natgillin/translations-raw huggingface dataset:
Cardioselective beta-blockade should only be considered for profound vilanterol overdose effects that are clinically concerning and unresponsive to supportive measures.
Primjenu kardioselektivnih beta-blokatora treba razmotriti samo kod teških klinički manifestinih predoziranja vilanterolom koji ne reagiraju na potporne mjere liječenja.
The bronchoprotective effect of fluticasone furoate/vilanterol 92/22 micrograms on the early and late asthmatic response to inhaled allergen was evaluated in a repeat dose, placebo-controlled four-way crossover study (HZA113126) in patients with mild asthma.
Bronhoprotektivni učinak flutikazonfuroata/vilanterola od 92/22 mikrograma na rani i kasni astmatički odgovor na inhalirani alergen ocijenjen je u placebom kontroliranom, četverosmjernom križnom ispitivanju ponovljenih doza (HZA113126) u bolesnika s blagom astmom.
Although there were more fractures in the Relvar Ellipta groups compared with the vilanterol 22 micrograms group, fractures typically associated with corticosteroid use (e.g., spinal compression/thoracolumbar vertebral fractures, hip and acetabular fractures) occurred in <1% of the Relvar Ellipta and vilanterol treatment arms.
Premda je u skupinama koje su primale Relvar Ellipta fraktura bilo više nego u skupinama koje su primale vilanterol od 22 mikrograma, frakture koje se u pravilu povezuju s primjenom kortikosteroida (npr. kompresivni prijelomi torako-lumbalnih kralježaka, frakture kuka i zglobne čašice) zabilježene su u <1% ispitanika i u skupinama koje su primale Relvar Ellipta i u onima koje su primale vilanterol.
The effects of haemodialysis have not been studied.
Učinci hemodijalize nisu ispitivani.
The pharmacokinetics of fluticasone furoate/vilanterol in patients less than 12 years of age has not been studied.
Nije ispitivana farmakokinetika flutikazonfuroata/vilanterola u bolesnika mlađih od 12 godina.
Put the mouthpiece between your lips and close your lips firmly around it.
Stavite nastavak za usta među usne i čvrsto ga obujmite usnama.
Rinse your mouth with water after you have used the inhaler, do not swallow.
Isperite usta vodom nakon korištenja inhalatora, nemojte je progutati.
The results of both studies showed that treatment with fluticasone furoate/vilanterol 92/22 micrograms once daily resulted in a lower annual rate of moderate/severe COPD exacerbations compared with vilanterol (Table 2).
Rezultati obaju ispitivanja pokazali su da je liječenje flutikazonfuroatom/vilanterolom od 92/22 mikrograma jedanput na dan rezultiralo nižom godišnjom stopom umjerenih/teških egzacerbacija KOPB-a u odnosu na vilanterol (Tablica 2).
In peripheral blood mononuclear cells from subjects with COPD, a larger anti-inflammatory effect was seen in the presence of the combination of fluticasone furoate/vilanterol compared with fluticasone furoate alone at concentrations achieved with clinical doses.
mononuklearnim stanicama periferne krvi ispitanika s KOPB-om primijećen je jači protuupalni učinak u prisutnosti kombinacije flutikazonfuroat/vilanterol u usporedbi s prisutnošću samo flutikazonfuroata pri koncentracijama koje se postižu primjenom kliničkh doza.
PHARMACEUTICAL FORM Inhalation powder, pre-dispensed (Inhalation powder).
OBLIK Prašak inhalata, dozirani (Prašak inhalata).
Allergen challenge study
Provokacijsko ispitivanje s alergenima
• If the dose counter does not count down as you hear the “click”, the inhaler will not deliver medicine.
• Ako se broj na brojaču doza ne smanji za 1 kada čujete ''klik'', inhalator neće isporučiti lijek.
Driving and using machines This medicine is unlikely to affect your ability to drive or use machines.
Nije vjerojatno da bi ovaj lijek mogao utjecati na Vašu sposobnost upravljanja vozilima ili rada sa strojevima.
Slide the cover upwards as far as it will go to cover the mouthpiece.
Povucite poklopac prema gore koliko ide kako biste prekrili nastavak za usta.
However, the patient should be informed that regular daily usage is necessary to maintain control of asthma symptoms and that use should be continued even when asymptomatic.
Međutim, bolesniku treba napomenuti da je za održavanje simptoma astme pod kontrolom potrebno redovito uzimati lijek svakoga dana te da s primjenom treba nastaviti čak i ako nema simptoma.
The MAH shall perform the required Pharmacovigilance activities and interventions detailed in the agreed RMP presented in Module 1.8.2 of the Marketing Authorisation and any agreed subsequent updates of the RMP.
• Plan upravljanja rizikom (RMP) Nositelj odobrenja obavljat će zadane farmakovigilancijske aktivnosti i intervencije, detaljno objašnjene u dogovorenom Planu upravljanja rizikom (RMP), koji se nalazi u Modulu 1.8.2
In two replicate 12 month studies in a total of 3,255 patients with COPD the incidence of bone fractures overall was low in all treatment groups, with a higher incidence in all Relvar Ellipta groups (2%) compared with the vilanterol 22 micrograms group (<1%).
U dva 12-mjesečna replikacijska ispitivanja u kojima je sudjelovalo ukupno 3255 bolesnika s KOPB-om, ukupna incidencija fraktura kostiju bila je niska u svim liječenim skupinama, s time da je incidencija bila viša u svim skupinama u kojima su bolesnici primali Relvar Ellipta (2%) nego u skupinama koje su primale vilanterol od 22 mikrograma (<1%).
A clinical pharmacology study of fluticasone furoate/vilanterol showed that severe renal impairment (creatinine clearance <30mL/min) did not result in significantly greater exposure to fluticasone furoate or vilanterol or more marked corticosteroid or beta2-agonist systemic effects compared with healthy subjects.
Kliničko farmakološko ispitivanje flutikazonfuroata/vilanterola pokazalo je da teško oštećenje bubrežne funkcije (klirens kreatinina <30 ml/min) nije rezultiralo značajno većom izloženošću flutikazonfuroatu ili vilanterolu niti izraženijim sistemskim učincima kortikosteroida ili beta2-agonista u odnosu na zdrave ispitanike.
There are no or limited data from the use of fluticasone furoate and vilanterol trifenatate in pregnant women.
Nema podataka ili postoje samo ograničeni podaci o primjeni flutikazonfuroata i vilanteroltrifenatata u trudnica.
The final decision on evening or morning dosing should be left to the discretion of the physician.
Konačnu odluku o tome hoće li se lijek uzimati uvečer ili ujutro donosi liječnik.
There is no specific treatment for an overdose with fluticasone furoate/vilanterol.
Nema posebne terapije za predoziranje flutikazonfuroatom/vilanterolom.
FF/VI 92/22 Once Daily vs FF 92 Once Daily
FF/VI 92/22 jedanput na dan naspram FF 92 jedanput na dan
If you feel you are getting breathless or wheezy more often than normal, or if you are using your quickacting inhaler more than usual, see your doctor.
Ako ostajete bez zraka, primjećujete piskanje pri disanju ili primjenjujete brzodjelujući inhalacijski lijek češće nego obično, posjetite svog liječnika.
The absolute bioavailability for fluticasone furoate and vilanterol when administered by inhalation as fluticasone furoate/vilanterol was on average 15.2% and 27.3%, respectively.
Apsolutna bioraspoloživost flutikazonfuroata i vilanterola primijenjenih inhalacijom u obliku flutikazonfuroata/vilanterola u prosjeku je iznosila 15,2% odnosno 27,3%.
Serial FEV1 measurements were compared with pre-allergen challenge values taken after saline inhalation (baseline).
Serijska mjerenja vrijednosti FEV1 uspoređena su s vrijednostima prije provokacije alergenom izmjerenima nakon inhalacije fiziološke otopine (početna vrijednost).
HZC112206 and HZC112207 were 24 week randomised, double-blind, placebo controlled, parallel group studies comparing the effect of the combination to vilanterol and FF alone and placebo.
Ispitivanja HZC112206 i HZC112207 bila su 24-tjedna randomizirana, dvostruko slijepa, placebom kontrolirana ispitivanja s paralelnim skupinama kojima se uspoređivao učinak kombinacije s učinkom vilanterola i flutikazonfuroata primijenjenih samostalno te učinkom placeba.
Relvar Ellipta has been shown to reduce flare-ups of COPD symptoms.
Pokazalo se da Relvar Ellipta smanjuje razbuktavanje simptoma KOPB-a.
In subjects with asthma, estimates of fluticasone furoate AUC(0-24) for East Asian, Japanese and South East Asian subjects (12-13% of subjects) were on average 33% to 53% higher compared with other racial groups.
U ispitanika s astmom procijenjene vrijednosti AUC(0-24) flutikazonfuroata za ispitanike iz istočne Azije, Japana i jugoistočne Azije (12-13% ispitanika) bile su u prosjeku 33% do 53% više u odnosu na ostale rasne skupine.
The Ellipta inhaler is packaged in a tray containing a desiccant sachet, to reduce moisture.
Ellipta inhalator zapakiran je u podložak u kojem se nalazi vrećica sa sredstvom za sušenje koje služi za smanjivanje količine vlage.
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS DEVICE LABEL
PODACI KOJE MORA NAJMANJE SADRŽAVATI MALO UNUTARNJE PAKIRANJE NALJEPNICA NA UREĐAJU
1 inhaler of 30 doses.
1 inhalator s 30 doza
In an integrated analysis of both studies, fluticasone furoate/vilanterol 92/22 micrograms showed clinically meaningful improvements in lung function.
U objedinjenoj analizi obaju ispitivanja flutikazonfuroat/vilanterol od 92/22 mikrograma pokazao je klinički značajna poboljšanja plućne funkcije.
• anxiety
• anksioznost
Asthma Relvar Ellipta is indicated for the regular treatment of asthma in adults and adolescents aged 12 years and older where use of a combination medicinal product (long-acting beta2-agonist and inhaled corticosteroid) is appropriate:
Relvar Ellipta je indiciran za redovito liječenje astme u odraslih osoba i adolescenata u dobi od 12 i više godina kod kojih je primjerena primjena kombiniranog lijeka (dugodjelujućeg beta2-agonista i inhalacijskog kortikosteroida) :
The higher strength of Relvar Ellipta (184 micrograms fluticasone furoate and 22 micrograms of vilanterol) is not suitable for the treatment of COPD.
Jača doza lijeka Relvar Ellipta (184 mikrograma flutikazonfuroata i 22 mikrograma vilanterola) nije prikladna za liječenje KOPB-a.
Fluticasone furoate belongs to a group of medicines called corticosteroids, often simply called steroids.
Flutikazonfuroat pripada skupini lijekova koje nazivamo kortikosteroidima ili steroidima.
- Contact your doctor if you experience increased thirst, frequent urination or unexplained tiredness
obratite se svom liječniku ako primijetite povećanu žeđ, učestalo mokrenje ili neobjašnjiv umor (znakovi visoke razine šećera u krvi).
Based on in vitro data, the major routes of metabolism of both fluticasone furoate and vilanterol in human are mediated primarily by CYP3A4.
Na temelju podataka iz ispitivanja in vitro, u glavnim metaboličkim putevima flutikazonfuroata i vilanterola u ljudi posreduje prvenstveno enzim CYP3A4.
Clinically significant drug interactions mediated by fluticasone furoate/vilanterol at clinical doses are considered unlikely due to the low plasma concentrations achieved after inhaled dosing.
Klinički značajne interakcije posredovane flutikazonfuroatom/vilanterolom u kliničkim dozama ne smatraju se vjerojatnima zbog malih koncentracija lijeka u plazmi nakon inhaliranja doze.
Inhale your medicine
Inhalirajte lijek
All subjects were using an ICS (Inhaled corticosteroid) with or without LABA for at least 12 weeks prior to visit 1.
Svi su ispitanici primjenjivali inhalacijski kortikosteroid s ili bez dugodjelujućeg beta2-agonista tijekom najmanje 12 tjedana prije 1. posjete.
Molecular interactions occur between corticosteroids and LABAs, whereby steroids activate the beta2receptor gene, increasing receptor number and sensitivity and LABAs prime the glucocorticoid receptor for steroid-dependent activation and enhance cell nuclear translocation.
Između kortikosteroida i dugodjelujućih beta2-agonista dolazi i do molekularnih interakcija, pri čemu steroidi aktiviraju gene za ekspresiju beta2-receptora te tako povećavaju broj i osjetljivost tih receptora, dok dugodjelujući beta2-agonisti pripremaju glukokortikoidni receptor za aktivaciju ovisnu o steroidima te pospješuju ulaz kompleksa glukokortikoida i glukokortikoidnog receptora u staničnu jezgru.
Do not breathe out into the inhaler.
Nemojte izdisati u inhalator.
The 24-hour bronchodilator effect of fluticasone furoate/vilanterol was maintained throughout a one-year treatment period with no evidence of loss in efficacy (no tachyphylaxis).
24-satni bronhodilatacijski učinak flutikazonfuroata/vilanterola održan je tijekom jednogodišnjeg razdoblja liječenja bez znakova smanjene djelotvornosti (bez tahifilaksije).
In inhalation studies in rabbits, vilanterol trifenatate caused effects similar to those seen with other beta2 agonists (cleft palate, open eyelids, sternebral fusion and limb flexure/malrotation).
U inhalacijskim ispitivanjima na kunićima vilanteroltrifenatat je izazvao učinke slične učincima zabilježenima kod ostalih beta2-agonista (rascjep nepca, otvoreni kapci, spojeni segmenti prsne kosti, fleksura/malrotacija ekstremiteta).
Cardioselective beta-blocking medicinal products should be used with caution in patients with a history of bronchospasm.
Kardioselektivni beta-blokatori moraju se primjenjivati uz oprez u bolesnika s bronhospazmom u anamnezi.
Do not open until ready to inhale.
Ne otvarati dok niste spremni za inhalaciju.
Six month studies
Šestomjesečna ispitivanja
There was no decrease in the extent of in vitro plasma protein binding in subjects with renal or hepatic impairment.
Nije zabilježen smanjen opseg vezivanja za proteine u plazmi in vitro u ispitanika s oštećenjem bubrežne ili jetrene funkcije.
FF/VI 184/22 Once Daily vs FP 500 Twice Daily
FF/VI 184/22 jedanput na dan naspram FP 500 dvaput na dan
The 92/22 micrograms strength is used for the regular treatment of chronic obstructive pulmonary disease (COPD) in adults, and asthma in adults and adolescents 12 years and over.
Doza od 92/22 mikrograma koristi se za redovito liječenje kronične opstruktivne plućne bolesti (KOPB) u odraslih osoba te astme u odraslih osoba i adolescenata u dobi od 12 i više godina.
NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER GlaxoSmithKline (Ireland) Limited, 12 Riverwalk, Citywest Business Campus, Dublin 24, Ireland GlaxoSmithKline (Ireland) Limited logo
11. NAZIV I ADRESA NOSITELJA ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET GlaxoSmithKline (Ireland) Limited, 12 Riverwalk, Citywest Business Campus, Dublin 24, Irska GlaxoSmithKline (Ireland) Limited logo
Fluticasone furoate/vilanterol should not be used to treat acute asthma symptoms, for which a short-acting bronchodilator is required.
Flutikazonfuroat/vilanterol se ne smije koristiti za liječenje akutnih simptoma astme, koje je potrebno liječiti kratkodjelujućim bronhodilatatorima.
However, fluticasone furoate/vilanterol should be used with caution in patients with severe cardiovascular disease or heart rhythm abnormalities, thyrotoxicosis, uncorrected hypokalaemia or patients predisposed to low levels of serum potassium.
Međutim, flutikazonfuroat/vilanterol treba primjenjivati uz oprez u bolesnika s teškom kardiovaskularnom bolešću ili poremećajima srčanog ritma, tireotoksikozom, nekorigiranom hipokalemijom ili u bolesnika s predispozicijom za niske razine kalija u serumu.
Relvar Ellipta should be discontinued immediately, the patient assessed and alternative therapy instituted if necessary.
Treba odmah prekinuti terapiju lijekom Relvar Ellipta, pregledati bolesnika te po potrebi uvesti drugu terapiju.
The 24-hour bronchodilator effect of fluticasone furoate/vilanterol was maintained from the first dose throughout a one-year treatment period with no evidence of loss in efficacy (no tachyphylaxis).
24-satni bronhodilatacijski učinak flutikazonfuroata/vilanterola održan je od prve doze do kraja jednogodišnjeg razdoblja liječenja bez znakova smanjene djelotvornosti (bez tahifilaksije).
However, other corticosteroids and beta2-agonists are detected in human milk (see section 5.3).
Međutim, u majčinu su mlijeku otkriveni drugi kortikosteroidi i beta2-agonisti (vidjeti dio 5.3).
The inhaler consists of a light grey body, a yellow mouthpiece cover and a dose counter, packed into a foil laminate tray containing a silica gel desiccant sachet.
Inhalator se sastoji od svijetlosivog tijela, žutog poklopca nastavka za usne i brojača doza, a zapakiran je u podložak od višeslojne folije koji sadrži vrećicu sa silika gelom kao sredstvom za sušenje.
If your breathing or wheezing gets worse straight after using Relvar Ellipta, stop using it and get medical help immediately.
Ako Vam se disanje ili piskanje u plućima pogoršaju neposredno nakon primjene lijeka Relvar Ellipta, odmah ga prestanite primjenjivati i zatražite liječničku pomoć.
The safety and efficacy of Relvar Ellipta in children under 12 years of age has not yet been established in the indication for asthma.
Sigurnost i djelotvornost lijeka Relvar Ellipta u indikaciji astme u djece mlađe od 12 godina nisu još ustanovljene.
The maximum recommended dose is Relvar Ellipta 184/22 micrograms once daily.
Najveća preporučena doza lijeka Relvar Ellipta je 184/22 mikrograma jedanput na dan.
Other side effects include:
Ti lijekovi uključuju:
In the COPD clinical development programme a total of 6,237 subjects were included in an integrated assessment of adverse reactions.
U kliničkom razvojnom programu za objedinjenu procjenu nuspojava kod KOPB-a uključeno je ukupno 6237 bolesnika.
Following repeat dosing of fluticasone furoate/vilanterol for 7 days, there was an increase in fluticasone furoate systemic exposure (up to three-fold as measured by AUC(0-24)) in subjects with hepatic impairment (Child-Pugh A, B or C) compared with healthy subjects.
Nakon primjene ponovljenih doza flutikazonfuroata/vilanterola tijekom 7 dana, došlo je do povećanja sistemske izloženosti flutikazonfuroatu (do tri puta prema vrijednosti AUC(0-24)) u ispitanika s oštećenjem jetrene funkcije (Child-Pugh stadij A, B ili C) u odnosu na zdrave ispitanike.
Following repeat dosing of fluticasone furoate/vilanterol for 7 days, there was no significant increase in systemic exposure to vilanterol (Cmax and AUC) in subjects with mild, moderate, or severe hepatic impairment (Child-Pugh A, B or C).
Nakon primjene ponovljenih doza flutikazonfuroata/vilanterola tijekom 7 dana, nije bilo značajnog povećanja sistemske izloženosti vilanterolu (Cmax i AUC) u ispitanika s blagim, umjerenim ili teškim oštećenjem jetrene funkcije (Child-Pugh stadij A, B ili C).
Chronic Obstructive Pulmonary Disease
Kronična opstruktivna plućna bolest
Both fluticasone furoate/vilanterol 92/22 micrograms and FF 92 micrograms virtually abolished the late asthmatic response compared with vilanterol alone.
I flutikazonfuroat/vilanterol od 92/22 mikrograma i flutikazonfuroat od 92 mikrograma praktički su iskorijenili kasni astmatički odgovor u odnosu na vilanterol primijenjen samostalno.
*FF/VI = fluticasone furoate/vilanterol
*FF/VI = flutikazonfuroat/vilanterol
Weighted Mean Serial FEV1 over 0-24 hours post-dose Treatment difference
Ponderirane srednje vrijednosti FEV1 mjerene serijski u razdoblju od 0-24 sata nakon uzimanja lijeka
Patients usually experience an improvement in lung function within 15 minutes of inhaling Relvar Ellipta.
Bolesnici obično osjete poboljšanje plućne funkcije unutar 15 minuta nakon inhaliranja lijeka Relvar Ellipta.
Prepare a dose Wait to open the cover until you are ready to take your dose.
Pripremite dozu Otvorite poklopac tek onda kada ste spremni uzeti dozu.
The exposureadjusted rates (per 1000 treatment years) for all fracture events were 13.6, 12.8, 13.2, 11.5 respectively; fractures commonly associated with ICS use were 3.4, 3.9, 2.4, 2.1 respectively.
Stope prilagođene za izloženost (na 1000 godina liječenja) za sve događaje fraktura iznosile su 13,6; 12,8; 13,2 odnosno 11,5, dok su za frakture koje se obično povezuju s inhalacijskim kortikosteroidima iznosile 3,4; 3,9; 2,4 odnosno 2,1.
Fluticasone furoate/vilanterol 92/22 micrograms provided significantly greater protection against allergen-induced bronchial hyper-reactivity compared with monotherapies FF and vilanterol as assessed on Day 22 by methacholine challenge.
Flutikazonfuroat/vilanterol od 92/22 mikrograma pružio je značajno veću zaštitu od bronhalne hiperreaktivnosti izazvane alergenom u usporedbi s monoterapijom flutikazonfuroatom odnosno vilanterolom, kako je ocijenjeno 22. dana provocirajućim metakolinskim testom.
Co-administration increased mean vilanterol AUC(0-t) and Cmax 65% and 22%, respectively.
Istodobna primjena povećala je srednju vrijednost AUC(0-t) i Cmax vilanterola za 65% odnosno 22%.
The co-primary endpoints in both studies were weighted mean FEV1 from zero to 4 hours post-dose at Day 168 and change from baseline in pre-dose trough FEV1 at Day 169.
Dvije primarne mjere ishoda u oba ispitivanja bile su ponderirana srednja vrijednost FEV1 mjerena od 0-4 sata nakon primjene doze 168. dana te promjena od početne najniže vrijednosti FEV1 prije uzimanja lijeka 169. dana.
This will make it less likely that you will develop a sore mouth or throat as side effects.
Time ćete smanjiti vjerojatnost pojave nuspojava poput boli u ustima ili grlu.
The primary efficacy endpoint was change from baseline in clinic visit trough (pre-bronchodilator and pre-dose) FEV1 at the end of the treatment period.
Primarna mjera ishoda za djelotvornost bila je promjena od početne najniže vrijednosti (prije primjene bronhodilatatora i prije uzimanja lijeka) FEV1 pri kliničkom posjetu na kraju terapijskog razdoblja.
For patients with moderate to severe hepatic impairment, the 92/22 micrograms dose should be used and patients should be monitored for systemic corticosteroid-related adverse reactions (see section 5.2).
Bolesnicima s umjerenim do teškim oštećenjem jetrene funkcije treba propisati dozu od 92/22 mikrograma te ih nadzirati zbog mogućih sistemskih nuspojava kortikosteroida (vidjeti dio 5.2).
Effects seen following inhalation administration of fluticasone furoate in combination with vilanterol in rats were similar to those seen with fluticasone furoate alone.
Učinci zabilježeni nakon inhalacijske primjene flutikazonfuroata u kombinaciji s vilanterolom u štakora bili su slični učincima zabilježenima kod primjene samo flutikazonfuroata.
If stored in a refrigerator, the inhaler should be allowed to return to room temperature for at least an hour before use.
Ako se inhalator čuva u hladnjaku, treba pričekati najmanje jedan sat prije primjene da se ugrije na sobnu temperaturu.
Dose-normalised fluticasone furoate systemic exposure was similar in subjects with moderate and severe hepatic impairment (Child-Pugh B or C).
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).
One inhalation of Relvar Ellipta 92/22 micrograms once daily.
Jedna inhalacija lijeka Relvar Ellipta 92/22 mikrograma jedanput na dan.
A clinical pharmacology study in healthy subjects with co-administered vilanterol and the potent P-gp and moderate CYP3A4 inhibitor verapamil did not show any significant effect on the pharmacokinetics of vilanterol.
Kliničko farmakološko ispitivanje istodobne primjene vilanterola i snažnog inhibitora P-glikoproteina te umjerenog inhibitora CYP3A4 verapamila, provedeno u zdravih ispitanika, nije pokazalo značajan učinak na farmakokinetiku vilanterola.
The increase in fluticasone furoate systemic exposure in subjects with moderate hepatic impairment (Child-Pugh B; fluticasone furoate/vilanterol 184/22 micrograms) was associated with an average 34% reduction in serum cortisol compared with healthy subjects.
Povećanje sistemske izloženosti flutikazonfuroatu u ispitanika s umjerenim oštećenjem jetrene funkcije (Child-Pugh stadij B; flutikazonfuroat/vilanterol od 184/22 mikrograma) povezano je s prosječnim smanjenjem kortizola u serumu od 34% u odnosu na zdrave ispitanike.
In subjects with COPD estimates of fluticasone furoate AUC(0-24) for East Asian, Japanese and South East Asian subjects (13-14% subjects) were on average 23% to 30% higher compared with Caucasian subjects.
U ispitanika s KOPB-om procijenjene vrijednosti AUC(0-24) flutikazonfuroata za ispitanike iz istočne Azije, Japana i jugoistočne Azije (13-14% ispitanika) bile su u prosjeku 23% do 30% više u odnosu na ispitanike bijele rase.