FrancophonIA/ELRC3.0 huggingface dataset:
English: If you get tightness of the chest, coughing, wheezing or breathlessness immediately after using your Rolufta Ellipta inhaler:
Croatian: Ako se javi stezanje u prsima, kašalj, piskanje pri disanju ili nedostatak zraka neposredno nakon primjene lijeka Rolufta Ellipta:
English: SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE
Croatian: POSEBNE MJERE ZA ZBRINJAVANJE NEISKORIŠTENOG LIJEKA ILI
English: Subjects with severe renal impairment (creatinine clearance <30mL/min) showed no evidence of an increase in systemic exposure to umeclidinium bromide (Cmax and AUC), and no evidence of altered protein binding between subjects with severe renal impairment and healthy volunteers.
Croatian: Oštećenje bubrežne funkcije U osoba s teškim oštećenjem bubrežne funkcije (klirens kreatinina < 30 ml/min) nisu pronađeni dokazi povećane sistemske izloženosti umeklidinijevu bromidu (Cmax i AUC) niti dokazi promijenjenog vezanja za proteine u ispitanika s teškim oštećenjem bubrežne funkcije u odnosu na zdrave dobrovoljce.
English: Skin and subcutaneous tissue disorders
Croatian: Poremećaji kože i potkožnog tkiva osip manje često
English: In the 24-week placebo-controlled study in patients with symptomatic COPD, Rolufta 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 Rolufta 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: Subjects with moderate hepatic impairment (Child-Pugh Class B) showed no evidence of an increase in systemic exposure to umeclidinium bromide (Cmax and AUC), and no evidence of altered protein binding between subjects with moderate hepatic impairment and healthy volunteers.
Croatian: Oštećenje jetrene funkcije U osoba s umjerenim oštećenjem jetrene funkcije (Child-Pugh stadij B) nisu pronađeni dokazi povećane sistemske izloženosti umeklidinijevu bromidu (Cmax i AUC) niti dokazi promijenjenog vezanja za proteine u ispitanika s umjerenim oštećenjem jetrene funkcije u odnosu na zdrave dobrovoljce.
English: Rolufta Ellipta contains lactose
Croatian: Rolufta Ellipta sadrži laktozu
English: The active substance is umeclidinium bromide.
Croatian: Djelatna tvar je umeklidinijev bromid.
English: What you need to know before you use Rolufta Ellipta 3.
Croatian: Što morate znati prije nego počnete primjenjivati lijek Rolufta Ellipta
English: - If you have any further questions, ask your doctor, pharmacist or nurse.
Croatian: - Ako imate dodatnih pitanja, obratite se liječniku, ljekarniku ili medicinskoj sestri.
English: Rolufta Ellipta has not been studied in patients with severe hepatic impairment and should be used with caution (see section
Croatian: Lijek Rolufta Ellipta nije ispitivan u bolesnika s teškim oštećenjem jetrene funkcije pa se mora primjenjivati uz oprez (vidjeti dio 5.2).
English: Rolufta Ellipta should not be used to relieve a sudden attack of breathlessness or wheezing.
Croatian: Rolufta Ellipta se ne smije primjenjivati za ublažavanje naglog napadaja nedostatka zraka ili piskanja pri disanju.
English: An approximately 1.3-fold increase in umeclidinium bromide AUC was observed at an 8fold 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: Multipack: 90 (3 inhalers of 30) doses
Croatian: Višestruko pakiranje: 90 (3 inhalatora s 30) doza.
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION
Croatian: NAZIV LIJEKA I PUT(EVI) PRIMJENE LIJEKA
English: Eye problems during treatment with Rolufta Ellipta
Croatian: Očne tegobe tijekom liječenja lijekom Rolufta Ellipta
English: Don't use this medicine if you are pregnant unless your doctor tells you so.
Croatian: Nemojte primjenjivati ovaj lijek ako ste trudni,
English: Don't breathe out into the inhaler.
Croatian: Nemojte izdisati u inhalator.
English: OTHER
Croatian: DRUGO
English: 1 inhaler of 30 doses.
Croatian: 1 inhalator s 30 doza.
English: Multipacks containing 90 (3 inhalers of 30) doses are also available.
Croatian: Dostupna su i višestruka pakiranja s 90 (3 inhalatora s 30) doza.
English: Possible side effects
Croatian: Moguće nuspojave
English: No dosage adjustment is required in patients with renal impairment (see section 5.2).
Croatian: Nije potrebno prilagođavati dozu u bolesnika s oštećenjem bubrežne funkcije (vidjeti dio 5.2).
English: The steady-state pharmacokinetics of umeclidinium bromide were assessed in healthy volunteers lacking CYP2D6 (poor metabolisers).
Croatian: Farmakokinetika umeklidinijeva bromida u stanju dinamičke ravnoteže ocijenjena je u zdravih dobrovoljaca koji nemaju CYP2D6
English: There are no data on the effects of umeclidinium bromide on human fertility.
Croatian: Nema podataka o učincima umeklidinijeva bromida na plodnost u ljudi.
English: Rolufta Ellipta 55 micrograms inhalation powder, pre-dispensed
Croatian: Rolufta Ellipta 55 mikrograma prašak inhalata, dozirani
English: If you stop using Rolufta Ellipta
Croatian: Ako prestanete primjenjivati lijek Rolufta Ellipta
English: The Ellipta inhaler consists of a grey body, light green mouthpiece cover and a dose counter, packed into a foil laminate tray containing a desiccant packet.
Croatian: Ellipta inhalator se sastoji od sivog tijela, svijetlozelenog poklopca nastavka za usta i brojača doza, a zapakiran je u podložak od višeslojne folije koji sadrži vrećicu sa sredstvom za sušenje.
English: Consistent with its antimuscarinic activity, umeclidinium bromide should be used with caution in patients with urinary retention or with narrow-angle glaucoma.
Croatian: Antimuskarinsko djelovanje Zbog antimuskarinskog djelovanja, umeklidinijev bromid treba primjenjivati uz oprez u bolesnika s retencijom mokraće ili glaukomom uskog kuta.
English: Inhalation use.
Croatian: Za inhaliranje.
English: The probability of having an exacerbation in patients receiving Rolufta Ellipta at week 24 was 8.9% compared with 13.7% for placebo.
Croatian: Vjerojatnost pojave egzacerbacije nakon 24 tjedna iznosila je 8,9% u bolesnika liječenih lijekom Rolufta Ellipta te 13,7% u onih koji su primali placebo.
English: An approximately 1.4-fold increase in umeclidinium bromide AUC was observed.
Croatian: Primijećeno je povećanje AUC-a umeklidinijeva bromida za oko 1,4 puta.
English: Animal studies indicate no effects of umeclidinium bromide on fertility.
Croatian: Ispitivanja na životinjama nisu pokazala utjecaj umeklidinijeva bromida na plodnost.
English: It is unknown whether umeclidinium bromide is excreted in human milk.
Croatian: Nije poznato izlučuje li se umeklidinijev bromid u majčino mlijeko u ljudi.
English: GlaxoSmithKline Pharmaceuticals s.a./n.v.
Croatian: GlaxoSmithKline Pharmaceuticals s.a./n.v. Belgique/Belgien
English: No new adverse drug reactions were identified with the addition of Rolufta Ellipta to FF/VI in these studies.
Croatian: U tim ispitivanjima nisu identificirane nove nuspojave kod dodavanja lijeka Rolufta Ellipta kombinaciji FF/VI.
English: • taste disturbance.
Croatian: • poremećaj osjeta okusa.
English: Umeclidinium bromide has not been evaluated in subjects with severe hepatic impairment.
Croatian: Umeklidinijev bromid nije ispitivan u bolesnika s teškim oštećenjem jetrene funkcije.
English: Write the date the inhaler should be thrown away on the label in the space provided.
Croatian: Napišite datum kad je inhalator potrebno baciti u predviđeno mjesto na naljepnici.
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).
Croatian: Učestalosti dodijeljene nuspojavama navedenima u tablici obuhvaćaju grube stope incidencije iz četiriju ispitivanja djelotvornosti te ispitivanja dugoročne sigurnosti (u kojem je sudjelovalo
English: BATCH NUMBER
Croatian: BROJ SERIJE
English: GlaxoSmithKline Trading Services Limited, Currabinny, Carrigaline, County Cork, Ireland GlaxoSmithKline Trading Service Limited logo
Croatian: GlaxoSmithKline Trading Services Limited, Currabinny, Carrigaline, County Cork, Irska GlaxoSmithKline Trading Service Limited logo
English: Symptomatic outcomes
Croatian: Ishodi na simptome
English: EXP In use shelf-life: 6 weeks.
Croatian: EXP Rok valjanosti nakon otvaranja: 6 tjedana.
English: Multipack of 3 x 30 dose inhalers.
Croatian: Višestruko pakiranje s 3 inhalatora x 30 doza.
English: There is no relevant use of Rolufta Ellipta in the paediatric population (under 18 years of age) in the indication for COPD.
Croatian: Nema relevantne primjene lijeka Rolufta Ellipta u pedijatrijskoj populaciji (bolesnici mlađi od
English: Wait to open the cover until you are ready to inhale your dose.
Croatian: Otvorite poklopac tek onda kada ste spremni inhalirati Vašu dozu.
English: Do not use this medicine to relieve a sudden attack of breathlessness or wheezing.
Croatian: Ovaj se lijek ne smije primjenjivati za ublažavanje naglog napadaja nedostatka zraka ili piskanja pri disanju.
English: Inhalation powder, pre-dispensed.
Croatian: Prašak inhalata, dozirani.
English: GlaxoSmithKline Trading Services Limited, Currabinny, Carrigaline, County Cork, Ireland GlaxoSmithKline Trading Services Limited logo
Croatian: GlaxoSmithKline Trading Services Limited, Currabinny, Carrigaline, County Cork, Irska GlaxoSmithKline Trading Services Limited logo
English: At Week 52, a statistically significant improvement in the least-squares (LS) mean change from baseline in trough FEV1 was observed for FF/UMEC/VI compared with FF/VI (mean change: +94 mL vs. -3 mL; treatment difference: 97 mL; 95% CI: 85, 109; p<0.001).
Croatian: Statistički značajno poboljšanje srednje vrijednosti promjene najnižeg FEV1 od početka ispitivanja do 52. tjedna, dobivene metodom najmanjih kvadrata opaženo je za FF/UMEC/VI u usporedbi s FF/VI, (srednja vrijednost promjene: +94 ml u odnosu na -3 ml; razlika između liječenja: 97 ml; 95% CI: 85, 109; p<0,001).
English: ANNEX II
Croatian: PRILOG II.
English: Umeclidinium bromide is a substrate of cytochrome P450 2D6 (CYP2D6).
Croatian: Interakcije utemeljene na metabolizmu i prijenosnicima Umeklidinijev bromid je supstrat citokroma P450 2D6 (CYP2D6).
English: The tray contains a desiccant packet, to reduce moisture in the packaging.
Croatian: Podložak sadrži vrećicu sa sredstvom za sušenje, koje služi za smanjivanje količine vlage u pakiranju.
English: It is packaged in a foil laminate tray with a peelable foil lid.
Croatian: Zapakiran je u podložak od višeslojne folije s pokrovnom folijom koja se može odlijepiti.
English: The proportion of patients who responded with at least the MCID in SGRQ score (defined as a decrease of 4 units from baseline) at Week 12 was greater for Rolufta Ellipta 55 micrograms (44%) compared with placebo (26%) in the 12-week study.
Croatian: U 12-tjednom ispitivanju je udio bolesnika koji su nakon 12 tjedana postigli barem MCID u SGRQ rezultatu (definiran kao smanjenje za 4 boda od početne vrijednosti) bio veći kod primjene lijeka Rolufta Ellipta od 55 mikrograma (44%) u usporedbi s primjenom placeba (26%).
English: Tel.: + 48 (0)22 576 9000
Croatian: GSK Services Sp. z o.o. Tel.: + 48 (0)22 576 9000
English: The air vents should not be blocked with fingers during use.
Croatian: Nemojte prstima blokirati otvore za zrak tijekom primjene.
English: In the 24-week study treatment with Rolufta Ellipta, the mean (SD) change from baseline in the number of puffs of rescue salbutamol over the 24-week treatment period was -1.4 (0.20) for placebo and -1.7 (0.16) for Rolufta Ellipta (Difference = -0.3; 95% CI: -0.8, 0.2, p=0.276).
Croatian: U 24-tjednom ispitivanju primjene lijeka Rolufta, srednja (SD) promjena broja udisaja salbutamola za hitno ublažavanje simptoma tijekom 24-tjednog razdoblja liječenja u odnosu na početnu vrijednost iznosila je -1,4 (0,20) za placebo te -1,7 (0,16) za lijek Rolufta Ellipta (razlika = -0,3; 95% CI: -0,8; 0,2; p=0,276).
English: Your Rolufta Ellipta inhaler carton contains
Croatian: Vaša kutija s Rolufta Ellipta inhalatorom sadrži
English: No effect of verapamil was observed on umeclidinium bromide Cmax.
Croatian: Nije primijećen učinak na Cmax umeklidinijeva bromida.
English: PHARMACEUTICAL FORM
Croatian: FARMACEUTSKI PODACI
English: GlaxoSmithKline AB
Croatian: GlaxoSmithKline Kft.
English: The inhaler will be in the ‘closed' position when it is first taken out of its sealed tray.
Croatian: Kada se inhalator prvi puta izvadi iz zatvorenog podloška, nalazit će se u 'zatvorenom' položaju.
English: The mean peak improvements in FEV1 within the first 6 hours following dosing relative to placebo were 130 ml (p<0.001*) at Week 24.
Croatian: Nakon 24 tjedna, srednje poboljšanje vršne vrijednosti FEV1 unutar prvih 6 sati nakon primjene lijeka u odnosu na placebo iznosilo je 130 ml (p<0,001*).
English: Rolufta Ellipta demonstrated a statistically significant greater improvement from baseline in weighted mean FEV1 over 0-6 hours post-dose at Week 12 compared with placebo (166 ml, p<0.001) in the 12-week pivotal study.
Croatian: Lijek Rolufta Ellipta je postigao statistički značajno veće poboljšanje ponderirane srednje vrijednosti FEV1 u razdoblju od 0 do 6 sati nakon primjene doze u odnosu na početne vrijednosti u usporedbi s placebom nakon 12 tjedana (166 ml, p<0,001) u 12-tjednom ključnom ispitivanju.
English: The frequency of adverse reactions is defined using the following convention: very common (≥1/10);
Croatian: Učestalost nuspojava definirana je kao: vrlo često (≥ 1/10), često (≥ 1/100 i < 1/10), manje često
English: Absorption
Croatian: Apsorpcija
English: • itching • skin rash (hives) or redness
Croatian: • svrbež • kožni osip (koprivnjača) ili crvenilo
English: Read the package leaflet before use.
Croatian: Prije uporabe pročitajte uputu o lijeku.
English: MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE
Croatian: PROIZVOĐAČ(I) ODGOVORAN(NI) ZA PUŠTANJE SERIJE LIJEKA U PROMET
English: Contents of the pack and other information Step-by-step instructions for use
Croatian: Kako čuvati lijek Rolufta Ellipta 6. Sadržaj pakiranja i druge informacije Upute za primjenu korak po korak
English: The proportion of patients who responded with at least the minimum clinically important difference (MCID) of 1 unit TDI focal score at Week 12 was greater for Rolufta Ellipta (38%) compared with placebo (15%) in the 12-week study.
Croatian: U 12-tjednom ispitivanju je udio bolesnika koji su nakon 12 tjedana odgovorili barem najmanjom klinički važnom razlikom (engl. minimum clinically important difference, MCID) od 1 boda u ukupnom TDI rezultatu bio veći kod primjene lijeka Rolufta Ellipta (38%) u usporedbi s primjenom placeba (15%).
English: If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse.
Croatian: U slučaju bilo kakvih pitanja u vezi s primjenom ovoga lijeka, obratite se liječniku, ljekarniku ili medicinskoj sestri.
English: Rolufta Ellipta is for inhalation use.
Croatian: Rolufta Ellipta namijenjen je za inhalacijsku primjenu.
English: See section 4.8 for how to report adverse reactions.
Croatian: Za postupak prijavljivanja nuspojava vidjeti dio 4.8.
English: The mouthpiece should be placed between the lips and the lips should then be closed firmly around it.
Croatian: Stavite nastavak za usta između usana i čvrsto ga obujmite usnama.
English: NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER
Croatian: 11. NAZIV I ADRESA NOSITELJA ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET
English: Tel: + 46 (0)8 638 93 00 info.produkt@gsk.com
Croatian: GlaxoSmithKline AB Tel: + 46 (0)8 638 93 00 info.produkt@gsk.com
English: Constipation Dry mouth common Uncommon
Croatian: Poremećaji probavnog sustava konstipacija suha usta često manje često
English: Pack sizes of 7 and 30 dose inhaler.
Croatian: Veličine pakiranja: inhalator sa 7 i 30 doza.
English: Rolufta Ellipta 55 mcg inhalation powder umeclidinium (umeclidinium bromide)
Croatian: Rolufta Ellipta 55 μg prašak inhalata umeklidinij (umeklidinijev bromid)
English: Pharyngitis
Croatian: FARMACEUTSKI
English: Each delivered dose contains 55 micrograms umeclidinium (equivalent to 65 micrograms of umeclidinium bromide).
Croatian: Jedna primijenjena doza sadrži 55 mikrograma umeklidinija (što odgovara količini od 65 mikrograma umeklidinijeva bromida).
English: Do not open the tray until you are ready to start using your new inhaler.
Croatian: Inhalator je zapakiran u podložak - Nemojte otvarati podložak dok ne budete spremni početi koristiti svoj novi inhalator.
English: What Rolufta Ellipta is used for
Croatian: Za što se Rolufta Ellipta koristi
English: Similarly, a greater proportion of patients achieved at least the MCID for Rolufta Ellipta at Week 24 (44%) compared with placebo (34%) in the 24-week study.
Croatian: Slično tome, u 24-tjednom ispitivanju je nakon 24 tjedna veći udio bolesnika ostvario barem MCID kod primjene lijeka Rolufta Ellipta (44%) u usporedbi s primjenom placeba (34%).
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).
Croatian: Stopa omjera: 0,85; 95% CI:0,80, 0,90; p<0,001)
English: The “Discard by” date is 6 weeks from the date of opening the tray.
Croatian: Sredstvo za sušenje baciti je 6 tjedana od datuma otvaranja podloška.
English: Nervous system disorders
Croatian: Poremećaji dišnog sustava,
English: D. 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
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.
Croatian: Nakon peroralne primjene u zdravih muških ispitanika, ukupna radioaktivnost prvenstveno se izlučila u feces (92%
English: Rolufta Ellipta also demonstrated a statistically significant improvement in health-related quality of life measured using the St. George's Respiratory Questionnaire (SGRQ) as indicated by a reduction in SGRQ total score at Week 12 compared with placebo (-7.90 units, p<0.001) in the 12-week study.
Croatian: St. George's Respiratory Questionnaire, SGRQ), na što ukazuje smanjenje ukupnog SGRQ rezultata nakon 12 tjedana u usporedbi s placebom (-7,90 bodova, p<0,001) u 12-tjednom ispitivanju.
English: Fertility
Croatian: Plodnost
English: What Rolufta Ellipta is and what it is used for 2.
Croatian: Što je Rolufta Ellipta i za što se koristi
English: Other side effects
Croatian: Druge nuspojave
English: A. LABELLING
Croatian: OZNAČIVANJE
English: Each single inhalation provides a delivered dose (the dose leaving the mouthpiece) of 55 micrograms umeclidinium (equivalent to 65 micrograms of umeclidinium bromide).
Croatian: Jedna pojedinačna inhalacija osigurava primijenjenu dozu (doza koja izlazi iz nastavka za usta) od 55 mikrograma umeklidinija (što odgovara količini od 65 mikrograma umeklidinijeva bromida).
English: When the tray is opened, write the “Discard by” date on the inhaler label in the space provided.
Croatian: Kad se podložak otvori, napišite datum kad je lijek potrebno baciti u predviđeno mjesto na naljepnici inhalatora.
English: 1) Read this before you start If you open and close the cover without inhaling the medicine, you will lose the dose.
Croatian: Ako otvorite i zatvorite poklopac inhalatora bez inhaliranja lijeka, izgubit ćete dozu.
English: Gastrointestinal disorders
Croatian: Tablični prikaz nuspojava
English: NAME OF THE MARKETING AUTHORISATION HOLDER
Croatian: NAZIV NOSITELJA ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET
English: Cough
Croatian: KOPB
English: Similarly, a greater proportion of patients achieved ≥1 unit TDI focal score for Rolufta Ellipta (53%) compared with placebo (41%) at Week 24 in the 24-week study.
Croatian: Slično tome, u 24-tjednom ispitivanju je nakon 24 tjedna veći udio bolesnika ostvario ukupan TDI rezultat od ≥1 boda kod primjene lijeka Rolufta Ellipta (53%) u usporedbi s primjenom placeba (41%).
English: 1 inhaler of 7 doses.
Croatian: 30 doza1 inhalator sa 7 doza.
English: 24-Week Study Treatment difference1 95% Confidence interval p-value
Croatian: 24-tjedno ispitivanje Terapijska razlika1 95% interval pouzdanosti p-vrijednost naspram placeba µg = mikrogrami 1srednja vrijednost najmanjih kvadrata (95% interval pouzdanosti)
English: Discard by:
Croatian: Baciti nakon:
English: Rolufta Ellipta 55 micrograms inhalation powder, pre-dispensed umeclidinium (umeclidinium bromide)
Croatian: Rolufta Ellipta 55 mikrograma prašak inhalata, dozirani umeklidinij (umeklidinijev bromid)
English: Posology
Croatian: PRIMJENU
English: The inhaler should be held away from the mouth breathing out as far as is comfortable.
Croatian: Držite inhalator dalje od usta i izdahnite koliko možete, do granice neugode.
English: • headache
Croatian: • kašalj
English: If you forget to use Rolufta Ellipta 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: • Blurred vision
Croatian: • zamagljen vid
English: The tray contains a desiccant sachet, to reduce moisture.
Croatian: Podložak sadrži vrećicu sa sredstvom za sušenje radi smanjenja vlage.
English: Rolufta Ellipta is for inhalation use only.
Croatian: Rolufta Ellipta se primjenjuje isključivo putem inhalacije.
English: • rash
Croatian: • osip
English: Desiccant
Croatian: Nuspojave
English: In both of the pivotal 12-week and 24-week studies, Rolufta Ellipta demonstrated statistically significant and clinically meaningful improvements in lung function (as defined by change from baseline trough FEV1 at Week 12 and Week 24 respectively, which was the primary efficacy endpoint in each study) compared with placebo (see Table 1).
Croatian: U oba ključna ispitivanja u trajanju od 12 tjedana i 24 tjedna lijek Rolufta Ellipta je postigao statistički značajna i klinički važna poboljšanja plućne funkcije (definirana promjenom najniže vrijednosti FEV1
English: A greater improvement compared with placebo in the change from baseline in SGRQ total score at Week 24 was demonstrated for Rolufta Ellipta (-4.69 units, p<0.001∗) in the 24-week study.
Croatian: Lijek Rolufta Ellipta je doveo do većeg poboljšanja promjene ukupnog SGRQ rezultata u odnosu na početne vrijednosti u usporedbi s placebom nakon 24 tjedna (-4,69 bodova, p<0,001*) u 24-tjednom ispitivanju.
English: Cardiovascular effects, such as cardiac arrhythmias e.g. atrial fibrillation and tachycardia, may be seen after the administration of muscarinic receptor antagonists including umeclidinium bromide.
Croatian: Nakon primjene antagonista muskarinskih receptora, uključujući umeklidinijev bromid, mogu nastupiti kardiovaskularni učinci poput srčanih aritmija, npr. fibrilacije atrija i tahikardije.
English: The tray is sealed with a peelable foil lid.
Croatian: Podložak je zatvoren pokrovnom folijom koja se može odlijepiti.
English: Package leaflet: Information for the user Rolufta Ellipta 55 micrograms inhalation powder, pre-dispensed umeclidinium (umeclidinium bromide) This medicine is subject to additional monitoring.
Croatian: Uputa o lijeku: Informacije za korisnika Rolufta Ellipta 55 mikrograma prašak inhalata, dozirani umeklidinij (umeklidinijev bromid)
English: Method of administration
Croatian: Način primjene
English: Table 1: Trough FEV1 (ml) at Week 12 and Week 24 (primary endpoint) Treatment with Rolufta Ellipta 55 mcg
Croatian: Tablica 1: Najniža vrijednost FEV1 (ml) nakon 12 i 24 tjedna (primarna mjera ishoda)