natgillin/translations-raw huggingface dataset:
The estimated 3-year probability of having pneumonia reported as an adverse event was 12.3% for placebo, 13.3% for salmeterol, 18.3% for FP and 19.6% for salmeterol/fluticasone propionate (hazard ratio for salmeterol/fluticasone propionate vs placebo: 1.64, 95% CI: 1.33 to 2.01, p<0.001). 
Ocenjena triletna verjetnost pljučnice kot neželenega učinka je bila 12,3 % za placebo, 13,3 % za salmeterol, 18,3 % za FP in 19,6 % za salmeterol/flutikazonpropionat (razmerje ogroženosti za salmeterol/flutikazonpropionat v primerjavi s placebom: 1,64; 95-odstotni IZ: 1,33 do 2,01, p < 0,001).
Aerivio Spiromax is not recommended for use in children and adolescents aged less than 18 years. 
Uporaba zdravila Aerivio Spiromax ni priporočljiva pri otrocih in mladostnikih, mlajših od 18 let.
As Aerivio Spiromax contains salmeterol and fluticasone propionate, the type and severity of adverse reactions associated with each of the active substance may be expected. 
Zdravilo Aerivio Spiromax vsebuje salmeterol in flutikazonpropionat, zato je mogoče pričakovati takšno vrsto in izrazitost neželenih učinkov, kot so povezane z vsako posamezno od teh dveh učinkovin.
If you are not getting enough medicine into your lungs, it will not help your 
Če niste dobili dovolj zdravila v pljuča, to ne bo pomagalo zdraviti astme ali KOPB, kot bi moralo.
Aerivio Spiromax is not indicated for use in children, 12 years of age and younger or adolescents, 13 to 17 years of age. 
Zdravilo Aerivio Spiromax ni indicirano za uporabo pri otrocih, starih 12 let in manj, ali mladostnikih, starih, od 13 do 17 let.
Patients are not required to shake the inhaler prior to use. 
Stresanje inhalatorja pred uporabo ni potrebno.
Regular review of patients as treatment is stepped down is important. 
Pri bolnikih, ki so prešli na blažje zdravljenje, so pomembni redni pregledi.
The concomitant administration of ketoconazole should be avoided, unless the benefits outweigh the potentially increased risk of systemic effects of salmeterol treatment. 
Sočasnemu dajanju ketokonazola se je treba izogniti, razen če koristi odtehtajo možna povečana tveganja sistemskih učinkov zdravljenja s salmeterolom.
• Thrush (sore, creamy-yellow, raised patches) in the mouth and throat. 
• kandidoza (boleči, kremasto-rumeni, dvignjeni predeli) v ustih in grlu Pekoč jezik, hripavost in draženje žrela.
• Feeling worried (although this effect occurs mainly in children when prescribed this combination of 
• občutek zaskrbljenosti (čeprav se ta učinek običajno pojavi pri otrocih, ki se jim predpiše ta kombinacija zdravil v manjši jakosti);
Under normal circumstances, low plasma concentrations of fluticasone propionate are achieved after inhaled dosing, due to extensive first pass metabolism and high systemic clearance mediated by cytochrome P450 
Po inhalacijski uporabi je koncentracija flutikazonpropionata v plazmi v normalnih okoliščinah majhna zaradi obsežne presnove prvega prehoda in velikega sistemskega očistka s citokromom P450 3A4 v črevesju in jetrih.
When your body is under stress such as from fever, trauma (such as an accident or injury), infection, or surgery, adrenal insufficiency can get worse and you may have any of the side effects listed above. 
• nizek krvni tlak in epileptične napade (konvulzije) Če je telo v stresu, na primer zaradi zvišane telesne temperature, poškodbe (npr. zaradi nesreče), okužbe ali kirurškega posega, se lahko oslabljeno delovanje nadledvične žleze poslabša in pojavijo se lahko zgoraj našteti neželeni učinki.
The dose of inhaled corticosteroid should always be reduced to the lowest dose at which effective control of asthma is maintained. 
Odmerek inhalacijskega kortikosteroida je treba vedno zmanjšati na najmanjši odmerek, ki še zagotavlja učinkovito
There were no other differences in safety profile between the treatment arms. 
Med obema zdravljenima skupinama glede varnostnih profilov ni bilo razlik.
GOAL showed more patients treated with salmeterol/fluticasone propionate achieved asthma control than patients treated with inhaled corticosteroid (ICS) alone and this control was attained at a lower corticosteroid dose. 
Študija GOAL je pokazala, da je nadzorovanje simptomov astme doseglo več bolnikov, ki so dobivali salmeterol/flutikazonproprionat, kot bolnikov, ki so dobivali samo IKS in da je bilo to obvladanje doseženo pri manjših odmerkih kortikosteroida.
Once asthma symptoms are controlled, consideration may be given to gradually reducing the dose of the inhaled corticosteroid and therefore a change to an alternative fixed-dose combination of salmeterol and fluticasone propionate containing a lower dose of the inhaled corticosteroid is required. 
Ko so simptomi astme pod nadzorom, je možno razmisliti o postopnem zmanjšanju odmerka inhalacijskega kortikosteroida, za kar je potreben prehod na drugo fiksno kombinacijo odmerka salmeterola in flutikazonpropionata, ki vsebuje manjši odmerek inhalacijskega kortikosteroida.
The increased incidence of reported pneumonia with salmeterol/fluticasone propionate 50/250 micrograms twice daily appears to be of similar magnitude to the incidence reported following treatment with salmeterol/fluticasone propionate 50/500 micrograms twice daily in TORCH. 
Kot kaže, je večja incidenca zabeleženih pljučnic s salmeterolom/flutikazonpropionatom 50/250 mikrogramov dvakrat na dan podobne velikosti kot incidenca, opisana po zdravljenju s salmeterolom/flutikazonpropionatom 50/500 mikrogramov dvakrat na dan v študiji TORCH.
There was an increased reporting of lower respiratory tract infections (particularly pneumonia and bronchitis) in the TORCH study in patients with COPD receiving salmeterol/fluticasone propionate 50/500 micrograms twice daily compared with placebo as well as in studies SCO40043 and SCO100250 comparing a lower dose of salmeterol/fluticasone propionate 50/250 micrograms twice daily, (a dose not authorised for use in COPD) with salmeterol 50 micrograms twice daily only (see section 4.8 and section 5.1). 
V študiji TORCH so pri bolnikih s KOPB, ki so prejemali salmeterol/flutikazonpropionat 50/500 mikrogramov dvakrat na dan, v primerjavi s placebom pogosteje poročali o okužbah spodnjih dihal (še zlasti o pljučnici in bronhitisu); prav tako kot v študijah SCO40043 in SCO100250 pri bolnikih, ki so prejemali manjši odmerek salmeterola/flutikazonpropionata 50/250 mikrogramov dvakrat na dan (odmerek, ki ni odobren za zdravljenje KOPB) v primerjavi s 50 mikrogramov salmeterola dvakrat na dan (glejte poglavji 4.8 in 5.1).
Breathe out gently (as far as is comfortable). 
Rahlo izdihnite (dokler vam to še ne predstavlja težave).
Rarely, Aerivio Spiromax may cause cardiac arrhythmias e.g. supraventricular tachycardia, extrasystoles and atrial fibrillation, and a mild transient reduction in serum potassium at high therapeutic doses. 
Pri velikih terapevtskih odmerkih lahko zdravilo Aerivio Spiromax redko povzroči aritmije srca, npr. supraventrikularno tahikardijo, ekstrasistole in atrijsko fibrilacijo in blago prehodno znižanje kalija v serumu.
Co-administration of ketoconazole (400 mg orally once daily) and salmeterol (50 micrograms inhaled twice daily) in 15 healthy subjects for 7 days resulted in a significant increase in plasma salmeterol exposure (1.4fold Cmax and 15-fold AUC). 
7-dnevno sočasno dajanje ketokonazola (400 mg peroralno enkrat na dan) in salmeterola (50 mikrogramov inhalirano dvakrat na dan) pri 15 zdravih osebah je povzročilo povečanje izpostavljenosti salmeterolu v plazmi (1,4-kratna Cmax in 15-kratna AUC).
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder: 
Za vse morebitne nadaljnje informacije o tem zdravilu se lahko obrnete na predstavništvo imetnika
Co-administration of erythromycin (500 mg orally three times a day) and salmeterol (50 micrograms inhaled twice daily) in 15 healthy subjects for 6 days resulted in a small but non-statistically significant increase in salmeterol exposure (1.4-fold Cmax and 1.2-fold AUC). 
6-dnevna sočasna uporaba eritromicina (500 mg peroralno trikrat na dan) in salmeterola (50 mikrogramov inhalirano dvakrat na dan) pri 15 zdravih osebah je povzročila majhno, vendar statistično neznačilno povečanje izpostavljenosti salmeterolu (1,4-kratna Cmax in 1,2-kratna AUC).
A clear benefit has not been shown as compared with inhaled fluticasone propionate alone used as initial maintenance therapy when one or two of the criteria of severity are missing. 
V primeru odsotnosti enega ali dveh kriterijev za ocenitev stopnje bolezni očitna korist pri začetnem vzdrževalnem zdravljenju,v primerjavi z uporabo inhalacijskega flutikazonpropionata samega, ni bila dokazana.
Aerivio Spiromax 50 micrograms/500 micrograms inhalation powder salmeterol/fluticasone propionate 
Aerivio Spiromax 50 mikrogramov/500 mikrogramov prašek za inhaliranje salmeterol/flutikazonproprionat
There are no data available on the use of Aerivio Spiromax in patients with hepatic impairment. 
Podatkov o uporabi zdravila Aerivio Spiromax pri bolnikih z okvaro jeter ni.
See leaflet for further information 
Drugi viri informacij
In the subset of steroid naive asthmatics the time to an individual well controlled week was 16 days in the salmeterol/fluticasone propionate treatment compared with 23 days following treatment with ICS. 
Pri podskupini bolnikov z astmo, ki se predhodno še niso zdravili s kortikosteriodi, je bil posamezni teden z dobro nadzorovanostjo dosežen po 16 dneh zdravljenja s salmeterolom/flutikazonproprionatom v primerjavi s 23 dnevi zdravljenja z IKS.
Salmeterol/fluticasone propionate COPD - clinical trials TORCH was a 3-year study to assess the effect of treatment with salmeterol/fluticasone propionate inhalation powder 50/500 micrograms twice daily, salmeterol inhalation powder 50 micrograms twice daily, fluticasone propionate (FP) inhalation powder 500 micrograms twice daily or placebo on all-cause mortality in patients with COPD. 
Klinična preskušanja salmeterola/flutikazonpropionata pri KOPB TORCH je bila tri leta trajajoča študija, katere cilj je bil pri bolnikih s KOPB oceniti učinek zdravljenja s salmeterolom/flutikazonpropionatom 50/500 mikrogramov dvakrat na dan, s salmeterolom 50 mikrogramov dvakrat na dan, s flutikazonpropionatom (FP) 500 mikrogramov dvakrat na dan ali s placebom na umrljivost zaradi vseh vzrokov pri bolnikih s KOPB.
*Well controlled asthma was achieved more rapidly with salmeterol/fluticasone propionate than with ICS alone. 
S salmeterolom/flutikazonproprionatom je bila *dobra nadzorovanost astme dosežena hitreje kot z IKS samim.
Following co-administration, increased incidences of transposed umbilical artery and incomplete ossification of occipital bone were found in rats at doses associated with known glucocorticoid 
Po sočasnem dajanju so pri podganah ugotovili pogostejšo pojavnost transpozicije umbilikalne arterije in nepopolno osifikacijo okcipitalne kosti, in sicer pri odmerkih, za katere je znano, da so povezani z nepravilnostmi, ki jih povzročajo kortikosteroidi.
Once control of asthma is attained treatment should be reviewed and consideration given as to whether patients should be stepped down to an alternative fixed-dose combination of salmeterol and fluticasone propionate containing a lower dose of the inhaled corticosteroid and then ultimately to an inhaled corticosteroid alone. 
Ko je astma pod nadzorom, je treba zdravljenje oceniti in razmisliti o prehodu na alternativno fiksno kombinacijo odmerka salmeterola in flutikazonpropionata, ki vsebuje manjše odmerke inhalacijskega kortikosteroida, na koncu pa samo na inhalacijski kortikosteroid.
Both hoarseness and incidence of mouth and throat candidiasis may be relieved by rinsing the mouth with water and spitting the water out and/or brushing the teeth after using the product. 
Tako hripavost kot pojavnost kandidoze ustne votline in žrela je možno ublažiti s splakovanjem ustne votline z vodo, ki jo nato bolnik izpljune, in/ali ščetkanjem zob po uporabi zdravila.
In order to ensure that patients achieve the PIFR needed to deliver the required dose, the patient is required to be trained on the use of the Spiromax device including instruction on the need to inhale forcefully (see Section 4.2). 
Bolnika je treba uporabo pripomočka Spiromax usposobiti in prejeti mora navodila, kako silovito vdihniti, da zagotovi doseganje PIFR, potrebne za dostavo potrebnega odmerka (glejte poglavje 4.2).
One inhalation of 50 micrograms salmeterol and 500 micrograms fluticasone propionate twice daily. 
Ena inhalacija 50 mikrogramov salmeterola in 500 mikrogramov flutikazonpropionata dvakrat na dan.
If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse. 
Če imate dodatna vprašanja o uporabi zdravila, se posvetujte z zdravnikom, farmacevtom ali
Therefore, concomitant use should be avoided, unless the potential benefit to the patient outweighs the risk of systemic corticosteroid side effects. 
Zato se je sočasni uporabi treba izogibati, razen če možne koristi za bolnika odtehtajo tveganje sistemskih neželenih učinkov kortikosteroidov.
Tell your doctor, but do not stop taking Aerivio Spiromax unless the doctor tells you to stop. 
Povedati morate zdravniku, vendar ne nehajte uporabljati zdravila Aerivio Spiromax, dokler vam tega ne naroči
If you have not received this training please ask your doctor, nurse or pharmacist to show you how to use your inhaler properly before you use it for the first time. 
Če vas ni nihče naučil uporabljati inhalatorja, pred prvo uporabo prosite zdravnika, medicinsko sestro ali farmacevta, da vam pokaže, kako morate
Aerivio Spiromax is not recommended for use in either children aged 12 years of age and younger or in adolescents aged 13 to 17 years. 
Uporaba zdravila Aerivio Spiromax ni priporočljiva pri otrocih, starih 12 let in manj, ali mladostnikih, starih, od 13 do 17 let.
Increased requirements for use of reliever medication (short-acting bronchodilators), or decreased response to reliever medication indicate deterioration of asthma control and patients should be reviewed by a 
Če bolnikova uporaba zdravil za olajšanje (kratkodelujočih bronhodilatatorjev) narašča, to kaže na slabšanje nadzorovanosti bolezni in bolnikovo stanje mora zdravnik znova oceniti.
You can also report side effects directly via the national reporting system listed in Appendix V*. 
O neželenih učinkih lahko poročate tudi neposredno na nacionalni center za poročanje, ki je naveden v Prilogi V. S tem, ko poročate o neželenih učinkih, lahko prispevate k zagotovitvi več informacij o
Open the mouthpiece cover by folding it down until you hear one loud click. 
Pokrovček ustnika preganite navzdol, da zaslišite en glasen klik, in ga tako odprite.
The main part of the dose is excreted in faeces as metabolites and unchanged drug. 
Glavni del odmerka se izloči v blatu v obliki presnovkov in kot
• Write the date you opened the foil pouch on the label on the inhaler. 
Datum odprtja ovoja iz folije zabeležite na nalepki na inhalatorju.
Detailed information on this medicine is available on the European Medicines Agency web site: 
Podrobne informacije o zdravilu so objavljene na spletni strani Evropske agencije za zdravila http://www.ema.europa.eu
Aerivio Spiromax has no or negligible influence on the ability to drive and use machines. 
4.7 Vpliv na sposobnost vožnje in upravljanja strojev Zdravilo Aerivio Spiromax nima vpliva ali ima zanemarljiv vpliv na sposobnost vožnje in upravljanja
[3%] vs 1 [<1%]) and a similar incidence of inhaled corticosteroid related adverse events (e.g. oral candidiasis - 6 [6%] vs 16 [8%], hoarseness - 2 [2%] vs 4 [2%]) compared with one inhalation twice daily. 
Študija je pokazala, da je podvojitev obeh jakosti, salmeterola/flutikazonpropionata za do 14 dni povzročila majhno povečanje neželenih učinkov, povezanih z agonisti β (tremor - 1 bolnik [1 %] v primerjavi z 0, palpitacije - 6 [3 %] v primerjavi z 1 [< 1 %], mišični krči - 6 [3 %] v primerjavi z 1 [< 1 %]) in podobno pojavnost neželenih učinkov, povezanih z inhalacijo kortikosteroidov (npr. kandidazo ustne votline - 6 [6 %] v primerjavi s 16 [8 %], hripavost - 2 [2 %] v primerjavi s 4 [2 %]) v primerjavi z enim inhaliranjem dvakrat na dan.
Patients should also be advised to rinse their mouth with water and spit the water out, and/or brush their teeth 
Bolnikom je treba svetovati tudi, naj si po inhaliranju usta izplaknejo z vodo, ki naj jo nato izpljunejo, in/ali oščetkajo zobe (glejte poglavje 4.4)
Symptomatic mouth and throat candidiasis can be treated with topical antifungal therapy whilst still continuing with Aerivio Spiromax. 
Simptomatsko kandidozo ustne votline in žrela je mogoče zdraviti z lokalno antimikotično terapijo ob nadaljevanju uporabe zdravila Aerivio Spiromax.
When to start using a new Aerivio Spiromax 
Kdaj morate začeti uporabljati novo zdravilo Aerivio Spiromax
• Cataract (cloudy lens in the eye). 
• katarakta (motnjava očesne leče);
COPD One inhalation of 50 micrograms salmeterol and 500 micrograms fluticasone propionate twice daily. 
KOPB Ena inhalacija 50 mikrogramov salmeterola in 500 mikrogramov flutikazonpropionata dvakrat na dan.
Do not open and close the mouthpiece cover unless you are about to use your inhaler. 
Pokrovčka ustnika ne odpirajte in zapirajte, razen pri uporabi
A flow rate of greater than 60L/min is required for optimal delivery of drugs to the lungs through the multidose dry powder Spiromax inhaler. 
Za optimalno dostavo zdravila v pljuča skozi večodmerni inhalator Spiromax, ki vsebuje suhi prašek, je potrebna hitrost pretoka nad 60 l/min.
The combination should be avoided unless the benefit outweighs the increased risk of systemic glucocorticoid undesirable effects. 
Kombinaciji se je treba izogniti, razen če koristi odtehtajo večje tveganje za neželene učinke sistemskih glukokortikoidov.
All patients should be provided with training by the prescribing Health Care Professional on how to use Aerivio Spiromax. 
Vse bolnike mora o uporabi inhalatorja Spiromax za zdravilo Aerivio podučiti zdravstveni delavec.
Take care not to block the air vents. 
Ne zamašite zračnika.
Aerivio Spiromax should only be used to treat severe asthma in adults aged 18 years and older and 
Zdravilo Aerivio Spiromax se lahko uporablja le za zdravljenje hude astme pri odraslih, starih 18 let in več, in pri odraslih s KOPB.
How to store Aerivio Spiromax 
Kako uporabljati zdravilo Aerivio Spiromax
The inhaler is white with a semi-transparent yellow mouthpiece cover. 
Inhalator je bel pripomoček s polprozornim rumenim pokrovčkom za ustnik.
• A fungal infection in the oesophagus (food canal), which might cause difficulties in swallowing. 
• glivična okužba požiralnika, ki lahko povzroči težave pri požiranju.
Hypersensitivity reactions with the following 
Bolezni imunskega sistema preobčutljivostne reakcije, ki se kažejo kot:
Patients may notice a taste when using Aerivio Spiromax due to the lactose excipient. 
Bolniki bodo med uporabo zdravila Aerivio Spiromax v ustih občutili okus zaradi pomožne snovi
Appropriate treatment should be promptly 
Če je indicirano, je treba takoj uvesti
Aerivio Spiromax contains salmeterol and fluticasone propionate, which have differing modes of action. 
Mehanizem delovanja in farmakodinamični učinki Zdravilo Aerivio Spiromax vsebuje salmeterol in flutikazonpropionat, ki imata različna načina
Fluticasone propionate: 
Flutikazonproprionat
Talk to your doctor, pharmacist or nurse before using Aerivio Spiromax if you have: 
Pred začetkom uporabe zdravila Aerivio Spiromax se posvetujte z zdravnikom, farmacevtom ali medicinsko sestro, če imate
It is recommended to establish the appropriate dosage of inhaled corticosteroid before any fixed-dose combination can be used in patients with severe asthma. 
Pri bolnikih s hudo astmo je pred uvedbo katere koli fiksne kombinacije odmerka priporočljivo določiti ustrezni odmerek inhalacijskega kortikosteroida.
• Do not stop taking Aerivio Spiromax or reduce the dose of Aerivio Spiromax without talking to your doctor first. 
• Zdravila Aerivio Spiromax ne prenehajte jemati in ne zmanjšujte odmerka zdravila Aerivio
Aerivio Spiromax is only appropriate for use in the treatment of patients with severe asthma. 
Zdravilo Aerivio Spiromax je primerno le za uporabo pri zdravljenju bolnikov s hudo astmo.
The mouthpiece cover is fixed to your inhaler and must not be taken off. Do not use your inhaler if it is damaged or if the mouthpiece has come apart from your inhaler. 
Inhalatorja ne uporabljajte, če je poškodovan ali če se je ustnik ločil od inhalatorja.
Co-treatment with other potent CYP3A inhibitors, such as itraconazole, and moderate CYP3A inhibitors, such as erythromycin, is also expected to increase the systemic fluticasone propionate exposure and the risk of systemic undesirable effects. 
Pričakovati je, da sistemsko izpostavljenost flutikazonpropionatu in tveganje za sistemske neželene učinke poveča tudi sočasno zdravljenje z drugimi močnimi zaviralci CYP3A, npr. z itrakonazolom, in zmernimi zaviralci CYP3A, npr. z eritromicinom.
- patients not adequately controlled on a lower strength corticosteroid combination product 
- bolniki, pri katerih simptomi niso pod ustreznim nadzorom s kombiniranim zdravilom, ki
The recommended dose is: 
V celoti so rezultati študije pokazali:
The effects include: Slowing of growth in children and adolescents 
Ti učinki vključujejo: upočasnitev rasti pri otrocih in mladostnikih okrogel (lunast) obraz (Cushingov sindrom)
Rounded (moon shaped) face (Cushing's syndrome) Your doctor will check you regularly for any of these side effects and make sure you are taking the lowest dose of this combination of drugs to control your asthma. 
Zdravnik vas bo redno pregledoval za te neželene učinke in zagotovil, da uporabljate najmanjši odmerek te kombinacije zdravil za nadzorovanje astme.
• Increased number of colds have been reported in patients with chronic obstructive pulmonary disease 
• pri bolnikih s kronično obstruktivno pljučno boleznijo (KOPB) so poročali o večjem številu
The small increase in β agonist-related adverse events should be taken into account if doubling the dose of salmeterol/fluticasone propionate is considered by the physician in adult patients requiring additional shortterm (up to 14 days) inhaled corticosteroid therapy. 
Če zdravnik razmišlja, da bi odmerek salmeterola/flutikazonpropionata pri odraslih bolnikih, ki potrebujejo dodatno kratkoročno (do 14-dnevno) zdravljenje z inhalacijskimi kortikosteroidi, podvojil, mora upoštevati majhno povečanje neželenih učinkov, povezanih z agonisti β.
TC 
PC:
Allergic reactions to Aerivio Spiromax are uncommon (they may affect up to 1 in 100 people). 
Alergijske reakcije na zdravilo Aerivio Spiromax so občasne (pojavijo se lahko pri največ
• Overactive thyroid gland 
Deutschland Teva GmbH
When it is appropriate to titrate down to a lower strength not available for Aerivio Spiromax, a change to an alternative fixed-dose combination of salmeterol and fluticasone propionate containing a lower dose of the inhaled corticosteroid is 
Če je treba odmerek zmanjšati na manjšo jakost, ki je z zdravilom Aerivio Spiromax ni mogoče zagotoviti, ga je treba zamenjati za drugo zdravilo s fiksno kombinacijo odmerka salmeterola in flutikazonpropionata, ki vsebuje manjši odmerek inhalacijskega kortikosteroida.
Patients using inhaled steroids Patients not using inhaled steroids African-American patients (Risk in bold is statistically significant at the 95% level.) 
Bolniki afroameriškega porekla 20/2.366 (Tveganje, navedeno v krepkem tisku, je pri 95 % stopnji zaupanja statistično značilno.)
The following side effects have also been reported in patients with chronic obstructive pulmonary disease (COPD): 
Pri bolnikih s kronično obstruktivno pljučno boleznijo (KOPB) so poročali tudi o naslednjih neželenih
Aerivio Spiromax is for the treatment of patients with severe asthma only. 
Zdravilo Aerivio Spiromax je le za zdravljenje bolnikov s hudo astmo.
Key findings from SMART: primary endpoint Patient group 
Ključne ugotovitve študije SMART: primarni opazovani dogodek Število primarnih opazovanih dogodkov