natgillin/translations-raw huggingface dataset:
These include: o corticosteroids that you take by mouth (such as prednisolone), o diuretics (such as furosemide or hydrochlorothiazide) used for high blood pressure, o some medicines used to treat breathing conditions called methylxanthines (such as theophylline);
Med takšnimi so: o kortikosteroidi, ki jih zaužijete (peroralni kortikosteroidi), na primer prednizolon, o diuretiki (na primer furosemid ali hidroklorotiazid), ki jih uporabljamo pri zvišanem krvnem tlaku, o nekatera zdravila, imenovana metilksantini, ki se uporabljajo za zdravljenje težav z dihanjem (na primer teofilin).
β-adrenergic blockers β-adrenergic blockers (including eye drops) can weaken or inhibit the effect of β2-adrenergic agonists, such as formoterol.
Blokatorji adrenergičnih receptorjev β (vključno s kapljicami za oči) lahko zmanjšajo ali zavirajo učinek agonistov adrenergičnih receptorjev β2, kot je formoterol.
If you have used more Bevespi Aerosphere than you should, talk to a doctor or pharmacist immediately.
Če ste uporabili več zdravila Bevespi Aerosphere, kot bi smeli, se takoj posvetujte z zdravnikom ali farmacevtom.
Although no formal in-vivo drug interaction studies have been performed with Bevespi Aerosphere, studies indicate no clinical evidence of interactions when used concomitantly with other COPD medicinal products including short-acting β2-adrenergic bronchodilators, methylxanthines, and oral and inhaled steroids.
Z zdravilom Bevespi Aerosphere sicer niso izvedli formalnih študij medsebojnega delovanja zdravil in vivo, vendar študije niso pokazale kliničnih znakov medsebojnih delovanj med sočasno uporabo z drugimi zdravili za KOPB, vključno s kratkodelujočimi β2-adrenergičnimi bronhodilatatorji, metilksantini ter peroralnimi in inhalacijskimi steroidi.
Renal function was found not to affect exposure to formoterol.
Delovanje ledvic ne vpliva na izpostavljenost formoterolu.
Bevespi Aerosphere is used regularly for long-term treatment of COPD.
Zdravilo Bevespi Aerosphere se uporablja redno za dolgotrajno zdravljenje KOPB.
Bevespi Aerosphere is not indicated for the treatment of acute episodes of bronchospasm, i.e. as a rescue therapy.
Zdravilo Bevespi Aerosphere ni indicirano za zdravljenje akutnih napadov bronhospazma, tj. ni indicirano kot rešilno zdravilo.
What Bevespi Aerosphere is and what it is used for
Kaj je zdravilo Bevespi Aerosphere in za kaj ga uporabljamo
There are no relevant data on the use of Bevespi Aerosphere in patients with severe hepatic impairment and the medicinal product should be used with caution in these patients (see sections 4.4 and 5.2).
O uporabi zdravila Bevespi Aerosphere pri bolnikih s hudo okvaro jeter ni ustreznih podatkov in pri takšnih bolnikih je treba to zdravilo uporabljati previdno (glejte poglavji 4.4 in 5.2).
Caution should also be exercised in patients with thyrotoxicosis or known or suspected prolongation of the QTc interval (see section 4.5).
Prav tako je previdnost potrebna pri bolnikih s tirotoksikozo ali znanim podaljšanjem intervala QTc ali sumom nanj (glejte poglavje 4.5).
The pharmacokinetics of glycopyrronium was best described by a two-compartment disposition model with first-order absorption and linear elimination.
Farmakokinetiko glikopironija je najbolje opisal dvoprostorni model odstranjevanja z absorpcijo prvega reda in linearnim izločanjem.
As a consequence of the differential density of muscarinic receptors and β2-adrenoceptors in the central and peripheral airways of the lung, muscarinic antagonists are more effective in relaxing central airways, and β2-adrenergic agonists are more effective in relaxing peripheral airways; relaxation of both central and peripheral airways with combination treatment may contribute to its beneficial effects on lung function.
Zaradi različne gostote muskarinskih receptorjev in adrenergičnih receptorjev β2 med osrednjimi in perifernimi dihalnimi potmi v pljučih, muskarinski antagonisti učinkoviteje sproščajo osrednje dihalne poti in adrenergični receptorji β2 učinkoviteje sproščajo periferne dihalne poti.
Bevespi Aerosphere should not be used to treat asthma.
Zdravila Bevespi Aerosphere se ne sme uporabljati za zdravljenje astme.
When the patient inhales through the mouthpiece at the same time as actuating the inhaler, the substance will follow the inspired air into the airways.
Če bolnik hkrati s sprožitvijo inhalatorja inhalira skozi ustnik, sproščena suspenzija sledi vdihanemu zraku v dihala.
Peak FEV1 (ml)
Najvišji FEV1 (ml)
If you do not use your Bevespi Aerosphere for more than 7 days or if exposed to low temperatures or is dropped:
Če inhalatorja Bevespi Aerosphere ne uporabljate več kot 7 dni, če je izpostavljen nizki temperaturi ali če vam kam pade:
Before you use Bevespi Aerosphere for the first time, you must prime the inhaler.
Preden inhalator Bevespi Aerosphere prvič uporabite, morate opraviti njegovo osnovno pripravo.
If you are not sure of how to use Bevespi Aerosphere, contact your doctor or pharmacist.
Če niste prepričani, kako uporabiti zdravilo Bevespi Aerosphere, se posvetujte z zdravnikom ali farmacevtom.
There were no major differences in total systemic exposure (AUC) for both compounds between healthy Japanese and Western subjects.
Med zdravimi japonskimi in zahodnimi preiskovanci ni bilo večjih razlik v celotni sistemski izpostavljenosti (AUC) ne za eno ne za drugo učinkovino.
If you do not use your Bevespi Aerosphere for more than 7 days, or if the inhaler is exposed to low temperatures or has been dropped, you will need to re-prime it before use.
Če inhalatorja Bevespi Aerosphere ne uporabite več kot 7 dni, če je izpostavljen nizki temperaturi ali vam je kam padel, ga boste morali pred uporabo znova pripraviti.
• Not use the inhaler if the drying agent, which is inside the foil pouch, has leaked out of its packet.
• Naj inhalatorja ne uporabi, če se je sušilno sredstvo, ki je v vrečki iz folije, izteklo iz svojega ovoja.
Inhalation of high doses of β2-adrenergic agonists may produce increases in plasma glucose.
Inhaliranje velikih odmerkov agonistov adrenergičnih receptorjev β2 lahko zveča koncentracijo glukoze v plazmi.
Administration of Bevespi Aerosphere to women who are breast-feeding should only be considered if the expected benefit to the mother is greater than any possible risk to the infant (see section 5.3).
Uporaba zdravila Bevespi Aerosphere pride pri doječih ženskah v poštev le v primeru, da je pričakovana korist za mater večja od vsakega možnega tveganja za dojenčka (glejte poglavje 5.3).
CYP2D6 was found to be the predominant enzyme involved in the metabolism of glycopyrronium.
CYP2D6 je glavni encim, ki sodeluje v presnovi glikopironija.
Patients who find it difficult to co-ordinate actuation with inspiration of breath may use Bevespi Aerosphere with a spacer to ensure proper administration of the product.
Bolniki, ki težko uskladijo sprožitev z vdihom, lahko uporabijo zdravilo Bevespi Aerosphere z ustnikom za zagotovitev ustreznega dajanja zdravila.
Cardiac arrhythmias (atrial fibrillation, supraventricular tachycardia, and extrasystoles)
Srčne bolezni tahikardija palpitacije motnje srčnega ritma (atrijska fibrilacija, supraventrikularna tahikardija in ekstrasistole)
Figure 17 Step 7: When the actuator is dry, gently press the pressurised container down in the actuator (See Figure 18).
Slika 17 7. korak: Ko je sprožilnik suh, vanj previdno potisnite tlačni vsebnik (glejte sliko 18).
What you need to know before you use Bevespi Aerosphere
Kaj morate vedeti, preden boste uporabili zdravilo Bevespi Aerosphere
Figure 2b 110 puffs
Slika 2b 110 vpihov
The dose indicator display window shows how many puffs of medicine you have left.
Okence kazalnika odmerka kaže, koliko vpihov zdravila je še preostalo v inhalatorju.
Musculoskeletal and connective tissue disorders
Bolezni mišično-skeletnega sistema in vezivnega tkiva mišični spazmi pogosti
Bevespi Aerosphere is indicated as a maintenance bronchodilator treatment to relieve symptoms in adult patients with chronic obstructive pulmonary disease (COPD) (see section 5.1).
Zdravilo Bevespi Aerosphere je indicirano kot vzdrževalno bronhodilatacijsko zdravljenje za olajšanje simptomov pri odraslih bolnikih s kronično obstruktivno pljučno boleznijo (KOPB) (glejte poglavje 5.1).
No evidence of carcinogenicity was seen in 2-year studies in rats and mice.
V dveletnih študijah na podganah in miših niso ugotovili znakov karcinogenosti.
Single-dose studies in humans found that very small amounts of glycopyrronium passed the placental barrier.
Študije enkratnih odmerkov pri človeku so pokazale zelo majhno prehajanje glikopironija skozi placentno pregrado.
Bevespi Aerosphere should be used with caution in patients with severe cardiovascular disorders, such as ischaemic heart disease, tachyarrhythmias or severe heart failure.
Zdravilo Bevespi Aerosphere je treba previdno uporabljati pri bolnikih s hudimi srčno-žilnimi boleznimi, na primer z ishemično boleznijo srca, tahikardnimi motnjami srčnega ritma ali hudim srčnim popuščanjem.
Bevespi Aerosphere contains two bronchodilators: glycopyrronium a long-acting muscarinic antagonist (also referred to as an anticholinergic) and formoterol a long-acting β2-adrenergic agonist with a rapid onset of action.
Zdravilo Bevespi Aerosphere vsebuje dva bronhodilatatorja: dolgodelujoč muskarinski antagonist (imenovan tudi antiholinergik) glikopironij in dolgodelujoč agonist adrenergičnih receptorjev β2 s hitrim začetkom delovanja formoterol.
The use of Bevespi Aerosphere with the Aerochamber Plus Flow-Vu spacer in COPD patients increased the total systemic exposure to glycopyrronium (as measured by AUC0-12) by 16% while formoterol exposure was unchanged.
Uporaba zdravila Bevespi Aerosphere z ustnikom Aerochamber Plus Flow-Vu je pri bolnikih s KOPB povečala celotno sistemsko izpostavljenost glikopironiju (merjeno z AUC0-12) za 16 %, izpostavljenost formoterolu pa se ni spremenila.
Animal reproduction studies with formoterol have shown a slightly reduced fertility in male rats at high systemic exposure and implantation losses, as well as decreased early postnatal survival and birth weight at considerably higher systemic exposures than those reached during clinical use.
Študije vpliva na sposobnost razmnoževanja na živalih so s formoterolom pokazale rahlo zmanjšano plodnost samcev ob veliki sistemski izpostavljenosti ter implantacijske izgube, pa tudi manjše zgodnje postnatalno preživetje in porodno telesno maso ob bistveno večjih sistemskih izpostavljenostih, kakor so dosežene med klinično uporabo.
Multipack containing 3 inhalers each with 120 actuations.
Skupno pakiranje, ki vsebuje 3 inhalatorje, vsak s 120 sprožitvami.
Using your Bevespi Aerosphere inhaler: Step 1: Remove the cap from the mouthpiece (See Figure 6).
Uporaba inhalatorja Bevespi Aerosphere: 1. korak: Odstranite pokrovček z ustnika (glejte sliko 6).
Carton containing 1 inhaler with 120 actuations.
Škatla, ki vsebuje 1 inhalator s 120 sprožitvami.
The excretion of formoterol was studied in six healthy subjects following simultaneous administration of radiolabelled formoterol via the oral and IV routes.
Izločanje formoterola so raziskali pri šestih zdravih preiskovancih po sočasni peroralni in intravenski uporabi radioaktivno označenega formoterola.
Glycopyrronium did not cause any adverse effects on fertility in rats.
Pri podganah glikopironij ni povzročal neželenih učinkov na plodnost.
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).
Zdravilo Bevespi Aerosphere je na voljo v tlačnem vsebniku s kazalnikom odmerka, opremljenim z belim plastičnim telesom sprožilnika in ustnikom (glejte sliko 1 v "Navodilih za uporabo zdravila" na koncu teh navodil za uporabo).
Step 3: Hold the inhaler with the mouthpiece pointing towards you and breathe out as fully as you comfortably can through your mouth (See Figure 8).
Slika 7 3. korak: Držite inhalator z ustnikom obrnjenim proti sebi in skozi usta izdihnite tako globoko, kot lahko, ne da bi vam bilo neprijetno (glejte sliko 8).
SIDE VIEW
POGLED OD STRANI
Clinical drug-drug interaction studies have not been conducted with Bevespi Aerosphere, however, the potential for metabolic interactions is considered to be low based on in-vitro studies (see section 5.2).
Kliničnih študij medsebojnega delovanja zdravil z zdravilom Bevespi Aerosphere niso izvedli, toda glede na študije in vitro je možnost presnovnih medsebojnih delovanj majhna (glejte poglavje 5.2).
Drug-induced hypokalaemia
Z zdravilom povzročena hipokaliemija
A population pharmacokinetic analysis of formoterol was performed based on data collected in a total of 437 subjects with COPD.
Populacijska farmakokinetična analiza formoterola je zajela podatke skupno 437 preiskovancev s KOPB.
Do not clean the pressurised container or let it get wet.
Tlačnega vsebnika ne čistite in pazite, da se ne zmoči.
Immune system disorders Hypersensitivity reactions including rash and pruritus
Bolezni imunskega sistema preobčutljivostne reakcije vključno z izpuščajem in srbenjem občasni
CARTON - SINGLE INHALER
ŠKATLA - EN INHALATOR
If you have any further questions on the use of this medicine, talk to your doctor or pharmacist.
Če imate dodatna vprašanja o uporabi zdravila, se posvetujte z zdravnikom ali farmacevtom.
Step 2: Take the cap off the mouthpiece.
2. korak: Snemite pokrovček z ustnika.
If you use more Bevespi Aerosphere than you should
Če ste uporabili večji odmerek zdravila Bevespi Aerosphere, kot bi smeli
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.