FrancophonIA/ELRC3.0 huggingface dataset:
English: o Do not use the Bevespi Aerosphere actuator with any other medicine.
Estonian: o Ärge kasutage Bevespi Aerosphere'i annustit mitte ühegi teise ravimiga.
English: Linear pharmacokinetics were observed for glycopyrronium (dose range: 14.4 to 115.2 mcg) and formoterol (dose range: 2.4 to 19.2 mcg) after oral inhalation.
Estonian: Glükopürrooniumi (annuste vahemik: 14,4...115,2 mcg) ja formoterooli (annuste vahemik: 2,4...19,2 mcg) farmakokineetika pärast suukaudset inhalatsiooni oli lineaarne.
English: Bevespi Aerosphere comes as a pressurised container with a dose indicator, supplied with a white plastic actuator body and mouthpiece (see Figure 1 of the Instructions for Use at the end of this leaflet).
Estonian: Bevespi Aerosphere'i tarnitakse annuse näidikuga rõhukonteineris koos valgest plastist annusti ja huulikuga (vt infolehe lõpus oleva kasutusjuhendi joonist 1).
English: The European Medicines Agency has waived the obligation to submit the results of studies with Bevespi Aerosphere in all subsets of the paediatric population in COPD (see section 4.2 for information on paediatric use).
Estonian: KOK-i korral ei kohusta Euroopa ravimiamet esitama Bevespi Aerosphere-iga tehtud uuringute tulemusi laste populatsiooni alarühmades (teavet lastel kasutamise kohta vt lõigust 4.2).
English: What Bevespi Aerosphere looks like and contents of the pack
Estonian: Kuidas Bevespi Aerosphere välja näeb ja pakendi sisu
English: Insufficient pharmacokinetic data are available to compare exposure for other ethnicities or races.
Estonian: Ekspositsiooni võrdlemiseks muu etnilise või rassilise päritoluga patsientide puhul ei ole piisavalt farmakokineetilisi andmeid.
English: Immune system disorders Hypersensitivity reactions including rash and pruritus
Estonian: Immuunsüsteemi häired Ülitundlikkusreaktsioonid, sh lööve ja sügelus Aeg-ajalt
English: Animal reproduction studies with glycopyrronium have shown reduced rat and rabbit fetal weights, and low body weight gain of rat offspring before weaning was observed at considerably higher systemic exposures than those reached during clinical use.
Estonian: Glükopürrooniumiga tehtud reproduktsiooniuuringud katseloomadel on näidanud loodete kaalu vähenemist rottidel ja küülikutel ning väikest kaaluiivet rottide järglastel enne emapiimast võõrutamist ning seda märkimisväärselt suurema süsteemse ekspositsiooni puhul, kui võrrelda kliinilise kasutamise korral saavutatuga.
English: This means that there are 110 puffs of medicine left in the pressurised container (See Figure 2b).
Estonian: See tähendab, et rõhukonteinerisse on veel jäänud 110 ravimiannust (vt joonis 2b).
English: Figure 16
Estonian: Joonis 16
English: Other pharmacodynamic interactions
Estonian: Muud farmakodünaamilised koostoimed
English: However, because formoterol is primarily eliminated via hepatic metabolism, an increased exposure can be expected in patients with severe liver impairment.
Estonian: Kuna formoterool eritub peamiselt maksametabolismi teel, siis võib raske maksafunktsiooni kahjustusega patsientidel eeldada ekspositsiooni suurenemist.
English: This means that there are 120 puffs of medicine left in the pressurised container (See Figure 2a).
Estonian: See tähendab, et rõhukonteinerisse on veel jäänud 120 ravimiannust (vt joonis 2a).
English: The terminal elimination half-life of formoterol following oral inhalation derived via population pharmacokinetics analysis was 13 hours.
Estonian: Formoterooli lõplik eritumise poolväärtusaeg suukaudse inhalatsiooni järel oli populatsiooni farmakokineetilise analüüsi alusel 13 tundi.
English: The excretion of formoterol was studied in six healthy subjects following simultaneous administration of radiolabelled formoterol via the oral and IV routes.
Estonian: Formoterooli eritumist uuriti kuuel tervel vabatahtlikul pärast radioaktiivselt märgistatud formoterooli samaaegset suukaudset ja intravenoosset manustamist.
English: • Not use the inhaler if the drying agent, which is inside the foil pouch, has leaked out of its packet.
Estonian: • et ta ei kasutaks inhalaatorit, kui fooliumkotikeses olev kuivatusaine on pakendist välja tulnud.
English: • Bevespi Aerosphere comes with a dose indicator on the top of the pressurised container (See Figure 1).
Estonian: • Bevespi Aerosphere on varustatud rõhukonteineri ülaosas oleva annusenäidikuga (vt joonis 1).
English: • agitation
Estonian: • rahutus
English: If you forget to use Bevespi Aerosphere
Estonian: Kui te unustate Bevespi Aerosphere'i kasutada
English: If any of the above applies to you, or if you are not sure, talk to your doctor or pharmacist before using Bevespi Aerosphere.
Estonian: Kui midagi ülaltoodust kehtib teie kohta või te ei ole selles kindel, pidage enne Bevespi Aerosphere'i kasutamist nõu oma arsti või apteekriga.
English: In patients with severe hepatic impairment, Bevespi Aerosphere should be used only if the expected benefit outweighs the potential risk (see section 5.2).
Estonian: Raske maksapuudulikkusega patsientidel võib Bevespi Aerosphere'i kasutada üksnes juhul, kui oodatav kasu on suurem kui võimalik risk (vt lõik 5.2).
English: This means that there are 100 puffs of medicine left in the pressurised container (See Figure 2c).
Estonian: See tähendab, et rõhukonteinerisse on veel jäänud 100 ravimiannust (vt joonis 2c).
English: The other ingredients are norflurane, 1,2- distearoyl-sn-glycero-3-phosphocholine and calcium chloride.
Estonian: Teised koostisained on norfluraan, 1,2- distearoüül-sn-glütsero-3-fosfokoliin ja kaltsiumkloriid.
English: Bevespi Aerosphere delivers the active ingredients directly to the airways in your lungs as you breathe in.
Estonian: Sissehingamise ajal toimetab Bevespi Aerosphere toimeained otse kopsudes olevatesse hingamisteedesse.
English: Figure 18
Estonian: Joonis 18
English: This will release a puff of medicine from the mouthpiece (See Figure 5).
Estonian: Selle tulemusel pihustatakse ravim huulikust välja (vt joonis 5).
English: Figure 15
Estonian: Joonis 15
English: CYP2D6 and CYP2C have been identified as being primarily responsible for Odemethylation.
Estonian: O-demetüleerimine toimub eelkõige CYP2D6 ja CYP2C vahendusel.
English: If you use more Bevespi Aerosphere than you should
Estonian: Kui te kasutate Bevespi Aerosphere'i rohkem kui ette nähtud
English: Step 5: Look into the actuator and the mouthpiece to make sure any medicine build-up has been completely washed away.
Estonian: 5. samm: Veenduge , et annustisse ja huulikusse ei ole jäänud ravimi kogumeid.
English: Figure 13
Estonian: Joonis 13
English: The inhaler is a pressurised metered dose inhaler, comprising an aluminium pressurised container with an attached dose indicator, supplied with a white plastic actuator body and mouthpiece with an orange dust cap. Each inhaler is individually packaged in a foil laminate pouch containing a desiccant sachet and packed into a carton.
Estonian: Inhalaator on rõhu all mõõdetavate annustega inhalaator, mis koosneb alumiiniumist rõhukonteinerist koos annusenäidikuga ja valgest plastist annustist ning oranži kaitsekorgiga huulikust.
English: INHALER LABEL (PRESSURISED CONTAINER)
Estonian: INHALAATORI ETIKETT (RÕHUKONTEINER)
English: Pressurised inhalation, suspension (pressurised inhalation).
Estonian: Inhalatsiooniaerosool, suspensioon (inhalatsiooniaerosool)
English: o Take the Bevespi Aerosphere inhaler out of the foil pouch.
Estonian: o Võtke Bevespi Aerosphere'i inhalaator fooliumkotist välja.
English: Norflurane 1,2-distearoyl-sn-glycero-3-phosphocholine and calcium chloride.
Estonian: Norfluraan, 1,2-distearoüül-sn-glütsero-3-fosfokoliin ja kaltsiumkloriid.
English: You may need to read it again.
Estonian: - Hoidke infoleht alles, et seda vajaduse korral uuesti lugeda.
English: Symptomatic outcomes
Estonian: Ravitulemused sümptomite puhul
English: NAMES OF THE MARKETING AUTHORISATION HOLDER
Estonian: MÜÜGILOA HOIDJA NIMI
English: Multipack containing 3 inhalers each with 120 actuations.
Estonian: Multipakend sisaldab kolme 120 annusega inhalaatorit.
English: The terminal elimination half-life of glycopyrronium following oral inhalation derived via population pharmacokinetics analysis was 15 hours.
Estonian: Glükopürrooniumi lõplik eritumise poolväärtusaeg suukaudse inhalatsiooni järel oli populatsiooni farmakokineetilise analüüsi alusel 15 tundi.
English: In animal studies formoterol and glycopyrronium, individually, have caused adverse effects in reproduction studies at very high doses/systemic exposure levels (see section 5.3).
Estonian: Katseloomade reproduktsiooniuuringutes on nii formoterooli kui ka glükopürrooniumi individuaalsel kasutamisel väga suurte annuste / süsteemse ekspositsiooni korral märgatud soovimatuid toimeid (vt lõik 5.3).
English: For inhalation use.
Estonian: Mõeldud inhalatsiooniks.
English: If you stop using Bevespi Aerosphere
Estonian: Kui te lõpetate Bevespi Aerosphere'i kasutamise
English: The parts of your Bevespi Aerosphere inhaler (See Figure 1):
Estonian: Bevespi Aerosphere'i inhalaatori osad (vt joonis 1):
English: The estimated formoterol Vc/F (volume of the central compartment), and Vp1/F (volume of the peripheral compartment) are 1030 L, and 647 L, respectively, via population pharmacokinetic analysis.
Estonian: Populatsiooni farmakokineetilise analüüsi põhjal on formoterooli hinnanguline Vc/F (volume of the central compartment) ja Vp1/F (volume of the peripheral compartment) vastavalt 1030 l ja 647 l. Kontsentratsioonide vahemikus 10...500 nmol/l oli formoterooli seondumine plasmavalkudega vahemikus 46...58%.
English: • shaking or tremor
Estonian: • värisemine (treemor)
English: • you have diabetes
Estonian: • teil on suhkurtõbi
English: • Remove the cap from the mouthpiece (See Figure 3).
Estonian: • Eemaldage huulikult kaitsekork (vt joonis 3).
English: On actuation of Bevespi Aerosphere, a volume of the suspension is expelled from the pressurised container at high velocity.
Estonian: Bevespi Aerosphere'i inhalaatori kasutamisel väljutatakse rõhukonteinerist suurel kiirusel üks suspensiooni pihustus.
English: • Your Bevespi Aerosphere inhaler comes in a foil pouch that contains a drying packet (desiccant).
Estonian: • Teie Bevespi Aerosphere'i inhalaator tarnitakse fooliumkotis, mis sisaldab kuivatusaine kotikest.
English: Evidence of transfer of glycopyrronium and formoterol into maternal milk in rats has been reported.
Estonian: On teada, et glükopürroonium ja formoterool erituvad rottide rinnapiima.
English: You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.
Estonian: Kõrvaltoimetest võite teavitada ka ise riikliku teavitussüsteemi kaudu, mis on esitatud V lisas.
English: • The pointer points between 100 and 120 after you use 10 more puffs.
Estonian: • Kui te kasutate veel 10 pihustust, siis näitab osuti 100 ja 120 vahelisele alale.
English: Cardiac disorders
Estonian: Kardiovaskulaarsed toimed
English: Drug-induced hypokalaemia
Estonian: Ravimitest põhjustatud hüpokaleemia
English: The estimated glycopyrronium Vc/F (volume of the central compartment), and Vp1/F (volume of the peripheral compartment) are 741 L, and 2990 L, respectively, via population pharmacokinetic analysis.
Estonian: Populatsiooni farmakokineetilise analüüsi põhjal on glükopürrooniumi hinnanguline tsentraalne jaotusruumala Vc/F (volume of the central compartment) ja perifeerne jaotusruumala Vp1/F (volume of the peripheral compartment) vastavalt 741 l ja 2990 l. Kontsentratsioonide vahemikus 2...500 nmol/l oli glükopürrooniumi seondumine plasmavalkudega vahemikus 43...54%.
English: If you find it difficult breathing in and pressing the inhaler at the same time talk to your doctor or pharmacist.
Estonian: Bevespi Aerosphere'i kasutamine koos vahemahutiga Kui teil on raske korraga vajutada inhalaatori annustile ja sisse hingata, rääkige sellest oma arstile või apteekrile.
English: It is not recommended to use Bevespi Aerosphere together with these medicines;
Estonian: Bevespi Aerosphere'i ei ole soovitatav kasutada koos järgmiste ravimitega:
English: In PINNACLE 1, PINNACLE 2 and PINNACLE 4, Bevespi Aerosphere provided an improvement in disease-specific health-related quality of life, as indicated by a reduction in the St George's Respiratory Questionnaire (SGRQ) total score over 24 weeks compared to placebo and glycopyrronium [see Table 2].
Estonian: Uuringutes PINNACLE 1, PINNACLE 2 ja PINNACLE 4 parandas Bevespi Aerosphere haigusspetsiifilist tervisega seotud elukvaliteeti, mida näitab SGRQ (St. George's Respiratory Questionnaire) üldskoori vähenemine 24 nädala vältel võrdluses platseebo ja glükopürrooniumiga [vt tabel 2].
English: If you are not sure, talk to your doctor or pharmacist before using Bevespi Aerosphere.
Estonian: Kui te ei ole milleski kindel, pidage enne Bevespi Aerosphere'i kasutamist nõu oma arsti või apteekriga.
English: A population pharmacokinetic analysis of formoterol was performed based on data collected in a total of 437 subjects with COPD.
Estonian: Kokku 437 KOK-iga patsiendilt saadud andmete alusel tehti formoterooli populatsiooni farmakokineetiline analüüs.
English: In studies PINNACLE 1, PINNACLE 2 and PINNACLE 4, Bevespi Aerosphere showed improvements in trough FEV1 over 24 weeks relative to placebo, glycopyrronium and formoterol (p<0.0001) [see Table 2].
Estonian: Uuringutes PINNACLE 1, PINNACLE 2 ja PINNACLE 4 parandas Bevespi Aerosphere 24-nädalase ravi vältel platseebo, glükopürrooniumi ja formoterooliga võrdluses toimeaja lõpu FEV1 väärtust (p < 0,0001) [vt tabel 2].
English: Hepatic impairment
Estonian: Peavalu Peapööritus
English: Bevespi Aerosphere 7.2 micrograms/5 micrograms pressurised inhalation, suspension
Estonian: Bevespi Aerosphere 7,2 mikrogrammi / 5 mikrogrammi inhalatsiooniaerosool, suspensioon
English: INHALER LABEL (ACTUATOR)
Estonian: INHALAATORI ETIKETT (ANNUSTI)
English: Both central and peripheral deposition were observed.
Estonian: Ravim jõudis nii kopsu tsentraalsetesse kui ka perifeersetesse osadesse.
English: 1,2-distearoyl-sn-glycero-3-phosphocholine Calcium chloride
Estonian: 1,2-distearoüül-sn-glütsero-3-fosfokoliin Kaltsiumkloriid
English: Step 2: Take the cap off the mouthpiece.
Estonian: 2. samm: Eemaldage huulikult kaitsekork.
English: CYP2D6 was found to be the predominant enzyme involved in the metabolism of glycopyrronium.
Estonian: Peamine glükopürrooniumi metabolismis osalev ensüüm on CYP2D6.
English: This corresponds to a metered dose of glycopyrronium bromide 10.4 micrograms equivalent to 8.3 micrograms of glycopyrronium, and formoterol fumarate dihydrate 5.8 micrograms.
Estonian: Üks mõõdetud annus sisaldab 10,4 mikrogrammi glükopürrooniumbromiidi (mis vastab 8,3 mikrogrammile glükopürrooniumile), ja 5,8 mikrogrammi formoteroolfumaraatdihüdraati.
English: However, these animal experimental results have little relevance to man. A slight increase in the incidence of uterine leiomyomas has been observed in rats and mice treated with formoterol; an effect which is considered to be a class-effect in rodents after long-term exposure to high doses of β2-adrenoreceptor agonists.
Estonian: Formoterooliga ravitud rottidel ja hiirtel on veidi suurenenud emaka leiomüoomide esinemissagedus, mida peetakse β2adrenoretseptori agonistide suurte annuste pikaajalise ekspositsiooni spetsiifiliseks toimeks närilistel.
English: Talk to your doctor or pharmacist before using Bevespi Aerosphere if:
Estonian: Enne Bevespi Aerosphere'i kasutamist pidage nõu oma arsti või apteekriga, kui:
English: How to use Bevespi Aerosphere
Estonian: Kuidas Bevespi Aerosphere'i kasutada
English: • you have low levels of potassium in the blood
Estonian: • teie vere kaaliumisisaldus on väike
English: • The pointer points to 100 after you take 10 more puffs.
Estonian: • Kui te kasutate veel 10 pihustust, siis näitab osuti 100-le.
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 glycopyrronium or formoterol.
Estonian: Muskariiniretseptorite antagonistide ja sümpatomimeetiliste ravimite, sh glükopürrooniumi või formoterooli manustamise järel võivad tekkida kardiovaskulaarsed toimed, näiteks südame rütmihäired, sh kodade virvendus ja tahhükardia.
English: • Bevespi Aerosphere comes as a pressurised container with a dose indicator that fits into an actuator.
Estonian: • Bevespi Aerosphere'i tarnitakse annusenäidikuga rõhukonteineris, mis sobitub kaasasolevasse annustisse.
English: Dose indicator display window
Estonian: Kõrvaltoimete loetelu tabelina
English: Bevespi Aerosphere also showed improvements in peak FEV1 within 2 hours post-dose over 24 weeks relative to placebo, glycopyrronium and formoterol (p<0.0001) [see Table 2].
Estonian: Bevespi Aerosphere parandas 24-nädalase ravi vältel platseebo, glükopürrooniumi ja formoterooliga võrdluses samuti suurimat FEV1 väärtust mõõdetuna kahe tunni jooksul pärast annustamist (p < 0,0001) [vt tabel 2].
English: Carton containing 1 inhaler with 120 actuations.
Estonian: Pakend sisaldab ühte 120 annusega inhalaatorit.
English: How to clean your Bevespi Aerosphere inhaler:
Estonian: Kuidas Bevespi Aerosphere'i inhalaatorit puhastada:
English: o Do not use the Bevespi Aerosphere pressurised container with an actuator from any other inhaler.
Estonian: o Ärge kasutage Bevespi Aerosphere'i rõhukonteinerit mitte ühegi teise inhalaatori annustiga.
English: In PINNACLE 1 and PINNACLE 2, Bevespi Aerosphere provided improvements in breathlessness as demonstrated by Self-administered Computerised Transitional Dyspnoea Index (SAC TDI) focal score over 24 weeks compared to placebo and glycopyrronium (see Table 2).
Estonian: Uuringutes PINNACLE 1 ja PINNACLE 2 vähendas Bevespi Aerosphere hingeldust, mida näitab SAC TDI (Self-administered Computerised Transitional Dyspnoea Index) skoor 24 nädala vältel võrdluses platseebo ja glükopürrooniumiga (vt tabel 2).
English: How to store Bevespi Aerosphere
Estonian: Kuidas Bevespi Aerosphere'i säilitada
English: Dose adjustments are not necessary based on the effect of age, sex and weight on the pharmacokinetic parameters of glycopyrronium and formoterol.
Estonian: Glükopürrooni ja formoterooli farmakokineetiliste parameetrite alusel ei ole patsiendi vanusest, soost ja kehakaalust lähtudes vaja annust kohandada.
English: A population pharmacokinetic analysis of glycopyrronium was performed based on data collected in a total of 311 subjects with COPD.
Estonian: Kokku 311 KOK-iga patsiendilt saadud andmete alusel tehti glükopürrooniumi populatsiooni farmakokineetiline analüüs.
English: Serious side effects
Estonian: Vahemahuti mõju
English: 120 actuations (1 inhaler)
Estonian: Inhalatsiooniaerosool, suspensioon 120 annust (1 inhalaator)
English: Bevespi Aerosphere (N=551) vs formoterol fumarate (N=480)
Estonian: Bevespi Aerosphere (N = 551) vs. formoteroolfumaraat (N = 480)
English: Aerosphere (N=551) vs placebo (N=235)
Estonian: Bevespi Aerosphere (N = 551) vs. platseebo (N = 235)
English: In PINNACLE 4, Bevespi Aerosphere provided improvements in breathlessness as demonstrated by TDI focal score over 24 weeks compared to placebo and glycopyrronium (see Table 2).
Estonian: Uuringus PINNACLE 4 vähendas Bevespi Aerosphere hingeldust, mida näitab TDI skoor 24 nädala vältel võrdluses platseebo ja glükopürrooniumiga (vt tabel 2).
English: Each single actuation contains glycopyrronium bromide equivalent to 7.2 micrograms of glycopyrronium, and 5 micrograms of formoterol fumarate dihydrate.
Estonian: Üks inhaleeritav annus sisaldab glükopürrooniumbromiidi koguses, mis vastab 7,2 mikrogrammile glükopürrooniumile, ja 5 mikrogrammi formoteroolfumaraatdihüdraati.
English: The individual studies were not specifically designed to evaluate the effect of treatments on COPD exacerbations and patients were withdrawn from the studies if a severe exacerbation or more than 2 moderate exacerbations occurred.
Estonian: Kui patsientidel esines raske ägenemine või 2 keskmise raskusega ägenemist uuringute jooksul, siis patsiendid eemaldati uuringust.
English: Priming your Bevespi Aerosphere inhaler:
Estonian: Bevespi Aerosphere'i inhalaatori kontrollimine:
English: Bevespi Aerosphere (N=526) vs formoterol fumarate (N=449)
Estonian: Bevespi Aerosphere (N = 526) vs. formoteroolfumaraat (N = 449)
English: Non-clinical data reveal no specific hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity and carcinogenic potential.
Estonian: Farmakoloogilise ohutuse, korduvtoksilisuse, genotoksilisuse ja kartsinogeensuse mittekliinilised uuringud ei ole näidanud kahjulikku toimet inimesele.
English: • Talk to your doctor or pharmacist if you have any questions about the use of your inhaler.
Estonian: • Kui teil on küsimusi oma inhalaatori kasutamise kohta, pidage nõu oma arsti või apteekriga.
English: Bevespi Aerosphere (N=510) vs formoterol fumarate (N=437)
Estonian: Bevespi Aerosphere (N = 510) vs. formoteroolfumaraat (N = 437)
English: The mouthpiece is covered with an orange protective cap. Bevespi Aerosphere is supplied in a foil pouch that contains a drying packet (desiccant) and packed into a carton.
Estonian: Bevespi Aerosphere on pakendatud fooliumkotti, mis sisaldab kuivatusaine kotikest, ning on koos fooliumkotiga omakorda pakendatud kartongkarpi.
English: Aerosphere (N=510) vs placebo (N=223)
Estonian: Bevespi Aerosphere (N = 510) vs. platseebo (N = 223)
English: The pharmacokinetics of formoterol was best described by a two compartment disposition model with a first-order rate constant of absorption and linear elimination.The typical clearance (CL/F) of formoterol was 99 L/h.
Estonian: Formoterooli farmakokineetikat kirjeldas kõige paremini kahekambriline jaotusmudel koos muutumatu kiirusega esimese järgu imendumise ja lineaarse eritumisega.
English: Aerosphere (N=526) vs placebo (N=219)
Estonian: Bevespi Aerosphere (N = 526) vs. platseebo (N = 219)
English: Dose indicator
Estonian: Infolehe sisukord
English: Each single puff delivers a dose of 9 micrograms glycopyrronium bromide (equivalent to 7.2 micrograms of glycopyrronium), and 5 micrograms of formoterol fumarate dihydrate.
Estonian: Üks pihustus sisaldab 9 mikrogrammi glükopürrooniumbromiidi (mis vastab 7,2 mikrogrammile glükopürrooniumile) ja 5 mikrogrammi formoteroolfumaraatdihüdraati.
English: Do not pierce the pressurised container.
Estonian: Rõhukonteinerit mitte läbi torgata.
English: Each single actuation (delivered dose, ex-actuator) contains glycopyrronium bromide 9 micrograms equivalent to 7.2 micrograms of glycopyrronium, and 5 micrograms of formoterol fumarate dihydrate.
Estonian: Üks inhaleeritav annus (huulikust väljuv annus) sisaldab 9 mikrogrammi glükopürrooniumbromiidi (mis vastab 7,2 mikrogrammile glükopürrooniumile), ja 5 mikrogrammi formoteroolfumaraatdihüdraati.
English: 120 actuations (1 inhaler).
Estonian: Inhalatsiooniaerosool, suspensioon 120 annust (1 inhalaator).
English: DAY 1
Estonian: PÄEV
English: Effects on lung function
Estonian: Toimed kopsufunktsioonile
English: Psychiatric disorders
Estonian: Psühhiaatrilised häired Ärevus
English: Aerosphere (N=510) vs
Estonian: Bevespi Aerosphere (N = 510)
English: Bevespi Aerosphere (N=551) vs glycopyrronium (N=474)
Estonian: Bevespi Aerosphere (N = 551) vs. glükopürroonium (N
English: Anxiety
Estonian: Annusti
English: The active substances are glycopyrronium and formoterol fumarate dihydrate.
Estonian: Mida Bevespi Aerosphere sisaldab Toimeained on glükopürroonium ja formoteroolfumaraatdihüdraat.
English: Preparing your Bevespi Aerosphere inhaler for use:
Estonian: Bevespi Aerosphere'i inhalaatori kasutamiseks ettevalmistamine:
English: Headache Dizziness
Estonian: Valu rinnus
English: • feeling sick (nausea)
Estonian: • iiveldus (süda on paha)
English: COPD exacerbations:
Estonian: KOK-i ägenemised:
English: Bevespi Aerosphere 7.2 micrograms / 5 micrograms pressurised inhalation, suspension glycopyrronium / formoterol fumarate dihydrate
Estonian: Bevespi Aerosphere 7,2 mikrogrammi / 5 mikrogrammi inhalatsiooniaerosool, suspensioon glycopyrronium/formoteroli fumaras dihydricus
English: Mouthpiece
Estonian: Platseebo