FrancophonIA/ELRC3.0 huggingface dataset:
English: It is important to instruct the patients to carefully read the Instructions for Use in the Package Leaflet, which is packed together with each inhaler.
Slovenian: Pomembno je bolnike podučiti, da natančno preberejo navodila za uporabo v Navodilu za uporabo, ki je priloženo vsakemu inhalatorju.
English: Maximal bronchodilatory effects were evident from day one and were maintained over the 6-month treatment period.
Slovenian: Maksimalni učinki bronhodilatacije so bili očitni od prvega dne in so ostali prisotni celotno 6-mesečno obdobje zdravljenja.
English: What to do if the control window is still red after pressing the button (Figure H).
Slovenian: Kaj storiti, če je kontrolno okence še vedno obarvano rdeče po tem, ko ste že pritisnili gumb (Slika H).
English: Patients discontinued treatment if they experienced a MACE event and entered into the post-treatment follow-up period during the study.
Slovenian: Če so bolniki doživeli dogodek MACE, so prenehali prejemati zdravilo in so vstopili v obdobje spremljanja po zdravljenju v okviru študije.
English: If your COPD symptoms (breathlessness, wheezing, cough) do not improve or get worse you should contact your doctor for advice as soon as possible.
Slovenian: Če se simptomi KOPB (zasoplost, piskajoče dihanje, kašelj) ne izboljšajo ali se poslabšajo, se čim prej posvetujte z zdravnikom.
English: Become familiar with the parts of your Genuair inhaler.
Slovenian: Seznanite se s sestavnimi deli vašega inhalatorja Genuair.
English: Some patients may experience a grainy sensation in their mouth, or a slightly sweet or bitter taste.
Slovenian: Nekateri bolniki lahko v ustih občutijo zrnavost ali pa okusijo rahlo sladek ali grenak okus.
English: The fraction of the inhaled dose that reaches the systemic circulation as unchanged aclidinium is very low at less than 5%.
Slovenian: Delež vdihanega odmerka, ki doseže sistemski krvni obtok kot nespremenjeni aklidinij, je zelo nizek in manjši od 5 %.
English: In the event of a change in COPD intensity while the patient is being treated with aclidinium bromide so that the patient considers additional rescue medication is required, a re-evaluation of the patient and the patients' treatment regimen should be conducted.
Slovenian: Če je sprememba intenzivnosti KOPB med zdravljenjem bolnika z aklidinijevim bromidom tolikšna, da bolnik razmišlja o dodatnem reševalnem zdravilu, je treba ponovno ovrednotiti režim zdravljenja bolnika.
English: Excipients with known effect Each delivered dose contains approximately 12 mg lactose (as monohydrate).
Slovenian: Pomožna snov z znanim učinkom: En dostavljen odmerek vsebuje približno 12 mg laktoze (v obliki monohidrata).
English: Approximately 48% of enrolled patients had a prior history of at least 1 documented previous cardiovascular event; cerebrovascular disease (13.1%), coronary artery disease (35.4%), peripheral vascular disease or history of claudication (13.6%).
Slovenian: Približno 48 % vključenih bolnikov je imelo anamnezo vsaj 1 dokumentiranega srčno-žilnega dogodka, cerebrovaskularno bolezen (13,1 %), koronarno bolezen (35,4 %), periferno žilno bolezen ali anamnezo klavdikacije (13,6 %).
English: If this occurs, treatment with Bretaris Genuair should be stopped and other treatments considered.
Slovenian: Če pride do tega, je treba zdravljenje z zdravilom Bretaris Genuair prekiniti in razmisliti o drugih terapijah.
English: Locked
Slovenian: Zaklenjeno
English: Patients should be instructed on how to administer the product correctly as the Genuair inhaler may work differently from inhalers the patients may have used previously.
Slovenian: Bolnike je treba poučiti o tem, kako pravilno vzamejo zdravilo, ker lahko inhalator Genuair deluje drugače od inhalatorjev, ki so jih bolniki že prej uporabljali.
English: If you are affected by any of these side effects do not drive or use machinery until the headache has cleared, the feeling of dizziness has passed and your vision has returned to normal.
Slovenian: Če imate katerega koli od teh neželenih učinkov, ne vozite in ne upravljajte strojev, dokler glavobol ali omotica ne mine in se povrne normalen vid.
English: How to store Bretaris Genuair Contents of the pack and other information Instructions for Use
Slovenian: Shranjevanje zdravila Bretaris Genuair Vsebina pakiranja in dodatne informacije Navodila za uporabo
English: 2.2 Hold your head upright, put the mouthpiece between your lips, and close your lips tightly around it (Figure J).
Slovenian: 2.2 Držite glavo pokonci, vstavite ustnik med ustnici in tesno sklenite ustnice okrog ustnika (Slika J).
English: Children and adolescents Bretaris Genuair is not for use in children or adolescents below 18 years of age.
Slovenian: Otroci in mladostniki Zdravilo Bretaris Genuair ni namenjeno za otroke ali mladostnike do 18. leta starosti.
English: This makes it easier for chronic obstructive pulmonary disease (COPD) patients to breathe.
Slovenian: Zaradi tega bolniki s kronično obstruktivno pljučno boleznijo (KOPB) lažje dihajo.
English: 2.1 Hold the inhaler away from your mouth, and breathe out completely.
Slovenian: 2.1 Držite inhalator stran od svojih ust in v celoti izdihnite.
English: Your medicine is ready to be inhaled.
Slovenian: Vaše zdravilo je sedaj pripravljeno za inhaliranje.
English: Use the control window to ensure you have inhaled correctly.
Slovenian: Poglejte kontrolno okence, da se prepričate ali ste pravilno inhalirali.
English: This leaflet was last revised in <{month YYYY}>.
Slovenian: Navodilo je bilo nazadnje revidirano dne {mesec LLLL}.
English: You should not use Bretaris Genuair if you are pregnant or are breast-feeding unless your doctor tells you so.
Slovenian: Zdravila Bretaris Genuair ne smete uporabljati, če ste noseči ali dojite, razen če vam tako ne naroči zdravnik.
English: 08740 Sant Andreu de la Barca, Barcelona Spain
Slovenian: 08740 Sant Andreu de la Barca, Barcelona Španija
English: When should you get a new inhaler?
Slovenian: Kdaj začeti uporabljati nov inhalator?
English: Do not use Bretaris Genuair - if you are allergic to aclidinium bromide or any of the other ingredients of this medicine (listed in section 6).
Slovenian: Ne uporabljajte zdravila Bretaris Genuair - če ste alergični na aklidinijev bromid ali katero koli sestavino tega zdravila (navedeno v poglavju 6).
English: Regular use of Bretaris Genuair can help you when you have ongoing shortness of breath related to your disease to help you minimise the effects of the disease on your everyday life and reduce the number of flare-ups (the worsening of your COPD symptoms for several days).
Slovenian: Redna uporaba zdravila Bretaris Genuair vam lahko pomaga, kadar imate dolgotrajnejše težave z zadihanostjo, ki je povezana z vašo boleznijo, in vam pomaga zmanjšati učinke bolezni na vaše vsakdanje življenje ter zmanjšati število poslabšanj (poslabšanje simptomov KOPB za več dni).
English: The inhaler device is a multicomponent device made of polycarbonate, acrylonitrile-butadiene-styrene, polyoxymethylene, polyester-butylene-terephthalate, polypropylene, polystyrene and stainless steel.
Slovenian: Inhalacijski pripomoček sestavlja več kosov iz polikarbonata, akrilonitril-butadien-stirena, polioksimetilena, poliester-butilen-tereftalata, polipropilena, polistirena in nerjavnega jekla.
English: A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from Bretaris Genuair therapy taking into account the benefit of breastfeeding for the child and the benefit of therapy for the woman.
Slovenian: Odločiti se je treba bodisi za prenehanje dojenja bodisi za prekinitev/prenehanje zdravljenja z zdravilom Bretaris Genuair, pri čemer je treba pretehtati prednosti dojenja za otroka in prednosti zdravljenja za mater.
English: This means you have inhaled your medicine correctly.
Slovenian: To pomeni, da ste pravilno inhalirali zdravilo.
English: b MCID of at least - 4 units change in SGRQ.
Slovenian: b MCID, ki znaša vsaj -4 enote spremembe vrednosti SGRQ.
English: The European Medicines Agency has waived the obligation to submit the results of studies with Bretaris 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 obveze za predložitev rezultatov študij z zdravilom Bretaris Genuair za vse podskupine pediatrične populacije s KOPB (za podatke o uporabi pri pediatrični populaciji glejte poglavje 4.2).
English: Aclidinium bromide demonstrated kinetic linearity and a time-independent pharmacokinetic behaviour in the therapeutic range.
Slovenian: Aklidinijev bromid je pokazal kinetično linearnost in časovno neodvisno farmakokinetično obnašanje v terapevtskem razponu.
English: Check mouthpiece opening
Slovenian: Preverite odprtino ustnika
English: Following repeated inhalations, the systemic exposure of aclidinium bromide has been observed to be similar in Japanese and Caucasian patients.
Slovenian: Po ponavljajočih inhalacijah je bila opažena podobna sistemska izpostavljenost aklidinijevega bromida pri japonskih in belopoltih bolnikih.
English: Up to 65% of the dose was eliminated as metabolites in the urine and up to 33% as metabolites in the faeces.
Slovenian: Do 65 % odmerka se je izločilo v obliki presnovkov z urinom, do 33 % pa v obliki presnovkov v blatu.
English: Aclidinium bromide is rapidly absorbed from the lung, achieving maximum plasma concentrations within 5 minutes of inhalation in healthy subjects, and normally within the first 15 minutes in COPD patients.
Slovenian: Aklidinijev bromid se hitro absorbira iz pljuč in doseže največjo koncentracijo v plazmi v 5 minutah po inhalaciji pri zdravih ljudeh in običajno v prvih 15 minutah pri bolnikih s KOPB.
English: Cardiovascular effects:
Slovenian: Srčno-žilni učinki:
English: 1.2 Look at the control window (should be red, Figure C).
Slovenian: 1.2 Poglejte kontrolno okence (mora biti obarvano rdeče, Slika C).
English: Administration of Bretaris Genuair may cause paradoxical bronchospasm.
Slovenian: Dajanje zdravila Bretaris Genuair lahko povzroči paradoksni bronhospazem.
English: The most frequently reported adverse reactions with Bretaris Genuair were headache (6.6%) and nasopharyngitis (5.5%).
Slovenian: Najpogosteje poročana neželena učinka zdravila Bretaris Genuair sta bila glavobol (6,6 %) in nazofaringitis (5,5 %).
English: STEP 1: Prepare your dose
Slovenian: KORAK 1: Priprava odmerka
English: Biotransformation via CYP450 enzymes plays a minor role in the total metabolic clearance of aclidinium bromide.
Slovenian: Biološka transformacija prek encimov CYP450 igra manjšo vlogo pri skupnem presnovnem očistku aklidinijevega bromida.
English: 1.5 Release the green button (Figure F).
Slovenian: 1.5 Sprostite zeleni gumb (Slika F).
English: High doses of aclidinium bromide may lead to anticholinergic signs and symptoms.
Slovenian: Veliki odmerki aklidinijevega bromida lahko povzročijo antiholinergične znake in simptome.
English: 2.6 Slowly breathe out away from the inhaler.
Slovenian: 2.6 Počasi izdihnite proč od inhalatorja.
English: Go back to ‘STEP 2 Inhale your medicine' and repeat steps 2.1 to 2.7.
Slovenian: Vrnite se na ‘KORAK 2 Inhaliranje odmerka vašega zdravila' in ponovite korake 2.1 do 2.7.
English: Because aclidinium bromide acts locally in the lungs and is quickly broken down in plasma there is no direct relationship between pharmacokinetics and pharmacodynamics.
Slovenian: Ker aklidinijev bromid deluje lokalno v pljučih in se hitro razgrajuje v plazmi, ni neposredne povezave med farmakokinetiko in farmakodinamiko.
English: The pharmacokinetic properties of aclidinium bromide in patients with moderate to severe COPD appear to be similar in patients aged 40-59 years and in patients aged ≥70 years.
Slovenian: Farmakokinetične lastnosti aklidinijevega bromida pri bolnikih z zmerno do hudo boleznijo KOPB so podobne pri bolnikih v starostni skupini od 40 do 59 let in pri bolnikih, starih ≥ 70 let.
English: The plasma protein binding of aclidinium bromide determined in vitro most likely corresponded to the protein binding of the metabolites due to the rapid hydrolysis of aclidinium bromide in plasma; plasma protein binding was 87% for the carboxylic acid metabolite and 15% for the alcohol metabolite.
Slovenian: Vezava aklidinijevega bromida na plazemske proteine, ki je bilo ugotovljeno in vitro, je najverjetneje ustrezalo vezavi presnovkov na proteine zaradi hitre hidrolize aklidinijevega bromida v plazmi; vezanje na plazemske proteine je znašalo 87 % za karboksikislinski presnovek in 15 % za alkoholni presnovek.
English: Bronchodilators relax airways and help keep bronchioles open.
Slovenian: Bronhodilatatorji sproščajo dihalne poti in pomagajo vzdrževati bronhiole v odprtem stanju.
English: 2.4 Take the inhaler out of your mouth.
Slovenian: 2.4 Inhalator odstranite iz ust.
English: Do not use the Bretaris Genuair if you notice that the pack is damaged or shows signs of tampering.
Slovenian: Ne uporabljajte zdravila Bretaris Genuair, če opazite, da je ovojnina poškodovana ali kaže znake poseganja vanjo.
English: Dry mouth, which has been observed with anticholinergic treatment, may in the long term be associated with dental caries.
Slovenian: Suha usta, učinek, ki ga opažajo pri zdravljenju z antiholinergiki, je lahko dolgoročno povezan z zobnim kariesom.
English: 2.3 Take a strong, deep breath through your mouth.
Slovenian: 2.3 Močno in globoko vdihnite skozi usta.
English: 1.3 Hold the inhaler horizontally with the mouthpiece facing you and the green button on top (Figure D).
Slovenian: 1.3 Držite inhalator vodoravno, z ustnikom obrnjenim proti vam in z zelenim gumbom na vrhu (Slika D).
English: EXP To be used within 90 days of opening the pouch.
Slovenian: EXP Uporabite v 90 dneh od odprtja vrečke.
English: Protective Cap
Slovenian: Zaščitni pokrovček
English: Efficacy was assessed by measures of lung function and symptomatic outcomes such as breathlessness, disease-specific health status, use of rescue medication and occurrence of exacerbations.
Slovenian: Učinkovitost so ocenjevali z merjenjem pljučne funkcije in simptomov, kot so zadihanost, zdravstveno stanje glede na bolezen, uporaba reševalnega zdravila in pojav poslabšanj.
English: The main plasma protein that binds aclidinium bromide is albumin.
Slovenian: Glavni plazemski protein, ki veže aklidinijev bromid, je albumin.
English: Co-administration of aclidinium bromide with other anticholinergic-containing medicinal products has not been studied and is not recommended.
Slovenian: Sočasno dajanje aklidinijevega bromida z drugimi zdravili, ki vsebujejo antiholinergike, ni bilo raziskano, zato ni priporočeno.
English: Stop using the medicine and contact your doctor immediately if you develop swelling of your face, throat, lips or tongue (with or without difficulty breathing or swallowing), dizziness or fainting, faster heart rate or if you get raised severely itchy bumps on your skin (hives) as these may be symptoms of an allergic reaction.
Slovenian: Zdravilo takoj prenehajte uporabljati in se obrnite na zdravnika, če opazite otekanje obraza, grla, ustnic ali jezika (z oteženim dihanjem ali požiranjem oziroma brez njiju), vrtoglavico ali omedlevico, hitrejši srčni utrip ali če dobite hud izbočen srbeč osip na koži (koprivnico), saj so to lahko simptomi alergijske reakcije.
English: The inhaler is supplied in a plastic laminate pouch, placed in a cardboard carton.
Slovenian: Inhalator je pakiran v vrečki iz plastičnega laminata ter v kartonski škatli.
English: To be used within 90 days of opening the pouch.
Slovenian: Uporabite v 90 dneh od odprtja vrečke.
English: Stop taking Bretaris Genuair and seek medical help immediately: - if you get tightness of the chest, coughing, wheezing or breathlessness immediately after using the medicine.
Slovenian: Zdravilo Bretaris Genuair prenehajte jemati in takoj poiščite zdravniško pomoč: - če vas začne stiskati v prsih, kašljate, sopete ali ste zadihani takoj po uporabi zdravila.
English: Bretaris Genuair also improved daily symptoms of COPD (dyspnoea, cough and sputum production) and night-time and early morning symptoms.
Slovenian: Zdravilo Bretaris Genuair je izboljšalo tudi dnevne simptome KOPB (dispneja, kašelj in nastajanje izpljuvka) ter nočne in zgodnje jutranje simptome.
English: The primary safety endpoint was the time to first occurrence of MACE, defined as any of the following adjudicated events: cardiovascular death, non-fatal myocardial infarction (MI), or non-fatal ischemic stroke.
Slovenian: Primarni opazovani dogodek varnosti je bil čas do prvega pojava MACE, ki je bil opredeljen kot kateri koli od naslednjih presojenih dogodkov: srčno-žilna smrt, miokardni infarkt (MI) brez smrtnega izida ali ishemična možganska kap brez smrtnega izida.
English: 58.7% were male and 90.7% were Caucasian, with a mean postbronchodilator FEV1 of 47.9% of predicted value and a mean CAT (COPD Assessment Test) of 20.7.
Slovenian: 58,7 % je bilo moških in 90,7 % je bilo belcev; povprečni FEV1 po bronhodilatatorju je bil 47,9 % predvidene vrednosti in povprečna ocena CAT (COPD Assessment Test) je bila 20,7.
English: Aclidinium bromide is quickly broken down in plasma, the level of systemic anticholinergic side effects is therefore low.
Slovenian: Aklidinijev bromid se hitro razgrajuje v plazmi, zato je raven sistemskih antiholinergičnih neželenih učinkov nizka.
English: Disease-Specific Health Status and Symptomatic Benefits Bretaris Genuair provided clinically meaningful improvements in breathlessness (assessed using the Transition Dyspnoea Index [TDI]) and disease-specific health status (assessed using the St. George's Respiratory Questionnaire [SGRQ]).
Slovenian: Od bolezni odvisno zdravstveno stanje in simptomatične koristi Zdravilo Bretaris Genuair je povzročilo klinično pomembno izboljšanje zadihanosti (ocenjeno s pomočjo indeksa ocene dispneje skozi čas [TDI - Transition Dyspnoea Index]) in od bolezni odvisnega zdravstvenega stanja (ocenjeno s pomočjo dihalnega vprašalnika ustanove St. George [SGRQ - St. George's Respiratory Questionnaire]).
English: Pregnancy There are no data available on the use of aclidinium bromide in pregnant women.
Slovenian: Nosečnost Podatkov o uporabi aklidinijevega bromida pri nosečnicah ni.
English: • When a red band appears in the dose indicator, this means you are nearing your last dose
Slovenian: • Ko se na indikatorju odmerka pojavi rdeča oznaka, to pomeni, da se približujete zadnjemu odmerku (Slika N), ali
English: - 4.6 units a Minimum clinically important difference (MCID) of at least 1 unit change in TDI.
Slovenian: -4,6 enot a Minimalna klinično pomembna razlika (MCID - Minimum clinically important difference) vsaj
English: What Bretaris Genuair is and what it is used for What you need to know before you use Bretaris Genuair How to use Bretaris Genuair Possible side effects
Slovenian: Kaj je zdravilo Bretaris Genuair in za kaj ga uporabljamo Kaj morate vedeti, preden boste uporabili zdravilo Bretaris Genuair Kako uporabljati zdravilo Bretaris Genuair Možni neželeni učinki
English: No dose adjustments are necessary.
Slovenian: Prilagajanje odmerka ni potrebno.
English: The terminal elimination half-life and effective half-life of aclidinium bromide are approximately 14 hours and 10 hours, respectively, following inhalation of twice daily 400 µg doses in COPD patients.
Slovenian: Končni razpolovni čas in efektivni razpolovni čas izločanja aklidinijevega bromida sta približno 14 ur in 10 ur po inhalaciji 400 µg odmerkov dvakrat dnevno pri bolnikih s KOPB.
English: Bretaris Genuair is indicated as a maintenance bronchodilator treatment to relieve symptoms in adult patients with chronic obstructive pulmonary disease (COPD) (see section 5.1).
Slovenian: Zdravilo Bretaris Genuair je indicirano za vzdrževalno bronhodilatacijsko zdravljenje za lajšanje simptomov pri odraslih bolnikih s kronično obstruktivno pljučno boleznijo (KOPB) (glejte poglavje 5.1).
English: What Bretaris Genuair looks like and contents of the pack Bretaris Genuair is a white or almost white powder.
Slovenian: Izgled zdravila Bretaris Genuair in vsebina pakiranja Zdravilo Bretaris Genuair je bel ali skoraj bel prašek.
English: Maximal bronchodilation was achieved within 1-3 hours after dosing with mean peak improvements in FEV1 relative to baseline of 227-268 mL at steady-state.
Slovenian: Največja bronhodilatacija je bila dosežena v 1-3 urah po odmerjanju s povprečnim najboljšim izboljšanjem FEV1 glede na izhodiščno vrednost 227-268 ml v stanju dinamičnega ravnovesja.
English: The frequency of patients with at least one MACE was 3.85% vs. 4.23% patients in the aclidinium and placebo groups, respectively.
Slovenian: V skupini z aklidinijem je imelo vsaj en dogodek MACE 3,85 % bolnikov in v skupini s placebom 4,23 % bolnikov.
English: Bretaris Genuair is a dry powder inhaler that uses your breath to deliver the medicine directly into your lungs.
Slovenian: Zdravilo Bretaris Genuair je inhalator s suhim praškom, ki uporablja vaše dihanje za dovajanje zdravila naravnost v pljuča.
English: However, single inhaled doses up to 6,000 µg aclidinium bromide have been administered to healthy subjects without systemic anticholinergic adverse reactions.
Slovenian: Vendar enkratni inhalacijski odmerek do 6000 µg aklidinijevega bromida pri zdravih prostovoljcih, ni imel neželenih sistemskih antiholinergičnih učinkov.
English: Aclidinium bromide is rapidly and extensively hydrolysed to its pharmacologically inactive alcoholand carboxylic acid-derivatives.
Slovenian: Aklidinijev bromid se hitro in znatno hidrolizira v farmakološko neaktivne derivate alkohola in karboksilne kisline.
English: - The other ingredient is lactose monohydrate (refer to Section 2 “Bretaris Genuair contains lactose”).
Slovenian: - Druga sestavina zdravila je laktoza (glejte poglavje 2 “Zdravilo Bretaris Genuair vsebuje laktozo”).
English: If you use more Bretaris Genuair than you should If you think you may have used more Bretaris Genuair than you should, contact your doctor or pharmacist.
Slovenian: Če ste uporabili večji odmerek zdravila Bretaris Genuair, kot bi smeli Če mislite, da ste uporabili več zdravila Bretaris Genuair, kot bi smeli, se posvetujte z zdravnikom ali farmacevtom.
English: The low absolute bioavailability of inhaled aclidinium bromide (<5%) is because aclidinium bromide undergoes extensive systemic and pre-systemic hydrolysis whether deposited in the lung or swallowed.
Slovenian: Majhna absolutna biološka uporabnost inhaliranega aklidinijevega bromida (< 5 %) je posledica obširne sistemske in predsistemske hidrolize aklidinijevega bromida, odloženega v pljuča ali zaužitega.
English: Patients treated with Bretaris Genuair required less rescue medication than patients treated with placebo (a reduction of 0.95 puffs per day at 6 months [p=0.005]).
Slovenian: Bolniki, zdravljeni z zdravilom Bretaris Genuair, potrebujejo manj reševalnega zdravila kot bolniki, zdravljeni s placebom (zmanjšanje za 0,95 vdihov na dan v 6. mesecu [p = 0,005]).
English: The active ingredient of Bretaris Genuair is aclidinium bromide, which belongs to a group of medicines called bronchodilators.
Slovenian: Učinkovina zdravila Bretaris Genuair je aklidinijev bromid, ki spada v skupino zdravil, imenovanih bronhodilatatorji.
English: Improvement over placebo p-value
Slovenian: Izboljšanje glede na placebo
English: Submission of the results of the agreed post-authorisation safety study (PASS) for aclidinium bromide to evaluate the overall mortality and the proposed cardiovascular safety endpoints (with an additional endpoint of cardiac arrhythmia) among patients with COPD using aclidinium, according to a protocol agreed by the PRAC.
Slovenian: Predložitev rezultatov neintervencijske študije o varnosti zdravila po pridobitvi dovoljenja za promet z zdravilom (PASS) za aklidinijev bromid za ovrednotenje celokupne umrljivosti in predlaganih opazovanih dogodkov srčno-žilne varnosti (z dodatnim opazovanim dogodkom motenj srčnega ritma) med bolniki s KOPB, ki uporabljajo aklidinij, v skladu s protokolom, dogovorjenim z odborom PRAC.