natgillin/translations-raw huggingface dataset:
Levetiracetam ratiopharm oral solution includes methyl parahydroxybenzoate (E218) and propyl parahydroxybenzoate (E216) which may cause allergic reactions (possibly delayed).
Zdravilo Levetiracetam ratiopharm vsebuje metilparahidroksibenzoat (E218) in propilparahidroksibenzoat (E216), ki lahko povzročata alergijske reakcije (lahko so zakasnele).
35 infants aged less than 1 year with partial onset seizures have been exposed in placebo-control clinical studies of which only 13 were aged < 6 months.
35 dojenčkov, starih manj kot 1 leto, s parcialnimi napadi, od katerih je bilo le 13 starih < 6 mesecev, je bilo vključenih v s placebom nadzorovane klinične študije.
Multipack: 200 (2 packs of 100) film-coated tablets Multipack: 120 (2 packs of 60) film-coated tablets
Skupno pakiranje: 200 (2 pakiranji po 100) filmsko obloženih tablet Skupno pakiranje: 120 (2 pakiranji po 60) filmsko obloženih tablet
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 od 70, 350 in
More than half of the subjects remained seizure free for 12 months (56.6 % and 58.5 % of subjects on levetiracetam and on carbamazepine CR respectively).
Več kot polovica preiskovancev 12 mesecev ni imela napadov (56,6 % preiskovancev, ki so prejemali levetiracetam, in 58,5 % preiskovancev, ki so prejemali karbamazepin z nadzorovanim sproščanjem).
Infants should start the treatment with Levetiracetam ratiopharm 100 mg/ml oral solution.
Pri dojenčkih moramo začeti zdravljenje z zdravilom Levetiracetam ratiopharm 100 mg/ml peroralna raztopina.
PVC/Aluminium blister packs.
Pretisni omot iz PVC/aluminija.
Levetiracetam ratiopharm is indicated as monotherapy in the treatment of partial onset seizures with or without secondary generalisation in adults and adolescents from 16 years of age with newly diagnosed epilepsy.
Zdravilo Levetiracetam ratiopharm je indicirano za samostojno zdravljenje parcialnih napadov s sekundarno generalizacijo ali brez nje pri odraslih in mladostnikih od 16. leta starosti z na novo diagnosticirano epilepsijo.
• as an add-on to other antiepileptic medicines to treat: partial onset seizures with or without generalisation in adults, adolescents, children and infants from one month of age myoclonic seizures (short, shock-like jerks of a muscle or group of muscles) in adults and adolescents from 12 years of age with juvenile myoclonic epilepsy, primary generalised tonic-clonic seizures (major fits, including loss of consciousness) in adults and adolescents from 12 years of age with idiopathic generalised epilepsy (the type of epilepsy that is thought to have a genetic cause).
parcialnih napadov z ali brez generalizacije pri odraslih, mladostnikih, otrocih in dojenčkih od 1 meseca dalje miokloničnih napadov (kratki, nenadni trzaji mišice ali skupine mišic) pri odraslih in mladostnikih od 12. leta starosti z juvenilno mioklonično epilepsijo primarno generaliziranih tonično-kloničnih napadov (veliki napadi, vključno z izgubo zavesti) pri odraslih in mladostnikih od 12. leta starosti z idiopatsko generalizirano epilepsijo (oblika epilepsije, za katero se domneva, da je genetskega izvora)
Rare: may affect up to 1 in 1000 people
Redki: pojavijo se lahko pri največ 1 do 1.000 bolnikov
Film-coated tablet Multipack: 200 (2 packs of 100) film-coated tablets
filmsko obložena tableta Skupno pakiranje: 200 (2 pakiranji po 100) filmsko obloženih tablet
Peak concentrations (Cmax) are typically 31 and 43 μg/ml following a single 1,000 mg dose and repeated 1,000 mg twice daily dose, respectively.
Po posamičnem 1.000 mg odmerku je največja koncentracija (Cmax) ponavadi 31 μg/ml, po ponavljajočih odmerkih 1.000 mg dvakrat na dan pa 43 μg/ml.
In vitro, levetiracetam and its primary metabolite have been shown not to inhibit the major human liver cytochrome P450 isoforms (CYP3A4, 2A6, 2C9, 2C19, 2D6, 2E1 and 1A2), glucuronyl transferase (UGT1A1 and UGT1A6) and epoxide hydroxylase activities.
In vitro so pokazali, da levetiracetam in njegov primarni presnovek ne zavirata aktivnosti glavnih izooblik človeškega jetrnega citokroma P450 (CYP3A4, 2A6, 2C9, 2C19, 2D6, 2E1 in 1A2),
Contains methyl and propyl parahydroxybenzoate and potassium.
Vsebuje metil- in propilparahidroksibenzoat ter kalij.
150 mg (1.5 ml) twice daily 450 mg (4.5 ml)twice daily
150 mg (1,5 ml) dvakrat na dan 450 mg (4,5 ml) dvakrat na dan
Other medicines and Levetiracetam ratiopharm
Druga zdravila in zdravilo Levetiracetam ratiopharm
Levetiracetam ratiopharm 250 mg film-coated tablets Levetiracetam ratiopharm 500 mg film-coated tablets Levetiracetam ratiopharm 750 mg film-coated tablets Levetiracetam ratiopharm 1000 mg film-coated tablets
Levetiracetam ratiopharm 250 mg filmsko obložene tablete Levetiracetam ratiopharm 500 mg filmsko obložene tablete Levetiracetam ratiopharm 750 mg filmsko obložene tablete Levetiracetam ratiopharm 1000 mg filmsko obložene tablete
Three presentations are available: - A 300 ml bottle with a 10 ml oral syringe (delivering up to 1000 mg levetiracetam) graduated every 0.25 ml (corresponding to 25 mg).
Na voljo so tri pakiranja: - 300 ml steklenica z 10 ml graduirano brizgo za peroralno uporabo (ki vsebuje do 1000 mg levetiracetama) z oznako za vsakih 0,25 ml (kar ustreza 25 mg).
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.
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 %).
60 mg (0.6 ml) twice daily 180 mg (1.8 ml) twice daily
60 mg (0,6 ml) dvakrat na dan 180 mg (1,8 ml)dvakrat na dan
How to store Levetiracetam ratiopharm Contents of the pack and other information
5 Shranjevanje zdravila Levetiracetam ratiopharm Vsebina pakiranja in dodatne informacije
100 film-coated tablets
60 filmsko obloženih tablet
35 mg (0.35 ml) twice daily 105 mg (1.05 ml) twice daily
35 mg (0.35 ml) dvakrat na dan 105 mg (1.05 ml) dvakrat na dan
In all of the above cases Levetiracetam ratiopharm 100 mg/ml oral solution should be used.
V vseh zgoraj naštetih primerih se priporoča uporaba peroralne raztopine Levetiracetam ratiopharm 100 mg/ml.
Dosing adjustment for infants, children and adolescents patients weighing less than 50 kg with impaired renal function:
Prilagoditev odmerjanja pri dojenčkih, otrocih in mladostnikih s telesno maso, manjšo kot 50 kg, z okvarjenim delovanjem ledvic.
The possible side effects of an overdose of Levetiracetam ratiopharm are sleepiness, agitation, aggression, decrease of alertness, inhibition of breathing and coma.
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.
If you stop taking Levetiracetam ratiopharm
Če ste prenehali jemati zdravilo Levetiracetam ratiopharm
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).
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).
Add-on therapy for infants aged from 1 month to less than 6 months
Dopolnilno zdravljenje za dojenčke, stare od 1 do manj kot 6 mesecev
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.
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.
Dose recommendations for infants aged from 1 month to less than 6 months:
Priporočeno odmerjanje za dojenčke, stare od 1 do manj kot 6 mesecev:
Monotherapy for adults and adolescents from 16 years of age
Odmerjanje Samostojno zdravljenje za odrasle in mladostnike od 16. leta starosti
UNIQUE IDENTIFIER - HUMAN READABLE DATA In case no outer packaging is used
EDINSTVENA OZNAKA - V BERLJIVI OBLIKI Če zunanje ovojnine ni
What Levetiracetam ratiopharm looks like and contents of the pack
Izgled zdravila Levetiracetam ratiopharm in vsebina pakiranja
Monotherapy in the treatment of partial onset seizures with or without secondary generalisation in patients from 16 years of age with newly diagnosed epilepsy.
Samostojno zdravljenje parcialnih napadov s sekundarno generalizacijo ali brez nje pri bolnikih, od 16. leta starosti, z na novo diagnosticirano epilepsijo
PARTICULARS TO APPEAR ON THE OUTER PACKAGING Outer wrapper label on multipacks wrapped in transparent foil - including the Blue Box
PODATKI NA ZUNANJI OVOJNINI Zunanja nalepka na skupnem pakiranju, zavitem v prozorno folijo - z Blue Box-om
The cumulative urinary excretion of levetiracetam and its primary metabolite accounted for 66 % and 24 % of the dose, respectively during the first 48 hours.
Kumulativno se v prvih 48 urah z izločanjem z urinom izloči 66 % odmerka levetiracetama ter 24 % odmerka njegovega primarnega presnovka.
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.
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).
The film-coated tablets must be taken orally, swallowed with a sufficient quantity of liquid and may be taken with or without food.
Filmsko obložene tablete se zaužijejo peroralno z dovolj tekočine.
The oral solution may be diluted in a glass of water or baby's bottle and may be taken with or without food.
Način uporabe Raztopina za peroralno uporabo se lahko raztopi v kozarcu vode ali steklenički za hranjenje.
Adjunctive therapy in the treatment of primary generalised tonic-clonic seizures in adults and adolescents from 12 years of age with idiopathic generalised epilepsy.
Dopolnilno zdravljenje primarno generaliziranih tonično-kloničnih napadov pri odraslih in mladostnikih, od 12. leta starosti, z idiopatsko generalizirano epilepsijo
• Levetiracetam ratiopharm is not indicated in children and adolescents below 16 years on its own (monotherapy).
• zdravilo Levetiracetam ratiopharm pri otrocih in mladostnikih, mlajših od 16 let, ni indicirano za samostojno zdravljenje (monoterapija).
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.
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
If stopping treatment, Levetiracetam ratiopharm should be discontinued gradually to avoid an increase of seizures.
Pri zdravilu Levetiracetam ratiopharm je potrebno zdravljenje opustiti postopoma, da se število napadov ne bi povečalo.
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.
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.
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.
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.
Use the 10 ml syringe included in the package.
Uporabite 10 ml brizgo, ki se nahaja v pakiranju.
Dose in infants (1 month to 23 months), children (2 to 11 years) and adolescents (12 to 17 years) weighing less than 50 kg:
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:
Levetiracetam ratiopharm 250 mg film-coated tablets The 250 mg film-coated tablets are blue, oblong and scored on one side.
Levetiracetam ratiopharm 250 mg filmsko obložene tablete 250 mg filmsko obložene tablete so modre, podolgovate z zarezo na eni strani.
Levetiracetam ratiopharm contains methyl parahydroxybenzoate, propyl parahydroxybenzoate, potassium and sodium.
Zdravilo Levetiracetam ratiopharm vsebuje metilparahidroksibenzoat, propilparahidroksibenzoat, kalij in natrij
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).
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.
Add-on therapy for adults (≥18 years) and adolescents (12 to 17 years) weighing 50 kg or more
Dopolnilno zdravljenje za odrasle (≥ 18 let) in mladostnike (od 12 do 17 let), težke 50 kg in več
Dose in adults and adolescents (from 16 years of age):
Odmerek pri za odrasle in mladostnike (od 16. leta starosti)
Not applicable.
da je to potrebno.
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.
25 kg, je 250 mg dvakrat na dan z največjim odmerkom 750 mg dvakrat na dan.
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).
Metilparahidroksibenzoat (E 218) in propilparahidroksibenzoat (E 216) Zdravilo Levetiracetam ratiopharm 100 mg/ml peroralna raztopina vsebuje metilparahidroksibenzoat
Levetiracetam ratiopharm 1000 mg film-coated tablets The 1000 mg film-coated tablets are white, oblong and scored on both sides.
Levetiracetam ratiopharm 1000 mg filmsko obložene tablete 1000 mg filmsko obložene tablete so bele, podolgovate, z zarezo na obeh straneh.
- 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)
- 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).
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.
Ugotovili so, da probenecid (500 mg štirikrat na dan), ki preprečuje ledvično tubularno sekrecijo,
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).
< 200 mg/kg/dan za samice in 200 mg/kg/dan za plodove (je enako največjemu priporočenemu odmerku pri ljudeh glede na mg/m2.
Levetiracetam ratiopharm oral solution is a clear liquid.
Zdravilo Levetiracetam ratiopharm peroralna raztopina je bistra tekočina.
Use the 3 ml syringe included in the package.
Uporabite 3 ml brizgo, ki se nahaja v pakiranju.
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).
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).
• Levetiracetam ratiopharm is not indicated in children and adolescents below 16 years on it's own (monotherapy)
• zdravilo Levetiracetam ratiopharm, pri otrocih in mladostnikih, mlajših od 16 let, ni indicirano za samostojno zdravljenje (monoterapija).
Use the 1 ml syringe included in the package.
Uporabite 1 ml brizgo, ki se nahaja v pakiranju.
100 mg/ml oral solution.
100 mg/ml peroralna raztopina.
CLcr (ml/min/1.73 m2) = ---------------------------- x 1.73 BSA subject (m2)
CLcr (ml/min/1,73 m2) = ------------------------ x 1,73 BSA bolnika (m2)
- 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)
- 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).
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.
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.
The safety and efficacy of Levetiracetam ratiopharm in children and adolescents below 16 years as monotherapy treatment have not been established.
Pri samostojnem zdravljenju pri otrocih in mladostnikih, mlajših od 16 let, varnost in učinkovitost zdravila Levetiracetam ratiopharm nista bili dokazani.
Lot See outer carton
Lot Glejte zunanjo ovojnino.
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.
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).
Dose in adults and adolescents from 16 years of age:
Odmerek za odrasle in mladostnike od 16. leta starosti
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.
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 %).
How to take Levetiracetam ratiopharm
Kako jemati zdravilo Levetiracetam ratiopharm
Levetiracetam ratiopharm 750 mg film-coated tablets EU/1/11/702/018
Levetiracetam ratiopharm 750 mg filmsko obložene tablete EU/1/11/702/018
MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS Blister
PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA PRETISNIH OMOTIH ALI DVOJNIH TRAKOVIH pretisni omot
CLcr (ml/min/1.73 m2) = ---------------------------- x 1.73
CLcr (ml/min/1,73 m2) = ---------------------------- x 1,73 BSA bolnika (m2)
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.
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.
In order to ensure the accuracy of the dosing, this presentation should be prescribed for infants aged 1 month to less than 6 months.
Da zagotovimo točnost odmerjanja moramo pri dojenčkih, starih od 1 do manj kot 6 mesecev,
Levetiracetam ratiopharm 500 mg film-coated tablets The 500 mg film-coated tablets are yellow, oval and scored on one side.
Levetiracetam ratiopharm 500 mg filmsko obložene tablete 500 mg filmsko obložene tablete so rumene, podolgovate, z zarezo na eni strani.
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)
10 film-coated tablets 20 film-coated tablets 30 film-coated tablets 50 film-coated tablets 60 film-coated tablets 100 film-coated tablets
10 filmsko obloženih tablet 20 filmsko obloženih tablet 30 filmsko obloženih tablet 50 filmsko obloženih tablet 60 filmsko obloženih tablet 100 filmsko obloženih tablet
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.
starejši od 1 meseca) in v postmarketinškem obdobju, so navedeni v spodnji tabeli po organskih sistemih in pogostnosti.
20 film-coated tablets 30 film-coated tablets 50 film-coated tablets 60 film-coated tablets 80 film-coated tablets 100 film-coated tablets
20 filmsko obloženih tablet 30 filmsko obloženih tablet 50 filmsko obloženih tablet 60 filmsko obloženih tablet 80 filmsko obloženih tablet 100 filmsko obloženih tablet
Levetiracetam ratiopharm 250 mg film-coated tablets EU/1/11/702/004
Levetiracetam ratiopharm 250 mg filmsko obložene tablete EU/1/11/702/004
Levetiracetam ratiopharm 1000 mg film-coated tablets EU/1/11/702/025
Levetiracetam ratiopharm 1000 mg filmsko obložene tablete EU/1/11/702/025
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.
Da zagotovimo točnost odmerjanja moramo pri dojenčkih, starejših od 6 mesecev, in otrocih,
Each film-coated tablet contains 1000 mg levetiracetam.
Ena filmsko obložena tableta vsebuje 1000 mg levetiracetama.
CLcr (ml/min/1.73 m2) = ------------------------------------------Serum Creatinine (mg/dl)
CLcr (ml/min/1,73 m2) = ----------------------------------------------------------koncentracija kreatinina v serumu (mg/dl)
1500 mg twice daily
1500 mg dvakrat na dan
Dose changes should not exceed increases or decreases of 7 mg/kg twice daily every two weeks.
Na vsaka dva tedna lahko odmerek povečamo ali zmanjšamo za ne več kot 7 mg/kg dvakrat na dan.
Macrogol 6000, Colloidal anhydrous silica, Crospovidone A, Cellulose powdered, Magnesium stearate.
makrogol 6000 brezvodni koloidni silicijev dioksid krospovidon A uprašena celuloza magnezijev stearat
PARTICULARS TO APPEAR ON THE OUTER PACKAGING Outer carton for blister packs
PODATKI NA ZUNANJI OVOJNINI Zunanja ovojnina za pretisne omote
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
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
Your doctor will prescribe the most appropriate pharmaceutical form of Levetiracetam ratiopharm according to the age, weight and dose.
Zdravnik bo glede na starost, telesno maso in odmerek predpisal najprimernejšo farmacevtsko obliko zdravila Levetiracetam ratiopharm.