FrancophonIA/ELRC3.0 huggingface dataset:
English: A placebo-controlled trial in 1791 patients with moderate to very severe COPD treated with Bretaris Genuair up to 36 months did not identify other adverse reactions.
Slovenian: S placebom nadzorovano preskušanje pri 1791 bolnikih z zmerno do zelo hudo KOPB, zdravljenih z zdravilom Bretaris Genuair do 36 mesecev, ni odkrilo drugih neželenih učinkov.
English: Aclidinium bromide is a maintenance bronchodilator and should not be used for the relief of acute episodes of bronchospasm, i.e. as a rescue therapy.
Slovenian: Aklidinijev bromid je vzdrževalni bronhodilatator in ga ne smete uporabljati za lajšanje akutnih epizod bronhospazmov, tj. kot reševalno terapijo.
English: Clinical efficacy studies showed that Bretaris Genuair provided clinically meaningful improvements in lung function (as measured by the forced expiratory volume in 1 second [FEV1]) over 12 hours following morning and evening administration, which were evident within 30 minutes of the first dose (increases from baseline of 124-133 mL).
Slovenian: V študiji klinične učinkovitosti so dokazali, da povzroči zdravilo Bretaris Genuair klinično pomembno izboljšanje delovanja pljuč (kot je bilo izmerjeno s forsiranim izdihanim volumnom v 1 sekundi [FEV1]) v času 12 ur po jutranjem in večernem dajanju, ki je bilo očitno v 30 minutah od prvega odmerka (povečanje od izhodiščne vrednosti 124-133 ml).
English: There is no relevant use of Bretaris Genuair in children and adolescents (under 18 years of age) for the indication of COPD.
Slovenian: Zdravilo Bretaris Genuair ni primerno za uporabo pri otrocih in mladostnikih (do 18. leta starosti) za indikacijo KOPB.
English: The low toxicity observed in nonclinical toxicity studies is in part due to rapid metabolism of aclidinium bromide in plasma and the lack of significant pharmacological activity of the major metabolites.
Slovenian: Nizka toksičnost, ki so jo opazili v predkliničnih študijah toksičnosti, je deloma posledica hitrega presnavljanja aklidinijevega bromida v plazmi in pomanjkanja pomembne farmakološke dejavnosti glavnih presnovkov.
English: RED
Slovenian: RDEČA
English: Bretaris Genuair is indicated to help open the airways and relieve symptoms of COPD, a serious, longterm lung disease characterised by breathing difficulties.
Slovenian: Zdravilo Bretaris Genuair je indicirano za pomoč pri odpiranju dihalnih poti in lajšanju simptomov KOPB, resni, dolgotrajni pljučni bolezni, za katero so značilne dihalne težave.
English: The hydrolysis occurs both chemically (non-enzymatically) and enzymatically by esterases, butyrylcholinesterase being the main human esterase involved in the hydrolysis.
Slovenian: Do hidrolize pride tako kemično (neencimsko) kot tudi encimsko z esterazami, kjer je butirilholinesteraza glavna esteraza pri človeku, vpletena v hidrolizo.
English: When the green button will not return to its full upper position and is locked in a middle position, you have reached the last dose (Figure O).
Slovenian: Ko je za inhalacijo pripravljen zadnji odmerek, se zeleni gumb ne vrne v popolnoma zgornji položaj, temveč ostane zaklenjen v srednjem položaju (Slika O).
English: As aclidinium bromide is metabolised mainly by chemical and enzymatic cleavage in the plasma, hepatic dysfunction is very unlikely to alter its systemic exposure.
Slovenian: Ker se aklidinijev bromid pretežno presnovi s kemičnim in encimskim cepljenjem v plazmi, je malo verjetno, da bi slabo delovanje jeter spremenilo njegovo sistemsko izpostavljenost.
English: Effects in nonclinical studies with respect to cardiovascular parameters (increased heart rates in dogs), reproductive toxicity (foetotoxic effects), and fertility (slight decreases in conception rate, number of corpora lutea, and pre- and post-implantation losses) were observed only at exposures considered sufficiently in excess of the maximum human exposure indicating little relevance to clinical use.
Slovenian: V predkliničnih študijah so učinke, povezane s srčno-žilnimi parametri (pospešen srčni utrip pri psih), vplivom na sposobnost razmnoževanja (fetotoksični učinki) in plodnostjo (rahlo zmanjšanje v stopnji spočetij, število rumenih teles ter pred- in poimplantacijskih izgub), opazili samo pri izpostavljenostih, ki presegajo največjo izpostavljenost za ljudi, kar je za klinično uporabo majhnega pomena.
English: Inform your doctor if you have been or are using similar medicines for breathing problems, such as medicines containing tiotropium, ipratropium.
Slovenian: Če ste uporabljali ali uporabljate podobna zdravila za težave z dihanjem, kot so zdravila, ki vsebujejo tiotropij, ipratropij, obvestite zdravnika.
English: Consistent with its anticholinergic activity, aclidinium bromide should be used with caution in patients with symptomatic prostatic hyperplasia or bladder-neck obstruction or with narrow-angle glaucoma (even though direct contact of the product with the eyes is very unlikely).
Slovenian: Skladno z antiholinergičnim učinkom je treba aklidinijev bromid uporabljati previdno pri bolnikih s simptomatično hiperplazijo prostate ali obstrukcijo vratu mehurja ali glavkomom zaprtega zakotja (čeprav neposreden stik zdravila z očmi ni zelo verjeten).
English: What you need to know before you use Bretaris Genuair
Slovenian: Kaj morate vedeti, preden boste uporabili zdravilo Bretaris Genuair
English: In the long-term safety studies, Bretaris Genuair was associated with bronchodilatory efficacy when administered over a 1-year treatment period.
Slovenian: V dolgotrajnih študijah varnosti je bilo zdravilo Bretaris Genuair povezano z učinkom bronhodilatacije, tudi če so bolnike z njim zdravili 1 leto.
English: After you have taken the last dose, the inhaler has to be disposed of.
Slovenian: Ko uporabite zadnji odmerek, morate inhalator zavreči.
English: Hypersensitivity to aclidinium bromide or to the excipients listed in section 6.1.
Slovenian: Preobčutljivost na aklidinijev bromid ali katero koli pomožno snov, navedeno v poglavju 6.1.
English: If you are not sure of how to use Bretaris Genuair, contact your doctor or pharmacist.
Slovenian: Če niste prepričani o uporabi zdravila Bretaris Genuair, se posvetujte z zdravnikom ali farmacevtom.
English: Bretaris Genuair is indicated for maintenance treatment and should not be used to treat a sudden attack of breathlessness or wheezing.
Slovenian: Zdravilo Bretaris Genuair je indicirano za vzdrževalno zdravljenje in ga ne smete uporabljati za zdravljenje nenadnega napada zadihanosti ali sopenja.
English: Store your inhaler with the protective cap in place until it is time to inhale your medicine, then remove the cap and start at Step 1.6.
Slovenian: Dokler ni čas za inhaliranje zdravila, shranjujte inhalator z zaščitnim pokrovčkom na mestu, nato pokrovček odstranite in začnite s Korakom 1.6.
English: The following side effects may occur whilst using Bretaris Genuair: Common: may affect up to 1 in 10 people - Headache - Inflammation of the sinuses (sinusitis) - Common cold (nasopharyngitis) - Cough - Diarrhoea - Nausea
Slovenian: Pri uporabi zdravila Bretaris Genuair se lahko pojavijo naslednji neželeni učinki: Pogosti: pojavijo se lahko pri največ 1 od 10 bolnikov - glavobol - vnetje sinusov (sinusitis) - običajen prehlad (nazofaringitis) - kašelj - diareja - siljenje na bruhanje (navzea)
English: Inhaled aclidinium bromide acts locally in the lungs to antagonise M3 receptors of airway smooth muscle and induce bronchodilation.
Slovenian: Vdihani aklidinijev bromid deluje lokalno v pljučih kot antagonist receptorjev M3 gladkih mišic dihalnih poti in sproži bronhodilatacijo.
English: Aclidinium bromide is a competitive, selective muscarinic receptor antagonist (also known as an anticholinergic), with a longer residence time at the M3 receptors than the M2 receptors.
Slovenian: Aklidinijev bromid je kompetitiven, selektivni antagonist muskarinskih receptorjev (znan tudi kot antiholinergik) z daljšim časom zadrževanja na receptorjih M3 kot receptorjih M2. Receptorji M3 posredujejo krčenje gladkih mišic dihalnih poti.
English: In addition, no clinically significant effects of Bretaris Genuair on cardiac rhythm were observed on 24-hour Holter monitoring after 3 months treatment of 336 patients (of whom 164 received Bretaris Genuair 322 µg twice daily).
Slovenian: Poleg tega niso opazili nobenih klinično pomembnih učinkov zdravila Bretaris Genuair na srčni ritem v 24-urnem spremljanju s Holter napravo po 3 mesecih zdravljenja 336 bolnikov (od katerih jih je 164 prejemalo zdravilo Bretaris Genuair 322 µg dvakrat na dan).
English: Following inhalation of 200 µg and 400 µg of aclidinium bromide by healthy subjects or COPD patients, the urinary excretion of unchanged aclidinium was very low at about 0.1% of the administered dose, indicating that renal clearance plays a minor role in the total aclidinium clearance from plasma.
Slovenian: Ko so zdrave osebe ali bolniki s KOPB inhalirali 200 µg in 400 µg aklidinijevega bromida, je bila mera aklidinija, izločenega z urinom, zelo nizka, približno 0,1 % danega odmerka, kar kaže, da ima ledvični očistek majhno vlogo pri celotnem očistku aklidinija iz plazme.
English: Dose indicator
Slovenian: Indikator odmerka
English: If a dose is missed the next dose should be taken as soon as possible.
Slovenian: Če izpustite odmerek, morate uporabiti naslednji odmerek takoj, ko je mogoče.
English: The Table below shows symptom relief obtained after 6 months treatment with Bretaris Genuair.
Slovenian: V spodnji preglednici so prikazani simptomi olajšanja po 6 mesecih zdravljenja z zdravilom Bretaris Genuair.
English: - 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: In vitro studies have shown that aclidinium bromide at the therapeutic dose or its metabolites do not inhibit or induce any of the cytochrome P450 (CYP450) enzymes and do not inhibit esterases (carboxylesterase, acetylcholinesterase and butyrylcholinesterase).
Slovenian: V študijah in vitro so pokazali, da aklidinijev bromid pri terapevtskem odmerku ali njegovi presnovki, ne zavirajo ali inducirajo nobenega od encimov citokroma P450 (CYP450) kot tudi ne zavirajo esteraz (karboksilesteraza, acetilholinesteraza in butirilholinesteraza).
English: Variable
Slovenian: Spremenljivo
English: COPD is a long-term disease; therefore, it is recommended that Bretaris Genuair is used every day, twice a day and not only when breathing problems or other symptoms of COPD are experienced.
Slovenian: Zaradi tega je priporočljivo zdravilo Bretaris Genuair uporabljati vsak dan dvakrat na dan in ne samo takrat, ko se pojavijo težave z dihanjem ali drugi simptomi KOPB.
English: No studies have been performed on hepatically-impaired patients.
Slovenian: Študij pri bolnikih z jetrnimi okvarami niso izvedli.
English: Similar observations were made with Bretaris Genuair in the 3 month study.
Slovenian: Podobno so za zdravilo Bretaris Genuair opažali tudi v 3-mesečni študiji.
English: GREEN
Slovenian: ZELENA
English: Nonclinical in vitro and in vivo studies showed rapid, dose-dependent and long-lasting inhibition by aclidinium of acetylcholine-induced bronchoconstriction.
Slovenian: V nekliničnih študijah in vitro in in vivo so dokazali, da aklidinij hitro, od odmerka odvisno in dolgotrajno zavira z acetilholinom inducirano bronhokonstrikcijo.
English: Bretaris Genuair should be used with caution in patients who had a myocardial infarction during the previous 6 months, unstable angina, newly diagnosed arrhythmia within the previous 3 months, or hospitalisation within the previous 12 months for heart failure functional classes III and IV as per the “New York Heart Association”.
Slovenian: Zdravilo Bretaris Genuair morate pri bolnikih, ki so imeli v zadnjih 6 mesecih miokardialni infarkt, nestabilno angino pektoris, na novo diagnosticirano aritmijo v zadnjih 3 mesecih ali so bili v zadnjih 12 mesecih hospitalizirani zaradi odpovedi srca funkcijskega razreda III in IV po razvrstitvi NYHA (New York Heart Association), uporabljati previdno.
English: Plasma levels of the acid metabolite are approximately 100-fold greater than those of the alcohol metabolite and the unchanged active substance following inhalation.
Slovenian: Koncentracije kislinskega presnovka v plazmi so približno 100-krat večje kot koncentracije alkoholnega presnovka in koncentracije nespremenjene učinkovine po inhalaciji.
English: Do not take an extra dose even if you do not taste or feel anything after inhaling.
Slovenian: Če po inhaliranju ne okušate ali občutite ničesar, ne vdihnite še enega odmerka.
English: This section contains information on how to use your Genuair inhaler.
Slovenian: To poglavje vsebuje informacije o uporabi inhalatorja Genuair.
English: Aclidinium bromide may have minor influence on the ability to drive and use machines.
Slovenian: Aklidinijev bromid lahko ima blag vpliv na sposobnost vožnje in upravljanja strojev.
English: Bretaris Genuair may have minor influence on the ability to drive and use machines.
Slovenian: Zdravilo Bretaris Genuair lahko ima blag vpliv na sposobnost vožnje in upravljanja strojev.
English: Acute intoxication by inadvertent medicinal product ingestion of aclidinium bromide is unlikely due to its low oral bioavailability and the breath-actuated dosing mechanism of the Genuair inhaler.
Slovenian: Akutna zastrupitev zaradi neželenega zaužitja aklidinijevega bromida ni verjetna zaradi njegove majhne biološke uporabnosti po peroralnem dajanju in z vdihom sproženega mehanizma odmerjanja inhalatorja Genuair.
English: Go to ‘STEP 2: Inhale your medicine'.
Slovenian: Preidite na ‘KORAK 2: Inhaliranje odmerka vašega zdravila'.
English: a) Before first use, tear open the sealed bag and remove the inhaler.
Slovenian: Pred uporabo: a) Pred prvo uporabo je treba raztrgati zavarjeno vrečko in odstraniti inhalator.
English: Bretaris Genuair statistically significantly reduced lung hyperinflation at rest (functional residual capacity [FRC]=0.197 L [95% CI=0.321, 0.072; p=0.002]; residual volume [RV]=0.238 L [95% CI=0.396, 0.079; p=0.004]) and also improved trough inspiratory capacity (by 0.078 L; 95% CI=0.01, 0.145; p=0.025) and reduced dyspnoea during exercise (Borg scale) (by 0.63 Borg units; 95% CI=1.11, 0.14; p=0.012).
Slovenian: Zdravilo Bretaris Genuair je statistično pomembno zmanjšalo prenapihnjenost (hiperinflacijo) pljuč v mirovanju (funkcionalna rezidualna kapaciteta [FRK] = 0,197 l [95 % IZ = 0,321, 0,072; p = 0,002]; rezidualni volumen [RV]=0,238 l [95 % IZ = 0,396, 0,079; p = 0,004]) in prav tako so se izboljšave pokazale v inspiratorni kapaciteti (za 0,078 l; 95 % IZ = 0,01, 0,145; p = 0,025) in zmanjšani dispneji med telesno vadbo (Borgova lestvica) (za 0,63 enot Borg; 95 % IZ = 1,11, 0,14; p = 0,012).
English: Dry mouth, which has been observed with medicines like Bretaris Genuair, may after using your medicine for a long time, be associated with tooth decay.
Slovenian: Suha usta, ki so jih opazili pri zdravilih kot je zdravilo Bretaris Genuair, so lahko po dolgotrajni uporabi zdravila povezana z zobno gnilobo.
English: In the 6-month study, patients receiving Bretaris Genuair 322 µg twice daily experienced a clinically meaningful improvement in their lung function (as measured by FEV1).
Slovenian: V 6-mesečni študiji je prišlo pri bolnikih, ki so prejemali Bretaris Genuair 322 µg dvakrat na dan, do klinično pomembnega izboljšanja pljučne funkcije (merjena z vrednostjo FEV1).
English: Bronchodilation
Slovenian: Bronhodilatacija
English: Following intravenous administration of 400 µg radiolabelled aclidinium bromide to healthy subjects, approximately 1% of the dose was excreted as unchanged aclidinium bromide in the urine.
Slovenian: Po intravenskem dajanju 400 µg radiološko označenega aklidinijevega bromida zdravim osebam se je približno 1 % odmerka izločilo v nespremenjeni obliki z urinom.
English: Inhaler label
Slovenian: Oznaka inhalatorja
English: White or almost white powder in a white inhaler with an integral dose indicator and a green dosage button.
Slovenian: Bel ali skoraj bel prašek v belem inhalatorju z vgrajenim indikatorjem odmerka in zelenim gumbom za odmerjanje.
English: It is unknown whether aclidinium bromide / metabolites are excreted in human milk.
Slovenian: Ni znano, ali se presnovki aklidinijevega bromida izločajo v materino mleko.
English: It is considered unlikely that aclidinium bromide administered at the recommended dose will affect fertility in humans.
Slovenian: Ni verjetno, da bi dajanje priporočenih odmerkov aklidinijevega bromida vplivalo na plodnost pri ljudeh.
English: 1.4 Press the green button all the way down to load your dose (Figure E).
Slovenian: 1.4 Pritisnite zeleni gumb do konca, da se vam naloži odmerek (Slika E).
English: Uncommon: may affect up to 1 in 100 people - Dizziness - Dry mouth - Inflammation of the mouth (stomatitis) - Hoarseness (dysphonia) - Faster heart beat (tachycardia) - Sensation of heart beating (palpitations) - Difficulty passing urine (urinary retention) - Blurred vision - Rash - Itching of the skin
Slovenian: Občasni: pojavijo se lahko pri največ 1 od 100 bolnikov - omotica - suha usta - vnetje ustne sluznice (stomatitis) - hripavost (disfonija) - hitrejši srčni utrip (tahikardija) - neprijetni občutki ob hitrem ali močnem utripanju srca (palpitacije) - težave pri uriniranju (zastajanje urina) - zamegljen vid - izpuščaj - srbenje kože
English: Studies in rats have shown slight reductions in fertility only at dose levels much higher than the maximum human exposure to aclidinium bromide (see section 5.3).
Slovenian: Študije na podganah so pokazale rahlo zmanjšanje plodnosti samo pri odmerkih, ki so bili veliko večji od največje izpostavljenosti človeka aklidinijevemu bromidu (glejte poglavje 5.3).
English: Pooled efficacy analysis of the 6-month and 3-month placebo controlled studies demonstrated a statistically significant reduction in the rate of moderate to severe exacerbations (requiring treatment with antibiotics or corticosteroids or resulting in hospitalisations) with aclidinium 322 µg twice daily compared to placebo (rate per patient per year: 0.31 vs 0.44 respectively; p=0.0149).
Slovenian: Zbrana analiza učinkovitosti v 6-mesečni in 3-mesečni študiji, nadzorovani s placebom, je prikazala statistično značilno zmanjšanje v razmerju zmernih do hudih poslabšanj (ki ga je bilo treba zdraviti z antibiotiki ali kortikosteroidi ali zaradi katerega je bila potrebna hospitalizacija) z aklidinijem 322 µg dvakrat na dan v primerjavi s placebom (razmerje na bolnika na leto: 0,31 v primerjavi z 0,44; p = 0,0149).
English: Studies in animals have shown foetotoxicity only at dose levels much higher than the maximum human exposure to aclidinium bromide (see section 5.3).
Slovenian: Študije na živalih so pokazale fetotoksičnost samo pri odmerkih, ki so bili veliko večji od največje izpostavljenosti človeka aklidinijevemu bromidu (glejte poglavje 5.3).
English: Anticholinergic activity:
Slovenian: Antiholinergični učinek:
English: However, if it is nearly time for your next dose, skip the missed dose.
Slovenian: Če je skoraj čas za naslednji odmerek, pozabljeni odmerek izpustite.
English: Steady state peak plasma concentrations achieved after dry powder inhalation by COPD patients of 400 µg aclidinium bromide were approximately 224 pg/mL.
Slovenian: Največje plazemske koncentracije v stanju dinamičnega ravnovesja pri bolnikih s KOPB po inhalaciji suhega praška v obliki enega odmerka 400 µg aklidinijevega bromida so bile približno 224 pg/ml.
English: What Bretaris Genuair is and what it is used for
Slovenian: Kaj je zdravilo Bretaris Genuair in za kaj ga uporabljamo
English: Patients in the aclidinium bromide group had a 18% relative reduction of the risk of an exacerbation (HR 0.82; 95% CI [0.73, 0.92], p<0.001).
Slovenian: Bolniki v skupini z aklidinijevim bromidom so imeli 18-odstotno relativno zmanjšanje tveganja za poslabšanje (HR 0,82, 95 % IZ [0,73; 0,92], p < 0,001).
English: The Bretaris Genuair group showed a statistically significant delay in the time to first moderate or severe exacerbation while on-treatment compared to the placebo group.
Slovenian: V skupini z zdravilom Bretaris Genuair so v primerjavi s placebom ugotovili statistično značilno podaljšanje časa do prvega zmernega ali hudega poslabšanja med zdravljenjem.
English: Steady-state plasma levels were attained within seven days of twice daily dosing.
Slovenian: Stanje dinamičnega ravnovesja plazemskih koncentracij je bilo doseženo v sedmih dneh od začetka odmerjanja dvakrat na dan.
English: In vitro studies have shown that aclidinium bromide or the metabolites of aclidinium bromide at the therapeutic dose are not expected to cause interactions with active substances that are substrates of Pglycoprotein (P-gp) or active substances metabolised by cytochrome P450 (CYP450) enzymes and esterases (see section 5.2).
Slovenian: V študijah in vitro so pokazali, da se za aklidinijev bromid ali presnovek aklidinijevega bromida v terapevtskem odmerku ne pričakuje medsebojnega delovanja z učinkovinami, ki so substrati P-glikoproteina (P-gp), ali učinkovinami, ki jih presnavljajo encimi citokroma P450 (CYP450) in esteraze (glejte poglavje 5.2).
English: Animal studies have shown excretion of small amounts of aclidinium bromide and/or metabolites into milk.
Slovenian: Študije na živalih so pokazale izločanje majhne količine presnovkov aklidinijevega bromida v materino mleko.
English: Red band
Slovenian: Rdeča oznaka
English: EU/1/12/781/003 3 inhalers each containing 60 doses
Slovenian: EU/1/12/781/003 3 inhalatorji; vsak vsebuje 60 odmerkov
English: This corresponds to a metered dose of 400 µg aclidinium bromide equivalent to 343 µg aclidinium.
Slovenian: To ustreza izmerjenemu odmerku 400 µg aklidinijevega bromida (kar ustreza 343 µg aklidinija).
English: The Bretaris Genuair Phase III clinical development programme included 269 patients treated with Bretaris Genuair 322 µg twice daily in one 6-month randomised, placebo-controlled study and 190 patients treated with Bretaris Genuair 322 µg twice daily in one 3-month randomised, placebocontrolled study.
Slovenian: V III. fazo kliničnega razvojnega programa zdravila Bretaris Genuair so v 6-mesečno, randomizirano, s placebom nadzorovano študijo vključili 269 bolnikov, ki so jih zdravili z zdravilom Bretaris Genuair 322 µg dvakrat na dan, v 3-mesečno randomizirano, s placebom nadzorovano študijo pa so vključili 190 bolnikov, ki so jih zdravili z zdravilom Bretaris Genuair 322 µg dvakrat na dan.
English: After 6 months treatment, the mean improvement in morning pre-dose (trough) FEV1 compared to placebo was 128 mL (95% CI=85-170; p<0.0001).
Slovenian: Po 6 mesecih zdravljenja je bilo povprečno izboljšanje jutranjega FEV1 (pred odmerkom) v primerjavi s placebom 128 ml (95-% IZ = 85-170; p<0,0001).
English: Read these Instructions for Use before you start using the medicine.
Slovenian: Pred začetkom uporabe zdravila preberite celotna Navodila za uporabo.
English: You should get a new inhaler:
Slovenian: Nov inhalator začnite uporabljati:
English: Whole lung deposition of inhaled aclidinium bromide via the Genuair inhaler averaged approximately 30% of the metered dose.
Slovenian: Odlaganje inhaliranega aklidinijevega bromida s pomočjo inhalatorja Genuair v celih pljučih je znašalo približno 30 % izmerjenega odmerka.
English: The frequencies assigned to the undesirable effects listed below are based on crude incidence rates of adverse reactions (i.e. events attributed to Bretaris Genuair) observed with Bretaris Genuair 322 µg (636 patients) in the pooled analysis of one 6-month and two 3-month randomised, placebo-controlled clinical trials.
Slovenian: Pogostnosti spodaj navedenih neželenih učinkov temeljijo na grobih stopnjah pojavnosti neželenih učinkov (npr. učinki, pripisani zdravilu Bretaris Genuair), ki so jih opazili pri zdravilu Bretaris Genuair 322 µg (636 bolnikov) v zbirni analizi enega 6-mesečnega in dveh 3-mesečnih randomiziranih, s placebom nadzorovanih kliničnih preskušanj.
English: STEP 2: Inhale your medicine
Slovenian: KORAK 2: Inhaliranje odmerka vašega zdravila