natgillin/translations-raw huggingface dataset:
500 to 1,500 mg twice daily 500 to 1,000 mg twice daily 250 to 750 mg twice daily 250 to 500 mg twice daily 500 to 1,000 mg once daily
500 do 1500 mg dvakrat na dan 500 do 1000 mg dvakrat na dan 250 do 750 mg dvakrat na dan 250 do 500 mg dvakrat na dan 500 do 1000 mg enkrat na dan(2)
Contains E216, E218 and maltitol liquid.
SEZNAM POMOŽNIH SNOVI Vsebuje E216, E218 in raztopino maltitola.
Keppra is used:
Zdravilo Keppra se uporablja:
You can switch from the film-coated tablets or from the oral solution to the intravenous formulation or reverse directly without dose adaptation.
Prehod od filmsko obloženih tablet ali od peroralne raztopine k intravenski obliki ali obratno je lahko neposreden brez prilagajanja odmerka.
Other medicines and Keppra
Druga zdravila in zdravilo Keppra
Dose and frequency (1) Infants 1 to less than 6 months
odmerjanje in pogostnost(1) Dojenčki od 1 do manj kot 6 mesecev
The recommended dose must be diluted in at least 100 ml of a compatible diluent and infused over 15-minutes.
Priporočen odmerek se mora razredčiti v vsaj 100 ml kompatibilnega topila in infundirano 15 minut.
• convulsion, balance disorder (equilibrium disorder), dizziness (sensation of unsteadiness),lethargy (lack of energy and enthusiasm), tremor (involuntary trembling);
• konvulzije, motnje ravnotežja, omotica (občutek nesigurnosti), letargija (pomanjkanje energije in navdušenja), tremor (nehoteno tresenje)
In all of the above cases Keppra oral solution should be used.
V vseh teh primerih se mora uporabiti zdravilo Keppra peroralna raztopina.
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 izpostavljenosti zdravila Keppra za intravensko uporabo in bioekvivalence med peroralno in intravensko obliko se informacije o varnosti za zdravilo Keppra za intravensko uporabo navezujejo na zdravilo Keppra za peroralno uporabo.
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 zdravila Keppra 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).
Results related to behavioural and emotional functioning indicated a worsening in levetiracetam treated patients on aggressive behaviour as measured in a standardised and systematic way using a validated instrument (CBCL - Achenbach Child Behavior Checklist).
Rezultati, povezani z vedenjskimi in emocionalnimi funkcijami, kažejo pri bolnikih, ki se zdravijo z levetiracetamom, poslabšanje agresivnega obnašanja, ki se izmeri na standardiziran in sistematičen način z uporabo validiranega merskega instrumenta (CBCL - Achenbach Child Behavior Checklist).
UCB Pharma SA, Chemin du Foriest, B-1420 Braine-l'Alleud, Belgium For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder.
UCB Pharma SA, Chemin du Foriest, B-1420 Braine-l'Alleud, Belgija Za vse morebitne nadaljnje informacije o tem zdravilu se lahko obrnete na predstavništvo imetnika dovoljenja za promet z zdravilom.
For doctors and nurses, more detailed direction for the proper use of Keppra is provided in section 6.
Za zdravnike in medicinske sestre so podrobna navodila za uporabo zdravila Keppra navedena v poglavju 6.
The active substance, levetiracetam, is a pyrrolidone derivative (S-enantiomer of -ethyl-2-oxo-1pyrrolidine acetamide), chemically unrelated to existing antiepileptic active substances.
Zdravilna učinkovina levetiracetam je pirolidonski derivat (S-enantiomer -etil-2-okso-1pirolidinacetamida), ki kemično ni podoben drugim protiepileptičnim učinkovinam.
• If you are allergic to levetiracetam, pyrrolidone derivatives or any of the other ingredients of this medicine (listed in Section 6).
• če ste alergični na levetiracetam, pirolidonske derivate ali katero koli sestavino tega zdravila
• Keppra is used as a chronic treatment.
• Zdravilo Keppra se uporablja za dolgotrajno zdravljenje.
The score line is only to facilitate breaking for ease of swallowing and not to divide into equal doses.
Razdelilna zareza je namenjena le delitvi tablete za lažje požiranje in ne delitvi na dva enaka odmerka.
Duration of treatment There is no experience with administration of intravenous levetiracetam for longer period than 4 days.
Trajanje zdravljenja • Ni izkušenj z intravensko uporabo levetiracetama za obdobje daljše od 4 dni.
Keppra concentrate for solution for infusion is an alternative for patients when administration of the antiepileptic oral Keppra medicine is temporarily not feasible.
Zdravilo Keppra koncentrat za raztopino za infundiranje je alternativa za bolnike, ko uporaba peroralnega protiepileptičnega zdravila Keppra začasno ni mogoča.
Keppra concentrate is an alternative for patients when oral administration is temporarily not feasible.
Koncentrat zdravila Keppra je alternativa za bolnike, pri katerih peroralna uporaba začasno ni mogoča.
43.6 % of the levetiracetam treated patients and 19.6 % of the patients on placebo were considered as responders.
43,6 % bolnikov, ki so se zdravili z levetiracetamom, in 19,6 % bolnikov, ki so prejemali placebo, se je na zdravljenje odzvalo.
• Dextrose 50 mg/ml (5%) solution for injection
• dekstroza 50 mg/ml (5 %) raztopina za injiciranje
Only limited evidence is available on the neurodevelopment of children exposed to Keppra monotherapy in utero.
O nevrološkem razvoju otrok, ki so bili in utero izpostavljeni zdravilu Keppra, uporabljenim samostojno, so na voljo samo omejeni dokazi.
Oral contraceptives and other pharmacokinetics interactions Levetiracetam 1,000 mg daily did not influence the pharmacokinetics of oral contraceptives (ethinylestradiol and levonorgestrel); endocrine parameters (luteinizing hormone and progesterone) were not modified.
Peroralni kontraceptivi in druge farmakokinetične interakcije Levetiracetam v odmerku 1000 mg na dan ni vplival na farmakokinetiko peroralnih kontraceptivov (etinilestradiola in levonorgestrela); endokrini parametri (luteinizirajoči hormon in progesteron) se niso spremenili.
The starting dose for a child or adolescent of 25kg should be 250mg twice daily with a maximum dose of 750mg twice daily.
Začetni odmerek za otroka ali mladostnika, težkega 25 kg, je 250 mg dvakrat na dan z največjim odmerkom 750 mg dvakrat na dan.
This presentation should be prescribed for children aged 4 years and older, adolescents and adults.
To pakiranje predpišemo otrokom, starim 4 leta in več, mladostnikom in odraslim.
It was concluded that Keppra was not different (non inferior) from placebo with regard to the change from baseline of the Leiter-R Attention and Memory, Memory Screen Composite score in the per-protocol population.
Ugotovili so, da se zdravilo Keppra pri populaciji po protokolu ne razlikuje (ni manjvredno) od placeba glede spremembe od začetnih vrednosti rezultatov testiranja spomina in pozornosti (Leiter-R Attention and Memory, Memory Screen Composite).
The 100 x 1 tablet packs are available in aluminium/PVC perforated unit dose blisters.
Pakiranje 100 x 1 tableta je na voljo v aluminij/PVC perforiranih pretisnih omotih za enkratni odmerek.
Intermediate packaging containing 100 tablets for box of 200 (2 x 100) tablets without blue box
Vmesno pakiranje, ki vsebuje 100 tablet, za škatlo z 200 (2 x 100) tabletami brez modrega okenca
For the full list of excipients, see section 6.1.
Za celoten seznam pomožnih snovi glejte poglevje 6.1.
• on its own in adults and adolescents from 16 years of age with newly diagnosed epilepsy, to treat a certain form of epilepsy.
• samostojno za zdravljenje pri odraslih in mladostnikih od 16. leta starosti z na novo diagnosticirano epilepsijo, za zdravljenje določene oblike epilepsije.
Example: if your daily dose is 1000 mg, your reduced starting dose is 2 tablets of 250 mg in the morning and 2 tablets of 250 mg in the evening.
Na primer: če je vaš dnevni odmerek 1000 mg,je vaš zmanjšan začetni odmerek 2 tableti po 250 mg zjutraj in 2 tableti po 250 mg zvečer.
A significant correlation between saliva and plasma concentrations has been shown in adults and children (ratio of saliva/plasma concentrations ranged from 1 to 1.7 for oral tablet formulation and after 4 hours post-dose for oral solution formulation).
Pri odraslih in otrocih so ugotovili pomembno povezavo med koncentracijo v plazmi in slini (razmerje koncentracij v slini/plazmi se giblje med 1 in 1,7 za tableto in za peroralno raztopino 4 ure po odmerku).
The most frequently reported adverse reactions were nasopharyngitis, somnolence, headache, fatigue and dizziness.The adverse reaction profile presented below is based on the analysis of pooled placebo-controlled clinical trials with all indications studied, with a total of 3,416 patients treated with levetiracetam.
Neželeni učinki, o katerih so najpogosteje poročali, so bili nazofaringitis, somnolenca, glavobol, utrujenost in omotica.Profil neželenih učinkov, ki je opisan spodaj, temelji na analizi združenih s placebom nadzorovanih kliničnih preskušanj za vse preučevane indikacije, v katerih so z levetiracetamom zdravili 3416 bolnikov.
In addition, it partially reverses the reductions in GABA- and glycine-gated currents induced by zinc and βcarbolines.
Poleg tega delno preprečuje inhibicijo GABA in glicinskih kanalčkov, povzročeno z Zn2+ in β- karbolini.
Keppra tablets are packaged in blister packs supplied in cardboard boxes containing:
Zdravilo Keppra tablete je na voljo v pretisnih omotih, ki so pakirani v škatle po:
Keppra therapy can be initiated with either intravenous or oral administration.
Zdravljenje z zdravilom Keppra lahko začnemo z intravensko ali peroralno uporabo.
• Separate the adaptor from the syringe (figure 2).
• Ločite adapter od brizge (slika 2).
Excipients Keppra 750 mg film-coated tablets contain E110 colouring agent which may cause allergic reactions.
Zdravilo Keppra 750 mg filmsko obložene tablete vsebuje barvilo E110, ki lahko povzroči alergijske reakcije.
General dose: Keppra is taken twice daily, in two equally divided doses, each individual dose being measured between 5 ml (500mg) and 15 ml (1500mg).
Običajni odmerek: zdravilo Keppra se jemlje dvakrat na dan, razdeljen na dva enaka odmerka, vsak posamezen odmerek znaša med 5 ml (500 mg) in 15 ml (1500 mg).
Paediatric population The tablet formulation is not adapted for use in infants and children under the age of 6 years.
Pediatrična populacija Farmacevtska oblika tableta ni prilagojena za uporabo pri dojenčkih in otrocih, mlajših od 6 let.
Six-month seizure freedom was achieved in 73.0 % of levetiracetam-treated patients and 72.8 % of carbamazepine-CR treated patients; the adjusted absolute difference between treatments was 0.2% (95 % CI: -7.8 8.2).
73,0 % bolnikov, ki so se zdravili z levetiracetamom, in 72,8 % bolnikov, ki so se zdravili s karbamazepinom z nadzorovanim sproščanjem (CR), je bilo šest mesecev brez napadov; prilagojena absolutna razlika med zdravljenjema je bila 0,2 % (95 % CI: 7,8-8,2).
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 in mlajših otrocih, starih od 6 mesecev do manj kot 4 leta, predpisati to pakiranje.
The oral solution may be diluted in a glass of water or baby's bottle and may be taken with or without food.
Raztopina za peroralno uporabo se lahko raztopi v kozarcu vode ali steklenici za hranjenje otrok.
Efficacy of levetiracetam as monotherapy was established in a double-blind, parallel group, noninferiority comparison to carbamazepine controlled release (CR) in 576 patients 16 years of age or older with newly or recently diagnosed epilepsy.
Učinkovitost levetiracetama za samostojno zdravljenje je bila dokazana v dvojno slepi študiji z vzporednimi skupinami, ki dokazuje, da levetiracetam po učinkovitosti ni nič slabši od karbamazepina z nadzorovanim sproščanjem (CR), pri 576 bolnikih, starih 16 let ali več, z na novo ali nedavno diagnosticirano epilepsijo.
UCB Pharma SA, Chemin du Foriest, B-1420 Braine-l'Alleud, Belgium or
UCB Pharma SA, Chemin du Foriest, B-1420 Braine-l'Alleud, Belgija ali
Keppra 250 mg film-coated tablets Keppra 500 mg film-coated tablets Keppra 750 mg film-coated tablets Keppra 1000 mg film-coated tablets
Keppra 250 mg filmsko obložene tablete Keppra 500 mg filmsko obložene tablete Keppra 750 mg filmsko obložene tablete Keppra 1000 mg filmsko obložene tablete levetiracetam
This medicinal product contains 2.5 mmol (or 57 mg) sodium per maximum single dose (0.8 mmol (or 19 mg) per vial).
To zdravilo vsebuje 2,5 mmol (ali 57 mg) natrija v največjem enkratnem odmerku (0,8 mmola (ali 19 mg) na vialo.
Aluminium/PVC perforated unit dose blisters placed into cardboard boxes containing 100 x 1 filmcoated tablet.
Aluminij/PVC perforirani pretisni omoti za enkratni odmerek so na voljo v škatlah po 100 x 1 filmsko obložena tableta.
CLcr (ml/min) = ----------------------------------------- (x 0.85 for women) 72 x serum creatinine (mg/dl)
[140 - starost (leta)] x masa (kg) CLcr (ml/min) = ------------------------------------------------------------- (x 0,85 za ženske) 72 x koncentracija kreatinina v serumu (mg/dl)
• Lactated Ringer's solution for injection
• Ringerjeva raztopina z laktatom za injiciranje
Each ml contains 2.7 mg of methyl parahydroxybenzoate (E218), 0.3 mg of propyl parahydroxybenzoate (E216) and 300 mg of maltitol liquid.
En mililiter vsebuje 2,7 mg metilparahidroksibenzoata (E218), 0,3 mg propilparahidroksibenzoata (E216) in 300 mg raztopine maltitola.
CLcr (ml/min/1.73 m 2) = ---------------------------- x 1.73 BSA subject (m
CLcr (ml/min/1,73 m2) = ---------------------------- x 1,73
If stopping treatment, Keppra should be discontinued gradually to avoid an increase of seizures.
Pri zdravilu Keppra je treba zdravljenje opustiti postopoma, da se število napadov ne bi povečalo.
Keppra is indicated as adjunctive therapy
Zdravilo Keppra je indicirano za dopolnilno zdravljenje:
Monotherapy should be preferred whenever possible because therapy with multiple antiepileptic medicines AEDs could be associated with a higher risk of congenital malformations than monotherapy, depending on the associated antiepileptics.
Kadar koli je mogoče, je treba uporabiti samostojno zdravljenje, ker je lahko zdravljenje z več antiepileptiki (odvisno od antiepileptika) povezano z večjim tveganjem za prirojene malformacije kot samostojno zdravljenje.
In a pooled analysis, the percentage of patients who achieved 50% or greater reduction from baseline in the partial onset seizure frequency per week at stable dose (12/14 weeks) was of 27.7 %, 31.6 % and 41.3 % for patients on 1000, 2000 or 3000 mg levetiracetam respectively and of 12.6 % for patients on placebo.
Delež bolnikov iz zbranih analiz, pri katerih je bilo doseženo 50- ali več odstotno zmanjšanje pogostnosti parcialnih napadov na teden pri stalnem odmerku (12/14 tednov), je bil 27,7 % pri bolnikih, ki so prejemali 1000 mg, 31,6 % pri bolnikih, ki so prejemali 2000 mg in 41,3 % pri bolnikih, ki so prejemali 3000 mg levetiracetama, ter 12,6 % pri bolnikih, ki so prejemali placebo.
• Fill the syringe with a small amount of solution by pulling the piston down (figure 5A), then push the piston upward in order to remove any possible bubble (figure 5B).
• Napolnite brizgo z majhno količino raztopine, tako da izvlečete bat navzdol (slika 5A), potem pritisnite bat navzgor, da odstranite morebitne zračne mehurčke (slika 5B), na koncu izvlecite bat navzdol do oznake, ki ustreza količini v mililitrih (ml), ki vam jo je predpisal zdravnik (slika 5C).
Keppra concentrate was found to be physically compatible and chemically stable when mixed with the following diluents for at least 24 hours and stored in PVC bags at controlled room temperature 1525°C.
Koncentrat zdravila Keppra je fizikalno kompatibilen in kemijsko stabilen vsaj 24 ur pri mešanju z naslednjimi raztopinami ter shranjen v PVC-vrečah pri kontrolirani sobni temperaturi 15 °C do 25 °C.
Ensure it is well fixed.
Zagotovite, da bo adapter dobro pritrjen.
Infants should start the treatment with Keppra 100 mg/ml oral solution.
Pri dojenčkih moramo začeti zdravljenje z zdravilom Keppra 100 mg/ml peroralna raztopina.
If stopping treatment, as with other antiepileptic medicines, Keppra should be discontinued gradually to avoid an increase of seizures.
Tako kot pri vseh protiepileptičnih zdravilih je tudi pri zdravilu Keppra treba zdravljenje opustiti postopoma, da se število napadov ne bi povečalo.
What Keppra looks like and contents of the pack Keppra concentrate for solution for infusion (sterile concentrate) is a clear, colourless liquid.
Keppra koncentrat za raztopino za infundiranje (sterilni koncentrat) je bistra, brezbarvna tekočina.
Dose in children and adolescents 50 kg or more is the same as in adults.
(2) Pri otrocih in mladostnikih, težkih 50 kg ali več, je odmerjanje enako kot pri odraslih.
If you forget to take Keppra:
Če ste pozabili vzeti zdravilo Keppra
• skin rash, which may form blisters and looks like small targets (central dark spots surrounded by a paler area, with a dark ring around the edge) (erythema multiforme), a widespread rash with blisters and peeling skin, particularly around the mouth, nose, eyes and genitals (StevensJohnson syndrome), and a more severe form causing skin peeling in more than 30% of the body surface (toxic epidermal necrolysis);
• kožni izpuščaj, ki lahko tvori mehurčke in izgleda kot majhne tarče (na sredini temne pike obkrožene s svetlejšim delom in s temnim krogom na robu) (multiformni eritem), široko razširjen izpuščaj z mehurčki in luščenjem kože, še posebej okoli ust, nosu, oči in v predelu spolovil (Stevens-Johnsonov sindrom) in bolj huda oblika, ki povzroči luščenje kože na več kot
Warnings and precautions Talk to your doctor before taking Keppra
Opozorila in previdnostni ukrepi Pred začetkom jemanja zdravila Keppra se posvetujte s svojim zdravnikom.
One maximum single dose of Keppra concentrate contains 2.5 mmol (or 57 mg) of sodium (0.8 mmol (or 19 mg) of sodium per vial).
Največji enkratni odmerek koncentrata zdravila Keppra vsebuje 2,5 mmol (ali 57 mg) natrija (0,8 mmola (ali 19 mg) natrija na vialo).
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), glukuronil-transferaze (UGT1A1 in UGT1A6) in epoksid-hidroksilaze.
The CLcr in ml/min/1.73 m may be estimated from serum creatinine (mg/dl) determination, for young adolescents, children and infants, using the following formula (Schwartz formula):
CLcr v ml/min/1,73 m2 je pri mlajših mladostnikih, otrocih in dojenčkih, mogoče oceniti iz koncentracije kreatinina v serumu (mg/dl) z uporabo naslednje formule (po Schwartzevi formuli):
Keppra concentrate for solution for infusion was found to be physically compatible and chemically stable for at least 24 hours when mixed with the following diluents and stored in PVC bags at controlled room temperature 15-25 °C.
Zdravilo Keppra koncentrat za raztopino za infundiranje je fizikalno kompatibilen in kemijsko stabilen vsaj 24 ur pri mešanju z naslednjimi raztopinami ter shranjen v PVC vrečah pri kontrolirani sobni temperaturi 15 °C do
Pre-marketing data from clinical studies conducted in adults indicate that levetiracetam did not influence the serum concentrations of existing antiepileptic medicinal products (phenytoin, carbamazepine, valproic acid, phenobarbital, lamotrigine, gabapentin and primidone) and that these antiepileptic medicinal products did not influence the pharmacokinetics of levetiracetam.
Predmarketinški podatki iz kliničnih študij, izvedenih pri odraslih kažejo, da levetiracetam ne vpliva na serumsko koncentracijo drugih protiepileptičnih zdravil (fenitoina, karbamazepina, valprojske kisline, fenobarbitala, lamotrigina, gabapentina in primidona) in da ta protiepileptična zdravila ne vplivajo na farmakokinetiko levetiracetama.
The safety and efficacy of Keppra concentrate for solution for infusion in infants and children less than 4 years have not been established.
Dopolnilno zdravljenje za dojenčke in otroke, mlajše od 4 let Varnost in učinkovitost zdravila Keppra, koncentrata za raztopino za infundiranje, pri dojenčkih in pri otrocih, mlajših od 4 let nista bili dokazani.
Do not use Keppra
Ne uporabljajte zdravila Keppra
Dose in children (4 to 11 years) and adolescents (12 to 17 years) weighing less than 50 kg: General dose: between 20 mg per kg bodyweight and 60 mg per kg bodyweight each day.
Odmerjanje pri otrocih (od 4 do 11 let) in mladostnikih (od 12 do 17 let), lažjih od 50 kg Običajni odmerek: med 20 mg na kg telesne mase in 60 mg na kg telesne mase vsak dan.
The primary measure of effectiveness was the responder rate (percent of patients with ≥ 50% reduction from baseline in average daily partial onset seizure frequency) assessed by a blinded central reader using a 48-hour video EEG.
Osnovno merilo učinkovitosti je bila stopnja odziva (odstotek bolnikov z ≥ 50 % znižanjem povprečnih pogostosti parcialnih napadov na dan glede na začetne vrednosti), ki jo je na 48-urnem EEG posnetku določil ocenjevalec, ki ni vedel, kdo je prejemal placebo in kdo zdravilo.
The other ingredients are: sodium citrate, citric acid monohydrate, methyl parahydroxybenzoate (E218), propyl parahydroxybenzoate (E216), ammonium glycyrrhizate, glycerol (E422), maltitol liquid (E965), acesulfame potassium (E950), grape flavour, purified water.
Druge sestavine zdravila so: natrijev citrat, citronska kislina monohidrat, metilparahidroksibenzoat (E218), propilparahidroksibenzoat (E216), amonijev glicirizinat, glicerol (E422), raztopina maltitola (E965), kalijev acesulfamat (E950), aroma grozdja, prečiščena voda
See Table 1 for the recommended preparation and administration of Keppra concentrate to achieve a total daily dose of 500 mg, 1000 mg, 2000 mg, or 3000 mg in two divided doses.
Glejte Preglednico 1 za priporočeno pripravo in uporabo koncentrata zdravila Keppra, da se doseže celotni dnevni odmerek 500 mg, 1000 mg, 2000 mg ali 3000 mg, razdeljen na dva odmerka.
The patients were randomized to carbamazepine CR 400 - 1200 mg/day or levetiracetam 1000 - 3000 mg/day, the duration of the treatment was up to 121 weeks depending on the response.
Bolniki so randomizirano prejemali 400-1200 mg karbamazepina z nadzorovanim sproščanjem (CR) na dan ali 1000-3000 mg levetiracetama na dan, trajanje zdravljenja pa je bilo do 121 tednov, odvisno od odziva.
Neither levetiracetam nor its primary metabolite are significantly bound to plasma proteins ( 10 %).
Tako levetiracetam kot njegov primarni presnovek se ne vežeta pomembno na beljakovine v plazmi
At 3600 mg/kg/day, in only one of the 2 EFD studies, there was a slight decrease in foetal weight associated with a marginal increase in skeletal variations/minor anomalies.
Pri 3600 mg/kg/dan se je samo v eni od dveh študijah embriofetalnega razvoja telesna masa plodu rahlo zmanjšala v povezavi z marginalnim povečanjem skeletnih sprememb/manjših anomalij.
Dose recommendations for infants aged from 1 month to less than 6 months:
Priporočeno odmerjanje za dojenčke, stare od 1 meseca do manj kot 6 mesecev:
Monotherapy for adults and adolescents from 16 years of age
Samostojno zdravljenje za odrasle in mladostnike od 16 leta starosti
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 meseca do manj kot 6 mesecev, predpisati to pakiranje.