natgillin/translations-raw huggingface dataset:
Co-administration of Bevespi Aerosphere with other anticholinergic and/or long-acting β2-adrenergic agonist containing medicinal products has not been studied and is not recommended as it may potentiate known inhaled muscarinic antagonist or beta2-adrenergic agonist adverse reactions (see section 4.4 and section 4.9). 
Sočasne uporabe zdravila Bevespi Aerosphere z drugimi antiholinergičnimi in/ali dolgodelujočimi agonisti adrenergičnih receptorjev β2 niso raziskali in ni priporočljiva, saj lahko okrepi znane neželene učinke inhalacijskih muskarinskih antagonistov oziroma agonistov adrenergičnih receptorjev β2 (glejte poglavje 4.4 in poglavje 4.9).
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. 
Inhalator je inhalator z odmerjenim odmerkom pod tlakom, ki vključuje aluminijski tlačni vsebnik z nameščenim kazalnikom odmerka in je opremljen z belim plastičnim telesom sprožilnika ter ustnikom z oranžnim zaščitnim pokrovčkom.
Do not pierce the pressurised container. 
Tlačnega vsebnika ne prebadajte.
There is no relevant use of Bevespi Aerosphere in children and adolescents (under 18 years of age) for the indication of COPD. 
Uporaba zdravila Bevespi Aerosphere za indikacijo KOPB pri otrocih in mladostnikih (mlajših od 18 let) ni ustrezna.
A population pharmacokinetic analysis of glycopyrronium was performed based on data collected in a total of 311 subjects with COPD. 
Populacijska farmakokinetična analiza glikopironija je zajela podatke skupno 311 preiskovancev s KOPB.
Due to its anticholinergic activity, Bevespi Aerosphere should be used with caution in patients with symptomatic prostatic hyperplasia, urinary retention or with narrow-angle glaucoma (see section 4.8). 
Zaradi antiholinergičnega delovanja zdravila Bevespi Aerosphere je treba to zdravilo previdno uporabljati pri bolnikih s simptomatsko hiperplazijo prostate, retenco urina ali glavkomom ozkega zakotja (glejte poglavje 4.8).
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). 
V študijah na živalih sta formoterol in glikopironij med uporabo zelo velikih odmerkov/ob veliki sistemski izpostavljenosti vsak zase povzročila neželene učinke v študijah sposobnosti razmnoževanje (glejte poglavje 5.3).
It is not recommended to use Bevespi Aerosphere together with these medicines; 
Zdravila Bevespi Aerosphere ni priporočljivo jemati skupaj s temi zdravili.
In patients with severe renal impairment or end-stage renal disease requiring dialysis it should be used only if the expected benefit outweighs the potential risk (see sections 4.4 and 5.2). 
Pri bolnikih s hudo okvaro ledvic ali končno odpovedjo ledvic, ki zahteva dializno zdravljenje, se sme to zdravilo uporabiti le, če pričakovana korist odtehta možno tveganje (glejte poglavji 4.4 in 5.2).
The active ingredients are present in a pressurised suspension inside the pressurised container. 
Učinkovini sta v inhalacijski suspenziji pod tlakom, ki je v tlačnem vsebniku.
Multipack: 360 actuations (3 packs of 120 actuations) 
inhalacijska suspenzija pod tlakom Skupno pakiranje: 360 sprožitev (3 pakiranja s 120 sprožitvami)
Compatibility with the Aerochamber Plus Flow-Vu spacer device has been demonstrated (see section 5.2). 
Aerochamber Plus Flow-Vu (glejte poglavje 5.2).
However, you will not get the right amount of medicine if you keep using it. 
Zdravilo bo učinkovito le, dokler ga uporabljate.
CYP2D6 and CYP2C have been identified as being primarily responsible for Odemethylation. 
Za O-demetilacijo sta v prvi vrsti odgovorna CYP2D6 in CYP2C.
Check inside the mouthpiece before you use the inhaler to make sure it is clear. 
Pred uporabo inhalatorja preverite, da je ustnik prazen.
Figure 2c 100 puffs 
Slika 2c 100 vpihov
How to use 
Kako uporabljati zdravilo
Bevespi Aerosphere is used to make breathing easier for adults who have a lung disease called chronic obstructive pulmonary disease (COPD). 
Zdravilo Bevespi Aerosphere uporabljamo za olajšanje dihanja pri odraslih s pljučno boleznijo, imenovano kronična obstruktivna pljučna bolezen (KOPB).
• The pointer points to 120 after 10 puffs are delivered from Bevespi Aerosphere. 
• Kazalec kaže proti oznaki 120 po tem, ko se iz inhalatorja Bevespi Aerosphere sprosti 10
To get adequate lung deposition of the active substances actuation must be co-ordinated with inhalation. 
Da se učinkovina ustrezno odloži v pljučih, mora biti sprožitev usklajena z vdihom.
As glycopyrronium is predominantly renally excreted, patients with severe renal impairment (creatinine clearance of < 30 mL/min), including those with end-stage renal disease requiring dialysis, should only be treated with Bevespi Aerosphere if the expected benefit outweighs the potential risk (see section 5.2). 
Zato je treba bolnike s hudo okvaro ledvic (očistek kreatinina < 30 ml/min), vključno z bolniki s končno odpovedjo ledvic, ki zahteva dializo, zdraviti z zdravilom Bevespi Aerosphere le, če pričakovana korist odtehta možno tveganje (glejte poglavje 5.2).
• Bevespi Aerosphere comes with a dose indicator on the top of the pressurised container (See Figure 1). 
• Inhalator Bevespi Aerosphere ima na vrhu tlačnega vsebnika kazalnik odmerka (glejte sliko 1).
Figure 12 Step 8: Replace the cap over the mouthpiece right away after use (See Figure 13). 
Slika 12 8. korak: Takoj po uporabi na ustnik znova namestite pokrovček (glejte sliko 13).
This information should be used alongside a discussion with your doctor about your medical condition and treatment. 
Poleg pogovora z vašim zdravnikom o vaši bolezni in njenem zdravljenju upoštevajte tudi informacije v teh navodilih.
Bevespi Aerosphere is a pressurised inhalation, suspension. 
Zdravilo Bevespi Aerosphere je inhalacijska suspenzija pod tlakom.
If you are not sure, talk to your doctor or pharmacist before using Bevespi Aerosphere. 
Če ste negotovi, se posvetujte z zdravnikom ali farmacevtom, preden uporabite zdravilo Bevespi Aerosphere.
Bevespi Aerosphere has no or negligible influence on the ability to drive and use machines. 
Zdravilo Bevespi Aerosphere nima vpliva ali ima zanemarljiv vpliv na sposobnost vožnje in upravljanja strojev, vendar sta omotica in navzea pogosta neželena učinka, kar je treba upoštevati pri vožnji ali upravljanju strojev.
Non-clinical data reveal no specific hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity and carcinogenic potential. 
Predklinični podatki na osnovi običajnih študij farmakološke varnosti, sistemske toksičnosti pri ponavljajočih se sistemskih odmerkih, genotoksičnosti in kancerogenega potenciala ne kažejo posebnega tveganja za človeka.
INHALER LABEL (PRESSURISED CONTAINER) 
NALEPKA INHALATORJA (TLAČNI VSEBNIK)
Do not use the inhaler if the drying agent has leaked out of its packet. 
Inhalatorja ne uporabite, če je sušilo izteklo iz svojega ovoja.
Other medicines and Bevespi Aerosphere 
Druga zdravila in zdravilo Bevespi Aerosphere
In patients with severe COPD, hypokalaemia may be potentiated by hypoxia and concomitant treatment (see section 4.5). 
Pri bolnikih s hudo KOPB lahko hipoksija in sočasno uporabljena zdravila okrepijo hipokaliemijo (glejte poglavje 4.5).
Effects on lung function 
Učinki na delovanje pljuč
Subjects with COPD with both low body weight and moderate-severe impaired renal function may have an approximate doubling of systemic exposure to glycopyrronium. 
Pri preiskovancih s KOPB in majhno telesno maso obenem z zmerno hudo okvaro ledvic je sistemska izpostavljenost glikopironiju lahko približno dvakratna.
1,2-distearoyl-sn-glycero-3-phosphocholine Calcium chloride 
1,2-distearoil-sn-glicero-3-fosfoholin kalcijev klorid
Do not use Bevespi Aerosphere if you are pregnant unless your doctor tells you that you can. 
Če ste noseči, ne uporabljajte zdravila Bevespi Aerosphere, razen če vam zdravnik svetuje, da ga lahko.
Pressurised inhalation, suspension (pressurised inhalation). 
inhalacijska suspenzija pod tlakom (inhalacijska tekočina pod tlakom)
Step 7: Breathe out gently (See Figure 12). 
Slika 11 7. korak: Počasi izdihnite (glejte sliko 12).
Table 2 Lung function, symptomatic and health related quality of life outcomes over 24 weeks Treatment comparisons with Bevespi 
Delovanje pljuč ter simptomatski izidi in izidi glede zdravstvene kakovosti življenja v 24 tednih
o Take the Bevespi Aerosphere inhaler out of the foil pouch. 
o Vzemite inhalator Bevespi Aerosphere iz vrečke iz folije.
If any of the above applies to you, or if you are not sure, talk to your doctor or pharmacist before using Bevespi Aerosphere. 
Če kaj od naštetega velja za vas, ali če ste negotovi, se posvetujte z zdravnikom ali farmacevtom, preden vzamete zdravilo Bevespi Aerosphere.
Bevespi Aerosphere should be administered with caution to patients being treated with medicinal products known to prolong the QTc interval (see section 4.4). 
Druga farmakodinamična medsebojna delovanja Zdravilo Bevespi Aerosphere je treba previdno uporabljati pri bolnikih, ki prejemajo zdravila, za katera je znano, da podaljšajo interval QTc (glejte poglavje 4.4).
In COPD, the muscles around the airways tighten which makes breathing difficult. 
Pri KOPB se mišice okrog dihalnih poti skrčijo in posledica je oteženo dihanje.
For inhalation use. 
Način uporabe za inhaliranje
o Do not use the Bevespi Aerosphere actuator with any other medicine. 
o Sprožilnika zdravila Bevespi Aerosphere ne uporabljajte z nobenim drugim zdravilom.
In patients with severe hepatic impairment, Bevespi Aerosphere should be used only if the expected benefit outweighs the potential risk (see section 5.2). 
Pri bolnikih s hudo okvaro jeter naj se zdravilo Bevespi Aerosphere uporablja le, če pričakovana korist odtehta možno tveganje (glejte poglavje 5.2).
In clinical studies, paradoxical bronchospasm was not observed with Bevespi Aerosphere at its recommended dose. 
V kliničnih študijah med uporabo zdravila Bevespi Aerosphere v priporočenem odmerku niso opažali paradoksnega bronhospazma.
On actuation of Bevespi Aerosphere, a volume of the suspension is expelled from the pressurised container at high velocity. 
Po sprožitvi inhalatorja Bevespi Aerosphere se iz tlačnega vsebnika z veliko hitrostjo sprosti določena količina suspenzije.
The largest mean (90% upper confidence bound) differences from placebo in baseline- and individually corrected QT was 3.1 (4.7) ms for Bevespi Aerosphere (14.4 /10 micrograms) and 7.6 (9.2) ms for glycopyrronium/formoterol with eight times the recommended dose of glycopyrronium and four times the recommended dose of formoterol. 
Rezultati s placebom in učinkovino (moksifloksacinom) kontrolirane temeljite študije QT ("thorough QT study") pri 69 zdravih preiskovancih niso dokazali klinično pomembnega vpliva na interval QT ob upoštevanju mejne vrednosti 10 ms. Največja povprečna (90 % zgornja meja zaupanja) razlika v intervalu QT glede na izhodiščno vrednost in korigirano za posameznika, je bila v primerjavi s placebom 3,1 (4,7) ms za zdravilo Bevespi Aerosphere (14,4/10 mikrogramov) in 7,6 (9,2) ms pri odmerjanju glikopironija/formoterola z osemkratno vrednostjo priporočenega odmerka glikopironija in štirikratno vrednostjo priporočenega odmerka formoterola.
This means that there are 110 puffs of medicine left in the pressurised container (See Figure 2b). 
To pomeni, da je v tlačnem vsebniku preostalo še 110 vpihov (glejte sliko 2b).
• Remove the cap from the mouthpiece (See Figure 3). 
• Odstranite pokrovček z ustnika (glejte sliko 3).
Read this instructions for use and the package leaflet before you start using Bevespi Aerosphere and each time you get a new inhaler. 
Ta navodila za uporabo zdravila in celotno Navodilo za uporabo preberite, preden začnete uporabljati zdravilo Bevespi Aerosphere.
• Bevespi Aerosphere comes as a pressurised container with a dose indicator that fits into an actuator. 
• Zdravilo Bevespi Aerosphere je na voljo v tlačnem vsebniku, ki ima kazalnik odmerka in je vložen v sprožilnik.
Bevespi Aerosphere contains two active substances called glycopyrronium and formoterol fumarate dihydrate. 
Zdravilo Bevespi Aerosphere vsebuje dve učinkovini imenovani glikopironij in formoterolijev fumarat dihidrat.
If you forget to use Bevespi Aerosphere 
Če ste pozabili uporabiti zdravilo Bevespi Aerosphere
Based on available data, no adjustment of the dosage of Bevespi Aerosphere in geriatric patients is necessary. 
Glede na podatke, ki so na voljo, starejšim bolnikom odmerka zdravila Bevespi Aerosphere ni treba prilagoditi.
The parts of your Bevespi Aerosphere inhaler (See Figure 1): 
Deli inhalatorja Bevespi Aerosphere (glejte sliko 1):
Improvements compared to formoterol were observed in PINNACLE 2 (see Table 2). 
V študiji PINNACLE 2 so opažali izboljšanje v primerjavi z uporabo formoterola (glejte preglednico 2).
Pharmacotherapeutic group: Drugs for obstructive airway diseases: adrenergics in combination with anticholinergics, ATC code: R03AL07. 
Farmakoterapevtska skupina: Zdravila za obstruktivne pljučne bolezni, adrenergiki v kombinaciji z antiholinergiki.
o Do not use the Bevespi Aerosphere pressurised container with an actuator from any other inhaler. 
o Tlačnega vsebnika z zdravilom Bevespi Aerosphere ne uporabljajte z nobenim drugim sprožilnikom iz katerega od drugih inhalatorjev.
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. 
Študije vpliva na sposobnost razmnoževanja na živalih z glikopironijem so pokazale manjšo maso plodov pri podganah in kuncih ter slabo pridobivanje telesne mase podganjih mladičev pred odstavitvijo pri precej večji sistemski izpostavljenosti od dosežene pri klinični uporabi.
Do not use Bevespi Aerosphere if you are breast-feeding unless your doctor tells you that you can. 
Če dojite, ne uporabljajte zdravila Bevespi Aerosphere, razen če vam zdravnik svetuje, da ga lahko.
Bevespi Aerosphere 7.2 micrograms/5 micrograms pressurised inhalation, suspension 
Bevespi Aerosphere 7,2 mikrograma/5 mikrogramov inhalacijska suspenzija pod tlakom
• The pointer points between 100 and 120 after you use 10 more puffs. 
• Po uporabi dodatnih 10 vpihov kazalec kaže med oznaki 100 in 120.
If you find it difficult breathing in and pressing the inhaler at the same time talk to your doctor or pharmacist. 
Uporaba zdravila Bevespi Aerosphere z ustnikom Če težko hkrati vdihnete in pritisnete inhalator, se posvetujte z zdravnikom ali farmacevtom.
o Throw away the pouch and the drying packet. 
o Vrečko in zavojček s sušilnim sredstvom zavrzite.
Glycopyrronium (N=451) 
z glikopironijem (N = 451)
This means that there are 120 puffs of medicine left in the pressurised container (See Figure 2a). 
To pomeni, da je v tlačnem vsebniku preostalo še 120 vpihov (glejte sliko 2a).
No pharmacokinetic studies have been performed with Bevespi Aerosphere in patients with hepatic impairment. 
Z zdravilom Bevespi Aerosphere niso izvedli farmakokinetičnih študij pri bolnikih z okvaro jeter.
This means that there are 100 puffs of medicine left in the pressurised container (See Figure 2c). 
To pomeni, da je v tlačnem vsebniku preostalo še 100 vpihov (glejte sliko 2c).
Glycopyrronium (N=439) 
z glikopironijem (N = 439)
• feeling sick (nausea) 
• občutek slabosti s siljenjem na bruhanje (navzea)
The other ingredients are norflurane, 1,2- distearoyl-sn-glycero-3-phosphocholine and calcium chloride. 
Druge sestavine zdravila so norfluran, 1,2-distearoil-sn-glicero-3-fosfoholin in kalcijev klorid.
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. 
To ustreza odmerjenemu odmerku 8,3 mikrograma glikopironija v obliki 10,4 mikrograma glikopironijevega bromida in 5,8 mikrograma formoterolijevega fumarata dihidrata.
If you stop using Bevespi Aerosphere 
Če ste prenehali uporabljati zdravilo Bevespi Aerosphere
The terminal elimination half-life of formoterol following oral inhalation derived via population pharmacokinetics analysis was 13 hours. 
S populacijsko farmakokinetično analizo ocenjeni končni razpolovni čas izločanja formoterola po peroralni inhalaciji je bil 13 ur.
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]. 
Zdravilo Bevespi Aerosphere je v 24 tednih izboljšalo tudi najvišji FEV1 v 2 urah po odmerku v primerjavi s placebom, glikopironijem in formoterolom (p < 0,0001) [glejte preglednico 2].
What Bevespi Aerosphere looks like and contents of the pack 
Izgled zdravila Bevespi Aerosphere in vsebina pakiranja
• Your Bevespi Aerosphere inhaler comes in a foil pouch that contains a drying packet (desiccant). 
• Zdravilo Bevespi Aerosphere je na voljo v vrečki iz folije, ki vsebuje zavojček s sušilnim sredstvom (sušilom).
number in Intent to Treat population primary endpoint in all studies PINNACLE 1 and PINNACLE 2 used SAC-TDI. 
V študijah PINNACLE 1 in PINNACLE 2 so uporabili SAC-TDI.
Repeat steps 2 to 7 to take your second puff of Bevespi Aerosphere. 
Za drugi vpih zdravila Bevespi Aerosphere ponovite postopek od 2. do 7. koraka.
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. 
14,4 do 115,2 mikrogramov) in pri formoterolu (razpon odmerkov: od 2,4 do 19,2 mikrogramov).
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. 
Pri podganah in miših, ki so prejemale formoterol, so opažali rahlo povečanje pojavnosti materničnih leiomiomov; ta učinek je domnevno učinek skupine pri glodalcih po dolgotrajni izpostavljenosti velikim odmerkom agonistov adrenergičnih receptorjev β2.
Table 1Adverse reactions by frequency and system organ class (SOC) 
Neželeni učinki po pogostnosti in organskih sistemih Organski sistem
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]. 
V študijah PINNACLE 1, PINNACLE 2 in PINNACLE 4 je zdravilo Bevespi Aerosphere v 24 tednih izboljšalo najnižji FEV1 v primerjavi s placebom, glikopironijem in formoterolom (p < 0,0001) [glejte preglednico 2].
Your inhaler may not feel empty and it may seem as though it still works. 
Morda se vam bo zdelo, da inhalator še ni povsem prazen in da še deluje, vendar v primeru nadaljnje uporabe ne bi več prejeli pravilne količine zdravila pri vpihu.
Preparing your Bevespi Aerosphere inhaler for use: 
Priprava inhalatorja Bevespi Aerosphere za uporabo:
Evidence of transfer of glycopyrronium and formoterol into maternal milk in rats has been reported. 
Pri podganah so poročali o dokazih prehajanja glikopironija in formoterola v mleko.
The terminal elimination half-life of glycopyrronium following oral inhalation derived via population pharmacokinetics analysis was 15 hours. 
S populacijsko farmakokinetično analizo ocenjeni končni razpolovni čas izločanja glikopironija po peroralni inhalaciji je bil 15 ur.
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. 
Farmakokinetiko formoterola je najbolje opisal dvoprostorni model odstranjevanja s konstanto absorpcije prvega reda in linearnim izločanjem.
Shake the inhaler well before each priming puff. 
Pred vsakim sproščanjem vpiha osnovne priprave inhalator dobro pretresite.
Bevespi Aerosphere is for inhalation use. 
Zdravilo Bevespi Aerosphere je namenjeno za inhaliranje.
TOP VIEW 
POGLED OD ZGORAJ
Immediate breathing difficulties If you get tightness of the chest, coughing, wheezing or breathlessness immediately after using Bevespi Aerosphere: Stop using this medicine and seek medical help immediately, as you may have a serious condition called paradoxical bronchospasm. 
Prenehajte uporabljati to zdravilo in takoj poiščite zdravniško pomoč, saj gre lahko za resno stanje, ki ga imenujemo paradoksni bronhospazem.
Do not press down too hard on the pressurised container. 
Na tlačni vsebnik ne pritiskajte premočno, da ne bi sprožili sprostitve vpiha zdravila.
Norflurane 1,2-distearoyl-sn-glycero-3-phosphocholine and calcium chloride. 
norfluran, 1,2-distearoil-sn-glicero-3-fosfoholin in kalcijev klorid
There were improvements compared to formoterol in PINNACLE 1 and PINNACLE 2. 
V študijah PINNACLE 1 in PINNACLE 2 je prišlo do izboljšanja v primerjavi s formoterolom.
How to use Bevespi Aerosphere 
Kako uporabljati zdravilo Bevespi Aerosphere
Agitation Restlessness Insomnia 
Psihiatrične motnje anksioznost pogosti agitiranost nemir nespečnost občasni
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]. 
V študijah PINNACLE 1, PINNACLE 2 in PINNACLE 4 je zdravilo Bevespi Aerosphere izboljšalo za bolezen specifično zdravstveno kakovost življenja, ugotovljeno z zmanjšanjem celotne ocene SGQR (St. George's Respiratory Questionnaire), v 24 tednih v primerjavi s placebom in glikopironijem [glejte preglednico 2].
It is unlikely that this medicine will affect your ability to drive and use machines. 
Ni verjetno, da bi to zdravilo vplivalo na vašo sposobnost upravljanja vozil in strojev, vendar lahko pride do omotice in slabosti s siljenjem na bruhanje, ki sta pogosta neželena učinka zdravila.
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. 
S populacijsko farmakokinetično analizo ocenjeni Vc/F (volumen centralnega prostora) glikopironija je 741 l in njegov Vp1/F (volumen perifernega prostora) je 2990 l. V razponu koncentracij od 2 do 500 nmol/l je segala vezava glikopironija na beljakovine v plazmi od 43 do 54 %.
In three Phase III, 24-week studies (PINNACLE 1, PINNACLE 2 and PINNACLE 4) Bevespi Aerosphere provided improvements over placebo in lung function (as measured by morning pre-dose trough forced expiratory volume in 1 second [FEV1]), with a demonstrated onset of action at 5 minutes following administration of the first dose on Day 1 (improvement over placebo by 187 mL, 186 mL and 179 mL in PINNACLE 1, PINNACLE 2 and PINNACLE 4, respectively [p <0.001]). 
Dokazan je bil začetek delovanja v 5 minutah po uporabi prvega odmerka 1. dan (izboljšanje v primerjavi s placebom za 187 ml v PINNACLE 1, za 186 ml v PINNACLE 2 in za 179 ml v PINNACLE 4 [p < 0,001]).
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. 
Zdravilo Bevespi Aerosphere je na voljo v vrečki iz folije, ki vsebuje zavojček s sušilnim sredstvom (sušilom) in je pakirana v škatli.
France or 
Francija ali
Dose adjustments are not necessary based on the effect of age, sex and weight on the pharmacokinetic parameters of glycopyrronium and formoterol. 
Glede na farmakokinetične parametre glikopironija in formoterola prilagajanje odmerka na osnovi starosti, spola in telesne mase ni potrebno.