FrancophonIA/ELRC3.0 huggingface dataset:
English: Add-on therapy for infants aged from 1 month to less than 6 months
Croatian: Dodatna terapija za dojenčad u dobi od navršenog 1. mjeseca do manje od 6 mjeseci
English: Matever concentrate was found to be physically compatible and chemically stable when mixed with the following diluents for at least 24 hours and stored in PVC bags at controlled room temperature 15-25 °C.
Croatian: Utvrđeno je da je Matever koncentrat fizikalno kompatibilan i kemijski stabilan kada se pomiješa sa sljedećim otopinama za razrjeđivanje tijekom barem 24 sata i ako se čuva u PVC vrećama pri kontroliranoj sobnoj temperaturi 15-25°C.
English: Do not use this medicine after the expiry date which is stated on the carton box and blister after “EXP”.
Croatian: Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na bočici i kutiji iza oznake „EXP:“.
English: Matever 250 mg, 750 mg film-coated tablets contain E110 colouring agent which may cause allergic reactions.
Croatian: Matever 250 mg, 750mg filmom obložene tablete sadrži bojilo E110 koje može izazvati alergijske reakcije.
English: There is no experience with administration of intravenous levetiracetam for longer period than 4 days.
Croatian: Trajanje liječenje Nema iskustva s levetiracetamom primijenjenim intravenski u razdoblju duljem od 4 dana.
English: Name and address of the manufacturer responsible for batch release
Croatian: Naziv i adrese proizvođača odgovornih za puštanje serije lijeka u promet
English: A significant correlation between saliva and plasma concentrations has been shown in adults and children (ratio of saliva/plasma concentrations ranged from 1 to 1.7 for oral tablet formulation and after 4 hours post-dose for oral solution formulation).
Croatian: U odraslih i djece postoji značajna korelacija između koncentracija ovog lijeka u slini i u plazmi (omjer koncentracija u slini i plazmi je u rasponu od 1 do 1,7 za lijek u obliku oralne tablete te nakon 4 sata od uzimanja lijeka u obliku oralne otopine).
English: No new safety concerns for levetiracetam were identified for infants less than 12 months of age with epilepsy.
Croatian: Nisu utvrđena nova sigurnosna pitanja vezana uz primjenu levetiracetama u dojenčadi mlađe od 12 mjeseci koja ima epilepsiju.
English: 5 ml glass vial (type I) with bromobutyl stoppers and sealed with an aluminium flip off cap. Each cartoncontains10 vials.
Croatian: Staklena bočica (tip I) od 5 ml s bromobutilnim čepom i zatvorena s aluminijskim „flip off“ zatvaračem.
English: Each film-coated tablet contains 3.8 mg lactose monohydrate.
Croatian: Jedna filmom obložena tableta sadrži 3,8 mg laktoze hidrata.
English: 500 to 1,500 mg twice daily 500 to 1,000 mg twice daily 250 to 750 mg twice daily 250 to 500 mg twice daily 500 to 1,000 mg once daily
Croatian: 500 do 1500 mg dva puta na dan 500 do 1000 mg dva puta na dan 250 do 750 mg dva puta na dan 250 do 500 mg dva puta na dan 500 do 1000 mg jedanput na dan
English: Pharmathen S.A., 6 Dervenakion Str., 15351 Pallini, Attiki, Greece
Croatian: Pharmathen S.A., 6 Dervenakion Str., 15351 Pallini, Attiki, Grčka
English: Pancytopenia,neutropen ia, agranulocytosis
Croatian: Pancitopenija, neutropenija, agranulocitoza
English: Adverse reactions not observed in clinical studies but seen in the rat and to a lesser extent in the mouse at exposure levels similar to human exposure levels and with possible relevance to clinical use were liver changes, indicating an adaptive response such as increased weight and centrilobular hypertrophy, fatty infiltration and increased liver enzymes in plasma.
Croatian: Štetni učinci s mogućim značajem za kliničku primjenu koji nisu primijećeni tijekom kliničkih studija, a koji su nađeni kod štakora i u manjoj mjeri kod miševa izloženih razinama sličnim razinama izloženosti kod ljudi, bili su promjene jetre koje su upućivale na prilagodbeni odgovor kao na primjer povećana težina i centrilobularna hipertrofija, masna infiltracija jetre i povišene razine jetrenih enzima u plazmi.
English: In patients aged 1 month to less than 4 years, a total of 190 patients have been treated with levetiracetam in placebo-controlled and open label extension studies.
Croatian: U bolesnika u dobi od 1 mjesec do manje od 4 godine, ukupno 190 bolesnika liječeno je s levetiracetamom u placebom kontroliranim i ispitivanjima otvorenog produžetka.
English: A single dose of 1500 mg levetiracetam diluted in 100 ml of a compatible diluent and infused intravenously over 15 minutes is bioequivalent to 1500 mg levetiracetam oral intake, given as three 500 mg tablets.
Croatian: Jednokratna doza 1500 mg levetiracetama razrijeđenog u 100 ml kompatibilne otopine za razrjeđivanje i infundiranog intravenski tijekom 15 minuta je bioekvivalentan 1500 mg levetiracetama uzetog oralno, danog kao tri tablete od 500 mg.
English: What Matever is and what it is used for What you need to know before you take Matever How to take Matever
Croatian: Što je Matever i za što se koristi Što morate znati prije nego počnete uzimati Matever Kako uzimati Matever
English: Infants 6 to 23 months, children and adolescents weighing less than 50 kg
Croatian: Dojenčad od 6 do 23 mjeseca, djeca i adolescenti teški manje od 50 kg
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: The total daily dose and frequency of administration should be maintained.
Croatian: Treba zadržati ukupnu dnevnu dozu i učestalost primjene.
English: Monotherapy for adults and adolescents from 16 years of age
Croatian: Monoterapija za odrasle i adolescente od navršene 16. godine života
English: Matever 250 mg, 750 mg tablets contain Sunset Yellow FCF (E110) Sunset Yellow FCF (E110) colouring agent may cause allergic reactions.
Croatian: Matever 250 mg, 750 mg tablete sadrže sunset yellow FCF (E110) Bojilo sunset yellow FCF (E110) može izazvati alergijske reakcije.
English: The total daily dose was administered twice daily.
Croatian: Ukupna dnevna doza davala se kao podjeljena doza primjenjena dvaput dnevno.
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: If you stop taking Matever
Croatian: Ako prestanete uzimati Matever
English: If levetiracetam has to be discontinued it is recommended to withdraw it gradually (e.g. in adults and adolescents weighing more than 50 kg: 500 mg decreases twice daily every two to four weeks; in infants older than 6 months, children and adolescents weighting less than 50 kg: dose decrease should not exceed 10 mg/kg twice daily every two weeks; in infants (less than 6 months): dose decrease should not exceed 7 mg/kg twice daily every two weeks).
Croatian: Ako treba prekinuti liječenje levetiracetamom, preporučuje se postupni prekid (npr. u odraslih i adolescenata tjelesne težine veće od 50 kg: smanjenje za 500 mg dva puta na dan svaka dva do četiri tjedna; u dojenčadi starije od 6 mjeseci, djece i adolescenata tjelesne težine manje od 50 kg: smanjenje doze ne smije biti veće od 10 mg/kg dva puta na dan svaka dva tjedna; u dojenčadi (mlađe od 6 mjeseci): smanjenje doze ne smije biti veće od 7 mg/kg dva puta dnevno svaka dva tjedna).
English: The starting dose for a child or adolescent of 25 kg should be 250 mg twice daily with a maximum dose of 750 mg twice daily.
Croatian: Početna doza za dijete ili adolescenta od 25 kg treba biti 250 mg dva puta na dan uz maksimalnu dozu od 750 mg dva puta na dan.Doza u djece od 50 kg ili više jednaka je kao u odraslih.
English: Matever concentrate is an alternative for patients when administration of the antiepileptic oral Matever medicine is temporarily not feasible.
Croatian: Matever koncentrat je druga mogućnost za bolesnike kada primjena aniepileptičkog lijeka Matever kroz usta privremeno nije moguća.
English: If stopping treatment Matever should be discontinued gradually to avoid an increase of seizures.
Croatian: Ako prekidate liječenje Mateverom, prekid mora biti postupan kako bi se izbjeglo pojačanje napadaja.
English: Dose in children (4 to 11 years) and adolescents (12 to 17 years) weighing less than 50 kg: General dose: between 20 mg per kg bodyweight and 60 mg per kg bodyweight each day.
Croatian: Doza u djece (4 do 11 godina) i adolescenata (12 do 17 godina) koji imaju manje od 50 kg: Uobičajena doza: između 20 mg na kg tjelesne težine i 60 mg na kg tjelesne težine svaki dan.
English: Pharmathen S.A. 6, Dervenakion str. 15351 Pallini, Attiki Greece
Croatian: Pharmathen S.A. 6, Dervenakion str. 15351 Pallini, Attiki Grčka
English: In vitro studies show that levetiracetam affects intraneuronal Ca levels by partial inhibition of N-type
Croatian: Studije in vitro pokazuju da levetiracetam utječe na razinu Ca2+ u neuronima na način da djelomično inhibira
English: What Matever is and what it is used for What you need to know before you are given Matever How Matever is given
Croatian: Što je Matever i za što se koristi Što morate znati prije nego primite Matever Kako se Matever daje Moguće nuspojave
English: A dose of 20 mg/kg/day titrating to 40 mg/kg/day for infants one month to less than six months and a dose of 25 mg/kg/day titrating to 50 mg/kg/day for infants and children 6 months to less than 4 years old, was use in this study.
Croatian: Doza od 20 mg/kg/dan titrirana je do 40 mg/kg/dan u dojenčadi u dobi od jednog do manje od 6 mjeseci, a doza od 25 mg/kg/dan titrirana je do 50 mg/kg/dan u dojenčadi i djece u dobi od 6 mjeseci do manje od 4 godine.
English: If levetiracetam has to be discontinued it is recommended to withdraw it gradually (e.g. in adults and adolescents weighing more than 50 kg: 500 mg decreases twice daily every two to four weeks; in children and adolescents weighting less than 50 kg: dose decrease should not exceed 10 mg/kg twice daily every two weeks).
Croatian: Ako treba prekinuti liječenje levetiracetamom, preporučuje se postupni prekid (npr. u odraslih i adolescenata tjelesne težine veće od 50 kg: smanjenje za 500 mg dva puta na dan svaka dva do četiri tjedna; u djece i adolescenata tjelesne težine manje od 50 kg: smanjenje doze ne smije biti veće od 10 mg/kg dva puta na dan svaka dva tjedna).
English: 500 mg tablet: quinoline yellow aluminium lake (E104) 750 mg tablet: indigo carmine aluminum lake (E132), sunset yellow FCF aluminum lake (E110) 1000 mg tablet: (no additional colourant).
Croatian: 500 mg tableta: quinoline yellow aluminium lake (E104) 750 mg tableta: indigo carmine aluminium lake (E132), sunset yellow FCF aluminium lake (E110) 1000 mg tableta: (nema dodatnih bojila).
English: For children 6 years and above, an oral solution should be used for doses under 250 mg, for doses not multiple of 250 mg when dosing recommendation is not achievable by taking multiple tablets and for patients unable to swallow tablets.
Croatian: U djece od 6 godina i starije, Levetiracetam oralnu otopinu treba primijenjivati za doze ispod 250 mg, za doze koje nisu višekratnici 250 mg gdje preporučeno doziranje ne može biti postignuto uzimanjem većeg broja tableta te u bolesnika koji ne mogu gutati tablete.
English: Levetiracetam 1,000 mg daily did not influence the pharmacokinetics of oral contraceptives (ethinylestradiol and levonorgestrel); endocrine parameters (luteinizing hormone and progesterone) were not modified.
Croatian: Oralni kontraceptivi i druge farmakokinetičke interakcije Levetiracetam primijenjen u dozi od 1000 mg na dan nije utjecao na farmakokinetiku oralnih kontraceptiva (etinil-estradiola i levonorgestrela); endokrini pokazatelji (luteinizirajući hormon i progesteron) ostali su nepromijenjeni.
English: Six-month seizure freedom was achieved in 73.0 % of levetiracetam-treated patients and 72.8 % of carbamazepine-CR treated patients; the adjusted absolute difference between treatments was 0.2% (95 % CI: -7.8 8.2).
Croatian: 73,0% bolesnika liječenih levetiracetamom i 72,8% bolesnika liječenih karbamazepinom s kontroliranim otpuštanjem (CR) bilo je šest mjeseci bez napadaja: prilagođena apsolutna razlika između liječenja bila je 0,2% (95% CI: 7,8 8,2).
English: Tél: +33 299 979 212 Hrvatska
Croatian: Panpharma Tél: +33 299 979 212
English: Four embryo-fetal development studies were performed in rabbits covering doses of 200, 600, 800, 1200 and 1800 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: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
Croatian: PODACI KOJE MORA NAJMANJE SDRŽAVATI MALO UNUTARNJE PAKIRANJE
English: • Lactated Ringer's injection
Croatian: • injekcija Ringerove otopine s laktatom
English: How to take Matever
Croatian: Kako uzimati Matever
English: The possible side effects of an overdose of Matever are sleepiness, agitation, aggression, decrease of alertness, inhibition of breathing and coma.
Croatian: Moguće su nuspojave predoziranja Mateverom pospanost, uznemirenost, agresija, smanjena pozornost, smetnje disanja i koma.
English: Matever 250 mg film-coated tablets Matever 500 mg film-coated tablets Matever 750 mg film-coated tablets Matever 1000 mg film-coated tablets
Croatian: Matever 250 mg filmom obložene tablete Matever 500 mg filmom obložene tablete Matever 750 mg filmom obložene tablete Matever 1000 mg filmom obložene tablete
English: Adverse reactions are presented in the order of decreasing seriousness and their frequency is defined as follows: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to<1/100); rare (≥1/10,000 to<1/1,000) and very rare (<1/10,000)
Croatian: : vrlo često (≥ 1/10); često (≥ 1/100 i <1/10); manje često (≥ 1/1000 i < 1/100); rijetko (≥ 1/10 000 i < 1/1000) i vrlo rijetko (<
English: Matever contains sodium
Croatian: Matevere sadrži natrij
English: 6, Dervenakion str., 153 51 Pallini Attiki, Greece Tel.: +30 210 66 04 300 Fax: +30 210 66 66 749
Croatian: 6, Dervenakion str., 153 51 Pallini Attiki, Grčka Tel.: +30 210 66 04 300 Fax: +30 210 66 66 749
English: • suicide attempt and suicidal ideation, mental disorder, abnormal behaviour, hallucination, anger,
Croatian: • pokušaj samoubojstva i suicidalne misli, mentalni poremećaj, poremećaj ponašanja, halucinacije,
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: U placebom kontroliranim kliničkim ispitivanjima lijeku je bilo izloženo 35 dojenčadi mlađe od 1 godine s parcijalnim napadajima, a samo je njih 13 bilo u dobi < 6 mjeseci.
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, labilnost afekta/promjene raspoloženja, agitacija
English: Pallini 15351, Attiki, Greece Tel.: +30 210 66 04 300
Croatian: Pallini 15351, Attiki, Grčka Tel.: +30 210 66 04 300
English: A large amount of post-marketing data on pregnant women exposed to levetiracetam monotherapy (more than 1,800, among which in more than 1,500 exposure occurred during the 1
Croatian: Velika količina podataka nakon stavljanja lijeka u promet o trudnicama koje su bile izložene monoterapiji levetiracetamom (više od njih 1800 od kojih su više od 1500 bile izložene levetiracetamu tijekom prvog trimestra trudnoće) ne ukazuje na povećanje rizika za velike kongenitalne malformacije.
English: Levetiracetam has minor or moderate influence on the ability to drive and use machines.
Croatian: Levetiracetam malo ili umjereno utječe na sposobnost upravljanja vozilima i rada sa strojevima
English: The patients were randomized to carbamazepine CR 400 -1200 mg/day or levetiracetam 1000 -3000 mg/day, the duration of the treatment was up to 121 weeks depending on the response.
Croatian: Bolesnici su randomizirani za dobivanje 400 - 1200 mg karbamazepina s kontroliranim otpuštanjem (CR) na dan ili 1000 - 3000 mg levetiracetama na dan, liječenje je trajalo do 121 tjedna, ovisno o odgovoru.
English: Children and adolescents • Matever is not indicated in children and adolescents below 16 years on its own (monotherapy).
Croatian: Djeca i adolescenti • U djece i adolescenata mlađih od 16 godina Matever se ne primjenjuje samostalno (kao monoterapija)
English: Rare: may affect up to 1 in 1,000 people
Croatian: Rijetko: mogu se javiti u manje od 1 na 1000 ljudi
English: 43.6 % of the levetiracetam treated patients and 19.6 % of the patients on placebo were considered as responders.
Croatian: Ocijenjeno je da je na liječenje odgovorilo 43,6% bolesnika koji su uzimali levetiracetam i 19,6% onih koji su uzimali placebo.
English: 250 mg tablet: indigo carmine aluminum lake (E132), sunset yellow FCF aluminum lake (E110),
Croatian: 250 mg tableta: indigo carmine aluminium lake (E132), sunset yellow FCF aluminium lake (E110),
English: Two embryo-fetal 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: • as an add-on to other antiepileptic medicines to treat: partial onset seizures with or without generalisation in adults, adolescents, children and infants from one month 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 primary generalised tonic-clonic seizures (major fits, including loss of consciousness) in adults and adolescents from 12 years of age with idiopathic generalised epilepsy (the type of epilepsy that is thought to have a genetic cause).
Croatian: • kao dodatna terapija uz druge antiepileptike u liječenju: djelomičnih napadaja sa sekundarnom generalizacijom ili bez nje u odraslih, adolescenata, djece i dojenčadi od prvog mjeseca života miokloničkih napadaja (kratki, iznenadni trzaji mišića ili skupine mišića) u odraslih i adolescenata starijih od navršene 12. godine života s juvenilnom miokloničkom epilepsijom primarno generaliziranih toničko-kloničkih napadaja (veliki napadaji, uključujući gubitak svijesti) u odraslih i adolescenata od navršene 12. godine života s idiopatskom generaliziranom epilepsijom (oblik epilepsije za koji se smatra da je genetski uvjetovan).
English: Sodium acetate trihydrate Glacial acetic acid Sodium chloride Water for injections
Croatian: 6.1 Popis pomoćnih tvari natrijev acetat trihidrat acetatna kiselina, ledena natrijev klorid voda za injekcije
English: Matever 1000 mg tablets contain lactose
Croatian: Matever 1000 mg tablete sadrži laktozu
English: Matever 100 mg/ml concentrate for solution for infusion levetiracetam
Croatian: Matever 100 mg/ml koncentrat za otopinu za infuziju levetiracetam
English: Matever 100 mg/ml concentrate for solution for infusion
Croatian: Matever 100 mg/ml koncentrat za otopinu za infuziju
English: • Dextrose 5 % injection
Croatian: • injekcija 5% glukoze
English: CLcr (ml/min)= ----------------------------------------- (x 0.85 for women) 72 x serum creatinine (mg/dl)
Croatian: [140 - dob (godine)] x težina (kg) CLcr (ml/min) = --------------------------------------------- (x 0,85 za žene) 72 x kreatinin u serumu (mg/dl)
English: As with all antiepileptic medicinal products, sudden discontinuation of levetiracetam should be avoided as this may lead to breakthrough seizures that could have serious consequences for the woman and the unborn child. Monotherapy should be preferred whenever possible because therapy with multiple antiepileptic medicinal products AEDs could be associated with a higher risk of congenital malformations than monotherapy, depending on the associated antiepileptics.
Croatian: Poželjna je monoterapija kad god je to moguće jer bi terapija kombinacijama antiepileptika mogla biti povezana s većim rizikom od kongenitalnih malformacija u odnosu na monoterapiju, ovisno o dotičnim antiepilepticima.
English: CLcr (ml/min) = ----------------------------------------- (x 0.85 for women) 72 x serum creatinine (mg/dl)
Croatian: [140 - dob (godine)] x težina (kg) CLcr (ml/min) = ----------------------------------------------- (x 0,85 za žene) 72 x kreatinin u serumu (mg/dl)
English: Then CLcr is adjusted for body surface area (BSA) as follows:
Croatian: Potom se klirens kreatinina prilagodi za površinu tijela (PT) prema sljedećem: CLcr (ml/min)
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: Creatinine clearance (ml/min/1.73m
Croatian: Klirens kreatinina (ml/min/1,73m2)
English: Česká republika ARDEZ Pharma, spol.
Croatian: Česká republika ARDEZ Pharma, spol. s.r.o.
English: Pancytopenia neutropenia, agranulocytosis
Croatian: Pancitopenija neutropenija, agranulocitoza
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 navršene 12. godine života s idiopatskom generaliziranom epilepsijom.
English: • Dose in adults and adolescents (12 to 17 years) weighing 50 kg or more: General dose: between 1,000 mg and 3,000 mg each day.
Croatian: • Doza u odraslih i adolescenata (12 do 17 godina) koji imaju 50 kg ili više: Uobičajena doza: između 1000 mg i 3000 mg svaki dan.
English: The requirements for submission of PSURs for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal.
Croatian: • Periodička izvješća o neškodljivosti (PSUR-evi) Zahtjevi za podnošenje PSUE-eva za ovaj lijek definirani su u referentnom popisu datuma EU (EURD popis) predviđenom člankom 107.c stavkom 7.
English: Coating agent (orange) consisting of: Hypromellose (E464) Indigo carmine aluminum lake (E132) Sunset yellow FCF aluminum lake (E110) Iron oxide red (E172) Macrogol/PEG 4000
Croatian: Sredstvo za oblaganje (narančasta) se sastoji od: hipromeloza (E464) bojilo indigo carmine aluminum lake (E132) bojilo sunset yellow FCF aluminium lake (E110) željezov oksid, crveni (E172) makrogol/PEG 4000 titanijev dioksid (E171)
English: The intravenous formulation is an alternative to your oral administration.
Croatian: Intravenski oblik predstavlja drugu mogućnost Vašoj primjeni kroz usta.
English: Contains sunset yellow FCF aluminum lake (E110).
Croatian: Sadrži bojilo sunset yellow FCF aluminium lake (E110).
English: Each ml of solution for infusion contains 100 mg of levetiracetam.
Croatian: Jedan ml otopine za infuziju sadrži 100 mg levetiracetama.
English: Slovenská republika ARDEZ Pharma, spol.
Croatian: Slovenská republika ARDEZ Pharma, spol. s.r.o.
English: Dose in adults and adolescents (12 to 17 years) weighing 50 kg or more: General dose: between 1,000 mg and 3,000 mg each day.
Croatian: Doza u odraslih i adolescenata (12 do 17 godina) koji imaju 50 kg ili više: Uobičajena doza: između 1000 mg i 3000 mg svaki dan.
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/m 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/m2).