FrancophonIA/ELRC3.0 huggingface dataset:
English: In children and adolescents aged 4 to 16 years, vomiting (very common, 11.2 %), agitation (common, 3.4 %), mood swings (common, 2.1 %), affect lability (common, 1.7 %), aggression (common, 8.2 %), abnormal behaviour (common, 5.6 %), and lethargy (common, 3.9%) were reported more frequently than in other age ranges or in the overall safety profile.
Slovenian: Pogosteje kot v drugih starostnih skupinah ali v skupnem varnostnem profilu so pri otrocih in mladostnikih, starih od 4 do 16 let, poročali o bruhanju (zelo pogosto, 11,2 %), agitaciji (pogosto, 3,4 %), nihanjih razpoloženja (pogosto, 2,1 %), čustveni labilnosti (pogosto, 1,7 %), agresiji (pogosto, 8,2 %), nenormalnem vedenju (pogosto, 5,6 %) in letargiji (pogosto, 3,9 %).
English: 60 mg (0.6 ml) twice daily 180 mg (1.8 ml) twice daily
Slovenian: 60 mg (0,6 ml) dvakrat na dan 180 mg (1,8 ml)dvakrat na dan
English: How to store Levetiracetam ratiopharm Contents of the pack and other information
Slovenian: 5 Shranjevanje zdravila Levetiracetam ratiopharm Vsebina pakiranja in dodatne informacije
English: 100 film-coated tablets
Slovenian: 60 filmsko obloženih tablet
English: 35 mg (0.35 ml) twice daily 105 mg (1.05 ml) twice daily
Slovenian: 35 mg (0.35 ml) dvakrat na dan 105 mg (1.05 ml) dvakrat na dan
English: In all of the above cases Levetiracetam ratiopharm 100 mg/ml oral solution should be used.
Slovenian: V vseh zgoraj naštetih primerih se priporoča uporaba peroralne raztopine Levetiracetam ratiopharm 100 mg/ml.
English: Dosing adjustment for infants, children and adolescents patients weighing less than 50 kg with impaired renal function:
Slovenian: Prilagoditev odmerjanja pri dojenčkih, otrocih in mladostnikih s telesno maso, manjšo kot 50 kg, z okvarjenim delovanjem ledvic.
English: The possible side effects of an overdose of Levetiracetam ratiopharm are sleepiness, agitation, aggression, decrease of alertness, inhibition of breathing and coma.
Slovenian: Če ste vzeli večji odmerek zdravila Levetiracetam ratiopharm, kot bi smeli Možni neželeni učinki pri prevelikem odmerjanju zdravila Levetiracetam ratiopharm so zaspanost, agitacija (motorični nemir), agresivnost, zmanjšana budnost, upočasnitev dihanja in koma.
English: If you stop taking Levetiracetam ratiopharm
Slovenian: Če ste prenehali jemati zdravilo Levetiracetam ratiopharm
English: General dose: Levetiracetam ratiopharm is taken twice daily, in two equally divided doses, each individual dose being measured between 0.1 ml (10 mg) and 0.3 ml (30 mg), per kg bodyweight of the child. (see table below for dose examples).
Slovenian: Običajni odmerek: zdravilo Levetiracetam ratiopharm se jemlje dvakrat na dan v dveh enakih odmerkih, pri čemer vsak posamezni odmerek znaša od 0,1 ml (10 mg) do 0,3 ml (30 mg) na kg telesne mase otroka (za primere odmerkov glejte spodnjo preglednico).
English: Add-on therapy for infants aged from 1 month to less than 6 months
Slovenian: Dopolnilno zdravljenje za dojenčke, stare od 1 do manj kot 6 mesecev
English: For children 6 years and above, Levetiracetam ratiopharm 100 mg/ml oral solution should be used for doses under 125 mg, for doses not multiple of 125 mg when dosing recommendation is not achievable by taking multiple tablets and for patients unable to swallow tablets.
Slovenian: Za otroke, stare 6 let in več, se mora pri odmerkih, manjših od 125 mg, pri odmerkih, ki niso večkratniki od 125 mg in se zato priporočenega odmerjanja ne more doseči z več tabletami in pri bolnikih, ki ne morejo požirati tablet, uporabiti zdravilo Levetiracetam ratiopharm 100 mg/ml peroralna raztopina.
English: Dose recommendations for infants aged from 1 month to less than 6 months:
Slovenian: Priporočeno odmerjanje za dojenčke, stare od 1 do manj kot 6 mesecev:
English: Monotherapy for adults and adolescents from 16 years of age
Slovenian: Odmerjanje Samostojno zdravljenje za odrasle in mladostnike od 16. leta starosti
English: UNIQUE IDENTIFIER - HUMAN READABLE DATA In case no outer packaging is used
Slovenian: EDINSTVENA OZNAKA - V BERLJIVI OBLIKI Če zunanje ovojnine ni
English: What Levetiracetam ratiopharm looks like and contents of the pack
Slovenian: Izgled zdravila Levetiracetam ratiopharm in vsebina pakiranja
English: Monotherapy in the treatment of partial onset seizures with or without secondary generalisation in patients from 16 years of age with newly diagnosed epilepsy.
Slovenian: Samostojno zdravljenje parcialnih napadov s sekundarno generalizacijo ali brez nje pri bolnikih, od 16. leta starosti, z na novo diagnosticirano epilepsijo
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING Outer wrapper label on multipacks wrapped in transparent foil - including the Blue Box
Slovenian: PODATKI NA ZUNANJI OVOJNINI Zunanja nalepka na skupnem pakiranju, zavitem v prozorno folijo - z Blue Box-om
English: The cumulative urinary excretion of levetiracetam and its primary metabolite accounted for 66 % and 24 % of the dose, respectively during the first 48 hours.
Slovenian: Kumulativno se v prvih 48 urah z izločanjem z urinom izloči 66 % odmerka levetiracetama ter 24 % odmerka njegovega primarnega presnovka.
English: General dose: Levetiracetam ratiopharm is taken twice daily, in two equally divided doses, each individual dose being measured between 0.07 ml (7 mg) and 0.21 ml (21 mg), per kg bodyweight of the infant.
Slovenian: Splošen odmerek: zdravilo Levetiracetam ratiopharm se jemlje dvakrat na dan v dveh enakih odmerkih, pri čemer vsak posamezni odmerek znaša od 0,07 ml (7 mg) do 0,21 ml (21 mg) na kg telesne mase dojenčka (za primere odmerkov glejte spodnjo preglednico).
English: The film-coated tablets must be taken orally, swallowed with a sufficient quantity of liquid and may be taken with or without food.
Slovenian: Filmsko obložene tablete se zaužijejo peroralno z dovolj tekočine.
English: The oral solution may be diluted in a glass of water or baby's bottle and may be taken with or without food.
Slovenian: Način uporabe Raztopina za peroralno uporabo se lahko raztopi v kozarcu vode ali steklenički za hranjenje.
English: Adjunctive therapy in the treatment of primary generalised tonic-clonic seizures in adults and adolescents from 12 years of age with idiopathic generalised epilepsy.
Slovenian: Dopolnilno zdravljenje primarno generaliziranih tonično-kloničnih napadov pri odraslih in mladostnikih, od 12. leta starosti, z idiopatsko generalizirano epilepsijo
English: • Levetiracetam ratiopharm is not indicated in children and adolescents below 16 years on its own (monotherapy).
Slovenian: • zdravilo Levetiracetam ratiopharm pri otrocih in mladostnikih, mlajših od 16 let, ni indicirano za samostojno zdravljenje (monoterapija).
English: In infants and children aged 1 month to less than 4 years, irritability (very common, 11.7 %) and coordination abnormal (common, 3.3 %) were reported more frequently than in other age groups or in the overall safety profile.
Slovenian: Pogosteje kot v drugih starostnih skupinah ali v skupnem varnostnem profilu so pri dojenčkih in otrocih, starih od 1 meseca do manj kot 4 leta, poročali o razdražljivosti (zelo pogosto, 11,7 %) in poslabšani koordinaciji
English: If stopping treatment, Levetiracetam ratiopharm should be discontinued gradually to avoid an increase of seizures.
Slovenian: Pri zdravilu Levetiracetam ratiopharm je potrebno zdravljenje opustiti postopoma, da se število napadov ne bi povečalo.
English: With continued longterm treatment, 11.4 % of the patients were seizure-free for at least 6 months and 7.2 % were seizurefree for at least 1 year.
Slovenian: Z nadaljevanjem dolgotrajnega zdravljenja je bilo 11,4 % bolnikov brez napada vsaj 6 mesecev, 7,2 % pa jih je bilo brez napada vsaj 1 leto.
English: The 300 ml glass bottle of Levetiracetam ratiopharm oral solution (for children aged 4 years and above, adolescents and adults) is packed in a cardboard box containing a 10 ml oral syringe (graduated every 0.25 ml) and an adaptor for the syringe.
Slovenian: 300 ml steklenice zdravila Levetiracetam ratiopharm peroralna raztopina (za otroke, stare 4 leta ali več, mladostnike in odrasle) so pakirane v škatle, ki vsebuje še 10 ml brizgo za peroralno dajanje (graduirano na vsakih 0,25 ml) in adapter za brizgo.
English: Use the 10 ml syringe included in the package.
Slovenian: Uporabite 10 ml brizgo, ki se nahaja v pakiranju.
English: Dose in infants (1 month to 23 months), children (2 to 11 years) and adolescents (12 to 17 years) weighing less than 50 kg:
Slovenian: Odmerek pri dojenčkih (od 1 meseca do 23 mesecev), otrocih (od 2 do 11 let) in mladostnikih (od 12 do 17 let), lažjih od 50 kg:
English: Levetiracetam ratiopharm 250 mg film-coated tablets The 250 mg film-coated tablets are blue, oblong and scored on one side.
Slovenian: Levetiracetam ratiopharm 250 mg filmsko obložene tablete 250 mg filmsko obložene tablete so modre, podolgovate z zarezo na eni strani.
English: Levetiracetam ratiopharm contains methyl parahydroxybenzoate, propyl parahydroxybenzoate, potassium and sodium.
Slovenian: Zdravilo Levetiracetam ratiopharm vsebuje metilparahidroksibenzoat, propilparahidroksibenzoat, kalij in natrij
English: Neonatal and juvenile animal studies in rats and dogs demonstrated that there were no adverse effects seen in any of the standard developmental or maturation endpoints at doses up to 1800 mg/kg/day (x 6 - 17 the MRHD on a mg/m2 basis).
Slovenian: V študijah pri novoskotenih živalih in mladičih živali so dokazali, da pri podganah in psih, pri odmerkih do 1800 mg/kg/dan (6-kratna do 17-kratna vrednost največjega priporočenega odmerka pri ljudeh glede na mg/m2), ni bilo neželenih učinkov na standardne parametre razvoja in dozorevanja.
English: Add-on therapy for adults (≥18 years) and adolescents (12 to 17 years) weighing 50 kg or more
Slovenian: Dopolnilno zdravljenje za odrasle (≥ 18 let) in mladostnike (od 12 do 17 let), težke 50 kg in več
English: Dose in adults and adolescents (from 16 years of age):
Slovenian: Odmerek pri za odrasle in mladostnike (od 16. leta starosti)
English: Not applicable.
Slovenian: da je to potrebno.
English: 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.
Slovenian: 25 kg, je 250 mg dvakrat na dan z največjim odmerkom 750 mg dvakrat na dan.
English: Methyl parahydroxybenzoate (E 218) and propyl parahydroxybenzoate (E 216) Levetiracetam ratiopharm 100 mg/ml oral solution contains methyl parahydroxybenzoate (E 218) and propyl parahydroxybenzoate (E 216) which may cause allergic reactions (possibly delayed).
Slovenian: Metilparahidroksibenzoat (E 218) in propilparahidroksibenzoat (E 216) Zdravilo Levetiracetam ratiopharm 100 mg/ml peroralna raztopina vsebuje metilparahidroksibenzoat
English: Levetiracetam ratiopharm 1000 mg film-coated tablets The 1000 mg film-coated tablets are white, oblong and scored on both sides.
Slovenian: Levetiracetam ratiopharm 1000 mg filmsko obložene tablete 1000 mg filmsko obložene tablete so bele, podolgovate, z zarezo na obeh straneh.
English: - A 150 ml bottle with a 3 ml oral syringe (delivering up to 300 mg levetiracetam) graduated every 0.1 ml (corresponding to 10 mg)
Slovenian: - 150 ml steklenica s 3 ml graduirano brizgo za peroralno uporabo (ki vsebuje do 300 mg levetiracetama) z oznako za vsak 0,1 ml (kar ustreza 10 mg).
English: Probenecid (500 mg four times daily), a renal tubular secretion blocking agent, has been shown to inhibit the renal clearance of the primary metabolite but not of levetiracetam.
Slovenian: Ugotovili so, da probenecid (500 mg štirikrat na dan), ki preprečuje ledvično tubularno sekrecijo,
English: The NOAEL was < 200 mg/kg/day for the dams and 200 mg/kg/day for the fetuses (equal to the MRHD on a mg/m2 basis).
Slovenian: < 200 mg/kg/dan za samice in 200 mg/kg/dan za plodove (je enako največjemu priporočenemu odmerku pri ljudeh glede na mg/m2.
English: Levetiracetam ratiopharm oral solution is a clear liquid.
Slovenian: Zdravilo Levetiracetam ratiopharm peroralna raztopina je bistra tekočina.
English: Use the 3 ml syringe included in the package.
Slovenian: Uporabite 3 ml brizgo, ki se nahaja v pakiranju.
English: General dose: Levetiracetam ratiopharm is taken twice daily, in two equally divided doses, each individual dose being measured between 5 ml (500 mg) and 15 ml (1500 mg).
Slovenian: Splošen odmerek: zdravilo Levetiracetam ratiopharm se jemlje dvakrat na dan v dveh enakih odmerkih, pri čemer vsak posamezni odmerek znaša od 5 ml (500 mg) do 15 ml (1500 mg).
English: • Levetiracetam ratiopharm is not indicated in children and adolescents below 16 years on it's own (monotherapy)
Slovenian: • zdravilo Levetiracetam ratiopharm, pri otrocih in mladostnikih, mlajših od 16 let, ni indicirano za samostojno zdravljenje (monoterapija).
English: Use the 1 ml syringe included in the package.
Slovenian: Uporabite 1 ml brizgo, ki se nahaja v pakiranju.
English: 100 mg/ml oral solution.
Slovenian: 100 mg/ml peroralna raztopina.
English: CLcr (ml/min/1.73 m2) = ---------------------------- x 1.73 BSA subject (m2)
Slovenian: CLcr (ml/min/1,73 m2) = ------------------------ x 1,73 BSA bolnika (m2)
English: - A 150 ml bottle with a 1 ml oral syringe (delivering up to 100 mg levetiracetam) graduated every 0.05 ml (corresponding to 5 mg)
Slovenian: - 150 ml steklenica z 1 ml graduirano brizgo za peroralno uporabo (ki vsebuje do 100 mg levetiracetama) z oznako za vsakih 0,05 ml (kar ustreza 5 mg).
English: The 150 ml glass bottle of Levetiracetam ratiopharm oral solution (for infants aged 6 months and above and children aged 2 to 4 years) is packed in a cardboard box containing a 3 ml oral syringe (graduated every 0.1 ml) and an adaptor for the syringe.
Slovenian: 150 ml steklenice zdravila Levetiracetam ratiopharm peroralna raztopina (za dojenčke, stare od 6 mesecev in več, ter otroke, stare od 2 do 4 leta) so pakirane v škatle, ki vsebujejo še 3 ml brizgo za peroralno dajanje (graduirano na vsakih 0,1 ml) in adapter za brizgo.
English: The safety and efficacy of Levetiracetam ratiopharm in children and adolescents below 16 years as monotherapy treatment have not been established.
Slovenian: Pri samostojnem zdravljenju pri otrocih in mladostnikih, mlajših od 16 let, varnost in učinkovitost zdravila Levetiracetam ratiopharm nista bili dokazani.
English: Lot See outer carton
Slovenian: Lot Glejte zunanjo ovojnino.
English: The NOAEL (No Observed Adverse Effect Level) was 3600 mg/kg/day for pregnant female rats (x 12 the MRHD on a mg/m2 basis) and 1200 mg/kg/day for fetuses.
Slovenian: Odmerek, pri katerem ni mogoče opaziti neželenih učinkov (NOAEL), je bil pri brejih podganah 3600 mg/kg/dan in pri plodovih 1200 mg/kg/dan (12-kratna vrednost največjega priporočenega odmerka pri ljudeh glede na mg/m2).
English: Dose in adults and adolescents from 16 years of age:
Slovenian: Odmerek za odrasle in mladostnike od 16. leta starosti
English: In children and adolescents aged 4 to 16 years, vomiting (very common, 11.2 %), agitation (common, 3.4%), mood swings (common, 2.1 %), affect lability (common, 1.7 %), aggression (common, 8.2 %), abnormal behaviour (common, 5.6 %), and lethargy (common, 3.9 %) were reported more frequently than in other age ranges or in the overall safety profile.
Slovenian: 3,4 %), nihanjih razpoloženja (pogosto, 2,1 %), čustveni labilnosti (pogosto, 1,7 %), agresiji (pogosto, 8,2 %), nenormalnem vedenju (pogosto, 5,6 %) in letargiji (pogosto, 3,9 %).
English: How to take Levetiracetam ratiopharm
Slovenian: Kako jemati zdravilo Levetiracetam ratiopharm
English: Levetiracetam ratiopharm 750 mg film-coated tablets EU/1/11/702/018
Slovenian: Levetiracetam ratiopharm 750 mg filmsko obložene tablete EU/1/11/702/018
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS Blister
Slovenian: PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA PRETISNIH OMOTIH ALI DVOJNIH TRAKOVIH pretisni omot
English: CLcr (ml/min/1.73 m2) = ---------------------------- x 1.73
Slovenian: CLcr (ml/min/1,73 m2) = ---------------------------- x 1,73 BSA bolnika (m2)
English: The 150 ml glass bottle of Levetiracetam ratiopharm oral solution (for infants aged 1 month to less than 6 months) is packed in a cardboard box containing a 1 ml oral syringe (graduated every 0.05 ml) and an adaptor for the syringe.
Slovenian: 150 ml steklenice zdravila Levetiracetam ratiopharm peroralna raztopina (za dojenčke, stare od 1 do 6 mesecev) so pakirane v škatle, ki vsebujejo še 1 ml brizgo za peroralno dajanje (graduirano na vsakih 0,05 ml) in adapter za brizgo.
English: In order to ensure the accuracy of the dosing, this presentation should be prescribed for infants aged 1 month to less than 6 months.
Slovenian: Da zagotovimo točnost odmerjanja moramo pri dojenčkih, starih od 1 do manj kot 6 mesecev,
English: Levetiracetam ratiopharm 500 mg film-coated tablets The 500 mg film-coated tablets are yellow, oval and scored on one side.
Slovenian: Levetiracetam ratiopharm 500 mg filmsko obložene tablete 500 mg filmsko obložene tablete so rumene, podolgovate, z zarezo na eni strani.
English: Drug reaction with eosinophilia and systemic symptoms (DRESS), hypersensitivity (including angioedema and anaphylaxis)
Slovenian: Bolezni imunskega sistema reakcija na zdravilo z eozinofilijo in sistemskimi simptomi (DRESS)
English: 10 film-coated tablets 20 film-coated tablets 30 film-coated tablets 50 film-coated tablets 60 film-coated tablets 100 film-coated tablets
Slovenian: 10 filmsko obloženih tablet 20 filmsko obloženih tablet 30 filmsko obloženih tablet 50 filmsko obloženih tablet 60 filmsko obloženih tablet 100 filmsko obloženih tablet
English: 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.
Slovenian: starejši od 1 meseca) in v postmarketinškem obdobju, so navedeni v spodnji tabeli po organskih sistemih in pogostnosti.
English: 20 film-coated tablets 30 film-coated tablets 50 film-coated tablets 60 film-coated tablets 80 film-coated tablets 100 film-coated tablets
Slovenian: 20 filmsko obloženih tablet 30 filmsko obloženih tablet 50 filmsko obloženih tablet 60 filmsko obloženih tablet 80 filmsko obloženih tablet 100 filmsko obloženih tablet
English: Levetiracetam ratiopharm 250 mg film-coated tablets EU/1/11/702/004
Slovenian: Levetiracetam ratiopharm 250 mg filmsko obložene tablete EU/1/11/702/004
English: Levetiracetam ratiopharm 1000 mg film-coated tablets EU/1/11/702/025
Slovenian: Levetiracetam ratiopharm 1000 mg filmsko obložene tablete EU/1/11/702/025
English: In order to ensure the accuracy of the dosing this presentation should be prescribed for infants and young children aged from 6 months to less than 4 years.
Slovenian: Da zagotovimo točnost odmerjanja moramo pri dojenčkih, starejših od 6 mesecev, in otrocih,
English: Each film-coated tablet contains 1000 mg levetiracetam.
Slovenian: Ena filmsko obložena tableta vsebuje 1000 mg levetiracetama.
English: CLcr (ml/min/1.73 m2) = ------------------------------------------Serum Creatinine (mg/dl)
Slovenian: CLcr (ml/min/1,73 m2) = ----------------------------------------------------------koncentracija kreatinina v serumu (mg/dl)
English: 1500 mg twice daily
Slovenian: 1500 mg dvakrat na dan
English: Dose changes should not exceed increases or decreases of 7 mg/kg twice daily every two weeks.
Slovenian: Na vsaka dva tedna lahko odmerek povečamo ali zmanjšamo za ne več kot 7 mg/kg dvakrat na dan.
English: Macrogol 6000, Colloidal anhydrous silica, Crospovidone A, Cellulose powdered, Magnesium stearate.
Slovenian: makrogol 6000 brezvodni koloidni silicijev dioksid krospovidon A uprašena celuloza magnezijev stearat
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING Outer carton for blister packs
Slovenian: PODATKI NA ZUNANJI OVOJNINI Zunanja ovojnina za pretisne omote
English: Add-on therapy for infants aged 6 to 23 months, children (2 to 11 years) and adolescents (12 to 17 years) weighing less than 50 kg
Slovenian: Dopolnilno zdravljenje za dojenčke, stare od 6 do 23 mesecev, otroke (od 2 do 11 let) in mladostnike (od 12 do 17 let), težke manj kot 50 kg
English: Your doctor will prescribe the most appropriate pharmaceutical form of Levetiracetam ratiopharm according to the age, weight and dose.
Slovenian: Zdravnik bo glede na starost, telesno maso in odmerek predpisal najprimernejšo farmacevtsko obliko zdravila Levetiracetam ratiopharm.
English: 20 film-coated tablets 30 film-coated tablets 50 film-coated tablets 60 film-coated tablets 100 film-coated tablets
Slovenian: 20 filmsko obloženih tablet 30 filmsko obloženih tablet 50 filmsko obloženih tablet 60 filmsko obloženih tablet 100 filmsko obloženih tablet
English: In addition, 101 infants aged less than 12 months have been exposed in a post authorization safety study.
Slovenian: Poleg tega je bilo v obdobju po začetku trženja zdravila 101 dojenčkov, mlajših od 12 mesecev,
English: 7 to 14 mg/kg (0.07 to 0.14 ml/kg)once daily (2) (4)
Slovenian: 7 do 14 mg/kg (0,07 di 0,14 ml/kg) enkrat na dan (2) (4)
English: (see table below for dose examples).
Slovenian: (glejte poglavje 4.2).
English: Levetiracetam ratiopharm 100 mg/ml oral solution Levetiracetam
Slovenian: Levetiracetam ratiopharm 100 mg/ml peroralna raztopina levetiracetam
English: (1) Levetiracetam ratiopharm 100 mg/ml oral solution should be used for doses under 125 mg, for doses not multiple of 125 mg when dosing recommendation is not achievable by taking multiple tablets and for patients unable to swallow tablets.
Slovenian: (1) Pri odmerkih, manjših od 125 mg, pri odmerkih, ki niso večkratniki od 250 mg in se priporočenega odmerjanja zato ne more doseči z več tabletami, in pri bolnikih, ki ne morejo požirati tablet, je treba uporabiti zdravilo Levetiracetam ratiopharm 100 mg/ml peroralna raztopina.
English: Levetiracetam ratiopharm 100 mg/ml oral solution is the preferred formulation for use in infants and children under the age of 6 years.
Slovenian: (od 12 do 17 let), težke manj kot 50 kg Farmacevtska oblika peroralna raztopina zdravila Levetiracetam ratiopharm 100 mg/ml je najprimernejša za uporabo pri dojenčkih in otrocih, mlajših od 6 let.
English: • convulsion, balance disorder (equilibrium disorder), dizziness (sensation of unsteadiness),
Slovenian: • konvulzije, motnje ravnotežja, omotica (občutek nesigurnosti), letargija (pomanjkanje energije in navdušenja), tremor (nehoteno tresenje)
English: After measuring the correct dose with an appropriate syringe, Levetiracetam ratiopharm oral solution may be diluted in a glass of water or baby's bottle.
Slovenian: Po tem, ko ste izmerili pravilen odmerek z ustrezno brizgo, lahko peroralno raztopino zdravila
English: One film-coated tablet of Levetiracetam ratiopharm 1000 mg contains 1000 mg levetiracetam.
Slovenian: Ena filmsko obložena tableta zdravila Levetiracetam ratiopharm 1000 mg filmsko obložene tablete vsebuje 1000 mg levetiracetama.
English: Dose in children 6 months and older
Slovenian: Odmerek pri dojenčkih, starejših od 6 mesecev
English: 300 ml brown glass bottle (type III) with a white child resistant closure (polypropylene) in a cardboard box also containing a 10 ml graduated oral syringe (polypropylene, polyethylene) and an adaptor for the syringe (polyethylene).
Slovenian: 300 ml steklenica (tip III) rjave barve z belo zaporko, varno za otroke (polipropilen) v škatli, ki vsebuje še 10 ml graduirano brizgo za peroralno dajanje (polipropilen, polietilen) in adapter za brizgo (polietilen).
English: Marketing Authorisation Holder ratiopharm GmbH Graf-Arco-Str. 3
Slovenian: Imetnik dovoljenja za promet z zdravilom: ratiopharm GmbH
English: Adjunctive therapy 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.
Slovenian: Zdravilo Levetiracetam ratiopharm je indicirano za dopolnilno zdravljenje • parcialnih napadov s sekundarno generalizacijo ali brez nje pri odraslih, mladostnikih, otrocih in dojenčkih od 1 meseca starosti, z epilepsijo.