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hetlioz sisaldab toimeainena tasimelteooni.
hetlioz contains the active substance tasimelteon.
Son Güncelleme: 2017-04-26
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iga kõvakapsel sisaldab 20 mg tasimelteooni.
each hard capsule contains 20 mg of tasimelteon.
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tasimelteooni üleannustamisega on vähe kliinilisi kogemusi.
there is limited clinical experience with the effects of an overdose of tasimelteon.
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teiste ravimite võimalik mõju tasimelteooni toimele
potential for other medicinal products to affect tasimelteon
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tasimelteooni keskmine absoluutne biosaadavus on 38%.
the mean absolute oral bioavailability of tasimelteon is 38%.
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ettevaatusabinõuna on soovitav vältida tasimelteooni kasutamist raseduse ajal.
as a precautionary measure, it is preferable to avoid the use of tasimelteon during pregnancy.
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tasimelteooni kasutamise kohta rasedatel andmed puuduvad või on piiratud.
there are no or limited amount of data from the use of tasimelteon in pregnant women.
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tasimelteooni kliinilist efektiivsust kliinilise üldseisundi paranemisel hinnati uuringus set.
the effectiveness of tasimelteon to improve clinical global functioning was evaluated in set.
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tasimelteooni plasmakontsentratsioon suurenes mõõduka maksakahjustusega isikutel vähem kui kaks korda.
tasimelteon exposure was increased less than two-fold in subjects with moderate hepatic impairment.
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eakatel suurenes tasimelteooni plasmakontsentratsioon ligikaudu kaks korda võrreldes mitteeakate täiskasvanutega.
in elderly subjects, tasimelteon exposure increased by approximately two-fold compared to non-elderly adults.
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cyp1a2 ja cyp3a4 on ensüümid, mille osalus tasimelteooni metabolismis on tõestatud.
cyp1a2 and cyp3a4 are enzymes identified to play a role in the metabolism of tasimelteon.
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tasimelteooni üldine keskmine plasmakontsentratsioon oli naistel umbes 1,6 korda suurem kui meestel.
the mean overall exposure of tasimelteon was approximately 1.6-fold greater in female than in male subjects.
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tasimelteooni efektiivsus võib vähendada patsientidel, kes manustavad samal ajal β-adrenoretseptorite antagoniste.
the efficacy of tasimelteon may be reduced in patients with concomitant administration of beta adrenergic receptor antagonists.
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tasimelteooni üldise patsientidevahelise varieeruvuse tõttu ei ole see suurenemine kliiniliselt oluline ja annuse kohandamist ei soovitata.
due to the overall inter-subject variability of tasimelteon, this increase is not clinically meaningful and dose adjustment is not recommended.
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tasimelteooni üks kord ööpäevas manustatav korduvannus ei põhjusta tasimelteooni farmakokineetiliste parameetrite muutumist ega tasimelteooni olulist kogunemist.
repeated once daily dosing with tasimelteon does not result in changes in pharmacokinetic parameters or significant accumulation of tasimelteon.
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suitsetajatel vähenes tasimelteooni kontsentratsioon ligikaudu 40% võrreldes mittesuitsetajatega (vt lõik 4.5).
tasimelteon exposure decreased by approximately 40% in smokers, compared to non-smokers (see section 4.5).
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on tõendatud, et cyp1a2-d ja cyp3a4-d inhibeerivad ravimid muudavad tasimelteooni metabolismi in vivo.
medicinal products that inhibit cyp1a2 and cyp3a4 have been shown to alter the metabolism of tasimelteon in vivo.
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tasimelteooni maksimaalne kontsentratsioon (tmax) tekkis tühja kõhuga ligikaudu 0,5 tundi pärast suukaudset manustamist.
the peak concentration (tmax) of tasimelteon occurred approximately 0.5 hours after fasted oral administration.
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seetõttu tuleb tasimelteooni võtta ilma toiduta; kui patsiendid söövad suure rasvasisaldusega toitu, soovitatakse enne tasimelteooni võtmist oodata vähemalt 2 tundi.
therefore, tasimelteon should be taken without food; if patients eat a high-fat meal, it is recommended to wait at least 2 hours before taking tasimelteon.
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kuigi hemodialüüs oli tõhus meetod tasimelteooni ja enamiku selle metaboliitide väljutamiseks neerukahjustusega patsientidel, ei ole teada, kas hemodialüüs vähendab efektiivselt plasmakontsentratsiooni üleannustamise korral.
while haemodialysis was effective at clearing tasimelteon and the majority of its major metabolites in patients with renal impairment, it is not known if hemodialysis will effectively reduce exposure in the case of overdose.
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