FrancophonIA/ELRC3.0 huggingface dataset:
English: ↔ Cmin 0.97 (0.82, 1.15) Cobicistat ↔ Cmax 1.06 (1.00, 1.12)
Estonian: ↔ Cmax 0,96 (0,89; 1,04) ↔ AUC 1,05 (1,01; 1,09)
English: Don't use Elebrato Ellipta if you already use these medicines.
Estonian: Ärge kasutage Elebrato Ellipta't, kui te juba kasutate nimetatud ravimeid.
English: It is very important that you use Elebrato Ellipta every day, as instructed by your doctor.
Estonian: Väga tähtis on Elebrato Ellipta't kasutada iga päev vastavalt arstilt saadud juhistele.
English: Treatment difference 95% CI
Estonian: Ravierinevus 95% CI
English: The first time you use Elebrato Ellipta you do not need to check that the inhaler is working properly; it contains previously measured doses and is ready to use straight away.
Estonian: Elebrato Ellipta esmakordsel kasutamisel ei ole vaja kontrollida, kas inhalaator töötab korralikult; see sisaldab doseeritud annuseid ja on kohe kasutamiseks valmis.
English: Administration of Elebrato Ellipta to pregnant women should only be considered if the expected benefit to the mother justifies the potential risk to the foetus.
Estonian: Elebrato Ellipta manustamist rasedatele tuleb kaaluda vaid juhul, kui oodatav kasu emale kaalub üles võimalikud ohud lootele.
English: A decision must be made whether to discontinue breast-feeding or to discontinue Elebrato Ellipta therapy taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman.
Estonian: Tuleb teha otsus, kas lõpetada rinnaga toitmine või ravi Elebrato Ellipta'ga, arvestades imetamise kasu lapsele ja ravi kasu naisele.
English: Elebrato Ellipta should be used every day and not only when you have breathing problems or other symptoms of COPD.
Estonian: Elebrato Ellipta't tuleb kasutada iga päev ning mitte ainult hingamisprobleemide või muude KOKi sümptomite esinemise korral.
English: One fatal case of pneumonia was reported in a patient who received Elebrato Ellipta.
Estonian: Ühte surmaga lõppenud pneumoonia juhtu kirjeldati patsiendil, kes sai Elebrato Ellipta't.
English: The most frequently reported adverse reactions with Elebrato Ellipta were nasopharyngitis (7%), headache (5%) and upper respiratory tract infection (2%).
Estonian: Elebrato Ellipta kasutamisel kõige sagedamini kirjeldatud kõrvaltoimed olid nasofarüngiit (7%), peavalu (5%) ja ülemiste hingamisteede infektsioon (2%).
English: Patients should not stop therapy with Elebrato Ellipta without physician supervision since symptoms may recur after discontinuation.
Estonian: Patsiendid ei tohi lõpetada ravi Elebrato Ellipta'ga ilma arsti järelevalveta, sest pärast ravi lõpetamist võivad sümptomid uuesti tekkida.
English: Also contains lactose and magnesium stearate.
Estonian: Sisaldab ka laktoosi ja magneesiumstearaati.
English: The other ingredients are lactose monohydrate (see section 2 under ‘Elebrato Ellipta contains lactose') and magnesium stearate.
Estonian: Teised koostisosad on laktoosmonohüdraat (vt lõik 2 „Elebrato Ellipta sisaldab laktoosi“) ja magneesiumstearaat.
English: Elebrato Ellipta (N = 4,151
Estonian: Elebrato (N = 4151)
English: See ‘Step-by-step instructions' in this leaflet for full information.
Estonian: Täieliku informatsiooni saamiseks vt „Üksikasjalik juhend“ käesolevas infolehes.
English: The active substances are present as a white powder in separate blister strips inside the inhaler.
Estonian: Toimeained on valge pulbrina eraldi blisterribades inhalaatori sisemuses.
English: Elebrato Ellipta should not be used in patients with asthma since it has not been studied in this patient population.
Estonian: Elebrato Ellipta't ei tohi kasutada astmahaigetel, sest nendel patsientidel ei ole ravimi kasutamist uuritud.
English: Each delivered dose contains approximately 25 mg of lactose (as monohydrate).
Estonian: Üks pihustatud annus sisaldab ligikaudu 25 mg laktoosi (monohüdraadina).
English: Elebrato Ellipta is used to treat chronic obstructive pulmonary disease (COPD) in adults.
Estonian: Elebrato Ellipta't kasutatakse kroonilise obstruktiivse kopsuhaiguse (KOK) raviks täiskasvanutel.
English: Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicinal product.
Estonian: Harvaesineva päriliku galaktoosi talumatusega, täieliku laktaasipuudulikkusega või glükoosi-galaktoosi malabsorptsiooniga patsiendid ei tohi seda ravimit kasutada..
English: Caution should be exercised when Elebrato Ellipta is used with other medicinal products that also have the potential to cause hypokalaemia (see section 4.5).
Estonian: Ettevaatlik peab olema Elebrato Ellipta kasutamisel koos teiste ravimitega, mis võivad samuti põhjustada hüpokaleemiat (vt lõik 4.5).
English: Because you are using this medicine for COPD you may be at an increased risk of developing an infection of the lungs known as pneumonia.
Estonian: Kuna te kasutate seda ravimit KOKi raviks, võib teil olla suurem oht kopsupõletiku (pneumoonia) tekkeks.
English: The recommended and maximum dose is one inhalation of Elebrato Ellipta 92/55/22 micrograms once daily, at the same time each day.
Estonian: Soovitatav ja maksimaalne annus on üks Elebrato Ellipta 92/55/22 mikrogrammi inhalatsioon üks kord ööpäevas, iga päev samal kellaajal.
English: Once the tray is opened Elebrato Ellipta is ready to use.
Estonian: Pärast aluse avamist on Elebrato Ellipta valmis kasutamiseks.
English: There are no clinical data to support the use of Elebrato Ellipta for the treatment of acute episodes of bronchospasm, or to treat an acute COPD exacerbation (i.e. as a rescue therapy).
Estonian: Puuduvad kliinilised andmed, mis toetaksid Elebrato Ellipta kasutamist ägedate bronhospasmi episoodide või KOKi ägenemise raviks (st hooravina).
English: Pneumonia which required hospitalisation occurred in 1% of patients receiving Elebrato Ellipta and <1% of patients receiving budesonide/formoterol up to 24 weeks.
Estonian: Haiglaravi vajanud pneumoonia tekkis kuni 24 nädala jooksul 1%-l Elebrato Ellipta't saanud ja  1%-l budesoniidi/formoterooli saanud patsientidest.
English: If you are breast-feeding, you must check with your doctor before you use Elebrato Ellipta.
Estonian: Kui te toidate last rinnaga, peate enne Elebrato Ellipta kasutamist nõu pidama oma arstiga.
English: Elebrato Ellipta is indicated as a maintenance treatment in adult patients with moderate to severe chronic obstructive pulmonary disease (COPD) who are not adequately treated by a combination of an inhaled corticosteroid and a long-acting β2-agonist or a combination of a long-acting β2-agonist and a long-acting muscarinic antagonist (for effects on symptom control and prevention of exacerbations see section 5.1).
Estonian: Elebrato Ellipta on näidustatud mõõduka kuni raske kroonilise obstruktiivse kopsuhaiguse säilitusraviks täiskasvanutele, kes ei ole saavutanud piisavat ravivastust inhaleeritava kortikosteroidi ja pikatoimelise beeta2-agonisti kombinatsiooni või pikatoimelise beeta2-agonisti ja pikatoimelise muskariiniretseptorite antagonisti kombinatsiooniga (toime sümptomite kontrollile ja ägenemiste ennetamisele vt lõik 5.1).
English: Patients should be informed about the signs and symptoms of acute narrow-angle glaucoma and should be informed to stop using Elebrato Ellipta and to contact their doctor immediately should any of these signs or symptoms develop.
Estonian: Patsiente tuleb teavitada ägeda suletud nurga glaukoomi nähtudest ja sümptomitest ning juhendada, et nimetatud nähtude ja sümptomite tekkimisel tuleb Elebrato Ellipta kasutamine otsekohe lõpetada ja ühendust võtta arstiga.
English: UMEC/VI
Estonian: UMEC/VI võrdlus
English: If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before using this medicine.
Estonian: Kui arst on teile öelnud, et te ei talu teatud suhkruid, peate teie enne ravimi kasutamist konsulteerima oma arstiga.
English: Keep the inhaler inside the sealed tray to protect from moisture and only remove immediately before first use.
Estonian: Hoidke inhalaatorit niiskuse eest kaitstult hermeetiliselt suletud alusel ja eemaldage see aluselt alles vahetult enne esmakordset kasutamist.
English: The fluticasone furoate/vilanterol component of Elebrato Ellipta was assessed in patients with all severities of hepatic impairment (Child-Pugh A, B or C).
Estonian: Elebrato Ellipta flutikasoonfuroaadi/vilanterooli komponenti on hinnatud erineva raskusega maksakahjustuse korral (Child-Pugh A, B või C).
English: Use Elebrato Ellipta regularly
Estonian: Kasutage Elebrato Ellipta't regulaarselt
English: Elebrato Ellipta is for inhalation use only.
Estonian: Elebrato Ellipta on ette nähtud ainult inhalatsiooni teel manustamiseks.
English: In the subset of 430 patients treated for up to 52 weeks, the incidence of pneumonia events reported in both Elebrato Ellipta and budesonide/formoterol arms was equal at 2%.
Estonian: Kuni 52 nädala jooksul ravi saanud 430 patsiendiga alarühmas oli pneumooniajuhtude esinemissagedus nii Elebrato Ellipta kui budesoniidi/formoterooli rühmas võrdselt 2%.
English: The incidence of pneumonia with Elebrato Ellipta is comparable with that observed in the fluticasone furoate/vilanterol (FF/VI) 100/25 arm of FF/VI clinical studies in COPD.
Estonian: Pneumoonia esinemissagedus Elebrato Ellipta kasutamisel on võrreldav sellega, mida täheldati KOKi flutikasoonfuroaadi/vilanterooli (FF/VI) kliiniliste uuringute FF/VI 100/25 rühmas.
English: When you take the inhaler out of the sealed tray, it will be in the ‘closed' position.
Estonian: Kui eemaldate inhalaatori hermeetiliselt suletud aluselt, on see „suletud“ asendis.
English: There is no relevant use of Elebrato Ellipta in the paediatric population (under 18 years of age) for the indication of COPD.
Estonian: Puudub Elebrato Ellipta asjakohane kasutus lastel (vanuses alla 18 aasta) KOKi näidustusel.
English: Tabulated summary of adverse reactions The safety profile of Elebrato Ellipta is based on three phase III clinical studies.
Estonian: Kõrvaltoimete kokkuvõte tabelina Elebrato Ellipta ohutusprofiil põhineb kolme III faasi kliinilise uuringu ohutusandmetel.
English: Elebrato Ellipta should not be used to relieve a sudden attack of breathlessness or wheezing.
Estonian: Elebrato Ellipta't ei tohi kasutada järsku tekkiva hingelduse või vilistava hingamise leevendamiseks.
English: Co-administration of Elebrato Ellipta with other long-acting muscarinic antagonists or long-acting beta2adrenergic agonists has not been studied and is not recommended as it may potentiate the adverse reactions (see section 4.8 and section 4.9).
Estonian: Elebrato Ellipta kasutamist koos teiste pikatoimeliste muskariiniretseptorite antagonistide või pikatoimeliste beeta2-agonistidega ei ole uuritud ning see ei ole soovitatav, sest võib potentseerida kõrvaltoimeid (vt lõigud 4.8 ja 4.9).
English: Patients with moderate to severe hepatic impairment receiving Elebrato Ellipta should be monitored for systemic corticosteroid-related adverse reactions (see section 5.2).
Estonian: Elebrato Ellipta't saavaid mõõduka kuni raske maksakahjustusega patsiente tuleb jälgida kortikosteroididega seotud süsteemsete kõrvaltoimete suhtes (vt lõik 5.2).
English: The European Medicines Agency has waived the obligation to submit the results of studies with Elebrato Ellipta in all subsets of the paediatric population in COPD (see section 4.2 for information on paediatric use).
Estonian: Euroopa Ravimiamet ei kohusta esitama Elebrato Ellipta'ga läbi viidud uuringute tulemusi laste kõikide alarühmade kohta KOKi korral (teave lastel kasutamise kohta: vt lõik 4.2).
English: Pneumonia (infection of the lung) in COPD patients (common side effect) Tell your doctor if you have any of the following while using Elebrato Ellipta - these could be symptoms of a lung infection:
Estonian: Pneumoonia (kopsupõletik) KOKiga patsientidel (sage kõrvaltoime) Teavitage oma arsti, kui teil esinevad Elebrato Ellipta kasutamise ajal ükskõik millised järgmistest haigusnähtudest, sest need võivad olla kopsupõletiku sümptomid:
English: Your Elebrato Ellipta inhaler carton contains
Estonian: Elebrato Ellipta inhalaatori karp sisaldab
English: Elebrato Ellipta should be used with caution in patients with convulsive disorders or thyrotoxicosis, and in patients who are unusually responsive to beta2-adrenergic agonists.
Estonian: Elebrato Ellipta't tuleb ettevaatlikult kasutada patsientidel, kellel esinevad krambiseisundid või türeotoksikoos, ning samuti patsientidel, kes on ebatavaliselt tundlikud beeta2-agonistide suhtes.
English: The inhaler contains two aluminium foil laminate blister strips that deliver a total of 14 or 30 doses (14 or 30 day supply).
Estonian: Inhalaator sisaldab kahte alumiiniumfooliumlaminaadist blisterriba kokku 14 või 30 annusega (14 või 30 päeva varu).
English: MARKETING AUTHORISATION NUMBER(S) EU/1/17/1237/001
Estonian: MÜÜGILOA NUMBER (NUMBRID) EU/1/17/1237/001
English: In the event of deterioration of COPD during treatment with Elebrato Ellipta, a re-evaluation of the patient and of the COPD treatment regimen should be undertaken.
Estonian: Kui KOK süveneb Elebrato Ellipta kasutamise ajal, tuleb uuesti hinnata patsiendi seisundit ja KOKi raviskeemi.
English: In FULFIL, Elebrato Ellipta improved daily symptoms of COPD as assessed by E-RS: COPD total score, compared with BUD/FOR (≥2 unit decrease from baseline).
Estonian: Uuringus FULFIL parandas Elebrato Ellipta KOKi igapäevaseid sümptomeid (kui hinnati KOKi respiratoorsete sümptomite hindamisinstrumendi E-RS-i üldskoori põhjal) võrreldes BUD/FOR-iga (vähenemine ≥ 2 ühikut võrreldes algväärtusega).
English: Don't use Elebrato Ellipta: - if you are allergic to fluticasone furoate, umeclidinium, vilanterol or any of the other ingredients of this medicine (listed in section 6).
Estonian: Ärge kasutage Elebrato Ellipta't: - kui olete flutikasoonfuroaadi, umeklidiiniumi, vilanterooli või selle ravimi mis tahes koostisosade
English: Eye problems during treatment with Elebrato Ellipta If you get eye pain or discomfort, temporary blurring of vision, visual halos or coloured images as well as red eyes during treatment with Elebrato Ellipta:
Estonian: Kui teil tekib Elebrato Ellipta-ravi ajal silmavalu või ebamugavustunne silmas, mööduv ähmane nägemine, halode või värviliste kujutiste nägemine ning silmade punetus:
English: Your doctor may wish to monitor you carefully if you are taking any of these medicines as they may increase the side effects of Elebrato Ellipta.
Estonian: Kui te võtate mõnda nimetatud ravimitest, võib arst soovida teid hoolikalt jälgida, sest nende ravimite toimel võivad sageneda Elebrato Ellipta kõrvaltoimed.
English: Elebrato Ellipta contains three active substances called fluticasone furoate, umeclidinium and vilanterol.
Estonian: Elebrato Ellipta sisaldab kolme toimeainet, mida nimetatakse flutikasoonfuroaadiks, umeklidiiniumiks ja vilanterooliks.
English: Each blister in one strip contains fluticasone furoate, each blister in the other strip contains umeclidinium (as bromide) and vilanterol (as trifenatate).
Estonian: Ühe riba kõik blistrid sisaldavad flutikasoonfuroaati, teise riba kõik blistrid sisaldavad umeklidiiniumi (bromiidina) ja vilanterooli (trifenataadina).
English: In FULFIL, bronchodilatory effects with Elebrato Ellipta were evident on the first day of treatment and were maintained over the 24-week treatment period (mean changes from baseline in FEV1 were 90-222 mL on day 1 and 160-339 mL at week 24).
Estonian: Elebrato Ellipta bronhe lõõgastav toime ilmnes esimesel ravipäeval ja püsis 24-nädalase raviperioodi jooksul (FEV1 keskmine muutus võrreldes algväärtusega oli 90...222 ml esimesel päeval ja 160....339 ml 24. nädalal).
English: The efficacy of Elebrato Ellipta (92/55/22 micrograms), administered as a once-daily treatment, has been evaluated in patients with a clinical diagnosis of COPD in two, active-controlled studies and in a single, noninferiority study.
Estonian: Üks kord ööpäevas manustatud Elebrato Ellipta (92/55/22 mikrogrammi) efektiivsust on hinnatud kahes aktiivse võrdlusravimiga kontrollitud uuringus ja ühes mittehalvemus-uuringus KOKi kliinilise diagnoosiga patsientidel.
English: There is no specific treatment for an overdose with Elebrato Ellipta.
Estonian: Elebrato Ellipta üleannustamise spetsiifiline ravi puudub.
English: If you forget to use Elebrato Ellipta
Estonian: Kui te unustate Elebrato Ellipta't kasutada
English: If beta-blockers are required, cardioselective beta-blockers should be considered, however, caution should be exercised during concurrent use of both non-selective and selective beta-blockers.
Estonian: Juhuk kui ravi beetablokaatoritega on vajalik, tuleb kaaluda kardioselektiivsete beetablokaatorite kasutamist, kuid ettevaatlik peab olema nii mitteselektiivsete kui selektiivsete beetablokaatorite samaaegsel kasutamisel.
English: In IMPACT, Elebrato Ellipta significantly improved (p<0.001) lung function when compared with FF/VI and UMEC/VI over a 52-week period (See Table 2).
Estonian: Uuringus IMPACT parandas Elebrato Ellipta 52-nädalase perioodi jooksul oluliselt (p < 0,001) kopsufunktsiooni võrreldes FF/VI ja UMEC/VI-ga (vt tabel 2).
English: Other medicines and Elebrato Ellipta Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Estonian: Teatage oma arstile või apteekrile, kui te kasutate, olete hiljuti kasutanud või kavatsete kasutada mis tahes muid ravimeid.
English: How to use Elebrato Ellipta 4.
Estonian: Kuidas Elebrato Ellipta't kasutada 4.
English: In a total of 1810 patients with advanced COPD (mean post bronchodilatory screening FEV1 45% of predicted, standard deviation (SD) 13%), 65% of whom had experienced a moderate/severe COPD exacerbation in the year prior to study entry (study CTT116853), there was a higher incidence of pneumonia events reported up to 24 weeks in patients receiving Elebrato Ellipta (20 patients, 2%) than in patients receiving budesonide/formoterol (7 patients, <1%).
Estonian: Kokku 1810 kaugelearenenud KOKiga (keskmine bronhodilataatori manustamise järgne FEV1 45% eeldatavast normist, standardhälve [SD] 13%) patsiendi seas, kellest 65%-l oli uuringuga (uuring CTT116853) liitumisele eelneva aasta jooksul esinenud mõõdukas/raske KOKi ägenemine, oli Elebrato Ellipta't saanud patsientidel kuni 24 nädala jooksul kirjeldatud pneumoonia esinemissagedus suurem (20 patsienti, 2%) kui budesoniidi/formoterooli saanud patsientidel (7 patsienti,  1%).
English: What you need to know before you use Elebrato Ellipta
Estonian: Mida on vaja teada enne Elebrato Ellipta kasutamist
English: • Slide the cover upwards as far as it will go, to cover the mouthpiece.
Estonian: • Lükake kate ülespoole nii kaugele kui võimalik, et huulik katta.
English: FF/VI
Estonian: BUD/FOR
English: Following repeat dosing of inhaled fluticasone furoate /vilanterol, steady state was achieved within 6 days with up to 1.6-fold accumulation.
Estonian: Pärast inhaleeritava flutikasoonfuroaadi/vilanterooli korduvat manustamist saavutati tasakaalukontsentratsiooni seisund 6 päeva jooksul kuni 1,6-kordse kuhjumisega.
English: Fatal pneumonia occurred in 12 of 4,151 patients (3.5 per 1,000 patientyears) receiving Elebrato Ellipta, 5 of 4,134 patients (1.7 per 1,000 patient-years) receiving fluticasone furoate/vilanterol, and 5 of 2,070 patients (2.9 per 1,000 patient-years) receiving umeclidinium/vilanterol.
Estonian: Pneumoonia tõttu suri Elebrato Ellipta't saanud 4151 patsiendist 12 (3,5 juhtu 1000 patsiendiaasta kohta), flutikasoonfuroaati/vilanterooli saanud 4134 patsiendist viis (1,7 juhtu 1000 patsiendiaasta kohta) ja umeklidiiniumi/vilanterooli saanud 2070 patsiendist viis (2,9 juhtu 1000 patsiendiaasta kohta).
English: IMPACT (CTT116855) was a 52-week study (N=10,355) that compared Elebrato Ellipta (92/55/22 micrograms) with fluticasone furoate/vilanterol 92/22 micrograms (FF/VI) and umeclidinium/vilanterol 55/22 micrograms (UMEC/VI).
Estonian: IMPACT (CTT116855) oli 52-nädalane uuring (N = 10 355), kus võrreldi Elebrato Ellipta't (92/55/22 mikrogrammi) flutikasoonfuroaadi/vilanterooliga annuses 92/22 mikrogrammi (FF/VI) ja umeklidiiniumi/vilanterooliga annuses 55/22 mikrogrammi (UMEC/VI).
English: Elebrato Ellipta contains lactose
Estonian: Elebrato Ellipta sisaldab laktoosi
English: Elebrato Ellipta should be used with caution in patients with narrow-angle glaucoma or urinary retention.
Estonian: Elebrato Ellipta't peab ettevaatlikult kasutama patsientidel, kellel esineb suletud nurga glaukoom või uriinipeetus.
English: Treatment with Elebrato Ellipta significantly reduced the annual rate of severe exacerbations by 34% compared with UMEC/VI (95% CI: 22, 44; p<0.001).
Estonian: Ravi Elebrato Ellipta'ga vähendas oluliselt raskete ägenemiste aastast määra, nimelt 34% võrreldes UMEC/VI-ga (95% CI: 22, 44; p < 0,001).
English: If you use too much of this medicine, contact your doctor or pharmacist for advice immediately as you may need medical attention.
Estonian: Kui te kasutate Elebrato Ellipta't rohkem kui ette nähtud Kui te manustate liiga palju ravimit, võtke nõu küsimiseks otsekohe ühendust oma arsti või apteekriga, sest te võite vajada arstiabi.
English: In FULFIL, Elebrato Ellipta significantly decreased the risk of a moderate/severe exacerbation compared with BUD/FOR over 24 weeks (33%; 95% CI: 12, 48; p=0.004).
Estonian: Uuringus FULFIL vähendas Elebrato Ellipta 24 nädala jooksul oluliselt mõõduka/raske ägenemise riski võrreldes BUD/FOR-iga (33%; 95% CI: 12, 48; p = 0,004).
English: What Elebrato Ellipta is and what it is used for
Estonian: Mis ravim on Elebrato Ellipta ja milleks seda kasutatakse
English: Lung function endpoint in FULFIL
Estonian: Kopsufunktsiooni tulemusnäitaja uuringus FULFIL Elebrato
English: FULFIL (CTT116853) was a 24-week study (N=1,810), with an extension up to 52 weeks in a subset of subjects (n=430), that compared Elebrato Ellipta (92/55/22 micrograms) with budesonide/formoterol 400/12 micrograms (BUD/FOR) administered twice-daily.
Estonian: FULFIL (CTT116853) oli 24-nädalane uuring (N = 1810) koos 52-nädalase jätku-uuringuga osalejate ühes alarühmas (n = 430), kus võrreldi Elebrato Ellipta't (92/55/22 mikrogramm) kaks korda ööpäevas manustatud budesoniidi/formoterooliga 400/12 mikrogrammi (BUD/FOR).
English: Study 200812 was a 24-week, non-inferiority study (N=1,055) that compared Elebrato Ellipta (92/55/22 micrograms) with FF/VI (92/22 micrograms) + UMEC (55 micrograms), co-administered once daily as a multi-inhaler therapy in patients with a history of moderate or severe exacerbations within the prior 12 months.
Estonian: Uuring 200812 oli 24-nädalane mittehalvemus-uuring (N = 1055), kus võrreldi Elebrato Ellipta't (92/55/22 mikrogrammi) ja FF/VI (92/22 mikrogrammi) + UMEC (55 mikrogrammi) manustatuna koos, mitme inhalaatoriga üks kord ööpäevas patsientidele, kellel oli anamneesis eelneva 12 kuu jooksul mõõdukas või raske ägenemine.
English: What Elebrato Ellipta contains The active substances are fluticasone furoate, umeclidinium bromide and vilanterol.
Estonian: Mida Elebrato Ellipta sisaldab Toimeained on flutikasoonfuroaat, umeklidiiniumbromiid ja vilanterool.
English: In a 52-week study, with a total of 10,355 patients with COPD and a history of moderate or severe exacerbations within the prior 12 months (mean post-bronchodilator screening FEV1 46% of predicted, SD 15%) (study CTT116855), the incidence of pneumonia was 8% (317 patients) for Elebrato Ellipta (n = 4,151), 7% (292 subjects) for fluticasone furoate/vilanterol (n = 4,134), and 5% (97 subjects) for umeclidinium/vilanterol (n = 2,070).
Estonian: 52-nädalases uuringus, kus osales kokku 10 355 KOKiga patsienti, kellel oli anamneesis eelnenud 12 kuul mõõdukas või raske ägenemine (keskmine bronhodilataatori manustamise järgne FEV1 sõelumisel 46% eeldatavast normist, SD 15%) (uuring CTT116855), oli pneumoonia tekkesagedus Elebrato Ellipta'ga (n = 4151) 8% (317 patsienti), flutikasoonfuroaadi/vilanterooliga (n = 4134) 7% (292 osalejat) ja umeklidiiniumi/vilanterooliga (n = 2070) 5% (97 osalejat).