natgillin/translations-raw huggingface dataset:
Change from Baseline in Percentage of Rescue-Free 24-hour Periods Treatment difference
Sprememba odstotka 24-urnih obdobij brez rešilnega zdravila glede na izhodišče Razlika zdravljenj
Hypersensitivity reactions including anaphylaxis, angioedema, rash, and urticaria.
Bolezni imunskega sistema preobčutliivostne reakcije, vključno z anafilakso, angioedemom,
If stored in a refrigerator, the inhaler should be allowed to return to room temperature for at least an hour before use.
Če je zdravilo shranjeno v hladilniku, je treba inhalator vsaj eno uro pred uporabo pustiti zunaj, da se ogreje na sobno temperaturo.
Improvements were also seen in this subgroup at week 52 when comparing the fluticasone furoate/vilanterol 92/22 micrograms vs. vilanterol 22 micrograms in adjusted mean trough FEV1 (44 mL 95% CI: 15, 73mL, (p=0.003)).
Izboljšanje so v tej podskupini zabeležili tudi 52. teden, ko so primerjali korigirani povprečni najnižji FEV1 s flutikazonfuroatom/vilanterolom 92/22 mikrogramov in z 22 mikrogrami vilanterola (44 ml, 95 % IZ: 15, 73 ml, (p = 0,003))
The European Medicines Agency has waived the obligation to submit the results of studies with Relvar Ellipta in all subsets of the paediatric population in COPD (see section 4.2 for information on paediatric use).
Ellipta za vse skupine pediatrične populacije pri KOPB (za podatke o uporabi pri pediatrični populaciji glejte poglavje 4.2).
Hypersensitivity to the active substances or to any of the excipients listed in section 6.1.
Preobčutljivost na učinkovini ali katero koli pomožno snov, navedeno v poglavju 6.1. 4.4 Posebna opozorila in previdnostni ukrepi
In an integrated analysis of the two replicate one year studies in moderate to severe COPD (mean predicted post-bronchodilator screening FEV1 of 45%, standard deviation (SD) 13%) with an exacerbation in the preceding year (n = 3255), the number of pneumonia events per 1000 patient years was 97.9 with FF/VI 184/22, 85.7 in the FF/VI 92/22 and 42.3 in the VI 22 group.
V integrirani analizi dveh repliciranih enoletnih študij pri zmerni do hudi KOPB (povprečni predvideni FEV1 po bronhodilatatorju ob presejanju 45 %, standardni odklon 13 %) s poslabšanjem v predhodnem letu (n = 3255) je bilo število pljučnic na 1000 bolnik-let v skupini s FF/VI 184/22 97,9, v skupini s FF/VI 92/22 85,7 in v skupini z VI 22 42,3.
Pack sizes of 14 or 30 dose Inhalers.
Velikost pakiranja je inhalator s 14 ali 30 odmerki.
The ratio of the exacerbation rate for fluticasone furoate/vilanterol 92/22 micrograms versus FF 92 micrograms was 0.755 (95% CI 0.603, 0.945).
Razmerje deležev poslabšanj z flutikazonfuroatom/vilanterolom 92/22 mikrogramov in s FF 92 mikrogramov je bilo 0,755 (95 % IZ 0,603, 0,945).
This leaflet
Opazovani dogodek
• infection of the nose sinuses or throat
• srbenje nosu, izcedek iz nosu ali zamašen nos,
For trough FEV1 subjects in the fluticasone furoate/vilanterol group achieved a LS mean change from baseline of 281 mL and subjects in the salmeterol/FP group a change of 300 mL; (the difference in adjusted mean of -19 mL (95%CI:-0.073, 0.034) was not statistically significant (p=0.485).
Kar zadeva najnižji FEV1, so preiskovanci v skupini s flutikazonfuroatom/vilanterolom dosegli povprečno spremembo (po metodi NK) glede na izhodišče 281 ml in v skupini s salmeterolom/FP spremembo 300 ml (razlika v korigiranem povprečju 19 ml (95 % IZ: -0,073, 0,034) ni bila statistično značilna (p = 0,485)).
Pneumonia in patients with COPD
Pljučnica pri bolnikih s KOPB
Change from baseline in the percentage of rescue-free 24 hour periods during treatment was a powered secondary endpoint.
Sprememba odstotka 24-urnih obdobij brez rešilnega zdravila med zdravljenjem je bila sekundarni opazovani dogodek, za ugotavljanje katerega je bila določena moč.
• awareness of heart beat (palpitations)
• neprijetni občutki ob hitrem ali močnem utripanju srca (palpitacije),
Following oral administration, vilanterol was eliminated mainly by metabolism followed by excretion of metabolites in urine and faeces approximately 70% and 30% of the radioactive dose respectively in a human radiolabel study conducted by the oral route.
V študiji radioaktivno označenega, peroralno uporabljenega zdravila pri človeku se je vilanterol odstranil predvsem s presnovo, ki ji je sledilo izločanje presnovkov: približno 70 % radioaktivnega odmerka v urinu in približno 30 % v blatu.
Glaxo Operations UK Limited (trading as Glaxo Wellcome Operations), Harmire Road,
Glaxo Operations UK Limited (posluje kot Glaxo Wellcome Operations), Harmire Road,
There was no evidence for gender, weight or BMI to influence the pharmacokinetics of vilanterol based on a population pharmacokinetic analysis in 856 subjects with asthma (500 females) and 1091 subjects with COPD (340 females).
Populacijska farmakokinetična analiza podatkov 856 preiskovancev z astmo (500 žensk) in 1091
You do not need to prepare Relvar Ellipta in any special way, not even the first time you use it.
Inhalatorja ni potrebno posebej pripraviti za uporabo, niti ko zdravilo Relvar Ellipta uporabite prvič.
• Rinse your mouth with water after you have used the inhaler, do not swallow.
• Po uporabi inhalatorja si usta splaknite z vodo, vode ne pogoltnite.
This represents a 25% reduction in the rate of severe asthma exacerbations for subjects treated with fluticasone furoate/vilanterol 92/22 micrograms compared with FF 92 micrograms(p=0.014).
To pomeni 25 % zmanjšanje deleža hudih poslabšanj astme pri preiskovancih, zdravljenih z flutikazonfuroatom/vilanterolom 92/22 mikrogramov, v primerjavi s prejemniki FF 92 mikrogramov (p = 0,014).
Rinsing your mouth out with water immediately after using Relvar Ellipta may help stop this side effect developing.
Nastanek tega učinka lahko pomaga preprečiti izpiranje ust z vodo takoj po uporabi zdravila Relvar Ellipta.
The COPD clinical development programme included a 12-week (HZC113107), two 6-month (HZC112206, HZC112207), two one-year (HZC102970, HZC102871), and one >1 year study (SUMMIT).
(HZC112206, HZC112207), dve 1-letni (HZC102970, HZC102871) in eno več kot 1 leto trajajočo študijo (SUMMIT).To so bile randomizirane kontrolirane študije pri bolnikih s klinično diagnozo KOPB.
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.
Absolutna biološka uporabnost za flutikazonfuorat in vilanterol v obliki inhaliranega flutikazonfuroata/vilanterola je bila v povprečju 15,2 % (za prvega) in 27,3 % (za drugega).
If you get any side effects, talk to your doctor or pharmacist.
Če opazite katerikoli neželeni učinek, se posvetujte z zdravnikom ali s farmacevtom.
Fluticasone furoate/vilanterol
Tako flutikazonfuroat/vilanterol
Take it back to a pharmacist for advice.
Bolnik naj ga nese k farmacevtu in se posvetuje z njim.
In-use shelf-life after opening the tray: 6 weeks.
Rok uporabnosti po prvem odprtju embalaže: 6 tednov.
Glaxo Operations UK Limited (trading as Glaxo Wellcome Operations), Priory Street,
Glaxo Operations UK Limited (posluje kot Glaxo Wellcome Operations), Priory Street,
Relvar Ellipta contains lactose
Zdravilo Relvar Ellipta vsebuje laktozo.
Don't use this medicine if you are pregnant unless your doctor tells you that you can.
Če ste noseči, tega zdravila ne uporabljajte, razen če vam je tako svetoval zdravnik.
The oral bioavailability of both fluticasone furoate and vilanterol was low, on average 1.26% and <2%, respectively.
Peroralna biološka uporabnost obeh učinkovin je bila majhna (v povprečju flutikazonfuroat 1,26 % in vilanterol
Multipack of 3 x 30 dose Inhalers.
Pakiranje z več inhalatorji - 3 x 30 odmerkov.
At Day 168 fluticasone furoate/vilanterol 92/22 micrograms and vilanterol increased adjusted mean weighted mean FEV1 over 0-4 hours by 193mL (95% CI: 156, 230 mL, p<0.001) and 145 mL (95% CI: 108, 181 mL, p<0.001) respectively compared to placebo.
Na 168. dan je flutikazonfuroat/vilanterol 92/22 mikrogramov povečal korigirani povprečni uteženi povprečni FEV1 v obdobju 0-4 ure za 193 ml (95 % IZ:156, 230 ml, p < 0,001) in vilanterol za 145 ml (95 % IZ: 108, 181 ml, p < 0,001) v primerjavi s placebom.
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:
Zdravilo Relvar Ellipta je indicirano za redno zdravljenje astme pri odraslih in mladostnikih, starih 12 let ali več, za katere je primerna uporaba kombiniranega zdravila (dolgodelujočega agonista adrenergičnih receptorjev beta2 in inhalacijskega kortikosteroida): • bolniki, ki bolezni nimajo ustrezno urejene ob uporabi inhalacijskih kortikosteroidov in inhalacijskih kratkodelujočih agonistov adrenergičnih receptorjev beta2 ''po potrebi'';
Fluticasone furoate/vilanterol 92/22 micrograms increased trough FEV1 by 46 mL compared to vilanterol (95% CI: 8, 83mL, p= 0.017).
Flutikazonfuroat/vilanterol 92/22 mikrogramov je povečal najnižji FEV1 v primerjavi z vilanterolom za 46 ml (95 % IZ: 8, 83 ml, p =
Caution should be exercised when dosing patients with hepatic impairment who may be more at risk of systemic adverse reactions associated with corticosteroids.
Bolniki z okvaro jeter imajo lahko večje tveganje za sistemske neželene učinke kortikosteroidov.
Infection of the lung
Okužba pljuč
Forty four percent of patients in the fluticasone furoate/vilanterol 92/22 micrograms group were well controlled (ACQ7 ≤0.75) at end of treatment compared to 36% of subjects in the FF 92 micrograms group (p<0.001 95% CI 1.23, 1.82).
44 % bolnikov v skupini s flutikazonfuroatom/vilanterolom 92/22 mikrogramov je imelo na koncu zdravljenja dobro urejeno bolezen (ACQ7 ≤ 0,75); v skupini z 92 mikrogrami FF je bilo takšnih 36 % (p < 0,001, 95 % IZ od 1,23 do 1,82).
How to use Relvar Ellipta
Kako uporabljati zdravilo Relvar Ellipta
There was no decrease in the extent of in vitro plasma protein binding in subjects with renal or hepatic impairment.
Vezava na plazemske beljakovine in vitro se pri preiskovancih z okvaro ledvic ali jeter ni zmanjšala.
You can also report side effects directly via the national reporting system listed in Appendix V .
da poročajo o kateremkoli domnevnem neželenem učinku zdravila na nacionalni center za poročanje, ki je naveden v Prilogi V.
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.
KOPB je bil protivnetni učinek ob koncentracijah, doseženih s kliničnimi odmerki, večji v prisotnosti kombinacije flutikazonfuroat/vilanterol kot samega flutikazonfuroata.
Posology
Študija
NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER
IMETNIK DOVOLJENJA ZA PROMET
HZC112207 evaluated the efficacy of fluticasone furoate/vilanterol 92/22 micrograms [n=204] and fluticasone furoate/vilanterol 184/22 micrograms [n=205] compared with FF 92 micrograms [n=204], FF 184 micrograms [n=203] and vilanterol 22 micrograms [n=203] and placebo [n = 205], all administered once daily.
Študija HZC112207 je ocenila učinkovitost flutikazonfuroata/vilanterola 92/22 mikrogramov [n = 204] in flutikazonfuroata/vilanterola 184/22 mikrogramov [n = 205] v primerjavi s FF 92 mikrogramov [n = 204], FF 184 mikrogramov [n = 203], vilanterolom 22 mikrogramov [n = 203] in placebom [n = 205]; vsi so bili uporabljeni enkrat na dan.
MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS TRAY LABEL
PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA PRETISNEM OMOTU ALI DVOJNEM TRAKU
HZA106827 was 12 weeks in duration and evaluated the efficacy of fluticasone furoate/vilanterol 92/22 micrograms [n=201] and FF 92 micrograms [n=205]) compared with placebo [n=203], all administered once daily.
Študija HZA106827 je trajala 12 tednov in je ocenila učinkovitost flutikazonfuroata/vilanterola 92/22 mikrogramov [n = 201] in 92 mikrogramov FF [n = 205] v primerjavi s placebom [n = 203], vseh uporabljenih enkrat na dan.
By reporting side effects you can help provide more information on the safety of this medicine.
O neželenih učinkih lahko poročate tudi neposredno na nacionalni center za poročanje, ki je naveden v Prilogi V. S poročanjem o neželenih učinkih lahko prispevate k boljši obveščenosti glede varnosti tega zdravila.
Three phase III randomised, double-blind studies (HZA106827, HZA106829 and HZA106837) of different durations evaluated the safety and efficacy of fluticasone furoate/vilanterol in adult and adolescent patients with persistent asthma.
Varnost in učinkovitost flutikazonfuroata/vilanterola pri odraslih in mladostnikih s perzistentno astmo so ocenili v treh randomiziranih, dvojno slepih študijah III. faze (HZA106827, HZA106829 in HZA106837), ki so trajale različno dolgo.
METHOD AND ROUTE(S) OF ADMINISTRATION ONCE DAILY
POSTOPEK IN POT(I) UPORABE ZDRAVILA ENKRAT NA DAN Pred uporabo preberite priloženo navodilo!
If the inhaler cover is opened and closed without inhaling the medicine, the dose will be lost.
Pred začetkom uporabe naj bolnik prebere ta navodila Če se pokrovček inhalatorja odpre in zapre, ne da bi bilo zdravilo vdihnjeno, bo odmerek zdravila izgubljen.
HZC112206 evaluated the efficacy of fluticasone furoate/vilanterol 46 /22 micrograms [n=206] and fluticasone furoate/vilanterol 92/22 micrograms [n=206] compared with FF 92 micrograms [n=206], vilanterol 22 micrograms [n=205] and placebo [n = 207], all administered once daily.
Študija HZC112206 je ocenila učinkovitost flutikazonfuroata/vilanterola 46/22 mikrogramov [n = 206] in flutikazonfuroata/vilanterola 92/22 mikrogramov [n = 206] v primerjavi s FF 92 mikrogramov [n = 206], vilanterolom 22 mikrogramov [n = 205] in placebom [n = 207]; vsi so bili uporabljeni enkrat na dan.
PARTICULARS TO APPEAR ON THE OUTER PACKAGING INTERMEDIATE OUTER CARTON (WITHOUT BLUE BOX- MULTIPACK ONLY) 184/22 micrograms
VMESNA ŠKATLA (BREZ MODREGA OKENCA - SAMO PAKIRANJE Z VEČ INHALATORJI) 184/22 mikrogramov
These may affect up to 1 in 1,000 people:
Ti se lahko pojavijo pri največ 1 od 100 bolnikov:
In use shelf-life: 6 weeks Discard by:
Rok uporabnosti po prvem odprtju: 6 tednov Zavrzite do:
PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON (SINGLE PACKS) 92/22 micrograms
PODATKI NA ZUNANJI OVOJNINI ŠKATLA (PAKIRANJE Z ENIM INHALATORJEM) 92/22 mikrogramov
PARTICULARS TO APPEAR ON THE OUTER PACKAGING INTERMEDIATE OUTER CARTON (WITHOUT BLUE BOX- MULTIPACK ONLY) 92/22 micrograms
VMESNA ŠKATLA (BREZ MODREGA OKENCA - SAMO PAKIRANJE Z VEČ INHALATORJI) 92/22 mikrogramov
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS DEVICE LABEL
PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MANJŠIH STIČNIH OVOJNINAH
Prepare a dose Wait to open the cover until you are ready to take your dose.
Pokrovček odprite šele, ko ste pripravljeni, da vzamete odmerek.
Talk to your doctor before you use Relvar Ellipta: if you have liver disease, as you may be more likely to have side effects.
Svojemu zdravniku morate povedati, če imate med jemanjem zdravila Relvar Ellipta kar koli od naslednjega, ker so to lahko simptomi okužbe pljuč:
This corresponds to a pre-dispensed dose of 100 micrograms of fluticasone furoate and 25 micrograms vilanterol (as trifenatate).
To ustreza odmerjenemu odmerku 100 mikrogramov flutikazonfuroata in 25 mikrogramov vilanterola (v obliki trifenatata).
This corresponds to a pre-dispensed dose of 200 micrograms of fluticasone furoate and 25 micrograms vilanterol (as trifenatate).
To ustreza odmerjenemu odmerku 200 mikrogramov flutikazonfuroata in 25 mikrogramov vilanterola (v obliki trifenatata).
• flu (influenza)
• okužba obnosnih votlin (sinusov) ali žrela, • gripa (influenca),
In an integrated analysis of the two replicate one year studies in moderate to severe COPD (mean predicted post-bronchodilator screening FEV1 of 45%, standard deviation (SD) 13%) with an exacerbation in the preceding year (n = 3255), the number of pneumonia events per 1000 patient years was 97.9 with FF/VI
V integrirani analizi dveh repliciranih enoletnih študij pri zmerni do hudi KOPB (povprečni predvideni FEV1 po bronhodilatatorju ob presejanju 45 %, standardni odklon 13 %) s poslabšanjem v predhodnem letu (n = 3255) je bilo število pljučnic na 1000 bolnik-let v skupini s FF/VI 184/22 97,9, v skupini s FF/VI 92/22 85,7
Nasopharyngitis Paradoxical bronchospasm Oropharyngeal pain Sinusitis
Bolezni dihal, prsnega koša in mediastinalnega prostora nazofaringitis paradoksni bronhospazem orofaringealna bolečina sinuzitis faringitis rinitis kašelj disfonija zelo pogosti redki pogosti
There was no evidence for gender, weight or BMI (body mass index) to influence the pharmacokinetics of fluticasone furoate based on a population pharmacokinetic analysis of phase III data in 1213 subjects with asthma (712 females) and 1225 subjects with COPD (392 females).
Populacijska farmakokinetična analiza podatkov III. faze pri 1213 preiskovancih z astmo (712 žensk) in
FF/VI 92/22 Once Daily vs placebo Once Daily Change from Baseline in Trough FEV1 Last Observation Carried Forward (LOCF) Treatment difference P value (95% CI)
Sprememba najnižjega FEV1 od izhodišča, prenos zadnjega opažanja (LOCF - last observation carried forward) Razlika zdravljenj Vrednost p (95 % IZ)
Multipacks contain 3 x 30 dose inhalers.
Pakiranje Relvar Ellipta z več inhalatorji vsebuje 3 inhalatorje s 30 odmerki.
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.
Primarni opazovani dogodek učinkovitosti je bila sprememba najnižjega FEV1 glede na izhodišče na kliničnem obisku
Asthma-related adverse events and exacerbations may occur during treatment with fluticasone furoate/vilanterol.
Med zdravljenjem s flutikazonfuroatom/vilanterolom se lahko pojavijo z astmo povezani neželeni učinki in poslabšanja.
Each delivered dose contains 184 micrograms of fluticasone furoate and 22 micrograms of vilanterol (as trifenatate).
En dostavljen odmerek vsebuje 184 mikrogramov flutikazonfuroata in 22 mikrogramov vilanterola (v obliki trifenatata).
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-urni bronhodilatacijski učinek flutikazonfuroata/vilanterola se je ohranil od prvega odmerka skozi celotno enoletno obdobje zdravljenja,
Interaction with beta-blockers
Medsebojno delovanje z antagonisti adrenergičnih receptorjev beta
Prior to run-in, subjects discontinued use of previous COPD medications except short-acting bronchodilators.
KOPB razen kratkodelujočih bronhodilatatorjev.
These include: beta-blockers, such as metoprolol, used to treat high blood pressure or a heart condition.
Med takšnimi so: - antagonisti adrenergičnih receptorjev beta, npr. metoprolol, ki se uporablja za zdravljenje visokega krvnega tlaka ali bolezni srca, - ketokonazol za zdravljenje glivičnih okužb, - ritonavir ali kobicistat za zdravljenje okužb z virusom HIV,
Glaxo Operations UK Ltd. (trading as Glaxo Wellcome Operations), Harmire Road,
Glaxo Operations UK Ltd. (posluje kot Glaxo Wellcome Operations) Harmire Road
Each delivered dose contains 92 micrograms of fluticasone furoate and 22 micrograms of vilanterol (as trifenatate).
En dostavljen odmerek vsebuje 92 mikrogramov flutikazonfuroata in 22 mikrogramov vilanterola (v obliki trifenatata).
There were no clinically relevant effects of the fluticasone furoate/vilanterol combination on beta-adrenergic systemic effects (heart rate or serum potassium) in subjects with mild or moderate hepatic impairment (vilanterol, 22 micrograms) or with severe hepatic impairment (vilanterol, 12.5 micrograms) compared with healthy subjects.
Pri preiskovancih z blago ali zmerno okvaro jeter (22 mikrogramov vilanterola) ali s hudo okvaro jeter (12,5 mikrogramov vilanterola) v primerjavi z zdravimi preiskovanci ni bilo klinično pomembnih učinkov kombinacije flutikazonfuroata/vilanterola na sistemske beta-adrenergične učinke (srčna frekvenca ali kalij v serumu).
In a 12 week study (HZC113107) in COPD patients both fluticasone furoate/vilanterol 92/22 micrograms given once daily in the morning and salmeterol/FP 50/500 micrograms given twice daily, demonstrated improvements from baseline in lung function.
V 12-tedenski študiji (HZC113107) pri bolnikih s KOPB so izboljšanje pljučne funkcije glede na izhodišče ugotovili tako s flutikazonfuroatom/vilanterolom 92/22 mikrogramov enkrat na dan zjutraj in kombinacijo salmeterola/FP 50/500 mikrogramov dvakrat na dan. Korigirano povprečno terapevtsko povečanje uteženega povprečja FEV1 0-24 ur glede na izhodišče je bilo s flutikazonfuroatom/vilanterolom 130 ml in s kombinacijo salmeterol/FP 108 ml; to kaže na celotno izboljšanje pljučne funkcije v 24-urnem obdobju z obema zdravljenjema.
What Relvar Ellipta looks like and contents of the pack The Ellipta device itself is a light grey inhaler with a yellow mouthpiece cover and a dose counter.
Pripomoček Ellipta je svetlo siv inhalator z rumenim pokrovčkom ustnika in števcem odmerkov.
Each single inhalation provides a delivered dose (the dose leaving the mouthpiece) of 92 micrograms of fluticasone furoate and 22 micrograms of vilanterol (as trifenatate).
Ena inhalacija zagotavlja oddani odmerek (odmerek, ki zapusti ustnik) 92 mikrogramov flutikazonfuroata in 22 mikrogramov vilanterola (v obliki trifenatata).
There was no increase in tumour incidence in rats or mice at exposures 2- or 30-fold, respectively, those at the maximum recommended human dose, based on AUC.
Pri izpostavljenostih, ki so bile pri podganah 2-krat, pri miših pa 30-krat tolikšne kot so izpostavljenosti (na podlagi AUC) med uporabo največjega priporočenega odmerka za človeka, niso ugotovili večje incidence tumorjev.
It should not be used to relieve a sudden attack of breathlessness or wheezing.
Zdravila Relvar Ellipta se ne sme uporabljati za olajšanje nenadnega napada zasoplosti ali piskajočega dihanja.
Each single inhalation provides a delivered dose (the dose leaving the mouthpiece) of 184 micrograms of fluticasone furoate and 22 micrograms of vilanterol (as trifenatate).
Ena inhalacija zagotavlja oddani odmerek (odmerek, ki zapusti ustnik) 184 mikrogramov flutikazonfuroata in 22 mikrogramov vilanterola (v obliki trifenatata).
NAME OF THE MEDICINAL PRODUCT Relvar Ellipta 92 micrograms/22 micrograms inhalation powder, pre-dispensed
IME ZDRAVILA Relvar Ellipta 92 mikrogramov/22 mikrogramov prašek za inhaliranje, odmerjeni
Your Relvar Ellipta inhaler carton contains
Škatla vašega zdravila Relvar Ellipta vsebuje
PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON (SINGLE PACK) 184/22 micrograms
ŠKATLA (PAKIRANJE Z ENIM INHALATORJEM) 184/22 mikrogramov
NAME OF THE MEDICINAL PRODUCT Relvar Ellipta 184 micrograms/22 micrograms inhalation powder, pre-dispensed
IME ZDRAVILA Relvar Ellipta 184 mikrogramov/22 mikrogramov prašek za inhaliranje, odmerjeni
Fluticasone furoate/vilanterol 92 /22 micrograms consistently demonstrated 83 mL to 95 mL improvements in trough FEV1 at weeks 12, 36 and 52 and Endpoint compared with FF 92 micrograms (p<0.001 95% CI 52, 126 mL at Endpoint).
Flutikazonfuroat/vilanterol 92/22 mikrogramov je v primerjavi z 92 mikrogrami FF dosledno dosegal izboljšanje najnižjega FEV1 za 83 do 95 ml 12., 36. in 52. teden ter na končni točki študije (p < 0,001 95 %
Check with your doctor before you use this medicine if you think any of these applies to you.
Če menite, da kaj od tega velja za vas, se posvetujte s svojim zdravnikom, preden uporabite to zdravilo.
Data from large asthma and COPD clinical trials were used to determine the frequency of adverse reactions associated with fluticasone furoate/vilanterol.
Za ugotavljanje pogostnosti neželenih učinkov, povezanih s flutikazonfuroatom/vilanterolom, so bili uporabljeni podatki velikih kliničnih preskušanj pri astmi in KOPB.