natgillin/translations-raw huggingface dataset:
The adjusted mean change from baseline in trough FEV1 on Day 85 was 111 mL in the fluticasone furoate/vilanterol group and 88 mL in the salmeterol/FP group; the 23 mL (95% CI: -20, 66) difference between the treatment groups was not clinically meaningful or statistically significant (p=0.294).
Korigirana povprečna sprememba najnižjega FEV1 glede na izhodišče je bila 85. dan 111 ml v skupini s flutikazonfuroatom/vilanterolom in 88 ml v skupini s salmeterolom/FP; razlika 23 ml (95 % IZ: -20, 66) med terapevtskima skupinama ni bila ne klinično pomembna ne statistično značilna (p = 0,294).
The incidence of pneumonia in patients with asthma taking fluticasone furoate/vilanterol 184/22 micrograms was numerically higher compared with those receiving fluticasone furoate/vilanterol 92/22 micrograms or placebo (see section 4.8).
Incidenca pljučnice je bila številsko večja pri bolnikih z astmo, ki so jemali flutikazonfuroat/vilanterol 184/22 mikrogramov, kot pri tistih, ki so jemali flutikazonfuroat/vilanterol 92/22 mikrogramov ali placebo (glejte poglavje 4.8).
This will make it less likely to develop a sore mouth or throat as side effects.
Tako bo manj verjetno, da se kot neželen učinek pojavi bolečina v ustih ali žrelu.
There are no or limited data from the use of fluticasone furoate and vilanterol trifenatate in pregnant women.
Podatkov o uporabi flutikazonfuroata in vilanterolijevega trifenatata pri nosečnicah je malo ali jih ni.
White powder in a light grey inhaler with a yellow mouthpiece cover and a dose counter.
Bel prašek v svetlo sivem inhalatorju z rumenim pokrovčkom ustnika in števcem odmerkov.
Do not breathe out into the inhaler.
Ne izdihnite v inhalator.
Your doctor may wish to monitor you carefully if you are taking any of these medicines as they may increase the side effects of Relvar Ellipta.
Če jemljete katero od teh zdravil, vas bo zdravnik morda skrbno spremljal, kajti ta zdravila lahko povečajo neželene učinke zdravila Relvar.
Slide the cover upwards as far as it will go to cover the mouthpiece.
Pokrovček mora potisniti navzgor, kolikor daleč gre, da pokrije ustnik.
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.
Pri astmi je bila ocenjena AUC(0-24) flutikazonfuroata za preiskovance iz vzhodne Azije, Japonske in jugovzhodne Azije (12-13 % preiskovancev) v povprečju za 33 do 53 % večja kot pri drugih rasnih skupinah.
What is the Ellipta inhaler?
Navodila po korakih Kaj je inhalator Ellipta?
No dose adjustment is required for patients with renal impairment.
Bolnikom z okvaro ledvic odmerka ni treba prilagoditi.
All patients were required to have a smoking history of at least 10 pack years; a post-salbutamol FEV1/FVC ratio less than or equal to 0.70; post-salbutamol FEV1 less than or equal to 70% predicted and have a
Vsi bolniki so morali imeti anamnezo kajenja vsaj 10 škatlic-let, razmerje FEV1/FVC po salbutamolu manj ali enako 0,70, FEV1 po salbutamolu manj ali enako 70 % predvidenega ter oceno mMRC (Modified Medical Research Council) ≥ 2 (lestvica 0-4) o presejanju.
No comparative studies versus salmeterol/FP or versus other established bronchodilators have been conducted to appropriately compare the effects on COPD exacerbations.
Primerjalnih študij s salmeterolom/FP ali drugimi uveljavljenimi bronhodilatatorji za ustrezno primerjavo vpliva na poslabšanja KOPB niso izvedli.
How to inhale the medicine
Kako vdihniti zdravilo
In an integrated analysis of 11 studies in asthma (7,034 patients), the incidence of pneumonia per 1000 patient years was 18.4 for FF/VI 184/22 versus 9.6 for FF/VI 92/22 and 8.0 in the placebo group.
V integrirani analizi 11 študij pri astmi (7.034 bolnikov) je bila incidenca pljučnice na 1000 bolnik-let v skupini s FF/VI 184/22 18,4, s FF/VI 92/22 9,6 in s placebom 8,0.
If you accidentally take more Relvar Ellipta than your doctor has instructed, talk to your doctor or pharmacist.
Če ste uporabili večji odmerek zdravila Relvar Ellipta, kot bi smeli Če pomotoma uporabite večji odmerek zdravila Relvar Ellipta, kot vam je naročil zdravnik, se posvetujte z zdravnikom ali farmacevtom.
Patients should be asked to continue treatment but to seek medical advice if asthma symptoms remain uncontrolled or worsen after initiation of treatment with Relvar Ellipta.
Bolnikom je treba naročiti, naj v primeru, da simptomi astme po uvedbi zdravila Relvar Ellipta niso obvladani ali se poslabšajo, zdravljenje nadaljujejo, a naj se hkrati posvetujejo z zdravnikom.
If you are breast-feeding, check with your doctor before you use Relvar Ellipta.
Če dojite, se posvetujte z zdravnikom, preden uporabite zdravilo Relvar Ellipta.
A repeat dose CYP3A4 drug interaction study was performed in healthy subjects with the fluticasone furoate/vilanterol combination (184/22 micrograms) and the strong CYP3A4 inhibitor ketoconazole (400mg).
Pri zdravih preiskovancih so izvedli študijo medsebojnega delovanja ponavljajočih se odmerkov kombinacije flutikazonfuroat/vilanterol (184/22 mikrogramov) in močnega zaviralca CYP3A4 ketokonazola (400 mg).
Visual disturbance may be reported with systemic and topical corticosteroid use.
Pri sistemski in topični uporabi kortikosteroidov lahko poročajo o motnjah vida.
No comparative studies versus salmeterol/FP or versus other ICS/LABA combinations have been conducted to appropriately compare the effects on asthma exacerbations.
Primerjalnih študij s salmeterolom/FP ali drugimi kombinacijami ICS/LABA za ustrezno primerjavo vpliva na poslabšanje astme niso izvedli.
In HZA106827/HZA106829 the co-primary efficacy endpoints were change from baseline in clinic visit trough (pre-bronchodilator and pre-dose) FEV1 at the end of the treatment period in all subjects and weighted mean serial FEV1 over 0-24 hours post-dose calculated in a subset of subjects at the end of the treatment period.
V študijah HZA106827/HZA106829 sta bila soprimarna opazovana dogodka učinkovitosti sprememba najnižjega FEV1 na ambulantnem obisku (pred bronhodilatatorjem in pred odmerkom) ob koncu zdravljenja v primerjavi z izhodiščem pri vseh bolnikih ter uteženega zaporednega povprečnega FEV1 v 0-24 urah po odmerku, izračunanega pri podskupini preiskovancev ob koncu zdravljenja.
• becoming very wheezy, coughing or having difficulty in breathing
• piskanje, kašelj ali težave pri dihanju,
The incidence of pneumonia in patients with asthma was common at the higher dose.
Z višjim odmerkom je bila incidenca pljučnice pri bolnikih z astmo pogosta.
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 92/22 mikrogramov je prinesel bistveno večjo zaščito pred bronhialno hiperreaktivnostjo, povzročeno z alergeni, kot monoterapiji s FF oziroma vilanterolom, ocenjeno 22. dan z metaholinskim testom.
The European Medicines Agency has deferred the obligation to submit the results of studies with Relvar Ellipta in one or more subsets of the paediatric population in asthma (see section 4.2 for information on paediatric use).
Ellipta za eno ali več skupin pediatrične populacije pri astmi (za podatke o uporabi pri pediatrični populaciji glejte poglavje 4.2).
95% CI p-value % reduction (95% CI)
Razmerje v primerjavi z VI 95 % IZ Vrednost p % zmanjšanja (95 % IZ)
• inflammation of the sinuses
• vnetje obnosnih votlin (sinusov),
14 doses
14 odmerkov
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 obeh študij so pokazali, da je bil letni delež zmernih/hudih poslabšanj KOPB med zdravljenjem s flutikazonfuroatom/vilanterolom 92/22 mikrogramov enkrat na dan manjši kot med zdravljenjem z vilanterolom (Preglednica 2).
The Ellipta inhaler is packaged in a tray containing a desiccant sachet, to reduce moisture.
Inhalator Ellipta se nahaja v embalaži iz laminatne folije, ki vsebuje vrečko s sušilom za zmanjšanje vlažnosti.
In HZA106837 patients were randomised to receive either fluticasone furoate/vilanterol 92/22 micrograms [n=1009] or FF 92 micrograms [n=1010] both administered once daily.
Bolniki v HZA106837 so bili randomizirani na prejemanje bodisi flutikazonfuroata/vilanterola 92/22 mikrogramov [n = 1009] bodisi FF 92 mikrogramov [n = 1010]; oba sta bila uporabljena enkrat na dan.
If you have moderate or severe liver disease, your doctor will limit your dose to the lower strength of Relvar Ellipta (92/22 micrograms once daily).
Če imate zmerno ali hudo bolezen jeter, vam bo zdravnik odmerek omejil na manjšo jakost zdravila Relvar Ellipta (92/22 mikrogramov enkrat na dan); če imate težave s srcem ali visok krvni tlak;
Symptoms include shortness of breath, cough, chest discomfort and coughing up mucus.
Med njenimi simptomi so kratka sapa, kašelj, nelagodje v prsih in izkašljevanje sluzi.
The use of concurrent inhaled long-acting bronchodilators (beta2-agonist and anticholinergic), ipratropium/salbutamol combination products, oral beta2-agonists, and theophylline preparations were not allowed during the treatment period.
Med obdobjem zdravljenja ni bila dovoljena sočasna uporaba inhaliranih dolgodelujočih bronhodilatatorjev (agonistov adrenergičnih receptorjev beta2, antiholinergikov), kombiniranih zdravil z ipratropijem in salbutamolom, peroralnih agonistov adrenergičnih receptorjev beta2 in pripravkov teofilina.
Relvar Ellipta has been shown to reduce flare-ups of COPD symptoms.
Dokazano je, da zdravilo Relvar Ellipta zmanjša pogostnost poslabšanj simptomov KOPB.
If you want to clean the mouthpiece, use a dry tissue, before closing the cover.
Če želi bolnik očistiti ustnik, mora uporabiti suho krpico, preden zapre pokrovček.
There were no effects on development in rats at exposures approximately 3-times greater than those at the maximum recommended human dose, based on AUC.
Pri podganah ob izpostavljenostih, ki so bile približno 3-krat večje od izpostavljenosti (na podlagi AUC) med uporabo največjega priporočenega odmerka za človeka, ni vplival na razvoj.
Do not stop using Relvar Ellipta without advice
Ne prenehajte uporabljati zdravila Relvar Ellipta, ne da bi vam to naročil zdravnik.
FF/VI 92/22 Once Daily vs FF 92 Once Daily
FF/VI 92/22 1-krat/dan v prim.
FF and FP both increased the percentage of 24 hour rescue free periods by 14.8% (95% CI 6.9, 22.7, p<0.001) and 17.9% (95% CI 10.0, 25.7, p<0.001) respectively versus placebo.
Oba, FF in FP, sta povečala odstotek 24-urnih obdobij brez rešilnega zdravila, in sicer FF za 14,8 % (95 % IZ od 6,9 do 22,7, p < 0,001) in FP za 17,9 % (95 % IZ od 10,0 do 25,7, p < 0,001) v primerjavi s placebom.
In HZA106837 the risk of experiencing a severe asthma exacerbation in patients receiving fluticasone furoate/vilanterol 92/22 micrograms was reduced by 20% compared with FF 92 micrograms alone (hazard ratio 0.795, p=0.036 95% CI 0.642, 0.985).
V HZA106837 se je tveganje za hudo poslabšanje astme pri prejemnikih flutikazonfuroata/vilanterola 92/22 mikrogramov zmanjšalo za 20 % v primerjavi z 92 mikrogrami samega FF (razmerje ogroženosti 0,795, p = 0,036, 95 % IZ: 0,642, 0,985).
If you forget to use Relvar Ellipta Do not take a double dose to make up for a forgotten dose.
Ne uporabite dvojnega odmerka, da bi nadomestili pozabljenega.
The safety and efficacy of fluticasone furoate/vilanterol in children under the age of 12 years has not yet been established.
Varnost in učinkovitost zdravila Relvar Ellipta pri otrocih, mlajših od 12 let, še nista ugotovljeni.
Both fluticasone furoate/vilanterol 92/22 micrograms and FF 92 micrograms virtually abolished the late asthmatic response compared with vilanterol alone.
92/22 mikrogramov kot 92 mikrogramov FF sta v primerjavi s samim vilanterolom praktično odpravila pozni astmatični odziv.
A 24 week randomised, double-blind placebo controlled study (FFA112059) evaluated the safety and efficacy of FF 92 micrograms once daily [n= 114] and FP 250 micrograms twice daily [n=114] versus placebo [n=115] in adult and adolescent patients with persistent asthma.
Monoterapija s flutikazonfuroatom24-tedenska randomizirana, dvojno slepa, s placebom kontrolirana študija (FFA112059) je ocenila varnost in učinkovitost 92 mikrogramov FF enkrat na dan [n = 114] in 250 mikrogramovov FP dvakrat na dan [n = 114] v primerjavi s placebom [n = 115] pri odraslih in mladostnikih s persistentno astmo.
In a placebo-controlled study in subjects with moderate COPD and a history of, or an increased risk of cardiovascular disease, there was no increase in the risk of cardiovascular events in patients receiving fluticasone furoate/vilanterol compared with placebo (see section 5.1).
S placebom kontrolirana študija pri bolnikih z zmerno KOPB, ki so imeli kardiovaskularno bolezen kdaj v preteklosti ali so imeli večje tveganje za takšno bolezen, ni pokazala, da bi se tveganje za kardiovaskularne dogodke pri prejemnikih kombinacije flutikazonfuroat/vilanterol povečalo v primerjavi s prejemniki placeba
Vision blurred (see section 4.4)
*Pljučnica (glejte poglavje 4.4)
Driving and using machines This medicine is unlikely to affect your ability to drive or use machines.
Vpliv na sposobnost upravljanja vozil in strojev Ni verjetno, da bi zdravilo Relvar Ellipta vplivalo na sposobnost upravljanja vozil in strojev.
Fluticasone furoate and vilanterol are both rapidly cleared by extensive first pass metabolism mediated by the liver enzyme CYP3A4.
Flutikazonfuroat in vilanterol se oba hitro očistita z obsežno presnovo prvega prehoda z jetrnim encimom
In patients with a cardiovascular history/risk factors, fluticasone furoate/vilanterol 92/22 micrograms resulted in a significantly lower annual rate of moderate/severe COPD exacerbations compared with vilanterol (adjusted mean annual rates of 0.83 and 1.18 respectively, 30% reduction (95% CI 16, 42%, p<0.001)).
Pri bolnikih s kardiovaskularno anamnezo/dejavniki tveganja je flutikazonfuroat/vilanterol 92/22 mikrogramov dosegel značilno manjši letni delež zmernih/hudih poslabšanj KOPB kot vilanterol (korigirana povprečna letna deleža 0,83 in 1,18, 30 % zmanjšanje, 95 % IZ: 16, 42 %,
Change from Baseline in Percentage of Symptom-Free 24-hour Periods Treatment difference
Sprememba odstotka 24-urnih obdobij brez simptomov glede na izhodišče Razlika zdravljenj
Adjusted mean change from baseline in trough FEV1 was also evaluated as a secondary endpoint.
Kot sekundarni opazovani dogodek je bila ocenjena tudi korigirana povprečna sprememba najnižjega FEV1 glede na izhodišče.
Overall, the greatest effects on the early asthmatic response were seen with fluticasone furoate/vilanterol 92/22 micrograms compared with FF 92 micrograms or vilanterol 22 micrograms alone.
V celoti so največje učinke na zgodnji astmatični odziv zabeležili s flutikazonfuroatom/vilanterolom 92/22 mikrogramov v primerjavi z 92 mikrogrami FF ali 22 mikrogrami vilanterola, uporabljenih samih.
EXP In use shelf-life: 6 weeks.
EXP: Rok uporabnosti po prvem odprtju: 6 tednov.
For severe pneumonia the corresponding number of events per 1000 patient years were 33.6, 35.5, and 7.6 respectively, while for serious pneumonia the corresponding events per 1000 patient years were 35.1 for FF/VI 184/22, 42.9 with FF/VI 92/22, 12.1 with VI 22.
Za hudo pljučnico je bilo ustrezno število pljučnic na 1000 bolnik-let 33,6, 35,5 in 7,6, za resno pljučnico pa je bilo ustrezno število pljučnic na 1000 bolnik-let 35,1 s FF/VI 184/22, 42,9 s FF/VI 92/22 in 12,1 z VI 22.
There was no effect of race on pharmacokinetic parameter estimates of vilanterol in subjects with COPD.
Pri preiskovancih s KOPB rasa ni vplivala na ocene farmakokinetičnih parametrov vilanterola.
Always use this medicine exactly as your doctor has told you to.
Zelo pomembno je, da to zdravilo uporabljate vsak dan, kot vam je naročil zdravnik.
Cardiovascular effects, such as cardiac arrhythmias e.g. supraventricular tachycardia and extrasystoles may be seen with sympathomimetic medicinal products including Relvar Ellipta.
Med uporabo simpatikomimetičnih zdravil, vključno z zdravilom Relvar Ellipta, se lahko pojavijo kardiovaskularni učinki, npr. motnje srčnega ritma, kakršne so supraventrikularna tahikardija in ekstrasistole.
Glaxo Operations UK Ltd. (trading as Glaxo Wellcome Operations) Priory Street
Glaxo Operations UK Ltd. (posluje kot Glaxo Wellcome Operations) Priory Street
The pharmacokinetics of fluticasone furoate/vilanterol in patients less than 12 years of age has not been studied.
Farmakokinetika zdravila Relvar Ellipta pri bolnikih, mlajših od 12 let, ni raziskana.
At screening, the mean pre-bronchodilator FEV1 was 42.6% and 43.6% predicted, and the mean reversibility was 15.9% and 12.0% in HZC112206 and HZC112207, respectively.
Ob presejanju je bil povprečni FEV1 pred bronhodilatatorjem v HZC112206 42,6 % predvidenega in povprečna reverzibilnost 15,9 % napovedane, v
Hold the inhaler away from your mouth and breathe out as far as is comfortable.
Bolnik naj drži inhalator odmaknjen od ust in izdihne čim bolj globoko, a ne toliko, da bi bilo neprijetno.
• patients already adequately controlled on both inhaled corticosteroid and long-acting beta2-agonist.
• bolniki, ki imajo bolezen ustrezno urejeno ob uporabi inhalacijskih kortikosteroidov in dolgodelujočih agonistov adrenergičnih receptorjev beta2.
The risk of the cardiovascular composite event with fluticasone furoate/vilanterol was not significantly different compared with placebo (HR 0.93; 95% CI: 0.75 to 1.14), fluticasone furoate (HR 1.03; 95% CI: 0.83 to 1.28) or vilanterol (HR 0.94; 95% CI: 0.76 to 1.16).
Tveganje za sestavljeni kardiovaskularni dogodek se s kombinacijo flutikazonfuroat/vilanterol ni značilno razlikovalo od placeba (RO 0,93, 95 % IZ: 0,75 do 1,14), flutikazonfuroata (RO 1,03, 95 % IZ: 0,83 do 1,28) ali vilanterola (RO 0,94, 95 % IZ: 0,76 do 1,16).
SUMMIT was a multi-centre, randomised, double-blind study evaluating the effect on survival of fluticasone furoate/vilanterol 92/22 micrograms compared with placebo in 16,485 subjects.
Študije, ki so trajale več kot 1 leto Študija SUMMIT je bila multicentrična, randomizirana dvojno slepa študija, ki je pri 16.485 bolnikih ocenjevala vpliv kombinacije flutikazonfuroat/vilanterol 92/22 mikrogramov v primerjavi s placebom na preživetje.
Change from baseline in the percentage of rescue-free 24 hour periods during the 24-week treatment period was a powered secondary.
Sprememba odstotka 24-urnih obdobij brez rešilnega zdravila med 24-tedenskim zdravljenjem glede na izhodišče je bil sekundarni opazovani dogodek, za ugotavljanje katerega je bila določena moč.
HZA106829 was 24 weeks in duration and evaluated the efficacy of fluticasone furoate/vilanterol 184/22 micrograms [n=197] and FF
HZA106829 je trajala 24 tednov in je ocenila učinkovitost flutikazonfuroata/vilanterola 184/22 mikrogramov
Put the mouthpiece between your lips and close your lips firmly around it.
• Ustnik namestite čvrsto med ustnici.
It is packaged in a foil laminate tray with a peelable foil lid.
Nahaja se v embalaži iz laminatne folije, zaprti s pokrovom iz folije.
Both fluticasone furoate and vilanterol have a low association with red blood cells.
Tako flutikazonfuroat kot vilanterol imata nizko povezanost z eritrociti.
HZC102970 and HZC102871 integrated
HZC102970 in HZC102871 skupaj vilanterol (n = 409)
At the 24-week time point FF and FP increased trough FEV1 by 146 mL (95% CI 36, 257 mL, p=0.009) and 145 mL (95% CI 33, 257 mL, p=0.011) respectively compared to placebo.
za 146 ml (95 % IZ od 36 do 257 ml, p = 0,009) in FP za 145 ml (95 % IZ od 33 do 257 ml, p = 0,011) v primerjavi s placebom.
Use this medicine for as long as your doctor recommends.
Zdravilo Relvar Ellipta uporabljajte toliko časa, kot vam svetuje vaš zdravnik.
Neither fluticasone furoate nor vilanterol trifenatate had any adverse effects on fertility or pre- and post-natal development in rats.
Niti flutikazonfuroat niti vilanterolijev trifenatat pri podganah nista imela neželenih učinkov na plodnost,
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.
Pri KOPB je bila ocenjena AUC(0-24) flutikazonfuroata za preiskovance iz vzhodne Azije, Japonske in jugovzhodne Azije (13-14 % preiskovancev) v povprečju za 23 do 30 % večja kot pri belcih.
Mortality risk with fluticasone furoate/vilanterol was not significantly different compared with placebo (HR 0.88; 95% CI: 0.74 to 1.04; p=0.137), fluticasone furoate (HR 0.96; 95% CI: 0.81 to 1.15; p=0.681) or vilanterol (HR 0.91; 95% CI: 0.77 to 1.09; p=0.299).
Tveganje umrljivosti se s kombinacijo flutikazonfuroat/vilanterol ni značilno razlikovalo od placeba (RO [razmerje ogroženosti] 0,88, 95 % IZ: 0,74 do 1,04, p = 0,137), flutikazonfuroata (RO 0,96, 95 % IZ: 0,81 do 1,15, p = 0,681) ali vilanterola (RO 0,91, 95 % IZ: 0,77 do 1,09, p = 0,299).
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.
Vendar je treba pri bolnikih s hudo kardiovaskularno boleznijo ali motnjami srčnega ritma, hipertiroidizmom, nekorigirano hipokaliemijo ali pri bolnikih, ki so nagnjeni k nizkim vrednostim kalija v serumu, flutikazonfuroat/vilanterol uporabljati previdno.
When given subcutaneously there were no effects at exposures 84-times greater than those at the maximum recommended human dose, based on AUC.
Med subkutano uporabo ob izpostavljenostih, 84-krat večjih od izpostavljenosti (na podlagi AUC) med uporabo največjega priporočenega odmerka za človeka,
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.
Po ponavljajočem se odmerjanju flutikazonfuroata/vilanterola 7 dni se je sistemska izpostavljenost flutikazonfuroatu pri preiskovancih z okvaro jeter (Child-Pugh A, B in C) povečala (do trikrat, merjeno z
A randomised, double-blind, parallel group, 24 week study (201378) was conducted to demonstrate noninferiority (using a margin of -100 mL for trough FEV1) of fluticasone furoate/vilanterol 92/22 once daily to salmeterol/FP 50/250 twice daily in adults and adolescents whose asthma was well controlled following 4 weeks of treatment with open-label salmeterol/FP 50/250 twice daily (N=1504).
Randomizirano, dvojno slepo 24-tedensko študijo vzporednih skupin (201378) so izvedli za ugotavljanje neinferiornosti (z uporabo meje -100 mL za najnižji FEV1) kombinacije flutikazonfuroat/vilanterol 92/22 mikrogramov enkrat na dan v primerjavi s kombinacijo salmeterol/FP 50/250 mikrogramov dvakrat na dan pri odraslih in mladostnikih, ki so imeli astmo dobro urejeno po 4 tednih zdravljenja (po shemi odprtega načrta zdravljenja) s kombinacijo salmeterol/FP 50/250 mikrogramov dvakrat na dan (N = 1504).
• voice disorders
• motnje glasu,
In an integrated analysis of HZC102970 and HZC102871 at week 52, an improvement was seen when comparing the fluticasone furoate/vilanterol 92/22 micrograms versus vilanterol 22 micrograms in adjusted mean trough FEV1 (42 mL 95% CI: 19, 64mL, p<0.001).
Integrirana analiza HZC102970 in HZC102871 52. teden je pokazala izboljšanje korigiranega povprečnega najmanjšega FEV1 s flutikazonfuroatom/vilanterolom 92/22 mikrogramov v primerjavi z 22 mikrogrami vilanterola (42 ml, 95 % IZ: 19, 64 ml, p < 0,001).
Two different strengths of Relvar Ellipta are available: fluticasone furoate 92 micrograms/vilanterol 22 micrograms and fluticasone furoate 184 micrograms/vilanterol 22 micrograms.
Na voljo sta dve različni jakosti zdravila Relvar Ellipta: flutikazonfuroat 92 mikrogramov/vilanterol 22 mikrogramov in flutikazonfuroat 184 mikrogramov/vilanterol 22 mikrogramov.
Gender, weight and BMI
Spol, telesna masa in ITM