FrancophonIA/ELRC3.0 huggingface dataset:
English: - When you start a new pack, use the new Enurev Breezhaler inhaler that is supplied in the pack.
Slovenian: - Ko odprete novo škatlo z zdravilom, začnite uporabljati tudi nov inhalator Enurev Breezhaler, ki je priložen pakiranju.
English: The long duration of action can be partly attributed to sustained concentrations of active substance in the lung as reflected by the prolonged terminal elimination half-life of glycopyrronium after inhalation via the Enurev Breezhaler inhaler in contrast to the half life after intravenous administration (see section 5.2).
Slovenian: Dolgotrajno delovanje je deloma mogoče pripisati ohranjanju ustrezne koncentracije učinkovine v pljučih, kar odraža dolg terminalni razpolovni čas izločanja glikopironija po inhalaciji z inhalatorjem Enurev Breezhaler v nasprotju z razpolovnim časom po intravenskem odmerjanju zdravila (glejte poglavje 5.2).
English: There is no relevant use of Enurev Breezhaler in the paediatric population (under 18 years) in the indication COPD.
Slovenian: Zdravilo Enurev Breezhaler ni namenjeno za uporabo pri pediatrični populaciji (v starosti pod 18 let) za indikacijo KOPB.
English: What Enurev Breezhaler is and what it is used for What you need to know before you use Enurev Breezhaler How to use Enurev Breezhaler Possible side effects
Slovenian: Kaj je zdravilo Enurev Breezhaler in za kaj ga uporabljamo Kaj morate vedeti, preden boste uporabili zdravilo Enurev Breezhaler Kako uporabljati zdravilo Enurev Breezhaler Možni neželeni učinki
English: Enurev Breezhaler is recommended to be administered, at the same time of the day each day.
Slovenian: Zdravilo Enurev Breezhaler je priporočeno jemati vsak dan ob istem času.
English: This includes medicines similar to Enurev Breezhaler used for your lung disease, such as ipratropium, oxitropium or tiotropium (so called anticholinergics).
Slovenian: To velja tudi za zdravila, ki so podobna zdravilu Enurev Breezhaler in jih uporabljate zaradi bolezni pljuč, kot so ipratropij, oksitropij ali tiotropij (tako imenovani antiholinergiki).
English: Enurev Breezhaler is a once-daily, long-term maintenance treatment and is not indicated for the initial treatment of acute episodes of bronchospasm, i.e. as a rescue therapy.
Slovenian: Zdravilo Enurev Breezhaler je namenjeno enkrat dnevni uporabi za dolgotrajno vzdrževalno zdravljenje in ni indicirano za začetno zdravljenje akutnih epizod bronhospazma kot nujno zdravilo (zdravilo po potrebi).
English: Acute intoxication by inadvertent oral ingestion of Enurev Breezhaler capsules is unlikely due to the low oral bioavailability (about 5%).
Slovenian: Akutna zastrupitev z nenamernim peroralnim zaužitjem kapsul zdravila Enurev Breezhaler je malo verjetna, saj ima učinkovina le majhno peroralno biološko uporabnost (približno 5 %).
English: Enurev Breezhaler is indicated as a maintenance bronchodilator treatment to relieve symptoms in adult patients with chronic obstructive pulmonary disease (COPD).
Slovenian: Zdravilo Enurev Breezhaler je indicirano kot vzdrževalno brohodilatatorno zdravljenje za lajšanje simptomov pri odraslih bolnikih s kronično obstruktivno pljučno boleznijo (KOPB).
English: Enurev Breezhaler 44 micrograms once daily provided consistently statistically significant improvement in lung function (forced expiratory volume in one second, FEV1, forced vital capacity, FVC, and inspiratory capacity, IC) in a number of clinical studies.
Slovenian: Zdravilo Enurev Breezhaler je v odmerku 44 mikrogramov enkrat na dan v več kliničnih študijah dosledno dosegalo statistično značilno izboljšanje pljučne funkcije (forsiranega ekspiratornega volumna v prvi sekundi - FEV1, forsirane vitalne kapacitete - FVC in inspiratorne kapacitete - IC).
English: The absolute bioavailability of glycopyrromium inhaled via Enurev Breezhaler was estimated to be about 45% of the delivered dose.
Slovenian: Ocenjena absolutna biološka uporabnost glikopironija po inhaliranju s pomočjo inhalatorja Enurev Breezhaler znaša približno 45 % prejetega odmerka.
English: Do not use Enurev Breezhaler - if you are allergic to glycopyrronium bromide or any of the other ingredients of this medicine
Slovenian: Ne uporabljajte zdravila Enurev Breezhaler - če ste alergični na glikopironijev bromid ali katero koli sestavino tega zdravila (navedeno v poglavju 6).
English: In a 3-week study where exercise tolerance was tested via cycle ergometer at submaximal (80%) workload (submaximal exercise tolerance test), Enurev Breezhaler, dosed in the morning, reduced dynamic hyperinflation and improved the length of time exercise could be maintained from the first dose onwards.
Slovenian: V 3-tedenski študiji, v kateri so ocenjevali sposobnost prenašanja napora na ergometričnem kolesu, in sicer pri submaksimalni (80 %) obremenitvi (submaksimalni obremenitveni test), je zdravilo Enurev Breezhaler, ki so ga odmerjali zjutraj, zmanjšalo dinamično hiperinflacijo pljuč in podaljšalo čas, ko so bolniki lahko izvajali vajo, in sicer od prvega odmerka dalje.
English: In COPD patients with mild and moderate renal impairment (estimated glomerular filtration rate, eGFR ≥30 ml/min/1.73 m2) Enurev Breezhaler can be used at the recommended dose.
Slovenian: Pri bolnikih s KOPB in blago oziroma zmerno okvaro ledvic (z ocenjeno hitrostjo glomerulne filtracije ≥30 ml/min/1,73 m2) je zdravilo Enurev Breezhaler mogoče uporabljati v priporočenem odmerku.
English: Although no formal drug interaction studies have been performed, Enurev Breezhaler has been used concomitantly with other medicinal products commonly used in the treatment of COPD without clinical evidence of drug interactions.
Slovenian: Formalnih študij medsebojnega delovanja z drugimi zdravili niso izvedli, so pa zdravilo Enurev Breezhaler uporabljali sočasno z drugimi zdravili, ki so pogosto v uporabi pri zdravljenju KOPB, in pri tem ni bilo kliničnih znakov medsebojnega delovanja.
English: • Do not use the Enurev Breezhaler capsules with any other inhaler.
Slovenian: • Kapsul Enurev Breezhaler ne uporabljajte z nobenim drugim inhalatorjem.
English: Enurev Breezhaler administered at 44 micrograms once daily statistically significantly reduced breathlessness as evaluated by the Transitional Dyspnoea Index (TDI).
Slovenian: Zdravilo Enurev Breezhaler v odmerku 44 mikrogramov na dan je statistično značilno zmanjšalo zadihanost po oceni z indeksom spreminjanja dispneje v času (TDI-Transitional Dyspnoea Index).
English: • Do not use the Enurev Breezhaler inhaler to take any other capsule medicine.
Slovenian: • Inhalatorja Enurev Breezhaler ne uporabljajte za inhaliranje drugih zdravil iz kapsul.
English: What Enurev Breezhaler looks like and contents of the pack Enurev Breeyhaler 44 micrograms inhalation powder, hard capsules are transparent and orange and contain a white powder.
Slovenian: Izgled zdravila Enurev Breezhaler in vsebina pakiranja Enurev Breezhaler 44 mikrogramov prašek za inhaliranje, trde kapsule so prozorne in oranžne barve ter vsebujejo bel prašek.
English: Only use the capsules with the inhaler provided in this pack (Enurev
Slovenian: Kapsule uporabljajte samo z inhalatorjem, ki je priložen v škatli (inhalator
English: Enurev Breezhaler should be used with caution in these patient groups.
Slovenian: Pri uporabi zdravila Enurev Breezhaler pri teh skupinah bolnikov je potrebna previdnost.
English: What you need to know before you use Enurev Breezhaler
Slovenian: Kaj morate vedeti, preden boste uporabili zdravilo Enurev Breezhaler
English: Please read the full Instructions for Use before using the Enurev Breezhaler.
Slovenian: Prosimo, da pred uporabo zdravila Enurev Breezhaler v celoti preberete spodnja navodila za uporabo.
English: When to inhale Enurev Breezhaler Use this medicine at the same time each day.
Slovenian: Kdaj je treba inhalirati zdravilo Enurev Breezhaler To zdravilo uporabljajte vsak dan ob istem času.
English: The usual dose is to inhale the content of one capsule each day.
Slovenian: Koliko zdravila Enurev Breezhaler je treba uporabljati Običajni odmerek je inhaliranje vsebine ene kapsule vsak dan.
English: In patients with severe renal impairment or end-stage renal disease requiring dialysis Enurev Breezhaler should be used only if the expected benefit outweighs the potential risk since the systemic exposure to glycopyrronium may be increased in this population (see sections 4.4 and 5.2).
Slovenian: Bolniki s hudo okvaro ledvic in bolniki, ki imajo končno ledvično odpoved in potrebujejo dializno zdravljenje, smejo uporabljati zdravilo Enurev Breezhaler samo v primeru, da pričakovana korist presega potencialno tveganje, ker je v tej skupini bolnikov sistemska izpostavljenost glikopironiju lahko povečana (glejte poglavji 4.4 in 5.2).
English: Enurev Breezhaler should be used with caution in patients with narrow-angle glaucoma or urinary retention.
Slovenian: Zdravilo Enurev Breezhaler je treba uporabljati previdno pri bolnikih z glavkomom zaprtega zakotja ali z zastojem urina.
English: If you forget to inhale a dose, take one as soon as possible.
Slovenian: Če ste pozabili uporabiti zdravilo Enurev Breezhaler Če pozabite inhalirati odmerek, ga inhalirajte čimprej, vendar ne vzemite dveh odmerkov na isti dan.
English: Enurev Breezhaler 44 micrograms inhalation powder, hard capsules
Slovenian: Enurev Breezhaler 44 mikrogramov prašek za inhaliranje, trde kapsule
English: Enurev Breezhaler once daily statistically significantly reduced the use of rescue medication (salbutamol) by 0.46 puffs per day (p=0.005) over 26 weeks and by 0.37 puffs per day (p=0.039) over 52 weeks, compared to placebo for the 6- and 12-month studies, respectively.
Slovenian: Odmerjanje zdravila Enurev Breezhaler enkrat dnevno je statistično značilno zmanjšalo potrebo po uporabi zdravil po potrebi (salbutamola), in sicer za 0,46 vpihov na dan (p=0,005) v obdobju 26 tednov v 6-mesečni študiji in za 0,37 vpihov na dan (p=0,039) v obdobju 52 tednov v 12-mesečni študiji.
English: What Enurev Breezhaler contains - The active substance is glycopyrronium bromide.
Slovenian: Kaj vsebuje zdravilo Enurev Breezhaler - Učinkovina je glikopironijev bromid.
English: In a pooled analysis of the first 6 months of treatment in the 6- and 12-month studies, compared to placebo Enurev Breezhaler statistically significantly prolonged time to first moderate or severe exacerbation and reduced the rate of moderate or severe COPD exacerbations (0.53 exacerbations/year versus 0.77exacerbations /year, p<0.001).
Slovenian: Po rezultatih analize združenih podatkov po 6 mesecih zdravljenja v 6-mesečni in 12-mesečni študiji je zdravilo Enurev Breezhaler v primerjavi s placebom statistično značilno podaljšalo čas do naslednjega zmernega oziroma hudega akutnega poslabšanja in zmanjšalo pogostnost zmernih oziroma hudih akutnih poslabšanj KOPB (0,53 akutnih poslabšanj/leto v primerjavi z 0,77 akutnih poslabšanj/leto, p<0,001).
English: In clinical studies with Enurev Breezhaler, paradoxical bronchospasm was not observed.
Slovenian: V kliničnih študijah z zdravilom Enurev Breezhaler niso opažali paradoksnega bronhospazma, opažali pa so ga pri uporabi drugih inhalacijskih zdravil.
English: In the 12-month study, Enurev Breezhaler produced statistically significant improvements in FEV1 compared to tiotropium in the first 4 hours after dosing on day 1 and at week 26, and numerically greater values for FEV1 in the first 4 hours after dosing than tiotropium at week 12 and week 52.
Slovenian: V 12-mesečni študiji je zdravilo Enurev Breezhaler doseglo statistično značilno izboljšanje FEV1 v primerjavi s tiotropijem v prvih 4 urah po odmerjanju, in sicer na prvi dan in po 26 tednih, poleg tega pa so bile pri bolnikih zdravljenih z zdravilom Enurev Breezhaler po 12 in po 52 tednih vrednosti FEV1 v prvih 4 urah po odmerjanju numerično večje kot pri uporabi tiotropija.
English: After three weeks of treatment the improvement in inspiratory capacity with Enurev Breezhaler was similar to the first day (200 ml), exercise endurance time however had increased by 89 seconds (an increase of 21%) compared to placebo.
Slovenian: Po treh tednih zdravljenja z zdravilom Enurev Breezhaler je bilo povečanje inspiratorne kapacitete primerljivo s prvim dnem (in sicer 200 ml), čas, ko je bolnik zmožen izvajati vajo, pa se je podaljšal za 89 sekund (kar je podaljšanje za 21 %) v primerjavi s placebom.
English: At 12 weeks (primary endpoint), Enurev Breezhaler increased trough FEV1 by 72 ml in patients with the lowest degree of reversibility (<5%) and by 113 ml in those patients with a higher degree of reversibility at baseline (≥5%) compared to placebo (both p<0.05).
Slovenian: Po 12 tednih je zdravilo Enurev Breezhaler pri bolnikih z najnižjo stopnjo reverzibilnosti ob izhodišču (<5 %) povečalo najnižjo vrednost FEV1 (kar je bil primarni cilj opazovanja) za 72 ml, pri bolnikih z višjo stopnjo reverzibilnosti ob izhodišču (≥5 %) pa za 113 ml v primerjavi s placebom (za obe primerjavi je vrednost p<0,05).
English: In the pooled 6-month database the frequency of dry mouth was 2.2% versus 1.1%, of insomnia 1.0% versus 0.8%, and of gastroenteritis 1.4% versus 0.9%, for Enurev Breezhaler and placebo respectively.
Slovenian: Po podatkih iz prvih 6 mesecev študij, združenih v eno podatkovno bazo, je pogostnost pojavljanja neželenih učinkov pri uporabi zdravila Enurev Breezhaler v primerjavi z uporabo placeba, naslednja: suha usta 2,2 % v primerjavi z 1,1 %, nespečnost 1,0 % v primerjavi z 0,8 % in gastroenteritis 1,4 % v primerjavi z 0,9 %.
English: Your Seebri Breezhaler Inhaler pack contains:
Slovenian: Vaše pakiranje zdravila Enurev Breezhaler vsebuje:
English: Breezhaler inhaler).
Slovenian: Enurev Breezhaler).
English: How to store Enurev Breezhaler Contents of the pack and other information
Slovenian: Shranjevanje zdravila Enurev Breezhaler Vsebina pakiranja in dodatne informacije
English: In the 6-month study, Enurev Breezhaler increased FEV1 after the first dose with an improvement of 93 ml within 5 minutes and 144 ml within 15 minutes of dosing, compared to placebo (both p<0.001).
Slovenian: V 6-mesečni študiji je zdravilo Enurev Breezhaler doseglo izboljšanje FEV1 v primerjavi s placebom za 93 ml v 5 minutah in za 144 ml v 15 minutah po odmerjanju (p<0,001za obe razliki).
English: What Enurev Breezhaler is and what it is used for
Slovenian: Kaj je zdravilo Enurev Breezhaler in za kaj ga uporabljamo
English: Enurev Breezhaler 44 micrograms inhalation powder, hard capsules glycopyrronium (as glycopyrronium bromide)
Slovenian: Enurev Breezhaler 44 mikrogramov prašek za inhaliranje, trde kapsule glikopironij (v obliki glikopironijevega bromida)
English: Enurev Breezhaler can be used at the recommended dose in elderly patients (75 years of age and older) (see section 4.8).
Slovenian: Starejši bolniki (stari 75 let ali več) lahko uporabljajo zdravilo Enurev Breezhaler v priporočenem odmerku (glejte poglavje 4.8).
English: This medicine is used to make breathing easier for adult patients who have breathing difficulties due to a lung disease called chronic obstructive pulmonary disease (COPD).
Slovenian: Za kaj uporabljamo zdravilo Enurev Breezhaler To zdravilo uporabljamo za lajšanje dihanja pri odraslih bolnikih, ki imajo težave z dihanjem zaradi bolezni, ki se imenuje kronična obstruktivna pljučna bolezen (KOPB).
English: Enurev Breezhaler is a single-dose inhaler.
Slovenian: Enurev Breezhaler je inhalator za inhaliranje posameznih odmerkov.
English: Enurev Breezhaler is used as a maintenance treatment for your COPD.
Slovenian: Zdravilo Enurev Breezhaler je namenjeno vzdrževalnemu zdravljenju vaše KOPB.
English: At 12 weeks (primary endpoint), Enurev Breezhaler increased trough FEV1 by 108 ml in the 6-month study and by 97 ml in the 12-month study compared to placebo (both p<0.001).
Slovenian: Po 12 tednih (primarni cilj opazovanja) je zdravilo Enurev Breezhaler izboljšalo FEV1, izmerjen 24 ur po odmerjanju, za 108 ml v 6-mesečni študiji in za 97 ml v 12-mesečni študiji v primerjavi s placebom (p<0,001za obe razliki).
English: 6 or 10 Seebri Breezhaler capsules to be used in the inhaler
Slovenian: 10 kapsul zdravila Enurev Breezhaler, ki jih vstavljate v inhalator.
English: 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, Enurev Breezhaler should be used only if the expected benefit outweighs the potential risk (see section 5.2).
Slovenian: 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, je mogoče zdravilo Enurev Breezhaler uporabljati samo v primeru, da pričakovana korist presega potencialno tveganje (glejte poglavje 5.2).
English: The co-administration of Enurev Breezhaler with other anticholinergic-containing medicinal products has not been studied and is therefore not recommended.
Slovenian: Sočasne uporabe zdravila Enurev Breezhaler in drugih zdravil, ki vsebujejo antiholinergične učinkovine, niso proučevali, zato tovrstna sočasna uporaba ni priporočena.
English: Immediate hypersensitivity reactions have been reported after administration of Enurev Breezhaler.
Slovenian: Poročali so o primerih takojšnje preobčutljivostne reakcije po odmerjanju zdravila Enurev Breezhaler.
English: Enurev Breezhaler also reduced dyspnoea at rest measured using the Transitional Dyspnoea Index.
Slovenian: Poleg tega je zdravilo Enurev Breezhaler zmanjšalo dispnejo v mirovanju po oceni z indeksom spreminjanja dispneje v času (angl. Transitional Dyspnoea Index).
English: Instructions for use of Enurev Breezhaler inhaler
Slovenian: Navodila za uporabo inhalatorja Enurev Breezhaler
English: No specific side effects have been reported when Enurev Breezhaler has been used together with other medicines used to treat COPD such as reliever inhalers (e.g. salbutamol), methylxanthines (e.g. theophylline) and/or oral and inhaled steroids (e.g. prednisolone).
Slovenian: Pri uporabi zdravila Enurev Breezhaler skupaj z drugimi zdravili, ki se uporabljajo pri zdravljenju KOPB, kot so inhalacijski olajševalci (npr. salbutamol), metilksantini (npr. teofilin) in/ali peroralni ali inhalacijski kortikosteroidi (npr. prednizolon), niso poročali o posebnih neželenih učinkih.
English: The pooled analysis also showed fewer patients treated with Enurev Breezhaler than with placebo experienced an exacerbation requiring hospitalisation (1.7% versus 4.2%, p=0.003).
Slovenian: Rezultati analize združenih podatkov poleg tega kažejo, da je bil delež bolnikov, pri katerih je prišlo do akutnega poslabšanja, zaradi katerega je bila potrebna hospitalizacija, manjši med bolniki, ki so prejemali zdravilo Enurev Breezhaler, v primerjavi s tovrstnim deležem pri tistih, ki so prejemali placebo (1,7 % v primerjavi s 4,2 %, p=0,003).
English: Talk to your doctor before using Enurev Breezhaler, if any of the following applies to you: - you have kidney problems.
Slovenian: Pred začetkom uporabe zdravila Enurev Breezhaler se posvetujte z zdravnikom, če kaj od navedenega velja za vas: - če imate težave z ledvicami, - če imate očesno bolezen, ki se imenuje glavkom zaprtega zakotja, - če imate težave pri uriniranju.
English: In patients with severe renal impairment (eGFR <30 ml/min/1.73 m2), including those with end-stage renal disease requiring dialysis, Enurev Breezhaler should only be used if the expected benefit outweighs the potential risk (see section 4.4).
Slovenian: Pri bolnikih s hudo okvaro ledvic (z ocenjeno hitrostjo glomerulne filtracije <30 ml/min/1,73 m2), vključno s tistimi s končno ledvično odpovedjo, ki potrebujejo dializo, je zdravilo Enurev Breezhaler mogoče uporabljati samo v primeru, da pričakovana korist presega potencialno tveganje (glejte poglavje 4.4).
English: 2) Reports have been received from post-approval marketing experience in association with the use of Enurev Breezhaler.
Slovenian: 2) Poročila izhajajo iz izkušenj z uporabo zdravila Enurev Breezhaler po njegovem prihodu na trg.
English: Enurev Breezhaler contains lactose
Slovenian: Zdravilo Enurev Breezhaler vsebuje laktozo
English: Ask your pharmacist how to dispose of medicines and inhalers that are no longer required.
Slovenian: Vprašajte farmacevta o načinu odstranjevanja inhalatorja, ki je skladen z lokalnimi predpisi.
English: Patients with hepatic impairment Clinical studies have not been conducted in patients with hepatic impairment.
Slovenian: Pri bolnikih z okvaro jeter niso izvajali kliničnih študij.
English: Enurev Breezhaler 44 mcg inhalation powder glycopyrronium
Slovenian: Enurev Breezhaler 44 μg prašek za inhaliranje glikopironij
English: Other medicines and Enurev Breezhaler
Slovenian: Druga zdravila in zdravilo Enurev Breezhaler
English: No change in mean heart rate or QTc interval was observed with Enurev Breezhaler in doses up to 176 micrograms in COPD patients.
Slovenian: Pri odmerjanju zdravila Enurev Breezhaler v odmerkih do 176 mikrogramov bolnikom s KOPB niso opažali nobenih sprememb srčne frekvence ali trajanja intervala QTc.
English: Enurev Breezhaler was found to decrease dyspnoea and leg discomfort when exercising as measured using Borg scales.
Slovenian: Ugotovili so, da zdravilo Enurev Breezhaler zmanjša dispnejo in bolečine v nogah pri naporu po Borgovi lestvici zaznavanja napora.
English: Show the pack of Enurev Breezhaler.
Slovenian: Tam pokažite škatlo z zdravilom Enurev Breezhaler.
English: During treatment with Enurev Breezhaler, stop taking this medicine and tell your doctor immediately: - if you experience tightness of the chest, coughing, wheezing or breathlessness immediately after using Enurev Breezhaler (signs of bronchospasm).
Slovenian: Med zdravljenjem z zdravilom Enurev Breezhaler, takoj prenehajte uporabljati to zdravilo in obvestite zdravnika: - če vas začne takoj po uporabi zdravila Enurev Breezhaler stiskati v prsih, če začnete kašljati, če vam v pljučih piska ali vam zmanjkuje sape (to so znaki bronhospazma), - če težko dihate ali požirate, če vam otekajo jezik, ustnice ali obraz, če se pojavi izpuščaj, srbenje in koprivnica (to so znaki alergijske reakcije), - če vas začne boleti ali ščemeti v očeh, če se vam začasno zamegli vid, če opažate svetlobne ali živobarvne kolobarje okrog luči, pri tem pa so vaše oči pordele.
English: A pooled analysis of the 6- and 12-month pivotal studies found a statistically significantly higher percentage of patients receiving Enurev Breezhaler responded with a 4 point or greater improvement in SGRQ compared to placebo at week 26 (57.8% and 47.6% respectively, p<0.001).
Slovenian: Po rezultatih analize združenih podatkov iz ključnih študij (6-mesečne in 12-mesečne) je bil po 26 tednih delež bolnikov, ki so dosegli izboljšanje ocene SGRQ za 4 točke ali več, statistično značilno večji med bolniki, ki so prejemali zdravilo Enurev Breezhaler, v primerjavi s tistimi, ki so prejemali placebo (57,8 % v primerjavi s 47,6 %, p<0,001).
English: In a pooled analysis of the 6and 12-month pivotal studies a statistically significantly higher percentage of patients receiving Enurev Breezhaler responded with a 1 point or greater improvement in the TDI focal score at week 26 compared to placebo (58.4% and 46.4% respectively, p<0.001).
Slovenian: Po rezultatih analize združenih podatkov iz ključnih študij (6-mesečne in 12-mesečne) je bil po 26 tednih delež bolnikov, ki so dosegli izboljšanje skupne ocene indeksa TDI za 1 točko ali več, statistično značilno večji med bolniki, ki so prejemali zdravilo Enurev Breezhaler, v primerjavi s tistimi, ki so prejemali placebo (58,4 % v primerjavi s 46,4 %, p<0,001).
English: How to use Enurev Breezhaler
Slovenian: Kako uporabljati zdravilo Enurev Breezhaler
English: In the 6-month study, the percentage of patients experiencing a moderate or severe exacerbation was 17.5% for Enurev Breezhaler and 24.2% for placebo (Hazard ratio: 0.69, p=0.023), and in the 12-month study it was 32.8% for Enurev Breezhaler and 40.2% for placebo (Hazard ratio: 0.66, p=0.001).
Slovenian: (razmerje ogroženosti: 0,69, p=0,023), medtem ko je bil v 12-mesečni študiji odstotek takih bolnikov pri uporabi zdravila Enurev Breezhaler 32,8 %, pri uporabi placeba pa 40,2 % (razmerje ogroženosti: 0,66, p=0,001).