natgillin/translations-raw huggingface dataset:
Completion of the internal evaluation work with new Member States (the EC-Canada MRA) Provision of assistance to the new Member States for external evaluations (the EC-Canada MRA) Expansion of scope of the MRA with Japan to include sterile medicinal products and biologicals
Zagotavljanje pomoči novim državam članicam pri zunanjem ocenjevanju (sporazum o vzajemnem priznavanju ES-Kanada).
This will allow the general public to access information in the database in all languages and it will include more information 9 The Agency will continue to develop the EudraVigilance database and will add a new component on suspected unexpected serious adverse reactions 9 EMEA will also prepare and design a database of manufacturing authorisations and good manufacturing practice certificates required under the new Directive on human medicines
EMEA bo tudi pripravila in oblikovala zbirko podatkov o dovoljenjih za izdelavo in potrdilih o dobri proizvodni praksi, ki jih zahteva nova direktiva o zdravilih za ljudi.
Translation
Nizozemec
Qualified as a veterinary surgeon from the Royal Veterinary College, University of London.
Izobrazba: Diplomirala iz farmakologije na Kings Collegu, Univerza v Londonu Veterinarsko izobrazbo je dobila na Kraljevskem kolidžu za veterino, Univerza v Londonu.
To assess PMF and VAMF dossiers within the timelines laid down in the legislation
V rokih, kot jih določa zakonodaja, oceniti dokumentacijo za PMF in VAMF.
Education: Doctorate in natural sciences (applied physics and materials science) from Saarbrücken University; diploma in physics from Tübingen University; master of arts (mathematics) from the University of Cambridge, UK.
Saarbruecknu, diploma iz fizike na Univerzi v Tuebingenu, magisterij iz družbenih ved (matematike)
Out of hours telephone: (44-7880) 55 06 97
Faks: (44-20) 74 18 85 90 Telefon izven uradnih ur: (44-7880) 55 06 97
In 1991 Mrs Mendosa was transferred to the London office of the European Commission Representation in the UK. She joined the EMEA in November 1994 and was nominated head of sector in November 2002.
Leta 1991 je bila premeščena v londonski urad Predstavništva Evropske komisije v Združenem kraljestvu.
Annex 4 EMEA contact points
Kontaktne osebe EMEA
Education: Qualified pharmacist from the Free University of Brussels.
Izobrazba: Diplomiral iz farmacije na Neodvisni univerzi v Bruslju.
Performance indicators for this objective are: o percentage of summaries of opinion published at the time of publication of the press release following the CHMP meeting.
o odstotek povzetkov mnenj, objavljenih hkrati z objavo sporočila za javnost, ki sledi zasedanju CHMP.
Total Title 1
Odhodki za drugo osebje Naslov 1 skupaj
To implement the new legislative requirements in the area of scientific advice To provide quality scientific advice to applicants and adhere to regulatory timelines The performance indicator for this activity is the percentage of applications resulting in adoption of the advice letter within the 30, 60 or 90-day deadline (depending on the procedure).
Kazalnik uspešnosti za to dejavnost je odstotek vlog, za katere je bilo sprejeto obvestilo o svetovanju v 30-, 60- ali 90-dnevnem roku (odvisno od postopka).
EU Comments in preparation of VICH Guideline after consultation
VICH po posvetovanju
Mr Lönngren was with the National Board of Health and Welfare, Sweden, from 1978 to 1990, during which time he was responsible for herbal medicines, cosmetics, medical devices, narcotics and contraceptives.
pristojen je bil za zeliščna zdravila, kozmetiko, medicinske pripomočke, narkotike in kontracepcijska sredstva.
Marijke KORTEWEG Direct telephone (44-20) 74 18 85 56 E-mail: iqmanagement@emea.eu.int
Marijke KORTEWEG Direktni telefon (44-20) 74 18 85 56
He was re-elected as vice-chairman of the CHMP in 2004.
Leta 2004 je bil ponovno izvoljen za podpredsednika.
To be re-released for consultation in 1Q 2005
V posvetovanje se da ponovno 2005
GMP inspection requests GCP inspection requests GLP inspection requests
Zahtevki za inšpekcijski pregled dobre laboratorijske prakse Zahtevki za inšpekcijski pregled dobre klinične prakse
Applications for designation (Input)
Vloge za določitev zdravila (Vhodni podatek)
Revision expected to be released for consultation in 2005 and finalised in
Revizija se da v posvetovanje predvidoma leta 2005 in zaključi 2006
Arbitration and Community referrals received/forecast (Input)
Prejete/predvidene arbitraže in predložitve
He was re-elected chairman of the CHMP in 2004.
Leta 2004 je bil ponovno izvoljen za predsednika.
CHMP Pharmacovigilance Working Party
Delovna skupina CHMP za farmakovigilanco Referenčna številka
MRLs new applications MRL ext./mod.
Nove vloge za MRL Vloge za povečanje/spremembo MRL
Type I variation opinions Type II variation opinions Line extension opinions
Mnenja za spremembo tipa II
To be finalised in 4Q 2005
Dokončno oblikovani v 4. četrt.
31 May - 1 June
31. maj-1.
Applications received (Input)
Prejete vloge (Vhodni podatek)
2003 final
2003 končno 2004 končno 2005 predvidoma
Revision to be finalised in 1/2Q 2005
Revizija se zaključi v 1./2.
Contents
junij
To be released for consultation in 1Q
V posvetovanje se da v 1. četrt.
EMEA scientific committees
Proračun EMEA
To be released for consultation in 2/3Q 2005
V posvetovanje se da v 2./3.
To provide quality opinions during post-authorisation activities adhering to regulatory timelines and to communicate post-authorisation information to interested parties The performance indicator for this objective is the percentage of applications evaluated within the 30, 60 or 90-day timeline (depending on the procedure).
Zagotavljati kakovostna mnenja med dejavnostmi po izdaji dovoljenja, ob upoštevanju predpisanih rokov, in sporočati informacije o dejavnostih po izdaji dovoljenja zainteresiranim stranem.
Date of first authorisation: 23 April 2014 Date of latest renewal: 15 January 2019
Datum prve odobritve: 23. april 2014 Datum zadnjega podaljšanja: 15. januar 2019
If you use more Ulunar Breezhaler than you should If you have inhaled too much of this medicine or if someone else accidentally uses your capsules, you must immediately either tell your doctor or go to the nearest emergency unit.
Če ste uporabili večji odmerek zdravila Ulunar Breezhaler, kot bi smeli Če ste vdihnili preveč tega zdravila ali če kdo drug pomotoma uporabi vaše kapsule, takoj obvestite zdravnika ali pojdite do najbližjega oddelka za nujno pomoč.
The recommended dose is the inhalation of the content of one capsule once daily using the Ulunar Breezhaler inhaler.
Priporočeni odmerek je inhalacija vsebine ene kapsule enkrat na dan z uporabo inhalatorja Ulunar Breezhaler.
- The other ingredients of the inhalation powder are lactose monohydrate and magnesium stearate (see section 2 under “Ulunar Breezhaler contains lactose”).
- Drugi sestavini inhalacijskega praška sta laktoza monohidrat in magnezijev stearat (glejte poglavje 2 pod “Zdravilo Ulunar Breezhaler vsebuje laktozo”).
The capsules must be administered only using the Ulunar Breezhaler inhaler (see section 6.6).
Kapsule so namenjene samo uporabi z inhalatorjem Ulunar Breezhaler (glejte poglavje 6.6).
Do not use Ulunar Breezhaler - if you are allergic to indacaterol or glycopyrronium or any of the other ingredients of this medicine (listed in section 6).
Ne uporabljajte zdravila Ulunar Breezhaler - če ste alergični na indakaterol, glikopironij ali katero koli sestavino tega zdravila (navedeno v poglavju 6).
Administration of Ulunar Breezhaler may result in paradoxical bronchospasm which can be life-threatening.
Odmerjanje zdravila Ulunar Breezhaler lahko povzroči paradoksni bronhospazem, ki je lahko življenjsko nevaren.
COPD is a long-term disease and you should use Ulunar Breezhaler every day and not only when you have breathing problems or other symptoms of COPD.
- KOPB je dolgotrajna bolezen in zdravilo Ulunar Breezhaler morate uporabljati vsak dan, ne le takrat, ko težko dihate ali imate katerega od drugih simptomov KOPB.
If signs suggesting allergic reactions occur, in particular, angioedema (difficulties in breathing or swallowing, swelling of the tongue, lips and face), urticaria or skin rash, treatment should be discontinued immediately and alternative therapy instituted.
Če pride do znakov, ki kažejo na alergijsko reakcijo, zlasti če pride do angioedema (oteženega dihanja ali požiranja, otekanja jezika, ustnic in obraza), urtikarije ali izpuščaja, je treba zdravljenje takoj ukiniti in ga nadomestiti z drugim zdravljenjem.
The European Medicines Agency has waived the obligation to submit the results of studies with Ulunar Breezhaler in all subsets of the paediatric population in chronic obstructive pulmonary disease (COPD) (see section 4.2 for information on paediatric use).
Evropska agencija za zdravila je odstopila od zahteve za predložitev rezultatov študij z zdravilom Ulunar Breezhaler za vse podskupine pediatrične populacije pri kronični obstruktivni pljučni bolezni (KOPB) (za podatke o uporabi pri pediatrični populaciji glejte poglavje 4.2).
The safety and efficacy of Ulunar Breezhaler in children have not been established.
Varnost in učinkovitost zdravila Ulunar Breezhaler pri otrocih nista bili dokazani.
Ulunar Breezhaler is recommended to be administered at the same time of the day each day.
Zdravilo Ulunar Breezhaler je priporočeno uporabiti vsak dan ob istem času.
Ulunar Breezhaler should not be used for the treatment of asthma due to the absence of data in this indication.
Zdravila Ulunar Breezhaler se ne sme uporabljati za zdravljenje astme, saj o uporabi pri tej indikaciji ni na voljo nobenih podatkov.
Other most common adverse reactions related to the medicinal product (at least 3% of patients for Ulunar Breezhaler and also greater than placebo) were cough, nasopharyngitis and headache.
Drugi najbolj pogosti neželeni učinki, ki jih povzroča zdravilo (pri najmanj 3 % bolnikov, ki so prejemali zdravilo Ulunar Breezhaler, in z večjo pogostnostjo kot pri uporabi placeba), so bili kašelj, nazofaringitis in glavobol.
The presentation of the safety profile is based on the experience with Ulunar Breezhaler and the individual active substances.
Predstavitev varnostnih lastnosti temelji na izkušnjah z uporabo zdravila Ulunar Breezhaler in njegovih posameznih učinkovin.
The co-administration of Ulunar Breezhaler with other anticholinergic-containing medicinal products has not been studied and is therefore not recommended (see section 4.4).
Sočasne uporabe zdravila Ulunar Breezhaler z drugimi zdravili, ki vsebujejo antiholinergične učinkovine, niso proučevali in zato ni priporočena (glejte poglavje 4.4).
The safety experience with Ulunar Breezhaler was comprised of exposure of up to 15 months at the recommended therapeutic dose.
Izkušnje glede varnosti pri uporabi zdravila Ulunar Breezhaler so pridobljene pri izpostavljenosti zdravilu v trajanju do 15 mesecev v priporočenem terapevtskem odmerku.
Ulunar Breezhaler, dosed in the morning, reduced dynamic hyperinflation and improved the length of time exercise could be maintained from the first dose onwards.
Zdravilo Ulunar Breezhaler, ki so ga odmerjali zjutraj, je zmanjšalo dinamično hiperinflacijo pljuč in podaljšalo čas, ko so bolniki lahko izvajali vajo, in sicer od prvega odmerka dalje.
Patients should be informed about the signs and symptoms of acute narrow-angle glaucoma and should be informed to stop using Ulunar Breezhaler should any of these signs or symptoms develop.
Bolnike je treba seznaniti z znaki in simptomi akutnega glavkoma zaprtega zakotja in jim naročiti, naj v primeru pojava teh simptomov ali znakov prenehajo uporabljati zdravilo Ulunar Breezhaler.
Therefore, Ulunar Breezhaler should only be used during pregnancy if the expected benefit to the patient justifies the potential risk to the foetus.
Iz tega razloga se sme zdravilo Ulunar Breezhaler v nosečnosti uporabiti samo v primeru, da pričakovana korist za bolnico upravičuje potencialno tveganje za plod.
Following inhalation of Ulunar Breezhaler, the absolute bioavailability of indacaterol has been estimated to range from 61 to 85% of the delivered dose, and that of glycopyrronium was about 47% of the delivered dose.
Ocenjujejo, da je po inhaliranju zdravila Ulunar Breezhaler absolutna biološka uporabnost indakaterola v razponu od 61 % do 85 % prejetega odmerka, za glikopironij pa znaša približno 47 % prejetega odmerka.
You should not use Ulunar Breezhaler unless your doctor tells you to do so.
Zdravila Ulunar Breezhaler ne smete uporabljati, razen če vam tako naroči zdravnik.
- When you start a new pack, use the new Ulunar Breezhaler inhaler that is supplied in the pack.
- Ko odprete novo škatlo z zdravilom, začnite uporabljati tudi nov inhalator Ulunar Breezhaler, ki je priložen pakiranju.
• Ulunar Breezhaler capsules must always be stored in the blister card and only removed immediately before use.
• Ulunar Breezhaler kapsule vedno shranjujte v pretisnem omotu in jih vzemite iz njega šele tik pred uporabo.
Ulunar Breezhaler is indicated as a maintenance bronchodilator treatment to relieve symptoms in adult patients with chronic obstructive pulmonary disease (COPD).
Zdravilo Ulunar Breezhaler je indicirano kot vzdrževalno bronhodilatatorno zdravljenje za lajšanje simptomov pri odraslih bolnikih s kronično obstruktivno pljučno boleznijo (KOPB).
There is no relevant use of Ulunar Breezhaler in the paediatric population (under 18 years) in the indication COPD.
Zdravilo Ulunar Breezhaler ni primerno za uporabo pri pediatrični populaciji (v starosti pod 18 let) za indikacijo KOPB.
Ulunar Breezhaler should be used with caution in patients with convulsive disorders or thyrotoxicosis, and in patients who are unusually responsive to beta2-adrenergic agonists.
Pri uporabi zdravila Ulunar Breezhaler je potrebna previdnost pri bolnikih s konvulzivnimi motnjami ali s hipertiroidizmom in pri bolnikih, ki so neobičajno odzivni na agoniste beta-2 adrenergičnih receptorjev.
There are no data available for the use of Ulunar Breezhaler in patients with severe hepatic impairment, therefore caution should be observed in these patients (see section 5.2).
O uporabi zdravila Ulunar Breezhaler pri bolnikih s hudo okvaro jeter ni na voljo nobenih podatkov, zato je pri teh bolnikih potrebna previdnost (glejte poglavje 5.2).
In patients with severe renal impairment or end-stage renal disease requiring dialysis, Ulunar Breezhaler should be used only if the expected benefit outweighs the potential risk.
Pri bolnikih s hudo okvaro ledvic ali s končno ledvično odpovedjo, ki potrebujejo dializo, se sme zdravilo Ulunar Breezhaler uporabljati samo v primeru, da pričakovana korist presega potencialno tveganje.
3H]-labelled glycopyrronium bromide, the mean urinary excretion of radioactivity in 48 hours amounted to 85% of the dose.
Po intravenskem odmerjanju s [3H] označenega glikopironijevega bromida se je v 48 urah v urinu izločilo povprečno 85 % radioaktivno označenega odmerka.
There are no data from the use of Ulunar Breezhaler in pregnant women available.
Ni podatkov o uporabi zdravila Ulunar Breezhaler pri nosečnicah.
The Ulunar Breezhaler clinical Phase III development programme included six studies in which over 8,000 patients were enrolled: 1) a 26-week placebo- and active-controlled (indacaterol once daily, glycopyrronium once daily, open-label tiotropium once daily) study; 2) a 26-week active-controlled (fluticasone/salmeterol twice daily) study; 3) a 64-week active-controlled (glycopyrronium once daily, open-label tiotropium once daily) study; 4) a 52-week placebo-controlled study; 5) a 3-week placeboand active-controlled (tiotropium once daily) exercise tolerance study; and 6) a 52-week activecontrolled (fluticasone/salmeterol twice daily) study.
Klinični razvojni program študij faze III zdravila Ulunar Breezhaler je vključeval šest študij, v katere je bilo vključenih več kot 8.000 bolnikov: 1) 26-tedensko s placebom in aktivno kontrolirano študijo (indakaterol enkrat na dan, glikopironij enkrat na dan in odprto zdravljenje s tiotropijem enkrat na dan), 2) 26-tedensko aktivno kontrolirano študijo (flutikazon/salmeterol dvakrat na dan), 3) 64-tedensko aktivno kontrolirano študijo (glikopironij enkrat na dan, odprto zdravljenje s tiotropijem enkrat na dan), 4) 52-tedensko s placebom kontrolirano študijo, 5) 3-tedensko s placebom in aktivno (s tiotropijem enkrat na dan) kontrolirano študijo prenašanja napora in 6) 52-tedensko aktivno kontrolirano študijo (flutikazon/salmeterol dvakrat na dan).
In patients with severe renal impairment (estimated glomerular filtration rate below 30 ml/min/1.73 m2), including those with end-stage renal disease requiring dialysis, Ulunar Breezhaler should be used only if the expected benefit outweighs the potential risk (see section 5.2).
Pri bolnikih s hudo okvaro ledvic (z ocenjeno hitrostjo glomerulne filtracije manj kot 30 ml/min/1,73 m2), med katere sodijo tudi tisti s končno ledvično odpovedjo, ki potrebujejo dializno zdravljenje, se sme zdravilo Ulunar Breezhaler uporabljati samo v primeru, da pričakovana korist presega potencialno tveganje (glejte poglavje 5.2).
Overall the effect on heart rate over time did not show a consistent pharmacodynamic effect of Ulunar Breezhaler.
V celoti rezultati opazovanja delovanja na srčno frekvenco v danem času niso potrdili enotnega farmakodinamičnega učinka zdravila Ulunar Breezhaler.
No specific interaction studies were conducted with Ulunar Breezhaler.
Specifičnih študij medsebojnega delovanja z zdravilom Ulunar Breezhaler niso izvedli.
Upon initiation of treatment with Ulunar Breezhaler plasma glucose should be monitored more closely in diabetic patients.
Pri sladkornih bolnikih je treba po začetku zdravljenja z zdravilom Ulunar Breezhaler še bolj natančno spremljati koncentracije glukoze v plazmi.
This will also help you to remember to use it. You can inhale Ulunar Breezhaler any time before or after food or drink.
Zdravilo Ulunar Breezhaler lahko inhalirate kadarkoli, pred ali po uživanju hrane oziroma pijače.
Following inhalation of Ulunar Breezhaler, the median time to reach peak plasma concentrations of indacaterol and glycopyrronium was approximately 15 minutes and 5 minutes, respectively.
Po inhalaciji zdravila Ulunar Breezhaler znaša mediana vrednost časa, ko indakaterol in glikopironij dosežeta najvišjo koncentracijo v plazmi, približno 15 minut oziroma 5 minut.
Not for acute use Ulunar Breezhaler is not indicated for the treatment of acute episodes of bronchospasm.
Zdravilo ni namenjeno akutni uporabi Zdravilo Ulunar Breezhaler ni indicirano za zdravljenje akutnih epizod bronhospazma.
During long-term clinical studies, more patients on Ulunar Breezhaler experienced clinically notable changes in blood glucose (4.9%) at the recommended dose than on placebo (2.7%).
V dolgoročnih kliničnih študijah so klinično opazne spremembe v koncentraciji glukoze v krvi pogosteje opažali pri bolnikih, ki so jemali zdravilo Ulunar Breezhaler v priporočenem odmerku, (4,9 %) v primerjavi s tistimi, ki so jemali placebo (2,7 %).
What Ulunar Breezhaler is and what it is used for What you need to know before you use Ulunar Breezhaler How to use Ulunar Breezhaler Possible side effects
Kaj je zdravilo Ulunar Breezhaler in za kaj ga uporabljamo Kaj morate vedeti, preden boste uporabili zdravilo Ulunar Breezhaler Kako uporabljati zdravilo Ulunar Breezhaler Možni neželeni učinki
Ulunar Breezhaler prolonged time to first moderate or severe exacerbation with a 22% reduction in risk of an exacerbation (p<0.001) and prolonged time to first severe exacerbation with a 19% reduction in risk of an exacerbation (p=0.046).
Zdravilo Ulunar Breezhaler je podaljšalo čas do prvega zmernega oziroma hudega poslabšanja z 22-odstotnim zmanjšanjem tveganja za poslabšanje (p<0,001), čas do prvega hudega poslabšanja pa je podaljšalo z 19-odstotnim zmanjšanjem tveganja za poslabšanje (p=0,046).
In a 64-week study comparing Ulunar Breezhaler (n=729), glycopyrronium (n=739) and tiotropium (n=737), Ulunar Breezhaler reduced the annualised rate of moderate or severe COPD exacerbations by 12% compared to glycopyrronium (p=0.038) and by 10% compared to tiotropium (p=0.096).
V 64-tedenski študiji, v kateri so primerjali zdravilo Ulunar Breezhaler (n=729), glikopironij (n=739) in tiotropij (n=737), je zdravilo Ulunar Breezhaler zmanjšalo letno pogostnost zmernih ali hudih akutnih poslabšanj KOPB za 12 % v primerjavi z glikopironijem (p=0,038) in za 10 % v primerjavi s tiotropijem (p=0,096).
Smoking status and baseline FEV1 had no apparent effect on systemic exposure to indacaterol and glycopyrronium after inhalation of Ulunar Breezhaler.
Status kajenja in izhodiščna vrednost FEV1 nimata opaznega vpliva na sistemsko izpostavljenost indakaterolu in glikopironiju po inhlairanju zdravila Ulunar Breezhaler.
What Ulunar Breezhaler contains - The active substances are indacaterol (as maleate) and glycopyrronium bromide.
Kaj vsebuje zdravilo Ulunar Breezhaler - Učinkovini sta indakaterol (v obliki maleata) in glikopironijev bromid.
Ulunar Breezhaler has not been investigated in patients for whom diabetes mellitus is not well controlled, therefore caution and appropriate monitoring are advised in such patients.
Uporabe zdravila Ulunar Breezhaler niso proučevali pri bolnikih, ki niso imeli dobro urejene sladkorne bolezni, zato sta pri uporabi zdravila pri takšnih bolnikih priporočena previdnost in ustrezno spremljanje.
• Do not use the Ulunar Breezhaler capsules with any other inhaler.
• Kapsul Ulunar Breezhaler ne uporabljajte z nobenim drugim inhalatorjem.
Ulunar Breezhaler should be used with caution in these patient groups.
Pri uporabi zdravila Ulunar Breezhaler pri teh skupinah bolnikov je potrebna previdnost.
What you need to know before you use Ulunar Breezhaler
Kaj morate vedeti, preden boste uporabili zdravilo Ulunar Breezhaler
How long to continue your treatment with Ulunar Breezhaler Keep using Ulunar Breezhaler for as long as your doctor tells you.
Kako dolgo je treba nadaljevati z uporabo zdravila Ulunar Breezhaler - Zdravljenje z zdravilom Ulunar Breezhaler nadaljujte tako dolgo, kot vam naroči zdravnik.
How to store Ulunar Breezhaler Contents of the pack and other information Instructions for use of Ulunar Breezhaler inhaler
Shranjevanje zdravila Ulunar Breezhaler Vsebina pakiranja in dodatne informacije Navodila za uporabo inhalatorja Ulunar Breezhaler
In healthy volunteers, after the administration of 4 times the recommended therapeutic dose of Ulunar Breezhaler, the effect on serum potassium was very small (maximal difference -0.14 mmol/l when compared to placebo).
Pri zdravih prostovoljcih je bil po odmerjanju zdravila Ulunar Breezhaler v odmerku, ki je bil 4-krat višji od priporočenega terapevtskega odmerka, učinek na koncentracijo kalija v serumu zelo majhen (z največjo razliko -0,14 mmol/l v primerjavi z uporabo placeba).
The effect was significantly greater for Ulunar Breezhaler, when compared to indacaterol, glycopyrronium or tiotropium alone (difference 110 ml, for each comparison).
Pri uporabi zdravila Ulunar Breezhaler je bil ta učinek statistično značilno večji v primerjavi s samostojno uporabo indakaterola, glikopironija ali tiotropija (z razliko 110 ml za vsako od primerjav).
The use of Ulunar Breezhaler by breast-feeding women should only be considered if the expected benefit to the woman is greater than any possible risk to the infant (see section 5.3).
O uporabi zdravila Ulunar Breezhaler v času dojenja je smiselno razmišljati samo v primeru, da pričakovana korist za bolnico presega potencialno tveganje za otroka (glejte poglavje 5.3).
The incidence of pneumonia was 3.2% in the Ulunar Breezhaler arm compared to 4.8% in the fluticasone/salmeterol arm (p=0.017).
Pogostnost pljučnice je v skupini z zdravilom Ulunar Breezhaler znašala 3,2 % v primerjavi s 4,8 % v skupini s kombinacijo flutikazon/salmeterol (p=0,017).