FrancophonIA/ELRC3.0 huggingface dataset:
English: In a pooled analysis, the percentage of patients who achieved 50% or greater reduction from baseline in the partial onset seizure frequency per week at stable dose (12/14 weeks) was of 27.7%, 31.6% and 41.3% for patients on 1,000, 2,000 or 3,000 mg levetiracetam respectively and of 12.6% for patients on placebo.
Croatian: Analizom zbirnih podataka utvrđeno je da je postotak bolesnika kod kojih je postignuto 50 %-tno ili više smanjenje učestalosti djelomičnih napadaja tjedno uz konstantnu dozu (12/14 tjedana) bio 27,7% kod uzetih 1000 mg, 31,6% kod uzetih 2000 mg i 41,3% kod uzetih 3000 mg levetiracetama te 12,6% kod uzimanja placeba.
English: More than half of the subjects remained seizure free for 12 months (56.6% and 58.5% of subjects on levetiracetam and on carbamazepine CR respectively).
Croatian: Više od pola ispitanika 12 mjeseci nije imalo napadaje (56,6% bolesnika koji su dobivali levetiracetam i 58,5% ispitanika koji su dobivali karbamazepin s kontroliranim otpuštanjem).
English: This medicinal product contains 2.5 mmol (or 57 mg) sodium per maximum single dose (0.8 mmol (or 19 mg) per vial).
Croatian: Ovaj lijek sadrži 2,5 mmol (ili 57 mg) natrija po maksimalnoj pojedinačnoj dozi (0,8 mmol (ili 19 mg) po bočici).
English: In paediatric patients (4 to 16 years of age), levetiracetam efficacy was established in a double-blind, placebo-controlled study, which included 198 patients and had a treatment duration of 14 weeks.
Croatian: U pedijatrijskih bolesnika (4. do 16. godina života) djelotvornost levetiracetama dokazana je u dvostruko slijepoj i placebom kontroliranoj studiji koja je trajala 14 dana i uključivala 198 bolesnika.
English: Levetiracetam therapy can be initiated with either intravenous or oral administration.
Croatian: Liječenje levetiracetamom se može započeti intravenskom ili peroralnom primjenom.
English: Do not use Levetiracetam Hospira
Croatian: Nemojte primjenjivati Levetiracetam Hospira
English: Dose in children and adolescents 50 kg or more is the same as in adults.
Croatian: Doza u djece i adolescenata od 50 kg ili više jednaka je kao u odraslih.
English: The total daily dose and frequency of administration should be maintained.
Croatian: Treba održavati ukupnu dnevnu dozu i učestalost primjene.
English: Efficacy of levetiracetam as monotherapy was established in a double-blind, parallel group, noninferiority comparison to carbamazepine controlled release (CR) in 576 patients 16 years of age or older with newly or recently diagnosed epilepsy.
Croatian: Djelotvornost levetiracetama kao monoterapije dokazana je kod paralelnih grupa u dvostruko slijepoj usporedbi neinferiornosti s karbamazepinom s kontroliranim otpuštanjem (engl. controlled release, CR) na 576 bolesnika u dobi od 16 godina ili starijih s novo- ili nedavno dijagnosticiranom epilepsijom.
English: 35 infants aged less than 1 year with partial onset seizures have been exposed in placebo-control clinical studies of which only 13 were aged < 6 months.
Croatian: 35 dojenčadi s parcijalnim napadajima u dobi od manje od 1 godine, od kojih je samo njih 13 bilo u dobi < 6 mjeseci, bilo je uključeno u placebo kontroliranu kliničku studiju.
English: Four embryo-foetal development studies were performed in rabbits covering doses of 200, 600, 800, 1,200 and 1,800 mg/kg/day.
Croatian: Četiri studije embrio-fetalnog razvoja provedene su u kunića s dozama od 200, 600, 800, 1200 i 1800 mg/kg/dan.
English: Two embryo-foetal development (EFD) studies were performed in rats at 400, 1200 and 3600 mg/kg/day.
Croatian: Provedene su dvije studije embrio-fetalnog razvoja (embryo fetal development, EFD) u štakora s dozama od 400, 1200 i 3600 mg/kg/dan.
English: In patients aged 4-16 years, a total of 645 patients have been treated with levetiracetam in placebo-controlled and open label extension studies.
Croatian: U bolesnika u dobi 4-16 godina, ukupno 645 bolesnika liječeno je levetiracetamom u placebom kontroliranim i ispitivanjima otvorenog produžetka.
English: One vial of Levetiracetam Hospira concentrate contains 500 mg levetiracetam (5 ml concentrate of 100 mg/ml).
Croatian: Jedna bočica Levetiracetam Hospira koncentrata sadrži 500 mg levetiracetama (5 ml koncentrata od 100 mg/ml).
English: The CLcr in ml/min/1.73 m2 may be estimated from serum creatinine (mg/dl) determination, for young adolescents and children using the following formula (Schwartz formula):
Croatian: Klirens kreatinina u ml/min/1,73 m može se za mlade adolescente i djecu procijeniti iz vrijednosti serumskog kreatinina (mg/dl) pomoću sljedeće formule (Schwartzova formula):
English: What Levetiracetam Hospira contains
Croatian: Što Levetiracetam Hospira sadrži
English: The adverse reaction profile of levetiracetam is generally similar across age groups and across the approved epilepsy indications.
Croatian: Profil nuspojava levetiracetama općenito je sličan u svim dobnim skupinama i u svim odobrenim indikacijama epilepsije.
English: The mean total body clearance was 0.96 ml/min/kg.
Croatian: Srednja vrijednost ukupnog tjelesnog klirensa iznosi 0,96 ml/min/kg.
English: Probenecid (500 mg four times daily), a renal tubular secretion blocking agent, has been shown to inhibit the renal clearance of the primary metabolite, but not of levetiracetam.
Croatian: Probenecid (500 mg četiri puta na dan), inhibitor bubrežne tubularne sekrecije, inhibira bubrežni klirens glavnog metabolita levetiracetama ali ne i samog levetiracetama.
English: Muscle weakness, myalgia
Croatian: Mišićna slabost, mijalgija
English: • Dextrose 50 mg/ml (5%) solution for injection
Croatian: • otopina glukoze 50 mg/ml (5%) za injekciju
English: The intravenous administration of doses up to 4,000 mg diluted in 100 ml of 0.9% sodium chloride infused over 15 minutes and doses up to 2,500 mg diluted in 100 ml of 0.9% sodium chloride infused over 5 minutes was evaluated.
Croatian: Procjenjivana je intravenska primjena doza do 4000 mg razrijeđenih u 100 ml 0,9% otopine natrijevog klorida danih infuzijom tijekom 15 minuta i doza do 2500 mg razrijeđenih u 100 ml 0,9% otopine natrijevog klorida danih infuzijom tijekom 5 minuta.
English: Renal impairment The daily dose must be individualised according to renal function.
Croatian: Dnevna doza mora se odrediti za svakog bolesnika pojedinačno u skladu s bubrežnom funkcijom.
English: In patients with severe hepatic impairment, the creatinine clearance may underestimate the renal insufficiency.
Croatian: U bolesnika s teškim oštećenjem jetre klirens kreatinina može lažno pokazivati niži stupanj bubrežne insuficijencije.
English: Dose and frequency Children from 4 years and adolescents weighing less than 50 kg
Croatian: Doza i učestalost primjene Djeca od 4. godine života i adolescenti teški manje od 50 kg
English: Levetiracetam efficacy was established in a 24-week double-blind, placebo-controlled study which included adults, adolescents and a limited number of children suffering from idiopathic generalized epilepsy with primary generalized tonic-clonic (PGTC) seizures in different syndromes (juvenile myoclonic epilepsy, juvenile absence epilepsy, childhood absence epilepsy, or epilepsy with Grand Mal seizures on awakening).
Croatian: Djelotvornost levetiracetama dokazana je u dvostruko slijepoj i placebom kontroliranoj studiji u trajanju od 24 tjedna, koja je uključivala odrasle, adolescente i ograničeni broj djece s idiopatskom generaliziranom epilepsijom s primarno generaliziranim toničko-kloničkim (PGTK) napadajima kod različitih sindroma (juvenilna mioklonična epilepsija, epilepsija s apsansima dječje i juvenilne dobi ili epilepsija s grand mal napadajima kod buđenja).
English: In patients with severely impaired hepatic function, assessment of renal function is recommended before dose selection (see section 4.2).
Croatian: U bolesnika s teško oštećenom jetrenom funkcijom treba odrediti funkciju bubrega prije odabira doze (vidjeti dio
English: Convulsion, balance disorder, dizziness, lethargy, tremor
Croatian: Konvulzije, poremećaj ravnoteže, omaglica, letargija, tremor
English: Do not use this medicine after the expiry date stated on the vial and carton box after EXP: The expiry date refers to the last day of the month.
Croatian: Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na bočici i kartonskoj kutiji iza oznake EXP ili „Rok valjanosti“.
English: Dosing adjustment for adult and adolescents patients weighing more than 50 kg with impaired renal function:
Croatian: Prilagođavanje doze za odrasle bolesnike i adolescente teške više od 50 kg s oštećenom bubrežnom funkcijom:
English: • pancreatitis (inflammation of the pancreas);
Croatian: • pankreatitis (upala gušterače);
English: Weight decreased, weight increase
Croatian: Gubitak tjelesne težine, povećanje tjelesne težine
English: A doctor or a nurse will administer you Levetiracetam Hospira as an intravenous infusion.
Croatian: Levetiracetam Hospira Vam može dati liječnik ili medicinska sestra u obliku intravenske infuzije.
English: Suicide attempt, suicidal ideation, psychotic disorder, abnormal behaviour, hallucination, anger, confusional state, panic attack, affect lability/mood swings, agitation
Croatian: Pokušaj samoubojstva, suicidalne misli, psihotični poremećaj, poremećaj ponašanja, halucinacije, srditost, konfuzno stanje, napadaj panike,nestabilnost afekta/promjene raspoloženja, agitacija
English: One maximum single dose of Levetiracetam Hospira concentrate contains 2.5 mmol (or 57 mg) of sodium (0.8 mmol (or 19 mg) of sodium per vial).
Croatian: Najveća pojedinačna doza Levetiracetam Hospira koncentrata sadrži 2,5 mmol (ili 57 mg) natrija (0,8 mmol (ili 19 mg) natrija po bočici).
English: The pharmacokinetic profile has been characterized following oral administration.
Croatian: Određen je farmakokinetički profil nakon peroralne primjene.
English: Each vial contains 19 mg of sodium.
Croatian: Jedna bočica sadrži 19 mg natrija.
English: The pharmacokinetic profile is linear with low intra- and inter-subject variability.
Croatian: Farmakokinetički profil je linearan, a varijabilnost je niska i među različitim bolesnicima, i za istog bolesnika.
English: With continued long-term treatment, 11.4% of the patients were seizure-free for at least 6 months and 7.2% were seizure-free for at least 1 year.
Croatian: S nastavkom dugotrajnog liječenja 11,4% bolesnika bilo je barem 6 mjeseci, a 7,2% barem 1 godinu bez napadaja.
English: A risk of birth defects for your unborn child cannot be completely excluded.
Croatian: Ne smijete prekinuti liječenje bez savjetovanja sa svojim liječnikom.Ne može se u potpunosti isključiti rizik uzrokovanja urođenih mana za Vaše nerođeno dijete.
English: Depression, hostility/aggression, anxiety, insomnia, nervousness/irritability
Croatian: Depresija, netrpeljivost/agresivnost, anksioznost, nesanica, nervoza/razdražljivost
English: 10 vials 25 vials
Croatian: 10 bočica 25 bočica
English: A single dose of 1,500 mg levetiracetam diluted in 100 ml of a compatible diluent and infused intravenously over 15 minutes is bioequivalent to 1,500 mg levetiracetam oral intake, given as three 500 mg tablets.
Croatian: Jednokratna doza od 1500 mg levetiracetama razrijeđenog u 100 ml kompatibilnog otapala i primijenjena intravenski tijekom 15 minuta je bioekvivalentna 1500 mg levetiracetama primijenjenog peroralno, danog u 3 tablete od 500 mg.
English: Levetiracetam concentrate for solution for infusion was found to be physically compatible and chemically stable when mixed with the following diluents:
Croatian: Utvrđeno je da je Levetiracetam koncentrat za otopinu za infuziju fizički kompatibilan i kemijski stabilan ako se miješa sa sljedećim otapalima:
English: Levetiracetam Hospira is not indicated in children and adolescents below 16 years on it's own (monotherapy)
Croatian: • Levetiracetam Hospira nije indiciran za samostalnu primjenu (monoterapija) u liječenju djece i adolescenata mlađih od 16 godina
English: With continued long-term treatment, 47.4% of the patients were free of tonic-clonic seizures for at least 6 months and 31.5% were free of tonic-clonic seizures for at least 1 year.
Croatian: S nastavkom dugotrajnog liječenja 47,4% bolesnika bilo je barem 6 mjeseci i 31,5% barem 1 godinu bez toničko-kloničkih napadaja.
English: Co-administration with digoxin, oral contraceptives and warfarin did not influence the pharmacokinetics of levetiracetam.
Croatian: Istodobna primjena levetiracetama s digoksinom, oralnim kontraceptivima i varfarinom nije utjecala na farmakokinetiku levetiracetama.
English: The most frequently reported adverse reactions were nasopharyngitis, somnolence (sleepiness), headache, fatigue and dizziness.
Croatian: Najčešće prijavljene nuspojave bile su nazofaringitis, somnolencija (izrazita pospanost), glavobolja, umor i omaglica.
English: Neonatal and juvenile animal studies in rats and dogs demonstrated that there were no adverse effects seen in any of the standard developmental or maturation endpoints at doses up to 1,800 mg/kg/day (x 6-17 the MRHD on a mg/m2 basis)
Croatian: Neonatalne i juvenilne studije na štakorima i psima pokazale su da nema nuspojava u uobičajenim mjerama ishoda razvoja ili sazrijevanja kod primjene doza do 1800 mg/kg/dan (6-erostruka do 17erostruka vrijednost najveće preporučene doze za čovjeka izražena u mg/m
English: The safety and efficacy of levetiracetam in children below and adolescents 16 years as monotherapy treatment have not been established.
Croatian: Sigurnost i djelotvornost levetiracetama kod monoterapije u djece i adolescenata mlađih od 16 godina nije još ustanovljena.
English: Levetiracetam Hospira 100 mg/ml sterile concentrate levetiracetam
Croatian: Levetiracetam Hospira 100 mg/ml sterilni koncentrat levetiracetam i.v.
English: If you suffer from kidney problems, follow your doctor's instructions.
Croatian: • ako patite od bubrežnih problema, slijedite upute svog liječnika koji će odlučiti treba li prilagoditi Vašu dozu.
English: Levetiracetam and related analogues show a rank order of affinity for binding to the synaptic vesicle protein 2A which correlates with the potency of their anti-seizure protection in the mouse audiogenic model of epilepsy.
Croatian: Levetiracetam i srodni analozi s različitim se afinitetom vežu za sinaptički vezikularni protein 2A, a to je, u mišjem modelu audiogene epilepsije, povezano s potencijalom zaštite od napada.
English: Levetiracetam efficacy was established in a double-blind, placebo-controlled study of 16 weeks duration, in patients 12 years of age and older suffering from idiopathic generalized epilepsy with myoclonic seizures in different syndromes.
Croatian: Djelotvornost levetiracetama dokazana je u dvostruko slijepoj i placebom kontroliranoj 16-tjednoj studiji u koju su bili uključeni bolesnici od 12 godina života i stariji s idiopatskom generaliziranom epilepsijom s miokloničkim napadajima kod različitih sindroma.
English: With continued long-term treatment, 28.6% of the patients were free of myoclonic seizures for at least 6 months and 21.0% were free of myoclonic seizures for at least 1 year.
Croatian: S nastavkom dugotrajnog liječenja 28,6% bolesnika bilo je barem 6 mjeseci i 21,0% barem 1 godinu bez miokloničkih napadaja.
English: Other ingredients include sodium acetate trihydrate, glacial acetic acid, sodium chloride, water for injections.
Croatian: Ostali sastojci uključuju natrijev acetat trihidrat, ledenu acetatnu kiselinu, natrijev klorid, vodu za injekcije.
English: Dosing adjustment for children and adolescents patients weighing less than 50 kg with impaired renal function:
Croatian: Prilagođavanje doze kod djece i adolescenata s manje od 50 kg tjelesne težine s oštećenom bubrežnom funkcijom:
English: Following dialysis, a 5 to 10 mg/kg (0.05 to 0.10 ml/kg) supplemental dose is recommended.
Croatian: Nakon dijalize preporučuje se dodatna doza od 5 do 10 mg/kg (0,05 do 0,10 ml/kg).
English: The NOAEL was ≥ 1800 mg/kg/day for the F0 females, and for the survival, growth and development of the F1 offspring up to weaning (x 6 the MRHD on a mg/m2 basis).
Croatian: NOAEL je iznosila ≥ 1800 mg/kg/dan za F0 ženke, te za preživljenje, rast i razvoj za F1 potomstvo do odbića (6-erostruka vrijednost najveće preporučene doze za čovjeka izražena u mg/m
English: 44.6% of the levetiracetam treated patients and 19.6% of the patients on placebo had a 50% or greater reduction from baseline in the partial onset seizure frequency per week.
Croatian: U 44,6% bolesnika liječenih levetiracetamom i 19,6% bolesnika koji su dobivali placebo zapaženo je 50%-tno ili više smanjenje od početne učestalosti parcijalnih napadaja tjedno.
English: Monotherapy for adults and adolescents from 16 years of age The recommended starting dose is 250 mg twice daily which should be increased to an initial therapeutic dose of 500 mg twice daily after two weeks.
Croatian: Preporučena početna doza je 250 mg dva puta na dan koju nakon dva tjedna treba povećati do inicijalne terapijske doze od 500 mg dva puta na dan.
English: See the table below for the recommended preparation and administration of Levetiracetam Hospira concentrate to achieve a total daily dose of 500 mg, 1,000 mg, 2,000 mg, or 3,000 mg in two divided doses.
Croatian: Pogledajte tablicu za preporučenu pripremu i primjenu Levetiracetam Hospira koncentrata kako bi se postigla ukupna dnevna doza od 500 mg, 1000 mg, 2000 mg ili 3000 mg podijeljena u dvije doze.
English: 1200 mg/kg/day for foetuses.
Croatian: 1800 mg/kg/dan.
English: Amnesia, memory impairment, coordination abnormal/ataxia, paraesthesia, disturbance in attention
Croatian: Amnezija, smetnje pamćenja, poremećaji koordinacije/ataksija, parestezija, smetnje u koncentraciji
English: Add-on therapy for infants and children less than 4 years The safety and efficacy of levetiracetam concentrate for solution for infusion in infants and children less than 4 years have not been established.
Croatian: Sigurnost i djelotvornost levetiracetam koncentarata za otopinu za infuziju kod dojenčadi i djece mlađe od 4 godine nije još ustanovljena.
English: However, data suggested a 20% higher levetiracetam clearance in children taking enzyme-inducing antiepileptic medicinal products.
Croatian: Međutim, podaci su pokazali da antiepileptici koji induciraju enzimsku aktivnost kod djece povisuju klirens levetiracetama za 20%.
English: Withdrawal Volume Volume of Diluent
Croatian: Volumen otapala
English: Sodium acetate trihydrate Glacial acetic acid Sodium chloride Water for injections
Croatian: Popis pomoćnih tvari natrijev acetat trihidrat acetatna kiselina, ledena natrijev klorid voda za injekcije
English: Adjustment of the dose is recommended in elderly patients with compromised renal function (see “Renal impairment” below).
Croatian: U starijih bolesnika sa smanjenom bubrežnom funkcijom preporučuje se prilagođavanje doze (vidjeti „Oštećenje bubrega“ ispod).
English: Levetiracetam Hospira is indicated as monotherapy in the treatment of partial onset seizures with or without secondary generalisation in adults and adolescents from 16 years of age with newly diagnosed epilepsy.
Croatian: Levetiracetam Hospira je indicirana kao monoterapija u liječenju parcijalnih napadaja sa sekundarnom generalizacijom ili bez nje u odraslih i adolescenata od 16. godine života s novodijagnosticiranom epilepsijom.
English: 72.2% of the levetiracetam treated patients and 45.2% of the patients on placebo had a 50% or greater decrease in the frequency of PGTC seizures per week.
Croatian: U 72,2% bolesnika liječenih levetiracetamom i 45,2% bolesnika koji su dobivali placebo primijećeno je 50%-tno ili više smanjenje učestalosti PGTK napadaja tjedno.
English: • sudden decrease in kidney function;
Croatian: • iznenadno smanjenje bubrežne funkcije
English: Duration of treatment
Croatian: Duljina liječenja
English: In adults, levetiracetam efficacy has been demonstrated in 3 double-blind, placebo--controlled studies at 1,000 mg, 2,000 mg, or 3,000 mg/day, given in 2 divided doses, with a treatment duration of up to 18 weeks.
Croatian: Djelotvornost levetiracetama dokazana je u odraslih u 3 dvostruko slijepe i placebom kontrolirane studije gdje su bolesnici tokom liječenja 18 tjedana dobivali 1000 mg, 2000 mg ili 3000 mg/dan, podijeljeno na dvije doze.
English: See the table below for the recommended preparation and administration of Levetiracetam Hospira concentrate for solution for infusion to achieve a total daily dose of 500 mg, 1,000 mg, 2,000 mg, or 3,000 mg in two divided doses.
Croatian: Pogledajte tablicu za preporučenu pripremu i primjenu Levetiracetam Hospira koncentrata za otopinu za infuziju kako bi se postigla ukupna dnevna doza od 500 mg, 1000 mg, 2000 mg ili 3000 mg podijeljena u dvije dnevne doze.
English: How to store Levetiracetam Hospira
Croatian: Kako čuvati Levetiracetam Hospira
English: The other ingredients are: sodium acetate trihydrate, glacial acetic acid, sodium chloride, water for injections.
Croatian: - Drugi sastojci su: natrijev acetat trihidrat, ledena acetatna kiselina, natrijev klorid, voda za injekcije.
English: • 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: • u liječenju parcijalnih napadaja sa sekundarnom generalizacijom ili bez nje u odraslih, adolescenata i djece od 4 godine života s epilepsijom.
English: The most frequently reported adverse reactions were nasopharyngitis, somnolence, headache, fatigue and dizziness.
Croatian: Najčešće prijavljene nuspojave bile su nazofaringitis, somnolencija, glavobolja, umor i omaglica.
English: The NOAEL was <200 mg/kg/day for the dams and 200 mg/kg/day for the foetuses (equal to the MRHD on a mg/m2 basis).
Croatian: NOAEL je za gravidne ženke iznosila <200 mg/kg/dan, a za fetuse 200 mg/kg/dan (što je jednako MRHD-u, Maximum Recommended Human Dose, izraženom u mg/m
English: Starting dose: 10 mg/kg twice daily
Croatian: Početna doza: 10 mg/kg dva puta na dan
English: Medicinal product with particulate matter or discoloration should not be used.
Croatian: Lijek koji sadrži čestice ili je promijenio boju ne smije se koristiti.
English: If you get any side effects talk to your doctor, pharmacist or nurse.
Croatian: Ako primijetite bilo koju nuspojavu, potrebno je obavijestiti liječnika, ljekarnika ili medicinsku sestru.
English: As in adults, there is no evidence of clinically significant medicinal product interactions in paediatric patients receiving up to 60 mg/kg/day levetiracetam.
Croatian: Kako u odraslih, tako i u pedijatrijskih bolesnika koji su dobivali do 60 mg/kg/dan levetiracetama, nema dokaza o klinički značajnim interakcijama lijekova.
English: Dose and frequency
Croatian: Doza i učestalost primjene
English: Completed suicide, personality disorder, thinking abnormal, delirium
Croatian: Počinjeno samoubojstvo, poremećaj osobnosti, poremećaj mišljenja, delirij
English: • asthenia/fatigue (tiredness).
Croatian: • astenija/umor (zamaranje).
English: as an add-on to other antiepileptic medicines to treat: partial onset seizures with or without generalisation in adults, adolescents and children from 4 years of age myoclonic seizures (short, shock-like jerks of a muscle or group of muscles) in adults and adolescents from 12 years of age with juvenile myoclonic epilepsy.
Croatian: • kao dodatna terapija uz druge antiepileptike u liječenju: parcijalnih napadaja sa sekundarnom generalizacijom ili bez nje u odraslih, adolescenata i djece od 4. godine života miokloničkih napadaja (kratki, nevoljni grčevi jednog ili grupe mišića) u odraslih i adolescenata starijih od 12. godine života s juvenilnom miokloničkom epilepsijom primarno generaliziranih toničko-kloničkih napadaja (veliki napadaji, uključujući gubitak svijesti) u odraslih i adolescenata starijih od 12. godine života s idiopatskom generaliziranom epilepsijom (oblik epilepsije za koju se pretpostavlja da je genetski uzrokovana).
English: • in the treatment of primary generalised tonic-clonic seizures in adults and adolescents from 12 years of age with Idiopathic Generalised Epilepsy.
Croatian: • u liječenju primarno generaliziranih toničko-kloničkih napadaja u odraslih i adolescenata od 12. godine života s idiopatskom generaliziranom epilepsijom.