FrancophonIA/ELRC3.0 huggingface dataset:
English: If possible, show them the inhaler, the package or this leaflet.
Slovenian: Če je mogoče, mu pokažite inhalator, ovojnino zdravila ali to navodilo.
English: The first time you use Rolufta Ellipta you do not need to check that the inhaler is working properly; it contains previously measured doses and is ready to use straight away.
Slovenian: Ko zdravilo Rolufta Ellipta prvič uporabite, vam ni treba preverjati, ali inhalator deluje pravilno; inhalator vsebuje predhodno odmerjene odmerke in je pripravljen za takojšnjo uporabo.
English: Asthma
Slovenian: Astma
English: • Whenever the risk management system is modified, especially as the result of new information being received that may lead to a significant change to the benefit/risk profile or as the result of an important (pharmacovigilance or risk minimisation) milestone being reached.
Slovenian: • ob vsakršni spremembi sistema za obvladovanje tveganj, zlasti kadar je tovrstna sprememba posledica prejema novih informacij, ki lahko privedejo do znatne spremembe razmerja med koristmi in tveganji, ali kadar je ta sprememba posledica tega, da je bil dosežen pomemben mejnik
English: It should not be used for the relief of acute symptoms, i.e. as rescue therapy for the treatment of acute episodes of bronchospasm.
Slovenian: Ne sme se ga uporabljati za lajšanje akutnih simptomov, tj. kot rešilnega zdravila za zdravljenje akutnih epizod bronhospazma.
English: After this date the inhaler should no longer be used.
Slovenian: Po tem datumu inhalatorja ne sme več uporabljati.
English: This medicine blocks the tightening of these muscles, making it easier for air to get in and out of the lungs.
Slovenian: To zdravilo prepreči skrčenje teh mišic in tako olajša vstopanje zraka v pljuča in njegovo izstopanje iz pljuč.
English: If you want to clean the mouthpiece, use a dry tissue, before you close the cover.
Slovenian: Če želite očistiti ustnik, uporabite suho krpico, preden zaprete pokrovček.
English: If you accidentally use too much of this medicine, contact your doctor or pharmacist for advice immediately as you may need medical attention.
Slovenian: Če pomotoma uporabite preveč tega zdravila, se za nasvet nemudoma obrnite na svojega zdravnika ali farmacevta, ker boste morda potrebovali zdravniško pomoč.
English: Umeclidinium bromide should not be used in patients with asthma since it has not been studied in this patient population.
Slovenian: Umeklidinijevega bromida se ne sme uporabljati pri bolnikih z astmo, ker v tej populaciji bolnikov ni raziskan.
English: Glaxo Wellcome Production Zone Industrielle No.2, 23 Rue Lavoisier, 27000 Evreux, France
Slovenian: Glaxo Wellcome Production Zone Industrielle No. 2 23. rue Lavoisier 27000 Evreux
English: You may notice that your heart is beating faster than usual, you have visual disturbances or have a dry mouth.
Slovenian: Morda boste pri sebi opazili hitrejši srčni utrip kot po navadi, motnje vida ali suha usta.
English: See ‘Step-by-step instructions for use' in this leaflet for full information.
Slovenian: Za celotne informacije glejte "Navodila za uporabo po korakih" v tem navodilu.
English: Systemic exposure to the metabolites is low.
Slovenian: Sistemska izpostavljenost presnovkom je majhna.
English: If your COPD symptoms (breathlessness, wheezing, cough) do not improve or get worse, or if you are using your quick-acting inhaler more often: contact your doctor as soon as possible.
Slovenian: Če se vam simptomi KOPB (težko dihanje, piskajoče dihanje, kašelj) ne izboljšajo ali se poslabšajo, ali če pogosteje uporabljate svoj hitrodelujoči inhalator: Čim prej se posvetujte z zdravnikom.
English: Pharmacotherapeutic group: Drugs for obstructive airway diseases, anticholinergics, ATC code: R03BB07
Slovenian: Farmakoterapevtska skupina: Zdravila za obstruktivne pljučne bolezni, antiholinergiki, oznaka ATC: R03BB07
English: This medicine is used to treat chronic obstructive pulmonary disease (COPD) in adults.
Slovenian: To zdravilo se uporablja za zdravljenje kronične obstruktivne pljučne bolezni (KOPB) pri odraslih.
English: Reporting suspected adverse reactions after authorisation of the medicinal product is important.
Slovenian: Poročanje o domnevnih neželenih učinkih Poročanje o domnevnih neželenih učinkih zdravila po izdaji dovoljenja za promet je pomembno.
English: If you think the above applies to you, don't use this medicine until you have checked with your doctor.
Slovenian: Če menite, da omenjeno velja za vas, ne uporabite tega zdravila, dokler se ne posvetujete s svojim zdravnikom.
English: Acute symptoms should be treated with an inhaled short-acting bronchodilator.
Slovenian: Akutne simptome je treba zdraviti z inhalacijskim kratkodelujočim bronhodilatatorjem.
English: If overdose occurs, the patient should be treated supportively with appropriate monitoring as necessary.
Slovenian: V primeru prevelikega odmerjanja je treba bolnika zdraviti podporno in ga po potrebi spremljati.
English: How to use the inhaler
Slovenian: Kako uporabljati inhalator
English: The safety profile of umeclidinium bromide was evaluated from 1663 patients with COPD who received doses of 55 micrograms or greater for up to one year.
Slovenian: Varnostne značilnosti umeklidinijevega bromida so ocenili pri 1.663 bolnikih s KOPB, ki so prejemali odmerke 55 mikrogramov ali več do eno leto.
English: Do not throw away any medicines via wastewater or household waste.
Slovenian: Zdravila ne smete odvreči v odpadne vode ali med gospodinjske odpadke.
English: b) How to inhale the medicinal product
Slovenian: b) Kako inhalirati zdravilo
English: You may not be able to taste or feel the medicine, even when you are using the inhaler correctly.
Slovenian: Zdravila morda ne boste ne okusili ne občutili, tudi če inhalator uporabljate pravilno.
English: a) Prepare a dose
Slovenian: a) Pripravite odmerek
English: ANNEX II
Slovenian: PRILOGA II
English: Don't use Rolufta Ellipta as well as these other medicines.
Slovenian: Ne uporabljajte zdravila Rolufta Ellipta hkrati s temi drugimi zdravili.
English: Contents of the pack and other information
Slovenian: Vsebina pakiranja in dodatne informacije
English: Absorption
Slovenian: Absorpcija
English: If you do not have a quick-acting inhaler contact your doctor.
Slovenian: Če nimate hitrodelujočega inhalatorja, se obrnite na svojega zdravnika.
English: In particular, tell your doctor or pharmacist if you are taking other long-acting medicines similar to this medicine for breathing problems, e.g. tiotropium.
Slovenian: Še zlasti morate svojemu zdravniku ali farmacevtu povedati, če zaradi težav z dihanjem jemljete druga dolgodelujoča zdravila, podobna temu zdravilu, npr. tiotropij.
English: Cardiac electrophysiology
Slovenian: Srčna elektrofiziologija
English: Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicinal product.
Slovenian: Bolniki z redko dedno intoleranco za galaktozo, laponsko obliko zmanjšane aktivnosti laktaze ali malabsorpcijo glukoze/galaktoze ne smejo jemati tega zdravila.
English: Administration of umeclidinium bromide may produce paradoxical bronchospasm that may be lifethreatening.
Slovenian: Uporaba umeklidinijevega bromida lahko povzroči paradoksni bronhospazem, ki je lahko smrtno nevaren.
English: No dosage adjustment is required in patients over 65 years (see section 5.2).
Slovenian: Bolnikom, starejšim od 65 let, odmerka ni treba prilagoditi (glejte poglavje 5.2).
English: The short duration of these two studies and limited number of exacerbation events, preclude any conclusion regarding additional effect of Rolufta Ellipta on COPD exacerbation rate.
Slovenian: Kratkotrajnost teh dveh študij in majhno število poslabšanj onemogočajo sklepanje o dodatnem učinku zdravila Rolufta Ellipta na delež poslabšanj KOPB.
English: Excipient with known effect: Each delivered dose contains approximately 12.5 mg of lactose (as monohydrate).
Slovenian: Pomožna snov z znanim učinkom: En oddani odmerek vsebuje približno 12,5 mg laktoze (v obliki laktoze monohidrata).
English: Detailed information on this medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu.
Slovenian: Podrobne informacije o zdravilu so objavljene na spletni strani Evropske agencije za zdravila http://www.ema.europa.eu.
English: Talk to your doctor before using this medicine: if you have asthma (Don't use Rolufta Ellipta to treat asthma)
Slovenian: Pred začetkom uporabe tega zdravila se posvetujte z zdravnikom: če imate astmo (ne uporabljajte zdravila Rolufta Ellipta za zdravljenje astme),
English: No formal statistical testing was performed on this endpoint.
Slovenian: Formalnega statističnega testiranja tega opazovanega dogodka niso izvedli.
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT
Slovenian: VSEBINA, IZRAŽENA Z MASO, PROSTORNINO ALI ŠTEVILOM ENOT
English: Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu.
Slovenian: Podrobne informacije o zdravilu so objavljene na spletni strani Evropske agencije za zdravila: http://www.ema.europa.eu.
English: Take it back to your pharmacist for advice.
Slovenian: Vrnite ga farmacevtu in se z njim posvetujte.
English: There was no attenuation of the bronchodilator effect over time.
Slovenian: Bronhodilatacijski učinek se sčasoma ni zmanjšal.
English: Less than 1% of the orally administered dose (1% of recovered radioactivity) was excreted in urine, suggesting negligible absorption following oral administration.
Slovenian: Manj kot 1 % peroralno uporabljenega odmerka (1 % najdene radioaktivnosti) se je izločil v urinu; to kaže zanemarljivo absorpcijo po peroralni uporabi.
English: Like all medicines, this medicine can cause side effects, although not everybody gets them.
Slovenian: Možni neželeni učinki Kot vsa zdravila ima lahko tudi to zdravilo neželene učinke, ki pa se ne pojavijo pri vseh bolnikih.
English: Read the package leaflet before use.
Slovenian: Pred uporabo preberite priloženo navodilo!
English: Adults
Slovenian: Odrasli
English: Use of rescue medicinal product
Slovenian: Uporaba rešilnega zdravila
English: Healthcare professionals are asked to report any suspected adverse reactions.
Slovenian: Zdravstvene delavce naprošamo, da poročajo o katerem koli domnevnem neželenem učinku zdravila.
English: - if you are allergic to umeclidinium or any of the other ingredients of this medicine (listed in section
Slovenian: - če ste alergični na umeklidinij ali katero koli sestavino tega zdravila (navedeno v poglavju 6).
English: The frequencies assigned to the adverse reactions identified in the table below include crude incidence rates observed from four efficacy studies and the long-term safety study (which involved 1,412 patients who received umeclidinium bromide).
Slovenian: Pogostnosti, pripisane neželenim učinkom, navedenim v spodnji preglednici, vključujejo grobe incidenčne stopnje, zabeležene v štirih študijah učinkovitosti in v dolgoročni študiji varnosti (ta je zajela 1.412 bolnikov,
English: • Remove the inhaler from your mouth.
Slovenian: • Vzemite inhalator iz ust.
English: • constipation.
Slovenian: • prehlad,
English: Hypersensitivity to the active substance(s) or to any of the excipients listed in section 6.1
Slovenian: Preobčutljivost na učinkovino ali katero koli pomožno snov, navedeno v poglavju 6.1.
English: The primary endpoint was annual rate of on-treatment moderate and severe exacerbations in subjects treated with FF/UMC/VI compared with FF/VI.
Slovenian: Primarni opazovani dogodek je bil letni delež zmernih in hudih poslabšanj med zdravljenjem pri bolnikih, zdravljenih s FF/UMC/VI v primerjavi s FF/VI.
English: 12-Week Study Treatment difference1 95% Confidence interval p-value
Slovenian: 12-tedenska študija Razlika zdravljenj1 95 % interval zaupanja vrednost p
English: • Slide the cover down until you hear a “click”.
Slovenian: • Potisnite pokrovček navzdol, dokler ne zaslišite "klik".
English: The desiccant sachet should be thrown away and it should not be opened, eaten or inhaled.
Slovenian: Vrečko s sušilom je treba zavreči in se je ne sme odpreti, zaužiti ali vdihniti.
English: It is not possible to accidentally take extra medicine or a double dose in one inhalation.
Slovenian: Ne more se zgoditi, da bi pri eni inhalaciji pomotoma vzeli dodatno količino zdravila ali dvojen odmerek.
English: The other ingredients are lactose monohydrate (see section 2 under ‘Rolufta Ellipta contains lactose') and magnesium stearate.
Slovenian: Drugi sestavini zdravila sta laktoza monohidrat (glejte poglavje 2 "Zdravilo Rolufta Ellipta vsebuje laktozo") in magnezijev stearat.
English: For the full list of excipients, see section 6.1.
Slovenian: Za celoten seznam pomožnih snovi glejte poglavje 6.1.
English: Slide the cover down until a “click” is heard.
Slovenian: Potisnite pokrovček dol, dokler se ne zasliši "klik".
English: This medicinal product contains lactose.
Slovenian: Zdravilo vsebuje laktozo.
English: A population pharmacokinetic analysis showed that no dose adjustment is required for umeclidinium bromide based on the effect of age, race, gender, inhaled corticosteroid use or weight.
Slovenian: Analiza populacijske farmakokinetike je pokazala, da odmerka umeklidinijevega bromida ni treba prilagoditi glede na starost, raso, spol, uporabo inhalacijskih kortikosteroidov ali telesno maso.
English: Atrial fibrillation Rhythm idioventricular Supraventricular tachycardia Supraventricular extrasystoles Tachycardia
Slovenian: Srčne bolezni atrijska fibrilacija idioventrikularni ritem supraventrikularna tahikardija supraventrikularne ekstrasistole tahikardija občasni občasni občasni občasni pogosti
English: Patients receiving Rolufta Ellipta had a higher percentage of days when no rescue medication was needed (on average 31.1%) compared with placebo (on average 21.7%).
Slovenian: Bolniki, ki so dobivali zdravilo Rolufta Ellipta so imeli večji odstotek dni brez potrebe po rešilnem zdravilu (povprečno 31,1 %) v primerjavi s placebom (povprečno 21,7 %).
English: A population pharmacokinetic analysis showed that pharmacokinetics of umeclidinium bromide are similar between COPD patients 65 years and older and those younger than 65 years of age.
Slovenian: Starejši Analiza populacijske farmakokinetike je pokazala, da je farmakokinetika umeklidinijevega bromida pri bolnikih s KOPB, starih 65 let ali več, podobna kot pri mlajših od 65 let.
English: • Put the mouthpiece between your lips, and close your lips firmly around it.
Slovenian: Ustnik namestite med ustnici in ju trdno stisnite okrog njega.
English: COPD is a long-term condition in which the airways and air-sacs in the lungs gradually become blocked or damaged, leading to breathing difficulties that slowly get worse.
Slovenian: KOPB je dolgotrajna bolezen, pri kateri se postopoma razvija zapiranje ali okvara dihalnih poti in dihalnih mešičkov v pljučih; to povzroči težave z dihanjem, ki se počasi slabšajo.
English: The Ellipta inhaler contains pre-dispensed doses and is ready to use.
Slovenian: Inhalator Ellipta vsebuje odmerjene odmerke in je pripravljen za uporabo.
English: 24-Week Study Treatment difference1 95% Confidence interval p-value
Slovenian: 24-tedenska študija Razlika zdravljenj1 95 % interval zaupanja vrednost p
English: Mechanism of action
Slovenian: Mehanizem delovanja
English: The tray can be discarded after first opening.
Slovenian: Embalažo lahko po prvem odprtju zavrže.
English: 30 doses
Slovenian: 30 odmerkov
English: The inhaler is a multi-component device composed of polypropylene, high density polyethylene, polyoxymethylene, polybutylene terephthalate, acrylonitrile butadiene styrene, polycarbonate and stainless steel.
Slovenian: Inhalator je večdelen pripomoček , izdelanih iz polipropilena, polietilena velike gostote, polioksimetilena, polibutilentereftalata, akrilonitril-butadienstirena, polikarbonata in nerjavečega jekla.
English: Don't use this medicine if you are pregnant unless your doctor tells you so.
Slovenian: Če ste noseči, ne uporabljajte tega zdravila, razen če vam tako naroči zdravnik.
English: Supporting efficacy studies
Slovenian: Dodatne študije učinkovitosti
English: Following repeat doses of umeclidinium 500 micrograms once daily for 10 days, no clinically relevant effect on prolongation of QT interval (corrected using the Fridericia method) or effects on heart rate were observed.
Slovenian: Po ponavljajoči se 10-dnevni uporabi 500 mikrogramov umeklidinija enkrat na dan niso opazili klinično pomembnega vpliva na podaljšanje intervala QT (korigiranega po Fridericijevi metodi) ali na srčno frekvenco.
English: 7 doses 30 doses
Slovenian: 7 odmerkov 30 odmerkov
English: When you take the inhaler out of its tray, it will be in the ‘closed' position.
Slovenian: Ko inhalator vzamete iz embalaže, bo v položaju "zaprto".
English: Open the cover when ready to take a dose.
Slovenian: Odprite pokrovček, ko ste pripravljeni, da vzamete odmerek.
English: • If the dose counter does not count down as you hear the “click”, the inhaler will not deliver medicine.
Slovenian: • Če se število na števcu odmerkov ne zmanjša, ko zaslišite "klik", inhalator ne bo oddal zdravila.
English: • taste disturbance.
Slovenian: • motnje okusa.
English: Umeclidinium bromide is a substrate of P-glycoprotein (P-gp) transporter.
Slovenian: Umeklidinijev bromid je substrat P-glikoproteinskega (P-gp) prenašalca.
English: A study in CYP2D6 poor metabolisers showed no evidence of a clinically significant effect of CYP2D6 genetic polymorphism on systemic exposure to umeclidinium bromide.
Slovenian: Študija slabih metabolizatorjev s CYP2D6 ni pokazala klinično pomembnega vpliva genetskega polimorfizma CYP2D6 na sistemsko izpostavljenost umeklidinijevemu bromidu.
English: The inhaler contains one aluminium foil laminate blister of 7 or 30 doses.
Slovenian: Inhalator vsebuje en pretisni omot iz aluminijaste laminatne folije s 7 ali 30 odmerki.
English: CLINICAL PARTICULARS 4.1 Therapeutic indications
Slovenian: 4.1 Terapevtske indikacije
English: Do not use this medicine after the expiry date which is stated on the carton, tray and inhaler after ‘EXP'.
Slovenian: Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatlah ali inhalatorju poleg oznake ‘Uporabno do/EXP'.
English: If you have any of the following symptoms after taking Rolufta Ellipta, stop using this medicine and tell your doctor immediately:
Slovenian: Če imate po jemanju zdravila Rolufta Ellipta katerega koli od naslednjih simptomov, zdravilo takoj nehajte uporabljati in nemudoma obvestite svojega zdravnika:
English: Throw this desiccant sachet away - don't open, eat or inhale it.
Slovenian: To vrečko s sušilom zavrzite - ne smete je odpreti, zaužiti ali vdihniti (inhalirati).
English: Glaxo Operations UK Limited (trading as Glaxo Wellcome Operations) Priory Street
Slovenian: Glaxo Operations UK Limited (posluje kot Glaxo Wellcome Operations) Priory Street
English: Step-by-step instructions for use What is the inhaler?
Slovenian: Navodilo za uporabo Kaj je inhalator?
English: EXPIRY DATE
Slovenian: Do datuma
English: Rolufta Ellipta is indicated as a maintenance bronchodilator treatment to relieve symptoms in adult patients with chronic obstructive pulmonary disease (COPD).
Slovenian: Zdravilo Rolufta Ellipta je indicirano za vzdrževalno bronhodilatacijsko zdravljenje za olajšanje simptomov pri odraslih bolnikih s kronično obstruktivno pljučno boleznijo (KOPB).
English: Not all pack sizes may be marketed.
Slovenian: Na trgu morda ni vseh navedenih pakiranj.
English: • Take one long, steady, deep breath in.
Slovenian: • Vdihnite z enim dolgim, enakomernim, globokim vdihom.
English: Difficulties in breathing is added to by tightening of the muscles around the airways, which narrows the airways and so restricts the flow of air.
Slovenian: K težavam z dihanjem pripomore skrčenost mišic, ki obdajajo dihalne poti, zaradi česar se dihalne poti zožijo in omejijo tok zraka.
English: Antimuscarinic activity
Slovenian: Antimuskarinsko delovanje
English: What you need to know before you use Rolufta Ellipta 3.
Slovenian: Kaj morate vedeti, preden boste uporabili zdravilo Rolufta Ellipta 3.
English: c) Close the inhaler
Slovenian: c) Zaprite inhalator
English: Description
Slovenian: Opis
English: UNIQUE IDENTIFIER - 2D BARCODE
Slovenian: EDINSTVENA OZNAKA - DVODIMENZIONALNA ČRTNA KODA
English: If you use more Rolufta Ellipta than you should
Slovenian: Če ste uporabili večji odmerek zdravila Rolufta Ellipta, kot bi smeli
English: • Decrease in vision or pain in your eyes due to high pressure (possible signs of glaucoma).
Slovenian: • zmanjšan vid ali bolečina v očeh zaradi povišanega tlaka (možni znaki glavkoma),
English: Glaxo Operations UK Ltd. (trading as Glaxo Wellcome Operations) Priory Street
Slovenian: Glaxo Operations (UK) Ltd. (posluje kot Glaxo Wellcome Operations) Priory Street
English: An overdose of umeclidinium bromide will likely produce signs and symptoms consistent with the known inhaled muscarinic antagonist adverse effects (e.g. dry mouth, visual accommodation disturbances and tachycardia).
Slovenian: Preveliko odmerjanje umeklidinijevega bromida bo verjetno povzročilo znake in simptome, skladne z neželenimi učinki inhalacijskih muskarinskih antagonistov (npr. suhost ust, motnje akomodacije vida in tahikardijo).
English: Rolufta Ellipta contains the active substance umeclidinium bromide, which belongs to a group of medicines called bronchodilators.
Slovenian: Zdravilo Rolufta Ellipta vsebuje učinkovino umeklidinijev bromid, ki spada v skupino zdravil, imenovanih bronhodilatatorji.
English: The following instructions for the 30 dose inhaler (30 day supply) also apply to the 7 dose inhaler (7 day supply).
Slovenian: Naslednja navodila za uporabo inhalatorja s 30 odmerki (30-dnevna zaloga) veljajo tudi za inhalator s 7 odmerki (7-dnevna zaloga).
English: It is not known whether the ingredients of Rolufta Ellipta can pass into breast milk.
Slovenian: Ni znano, ali lahko sestavine zdravila Rolufta Ellipta prehajajo v materino mleko.
English: The MAH shall perform the required pharmacovigilance activities and interventions detailed in the agreed RMP presented in Module 1.8.2 of the Marketing Authorisation and any agreed subsequent updates of the RMP.
Slovenian: podrobno opisane v sprejetem RMP, predloženem v modulu 1.8.2 dovoljenja za promet z zdravilom, in vseh nadaljnjih sprejetih posodobitvah RMP.
English: These may affect up to 1 in 100 people:
Slovenian: Pojavijo se lahko pri največ 1 od 100 bolnikov:
English: Although no formal in vivo interaction studies have been performed, inhaled umeclidinium bromide has been used concomitantly with other COPD medicinal products including short and long acting sympathomimetic bronchodilators and inhaled corticosteroids without clinical evidence of interactions.
Slovenian: Druga zdravila za KOPB Čeprav uradnih študij medsebojnega delovanja in vivo še niso izvedli, je bil umeklidinijev bromid za inhaliranje sočasno že uporabljan z drugimi zdravili za KOPB, vključno s kratko- in dolgodelujočimi simpatikomimetičnimi bronhodilatatorji in inhalacijskimi kortikosteroidi, vendar kliničnih dokazov za medsebojno delovanje z drugimi zdravili ni.
English: Pharmacodynamic effects
Slovenian: Farmakodinamični učinki
English: The requirements for submission of periodic safety update reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal.
Slovenian: • Redno posodobljena poročila o varnosti zdravila (PSUR) Zahteve glede predložitve rednega posodobljenega poročila o varnosti zdravila za to zdravilo so določene v seznamu referenčnih datumov EU (seznamu EURD), opredeljenem v členu 107c(7) Direktive
English: If the inhaler cover is opened and closed without inhaling the medicinal product, the dose will be lost.
Slovenian: Če pokrovček inhalatorja odpre in zapre, ne da bi vdihnil zdravilo, bo odmerek izgubljen.