natgillin/translations-raw huggingface dataset:
In IMPACT, over 52 weeks, Trelegy Ellipta significantly reduced (p<0.001) the annual rate of moderate/severe exacerbations by 15% (95% CI:10, 20) compared with FF/VI (rate; 0.91 vs 1.07 events per patient year) and by 25% (95% CI: 19, 30) compared with UMEC/VI (rate; 0.91 vs 1.21 events per patient year).
U ispitivanju IMPACT, Trelegy Ellipta je tijekom 52 tjedna značajno smanjio (p < 0,001) godišnju stopu umjerenih/teških egzacerbacija za 15% (95% CI: 10; 20) u odnosu na FF/VI (stopa: 0,91 naspram 1,07 događaja po bolesnik-godini) te za 25% (95% CI: 19; 30) u odnosu na UMEK/VI (stopa: 0,91 naspram 1,21 događaj po bolesnik-godini).
Following repeat dosing of inhaled fluticasone furoate /vilanterol, steady state was achieved within 6 days with up to 1.6-fold accumulation
Nakon inhalacije ponovljenih doza flutikazonfuroata/vilanterola, stanje dinamičke ravnoteže postignuto je unutar 6 dana, s kumulacijom do 1,6 puta.
• faster heart beat
• ubrzani otkucaji srca
If you stop using Trelegy Ellipta
Ako prestanete primjenjivati Trelegy Ellipta
FULFIL (CTT116853) was a 24-week study (N=1,810), with an extension up to 52 weeks in a subset of subjects (n=430), that compared Trelegy Ellipta (92/55/22 micrograms) with budesonide/formoterol 400/12 micrograms (BUD/FOR) administered twice-daily.
Ispitivanje FULFIL (CTT116853) bilo je 24-tjedno ispitivanje (N = 1810) koje je u jednoj podskupini ispitanika (n = 430) bilo produženo do 52 tjedna i u kojem se Trelegy Ellipta (92/55/22 mikrograma) uspoređivao se s budezonidom/formoterolom u dozi od 400/12 mikrograma (BUD/FOR) primijenjenim dvaput na dan.
If you forget to use Trelegy Ellipta
Ako ste zaboravili primijeniti Trelegy Ellipta
Elderly patients
Posebne populacije Stariji bolesnici
The “Discard by” date is 6 weeks from the date of opening the tray.
Datum kada lijek treba baciti je 6 tjedana nakon datuma otvaranja podloška.
In a 52-week study, with a total of 10,355 patients with COPD and a history of moderate or severe exacerbations within the prior 12 months (mean post-bronchodilator screening FEV1 46% of predicted, SD 15%) (study CTT116855), the incidence of pneumonia was 8% (317 patients) for Trelegy Ellipta (n = 4,151), 7% (292 subjects) for fluticasone furoate/vilanterol (n = 4,134), and 5% (97 subjects) for umeclidinium/vilanterol (n = 2,070).
U 52-tjednom ispitivanju koje je obuhvatilo ukupno 10 355 bolesnika s KOPB-om i umjerenim ili teškim egzacerbacijama unutar proteklih 12 mjeseci (srednja vrijednost FEV1 nakon primjene bronhodilatatora pri probiru: 46% predviđene vrijednosti; standardno odstupanje: 15%) (ispitivanje CTT116855), incidencija pneumonije iznosila je 8% (317 bolesnika) uz Trelegy Ellipta (n = 4151), 7% (292 ispitanika) uz flutikazonfuroat/vilanterol (n = 4134) te 5% (97 ispitanika) uz umeklidinij/vilanterol (n = 2070).
Hypersensitivity to the active substances or to any of the excipients listed in section 6.1.
Preosjetljivost na djelatne tvari ili neku od pomoćnih tvari navedenih u dijelu 6.1. 4.4 Posebna upozorenja i mjere opreza pri uporabi Astma
FEV1=forced expiratory volume in 1 second; L=litres; LS=least squares; SE= standard error, N=number in the intent-totreat population; CI= confidence interval, a Statistically significant treatment difference for FF/UMEC/VI vs. BUD/FOR also observed at the other assessment timepoints (weeks 2, 4 and 12).
FEV1 (forced expiratory volume in 1 second) = forsirani izdisajni volumen u 1 sekundi; l = litra; LS (least squares) = metoda najmanjih kvadrata; SE (standard error) = standardna pogreška, N = broj bolesnika u populaciji predviđenoj za liječenje; CI (confidence interval) = interval pouzdanosti.
IMPACT (CTT116855) was a 52-week study (N=10,355) that compared Trelegy Ellipta (92/55/22 micrograms) with fluticasone furoate/vilanterol 92/22 micrograms (FF/VI) and umeclidinium/vilanterol 55/22 micrograms (UMEC/VI).
Ispitivanje IMPACT (CTT116855) bilo je 52-tjedno ispitivanje (N = 10 355) u kojem se Trelegy Ellipta (92/55/22 mikrograma) uspoređivao s flutikazonfuroatom/vilanterolom u dozi od 92/22 mikrograma (FF/VI) i umeklidinijem/vilanterolom u dozi od 55/22 mikrograma (UMEK/VI).
Supraventricular tachyarrhythmia Tachycardia
Srčani poremećaji supraventrikularna tahiaritmija tahikardija fibrilacija atrija manje često
Trough FEV1 (L) at Week 52, LS mean change from baseline (SE) a
Najniža vrijednost FEV1 (l) u 52. tjednu, srednja vrijednost promjene (LS) od početne vrijednosti
The proportion of responders during weeks 21-24 was significantly higher (p<0.001) for patients treated with Trelegy Ellipta compared with BUD/FOR (47% and 37% respectively; OR 1.59; 95% CI: 1.30, 1.94).
Udio bolesnika s odgovorom tijekom razdoblja od 21. do 24. tjedna bio je značajno veći (p < 0,001) uz Trelegy Ellipta nego uz BUD/FOR (47% odnosno 37%; OR 1,59; 95% CI: 1,30; 1,94).
An increase in the incidence of pneumonia, including pneumonia requiring hospitalisation, has been observed in patients with COPD receiving inhaled corticosteroids.
U bolesnika s KOPB-om koji su primali inhalacijske kortikosteroide zabilježeno je povećanje incidencije pneumonije, uključujući pneumoniju koja je zahtijevala hospitalizaciju.
ONCE DAILY
Za inhaliranje, JEDANPUT NA DAN
Trough FEV1 (L) at Week 24, LS mean change from baseline (SE)a
Najniža vrijednost FEV1 (l) u 24. tjednu, srednja vrijednost promjene (LS) od početne vrijednosti (SE)a
Systemic drug levels (steady state Cmax and AUC) of FF, UMEC and VI following FF/UMEC/VI in one inhaler (triple combination) were within the range of those observed following FF/VI + UMEC as two inhalers, dual combinations (FF/VI and UMEC/VI), as well as individual single inhalers (FF, UMEC and VI).
Sistemske razine (Cmax i AUC u stanju dinamičke ravnoteže) flutikazonfuroata, umeklidinija i vilanterola nakon primjene kombinacije FF/UMEK/VI u jednom inhalatoru (trojna kombinacija) bile su unutar raspona razina opaženih nakon primjene kombinacije FF/VI + UMEK dvama inhalatorima,
In FULFIL, Trelegy Ellipta improved daily symptoms of COPD as assessed by E-RS: COPD total score, compared with BUD/FOR (≥2 unit decrease from baseline).
Evaluating Respiratory Symptoms in COPD, E-RS:COPD) u odnosu na BUD/FOR (smanjenje početnog rezultata za ≥ 2 jedinice).
The inhaler will be in the ‘closed' position when it is first taken out of its sealed tray.
Kada se inhalator prvi puta izvadi iz zatvorenog podloška, nalazi se u 'zatvorenom' položaju.
Trelegy Ellipta should be used with caution in patients with narrow-angle glaucoma or urinary retention.
Trelegy Ellipta treba primjenjivati uz oprez u bolesnika s glaukomom uskog kuta ili retencijom mokraće.
Following intravenous administration of umeclidinium to healthy volunteers, the mean volume of distribution was 86 litres.
Nakon intravenske primjene umeklidinija u zdravih ispitanika, srednja vrijednost volumena distribucije iznosila je 86 litara.
However, studies have been conducted with fluticasone furoate/vilanterol and umeclidinium/vilanterol.
Međutim, provedena su ispitivanja s flutikazonfuroatom/vilanterolom te umeklidinijem/vilanterolom.
In FULFIL the proportion of responders according to TDI (defined as at least 1 unit) was significantly higher (p<0.001) for Trelegy Ellipta compared with BUD/FOR (61% vs 51%; OR 1.61; 95% CI: 1.33, 1.95).
U ispitivanju FULFIL, udio bolesnika koji su postigli odgovor prema TDI rezultatu (koji se definirao kao najmanje 1 jedinica) bio je značajno veći (p < 0,001) uz Trelegy Ellipta nego uz BUD/FOR (61% naspram 51%; OR 1,61; 95% CI: 1,33; 1,95).
MARKETING AUTHORISATION NUMBER(S) EU/1/17/1236/001
12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/17/1236/001
Do not open the tray until you are ready to inhale a dose of your medicine.
Nemojte otvarati podložak dok ne budete spremni inhalirati dozu lijeka.
The second study included safety data from 527 patients with COPD who received fluticasone furoate/umeclidinium/vilanterol (92/55/22 micrograms) and 528 patients with COPD who received fluticasone furoate/vilanterol (92/22 micrograms) + umeclidinium (55 micrograms) once daily for up to 24 weeks (study 200812).
U drugom su se ispitivanju podaci o sigurnosti prikupljali u 527 bolesnika s KOPB-om koji su primali flutikazonfuroat/umeklidinij/vilanterol (92/55/22 mikrograma) i 528 bolesnika s KOPB-om koji su primali flutikazonfuroat/vilanterol (92/22 mikrograma) + umeklidinij (55 mikrograma) jedanput na dan tijekom najviše 24 tjedna (ispitivanje 200812).
When given subcutaneously there were no effects at exposures 62-fold the human clinical exposure at a daily dose of 22 micrograms, based on AUC.
Kod supkutane primjene nisu primijećeni učinci pri izloženosti 62 puta većoj od kliničke izloženosti u ljudi nakon primjene dnevne doze od 22 mikrograma, što je utvrđeno na temelju AUC-a.
In IMPACT, Trelegy Ellipta statistically significantly reduced the mean number of nighttime awakenings due to COPD compared with FF/VI (-0.05; 95% CI: -0.08, -0.01; p=0.005) and with UMEC/VI (-0.10; 95% CI: -0.14, -0.05; p<0.001) at weeks 49 to 52.
Buđenje noću U ispitivanju IMPACT, Trelegy Ellipta statistički je značajno smanjio srednju vrijednost broja buđenja noću zbog KOPB-a u odnosu na FF/VI (-0,05; 95% CI: -0,08; -0,01; p = 0,005) i UMEK/VI (-0,10; 95% CI: -0,14; -0,05; p < 0,001) između 49. i 52. tjedna.
Vilanterol had no adverse effect on preor post-natal development in rats.
Vilanterol nije imao štetnih učinaka na prenatalni ni postnatalni razvoj štakora.
The step-by-step instructions for use of the inhaler provided below can be used for either the 30-dose (30 day supply) or the 14-dose (14 day supply) Ellipta inhaler.
Upute za uporabu inhalatora korak po korak prikazane u nastavku odnose se i na inhalator s 30 doza (terapija za 30 dana) i na inhalator s 14 doza (terapija za 14 dana).
NAME OF THE MEDICINAL PRODUCT Trelegy Ellipta 92 micrograms/55 micrograms/22 micrograms inhalation powder, pre-dispensed
NAZIV LIJEKA Trelegy Ellipta 92 mikrograma/55 mikrograma/22 mikrograma prašak inhalata, dozirani
Warnings and precautions
(naveden u dijelu 6.) Upozorenja i mjere opreza
Trelegy Ellipta significantly improved (p<0.001) Health Related Quality of Life (as measured by the St George's Respiratory Questionnaire [SGRQ] total score) in both FULFIL (week 24) when compared with BUD/FOR (-2.2 units; 95% CI: -3.5, -1.0) and IMPACT (week 52) when compared with FF/VI (-1.8 units; 95% CI: -2.4, -1.1) and UMEC/VI (-1.8 units; 95% CI: -2.6, -1.0).
St. George's Respiratory Questionnaire, SGRQ]) i u ispitivanju FULFIL (24. tjedan) u usporedbi s kombinacijom BUD/FOR (-2,2 jedinice; 95% CI: -3,5; -1,0) i u ispitivanju IMPACT (52. tjedan) u usporedbi s kombinacijom FF/VI (-1,8 jedinica; 95% CI: -2,4; -1,1) i UMEK/VI (-1,8 jedinica; 95% CI: -2,6; -1,0).
Fluticasone furoate/umeclidinium/vilanterol is a combination of inhaled synthetic corticosteroid, long-acting muscarinic receptor antagonist and long-acting beta2-adrenergic agonist (ICS/LAMA/LABA).
Flutikazonfuroat/umeklidinij/vilanterol je kombinacija inhalacijskog sintetičkog kortikosteroida, dugodjelujućeg antagonista muskarinskih receptora (engl. long-acting muscarinic receptor antagonist,
The third study included safety data from 4,151 patients with COPD who received fluticasone furoate/umeclidinium/vilanterol 92/55/22 micrograms once daily for up to 52 weeks, with two active comparators (study CTT116855, IMPACT).
U trećem su se ispitivanju podaci o sigurnosti prikupljali u 4151 bolesnika s KOPB-om koji je primao flutikazonfuroat/umeklidinij/vilanterol u dozi od 92/55/22 mikrograma jedanput na dan tijekom najviše 52 tjedna; ispitivanje je uključivalo dva aktivna usporedna lijeka (ispitivanje CTT116855, IMPACT).
No clinically relevant effects on the QTc interval were observed on review of centrally read ECGs from 911 subjects with COPD exposed to fluticasone furoate/umeclidinium/vilanterol for up to 24 weeks, or in the subset of 210 subjects exposed for up to 52 weeks.
911 ispitanika s KOPB-om izloženih flutikazonfuroatu/umeklidiniju/vilanterolu do 24 tjedna niti u podskupini od 210 ispitanika koji su toj kombinaciji bili izloženi do 52 tjedna.
No clinically relevant differences requiring dose adjustment based on race, gender or weight were observed in fluticasone furoate, umeclidinium or vilanterol systemic exposure.
Nisu opažene klinički važne razlike u sistemskoj izloženosti flutikazonfuroatu, umeklidiniju ili vilanterolu koje bi zahtijevale prilagodbu doze na temelju rase, spola ili tjelesne težine.
There is no relevant use of Trelegy Ellipta in the paediatric population (under 18 years of age) for the indication of COPD.
Nema relevantne primjene lijeka Trelegy Ellipta u pedijatrijskoj populaciji (bolesnici mlađi od
In IMPACT, Trelegy Ellipta prolonged the time to first moderate/severe exacerbation and significantly decreased (p<0.001) the risk of a moderate/severe exacerbation, as measured by time to first exacerbation, compared with both FF/VI (14.8%; 95% CI: 9.3, 19.9) and UMEC/VI (16.0%; 95% CI: 9.4, 22.1).
U ispitivanju IMPACT, Trelegy Ellipta produljio je vrijeme do prve umjerene/teške egzacerbacije te je značajno smanjio (p < 0,001) rizik od umjerene/teške egzacerbacije, mjeren vremenom do prve egzacerbacije, i u odnosu na FF/VI (14,8%; 95% CI: 9,3; 19,9) i u odnosu na UMEK/VI (16,0%;
The tray contains a desiccant sachet, to reduce moisture in the packaging.
Podložak sadrži vrećicu sa sredstvom za sušenje, koje služi za smanjivanje količine vlage u pakiranju.
The mouthpiece should be placed between the lips and the lips should then be closed firmly around it.
Stavite nastavak za usta među usne i čvrsto ga obujmite usnama.
There was no effect of race on pharmacokinetic parametersof umeclidinium or vilanterol in subjects with COPD.
Rasa ispitanika nije utjecala na farmakokinetičke parametre umeklidinija ili vilanterola u ispitanika s KOPB-om.
The dose counter will appear completely red if the cover is opened again.
Ako se poklopac ponovno otvori, brojač doza će postati potpuno crven.
Wait to open the cover until you are ready to take your dose.
Otvorite poklopac tek onda kada ste spremni uzeti dozu.
Multipack of 90 (3 packs of 30) dose inhalers.
Višestruko pakiranje: inhalatori s 90 (3 pakiranja s 30) doza.
Symptom Relief
Ublažavanje simptoma
Don't use Trelegy Ellipta: - if you are allergic to fluticasone furoate, umeclidinium, vilanterol or any of the other ingredients of this medicine (listed in section 6).
- ako ste alergični na flutikazonfuroat, umeklidinij, vilanterol ili neki drugi sastojak ovoga lijeka
However, other corticosteroids, muscarinic antagonists and beta2-adrenergic agonists are detected in human milk.
Međutim, u majčinu su mlijeku otkriveni drugi kortikosteroidi, muskarinski antagonisti i beta2-adrenergički agonisti.
The first study included safety data from 911 patients with COPD who received fluticasone furoate/umeclidinium/vilanterol 92/55/22 micrograms, once daily, for up to 24 weeks, of whom 210 patients received fluticasone furoate/umeclidinium/vilanterol 92/55/22 micrograms once daily for up to 52 weeks, with an active comparator (study CTT116853, FULFIL).
U prvom su se ispitivanju podaci o sigurnosti prikupljali u 911 bolesnika s KOPB-om koji su primali flutikazonfuroat/umeklidinij/vilanterol u dozi od 92/55/22 mikrograma jedanput na dan tijekom najviše 24 tjedna, od kojih je njih 210 primalo flutikazonfuroat/umeklidinij/vilanterol u dozi od 92/55/22 mikrograma jedanput na dan tijekom najviše 52 tjedna; ispitivanje je uključivalo aktivan usporedni lijek (ispitivanje CTT116853, FULFIL).
MARKETING AUTHORISATION NUMBER(S) EU/1/17/1236/003
12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/17/1236/003
Trelegy Ellipta 92 micrograms/55 micrograms/22 micrograms inhalation powder, pre-dispensed fluticasone furoate/umeclidinium/vilanterol
Trelegy Ellipta 92 mikrograma/55 mikrograma/22 mikrograma prašak inhalata, dozirani flutikazonfuroat/umeklidinij/vilanterol
In FULFIL, bronchodilatory effects with Trelegy Ellipta were evident on the first day of treatment and were maintained over the 24-week treatment period (mean changes from baseline in FEV1 were 90-222 mL on day 1 and 160-339 mL at week 24).
FEV1 u odnosu na početnu vrijednost iznosila je 90 - 222 ml prvog dana te 160 - 339 ml u 24. tjednu).
What Trelegy Ellipta contains The active substances are fluticasone furoate, umeclidinium bromide and vilanterol.
Djelatne tvari su flutikazonfuroat, umeklidinijev bromid i vilanterol.
Pharmacological and toxicological effects seen with fluticasone furoate, umeclidinium or vilanterol in nonclinical studies were those typically associated with glucocorticoids, muscarinic receptor antagonists, or beta2-adrenergic receptor agonists.
Farmakološki i toksikološki učinci zabilježeni kod primjene flutikazonfuroata, umeklidinija ili vilanterola u nekliničkim ispitivanjima bili su oni koji se tipično povezuju s glukokortikoidima,
NAME OF THE MEDICINAL PRODUCT Trelegy Ellipta 92/55/22 mcg inhalation powder fluticasone furoate/umeclidinium/vilanterol
Trelegy Ellipta 92/55/22 µg prašak inhalata Fluticasone furoate/Umeclidinium/Vilanterol
Following inhaled administration of fluticasone furoate/umeclidinium/vilanterol in healthy subjects, vilanterol Cmax occurred at 7 minutes.
Nakon inhalacijske primjene flutikazonfuroata/umeklidinija/vilanterola u zdravih ispitanika, vilanterol je dosegnuo Cmax nakon 7 minuta.
The desiccant sachet should be thrown away and it should not be opened, eaten or inhaled.
Vrećicu sa sredstvom za sušenje treba baciti; njezin se sadržaj ne smije otvoriti,
At weeks 49-52, the treatment difference was -0.28 (95% CI: -0.37, -0.19) when compared with FF/VI and -0.30 (95% CI: -0.41, -0.19) with UMEC/VI.
Razlika između liječenja u razdoblju od 49. do 52. tjedna iznosila je -0,28 (95% CI: -0,37; -0,19) u odnosu na FF/VI te -0,30 (95% CI: -0,41; -0,19) u odnosu na UMEK/VI.
In vitro studies showed that fluticasone furoate is primarily metabolised by cytochrome P450 3A4 (CYP3A4) and is a substrate for the P-gp transporter.
Ispitivanja in vitro pokazala su da se flutikazonfuroat prvenstveno metabolizira posredstvom izoenzima 3A4 citokroma P450 (CYP3A4) i da je supstrat prijenosnika P-gp-a.
Based on the magnitude of these changes, no clinically relevant drug interaction is expected when fluticasone furoate/umeclidinium/vilanterol is co-administered with CYP2D6 inhibitors or when administered to patients who are genetically deficient in CYP2D6 activity (poor metabolisers).
CYP2D6 niti pri primjeni flutikazonfuroata/umeklidinija/vilanterola u bolesnika s genetski nedostatnom aktivnošću CYP2D6 (spori metabolizatori).
In vitro studies showed that vilanterol is primarily metabolised by cytochrome P450 3A4 (CYP3A4) and is a substrate for the P-gp transporter.
Ispitivanja in vitro pokazala su da se vilanterol prvenstveno metabolizira posredstvom izoenzima 3A4 citokroma P450 (CYP3A4) i da je supstrat prijenosnika P-gp-a.
Cardiovascular effects, such as cardiac arrhythmias, e.g. atrial fibrillation and tachycardia, may be seen after the administration of muscarinic receptor antagonists and sympathomimetics, including umeclidinium and vilanterol, respectively.
Nakon primjene antagonista muskarinskih receptora i simpatomimetika, uključujući umeklidinij i vilanterol, mogu nastupiti kardiovaskularni učinci poput srčanih aritmija, npr. fibrilacije atrija i tahikardije.
Following inhaled administration of fluticasone furoate/umeclidinium/vilanterol in healthy subjects, fluticasone furoate Cmax occurred at 15 minutes.
Nakon inhalacijske primjene flutikazonfuroata/umeklidinija/vilanterola u zdravih ispitanika, flutikazonfuroat je dosegnuo Cmax nakon 15 minuta.
Comparison Trelegy vs. UMEC/VI
Trelegy u odnosu na UMEK/VI
Each delivered dose contains 92 micrograms of fluticasone furoate, 55 micrograms of umeclidinium (equivalent to 65 micrograms umeclidinium bromide) and 22 micrograms of vilanterol (as trifenatate).
Jedna isporučena doza sadrži 92 mikrograma flutikazonfuroata, 55 mikrograma umeklidinija (što odgovara količini od 65 mikrograma umeklidinijeva bromida) i 22 mikrograma vilanterola (u obliku trifenatata).
The effect of fluticasone furoate/umeclidinium/vilanterol has not been evaluated in subjects with hepatic impairment.
Učinak flutikazonfuroata/umeklidinija/vilanterola nije se ocjenjivao u ispitanika s oštećenjem jetrene funkcije.
What Trelegy Ellipta is used for
Za što se Trelegy Ellipta koristi
How to store Trelegy Ellipta
Kako primjenjivati Trelegy Ellipta
In IMPACT, the proportion of responders was also significantly higher (p<0.001) for Trelegy Ellipta (36%) compared with FF/VI (29%; OR 1.36; 95% CI: 1.19, 1.55) and UMEC/VI (30%; OR 1.33; 95% CI: 1.13, 1.57).
FF/VI (29%; OR 1,36; 95% CI: 1,19; 1,55) i UMEK/VI (30%; OR 1,33; 95% CI: 1,13; 1,57).
In vitro studies showed that umeclidinium is primarily metabolised by cytochrome P450 2D6 (CYP2D6) and is a substrate for the P-gp transporter.
Ispitivanja in vitro pokazala su da se umeklidinij prvenstveno metabolizira posredstvom izoenzima 2D6 citokroma P450 (CYP2D6) i da je supstrat prijenosnika P-gp-a.
Package leaflet: Information for the patient Trelegy Ellipta 92 micrograms/55 micrograms/22 micrograms inhalation powder, pre-dispensed fluticasone furoate/umeclidinium/vilanterol
Uputa o lijeku: Informacije za bolesnika Trelegy Ellipta 92 mikrograma/55 mikrograma/22 mikrograma prašak inhalata, dozirani flutikazonfuroat/umeklidinij/vilanterol
Use of Rescue Medication
NAČIN PRIMJENE LIJEKA
What Trelegy Ellipta is
Što je Trelegy Ellipta
4) Close the inhaler and rinse your mouth
4) Zatvorite inhalator i isperite usta • Povucite poklopac prema gore koliko ide kako biste prekrili nastavak za usta.
PHARMACEUTICAL FORM AND CONTENTS Inhalation powder, pre-dispensed.
Prašak inhalata, dozirani.
c) Close the inhaler and rinse your mouth
c) Zatvorite inhalator i isperite usta Povucite poklopac prema gore koliko ide kako biste prekrili nastavak za usta.
Dry mouth
Sredstvo za sušenje
The “Discard by” date should be written on the inhaler label and carton in the space provided.
Datum kada lijek treba baciti treba napisati na za to predviđeno mjesto na naljepnici inhalatora i kutiji.
Following inhaled administration of fluticasone furoate/umeclidinium/vilanterol in healthy subjects, umeclidinium Cmax occurred at 5 minutes.
Nakon inhalacijske primjene flutikazonfuroata/umeklidinija/vilanterola u zdravih ispitanika, umeklidinij je dosegnuo Cmax nakon 5 minuta.
The tray contains a desiccant sachet, to reduce moisture.
Podložak sadrži vrećicu sa sredstvom za sušenje radi smanjivanja vlage.
Umeclidinium was not genotoxic in a standard battery of studies and was not carcinogenic in lifetime inhalation studies in mice or rats at exposures ≥ 20- or ≥ 17- fold the human clinical exposure at a daily dose of 55 micrograms umeclidinium, based on AUC respectively.
Umeklidinij se nije pokazao genotoksičnim u standardnom skupu ispitivanja niti kancerogenim u ispitivanjima cjeloživotne inhalacije na miševima odnosno štakorima pri razinama izloženosti
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Trelegy Ellipta 92 /55 /22 mcg inhalation powder fluticasone furoate/umeclidinium/vilanterol
NAZIV LIJEKA I PUT(EVI) PRIMJENE LIJEKA Trelegy Ellipta 92/55/22 µg prašak inhalata Fluticasone furoate/Umeclidinium/Vilanterol
In a pre- and post-natal study, subcutaneous administration of umeclidinium 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 61-fold the human clinical exposure of umeclidinium at a daily dose of 55 micrograms, based on AUC).
U prenatalnom i postnatalnom ispitivanju supkutana primjena umeklidinija u štakora 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
• itchy, runny or blocked nose
• svrbež nosa, curenje iz nosa ili začepljen nos
• inflammation of the sinuses
• upala sinusa
There was no increase in tumour incidence in rats or mice at exposures 0.9- or 22-fold, respectively, the human clinical exposure of vilanterol at a daily dose of 22 micrograms based on AUC.
0,9 odnosno 22 puta veće od kliničke izloženosti u ljudi nakon primjene dnevne doze vilanterola od 22 mikrograma, što je utvrđeno na temelju AUC-a.