FrancophonIA/ELRC3.0 huggingface dataset:
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.
Croatian: Iako nisu provedena formalna ispitivanja interakcija in vivo, pri istodobnoj primjeni inhalacijskog umeklidinijeva bromida i drugih lijekova za KOPB, uključujući kratkodjelujuće i dugodjelujuće simpatomimetičke bronhodilatatore i inhalacijske kortikosteroide, nije bilo kliničkih dokaza interakcija.
English: The patient should be advised to not open the tray until they are ready to inhale a dose.
Croatian: Bolesnike treba savjetovati da ne otvaraju podložak sve dok ne budu spremni za inhaliranje doze lijeka.
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.
Croatian: Nakon inhalacije ponovljenih doza umeklidinijeva bromida, stanje dinamičke ravnoteže postignuto je unutar 7 do 10 dana, a kumulacija se povećala za 1,5 do 1,8 puta.
English: Keep the inhaler inside the sealed tray in order to protect from moisture and only remove immediately before first use.
Croatian: Čuvati inhalator u zatvorenom podlošku radi zaštite od vlage i otvoriti ga tek neposredno prije prve uporabe.
English: The inhaler contains one aluminium foil laminate blister of 7 or 30 doses.
Croatian: Inhalator sadrži jedan blister od višeslojne aluminijske folije sa 7 ili 30 doza.
English: Inhaler
Croatian: Inhalator
English: Other medicinal products for COPD
Croatian: Drugi lijekovi za KOPB
English: Slide the cover down until a “click” is heard.
Croatian: Povlačite poklopac prema dolje dok ne čujete ''klik''.
English: Supporting efficacy studies
Croatian: Potporna ispitivanja djelotvornosti
English: Don't block the air vent with your fingers.
Croatian: Nemojte prstima blokirati otvore za zrak.
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%).
Croatian: Bolesnici koji su primali lijek Rolufta Ellipta imali su veći postotak dana kada im nije bila potrebna primjena lijekova za hitno ublažavanje simptoma (u prosjeku 31,1%) u usporedbi s placebom (u prosjeku 21,7%).
English: For the full list of excipients, see section 6.1.
Croatian: Za cjeloviti popis pomoćnih tvari vidjeti dio 6.1.
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS INHALER LABEL
Croatian: PODACI KOJE MORA NAJMANJE SADRŽAVATI MALO UNUTARNJE PAKIRANJE NALJEPNICA INHALATORA
English: Administration of umeclidinium bromide may produce paradoxical bronchospasm that may be lifethreatening.
Croatian: Paradoksalni bronhospazam Primjena umeklidinijeva bromida može uzrokovati paradoksalni bronhospazam, koji može biti opasan po život.
English: If you are breast-feeding, you must check with your doctor before you use Rolufta Ellipta.
Croatian: Ako dojite, morate se obratiti svom liječniku prije nego primijenite lijek Rolufta Ellipta.
English: The active substance is present as a white powder in a blister inside the inhaler.
Croatian: Djelatna tvar dolazi u obliku bijeloga praška u blisteru unutar inhalatora.
English: Do not use this medicine after the expiry date which is stated on the carton, tray and inhaler after ‘EXP'.
Croatian: Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na kutiji, podlošku i inhalatoru iza oznake 'Rok valjanosti' ili 'EXP'.
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).
Croatian: Predoziranje umeklidinijevim bromidom vjerojatno će izazvati znakove i simptome koji odgovaraju poznatim nuspojavama koje se javljaju kod primjene inhalacijskih muskarinskih antagonista (npr. suha usta, poremećaji vidne akomodacije i tahikardija).
English: Cardiac electrophysiology
Croatian: Elektrofiziologija srca
English: Healthcare professionals are asked to report any suspected adverse reactions.
Croatian: Od zdravstvenih radnika se traži da prijave svaku sumnju na nuspojavu za ovaj lijek.
English: System Organ Class
Croatian: Klasifikacija organskih sustava
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.
Croatian: U ispitivanju sa slabim metabolizatorima CYP2D6 nisu pronađeni dokazi klinički značajnog učinka genetskog polimorfizma CYP2D6 na sistemsku izloženost umeklidinijevu bromidu.
English: EXPIRY DATE
Croatian: Do datuma
English: Therefore, umeclidinium bromide should be used with caution in patients with severe cardiovascular disorders, particularly cardiac arrhythmias.
Croatian: Stoga umeklidinijev bromid treba primjenjivati uz oprez u bolesnika s teškim kardiovaskularnim poremećajima, osobito srčanim aritmijama.
English: • constipation.
Croatian: • prehlada
English: SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF THE SIGHT AND REACH OF CHILDREN
Croatian: POSEBNO UPOZORENJE O ČUVANJU LIJEKA IZVAN POGLEDA
English: Effects on lung function
Croatian: Učinci na plućnu funkciju
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.
Croatian: Bronhodilatacijski učinci kod primjene lijeka Rolufta Ellipta u odnosu na placebo u oba su ispitivanja bili primjetni već nakon prvoga dana liječenja, a održali su se tijekom čitavog 12-tjednog i 24-tjednog razdoblja liječenja.
English: Umeclidinium bromide is a substrate of P-glycoprotein (P-gp) transporter.
Croatian: Umeklidinijev bromid je supstrat za prijenosnik P-glikoprotein (P-gp).
English: NAME OF THE MEDICINAL PRODUCT
Croatian: NAZIV LIJEKA
English: Mechanism of action
Croatian: Mehanizam djelovanja
English: INFORMATION IN BRAILLE
Croatian: 16. PODACI NA BRAILLEOVOM PISMU
English: The lost dose will be securely held inside the inhaler, but it will no longer be available to be inhaled.
Croatian: Izgubljena doza ostat će čvrsto zatvorena u inhalatoru, ali više neće biti dostupna za inhalaciju.
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.
Croatian: je dugotrajna bolest kod koje dolazi do postupne blokade ili oštećenja dišnih putova i zračnih mjehurića (alveola) u plućima, što uzrokuje tegobe s disanjem koje se polako pogoršavaju.
English: 2 years In-use shelf-life after opening the tray: 6 weeks.
Croatian: 2 godine Rok valjanosti nakon otvaranja podloška: 6 tjedana.
English: The absolute bioavailability of inhaled umeclidinium bromide was on average 13% of the dose, with negligible contribution from oral absorption.
Croatian: Apsolutna bioraspoloživost inhaliranog umeklidinijeva bromida u prosjeku je iznosila 13% doze, pri čemu je udio oralne apsorpcije bio zanemariv.
English: Umeclidinium bromide is a long acting muscarinic receptor antagonist (also referred to as an anticholinergic).
Croatian: Umeklidinijev bromid je dugodjelujući antagonist muskarinskih receptora (naziva se još i antikolinergikom).
English: c) Close the inhaler
Croatian: c) Zatvorite inhalator
English: To use Rolufta Ellipta, you breathe it into your lungs through your mouth using the Ellipta inhaler.
Croatian: Rolufta Ellipta se primjenjuje tako da ga udahnete kroz usta u pluća uz pomoć Ellipta inhalatora.
English: If you become wheezy or breathless, use your quick-acting inhaler (such as salbutamol), then seek medical advice.
Croatian: Ako dođe do piskanja pri disanju ili ako ostanete bez zraka, primijenite brzodjelujući inhalacijski lijek (npr. salbutamol), a zatim zatražite savjet liječnika.
English: Use Rolufta Ellipta regularly
Croatian: Primjenjujte lijek Rolufta Ellipta redovito
English: Excipients: lactose and magnesium stearate.
Croatian: Pomoćne tvari: laktoza i magnezijev stearat.
English: The medicinal product is now ready to be inhaled.
Croatian: Lijek je sada spreman za inhaliranje.
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.
Croatian: U randomiziranom, dvostruko slijepom, 52-tjednom ispitivanju (CTT116855, IMPACT) provedenom u 10 355 odraslih bolesnika sa simptomatskim KOPB-om koji su u proteklih 12 mjeseci imali 1 ili više umjerenih ili teških egzacerbacija, ispitivalo se liječenje kombinacijom flutikazonfuroat/umeklidinij/vilanterol (FF/UMEC/VI 99/55/22 mikrograma) pomoću jedinog inhalatora primijenjenim jedanput na dan u usporedbi s primjenom kombinacije flutikazonfuroat/vilanterol (FF/VI 99/22 mikrograma) pomoću jedinog inhalatora primijenjenim jedanput na dan.
English: Description
Croatian: Opis
English: Pharmacodynamic effects
Croatian: Farmakodinamički učinci
English: The maximum dose is one inhalation of umeclidinium bromide once daily.
Croatian: Maksimalna doza je jedna inhalacija umeklidinijeva bromida jedanput na dan.
English: 4) Close the inhaler
Croatian: 4) Zatvorite inhalator
English: Other special populations
Croatian: Druge posebne populacije bolesnika
English: The most frequently reported adverse reactions with Rolufta Ellipta were nasopharyngitis and upper respiratory tract infection.
Croatian: Najčešće prijavljivane nuspojave kod primjene lijeka Rolufta Ellipta bile su nazofaringitis i infekcija gornjeg dišnog sustava.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING BUNDLE LABEL (WITH BLUE BOX - MULTIPACK) 55 micrograms
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU NALJEPNICA NA OMOTU (S PLAVIM OKVIROM - VIŠESTRUKO PAKIRANJE) 55 mikrograma
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.
Croatian: kada čujete ''klik'', inhalator neće isporučiti dozu i trebate ga vratiti ljekarniku i zatražiti savjet.
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).
Croatian: U prenatalnom i postnatalnom ispitivanju supkutana primjena umeklidinijeva bromida štakorima smanjila je prirast majčine tjelesne težine i unos hrane te blago smanjila tjelesnu težinu mladunčadi prije prestanka sisanja u ženki koje su primale dozu od 180 mikrograma/kg na dan (izloženost približno 80 puta veća od kliničke izloženosti u ljudi nakon primjene umeklidinija u dozi od 55 mikrograma, što je utvrđeno na temelju AUC-a).
English: Pregnancy and breast-feeding
Croatian: Trudnoća i dojenje
English: 3) Inhale your medicine • While holding the inhaler away from your mouth, breathe out as far as is comfortable.
Croatian: 3) Inhalirajte lijek • Držite inhalator dalje od usta i izdahnite koliko možete, do granice neugode.
English: Talk to your doctor before using this medicine: if you have asthma (Don't use Rolufta Ellipta to treat asthma)
Croatian: ako imate astmu (ne smijete koristiti lijek Rolufta Ellipta za liječenje astme)
English: Based on the magnitude of these changes, no clinically relevant interaction is expected when umeclidinium bromide is co-administered with P-gp inhibitors.
Croatian: obzirom na opseg tih promjena, ne očekuje se klinički značajna interakcija pri istodobnoj primjeni umeklidinijeva bromida s inhibitorima P-gp-a.
English: What Rolufta Ellipta is and what it is used for What Rolufta Ellipta is
Croatian: Što je Rolufta Ellipta i za što se koristi Što je Rolufta Ellipta
English: United Kingdom or
Croatian: Ujedinjeno Kraljevstvo ili
English: It is a quinuclidine derivative that is a muscarinic receptor antagonist with activity across multiple muscarinic cholinergic receptor subtypes.
Croatian: To je kinuklidinski derivat i antagonist muskarinskih receptora koji djeluje na niz različitih podvrsta muskarinskih kolinergičkih receptora.
English: The recommended dose is one inhalation of umeclidinium bromide once daily.
Croatian: Preporučena doza je jedna inhalacija umeklidinijeva bromida jedanput na dan.
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.
Croatian: Ispitivanja in vitro pokazala su da se umeklidinijev bromid prvenstveno metabolizira posredstvom citokroma P450 2D6 (CYP2D6) i da je supstrat za prijenosnik P-glikoprotein (P-gp).
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).
Croatian: Klinička djelotvornost lijeka Rolufta Ellipta primijenjenog jedanput na dan ocijenjena je u dva ključna klinička ispitivanja faze III u 904 odrasla bolesnika s kliničkom dijagnozom KOPB-a koji su primali umeklidinijev bromid ili placebo: jednom 12-tjednom (AC4115408) i jednom 24-tjednom ispitivanju (DB2113373).
English: There was no evidence for tachyphylaxis in the effect of Rolufta Ellipta over time.
Croatian: Nije bilo znakova tahifilaksije na učinke lijeka Rolufta Ellipta tijekom vremena.
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.
Croatian: Istodobna primjena umeklidinijeva bromida s drugim dugodjelujućim muskarinskim antagonistima ili lijekovima koji sadrže tu djelatnu tvar nije ispitivana te se ne preporučuje jer može potencirati poznate nuspojave koje se javljaju pri inhalaciji muskarinskih antagonista.
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).
Croatian: obzirom na opseg tih promjena, ne očekuje se klinički značajna interakcija pri istodobnoj primjeni umeklidinija s inhibitorima CYP2D6 niti pri primjeni umeklidinija u ispitanika s genetski nedostatnom aktivnošću CYP2D6 (slabi metabolizatori).
English: PHARMACOLOGICAL PROPERTIES 5.1 Pharmacodynamic properties
Croatian: 5.1 Farmakodinamička svojstva
English: If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before using this medicine.
Croatian: Ako Vam je liječnik rekao da ne podnosite neke šećere, savjetujte se s liječnikom prije uzimanja ovog lijeka.
English: Rolufta Ellipta is indicated as a maintenance bronchodilator treatment to relieve symptoms in adult patients with chronic obstructive pulmonary disease (COPD).
Croatian: Lijek Rolufta Ellipta je indiciran kao bronhodilatator u terapiji održavanja u odraslih bolesnika s kroničnom opstruktivnom plućnom bolešću (KOPB) s ciljem ublažavanja simptoma.
English: Don't use more than your doctor tells you to use.
Croatian: Nemojte primijeniti više lijeka nego što Vam je rekao liječnik.
English: When you are ready to use your inhaler, peel back the lid to open the tray.
Croatian: Kada ste spremni primijeniti Vaš inhalator, odlijepite poklopac kako biste otvorili podložak.
English: Laboratoire GlaxoSmithKline Tél: + 33 (0)1 39 17 84 44 diam@gsk.com
Croatian: Laboratorie GlaxoSmithKline Tél: + 33 (0)1 39 17 84 44 diam@gsk.com
English: Improvements in lung function were supported with reductions in use of salbutamol over Weeks 1-12 (-0.4 puffs per day (95% CI: -0.7, -0.2; p<0.001) and -0.3 puffs per day (95% CI: -0.5, -0.1; p=0.003)) compared to placebo plus FF/VI but improvements in SGRQ at week 12 were not statistically significant (200109) or clinically relevant (200109 and 200110).
Croatian: Poboljšanja plućne funkcije bila su podržana smanjenjem uporabe salbutamola tijekom 1-12 tjedna (0,4 udisaja dnevno (95% CI -0,7, -0,2, p<0,001) i -0,3 udisaja dnevno (95% CI -0,5, -0,1, p=0,003)) u usporedbi s placebom uz FF/VI , međutim, poboljšanja u 12. tjednu prema SGRQ nisu bila statistički značajna (200109) ili klinički bitna (200109 i 200110).
English: Other medicines and Rolufta Ellipta
Croatian: Drugi lijekovi i Rolufta Ellipta
English: Don't open the inhaler until you are ready to inhale a dose of medicine.
Croatian: Nemojte otvarati inhalator sve dok ne budete spremni inhalirati dozu lijeka.
English: • painful and frequent urination (may be signs of a urinary tract infection)
Croatian: • bolno i učestalo mokrenje (mogu biti znakovi infekcije mokraćnog sustava)
English: The excretion of the drug-related material in the faeces following intravenous dosing indicated secretion into the bile.
Croatian: Izlučivanje tvari povezanih s lijekom u fecesu nakon intravenske primjene ukazivalo je na izlučivanje u žuč.
English: There are no data from the use of umeclidinium bromide in pregnant women.
Croatian: Nema podataka o primjeni umeklidinijeva bromida u trudnica.
English: If stored in the refrigerator, allow the inhaler to return to room temperature for at least an hour before use.
Croatian: Ako se inhalator čuva u hladnjaku, treba pričekati najmanje jedan sat prije primjene da se ugrije na sobnu temperaturu.
English: Rolufta Ellipta is an inhalation powder, pre-dispensed.
Croatian: Rolufta Ellipta je prašak inhalata, dozirani.
English: 6.6 Special precautions for disposal and other handling
Croatian: 6.6 Posebne mjere za zbrinjavanje i druga rukovanja lijekom
English: Urinary elimination accounted for 22% of the administered radiolabelled dose by 168 hours (27% of recovered radioactivity).
Croatian: U mokraću se izlučilo 22% primijenjene radioaktivno označene doze i to unutar 168 sati (27% pronađene radioaktivnosti).
English: Inhalation powder, pre-dispensed (inhalation powder).
Croatian: Prašak inhalata, dozirani (prašak inhalata).
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).
Croatian: Upute za uporabu Ellipta inhalatora prikazane u nastavku odnose se i na inhalator s 30 doza (terapija za 30 dana) i na inhalator sa 7 doza (terapija za 7 dana).
English: Following intravenous administration, approximately 58% of the administered radiolabelled dose (or 73% of the recovered radioactivity) was excreted in faeces by 192 hours post-dose.
Croatian: približno 58% primijenjene radioaktivno označene doze (ili 73% pronađene radioaktivnosti) izlučilo se u feces unutar 192 sata nakon primjene doze.
English: common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare
Croatian: (≥ 1/1000 i < 1/100), rijetko (≥ 1/10 000 i < 1/1000), vrlo rijetko (< 1/10 000) i nepoznato (ne može se procijeniti iz dostupnih podataka).
English: The following instructions for the 30 dose inhaler (30 day supply) also apply to the 7 dose inhaler (7 day supply).
Croatian: Upute u nastavku, koje opisuju uporabu inhalatora s 30 doza (terapija za 30 dana), odnose se i na inhalator sa 7 doza (terapija za 7 dana).
English: SG12 0DJ
Croatian: Hertfordshire SG12 0DJ
English: Treatment should be discontinued immediately if paradoxical bronchospasm occurs and alternative therapy instituted if necessary.
Croatian: U slučaju paradoksalnog bronhospazma treba odmah prekinuti liječenje te po potrebi uvesti drugu terapiju.
English: See ‘Step-by-step instructions for use' in this leaflet for full information.
Croatian: Za više informacija pročitajte 'Upute za primjenu korak po korak' u ovoj uputi.
English: The mouthpiece of the inhaler may be cleaned using a dry tissue before closing the cover.
Croatian: Nastavak za usta na inhalatoru možete očistiti suhom maramicom prije zatvaranja poklopca.
English: Renal and urinary disorders Urinary retention Dysuria
Croatian: Poremećaji bubrega i mokraćnog sustava urinarna retencija dizurija nepoznato nepoznato
English: The inhaler is packaged in a tray containing a desiccant sachet, to reduce moisture.
Croatian: Inhalator je zapakiran u podložak u kojem se nalazi vrećica sa sredstvom za sušenje, koje služi za smanjivanje vlage.
English: CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
Croatian: UVJETI ILI OGRANIČENJA VEZANI UZ SIGURNU I UČINKOVITU PRIMJENU LIJEKA
English: Each inhaler contains either 7 or 30 doses.
Croatian: Jedan inhalator sadrži ili 7 ili 30 doza.
English: Excipient with known effect: Each delivered dose contains approximately 12.5 mg of lactose (as monohydrate).
Croatian: Jedna primijenjena doza sadrži približno 12,5 mg laktoze (u obliku hidrata).
English: Do not shake the inhaler.
Croatian: Nemojte tresti inhalator.
English: White powder in a grey inhaler (Ellipta) with a light green mouthpiece cover and a dose counter.
Croatian: Bijeli prašak u sivom inhalatoru (Ellipta) sa svijetlozelenim poklopcem nastavka za usta i brojačem doza.
English: In the 12-week study, Rolufta Ellipta statistically significantly reduced the use of rescue medication with salbutamol compared with placebo (on average a reduction of 0.7 puffs per day over Weeks 1-12, p=0.025) and demonstrated a higher percentage of days when no rescue medication was needed (on average 46.3%) compared with placebo (on average 35.2%; no formal statistical analysis was performed on this endpoint).
Croatian: U 12-tjednom ispitivanju je primjena lijeka Rolufta Ellipta statistički značajno smanjila uporabu salbutamola kao lijeka za hitno ublažavanje simptoma (engl. rescue medication) u usporedbi s placebom (prosječno smanjenje za 0,7 udisaja na dan u razdoblju od 1. do 12. tjedna, p=0,025) te povećala postotak dana kada uporaba lijekova za hitno ublažavanje simptoma nije bila potrebna (u prosjeku 46,3%) u usporedbi s placebom (u prosjeku 35,2%; nije provedena formalna statistička analiza za tu mjeru ishoda).
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.
Croatian: Primarna mjera ishoda bila je smanjenje godišnje stope umjerenih/teških egzacerbacija u ispitanika liječenih s kombinacijom FF/UMEC/VI u usporedbi s kombinacijom FF/VI.
English: If you get eye pain or discomfort, temporary blurring of vision, visual halos or coloured images in association with red eyes during treatment with Rolufta Ellipta:
Croatian: Ako se tijekom liječenja lijekom Rolufta Ellipta pojave bol ili nelagoda u oku, privremeno zamagljenje vida, odbljesak ili krugovi duginih boja pred očima (halo efekt) u kombinaciji s crvenilom očiju:
English: It is not known whether the ingredients of Rolufta Ellipta can pass into breast milk.
Croatian: Nije poznato mogu li se sastojci lijeka Rolufta Ellipta izlučiti u majčino mlijeko.
English: Umeclidinium bromide is intended for the maintenance treatment of COPD.
Croatian: Umeklidinijev bromid namijenjen je za terapiju održavanja u bolesnika s KOPB-om.
English: The Ellipta inhaler consists of a grey plastic body, a light green mouthpiece cover and a dose counter.
Croatian: Ellipta inhalator sastoji se od sivog plastičnog tijela, svijetlozelenog poklopca nastavka za usta i brojača doza.
English: CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE
Croatian: UVJETI ILI OGRANIČENJA VEZANI UZ OPSKRBU I PRIMJENU