FrancophonIA/ELRC3.0 huggingface dataset:
English: In a phase III study in combination with cyclophosphamide (CPA) comparing Myocet liposomal (60 mg/m2) + CPA (600 mg/m2) versus doxorubicin (60 mg/m2) + CPA (600 mg/m2), 6% versus 21% of patients, respectively, developed a significant decrease in left ventricular ejection fraction (LVEF).
Croatian: U ispitivanju faze III u kombinaciji s ciklofosfamidom (CPA), u kojem je uspoređivan Myocet liposomal (60 mg/m2) + CPA (600 mg/m2) naspram doksorubicinu (60 mg/m2) + CPA (600 mg/m2),
English: These may be signs of heart failure, uneven heart beat or a low potassium level in your blood
Croatian: neujednačenog srčanog ritma ili niske razine kalija u krvi • abnormalni testovi jetrene funkcije
English: Myocet liposomal has been reported to cause dizziness.
Croatian: Zabilježeno je da Myocet liposomal uzrokuje omaglicu.
English: Read the package leaflet before use
Croatian: NAČIN PRIMJENE Prije uporabe pročitajte Uputu o lijeku
English: If you get any side effects, talk to your doctor or pharmacist or nurse.
Croatian: Ako primijetite bilo koju nuspojavu, potrebno je obavijestiti liječnika, ljekarnika ili medicinsku sestru.
English: • Shake well.
Croatian: • koliko dobro
English: Vial 1 - doxorubicin HCl • lactose
Croatian: Bočica 1 - doksorubicin HCl • laktoza
English: Tumour response rate 43% 43% 46% 39% 26% 26% Relative Risk (95% C.I.)
Croatian: Stopa odgovora tumora Relativni rizik (95% C.I.)
English: Modification
Croatian: Izmjena
English: Dehydration
Croatian: Vrlo često dehidracija
English: Muscle weakness
Croatian: • slabost u mišićima
English: • phosphatidylcholine
Croatian: • fosfatidilkolin
English: Add pH-adjusted liposomes to doxorubicin
Croatian: 5. korak Liposome s podešenom pH vrijednosti dodajte doksorubicinu
English: Myocet liposomal may cause some side effects that are related to how fast the drip is given.
Croatian: Crvenilo i bol u šakama i stopalima Myocet liposomal može uzrokovati neke nuspojave koje su povezane s brzinom davanja dripa.
English: Uncommon (may affect up to 1 in 100 people):
Croatian: Manje često (mogu pogoditi najviše 1 od 100 osoba): • iskašljavanje krvi
English: SHAKE
Croatian: OBLIK
English: Leucopenia
Croatian: liposoma.
English: Vial 1 - doxorubicin HCl lactose
Croatian: Bočica 1 - doksorubicin HCl laktoza
English: Musculoskeletal, connective tissue and bone disorders
Croatian: Poremećaji mišićno-koštanog sustava i vezivnog tkiva bol u leđima
English: Preparation of Myocet liposomal
Croatian: Priprema lijeka Myocet liposomal
English: Pericardial effusion
Croatian: Često kardiomiopatija
English: As for other anthracyclines and doxorubicin products, radiation recall may occur in previously irradiated fields.
Croatian: Za mjere opreza glede primjene lijeka Myocet liposomal s drugim lijekovima, vidjeti dio 4.5. Kao i s drugim antraciklinima i lijekovima koji sadrže doksorubicin, može se dogoditi recidiv radijacijskog dermatitisa u prethodno ozračenom području.
English: PRESENTATION
Croatian: DODATAK
English: Neutropenic fever
Croatian: Nepoznato pleuralni izljev pneumonitis
English: Plasma levels of doxorubicin and its metabolite, doxorubicinol, may be increased when doxorubicin is administered with cyclosporin, verapamil, paclitaxel or other agents that inhibit Pglycoprotein (P-Gp).
Croatian: paklitakselom ili drugim lijekovima koji inhibiraju P-glikoprotein (P-Gp).
English: 1 vial doxorubicin HCl 1 vial liposomes 1 vial buffer
Croatian: 1 bočica liposoma 1 bočica pufera
English: • nose bleeds, hot flushes
Croatian: • teškoće prilikom spavanja • krvarenje iz nosa, navale vrućine
English: Arrhythmia
Croatian: Doza
English: Agitation
Croatian: ODLAGANJE
English: Abnormal gait
Croatian: Često mialgija
English: You may feel dizzy after having Myocet liposomal.
Croatian: Moguće nuspojave Kako čuvati Myocet liposomal
English: Oesophagitis
Croatian: Često ezofagitis
English: Gastric ulcer
Croatian: Nepoznato faringitis
English: If you notice any of the side effects listed above, tell your doctor or nurse straight away.
Croatian: Ako primijetite bilo koju nuspojavu, potrebno je obavijestiti liječnika ili medicinsku sestru.
English: Nadir Platelet Count (cells/µl)
Croatian: Najniži broj trombocita (stanice/µl)
English: Respiratory, thoracic and mediastinal disorders
Croatian: Poremećaji dišnog sustava, prsišta i sredoprsja bol u prsištu
English: MARKETING AUTHORISATION HOLDER
Croatian: Nositelj odobrenja za stavljanje gotovog lijeka u promet
English: Instructions for use: a) Prepare a dose
Croatian: Upute za primjenu: a) Pripremite dozu
English: Date of latest renewal: 11 January 2019
Croatian: Datum posljednje obnove odobrenja: 11. siječanja 2019.
English: Umeclidinium bromide should be used during pregnancy only if the expected benefit to the mother justifies the potential risk to the foetus.
Croatian: Umeklidinijev bromid se tijekom trudnoće smije primjenjivati samo ako očekivana korist za majku opravdava mogući rizik za plod.
English: Don't inhale an extra dose to make up for a forgotten dose.
Croatian: Nemojte inhalirati još jednu dozu kako biste nadoknadili zaboravljenu dozu.
English: if you are allergic to umeclidinium or any of the other ingredients of this medicine (listed in section 6).
Croatian: - ako ste alergični na umeklidinij ili neki drugi sastojak ovoga lijeka (naveden u dijelu 6.).
English: It is very important that you use Incruse Ellipta every day, as instructed by your doctor.
Croatian: Vrlo je važno da lijek Incruse Ellipta primjenjujete svaki dan, prema uputama liječnika.
English: If you have any of the following symptoms after taking Incruse Ellipta, stop using this medicine and tell your doctor immediately:
Croatian: Ako imate bilo koji od sljedećih simptoma nakon primjene lijeka Incruse Ellipta, prekinite primjenu ovog lijeka i odmah obavijestite svog liječnika:
English: Plasma clearance following intravenous administration was 151 litres/hour.
Croatian: Klirens iz plazme nakon intravenske primjene iznosio je 151 litara/sat.
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 webportal.
Croatian: Zahtjevi za podnošenje izvješća o neškodljivosti za ovaj lijek definirani su u referentnom popisu datuma EU (EURD popis) predviđenom člankom 107.c stavkom 7. Direktive 2001/83/EZ i svim sljedećim ažuriranim verzijama objavljenima na europskom internetskom portalu za lijekove.
English: Don't use Incruse Ellipta as well as these other medicines.
Croatian: Nemojte primjenjivati Incruse Ellipta zajedno s tim drugim lijekovima.
English: Incruse Ellipta should be administered at the same time of the day each day to maintain bronchodilation.
Croatian: Incruse Ellipta treba primjenjivati svakoga dana u isto vrijeme, kako bi se održao bronhodilatacijski učinak.
English: Toxicity to reproduction
Croatian: Reproduktivna toksičnost
English: A decision must be made whether to discontinue breast-feeding or to discontinue Incruse Ellipta therapy taking into account the benefit of breastfeeding for the child and the benefit of therapy for the woman.
Croatian: Mora se donijeti odluka o tome hoće li se prekinuti dojenje ili liječenje lijekom Incruse Ellipta, uzimajući pritom u obzir korist dojenja za dijete te korist liječenja za majku.
English: Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not use this medicinal product.
Croatian: Bolesnici s rijetkim nasljednim poremećajem nepodnošenja galaktoze, potpunim nedostatkom laktaze ili malapsorpcijom glukoze i galaktoze ne bi smjeli primjenjivati ovaj lijek.
English: No dose adjustment is required in patients over 65 years (see section 5.2).
Croatian: Nije potrebno prilagođavati dozu u bolesnika starijih od 65 godina (vidjeti dio 5.2).
English: The European Medicines Agency has waived the obligation to submit the results of studies with Incruse Ellipta in all subsets of the paediatric population in COPD (see section 4.2 for information on paediatric use).
Croatian: Europska agencija za lijekove izuzela je obvezu podnošenja rezultata ispitivanja lijeka Incruse Ellipta u svim podskupinama pedijatrijske populacije za KOPB (vidjeti dio 4.2 za informacije o pedijatrijskoj primjeni).
English: 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: The first time you use Incruse 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.
Croatian: Kada primjenjujete Incruse Ellipta po prvi puta ne morate provjeravati radi li inhalator ispravno, on sadrži prethodno odmjerene doze i odmah je spreman za uporabu.
English: Incruse Ellipta has not been studied in patients with severe hepatic impairment and should be used with caution (see section 5.2).
Croatian: Incruse Ellipta nije ispitivan u bolesnika s teškim oštećenjem jetrene funkcije pa se mora primjenjivati uz oprez (vidjeti dio 5.2).
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 „EXP“.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 28 April 2014
Croatian: Datum prvog odobrenja: 28. travnja 2014.
English: The other ingredients are lactose monohydrate (see section 2 under ‘Incruse Ellipta contains lactose') and magnesium stearate.
Croatian: Drugi sastojci su laktoza hidrat (vidjeti odlomak „Incruse Ellipta sadrži laktozu“ u dijelu 2.) i magnezijev stearat.
English: In nonclinical studies with umeclidinium bromide, findings were those typically associated with the primary pharmacology of muscarinic receptor antagonists and/or local irritancy.
Croatian: nekliničkim ispitivanjima s umeklidinijevim bromidom rezultati su bili jednaki onima koji se tipično povezuju s primarnom farmakologijom antagonista muskarinskih receptora i/ili lokalnom iritacijom.
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 7 doses
Croatian: SADRŽAJ PO TEŽINI, VOLUMENU ILI DOZNOJ JEDINICI 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, s povećanjem akumulacije za 1,5 do 1,8 puta.
English: The short duration of these two studies and limited number of exacerbation events, preclude any conclusion regarding additional effect of Incruse Ellipta on COPD exacerbation rate.
Croatian: Kratko trajanje ova dva ispitivanja i ograničeni broj pojava egzacerbacija, onemogućuje donošenje zaključka o dodatnom učinku lijeka Incruse Ellipta na stopu egzacerbacija KOPB-a.
English: Incruse Ellipta contains the active substance umeclidinium bromide, which belongs to a group of medicines called bronchodilators.
Croatian: Incruse Ellipta sadrži djelatnu tvar umeklidinijev bromid, a pripada skupini lijekova koje nazivamo bronhodilatatorima.
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 Incruse Ellipta compared with tiotropium (study 201038), according to a protocol agreed by the PRAC.
Croatian: Podnijeti završno izvješće o kliničkom ispitivanju za opservacijsko kohortno ispitivanje sigurnosti primjene nakon dobivanja odobrenja, koje ima za cilj kvantificirati incidenciju i usporediti sigurnost s obzirom na odabrane kardiovaskularne i cerebrovaskularne događaje u bolesnika s KOPB-om kod primjene lijeka Incruse Ellipta u usporedbi s tiotropijem (ispitivanje: 201038), prema protokolu dogovorenom od strane Povjerenstva za ocjenu rizika na području farmakovigilancije.
English: The effect of umeclidinium 500 micrograms (pre-dispensed) on the QT interval was evaluated in a placebo- and moxifloxacin-controlled QT trial of 103 healthy volunteers.
Croatian: Učinak umeklidinija u dozi od 500 mikrograma (doziranog) na QT-interval ocijenjen je u placebom i moksifloksacinom kontroliranom ispitivanju QT-intervala u 103 zdrava dobrovoljca.
English: The bronchodilatory effects with Incruse 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 Incruse 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: Patients receiving Incruse 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 Incruse 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: Slide the cover down until a “click” is heard.
Croatian: Povlačite poklopac prema dolje dok ne čujete „klik“.
English: If you are breast-feeding, you must check with your doctor before you use Incruse Ellipta.
Croatian: Ako dojite, morate se obratiti svom liječniku prije nego primijenite Incruse Ellipta.
English: Incruse Ellipta is indicated as a maintenance bronchodilator treatment to relieve symptoms in adult patients with chronic obstructive pulmonary disease (COPD).
Croatian: Incruse Ellipta je indiciran kao bronhodilatator u terapiji održavanja u odraslih bolesnika s kroničnom opstruktivnom plućnom bolešću (KOPB) s ciljem ublažavanja simptoma.
English: Other medicines and Incruse Ellipta
Croatian: Drugi lijekovi i Incruse Ellipta
English: Talk to your doctor before using this medicine: if you have asthma (Don't use Incruse Ellipta to treat asthma) if you have heart problems if you have an eye problem called narrow-angle glaucoma if you have an enlarged prostate, difficulty passing urine or a blockage in your bladder if you have severe liver problems
Croatian: ako imate astmu (ne smijete koristiti Incruse Ellipta za liječenje astme) ako imate srčane tegobe ako imate bolest oka koja se zove glaukom uskog kuta ako imate povećanu prostatu, otežano mokrite ili imate otežan protok mokraće kroz mokraćni mjehur ako imate teške jetrene tegobe
English: There was no evidence for tachyphylaxis in the effect of Incruse Ellipta over time.
Croatian: Nije bilo znakova tahifilaksije na učinke lijeka Incruse Ellipta tijekom vremena.
English: Use Incruse Ellipta regularly
Croatian: Primjenjujte Incruse Ellipta redovito
English: The most frequently reported adverse reactions with Incruse Ellipta were nasopharyngitis and upper respiratory tract infection.
Croatian: Najčešće prijavljivane nuspojave kod primjene lijeka Incruse Ellipta bile su nazofaringitis i infekcija gornjeg dišnog sustava.
English: Driving and using machines It is unlikely that this medicine will affect your ability to drive or use machines.
Croatian: Nije vjerojatno da bi ovaj lijek mogao utjecati na sposobnost upravljanja vozilima i rada sa strojevima.
English: NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER GlaxoSmithKline (Ireland) Limited, 12 Riverwalk, Citywest Business Campus, Dublin 24, Ireland GlaxoSmithKline (Ireland) Limited logo
Croatian: GlaxoSmithKline (Ireland) Limited, 12 Riverwalk, Citywest Business Campus, Dublin 24, Irska GlaxoSmithKline (Ireland) Limited logo
English: It is not known whether the ingredients of Incruse Ellipta can pass into breast milk.
Croatian: Nije poznato mogu li se sastojci lijeka Incruse Ellipta izlučiti u majčino mlijeko.
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, ispitivano je liječenje kombinacijom flutikazonfuroat/umeklidinij/vilanterol (FF/UMEC/VI 99/55/22 mikrograma) pomoću jednog inhalatora primijenjenim jedanput na dan u usporedbi s primjenom kombinacije flutikazonfuroat/vilanterol (FF/VI 99/22 mikrograma) pomoću jednog inhalatora primijenjenim jedanput na dan.
English: 1 inhaler of 7 doses.
Croatian: 1 inhalator sa 7 doza.
English: Eye problems during treatment with Incruse Ellipta If you get eye pain or discomfort, temporary blurring of vision, visual halos or coloured images in association with red eyes during treatment with Incruse Ellipta:
Croatian: Ako se tijekom liječenja lijekom Incruse 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: To use Incruse Ellipta, you breathe it into your lungs through your mouth using the Ellipta inhaler.
Croatian: Incruse Ellipta se primjenjuje tako da ga udahnete kroz usta u pluća uz pomoć Ellipta inhalatora.
English: If you use more Incruse Ellipta than you should
Croatian: Ako primijenite više lijeka Incruse Ellipta nego što ste trebali
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: These may affect up to 1 in 10 people:
Croatian: Mogu se javiti u do 1 na 100 osoba:
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: Incruse Ellipta should not be used to relieve a sudden attack of breathlessness or wheezing.
Croatian: Incruse Ellipta se ne smije primjenjivati za ublažavanje naglog napadaja nedostatka zraka ili piskanja pri disanju.
English: The clinical efficacy of Incruse 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 Incruse 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: Sími: + 354 535 7000
Croatian: Vistor hf. Sími: + 354 535 7000
English: LIST OF EXCIPIENTS Excipients: lactose and magnesium stearate.
Croatian: Pomoćne tvari: laktoza i magnezijev stearat.
English: Incruse Ellipta contains lactose
Croatian: Incruse Ellipta sadrži laktozu
English: The inhaler is a multi-component device composed of polypropylene, high density polyethylene, polyoxymethylene, polybutylene terephthalate, acrylonitrile butadiene styrene, polycarbonate and stainless steel.
Croatian: polioksimetilena, polibutilen tereftalata, akrilonitril butadien stirena, polikarbonata i nehrđajućeg čelika.
English: The recommended dose is one inhalation of umeclidinium bromide once daily.
Croatian: Odrasli Preporučena doza je jedna inhalacija umeklidinijeva bromida jedanput na dan.
English: In a Phase III, 6-month study (DB2113373) Incruse Ellipta provided a clinically meaningful improvement over placebo in lung function (as measured by forced expiratory volume in 1 second [FEV1]) over 24 hours following once daily administration, which was evident at 30 minutes following administration of the first dose (improvement over placebo by 102 mL, p<0.001*).
Croatian: 6-mjesečnom ispitivanju faze III (DB2113373), primjena lijeka Incruse Ellipta dovela je do klinički značajnog poboljšanja plućne funkcije (mjereno forsiranim izdisajnim volumenom u 1 sekundi [FEV1]) u odnosu na placebo tijekom 24 sata nakon primjene jedanput na dan, što je bilo primjetno 30 minuta nakon primjene prve doze (poboljšanje za 102 ml u odnosu na placebo, p<0,001*).
English: In the 12-week study, Incruse 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 Incruse 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: How to use the inhaler 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: What you need to know before you use Incruse Ellipta 3.
Croatian: Što morate znati prije nego počnete primjenjivati Incruse Ellipta
English: In the 24-week placebo-controlled study in patients with symptomatic COPD, Incruse Ellipta reduced the risk of a moderate/severe COPD exacerbation by 40% compared with placebo (analysis of time to first exacerbation; Hazard Ratio 0.6; 95% CI: 0.4, 1.0, p=0.035*).
Croatian: U 24-tjednom placebo kontroliranom ispitivanju u bolesnika sa simptomatskim KOPB-om primjena lijeka Incruse Ellipta smanjila je rizik od umjerenih/teških egzacerbacija KOPB-a za 40% u usporedbi s placebom (na temelju analize vremena do prve egzacerbacije; omjer hazarda 0,6; 95% CI:0,4, 1,0, p=0,035*).
English: An approximately 1.3-fold increase in umeclidinium bromide AUC was observed at an 8-fold higher dose with no effect on umeclidinium bromide Cmax.
Croatian: Pri primjeni osmerostruko veće doze primijećeno je povećanje AUC-a umeklidinijeva bromida za oko 1,3 puta, dok na Cmax umeklidinijeva bromida nije bilo učinka.
English: No new adverse drug reactions were identified with the addition of Incruse Ellipta to FF/VI in these studies.
Croatian: U tim ispitivanjima nisu identificirane nove nuspojave kod dodavanja lijeka Incruse Ellipta kombinaciji FF/VI.
English: The primary endpoint was annual rate of ontreatment 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: UNIQUE IDENTIFIER - HUMAN READABLE DATA PC:
Croatian: JEDINSTVENI IDENTIFIKATOR - PODACI ČITLJIVI LJUDSKOM OKU