FrancophonIA/ELRC3.0 huggingface dataset:
English: 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 1,000, 2,000 or 3,000 mg levetiracetam respectively and of 12.6 % for patients on placebo.
Slovenian: Delež bolnikov iz zbranih analiz, pri katerih je bilo doseženo 50 ali več odstotno zmanjšanje pogostnosti napadov parcialnega izvora 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.
English: After an acute overdose, the stomach may be emptied by gastric lavage or by induction of emesis.
Slovenian: Po akutnem prevelikem odmerjanju lahko želodec izpraznimo z izpiranjem ali sprožitvijo bruhanja.
English: The dose level of 1,800 mg/kg/day induced a marked maternal toxicity and a decrease in foetal weight associated with increased incidence of foetuses 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: The CLcr in ml/min/1.73 m2 may be estimated from serum creatinine (mg/dl) determination, for young adolescents, children and infants, using the following formula (Schwartz formula):
Slovenian: 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 Schwartz-evi formuli):
English: Two embryo-foetal development (EFD) studies were performed in rats at 400, 1,200 and 3,600 mg/kg/day.
Slovenian: Dve študiji embrio-fetalnega razvoja pri podganah so izvedli pri odmerkih 400, 1200 in 3600 mg/kg/dan.
English: It is therefore recommended to adjust the maintenance daily dose of Levetiracetam Actavis, based on creatinine clearance in patients with moderate and severe renal impairment (see section 4.2).
Slovenian: Zato je priporočljivo dnevni vzdrževalni odmerek zdravila Levetiracetam Actavis pri bolnikih z zmerno in hudo ledvično okvaro prilagoditi očistku kreatinina (glejte poglavje 4.2).
English: Contents of the pack and other information What Levetiracetam Actavis contains
Slovenian: Vsebina pakiranja in dodatne informacije Kaj vsebuje zdravilo Levetiracetam Actavis
English: Specifar S.A 1, 28 Octovriou str., 123 51 Ag. Varvara, Athens, Greece
Slovenian: 1, 28 Octovriou str., 123 51 Ag. Varvara, Atene, Grčija
English: 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).
Slovenian: Pri odraslih in otrocih so pokazali pomembno povezavo med koncentracijo v plazmi in slini (razmerje koncentracij slina/plazma se giblje med 1 in 1,7 za tableto za peroralno uporabo in za peroralno raztopino 4 ure po odmerku).
English: An oral solution is the preferred formulation for use in infants and children under the age of 6 years.
Slovenian: Peroralna raztopina je najprimernejša oblika za uporabo pri dojenčkih in otrocih, mlajših od 6 let.
English: Probenecid (500 mg four times daily), a renal tubular secretion blocking agent, has been shown to inhibit the renal clearance of the primary metabolite, but not of levetiracetam.
Slovenian: Ugotovili so, da probenecid (500 mg štirikrat na dan), ki blokira ledvično tubularno sekrecijo, zavre ledvični očistek primarnega presnovka, ne pa levetiracetama.
English: For adult patients, refer to the following table and adjust the dose as indicated.
Slovenian: Sklicujoč se na spodnjo tabelo se odmerek za odrasle bolnike prilagodi kot je navedeno.
English: An oral solution is a formulation more appropriate to infants and children under the age of 6 years and to children and adolescents (from 6 to 17 years) weighing less than 50 kg and when tablets do not allow accurate dosage.
Slovenian: Peroralna raztopina je farmacevtska oblika, ki je najprimernejša za dojenčke in otroke, mlajše od 6 let in za otroke in mladostnike (od 6 do 17 let), lažjih od 50 kg in kadar s tabletami ne moremo zagotoviti natančnega odmerjanja.
English: In adults, levetiracetam efficacy has been demonstrated in 3 double-blind, placebo-controlled studies at 1,000 mg, 2,000 mg, or 3,000 mg/day, given in 2 divided doses, with a treatment duration of up to 18 weeks.
Slovenian: 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.
English: An oral solution is the preferred formulation for use in this population.
Slovenian: Peroralna raztopina je najprimernejša farmacevtska oblika za uporabo pri tej populaciji.
English: Tjoapack Netherlands B.V. Nieuwe Donk 9, ETTEN-LEUR, 4879AC, Netherlands
Slovenian: Nieuwe Donk 9, ETTEN-LEUR, 4879AC, Nizozemska
English: The patients were randomized to carbamazepine CR 400--1,200 mg/day or levetiracetam 1,000--3,000 mg/day, the duration of the treatment was up to 121 weeks depending on the response.
Slovenian: 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 oziroma odvisno od odziva.
English: Following repeated oral dose administration (20 to 60 mg/kg/day) to epileptic children (4 to 12 years), levetiracetam was rapidly absorbed.
Slovenian: 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.
English: Do not use this medicine after the expiry date which is stated on the carton, label or blister after EXP.
Slovenian: Tega zdravila ne smete uporabljati po datumu izteka uporabnosti, ki je naveden na škatli, nalepki ali pretisnem omotu poleg oznake EXP. Datum izteka roka uporabnosti se nanaša na zadnji dan navedenega meseca.
English: The physician should prescribe the most appropriate pharmaceutical form, presentation and strength according to age, weight and dose.
Slovenian: Zdravnik mora glede na starost, telesno maso in odmerek predpisati najbolj ustrezno farmacevtsko obliko, velikost pakiranja in jakost.
English: Dose in adults and adolescents (12 to 17 years) weighing 50 kg or more:
Slovenian: Odmerjanje pri odraslih in mladostnikih (od 12 do 17 let), težkih 50 kg ali več:
English: Levetiracetam and related analogs 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.
Slovenian: 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.
English: How to store Levetiracetam Actavis Contents of the pack and other information
Slovenian: Shranjevanje zdravila Levetiracetam Actavis Vsebina pakiranja in dodatne informacije
English: However, data suggested a 20 % higher levetiracetam clearance in children taking enzymeinducing antiepileptic medicinal products.
Slovenian: Vendar pa podatki nakazujejo, da je pri otrocih, kateri jemljejo protiepileptična zdravila, ki inducirajo encime, povečan očistek levetiracetama za 20 %.
English: In both population pharmacokinetic analyses, there was about a 20 % increase of apparent clearance of levetiracetam when it was co-administered with an enzyme-inducing antiepileptic medicinal product.
Slovenian: V obeh farmakokinetičnih analizah populacije se je navidezni očistek levetiracetama pri sočasni uporabi protiepileptičnega zdravila, ki inducira encime, povečal za približno 20 %.
English: This finding suggests that the interaction between levetiracetam and the synaptic vesicle protein 2A seems to contribute to the antiepileptic mechanism of action of the medicinal product.
Slovenian: Ta odkritja kažejo, da bi lahko interakcija med levetiracetamom in sinaptičnim vezikularnim proteinom 2A prispevala k protiepileptičnemu delovanju zdravila.
English: Tjoapack Netherlands B.V. Nieuwe Donk 9
Slovenian: Tjoapack Netherlands B.V.
English: In the elderly, the half-life is increased by about 40 % (10 to 11 hours).
Slovenian: Zaradi zmanjšanega delovanja ledvic se pri starejših razpolovni čas podaljša za približno 40 % (10 do
English: In vitro studies show that levetiracetam affects intraneuronal Ca2+ levels by partial inhibition of N-type
Slovenian: 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.
English: In human hepatocytes in culture, levetiracetam had little or no effect on CYP1A2, SULT1E1 or UGT1A1.
Slovenian: V kulturi človeških hepatocitov je imel levetiracetam majhen učinek ali pa ni imel učinka na CYP1A2,
English: 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.
Slovenian: 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),
English: The primary measure of effectiveness was the responder rate (percent of patients with ≥ 50 %
Slovenian: Osnovno merilo učinkovitosti je bila reakcijska stopnja (odstotek bolnikov z ≥ 50 % znižanjem povprečnih pogostosti napadov parcialnega izvora na dan glede na začetne vrednosti), ki jo je na
English: 43.6 % of the levetiracetam treated patients and 19.6 % of the patients on placebo were considered as responders.
Slovenian: 43,6 % bolnikov, ki so se zdravili z levetiracetamom in 19,6 % bolnikov, ki so prejemali placebo, se je na zdravljenje odzvalo.
English: Tablet containers: 30, 100 and 200 film-coated tablets.
Slovenian: Vsebniki za tablete: 30, 100 in 200 filmsko obloženih tablet.
English: Renal impairment The daily dose must be individualised according to renal function.
Slovenian: Dnevni odmerek je potrebno prilagoditi individualno glede na delovanje ledvic.
English: Levetiracetam Actavis 750 mg contains colouring agent sunset yellow (E110) which may cause allergic reactions.
Slovenian: Zdravilo Levetiracetam Actavis 750 mg vsebuje barvilo sončno rumeno FCF (E110), ki lahko povzroči alergično reakcijo.
English: The safety profile of levetiracetam is generally similar across age groups (adult and paediatric patients) and across the approved epilepsy indications.
Slovenian: Varnostni profil levetiracetama je v splošnem podoben v vseh starostnih skupinah (odrasli in pediatrični bolniki)
English: 30 tablets 100 tablets 200 tablets
Slovenian: 30 tablet 100 tablet 200 tablet
English: Therefore, there is no need for plasma level monitoring of levetiracetam.
Slovenian: Koncentracije levetiracetama v plazmi zato ni potrebno kontrolirati.
English: White tablet containers (HDPE) closed with snap-on cap (LDPE) with a tamper evident ring.
Slovenian: Beli vsebniki za tablete (HDPE) zaprti z zaskočno zaporko (LDPE) z zaščitnim obročkom.
English: Blisters: 20, 30, 50, 60, 100, 120 and 200 film-coated tablets.
Slovenian: Pretisni omoti: 20, 30, 50, 60, 100, 120 in 200 filmsko obloženih tablet.
English: In this study, levetiracetam dose was 3,000 mg/day for adults and adolescents or 60 mg/kg/day for children, given in 2 divided doses.
Slovenian: V tej študiji je bil odmerek levetiracetama za odrasle in mladostnike 3000 mg na dan, za otroke pa 60 mg/kg/dan, razdeljen na dva odmerka.
English: A double-blind, placebo-controlled paediatric safety study with a non-inferiority design has assessed the cognitive and neuropsychological effects of levetiracetam in children 4 to 16 years of age with partial onset seizures.
Slovenian: Dvojno slepa, s placebom nadzorovana pediatrična študija o varnosti z modelom o enakovrednosti zdravljenja je pokazala kognitivne in nevropsihološke učinke levetiracetama , pri pediatričnih bolnikih, starih od 4 do 16 let z napadi parcialnega izvora.
English: The most frequently reported side effects are nasopharyngitis, somnolence (sleepiness), headache, fatigue and dizziness.
Slovenian: Neželeni učinki, o katerih so najpogosteje poročali, so nazofaringitis, somnolenca (zaspanost), glavobol, utrujenost in omotica.
English: Creatinine clearance (ml/min/1.73 m2)
Slovenian: skupina očistek kreatinina (ml/min/1,73m2)
English: Levetiracetam Actavis is not indicated in children and adolescents below 16 years on its own (monotherapy).
Slovenian: Zdravilo Levetiracetam Actavis, pri otrocih in mladostnikih, mlajših od 16 let, ni indicirano za samostojno zdravljenje (monoterapija).
English: In paediatric patients (1 month to less than 4 years of age), levetiracetam efficacy was established in a double-blind, placebo-controlled study, which included 116 patients and had a treatment duration of 5 days.
Slovenian: Pri pediatričnih bolnikih (od 1 meseca do manj kot 4. leta starosti) je bila učinkovitost levetiracetama dokazana v dvojno slepi, s placebom nadzorovani študiji, ki je vključevala 116 bolnikov in je trajala 5 dni.
English: 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.
Slovenian: 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.
English: 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 %
Slovenian: 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).
English: Adjustment of the dose is recommended in elderly patients with compromised renal function (see “Renal impairment” below).
Slovenian: Pri starejših bolnikih z okvarjenim delovanjem ledvic je priporočljiva prilagoditev odmerka (glejte spodaj “Bolniki z ledvično okvaro”).
English: 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).
Slovenian: Več kot polovica preiskovancev 12 mesecev ni imela napadov (56,6 % preiskovancev, ki so prejemali levetiracetam, in 58,5 %
English: PUREN Pharma GmbH & Co. KG Telefon: +49 (0)89 558909 0
Slovenian: KG Telefon: +49 (0)89 558909 0
English: If stopping treatment, Levetiracetam Actavis should be discontinued gradually to avoid an increase of seizures.
Slovenian: Pri zdravilu Levetiracetam Actavis je potrebno zdravljenje opustiti postopoma, da se število napadov ne bi povečalo.
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 4.2).
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: Dose in infants (1 month to 23 months), children (2 to 11 years) and adolescents (12 to 17 years) weighing less than 50 kg:
Slovenian: Odmerjanje pri dojenčkih (od 1 meseca do 23 mesecev), otrocih (od 2 do 11 let) in mladostnikih (od 12 do 17 let), lažjih od 50 kg
English: Actavis treatment for as long as your doctor has told you.
Slovenian: Zdravljenje z zdravilom Levetiracetam Actavis morate nadaljevati tako dolgo, kot vam je naročil zdravnik.
English: Other medicines and Levetiracetam Actavis
Slovenian: Druga zdravila in zdravilo Levetiracetam Actavis
English: The fractional removal of levetiracetam was 51 % during a typical 4-hour dialysis session.
Slovenian: Frakcijska odstranitev levetiracetama med značilno 4-urno dializo je bila 51 %.
English: Contains colouring agent sunset yellow (E110).
Slovenian: Vsebuje barvilo sončno rumeno FCF (E110).
English: Perforated unit dose blisters: 60 x 1 film-coated tablets.
Slovenian: Perforiranem pretisnem omotu za enkratni odmerek: 60 x 1fimsko obloženih tablet.
English: (1) An 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: (1) Pri odmerkih, manjših od 250 mg, pri odmerkih, ki niso večkratniki od 250 mg in se priporočenega odmerjanja zato ne more doseči z večimi tabletami in pri bolnikih, ki ne morejo požirati tablet, je treba uporabiti peroralno raztopino.
English: - If you have any further questions, ask your doctor or pharmacist.
Slovenian: − Če imate dodatna vprašanja, se posvetujte s svojim zdravnikom ali s farmacevtom.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING Carton for Aluminium/PVC blisters
Slovenian: PODATKI NA ZUNANJI OVOJNINI Škatla za pretisne omote iz Al/PVC
English: For children 6 years and above, an 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 Levetiracetam Actavis peroralna raztopina.
English: If you stop taking Levetiracetam Actavis
Slovenian: Če ste prenehali jemati zdravilo Levetiracetam Actavis
English: As in adults, there is no evidence of clinically significant medicinal product interactions in paediatric patients receiving up to 60 mg/kg/day levetiracetam.
Slovenian: Tako kot pri odraslih, tudi pri otrocih, ki so prejemali do 60 mg/kg/dan levetiracetama, ni jasnih dokazov o klinično značilnem medsebojnem delovanju z zdravili.
English: Four embryo-foetal development studies were performed in rabbits covering doses of 200, 600, 800, 1,200 and 1,800 mg/kg/day.
Slovenian: Štiri študije embrio-fetalnega razvoja pri kuncih so izvedli pri odmerkih 200, 600, 800, 1200 in
English: Levetiracetam Actavis 250 mg film-coated tablets Levetiracetam Actavis 500 mg film-coated tablets Levetiracetam Actavis 750 mg film-coated tablets Levetiracetam Actavis 1,000 mg film-coated tablets
Slovenian: Levetiracetam Actavis 250 mg filmsko obložene tablete Levetiracetam Actavis 500 mg filmsko obložene tablete Levetiracetam Actavis 750 mg filmsko obložene tablete Levetiracetam Actavis 1.000 mg filmsko obložene tablete
English: With continued long-term treatment, 47.4 % of the patients were free of tonic-clonic seizures for at least 6 months and 31.5 % were free of tonic-clonic seizures for at least 1 year.
Slovenian: Z nadaljevanjem dolgotrajnega zdravljenja je bilo 47,4 % bolnikov brez tonično-kloničnih napadov vsaj 6 mesecev, 31,5 % pa jih je bilo brez tonično-kloničnih napadov vsaj 1 leto.
English: Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, genotoxicity and carcinogenic potential.
Slovenian: Predklinični podatki na osnovi običajnih študij farmakološke varnosti, genotoksičnosti in kancerogenega potenciala, ne kažejo posebnega tveganja za človeka.
English: What Levetiracetam Actavis looks like and contents of the pack
Slovenian: Izgled zdravila Levetiracetam Actavis in vsebina pakiranja
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: Dopolnilno zdravljenje primarno generaliziranih tonično-kloničnih napadov pri odraslih in mladostnikih, od 12. leta starosti, z idiopatsko generalizirano epilepsijo 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: The safety and efficacy of levetiracetam in children and adolescents below 16 years as monotherapy treatment have not been established.
Slovenian: Pri samostojnem zdravljenju pri otrocih in mladostnikih, mlajših od 16 let, varnost in učinkovitost levetiracetama nista bili dokazani.
English: The NOAEL was <200 mg/kg/day for the dams and 200 mg/kg/day for the foetuses (equal to the MRHD on a mg/m2 basis).
Slovenian: mg/kg/dan za samice in 200 mg/kg/dan za zarodke (je enako največjemu priporočenemu odmerku pri ljudeh glede na mg/m2).
English: Crospovidon, povidone, silica colloidal anhydrous, magnesium stearate, polyvinyl alcohol-part. hydrolyzed, macrogol 4000, talc, titanium dioxide (E171), colourants*.
Slovenian: Pomožne snovi so: krospovidon, povidon, brezvodni koloidni silicijev dioksid, magnezijev stearat, polivinilalkohol - delno hidroliziran, makrogol 4000, smukec, titanov dioksid (E171), barvila*.
English: 750 mg tablet: Indigo carmine (E132), sunset yellow (E110), iron oxide red (E172).
Slovenian: 750 mg tableta: indigotin (E132), sončno rumeno FCF (E110), rdeči železov oksid (E172)
English: A dose of 20 mg/kg/day titrating to 40 mg/kg/day for infants one month to less than six month and a dose of 25 mg/kg/day titrating to 50 mg/kg/day for infants and children 6 month to less than 4 years old, was used 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: Oral absolute bioavailability is close to Peak plasma concentrations (Cmax) are achieved at 1.3 hours after dosing.
Slovenian: Največjo koncentracijo v plazmi (Cmax) dosežemo 1,3 ure po odmerku.
English: In addition, the available dose strengths of the tablets are not appropriate for initial treatment in children weighing less than 25 kg, for patients unable to swallow tablets or for the administration of doses below 250 mg.
Slovenian: Poleg tega jakosti tablet, ki so na voljo, niso primerne za začetno zdravljenje pri otrocih, težkih manj kot 25 kg,
English: Dosing adjustment for infants, children and adolescents patients weighing less than 50 kg with impaired renal function
Slovenian: Prilagoditev odmerjanja pri dojenčkih, otrocih in mladostnikih s telesno maso, manjšo kot 50 kg, z okvarjenim delovanjem ledvic:
English: The dose can be further increased by 250 mg twice daily every two weeks depending upon the clinical response.
Slovenian: Dnevni odmerek se lahko poveča do 1500 mg dvakrat na dan glede na klinični odziv in toleranco.
English: The NOAEL was ≥ 1,800 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: ≥1800 mg/kg/dan za F0 samice in za preživetje, rast in razvoj F1 mladičev do prenehanja dojenja (6