natgillin/translations-raw huggingface dataset:
In addition, compared with both a fixed combination of beclometasone dipropionate and formoterol and with tiotropium, Riarify significantly prolonged the time to first exacerbation (hazard ratio 0.80 and 0.84 respectively; p = 0.020 and 0.015 respectively), with no differences between Riarify and the extemporary triple combination made of beclometasone dipropionate and formoterol fixed combination plus tiotropium (hazard ratio 1.06). 
Poleg tega je tako v primerjavi s fiksno kombinacijo beklometazondipropionata in formoterola kot tiotropija zdravilo Riarify značilno podaljšalo čas do prvega poslabšanja (razmerje tveganja 0,80 oz. 0,84; p = 0,020 oz. 0,015), brez razlik med zdravilom Riarify in trojno kombinacijo, ki je bila sestavljena iz fiksne kombinacije beklometazondipropionata in formoterola plus tiotropija (razmerje tveganja 1,06).
Riarify is provided with a dose counter or dose indicator on the back of the inhaler, which shows how many actuations are left. 
Zdravilo Riarify je opremljeno s števcem odmerkov ali kazalnikom odmerkom, ki je na zadnji strani inhalatorja in kaže, koliko sprožitev je še ostalo.
Riarify is for inhalation use. 
Zdravilo Riarify se uporablja za inhaliranje.
A responder analysis showed that a significantly greater percentage of patients had a clinically significant improvement (focal score greater than or equal to 1) after 26 weeks with Riarify than with a fixed combination of beclometasone dipropionate and formoterol (57.4% versus 51.8%; p = 0.027). 
Analiza odzivnih bolnikov je pokazala, da je imel značilno večji odstotek bolnikov klinično pomembno izboljšanje (fokalni seštevek 1 ali več) po 26 tednih zdravljenja z zdravilom Riarify v primerjavi s fiksno kombinacijo beklometazondipropionata in formoterola (57,4 % v primerjavi z 51,8 %; p = 0,027).
• burning sensation of the lips 
• skeleč občutek na ustnicah;
• other medicines used to treat COPD (theophylline, aminophylline or corticosteroids) and diuretics may also cause a fall in your potassium level. 
• drugimi zdravili za zdravljenje KOPB (teofilin, aminofilin ali kortikosteroidi) in diuretiki lahko prav tako povzroči zmanjšanje koncentracije kalija;
This endpoint was only measured in study TRINITY. 
Ta opazovani dogodek so merili le v študiji TRINITY.
After inhaling, patients should rinse their mouth or gargle with water without swallowing it or brush their teeth (see sections 4.2 and 4.4). 
Po inhaliranju naj si bolnik izpere usta ali grgra vodo, a naj je ne pogoltne, ali pa si umije zobe (glejte poglavji 4.2 in 4.4).
Glycopyrronium works by blocking the bronchoconstrictor action of acetylcholine on airway smooth muscle cells, thereby dilating the airways. 
Glikopironij deluje tako, da zavira bronhokonstriktorno delovanje acetilholina na gladke mišične celice v dihalnih poteh, s čimer omogoči dilatacijo dihalnih poti.
Therefore, as a precautionary measure, it is preferable to avoid the use of Riarify during pregnancy and during labour. 
Iz previdnostnih razlogov se je med nosečnostjo in med porodom uporabi zdravila Riarify bolje izogibati.
Since glycopyrronium is eliminated mainly by the renal route, drug interaction could potentially occur with medicinal products affecting renal excretion mechanisms (see section 5.2). 
Farmakokinetično medsebojno delovanje Ker se glikopironij izloča v glavnem skozi ledvice, se lahko pojavijo interakcije z zdravili, ki vplivajo na mehanizem ledvičnega izločanja (glejte poglavje 5.2).
They should not remove the pressurised container from the actuator and should not use water or other liquids to clean the mouthpiece. 
Tlačnega vsebnika naj ne ločuje od sprožilca in naj za čiščenje ustnika ne uporablja vode ali drugih tekočin.
• palpitations (feeling of abnormal beating of the heart) 
• palpitacije (občutek nenormalnega bitja srca); • zardevanje obraza;
A total of 3,346 patients were treated with beclometasone dipropionate/formoterol fumarate dihydrate/glycopyrronium 87 micrograms/5 micrograms/9 micrograms at the target dose regimen (two inhalations twice daily) in multiple dose studies. 
Skupaj 3.346 bolnikov so zdravili z beklometazondipropionatom/formoterolijevim fumaratom dihidratom/glikopironijem 87 mikrogramov/5 mikrogramov/9 mikrogramov z režimom ciljnega odmerka (dve inhalaciji dvakrat na dan) v študijah z več odmerki.
Faecal excretion is the major route of beclometasone dipropionate elimination mainly as polar metabolites. 
Izločanje v blatu je glavna pot izločanja beklometazondipropionata, pretežno kot polarnih presnovkov.
There was no clear evidence of pharmacokinetic interaction, however the extemporary combination showed formoterol and glycopyrronium levels transiently slightly higher immediately after dosing compared with the single components. 
Jasnih dokazov o farmakokinetičnih interakcijah ni bilo, vendar je trojna kombinacija, ki je bila sestavljena iz fiksne kombinacije beklometazondipropionata in formoterola plus glikopironija pokazala, da so ravni formoterola in glikopironija v primerjavi s posamičnimi sestavinami začasno nekoliko večje takoj po odmerjanju.
Anticholinergic agents like glycopyrronium could suppress lactation. 
Antiholinergična zdravila kot glikopironij lahko zavrejo laktacijo.
Reproductive and development toxicity 
Vpliv na sposobnost razmnoževanja in razvoja
This study also investigated the potential pharmacokinetic interaction between the active components of Riarify by comparing the pharmacokinetic data obtained after a single dose of the extemporary combination or after a single dose of the single components beclometasone dipropionate/formoterol or glycopyrronium. 
Ta študija je preučila tudi morebitne farmakokinetične interakcije med učinkovinami v zdravilu Riarify na tak način, da je primerjala farmakokinetične podatke, pridobljene po enkratneme odmerku trojne kombinacije, ki je bila sestavljena iz fiksne kombinacije beklometazondipropionata in formoterola plus glikopironija ali po enem odmerku posamičnih sestavin beklometazondipropionata /formoterola ali glikopironija.
For glycopyrronium, there was no impact in subjects with mild and moderate renal impairment. 
Pri glikopironiju ni bilo vpliva pri osebah z blago in zmerno okvaro ledvic.
Immediately after starting to breathe in, patients should firmly press down on the top of the pressurised container to release one puff. 
Takoj potem ko začne vdihavati, naj bolnik čvrsto pritisne na zgornji del tlačnega vsebnika, da sprosti en vdih.
Based on plasma concentrations measured following inhalation of a single 120 micrograms dose by 12 healthy subjects, the mean terminal elimination half-life was determined to be 10 hours. 
ko je 12 zdravih prostovoljcev inhaliralo en 120-mikrogramski odmerek, je bilo ugotovljeno, da je povprečna končna razpolovna doba izločanja 10 ur.
If you find it difficult to use the inhaler while starting to breathe in, you may use the AeroChamber Plus spacer device. 
Če med začetkom vdihovanja težko uporabljate inhalator, lahko uporabite nastavek za inhaliranje
The second major pathway involves O-demethylation followed by conjugation at the phenolic 2'-hydroxyl group. 
O-demetilacijo, ki ji sledi konjugacija pri fenolni 2'-hidroksilni skupni.
• low level in the number of certain blood cells called platelets 
• nizka raven nekaterih krvnih celic, imenovanih trombociti;
After inhaling, patients should rinse their mouth or gargle with water without swallowing it or brush their teeth (see section 4.4 and 6.6). 
Po inhaliranju naj si bolnik izpere usta ali grgra vodo, a naj je ne pogoltne, ali pa si umije zobe (glejte poglavji 4.2 in 6.6).
Patients should be advised not to drop the inhaler as this may cause the counter to count down. 
Bolnikom je treba naročiti, naj pazijo, da jim inhalator ne pade iz rok, ker to lahko povzroči odštevanje števca.
The European Medicines Agency has waived the obligation to submit the results of studies with Riarify in all subsets of the paediatric population in COPD (see section 4.2 for information on paediatric use). 
Riarify za vse podskupine pediatrične populacije s KOPB (za podatke o uporabi pri pediatrični populaciji glejte poglavje 4.2).
• if you have any disease of your liver or kidneys. 
• če imate katero od bolezni jeter ali ledvic;
• if you have disorders of your heart rhythm such as irregular heart rate, a fast pulse rate or palpitations or if you have been told that your heart trace (ECG) is abnormal. 
• če imate motnje srčnega ritma, npr. nereden srčni utrip, hitro bitje srca, razbijanje srca ali palpitacije oz. so vam povedali, da imate nenormalen posnetek delovanja srca (EKG);
• leakage of blood from a vessel into the tissues surrounding it 
• iztekanje krvi iz žile v okoliško tkivo;
• if you have a tumour of the adrenal gland (known as a phaeochromocytoma). 
• če imate tumor nadledvične žleze (imenovan tudi feokromocitom);
If you have been prescribed a container providing 180 puffs There is an indicator on the back of the inhaler, which tells you how many doses are left. 
Če vam je zdravnik predpisal vsebnik, ki zagotavlja 180 vdihov Na zadnji strani inhalatorja je kazalnik, ki kaže, koliko odmerkov je še ostalo.
• if you experience any allergic reactions like skin allergies, hives, skin itching, skin rash (may affect up to 1 in 100 people), reddening of the skin, swelling of the skin or mucous membranes especially of the eyes, face, lips and throat (may affect up to 1 in 1,000 people). 
• če opazite kakršne koli alergijske reakcije, kot so kožne alergije, izpuščaj, srbenje kože, osip na koži, (pojavijo se lahko pri največ 1 od 100 bolnikov), rdečina kože, oteklost kože ali sluznic,
How to use your inhaler 
Kako uporabljati inhalator
Formoterol and glycopyrronium are medicines called long-acting bronchodilators. 
Formoterol in glikopironij sta zdravili, imenovana dolgodelujoča bronhodilatatorja.
If you are already using Riarify 
Če že uporabljate zdravilo Riarify
180 actuations 
180 sprožitev
The renal clearance of formoterol is 150 mL/min. 
150 ml/min.
• feeling breathless or short of breath 
• občutek zasoplosti ali kratke sape;
For the 180 actuation pressurised container, each time the patient presses the pressurised container a puff of the solution is released and the counter rotates by a small amount; the number of puffs remaining is displayed in intervals of 20. 
Pri tlačnem vsebniku s 180 sprožitvami se z vsakim bolnikovim pritiskom na vsebnik števec malo zasuče, število preostalih vdihov pa je prikazano v intervalih po 20.
Stop using the inhaler when the counter or indicator shows 0, as any medicine left in the inhaler may not be enough to give you a full puff. 
Ko števec ali kazalnik odmerkov pokaže 0, inhalator nehajte uporabljati, saj morebitni preostali vdihi v njem morda ne bodo zadoščali za poln odmerek.
There is no relevant use of Riarify in the paediatric population (under 18 years of age) for the indication of COPD. 
Zdravilo Riarify ni namenjeno za uporabo pri pediatrični populaciji (pri otrocih, starih do 18 let) za indikacijo kronične obstruktivne pljučne bolezni (KOPB).
• medicines for treating - abnormal heart rhythms (quinidine, disopyramide, procainamide), - allergic reactions (antihistamines), - symptoms of depression or mental disorders such as monoamine oxidase inhibitors (for example phenelzine and isocarboxazid), tricyclic antidepressants (for example amitriptyline and imipramine), phenothiazines can cause some changes in the electrocardiogram (ECG, heart trace). 
• zdravili za zdravljenje - nenormalnega srčnega ritma (kinidin, dizopiramid, prokainamid), - alergijskih reakcij (antihistaminiki), - simptomov depresije ali duševnih bolezni, kot so zaviralci monoaminooksidaze (na primer fenelzin in izokarboksazid), triciklični antidepresivi (na primer amitriptilin in imipramin),
Beta-blockers (including beta-blocker eye-drops) may reduce the effects of formoterol or make it not work at all. 
Antagonisti adrenergičnih receptorjev beta (to velja tudi za kapljice za oko z antagonisti adrenergičnih receptorjev beta) lahko zmanjšajo učinek formoterola ali pa formoterol morda sploh ne bo deloval.
Riarify should be administered with caution in patients with active or quiescent pulmonary tuberculosis, fungal and viral infections in the airways. 
Zdravilo Riarify je treba pri bolnikih z aktivno ali mirujočo pljučno tuberkulozo ter glivično in virusno okužbo dihal uporabljati previdno.
For beclometasone dipropionate, this results in a more potent effect than formulations with a non-extrafine particle size distribution (100 micrograms of beclometasone dipropionate extrafine in Riarify are equivalent to 250 micrograms of beclometasone dipropionate in a non-extrafine formulation). 
Beklometazondipropionat v obliki izredno majhnih delcev ima veliko močnejši učinek kot formulacije, kjer porazdelitev ni v obliki izredno majhnih delcev (100 mikrogramov beklometazondipropionata v obliki izredno majhnih delcev v zdravilu Riarify ustreza 250 mikrogramom beklometazondipropionata v formulacijah, ki niso v obliki izredno majhnih delcev).
Each pack contains one pressurised container either providing 60 puffs, 120 puffs or 180 puffs. 
Eno pakiranje vsebuje en tlačni vsebnik, ki omogoča 60 vdihov, 120 vdihov ali 180 vdihov.
Patients should hold the inhaler vertically with its body upwards and place the mouthpiece between their teeth without biting. 
Bolnik naj drži inhalator navpično, tako da je njegovo telo obrnjeno navzgor, in vstavi ustnik med zobe, vendar ga ne sme ugrizniti.
If you forget to use Riarify 
Če ste pozabili uporabiti zdravilo Riarify
For the 60 and 120 actuation pressurised containers each time the patient presses the container a puff of the solution is released and the counter counts down by one. 
Pri tlačnem vsebniku s 60 in 120 sprožitvami vsak bolnikov pritisk na vsebnik sprosti vdih raztopine, števec pa se pomakne za eno navzdol.
This incorporates a mouthpiece provided with a plastic protective cap, and either a dose counter (containers with 60 and 120 puffs) or a dose indicator (containers with 180 puffs). 
Sestavljata ga ustnik s plastičnim zaščitnim pokrovčkom in bodisi števec odmerkov (vsebniki s 60 in 120 vdihi) ali kazalnikom odmerkov (vsebniki s 180 vdihi).
• inflammation of the mucous membrane of the mouth with or without ulcers 
• vnetje ustne sluznice z razjedami ali brez;
The pressurised container is inserted in a polypropylene inhaler which incorporates a mouthpiece and a dose counter (60 actuations or 120 actuations per pressurised container) or dose indicator (180 actuations per pressurised container) and is provided with a polypropylene mouthpiece cap. 
Tlačni vsebnik je vstavljen v polipropilenski inhalator, ki ga sestavljata ustnik in števec odmerkov (60 sprožitev ali 120 sprožitev na tlačni vsebnik) ali kazalnik odmerka (180 sprožitev na tlačni vsebnik) in je na voljo s polipropilenskim pokrovčkom ustnika.
The pharmacokinetics of beclometasone dipropionate in patients with hepatic impairment has not been studied, however, as beclometasone dipropionate undergoes a very rapid metabolism via esterase enzymes present in intestinal fluid, serum, lungs and liver to form the more polar products beclometasone 21-monopropionate, beclometasone 17-monopropionate and beclometasone, hepatic impairment is not expected to modify the pharmacokinetics and safety profile of beclometasone dipropionate. 
Farmakokinetike beklometazondipropionata pri bolnikih z jetrno okvaro niso preučili, vendar pa se ne pričakuje, da bi jetrna okvara spremenila farmakokinetiko in profil varnosti beklometazondipropionata, saj se beklometazondipropionat zelo hitro presnovi z encimi esteraze, ki so prisotni v črevesnem soku, serumu, pljučih in jetrih, in tvori bolj polarne produkte, beklometazon 21monopropionat, beklometazon 17-monopropionat in beklometazon.
Before using the inhaler for the first time, you should test your inhaler to make sure that it is working properly, as follows. 
Pred prvo uporabo inhalatorja morate na spodaj opisani način preveriti, ali deluje pravilno.
Cleaning 
Čiščenje
Glycopyrronium should be used with caution in patients with narrow-angle glaucoma, prostatic hyperplasia or urinary retention. 
Antiholinergični učinek Glikopironij je treba pri bolnikih z glavkomom z zaprtim zakotjem, prostatično hiperplazijo ali zastajanjem urina uporabljati previdno.
Beclometasone dipropionate belongs to a group of medicines called corticosteroids which act to reduce the swelling and irritation in your lungs. 
Beklometazondipropionat spada v skupino zdravil, imenovanih kortikosteroidi, ki zmanjšajo oteklost in draženje v pljučih.
It is preferable to avoid the use of Riarify during labour due to the inhibitory effects of formoterol on uterine contractions. 
Med rojevanjem se je uporabi zdravila Riarify bolje izogniti zaradi zaviralnih učinkov formoterola na krčenje maternice.
What Riarify looks like and contents of the pack 
Izgled zdravila Riarify in vsebina pakiranja
Patients should then hold their breath for as long as comfortably possible, then remove the inhaler from the mouth and breathe out slowly. 
Bolnik naj zadrži dih tako dolgo, kot lahko, da mu še ni neprijetno, nato vzame inhalator iz ust in počasi izdihne.
How to use Riarify 
Kako uporabljati zdravilo Riarify
Glycopyrronium is a high-affinity, long-acting muscarinic receptor antagonist (anticholinergic) used for inhalation as bronchodilator treatment of COPD. 
Glikopironij je dolgodelujoči antagonist muskarinskih receptorjev (antiholinergik) z visoko afiniteto, ki se uporablja za inhaliranje pri bronhodilatatornem zdravljenju KOPB.
Compared with tiotropium, Riarify significantly improved IC by 39 mL (p = 0.025) and 60 mL (p = 0.001) after 26 and 52 weeks of treatment respectively. 
V primerjavi s tiotropijem je zdravilo Riarify značilno izboljšalo IC za 39 ml (p = 0,025) oz. 60 ml (p = 0,001) po 26 oz. 52 tednih zdravljenja.
If you stop using Riarify 
Če ste prenehali uporabljati zdravilo Riarify
Patients should breathe out slowly and as deeply as comfortable, in order to empty their lungs. 
Bolnik naj izdihne počasi in čim bolj globoko, kolikor je le mogoče, da izprazni pljuča.
Talk to your doctor or pharmacist before using Riarify: 
Pred začetkom uporabe zdravila Riarify se posvetujte z zdravnikom ali farmacevtom:
To prevent a fungal infection in the mouth and throat, rinse your mouth or gargle with water without swallowing it or brush your teeth after each use of your inhaler. 
Za preprečitev glivične okužbe ust in žrela, si po vsaki uporabi inhalatorja splaknite usta ali grgrajte vodo, vendar je ne pogoltnite, ali si umijte zobe.
• painful and frequent urination 
• boleče in pogosto uriniranje; • težave in bolečina pri uriniranju;
Study TRINITY compared Riarify with tiotropium 18 micrograms inhalation powder, hard capsule, one inhalation once daily; in addition, effects were compared with an extemporary triple combination made of a fixed combination of beclometasone dipropionate and formoterol 100/6 micrograms two inhalations twice daily plus tiotropium 18 micrograms inhalation powder, hard capsule, one inhalation once daily (2,691 randomised patients). 
V študiji TRINITY so primerjali zdravilo Riarify s tiotropijem 18 mikrogramov praška za inhaliranje, trda kapsula, ena inhalacija enkrat na dan; poleg tega so učinke primerjali s trojno kombinacijo, ki je bila sestavljena iz fiksne kombinacije beklometazondipropionata in formoterola 100/6 mikrogramov, dve inhalaciji dvakrat na dan, plus tiotropij 18 mikrogramov prašek za inhaliranje, trda kapsula, ena inhalacija enkrat na dan (2.691 randomiziranih bolnikov).
No differences were observed when comparing Riarify and the extemporary triple combination made of a fixed combination of beclometasone dipropionate and formoterol plus tiotropium (difference of 3 mL in pre-dose FEV1 after 52 weeks of treatment). 
V primerjavi zdravila Riarify in trojne kombinacije, ki je bila sestavljena iz fiksne kombinacije beklometazondipropionata in formoterola plus tiotropija, niso opazili razlik (razlika 3 ml v FEV1 pred odmerkom po 52 tednih zdravljenja).
Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeat dose toxicity and toxicity to reproduction and development. 
Predklinični podatki na osnovi običajnih študij farmakološke varnosti, toksičnosti pri ponavljajočih odmerkih in vpliva na sposobnost razmnoževanja in razvoja ne kažejo posebnega tveganja za človeka.
Riarify comes in a pressurised container (coated aluminium), with a metering valve. 
Zdravilo Riarify je na voljo v tlačnem vsebniku (obloženem z aluminijem) z odmernim ventilom.
Each time you press the pressurised container, a puff of medicine is released and the dose indicator rotates by a small amount. 
Vsakič ko pritisnete na tlačni vsebnik, se sprosti odmerek zdravila, kazalnik pa se nekoliko obrne.
• a container providing 60 puffs 
• vsebnik, ki zagotavlja 60 vdihov
What you need to know before you use Riarify Do not use Riarify: 
Kaj morate vedeti, preden boste uporabili zdravilo Riarify Ne uporabljajte zdravila Riarify:
Influenza1, oral fungal infection, oropharyngeal candidiasis, oesophageal candidiasis1, sinusitis1, rhinitis1, gastroenteritis1, vulvovaginal candidiasis1 
pogosti gripa1, oralna glivična okužba, orofaringealna kandidiaza, ezofagealna kandidiaza1, sinusitis1, rinitis1, gastroenteritis1, vulvovaginalna kandidiaza1
Take care not to drop the inhaler as this may cause the dose indicator to count down. 
Pazite, da vam inhalator ne pade iz rok, ker to lahko povzroči odštevanje kazalnika.
• clouding of the lens of your eyes (cataract). 
• motnost očesne leče (katarakta).
Ask your doctor or pharmacist about this device. 
O tem pripomočku se posvetujte z zdravnikom ali farmacevtom.
Frequency not known 
neznana pogostnost nespečnost redki
• dry throat 
• suho žrelo;
Therefore, your doctor may wish to measure the potassium levels in your blood from time to time. 
Zato vam bo zdravnik morda občasno spremljal koncentracijo kalija v krvi;
Patients should stand or sit in an upright position when inhaling from their inhaler. 
Bolnik naj med vdihavanjem iz inhalatorja stoji ali vzravnano sedi.
Contents of the pack and other information 
Shranjevanje zdravila Riarify Vsebina pakiranja in dodatne informacije
Riarify 87 micrograms/5 micrograms/9 micrograms pressurised inhalation, solution 
Riarify 87 mikrogramov/5 mikrogramov/9 mikrogramov inhalacijska raztopina pod tlakom
The most frequently reported adverse reactions with Riarify were oral candidiasis (which occurred in 0.8% of the exposed subjects), which is normally associated with inhaled corticosteroids; muscle spasms (0.4%), which can be attributed to the long-acting beta2-agonist component; dry mouth (0.4%), which is a typical anticholinergic effect. 
izpostavljenih oseb), ki je normalno povezana z inhalacijskimi kortikosteroidi; mišični spazmi (0,4 %), ki se lahko pripišejo sestavini dolgodelujočega agonista adrenergičnih receptorjev beta2; suha usta (0,4 %), kar je običajni antiholinergični učinek.
High doses of formoterol may increase your blood glucose and therefore you may need to have extra blood tests to check your blood sugar when you start using this medicine, and from time to time during treatment. 
Zato boste na začetku uporabe tega inhalatorja in občasno med zdravljenjem morda potrebovali dodatne preiskave krvi za kontrolo krvnega sladkorja;
• decrease in bone mineral density (thinning of the bones) 
• težave z delovanjem nadledvične žleze (adrenosupresija); • zmanjšanje mineralne gostote kosti (redčenje kosti);
Compared with tiotropium, Riarify also reduced the rate of severe exacerbations (i.e. excluding moderate exacerbations) by 32% (rate: 0.067 versus 0.098 events per patient/year; p = 0.017). 
V primerjavi s tiotropijem je zdravilo Riarify zmanjšalo tudi stopnjo hudih poslabšanj (tj. brez zmernih poslabšanj) za 32 % (razmerje: 0,067 v primerjavi z 0,098 dogodka na bolnika/leto; p = 0,017).
Study TRILOGY compared Riarify with a fixed combination of beclometasone dipropionate and formoterol 100/6 micrograms two inhalations twice daily (1,368 randomised patients). 
V študiji TRILOGY so primerjali zdravilo Riarify s fiksno kombinacijo beklometazondipropionata in formoterola 100/6 mikrogramov, dve inhalaciji dvakrat na dan (1.368 randomiziranih bolnikov).