natgillin/translations-raw huggingface dataset:
In FULFIL, Trelegy Ellipta significantly reduced (p<0.001) the use of rescue medication between weeks 1-24 compared with BUD/FOR (treatment difference: -0.2 occasions per day; 95% CI: -0.3, -0.1).
V študiji FULFIL je zdravilo Trelegy Ellipta med 1. in 24. tednom značilno bolj zmanjšalo (p < 0,001) uporabo rešilnega zdravila kot BUD/FOR (razlika med zdravljenjema: -0,2 dogodka na dan; 95 % IZ: -0,3,
c) Close the inhaler and rinse your mouth
c) Bolnik naj zapre inhalator in si splakne usta
Fatal pneumonia occurred in 12 of 4,151 patients (3.5 per 1,000 patientyears) receiving Trelegy Ellipta, 5 of 4,134 patients (1.7 per 1,000 patient-years) receiving fluticasone furoate/vilanterol, and 5 of 2,070 patients (2.9 per 1,000 patient-years) receiving umeclidinium/vilanterol.
ki so prejemali zdravilo Trelegy Ellipta, pri 5 od 4134 bolnikov (1,7 na 1000 bolnik-let), ki so prejemali kombinacijo flutikazonfuroat/vilanterol in pri 5 od 2070 bolnikov (2,9 na 1000 bolnik-let), ki so prejemali kombinacijo umeklidinij/vilanterol.
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.
Spodaj navedena navodila po korakih za uporabo inhalatorja veljajo tako za inhalator Ellipta s 30 odmerki (30-dnevna zaloga) kot za inhalator Ellipta s 14 odmerki (14-dnevna zaloga).
In FULFIL, Trelegy Ellipta significantly decreased the risk of a moderate/severe exacerbation compared with BUD/FOR over 24 weeks (33%; 95% CI: 12, 48; p=0.004).
V študiji FULFIL je zdravilo Trelegy Ellipta značilno zmanjšalo tveganje za zmerno ali hudo poslabšanje v primerjavi z BUD/FOR v 24 tednih (33 %; 95 % IZ: 12, 48; p = 0,004).
Trelegy Ellipta contains lactose
Zdravilo Trelegy Ellipta vsebuje laktozo
There are no data on the effects of fluticasone furoate/umeclidinium/vilanterol on human fertility.
Podatkov o vplivu kombinacije flutikazonfuroat/umeklidinij/vilanterol na plodnost pri človeku ni.
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).
V študiji IMPACT je zdravilo Trelegy Ellipta podaljšalo čas do prvega zmernega ali hudega poslabšanja in značilno zmanjšalo (p < 0,001) tveganje za zmerno ali hudo poslabšanje, merjeno s časom do prvega poslabšanja, tako v primerjavi s FF/VI (14,8 %; 95 % IZ: 9,3, 19,9) kot z UMEC/VI (16,0 %; 95% IZ: 9,4,
There is no specific treatment for an overdose with Trelegy Ellipta.
Za preveliko odmerjanje zdravila Trelegy Ellipta ni specifičnega zdravljenja.
If you are breast-feeding, you must check with your doctor before you use Trelegy Ellipta.
Če dojite, se morate pred uporabo zdravila Trelegy Ellipta posvetovati z zdravnikom.
The European Medicines Agency has waived the obligation to submit the results of studies with Trelegy Ellipta in all subsets of the paediatric population in COPD (see section 4.2 for information on paediatric use).
Ellipta za vse podskupine pediatrične populacije pri KOPB (za podatke o uporabi pri pediatrični populaciji glejte poglavje 4.2).
Your Trelegy Ellipta inhaler carton contains
Škatla vašega inhalatorja Trelegy Ellipta vsebuje
Co-administration of Trelegy Ellipta with other long-acting muscarinic antagonists or long-acting beta2adrenergic agonists has not been studied and is not recommended as it may potentiate the adverse reactions (see section 4.8 and section 4.9).
Druge dolgodelujoče antimuskarinske učinkovine in dolgodelujoči agonisti adrenergičnih receptorjev beta2 Sočasna uporaba zdravila Trelegy Ellipta z drugimi dolgodelujočimi muskarinskimi antagonisti ali dolgodelujočimi agonisti adrenergičnih receptorjev beta2 ni raziskana in ni priporočljiva, ker lahko poveča neželene učinke (glejte poglavji 4.8 in 4.9).
Comparison Trelegy vs. UMEC/VI
Primerjava zdravila Trelegy z UMEC/VI
However, other corticosteroids, muscarinic antagonists and beta2-adrenergic agonists are detected in human milk.
Vendar so v materinem mleku ugotovili druge kortikosteroide, muskarinske antagoniste in agoniste adrenergičnih receptorjev beta2.
Trelegy Ellipta should be used with caution in patients with moderate to severe hepatic impairment (see sections 4.4 and 5.2).
Pri bolnikih z zmerno do hudo okvaro jeter je treba zdravilo Trelegy Ellipta uporabljati previdno (glejte poglavji 4.4 in 5.2).
Study 200812 was a 24-week, non-inferiority study (N=1,055) that compared Trelegy Ellipta (92/55/22 micrograms) with FF/VI (92/22 micrograms) + UMEC (55 micrograms), co-administered once daily as a multi-inhaler therapy in patients with a history of moderate or severe exacerbations within the prior 12 months.
Študija 200812 je bila 24 tednov trajajoča študija neinferiornosti (N = 1055), v kateri so primerjali zdravilo Trelegy Ellipta (92/55/22 mikrogramov) s sočasno uporabljeno kombinacijo FF/VI (92/22 mikrogramov) + UMEC (55 mikrogramov) enkrat na dan kot zdravljenje z več inhalatorji pri bolnikih z anamnezo zmernih ali hudih poslabšanj v 12 mesecih pred vstopom v študijo.
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.
Subkutano dajanje ni povzročilo učinkov ob izpostavljenostih, ki so bile na podlagi AUC 62-kratnik klinične izpostavljenosti pri človeku med uporabo dnevnega odmerka 22 mikrogramov.
How to store Trelegy Ellipta 6.
Shranjevanje zdravila Trelegy Ellipta 6.
2 years Shelf-life after opening the tray: 6 weeks
Rok uporabnosti po prvem odprtju: 6 tednov.
Following intravenous administration of vilanterol to healthy volunteers, the mean volume of distribution at steady state was 165 litres.
Povprečni volumen porazdelitve vilanterola po intravenski uporabi je bil pri zdravih prostovoljcih v stanju dinamičnega ravnovesja 165 litrov.
Open the cover when ready to take a dose.
Pokrovček odprite šele, ko ste pripravljeni, da vzamete odmerek.
MARKETING AUTHORISATION NUMBER(S) EU/1/17/1236/001
ŠTEVILKA (ŠTEVILKE) DOVOLJENJA (DOVOLJENJ) ZA PROMET Z ZDRAVILOM EU/1/17/1236/001
There are limited data from the use of fluticasone furoate/umeclidinium/vilanterol in pregnant women.
Podatkov o uporabi kombinacije flutikazonfuroat/umeklidinij/vilanterol pri nosečnicah je malo.
Following repeat dosing of inhaled fluticasone furoate /vilanterol, steady state was achieved within 6 days with up to 1.6-fold accumulation
Po večkratnem odmerjanju inhalirane kombinacije flutikazonfuroat/vilanterol je bilo stanje dinamičnega ravnovesja doseženo v 6 dneh; kopičenje je bilo do 1,6-kratno.
No clinically relevant effects of hypokalaemia were observed in clinical studies with Trelegy Ellipta at the recommended therapeutic dose.
V kliničnih študijah zdravila Trelegy Ellipta med uporabo priporočenih terapevtskih odmerkov niso opažali klinično pomembnih učinkov hipokaliemije.
The tray contains a desiccant sachet, to reduce moisture in the packaging.
Pladenj vsebuje vrečko s sušilom za zmanjšanje vlažnosti v pakiranju.
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).
V študiji IMPACT je zdravilo Trelegy Ellipta v 52 tednih značilno zmanjšalo (p < 0,001) letni delež zmernih ali hudih poslabšanj za 15 % (95 % IZ: 10, 20) v primerjavi s FF/VI (delež; 0,91 v primerjavi z 1,07 dogodkov na bolnik-leto) in za 25 % (95 % IZ: 19, 30) v primerjavi z UMEC/VI (delež; 0,91 v primerjavi z 1,21 dogodkov na bolnik-leto).
Talk to your doctor before using Trelegy Ellipta - if you have asthma (Don't use Trelegy Ellipta to treat asthma) - if you have heart problems or high blood pressure - if you have liver problems - if you have tuberculosis (TB) of the lung, or any long standing or untreated infections - if you have an eye problem called narrow-angle glaucoma - if you have an enlarged prostate, difficulty passing urine or a blocking in your bladder - if you suffer from epilepsy - if you have thyroid gland problems - if you have low potassium in your blood - if you have a history of diabetes - if you experience blurred vision or other visual disturbances
- če imate astmo (zdravila Trelegy Ellipta ne uporabljajte za zdravljenje astme), - če imate težave s srcem ali visok krvni tlak, - če imate težave z jetri, - če imate pljučno tuberkulozo (TB) ali kakšne dolgotrajne ali nezdravljene okužbe,
The primary metabolic routes for umeclidinium are oxidative (hydroxylation, O-dealkylation) followed by conjugation (glucuronidation, etc), resulting in a range of metabolites with either reduced pharmacological activity or for which the pharmacological activity has not been established.
Primarne poti presnove umeklidinija so oksidativne (hidroksilacija, O-dealkilacija) in nato konjugacijske (glukuronidacija itn.).
This corresponds to a pre-dispensed dose of 100 micrograms fluticasone furoate, 74.2 micrograms umeclidinium bromide equivalent to 62.5 micrograms umeclidinium and 25 micrograms vilanterol (as trifenatate).
To ustreza odmerjenemu odmerku 100 mikrogramov flutikazonfuroata, 74,2 mikrograma umeklidinijevega bromida, kar je enakovredno 62,5 mikrograma umeklidinija in 25 mikrogramov vilanterola (kot trifenatata).
Following intravenous dosing of fluticasone furoate to healthy volunteers, the mean volume of distribution at steady state of 661 litres.
Povprečni volumen porazdelitve v stanju dinamičnega ravnovesja po intravenski uporabi flutikazonfuroata pri zdravih prostovoljcih je bil 661 litrov.
After inhalation, patients should rinse their mouth with water without swallowing.
Po uporabi inhalatorja si mora usta splakniti z vodo, vode ne sme pogoltniti.
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).
Tudi v študiji IMPACT je bil delež odzivnih bolnikov značilno večji (p < 0,001) pri zdravilu Trelegy Ellipta (36 %) v primerjavi s FF/VI (29 %; RO 1,36; 95 % IZ: 1,19, 1,55) in UMEC/VI (30 %; OR 1,33; 95 % IZ: 1,13, 1,57).
Trelegy Ellipta should be used with caution in patients with narrow-angle glaucoma or urinary retention.
Zdravilo Trelegy Ellipta je treba uporabljati previdno pri bolnikih z glavkomom z ozkim zakotjem ali retenco urina.
NAME OF THE MEDICINAL PRODUCT Trelegy Ellipta 92 micrograms/55 micrograms/22 micrograms inhalation powder, pre-dispensed
IME ZDRAVILA Trelegy Ellipta 92 mikrogramov/55 mikrogramov/22 mikrogramov prašek za inhaliranje, odmerjeni
Pneumonia (infection of the lung) in COPD patients (common side effect) Tell your doctor if you have any of the following while using Trelegy Ellipta - these could be symptoms of a lung infection:
Svojemu zdravniku morate povedati, če imate med jemanjem zdravila Trelegy Ellipta kar koli od naslednjega, ker so to lahko simptomi okužbe pljuč:
Multipack of 90 (3 packs of 30) dose inhalers.
Skupno pakiranje z 90 (3 pakiranja po 30) odmerki.
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.
S centralnim odčitanjem EKG 911 preiskovancev s KOPB, ki so bili izpostavljeni kombinaciji flutikazonfuroat/umeklidinij/vilanterol do 24 tednov, in podskupine 210 preiskovancev, ki so bili izpostavljeni do 52 tednov, niso ugotovili klinično pomembnih učinkov na interval QTc.
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).
Delež odzivnih bolnikov je bil med 21. in 24. tednom značilno večji (p < 0,001) pri zdravljenih z zdravilom Trelegy Ellipta v primerjavi z BUD/FOR (47 % v primerjavi s 37 %; RO 1,59; 95 % IZ: 1,30, 1,94).
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).
Druga študija je obsegala podatke o varnosti, zbrane pri 527 bolnikih s KOPB, ki so prejemali kombinacijo flutikazonfuroat/umeklidinij/vilanterol 92/55/22 mikrogramov in 528 bolnikih s KOPB, ki so prejemali kombinacijo flutikazonfuroat/vilanterol 92/22 mikrogramov in umeklidinij 55 mikrogramov enkrat na dan do 24 tednov (študija 200812).
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).
V študiji FULFIL je bil delež bolnikov, ki so bili odzivni po TDI (opredeljeno kot vsaj 1 enota) značilno večji (p < 0,001) pri zdravilu Trelegy Ellipta v primerjavi z BUD/FOR (61 % v primerjavi z 51 %; RO 1,61; 95 % IZ: 1,33, 1,95).
Plasma metabolic profiles following oral administration of vilanterol in a human radiolabel study were consistent with high first-pass metabolism.
V študiji z radioaktivno označenim vilanterolom pri človeku so se plazemske presnovne značilnosti po peroralni uporabi skladale z obsežno presnovo prvega prehoda.
Following intravenous administration of umeclidinium to healthy volunteers, the mean volume of distribution was 86 litres.
Povprečni volumen porazdelitve umeklidinija po intravenski uporabi je bil pri zdravih prostovoljcih 86 litrov.
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.
Pri podganah in miših se pojavnost tumorjev ni povečala med izpostavljenostjo, ki je bila na podlagi AUC 0,9-kratnik (podgane) ali 22-kratnik (miši) klinične izpostavljenosti vilanterolu pri človeku med uporabo dnevnega odmerka 22 mikrogramov.
b) How to inhale the medicinal product
b) Kako vdihniti zdravilo
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).
- če ste alergični na flutikazonfuroat, umeklidinij, vilanterol ali katero koli sestavino tega zdravila
One fatal case of pneumonia was reported in a patient who received Trelegy Ellipta.
Med bolniki, ki so prejemali zdravilo Trelegy Ellipta, je bil zabeležen en primer pljučnice s smrtnim izidom.
In inhalation studies in rabbits, vilanterol caused effects similar to those seen with other beta2-adrenergic agonists (cleft palate, open eyelids, sternebral fusion and limb flexure/malrotation).
V inhalacijskih študijah pri kuncih je vilanterol povzročil podobne učinke, kot se pojavljajo z drugimi agonisti adrenergičnih receptorjev beta2 (palatoshiza, odprte veke,
In vitro studies showed that vilanterol is primarily metabolised by cytochrome P450 3A4 (CYP3A4) and is a substrate for the P-gp transporter.
Študije in vitro so pokazale, da se vilanterol presnavlja predvsem s citokromom P450 3A4 (CYP3A4) in da je substrat prenašalca P-gp.
In vitro studies showed that fluticasone furoate is primarily metabolised by cytochrome P450 3A4 (CYP3A4) and is a substrate for the P-gp transporter.
Študije in vitro so pokazale, da se flutikazonfuroat presnavlja predvsem s citokromom P450 3A4 (CYP3A4) in da je substrat prenašalca P-gp.
MARKETING AUTHORISATION NUMBER(S) EU/1/17/1236/003
ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/17/1236/003
Clinically significant drug interactions mediated by fluticasone furoate/umeclidinium/vilanterol at clinical doses are considered unlikely due to the low plasma concentrations achieved after inhaled dosing.
4.5 Medsebojno delovanje z drugimi zdravili in druge oblike interakcij Klinično pomembna medsebojna delovanja z zdravili zaradi flutikazonfuroata/umeklidinja/vilanterola v kliničnih odmerkih niso verjetna, ker je koncentracija v plazmi po inhaliranju nizka.
How to use Trelegy Ellipta
Kako uporabljati zdravilo Trelegy Ellipta
Trelegy Ellipta
Zdravilo Trelegy Ellipta
PARTICULARS TO APPEAR ON THE OUTER PACKAGING BUNDLE LABEL (WITH BLUE BOX- MULTIPACK)
NALEPKA NA SKUPNEM PAKIRANJU (Z MODRIM OKENCEM - PAKIRANJE Z VEČ INHALATORJI)
Comparison
Odmerjanje
Following inhaled administration of fluticasone furoate/umeclidinium/vilanterol in healthy subjects, fluticasone furoate Cmax occurred at 15 minutes.
Po inhalacijski uporabi kombinacije flutikazonfuroat/umeklidinij/vilanterol pri zdravih preiskovancih se je Cmax flutikazonfuroata pojavila po 15 minutah.
The effect of fluticasone furoate/umeclidinium/vilanterol has not been evaluated in subjects with hepatic impairment.
Učinkov kombinacije flutikazonfuroat/umeklidinij/vilanterol niso ocenili pri bolnikih z okvaro ledvic.
In vitro studies showed that umeclidinium is primarily metabolised by cytochrome P450 2D6 (CYP2D6) and is a substrate for the P-gp transporter.
Študije in vitro so pokazale, da se umeklidinij presnavlja predvsem s citokromom P450 2D6 (CYP2D6) in da je substrat prenašalca P-gp.
What Trelegy Ellipta is and what it is used for
Kaj je zdravilo Trelegy Ellipta in za kaj ga uporabljamo Kaj je zdravilo Trelegy Ellipta
It is packaged in a foil laminate tray with a peelable foil lid.
Inhalator se nahaja v embalaži iz laminatne folije, zaprti s pokrovom iz folije.
1 inhaler of 30 doses
1 inhalator s 14 odmerki 1 inhalator s 30 odmerki
A repeat dose study was performed in healthy subjects with the fluticasone furoate/vilanterol combination (184/22 micrograms) and ketoconazole (400 milligrams, a strong CYP3A4 inhibitor).
Pri zdravih preiskovancih so izvedli študijo s ponavljajočimi se odmerki kombinacije flutikazonfuroata/vilanterola (184/22 mikrogramov)
Lung Function
Pljučna funkcija
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.
Učinki na srce in ožilje Po uporabi antagonistov muskarinskih receptorjev in simpatikomimetikov, vključno z umeklidinijem in vilanterolom, se lahko pojavijo kardiovaskularni učinki, npr. motnje srčnega ritma, kot sta atrijska fibrilacija in tahikardija.
Rinsing your mouth out with water immediately after using Trelegy Ellipta may help prevent this side effect.
Nastanek tega neželenega učinka lahko pomaga preprečiti izpiranje ust z vodo takoj po uporabi zdravila Trelegy
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).
V študiji FULFIL so bili bronhodilatacijski učinki zdravila Trelegy Ellipta opazni že prvi dan zdravljenja in so se ohranili med 24-tedenskim obdobjem zdravljenja (povprečna sprememba FEV1 od izhodišča je bila 1.
Following inhaled administration of fluticasone furoate/umeclidinium/vilanterol in healthy subjects, vilanterol Cmax occurred at 7 minutes.
Po inhalacijski uporabi kombinacije flutikazonfuroat/umeklidinij/vilanterol pri zdravih preiskovancih se je Cmax vilanterola pojavila po 7 minutah.
What Trelegy Ellipta contains The active substances are fluticasone furoate, umeclidinium bromide and vilanterol.
Zdravilne učinkovine so flutikazonfuroat, umeklidinijev bromid in vilanterol.
Trough FEV1 (L) at Week 52, LS mean change from baseline (SE) a
Najnižji FEV1 (L), povprečna sprememba (po mNK) od izhodišča (SN) po 52 tednih a
Trough FEV1 (L) at Week 24, LS mean change from baseline (SE)a
Najnižji FEV1 (L), povprečna sprememba (po mNK) od izhodišča (SN) po 24 tednih a
Following inhaled administration of fluticasone furoate/umeclidinium/vilanterol in healthy subjects, umeclidinium Cmax occurred at 5 minutes.
Po inhalacijski uporabi kombinacije flutikazonfuroat/umeklidinij/vilanterol pri zdravih preiskovancih se je Cmax umeklidinija pojavila po 5 minutah.
Trelegy Ellipta 92 micrograms/55 micrograms/22 micrograms inhalation powder, pre-dispensed fluticasone furoate/umeclidinium/vilanterol
Trelegy Ellipta 92 mikrogramov/55 mikrogramov/22 mikrogramov prašek za inhaliranje, odmerjeni flutikazonfuroat/umeklidinij/vilanterol
Do not open the tray until you are ready to inhale a dose of your medicine.
Ne odpirajte embalaže, dokler niste pripravljeni za vdihanje odmerka zdravila.
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.
Nočna prebujanja V študiji IMPACT je zdravilo Trelegy Ellipta statistično značilno bolj zmanjšalo povprečno število nočnih prebujanj zaradi KOPB kot FF/VI (-0,05; 95 % IZ: -0,08, -0,01; p = 0,005) ali UMEC/VI (-0,10; 95 % IZ:
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 ni bil genotoksičen v standardni skupini študij in ni bil kancerogen v študijah vseživljenjskega vdihavanja pri miših ali podganah ob izpostavljenostih, ki so na podlagi AUC ≥ 20-kratnik (miši) ali
In IMPACT, the proportion of patients who were CAT responders at week 52 was significantly higher (p<0.001) for patients treated with Trelegy Ellipta (42%) compared with FF/VI (37%; OR 1.24; 95% CI: 1.14, 1.36) and UMEC/VI (36%; OR 1.28; 95% CI: 1.15, 1.43).
V študiji IMPACT je bil delež bolnikov, ki so bili po 52. tednih opredeljeni kot odzivni glede na CAT značilno večji (p < 0,001) med prejemniki zdravila Trelegy Ellipta (42 %) kot med prejemniki FF/VI (37 %; RO 1,24; 95 % IZ: 1,14, 1,36) in UMEC/VI (36 %; RO 1,28; 95 % IZ: 1,15,
In FULFIL, based upon data up to 24 weeks, Trelegy Ellipta significantly reduced (p=0.002) the annual rate of moderate/severe exacerbations by 35% (95% CI: 14, 51) compared with BUD/FOR.
tednov značilno zmanjšalo (p = 0,002) letni delež zmernih ali hudih poslabšanj za 35 % (95 % IZ: 14, 51) v primerjavi z BUD/FOR.
• infection of the upper airways
• okužba zgornjih dihal,
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Trelegy Ellipta 92 /55 /22 mcg inhalation powder fluticasone furoate/umeclidinium/vilanterol
IME ZDRAVILA IN POT(I) UPORABE Trelegy Ellipta 92 /55 /22 µg prašek za inhaliranje fluticasonum furoas/ umeclidinium/ vilanterolum za inhaliranje
• Don't shake the inhaler at any time.
• Inhalatorja nikoli ne smete stresati.
If you get tightness of the chest, coughing, wheezing or breathlessness immediately after using your Trelegy Ellipta inhaler:
Če se vam takoj po uporabi inhalatorja Trelegy Ellipta pojavi tiščanje v prsih, kašelj, piskajoče dihanje ali težko dihanje:
Exacerbations
Poslabšanja
Treatment with Trelegy Ellipta should be discontinued immediately if paradoxical bronchospasm occurs.
Če se pojavi paradoksni bronhospazem, je treba zdravljenje z zdravilom Trelegy Ellipta nemudoma prenehati.
Tell your doctor as soon as possible if you develop any of these symptoms.
Če se vam pojavi kateri od teh simptomov, o tem čim prej obvestite zdravnika.
Inhalation powder, pre-dispensed (inhalation powder).
FARMACEVTSKA OBLIKA Prašek za inhaliranje, odmerjeni (prašek za inhaliranje).
NAME OF THE MEDICINAL PRODUCT Trelegy Ellipta 92/55/22 mcg inhalation powder fluticasone furoate/umeclidinium/vilanterol
Trelegy Ellipta 92/55/22 µg prašek za inhaliranje fluticasonum furoas/ umeclidinium/ vilanterolum
Write the “Discard by” date on the inhaler label and the carton in the space provided.
V predvideni prostor na nalepki in škatli inhalatorja vpišite datum "Zavrzite do".
If you get any side effects, talk to your doctor, pharmacist or nurse.
Če opazite kateri koli neželeni učinek, se posvetujte z zdravnikom, s farmacevtom ali medicinsko sestro.