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Flutikazonfuroat)
za flutikazonfuroat 110 mikrograma jednom na dan i 1(< 1%) za placebo.
7(2%) for fluticasone furoate 110 micrograms once daily and 1(< 1%) for placebo.Flutikazonfuroat se nije pokazao genotoksičnim u standardnom skupu ispitivanja
Fluticasone furoate was not genotoxic in a standard battery of studiesdjeca s višegodišnjim alergijskim rinitisom primali su ili flutikazonfuroat(n=367) ili placebo n=181.
adolescents with perennial allergic rhinitis received either fluticasone furoate(n=367) or placebo n=181.Dostupne su dvije različite doze lijeka Relvar Ellipta: flutikazonfuroat od 92 mikrograma/vilanterol od 22 mikrograma i flutikazonfuroat od 184 mikrograma/vilanterol od 22 mikrograma.
Two different strengths of Relvar Ellipta are available: fluticasone furoate 92 micrograms/vilanterol 22 micrograms and fluticasone furoate 184 micrograms/vilanterol 22 micrograms.Nisu provedena klinička farmakološka ispitivanja sa specifičnim inhibitorom P-gp-a i flutikazonfuroatom.
Clinical pharmacology studies with a specific P-gp inhibitor and fluticasone furoate have not been conducted.Više od 2700 bolesnika sa sezonskim i cjelogodišnjim alergijskim rinitisom liječeno je flutikazonfuroatom u ispitivanjima sigurnosti i djelotvornosti.
There were over 2700 patients treated with fluticasone furoate in safety and efficacy studies for seasonal and perennial allergic rhinitis.Ne preporučuje se istovremena primjena s ritonavirom zbog rizika od povećane sistemske izloženosti flutikazonfuroatu vidjeti dio 4.5.
Concomitant administration with ritonavir is not recommended because of the risk of increased systemic exposure of fluticasone furoate see section 4.5.Dva su ispitivanja usporedila različite doze lijeka Relvar Ellipta s flutikazonfuroatom i vilanterolom, koji su primijenjeni zasebno, i placebom.
Two studies compared different doses of Relvar Ellipta with fluticasone furoate and vilanterol given separately and placebo.Ovi događaji bili su prolazne naravi za 6 ispitanika iz skupine liječene flutikazonfuroatom i za jednog ispitanika iz placebo skupine.
These events were transient in nature for six subjects in the fluticasone furoate group and one placebo subject.U dva od tri ispitivanja, Relvar Ellipta je uspoređen samo s inhalat praškom flutikazonfuroatom ili flutikazonpropionatom ili placebom lažnim liječenjem.
In two of the studies, Relvar Ellipta was compared with fluticasone furoate or fluticasone propionate inhalation powder alone or placebo dummy treatment.Na temelju tih nalaza, ne očekuje se da će u toj populaciji bolesnika, prosječna predviđena izloženost intranazalnom flutikazonfuroatu od 110 mikrograma rezultirati supresijom kortizola.
Based on these findings the average predicted exposure of 110 micrograms of intranasal fluticasone furoate in this patient population would not be expected to result in suppression of cortisol.teškim oštećenjem jetrene funkcije ukazala su na povećanje sistemske izloženosti flutikazonfuroatu(i Cmax i AUC)
moderate and severe hepatic impairment showed an increase in systemic exposure to fluticasone furoate(both Cmax and AUC)Sistemska izloženost flutikazonfuroatu uz normalizirano doziranje lijeka bila je slična u ispitanika s umjerenim i u onih s teškim oštećenje jetrene funkcije Child-Pugh stadij B ili C.
Dose-normalised fluticasone furoate systemic exposure was similar in subjects with moderate and severe hepatic impairment Child-Pugh B or C.ne preporučuje se istovremena primjena s ritonavirom zbog povećanog rizika od sistemske izloženosti flutikazonfuroatu.
coadministration with ritonavir is not recommended because of the risk of increased systemic exposure of fluticasone furoate.postoji mogućnost povećane sistemske izloženosti i flutikazonfuroatu i vilanterolu pa istodobnu primjenu treba izbjegavati.
as there is potential for increased systemic exposure to both fluticasone furoate and vilanterol, and concomitant use should be avoided.od čega je 176 ispitanika bilo izloženo flutikazonfuroatu.
of whom 176 were exposed to fluticasone furoate.Flutikazonfuroat se brzo uklanja ekstenzivnim metabolizmom prvog prolaza putem citokroma P450 3A4.
Fluticasone furoate is rapidly cleared by extensive first pass metabolism mediated by the cytochrome P450 3A4.Vilanterol i flutikazonfuroat za liječenje kronične astme u odraslih i djece| Cochrane.
Nedocromil sodium for chronic asthma in children| Cochrane Jump to navigation.Vilanterol i flutikazonfuroat za liječenje kronične astme u odraslih i djece| Cochrane.
Oxatomide(antihistamine) for asthma in adults and children| Cochrane.Stupanj vezivanja flutikazonfuroata i vilanterola za proteine u ljudskoj plazmi in vitro bio je visok, prosječno> 99,6% za flutikazonfuroat odnosno 93,9% za vilanterol.
In vitro plasma protein binding in human plasma of fluticasone furoate and vilanterol was high, on average> 99.6% and 93.9%, respectively.
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