natgillin/translations-raw huggingface dataset:
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 
Nakon istovremene primjene, povećana incidencija transpozicije umbilikalne arterije i nepotpune osifikacije okcipitalne kosti pronađena je u štakora pri dozama povezanima s poznatim abnormalnostima koje izazivaju glukokortikoidi.
Keep the mouthpiece cover closed and use within 3 months of removing from foil wrapping. 
Poklopac nastavka za usta držati zatvorenim i uporabiti unutar 3 mjeseca nakon uklanjanja omota od folije.
Patients should be made aware that Aerivio Spiromax must be used daily for optimum benefit, even when asymptomatic. 
Bolesnici trebaju biti svjesni da se za postizanje optimalne koristi Aerivio Spiromax mora primjenjivati svaki dan, čak i kad nema simptoma.
• You do not need to shake your inhaler before you use it. 
• Nije potrebno protresti inhalator prije uporabe.
Physicians should remain vigilant for the possible development of pneumonia in patients with COPD as the clinical features of such infections overlap with the symptoms of COPD exacerbations. 
Liječnici moraju paziti na mogući razvoj pneumonije u bolesnika s KOPB-om jer se klinička slika takvih infekcija preklapa sa simptomima egzacerbacije KOPB-a.
It is unknown whether salmeterol and fluticasone propionate /metabolites are excreted in human milk. 
Nije poznato izlučuju li se salmeterol i flutikazonpropionat /metaboliti u majčino mlijeko.
The dose of inhaled corticosteroid should always be reduced to the lowest dose at which effective control of asthma is maintained. 
Dozu inhalacijskog kortikosteroida uvijek treba sniziti na onu najnižu kojom se održava učinkovita kontrola astme.
The safety and efficacy of Aerivio Spiromax in children and adolescents aged less than 18 years of age has not been established. 
Sigurnost i djelotvornost Aerivio Spiromaxa u djece i adolescenata mlađih od 18 godina nije ustanovljena.
The impact of optimal training (i.e. breathing in forcefully upon inhalation) in dry powder inhaler inhalation technique on inhalation speed and volume was assessed in these subject groups, together with assessment of potential differences in inhalation outputs according to the devices used. 
U ovim je skupinama ispitanika bio procijenjen učinak optimalne poduke (tj. snažni udah prilikom inhalacije) na brzinu i volumen udaha kod tehnike udisanja suhog praška iz inhalatora, zajedno s procjenom mogućih razlika u inhalacijskim rezultatima s obzirom na uporabljeni inhalator.
D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE 
UVJETI ILI OGRANIČENJA VEZANI UZ SIGURNU I UČINKOVITU
In an interaction study in healthy subjects with intranasal fluticasone propionate, ritonavir (a highly potent cytochrome P450 3A4 inhibitor) 100 mg twice daily increased the fluticasone propionate plasma concentrations several hundred fold, resulting in markedly reduced serum cortisol concentrations. 
U ispitivanju interakcija u zdravih ispitanika s intranazalno primijenjenim flutikazonpropionatom, ritonavir (izrazito jak inhibitor citokroma P450 3A4) u dozi od 100 mg dvaput dnevno povisio je koncentracije flutikazonpropionata u plazmi za nekoliko stotina puta, što je dovelo do izazito smanjenih koncentracija kortizola u serumu.
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. 
U rijetkim slučajevima, Aerivio Spiromax može prouzročiti srčane aritmije, npr. supraventrikularnu tahikardiju, ekstrasistole i atrijsku fibrilaciju te blago, prolazno sniženje kalija u serumu pri visokim terapijskim dozama.
The excipient lactose may contain small amounts of milk proteins which may cause allergic reactions in those with severe hypersensitivity or allergy 
Pomoćna tvar laktoza može sadržavati male količine proteina mlijeka, koji mogu uzrokovati alergijsku reakciju u osoba s teškom preosjetljivošću ili alregijom na proteine mlijeka.
• Low potassium in your blood 
• nizak kalij u krvi
The renal clearance of fluticasone propionate is negligible. 
Bubrežni klirens flutikazonpropionata je zanemariv.
Place the mouthpiece between the teeth with the lips closed around the mouthpiece, do not bite the mouthpiece of the inhaler. 
Postavite nastavak za usta između zubiju i obuhvatite ga usnama; nemojte zagristi nastavak za usta inhalatora.
Co-treatment with CYP3A inhibitors, including cobicistat-containing products, is expected to increase the risk of systemic side-effects. 
Očekuje se da će istodobna primjena inhibitora CYP3A, uključujući lijekove koji sadrže kobicistat, povećati rizik od sistemskih nuspojava.
Keep the mouthpiece closed all the time unless you are about to use your inhaler. 
Poklopac nastavka za usta uvijek držite zatvorenim osim kad se spremate uporabiti inhalator.
Pooled results across the 3 treatment levels *Well controlled asthma - less than or equal to 2 days with symptom score greater than 1 (symptom score 1 defined as ‘symptoms for one short period during the day'), SABA use on less than or equal to 2 days and less than or equal to 4 occasions/week, greater than or equal to 80% predicted morning peak expiratory flow, no night-time awakenings, no exacerbations and no side effects enforcing a change in therapy **Total control of asthma - no symptoms, no SABA use, greater than or equal to 80% predicted morning peak expiratory flow, no night-time awakenings, no exacerbations and no side effects enforcing a change in 
Objedinjeni rezultati sve 3 razine liječenja *Dobro kontrolirana astma - manje od ili jednako 2 dana s skorom simptoma većim od 1 (skor simptoma koji iznosi 1 bio je definiran kao ‘simptomi tijekom jednog kratkog razdoblja tijekom dana'), primjena SABA-a manje od ili jednako 2 dana i u manje od ili jednako 4 navrata/tjedan, više od ili jednako 80% predviđenog jutarnjeg vršnog ekspiracijskog protoka, bez buđenja tijekom noći, bez egzacerbacija i bez nuspojava koje bi iziskivale promjenu terapije
Patients should not be initiated on Aerivio Spiromax during an exacerbation, or if they have significantly worsening or acutely deteriorating asthma. 
Bolesnicima se ne smije započeti liječenje Aerivio Spiromaxom tijekom egzacerbacije ili ako imaju značajno ili akutno pogoršanje astme.
• The dose indicator shows the number of inhalations remaining in even numbers only. 
• Pokazatelj doza pokazuje samo parni broj preostalih udaha.
CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND 
UVJETI ILI OGRANIČENJA VEZANI UZ OPSKRBU I PRIMJENU
Children received either salmeterol/fluticasone propionate (50/100 micrograms) or fluticasone propionate (100 micrograms) alone twice daily. 
Djeca su primala salmeterol/flutikazonpropionat (50/100 mikrograma) ili samo flutikazonpropionat (100 mikrograma) dvaput na dan.
To reduce the chance of side effects your doctor will prescribe the lowest dose of this combination of drugs to control your 
Da bi se smanjila vjerojatnost nuspojava, liječnik će Vam propisati najnižu dozu ove kombinacije za kontrolu astme
Presenting symptoms are typically vague and may include anorexia, abdominal pain, weight loss, tiredness, headache, nausea, vomiting, hypotension, decreased level of consciousness, hypoglycaemia, and seizures. 
Simptomi kojima se očituje obično su neodređeni i mogu uključivati anoreksiju, abdominalnu bol, gubitak tjelesne težine, umor, glavobolju, mučninu, povraćanje, hipotenziju, sniženu razinu svijesti, hipoglikemiju i napadaje.
The concomitant administration of ketoconazole should be avoided, unless the benefits outweigh the potentially increased risk of systemic effects of salmeterol treatment. 
Istodobnu primjenu ketokonazola treba izbjegavati, osim ako su koristi veće od potencijalno povećanog rizika od sistemskih učinaka liječenja salmeterolom.
The average improvement over three years for salmeterol/fluticasone propionate compared with placebo was -3.1 units (95% CI: -4.1 to -2.1; p<0.001) and when compared with salmeterol was -2.2 units (p<0.001) and when compared with FP was -1.2 units (p=0.017). 
Prosječno poboljšanje tijekom tri godine uzimanja salmeterola/flutikazonpropionata u usporedbi s placebom iznosilo je -3,1 jedinice (95% CI: -4,1 do -2,1; p<0,001), i u usporedbi sa salmeterolom iznosilo je -2,2 jedinice (p<0,001), a u usporedbi s FP-om iznosilo je -1,2 jedinica (p=0,017).
• Thrush (sore, creamy-yellow, raised patches) in the mouth and throat. 
• soor (bolne, mliječno-žute, odignute naslage uzrokovane infekcijom kandidom) u ustima i grlu.
Adverse reactions which have been associated with salmeterol/fluticasone propionate are given below, listed by system organ class and frequency. 
Nuspojave koje su povezane sa salmeterolom/flutikazonpropionatom navedene su niže prema klasifikaciji organskih sustava i učestalosti.
A similar incidence of pneumonia in the salmeterol/fluticasone propionate group was seen across all studies. 
U skupini koja je primala salmeterol/flutikazonpropionat bila je opažena slična incidencija pneumonije u svim ispitivanjima.
The results of both studies showed that treatment with salmeterol/fluticasone propionate 50/250 resulted in a significantly lower annual rate of moderate/severe COPD exacerbations compared with salmeterol (SCO40043: 1.06 and 1.53 per subject per year, respectively, rate ratio of 0.70, 95% CI: 0.58 to 0.83, p<0.001; SCO100250: 1.10 and 1.59 per subject per year, respectively, rate ratio of 0.70, 95% CI: 0.58 to 0.83, p<0.001). 
Rezultati oba ispitivanja pokazali su da je liječenje salmeterolom/flutikazonpropionatom 50/250 rezultiralo značajno nižom godišnjom stopom umjerenih/teških egzacerbacija KOPB-a u usporedbi sa salmeterolom (SCO40043: 1,06 odnosno 1,53 po ispitaniku po godini, omjer stopa 0,70; 95% CI: 0,58 do 0,83, p<0,001; SCO100250: 1,10 odnosno 1,59 po ispitaniku po godini, omjer stopa 0,70; 95% CI: 0,58 do 0,83, p<0,001).
The studies described were carried out with a previously authorised product available in three different strengths; the studies were not carried out with 
Opisana ispitivanja bila su provedena s prethodno odobrenim lijekom koji je dostupan u tri različite doze; ta ispitivanja nisu bila provedena s Aerivio Spiromaxom.
The mean number of moderate to severe exacerbations per year was significantly reduced with salmeterol/fluticasone propionate (FP) as compared with treatment with salmeterol, FP and placebo (mean rate in the salmeterol/fluticasone propionate group 0.85 compared with 0.97 in the salmeterol group, 0.93 in the FP group and 1.13 in the placebo). 
Srednja vrijednost broja umjerenih do teških egzacerbacija godišnje bila je značajno smanjena uz salmeterol/flutikazonpropionat (FP) u usporedbi s liječenjem salmeterolom, FP-om i placebom (srednja vrijednost stope u skupini liječenoj salmeterolom/flutikazonpropionatom bila je 0,85 u odnosu na 0,97 u skupini liječenoj salmeterolom, 0,93 u skupini liječenoj FP-om i 1,13 u skupini koja je primala placebo).
Paradoxical bronchospasm may occur with an immediate increase in wheezing and shortness of breath after dosing. 
Nakon doziranja može nastati paradoksalni bronhospazam koji je odmah praćen pojačanim piskanjem pri disanju i nedostatkom zraka.
Physicians should remain vigilant for the possible development of pneumonia and other lower respiratory tract infections in patients with COPD as the clinical features of such infections and exacerbation frequently overlap. 
Liječnici trebaju budno paziti na mogući razvoj pneumonije i drugih infekcija donjih dišnih putova u bolesnika s KOPB-om jer se klinička slika takvih infekcija često preklapa sa slikom egzacerbacije.
If this happens you need to use a fast-acting ‘reliever' (‘rescue') inhaler, such as salbutamol. 
Ako se to dogodi, trebate primijeniti inhalator s brzodjelujućim lijekom za ublažavanje simptoma, kao što je salbutamol.
The Spiromax device is a breath actuated, inspiratory flow-driven inhaler, which means that the active substances are delivered into the airways when the patient inhales through the mouthpiece. 
Spiromax je inhalator koji se aktivira udahom i pogoni ga protok zraka tijekom udisanja, što znači da se djelatne tvari isporučuju u dišne putove kada bolesnik udiše kroz nastavak za usta.
COPD patients with a baseline (pre-bronchodilator) FEV1 <60% of predicted normal were randomised to double-blind medication. 
Bolesnici s KOPB-om i početnim (prije bronhodilatatora) FEV1 <60% predviđene normale bili su randomizirani u terapijske skupine na dvostruko slijepi način.
• Feeling worried (although this effect occurs mainly in children when prescribed this combination of 
• osjećaj zabrinutosti (iako se ovaj učinak javlja uglavnom u djece kad im se propisuje ova kombinacija lijekova premda u nižoj dozi)
Hence, clinically significant drug interactions mediated by fluticasone propionate 
Stoga klinički značajne interakcije lijekova posredovane flutikazonpropionatom nisu vjerojatne.
Studies have shown that salmeterol and fluticasone propionate and their metabolites, are excreted into the 
Ispitivanja su pokazala da se salmeterol i flutikazonpropionat te njihovi metaboliti izlučuju u mlijeko ženki
Read the package leaflet carefully before use. 
Prije uporabe pažljivo pročitajte uputu o lijeku.
Treatment with Aerivio Spiromax should not be stopped abruptly in patients with asthma due to risk of exacerbation. 
Liječenje Aerivio Spiromaxom ne smije se naglo prekinuti u bolesnika s astmom zbog rizika od egzacerbacije.
Teva B.V., Swensweg 5, 2031 GA Haarlem, Netherlands 
Teva B.V., Swensweg 5, 2031 GA Haarlem, Nizozemska
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). 
Procijenjena trogodišnja vjerojatnost razvoja pneumonije koja se prijavljivala kao štetni događaj iznosila je 12,3% za placebo, 13,3% za salmeterol, 18,3% za FP i 19,6% za salmeterol/flutikazonpropionat (omjer hazarda za flutikazonpropionat/salmeterol naspram placeba: 1,64, 95% CI: 1,33 do 2,01, p<0,001).
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. 
Budući da Aerivio Spiromax sadrži salmeterol i flutikazonpropionat, mogu se očekivati vrste i težine nuspojava povezanih sa svakom od tih djelatnih tvari.
You may be very wheezy and cough or be short of breath. 
Možete imati jako piskanje pri disanju, kašljati ili osjećati nedostatak zraka.
It is important, therefore, that the patient is reviewed regularly and the dose of inhaled corticosteroid is reduced to the lowest dose at which effective control of asthma is 
Stoga je važno redovito pregledavati bolesnika i sniziti dozu inhalacijskog kortikosteroida na onu najnižu kojom se održava učinkovita kontrola astme.
Patients should be advised to have their inhaler to be used for relief in an acute asthma attack available at all times. 
Bolesnicima treba savjetovati da uvijek pri ruci imaju inhalator koji koriste za ublažavanje akutnog napadaja astme.
Baseline ICS use at study entry was recorded, but not required in the study. 
Zabilježena je početna primjena inhalacijskog kortikosteroida pri ulasku u ispitivanje, ali nije se zahtijevala tijekom ispitivanja.
Pneumonia-related events were reported for 55 (7%) subjects in the salmeterol/fluticasone propionate 50/250 micrograms twice daily group and 25 (3%) in the salmeterol group. 
Događaji povezani s pneumonijom bili su zabilježeni u 55 (7%) ispitanika u skupini liječenoj salmeterolom/flutikazonpropionatom u dozi od 50/250 mikrograma dvaput dnevno i njih 25 (3%) u skupini liječenoj salmeterolom.
Aerivio Spiromax helps to stop breathlessness and wheeziness coming on. 
Aerivio Spiromax pomaže u sprječavanju pojave nedostatka zraka i piskanja pri disanju.
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 
U normalnim okolnostima, nakon primjene inhalacijom postižu se niske koncentracije flutikazonpropionata u plazmi zbog opsežnog metabolizma prvog prolaska kroz jetru i visokog sistemskog klirensa posredovanog citokromom P450 3A4 u crijevima i jetri.
This translates to a reduction in the rate of moderate to severe exacerbations of 25% (95% CI: 19% to 31%; p<0.001) compared with placebo, 12% compared with salmeterol (95% CI: 5% to 19%, p=0.002) and 9% compared with FP (95% CI: 1% to 16%, p=0.024). 
To je odgovaralo smanjenju stope umjerenih do teških egzacerbacija od 25% (95% CI: 19% do 31%; p<0,001) u usporedbi s placebom, 12% u usporedbi sa salmeterolom (95% CI: 5% do 19%, p=0,002) i 9% u usporedbi s FP-om (95% CI: 1% do 16%, p=0,024).
Aerivio Spiromax should be used with caution in patients with severe cardiovascular disorders or heart rhythm abnormalities and in patients with diabetes mellitus, thyrotoxicosis, uncorrected hypokalaemia or patients predisposed to low levels of serum potassium. 
Aerivio Spiromax treba primjenjivati s oprezom u bolesnika s teškim kardiovaskularnim poremećajima i poremećajima srčanog ritma te u bolesnika sa šećernom bolešću, tireotoksikozom, nekorigiranom hipokalijemijom ili u bolesnika sklonih niskim razinama kalija u serumu.
Possible systemic effects include Cushing's syndrome, Cushingoid features, adrenal suppression, decrease in bone mineral density, cataract and glaucoma and more rarely, a range of psychological or behavioural effects including psychomotor hyperactivity, sleep disorders, anxiety, depression or aggression (particularly in children) (see Paediatric population sub-heading below for information on the systemic effects of inhaled corticosteroids in children and adolescents). 
Mogući sistemski učinci uključuju Cushingov sindrom, kušingoidni izgled, supresiju nadbubrežnih žlijezda, smanjenje mineralne gustoće kostiju, kataraktu i glaukom te rjeđe, niz psihičkih učinaka ili učinaka na ponašanje uključujući psihomotornu hiperaktivnost, poremećaje spavanja, anksioznost, depresiju ili agresivnost (osobito u djece) (vidjeti niže podnaslov „Pedijatrijska populacija“ za informacije o sistemskim učincima inhalacijskih kortikosteroida u djece i adolescenata).
Findings for the secondary efficacy measures (time to first moderate/severe exacerbation, the annual rate of exacerbations requiring oral corticosteroids, and pre-dose morning (AM) FEV1) significantly favoured salmeterol/fluticasone propionate 50/250 micrograms twice daily over salmeterol. 
Nalazi za sekundarne mjere djelotvornosti (vrijeme do prve umjerene/teške egzacerbacije, godišnja stopa egzacerbacija koja zahtijeva peroralne kortikosteroide i jutarnji (AM) FEV1 prije doziranja) davali su značajnu prednost salmeterolu/flutikazonpropionatu u dozi od 50/250 mikrograma dvaput dnevno nad salmeterolom.
Once control of asthma is achieved patients should be reviewed regularly and the dose of inhaled corticosteroid titrated downwards as appropriate to maintain disease control. 
Kad se postigne kontrola astme, bolesnike treba redovito pregledavati i postupno snižavati dozu inhalacijskog kortikosteroida na onu koja je potrebna da se održi kontrola bolesti.
There are no data available on the use of Aerivio Spiromax in patients with hepatic impairment. 
Nema dostupnih podataka o primjeni Aerivio Spiromaxa u bolesnika s oštećenjem funkcije jetre.
Aerivio Spiromax is not recommended for use in children and adolescents aged less than 18 years. 
Aerivio Spiromax se ne preporučuje za primjenu u djece i adolescenata mlađih od 18 godina.
Salmeterol/Fluticasone propionate - Asthma clinical trials A twelve month study (Gaining Optimal Asthma ControL, GOAL), in 3416 adult and adolescent patients with persistent asthma, compared the safety and efficacy of salmeterol/fluticasone propionate versus inhaled corticosteroid (fluticasone propionate) alone to determine whether the goals of asthma management were achievable. 
Gaining Optimal Asthma ControL - GOAL) u 3416 odraslih i adolescentnih bolesnika s perzistentnom astmom u usporedilo je sigurnost i djelotvornost salmeterola/flutikazonpropionata naspram samo inhalacijskog kortikosteroida (flutikazonpropionata) kako bi se utvrdilo mogu li se ostvariti ciljevi liječenja astme.
Patients with severe asthma and COPD were shown to be able to generate sufficient inspiratory flow rate when they breathed in forcefully through the Spiromax device to enable the delivery of the required therapeutic dose to the lungs (see also section 5.1 - last five paragraphs) 
Bolesnici s teškom astmom i KOPB-om, kada snažno udahnu kroz Spiromax inhalator,.mogu stvoriti dovoljnu brzinu protoka zraka tijekom udaha da bi se iz Spiromaxa isporučila terapijska doza u pluća (također vidjeti dio 5.1
The time on treatment for 50% of subjects to achieve a first individual well controlled week was 16 days for salmeterol/fluticasone propionate compared with 37 days for the ICS group. 
Liječenje do postizanja prvog individualnog dobro kontroliranog tjedna u 50% ispitanika trajalo je 16 dana u skupini koja je primala salmeterol/flutikazonpropionat u usporedbi s 37 dana u skupini koja je primala inhalacijski kortikosteroid.
You do not need to shake your inhaler. 
Nije potrebno protresti inhalator.
How to store Aerivio Spiromax 
Kako primjenjivati Aerivio Spiromax
Aerivio Spiromax should be discontinued immediately, the patient assessed and alternative therapy instituted if necessary. 
Potrebno je odmah prekinuti primjenu Aerivio Spiromaxa, pregledati bolesnika i, po potrebi, uvesti zamjensku terapiju.
Patients with severe lactose intolerance should use this medicine with caution and those with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine. 
Bolesnici s teškom intolerancijom laktoze trebaju koristiti ovaj lijek s oprezom, a bolesnici s rijetkim nasljednim poremećajem intolerancije galaktoze, nedostatkom
Patients should also be advised to rinse their mouth with water and spit the water out, and/or brush their teeth 
Bolesnicima također treba savjetovati da nakon inhalacije isperu usta vodom i ispljunu je i/ili da operu zube
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. 
Minimalna brzina protoka potrebna za optimalnu dostavu lijekova u pluća kroz multidozni inhalator Spiromax sa suhim praškom iznosi više od 60L/min.
Placebo-controlled clinical trials, over 6 and 12 months, have shown that regular use of salmeterol/fluticasone propionate 50/500 micrograms improves lung function and reduces breathlessness and 
Placebom kontrolirana klinička ispitivanja tijekom 6 i 12 mjeseci pokazala su da redovita primjena salmeterola/flutikazonpropionata u dozi od 50/500 mikrograma poboljšava funkciju pluća i smanjuje nedostatak zraka i uporabu lijekova za brzo ublažavanje simptoma.
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). 
Broj prijavljenih infekcija donjih dišnih putova (osobito pneumonije i bronhitisa) bio je povećan u ispitivanju TORCH u bolesnika s KOPB-om koji su primali salmeterol/flutikazonpropionat u dozi od 50/500 mikrograma dvaput dnevno u usporedbi s placebom, kao i u ispitivanjima SCO40043 i SCO100250 u kojima se uspoređivala niža doza salmeterol/flutikazonpropionata od 50/250 mikrograma dvaput dnevno (doza koja nije odobrena za primjenu u KOPB-u), sa samo salmeterolom u dozi od 50 mikrograma dvaput dnevno (vidjeti dio 4.8 i dio 5.1).