natgillin/translations-raw huggingface dataset:
1 inhaler of 14 doses 1 inhaler of 30 doses
1 inhalator s 14 odmerki 1 inhalator s 30 odmerki
The device does not need to be stored in the foil laminate tray once it has been opened.
Pripomočka vam ni treba shranjevati v embalaži, potem ko ste jo že odprli.
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.
Klinično pomembna medsebojna delovanja z zdravili zaradi flutikazonfuroata/vilanterola v kliničnih odmerkih niso verjetna, ker je koncentracija v plazmi po inhaliranju nizka.
• inflammation of the lungs (bronchitis)
• vnetje pljuč (bronhitis),
Both studies had a 4 week run-in period during which all subjects received open-label salmeterol/FP 50/250 twice daily to standardise COPD pharmacotherapy and stabilise disease prior to randomisation to blinded study medication for 52 weeks.
Med obdobjem uvajanja so vsi bolniki odprto prejemali salmeterol/FP 50/250 dvakrat na dan za standardizacijo farmakoterapije KOPB in stabilizacijo bolezni pred randomizacijo v 52-tedensko obdobje slepljenega raziskovanega zdravila.
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-urni brohodilatacijski učinek flutikazonfuroata/vilanterola se je med enoletnim obdobjem zdravljenja ohranil in ugotovili niso nobenih znakov zmanjšanja učinkovitosti (tj. nobene tahifilaksije).
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.
Klinična farmakološka študija flutikazonfuroata/vilanterola je pokazala, da huda okvara ledvic (očistek kreatinina < 30 ml/min) ne povzroči bistveno večje izpostavljenosti flutikazonfuroatu ali vilanterolu ali izrazitejših kortikosteroidnih ali beta2-agonističnih sistemskih učinkov v primerjavi z zdravimi preiskovanci.
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.
Za izpostavljenost prilagojeni deleži (na 1000 let zdravljenja) so bili za vse zlome 13,6, 12,8, 13,2, 11,5 (v tem zaporedju) in za zlome, pogosto povezane z uporabo ICS 3,4, 3,9, 2,4, 2,1 (v tem zaporedju).
• increase in blood sugar (hyperglycaemia)
• zamegljen vid, • povišanje sladkorja v krvi (hiperglikemija).
There is no relevant use of Relvar Ellipta in the paediatric population for the indication of COPD.
Pediatrična populacija Zdravilo Relvar Ellipta ni primerno za uporabo v pediatrični populaciji za indikacijo KOPB.
If you have severe asthma, your doctor may decide that you should use one inhalation of the higher strength inhaler (184 micrograms fluticasone furoate and 22 micrograms of vilanterol).
Če imate hudo astmo, vam lahko zdravnik predpiše uporabo ene inhalacije višje jakosti (184 mikrogramov flutikazonfuroata in 22 mikrogramov vilanterola).
The inhaler contains two aluminium foil laminate strips of 14 or 30 doses.
V notranjosti inhalatorja sta dva laminatna trakova iz aluminija s 14 ali 30 odmerki.
Pharmacological and toxicological effects seen with fluticasone furoate or vilanterol in nonclinical studies were those typically associated with either glucocorticoids or beta2-agonists.
Farmakološki in toksikološki učinki, ki so jih s flutikazonfuroatom ali vilanterolom zabeležili v nekliničnih študijah, so bili takšni, kot tipično spremljajo glukokortikoide ali agoniste adrenergičnih receptorjev beta2.
An overdose of fluticasone furoate/vilanterol may produce signs and symptoms due to the individual component's actions, including those seen with overdose of other beta2-agonists and consistent with the known inhaled corticosteroid class effects (see section 4.4).
Preveliko odmerjanje flutikazonfuroata/vilanterola lahko povzroči znake in simptome, ki so posledica delovanja vsake od obeh sestavin, vključno z znaki in simptomi prevelikega odmerjanja drugih agonistov adrenergičnih receptorjev beta2 in skladnih z znanimi učinki inhaliranih kortikosteroidov (glejte poglavje
Effects seen following inhalation administration of fluticasone furoate in combination with vilanterol in rats were similar to those seen with fluticasone furoate alone.
Učinki, ki so jih pri podganah zabeležili po inhalacijski uporabi flutikazonfuroata v kombinaciji z vilanterolom, so bili podobni kot s samim flutikazonfuroatom.
Patients usually experience an improvement in lung function within 15 minutes of inhaling Relvar Ellipta.
Bolnikom se pljučna funkcija po navadi izboljša v 15 minutah po inhaliranju zdravila Relvar Ellipta.
Studies versus salmeterol/fluticasone propionate combinations
Študije v primerjavi s kombinacijami salmeterola/flutikazonpropionata
Consistent with findings for other beta2 agonists, in lifetime inhalation studies vilanterol trifenatate caused proliferative effects in the female rat and mouse reproductive tract and rat pituitary gland.
Skladno z izsledki pri drugih agonistih adrenergičnih receptorjev beta2 je vilanterolijev trifenatat v študijah vseživljenjskega vdihavanja povzročil proliferacijske učinke v reproduktivnem traktu podganjih in mišjih samic ter v podganji hipofizi.
If your breathing or wheezing gets worse straight after using this medicine, stop using it and get medical help immediately.
Če se vam dihanje ali piskanje takoj po uporabi zdravila poslabša, zdravilo nehajte uporabljati in takoj poiščite zdravniško pomoč.
Fluticasone furoate was not genotoxic in a standard battery of studies and was not carcinogenic in lifetime inhalation studies in rats or mice at exposures similar to those at the maximum recommended human dose, based on AUC.
Flutikazonfuroat ni bil genotoksičen v standardni skupini študij in ni bil kancerogen v študijah vseživljenjskega vdihavanja pri podganah ali miših pri izpostavljenostih, podobnih kot so izpostavljenosti
When the inhaler is used for the first time, there is no need to check that it is working properly, and to prepare it for use in any special way.
Ob prvi uporabi inhalatorja bolniku ni treba preveriti, ali deluje pravilno in mu ga tudi ni treba posebej pripravljati za uporabo.
Slide the cover down until you hear a ‘click'.
Pokrovček mora potisniti navzdol, dokler se ne zasliši "klik".
In subjects with asthma and subjects with COPD there are no recommended dose modifications.
Pri preiskovancih z astmo in preiskovancih s KOPB ni priporočenih prilagoditev odmerka.
• Slide the cover upwards as far as it will go, to cover the mouthpiece.
• Potisnite pokrovček navzgor, kolikor daleč gre, da boste pokrili ustnik.
The adjusted mean treatment difference of 22 mL (95% CI: -18, 63mL) between the groups was not statistically significant (p=0.282).
Korigirana povprečna razlika med zdravljenjema 22 ml (95 % IZ: -18, 63 ml) med skupinama ni bila statistično značilna (p = 0,282).
The date should be added as soon as the inhaler has been removed from the tray.
Ta datum morate zapisati takoj, ko inhalator vzamete iz embalaže.
Subjects had moderate COPD (mean percent post-bronchodilator screening FEV1 of 60% [SD = 6%]), and a history of, or an increased risk of cardiovascular disease.
Bolniki so imeli zmerno KOPB (povprečni delež FEV1 po bronhodilatatorju ob presejanju 60 % [standardni odklon = 6 %] ter anamnezo kardiovaskularne bolezni ali večje tveganje za takšno bolezen.
There is no additional benefit of the 184/22 micrograms dose compared to the 92/22 micrograms dose and there is a potential increased risk of pneumonia and systemic corticosteroid-related adverse reactions (see sections 4.4 and 4.8).
Odmerek 184/22 mikrogramov v primerjavi z odmerkom 92/22 mikrogramov nima dodatnih koristi, obstaja pa lahko večje tveganje za pljučnico in sistemske neželene učinke, povezane s kortikosteroidi (glejte poglavji 4.4 in
• swelling, sometimes of the face or mouth (angioedema)
• kožni izpuščaj (koprivnica) ali rdečina, • otekanje, včasih obraza ali ust (angioedem),
On average, vilanterol Cmax is predicted to be 220 to 287% higher and AUC(0-24) comparable for those subjects from an Asian heritage compared with subjects from other racial groups.
V povprečju je predvidena Cmax vilanterola pri preiskovancih azijskega porekla za 220 do 287 % večja, njegova AUC(0-24) pa primerljiva tisti pri preiskovancih drugih rasnih skupin.
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.
Soprimarna opazovana dogodka v obeh študijah sta bila utežen povprečni FEV1 od 0 do 4 ure po odmerku 168. dan in sprememba najnižjega FEV1 pred odmerkom glede na izhodišče 169. dan.
Cardioselective beta-blocking medicinal products should be used with caution in patients with a history of bronchospasm.
Kardioselektivne blokatorje adrenergičnih receptorjev beta je treba previdno uporabljati pri bolnikih, ki imajo v anamnezi bronhospazem.
Patients should not stop therapy with fluticasone furoate/vilanterol in asthma, without physician supervision since symptoms may recur after discontinuation.
Bolniki zdravljenja astme ali KOPB s flutikazonfuroatom/vilanterolom ne smejo končati brez zdravniškega nadzora, ker se lahko simptomi po prenehanju ponovijo.
NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER GlaxoSmithKline (Ireland) Limited, 12 Riverwalk, Citywest Business Campus, Dublin 24, Ireland GlaxoSmithKline (Ireland) Limited logo
IME IN NASLOV IMETNIKA DOVOLJENJA ZA PROMET Z ZDRAVILOM GlaxoSmithKline (Ireland) Limited, 12 Riverwalk, Citywest Business Campus, Dublin 24, Irska GlaxoSmithKline (Ireland) Limited logo
If patients are inadequately controlled on Relvar Ellipta 92/22 micrograms, the dose can be increased to 184/22 micrograms, which may provide additional improvement in asthma control.
Če bolniki z zdravilom Relvar Ellipta 92/22 mikrogramov bolezni nimajo ustrezno urejene, pride v poštev zvišanje odmerka na 184/22 mikrogramov; to lahko prinese dodatno izboljšanje urejenosti astme.
The higher strength of Relvar Ellipta (184 micrograms fluticasone furoate and 22 micrograms of vilanterol) is not suitable for the treatment of COPD.
Višja jakost zdravila Relvar Ellipta (184 mikrogramov flutikazonfuroata in 22 mikrogramov vilanterola) ni primerna za zdravljenje KOPB.
If the dose counter does not count down as you hear the ‘click', the inhaler will not deliver medicine.
Če se število na števcu odmerkov ne zmanjša, ko se zasliši ''klik'', inhalator ne bo oddal zdravila.
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.
Klinična farmakološka študija s sočasno uporabo vilanterola in verapamila, ki je močan zaviralec P-gp in zmeren zaviralec CYP3A4, pri zdravih preiskovancih ni pokazala pomembnega vpliva na farmakokinetiko vilanterola.
There is insufficient information on the excretion of fluticasone furoate or vilanterol trifenatate and/or metabolites in human milk.
Dojenje Podatkov o izločanju flutikazonfuroata oziroma vilanterolijevega trifenatata in/ali njunih presnovkov v materinem mleku pri človeku ni dovolj.
The most commonly reported adverse reactions with fluticasone furoate and vilanterol were headache and nasopharyngitis.
Najpogosteje zabeležena neželena učinka flutikazonfuroata in vilanterola sta bila glavobol in nazofaringitis.
If you have any of the following symptoms after taking Relvar Ellipta stop taking this medicine and tell your doctor immediately.
Če imate po jemanju zdravila Relvar Ellipta katerega koli od naslednjih simptomov, zdravilo takoj nehajte uporabljati in nemudoma obvestite svojega zdravnika:
Following intravenous dosing, both fluticasone furoate and vilanterol are extensively distributed with average volumes of distribution at steady state of 661 L and 165 L, respectively.
Porazdelitev Po intravenski uporabi se flutikazonfuroat in vilanterol obširno porazdelita; povprečni volumen porazdelitve v stanju dinamičnega ravnovesja je za flutikazonfuroat 661 l in za vilanterol 165 l.
What Relvar Ellipta is and what it is used for
Kaj je zdravilo Relvar Ellipta in za kaj ga uporabljamo
Close the inhaler and rinse your mouth
Zaprite inhalator in si splaknite usta.
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.
Jakost 92/22 mikrogramov se uporablja za zdravljenje kronične obstruktivne pljučne bolezni (KOPB) pri odraslih in za zdravljenje astme pri odraslih in mladostnikih, starih 12 let ali več.
Take one long, steady, deep breath in.
Naredi naj en dolg, enakomeren, globok vdih.
Use Relvar Ellipta at the same time each day as it is effective over 24 hours It is very important that you use this medicine every day, as instructed by your doctor.
Zdravilo Relvar Ellipta uporabljajte vsak dan ob istem času, saj učinkuje 24 ur.
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).
V inhalacijskih študijah pri podganah je povzročil podobne učinke, kot se pojavljajo z drugimi agonisti adrenergičnih receptorjev beta2 (palatoshiza, odprte veke, sternebralna fuzija in fleksura/malrotacija udov).
Relvar Ellipta should not be used in conjunction with other long-acting beta2-adrenergic agonists or medicinal products containing longacting beta2-adrenergic agonists.
Zdravila Relvar Ellipta se ne sme uporabljati skupaj z drugimi dolgodelujočimi agonisti adrenergičnih receptorjev beta2 ali z zdravili, ki vsebujejo dolgodelujoče agoniste adrenergičnih receptorjev beta2.
Read this before you start
Pred začetkom uporabe preberite ta navodila.
Don't open the inhaler until you are ready to inhale a dose of medicine.
Ne odpirajte inhalatorja, dokler niste pripravljeni za vdihanje odmerka zdravila.
The effects of age on the pharmacokinetics of fluticasone furoate and vilanterol were determined in phase III studies in COPD and asthma.
Vplive starosti na farmakokinetiko flutikazonfuroata in vilanterola so preučili v študijah III. faze pri KOPB
Exposure-adjusted all-cause mortality per 100 patients/year (%/yr) was: fluticasone furoate/vilanterol, 3.1 %/yr; placebo, 3.5 %/yr; fluticasone furoate, 3.2 %/yr; and vilanterol, 3.4 %/yr.
Za izpostavljenost korigirana umrljivost zaradi vseh vzrokov na 100 bolnik-let (%/bl) je bila med uporabo flutikazonfuroata/vilanterola 3,1 %/leto, placeba 3,5 %/leto, flutikazonfuroata 3,2 %/leto in vilanterola 3,4 %/leto.
There was no evidence for age (12-84) to affect the pharmacokinetics of fluticasone furoate and vilanterol in subjects with asthma.
Izsledki niso pokazali, da bi starost (od 12 do 84 let) pri preiskovancih z astmo vplivala na farmakokinetiko flutikazonfuroata in vilanterola.
The 184/22 micrograms strength is not approved for the treatment of COPD.
Jakost 184/22 mikrogramov ni odobrena za zdravljenje KOPB.
Following oral administration, fluticasone furoate was eliminated in humans mainly by metabolism with metabolites being excreted almost exclusively in faeces, with <1% of the recovered radioactive dose eliminated in the urine.
Po peroralni uporabi se flutikazonfuroat pri človeku odstrani predvsem s presnovo; presnovki se izločijo skoraj samo v blatu in < 1 % najdenega radioaktivnega odmerka se je izločil v urinu.
Subjects randomised to once-daily FF/VI maintained lung function comparable with those randomised to twice-daily salmeterol/FP [difference in trough FEV1 of +19 mL (95% CI: -11, 49)].
Preiskovanci, randomizirani na kombinacijo FF/VI enkrat na dan, so ohranili pljučno funkcijo primerljivo preiskovancem, randomiziranim na kombinacijo salmeterol/FP dvakrat na dan [razlika v najnižjem FEV1 +19 mL (95 % IZ: -11, 49)].
If you have further questions on the use of this medicine, ask your doctor, pharmacist or nurse.
Če imate dodatna vprašanja o uporabi tega zdravila, se posvetujte s svojim zdravnikom, s farmacevtom ali z medicinsko sestro.
• Take one long, steady, deep breath in.
• Naredi naj en dolg, enakomeren, globok vdih.
Sympathomimetic medicinal products
Simpatikomimetična zdravila
Relvar Ellipta has been shown to reduce flare-ups and symptoms of asthma.
Dokazano je, da zdravilo Relvar Ellipta zmanjša pogostnost poslabšanj in simptomov astme.
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).
Bolniki z okvaro jeter Pri bolnikih z zmerno do hudo okvaro jeter je treba uporabiti odmerek 92/22 mikrogramov in bolnike je treba kontrolirati glede sistemskih neželenih učinkov, povezanih s kortikosteroidi (glejte poglavje 5.2).
• While holding the inhaler away from your mouth, breathe out as far as is comfortable.
• Medtem ko inhalator držite še odmaknjen od ust, izdihnite čim bolj globoko, a ne toliko, da bi bilo neprijetno.
Co-administration increased mean vilanterol AUC(0-t) and Cmax 65% and 22%, respectively.
Sočasna uporaba je povečala povprečno AUC(0-t) vilanterola za 65 % in njegovo Cmax za 22 %.
When the inhaler is taken out of its tray, it will be in the ‘closed' position.
Ko bolnik vzame inhalator iz embalaže, bo le-ta v položaju ''zaprto''.
Based on in vitro data, the major routes of metabolism of both fluticasone furoate and vilanterol in human are mediated primarily by CYP3A4.
Na podlagi podatkov in vitro poteka pri človeku glavna pot presnove obeh, flutikazonfuroata in vilanterola, predvsem preko CYP3A4.
1 inhaler of 30 doses.
1 inhalator s 30 odmerki.
Other medicines and Relvar Ellipta
Druga zdravila in zdravilo Relvar Ellipta
It should be administered at the same time of the day, each day.
Zdravilo je treba uporabljati vsak dan ob istem času.
What you need to know before you use Relvar Ellipta
Kaj morate vedeti, preden boste uporabili zdravilo Relvar Ellipta
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 vpliv flutikazonfuroata/vilanterola 92/22 mikrogramov na zgodnji in pozni astmatični odziv na inhalirani alergen so ocenili v štirismerni navzkrižni, s placebom kontrolirani študiji ponavljajočih se odmerkov (HZA113126) pri bolnikih z blago astmo.
if you experience blurred vision or other visual disturbances.
če se vam pojavi zamegljen vid.
Relvar Ellipta should not be used to relieve a sudden attack of breathlessness or wheezing.
Zdravila Relvar Ellipta se ne sme uporabljati za olajšanje nenadnega napada težkega dihanja ali piskanja.
Weighted Mean Serial FEV1 over 0-24 hours post-dose Treatment difference
Uteženi povprečni zaporedni FEV1 v 0-24 urah po odmerku
Vilanterol trifenatate is a selective long-acting, beta2-adrenergic agonist (LABA).
Vilanterolijev trifenatat je selektiven, dolgodelujoč agonist adrenergičnih receptorjev beta2 (LABA - long acting, beta2-adrenergic agonist).
Relvar Ellipta 184/22 micrograms is not indicated for patients with COPD.
Zdravilo Relvar Ellipta 184/22 mikrogramov ni indicirano pri bolnikih s KOPB.
The rate of severe asthma exacerbations per patient per year was 0.19 in the FF 92 micrograms group (approximately 1 in every 5 years) and 0.14 in the fluticasone furoate/vilanterol 92/22 micrograms group (approximately 1 in every 7 years).
Delež hudih poslabšanj astme na bolnika na leto je bil v skupini z 92 mikrogrami FF 0,19 (približno 1 na 5 let) in v skupini z flutikazonfuroatom/vilanterolom 92/22 mikrogramov 0,14 (približno 1 na 7 let).
PHARMACEUTICAL FORM AND CONTENTS Inhalation powder, pre-dispensed.
FARMACEVTSKA OBLIKA IN VSEBINA prašek za inhaliranje, odmerjeni
FF/VI 184/22 Once Daily vs FF 184 Once Daily
FF/VI 184/22 1-krat/dan v prim.
In a placebo-controlled study (SUMMIT) in subjects with moderate COPD (mean percent postbronchodilator screening FEV1 of 60%, SD 6%), and a history of, or an increased risk of cardiovascular disease, the incidence of pneumonia with FF/VI, FF, VI and placebo was: adverse events (6%, 5%, 4%, 5%); serious adverse events (3%, 4%, 3%, 3%); adjudicated on treatment deaths due to pneumonia (0.3%, 0.2%, 0.1%, 0.2%); the exposure adjusted rates (per 1000 treatment years) were: adverse events (39.5, 42.4, 27.7, 38.4); serious adverse events (22.4, 25.1, 16.4, 22.2); adjudicated on-treatment deaths due to pneumonia (1.8, 1.5, 0.9, 1.4) respectively.
FEV1 po bronhodilatatorju ob presejanju 60 %, standardni odklon 6 %), ki so imeli kardiovaskularno bolezen kdaj v preteklosti ali so imeli večje tveganje za takšno bolezen, je bila pojavnost pljučnice s FF/VI, FF, VI in placebom: neželeni učinki (6 %, 5 %, 4 %, 5 %), resni neželeni učinki (3 %, 4 %, 3 %, 3 %), presojene smrti zaradi pljučnice med zdravljenjem (0,3 %, 0,2 %, 0,1 %, 0,2 %); za izpostavljenost prilagojeni deleži (na 1000 bolnik-let zdravljenja) so bili: neželeni učinki (39,5, 42,4, 27,7, 38,4), resni neželeni učinki (22,4, 25,1, 16,4, 22,2), presojene smrti zaradi pljučnice med zdravljenjem (1,8, 1,5, 0,9, 1,4) v tem zaporedju.
Patients were randomized to receive fluticasone furoate/vilanterol 92/22 micrograms, FF 92 micrograms, vilanterol 22 micrograms or placebo once daily for 21 days followed by challenge with allergen 1 hour after the final dose.
Bolnike so randomizirali na prejemanje 92/22 mikrogramov flutikazonfuroata/vilanterola, 92 mikrogramov FF, 22 mikrogramov vilanterola ali placeba enkrat na dan za 21 dni; temu je sledila provokacija z alergenom 1 uro po zadnjem odmerku.
The maximum recommended dose is Relvar Ellipta 184/22 micrograms once daily.
Največji priporočeni odmerek zdravila Relvar Ellipta je 184/22 mikrogramov enkrat na dan.
How to use Relvar Ellipta See ‘Step-by-step instructions' after section 6 of this leaflet for full information.
Kako uporabiti inhalator Za celotne informacije glejte Navodila, ki so za poglavjem 6 tega navodila za uporabo.
Interaction with P-glycoprotein inhibitors
Medsebojno delovanje z zaviralci P-glikoproteina
SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF THE SIGHT AND REACH OF CHILDREN
za inhaliranje POSEBNO OPOZORILO O SHRANJEVANJU ZDRAVILA ZUNAJ DOSEGA IN POGLEDA OTROK Zdravilo shranjujte nedosegljivo otrokom!
Time to first exacerbation: Hazard ratio (95% CI) % risk reduction p-value p<0.001
Čas do prvega poslabšanja: Razmerje ogroženosti (95 % IZ) % zmanjšanja tveganja
Dose-normalised fluticasone furoate systemic exposure was similar in subjects with moderate and severe hepatic impairment (Child-Pugh B or C).
Na odmerek normalizirana sistemska izpostavljenost flutikazonfuroatu je bila pri preiskovancih z zmerno in hudo okvaro jeter (Child-Pugh B ali C) podobna.
If your breathing or wheezing gets worse straight after using Relvar Ellipta, stop using it and get medical help immediately.
Če se vam dihanje ali piskanje takoj po uporabi zdravila Relvar Ellipta poslabša, zdravilo nehajte uporabljati in nemudoma poiščite zdravniško pomoč.
How to store Relvar Ellipta 6.
Shranjevanje zdravila Relvar Ellipta 6.
Finally, the exposure-adjusted cases of fatal pneumonia were 8.8 for FF/VI 184/22 versus 1.5 for FF/VI 92/22 and 0 for VI 22.
In navsezadnje, glede na izpostavljenost korigirano število pljučnic s smrtnim izidom je bilo 8,8 s FF/VI 184/22, 1,5 s FF/VI 92/22 in 0 z VI 22.
One inhalation of Relvar Ellipta 92/22 micrograms once daily.
Ena inhalacija zdravila Relvar Ellipta 92/22 mikrogramov enkrat na dan.
Co-administration increased mean fluticasone furoate AUC(0-24) and Cmax by 36% and 33%, respectively.
Sočasna uporaba je povečala povprečno AUC(0-24) flutikazonfuroata za 36 % in njegovo Cmax za 33 %.