FrancophonIA/ELRC3.0 huggingface dataset:
English: 5 ml glass vial (type I) closed by a polytetrafluoroethylene grey chlorobutyl rubber stopper or an uncoated grey bromobutyl rubber stopper and sealed with an aluminium/polypropylene flip cap. Each carton contains 10 vials.
Slovenian: Koncentrat zdravila Keppra je na voljo v 5 ml stekleni viali (tip I), ki je zaprta s sivim klorbutilnim gumijastim zamaškom prevlečenim s politetrafluoroetilenom ali z neprevlečenim sivim brombutilnim gumijastim zamaškom in zapečatena z aluminijasto/polipropilensko zaporko (flip).
English: Keppra oral solution is the preferred formulation for use in infants and children under the age of 6 years.
Slovenian: Zdravilo Keppra peroralna raztopina je najprimernejša farmacevtska oblika, za uporabo pri dojenčkih in otrocih, mlajših od 6 let.
English: What you need to know before you take Keppra
Slovenian: Kaj morate vedeti, preden boste vzeli zdravilo Keppra
English: What Keppra is and what it is used for What you need to know before you take Keppra How to take Keppra
Slovenian: Kaj je zdravilo Keppra in za kaj ga uporabljamo Kaj morate vedeti, preden boste vzeli zdravilo Keppra Kako jemati zdravilo Keppra Možni neželeni učinki
English: In most subjects with severe hepatic impairment, the clearance of levetiracetam was reduced by more than 50 % due to a concomitant renal impairment (see section
Slovenian: Pri preiskovancih z blago in zmerno jetrno okvaro se očistek levetiracetama ni pomembno spremenil, pri večini preiskovancev s hudo jetrno okvaro pa se je zaradi sočasne okvare ledvic zmanjšal za več kot 50 % (glejte poglavje 4.2).
English: 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).
Slovenian: Na voljo so naslednja tri pakiranja: - 300 ml steklenica z 10 ml brizgo za peroralno uporabo (ki vsebuje do 1000 mg levetiracetama) z oznako za vsakih 0,25 ml (kar ustreza 25 mg).
English: Do not use this medicine after the expiry date stated on the carton box and blister after EXP.
Slovenian: Tega zdravila ne smete uporabljati po datumu izteka uporabnosti, ki je naveden na škatli in pretisnem omotu poleg oznake EXP.
English: The possible side effects of an overdose of Keppra are sleepiness, agitation, aggression, decrease of alertness, inhibition of breathing and coma.
Slovenian: Pri prevelikem odmerjanju zdravila Keppra so opažali somnolenco, agitiranost, agresivnost, zmanjšano stopnjo zavesti, depresijo dihanja in komo.
English: For children above 4 years, measure the appropriate dosage using the 10 ml syringe included in the package.
Slovenian: Za otroke, starejše od 4 let, ustrezen odmerek izmerite z uporabo 10 ml brizge, ki je priložena k zdravilu.
English: Box of 10 vials
Slovenian: PODATKI NA ZUNANJI OVOJNINI Škatla z 10 vialami
English: Toxic epidermal necrolysis, StevensJohnson syndrome, erythema multiforme
Slovenian: Bolezni kože in podkožja izpuščaj alopecija, ekcem, pruritus toksična epidermalna nekroliza, StevensJohnsonov sindrom, multiformni eritem
English: 250 mg tablet: indigo carmine aluminium lake (E132) 500 mg tablet: iron oxide yellow (E172) 750 mg tablet: sunset yellow FCF (E110), iron oxide red (E172)
Slovenian: 500 mg tableta: rumeni železov oksid (E172) 750 mg tableta: sončno rumeno FCF (E110), rdeči železov oksid (E172)
English: General dose: Keppra is taken twice daily, in two equally divided doses, each individual dose being measured between 0.07 ml (7mg) and 0.21 ml (21mg), per kg bodyweight of the infant.
Slovenian: Običajni odmerek: zdravilo Keppra se jemlje dvakrat na dan, razdeljen na dva enaka odmerka, vsak posamezen odmerek znaša med 0,07 ml (7 mg) in 0,21 ml (21 mg) na kg telesne mase otroka (glejte spodnjo preglednico za primere odmerkov).
English: Four embryo-foetal development studies were performed in rabbits covering doses of 200, 600, 800, 1200 and 1800 mg/kg/day.
Slovenian: Štiri študije embriofetalnega razvoja pri kuncih so izvedli pri odmerkih 200, 600, 800, 1200 in 1800 mg/kg/dan.
English: Only use the 1 ml syringe included in the package.
Slovenian: Uporabite samo 1 ml brizgo, ki se nahaja v pakiranju.
English: In vitro studies show that levetiracetam affects intraneuronal Ca levels by partial inhibition of N
Slovenian: 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.
English: Keppra contains methyl parahydroxybenzoate, propyl parahydroxybenzoate and maltitol Keppra oral solution includes methyl parahydroxybenzoate (E218) and propyl parahydroxybenzoate (E216) which may cause allergic reactions (possibly delayed).
Slovenian: Zdravilo Keppra vsebuje metilparahidroksibenzoat, propilparahidroksibenzoat in maltitol Zdravilo Keppra vsebuje metilparahidroksibenzoat (E218) in propilparahidroksibenzoat (E216), ki lahko povzročata alergijske reakcije (lahko so zakasnele).
English: Excipient with known effect: Each film-coated tablet contains 0.19 mg of sunset yellow FCF (E110).
Slovenian: Ena filmsko obložena tableta vsebuje 0,19 mg barvila sončno rumeno FCF (E110).
English: How to take Keppra
Slovenian: Kako jemati zdravilo Keppra
English: The other ingredients are: Tablet core: croscarmellose sodium, macrogol 6000, silica colloidal anhydrous, magnesium stearate.
Slovenian: Jedro tablete: premreženi natrijev karmelozat, makrogol 6000, brezvodni koloidni silicijev dioksid, magnezijev stearat
English: The other ingredients are: sodium acetate, glacial acetic acid, sodium chloride, water for injections.
Slovenian: Druge sestavine zdravila so: natrijev acetat, koncentrirana ocetna kislina, natrijev klorid, voda za injekcije
English: 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.
Slovenian: Odmerki 1800 mg/kg/dan so sprožili izrazito toksičnost pri samicah in zmanjšanje telesne mase zarodka, povezano s povečanjem pogostnosti zarodkov s kardiovaskularnimi/skeletnimi anomalijami.
English: 44.6 % of the levetiracetam treated patients and 19.6 % of the patients on placebo had a 50 % or greater reduction from baseline in the partial onset seizure frequency per week.
Slovenian: Pri 44,6 % bolnikov, ki so se zdravili z levetiracetamom, in 19,6 % bolnikov, ki so prejemali placebo, je bilo 50- ali več odstotno zmanjšanje pogostnosti parcialnih napadov na teden.
English: Serum Creatinine (mg/dl)
Slovenian: 72 x koncentracija kreatinina v serumu (mg/dl)
English: Preparation and administration of Keppra concentrate
Slovenian: Preglednica 1: Priprava in uporaba koncentrata zdravila Keppra
English: The in vitro data and in vivo interaction data on oral contraceptives, digoxin and warfarin indicate that no significant enzyme induction is expected in vivo.
Slovenian: In vitro podatki in in vivo podatki medsebojnega delovanja peroralnih kontraceptivov, digoksina in varfarina kažejo, da ni pričakovati pomembne in vivo encimske indukcije, zato je malo možnosti za interakcije med zdravilom Keppra in drugimi snovmi oz. obratno.
English: Only use the 10 ml syringe included in the package.
Slovenian: Uporabite samo 10 ml brizgo, ki se nahaja v pakiranju.
English: The 300 ml glass bottle of Keppra (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 Keppra (za otroke, stare 4 leta in več, mladostnike in odrasle) so pakirane v škatle, ki vsebujejo še 10 ml brizgo za peroralno dajanje (z oznako na vsakih 0,25 ml) in adapter za brizgo.
English: Multipack: 200 (2 packs of 100) film-coated tablets
Slovenian: FARMACEVTSKA OBLIKA IN VSEBINA Večkratno pakiranje: 200 (2 pakiranji po 100) filmsko obloženih tablet
English: Contains sunset yellow (E 110).
Slovenian: Vsebuje sončno rumeno FCF (E110).
English: Other ingredients include sodium acetate, glacial acetic acid, sodium chloride, water for injections.
Slovenian: Pomožne snovi so natrijev acetat, koncentrirana ocetna kislina, natrijev klorid, voda za injekcije.
English: See Table 1 for the recommended preparation and administration of Keppra concentrate for solution for infusion to achieve a total daily dose of 500 mg, 1,000 mg, 2,000 mg, or 3,000 mg in two divided doses.
Slovenian: 6.6 Posebni varnostni ukrepi za odstranjevanje in ravnanje z zdravilom Glejte Preglednico 1 za priporočeno pripravo in uporabo zdravila Keppra koncentrat za raztopino za infundiranje, da se doseže celokupni dnevni odmerek 500 mg, 1000 mg, 2000 mg ali 3000 mg razdeljen na dva odmerka.
English: Levetiracetam efficacy was established in a 24-week double-blind, placebo-controlled study, which included adults, adolescents and a limited number of children suffering from idiopathic generalized epilepsy with primary generalized tonic-clonic (PGTC) seizures in different syndromes (juvenile myoclonic epilepsy, juvenile absence epilepsy, childhood absence epilepsy, or epilepsy with Grand Mal seizures on awakening).
Slovenian: Učinkovitost levetiracetama je bila dokazana v 24-tedenski dvojno slepi, s placebom nadzorovani študiji, ki je vključevala odrasle, mladostnike in omejeno število otrok z idiopatsko generalizirano epilepsijo s primarno generaliziranimi tonično-kloničnimi (PGTC) napadi pri različnih sindromih (juvenilna mioklonična epilepsija, juvenilna epilepsija z absencami, otroška epilepsija z absencami ali epilepsija z grand mal napadi pri prebujanju).
English: One vial of Keppra concentrate contains 500 mg levetiracetam (5 ml concentrate of 100 mg/ml).
Slovenian: Ena viala koncentrata zdravila Keppra vsebuje 500 mg levetiracetama (5 ml koncentrata po
English: Only use the 3 ml syringe included in the package.
Slovenian: Uporabite samo 3 ml brizgo, ki se nahaja v pakiranju.
English: EU/1/00/146/028 200 tablets (2 packs of 100) EU/1/00/146/036 100 x 1 tablets
Slovenian: EU/1/00/146/028 200 tablet (2 pakiranji po 100) EU/1/00/146/036 100 x 1 tableta
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 brizgo za peroralno uporabo (ki vsebuje do 300 mg levetiracetama) z oznako za vsak 0,1 ml (kar ustreza 10 mg).
English: How Keppra is given
Slovenian: Kako se daje zdravilo Keppra
English: For children 6 years and above, Keppra 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.
Slovenian: Za otroke, stare 6 let in več, se mora pri odmerkih, manjših od 250 mg, pri odmerkih, ki niso večkratniki od 250 mg in se zato priporočenega odmerjanja ne more doseči z večimi tabletami in pri bolnikih, ki ne morejo požirati tablet, uporabiti zdravilo Keppra peroralna raztopina.
English: EU/1/00/146/026 200 tablets (2 packs of 100) EU/1/00/146/037 100 x 1 tablets
Slovenian: EU/1/00/146/026 200 tablet (2 pakiranji po 100) EU/1/00/146/037 100 x 1 tableta
English: Film-coating: Polyvinyl alcohol-part. hydrolyzed, titanium dioxide (E171), macrogol 3350, talc, colourants*.
Slovenian: Filmska obloga: delno hidroliziran polivinilalkohol, titanov dioksid (E171), makrogol 3350, smukec, barvila*
English: • Dose in adults and adolescents (12 to 17 years) weighing 50 kg or more: General dose: between 1,000 mg and 3,000 mg each day.
Slovenian: • Odmerjanje pri odraslih in mladostnikih (od 12 do 17 let), težkih 50 kg ali več Običajni odmerek: med 1000 mg in 3000 mg na dan.
English: Concentrate for solution for infusion (sterile concentrate).
Slovenian: FARMACEVTSKA OBLIKA koncentrat za raztopino za infundiranje (sterilni koncentrat) Bistra, brezbarvna tekočina.
English: • in the treatment of primary generalised tonic-clonic seizures in adults and adolescents from 12 years of age with Idiopathic Generalised Epilepsy.
Slovenian: • primarno generaliziranih tonično-kloničnih napadov pri odraslih in mladostnikih od 12. leta starosti z idiopatsko generalizirano epilepsijo
English: One tablet of Keppra 1,000 mg contains 1,000 mg of levetiracetam.
Slovenian: Ena tableta zdravila Keppra 1000 mg vsebuje 1000 mg levetiracetama.
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 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 Keppra (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 Keppra (za dojenčke, stare od 1 meseca do manj kot 6 mesecev) so pakirane v škatle, ki vsebujejo še 1 ml brizgo za peroralno dajanje (z oznako na vsakih 0,05 ml) in adapter za brizgo.
English: Dose in adults and adolescents (12 to 17 years) weighing 50 kg or more: General dose: between 1,000 mg and 3,000 mg each day.
Slovenian: Odmerjanje pri odraslih in mladostnikih (od 12 do 17 let), težkih 50 kg ali več Običajni odmerek: med 1000 mg in 3000 mg na dan.
English: • in the treatment of myoclonic seizures in adults and adolescents from 12 years of age with Juvenile Myoclonic Epilepsy.
Slovenian: • miokloničnih napadov pri odraslih in mladostnikih od 12. leta starosti z juvenilno mioklonično epilepsijo
English: EU/1/00/146/030 (polytetrafluoroethylene -faced stopper) EU/1/00/146/033 (Uncoated stopper)
Slovenian: ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/00/146/030 (s politetrafluoroetilenom prevlečen zamašek) EU/1/00/146/033 (neprevlečen zamašek)
English: For infants 1 month to less than 6 months, measure the appropriate dosage using the 1 ml syringe included in the package.
Slovenian: Odmerjanje pri dojenčkih (od 1 meseca do manj kot 6 mesecev) Za dojenčke, stare od 1 meseca do manj kot 6 mesecev, ustrezen odmerek izmerite z uporabo 1 ml brizge, ki je priložena k zdravilu.
English: • Keppra is not indicated in children and adolescents below 16 years on its own (monotherapy).
Slovenian: • zdravilo Keppra, pri otrocih in mladostnikih, mlajših od 16 let, ni indicirano za samostojno zdravljenje (monoterapija).
English: If you stop using Keppra:
Slovenian: Če ste prenehali uporabljati zdravilo Keppra
English: The 150 ml glass bottle of Keppra (for infants and young children aged from 6 months to less than 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 Keppra (za dojenčke in mlajše otroke, stare od 6 mesecev do manj kot 4 let) so pakirane v škatle, ki vsebujejo še 3 ml brizgo za peroralno dajanje (z oznako na vsakih 0,1 ml) in adapter za brizgo.
English: Keppra 100 mg/ml oral solution Levetiracetam
Slovenian: Keppra 100 mg/ml peroralna raztopina levetiracetam
English: anger, confusion, panic attack, emotional instability/mood swings, agitation;
Slovenian: halucinacije, jeza, zmedenost, napad panike, čustvena nestabilnost/nihanja v razpoloženju,
English: Keppra 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.
Slovenian: Zdravilo Keppra 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.
English: EU/1/00/146/001 20 tablets EU/1/00/146/002 30 tablets EU/1/00/146/003 50 tablets EU/1/00/146/004 60 tablets EU/1/00/146/005 100 tablets EU/1/00/146/029 200 tablets (2 packs of 100) EU/1/00/146/034 100 x 1 tablets
Slovenian: EU/1/00/146/001 20 tablet EU/1/00/146/002 30 tablet EU/1/00/146/003 50 tablet EU/1/00/146/004 60 tablet EU/1/00/146/005 100 tablet EU/1/00/146/029 200 tablet (2 pakiranji po 100) EU/1/00/146/034 100 x 1 tableta
English: What Keppra contains
Slovenian: Kaj vsebuje zdravilo Keppra
English: Blue, 13mm oblong, scored and debossed with the code “ucb” and “250” on one side.
Slovenian: Modra, 13 mm podolgovata tableta z zarezo, z vtisnjenima oznakama “ucb” in “250” na eni strani.
English: 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.
Slovenian: Po posamičnem 1000 mg odmerku je največja koncentracija (Cmax) ponavadi 31 µg/ml, po ponavljajočih odmerkih 1000 mg dvakrat na dan pa 43 µg/ml.
English: Keppra 1000 mg
Slovenian: PODATKI V BRAILLOVI PISAVI Keppra 1000 mg
English: EU/1/00/146/006 10 tablets EU/1/00/146/007 20 tablets EU/1/00/146/008 30 tablets EU/1/00/146/009 50 tablets EU/1/00/146/010 60 tablets EU/1/00/146/011 100 tablets EU/1/00/146/012 120 tablets EU/1/00/146/013 200 tablets (2 packs of 100) EU/1/00/146/035 100 x 1 tablets
Slovenian: EU/1/00/146/006 10 tablet EU/1/00/146/007 20 tablet EU/1/00/146/008 30 tablet EU/1/00/146/009 50 tablet EU/1/00/146/010 60 tablet EU/1/00/146/011 100 tablet EU/1/00/146/012 120 tablet EU/1/00/146/013 200 tablet (2 pakiranji po 100) EU/1/00/146/035 100 x 1 tableta
English: Keppra 750 mg film-coated tablets are orange, 18 mm oblong, scored and debossed with the code “ucb” and “750” on one side.
Slovenian: Zdravilo Keppra 750 mg filmsko obložene tablete so oranžne, 18 mm podolgovate, z zarezo in imajo na eni strani vtisnjeni oznaki »ucb« in »750«.
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 (12-kratna vrednost največjega priporočenega odmerka pri ljudeh glede na mg/m2) in pri plodovih 1200 mg/kg/dan.
English: One tablet of Keppra 750 mg contains 750 mg of levetiracetam.
Slovenian: Ena tableta zdravila Keppra 750 mg vsebuje 750 mg levetiracetama.
English: If you stop taking Keppra:
Slovenian: Če ste prenehali jemati zdravilo Keppra
English: Preparation and administration of Keppra concentrate for solution for infusion Dose Withdrawal Volume
Slovenian: Preglednica 1: Priprava in uporaba zdravila Keppra koncentrat za raztopino za infundiranje
English: Indigo carmine aluminium lake (E132)
Slovenian: 250 mg tableta: indigotin (E132)
English: Keppra 100 mg/ml concentrate for solution for infusion
Slovenian: IME ZDRAVILA Keppra 100 mg/ml koncentrat za raztopino za infundiranje
English: Keppra contains sodium
Slovenian: Zdravilo Keppra vsebuje natrij
English: Orange, 18 mm oblong, scored and debossed with the code “ucb” and “750” on one side.
Slovenian: Oranžna, 18 mm podolgovata tableta z zarezo, z vtisnjenima oznakama “ucb” in “750” na eni strani.
English: Keppra 1000 mg film-coated tablets are white, 19 mm oblong, scored and debossed with the code “ucb” and“1000” on one side.
Slovenian: Zdravilo Keppra 1000 mg filmsko obložene tablete so bele, 19 mm podolgovate, z zarezo in imajo na eni strani vtisnjeni oznaki »ucb« in »1000«.
English: One tablet of Keppra 250 mg contains 250 mg of levetiracetam.
Slovenian: Ena tableta zdravila Keppra 250 mg vsebuje 250 mg levetiracetama.
English: The NOAEL was ≥ 1800 mg/kg/day for the F0 females, and for the survival, growth and development of the F1 offspring up to weaning (x 6 the MRHD on a mg/m2 basis).
Slovenian: Odmerek, pri katerem ni mogoče opaziti neželenih učinkov (NOAEL) je bil ≥1800 mg/kg/dan tako za F0 samice kot za preživetje, rast in razvoj F1 mladičev do prenehanja dojenja (6-kratna vrednost največjega priporočenega odmerka pri ljudeh glede na mg/m2).
English: One tablet of Keppra 500 mg contains 500 mg of levetiracetam.
Slovenian: Ena tableta zdravila Keppra 500 mg vsebuje 500 mg levetiracetama.
English: Keppra 100 mg/ml concentrate for solution for infusion Levetiracetam
Slovenian: Keppra 100 mg/ml koncentrat za raztopino za infundiranje levetiracetam
English: A dose of 20 mg/kg/day titrating to 40 mg/kg/day for infants one month to less than six months and a dose of 25 mg/kg/day titrating to 50 mg/kg/day for infants and children 6 months to less than 4 years old, was use in this study.
Slovenian: V tej študiji so pri dojenčkih, od 1. meseca do manj kot 6. meseca starosti, uporabljali odmerek 20 mg/kg/dan, titriran do 40 mg/kg/dan, za dojenčke in otroke, od 6. meseca do manj kot 4. leta starosti, pa odmerek 25 mg/kg/dan titriran do 50 mg/kg/dan.
English: Keppra concentrate for solution for infusion is packed in a cardboard box containing 10 vials of 5 ml.
Slovenian: 5 ml viale zdravila Keppra koncentrat za raztopino za infundiranje so pakirane v škatle po 10 skupaj.
English: White, 19 mm oblong, scored and debossed with the code “ucb” and “1000” on one side.
Slovenian: Bela, 19 mm podolgovata tableta z zarezo, z vtisnjenima oznakama “ucb” in “1000” na eni strani.
English: What Keppra looks like and contents of the pack Keppra 100 mg/ml oral solution is a clear liquid.
Slovenian: Zdravilo Keppra 100 mg/ml peroralna raztopina je bistra tekočina.
English: 60 mg (0.6 ml) twice daily 180 mg (1.8 ml) twice daily
Slovenian: 180 mg (1,8 ml) dvakrat na dan
English: Citric acid monohydrate Methyl parahydroxybenzoate (E218) Propyl parahydroxybenzoate (E216) Ammonium glycyrrhizate Glycerol (E422)
Slovenian: 6.1 Seznam pomožnih snovi natrijev citrat citronska kislina monohidrat metilparahidroksibenzoat (E218) propilparahidroksibenzoat (E216) amonijev glicirizinat glicerol (E422) raztopina maltitola (E965) kalijev acesulfamat (E950) aroma grozdja prečiščena voda
English: Keppra 750 mg
Slovenian: PODATKI V BRAILLOVI PISAVI Keppra 750 mg
English: Following dialysis, a 3.5 to 7 mg/kg (0.035 to 0.07 ml/kg) supplemental dose is recommended.
Slovenian: (4) Po dializi je priporočljiv dodatni odmerek od 3,5 do 7 mg/kg (0,035 do 0,07 ml/kg).
English: MARKETING AUTHORISATION NUMBER(S) EU/1/00/146/014 20 tablets
Slovenian: ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/00/146/032
English: Keppra 500 mg film-coated tablets are yellow, 16 mm oblong, scored and debossed with the code “ucb” and “500” on one side.
Slovenian: Zdravilo Keppra 500 mg filmsko obložene tablete so rumene, 16 mm podolgovate, z zarezo in imajo na eni strani vtisnjeni oznaki »ucb« in »500«.
English: Following dialysis, a 5 to 10 mg/kg (0.05 to 0.10 ml/kg) supplemental dose is recommended.
Slovenian: (2) Po dializi je priporočljiv dodatni odmerek od 5 to 10 mg/kg (0,05 do 0,10 ml/kg).
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: mg/kg/dan za samice in 200 mg/kg/dan za plodove (je enako največjemu priporočenemu odmerku pri ljudeh glede na mg/m2).
English: • 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).
Slovenian: • kot dopolnilo drugim protiepileptičnim zdravilom za zdravljenje: ▪ parcialnih napadov z generalizacijo ali brez nje pri odraslih, mladostnikih, otrocih in dojenčkih od 1 meseca starosti ▪ 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).
English: Therefore a 50 % reduction of the daily maintenance dose is recommended when the creatinine clearance is < 60 ml/min/1.73 m
Slovenian: Če je očistek kreatinina < 60 ml/min/1,73 m2, je priporočljivo zmanjšati dnevni vzdrževalni odmerek za