natgillin/translations-raw huggingface dataset:
For practical information about using MiPet Easecto, animal owners or keepers should read the package leaflet or contact their veterinarian or pharmacist.
Za praktične informacije o uporabi zdravila MiPet Easecto naj lastniki ali skrbniki živali preberejo navodilo za uporabo ali se posvetujejo z veterinarjem ali farmacevtom.
189 dogs were treated with MiPet Easecto for three months whilst 96 dogs were given another medicine, spinosad.
189 psov je tri mesece prejemalo zdravilo MiPet Easecto, 96 psov pa drugo zdravilo, spinosad.
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).
V študiji, ki je vključevala pse z infestacijami ušesnih garjavcev, je bilo 283 psov zdravljenih z zdravilom MiPet Easecto, 131 psov pa je prejemalo moksidektin/imidakloprid (zdravilo proti garjam za kožni nanos).
53 dogs were treated with MiPet Easecto for two months whilst 26 dogs were given a medicine containing moxidectin and imidacloprid.
53 psov je dva meseca prejemalo zdravilo MiPet Easecto, 26 psov pa zdravilo, ki je vsebovalo moksidektin in imidakloprid.
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.
V študiji, ki je vključevala 98 psov z garjavci vrste Demodex canis, je bilo 63 psov zdravljenih enkrat na mesec z zdravilom MiPet Easecto v obdobju do šestih mesecev, medtem ko je 35 psov prejemalo moksidektin/imidakloprid.
MiPet Easecto was as effective as fipronil in reducing tick counts for up to 90 days after treatment.
Zdravilo MiPet Easecto je bilo pri zmanjševanju števila klopov enako učinkovito kot zdravilo fipronil do 90 dni po zdravljenju.
After MiPet Easecto is given its activity against ticks and fleas lasts for at least 5 weeks.
Po dajanju zdravila MiPet Easecto učinek proti klopom in bolham traja najmanj pet tednov.
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.
Ustrezna jakost tablete se določi glede na telesno maso psa. Za zdravljenje infestacij s klopi in bolhami se zdravilo MiPet Easecto v sezoni klopov in/ali bolh daje enkrat mesečno, da bi dosegli optimalen nadzor.
MiPet Easecto was as effective as spinosad in reducing flea counts for up to 90 days after treatment.
Zdravilo MiPet Easecto je bilo pri zmanjševanju števila bolh enako učinkovito kot zdravilo spinosad do 90 dni po zdravljenju.
How does MiPet Easecto work?
Kako zdravilo MiPet Easecto deluje?
122 dogs were treated with MiPet Easecto for three months whilst 59 dogs were treated with another medicine, fipronil, against ticks.
122 psov je proti klopom tri mesece prejemalo zdravilo MiPet Easecto, 59 psov pa drugo zdravilo, fipronil.
MiPet Easecto was as effective as moxidectin and imidacloprid in eliminating live mites in skin scrapings.
Zdravilo MiPet Easecto je bilo pri odpravljanju živih garjavcev v kožnih ostružkih enako učinkovito kot moksidektin in imidakloprid.
For treatment of demodectic mange MiPet Easecto should be given once a month for at least three months.
Za zdravljenje infestacij z garjami vrste Demodex canis se zdravilo MiPet Easecto daje enkrat na mesec najmanj tri mesece zapored.
How is MiPet Easecto used?
Kako se zdravilo MiPet Easecto uporablja?
• Risk management plan (RMP) Not applicable.
• Načrt za obvladovanje tveganja (RMP) Navedba smiselno ni potrebna.
Date of latest renewal: 14 November 2016
Datum zadnjega podaljšanja: 14, november 2016
This leaflet was last revised in {month/YYYY} Other sources of information
Navodilo je bilo nazadnje revidirano dne {mesec/LLLL} Drugi viri informacij
MARKETING AUTHORISATION NUMBER(S) EU/1/11/741/001
ŠTEVILKA(E) DOVOLJENJA(DOVOLJENJ) ZA PROMET EU/1/11/741/001
Levetiracetam SUN must be administered twice a day, once in the morning and once in the evening, at about the same time each day.
Zdravilo Levetiracetam SUN morate prejeti dvakrat na dan, enkrat zjutraj in enkrat zvečer, vsak dan ob približno istem času.
Your total daily dose and frequency of administration remain the same.
Vaš celokupni dnevni odmerek in pogostost uporabe ostaneta enaki.
NL-2132 JH Hoofddorp The Netherlands
NL-2132 JH Hoofddorp Nizozemska
If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine.
Če ste noseči ali dojite,menite, da bi lahko bili noseči ali načrtujete zanositev, se posvetujte z zdravnikom, preden vzamete to zdravilo.
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 14 December 2011
Datum prve odobritve: 14. december 2011
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).
Neželeni učinki so navedeni po padajoči resnosti in njihova pogostnost je opredeljena takole: zelo pogosti: (≥1/10); pogosti: (≥1/100 do <1/10); občasni: (≥1/1.000 do <1/100); redki: (≥1/10.000 do <1/1.000) in zelo redki: (<1/10.000).
Do not use Levetiracetam SUN - if you are allergic to levetiracetam, pyrrolidone derivatives or any of the other ingredients of this medicine (listed in section 6).
Ne uporabljajte zdravila Levetiracetam SUN - če ste alergični na levetiracetam, pirolidonske derivate ali katero koli sestavino tega zdravila (navedeno v poglavju 6).
Dose and frequency
Odmerjanje in pogostnost
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.
Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na viali in škatli poleg oznake EXP. Rok uporabnosti zdravila se iztečena zadnji dan navedenega meseca.
Alcohol No data on the interaction of levetiracetam with alcohol are available.
Alkohol Podatkov o interakciji levetiracetama z alkoholom ni.
Neither levetiracetam nor its primary metabolite are significantly bound to plasma proteins (< 10 %).
Tako levetiracetam kot njegov primarni presnovek se ne vežeta pomembno na beljakovine v plazmi (< 10 %).
EXP Use immediately after dilution.
EXP : Uporabite takoj po razredčenju.
Patients are advised not to drive or use machines until it is established that their ability to perform such activities is not affected.
Bolnikom svetujemo, naj ne vozijo ali upravljajo s stroji, dokler ni ugotovljeno, da zdravilo ne vpliva na njihovo sposobnost za izvajanje teh dejavnosti.
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
Kaj je Levetiracetam SUN in za kaj ga uporabljamo Kaj morate vedeti, preden boste prejeli Levetiracetam SUN Kako se daje Levetiracetam SUN Možni neželeni učinki
CLcr (ml/min) = -------------------------------------- (x 0.85 for women)
CLcr (ml/min) = ------------------------------------------------------------- (x 0,85 za ženske)
The following information is intended for healthcare professionals only: Directions for the proper use of Levetiracetam SUN is provided in section 3.
Naslednje informacije so namenjene samo zdravstvenemu osebju: Navodila za pravilno uporabo zdravila Levetiracetam SUN se nahajajo v poglavju 3.
72 x serum creatinine (mg/dl)
72 x koncentracija kreatinina v serumu (mg/dl)
A doctor or a nurse will administer you Levetiracetam SUN as an intravenous infusion.
Zdravnik ali medicinska sestra vam bosta dala zdravilo Levetiracetam SUN kot intravensko infuzijo.
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.
Kljub temu pa se osebam, ki so jemale levetiracetam med dolgotrajno, odprto, sledilno študijo v povprečju niso poslabšale njihove vedenjske in emocionalne funkcije; natančneje, rezultati meritev agresivnega obnašanja niso bili slabši od začetnih vrednosti.
BSA subject (m2)
BSA bolnika (m2)
Hypersensitivity to the active substance or other pyrrolidone derivatives or to any of the excipients listed in section 6.1.
Preobčutljivost na zdravilno učinkovino ali druge pirolidonske derivate ali katero koli pomožno snov, navedeno v poglavju 6.1.
- If you notice any slow down in growth, or if there is unexpected puberty development in your child, please contact your doctor.
- če ste pri otroku opazili počasnejšo rast ali nepričakovan razvoj v puberteti se posvetujte z zdravnikom.
Very common: may affect more than 1 in 10 people - nasopharyngitis - somnolence (sleepiness), headache
Zelo pogosti: pojavijo se lahko pri več kot 1 od 10 bolnikov - nazofaringitis - somnolenca (zaspanost), glavobol
For storage conditions of the diluted medicinal product, see section 6.3.
Za pogoje shranjevanja zdravila po redčenju glejte poglavje 6.3.
At the beginning of the treatment or at dose increase of the side effects like sleepiness, tiredness and dizziness may be more common.
Na začetku zdravljenja ali po povečanju odmerka lahko neželeni učinki, kot so na primer zaspanost, utrujenost in omotica, postanejo pogostejši.
[140-age (years)] x weight (kg)
[140 - starost (leta)] x masa (kg)
Dose Withdrawal Volume
Odmerek Odvzeti volumen Volumen topila
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).
Rezultati povezani z vedenjskimi in emocionalnimi funkcijami kažejo pri bolnikih, ki se zdravijo z levetiracetamom, poslabšanje agresivnega obnašanja, ki se izmeri na standardiziran in sistematičen način z uporabo validiranega merskega instrumenta (CBCLAchenbach Child Behavior Checklist).
Levetiracetam SUN may impair your ability to drive or operate any tools or machinery, as it may make you feel sleepy.
Vpliv na sposobnost upravljanja vozil in strojev Zdravilo Levetiracetam SUN lahko oslabi vašo sposobnost vožnje ali upravljanja z orodjem ali stroji, saj lahko Levetiracetam SUN povzroči zaspanost.
Should your doctor decide to stop your Levetiracetam SUN treatment, he/she will instruct you about the gradual withdrawal of Levetiracetam SUN.
Če se bo vaš zdravnik odločil za prekinitev zdravljenja z zdravilom Levetiracetam SUN, vam bo dal napotke o postopni ukinitvi zdravila Levetiracetam SUN.
A. MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
A. PROIZVAJALCI, ODGOVORNI ZA SPROŠČANJE SERIJ
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).
73,0 % bolnikov, ki so se zdravili z levetiracetamom, in 72,8 % bolnikov, ki so se zdravili s karbamazepinom z nadzorovanim sproščanjem (CR) je bilo šest mesecev brez napadov; prilagojena absolutna razlika med zdravljenjema je bila 0,2 % (95 % CI: 7,8-8,2).
The physician should prescribe the most appropriate pharmaceutical form, presentation and strength according to age, weight and dose.
Zdravnik mora glede na starost, telesno maso in odmerek predpisati najustreznejš farmacevtsko obliko, velikost pakiranja in jakost.
What Levetiracetam SUN is and what is it used for
Kaj je zdravilo Levetiracetam SUN in za kaj ga uporabljamo
You should not drive or use machines until it is established that your ability to perform such activities is not affected.
Ne smete voziti ali upravljati s stroji, dokler zdravilo ne ugotovljeno, da zdravilo ne vpliva na vašo sposobnost za izvajanje teh dejavnosti.
In vitro studies show that levetiracetam affects intraneuronal Ca2+ levels by partial inhibition of N-type Ca2+ currents and by reducing the release of Ca2+ from intraneuronal stores.
In vitro študije so pokazale, da levetiracetam vpliva na nivo Ca2+ znotraj nevrona preko delne inhibicije Ca2+ kanalčkov tipa N in zmanjšanjemsproščanja Ca2+ iz zalog znotraj nevrona.
Dose in adults and adolescents (from 16 years of age) When you will first start taking Levetiracetam SUN, your doctor will prescribe a lower dose for 2 weeks before adjusting the dose as necessary.
Odmerjanje pri odraslih in mladostnikih (od 16. leta starosti) Na začetku jemanja zdravila Levetiracetam SUN vam bo zdravnik, preden vam bo predpisal najmanjši običajni odmerek, za dva tedna predpisal manjši odmerek.
Adverse reactions reported in clinical studies (adults, adolescents, children and infants > 1 month) and from post-marketing experience are listed in the following table per System Organ Class and per frequency.
Neželeni učinki, o katerih so poročali v kliničnih študijah (odrasli, mladostniki otroci in dojenčki, starejši od 1 meseca) in v postmarketinškem obdobju, so navedeni v spodnji preglednici po organskih sistemih in pogostnosti.
What you need to know before you are given Levetiracetam SUN
Kaj morate vedeti, preden boste prejeli zdravilo Levetiracetam SUN
However, data suggested a 20% higher levetiracetam clearance in children taking enzyme-inducing antiepileptic medicinal products.
Vendar pa podatki nakazujejo, da je pri otrocih, ki jemljejo protiepileptična zdravila, ki inducirajo encime, povečan očistek levetiracetama za 20 %.
In man, an activity in both partial and generalised epilepsy conditions (epileptiform discharge/ photoparoxysmal response) has confirmed the broad spectrum pharmacological profile of levetiracetam.
Delovanje na parcialne in generalizirane epileptične napade (epileptiformno proženje/fotoparoksizmalen odgovor) potrjuje njegov širok spekter farmakološkega profila levetiracetama pri ljudeh.
Drug reaction with eosinophilia and systemic symptoms (DRESS), hypersensitivity (including angioedema and anaphylaxis)
Bolezni imunskega sistema reakcija na zdravilo z eozinofilijo in sistemskimi simptomi (DRESS), preobčutljivost (vključno z angioedemom in anafilakso)
The time independent pharmacokinetic profile of levetiracetam was also confirmed following 1500 mg intravenous infusion for 4 days with twice daily dosing.
Potrjen je bil tudi časovno neodvisen farmakokinetični profil levetiracetama pri intravenski infuziji 1500 mg dvakrat dnevno 4 dni.
Levetiracetam SUN is packed in colorless tubular glass vial (type I) with 20 mm grey bromobutyl rubber stopper sealed with white flip-top aluminum seal.
Levetiracetam SUN je pakiran v brezbarvnih steklenih vialah (tip I) z 20 mm sivimi bromobutilnimi gumijastimi zamaški, zapečatenih z belo aluminijasto/polipropilensko zaporko (flip top).
From a microbiological point of view, the product should be used immediately after dilution.
Z mikrobiološkega vidika je zdravilo treba uporabiti takoj po redčenju.
Levetiracetam SUN is for intravenous use.
Zdravilo Levetiracetam SUN je za intravensko uporabo.
Monotherapy for adults and adolescents from 16 years of age
Samostojno zdravljenje za odrasle in mladostnike od 16. leta starosti
If you have any symptoms of depression and/or thoughts about committing suicide, please contact your doctor.
Če imate kakršnekoli simptome depresije ali misli o samomoru ali oboje, se posvetujte z zdravnikom.
A retrospective assessment of pharmacokinetic interactions in children and adolescents with epilepsy (4 to 17 years) confirmed that adjunctive therapy with orally administered levetiracetam did not influence the steady-state serum concentrations of concomitantly administered carbamazepine and valproate.
Retrospektivna ocena o farmakokinetičnih interakcijah pri otrocih in mladostnikih z epilepsijo (od 4 do 17 let) je potrdila, da dopolnilna terapija s peroralno vzetim levetiracetamom ni vplivala na koncentracije v serumu v stanju dinamičnega ravnotežja pri sočasnem dajanju karbamazepina in valproata.
- A small number of people being treated with anti-epileptics such as Levetiracetam SUN have had thoughts of harming or killing themselves.
- pri majhnem številu bolnikov, ki so se zdravili z antiepileptiki kot je zdravilo Levetiracetam SUN, so se pojavile misli na samopoškodovanje ali samomor.
At 3600 mg/kg/day, in only one of the 2 EFD studies, there was a slight decrease in foetal weight associated with a marginal increase in skeletal variations/minor anomalies.
Pri 3.600 mg/kg/dan se je samo v eni od dveh študij embrio-fetalnega razvoja telesna masa plodu rahlo zmanjšala v povezavi z marginalnim povečanjem skeletnih sprememb/manjših anomalij.
The recommended dose must be diluted in at least 100 ml of a compatible diluent and infused over 15 minutes.
Priporočen odmerek se mora razredčiti v vsaj 100 ml kompatibilnega topila in infundirano15 minut.
(2) Following dialysis, a 250 to 500 mg supplemental dose is recommended.
Po dializi je priporočljiv dodatni odmerek od 250 do 500 mg.
If stopping treatment, as with other antiepileptic medicines, Levetiracetam SUN should be discontinued gradually to avoid an increase of seizures.
Če ste prenehali uporabljati zdravilo Levetiracetam SUN Tako kot pri vseh protiepileptičnih zdravilih je tudi pri zdravilu Levetiracetam SUN treba zdravljenje opustiti postopoma, da se število napadov ne bi povečalo.
In addition, it partially reverses the reductions in GABA- and glycine-gated currents induced by zinc and β-carbolines.
Poleg tega delno preprečuje inhibicijo GABA in glicinskih kanalčkov povzročeno z Zn2+ in β- karbolini.
Pre-marketing data from clinical studies conducted in adults indicate that levetiracetam did not influence the serum concentrations of existing antiepileptic medicinal products (phenytoin, carbamazepine, valproic acid, phenobarbital, lamotrigine, gabapentin and primidone) and that these antiepileptic medicinal products did not influence the pharmacokinetics of levetiracetam.
Podatki pred prihodom zdravila na tržišče, pridobljeni iz kliničnih študij izvedenih pri odraslih kažejo, da levetiracetam ne vpliva na serumsko koncentracijo drugih protiepileptičnih zdravil (fenitoina, karbamazepina, valprojske kisline, fenobarbitala, lamotrigina, gabapentina in primidona), in da ta protiepileptična zdravila ne vplivajo na farmakokinetiko levetiracetama.
What Levetiracetam SUN looks like and contents of the pack Levetiracetam SUN concentrate for solution for infusion (sterile concentrate) is a clear, colourless liquid.
Izgled zdravila Levetiracetam SUN in vsebina pakiranja Levetiracetam SUN koncentrat za raztopino za infundiranje (sterilni koncentrat) je bistra, brezbarvna, tekočina.
In use shelf life: from a microbiological point of view, the product should be used immediately after dilution.
Rok uporabnosti po redčenju: z mikrobiološkega vidika je zdravilo treba uporabiti takoj po redčenju.
Oral contraceptives and other pharmacokinetics interactions 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.
Peroralni kontraceptivi in druge farmakokinetične interakcije Levetiracetam v odmerku 1.000 mg na dan ni vplival na farmakokinetiko peroralnih kontraceptivov (etinilestradiola in levonorgestrela); endokrini parametri (luteinizirajoči hormon in progesteron) se niso spremenili.
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).
Če je treba zdravljenje z levetiracetamom prekiniti je priporočljivo zdravljenje opustiti postopno (npr. pri odraslih in mladostnikih, težkih več kot 50 kg: zmanjševanje odmerka za 500 mg dvakrat na dan na vsaka dva tedna do štiri tedne; pri otrocih in mladostnikih s telesno maso manj kot 50 kg: zmanjšanje odmerka ne sme preseči 10 mg/kg dvakrat na dan vsaka dva tedna.
Levetiracetam SUN concentrate is an alternative for patients when oral administration is temporarily not feasible.
Koncentrat zdravila Levetiracetam SUN je alternativa za bolnike, pri katerih peroralna uporaba začasno ni mogoča.
The dose level of 1800 mg/kg/day induced a marked maternal toxicity and a decrease in foetal weight associated with increased incidence of fetuses with cardiovascular/skeletal anomalies.
Odmerki 1.800 mg/kg/dan so sprožili izrazito toksičnost pri samicah in zmanjšanje telesne mase plodov, povezano s povečanjem pogostnosti zarodkov s kardiovaskularnimi/skeletnimi anomalijami.
The intravenous formulation is an alternative to the oral formulation.
Intravenska oblika je alternativa vaši peroralni uporabi.
INFORMATION IN BRAILLE Justification for not including Braille accepted
PODATKI V BRAILLOVI PISAVI Razlog za nedostopnost v Braillovi pisavi zaveden.
In the elderly, the half-life is increased by about 40 % (10 to 11 hours).
Zaradi zmanjšanega delovanja ledvic se pri starejših razpolovni čas podaljša za približno 40 % (10 do 11 ur) (glejte poglavje 4.2).
This medicinal product is for single use only, any unused solution should be discarded.
Zdravilo je samo za enkratno uporabo, neporabljeno raztopino je treba zavreči.
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 1000, 2000 or 3000 mg levetiracetam respectively and of 12.6% for patients on placebo.
Delež bolnikov iz zbranih analiz, pri katerih je bilo doseženo 50 ali več odstotno zmanjšanje pogostnosti parcialnih napadov na teden pri stalnem odmerku (12/14 tednov), je bil 27,7 % pri bolnikih, ki so prejemali 1.000 mg, 31,6 % pri bolnikih, ki so prejemali 2.000 mg in 41,3 % pri bolnikih, ki so prejemali 3.000 mg levetiracetama, ter 12,6 % pri bolnikih, ki so prejemali placebo.
Levetiracetam therapy can be initiated with either intravenous or oral administration.
Zdravljenje z zdravilom Levetiracetam lahko začnemo z intravensko ali peroralno uporabo.
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.
Vendar je na osnovi farmakokinetičnih značilnosti levetiracetama, farmakokinetike pri odraslih po intravenskem dajanju in farmakokinetike pri otrocih po peroralnem dajanju, pričakovati pri otrocih, od 4 do 12 let, podobno razpoložljivost (AUC) levetiracetama po intravenskem in peroralnem dajanju.
In adults, levetiracetam efficacy has been demonstrated in 3 double-blind, placebo-controlled studies at 1000 mg, 2000 mg, or 3000 mg/day, given in 2 divided doses, with a treatment duration of up to 18 weeks.
Pri odraslih je bila učinkovitost levetiracetama dokazana v 3 dvojno slepih, s placebom nadzorovanih študijah s 1.000 mg, 2.000 mg ali 3.000 mg/dan, razdeljenih na dva odmerka, ter s trajanjem zdravljenja do 18 tednov.
How to store Levetiracetam SUN Contents of the pack and other information
Shranjevanje Levetiracetama SUN Vsebina pakiranja in dodatne informacije
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).
Koncentrat zdravila Levetiracetam SUN je samo za intravensko uporabo, priporočeni odmerek mora biti razredčen v vsaj 100 ml kompatibilnega topila in uporabljen intravensko kot 15-minutna intravenska infuzija (glejte poglavje 6.6).
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.
Zaradi majhne uporabe zdravila levetiracetama za intravensko uporabo in bioekvivalence med peroralno in intravensko obliko se informacije o varnosti za zdravilo levetiracetama za intravensko uporabo navezujejo na zdravilo levetiracetama za peroralno uporabo.