FrancophonIA/ELRC3.0 huggingface dataset:
English: In vitro and in vivo experiments suggest that levetiracetam does not alter basic cell characteristics and normal neurotransmission.
Croatian: Eksperimenti in vitro i in vivo pokazuju da levetiracetam ne utječe na osnovna svojstva stanica i normalnu neurotransmisiju.
English: If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
Croatian: Ako Vam je liječnik rekao da imate bolest nepodnošenja nekih šećera, prije nego što počnete uzimati ovaj lijek posavjetujte se sa svojim liječnikom.
English: Your doctor will prescribe the most appropriate pharmaceutical form of levetiracetam according to the age, weight and dose.
Croatian: Liječnik će propisati najprikladniji farmaceutski oblik levetiracetama sukladno dobi, tjelesnoj težini i dozi.
English: Contents of the pack and other information What Levetiracetam Actavis Group contains
Croatian: Sadržaj pakiranja i druge informacije Što Levetiracetam Actavis Group sadrži
English: Contains E216, E218, maltitol liquid (E965) and propylene glycol (E1520).
Croatian: Sadrži E216, E218, tekući maltitol (E965) i propilenglikol (E1520).
English: It was concluded that levetiracetam was not different (non inferior) from placebo with regard to the change from baseline of the Leiter-R Attention and Memory, Memory Screen Composite score in the per-protocol population.
Croatian: Zaključeno je da se levetiracetam u populaciji po protokolu nije razlikovao od placeba (nije bio inferioran) s obzirom na promjene od početnih vrijednosti rezultata testiranja dobivenih ljestvicom Leiter-R Attention and Memory, Memory Screen Composite.
English: Group
Croatian: Skupina
English: In children and adolescents aged 4 to 16 years, vomiting (very common, 11.2%), agitation (common, 3.4%), mood swings (common, 2.1%), affect lability (common, 1.7%), aggression (common, 8.2%), abnormal behaviour (common, 5.6%), and lethargy (common, 3.9%) were reported more frequently than in other age ranges or in the overall safety profile.
Croatian: U djece i adolescenata u dobi 4 do 16 godina povraćanje (vrlo često, 11,2%), agitacija (često, 3,4%), promjene raspoloženja (često, 2,1%), labilnost afekta (često, 1,7%), agresija (često, 8,2%), poremećaj ponašanja (često, 5,6%) i letargija (često, 3,9%) bili su prijavljeni češće nego u drugim dobnim rasponima ili u cjelokupnom sigurnosnom profilu.
English: Dose recommendations for infants from 6 months of age, children and adolescents:
Croatian: Preporučene doze za dojenčad od 6. mjeseca života, djecu i adolescente:
English: 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: However subjects, who took levetiracetam in the long-term open label follow-up study, did not experience a worsening, on average, in their behavioural and emotional functioning; in particular measures of aggressive behavior were not worse than baseline.
Croatian: No u ispitanika koji su uzimali levetiracetam tijekom dugoročnog, otvorenog ispitivanja provedenog praćenjem u prosjeku nije bilo pogoršanja bihevioralnog i emocionalnog funkcioniranja, a osobito nije bilo pogoršanja pokazatelja agresivnog ponašanja u odnosu na početno stanje.
English: The contents of the syringe can also be given directly from the syringe into the mouth or emptied onto a spoon (Figure 3).
Croatian: Sadržaj štrcaljke možete izravno dati u usta ili ga isprazniti na žlicu (slika 3).
English: The use of levetiracetam has been very rarely associated with acute kidney injury, with a time to onset ranging from a few days to several months.
Croatian: Primjena levetiracetama vrlo je rijetko bila povezana s akutnim oštećenjem bubrega, a može se pojaviti u rasponu od nekoliko dana do nekoliko mjeseci od početka primjene.
English: In addition, levetiracetam does not affect the in vitro glucuronidation of valproic acid.
Croatian: Levetiracetam ne utječe na glukuronidaciju valproične kiseline in vitro.
English: For children aged 6 months to less than 4 years
Croatian: Za djecu u dobi od 6 mjeseci do manje od 4 godine
English: 233 of these patients were treated with levetiracetam in placebo-controlled studies.
Croatian: 233 od tih bolesnika bilo je liječeno levetiracetamom u placebom kontroliranim ispitivanjima.
English: The total daily dose was administered twice daily.
Croatian: Ukupna se dnevna doza davala dva puta na dan.
English: • decreased blood sodium concentration;
Croatian: • snižena koncentracija natrija u krvi;
English: 58.3% of the levetiracetam treated patients and 23.3% of the patients on placebo had at least a 50% reduction in myoclonic seizure days per week.
Croatian: 58,3 % bolesnika liječenih levetiracetamom i 23,3 % bolesnika koji su dobivali placebo imalo je barem 50 %-tno smanjenje broja dana s miokloničkim napadajima tjedno.
English: Push the tip of the syringe into the adaptor opening.
Croatian: Utisnite vrh štrcaljke u otvor nastavka.
English: At the beginning of the treatment or at dose increase side effects like sleepiness, tiredness and dizziness may be more common.
Croatian: Na početku liječenja ili nakon povećanja doze nuspojave poput pospanosti, umora i omaglice, mogu se javiti češće.
English: What Levetiracetam Actavis Group is and what it is used for
Croatian: Što je Levetiracetam Actavis Group i za što se koristi
English: In a study reflecting clinical practice, the concomitant antiepileptic medication could be withdrawn in a limited number of patients who responded to levetiracetam adjunctive therapy (36 adult patients out of 69).
Croatian: U ispitivanju koje je bilo odraz kliničke prakse bilo je moguće prekinuti istodobno antiepileptičko liječenje u ograničenog broja bolesnika koji su odgovorili na dodatno liječenje levetiracetamom (36 od
English: Monotherapy for adults and adolescents from 16 years of age
Croatian: Doziranje Monoterapija za odrasle i adolescente od 16. godine života
English: Add-on therapy for adults (≥18 years) and adolescents (12 to 17 years) weighing 50 kg or more
Croatian: Dodatna terapija za odrasle (≥18 godina) i adolescente (12 do 17 godina) teške 50 kg ili više
English: No enantiomeric interconversion was evidenced in vivo for either levetiracetam or its primary metabolite.
Croatian: Interkonverzije enantiomera nisu utvrđene in vivo ni za levetiracetam ni za njegov glavni metabolit.
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 od početne 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: The pharmacokinetic profile is comparable in healthy volunteers and in patients with epilepsy.
Croatian: Farmakokinetički profil zdravih dobrovoljaca i bolesnika s epilepsijom jest komparabilan.
English: Dose in infants (1 month to less than 6 months):
Croatian: Doza u dojenčadi (1 mjesec do manje od 6 mjeseci):
English: The apparent body clearance of both levetiracetam and of its primary metabolite is correlated to the creatinine clearance.
Croatian: Prividni tjelesni klirens levetiracetama i njegovog glavnog metabolita povezan je s klirensom kreatinina.
English: In anuric end-stage renal disease adult subjects the half-life was approximately 25 and 3.1 hours during interdialytic and intradialytic periods, respectively.
Croatian: U odraslih bolesnika s anuričnom krajnjom fazom bubrežne bolesti poluvijek iznosi približno 25 i 3,1 sati u razdoblju između dijalize, odnosno tijekom dijalize.
English: No new safety concerns for levetiracetam were identified for infants less than 12 months of age with epilepsy.
Croatian: Nisu utvrđeni novi problemi u vezi sa sigurnošću primjene levetiracetama u dojenčadi mlađe od 12 mjeseci s epilepsijom.
English: This medicine contains less than 1 mmol sodium (23 mg) per ml, that is to say essentially ‘sodiumfree'.
Croatian: Ovaj lijek sadrži manje od 1 mmol (23 mg) natrija po ml, tj. zanemarive količine natrija.
English: If any bubbles appear in the syringe keep the bottle upside down and slightly push in the plunger and pull it back again.
Croatian: Ako se u štrcaljki pojave mjehurići, neka boca bude i dalje okrenuta naopako.
English: In vitro, levetiracetam and its primary metabolite have been shown not to inhibit the major human liver cytochrome P450 isoforms (CYP3A4, 2A6, 2C9, 2C19, 2D6, 2E1 and 1A2), glucuronyl transferase (UGT1A1 and UGT1A6) and epoxide hydroxylase activities.
Croatian: In vitro je pokazano da levetiracetam i njegov glavni metabolit ne inhibiraju aktivnost izoformi glavnog humanog citokroma P450 (CYP3A4, 2A6, 2C9, 2C19, 2D6, 2E1 i 1A2), glukuronil transferaze
English: The mechanism of action of levetiracetam still remains to be fully elucidated.
Croatian: Mehanizam djelovanja levetiracetama nije u potpunosti razriješen.
English: Peak plasma concentration was observed 0.5 to 1.0 hour after dosing.
Croatian: Vršna koncentracija u plazmi postignuta je 0,5 do 1,0 sat nakon uzimanja lijeka.
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 mjeseca do manje od 4 godine, ukupno 190 bolesnika liječeno je levetiracetamom u placebom kontroliranim i ispitivanjima otvorenog produžetka.
English: • diplopia (double vision), vision blurred;
Croatian: • diplopija (dvoslike), zamagljen vid;
English: Levetiracetam Actavis Group is indicated as adjunctive therapy
Croatian: Levetiracetam Actavis Group je indiciran kao dodatna terapija
English: Furthermore, levetiracetam has been shown in in vitro studies to bind to a specific site in rodent brain tissue.
Croatian: Nadalje, ispitivanjima in vitro pokazano je da se levetiracetam veže za specifično mjesto u moždanom tkivu glodavaca.
English: • flu-like symptoms and a rash on the face followed by an extended rash with a high temperature, increased levels of liver enzymes seen in blood tests and an increase in a type of white blood cell (eosinophilia) and enlarged lymph nodes (Drug Reaction with Eosinophilia and Systemic Symptoms [DRESS]);
Croatian: • simptome nalik gripi i osip na licu popraćen proširenim osipom s visokom tjelesnom temperaturom, povećane vrijednosti jetrenih enzima u krvnim testovima, povećanje posebne vrste bijelih krvnih stanica (eozinofilija) i povećane limfne čvorove (reakcija na lijek s eozinofilijom i sistemskim simptomima [DRESS])
English: Levetiracetam elimination is correlated to creatinine clearance.
Croatian: Eliminacija levetiracetama povezana je s klirensom kreatinina.
English: 1,500 mg twice daily (1) Children 25 kg or less should preferably start the treatment with Levetiracetam Actavis Group
Croatian: 1500 mg dva puta na dan (1) U djece od 25 kg ili manje liječenje je najbolje započeti Levetiracetam Actavis Group 100 mg/ml oralnom otopinom.
English: • liver failure, hepatitis;
Croatian: • zatajenje jetre, hepatitis;
English: In order to ensure the accuracy of the dosing, this presentation should be prescribed for infants and young children aged from 6 months to less than 4 years.
Croatian: Kako bi se osiguralo točno doziranje to pakiranje treba propisivati dojenčadi i maloj djeci u dobi od 6 mjeseci do manje od 4 godine.
English: What Levetiracetam Actavis Group is and what it is used for What you need to know before you take Levetiracetam Actavis Group How to take Levetiracetam Actavis Group Possible side effects
Croatian: Što je Levetiracetam Actavis Group i za što se koristi Što morate znati prije nego počnete uzimati Levetiracetam Actavis Group Kako uzimati Levetiracetam Actavis Group
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: Levetiracetam primijenjen u dozi od 1000 mg na dan nije utjecao na farmakokinetiku oralnih kontraceptiva (etinilestradiola i levonorgestrela); endokrini pokazatelji (luteinizirajući hormon i progesteron) ostali su nepromijenjeni.
English: Push the plunger down slowly to introduce air inside the bottle (Figure 3).
Croatian: Polako potisnite klip prema dolje kako biste unijeli zrak u bocu (slika 3).
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 starosnim skupinama i u svim odobrenim indikacijama epilepsije.
English: These could be symptoms of an encephalopathy.
Croatian: To mogu biti simptomi oštećenja mozga.
English: Add-on therapy for infants aged 6 to 23 months, children (2 to 11 years) and adolescents (12 to 17 years) weighing less than 50 kg
Croatian: Dodatna terapija za dojenčad u dobi od 6 do 23 mjeseca, djecu (2 do 11 godina) i adolescente (12 do 17 godina) s manje od 50 kg tjelesne težine
English: Decrease in levetiracetam plasma concentrations has been observed during pregnancy.
Croatian: Tijekom trudnoće su primijećena sniženja koncentracija levetiracetama u plazmi.
English: The mean total body clearance was 0.96 ml/min/kg.
Croatian: Srednji ukupni tjelesni klirens iznosi 0,96 ml/min/kg.
English: Sixty of these patients were treated with levetiracetam in placebo-controlled studies.
Croatian: Šezdeset od tih bolesnika bilo je liječeno levetiracetamom u placebom kontroliranim ispitivanjima.
English: Maltitol liquid
Croatian: Tekući maltitol
English: The CLcr in ml/min/1.73 m2 may be estimated from serum creatinine (mg/dl) determination using, for young adolescents, children and infants, using the following formula (Schwartz formula):
Croatian: Klirens kreatinina u ml/min/1,73 m2 može se za mlade adolescente, djecu i dojenčad procijeniti iz vrijednosti serumskoga kreatinina (mg/dl) s pomoću sljedeće formule (Schwartzova formula):
English: • hair loss, eczema, pruritus;
Croatian: • gubitak kose, ekcem, svrbež;
English: How to store Levetiracetam Actavis Group Contents of the pack and other information
Croatian: Kako čuvati Levetiracetam Actavis Group Sadržaj pakiranja i druge informacije
English: In this study, patients were prescribed 20 mg/kg, 25 mg/kg, 40 mg/kg or 50 mg/kg daily dose of oral solution based on their age titration schedule.
Croatian: U tom je ispitivanju bolesnicima propisana oralna otopina u dnevnoj dozi od 20 mg/kg, 25 mg/kg, 40 mg/kg ili 50 mg/kg prema shemi titriranja ovisnoj o dobi.
English: In this study, levetiracetam dose was 3,000 mg/day for adults and adolescents or 60 mg/kg/day for children, given in 2 divided doses.
Croatian: Doza levetiracetama u toj studiji bila je 3000 mg na dan za odrasle i adolescente, a za djecu 60 mg/kg/dan, podjeljeno na dvije doze.
English: The daily dose must be individualised according to renal function.
Croatian: Dnevna doza određuje se za svakog bolesnika pojedinačno u skladu s bubrežnom funkcijom.
English: The efficacy analysis consisted of 109 patients who had at least 24 hours of video EEG in both baseline and evaluation periods.
Croatian: Analizom djelotvornosti obuhvaćeno je 109 bolesnika u kojih je snimljen barem 24-satni EEG na početku i na kraju razdoblja procjene.
English: There have been isolated reports of decreased levetiracetam efficacy when the osmotic laxative macrogol has been concomitantly administered with oral levetiracetam.
Croatian: Postoje pojedina izvješća o smanjenoj učinkovitosti levetiracetama pri istodobnoj primjeni osmotskog laksativa makrogola i oralne primjene levetiracetama.
English: Hepatic failure, hepatitis
Croatian: Zatajenje jetre, hepatitis
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 pokazati niži stupanj bubrežne insuficijencije.
English: Measure the appropriate dosage using the 10 ml syringe included in the package for patients of 4 years and above.
Croatian: Odgovarajuću dozu izmjerite pomoću štrcaljke od 10 ml koja se nalazi u pakiranju za bolesnike od navršene 4 godine nadalje.
English: The fractional removal of levetiracetam was 51% during a typical 4-hour dialysis session.
Croatian: Frakcijsko uklanjanje levetiracetama iznosi 51% tijekom uobičajene četverosatne dijalize.
English: • suicide, personality disorders (behavioural problems), thinking abnormal (slow thinking, unable to concentrate);
Croatian: • samoubojstvo, poremećaj osobnosti (problemi u ponašanju), poremećaj mišljenja (sporo razmišljanje, nemogućnost koncentriranja);
English: Dose in children and adolescents 50 kg or more is the same as in adults.
Croatian: (2) Doza u djece i adolescenata od 50 kg ili više jednaka je kao u odraslih.
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: What Levetiracetam Actavis Group looks like and contents of the pack
Croatian: Kako Levetiracetam Actavis Group izgleda i sadržaj pakiranja
English: Peak concentrations (Cmax) are typically 31 and 43 µg/ml following a single 1,000 mg dose and repeated 1,000 mg twice daily dose, respectively.
Croatian: Vršna koncentracija (Cmax) uglavnom je 31 μg/ml nakon jedne doze od 1000 mg i 43 μg/ml nakon ponovljene doze od 1000 mg dva puta na dan.
English: Following repeated oral dose administration (20 to 60 mg/kg/day) to epileptic children (4 to 12 years), levetiracetam was rapidly absorbed.
Croatian: Nakon ponovljene primjene oralne doze (20 do 60 mg/kg/na dan) u djece s epilepsijom (4 do 12 godina) levetiracetam se brzo apsorbira.
English: Due to its complete and linear absorption, plasma levels can be predicted from the oral dose of levetiracetam expressed as mg/kg bodyweight.
Croatian: Uslijed potpune i linearne apsorpcije levetiracetama moguće je na temelju oralne doze izražene u mg/kg tjelesne težine predvidjeti razinu lijeka u plazmi.
English: A peri- and post-natal development study was performed in rats with levetiracetam doses of 70, 350 and 1,800 mg/kg/day.
Croatian: Ispitivanje peri- i postnatalnog razvoja provedeno je u štakora dozama levetiracetama od 70, 350 i 1800 mg/kg/dan.
English: To measure the dosing quantity, use one hand to hold the dosing body and the other hand to pull up the plunger until you reach the graduation mark corresponding to the quantity in milliliters (ml) prescribed by your doctor (Figure 1).
Croatian: Kako biste odmjerili potrebnu dozu, s jednom rukom primite tijelo graduirane štrcaljke a s drugom izvucite njen klip do oznake koja odgovara količini u mililitrima (ml)
English: Levetiracetam 2,000 mg daily did not influence the pharmacokinetics of digoxin and warfarin; prothrombin times were not modified.
Croatian: Levetiracetam u dozi od 2000 mg na dan nije utjecao na farmakokinetiku digoksina i varfarina; protrombinsko vrijeme ostalo je nepromijenjeno.
English: • depression, hostility or aggression, anxiety, insomnia, nervousness or irritability;
Croatian: • depresija, netrpeljivost ili agresivnost, tjeskoba, nesanica, nervoza ili razdražljivost;
English: Creatinine clearance (ml/min/1.73m2)
Croatian: Klirens kreatinina (ml/min/1,73 m2)
English: The primary measure of effectiveness was the responder rate (percent of patients with ≥ 50% reduction from baseline in average daily partial onset seizure frequency) assessed by a blinded central reader using a 48-hour video EEG.
Croatian: Primarna mjera učinkovitosti bila je stopa bolesnika s odgovorom (postotak bolesnika u kojih je dnevna prosječna učestalost napadaja smanjena za ≥ 50 % u odnosu na početno stanje) određena središnjim pregledavanjem 48-satnog video EEG-a od strane ocjenjivača koji nije znao tko je dobivao placebo, a tko lijek.
English: After oral administration the bitter taste of levetiracetam may be experienced.
Croatian: Nakon peroralne primjene može se očekivati gorak okus levetiracetama.
English: • Levetiracetam Actavis Group is used as a chronic treatment.
Croatian: • Levetiracetam Actavis Group se koristi za dugotrajno liječenje.
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 slijepom i placebom kontroliranom ispitivanju u trajanju od 24 tjedna, koje je uključivalo 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: 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: Clear, faint yellowish-brown solution.
Croatian: Bistra, blijedo žućkasto-smeđa otopina.
English: Due to possible different individual sensitivity, some patients might experience somnolence or other central nervous system related symptoms, especially at the beginning of treatment or following a dose increase.
Croatian: Levetiracetam malo ili umjereno utječe na sposobnost upravljanja vozilima i rada sa strojevima Uslijed mogućih razlika u osjetljivosti među pojedincima, u nekih bolesnika može se javiti somnolencija ili drugi simptomi vezani za središnji živčani sustav, osobito na početku liječenja ili nakon povećanja doze.
English: In this study, the patients received levetiracetam as a fixed dose of 60 mg/kg/day (with twice a day dosing).
Croatian: Bolesnici su u tom ispitivanju dobivali konstantnu dozu od 60 mg/kg/dan (doziranje dva puta na dan).
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: The oral solution is the preferred formulation for use in infants and children under the age of 6 years.
Croatian: Oralna otopina najprikladniji je farmaceutski oblik za primjenu kod dojenčadi i djece mlađe od 6 godina.
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 ispitivanja embrio-fetalnog razvoja provedena su u kunića s dozama od 200, 600, 800, 1200 i 1800 mg/kg/dan.
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: 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