were CNS related (mainly transient CNS depression and decreased spontaneous locomotor activity) seen at multiples (greater than 50 fold) of the pharmacologically active dose of brivaracetam, 2 mg/kg.
Croatian: Sigurnosna farmakološka ispitivanja pokazala su da su predominantni učinci bili povezani sa SŽS-om (uglavnom prolazna depresija SŽS-a i smanjena spontana lokomotorna aktivnost), primijećeni kod primjene doza višestruko većih (više od 50 puta) od farmakološki aktivne doze brivaracetama od 2 mg/kg.
English: A 40 % decrease in steady-state plasma concentration has been estimated across a body weight range from 46 kg to 115 kg.
Croatian: Procjenjuje se da plazmatska koncentracija u stanju dinamičke ravnoteže opada za 40% kroz raspon tjelesne težine od 46 kg do 115 kg.
English: Apart from dose-dependent increases in incidences of somnolence and fatigue brivaracetam 50 mg/day and 100 mg/day had a similar safety profile including CNSrelated AEs and with long-term use.
Croatian: Osim o dozi ovisnih povećanja incidencije somnolencije i umora, doze brivaracetama od 50 mg/dan i 100 mg/dan imale su sličan sigurnosni profil, uključujući nuspojave povezane sa SŽS-om i one kod dugoročne primjene.
English: 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.
Croatian: Europska agencija za lijekove izuzela je obvezu podnošenja rezultata ispitivanja brivaracetama u jednoj ili više podskupina pedijatrijske populacije za liječenje epilepsije s parcijalnim nastupima napadaj.
English: Briviact is indicated as adjunctive therapy in the treatment of partial onset seizures with or without secondary generalisation in adults, adolescents and children from 4 years of age with epilepsy.
Croatian: Briviact je indiciran kao dodatna terapija u liječenju parcijalnih nastupa napadaja sa sekundarnom generalizacijom ili bez nje u odraslih bolesnika, adolescenata i djece od navršene 4 godine života koji boluju od epilepsije.
English: Therefore, starting or ending treatment with St John's wort should be done with caution.
Croatian: Stoga uvođenje ili prekid liječenja gospinom travom treba provoditi uz oprez.