natgillin/translations-raw huggingface dataset:
A decision must be made whether to discontinue breast-feeding or to discontinue Incruse Ellipta therapy taking into account the benefit of breastfeeding for the child and the benefit of therapy for the woman.
Odločiti se je treba bodisi za prenehanje dojenja bodisi za prenehanje zdravljenja z zdravilom Incruse Ellipta, upoštevaje koristi dojenja za otroka in koristi zdravljenja za žensko.
Don't inhale an extra dose to make up for a forgotten dose.
Ne vdihnite dodatnega odmerka, da bi nadomestili pozabljenega.
Incruse Ellipta should be administered at the same time of the day each day to maintain bronchodilation.
Zdravilo Incruse Ellipta je treba uporabljati vsak dan ob istem času, za ohranjanje bronhodilatacije.
Do not use this medicine after the expiry date which is stated on the carton, tray and inhaler after ‘EXP'.
Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatlah, embalaži ali inhalatorju poleg oznake ‘EXP'.
Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not use this medicinal product.
Bolniki z redko dedno intoleranco za galaktozo, odsotnostjo encima laktaze ali malabsorpcijo glukoze/galaktoze ne smejo uporabljati tega zdravila.
Toxicity to reproduction
Reprodukcijska toksičnost
Not all pack sizes may be marketed.
Na trgu morda ni vseh velikosti pakiranj.
Don't use Incruse Ellipta as well as these other medicines.
Ne uporabljajte zdravila Incruse Ellipta hkrati s temi drugimi zdravili.
The short duration of these two studies and limited number of exacerbation events, preclude any conclusion regarding additional effect of Incruse Ellipta on COPD exacerbation rate.
Kratkotrajnost teh dveh študij in majhno število poslabšanj onemogočajo sklepanje o dodatnem učinku zdravila Incruse Ellipta na delež poslabšanj KOPB.
1) Read this before you start
1) Pred začetkom uporabe preberite navodila.
These may affect up to 1 in 1,000 people:
Pojavijo se lahko pri največ 1 od 1.000 bolnikov:
The tray can be discarded after first opening.
Embalažo se lahko po prvem odprtju zavrže.
The other ingredients are lactose monohydrate (see section 2 under ‘Incruse Ellipta contains lactose') and magnesium stearate.
Drugi sestavini zdravila sta laktoza monohidrat (glejte poglavje 2 "Zdravilo Incruse Ellipta vsebuje laktozo") in magnezijev stearat.
The absolute bioavailability of inhaled umeclidinium bromide was on average 13% of the dose, with negligible contribution from oral absorption.
Absolutna biološka uporabnost inhaliranega umeklidinijevega bromida je bila v povprečju 13 % odmerka; prispevek peroralne absorpcije je bil zanemarljiv.
• Remove the inhaler from the mouth.
• Vzemite inhalator iz ust.
Patients receiving Incruse Ellipta had a higher percentage of days when no rescue medication was needed (on average 31.1%) compared with placebo (on average 21.7%).
Bolniki, ki so dobivali zdravilo Incruse Ellipta so imeli večji odstotek dni brez potrebe po rešilnem zdravilu (povprečno 31,1 %) v primerjavi s placebom (povprečno 21,7 %).
The primary endpoint was annual rate of ontreatment moderate and severe exacerbations in subjects treated with FF/UMC/VI compared with FF/VI.
Primarni opazovani dogodek je bil letni delež zmernih in hudih poslabšanj med zdravljenjem pri bolnikih, zdravljenih s FF/UMC/VI v primerjavi s FF/VI.
If you have any of the following symptoms after taking Incruse Ellipta, stop using this medicine and tell your doctor immediately:
Če imate po jemanju zdravila Incruse Ellipta katerega koli od naslednjih simptomov, zdravilo takoj nehajte uporabljati in nemudoma obvestite svojega zdravnika:
2) Prepare a dose
2) Priprava odmerka
It is not known whether the ingredients of Incruse Ellipta can pass into breast milk.
Ni znano, ali lahko sestavine zdravila Incruse Ellipta prehajajo v materino mleko.
No dose adjustment is required in patients over 65 years (see section 5.2).
Starejši bolniki Bolnikom, starejšim od 65 let, odmerka ni treba prilagoditi (glejte poglavje 5.2).
Incruse Ellipta is indicated as a maintenance bronchodilator treatment to relieve symptoms in adult patients with chronic obstructive pulmonary disease (COPD).
Zdravilo Incruse Ellipta je indicirano za vzdrževalno bronhodilatacijsko zdravljenje za olajšanje simptomov pri odraslih bolnikih s kronično obstruktivno pljučno boleznijo (KOPB).
Component of a multipack, can't be sold separately.
Del pakiranja z več inhalatorji, ni za ločeno prodajo.
Allergic reactions are uncommon (may affect up to 1 in 100 people).
Alergijske reakcije pri zdravilu Incruse Ellipta so občasne (pojavijo se lahko pri največ 1 od 100 bolnikov).
How to use the inhaler See ‘Step-by-step instructions for use' in this leaflet for full information.
Za celotne informacije glejte "Navodila za uporabo po korakih" v tem navodilu.
If you open and close the cover without inhaling the medicine, you will lose the dose.
Če pokrovček odprete in zaprete, ne da bi vdihnili zdravilo, boste izgubili odmerek.
Incruse Ellipta contains the active substance umeclidinium bromide, which belongs to a group of medicines called bronchodilators.
Zdravilo Incruse Ellipta vsebuje učinkovino umeklidinijev bromid, ki spada v skupino zdravil, imenovanih bronhodilatatorji.
Submission of the final clinical study report on a Post-Authorisation Safety (PAS) Observational Cohort Study to Quantify the Incidence and Comparative Safety of Selected Cardiovascular and Cerebrovascular Events in COPD Patients with Incruse Ellipta compared with tiotropium (study 201038), according to a protocol agreed by the PRAC.
Opazovalna kohortna študija za določitev incidence in primerjalne varnosti za izbrane kardiovaskularne in cerebrovaskularne dogodke pri bolnikih s KOPB z zdravilom Incruse Ellipta v primerjavi s tiotropijem (študija 201038), po porotokolu, ki ga je potrdil PRAC.
The requirements for submission of periodic safety update reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines webportal.
• Redno posodobljena poročila o varnosti zdravila (PSUR) Zahteve glede predložitve rednega posodobljenega poročila o varnosti zdravila za to zdravilo so določene v seznamu referenčnih datumov EU (seznamu EURD), opredeljenem v členu 107c(7) Direktive
What you need to know before you use Incruse Ellipta 3.
Kaj morate vedeti, preden boste uporabili zdravilo Incruse Ellipta 3.
The bronchodilatory effects with Incruse Ellipta compared with placebo were evident after the first day of treatment in both studies and were maintained over the 12-week and 24-week treatment periods.
V obeh študijah so bili bronhodilatacijski učinki zdravila Incruse Ellipta v primerjavi s placebom opazni že po prvem dnevu zdravljenja in so se ohranili med 12- in 24-tedenskim obdobjem zdravljenja.
Driving and using machines It is unlikely that this medicine will affect your ability to drive or use machines.
Ni verjetno, da bi to zdravilo vplivalo na vašo sposobnost upravljanja vozil in strojev.
There was no evidence for tachyphylaxis in the effect of Incruse Ellipta over time.
Ni bilo znakov, da bi se skozi čas razvila tahifilaksija na učinek zdravila Incruse Ellipta.
Incruse Ellipta has not been studied in patients with severe hepatic impairment and should be used with caution (see section 5.2).
Uporaba zdravila Incruse Ellipta ni raziskana pri bolnikih s hudo okvaro jeter, zato ga je pri takšnih bolnikih treba uporabljati previdno (glejte poglavje 5.2).
Table 1: Trough FEV1 (ml) at Week 12 and Week 24 (primary endpoint) Treatment with Incruse Ellipta 55 mcg
Preglednica 1: Najnižji FEV1 (ml) 12. in 24. teden (primarni opazovani dogodek) Zdravljenje z zdravilom Incruse Ellipta 55 µg
It is not possible to accidentally take extra medicinal product or a double dose in one inhalation.
Ne more se zgoditi, da bi pri eni inhalaciji pomotoma vzeli dodatno količino zdravila ali dvojen odmerek.
The mouthpiece should be placed between the lips and the lips should then be closed firmly around it.
Ustnik namestite med ustnici in ju trdno stisnite okrog njega.
LIST OF EXCIPIENTS Excipients: lactose and magnesium stearate.
Pomožne snovi: laktoza in magnezijev stearat.
Each delivered dose contains approximately 12.5 mg of lactose (as monohydrate).
Pomožna snov z znanim učinkom: En oddani odmerek vsebuje približno 12,5 mg laktoze (v obliki laktoze monohidrata).
The effect of umeclidinium 500 micrograms (pre-dispensed) on the QT interval was evaluated in a placebo- and moxifloxacin-controlled QT trial of 103 healthy volunteers.
Vpliv 500 mikrogramov umeklidinija (odmerjeni) na interval QT so ocenili pri 103 zdravih prostovoljcih v študiji QT, kontrolirani s placebom in moksifloksacinom.
In a pre- and post-natal study, subcutaneous administration of umeclidinium bromide to rats resulted in lower maternal body weight gain and food consumption and slightly decreased pre-weaning pup body weights in dams given 180 micrograms/kg/day dose (approximately 80-times the human clinical exposure of umeclidinium 55 micrograms, based on AUC).
V pre- in postnatalni študiji je subkutano dajanje umeklidinijevega bromida pri podganah zmanjšalo materino povečanje telesne mase in uživanje hrane ter rahlo zmanjšalo telesno maso mladičev pred odstavitvijo pri samicah-materah, ki so dobivale odmerek 180 mikrogramov/kg/dan (to je na podlagi AUC približno 80-kratnik klinične izpostavljenosti pri človeku z odmerkom 55 mikrogramov umeklidinija).
Stop using this medicine and seek medical help immediately, these may be signs of an acute attack of narrow-angle glaucoma.
Prenehajte uporabljati to zdravilo in nemudoma poiščite zdravniško pomoč; to so lahko znaki akutnega napada glavkoma z ozkim zakotjem.
What you need to know before you use Incruse Ellipta Do not use Incruse Ellipta:
Kaj morate vedeti, preden boste uporabili zdravilo Incruse Ellipta Ne uporabljajte zdravila Incruse Ellipta:
It is not possible to accidentally take extra medicine or a double dose in one inhalation.
Ne more se zgoditi, da bi pri eni inhalaciji pomotoma vzeli dodatno količino zdravila ali dvojni odmerek.
If the inhaler cover is opened and closed without inhaling the medicinal product, the dose will be lost.
Če se pokrovček inhalatorja odpre in zapre, ne da bi se zdravilo vdihnilo, bo odmerek izgubljen.
The clinical efficacy of Incruse Ellipta administered once daily was evaluated in 904 adult patients who received umeclidinium bromide or placebo from two pivotal Phase III clinical studies with a clinical diagnosis of COPD; a 12-week study (AC4115408) and a 24-week study (DB2113373).
Klinično učinkovitost zdravila Incruse Ellipta enkrat na dan so ocenili pri 904 odraslih bolnikih s klinično diagnozo KOPB, ki so prejemali umeklidinijev bromid ali placebo v dveh ključnih kliničnih študijah III. faze: v 12-tedenski študiji (AC4115408) in 24-tedenski študiji (DB2113373).
• While holding the inhaler away from your mouth, breathe out as far as is comfortable.
• Medtem ko inhalator držite odmaknjen od ust, izdihnite čim bolj globoko, a ne toliko, da bi bilo neprijetno.
The most frequently reported adverse reactions with Incruse Ellipta were nasopharyngitis and upper respiratory tract infection.
Najpogosteje poročana neželena učinka med uporabo zdravila Incruse Ellipta sta bila nazofaringitis in okužba zgornjih dihal.
If you accidentally use too much of this medicine, contact your doctor or pharmacist for advice immediately as you may need medical attention.
Če ste uporabili večji odmerek zdravila Incruse Ellipta, kot bi smeli Če pomotoma uporabite preveč tega zdravila, se za nasvet nemudoma obrnite na svojega zdravnika ali farmacevta, ker boste morda potrebovali zdravniško pomoč.
Following intravenous administration to healthy subjects, the mean volume of distribution was 86 litres.
Porazdelitev Povprečni volumen porazdelitve po intravenski uporabi je bil pri zdravih preiskovancih 86 litrov.
There is no relevant use of Incruse Ellipta in the paediatric population (under 18 years of age) in the indication for COPD.
V pediatrični populaciji (mlajši od 18 let) zdravilo Incruse Ellipta nima relevantne uporabe za indikacijo KOPB.
What Incruse Ellipta is and what it is used for 2.
Kaj je zdravilo Incruse Ellipta in za kaj ga uporabljamo 2.
Incruse Ellipta should not be used to relieve a sudden attack of breathlessness or wheezing.
Zdravila Incruse Ellipta se ne sme uporabljati za ublažitev nenadnega napada težkega ali piskajočega dihanja.
Eye problems during treatment with Incruse Ellipta If you get eye pain or discomfort, temporary blurring of vision, visual halos or coloured images in association with red eyes during treatment with Incruse Ellipta:
Če se vam med zdravljenjem z zdravilom Incruse Ellipta pojavijo bolečine ali nelagodje v očesu, prehodna zamegljenost vida, videnje odsevov okrog stvari ali obarvane slike skupaj s pordelimi očmi:
In the 12-week study, Incruse Ellipta statistically significantly reduced the use of rescue medication with salbutamol compared with placebo (on average a reduction of 0.7 puffs per day over Weeks 1-12, p=0.025) and demonstrated a higher percentage of days when no rescue medication was needed (on average 46.3%) compared with placebo (on average 35.2%; no formal statistical analysis was performed on this endpoint).
Uporaba rešilnega zdravila V 12-tedenski študiji je zdravilo Incruse Ellipta statistično značilno zmanjšalo uporabo rešilnega zdravila s salbutamolom v primerjavi s placebom (povprečno zmanjšanje 0,7 vdiha na dan v obdobju od 1. do 12. tedna, p = 0,025) in je doseglo večji odstotek dni brez potrebe po rešilnem zdravilu (povprečno 46,3 %) kot placebo (povprečno 35,2 %; formalne statistične analize tega opazovanega dogodka niso izvedli).
Multipack: 90 (3 packs of 30) doses
Skupno pakiranje: 90 (3 inhalatorji po 30) odmerkov
No dose adjustment is required in patients with mild or moderate hepatic impairment.
Bolnikom z blago ali zmerno okvaro jeter odmerka ni treba prilagoditi.
The European Medicines Agency has waived the obligation to submit the results of studies with Incruse Ellipta in all subsets of the paediatric population in COPD (see section 4.2 for information on paediatric use).
Ellipta za vse podskupine pediatrične populacije pri KOPB (za podatke o uporabi pri pediatrični populaciji glejte poglavje 4.2).
The active substance is present as a white powder in a blister inside the inhaler.
Učinkovina je bel prašek v pretisnem traku v notranjosti inhalatorja.
Use Incruse Ellipta regularly
Zdravilo Incruse Ellipta uporabljajte redno
To use Incruse Ellipta, you breathe it into your lungs through your mouth using the Ellipta inhaler.
Zdravilo Incruse Ellipta uporabite tako, da ga s pomočjo inhalatorja Ellipta skozi usta vdihnete v pljuča.
If you forget to use Incruse Ellipta
Če ste pozabili uporabiti zdravilo Incruse Ellipta
Other medicines and Incruse Ellipta
Druga zdravila in zdravilo Incruse Ellipta
In two 12-week, placebo controlled studies (200109 and 200110), the addition of Incruse Ellipta to fluticasone furoate/vilanterol (FF/VI) (92/22 micrograms) once daily in adult patients with a clinical diagnosis of COPD, resulted in statistically significant and clinically meaningful improvements in the primary endpoint of trough FEV1 at Day 85 compared to placebo plus FF/VI (124 mL 95% CI: 93, 154; p<0.001and 122 mL 95% CI: 91, 152; p<0.001).
V dveh 12-tedenskih, s placebom kontroliranih študijah (200109 in 200110) je dodatek zdravila Incruse Ellipta kombinaciji flutikazonfuroat/vilanterol (FF/VI) (92/22 mikrogramov) enkrat na dan v primerjavi s placebom in FF/VI pri odraslih bolnikih s klinično diagnozo KOPB po 85 dneh dosegel statistično značilno in klinično pomembno izboljšanje primarnega opazovanega dogodka, najnižje vrednosti FEV1 (124 ml 95odstotni IZ: 93, 154; p < 0,001) in 122 ml 95-odstotni IZ: 91, 152; p < 0,001).
Step-by-step instructions for use
Navodila za uporabo po korakih
The proportion of patients who responded with at least the minimum clinically important difference (MCID) of 1 unit TDI focal score at Week 12 was greater for Incruse Ellipta (38%) compared with placebo (15%) in the 12-week study.
Delež bolnikov, ki so se odzvali z vsaj minimalno klinično pomembno razliko (MCID - minimum clinically important difference) 1 enote fokalnega seštevka TDI po 12 tednih, je bil v 12-tedenski študiji z zdravilom Incruse Ellipta večji (38 %) kot s placebom (15 %).
Incruse Ellipta is for inhalation use only.
Zdravilo Incruse Ellipta je namenjeno samo za inhalacijsko uporabo.
No new adverse drug reactions were identified with the addition of Incruse Ellipta to FF/VI in these studies.
V teh študijah niso ugotovili novih neželenih učinkov med uporabo zdravila Incruse Ellipta ob FF/VI.
In the 24-week study treatment with Incruse Ellipta, the mean (SD) change from baseline in the number of puffs of rescue salbutamol over the 24-week treatment period was -1.4 (0.20) for placebo and -1.7 (0.16) for Incruse Ellipta (Difference = -0.3; 95% CI: -0.8, 0.2, p=0.276).
V 24tedenski študiji zdravljenja z zdravilom Incruse Ellipta je bila povprečna sprememba (standardni odklon) števila vdihov rešilnega salbutamola med 24-tedenskim obdobjem zdravljenja od izhodišča -1,4 (0,20) za placebo in -1,7 (0,16) za zdravilo Incruse Ellipta (razlika = -0,3, 95 % IZ: -0,8, 0,2, p = 0,276).
Improvements in lung function were supported with reductions in use of salbutamol over Weeks 1-12 (-0.4 puffs per day (95% CI: -0.7, -0.2; p<0.001) and -0.3 puffs per day (95% CI: -0.5, -0.1; p=0.003)) compared to placebo plus FF/VI but improvements in SGRQ at week 12 were not statistically significant (200109) or clinically relevant (200109 and 200110).
odstotni IZ: -0,7, -0,2; p < 0,001) in -0,3 vpiha na dan (95-odstotni IZ: -0,5, -0,1; p = 0,003)) v primerjavi s placebom in FF/VI, izboljšanje SGRQ po 12 tednih pa ni bilo statistično značilno (200109) ali klinično pomembno (200109 in 200110).
The inhaler is a multi-component device composed of polypropylene, high density polyethylene, polyoxymethylene, polybutylene terephthalate, acrylonitrile butadiene styrene, polycarbonate and stainless steel.
polibutilentereftalata, akrilonitril-butadienstirena, polikarbonata in nerjavečega jekla.
These may affect up to 1 in 10 people:
Pojavijo se lahko pri največ 1 od 100 bolnikov:
In both of the pivotal 12-week and 24-week studies, Incruse Ellipta demonstrated statistically significant and clinically meaningful improvements in lung function (as defined by change from baseline trough FEV1 at Week 12 and Week 24 respectively, which was the primary efficacy endpoint in each study) compared with placebo (see Table 1).
Tako 12-tedenska kot 24-tedenska ključna študija sta pokazali, da je zdravilo Incruse Ellipta v primerjavi s placebom statistično značilno in klinično pomembno izboljšalo delovanje pljuč (opredeljeno kot sprememba FEV1 od izhodišča do 12. oziroma 24. tedna; to je bil primarni opazovani dogodek učinkovitosti v obeh študijah) (glejte preglednico 1).
CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 7 doses
VSEBINA, IZRAŽENA Z MASO, PROSTORNINO ALI ŠTEVILOM ENOT
If you are breast-feeding, you must check with your doctor before you use Incruse Ellipta.
Če dojite, se morate pred uporabo zdravila Incruse Ellipta posvetovati z zdravnikom.
In-use shelf-life after opening the tray: 6 weeks.
Rok uporabnosti po prvem odprtju: 6 tednov.
Incruse Ellipta is for inhalation use.
Zdravilo Incruse Ellipta je namenjeno za inhalacijsko uporabo.
No dose adjustment is required in patients with renal impairment (see section 5.2).
Okvara ledvic Bolnikom z okvaro ledvic odmerka ni treba prilagoditi (glejte poglavje 5.2).
1.least squares mean (95% confidence interval)
V primerjavi s placebom µg = mikrogrami 1 povprečje po metodi najmanjših kvadratov (95 % interval zaupanja)
What is the inhaler?
Navodilo za uporabo Kaj je inhalator?
How to store Incruse Ellipta 6.
Shranjevanje zdravila Incruse Ellipta 6.
The proportion of patients who responded with at least the MCID in SGRQ score (defined as a decrease of 4 units from baseline) at Week 12 was greater for Incruse Ellipta 55 micrograms (44%) compared with placebo (26%) in the 12-week study.
Delež bolnikov, ki so se odzvali z vsaj minimalno klinično pomembno razliko seštevka SGRQ (ta je bila opredeljena kot znižanje za 4 enote v primerjavi z izhodiščem) po 12 tednih, je bil v 12-tedenski raziskavi z zdravilom Incruse Ellipta večji (44 %) kot s placebom (26 %).
It is packaged in a foil laminate tray with a peelable foil lid.
Pakiran je v embalaži iz laminatne folije, ki vsebuje vrečko s sušilom silikagel.
In the 12-week study, a statistically significant improvement compared with placebo in the TDI focal score at Week 12 was not demonstrated for Incruse Ellipta (1.0 units, p=0.05).
V 12-tedenski študiji z zdravilom Incruse Ellipta v primerjavi s placebom niso ugotovili statistično značilnega izboljšanja fokalnega seštevka TDI po 12 tednih (1,0 enota, p = 0,05).
• skin rash (hives) or redness
• kožni izpuščaj (koprivnica) ali rdečina.
Incruse Ellipta contains lactose
Zdravilo Incruse Ellipta vsebuje laktozo
In a Phase III, 6-month study (DB2113373) Incruse Ellipta provided a clinically meaningful improvement over placebo in lung function (as measured by forced expiratory volume in 1 second [FEV1]) over 24 hours following once daily administration, which was evident at 30 minutes following administration of the first dose (improvement over placebo by 102 mL, p<0.001*).
V 6-mesečni študiji III. faze (DB2113373) je zdravilo Incruse Ellipta v primerjavi s placebom klinično pomembno izboljšalo pljučno funkcijo (merjeno s forsiranim ekspiracijskim volumnom v 1. sekundi [FEV1])
How to use Incruse Ellipta
Kako uporabljati zdravilo Incruse Ellipta
A. MANUFACTURER RESPONSIBLE FOR BATCH RELEASE Name and address of the manufacturer responsible for batch release Glaxo Operations UK Ltd. (trading as Glaxo Wellcome Operations) Priory Street
Glaxo Operations (UK) Ltd. (posluje kot Glaxo Wellcome Operations) Priory Street
An approximately 1.3-fold increase in umeclidinium bromide AUC was observed at an 8-fold higher dose with no effect on umeclidinium bromide Cmax.
Verapamil ni vplival na Cmax umeklidinijevega bromida, ugotovili pa so približno 1,4-kratno povečanje AUC umeklidinijevega bromida.
Use of rescue medicinal product
IMETNIK DOVOLJENJA ZA PROMET Z ZDRAVILOM
In a randomised, double-blind, 52-week study (CTT116855, IMPACT) of 10,355 adult patients with symptomatic COPD and a history of 1 or more moderate or severe exacerbations within the prior 12 months, treatment with fluticasone furoate/umeclidinium/vilanterol (FF/UMEC/VI 99/55/22 micrograms) once daily as a single inhaler was compared with fluticasone furoate/vilanterol (FF/VI 99/22 micrograms) once daily as a single inhaler.
12 mesecih, so primerjali zdravljenje s flutikazonfuroat/umeklidinij/vilanterol (FF/UMEC/VI 99/55/22 mikrogramov) enkrat na dan v enem inhalatorju z zdravljenjem s flutikazonfuroat/vilanterol (FF/VI 99/22 mikrogramov) enkrat na dan v enem inhalatorju.
Infections and infestations Nasopharyngitis Upper respiratory tract infection Urinary tract infection
Infekcijske in parazitske bolezni nazofaringitis okužba zgornjih dihal okužba sečil sinuzitis faringitis pogosti pogosti pogosti pogosti občasni
The inhaler will be in the ‘closed' position when it is first taken out of its sealed tray.
Ko se inhalator prvič vzame iz embalaže, je v položaju ˝zaprto˝.
In the 24-week placebo-controlled study in patients with symptomatic COPD, Incruse Ellipta reduced the risk of a moderate/severe COPD exacerbation by 40% compared with placebo (analysis of time to first exacerbation; Hazard Ratio 0.6; 95% CI: 0.4, 1.0, p=0.035*).
V 24-tedenski s placebom kontrolirani študiji pri bolnikih s simptomatsko KOPB je zdravilo Incruse Ellipta zmanjšalo tveganje za zmerno/hudo poslabšanje KOPB za 40 % v primerjavi s placebom (analiza časa do prvega poslabšanja; razmerje ogroženosti 0,6; 95 % IZ: 0,4, 1,0; p = 0,035∗).Verjetnost poslabšanja je bila po 24 tednih 8,9 % med bolniki, ki so prejemali zdravilo Incruse Ellipta in 13,7 % med bolniki, ki so prejemali placebo.
Close the inhaler
c) Zaprite inhalator