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eslikarbasepiinatsetaadi täpne toimemehhanism on teadmata.
the precise mechanisms of action of eslicarbazepine acetate are unknown.
Ultimo aggiornamento 2017-04-26
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hemodialüüsiga eslikarbasepiinatsetaadi metaboliidid eemaldatakse plasmast.
haemodialysis removes eslicarbazepine acetate metabolites from plasma.
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eslikarbasepiinatsetaadi annuse suurenedes hüponatreemia esinemissagedus suurenes.
frequency of hyponatraemia increased with increasing eslicarbazepine acetate dose.
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mõõdukas maksafunktsiooni kahjustus eslikarbasepiinatsetaadi farmakokineetikat ei mõjutanud.
moderate hepatic impairment did not affect the pharmacokinetics of eslicarbazepine acetate.
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eslikarbasepiinatsetaadi genotoksilisuse uuringud erilist ohtu inimesele ei näita.
genotoxicity studies with eslicarbazepine acetate indicate no special hazards for humans.
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eslikarbasepiinatsetaadi kliinilistes uuringutes on täheldatud pr-intervalli pikenemisi.
prolongations in pr interval have been observed in clinical studies with eslicarbazepine acetate.
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eslikarbasepiinatsetaadi farmakokineetikat raskekujulise maksafunktsiooni kahjustusega patsientidel ei ole hinnatud.
the pharmacokinetics of eslicarbazepine acetate has not been evaluated in patients with severe hepatic impairment.
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uuringutes tervete osalejate ja patsientidega sugu eslikarbasepiinatsetaadi farmakokineetikat ei mõjutanud.
studies in healthy subjects and patients showed that pharmacokinetics of eslicarbazepine acetate were not affected by gender.
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eslikarbasepiinatsetaadi metaboliidid elimineeruvad süsteemsest ringest eelkõige neerude kaudu eritumise teel.
eslicarbazepine acetate metabolites are eliminated from the systemic circulation primarily by renal excretion.
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fertiilsusuuringus isas- ja emasrottidega täheldati emasrottide sigivuse langust eslikarbasepiinatsetaadi mõjul.
in a fertility study in male and female rats, impairment of female fertility by eslicarbazepine acetate was shown.
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rottidel ja hiirtel uuriti eslikarbasepiinatsetaadi võimalikke kõrvalmõjusid vanematele ja f1-põlvkonnale.
eslicarbazepine acetate was evaluated in rats and mice for potential adverse reactions on fertility of the parental and f1 generation.
Ultimo aggiornamento 2017-04-26
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rottidel ja hiirtel uuriti eslikarbasepiinatsetaadi võimalikku kahjulikku mõju vanematele ja f1-põlvkonnale.
eslicarbazepine acetate was evaluated in rats and mice for potential adverse effects on fertility of the parental and f1 generation.
Ultimo aggiornamento 2017-04-26
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esialgsel ülevaatusel arvestati topeltpimedate epilepsiauuringute eslikarbasepiinatsetaadi üldrühmas tekkinud kõiki raviga seotud kõrvaltoimeid.
the initial review was done by considering all treatment emergent adverse events in the double-blind epilepsy studies in the total eslicarbazepine acetate group.
Ultimo aggiornamento 2017-04-26
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eslikarbasepiinatsetaadi kasutamine samaaegselt okskarbasepiiniga ei ole soovitatav, sest see võib põhjustada aktiivsete metaboliitide ülemäärast taset.
concomitant use of eslicarbazepine acetate with oxcarbazepine is not recommended because this may cause overexposure to the active metabolites.
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eslikarbasepiinatsetaadi tahtmatu üleannustamise korral on esinenud selliseid kesknärvisüsteemi sümptomeid nagu vertiigo, ebastabiilne kõnnak ja hemiparees.
central nervous symptoms such as vertigo, walking instability and hemi-paresis have been observed with accidental eslicarbazepine acetate overdose.
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biosaadavus on eeldatavasti kõrge, sest uriiniga väljuvate metaboliitide hulk moodustas rohkem kui 90% eslikarbasepiinatsetaadi annusest.
bioavailability may be assumed as high because the amount of metabolites recovered in urine corresponded to more than 90% of an eslicarbazepine acetate dose.
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eslikarbasepiinatsetaadi farmakokineetika on vahemikus 400–1200 mg nii tervetel uuringus osalejatel kui ka patsientidel lineaarne ja annusega proportsionaalne.
the pharmacokinetics of eslicarbazepine acetate is linear and dose-proportional in the range 400-1,200 mg both in healthy subjects and patients.
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allpool tabelis on kõik kõrvaltoimed, mis tuvastati eslikarbasepiinatsetaadi ohutusalase andmebaasi täieliku ülevaatuse põhjal, loetletud organsüsteemide ja esinemissageduse järgi.
in the table below all adverse reactions, which were identified based on the review of the full eslicarbazepine acetate safety database are presented by system organ class and frequency.
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loomkatsetes täheldatud kõrvaltoimed tekkisid eslikarbasepiini (eslikarbasepiinatsetaadi põhiline ja farmakoloogiliselt aktiivne metaboliit) kliinilistest kontsentratsioonitasemetest tunduvalt madalamatel kontsentratsioonitasemetel.
adverse affects observed in animal studies occurred at exposure levels appreciably lower than the clinical exposure levels to eslicarbazepine (the principal and pharmacologically active metabolite of eslicarbazepine acetate).
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eslikarbasepiinatsetaadi efektiivsust ja ohutust on tõestatud kolmes iii faasi topeltpimedas platseebokontrolliga uuringus 1049 täiskasvanud patsiendiga, kelle partsiaalsed epilepsiahood ei allunud ravile ühe kuni kolme samaaegselt kasutatud epilepsiaravimiga.
the efficacy and safety of eslicarbazepine acetate has been demonstrated in three phase iii double-blind placebo-controlled studies in 1,049 adult patients with partial epilepsy refractory to treatment with one to three concomitant anti-epileptic medicinal products.
Ultimo aggiornamento 2017-04-26
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