FrancophonIA/ELRC3.0 huggingface dataset:
English: There were no effects on development in rats at exposures 6.6fold the human clinical exposure at a daily dose of 92 micrograms, based on AUC.
Estonian: Puudus toime rottide arengule ekspositsiooni väärtuste juures, mis olid AUC-i põhjal 6,6 korda suuremad 92-mikrogrammise ööpäevase annuse manustamise järgsetest kliinilise ekspositsiooni väärtustest inimestel.
English: Rinsing your mouth out with water immediately after using Trelegy Ellipta may help prevent this side effect.
Estonian: Seda kõrvaltoimet võib aidata vältida suu loputamine veega vahetult pärast Trelegy Ellipta kasutamist;
English: Following repeat dosing of inhaled umeclidinium, steady state was achieved within 7 to 10 days with 1.5 to 2-fold accumulation.
Estonian: Pärast inhaleeritava umeklidiiniumi korduvat manustamist saavutati tasakaalukontsentratsiooni seisund 7...10 päeva jooksul 1,5...2-kordse kuhjumisega.
English: How to use Trelegy Ellipta 4.
Estonian: Kuidas Trelegy Ellipta't kasutada 4.
English: Trelegy Ellipta significantly improved (p<0.001) Health Related Quality of Life (as measured by the St George's Respiratory Questionnaire [SGRQ] total score) in both FULFIL (week 24) when compared with BUD/FOR (-2.2 units; 95% CI: -3.5, -1.0) and IMPACT (week 52) when compared with FF/VI (-1.8 units; 95% CI: -2.4, -1.1) and UMEC/VI (-1.8 units; 95% CI: -2.6, -1.0).
Estonian: Trelegy Ellipta parandas tervisega seotud elukvaliteeti (mõõdetuna St. George'i hingamisteede küsimustiku [SGRQ] koguskoori abil) oluliselt (p < 0,001) nii uuringus FULFIL (24. nädal) võrreldes BUD/FOR-iga (2,2 ühikut; 95% CI: -3,5; -1,0) kui ka uuringus IMPACT (52. nädal) võrreldes FF/VI (-1,8 ühikut; 95% CI:2,4; -1,1) ja UMEC/VI-ga (-1,8 ühikut; 95% CI: -2,6; -1,0).
English: In vitro studies showed that vilanterol is primarily metabolised by cytochrome P450 3A4 (CYP3A4) and is a substrate for the P-gp transporter.
Estonian: In vitro uuringud on näidanud, et vilanterool metaboliseerub peamiselt tsütokroom P450 3A4 (CYP3A4) vahendusel ning on P-gp transporteri substraat.
English: Breathlessness was measured using the Transition Dyspnoea Index (TDI) focal score at week 24 in FULFIL and week 52 in IMPACT (a subset of patients, n=5,058).
Estonian: Hingelduse hindamiseks kasutati uuringus FULFIL 24. nädalal ja uuringus IMPACT 52. nädalal (patsientide alarühm, n = 5058) düspnoe muutuse indeksi (TDI) koondskoori.
English: TQT studies for FF/VI and umeclidinium/vilanterol (UMEC/VI) did not show clinically relevant effects on QT interval at clinical doses of FF, UMEC and VI.
Estonian: FF/VI ja umeklidiiniumi/vilanterooli (UMEC/VI) TQT uuringud ei näidanud kliiniliselt olulist toimet QT-intervallile flutikasoonfuroaadi, umeklidiiniumi ja vilanterooli kliiniliselt kasutatavate annuste manustamisel.
English: In IMPACT, over 52 weeks, Trelegy Ellipta significantly reduced (p<0.001) the annual rate of moderate/severe exacerbations by 15% (95% CI:10, 20) compared with FF/VI (rate; 0.91 vs 1.07 events per patient year) and by 25% (95% CI: 19, 30) compared with UMEC/VI (rate; 0.91 vs 1.21 events per patient year).
Estonian: Uuringus IMPACT vähendas Trelegy Ellipta 52 nädala jooksul oluliselt (p < 0,001) mõõdukate/raskete ägenemiste aastast määra: 15% (95% CI: 10, 20) võrreldes FF/VI-ga (määr; 0,91 vs. 1,07 juhtu patsiendiaasta kohta) ja 25% (95% CI: 19, 30) võrreldes UMEC/VI-ga (määr; 0,91 vs. 1,21 juhtu patsiendiaasta kohta).
English: In IMPACT, the proportion of responders was also significantly higher (p<0.001) for Trelegy Ellipta (36%) compared with FF/VI (29%; OR 1.36; 95% CI: 1.19, 1.55) and UMEC/VI (30%; OR 1.33; 95% CI: 1.13, 1.57).
Estonian: Uuringus IMPACT oli ravivastuse saavutanute osakaal samuti Trelegy Ellipta'ga oluliselt suurem (p < 0,001; 36%) kui FF/VI (29%; OR 1,36; 95% CI: 1,19; 1,55) ja UMEC/VI-ga (30%; OR 1,33; 95% CI: 1,13; 1,57).
English: In Study 200812, Trelegy Ellipta was non-inferior compared with FF/VI+UMEC, co-administered in two inhalers, in the improvement from baseline in trough FEV1 at week 24.
Estonian: Uuringu 200812 nädalal 24 ei olnud Trelegy Ellipta FEV1 parandamisel algväärtustest halvem kui FF/VI+UMEC (manustatuna koos, kahe inhalaatoriga).
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING BUNDLE LABEL (WITH BLUE BOX- MULTIPACK)
Estonian: VÄLISPAKENDIL PEAVAD OLEMA JÄRGMISED ANDMED VÄLISKARP (BLUE BOX'IGA - AINULT MITMIKPAKEND)
English: Trelegy Ellipta should be administered with caution in patients with pulmonary tuberculosis or in patients with chronic or untreated infections.
Estonian: Trelegy Ellipta't peab ettevaatlikult kasutama kopsutuberkuloosi või krooniliste või ravimata infektsioonidega patsientidel.
English: In vitro studies showed that fluticasone furoate is primarily metabolised by cytochrome P450 3A4 (CYP3A4) and is a substrate for the P-gp transporter.
Estonian: In vitro uuringud on näidanud, et flutikasoonfuroaat metaboliseerub peamiselt tsütokroom P450 3A4 (CYP3A4) vahendusel ja on P-gp transporteri substraat.
English: The second study included safety data from 527 patients with COPD who received fluticasone furoate/umeclidinium/vilanterol (92/55/22 micrograms) and 528 patients with COPD who received fluticasone furoate/vilanterol (92/22 micrograms) + umeclidinium (55 micrograms) once daily for up to 24 weeks (study 200812).
Estonian: Teine uuring hõlmas ohutusandmeid 527-lt KOKiga patsiendilt, kes said flutikasoonfuroaati/umeklidiiniumi/vilanterooli (92/55/22 mikrogrammi), ja 528-lt KOKiga patsiendilt, kes said flutikasoonfuroaati/vilanterooli (92/22 mikrogrammi) + umeklidiiniumi (55 mikrogrammi) üks kord ööpäevas kuni 24 nädalat (uuring 200812).
English: ONCE DAILY
Estonian: Aeg-ajalt
English: The dose counter will appear completely red if the cover is opened again.
Estonian: Katte uuesti avamisel muutub annuselugeja täiesti punaseks.
English: In FULFIL the proportion of responders according to TDI (defined as at least 1 unit) was significantly higher (p<0.001) for Trelegy Ellipta compared with BUD/FOR (61% vs 51%; OR 1.61; 95% CI: 1.33, 1.95).
Estonian: Uuringus FULFIL oli TDI järgi ravivastuse (määratletud kui vähemalt üks ühik) saavutanute osakaal Trelegy Ellipta'ga oluliselt suurem (p < 0,001) kui BUD/FOR-iga (61% vs. 51%; OR 1,61; 95% CI: 1,33; 1,95).
English: The pharmacologic effects of beta2-adrenergic agonists, including vilanterol, are at least in part attributable to stimulation of intracellular adenylate cyclase, the enzyme that catalyses the conversion of adenosine triphosphate (ATP) to cyclic-3',5'-adenosine monophosphate (cyclic AMP).
Estonian: See on ensüüm, mis katalüüsib adenosiintrifosfaadi (ATP) konversiooni tsükliliseks 3',5'-adenosiinmonofosfaadiks (tsükliline AMP).
English: c) Close the inhaler and rinse your mouth
Estonian: c) Inhalaatori sulgemine ja suu loputamine
English: In IMPACT, treatment with Trelegy Ellipta reduced the annual rate of severe exacerbations (i.e., requiring hospitalisation or resulting in death) by 13% compared with FF/VI (95% CI: -1, 24; p=0.064).
Estonian: Uuringus IMPACT vähendas ravi Trelegy Ellipta'ga raskete (st haiglaravi vajate või surmaga lõppevate) ägenemiste aastast määra 13% võrreldes FF/VI-ga (95% CI: -1, 24; p = 0,064).
English: Your lips fit over the contoured shape of the mouthpiece for inhaling.
Estonian: Inhaleerimise ajal sobituvad teie huuled huuliku kontuurse kujuga.
English: There was no increase in tumour incidence in rats or mice at exposures 0.9- or 22-fold, respectively, the human clinical exposure of vilanterol at a daily dose of 22 micrograms based on AUC.
Estonian: Rottidel või hiirtel ei täheldatud kasvajate esinemissageduse suurenemist ekspositsiooni väärtuste juures, mis olid AUC-i põhjal vastavalt 0,9 ja 22 korda suuremad vilanterooli 22-mikrogrammise ööpäevase annuse manustamise järgsetest kliinilise ekspositsiooni väärtustest inimestel.
English: Viral respiratory tract infection
Estonian: Hingamisteede viirusinfektsioon
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 Trelegy 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: Upon initiation of treatment with Trelegy Ellipta, plasma glucose should be monitored more closely in diabetic patients.
Estonian: Suhkurtõvega patsientidel tuleb pärast Trelegy Ellipta'ga ravi alustamist sagedamini jälgida vere glükoosisisaldust.
English: In vitro studies showed that umeclidinium is primarily metabolised by cytochrome P450 2D6 (CYP2D6) and is a substrate for the P-gp transporter.
Estonian: In vitro uuringud on näidanud, et umeklidiinium metaboliseerub peamiselt tsütokroom P450 2D6 (CYP2D6) vahendusel ning on P-gp transporteri substraat.
English: Umeclidinium
Estonian: Umeklidiinium
English: A higher percentage of patients receiving Trelegy Ellipta responded with a clinically meaningful improvement in SGRQ total score in FULFIL at week 24 compared with BUD/FOR (50% and 41% respectively), odds ratios of response vs. non-response (OR) (1.41; 95% CI: 1.16, 1.70) and in IMPACT at week 52 compared with FF/VI and UMEC/VI (42%, 34% and 34% respectively), OR vs. FF/VI (1.41; 95% CI:1.29, 1.55) and OR vs. UMEC/VI (1.41; 95% CI: 1.26, 1.57); all treatment comparisons were statistically significant (p<0.001).
Estonian: Nende patsientide protsent, kelle SGRQ koguskoor paranes kliiniliselt oluliselt, oli Trelegy Ellipta't saanute hulgas suurem esiteks uuringus FULFIL 24. nädalal võrreldes BUD/FOR-i saanutega (vastavalt 50% ja 41%), ravivastuse olemasolu vs. puudumise riskisuhted (OR) (1,41, 95% CI: 1,16; 1,70), ning teiseks uuringus IMPACT 52. nädalal võrreldes FF/VI ja UMEC/VI-ga (vastavalt 42%, 34% ja 34%), OR vs. FF/VI (1,41; 95% CI: 1,29; 1,55) ja OR vs. UMEC/VI (1,41; 95% CI: 1,26; 1,57); kõigi ravide võrdlused olid statistiliselt olulised (p < 0,001).
English: When you are ready to use your inhaler, peel back the lid to open the tray.
Estonian: Kui olete valmis inhalaatorit kasutama, eemaldage aluselt kate.
English: If you stop using Trelegy Ellipta
Estonian: Kui te lõpetate Trelegy Ellipta kasutamise
English: Umeclidinium was not genotoxic in a standard battery of studies and was not carcinogenic in lifetime inhalation studies in mice or rats at exposures ≥ 20- or ≥ 17- fold the human clinical exposure at a daily dose of 55 micrograms umeclidinium, based on AUC respectively.
Estonian: Umeklidiinium ei olnud genotoksiline standardsetes uuringutes ega kartsinogeenne eluaegse inhalatsiooni uuringutes hiirtel või rottidel ekspositsiooni väärtuste juures, mis on AUC-i põhjal vastavalt  20 ja  17 korda suuremad umeklidiiniumi 55-mikrogrammise ööpäevase annuse manustamise järgsetest kliinilise ekspositsiooni väärtustest inimestel.
English: Cough Oropharyngeal pain
Estonian: Köha Orofarüngeaalne valu
English: In FULFIL, Trelegy Ellipta significantly reduced (p<0.001) the use of rescue medication between weeks 1-24 compared with BUD/FOR (treatment difference: -0.2 occasions per day; 95% CI: -0.3, -0.1).
Estonian: Uuringus FULFIL vähendas Trelegy Ellipta 1. ja 24. nädala võrdluses oluliselt (p < 0,001) hooravimi kasutamist võrreldes BUD/FOR-iga (ravierinevus: -0,2 juhtu päeva kohta; 95% CI: -0,3; -0,1).
English: Dysphonia
Estonian: Düsfoonia
English: In IMPACT, Trelegy Ellipta statistically significantly reduced the mean number of nighttime awakenings due to COPD compared with FF/VI (-0.05; 95% CI: -0.08, -0.01; p=0.005) and with UMEC/VI (-0.10; 95% CI: -0.14, -0.05; p<0.001) at weeks 49 to 52.
Estonian: Uuringus IMPACT vähendas Trelegy Ellipta 49.-52. nädalal öiseid KOKi tõttu ärkamisi statistiliselt oluliselt võrreldes FF/VI (-0,05; 95% CI: -0,08; -0,01; p = 0,005) ja UMEC/VI-ga (-0,10; 95% CI: -0,14; -0,05; p < 0,001).
English: This corresponds to a pre-dispensed dose of 100 micrograms fluticasone furoate, 74.2 micrograms umeclidinium bromide equivalent to 62.5 micrograms umeclidinium and 25 micrograms vilanterol (as trifenatate).
Estonian: See vastab 100 mikrogrammi flutikasoonfuroaadi, 74,2 mikrogrammi umeklidiiniumbromiidi (vastab 62,5 mikrogrammile umeklidiiniumile) ja 25 mikrogrammi vilanterooli (trifenataadina) mõõdetud annusele.
English: The first study included safety data from 911 patients with COPD who received fluticasone furoate/umeclidinium/vilanterol 92/55/22 micrograms, once daily, for up to 24 weeks, of whom 210 patients received fluticasone furoate/umeclidinium/vilanterol 92/55/22 micrograms once daily for up to 52 weeks, with an active comparator (study CTT116853, FULFIL).
Estonian: Esimene uuring hõlmas ohutusandmeid aktiivse võrdlusravimiga kontrollitud uuringus osalenud 911-lt KOKiga patsiendilt, kes said flutikasoonfuroaati/umeklidiiniumi/vilanterooli 92/55/22 mikrogrammi üks kord ööpäevas kuni 24 nädala jooksul ja kellest 210 patsienti said flutikasoonfuroaati/umeklidiiniumi/vilanterooli 92/55/22 mikrogrammi üks kord ööpäevas kuni 52 nädala jooksul (uuring CTT116853, FULFIL).
English: There are limited data from the use of fluticasone furoate/umeclidinium/vilanterol in pregnant women.
Estonian: Flutikasoonfuroaadi/umeklidiiniumi/vilanterooli kasutamise kohta rasedatel on andmeid piiratud hulgal.
English: NAME OF THE MEDICINAL PRODUCT Trelegy Ellipta 92/55/22 mcg inhalation powder fluticasone furoate/umeclidinium/vilanterol
Estonian: Trelegy Ellipta 92/55/22 µg inhalatsioonipulber fluticasonum furoas/umeclidinium/vilanterolum
English: The proportion of responders during weeks 21-24 was significantly higher (p<0.001) for patients treated with Trelegy Ellipta compared with BUD/FOR (47% and 37% respectively; OR 1.59; 95% CI: 1.30, 1.94).
Estonian: 21.-24. nädalal oli Trelegy Ellipta'ga ravitud patsientide seas ravivastuse saavutanute osakaal oluliselt suurem (p < 0,001) kui BUD/FOR-iga ravitud patsientide seas (vastavalt 47% ja 37%; OR 1,59; 95% CI: 1,30; 1,94).
English: Do not open the tray until you are ready to inhale a dose of your medicine.
Estonian: Ärge avage alust enne, kui olete valmis ravimi annust inhaleerima.
English: The “Discard by” date should be written on the inhaler label and carton in the space provided.
Estonian: Inhalaatori etiketile ja karbile tuleb selleks ettenähtud kohta kirjutada „Kasutada kuni“ kuupäev.
English: Not for acute use
Estonian: Mitte kasutada ägedate episoodide raviks
English: No clinically relevant effects of hypokalaemia were observed in clinical studies with Trelegy Ellipta at the recommended therapeutic dose.
Estonian: Trelegy Ellipta kliinilistes uuringutes ei ole soovitatava terapeutilise annuse kasutamisel täheldatud kliiniliselt olulist hüpokaleemilist toimet.
English: How to store Trelegy Ellipta 6.
Estonian: Kuidas Trelegy Ellipta't säilitada 6.
English: Following inhaled administration of fluticasone furoate/umeclidinium/vilanterol in healthy subjects, vilanterol Cmax occurred at 7 minutes.
Estonian: Pärast flutikasoonfuroaadi/umeklidiiniumi/vilanterooli inhalatsiooni teel manustamist tervetele isikutele saabus vilanterooli Cmax 7 minuti pärast.
English: The inhaler is packaged in a tray containing a desiccant sachet, to reduce moisture.
Estonian: Inhalaator on pakendatud alusele, mis sisaldab niiskuse sidumiseks desikandi pakikest.
English: Following inhaled administration of fluticasone furoate/umeclidinium/vilanterol in healthy subjects, fluticasone furoate Cmax occurred at 15 minutes.
Estonian: Pärast flutikasoonfuroaadi/umeklidiiniumi/vilanterooli inhalatsiooni teel manustamist tervetele isikutele saabus flutikasoonfuroaadi Cmax 15 minuti pärast.
English: How to use Trelegy Ellipta
Estonian: Kuidas Trelegy Ellipta't kasutada
English: In IMPACT, the proportion of patients who were CAT responders at week 52 was significantly higher (p<0.001) for patients treated with Trelegy Ellipta (42%) compared with FF/VI (37%; OR 1.24; 95% CI: 1.14, 1.36) and UMEC/VI (36%; OR 1.28; 95% CI: 1.15, 1.43).
Estonian: Uuringus IMPACT oli 52. nädalaks CAT-i järgi ravivastuse saavutanute osakaal Trelegy Ellipta'ga ravitud patsientide seas oluliselt suurem (p < 0,001; 42%) kui FF/VI-ga ravitud (37%; OR 1,24; 95% CI: 1,14; 1,36) ja UMEC/VI-ga ravitud patsientide seas (36%; OR 1,28; 95% CI: 1,15; 1,43).
English: When given subcutaneously there were no effects at exposures 62-fold the human clinical exposure at a daily dose of 22 micrograms, based on AUC.
Estonian: Subkutaansel manustamisel puudusid toimed ekspositsiooni väärtuste juures, mis olid AUC-i põhjal 62 korda suuremad 22-mikrogrammise ööpäevase annuse manustamise järgsetest kliinilise ekspositsiooni väärtustest inimestel.
English: What Trelegy Ellipta is used for
Estonian: Milleks Trelegy Ellipta't kasutatakse
English: Fractures
Estonian: Luumurrud
English: NAME OF THE MEDICINAL PRODUCT Trelegy Ellipta 92 micrograms/55 micrograms/22 micrograms inhalation powder, pre-dispensed
Estonian: Trelegy Ellipta 92 mikrogrammi/55 mikrogrammi/22 mikrogrammi annustatud inhalatsioonipulber
English: In FULFIL, the proportion of patients who were CAT responders (defined as 2 units below baseline or lower) at week 24, was significantly higher (p<0.001) for patients treated with Trelegy Ellipta compared with BUD/FOR (53% vs. 45%; OR 1.44; 95% CI: 1.19, 1.75).
Estonian: Uuringus FULFIL oli 24. nädalaks CAT-i järgi (määratletud kui kaks või rohkem ühikut alla algväärtuse) ravivastuse saavutanute osakaal Trelegy Ellipta'ga ravitud patsientide seas oluliselt suurem (p < 0,001) kui BUD/FOR-iga ravitud patsientide seas (53% vs. 45%; OR 1,44; 95% CI: 1,19; 1,75).
English: Rinse your mouth with water after you have used the inhaler, do not swallow.
Estonian: Pärast inhalaatori kasutamist loputage suud veega, kuid ärge vett alla neelake.
English: 1 inhaler of 30 doses
Estonian: Üks 14 annusega inhalaator Üks 30 annusega inhalaator
English: The effects of race, gender and weight on the pharmacokinetics of fluticasone furoate, umeclidinium and vilanterol were also evaluated in the population pharmacokinetic analysis.
Estonian: Üldkogumi farmakokineetilises analüüsis hinnati ka rassi, soo ja kehakaalu mõju flutikasoonfuroaadi, umeklidiiniumi ja vilanterooli farmakokineetikale.
English: Treatment with Trelegy Ellipta should be discontinued immediately if paradoxical bronchospasm occurs.
Estonian: Paradoksaalse bronhospasmi tekkimisel tuleb ravi Trelegy Ellipta'ga otsekohe lõpetada.
English: If you get tightness of the chest, coughing, wheezing or breathlessness immediately after using your Trelegy Ellipta inhaler:
Estonian: Vahetult pärast ravimi manustamist tekkivad hingamisraskused Kui teil tekib vahetult pärast Trelegy Ellipta inhalaatori kasutamist pingetunne rindkeres, köha, vilistav hingamine või hingeldus:
English: Cardiovascular effects, such as cardiac arrhythmias, e.g. atrial fibrillation and tachycardia, may be seen after the administration of muscarinic receptor antagonists and sympathomimetics, including umeclidinium and vilanterol, respectively.
Estonian: Muskariiniretseptorite antagonistide ja sümpatomimeetikumide (sh vastavalt umeklidiiniumi ja vilanterooli) kasutamisel on täheldatud kardiovaskulaarseid toimeid, näiteks südame rütmihäireid nagu kodade virvendusarütmia ja tahhükardia.
English: METHOD AND ROUTE(S) OF ADMINISTRATION Inhalation use,
Estonian: MANUSTAMISVIIS JA -TEE(D)
English: Following inhaled administration of fluticasone furoate/umeclidinium/vilanterol in healthy subjects, umeclidinium Cmax occurred at 5 minutes.
Estonian: Pärast flutikasoonfuroaadi/umeklidiiniumi/vilanterooli inhalatsiooni teel manustamist tervetele isikutele saabus umeklidiiniumi Cmax 5 minuti pärast.
English: Trelegy Ellipta 92 micrograms/55 micrograms/22 micrograms inhalation powder, pre-dispensed fluticasone furoate/umeclidinium/vilanterol
Estonian: Trelegy Ellipta 92 mikrogrammi/55 mikrogrammi/22 mikrogrammi annustatud inhalatsioonipulber flutikasoonfuroaat/umeklidiinium/vilanterool
English: PHARMACEUTICAL FORM AND CONTENTS Inhalation powder, pre-dispensed 1 inhaler of 30 doses.
Estonian: Annustatud inhalatsioonipulber Üks 30 annusega inhalaator.
English: The effect of fluticasone furoate/umeclidinium/vilanterol on the QT interval has not been evaluated in a thorough QT (TQT) study.
Estonian: Põhjalikus QT (TQT) uuringus ei ole hinnatud flutikasoonfuroaadi/umeklidiiniumi/vilanterooli toimet QT-intervallile.
English: After inhalation, patients should rinse their mouth with water without swallowing.
Estonian: 6.6 Erihoiatused ravimpreparaadi hävitamiseks ja käsitlemiseks Pärast inhalatsiooni peavad patsiendid suud veega loputama ilma vett alla neelamata.
English: Therefore, Trelegy Ellipta should be used with caution in patients with unstable or life-threatening cardiovascular disease.
Estonian: Seetõttu peab ebastabiilse või eluohtliku kardiovaskulaarse haigusega patsientidel Trelegy Ellipta't kasutama ettevaatlikult.
English: Lung function endpoint in FULFIL
Estonian: Kopsufunktsiooni tulemusnäitaja uuringus FULFIL Trelegy
English: FEV1= forced expiratory volume in 1 second; L= litres; LS=least squares; SE= standard error; N= number in the intentto-treat population; CI= confidence interval; a Statistically significant treatment differences for FF/UMEC/VI vs. FF/VI and FF/UMEC/VI vs. UMEC/VI were also observed at the other assessment timepoints (Weeks 4, 16, 28, and 40).
Estonian: Statistiliselt olulist ravierinevust FF/UMEC/VI vs. FF/VI ja FF/UMEC/VI vs. UMEC/VI täheldati ka hindamise teistes ajapunktides (4., 16., 28. ja 40. nädalal).
English: See ‘Step-by-step instructions' in this leaflet for full information.
Estonian: Kuidas inhalaatorit kasutada Täieliku informatsiooni saamiseks vt „Üksikasjalik juhend“ käesolevas infolehes.
English: How to store Trelegy Ellipta
Estonian: Kuidas Trelegy Ellipta't säilitada
English: Lung Function
Estonian: Kopsufunktsioon
English: Use of Rescue Medication
Estonian: RAVIMI VÄLJASTAMISTINGIMUSED
English: Umeclidinium has not been evaluated in patients with severe hepatic impairment.
Estonian: Raske maksakahjustusega patsientidel ei ole umeklidiiniumi kasutamist hinnatud.
English: FEV1=forced expiratory volume in 1 second; L=litres; LS=least squares; SE= standard error, N=number in the intent-totreat population; CI= confidence interval, a Statistically significant treatment difference for FF/UMEC/VI vs. BUD/FOR also observed at the other assessment timepoints (weeks 2, 4 and 12).
Estonian: FEV1 = forsseeritud ekspiratoorne sekundimaht, L = liitrid, LS = vähimruudud, SE = standardviga, N = ravikavatsuse kohase üldkogumi arv, CI = usaldusintervall.
English: Step-by-step instructions
Estonian: Üksikasjalik juhend
English: Multipack of 90 (3 packs of 30) dose inhalers.
Estonian: Mitmikpakendis on 90 annust (kolm 30 annusega pakendit).
English: Each delivered dose contains 92 micrograms of fluticasone furoate, 55 micrograms of umeclidinium (equivalent to 65 micrograms umeclidinium bromide) and 22 micrograms of vilanterol (as trifenatate).
Estonian: Üks inhaleeritav annus sisaldab 92 mikrogrammi flutikasoonfuroaati, 55 mikrogrammi umeklidiiniumi (vastab 65 mikrogrammile umeklidiiniumbromiidile) ja 22 mikrogrammi vilanterooli (trifenataadina).
English: No clinically relevant differences requiring dose adjustment based on race, gender or weight were observed in fluticasone furoate, umeclidinium or vilanterol systemic exposure.
Estonian: Flutikasoonfuroaadi, umeklidiiniumi ega vilanterooli süsteemse ekspositsiooni juures ei täheldatud rassist, soost või kehakaalust tingitud kliiniliselt olulisi erinevusi, mis nõuaksid annuse kohandamist.
English: Each single inhalation provides a delivered dose (the dose leaving the mouthpiece) of 92 micrograms of fluticasone furoate, 65 micrograms umeclidinium bromide equivalent to 55 micrograms umeclidinium and 22 micrograms of vilanterol (as trifenatate).
Estonian: Üks pihustatud inhaleeritav annus (huuliku kaudu väljuv annus) sisaldab 92 mikrogrammi flutikasoonfuroaati, 65 mikrogrammi umeklidiiniumbromiidi (vastab 55 mikrogrammile umeklidiiniumile) ja 22 mikrogrammi vilanterooli (trifenataadina).
English: Dose counter
Estonian: Aluse kate
English: • infection of the upper airways
Estonian: • ülemiste hingamisteede infektsioon;
English: Constipation
Estonian: Suukuivus
English: or
Estonian: a