natgillin/translations-raw huggingface dataset:
• severe allergic reactions (DRESS, anaphylactic reaction [severe and important allergic reaction], Quincke's oedema [swelling of the face, lips, tongue and throat]); 
• hude alergijske reakcije (DRESS), anafilaktična reakcija (resna in pomembna alergijska reakcija), Quinckov edem (otekanje obraza, ustnic, jezika in grla)
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 treba zdravilo uporabiti takoj po redčenju.
It is therefore recommended to adjust the maintenance daily dose of Matever, based on creatinine clearance in patients with moderate and severe renal impairment (see section 4.2). 
Zato je priporočljivo dnevni vzdrževalni odmerek levetiracetama pri bolnikih z zmerno in hudo ledvično okvaro prilagoditi očistku kreatinina (glejte poglavje 4.2).
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 
500 do 1500 mg dvakrat na dan 500 do 1000 mg dvakrat na dan 250 do 750 mg dvakrat na dan 250 do 500 mg dvakrat na dan 500 do 1000 mg enkrat na dan
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 omejene izpostavljenosti 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.
The dose level of 1800 mg/kg/day induced a marked maternal toxicity and a decrease in fetal weight associated with increased incidence of fetuses with cardiovascular/skeletal anomalies. 
Odmerki 1800 mg/kg/dan so sprožili izrazito toksičnost pri samicah in zmanjšanje telesne mase plodov, povezano s povečanjem pogostnosti zarodkov s kardiovaskularnimi/skeletnimi anomalijami.
Do not use this medicine after the expiry date which is stated on the vial and carton box after “EXP”. 
Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na viali in škatli poleg oznake ‘EXP'.
Results related to behavioural and emotional functioning indicated a worsening in levetiracetam treated patients on aggressive behavior 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 (CBCL - Achenbach Child Behavior Checklist).
This medicinal product contains 57.21 mg sodium per maximum single dose, equivalent to 2.86 % of the WHO recommended maximum daily intake of 2 g sodium for an adult. 
To zdravilo vsebuje 57,21 mg natrija na največji enkratni odmerek, kar je enako 2,86 % največjega dnevnega vnosa natrija za odrasle osebe, ki ga priporoča SZO in znaša 2 g.
Matever is indicated as adjunctive therapy 
Zdravilo Matever je indicirano za dopolnilno zdravljenje
CLcr (ml/min/1.73 m 2) = ---------------------------- x 1.73 BSA subject (m 
CLcr (ml/min/1,73 m 2) = ---------------------------- x 1,73 BSA bolnika (m
Add-on therapy for infants and children less than 4 years 
Dopolnilno zdravljenje za dojenčke in otroke, mlajše od 4 let
Aluminium/ PVC/PE/PVDC blister 
Aluminij/ PVC/PE/PVDC pretisni omot
• if you are allergic to levetiracetam, pyrrolidone derivatives or any of the other ingredients of this medicine (listed in section 6). 
• če ste alergični na levetiracetam, pirolidonske derivate ali katero koli sestavino tega zdravila (navedeno v poglavju 6).
If stopping treatment, as with other antiepileptic medicines, Matever should be discontinued gradually to avoid an increase of seizures. 
Če ste prenehali uporabljati zdravilo Matever Tako kot pri vseh protiepileptičnih zdravilih, je tudi pri zdravilu Matever treba zdravljenje opustiti postopoma, da se število napadov ne bi povečalo.
• decreased blood sodium concentration; 
• znižana koncentracija natrija v krvi
The safety and efficacy of Matever concentrate for solution for infusion in infants and children less than 4 years have not been established. 
Varnost in učinkovitost zdravila Matever, koncentrat za raztopino za infundiranje, pri dojenčkih in otrocih, mlajših od 4 let, nista bili dokazani.
For doctors and nurses, more detailed direction for the proper use of Matever is provided in section 
Za zdravnike in medicinske sestre so podrobna navodila za uporabo zdravila Matever navedena v poglavju 6.
Matever concentrate is an alternative for patients when oral administration is temporarily not feasible. 
Koncentrat zdravila Matever je alternativa za bolnike, pri katerihperoralna uporaba začasno ni mogoča.
Each film-coated tablet contains 3.8 mg lactose monohydrate. 
Ena filmsko obložena tableta vsebuje 3,8 mg laktoze monohidrata.
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. 
Predmarketinški podatki 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.
Do not use this medicine after the expiry date which is stated on the carton box and blister after “EXP”. 
Tega zdravila ne smete uporabljati po datumu izteka uporabnosti, ki je naveden na škatli in pretisnem omotu poleg oznake ‘EXP'.
Intermediate packaging containing 100 tablets for multipack of 200 (2 x 100) tablets [without Blue Box] 
Vmesno pakiranje, ki vsebuje 100 tablet, za skupno pakiranje z 200 (2 x 100) tabletami [BREZ PODATKOV ZA t.i.
Matever 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 Matever lahko oslabi vašo sposobnost vožnje ali upravljanja z orodjem ali stroji, saj lahko povzroči zaspanost.
Matever is for intravenous use. 
Zdravilo Matever je namenjeno intravenski aplikaciji.
The recommended dose must be diluted in at least 100 ml of a compatible diluent and infused over 15 minutes. 
Priporočljivo odmerjanje bo razredčeno v vsaj 100 ml kompatibilnega topila in infundirano 15 minut.
What Matever looks like and contents of the pack 
Izgled zdravila Matever in vsebina pakiranja
Hypersensitivity to the active substance or other pyrrolidone derivatives or to any of the excipients listed in section 6.1. 
Preobčutljivost na učinkovino ali druge pirolidonske derivate ali katerokoli pomožno snov, navedeno v poglavju 6.1.
Do not take Matever 
Ne jemljite zdravila Matever
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). 
Pri odraslih in otrocih so ugotovili pomembno povezavo med koncentracijo v plazmi in slini (razmerje koncentracij slina/plazma se giblje med 1 in 1,7 za tableto in za peroralno raztopino 4 ure po odmerku).
• 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]) 
• gripi podobne simptome in izpuščaj na obrazu, ki se v nadaljevanju razširi in ga spremlja visoka temperatura, zvišane vrednosti jetrnih encimov pri krvnih testih in povečanje števila določenega tipa belih krvnih celic (eozinofilija) ter povečane bezgavke (reakcija na zdravilo z eozinofilijo in sistemskimi simptomi [DRESS])
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. 
Začetni odmerek za otroke in mladostnike do 25 kg je 250 mg dvakrat na dan, največji odmerek pa 750 mg dvakrat na dan.
Do not take macrogol (a medicine used as laxative) for one hour before and one hour after taking levetiracetam as this may results in a reduction of its effect. 
Ne vzemite makrogola (učinkovine, ki se uporablja kot odvajalo) eno uro pred in eno uro po jemanju levetiracetama, saj lahko zmanjša učinek zdravila.
Vial of 5 ml 
Viala po 5 ml
In addition, 101 infants aged less than 12 months have been exposed in a post authorization safety study. 
Dodatno so v študijo o varnosti zdravila po pridobitvi dovoljenja za promet z zdravilom vključil 101 dojenčka, mlajšega od 12 mesecev.
A peri- and post-natal development study was performed in rats with levetiracetam doses of 70, 350 and 1800 mg/kg/day. 
Peri- in postnatalno študijo razvoja so izvedli pri podganah z odmerki levetiracetama po 70, 350 in 1800 mg/kg/dan.
See Table 1 for the recommended preparation and administration of Matever concentrate to achieve a total daily dose of 500 mg, 1000 mg, 2000 mg, or 3000 mg in two divided doses. 
Glejte Tabelo 1 za priporočeno pripravo in uporabo koncentrata zdravila Matever, da se doseže celokupni dnevni odmerek 500 mg, 1000 mg, 2000 mg ali 3000 mg razdeljen na dva odmerka.
Conversion to or from oral to intravenous administration can be done directly without titration. 
Prehod s peroralnega na intravensko dajanje ali obratno je lahko storjen neposredno, brez titracije.
Matever tablets are packaged in blister packs supplied in cardboard boxes containing: 
Zdravilo Matever tablete je na voljo v pretisnih omotih, ki so pakirani v škatle po:
(impaired coordinated movements), paraesthesia (tingling), disturbance in attention (loss of concentration); 
(motena usklajenost mišičnih gibov), parestezija (mravljinčenje), motnje pozornosti (izguba
White opaque PVC/PE/PVDC-Aluminium foil blister in cardboard boxes. 
Bel neprosojni pretisni omot iz PVC/PE/PVDC in aluminijaste folije v kartonski škatlici.
Clear, colourless concentrate. 
bister, brezbarven koncentrat
Two embryo-fetal development (EFD) studies were performed in rats at 400, 1200 and 3600 mg/kg/day. 
Dve študiji embrio-fetalnega razvoja pri podganah so izvedli z odmerki 400, 1200 in 3600 mg/kg/dan.
Pharmathen S.A., 6 Dervenakion Str., 15351 Pallini, Attiki, Greece 
Pharmathen S.A, 6 Dervenakion Str., 15351 Pallini, Attiki, Grčija
The intravenous administration of doses up to 4000 mg diluted in 100 ml of 0.9 % sodium chloride infused over 15 minutes and doses up to 2500 mg diluted in 100 ml of 0.9 % sodium chloride infused over 5 minutes was evaluated. 
Ovrednotena je bila intravenska uporaba odmerkov do 4000 mg, razredčenih v 100 ml 0,9 % natrijevega klorida, infundiranih 15 minut in odmerkov do 2500 mg, razredčenih v 100 ml 0,9 % natrijevega klorida, infundiranih 5 minut.
There is no experience with administration of intravenous levetiracetam for longer period than 4 days. 
Trajanje zdravljenja • Ni izkušenj z intravensko uporabo levetiracetama za obdobje, daljše od 4 dni.
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. 
Neželeni učinki, ki jih niso opazili v kliničnih študijah, opazili pa so jih v študijah pri podganah in v manjši meri pri miših (pri stopnjah izpostavljenosti, ki so bile podobne stopnjam klinične izpostavljenosti) ter imajo možen pomen za klinično uporabo, so naslednji: jetrne spremembe, ki kažejo na prilagoditveni odgovor, kot so povečanje mase jeter in centrolobularna hipertrofija, maščobna infiltracija in zvišanje jetrnih encimov v plazmi.
Efficacy of levetiracetam as monotherapy was established in a double-blind, parallel group, noninferiority comparison to carbamazepine controlled release (CR) in 576 patients 16 years of age or older with newly or recently diagnosed epilepsy. 
Učinkovitost levetiracetama za samostojno zdravljenje je bila dokazana, v dvojno slepi študiji z vzporednimi skupinami, ki dokazuje da levetiracetam po učinkovitosti ni nič slabši od karbamazepina z nadzorovanim sproščanjem (CR), pri 576 bolnikih, starih 16 let ali več, z na novo ali nedavno diagnosticirano epilepsijo.
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.
In this study, levetiracetam dose was 3000 mg/day for adults and adolescents or 60 mg/kg/day for children, given in 2 divided doses. 
V tej študiji je bil odmerek levetiracetama za odrasle in mladostnike 3000 mg na dan, za otroke pa 60 mg/kg/dan, razdeljen na dva odmerka.
The active substance, levetiracetam, is a pyrrolidone derivative (S-enantiomer of α-ethyl-2-oxo-1pyrrolidine acetamide), chemically unrelated to existing antiepileptic active substances. 
Učinkovina levetiracetam je pirolidonski derivat (S-enantiomer -etil-2-okso-1- pirolidinacetamida), ki kemično ni podoben drugim protiepileptičnim učinkovinam.
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. 
Enkratni odmerek 1500 mg levetiracetama, razredčen v 100 ml kompatibilnega topila in 15 minut intravensko infundiran, je bioekvivalenten 1500 mg peroralnega levetiracetama, to so 3 tablete po 500 mg.
Then CLcr is adjusted for body surface area (BSA) as follows: 
CLcr je prilagojen na telesno površino (BSA-body surface area) na sledeč način: CLcr (ml/min)
Preparation and administration of Matever concentrate 
Preglednica 1: Priprava in uporaba koncentrata zdravila Matever
If stopping treatment Matever should be discontinued gradually to avoid an increase of seizures. 
Pri zdravilu Matever je treba zdravljenje opustiti postopoma, da se število napadov ne bi povečalo.
Name and address of the manufacturer responsible for batch release 
Ime in naslov izdelovalca (izdelovalcev), odgovornega (odgovornih) za sproščanje serij Pharmathen S.A.
If you stop taking Matever 
Če ste prenehali jemati zdravilo Matever
One vial of Matever concentrate contains 500 mg levetiracetam (5 ml concentrate of 100 mg/ml). 
Ena viala koncentrata zdravila Matever vsebuje 500 mg levetiracetama (5 ml koncentrata po 100 mg/ml).
Matever concentrate is an alternative for patients when administration of the antiepileptic oral Matever medicine is temporarily not feasible. 
Zdravilo Matever koncentrat za raztopino za infundiranje je alternativa za bolnike, ko uporaba peroralnega protiepileptičnega zdravila Matever začasno ni mogoča.
Read all of this leaflet carefully before you or your child start using this medicine because it contains important information for you. 
Pred začetkom uporabe zdravila natančno preberite navodilo, ker vsebuje za vas pomembne podatke!
•Lactated Ringer's injection 
• injekcija Ringerjeve raztopine z laktatom
In vitro studies show that levetiracetam affects intraneuronal Ca 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 Ca znotraj nevrona preko delne inhibicije Ca kanalčkov tipa N in zmanjšanjem sproščanja Ca iz zalog znotraj nevrona.
No new safety concerns for levetiracetam were identified for infants less than 12 months of age with epilepsy. 
Pri dojenčkih, mlajših od 12 mesecev ni bil ugotovoljen noben nov zadržek glede varnosti levetiracetama.
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. 
Bolniki so randomizirano prejemali 400-1200 mg karbamazepina z nadzorovanim sproščanjem (CR) na dan ali 1000-3000 mg levetiracetama na dan, trajanje zdravljenja pa je bilo do 121 tednov odvisno od odziva.
10 vials of concentrate for solution for infusion 
10 vial koncentrata za raztopino za infundiranje
Read all of this leaflet carefully before you or your child start taking this medicine because it contains important information for you. 
Pred začetkom jemanja zdravila natančno preberite navodilo ker vsebuje za vas pomembne podatke!
Matever concentrate 5 ml vial is packed in a cardboard box of 10 vials. 
5 ml viale koncentrata zdravila Matever so pakirane v škatle po 10 skupaj.
Four embryo-fetal development studies were performed in rabbits covering doses of 200, 600, 800, 1200 and 1800 mg/kg/day. 
Štiri študije embrio-fetalnega razvoja pri kuncih so izvedli z odmerki 200, 600, 800, 1200 in 1800 mg/kg/dan.
• amnesia (loss of memory),memory impairment (forgetfulness), abnormal coordination/ataxia 
• amnezija (izguba spomina), oslabljen spomin (pozabljivost), poslabšana koordinacija/ataksija
Tablet core: calcium hydrogen phosphate dihydrate, cellulose microcrystalline, crospovidone type A, hydroxypropylcellulose (L). 
Jedro tablete: kalcijev hidrogenfosfat dihidrat, mikrokristalna celuloza, krospovidon (vrsta A), hidroksipropilceluloza (L)
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).
MARKETING AUTHORISATION NUMBER(S) EU/1/11/711/014 
ŠTEVILKA (ŠTEVILKE) DOVOLJENJA (DOVOLJENJ) ZA PROMET Z ZDRAVILOM EU/1/11/711/030
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. 
Odmerjanje pri otrocih (od 4 do 11 let) in mladostnikih (od 12 do 17 let), lažjih od 50 kg: Običajni odmerek: med 20 mg na kg telesne mase in 60 mg na kg telesne mase na dan.
• skin rash, which may form blisters and looks like small targets (central dark spots surrounded by a paler area, with a dark ring around the edge) (erythema multiforme), a widespread rash with blisters and peeling skin, particularly around the mouth, nose, eyes and genitals (StevensJohnson syndrome), and a more severe form causing skin peeling in more than 30% of the body surface (toxic epidermal necrolysis); 
• kožni izpuščaj, ki lahko tvori mehurčke in po videzu spominja na majhne tarče (na sredini temne pike, obkrožene s svetlejšim delom in s temnim krogom na robu) (multiformni eritem), široko razširjen izpuščaj z mehurčki in luščenjem kože, še posebej okoli ust, nosu, oči in v predelu spolovil (Stevens-Johnsonov sindrom) in hujša oblika, ki povzroči luščenje kože na več kot 30 % telesne površine (toksična epidermalna nekroliza).
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 Zn in β- karbolini.
1500 mg twice daily Children 25 kg or less should preferably start the treatment with levetiracetam 100 mg/ml oral solution. 
Pri otrocih s telesno maso 25 kg ali manj, je bolje začeti zdravljenje z levetiracetamom 100 mg/ml peroralno raztopino.
The other ingredients are: sodium acetate trihydrate, glacial acetic acid, sodium chloride, water for injections. 
- Druge sestavine zdravila so: natrijev acetat trihidrat, koncentrirana ocetna kislina, natrijev klorid, voda za injekcije.
This includes any possible side effects not listed in this leaflet. 
Posvetujte se tudi, če opazite katere koli neželene učinke, ki niso niso navedeni v tem navodilu.
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). 
Če je treba zdravljenje z levetiracetamom prekiniti, je skladno s trenutno klinično prakso priporočljivo zdravljenje opustiti postopno (npr. pri odraslih in mladostnikih s telesno maso več kot 50 kg: zmanjševanje odmerka za 500 mg dvakrat na dan na vsaka dva tedna do štiri tedne; pri dojenčkih, starejših od 6 mesecev, otrocih in mladostnikih s telesno maso manj kot 50 kg: zmanjšanje odmerka ne sme preseči 10 mg/kg dvakrat na dan vsaka dva tedna; pri dojenčkih (mlajših od 6 mesecev): zmanjšanje odmerka ne sme preseči 7 mg/kg dvakrat na dan vsaka dva tedna).
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. 
Pri otrocih, starejših od 6 let, je treba uporabiti levetiracetam v obliki peroralne raztopine pri odmerkih, manjših od 250 mg, pri odmerkih, večjih od 250 mg, pri katerih priporočljivega odmerjanja ni mogoče doseči z jemanjem več tablet in pri bolnikih, ki ne morejo požirati tablet.
Children (4 to 12 years) 
Pediatrična populacija Otroci (od 4 do 12 let)
A double-blind, placebo-controlled paediatric safety study with a non-inferiority design has assessed the cognitive and neuropsychological effects of levetiracetam in children 4 to 16 years of age with partial onset seizures. 
Dvojno slepa, s placebom nadzorovana pediatrična študija o varnosti z modelom o enakovrednosti zdravljenja je pokazala kognitivne in nevropsihološke učinke zdravila Levetiracetama, pri pediatričnih bolnikih, starih od 4 do 16 let s parcialnimi napadi.
Dose in children 50 kg or greater is the same as in adults. 
Pri otrocih s telesno maso 50 kg ali več je odmerjanje enako kot pri odraslih.
CLcr (ml/min)= ----------------------------------------- (x 0.85 for women) 72 x serum creatinine (mg/dl) 
[140 - starost (leta)] x masa (kg) CLcr (ml/min) = ------------------------------------------------------------- (x 0,85 za ženske) 72 x koncentracija kreatinina v serumu (mg/dl)