natgillin/translations-raw huggingface dataset:
Irbesartan Zentiva 150 mg film-coated tablets are supplied in blister packs of 14, 28, 30, 56, 84, 90 or 98 film-coated tablets. 
Irbesartan Zentiva 150 mg filmsko obložene tablete so na voljo v pretisnih omotih s 14, 28, 30, 56, 84, 90 ali 98 filmsko obloženimi tabletami.
Package leaflet: Information for the user Irbesartan Zentiva 75 mg tablets irbesartan 
Navodilo za uporabo Irbesartan Zentiva 75 mg tablete irbesartan
Do not pass it on to others. 
ne sme uporabljati sočasno.
This results in an increase in blood pressure. 
za zdravljenje povečanega krvnega tlaka (primarne hipertenzije).
Irbesartan Zentiva with food and drink Irbesartan Zentiva can be taken with or without food. 
Zdravilo Irbesartan Zentiva skupaj s hrano in pijačo
EU/1/06/376/011 - 14 tablets EU/1/06/376/012 - 28 tablets EU/1/06/376/013 - 56 tablets EU/1/06/376/014 - 56 x 1 tablets EU/1/06/376/015 - 98 tablets 
EU/1/06/376/014 - 56 x 1 tableta EU/1/06/376/015 - 98 tablet
PHARMACEUTICAL FORM AND CONTENTS 14 tablets 28 tablets 56 tablets 56 x 1 tablets 98 tablets METHOD AND ROUTE(S) OF ADMINISTRATION Oral use. 
14 tablet 28 tablet 56 tablet 56 x 1 tableta 98 tablet
QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 75 mg of irbesartan. 
Ena filmsko obložena tableta vsebuje 75 mg irbesartana.
What Irbesartan Zentiva looks like and contents of the pack Irbesartan Zentiva 75 mg film-coated tablets are white to off-white, biconvex, and oval-shaped with a heart debossed on one side and the number 2871 engraved on the other side. 
Irbesartan Zentiva 75 mg filmsko obložene tablete so bele do kremaste barve, izbočene na obeh straneh in ovalne oblike.
Package leaflet: Information for the user Irbesartan Zentiva 75 mg film-coated tablets irbesartan 
Navodilo za uporabo Irbesartan Zentiva 75 mg filmsko obložene tablete irbesartan
EU/1/06/376/006 - 14 tablets EU/1/06/376/007 - 28 tablets EU/1/06/376/008 - 56 tablets EU/1/06/376/009 - 56 x 1 tablets EU/1/06/376/010 - 98 tablets 
EU/1/06/376/009 - 56 x 1 tableta EU/1/06/376/010 - 98 tablet
EU/1/06/376/001 - 14 tablets EU/1/06/376/002 - 28 tablets EU/1/06/376/003 - 56 tablets EU/1/06/376/004 - 56 x 1 tablets EU/1/06/376/005 - 98 tablets 
EU/1/06/376/004 - 56 x 1 tableta EU/1/06/376/005 - 98 tablet
QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 150 mg of irbesartan. 
Ena filmsko obložena tableta vsebuje 150 mg irbesartana.
NAME OF THE MEDICINAL PRODUCT Irbesartan Zentiva 75 mg film-coated tablets. 
Irbesartan Zentiva 75 mg filmsko obložene tablete.
Package leaflet: Information for the user Irbesartan Zentiva 300 mg tablets irbesartan 
Navodilo za uporabo Irbesartan Zentiva 300 mg tablete irbesartan
Package leaflet: Information for the user Irbesartan Zentiva 300 mg film-coated tablets irbesartan 
Navodilo za uporabo Irbesartan Zentiva 300 mg filmsko obložene tablete irbesartan
Film-coating: 
Ledvična okvara:
QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 300 mg of irbesartan. 
Ena filmsko obložena tableta vsebuje 300 mg irbesartana.
Package leaflet: Information for the user Irbesartan Zentiva 150 mg film-coated tablets irbesartan 
Navodilo za uporabo Irbesartan Zentiva 150 mg filmsko obložene tablete irbesartan
NAME OF THE MEDICINAL PRODUCT Irbesartan Zentiva 300 mg film-coated tablets. 
Irbesartan Zentiva 300 mg filmsko obložene tablete.
NAME OF THE MEDICINAL PRODUCT Irbesartan Zentiva 150 mg film-coated tablets. 
Irbesartan Zentiva 150 mg filmsko obložene tablete.
What Irbesartan Zentiva looks like and contents of the pack Irbesartan Zentiva 75 mg tablets are white to off-white, biconvex, and oval-shaped with a heart debossed on one side and the number 2771 engraved on the other side. 
Irbesartan Zentiva 75 mg tablete so bele do kremaste barve, izbočene na obeh straneh in ovalne oblike.
What Irbesartan Zentiva looks like and contents of the pack Irbesartan Zentiva 150 mg film-coated tablets are white to off-white, biconvex, and oval-shaped with a heart debossed on one side and the number 2872 engraved on the other side. 
Irbesartan Zentiva 150 mg filmsko obložene tablete so bele do kremaste barve, izbočene na obeh straneh in ovalne oblike.
impaired renal function including cases of renal failure in patients at risk (see section 4.4) Reproductive system and breast disorders Uncommon: sexual dysfunction 
(glejte poglavje 4.4) Motnje reprodukcije in dojk
hyperkalaemia Nervous system disorders Common: 
hiperkaliemijo in spremembe delovanja ledvic.
Annex III Conditions for lifting the suspension 
Dodatek III Pogoji za preklic začasnega umika
New clinical and bioanalytical studies are performed and submitted to the relevant national competent authorities. 
Nove kritične in bioanalitične študije se izvedejo in predložijo zadevnim pristojnim nacionalnim organom.
The marketing authorisation holder should demonstrate therapeutic equivalence based on a clinical and bioanalytical study performed in compliance with GCP requirements. 
Imetnik dovoljenja za promet z zdravilom mora dokazati terapevtsko enakovrednost na podlagi klinične in bioanalitične študije, izvedene v skladu z zahtevami dobre klinične prakse.
Prior to the lifting of the suspension of the marketing authorisations, the national competent authorities, coordinated by the reference Member State, shall ensure that the following conditions are fulfilled by the marketing authorisation holder: 
Pred preklicem začasnega umika dovoljenj za promet z zdravilom morajo pristojni nacionalni organi, ki jih koordinira referenčna država članica, zagotoviti, da imetnik dovoljenja za promet z zdravilom izpolni naslednje pogoje:
If your symptoms do not improve 
Če se vaši simptomi ne izboljšajo
contact your doctor as soon as possible. 
Čimprej se posvetujte z zdravnikom.
No risk factors were identified. 
Dejavnikov tveganja niso ugotovili.
It is not known whether the ingredients of this medicine can pass into breast milk. 
Ni znano, ali lahko sestavine tega zdravila prehajajo v materino mleko.
These differences are unlikely to be of clinical relevance. 
Ni verjetno, da bi bile te razlike klinično pomembne.
Just take your next dose at the usual time. 
Preprosto vzemite naslednji odmerek ob običajnem času.
Results for the primary and key secondary endpoints in these studies are described in Table 1. 
Rezultati primarnega in ključnih sekundarnih opazovanih dogodkov v teh študijah so prikazani v preglednici 1.
Date of latest renewal: 26 July 2018 
Datum zadnjega podaljšanja: 26. julij 2018
Further management should be as clinically indicated or as recommended by the national poisons centre, where available. 
Nadaljnje ukrepanje mora potekati, kot je klinično indicirano ali kot priporoča nacionalni Center za zastrupitve, kjer je ta na voljo.
The final decision on evening or morning dosing should be left to the discretion of the physician. 
Dokončna odločitev o uporabi zvečer ali zjutraj mora biti prepuščena presoji zdravnika.
if you have low potassium in your blood. 
če imate nizek kalij v krvi;
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 13 November 2013 
DATUM PRIDOBITVE/PODALJŠANJA DOVOLJENJA ZA PROMET Z ZDRAVILOM Datum prve odobritve: 13. november 2013
• suddenly feeling weak or light headed (which may lead to collapse or loss of consciousness) 
• nenadno slabo počutje ali omotičnost (ki lahko vodi v kolaps ali izgubo zavesti).
Other side effects include: 
Ostali neželeni učinki vključujejo:
No dose adjustment is required in this population (see section 5.2). 
Prilagoditev odmerka v tej populaciji ni potrebna (glejte poglavje 5.2).
This dose is also used once daily at the same time each day. 
Tudi ta odmerek se uporablja enkrat na dan, vsak dan ob istem času.
See section 4 for information on symptoms to look out for while you are using this medicine. 
Glejte poglavje 4 za informacije o simptomih, na katere morate biti pozorni, medtem ko uporabljate to zdravilo.
Table 2: Analysis of Exacerbation Rates following 12 months of treatment 
Preglednica 2: Analiza deležev poslabšanj po 12 mesecih zdravljenja
Immediate breathing difficulties 
Takojšnje težave z dihanjem
*, ** See below ‘Description of selected adverse reactions' 
*, ** Glejte spodaj "Opis izbranih neželenih učinkov" Opis izbranih neželenih učinkov
How to prepare a dose 
Kako pripraviti odmerek
Children aged under 12 years 
Otroci, mlajši od 12 let:
The dose should be titrated to the lowest dose at which effective control of symptoms is maintained. 
Odmerek je treba titrirati do najnižjega odmerka, ki učinkovito obvladuje simptome.
Hold this breath for as long as possible (at least 3-4 seconds). 
Dih zadržite, kolikor je mogoče dolgo (vsaj 3 do 4 sekunde).
if you have ever been told you have diabetes or high blood sugar. 
če so vam kdaj povedali, da imate sladkorno bolezen ali povišan sladkor v krvi;
• weakening of the bones, leading to fractures 
• oslabitev kosti, ki je vzrok zlomov,
If overdose occurs, the patient should be treated supportively with appropriate monitoring as necessary. 
V primeru prevelikega odmerka je treba bolnika zdraviti podporno in ga ustrezno nadzorovati, kot je potrebno.
Elderly patients (> 65 years old) 
Starejši ljudje (> 65 let)
If a dose is missed the next dose should be taken at the usual time the next day. 
V primeru pozabljenega odmerka je treba naslednji odmerek uporabiti ob običajnem času naslednji dan.
The dose counter counts down by 1 to confirm. 
Števec odmerkov za potrditev odšteva po 1.
Do not use Relvar Ellipta if you are allergic to fluticasone furoate, vilanterol or any other ingredients of this medicine (listed in section 6). 
Ne uporabljajte zdravila Relvar Ellipta če ste alergični na flutikazonfuroat, vilanterol ali katero koli sestavino tega zdravila (navedeno v poglavju 6).
If your symptoms (breathlessness, wheezing, cough) do not improve or get worse, or if you are using your quick-acting inhaler more often: 
Če se vaši simptomi (zasoplost, piskajoče dihanje, kašelj) ne izboljšajo ali se poslabšajo, ali če uporabljate vaš kratkodelujoči inhalator pogosteje:
This helps to open the airways and makes it easier for air to get in and out of the lungs. 
To pomaga odpreti dihalne poti in olajša vstopanje in izstopanje zraka v pljuča in iz njih.
**Fractures 
**Zlomi
NAME OF THE MARKETING AUTHORISATION HOLDER GSK Logo 
IME IMETNIKA DOVOLJENJA ZA PROMET GSK Logo
The primary endpoint was the annual rate of moderate and severe exacerbations. 
Primarni opazovani dogodek je bil letni delež zmernih in hudih poslabšanj.
Corticosteroids reduce inflammation. 
Kortikosteroidi zmanjšajo vnetje.
The effects of haemodialysis have not been studied. 
Učinki hemodialize niso raziskani.
If you have been told by your doctor that you have an intolerance to some sugars, or to milk protein, contact your doctor before using this medicine. 
Če vam je vaš zdravnik povedal, da imate intoleranco za nekatere sladkorje ali mlečne beljakovine, se posvetujte z zdravnikom, preden uporabite zdravilo.
They reduce the swelling and irritation in the small air passages in the lungs and so gradually ease breathing problems. 
Zmanjšajo oteklost in draženje v malih dihalnih poteh v pljučih in tako postopoma olajšajo težave z dihanjem.
However, there was no evidence for the higher systemic exposure in this population to be associated with greater effect on 24 hour urinary cortisol excretion. 
Vendar ni dokazov, da bi večjo sistemsko izpostavljenost pri tej populaciji spremljal večji učinek na 24-urno izločanje kortizola v urinu.
• Whenever the risk management system is modified, especially as the result of new information being received that may lead to a significant change to the benefit/risk profile or as the result of an important (Pharmacovigilance or risk minimisation) milestone being reached. 
• ob vsakršni spremembi sistema za obvladovanje tveganj, zlasti kadar je tovrstna sprememba posledica prejema novih informacij, ki lahko privedejo do znatne spremembe razmerja med koristmi in tveganji, ali kadar je ta sprememba posledica tega, da je bil dosežen pomemben mejnik
Similar effects in reduction of moderate and severe exacerbations were observed in this subgroup as compared with the overall population. 
V tej podskupini so opažali podobne učinke na zmanjšanje zmernih in hudih poslabšanj kot v celotni populaciji.
These studies included measures of lung function, dyspnoea and moderate and severe exacerbations. 
Te študije so vključevale meritve pljučne funkcije, dispneje ter zmernih in hudih poslabšanj.
Allergic reactions to Relvar Ellipta are rare (may affect up to 1 in 1,000 people). 
Alergijske reakcije pri zdravilu Relvar Ellipta so redke (pojavijo se lahko pri največ 1 od 1.000 bolnikov).
In an integrated analysis of 11 studies in asthma (7,034 patients), the incidence of fractures was <1%, and usually associated with trauma. 
V integrirani analizi 11 študij pri astmi (7.034 bolnikov) je bila incidenca zlomov < 1 % in so bili po navadi povezani s poškodbo.
if you have tuberculosis (TB) of the lung, or any long standing or untreated infections. 
če imate pljučno tuberkulozo (TB) ali katerokoli dolgotrajno nezdravljeno okužbo;
For the SUMMIT study, the incidence of all events of fracture with FF/VI, FF, VI and placebo were 2% in each arm; fractures commonly associated with ICS use were less than 1 % in each arm. 
V študiji SUMMIT je bila pojavnost vseh zlomov s FF/VI, FF, VI in placebom v vseh skupinah 2 %; zlomov, ki so pogosto povezani z uporabo ICS, je bilo v vsaki od skupin manj kot 1 %.
HZA106837 was of variable treatment duration (from a minimum of 24 weeks to a maximum of 76 weeks with the majority of patients treated for at least 52 weeks). 
V HZA106837 je bilo trajanje zdravljenja spremenljivo (od najmanj 24 tednov do največ 76 tednov; večina bolnikov je bila zdravljenih vsaj 52 tednov).
Tell your doctor or pharmacist if you are taking any of these medicines. 
Svojemu zdravniku ali farmacevtu morate povedati, če jemljete katerokoli od teh zdravil.
These effects are much less likely to occur than with oral corticosteroids. 
Ti učinki so veliko manj verjetni kot med uporabo peroralnih kortikosteroidov.
Administration of fluticasone furoate/vilanterol to pregnant women should only be considered if the expected benefit to the mother is greater than any possible risk to the foetus. 
Uporaba flutikazonfuroata/vilanterola pri nosečnicah pride v poštev le, če je pričakovana korist za mater večja od možnega tveganja za plod.
Systemic corticosteroid effects 
Sistemski učinki kortikosteroidov
Relvar Ellipta should be used every day and not only when you have breathing problems or other symptoms of COPD and asthma. 
Zdravilo Relvar Ellipta morate uporabljati vsak dan in ne samo, kadar imate težave z dihanjem ali druge simptome KOPB in astme.
Genotoxicity and carcinogenicity 
Genotoksičnost in kancerogenost
You may notice that your heart is beating faster than usual, you feel shaky or have a headache. 
Opazite lahko hitrejše bitje srca kot po navadi, občutek drhtenja ali glavobol.
Moderate and severe exacerbations Adjusted mean annual rate 
Zmerna in huda poslabšanja Korigirani povprečni letni delež
PHARMACEUTICAL PARTICULARS 6.1 List of excipients Lactose monohydrate Magnesium stearate 
FARMACEVTSKI PODATKI 6.1 Seznam pomožnih snovi laktoza monohidrat magnezijev stearat
ONCE DAILY 
1-krat/dan
Treatment Dose of FF/VI*(micrograms) 
Terapevtski odmerek FF/VI* (mikrogrami)
12 month studies 
12-mesečni študiji
Concurrent use of both non-selective and selective beta2-adrenergic blockers should be avoided unless there are compelling reasons for their use. 
Sočasni uporabi z antagonisti adrenergičnih receptorjev beta2 (tako neselektivnih kot selektivnih) se je treba izogibati, razen če ostajajo nujni razlogi za njihovo uporabo.
The enhanced anti-inflammatory effect of the LABA component was similar to that obtained with other ICS/LABA combinations. 
Izrazitejši protivnetni učinek LABA je bil podoben, kot je dosežen z drugimi kombinacijami ICS/LABA.
When you take these two active substances together regularly, they will help to control your breathing difficulties more than either medicine alone. 
Če ti zdravilni učinkovini redno uporabljate skupaj, vam bosta pomagali obvladovati težave z dihanjem bolj kot vsako zdravilo posebej.
Corticosteroids also help to prevent attacks of asthma and aggravation of COPD. 
Kortikosteroidi pomagajo tudi preprečiti napade astme in poslabšanje KOPB.
The following convention has been used for the classification of frequencies: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000). 
Za razvrstitev pogostnosti je uporabljen naslednji dogovor: zelo pogosti (≥ 1/10); pogosti (≥ 1/100 do < 1/10); občasni (≥ 1/1000 do < 1/100); redki (≥ 1/10.000 do < 1/1000); zelo redki (< 1/10.000).
Fluticasone furoate belongs to a group of medicines called corticosteroids, often simply called steroids. 
Flutikazonfuroat spada v skupino zdravil, imenovanih kortikosteroidi, pogosto preprosto imenovanih steroidi.
In HZA106837 all patients had at least one exacerbation that required treatment with oral corticosteroids in the year prior to visit 1. 
V študiji HZA106837 so imeli vsi bolniki vsaj eno poslabšanje, ki je zahtevalo zdravljenje s peroralnimi kortikosteroidi v letu pred 1. obiskom.
Adults aged 18 years and over 
Odrasli, stari 18 let ali več
In adolescents (12 years or older), there are no recommended dose modifications. 
Pediatrična populacija Pri mladostnikih (starih 12 let ali več) ni priporočenih prilagoditev odmerka.
Absolute difference in number per year vs VI (95% CI) 
Absolutna razlika v številu/leto v primerjavi z VI (95% CI)
The allergen was house dust mite, cat dander, or birch pollen; the selection was based on individual screening tests. 
Alergeni so bili pršica iz hišnega prahu, mačji prhljaj ali brezin pelod; alergen so izbrali na podlagi individualnih presejalnih testov.
If you have used more than instructed for a long period of time, it is particularly important that you ask your doctor or pharmacist for advice. 
Če ste odmerke, večje od priporočenega, uporabljali dolgo časa, je še posebej pomembno, da se posvetujete z zdravnikom ali farmacevtom.
Each delivered dose contains approximately 25 mg of lactose (as monohydrate). 
Vsak dostavljen odmerek vsebuje približno 25 mg laktoze (v obliki monohidrata).
If you are using this medicine for COPD you may be at an increased risk of developing an infection of the lungs known as pneumonia. 
Če uporabljate zdravilo za zdravljenje KOPB, imate lahko večje tveganje za pojav okužbe pljuč, imenovane pljučnica.
- Contact your doctor if you experience blurred vision or other visual disturbances. 
- Posvetujte se s svojim zdravnikom, če se vam pojavi zamegljen vid ali druge motnje vida.
A decision must be made whether to discontinue breast-feeding or to discontinue fluticasone furoate/vilanterol therapy taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman. 
Odločiti se je treba bodisi za prenehanje dojenja bodisi za prenehanje zdravljenja s flutikazonfuroat/vilanterolom, upoštevaje koristi dojenja za otroka in korist zdravljenja za žensko.
Step by step instructions 
Navodila po korakih
This is because larger doses of Relvar Ellipta may reduce the amount of steroid hormones produced naturally by your body. 
Večji odmerki zdravila Relvar Ellipta namreč lahko zmanjšajo količino steroidnih hormonov, ki naravno nastajajo v telesu.
The incidence of cardiovascular history/risk factors was similar across the treatment groups with patients most commonly suffering from hypertension (46%), followed by hypercholesterolemia (29%) and diabetes mellitus (12%). 
Incidenca kardiovaskularne anamneze/dejavnikov tveganja je bila po terapevtskih skupinah podobna; bolniki so najpogosteje imeli hipertenzijo (46 %), ki sta ji sledili hiperholesterolemija (29 %) in sladkorna bolezen (12 %).
Co-administration should be avoided unless the benefit outweighs the increased risk of systemic corticosteroid undesirable effects, in which case patients should be monitored for systemic corticosteroid undesirable effects. 
Sočasni uporabi se je treba izogniti, razen če korist odtehta povečano tveganje za pojav sistemskih neželenih učinkov kortikosteroidov; v tem primeru je treba bolnike nadzorovati glede sistemskih neželenih učinkov kortikosteroidov.
The requirements for submission of periodic safety update reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal. 
• Redno posodobljena poročila o varnosti zdravila (PSUR) Zahteve glede predložitve rednega posodobljenega poročila o varnosti zdravila za to zdravilo so določene v seznamu referenčnih datumov EU (seznamu EURD), opredeljenem v členu 107c(7) Direktive 2001/83/ES,
The medicine is now ready to be inhaled. 
Zdravilo je zdaj pripravljeno za inhaliranje.
Immediate breathing difficulties after using Relvar Ellipta are rare. 
Takojšnje težave z dihanjem Takojšnje težave z dihanjem po uporabi zdravila Relvar Ellipta so redke.
Administration of fluticasone furoate combined with vilanterol did not result in any significant new toxicity. 
Uporaba flutikazonfuroata v kombinaciji z vilanterolom ni povzročila pomembnih novih toksičnih učinkov.
When it is taken regularly, it helps the small air passages to remain open. 
Če je vilanterol rabljen redno, pomaga ohraniti male dihalne poti odprte.
Increased cyclic AMP levels cause relaxation of bronchial smooth muscle and inhibition of release of mediators of immediate hypersensitivity from cells, especially from mast cells. 
Zvišanje ravni cikličnega AMP povzroči sprostitev bronhialnih gladkih mišic in zavre sproščanje mediatorjev takojšnje preobčutljivosti iz celic, predvsem iz mastocitov.
A severe asthma exacerbation was defined as deterioration of asthma requiring the use of systemic corticosteroids for at least 3 days or an inpatient hospitalization or emergency department visit due to asthma that required systemic corticosteroids. 
Hudo poslabšanje astme je bilo opredeljeno kot poslabšanje astme, ki je zahtevalo vsaj 3-dnevno uporabo sistemskih kortikosteroidov ali sprejem v bolnišnico ali obisk na oddelku za nujno medicinsko pomoč zaradi astme, ki je zahtevala sistemske kortikosteroide.
No dosage adjustment is necessary based on gender, weight or BMI. 
Odmerjanja ni treba prilagoditi glede na spol, telesno maso ali ITM.
The adjusted mean treatment difference of -37 mL between the groups was not statistically significant (p=0.162). 
Korigirana povprečna razlika med zdravljenjema 37 ml med skupinama ni bila statistično značilna (p = 0,162).
Patients should be regularly reassessed by a healthcare professional so that the strength of fluticasone furoate/vilanterol they are receiving remains optimal and is only changed on medical advice. 
Zdravnik mora bolnike redno kontrolirati, da ostane jakost uporabljane kombinacije flutikazonfuroat/vilanterol optimalna in se spremeni le po nasvetu zdravnika.
Some medicines may affect how this medicine works, or make it more likely that you will have side effects. 
Nekatera zdravila lahko vplivajo na delovanje tega zdravila ali povečajo verjetnost neželenih učinkov.
Moderate/ severe exacerbations were defined as worsening symptoms that required treatment with oral corticosteroids and/or antibiotics or in-patient hospitalisation. 
Zmerna/huda poslabšanja so bila opredeljena kot poslabšanje simptomov, ki je zahtevalo zdravljenje s peroralnimi kortikosteroidi in/ali antibiotiki ali sprejem v bolnišnico.
Fluticasone furoate and vilanterol are both substrates of P-glycoprotein (P-gp). 
Flutikazonfuroat in vilanterol sta oba substrata P-glikoproteina (P-gp).
Six month studies 
6-mesečni študiji
All subjects had to have been on a stable dose of an ICS for at least 4 weeks prior to visit 1 (screening visit) and the use of LABAs was not permitted within 4 weeks of visit 1. 
Vsi preiskovanci so morali prejemati stabilen odmerek inhaliranega kortikosteroida vsaj 4 tedne pred 1. obiskom (presejalni obisk) in uporaba LABA ni bila dovoljena v 4-tedenskem obdobju po 1. obisku.