FrancophonIA/ELRC3.0 huggingface dataset:
English: Following repeat dosing of inhaled umeclidinium bromide, steady state was achieved within 7 to 10 days with 1.5 to 1.8-fold accumulation.
Slovenian: Po večkratnem inhaliranju umeklidinijevega bromida je bilo stanje dinamičnega ravnovesja doseženo v 7 do 10 dneh; kopičenje je bilo od 1,5- do 1,8-kratno.
English: It demonstrates slow reversibility at the human M3 muscarinic receptor subtype in vitro and a long duration of action in vivo when administered directly to the lungs in pre-clinical models.
Slovenian: Na podtipu M3 človeških muskarinskih receptorjev in vitro je njegovo delovanje počasi reverzibilno, in vivo pa je dolgotrajno, če je bil v predkliničnih modelih uporabljen neposredno na pljučih.
English: Submission of the final clinical study report on a Post-Authorisation Safety (PAS) Observational Cohort Study to Quantify the Incidence and Comparative Safety of Selected Cardiovascular and Cerebrovascular Events in COPD Patients with Rolufta Ellipta compared with tiotropium (study 201038), according to a protocol agreed by the PRAC.
Slovenian: Opazovalna kohortna študija za določitev incidence in primerjalne varnosti za izbrane kardiovaskularne in cerebrovaskularne dogodke pri bolnikih s KOPB z zdravilom Rolufta Ellipta v primerjavi s tiotropijem (študija 201038), po porotokolu, ki ga je potrdil PRAC.
English: Excipients: lactose and magnesium stearate.
Slovenian: Pomožne snovi: laktoza in magnezijev stearat.
English: You can help by reporting any side effects you may get.
Slovenian: Tudi sami lahko k temu prispevate tako, da poročate o katerem koli neželenem učinku zdravila, ki bi se utegnil pojaviti pri vas.
English: common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare
Slovenian: Pogostnost neželenih učinkov je opredeljena z naslednjim dogovorom: zelo pogosti (≥ 1/10), pogosti (≥ 1/100 do < 1/10), občasni (≥ 1/1.000 do < 1/100), redki (≥ 1/10.000 do < 1/1.000), zelo redki (< 1/10.000) in neznana pogostnost (ni mogoče oceniti iz razpoložljivih podatkov).
English: If you become wheezy or breathless, use your quick-acting inhaler (such as salbutamol), then seek medical advice.
Slovenian: Če se vam pojavi piskajoče ali težko dihanje, uporabite svoj hitrodelujoči inhalator (kot je salbutamol) in nato poiščite zdravniški nasvet.
English: The steady-state pharmacokinetics of umeclidinium bromide were assessed in healthy volunteers lacking CYP2D6 (poor metabolisers).
Slovenian: Farmakokinetiko umeklidinijevega bromida v stanju dinamičnega ravnovesja so ocenili pri zdravih prostovoljcih s pomanjkanjem CYP2D6 (slabi metabolizatorji).
English: What Rolufta Ellipta is and what it is used for 2.
Slovenian: Kaj je zdravilo Rolufta Ellipta in za kaj ga uporabljamo 2.
English: The lost dose will be securely held inside the inhaler, but it will no longer be available to be inhaled.
Slovenian: Izgubljeni odmerek bo varno shranjen v inhalatorju, vendar ne bo več na voljo za vdihanje.
English: Treatment should be discontinued immediately if paradoxical bronchospasm occurs and alternative therapy instituted if necessary.
Slovenian: Če se pojavi paradoksni bronhospazem, je treba uporabo zdravila nemudoma prekiniti in uvesti drugo zdravljenje, če je potrebno.
English: To be used within 6 weeks of first opening of the tray.
Slovenian: Uporabite v 6 tednih po prvem odprtju embalaže.
English: Multipack: 90 (3 inhalers of 30) doses
Slovenian: Skupno pakiranje: 90 (3 inhalatorji po 30) odmerkov
English: Use Rolufta Ellipta regularly
Slovenian: Zdravilo Rolufta Ellipta uporabljajte redno
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION
Slovenian: IME ZDRAVILA IN POT(I) UPORABE
English: The bronchodilatory effects with Rolufta Ellipta compared with placebo were evident after the first day of treatment in both studies and were maintained over the 12-week and 24-week treatment periods.
Slovenian: V obeh študijah so bili bronhodilatacijski učinki zdravila Rolufta Ellipta v primerjavi s placebom opazni že po prvem dnevu zdravljenja in so se ohranili med 12- in 24-tedenskim obdobjem zdravljenja.
English: Co-administration of umeclidinium bromide with other long-acting muscarinic antagonists or medicinal products containing this active substance has not been studied and is not recommended as it may potentiate known inhaled muscarinic antagonist adverse reactions.
Slovenian: Sočasna uporaba umeklidinijevega bromida z drugimi dolgodelujočimi muskarinskimi antagonisti ali zdravili, ki vsebujejo to učinkovino, ni raziskana in ni priporočljiva, ker lahko poveča znane neželene učinke inhalacijskega muskarinskega antagonista.
English: Frequency
Slovenian: Pogostnost
English: The air vents should not be blocked with fingers during use.
Slovenian: Med uporabo ne smete s prsti prekriti rež za zrak.
English: If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before using this medicine.
Slovenian: Če vam je zdravnik povedal, da ne prenašate nekaterih sladkorjev, se z njim posvetujte, preden uporabite to zdravilo.
English: Umeclidinium bromide is intended for the maintenance treatment of COPD.
Slovenian: Umeklidinijev bromid je namenjen za vzdrževalno zdravljenje KOPB.
English: Once the tray is opened, the inhaler can be used for up to 6 weeks, starting from the date of opening the tray.
Slovenian: Ko je embalaža odprta, lahko inhalator uporabljate do 6 tednov; to obdobje začne teči z dnem, ko odprete embalažo.
English: Umeclidinium bromide plasma elimination half-life following inhaled dosing for 10 days averaged 19 hours, with 3% to 4% active substance excreted unchanged in urine at steady-state.
Slovenian: Plazemski eliminacijski razpolovni čas umeklidinijevega bromida po 10-dnevni inhalacijski uporabi je bil v povprečju 19 ur; v stanju dinamičnega ravnovesja se je od 3 % do 4 % učinkovine izločilo nespremenjene v urinu.
English: The effect of umeclidinium 500 micrograms (pre-dispensed) on the QT interval was evaluated in a placeboand moxifloxacin-controlled QT trial of 103 healthy volunteers.
Slovenian: Vpliv 500 mikrogramov umeklidinija (odmerjeni) na interval QT so ocenili pri 103 zdravih prostovoljcih v študiji QT, kontrolirani s placebom in moksifloksacinom.
English: The lost dose will be securely held inside the inhaler, but it will no longer be available.
Slovenian: Izgubljeni odmerek bo varno shranjen v inhalatorju, vendar vam ne bo več na voljo.
English: In nonclinical studies with umeclidinium bromide, findings were those typically associated with the primary pharmacology of muscarinic receptor antagonists and/or local irritancy.
Slovenian: Izsledki predkliničnih študij z umeklidinijevim bromidom so bili takšni, kot so značilno povezani s primarno farmakologijo antagonistov muskarinskih receptorjev in/ali lokalnim draženjem.
English: Name and address of the manufacturer responsible for batch release
Slovenian: Ime in naslov izdelovalca, odgovornega za sproščanje serij
English: If you are not sure what your medicine contains talk to your doctor or pharmacist.
Slovenian: Če niste prepričani, kaj vsebuje vaše zdravilo, se posvetujte z zdravnikom ali farmacevtom.
English: In the event of deterioration of COPD during treatment with umeclidinium bromide, a re-evaluation of the patient and of the COPD treatment regimen should be undertaken.
Slovenian: Če se stanje KOPB med zdravljenjem z umeklidinijevim bromidom poslabša, je treba znova oceniti tako bolnika kot shemo zdravljenja KOPB.
English: In a randomised, double-blind, 52-week study (CTT116855, IMPACT) of 10,355 adult patients with symptomatic COPD and a history of 1 or more moderate or severe exacerbations within the prior 12 months, treatment with fluticasone furoate/umeclidinium/vilanterol (FF/UMEC/VI 99/55/22 micrograms) once daily as a single inhaler was compared with fluticasone furoate/vilanterol (FF/VI 99/22 micrograms) once daily as a single inhaler.
Slovenian: V randomizirani, dvojno slepi 52-tedenski študiji (CTT116855, IMPACT), ki je zajela 10.355 odraslih bolnikov s simptomatsko KOPB in anamnezo 1 ali več zmernih ali hudih poslabšanj v predhodnih 12 mesecih, so primerjali zdravljenje s flutikazonfuroat/umeklidinij/vilanterol (FF/UMEC/VI 99/55/22 mikrogramov) enkrat na dan v enem inhalatorju z zdravljenjem s flutikazonfuroat/vilanterol (FF/VI 99/22 mikrogramov) enkrat na dan v enem inhalatorju.
English: Ask your pharmacist how to dispose of medicines no longer required.
Slovenian: O načinu odstranjevanja zdravila, ki ga ne uporabljate več, se posvetujte s farmacevtom.
English: Don't use more than your doctor tells you to use.
Slovenian: Ne uporabite več zdravila, kot vam naroči zdravnik.
English: Rolufta Ellipta has not been studied in patients with severe hepatic impairment and should be used with caution (see section
Slovenian: Zdravilo Rolufta Ellipta ni raziskano pri bolnikih s hudo okvaro jeter, zato ga je pri takšnih bolnikih treba uporabljati previdno (glejte poglavje
English: The mouthpiece of the inhaler may be cleaned using a dry tissue before closing the cover.
Slovenian: Ustnik inhalatorja lahko očistite s suho krpico, preden zaprete pokrovček.
English: Table 1: Trough FEV1 (ml) at Week 12 and Week 24 (primary endpoint) Treatment with Rolufta Ellipta 55 mcg
Slovenian: Preglednica 1: Najnižji FEV1 (ml) 12. in 24. teden (primarni opazovani dogodek) Zdravljenje z zdravilom Rolufta Ellipta 55 µg
English: The patient should be advised to not open the tray until they are ready to inhale a dose.
Slovenian: Bolniku je treba naročiti, naj ne odpira embalaže, dokler ni pripravljen na inhalacijo odmerka.
English: Your medicine is now ready to be inhaled.
Slovenian: Zdravilo je zdaj pripravljeno za inhaliranje.
English: There was no evidence for tachyphylaxis in the effect of Rolufta Ellipta over time.
Slovenian: Ni bilo znakov, da bi se skozi čas razvila tahifilaksija na učinek zdravila Rolufta Ellipta.
English: In a pre- and post-natal study, subcutaneous administration of umeclidinium bromide to rats resulted in lower maternal body weight gain and food consumption and slightly decreased pre-weaning pup body weights in dams given 180 micrograms/kg/day dose (approximately 80-times the human clinical exposure of umeclidinium 55 micrograms, based on AUC).
Slovenian: V pre- in postnatalni študiji je subkutano dajanje umeklidinijevega bromida pri podganah povzročilo zmanjšanje maternalnega povečanja telesne mase in uživanje hrane ter rahlo manjšo telesno maso mladičev pred odstavitvijo pri samicah-materah, ki so dobivale odmerek 180 mikrogramov/kg/dan (to je na podlagi AUC približno 80-kratnik klinične izpostavljenosti pri človeku z odmerkom 55 mikrogramov umeklidinija).
English: If the dose counter does not count down as the “click” is heard, the inhaler will not deliver a dose and should be taken back to a pharmacist for advice.
Slovenian: Če se število na števcu odmerkov ne zmanjša, ko se zasliši "klik", inhalator ne bo oddal odmerka; vrnite ga farmacevtu in se z njim posvetujte.
English: In vitro studies showed that umeclidinium bromide is principally metabolised by cytochrome P450 2D6 (CYP2D6) and is a substrate for the P-glycoprotein (P-gp) transporter.
Slovenian: Študije in vitro so pokazale, da se umeklidinijev bromid presnavlja predvsem s citokromom P450 2D6 (CYP2D6) in da je substrat prenašalca P-glikoproteina (P-gp).
English: There are no data from the use of umeclidinium bromide in pregnant women.
Slovenian: O uporabi umeklidinijevega bromida pri nosečnicah ni podatkov.
English: If you get this sort of attack you must use a quick-acting reliever inhaler (such as salbutamol).
Slovenian: Če se vam pojavi takšen napad, morate uporabiti hitrodelujoč inhalator za olajšanje (kot je salbutamol).
English: Based on the magnitude of these changes, no clinically relevant drug interaction is expected when umeclidinium is co-administered with CYP2D6 inhibitors or when administered to subjects genetically deficient in CYP2D6 activity (poor metabolisers).
Slovenian: Glede na velikost teh sprememb ni pričakovati klinično pomembnih medsebojnih delovanj zdravil, če je umeklidinij uporabljen sočasno z zaviralci CYP2D6 ali pri osebah z genetskim pomanjkanjem aktivnosti CYP2D6 (slabi metabolizatorji).
English: What you need to know before you use Rolufta Ellipta Do not use Rolufta Ellipta:
Slovenian: Kaj morate vedeti, preden boste uporabili zdravilo Rolufta Ellipta Ne uporabljajte zdravila Rolufta Ellipta:
English: The “Discard by” date is 6 weeks from the date you opened the tray.
Slovenian: Datum "Zavrzite do" je 6 tednov od datuma, ko ste odprli embalažo.
English: The clinical efficacy of Rolufta Ellipta administered once daily was evaluated in 904 adult patients who received umeclidinium bromide or placebo from two pivotal Phase III clinical studies with a clinical diagnosis of COPD; a 12-week study (AC4115408) and a 24-week study (DB2113373).
Slovenian: Klinično učinkovitost zdravila Rolufta Ellipta enkrat na dan so ocenili pri 904 odraslih bolnikih s klinično diagnozo KOPB, ki so prejemali umeklidinijev bromid ali placebo v dveh ključnih kliničnih študijah III. faze: v 12-tedenski študiji (AC4115408) in 24-tedenski študiji (DB2113373).
English: Urinary elimination accounted for 22% of the administered radiolabelled dose by 168 hours (27% of recovered radioactivity).
Slovenian: V urinu se je v 168 urah izločilo 22 % uporabljenega radioaktivno označenega odmerka (27 % najdene radioaktivnosti).
English: • painful and frequent urination (may be signs of a urinary tract infection)
Slovenian: • boleče in pogosto odvajanje vode (to je lahko znak okužbe sečil),
English: Eye problems during treatment with Rolufta Ellipta
Slovenian: Težave z očmi med zdravljenjem z zdravilom Rolufta Ellipta
English: Do not open the tray until you are ready to start using your new inhaler.
Slovenian: Ne odpirajte embalaže, dokler niste pripravljeni na začetek uporabe vašega novega inhalatorja.
English: Based on the magnitude of these changes, no clinically relevant interaction is expected when umeclidinium bromide is co-administered with P-gp inhibitors.
Slovenian: Glede na velikost teh sprememb ni pričakovati klinično pomembnih medsebojnih delovanj, če je umeklidinijev bromid uporabljen sočasno z zaviralci P-gp.
English: The mean annual rate of exacerbations was 0.91 and 1.07 for FF/UMEC/VI and FF/VI respectively (Rate Ratio: 0.85; 95% CI: 0.80, 0.90; p<0.001).
Slovenian: Povprečni letni delež poslabšanj je bil 0,91 pri FF/UMEC/VI in 1,07 pri FF/VI (razmerje deležev: 0,85, 95 % IZ: 0,80, 0,90, p<0,001).
English: The inhaler is packaged in a tray.
Slovenian: Inhalator se nahaja v embalaži.
English: OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION
Slovenian: DRUGI POGOJI IN ZAHTEVE DOVOLJENJA ZA PROMET Z ZDRAVILOM
English: Keep the inhaler inside the sealed tray in order to protect from moisture and only remove immediately before first use.
Slovenian: Inhalator hranite v zaprti embalaži za zagotovitev zaščite pred vlago in ga odprite šele tik pred prvo uporabo.
English: Component of a multipack can't be sold separately.
Slovenian: Del pakiranja z več inhalatorji, ni za ločeno prodajo.
English: Umeclidinium bromide exerts its bronchodilatory activity by competitively inhibiting the binding of acetylcholine with muscarinic cholinergic receptors on airway smooth muscle.
Slovenian: Umeklidinijev bromid deluje bronhodilatacijsko s kompetitivnim zavrtjem vezave acetilholina na muskarinske holinergične receptorje gladkih mišic v dihalih.
English: Following oral administration to healthy male subjects, total radioactivity was excreted primarily in faeces (92% of the administered radiolabelled dose or 99% of the recovered radioactivity) by 168 hours post-dose.
Slovenian: Po peroralni uporabi pri zdravih moških se je celotna radioaktivnost v 168 urah po odmerku izločila v prvi vrsti v blatu (92 % uporabljenega radioaktivno označenega odmerka in 99 % najdene radioaktivnosti).
English: There is no relevant use of Rolufta Ellipta in the paediatric population (under 18 years of age) in the indication for COPD.
Slovenian: V pediatrični populaciji (mlajši od 18 let) zdravilo Rolufta Ellipta nima relevantne uporabe za indikacijo KOPB.
English: The excretion of the drug-related material in the faeces following intravenous dosing indicated secretion into the bile.
Slovenian: Izločanje z zdravilom povezanih snovi v blatu po intravenski uporabi kaže na izločanje v žolču.
English: Other antimuscarinics
Slovenian: Druga antimuskarinska zdravila
English: Elimination
Slovenian: Izločanje
English: CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE
Slovenian: POGOJI ALI OMEJITVE GLEDE OSKRBE IN UPORABE
English: CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
Slovenian: POGOJI ALI OMEJITVE V ZVEZI Z VARNO IN UČINKOVITO UPORABO ZDRAVILA
English: 4.4 Special warnings and precautions for use
Slovenian: 4.4 Posebna opozorila in previdnostni ukrepi
English: No dosage adjustment is required in patients with renal impairment (see section 5.2).
Slovenian: Bolnikom z okvaro ledvic odmerka ni treba prilagoditi (glejte poglavje 5.2).
English: It is a quinuclidine derivative that is a muscarinic receptor antagonist with activity across multiple muscarinic cholinergic receptor subtypes.
Slovenian: Je derivat kvinuklidina, ki deluje kot antagonist muskarinskih receptorjev na številnih podtipih muskarinskih holinergičnih receptorjev.
English: Following intravenous administration to healthy subjects, the mean volume of distribution was 86 litres.
Slovenian: Povprečni volumen porazdelitve po intravenski uporabi je bil pri zdravih preiskovancih 86 litrov.
English: The date should be added as soon as the inhaler has been removed from the tray.
Slovenian: Ta datum morate zapisati, takoj ko inhalator vzamete iz embalaže.
English: Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V.
Slovenian: da poročajo o katerem koli domnevnem neželenem učinku zdravila na nacionalni center za poročanje, ki je naveden v Prilogi V*.
English: 2 years In-use shelf-life after opening the tray: 6 weeks.
Slovenian: 2 leti Rok uporabnosti po prvem odprtju embalaže: 6 tednov.
English: The recommended dose is one inhalation of umeclidinium bromide once daily.
Slovenian: Priporočeni odmerek je en vdih umeklidinijevega bromida enkrat na dan.
English: • feeling of pressure or pain in the cheeks and forehead (may be signs of inflammation of the sinuses called sinusitis)
Slovenian: • občutek tiščanja ali bolečina v licih in čelu (to so lahko znaki vnetja obnosnih votlin, ki ga imenujemo sinuzitis),
English: This includes any possible side effects not listed in this leaflet.
Slovenian: Posvetujte se tudi, če opazite katere koli neželene učinke, ki niso navedeni v tem navodilu.
English: It is unknown whether umeclidinium bromide is excreted in human milk.
Slovenian: Ni znano, ali se umeklidinijev bromid pri človeku izloča v materino mleko.
English: The most frequently reported adverse reactions with Rolufta Ellipta were nasopharyngitis and upper respiratory tract infection.
Slovenian: Najpogosteje poročana neželena učinka med uporabo zdravila Rolufta Ellipta sta bila nazofaringitis in okužba zgornjih dihal.
English: Umeclidinium bromide was not teratogenic in rats or rabbits.
Slovenian: Umeklidinijev bromid pri podganah in kuncih ni bil teratogen.
English: MARKETING AUTHORISATION NUMBER(S)
Slovenian: ŠTEVILKA (ŠTEVILKE) DOVOLJENJA (DOVOLJENJ) ZA PROMET Z ZDRAVILOM
English: The active substance is present as a white powder in a blister inside the inhaler.
Slovenian: Učinkovina je bel prašek v pretisnem omotu v notranjosti inhalatorja.
English: What Rolufta Ellipta is and what it is used for What Rolufta Ellipta is
Slovenian: Kaj je zdravilo Rolufta Ellipta in za kaj ga uporabljamo Kaj je zdravilo Rolufta Ellipta
English: The “Discard by” date is 6 weeks from the date of opening the tray.
Slovenian: Datum "Zavrzite do" je 6 tednov od datuma odprtja embalaže.
English: If stored in the refrigerator, allow the inhaler to return to room temperature for at least an hour before use.
Slovenian: Če je zdravilo shranjeno v hladilniku, je treba inhalator vsaj eno uro pred uporabo pustiti, da se ogreje na sobno temperaturo.
English: • Difficulty and pain when passing urine - these may be signs of a bladder obstruction or urinary retention
Slovenian: • povišan izmerjeni očesni tlak, • težave in bolečina pri uriniranju - to so lahko znaki obstrukcije sečnega mehurja ali zastoja urina,
English: The absolute bioavailability of inhaled umeclidinium bromide was on average 13% of the dose, with negligible contribution from oral absorption.
Slovenian: Absolutna biološka uporabnost inhaliranega umeklidinijevega bromida je bila v povprečju 13 % odmerka;
English: Umeclidinium bromide is a long acting muscarinic receptor antagonist (also referred to as an anticholinergic).
Slovenian: Umeklidinijev bromid je dolgodelujoč antagonist muskarinskih receptorjev (te antagoniste imenujejo tudi antiholinergiki).
English: The effect of the moderate P-gp inhibitor verapamil (240 mg once daily) on the steady-state pharmacokinetics of umeclidinium bromide was assessed in healthy volunteers.
Slovenian: Pri zdravih prostovoljcih so ocenili vpliv zmernega zaviralca P-gp verapamila (v odmerku 240 mg enkrat dnevno) na farmakokinetiko umeklidinijevega bromida v stanju dinamičnega ravnovesja.
English: 6.6 Special precautions for disposal and other handling
Slovenian: 6.6 Posebni varnostni ukrepi za odstranjevanje in ravnanje z zdravilom
English: To use Rolufta Ellipta, you breathe it into your lungs through your mouth using the Ellipta inhaler.
Slovenian: Zdravilo Rolufta Ellipta uporabite tako, da ga s pomočjo inhalatorja Ellipta skozi usta vdihnete v pljuča.
English: BATCH NUMBER
Slovenian: ŠTEVILKA SERIJE
English: The inhaler is packaged in a tray containing a desiccant sachet, to reduce moisture.
Slovenian: Inhalator je pakiran v embalaži, ki vsebuje vrečko s sušilom za zmanjšanje vlažnosti.
English: Non clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity and carcinogenic potential.
Slovenian: Predklinični podatki na osnovi običajnih študij farmakološke varnosti, toksičnosti pri ponavljajočih se odmerkih, genotoksičnosti in kancerogenega potenciala ne kažejo posebnega tveganja za človeka.
English: The European Medicines Agency has waived the obligation to submit the results of studies with Rolufta Ellipta in all subsets of the paediatric population in COPD (see section 4.2 for information on paediatric use).
Slovenian: Ellipta za vse podskupine pediatrične populacije pri KOPB (za podatke o uporabi pri pediatrični populaciji glejte poglavje 4.2).
English: Don't open the inhaler until you are ready to inhale a dose of medicine.
Slovenian: Ne odpirajte inhalatorja, dokler niste pripravljeni za vdihovanje odmerka zdravila.
English: Store in the original package in order to protect from moisture.
Slovenian: Shranjujte v originalni ovojnini za zagotovitev zaščite pred vlago.
English: Each inhaler contains either 7 or 30 doses.
Slovenian: En inhalator vsebuje ali 7 ali 30 odmerkov.
English: The maximum dose is one inhalation of umeclidinium bromide once daily.
Slovenian: Največji odmerek je en vdih umeklidinijevega bromida enkrat na dan.
English: No dosage adjustment is required in patients with mild or moderate hepatic impairment.
Slovenian: Bolnikom z blago ali zmerno okvaro jeter odmerka ni treba prilagoditi.
English: The instructions for use of the Ellipta inhaler provided below can be used for either the 30-dose inhaler (30 day supply) or the 7-dose inhaler (7 day supply).
Slovenian: Spodaj navedena navodila za uporabo inhalatorja veljajo za inhalator s 30 odmerki (30-dnevna zaloga) in za inhalator s 7 odmerki (7-dnevna zaloga).
English: Animal studies indicate no effects of umeclidinium bromide on fertility.
Slovenian: Študije na živalih ne kažejo, da bi umeklidinijev bromid vplival na plodnost.
English: Pregnancy and breast-feeding
Slovenian: Nosečnost in dojenje
English: The inhaler should be held away from the mouth breathing out as far as is comfortable.
Slovenian: Inhalator držite odmaknjen od ust in izdihnite, kolikor je mogoče, ne da bi bilo neprijetno.