FrancophonIA/ELRC3.0 huggingface dataset:
English: In a 24 week study (HZA113091) in adult and adolescent patients with uncontrolled persistent asthma both fluticasone furoate/vilanterol 92/22 micrograms given once daily in the evening and salmeterol/FP 50/250 micrograms given twice daily demonstrated improvements from baseline in lung function.
Estonian: 24-nädalases uuringus (HZA113091) püsiva astmaga täiskasvanutel ja noorukitel, kelle astmanähud ei olnud kontrolli all, demonstreeriti nii flutikasoonfuroaadi/vilanterooli 92/22 mikrogrammi manustamisel üks kord ööpäevas õhtuti kui salmeterooli/FP 50/250 mikrogrammi manustamisel kaks korda päevas kopsufunktsiooni paranemist ravieelsega võrreldes.
English: 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.
Estonian: Uuringus HZA106837 randomiseeriti patsiendid saama kas flutikasoonfuroaati/vilanterooli annuses 92/22 mikrogrammi [n=1009] või flutikasoonfuroaati annuses 92 mikrogrammi [n=1010], mida mõlemat manustati üks kord ööpäevas.
English: Subjects used salbutamol on an as-needed basis throughout the studies.
Estonian: Uuringute kestel kasutasid uuritavad salbutamooli vastavalt vajadusele.
English: Uncommon side effects This may affect up to 1 in 100 people:
Estonian: Aeg-ajalt esinevad kõrvaltoimed See võib tekkida kuni ühel inimesel sajast:
English: For trough FEV1 subjects in the fluticasone furoate/vilanterol group achieved a LS mean change from baseline of 281 mL and subjects in the salmeterol/FP group a change of 300 mL; (the difference in adjusted mean of -19 mL (95%CI:-0.073, 0.034) was not statistically significant (p=0.485).
Estonian: Minimaalse FEV1 osas saavutasid flutikasoonfuroaadi/vilanterooli grupi uuritavad vähimruutude (LS) keskmise muutuse 281 ml ravieelsega võrreldes ning salmeterooli/FP grupi uuritavatel oli vastav muutus 300 ml; kohandatud keskmise väärtuse erinevus -19 ml (95% CI: -0,073, 0,034) ei olnud statistiliselt oluline (p=0,485).
English: Glaxo Operations UK Limited (trading as Glaxo Wellcome Operations), Harmire Road,
Estonian: Glaxo Operations UK Limited (tootmistegevus kui GlaxoWellcome Operations), Harmire Road,
English: • heart beating faster (tachycardia)
Estonian: • kiirenenud südametegevus (tahhükardia)
English: Fluticasone furoate/vilanterol 92/22 micrograms increased trough FEV1 by 46 mL compared to vilanterol (95% CI: 8, 83mL, p= 0.017).
Estonian: Flutikasoonfuroaadi/vilanterooli 92/22 mikrogrammi toimel suurenes minimaalne FEV1 vilanterooliga võrreldes 46 ml võrra (95% CI: 8, 83 ml, p=0,017).
English: Subjects were then randomized to receive either fluticasone furoate/vilanterol 92/22 micrograms, fluticasone furoate 92 micrograms, vilanterol 22 micrograms, or placebo, and treated for a mean of 1.7 years (SD = 0.9 years).
Estonian: Seejärel randomiseeriti uuritavad kasutama kas flutikasoonfuroaati/vilanterooli 92/22 g annust, flutikasoonfuroaadi 92 g annust, vilanterooli 22 g annust või platseebot ning uuritavad kasutasid ravi keskmiselt 1,7 aastat (SD = 0,9 aastat).
English: In an integrated analysis of both studies, fluticasone furoate/vilanterol 92/22 micrograms showed clinically meaningful improvements in lung function.
Estonian: Mõlema uurigu kombineeritud analüüs näitas kopsufunktsiooni kliiniliselt märkimisväärset paranemist flutikasoonfuroaadi/vilanterooli 92/22 mikrogrammi kasutamisel.
English: 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
Estonian: Kõikidel patsientidel pidi olema skriiningu ajal suitsetamise anamnees vähemalt 10 pakkaastat; salbutamooli manustamise järgne FEV1/FVC suhe ≤0,70; salbutamooli manustamise järgne FEV1 ≤70% eeldatavast normist ning mMRC (Modified Medical Research Council) düspnoe skoor ≥2 (skaalal 0...4).
English: How to store Relvar Ellipta
Estonian: Kuidas Relvar Ellipta't säilitada
English: The recommended dose to treat COPD is one inhalation (92 micrograms of fluticasone furoate and 22 micrograms of vilanterol) once daily at the same time each day.
Estonian: Soovitatav annus KOKi raviks on üks inhalatsioon (92 mikrogrammi flutikasoonfuroaati ja 22 mikrogrammi vilanterooli) üks kord ööpäevas, iga päev samal kellaajal.
English: Improvements were also seen in this subgroup at week 52 when comparing the fluticasone furoate/vilanterol 92/22 micrograms vs. vilanterol 22 micrograms in adjusted mean trough FEV1 (44 mL 95% CI: 15, 73mL, (p=0.003)).
Estonian: Paranemist täheldati selles alagrupis ka 52. nädalal, kui võrreldi 92/22 mikrogrammi flutikasoonfuroaadi/vilanterooli ja 22 mikrogrammi vilanterooli toimet minimaalse FEV1 väärtuse kohandatud keskmisele (44 ml 95% CI: 15, 73 ml, p=0,003).
English: Asthma-related adverse events and exacerbations may occur during treatment with fluticasone furoate/vilanterol.
Estonian: Flutikasoonfuroaadi/vilanterooli kasutamise ajal võivad tekkida astmaga seotud kõrvaltoimed ja ägenemised.
English: Metabolism and nutrition disorders
Estonian: Ainevahetus- ja toitumishäired Hüperglükeemia
English: • Rinse your mouth with water after you have used the inhaler, do not swallow.
Estonian: • Pärast inhalaatori kasutamist loputage suud veega, mitte alla neelata.
English: Tray
Estonian: Ravi
English: There is no relevant use of Relvar Ellipta in the paediatric population for the indication of COPD.
Estonian: Puudub Relvar Ellipta asjakohane kasutus lastel KOKi näidustusel.
English: Fluticasone furoate/vilanterol
Estonian: Flutikasoonfuroaat/vilanterool
English: There was no effect of race on pharmacokinetic parameter estimates of vilanterol in subjects with COPD.
Estonian: Puudus rassi mõju vilanterooli farmakokineetilistele näitajatele KOKiga uuritavatel.
English: Change from baseline in the percentage of rescue-free 24 hour periods during the 24-week treatment period was a powered secondary.
Estonian: Teiseseks tulemusnäitajaks oli hooravimi vabade 24-tunniste perioodide protsendi muutus ravieelsega võrreldes 24-nädalase raviperioodi jooksul.
English: If you store in a refrigerator, allow the inhaler to return to room temperature for at least an hour before use.
Estonian: Kui hoiate inhalaatorit külmkapis, laske sellel enne kasutamist vähemalt tunni aja jooksul saavutada toatemperatuur.
English: When you are ready to use your inhaler, peel back the lid to open the tray.
Estonian: Kui olete valmis annust inhaleerima, avage kaas.
English: HZA106829 was 24 weeks in duration and evaluated the efficacy of fluticasone furoate/vilanterol 184/22 micrograms [n=197] and FF 184 micrograms [n=194]) both administered once daily compared with FP 500 micrograms twice daily [n=195].
Estonian: HZA106829 oli 24-nädalane uuring, mis hindas üks kord ööpäevas manustatud flutikasoonfuroaadi/vilanterooli 184/22 mikrogrammi [n=197] ja FF 184 mikrogrammi [n=194] efektiivsust võrreldes kaks korda ööpäevas manustatud 500 mikrogrammi FP-ga [n=195].
English: 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).
Estonian: Uuringute HZC102970 ja HZC102871 kombineeritud analüüs 52. nädalal näitas kohandatud keskmise minimaalse FEV1 paranemist (42 ml 95% CI: 19, 64 ml, p<0,001), kui 92/22 mikrogrammi flutikasoonfuroaati/vilanterooli võrreldi 22 mikrogrammi vilanterooliga.
English: HZC112207 evaluated the efficacy of fluticasone furoate/vilanterol 92/22 micrograms [n=204] and fluticasone furoate/vilanterol 184/22 micrograms [n=205] compared with FF 92 micrograms [n=204], FF 184 micrograms [n=203] and vilanterol 22 micrograms [n=203] and placebo [n = 205], all administered once daily.
Estonian: Uuringus HZC112207 hinnati flutikasoonfuroaadi/vilanterooli 92/22 mikrogrammi [n=204] ja flutikasoonfuroaadi/vilanterooli 184/22 mikrogrammi [n=205] efektiivsust võrreldes FF 92 mikrogrammi [n=204], FF 184 mikrogrammi [n=203] ja vilanterooli 22 mikrogrammi [n=203] ning platseeboga [n=205], mida kõiki manustati üks kord ööpäevas.
English: • sore, raised patches in the mouth or throat caused by a fungal infection (candidiasis).
Estonian: • valulikud, ümbritsevast kõrgemad laigud suus või kurgus, mille põhjuseks on seennakkus
English: • patients not adequately controlled with inhaled corticosteroids and 'as needed' inhaled short acting beta2-agonists.
Estonian: • patsientidel, kellel inhaleeritavad kortikosteroidid ja „vastavalt vajadusele“ inhaleeritavad lühitoimelised beeta2-agonistid ei taga piisavat kontrolli astmanähtude üle;
English: Deterioration of disease
Estonian: • külmetushaigus
English: HZC112206 evaluated the efficacy of fluticasone furoate/vilanterol 46 /22 micrograms [n=206] and fluticasone furoate/vilanterol 92/22 micrograms [n=206] compared with FF 92 micrograms [n=206], vilanterol 22 micrograms [n=205] and placebo [n = 207], all administered once daily.
Estonian: Uuringus HZC112206 hinnati flutikasoonfuroaadi/vilanterooli 46/22 mikrogrammi [n=206] ja flutikasoonfuroaadi/vilanterooli 92/22 mikrogrammi [n=206] efektiivsust võrreldes FF 92 mikrogrammi [n=206], vilanterooli 22 mikrogrammi [n=205] ja platseeboga [n=207], mida kõiki manustati üks kord ööpäevas.
English: This corresponds to a pre-dispensed dose of 100 micrograms of fluticasone furoate and 25 micrograms vilanterol (as trifenatate).
Estonian: See vastab doseeritud annusele 100 mikrogrammi flutikasoonfuroaati ja 25 mikrogrammi vilanterooli (trifenataadina).
English: • infection of the nose sinuses or throat
Estonian: • sügelus ninas, ninavoolus või ninakinnisus
English: Do not open until ready to inhale.
Estonian: Mitte avada enne, kui olete valmis ravimit inhaleerima.
English: This corresponds to a pre-dispensed dose of 200 micrograms of fluticasone furoate and 25 micrograms vilanterol (as trifenatate).
Estonian: See vastab doseeritud annusele 200 mikrogrammi flutikasoonfuroaati ja 25 mikrogrammi vilanterooli (trifenataadina).
English: България ГлаксоСмитКлайн ЕООД
Estonian: ГлаксоСмитКлайн ЕООД Teл.
English: Rinse your mouth with water after you have used the inhaler, do not swallow.
Estonian: Pärast inhalaatori kasutamist loputage suud veega, mitte alla neelata.
English: What Relvar Ellipta looks like and contents of the pack The Ellipta device itself is a light grey inhaler with a yellow mouthpiece cover and a dose counter.
Estonian: Ellipta ise on helehall inhalaator, millel on kollane huuliku kate ja annuselugeja.
English: Magnesium stearate
Estonian: Laktoosmonohüdraat Magneesiumstearaat
English: Cardioselective beta-blocking medicinal products should be used with caution in patients with a history of bronchospasm.
Estonian: Bronhospasmi anamneesiga patsientidel peab kardioselektiivsete beetablokaatorite kasutamisel olema ettevaatlik.
English: There was no evidence for gender, weight or BMI to influence the pharmacokinetics of vilanterol based on a population pharmacokinetic analysis in 856 subjects with asthma (500 females) and 1091 subjects with COPD (340 females).
Estonian: Populatsiooni farmakokineetilise analüüsi põhjal, mis hõlmas 856 astmaga uuritavat (500 naist) ja 1091 KOKiga uuritavat (340 naist), puudusid tõendid soo, kehakaalu või KMI mõju kohta vilanterooli farmakokineetikale
English: In a 12 week study (HZC113107) in COPD patients both fluticasone furoate/vilanterol 92/22 micrograms given once daily in the morning and salmeterol/FP 50/500 micrograms given twice daily, demonstrated improvements from baseline in lung function.
Estonian: 12-nädalases uuringus (HZC113107) KOKiga patsientidel ilmnes kopsufunktsiooni paranemine ravieelsega võrreldes nii 92/22 mikrogrammi flutikasoonfuroaadi/vilanterooli manustamisel üks kord ööpäevas hommikul kui salmeterooli/FP 50/500 mikrogrammi manustamisel kaks korda ööpäevas.
English: HZA106827 was 12 weeks in duration and evaluated the efficacy of fluticasone furoate/vilanterol 92/22 micrograms [n=201] and FF 92 micrograms [n=205]) compared with placebo [n=203], all administered once daily.
Estonian: Uuring HZA106827 oli 12-nädalase kestusega ja hindas flutikasoonfuroaadi/vilanterooli 92/22 mikrogrammi [n=201] ja FF 92 mikrogrammi [n=205] efektiivsust võrreldes platseeboga [n=203], mida kõiki manustati üks kord ööpäevas.
English: Adjusted mean change from baseline in trough FEV1 was also evaluated as a secondary endpoint.
Estonian: Teisese tulemusnäitajana hinnati ka minimaalse FEV1 kohandatud keskmist muutust ravieelsest väärtusest.
English: At Day 168 fluticasone furoate/vilanterol 92/22 micrograms and vilanterol increased adjusted mean weighted mean FEV1 over 0-4 hours by 193mL (95% CI: 156, 230 mL, p<0.001) and 145 mL (95% CI: 108, 181 mL, p<0.001) respectively compared to placebo.
Estonian: 168. päeval suurenes flutikasoonfuroaadi/vilanterooli 92/22 mikrogrammi ja vilanterooli toimel kohandatud keskmine FEV1 0...4 tunni kaalutud keskmine platseeboga võrreldes vastavalt 193 ml (95% CI: 156, 230 ml, p<0,001) ja 145 ml (95% CI: 108, 181 ml, p<0,001) võrra.
English: The tray contains a desiccant sachet, to reduce moisture in the packaging.
Estonian: Alus sisaldab kuivatusaine kotikest, mis vähendab pakendis olevat niiskust.
English: The pharmacologic effects of beta2-adrenoceptor agonist active substances, including vilanterol trifenatate, are at least in part attributable to stimulation of intracellular adenylate cyclase, the enzyme that catalyzes 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: Fluticasone furoate/vilanterol 92/22 micrograms increased adjusted mean weighted mean FEV1 over 0-4 hours by 148 ml compared to FF alone (95% CI: 112, 184 mL, p< 0.001).
Estonian: Flutikasoonfuroaadi/vilanterooli 92/22 mikrogrammi toimel suurenes kohandatud keskmine FEV1 0...4 tunni kaalutud keskmine 148 ml võrra ainult flutikasoonfuroaadiga võrreldes (95% CI: 112, 184 ml, p<0,001).
English: There was no evidence for gender, weight or BMI (body mass index) to influence the pharmacokinetics of fluticasone furoate based on a population pharmacokinetic analysis of phase III data in 1213 subjects with asthma (712 females) and 1225 subjects with COPD (392 females).
Estonian: III faasi, mis hõlmas 1213 astmaga uuritavat (712 naist) ja 1225 KOKiga uuritavat (392 naist), populatsiooni farmakokineetilise analüüsi andmete põhjal puudusid tõendid soo, kehakaalu või KMI (kehamassiindeksi) mõju kohta flutikasoonfuroaadi farmakokineetikale.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING INTERMEDIATE OUTER CARTON (WITHOUT BLUE BOX- MULTIPACK ONLY) 184/22 micrograms
Estonian: VÄLISPAKENDIL PEAVAD OLEMA JÄRGMISED ANDMED VAHEVÄLISPAKEND (ILMA BLUE BOX'ITA - AINULT MITMIKPAKEND) 184/22 mikrogrammi
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING INTERMEDIATE OUTER CARTON (WITHOUT BLUE BOX- MULTIPACK ONLY) 92/22 micrograms
Estonian: VÄLISPAKENDIL PEAVAD OLEMA JÄRGMISED ANDMED VAHEVÄLISPAKEND (ILMA BLUE BOX'ITA - AINULT MITMIKPAKEND) 92/22 mikrogrammi
English: At Day 169 fluticasone furoate/vilanterol 92/22 micrograms and vilanterol increased adjusted mean trough FEV1 by 129 mL (95% CI: 91, 167 mL, p<0.001) and 83 mL (95% CI: 46, 121mL, p<0.001) respectively compared to placebo.
Estonian: 169. päeval oli flutikasoonfuroaadi/vilanterooli 92/22 mikrogrammi ja vilanterooli toimel kohandatud keskmine minimaalne FEV1 platseeboga võrreldes suurenenud vastavalt 129 ml (95% CI: 91, 167 ml, p<0,001) ja 83 ml (95% CI: 46, 121 ml, p<0,001) võrra.
English: • skin rash (hives) or redness
Estonian: • nahalööve (nõgestõbi) või -punetus
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON (SINGLE PACK) 184/22 micrograms
Estonian: VÄLISPAKENDIL PEAVAD OLEMA JÄRGMISED ANDMED VÄLISKARP (AINULT ÜKSIKPAKENDID) 184/22 mikrogrammi
English: Each delivered dose contains 184 micrograms of fluticasone furoate and 22 micrograms of vilanterol (as trifenatate).
Estonian: Üks manustatav annus sisaldab 184 mikrogrammi flutikasoonfuroaati ja 22 mikrogrammi vilanterooli (trifenataadina).
English: While you're using Relvar Ellipta
Estonian: Kui te unustate Relvar Ellipta't kasutada
English: Fluticasone furoate/vilanterol 92 /22 micrograms consistently demonstrated 83 mL to 95 mL improvements in trough FEV1 at weeks 12, 36 and 52 and Endpoint compared with FF 92 micrograms (p<0.001 95% CI 52, 126 mL at Endpoint).
Estonian: Flutikasoonfuroaadi/vilanterooli 92/22 mikrogrammi kasutamisel täheldati järjekindlalt minimaalse FEV1 väärtuse paranemist 83...95 ml võrra nädalatel 12, 36 ja 52 ning uuringu lõpus FF 92 mikrogrammiga võrreldes (p<0,001 95% CI 52, 126 ml uuringu lõpus).
English: Following oral administration, fluticasone furoate was eliminated in humans mainly by metabolism with metabolites being excreted almost exclusively in faeces, with <1% of the recovered radioactive dose eliminated in the urine.
Estonian: Metaboliidid eritusid peaaegu täielikult väljaheitega, uriiniga eritus alla 1% radioaktiivselt märgistatud annusest.
English: Allergen challenge study
Estonian: Provokatsioonitest allergeeniga
English: Each delivered dose contains 92 micrograms of fluticasone furoate and 22 micrograms of vilanterol (as trifenatate).
Estonian: Üks manustatav annus sisaldab 92 mikrogrammi flutikasoonfuroaati ja 22 mikrogrammi vilanterooli (trifenataadina).
English: Fluticasone furoate monotherapy
Estonian: Flutikasoonfuroaadi monoteraapia
English: - For the 92/22mcg dose: each single inhalation provides a delivered dose (the dose leaving the mouthpiece) of 92 micrograms of fluticasone furoate and 22 micrograms of vilanterol (as trifenatate).
Estonian: 92/22-mikrogrammi annus: iga inhalatsiooniga manustatav annus (annus, mis väljub huulikust) sisaldab 92 mikrogrammi flutikasoonfuroaati ja 22 mikrogrammi vilanterooli (trifenataadina).
English: The incidence of pneumonia in patients with asthma was common at the higher dose.
Estonian: Suurema annuse kasutamisel esines astmahaigetel sageli pneumooniat.
English: Relvar Ellipta has been shown to reduce flare-ups of COPD symptoms.
Estonian: On tõestatud, et Relvar Ellipta vähendab KOKi ägenemisi.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/13/886/004
Estonian: MÜÜGILOA NUMBER (NUMBRID) EU/1/13/886/004
English: • becoming very wheezy, coughing or having difficulty in breathing
Estonian: • tugev vilistav hingamine, köha või hingamisraskus
English: The bronchoprotective effect of fluticasone furoate/vilanterol 92/22 micrograms on the early and late asthmatic response to inhaled allergen was evaluated in a repeat dose, placebo-controlled four-way crossover study (HZA113126) in patients with mild asthma.
Estonian: Kerge astmaga patsientidel läbi viidud korduvate annuste platseebokontrolliga, nelja uuringurühmaga, ristuva ülesehitusega uuringus (HZA113126) hinnati 92/22 mikrogrammi flutikasoonfuroaadi/vilanterooli bronhoprotektiivset toimet inhaleeritava allergeeni suhtes tekkivale varasele ja hilisele astmaatilisele reaktsioonile.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON (SINGLE PACKS) 92/22 micrograms
Estonian: VÄLISPAKENDIL PEAVAD OLEMA JÄRGMISED ANDMED VÄLISKARP (AINULT ÜKSIKPAKENDID) 92/22 mikrogrammi
English: Data from large asthma and COPD clinical trials were used to determine the frequency of adverse reactions associated with fluticasone furoate/vilanterol.
Estonian: Flutikasoonfuroaadi/vilanterooliga seotud kõrvaltoimete esinemissageduse määramisel kasutati andmeid suurtest astma ja KOKi kliinilistest uuringutest.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/13/886/001
Estonian: MÜÜGILOA NUMBER (NUMBRID) EU/1/13/886/001
English: - For the 184/22 dose: each single inhalation provides a delivered dose (the dose leaving the mouthpiece) of 184 micrograms of fluticasone furoate and 22 micrograms of vilanterol (as trifenatate).
Estonian: 184/22-mikrogrammi annus: iga inhalatsiooniga manustatav annus (annus, mis väljub huulikust) sisaldab 184 mikrogrammi flutikasoonfuroaati ja 22 mikrogrammi vilanterooli (trifenataadina).
English: If your breathing or wheezing gets worse straight after using Relvar Ellipta, stop using it and get medical help immediately.
Estonian: Vahetult pärast ravimi manustamist tekkivad hingamisraskused Kui teil tekib hingamisraskus või vilistava hingamise süvenemine vahetult pärast Relvar Ellipta kasutamist, lõpetage ravimi kasutamine ja pöörduge otsekohe arsti poole.
English: Use this medicine for as long as your doctor recommends.
Estonian: Selle toime püsib vaid senikaua, kui te ravimit kasutate.
English: It is packaged in a foil laminate tray with a peelable foil lid.
Estonian: See on pakendatud fooliumlaminaadist alusele, millel on äratõmmatav fooliumkate.
English: 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).
Estonian: Kui teil on mõõdukas või raske maksahaigus, piirab arst teie annust, määrates Relvar Ellipta väiksema tugevuse
English: What Relvar Ellipta is and what it is used for 2.
Estonian: 1. Mis ravim on Relvar Ellipta ja milleks seda kasutatakse 2. Mida on vaja teada enne Relvar Ellipta kasutamist 3.
English: There was no evidence for gender, weight or BMI to influence the pharmacokinetics of vilanterol based on a population pharmacokinetic analysis in 856 subjects with asthma (500 females).
Estonian: Populatsiooni farmakokineetilise analüüsi põhjal, mis hõlmas 856 astmaga uuritavat (500 naist), puudusid tõendid soo, kehakaalu või KMI mõju kohta vilanterooli farmakokineetikale
English: No dosage adjustment is necessary based on gender, weight or BMI.
Estonian: Soo, kehakaalu või KMI põhjal ei ole vaja annust muuta.
English: • inflammation of the sinuses
Estonian: • ninakõrvalkoobaste põletik
English: The device does not need to be stored in the foil laminate tray once it has been opened.
Estonian: Pärast avamist ei ole inhalaatorit vaja hoida fooliumlaminaadist alusel.
English: 184 micrograms [n=194]) both administered once daily compared with FP 500 micrograms twice daily [n=195].
Estonian: 200 mikrogrammi üks kord ööpäevas on ligikaudu samaväärne toime nagu FP annusel 500 mikrogrammi kaks korda ööpäevas.
English: Do not stop using Relvar Ellipta without advice
Estonian: Ärge lõpetage Relvar Ellipta kasutamist ilma nõu pidamata Kasutage seda ravimit senikaua, kui arst soovitab.
English: Both fluticasone furoate and vilanterol have a low association with red blood cells.
Estonian: Flutikasoonfuroaat ja vilanterool seonduvad erütrotsüütidega vähesel määral.
English: • common cold
Estonian: • värin
English: Rhinitis
Estonian: Köha
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING BUNDLE LABEL (WITH BLUE BOX- MULTIPACK) 184/22 micrograms
Estonian: VÄLISPAKENDIL PEAVAD OLEMA JÄRGMISED ANDMED MITMIKPAKENDI VÄLISETIKETT (BLUE BOX'IGA - AINULT MITMIKPAKEND) 184/22 mikrogrammi
English: Package leaflet: Information for the user Relvar Ellipta 92 micrograms/22 micrograms inhalation powder, pre-dispensed Relvar Ellipta 184 micrograms/22 micrograms inhalation powder, pre-dispensed
Estonian: Relvar Ellipta 92 mikrogrammi/22 mikrogrammi annustatud inhalatsioonipulber Relvar Ellipta 184 mikrogrammi/22 mikrogrammi annustatud inhalatsioonipulber
English: Each single inhalation provides a delivered dose (the dose leaving the mouthpiece) of 92 micrograms of fluticasone furoate and 22 micrograms of vilanterol (as trifenatate).
Estonian: Üks inhaleeritav pihustatud annus (annus, mis väljub huulikust) sisaldab 92 mikrogrammi flutikasoonfuroaati ja 22 mikrogrammi vilanterooli (trifenataadina).
English: Each single inhalation provides a delivered dose (the dose leaving the mouthpiece) of 184 micrograms of fluticasone furoate and 22 micrograms of vilanterol (as trifenatate).
Estonian: Üks inhaleeritav pihustatud annus (annus, mis väljub huulikust) sisaldab 184 mikrogrammi flutikasoonfuroaati ja 22 mikrogrammi vilanterooli (trifenataadina).
English: 92/22 micrograms group (approximately 1 in every 7 years).
Estonian: (92/22 mikrogrammi üks kord ööpäevas).