natgillin/translations-raw huggingface dataset:
A study conducted in paediatric patients (4 to 16 years) with partial onset seizures showed that 55.4% of the patients in the Keppra group and 40.2% of the patients in the placebo group experienced undesirable effects.
41 Študija, ki je bila izvedena pri otrocih (od 4 let do 16 let) z napadi parcialnega izvora, je pokazala, da je 55, 4% bolnikov, ki so prejemali Keppro, in 40, 2% bolnikov, ki so prejemali placebo, imelo neželene učinke.
Common: agitation, depression, emotional lability/ mood swings, hostility/ aggression, insomnia, nervousness/ irritability, personality disorders, thinking abnormal Post-marketing experience: abnormal behaviour, anger, anxiety, confusion, hallucination, psychotic disorder, suicide, suicide attempt and suicidal ideation
− Psihiatrične motnje Pogosti: agitiranost, depresija, čustvena labilnost/ nihanja v razpoloženju, sovražnost/ agresivnost, nespečnost, živčnost / razdražljivost, osebnostne motnje, motnje mišljenja Postmarketinške izkušnje: nenormalno vedenje, jeza, anksioznost, zmedenost, halucinacije, psihotične motnje, samomor, poskus samomora in razmišljanje o samomoru
- Ear and labyrinth disorders
42 − Ušesne bolezni, vključno z motnjami labirinta Pogosti: vrtoglavica
- Musculoskeletal and connective tissue disorders
− Očesne bolezni Pogosti: diplopija, zamegljen vid
- Injury, poisoning and procedural complications
− Bolezni mišično- skeletnega sistema in vezivnega tkiva Pogosti: mialgija
43 Somnolence, agitation, aggression, depressed level of consciousness, respiratory depression and coma were observed with Keppra overdoses.
Pri prevelikem odmerjanju Keppre so opažali zaspanost, agitiranost, agresivnost, zmanjšano stopnjo zavesti, depresijo dihanja in komo.
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.
43 In vitro študije so pokazale, da levetiracetam vpliva na nivo Ca2+ znotraj nevrona preko delne inhibicije N- tipa Ca2+ kanalov in znižanjem sproščanja Ca2+ iz zalog znotraj nevrona.
44 In pediatric patients (4 to 16 years of age), levetiracetam efficacy was established in a double-blind, placebo-controlled study, which included 198 patients and had a treatment duration of 14 weeks.
Pri otrocih (od 4 do 16 let) je bila učinkovitost levetiracetama dokazana v dvojno slepi, s placebom nadzorovani študiji, ki je vključevala 198 bolnikov in trajala 14 tednov.
In a study reflecting clinical practice, the concomitant antiepileptic medication could be withdrawn in a limited number of patients who responded to levetiracetam adjunctive therapy (36 adult patients out of 69).
44 V študiji, ki je odražala klinično prakso, je bilo mogoče pri omejenem številu bolnikov, ki so se odzvali na dopolnilno zdravljenje z levetiracetamom (36 od 69 odraslih bolnikov), prekiniti sočasno protiepileptično zdravljenje.
45 5.2 Pharmacokinetic properties
5. 2 Farmakokinetične lastnosti
Distribution
45 Porazdelitev
Following repeated oral dose administration (20 to 60 mg/ kg/ day) to epileptic children (4 to 12 years), levetiracetam was rapidly absorbed.
46 Po uporabi večkratnega peroralnega odmerka (od 20 do 60 mg/ kg/ dan) pri otrocih z epilepsijo (od 4 do 12 let) se je levetiracetam hitro absorbiral.
Sodium croscarmellose Macrogol 6000 Colloidal anhydrous silica Magnesium stearate
Jedro: premreženi natrijev karmelozat, makrogol 6000,
Film-coating Opadry 85F18422:
47 brezvodni koloidni silicijev dioksid, magnezijev stearat
Polyvinyl alcohol-part. hydrolyzed Titanium dioxide (E171) Macrogol 3350 Talc
Filmska obloga Opadry 85F18422: delno hidroliziran polivinilalkohol, titanov dioksid (E171), makrogol 3350 smukec
48 Keppra 1000 mg film-coated tablets are packaged in aluminium/ PVC blisters placed into cardboard boxes containing 10, 20, 30, 50, 60, 100 and 200 film-coated tablets.
Keppra 1000 mg filmsko obložene tablete so pakirane v pretisnih omotih aluminij/ PVC, v kartonskih škatlah po 10, 20, 30, 50, 60, 100 in 200 filmsko obloženih tablet.
Keppra 100 mg/ ml oral solution.
Keppra 100 mg/ ml peroralna raztopina
Each ml contains 100 mg levetiracetam Excipients: methyl parahydroxybenzoate (E218), propyl parahydroxybenzoate (E216) and 300 mg maltitol.
Pomožne snovi: metilparahidroksibenzoat (E218), propilparahidroksibenzoat (E216) in 300 mg maltitola.
The oral solution may be diluted in a glass of water and may be taken with or without food.
Jemlje se lahko s hrano ali brez nje.
A graduated oral syringe and instructions for use in the package leaflet are provided with Keppra.
Skupaj s Keppro je dobavljena še graduirana brizga za peroralno dajanje z napotki za uporabo, ki so opisani v navodilu za uporabo.
50 Depending upon the clinical response and tolerability, the daily dose can be increased up to 1,500 mg twice daily.
Dnevni odmerek se lahko poveča do 1500 mg dvakrat na dan glede na klinični odziv in toleranco.
Adjustment of the dose is recommended in elderly patients with compromised renal function (see “ Patients with renal impairment ” below).
50 Pri starejših bolnikih z okvarjenim delovanjem ledvic je priporočljiva prilagoditev odmerka (glejte spodaj “ Bolniki z ledvično okvaro ”).
The graduated oral syringe contains up to 1,000 mg levetiracetam (corresponding to 10 ml) with a graduation every 25 mg (corresponding to 0.25 ml).
Graduirana brizga za peroralno dajanje vsebuje do 1. 000 mg levetiracetama (kar ustreza do 10 ml) s stopnjevanjem po 25 mg (kar ustreza do 0, 25 ml).
Infants and children less than 4 years
Doječki in otroci, mlajši od 4 let
Keppra is not recommended for use in children below 4 years of age due to insufficient data on safety and efficacy (see section 5.2).
Pri otrocih, mlajših od 4 let, zdravila Keppra ni priporočljivo uporabljati, ker ni dovolj podatkov glede varnosti in učinkovitosti (glejte poglavje 5. 2).
51 Dosing adjustment for adult patients with impaired renal function
51 skupina
52 Therefore patients should be monitored for signs of depression and/ or suicidal ideation and behaviours and appropriate treatment should be considered.
Zato je treba bolnike med zdravljenjem nadzirati glede znakov depresije in/ ali samomorilnega razmišljanja in vedenja ter razmisliti o ustreznem zdravljenju.
Keppra 100 mg/ ml oral solution includes methyl parahydroxybenzoate (E218) and propyl parahydroxybenzoate (E216) which may cause allergic reactions (possibly delayed).
Keppra 100 mg/ ml peroralna raztopina vsebuje metilparahidroksibenzoat (E218) in propilparahidroksibenzoat (E216), ki lahko povzročata alergijske reakcije (lahko so zakasnele).
It also includes maltitol; patients with rare hereditary problems of fructose intolerance should not take this medicine.
Vsebuje tudi maltittol; bolniki z redko prirojeno intoleranco za fruktozo ne smejo jemati tega zdravila.
4.5 Interaction with other medicinal products and other forms of interaction
52 4. 5 Medsebojno delovanje z drugimi zdravili in druge oblike interakcij
Therefore, caution is recommended in those patients when performing skilled tasks, e. g. driving vehicles or operating machinery.
Ti bolniki morajo biti zato previdni pri izvajanju zahtevnih opravil, npr. pri vožnji
Pooled safety data from clinical studies conducted with Keppra oral formulations in adult patients with partial onset seizures showed that 46.4% of the patients in the Keppra group and 42.2% of the patients in the placebo group experienced undesirable effects.
Kumulativni varnostni podatki iz kliničnih študij izvedenih pri odraslih bolnikih z napadi parcialnega izvora, ki so prejemali peroralne oblike, kažejo, da so se neželeni učinki pojavili pri 46, 4% bolnikov, ki so prejemali Keppro, in 42, 2% bolnikov, ki so prejemali placebo.
54 Very common: asthenia/ fatigue.
− Splošne težave in spremembe na mestu aplikacije Zelo pogosti: astenija/ utrujenost
Common: abdominal pain, diarrhoea, dyspepsia, nausea, vomiting Post-marketing experience: pancreatitis
54 Postmarketinške izkušnje: nenormalno vedenje, jeza, anksioznost, zmedenost, halucinacije, psihotične motnje, samomor, poskus samomora in razmišljanje o samomoru
- Skin and subcutaneous tissue disorders
− Bolezni dihal, prsnega koša in mediastinalnega prostora Pogosti: zmanjšan kašelj
Common: thrombocytopenia Post-marketing experience: leukopenia, neutropenia, pancytopenia (with bone marrow suppression identified in some of the cases).
− Bolezni krvi in limfatičnega sistema Pogosti: trombocitopenija Postmarketinške izkušnje: levkopenija, nevtropenija, pancitopenija (s supresijo kostnega mozga v posameznih primerih)
55 Symptoms Somnolence, agitation, aggression, depressed level of consciousness, respiratory depression and coma were observed with Keppra overdoses.
Pri prevelikem odmerjanju Keppre so opažali zaspanost, agitiranost, agresivnost, zmanjšano stopnjo zavesti, depresijo dihanja in komo.
Management of overdose After an acute overdose, the stomach may be emptied by gastric lavage or by induction of emesis.
Po akutnem prevelikem odmerjanju lahko želodec izpraznimo z izpiranjem ali sprožitvijo bruhanja.
N03AX14 The active substance, levetiracetam, is a pyrrolidone derivative (S-enantiomer of α -ethyl-2-oxo-1- pyrrolidine acetamide), chemically unrelated to existing antiepileptic active substances.
Zdravilna učinkovina levetiracetam je pirolidonski derivat (S- enantiomer α- etil- 2- okso- 1 - pirolidinacetamida), ki kemično ni podoben drugim protiepileptičnim učinkovinam.
Pharmacodynamic effects Levetiracetam induces seizure protection in a broad range of animal models of partial and primary generalised seizures without having a pro-convulsant effect.
Levetiracetam povzroči zaščito pred parcialnimi in primarno generaliziranimi napadi pri širokem spektru živalskih modelov in nima prokonvulzivnega učinka.
56 In pediatric patients (4 to 16 years of age), levetiracetam efficacy was established in a double-blind, placebo-controlled study, which included 198 patients and had a treatment duration of 14 weeks.
Pri otrocih (od 4 do 16 let) je bila učinkovitost levetiracetama dokazana v dvojno slepi, s placebom nadzorovani študiji, ki je vključevala 198 bolnikov in trajala 14 tednov.
Efficacy of levetiracetam as monotherapy was established in a double-blind, parallel group, non- inferiority comparison to carbamazepine controlled release (CR) in 576 patients 16 years of age or older with newly or recently diagnosed epilepsy.
Samostojno zdravljenje napadov parcialnega izvora s sekundarno generalizacijo ali brez nje pri bolnikih, od 16. leta starosti, z na novo diagnosticirano epilepsijo 56 Učinkovitost levetiracetama za samostojno zdravljenje je bila dokazana pri vzporednih skupinah, v dvojno slepi študiji, 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.
57 5.2 Pharmacokinetic properties
5. 2 Farmakokinetične lastnosti
Adults and adolescents
57 Odrasli in mladostniki
The renal clearance of levetiracetam and ucb L057 is 0.6 and 4.2 ml/ min/ kg respectively indicating that levetiracetam is excreted by glomerular filtration with subsequent tubular reabsorption and that the primary metabolite is also excreted by active tubular secretion in addition to glomerular filtration.
Ledvični očistek levetiracetama 0, 6 ml/ min/ kg in njegovega primarnega presnovka ucb L057 4, 2 ml/ min/ kg kažeta na to, da se levetiracetam izloča z glomerulno filtracijo, ki ji sledi tubularna
In the rabbit foetal effects (embryonic death, increased skeletal anomalies, and increased malformations) were observed in the presence of maternal toxicity.
Pri kuncih so v primeru toksičnosti pri materi opažali učinke na plod (smrt zarodkov, številnejše anomalije okostja in
Sodium citrate Citric acid monohydrate Methyl parahydroxybenzoate (E218) Propyl parahydroxybenzoate (E216) Ammonium glycyrrhizate Glycerol (E422) Maltitol (E965) Acesulfame potassium (E950) Grape flavour Purified water
natrijev citrat citronska kislina monohidrat metilparahidroksibenzoat (E218) propilparahidroksibenzoat (E216) amonijev glicirizinat glicerol (E422) maltitol (E965) kalijev acesulfamat (E950) aroma grozdja prečiščena voda
Finished product:
Končni izdelek:
2 months
2 meseca.
60 300 ml amber glass bottle (type III) with a white child resistant closure (polypropylene) in a cardboard box also containing a graduated oral syringe (polyethylene, polystyrene) and a patient information leaflet.
300 ml steklenica (tip III) jantarne barve z belo za otroke varno zaporko (polipropilen) v kartonski škatli, ki vsebuje še graduirano brizgo za peroralno dajanje (polietilen, polistiren) in navodilo za uporabo.
EU/ 1/ 00/ 146/ 027
60 EU/ 1/ 00/ 146/ 027
Keppra 100 mg/ ml concentrate for solution for infusion.
Keppra 100 mg/ ml koncentrat za raztopino za infundiranje
The 5 ml vial contains 500 mg of levetiracetam.
5 ml viala vsebuje 500 mg levetiracetama.
Keppra concentrate is a clear, colorless, sterile solution.
Koncentrat Keppre je bistra, brezbarvna, sterilna raztopina.
Keppra concentrate is an alternative for patients when oral administration is temporarily not feasible.
Koncentrat Keppre je alternativa za bolnike, ko peroralna uporaba začasno ni mogoča.
Keppra therapy can be initiated with either intravenous or oral administration.
Zdravljenje s Keppro lahko začnemo z intravensko ali peroralno uporabo.
The total daily dose and frequency of administration should be maintained.
Celotni dnevni odmerek in pogostost uporabe morata ostati enaka.
Keppra concentrate is for intravenous use only and the recommended dose must be diluted in at least 100 ml of a compatible diluent and administered intravenously as a 15-minute intravenous infusion (see section 6.6).
Koncentrat Keppre je samo za intravensko uporabo, priporočeni odmerek mora biti razredčen v vsaj 100 ml kompatibilnega topila in uporabljen intravensko kot 15- minutna intravenska infuzija (glejte poglavje 6. 6).
62 Adults (≥ 18 years) and adolescents (12 to 17 years) weighing 50 kg or more
• Dopolnilno zdravljenje Odrasli (≥ 18 let) in mladostniki (od 12 do 17 let), težki 50 kg in več.
The initial therapeutic dose is 500 mg twice daily.
62 Začetni terapevtski odmerek je 500 mg dvakrat na dan.
A Keppra concentrate vial contains 500 mg levetiracetam in 5 ml (corresponding to 100 mg/ ml).
Viala koncentrata Keppre vsebuje 500 mg v 5 ml (ustreza 100 mg/ ml).
Infants and children less than 4 years
Doječki in otroci, mlajši od 4 let Pri otrocih, mlajših od 4 let, zdravilo Keppra ni priporočljivo uporabljati, ker ni dovolj podatkov glede varnosti in učinkovitosti (glejte poglavje 5. 2).
63 CLcr (ml/ min) CLcr (ml/ min/ 1.73 m2) = ---------------------------- x 1.73 BSA subject (m2)
63 CLcr (ml/ min) CLcr (ml/ min/ 1, 73 m2) = ---------------------------- x 1, 73 BSA (m2)
Dosing adjustment for adult patients with impaired renal function
Prilagoditev odmerjanja pri odraslih bolnikih z okvarjenim delovanjem ledvic
500 500 250 250 500
500 do 1. 500 mg dvakrat na dan 500 do 1. 000 mg dvakrat na dan 250 do 750 mg dvakrat na dan 250 do 500 mg dvakrat na dan 500 do 1. 000 mg enkrat na dan( 2)
to 1,500 mg twice daily to 1,000 mg twice daily to 750 mg twice daily to 500 mg twice daily to 1,000 mg once daily (2)
končna ledvična odpoved (1) bolniki na dializi (1)
A meta-analysis of randomized placebo-controlled
Pri bolnikih, ki so se zdravili z antiepileptiki (vključno z levetiracetamom), so poročali o samomoru, poskusu samomora, samomorilnem razmišljanju in vedenju.
64 trials of anti-epileptic drugs has shown a small increased risk of suicidal thoughts and behaviour.
Majhno povečanje tveganja za pojav samomorilnega razmišljanja in vedenja je pokazala tudi metaanaliza randomiziranih, s placebom nadzorovanih kliničnih preskušanj antiepileptikov.
Therefore patients should be monitored for signs of depression and/ or suicidal ideation and behaviours and appropriate treatment should be considered.
64 Zato je treba bolnike med zdravljenjem nadzirati glede znakov depresije in/ ali samomorilnega razmišljanja in vedenja ter razmisliti o ustreznem zdravljenju.
This medicinal product contains 0.313 mmol (or 7.196 mg) of sodium per vial.
To zdravilo vsebuje 0, 313 mmol (ali 7, 196 mg) natrija na vialo.
65 4.7 Effects on ability to drive and use machines
4. 7 Vpliv na sposobnost vožnje in upravljanja s stroji
Due to possible different individual sensitivity, some patients might experience somnolence or other central nervous system related symptoms, especially at the beginning of treatment or following a dose increase.
65 Pri nekaterih bolnikih se lahko zaradi različne individualne občutljivosti predvsem na začetku zdravljenja ali po povečanju odmerka pojavi zaspanost ali drugi simptomi povezani s centralnim živčnim sistemom.
Undesirable effects that resulted from Keppra intravenous use are similar to those associated with Keppra oral use.
Neželeni učinki pri intravenski uporabi Keppre so podobni tistim, ki so povezani s peroralno uporabo Keppre.
The most frequently reported adverse reactions were dizziness, somnolence, headache and postural dizziness.
Neželeni učinki, o katerih so najpogosteje poročali, so omotica, zaspanost, glavobol in posturalna omotica.
Since there was limited exposure for Keppra intravenous use and since oral and intravenous formulations are bioequivalent, the safety information of Keppra intravenous will rely on Keppra oral use.
Zaradi omejene uporabe Keppre za intravensko uporabo in bioekvivalence med peroralno in intravensko obliko, se podatki o varnosti pri Keppri za intravensko uporabo nanašajo na Keppro za peroralno uporabo.
For clinical trials, the frequency is defined as follows: very common (≥ 1/ 10); common (≥ 1/ 100, < 1/ 10); uncommon:
(≥1/ 10); pogosti:
(≥ 1/ 1,000, < 1/ 100); rare (≥ 1/ 10,000, < 1/ 1,000); very rare (< 1/ 10,000), including isolated reports.
(≥1/ 1, 000, < 1/ 100); redki:
Common: amnesia, ataxia, convulsion, dizziness, headache, hyperkinesia, tremor, balance disorder, disturbance in attention, memory impairment Post-marketing experience: paraesthesia
− Bolezni živčevja Zelo pogosti: somnolenca 66 Pogosti: amnezija, ataksija, konvulzije, omotica, glavobol, hiperkinezija, tremor, motnje ravnotežja, motnje pozornosti, oslabljen spomin Postmarketinške izkušnje: parestezija
Post-marketing experience: abnormal behaviour, anger, anxiety, confusion, hallucination, psychotic disorder, suicide, suicide attempt and suicidal ideation.
− Psihiatrične motnje Pogosti: agitiranost, depresija, čustvena labilnost/ nihanja v razpoloženju, sovražnost/ agresivnost, nespečnost, živčnost/ razdražljivost, osebnostne motnje, motnje mišljenja Postmarketinške izkušnje: nenormalno vedenje, jeza, anksioznost, zmedenost, halucinacije, psihotične motnje, samomor, poskus samomora in razmišljanje o samomoru
Post-marketing experience: pancreatitis
− Bolezni prebavil Pogosti: bolečina v trebuhu, driska, dispepsija, navzea, bruhanje Postmarketinške izkušnje: pankreatitis
Post-marketing experience: hepatic failure, hepatitis, liver function test abnormal
– Bolezni jeter, žolčnika in žolčevodov Postmarketinške izkušnje: odpoved jeter, hepatitis, nenormalne vrednosti testov jetrnih funkcij − Presnovne in prehranske motnje Pogosti: anoreksija, povečanje telesne mase.
The risk of anorexia is higher when topiramate is coadministered with levetiracetam.
Tveganje za pojav anoreksijo je večje pri sočasni uporabi topiramata in levetiracetama.
Common: rash, eczema, pruritus Post-marketing experience: alopecia: in several cases, recovery was observed when Keppra was discontinued
− Bolezni kože in podkožja Pogosti: izpuščaj, ekcem, pruritus Postmarketinške izkušnje: alopecija: v nekaterih primerih so po prekinitvi zdravljenja s Keppro opazili izboljšanje.
Common: thrombocytopenia Post-marketing experience: leukopenia, neutropenia, pancytopenia (with bone marrow suppression identified in some of the cases).
− Bolezni krvi in limfatičnega sistema Pogosti: trombocitopenija Postmarketinške izkušnje: levkopenija, nevtropenija, pancitopenija
67 4.9 Overdose
4. 9 Preveliko odmerjanje
There is no specific antidote for levetiracetam.
67 Specifičnega antidota za levetiracetam ni.
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 N- tipa Ca2+ kanalov in znižanjem sproščanja Ca2+ iz zalog znotraj nevrona.
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 kanalov povzročeno z Zn2+ in β - karbolini.
Levetiracetam and related analogues 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 afinitetno vrsto za vezavo na sinaptični vezikularni protein 2A, ki korelira z jakostjo protiepileptične zaščite pri mišjem audiogenem modelu epilepsije.
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 68 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.
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.
Z
With continued long-term treatment, 11.4% of the patients were seizure-free for at least 6 months and 7.2% were seizure-free for at least 1 year.
68 nadaljevanjem dolgotrajnega zdravljenja je bilo 11, 4% bolnikov brez napada vsaj 6 mesecev, 7, 2% pa jih je bilo brez napada vsaj 1 leto.
69 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.
The intravenous administration of doses up to 4000 mg diluted in 100 ml of 0.9% sodium chloride infused over 15 minutes and doses up to 2500 mg diluted in 100 ml of 0.9% sodium chloride infused over 5 minutes was evaluated.
Ovrednotena je bila intravenska uporaba odmerkov do 4000 mg, razredčenih v 100 ml 0, 9% natrijevega klorida, infundiranih 15 minut in odmerkov do 2500 mg, razredčenih v 100 ml 0, 9%
The time independent pharmacokinetic profile of levetiracetam was also confirmed following 1500 mg intravenous infusion for 4 days with b. i. d dosing.
Potrjen je bil tudi časovno neodvisen farmakokinetični profil levetiracetama pri intravenski infuziji 1500 mg dvakrat dnevno 4 dni.
Peak plasma concentration (Cmax) observed in 17 subjects following a single intravenous dose of 1500 mg infused over 15 minutes was 51 ± 19 µg/ mL (arithmetic average ± standard deviation).
Največja plazemska koncentracija (Cmax) 51 ± 19 μg/ ml (aritmetična sredina ± standardna deviacija) je bila pri 17 preiskovancih po enkratnem intravenskem odmerku 1500 mg, infundiranem 15 minut.
The in vitro data and in
Levetiracetam je povzročil blago indukcijo CYP2B6 in CYP3A4.
The renal clearance of levetiracetam and ucb L057 is 0.6 and 4.2 ml/ min/ kg respectively indicating that levetiracetam is excreted by glomerular filtration with subsequent tubular reabsorption and that the primary metabolite is also excreted by active tubular secretion in addition to glomerular filtration.
Ledvični očistek levetiracetama 0, 6 ml/ min/ kg in njegovega primarnega presnovka ucb L057 4, 2 ml/ min/ kg kažeta na to, da se levetiracetam izloča z glomerulno filtracijo, ki ji sledi tubularna 70 reabsorpcija, primarni presnovek pa se poleg glomerulne filtracije izloča tudi z aktivno tubularno sekrecijo.