FrancophonIA/ELRC3.0 huggingface dataset:
English: Uncommon side effects (may affect up to 1 in 100 people): - dizziness - low blood pressure - feeling weak or tired - feeling drowsy or sleepy - flushing, hot flush - feeling hot, fever - sweating (including night sweats) - chills - high blood pressure (sudden increase in blood pressure) - skin rash, itching, darkening of an area of skin or nails, bruising, hives - burning sensation of skin - shortness of breath - diarrhoea - constipation - stomach pain/discomfort - stomach distension or bloating - nausea, vomiting
Slovenian: Občasni neželeni učinki (lahko se pojavijo pri največ 1 od 100 bolnikov): - omotičnost - nizek krvni tlak - občutek šibkosti ali utrujenosti - občutek dremavosti ali zaspanosti - zardevanje, navali vročine - občutek vročine, zvišana telesna temperatura - potenje (vključno nočna potenja)
English: No adverse effects on fertility or general reproductive performance were noted in rats given IV Rienso at doses up to 18 mg Fe/kg/day (Human Equivalent Dose of 2.9 mg Fe/kg/day).
Slovenian: dajanju zdravila Rienso podganam v odmerkih do 18 mg Fe/kg/dan (kar ustreza odmerku 2,9 mg Fe/kg/dan pri človeku), niso opazili neželenih učinkov na plodnost ali splošno sposobnost razmnoževanja.
English: Hepatic Impairment
Slovenian: Jetrna okvara
English: Sodium hydroxide (for pH adjustment) Hydrocholric acid (for pH adjustment)
Slovenian: (za uravnavanje pH), klorovodikova kislina (za uravnavanje pH) in voda za injekcije.
English: Eosinophilia
Slovenian: Sprememba feritina
English: See section 4.
Slovenian: Pri i.v.
English: In clinical trials, adverse reactions leading to treatment discontinuation and occurring in ≥ 2
Slovenian: Študija 3 bolniki s kronično ledvično boleznijo, ki so na dializi
English: Laryngeal oedema Pharyngeal oedema Respiratory arrest Respiratory failure Throat irritation Throat tightness Wheezing
Slovenian: Bolezni dihal, prsnega koša in mediastinalnega prostora krvavitev iz nosu bronhospazem kašelj hiperventilacija hipoksija edem grla edem žrela dihalni zastoj dihalna odpoved draženje žrela stiskanje v grlu sopenje
English: Baseline at Day 35 (mean ± SD, %)
Slovenian: 35. dan od izhodišča (srednja vrednost ±
English: EXPIRY DATE
Slovenian: Datum
English: Overall conclusion and Benefit -risk balance
Slovenian: Splošni zaključek ter razmerje med tveganji in koristmi
English: Overall summary of the scientific evaluation of Leflunomide Actavis (see Annex I)
Slovenian: Splošni povzetek znanstvenega vrednotenja zdravila Leflunomide Actavis (glejte Prilogo I)
English: The single pivotal bioequivalence study 125-07 was conducted in May 2008 at the Cetero Research facilities in Houston.
Slovenian: Ena ključna študija biološke enakovrednosti 125-07 je bila opravljena maja 2008 v ustanovi Cetero Research v Houstonu.
English: It is indicated for the treatment of adults with active moderate to severe rheumatoid arthritis and psoriatic arthritis.
Slovenian: Uporablja se za zdravljenje odraslih z aktivnim zmernim do hudim revmatoidnim artritisom in psoriaznim artritisom.
English: • The Committee considered the procedure under Article 31 of Directive 2001/83/EC for Leflunomide Actavis and associated names.
Slovenian: • Odbor je obravnaval postopek v skladu s členom 31 Direktive 2001/83/ES za zdravilo Leflunomide Actavis in povezana imena.
English: In response to the CHMP list of questions, the MAH declared that the medicinal product Leflunomide Actavis was never marketed and is currently not available on any market.
Slovenian: Kot odgovor na seznam vprašanj odbora CHMP je imetnik dovoljenja za promet z zdravilom navedel, da se zdravilo Leflunomide Actavis ni nikoli tržilo in trenutno ni na voljo na nobenem trgu.
English: Leflunomide Actavis is available as 10 mg, 20 mg and 100 mg film-coated tablets.
Slovenian: Zdravilo Leflunomide Actavis je na voljo v obliki 10-, 20- in 100-miligramskih filmsko obloženih tablet.
English: Leflunomide Actavis contains leflunomide, a pyrimidine synthesis inhibitor belonging to the DMARD (disease-modifying antirheumatic drug) class of drugs, which are chemically and pharmacologically very heterogeneous.
Slovenian: Zdravilo Leflunomide Actavis vsebuje leflunomid, zaviralec sinteze pirimidina, ki spada v skupino imunomodulirajočih protirevmatičnih zdravil (DMARD), ki je kemijsko in farmakološko zelo heterogena.
English: The MAH is currently in the process of withdrawing the marketing authorisations in all EU member states and did therefore not provide any responses to the CHMP list of questions.
Slovenian: Imetnik dovoljenja za promet z zdravilom je trenutno v postopku umika dovoljenja za promet z zdravilom v vseh državah članicah EU, zato ni odgovoril na seznam vprašanj odbora CHMP.
English: The Committee, as a consequence, recommended the suspension of the marketing authorisations for Leflunomide Actavis and associated names, pursuant to Article 116 of Directive 2001/83/EC; as a. the risk-benefit balance cannot be considered favourable and b. the particulars supporting the application as provided in Article 10 of Directive 2001/83/EC cannot be considered correct
Slovenian: je odbor priporočil začasen umik dovoljenj za promet z zdravilom Leflunomide Actavis in povezanimi imeni v skladu s členom 116 Direktive 2001/83/ES, ker a. razmerje med tveganji in koristmi ni pozitivno ter b. podatki, ki naj bi podprli vlogo v skladu s členom 10 Direktive 2001/83/ES, niso pravilni.
English: • The Committee considered that the available data gave rise to serious doubts as to the evidence of the bioequivalence of Leflunomide Actavis and associated names with the EU reference product in view of concerns on the reliability of the data, due to the findings of the inspection of the Cetero Research facilities.
Slovenian: • Odbor je menil, da so razpoložljivi podatki povzročili resne dvome glede dokazov o biološki enakovrednosti zdravila Leflunomide Actavis in povezanih imen ter referenčnega zdravila v EU zaradi pomislekov glede zanesljivosti podatkov, ki so bili izpostavljeni v ugotovitvah inšpekcijskega pregleda ustanove Cetero Research.
English: Therefore, given the serious doubts regarding the reliability and the correctness of the data from the critical pivotal bioequivalence study 125-07, submitted in support of the marketing authorisation, and in the absence of a reliable bioequivalence study specifically designed to establish the bioequivalence Leflunomide Actavis to its EU reference product, the CHMP was unable to conclude on the bioequivalence of Leflunomide Actavis.
Slovenian: Zaradi resnih pomislekov glede zanesljivosti in pravilnosti podatkov iz kritične, ključne študije biološke enakovrednosti 125-07, predložene kot podpora za dovoljenje za promet z zdravilom, in zaradi odsotnosti zanesljive študije biološke enakovrednosti, posebej zasnovane za ugotavljanje biološke enakovrednosti zdravila Leflunomide Actavis in referenčnega zdravila v EU, odbor CHMP ni mogel sklepati o biološki enakovrednosti zdravila Leflunomide Actavis.
English: • The Committee is of the opinion that considering the serious doubts in respect of the evidence of bioequivalence, the benefit-risk of Leflunomide Actavis and associated names cannot be confirmed.
Slovenian: • Odbor je mnenja, da zaradi resnih dvomov glede dokazov o biološki enakovrednosti ni mogoče potrditi razmerja med tveganji in koristmi zdravila Leflunomide Actavis in povezanih imen.
English: As no data has been submitted by the MAH in response to the CHMP List of Questions, the CHMP retained serious doubts due to the findings of the inspection of the Cetero Research facilities in Houston (Texas, USA), regarding the reliability and the correctness of the data from the critical pivotal bioequivalence study submitted in support of the marketing authorisation.
Slovenian: Ker imetnik dovoljenja za promet z zdravilom ni predložil nobenih podatkov kot odgovor na seznam vprašanj odbora CHMP, ima odbor CHMP še vedno resne dvome zaradi ugotovitev inšpekcijskega pregleda prostorov ustanove Cetero Research v Houstonu (Teksas, ZDA) glede zanesljivosti in pravilnosti podatkov iz kritične, ključne študije biološke enakovrednosti, predložene kot podpora za dovoljenje za promet z zdravilom.
English: Therefore, and in the absence of a reliable bioequivalence study specifically designed to establish the bioequivalence of Leflunomide Actavis to its EU reference product, the benefit-risk balance of Leflunomide Actavis cannot be considered to be favourable.
Slovenian: Zaradi odsotnosti zanesljive študije biološki enakovrednosti, posebej zasnovane za ugotavljanje biološki enakovrednosti zdravila Leflunomide Actavis in referenčnega zdravila v EU, razmerja med tveganji in koristmi pri zdravilu Leflunomide Actavis ni mogoče obravnavati kot pozitivnega.
English: Frequency of this reaction cannot be estimated from the available data.
Slovenian: Pogostnosti te reakcije ni mogoče oceniti na podlagi podatkov, ki so na voljo.
English: The Instructions for Use is divided into the following sections: - Getting started - Step 1: Prepare your dose - Step 2: Inhale your medicine - Additional information
Slovenian: Navodila za uporabo so razdeljena v naslednja poglavja: - Začetek - Korak 1: Priprava odmerka - Korak 2: Inhaliranje odmerka vašega zdravila - Dodatne informacije
English: - You can use Duaklir Genuair anytime before or after food or drink.
Slovenian: - Zdravilo Duaklir Genuair lahko uporabite kadar koli pred uživanjem hrane ali pijače ali po tem.
English: Duaklir Genuair should only be used during pregnancy if the expected benefits outweigh the potential risks.
Slovenian: Zdravilo Duaklir Genuair se lahko uporablja med nosečnostjo samo, če se pričakuje, da koristi odtehtajo morebitna tveganja.
English: If you use Duaklir Genuair with some other medicines, the effect of Duaklir Genuair or the other medicines may be altered.
Slovenian: Če zdravilo Duaklir Genuair uporabljate z drugimi zdravili, se lahko učinek zdravila Duaklir Genuair ali drugih zdravil spremeni.
English: It is important that you read this information as the Genuair may work differently from inhalers you have used previously.
Slovenian: Pomembno je, da si preberete te informacije, ker lahko inhalator Genuair deluje drugače od inhalatorjev, ki ste jih že prej uporabljali.
English: You should not use Duaklir Genuair if you are pregnant or are breast-feeding unless your doctor tells you to do so.
Slovenian: Zdravila Duaklir Genuair ne smete uporabljati, če ste noseči ali dojite, razen če vam tako ne naroči zdravnik.
English: 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) and not known (cannot be estimated from available data).
Slovenian: Pogostnost neželenih učinkov je opredeljena po naslednjem dogovoru: zelo pogosti (≥1/10), pogosti (≥1/100 do <1/10), občasni (≥1/1.000 do <1/100), redki (≥1/10.000 do <1/1.000), zelo redki (<1/10.000) in neznana (ni mogoče oceniti iz razpoložljivih podatkov).
English: Also contains: Lactose See leaflet for further information
Slovenian: Vsebuje tudi: laktozo Za dodatne informacije glejte navodilo za uporabo
English: The most frequently reported adverse reactions with Duaklir Genuair were nasopharyngitis (7.9%) and headache (6.8%).
Slovenian: Najpogosteje poročana neželena učinka zdravila Duaklir Genuair sta bila nazofaringitis (7,9 %) in glavobol (6,8 %).
English: Do not use Duaklir Genuair: - if you are allergic to aclidinium, formoterol fumarate dihydrate or to the other ingredient of this medicine (listed in section 6).
Slovenian: Ne uporabljajte zdravila Duaklir Genuair: - če ste alergični na aklidinij, formoterolijev fumarat dihidrat ali katero koli drugo sestavino tega zdravila (navedeno v poglavju 6).
English: b) Do not press the orange button until you are ready to take a dose.
Slovenian: b) Ne pritisnite oranžnega gumba, dokler niste pripravljeni, da vzamete odmerek.
English: If your usual COPD symptoms (breathlessness, wheezing, cough) do not improve or get worse while you are using Duaklir Genuair you should continue to use it, but go to see your doctor as soon as possible because you may need another medicine.
Slovenian: Če se vaši simptomi KOPB (zadihanost, piskajoče dihanje ali kašelj) med uporabo zdravila Duaklir Genuair ne izboljšajo ali če se poslabšajo, nadaljujte z uporabo zdravila, vendar čim prej obiščite zdravnika, saj boste morda potrebovali drugo zdravilo.
English: The European Medicines Agency has waived the obligation to submit the results of studies with Duaklir Genuair in all subsets of the paediatric population in COPD (see section 4.2 for information on paediatric use).
Slovenian: Evropska agencija za zdravila je odstopila od zahteve za predložitev rezultatov študij z zdravilom Duaklir Genuair za vse podskupine pediatrične populacije s KOPB (za podatke o uporabi pri pediatrični populaciji glejte poglavje 4.2).
English: Children and adolescents Duaklir Genuair is not for use in children or adolescents below 18 years of age.
Slovenian: Otroci in mladostniki Zdravilo Duaklir Genuair ni namenjeno za otroke ali mladostnike do 18. leta starosti.
English: - The other ingredient is lactose monohydrate (see end of section 2 under ‘Duaklir Genuair contains lactose' for more information).
Slovenian: - Druga sestavina zdravila je laktoza monohidrat (za več informacij glejte konec poglavja 2 pod naslovom »Zdravilo Duaklir Genuair vsebuje laktozo«).
English: The presentation of the safety profile is based on the experience with Duaklir Genuair and the individual components.
Slovenian: Prikaz varnostnega profila temelji na izkušnjah z zdravilom Duaklir Genuair in njegovima posameznima učinkovinama.
English: Do not use Duaklir Genuair if you notice that the pack is damaged or shows signs of tampering.
Slovenian: Ne uporabljajte zdravila Duaklir Genuair, če opazite, da je ovojnina poškodovana ali kaže znake poseganja vanjo.
English: No clinically significant effects of Duaklir Genuair on cardiac rhythm were observed on 24-hour Holter monitoring in a subset of 551 patients, of whom 114 received Duaklir Genuair twice daily.
Slovenian: Poleg tega niso opazili nobenih klinično pomembnih učinkov zdravila Duaklir Genuair na srčni ritem v 24-urnem spremljanju z napravo Holter v podskupini 551 bolnikov, od katerih jih je 114 prejemalo zdravilo Duaklir Genuair dvakrat na dan.
English: Other side effects which may occur while using Duaklir Genuair:
Slovenian: Drugi neželeni učinki, ki se lahko pojavijo med uporabo zdravila Duaklir Genuair:
English: Duaklir Genuair should not be used in asthma; clinical studies of Duaklir Genuair in asthma have not been conducted.
Slovenian: Zdravilo Duaklir Genuair ni namenjeno uporabi pri astmi; klinične študije z zdravilom Duaklir Genuair pri astmi niso bile izvedene.
English: • On first use, every inhaler contains at least 60 doses, or at least 30 doses, depending on the pack size.
Slovenian: • Ob prvi uporabi vsak inhalator vsebuje najmanj 60 odmerkov ali najmanj 30 odmerkov,
English: Taking Duaklir Genuair regularly will reduce the effects of COPD on your everyday life.
Slovenian: Redna uporaba zdravila Duaklir Genuair zmanjša učinke bolezni KOPB na vaše vsakdanje življenje.
English: COPD is a long-term disease; therefore, Duaklir Genuair is for long-term use.
Slovenian: KOPB je dolgotrajna bolezen, zato je tudi zdravilo Duaklir Genuair namenjeno za dolgotrajno uporabo.
English: Lung volumes, exercise endurance and physical activity The effect of Duaklir Genuair on lung volumes, exercise endurance and physical activity was investigated in an 8-week parallel, randomised, placebo-controlled clinical study in COPD patients with hyperinflation (functional residual capacity [FRC] >120%).
Slovenian: Pljučni volumni, obremenitvena vzdržljivost in telesna dejavnost Vpliv zdravila Duaklir Genuair na pljučne volumne, obremenitveno vzdržljivost in telesno dejavnost so raziskali v 8-tedenski vzporedni, randomizirani, s placebom kontrolirani klinični študiji bolnikov s KOPB, ki so imeli hiperinflacijo (funkcionalna rezidualna kapaciteta [FRC] > 120 %).
English: The safety experience with Duaklir Genuair comprised exposure in clinical trials at the recommended therapeutic dose for up to 12 months, and in post-marketing experience.
Slovenian: Izkušnje o varnosti z zdravilom Duaklir Genuair vključujejo izpostavljenost v kliničnih preskušanjih do 12 mesecev pri priporočenem terapevtskem odmerku in izkušnje iz obdobja trženja zdravila.
English: The Duaklir Genuair clinical development programme was conducted in patients with moderate or severe COPD.
Slovenian: Klinični razvojni program zdravila Duaklir Genuair je bil izveden pri bolnikih z zmerno ali hudo KOPB.
English: In Phase III clinical studies, the frequency of notable increases in blood glucose with Duaklir Genuair was low (0.1%) and similar to placebo.
Slovenian: V kliničnih študijah 3. faze zdravila Duaklir Genuair je bila pogostnost pomembnega povečanja glukoze v krvi nizka (0,1 %) in podobna ravni s placebom.
English: There are no data available on the use of Duaklir Genuair in pregnant women.
Slovenian: Podatkov o uporabi zdravila Duaklir Genuair pri nosečnicah ni.
English: If you use more Duaklir Genuair than you should If you think you may have used more Duaklir Genuair than you should, you are more likely to experience some of its side effects, such as blurred vision, dry mouth, feeling sick, shaking/tremor, headache, palpitations or an increase in blood pressure, therefore you must immediately contact your doctor or go to the nearest emergency unit.
Slovenian: Če ste uporabili večji odmerek zdravila Duaklir Genuair, kot bi smeli Če mislite, da ste uporabili več zdravila Duaklir Genuair, kot bi smeli, obstaja verjetnost, da se bodo pri vas pojavili kateri od njegovih neželenih učinkov, kot so zamegljen vid, suha usta, občutek slabosti, tresenje/tresavica, glavobol, palpitacije ali povečan krvni tlak, zato se takoj posvetujte z zdravnikom ali obiščite najbližjo ambulanto za nujno pomoč.
English: The onset of action of Duaklir Genuair was comparable to the effect of the fastacting β2-agonist formoterol 12 micrograms.
Slovenian: Začetek delovanja zdravila Duaklir Genuair je primerljiv z učinkom hitro delujočega agonista β2 formoterola 12 mikrogramov.
English: If you are not sure of how to use Duaklir Genuair, contact your doctor or pharmacist.
Slovenian: Če niste prepričani o uporabi zdravila Duaklir Genuair, se posvetujte z zdravnikom ali farmacevtom.
English: Duaklir Genuair contains two bronchodilators: aclidinium is a long-acting muscarinic antagonist (also known as an anticholinergic) and formoterol is a long-acting β2-adrenergic agonist.
Slovenian: Zdravilo Duaklir Genuair vsebuje dva bronhodilatatorja: aklidinij, dolgo delujoči muskarinski antagonist (poznan tudi pod imenom antiholinergik), in formoterol, dolgo delujoči agonist β2-adrenergičnih receptorjev.
English: There is no relevant use of Duaklir Genuair in children and adolescents (under 18 years of age) for the indication of COPD.
Slovenian: Zdravilo Duaklir Genuair ni primerno za uporabo pri otrocih in mladostnikih (do 18. leta starosti) za indikacijo KOPB.
English: Duaklir Genuair is indicated as a maintenance bronchodilator treatment to relieve symptoms in adult patients with chronic obstructive pulmonary disease (COPD).
Slovenian: Zdravilo Duaklir Genuair je indicirano za vzdrževalno bronhodilatacijsko zdravljenje za lajšanje simptomov pri odraslih bolnikih s kronično obstruktivno pljučno boleznijo (KOPB).
English: - Duaklir Genuair is for inhalation use.
Slovenian: - Zdravilo Duaklir Genuair je samo za inhaliranje.
English: Duaklir Genuair contains lactose
Slovenian: Zdravilo Duaklir Genuair vsebuje laktozo
English: Duaklir Genuair should be discontinued in case of overdose.
Slovenian: Zdravljenje z zdravilom Duaklir Genuair je treba v primeru prevelikega odmerjanja prekiniti.
English: Due to its anticholinergic activity, Duaklir Genuair should be used with caution in patients with symptomatic prostatic hyperplasia, urinary retention or narrow-angle glaucoma (even though direct contact of the product with the eyes is very unlikely).
Slovenian: Zaradi njegovega antiholinergičnega delovanja je treba zdravilo Duaklir Genuair uporabljati previdno pri bolnikih s simptomatično hiperplazijo prostate, zastajanjem urina ali glavkomom zaprtega zakotja (čeprav neposreden stik zdravila z očmi ni zelo verjeten).
English: In long-term safety studies, Duaklir Genuair was associated with sustained efficacy when administered over a one-year treatment period with no evidence of tachyphylaxis.
Slovenian: V dolgotrajnih študijah varnosti je bilo zdravilo Duaklir Genuair povezano s trajno učinkovitostjo brez pojava tahifilaksije, tudi če so bolnike z njim zdravili eno leto.
English: Nevertheless, it is considered unlikely that Duaklir Genuair administered at the recommended dose will affect fertility in humans.
Slovenian: Ni verjetno, da bi dajanje priporočenih odmerkov zdravila Duaklir Genuair vplivalo na plodnost pri ljudeh.
English: Co-administration of Duaklir Genuair with other anticholinergic and/or long-acting β2-adrenergic agonist containing medicinal products has not been studied and is not recommended.
Slovenian: Sočasno dajanje zdravila Duaklir Genuair z drugimi zdravili, ki vsebujejo antiholinergike in/ali dolgo delujoče agoniste β2-adrenergičnih receptorjev, ni bilo raziskano, zato ni priporočeno.
English: EU/1/14/964/001 1 inhaler with 60 doses EU/1/14/964/002 3 inhalers each with 60 doses EU/1/14/964/003 1 inhaler with 30 doses
Slovenian: EU/1/14/964/002 3 inhalatorji, ki vsebujejo vsak po 60 odmerkov EU/1/14/964/003 1 inhalator, ki vsebuje 30 odmerkov
English: Duaklir Genuair should be used with caution in patients with severe cardiovascular disorders, convulsive disorders, thyrotoxicosis and phaeochromocytoma.
Slovenian: Zdravilo Duaklir Genuair je treba pri bolnikih s hudimi srčno-žilnimi boleznimi, konvulzivnimi motnjami, tirotoksikozo in feokromocitomom uporabljati previdno.
English: Other medicines and Duaklir Genuair
Slovenian: Druga zdravila in zdravilo Duaklir Genuair
English: Pooled efficacy analysis of the two 6-month Phase III studies demonstrated a statistically significant reduction of 29% in the rate of moderate or severe exacerbations (requiring treatment with antibiotics or corticosteroids or resulting in hospitalisations) with Duaklir Genuair compared to placebo (rates per patient per year: 0.29 vs. 0.42, respectively; p=0.036).
Slovenian: Zbirna analiza učinkovitosti v 6-mesečni študiji 3. faze je pokazala statistično značilno 29-odstotno zmanjšanje v razmerju do zmernih ali hudih poslabšanj (ki jih je bilo treba zdraviti z antibiotiki ali kortikosteroidi ali zaradi katerega je bila potrebna hospitalizacija) z zdravilom Duaklir Genuair v primerjavi s placebom (razmerje na bolnika na leto: 0,29 v. 0,42; p = 0,036).
English: What you need to know before you use Duaklir Genuair
Slovenian: Kaj morate vedeti, preden boste uporabili zdravilo Duaklir Genuair
English: Duaklir Genuair has no or negligible influence on the ability to drive and use machines.
Slovenian: Zdravilo Duaklir Genuair nima vpliva ali ima zanemarljiv vpliv na sposobnost vožnje in upravljanja s stroji.
English: If you forget a dose of Duaklir Genuair, just take it as soon as possible and take your next dose at the usual time.
Slovenian: Če ste pozabili uporabiti zdravilo Duaklir Genuair Če pozabite vzeti odmerek zdravila Duaklir Genuair, ga enostavno vzemite čim prej, svoj naslednji odmerek pa vzemite ob običajnem času.
English: Duaklir Genuair improved daily symptoms of COPD such as ‘breathlessness', ‘chest symptoms', ‘cough and sputum' (assessed by E-RS total score) as well as overall night-time symptoms, overall early morning symptoms and symptoms limiting early morning activities compared to placebo, aclidinium and formoterol but the improvements were not always statistically significant.
Slovenian: Zdravilo Duaklir Genuair je v primerjavi s placebom, aklidinijem in formoterolom (vsi p < 0,05) izboljšalo tudi dnevne simptome KOPB, kot so »zasoplost«, »simptomi v prsnem košu«, »kašelj in sputum«, (ocenjene na osnovi celokupne ocene E-RS) ter nočne in zgodnje jutranje simptome ter simptome, ki bolnika omejujejo pri zgodnjih jutranjih aktivnostih, vendar izboljšanja niso bila vedno statistično značilna.