natgillin/translations-raw huggingface dataset:
First Opening:
Prvo odprtje:
Date of first authorisation: 26 August 2011 Date of latest renewal: 28 April 2016
Datum prve odobritve: 26. avgust 2011 Datum zadnjega podaljšanja: 28. april 2016
The tablets can be divided into equal halves.
Tablete se lahko delijo na enake polovice.
Then CLcr is adjusted for body surface area (BSA) as follows:
CLcr je prilagojen na telesno površino (BSA-»body surface area«) na sledeč način:
• Close the bottle with the plastic screw cap after every usage.
• Zaprite steklenico s plastično navojno zaporko po vsaki uporabi.
Component of a multipack, can't be sold separately
Del skupnega pakiranja, ni mogoče prodati ločeno.
For this the piston must be completely pushed into the syringe
Za to mora biti bat do konca pritisnjen v brizgo
Do not use after 4 months of first opening the bottle.
Ne uporabljajte več kot 4 mesece po prvem odprtju steklenice.
This decrease is more pronounced during the third trimester (up to 60 % of baseline concentration before pregnancy).
To zmanjšanje koncentracije je bolj izrazito v tretjem trimesečju (do 60 % glede na običajno koncentracijo pred nosečnostjo).
6-48 months
6-48 mesecev
Levetiracetam ratiopharm must be taken twice a day, once in the morning and once in the evening, at about the same time each day.
Zdravilo Levetiracetam ratiopharm morate jemati dvakrat na dan, enkrat zjutraj in enkrat zvečer, vsak dan ob približno istem času.
Physiological changes during pregnancy may affect levetiracetam concentration.
Fiziološke spremembe med nosečnostjo vplivajo na koncentracijo levetiracetama.
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 vi ali vaš otrok natančno preberite navodilo, ker vsebuje za vas pomembne podatke!
• Take the syringe and put it in the opening of the bottle.
• Vzemite brizgo in jo dajte v odprtino steklenice.
He/she may decide if your dose should be adjusted.
Le ta se odloči, če je vaš odmerek potrebno prilagoditi.
• Remove the filled syringe from the bottle (figure ).
• Odstranite napolnjeno brizgo iz steklenice (slika ).
EXP Do not use after 4 months of first opening the bottle.
EXP Ne uporabljajte več kot 4 mesece po prvem odprtju steklenice.
Levetiracetam ratiopharm may impair your ability to drive or operate any tools or machinery, as it may make you feel sleepy.
Zdravilo Levetiracetam ratiopharm lahko oslabi vašo sposobnost vožnje ali upravljanja z orodjem ali stroji, saj lahko povzroči zaspanost.
1-6 months
1-6 mesecev
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 potrjeno, da zdravilo ne vpliva na njihovo sposobnost izvajanja teh dejavnosti.
This medicine contains 1.2 mmol (or 46.65 mg) potassium per 15 ml.
To zdravilo vsebuje 1,2 mmol (ali 46,65 mg) kalija na 15 ml.
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 ni potrjeno, da zdravilo ne vpliva na vašo sposobnost izvajanja teh dejavnosti.
• Fill the syringe with the liquid by pulling the piston to the graduation mark corresponding to the quantity in millilitre (ml) prescribed by your doctor.
• Napolnite brizgo s tekočino, tako da vlečete bat navzdol do oznake, ki ustreza količini v mililitrih (ml), ki vam jo je predpisal zdravnik.
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.
• A small number of people being treated with anti-epileptics such as Levetiracetam ratiopharm have had thoughts of harming or killing themselves.
• pri majhnem številu bolnikov, ki so se zdravili z antiepileptiki kot je zdravilo Levetiracetam ratiopharm, so se pojavile misli na samopoškodovanje ali samomor.
• Move bottle and the filled syringe back in starting position.
• Postavite steklenico in napolnjeno brizgo nazaj v začetni položaj.
• If bubbles occur push the piston into the syringe again and fill the syringe once more slowly.
• Če se v brizgi pojavijo mehurčki ponovno potisnite bat v brizgo in nato počasneje ponovno napolnite brizgo.
You may take Levetiracetam ratiopharm with or without food.
Levetiracetam ratiopharm lahko vzamete s hrano ali brez nje.
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 zmanjšanjem sproščanja Ca2+ iz zalog znotraj nevrona.
ks= 0.45 in Term infants to 1 year old; ks= 0.55 in Children to less than 13 years and in adolescent female; ks= 0.7 in adolescent male
ks = 0,45 pri dojenčkih do 1 leta starosti; ks = 0,55 pri otrocih, mlajših od 13 let in pri mladostnicah; ks = 0,7 pri mladostnikih moškega spola
Results related to behavioural and emotional functioning indicated a worsening in levetiracetam treated patients on aggressive behaviour as measured in a standardised 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).
[140-age (years)] x weight (kg)
[140-starost (leta)] x masa (kg)
For adults and children aged 4 years and older.
Za odrasle in otroke, stare 4 leta in starejše.
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).
Clear liquid.
Bistra tekočina.
• uncontrollable muscle spasms affecting the head, torso and limbs, difficulty in controlling movements, hyperkinesia (hyperactivity);
• nekontrolirani mišični spazmi, ki prizadenejo glavo, trup in okončine, težave pri nadzoru gibanja, hiperkinezija (hiperaktivnost)
• severe allergic reactions (DRESS, anaphylactic reaction [severe and important allergic reaction],
• hude alergijske reakcije (DRESS anafilaktična reakcija [huda in pomembna alergijska reakcija],
• Empty the contents of the syringe in a glass of water by pushing the piston into the syringe (figure ).
• Brizgo spraznite v kozarec vode tako, da potisnete bat v brizgo (slika ).
(1) Children 25 kg or less should preferably start the treatment with Levetiracetam ratiopharm
(1) Pri otrocih, težkih 20 kg ali manj, je boljše začeti zdravljenje z zdravilom Levetiracetam ratiopharm
You should continue Levetiracetam ratiopharm treatment for as long as your doctor has told you.
Zdravljenje z zdravilom Levetiracetam ratiopharm morate nadaljevati tako dolgo, kot vam je naročil zdravnik.
4+ years
4+ leta
This medicine contains less than 1 mmol sodium (23 mg) per 15 ml that is to say essentially ‘sodiumfree'.
To zdravilo vsebuje manj kot 1 mmol (23 mg) natrija na 15 ml, kar v bistvu pomeni ‘brez natrija'.
When you will first start taking Levetiracetam ratiopharm, your doctor will prescribe you a lower dose during 2 weeks before giving you the lowest general dose.
Na začetku jemanja zdravila Levetiracetam ratiopharm vam bo zdravnik, preden vam bo predpisal najmanjši splošen odmerek, za dva tedna predpisal manjši odmerek.
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 katerokoli pomožno snov, navedeno v poglavju 6.1.
Should your doctor decide to stop your Levetiracetam ratiopharm treatment, he/she will instruct you about the gradual withdrawal of Levetiracetam ratiopharm.
Če se bo vaš zdravnik odločil za prekinitev zdravljenja z zdravilom Levetiracetam ratiopharm, vam bo dal napotke o postopni ukinitvi zdravila Levetiracetam ratiopharm.
• Levetiracetam ratiopharm is used as a chronic treatment.
• Zdravilo Levetiracetam ratiopharm se uporablja za kronično zdravljenje.
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.
Antiepileptiki Predmarketinški podatki iz kliničnih študij, izvedenih pri odraslih kažejo, da levetiracetam ne vpliva na serumsko koncentracijo ostalih protiepileptičnih zdravil (fenitoina, karbamazepina, valprojske kisline, fenobarbitala, lamotrigina, gabapentina in primidona), in da ta protiepileptična zdravila ne vplivajo na farmakokinetiko levetiracetama.
Name and address of the manufacturers responsible for batch release
Ime in naslov izdelovalcev, odgovornih za sproščanje serij Merckle GmbH
Dose recommendations for infants from 6 months of age, children and adolescents:
Priporočeno odmerjanje za dojenčke od 6. meseca starosti, otroke in mladostnike:
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 ravnovesja pri sočasnem dajanju karbamazepina in valproata.
• You can read the corresponding millilitre at the beginning of the thicker part of the piston figure
• Ustrezno količino v mililitrih lahko preberete na začetku odebeljenega dela brizge (slika ).
Two embryo-foetal 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.
What you need to know before you take Levetiracetam ratiopharm Do not take Levetiracetam ratiopharm
Kaj morate vedeti, preden boste vzeli zdravilo Levetiracetam ratiopharm Ne jemljite zdravila Levetiracetam ratiopharm
In addition, the available dose strengths of the tablets are not appropriate for initial treatment in children weighing less than 25 kg, for patients unable to swallow tablets or for the administration of doses below 125 mg.
Prav tako jakosti tablet, ki so na voljo, niso primerne za doseganje začetnega odmerka pri otrocih, ki so težki do 25 kg, za uporabo pri bolnikih, ki ne morejo pogoltniti tablet ali za dajanje odmerkov nižjih od 125 mg.
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 1000 mg, 31,6 % pri bolnikih, ki so prejemali 2000 mg in 41,3 % pri bolnikih, ki so prejemali 3000 mg levetiracetama, ter 12,6 % pri bolnikih, ki so prejemali placebo.
Do not use this medicine after the expiry date stated on the cardboard box and bottle after EXP.
Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli in steklenici poleg oznake EXP.
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
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).
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 kanalčov povzročeno z Zn2+ in β- karbolini.
(2) Dose in children and adolescents 50 kg or more is the same as in adults.
(2) Pri otrocih in mladostnikih, težkih 50 kg ali več, je odmerjanje enako kot pri odraslih.
What Levetiracetam ratiopharm is and what it is used for What you need to know before you take Levetiracetam ratiopharm How to take Levetiracetam ratiopharm Possible side effects
Kaj je zdravilo Levetiracetam ratiopharm in za kaj ga uporabljamo Kaj morate vedeti, preden boste vzeli zdravilo Levetiracetam ratiopharm Kako jemati zdravilo Levetiracetam ratiopharm
The active substance, levetiracetam, is a pyrrolidone derivative (S-enantiomer of α-ethyl-2-oxo-1pyrrolidine acetamide), chemically unrelated to existing antiepileptic active substances.
Zdravilna učinkovina levetiracetam je pirolidonski derivat (S-enantiomer α-etil-2-okso-1pirolidinacetamida), ki kemično ni podoben drugim protiepileptičnim učinkovinam.
However, data suggested a 20 % higher levetiracetam clearance in children taking enzymeinducing antiepileptic medicinal products.
Vendar pa podatki nakazujejo, da je pri otrocih, ki jemljejo protiepileptična zdravila, ki inducirajo encime, povečan očistek levetiracetama za 20 %.
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 3600 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.
• Open the bottle: press the cap and turn it anticlockwise.
• Odprite steklenico: pritisnite zaporko in jo obrnite v nasprotni smeri urinega kazalca.
Levetiracetam and related analogs show a rank order of affinity for binding to the synaptic vesicle protein 2A which correlates with the potency of their anti-seizure protection in the mouse audiogenic model of epilepsy.
Levetiracetam in sorodni analogi kažejo vrstni red afinitetne za vezavo na sinaptični vezikularni protein 2A, ki korelira z jakostjo protiepileptične zaščite pri mišjem audiogenem modelu epilepsije.
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 pokazali pomembno povezavo med koncentracijo v plazmi in slini (razmerje koncentracij v slini/plazmi se giblje med 1 in 1,7 za tableto in za peroralno raztopino 4 ure po odmerku).
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.
Levetiracetam v odmerku 1000 mg na dan ni vplival na farmakokinetiko peroralnih kontraceptivov (etinilestradiola in levonorgestrela); endokrini parametri (luteinizirajoči hormon in progesteron) se niso spremenili.
What Levetiracetam ratiopharm is and what it is used for
Kaj je zdravilo Levetiracetam ratiopharm in za kaj ga uporabljamo
Germany e-mail: info@ratiopharm.de
Nemčija info@ratiopharm.de
Swallow Levetiracetam ratiopharm film-coated tablets with a sufficient quantity of liquid (e.g. a glass of water).
Tablete zdravila Levetiracetam ratiopharm zaužijte z dovolj tekočine (npr. s kozarcem vode).
When you will first start taking Levetiracetam ratiopharm, your doctor will prescribe you a lower dose (500 mg each day) during 2 weeks before giving you the lowest general dose of 1000 mg.
Na začetku jemanja zdravila Levetiracetam ratiopharm vam bo zdravnik, preden vam bo predpisal najnižji splošen odmerek 1000 mg, za dva tedna predpisal nižji odmerek (500 mg vsak dan).
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 400-1.200 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.
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.
Osnovno merilo učinkovitosti je bila stopnja odziva (odstotek bolnikov z ≥ 50 % znižanjem povprečnih pogostosti parcialnih napadov na dan glede na začetne vrednosti), ki jo je na 48-urnem EEG posnetku določil ocenjevalec, ki ni vedel kdo je prejemal placebo in kdo zdravilo.
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 1000 mg, 2000 mg ali 3000 mg/dan, razdeljenih na dva odmerka, ter s trajanjem zdravljenja do 18 tednov.
Finished product: 36 months After first opening: 4 months
Končni izdelek: 36 mesecev.
To take as follows: [Box for the prescription dose]
Uporabljajte v skladu s spodnjimi navodili: [Polje za predpisovanje odmerkov]
This presentation should be prescribed for children aged 4 years and older, adolescents and adults.
To pakiranje predpišemo otrokom starejšim od 4 let, mladostnikom in odraslim.
For children aged 6 months to less than 4 years.
Za otroke, stare od 6 mesecev do manj kot 4 leta.
Following single dose administration (20 mg/kg) of a 100 mg/ml oral solution to epileptic children (1 month to 4 years), levetiracetam was rapidly absorbed and peak plasma concentrations were observed approximately 1 hour after dosing.
Po uporabi posamičnega odmerka (20 mg/kg) 100 mg/ml peroralne raztopine pri otrocih z epilepsijo (od 1 meseca do 4 let) se je levetiracetam hitro absorbiral in plazemska koncentracija je bila dosežena približno 1 uro po odmerku.
72.2 % of the levetiracetam treated patients and 45.2 % of the patients on placebo had a 50 % or greater decrease in the frequency of PGTC seizures per week.
Pri 72,2 % bolnikov, ki so se zdravili z levetiracetamom, in 45,2 % bolnikov, ki so prejemali placebo, je bilo 50 ali več odstotno zmanjšanje pogostnosti PGTC napadov na teden.
General dose: between 1000 mg and 3,000 mg each day.
Splošen odmerek: med 1000 mg in 3000 mg na dan.
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 1800 mg/kg/dan so sprožili izrazito toksičnost pri samicah in zmanjšanje telesne mase plodov, povezano s povečanjem pogostnosti zarodkov s kardiovaskularnimi/skeletnimi anomalijami.
CLcr (ml/min) = ----------------------------------------- (x 0.85 for women) 72 x serum creatinine (mg/dl)
CLcr (ml/min) = ----------------------------------------------------------- (x 0.85 za ženske) 72 x koncentracija kreatinina v serumu (mg/dl)
• Hold bottle and syringe securely tight.
• Varno držite steklenico in brizgo.
• depression, hostility or aggression, anxiety, insomnia, nervousness or irritability;
• depresija, sovražnost ali agresivnost, tesnoba, nespečnost, živčnost ali razdražljivost
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, težkih 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).
Contents of the pack and other information What Levetiracetam ratiopharm contains
Vsebina pakiranja in dodatne informacije Kaj vsebuje zdravilo Levetiracetam ratiopharm
EXP See outer carton
EXP Glejte zunanjo ovojnino.
• in the treatment of partial onset seizures with or without secondary generalisation in adults, adolescents, children and infants from 1 month of age with epilepsy.
• parcialnih napadov s sekundarno generalizacijo ali brez nje pri odraslih, mladostnikih, otrocih in dojenčkih od 1 meseca starosti, z epilepsijo.
• Wash the syringe afterwards with clear water by filling and emptying the syringe repeatedly.
• Sperite brizgo z vodo, tako da jo večkrat napolnite in izpraznite.
PARTICULARS TO APPEAR ON THE OUTER PACKAGING Multipack Carton for blister packs- without the Blue Box
PODATKI NA ZUNANJI OVOJNINI Zunanja ovojnina (skupno pakiranje) za pretisne omote - brez Blue Box-a
Each ml contains 1.4 mg methyl parahydroxybenzoate (E 218), 0.27 mg propyl parahydroxybenzoate (E 216) and 3.1 mg potassium.
En mililiter vsebuje 1.4 mg metilparahidroksibenzoata (E218), 0.27 mg propilparahidroksibenzoata (E216) in 3.1 mg kalija.
The CLcr in ml/min may be estimated from serum creatinine (mg/dl) determination, for adults and adolescents weighting 50 kg or more, the following formula:
CLcr v ml/min je pri odraslih in mladostnikih, s telesno maso 50 kg in več, mogoče oceniti iz koncentracije kreatinina v serumu (mg/dl) po formuli:
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.
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 levetiracetama, pri pediatričnih bolnikih, starih od 4 do 16 let, s parcialnimi napadi.
Tablet core: Macrogol 6000, Colloidal anhydrous silica, Crospovidone, Cellulose powdered, Magnesium stearate.
Jedro tablete: makrogol 6000, brezvodni, koloidni silicijev dioksid, krospovidon, uprašena celuloza, magnezijev stearat.
Levetiracetam ratiopharm is indicated as adjunctive therapy
Zdravilo Levetiracetam ratiopharm je indicirano za dopolnilno zdravljenje
Four embryo-foetal 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