FrancophonIA/ELRC3.0 huggingface dataset:
English: The Agency's Committee for Medicinal Products for Veterinary Use (CVMP) concluded that MiPet Easecto's benefits are greater than its risks and recommended that it be approved for use in the EU.
Croatian: Odbor za veterinarsko-medicinske proizvode (CVMP) pri Agenciji odlučio je da koristi od VMP-a MiPet Easecto nadmašuju s njim povezane rizike te je preporučio njegovo odobrenje za primjenu u Europskoj uniji.
English: Another study involved dogs infested with sarcoptic mange.
Croatian: Još jedno ispitivanje obuhvatilo je pse zaražene sarkoptes šugom.
English: The company that makes Simparica has agreed that its scientific data can be used for MiPet Easecto (‘informed consent').
Croatian: Proizvođač VMP-a Simparica pristao je na to da se njegovi znanstveni podatci koriste za VMP MiPet Easecto (tzv. „informirani pristanak”).
English: What is MiPet Easecto and what is it used for?
Croatian: Što je MiPet Easecto i za što se koristi?
English: Other information about MiPet Easecto
Croatian: Ostale informacije o VMP-u MiPet Easecto
English: Why is MiPet Easecto approved?
Croatian: Zašto je MiPet Easecto odobren?
English: MiPet Easecto is a veterinary medicine used to treat infestations with ticks and fleas, demodectic and sarcoptic mange (skin infestations caused by two different types of mites) and ear mite infestations in dogs.
Croatian: MiPet Easecto je vrsta VMP-a koja se koristi za liječenje infestacija krpeljima i buhama, demodikoze i sarkoptes šuge (infestacije kože koje uzrokuju dvije različite vrste grinja) i infestacije ušnim grinjama u pasa.
English: The active substance in MiPet Easecto, sarolaner acts as an ‘ectoparasiticide'.
Croatian: Djelatna tvar u VMP-u MiPet Easecto, sarolaner, djeluje kao „ektoparaziticid”.
English: What are the risks associated with MiPet Easecto?
Croatian: Koji su rizici povezani s VMP-om MiPet Easecto?
English: For treatment of tick and flea infestations MiPet Easecto should be given once every month throughout the flea and/or tick season for optimal control.
Croatian: Za potrebe liječenja infestacija krpeljima i buhama VMP MiPet Easecto daje se jedanput svaki mjesec tijekom sezone buha i/ili krpelja radi optimalne kontrole.
English: The effectiveness of MiPet Easecto against fleas was investigated in a field study in dogs infested with at least five live fleas.
Croatian: Djelovanje VMP-a MiPet Easecto protiv buha ispitano je u terenskom ispitivanju u pasa zaraženih s najmanje pet živih buha.
English: If the product is accidentally swallowed by a person, the advice of a doctor should be sought immediately.
Croatian: U slučaju da se VMP nehotice proguta, treba odmah potražiti liječničku pomoć.
English: For MiPet Easecto the percentage of dogs with no live ear mites present was 91% at day 30 increasing to 99% on day 60, following two treatments.
Croatian: Prilikom liječenja VMP-om MiPet Easecto postotak pasa koji nisu imali žive grinje nakon 30 dana iznosio je 91 %, s time da je taj postotak porastao do 99 % nakon 60 dana, odnosno nakon dviju terapija.
English: This is a summary of the European public assessment report (EPAR) for MiPet Easecto.
Croatian: Ovo je sažetak europskoga javnog izvješća o procjeni (EPAR) za veterinarsko-medicinski proizvod MiPet Easecto.
English: MiPet Easecto can be used as part of the management of flea allergy dermatitis (an allergic reaction to flea bites).
Croatian: MiPet Easecto može se koristiti i u okviru liječenja alergijskog dermatitisa uzrokovanog buhama (alergijske reakcije na ugrize buha).
English: After MiPet Easecto is given its activity against ticks and fleas lasts for at least 5 weeks.
Croatian: Nakon primjene VMP-a MiPet Easecto, on djeluje protiv krpelja i buha najmanje pet tjedana.
English: For treatment of sarcoptic mange, MiPet Easecto is given monthly for two consecutive months.
Croatian: Za potrebe liječenja sarkoptes šuge MiPet Easecto daje se jedanput mjesečno tijekom dva uzastopna mjeseca.
English: In a study involving dogs with ear mite infestation, 283 dogs were treated with MiPet Easecto and 131 dogs received moxidectin/imidacloprid (a spot-on mite treatment).
Croatian: U ispitivanju koje je obuhvatilo pse s infestacijom ušnim škugarcem, 283 psa liječeno je VMP-om MiPet Easecto, a 131 pas primio je moksidektin/imidakloprid (terapiju nakapavanjem protiv grinja).
English: MiPet Easecto was as effective as moxidectin/imidacloprid.
Croatian: VMP MiPet Easecto bio je jednako djelotvoran kao moksidektin/imidakloprid.
English: MiPet Easecto was as effective as moxidectin and imidacloprid in eliminating live mites in skin scrapings.
Croatian: VMP MiPet Easecto bio je jednako djelotvoran kao moksidektin i imidakloprid u eliminaciji živih grinja u kožnim strugotinama.
English: For treatment of demodectic mange MiPet Easecto should be given once a month for at least three months.
Croatian: Za potrebe liječenja demodikoze MiPet Easecto daje se jedanput mjesečno u razdoblju od barem tri mjeseca.
English: In a study with 98 dogs with demodectic mange, 63 dogs were treated with MiPet Easecto monthly for up to six months and 35 dogs received moxidectin/imidacloprid.
Croatian: U ispitivanju koje je obuhvatilo 98 pasa s demodikozom, 63 psa liječena su VMP-om MiPet Easecto jedanput mjesečno u razdoblju od najviše šest mjeseci, a 35 pasa primilo je moksidektin/imidakloprid.
English: MiPet Easecto was as effective as fipronil in reducing tick counts for up to 90 days after treatment.
Croatian: VMP MiPet Easecto bio je jednako djelotvoran kao fipronil u smanjivanju broja krpelja do 90 dana nakon terapije.
English: 122 dogs were treated with MiPet Easecto for three months whilst 59 dogs were treated with another medicine, fipronil, against ticks.
Croatian: Tijekom tri mjeseca 122 psa liječena su VMP-om MiPet Easecto, dok je 59 pasa liječeno drugim VMP-om, fipronilom, protiv krpelja.
English: How does MiPet Easecto work?
Croatian: Kako djeluje MiPet Easecto?
English: How is MiPet Easecto used?
Croatian: Kako se MiPet Easecto koristi?
English: MiPet Easecto was as effective as spinosad in reducing flea counts for up to 90 days after treatment.
Croatian: VMP MiPet Easecto bio je jednako djelotvoran kao spinosad u smanjivanju broja buha do 90 dana nakon terapije.
English: Side effects with MiPet Easecto are not common.
Croatian: Nuspojave VMP-a MiPet Easecto nisu česte.
English: 189 dogs were treated with MiPet Easecto for three months whilst 96 dogs were given another medicine, spinosad.
Croatian: Tijekom tri mjeseca 189 pasa liječeno je VMP-om MiPet Easecto, dok je 96 pasa primilo drugi VMP, spinosad.
English: 53 dogs were treated with MiPet Easecto for two months whilst 26 dogs were given a medicine containing moxidectin and imidacloprid.
Croatian: Tijekom dva mjeseca 53 pasa liječeno je VMP-om MiPet Easecto, dok je 26 pasa primilo VMP koji je sadržavao moksidektin i imidakloprid.
English: Safety information has been included in the summary of product characteristics and the package leaflet for MiPet Easecto, including the appropriate precautions to be followed by healthcare professionals and animal owners or keepers.
Croatian: U sažetku opisa svojstava i u uputi o VMP-u MiPet Easecto nalaze se sigurnosne informacije, uključujući odgovarajuće mjere opreza kojih se veterinari te vlasnici životinja ili uzgajivači trebaju pridržavati.
English: For practical information about using MiPet Easecto, animal owners or keepers should read the package leaflet or contact their veterinarian or pharmacist.
Croatian: Praktične informacije o primjeni VMP-a MiPet Easecto vlasnici životinja ili uzgajivači trebaju pročitati u uputi o VMP-u, odnosno trebaju se obratiti svojem veterinaru ili ljekarniku.
English: For more information about treatment with MiPet Easecto, animal owners or keepers should read the package leaflet or contact their veterinarian or pharmacist.
Croatian: Dodatne informacije o terapiji VMP-om MiPet Easecto vlasnici životinja ili uzgajivači trebaju pročitati u uputi o VMP-u, odnosno trebaju se obratiti svojem veterinaru ili ljekarniku.
English: What benefits of MiPet Easecto have been shown in studies?
Croatian: Koje su koristi VMP-a MiPet Easecto utvrđene u ispitivanjima?
English: • Risk management plan (RMP) Not applicable.
Croatian: • Plan upravljanja rizikom (RMP) Nije primjenjivo.
English: Str. Fabricii nr 124
Croatian: Fabricii nr 124
English: The elimination half-life was approximately 5 hours.
Croatian: Poluvijek eliminacije iznosilo je oko 5 sati.
English: Currently available data are described in sections 4.8, 5.1, and 5.2 but no recommendation on a posology can be made.
Croatian: Trenutno dostupni podaci su opisani u dijelovima 4.8, 5.1 i 5.2, no nema preporuka za doziranje.
English: Date of latest renewal: 14 November 2016
Croatian: Datum posljednje obnove odobrenja:14. studeni 2016
English: This leaflet was last revised in {month/YYYY} Other sources of information
Croatian: Ova uputa je zadnji puta revidirana u {mjesec/GGGG} Ostali izvori informacija
English: Levetiracetam SUN must be administered twice a day, once in the morning and once in the evening, at about the same time each day.
Croatian: Levetiracetam SUN se mora primijeniti dva puta na dan, jednom ujutro i jednom navečer, u približno isto vrijeme svaki dan.
English: You can be switched from one to the other without changing dose.
Croatian: Možete biti prebačeni s jednog na drugi oblik bez prilagođavanja doze.
English: Do not take macrogol (a drug used as laxative) for one hour before and one hour after taking levetiracetam as this may results in a reduction of its effect.
Croatian: Ne uzimajte makrogol (lijek koji se koristi kao laksativ) jedan sat prije i jedan sat nakon uzimanja levetiracetama zbog toga što se može smanjiti učinak levetiracetama.
English: The pharmacokinetic and safety profiles did not identify any safety concerns.
Croatian: Farmakokinetički i sigurnosni profili nisu identificirali nikakvu zabrinutost glede sigurnosti primjene.
English: Polska Ranbaxy (Poland) Sp. Z o. o.
Croatian: Ranbaxy (Poland) Sp. Z o. o. ul.
English: België/Belgique/Belgien/България/Česká republika/ Danmark/Eesti/Ελλάδα/Hrvatska/Ireland/Ísland/ Κύπρος/Latvija/Lietuva/Luxembourg/Luxemburg/Magyarország/ Malta/Nederland/Norge/Österreich/Portugal/ Slovenija/Slovenská republika/Suomi/Finland/Sverige Sun Pharmaceutical Industries Europe B.V.
Croatian: België/Belgique/Belgien/България/Česká republika/ Danmark/Eesti/Ελλάδα/Hrvatska/Ireland/Ísland/ Κύπρος/Latvija/Lietuva/Luxembourg/Luxemburg/Magyarország/ Malta/NederlandNorge/ Österreich/Portugal/ Slovenija/Slovenská republika/Suomi/Finland/Sverige Sun Pharmaceutical Industries Europe B.V.
English: What Levetiracetam SUN is and what is it used for
Croatian: Što je Levetiracetam SUN i za što se koristi
English: EXP Use immediately after dilution.
Croatian: EXP Primijenite odmah nakon razrjeđivanja.
English: Read all of this leaflet carefully before you or your child start using this medicine because it contains important information for you.
Croatian: Vi ili Vaše dijete počnete koristiti ovaj lijek jer sadrži Vama važne podatke.
English: Duration of treatment
Croatian: Trajanje liječenje
English: How to store Levetiracetam SUN Contents of the pack and other information
Croatian: Kako čuvati Levetiracetam SUN Sadržaj pakiranja i druge informacije
English: If you have any symptoms of depression and/or thoughts about committing suicide, please contact your doctor.
Croatian: Ako imate bilo kakve simptome depresije i/ili samoubilačke ideje, molimo obavijestite svog liječnika.
English: Conversion to or from oral to intravenous administration can be done directly without titration.
Croatian: Prijelaz na ili sa peroralne na intravensku primjenu može se učiniti izravno bez titracije.
English: The patients had to present with unprovoked partial seizures or with generalized tonic-clonic seizures only.
Croatian: Bolesnici su morali imati spontane parcijalne napadaje ili samo generalizirane toničko-kloničke napadaje.
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: Nuspojave su prikazane u padajućem nizu s obzirom na ozbiljnost i njihova učestalost je definirana na sljedeći način: 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: - A small number of people being treated with anti-epileptics such as Levetiracetam SUN have had thoughts of harming or killing themselves.
Croatian: - mali broj ljudi liječenih antiepilepticima kao što je Levetiracetam SUN imali su misli o samoozljeđivanju ili samoubojstvu.
English: If not used immediately, in-use storage time and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2 to 8°C, unless dilution has taken place in controlled and validated aseptic conditions.
Croatian: Ako se ne primijeni odmah, vrijeme čuvanja i uvjeti prije primjene su odgovornost korisnika i normalno ne bi smjeli biti dulje od 24 sata na 2 do 8°C, osim ako razrijeđivanje nije provedeno u kontroliranim i validiranim aseptičkim uvjetima.
English: Hypersensitivity to the active substance or other pyrrolidone derivatives or to any of the excipients listed in section 6.1.
Croatian: Preosjetljivost na djelatnu tvar ili neki drugi pirolidonski derivat ili na neku od pomoćnih tvari navedenih u dijelu 6.1.
English: - If you notice any slow down in growth, or if there is unexpected puberty development in your child, please contact your doctor.
Croatian: - ako primijetite usporen rast ili neočekivan razvoj djeteta u pubertetu, obavijestite svog liječnika.
English: Blood methotrexate and levetiracetam levels should be carefully monitored in patients treated concomitantly with the two drugs
Croatian: Razine metotreksata i levetiracetama u krvi treba pažljivo pratiti u bolesnika istodobno liječenih s ova dva lijeka.
English: Alcohol No data on the interaction of levetiracetam with alcohol are available.
Croatian: Ne postoje podaci o interakciji levetiracetama s alkoholom.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING Box of 10 vials
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU Kutija sa 10 bočica
English: The following information is intended for healthcare professionals only: Directions for the proper use of Levetiracetam SUN is provided in section 3.
Croatian: Sljedeće informacije namijenjene su samo zdravstvenim djelatnicima: Upute za pravilnu primjenu Levetiracetam SUN-a nalaze se u dijelu 3.
English: What Levetiracetam SUN is and what it is used for What you need to know before you are given Levetiracetam SUN How Levetiracetam SUN is given Possible side effects
Croatian: Što je Levetiracetam SUN i za što se koristi Što morate znati prije nego počnete dobivati Levetiracetam SUN Kako se Levetiracetam SUN daje Moguće nuspojave
English: A doctor or a nurse will administer you Levetiracetam SUN as an intravenous infusion.
Croatian: Liječnik ili medicinska sestra će Vam primijeniti Levetiracetam SUN u obliku intravenske infuzije.
English: Very common: may affect more than 1 in 10 people - nasopharyngitis - somnolence (sleepiness), headache
Croatian: Vrlo često: mogu se javiti u više od 1 na 10 ljudi - nazofaringitis - somnolencija (pospanost), glavobolja
English: MARKETING AUTHORISATION NUMBER(S) EU/1/11/741/001
Croatian: 12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/11/741/001
English: For doctors and nurses, more detailed direction for the proper use of Levetiracetam SUN is provided in section 6.
Croatian: Za liječnike i medicinske sestre, detaljnija uputa za pravilnu primjenu Levetiracetam SUN-a nalazi se u poglavlju 6.
English: What Levetiracetam SUN looks like and contents of the pack Levetiracetam SUN concentrate for solution for infusion (sterile concentrate) is a clear, colourless liquid.
Croatian: Kako Levetiracetam SUN izgleda i sadržaj pakiranja Levetiracetam SUN koncentrat za otopinu za infuziju (sterilni koncentrat) je bistra, bezbojna tekućina.
English: What Levetiracetam SUN contains - The active substance is called levetiracetam.
Croatian: Što Levetiracetam SUN sadrži - Djelatna tvar zove se levetiracetam.
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 studiji koja je bila odraz kliničke prakse bilo je moguće prekinuti istodobno antiepileptičko liječenje u ograničenog broja bolesnika koji su odgovorili na dodatno liječenje levetiracetamom (36 od 69 odraslih bolesnika).
English: INFORMATION IN BRAILLE Justification for not including Braille accepted
Croatian: 16. PODACI NA BRAILLEOVOM PISMU obrazloženje za nenavođenje Braillea je prihvaćeno
English: Drug reaction with eosinophilia and systemic symptoms (DRESS), hypersensitivity (including angioedema and anaphylaxis)
Croatian: Reakcija na lijek s eozinofilijom i sistemskim simptomima (DRESS) (uključujući angioedem i anafilaksu)
English: Monotherapy for adults and adolescents from 16 years of age
Croatian: Monoterapija za odrasle i adolescente od 16. godine života
English: In man, an activity in both partial and generalised epilepsy conditions (epileptiform discharge/ photoparoxysmal response) has confirmed the broad spectrum pharmacological profile of levetiracetam.
Croatian: Kod ljudi je njegova aktivnost u stanjima i parcijalne i generalizirane epilepsije (epileptiformno izbijanje/fotoparoksizmalni odgovor) potvrdila širok spektar farmakološkog profila levetiracetama.
English: 1500 mg twice daily (1) Children 25 kg or less should preferably start the treatment with an oral solution.
Croatian: 1500 mg dva puta na dan (1) U djece od 25 kg ili manje liječenje je najbolje započeti oralnom otopinom.
English: Should your doctor decide to stop your Levetiracetam SUN treatment, he/she will instruct you about the gradual withdrawal of Levetiracetam SUN.
Croatian: Ako Vaš liječnik odluči prekinuti liječenje Levetiracetamom SUN, uputit će Vas kako postupno prekinuti liječenje Levetiracetamom SUN.
English: Your total daily dose and frequency of administration remain the same.
Croatian: Vaša ukupna dnevna doza i učestalost primjene lijeka ostaje ista.
English: Therefore patients should be monitored for signs of depression and/or suicidal ideation and behaviours and appropriate treatment should be considered.
Croatian: Stoga sekod bolesnika moraju pratiti znakovi depresije i/ili samoubilačke ideje i ponašanje te razmotriti prikladan oblik liječenja.
English: necrolysis, Stevens-Johnson syndrome, erythema multiforme
Croatian: Toksična epidermalna nekroliza, StevensJohnsonov sindrom, multiformni eritem
English: In both these paediatric age ranges, these data are supplemented with the post-marketing experience of the use of levetiracetam.
Croatian: U obje od tih pedijatrijskih dobnih skupina, ti podaci dopunjeni su s iskustvom primjene levetiracetama nakon stavljanja lijeka u promet.
English: Other medicines and Levetiracetam SUN
Croatian: Drugi lijekovi i Levetiracetam SUN
English: At the beginning of the treatment or at dose increase of the 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: These data are supplemented with the use of levetiracetam in corresponding open-label extension studies, as well as post-marketing experience.
Croatian: Ti podaci dopunjeni su s podacima iz odgovarajućih ispitivanja otvorenog produžetka o primjeni levetiracetama, kao i iskustvima nakon stavljanja lijeka u promet.
English: Only limited evidence is available on the neurodevelopment of children exposed to levetiracetam monotherapy in utero.
Croatian: Dostupni su samo ograničeni podaci o neurološkom razvoju djece izložene monoterapiji lijekom levetiracetamom in utero.
English: Results related to behavioural and emotional functioning indicated a worsening in levetiracetam treated patients on aggressive behaviour as measured in a standardized and systematic way using a validated instrument (CBCL - Achenbach Child Behavior Checklist).
Croatian: Rezultati ocjene funkcioniranja ponašanja i emocionalnog funkcioniranja uputili su na pogoršanje u smislu agresivnijeg ponašanja u skupini koja je uzimala levetiracetam, ocijenjenog na standardiziran i sistematičan način koristeći validirani instrument (CBCL - Achenbach Child Behavior Checklist) na standardiziran i sistematičan način.
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: Since there was limited exposure for levetiracetam intravenous use and since oral and intravenous formulations are bioequivalent, the safety information of levetiracetam intravenous will rely on levetiracetam oral use.
Croatian: S obzirom na ograničenu izloženost intravenskoj primjeni levetiracetama i s obzirom da su oralni i intravenski oblici bioekvivalentni, sigurnosni podaci za levetiracetam primijenjen intravenski se oslanjaju na levetiracetam primijenjen peroralno.
English: If you stop using Levetiracetam SUN
Croatian: Ako prestanete dobivati Levetiracetam SUN
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: Međutim, u ispitanika koji su uzimali levetiracetam tijekom dugoročne, otvorene studije provedene praćenjem u prosjeku nije bilo pogoršanja bihevioralnog i emocionalnog funkcioniranja; osobito nije bilo pogoršanja pokazatelja agresivnog ponašanja u odnosu na početno stanje.
English: However, based on the pharmacokinetic characteristics of levetiracetam, the pharmacokinetics in adults after intravenous administration and the pharmacokinetics in children after oral administration, the exposure (AUC) of levetiracetam is expected to be similar in paediatric patients aged 4 to 12 years after intravenous and oral administration.
Croatian: No, na temelju farmakokinetičkih karakteristika levetiracetama, farmakokinetike u odraslih nakon intravenske primjene i farmakokinetike u djece nakon oralne primjene, očekuje se da je izloženost (AUC) levetiracetama u pedijatrijskih bolesnika u dobi 4 do 12 godina slična nakon intravenske i oralne primjene.
English: PHARMACEUTICAL FORM AND CONTENTS 500 mg/5 ml
Croatian: OBLIK I SADRŽAJ 500 mg/5 ml
English: This medicinal product is for single use only, any unused solution should be discarded.
Croatian: Ovaj lijek je samo za jednokratnu primjenu, neupotrijebljena otopina mora se odbaciti.
English: The adverse reaction profile presented below is based on the analysis of pooled placebo-controlled clinical trials with all indications studied, with a total of 3,416 patients treated with levetiracetam.
Croatian: Profil nuspojava opisan niže temelji se na analizi objedinjenih placebom konroliranih kliničkih istraživanja za sve ispitivane indikacije, u kojima je s levetiracetamom liječeno ukupno 3416 bolesnika.
English: Levetiracetam SUN concentrate is for intravenous use only and the recommended dose must be diluted in at least 100 ml of a compatible diluent and administered intravenously as a 15-minute intravenous infusion (see section 6.6).
Croatian: Levetiracetam SUN koncentrat je samo za intravensku primjenu i preporučena doza se mora razrijediti u najmanje 100 ml kompatibilne otopine za razrjeđivanje i primjeniti intravenski kao 15minutna intravenska infuzija (vidjeti dio 6.6).