FrancophonIA/ELRC3.0 huggingface dataset:
English: Immediate breathing difficulties after using LAVENTAIR ELLIPTA are rare.
Slovenian: Takojšnje težko dihanje po uporabi zdravila LAVENTAIR ELLIPTA je redko.
English: You may notice that your heart is beating faster than usual, you feel shaky, you have visual disturbances, have a dry mouth, or have a headache.
Slovenian: Morda boste pri sebi opazili hitrejši srčni utrip od običajnega, tresavica, motnje vida, suha usta ali glavobol.
English: It is not known whether the ingredients of LAVENTAIR ELLIPTA can pass into breast milk.
Slovenian: Ni znano, ali lahko sestavine zdravila LAVENTAIR ELLIPTA prehajajo v materino mleko.
English: If you have any of the following symptoms after taking LAVENTAIR ELLIPTA stop using this medicine and tell your doctor immediately.
Slovenian: Če imate po jemanju zdravila LAVENTAIR ELLIPTA katerega koli od naslednjih simptomov, zdravilo takoj nehajte uporabljati in nemudoma obvestite svojega zdravnika.
English: EU/1/14/899/001 1 inhaler of 7 doses EU/1/14/899/002 1 inhaler of 30 doses
Slovenian: EU/1/14/899/001 1 inhalator s 7 odmerki EU/1/14/899/002 1 inhalator s 30 odmerki
English: Don't use LAVENTAIR ELLIPTA if you already use these medicines.
Slovenian: Ne uporabite zdravila LAVENTAIR ELLIPTA, če ste že vzeli katero od teh zdravil.
English: Plasma clearance following intravenous administration was 151 litres/hour.
Slovenian: Umeklidinij Plazemski očistek po intravenski uporabi je bil 151 litrov/uro.
English: DL12 8DT
Slovenian: DL12 8DT Velika Britanija
English: - ketoconazole or itraconazole, to treat fungal infections - clarithromycin or telithromycin, to treat bacterial infections - ritonavir, to treat HIV infection - medicines that lower the amount of potassium in your blood, such as some diuretics (water tablets) or some medicines used to treat asthma (such as methylxanthine or steroids) - other long-acting medicines similar to this medicine that are used to treat breathing problems, e.g.
Slovenian: - ketokonazol ali itrakonazol za zdravljenje glivičnih okužb, - klaritromicin ali telitromicin za zdravljenje bakterijskih okužb, - ritonavir za zdravljenje okužbe z virusom HIV, - zdravila, ki znižajo kalij v krvi, npr. nekateri diuretiki (zdravila za odvajanje vode) ali zdravila, ki se uporabljajo za zdravljenje astme (npr. metilksantin ali steroidi),
English: It is unlikely that LAVENTAIR ELLIPTA will affect your ability to drive or use machines.
Slovenian: Ni verjetno, da bi zdravilo LAVENTAIR ELLIPTA vplivalo na vašo sposobnost upravljanja vozil in strojev.
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 Laventair Ellipta compared with tiotropium (study 201038), according to a protocol agreed by the PRAC.
Slovenian: Opazovalna kohortna raziskava za določitev incidence in primerjalne varnosti za izbrane kardiovaskularne in cerebrovaskularne dogodke pri bolnikih s KOPB z zdravilom Laventair Ellipta v primerjavi s tiotropijem (raziskava 201038), po porotokolu, ki ga je potrdil PRAC.
English: In the other two active-comparator studies, a similar proportion of patients achieved at least the MCID with LAVENTAIR ELLIPTA and tiotropium; 49% and 54% for LAVENTAIR ELLIPTA 55/22 micrograms and 52% and 55% for tiotropium.
Slovenian: V drugih dveh študijah z aktivno primerjalno učinkovino je podoben delež bolnikov dosegel vsaj MCID z zdravilom LAVENTAIR ELLIPTA kot s tiotropijem: 49 % oz. 54 % z zdravilom LAVENTAIR ELLIPTA 55/22 mikrogramov in 52 % oz. 55 % s tiotropijem.
English: Atrial fibrillation Supraventricular tachycardia Rhythm idioventricular Tachycardia
Slovenian: Srčne bolezni atrijska fibrilacija supraventrikularna tahikardija idioventrikularni ritem tahikardija občasni občasni občasni občasni
English: LAVENTAIR ELLIPTA is indicated as a maintenance bronchodilator treatment to relieve symptoms in adult patients with chronic obstructive pulmonary disease (COPD).
Slovenian: Zdravilo LAVENTAIR ELLIPTA je indicirano za vzdrževalno bronhodilatacijsko zdravljenje za olajšanje simptomov pri odraslih bolnikih s kronično obstruktivno pljučno boleznijo (KOPB).
English: The safety profile of LAVENTAIR ELLIPTA is based on safety experience with umeclidinium/vilanterol and the individual components from the clinical development program comprising of 6,855 patients with COPD and from spontaneous reporting.
Slovenian: Varnostne značilnosti zdravila LAVENTAIR ELLIPTA temeljijo na izkušnjah z varnostjo kombinacije umeklidinij/vilanterol in s posameznima sestavinama iz programa kliničnega razvoja, ki je zajel 6.855
English: In the second study, the treatment difference in EET between LAVENTAIR ELLIPTA 55/22 micrograms and placebo was 21.9 seconds (p=0.234) at Week 12.
Slovenian: V drugi študiji je bila razlika EET med zdravilom LAVENTAIR ELLIPTA 55/22 mikrogramov in placebom 21,9 sekunde (p = 0,234) v 12. tednu.
English: What you need to know before you use LAVENTAIR ELLIPTA 3.
Slovenian: Kaj morate vedeti, preden boste uporabili zdravilo LAVENTAIR ELLIPTA 3.
English: What you need to know before you use LAVENTAIR ELLIPTA Do not use LAVENTAIR ELLIPTA:
Slovenian: Kaj morate vedeti, preden boste uporabili zdravilo LAVENTAIR ELLIPTA Ne uporabljajte zdravila LAVENTAIR ELLIPTA:
English: If you use more LAVENTAIR ELLIPTA than you should
Slovenian: Če ste uporabili večji odmerek zdravila LAVENTAIR ELLIPTA, kot bi smeli
English: LAVENTAIR ELLIPTA contains two active substances umeclidinium bromide and vilanterol.
Slovenian: Zdravilo LAVENTAIR ELLIPTA vsebuje dve učinkovini, umeklidinijev bromid in vilanterol.
English: LAVENTAIR ELLIPTA reduced the use of rescue medication with salbutamol over Weeks 1-24 compared with placebo and umeclidinium (see Table 1) and demonstrated an increase from baseline in the proportion of days when no rescue medication was needed (on average 11.1%) compared with a decrease from baseline on placebo (on average 0.9%).
Slovenian: Zdravilo LAVENTAIR ELLIPTA je zmanjšalo uporabo rešilnega zdravila s salbutamolom tekom 1.-24. tedna v primerjavi s placebom in umeklidinijem (glejte preglednico 1) ter je doseglo zvišanje deleža dni glede na izhodišče , ko ni bilo treba uporabiti rešilnega zdravila (v povprečju 11,1 %), v primerjavi z znižanjem deleža glede na izhodišče pri placebu (v povprečju 0,9 %).
English: Eye problems during treatment with LAVENTAIR ELLIPTA
Slovenian: Težave z očmi med zdravljenjem z zdravilom LAVENTAIR ELLIPTA
English: - if you have an enlarged prostate, difficulty passing urine or a blockage in your bladder
Slovenian: - če imate povečano prostato, težave pri odvajanju urina ali zaporo v mehurju, - če imate epilepsijo,
English: LAVENTAIR ELLIPTA also demonstrated a greater increase from baseline in the proportion of days when no rescue medication was needed in all three studies (average within the range 17.6% to 21.5%) compared with tiotropium (average within the range 11.7% to 13.4%).
Slovenian: Zdravilo LAVENTAIR ELLIPTA je v vseh treh študijah doseglo tudi večje zvišanje deleža dni glede na izhodišče, ko rešilno zdravilo ni bilo potrebno (povprečje v razponu od 17,6 % do 21,5 %), v primerjavi s tiotropijem (povprečje v razponu od
English: These include: - medicines called beta blockers (such as propranolol), to treat high blood pressure or other heart problems
Slovenian: - zaviralci adrenergičnih receptorjev beta (kot je propranolol); uporabljajo se za zdravljenje visokega krvnega tlaka ali drugih težav s srcem,
English: There is no relevant use of LAVENTAIR ELLIPTA in the paediatric population (under 18 years of age) for the indication of COPD.
Slovenian: Zdravilo LAVENTAIR ELLIPTA za indikacijo KOPB v pediatrični populaciji (mlajši od 18 let) nima relevantne uporabe.
English: The frequency of adverse reactions is defined using the following convention: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare
Slovenian: (≥ 1/100 do < 1/10); občasni (≥ 1/1.000 do < 1/100); redki (≥ 1/10.000 do < 1/1.000); zelo redki (< 1/10.000)
English: To use LAVENTAIR ELLIPTA, you breathe it into your lungs through your mouth using the ELLIPTA inhaler.
Slovenian: uporabite tako, da ga s pomočjo inhalatorja ELLIPTA skozi usta vdihnete v pljuča.
English: The use of LAVENTAIR ELLIPTA has not been studied in patients with severe hepatic impairment and should be used with caution.
Slovenian: Uporaba zdravila LAVENTAIR ELLIPTA ni raziskana pri bolnikih s hudo okvaro jeter, zato ga je pri takšnih bolnikih treba uporabljati previdno.
English: What LAVENTAIR ELLIPTA is and what it is used for 2.
Slovenian: Kaj je zdravilo LAVENTAIR ELLIPTA in za kaj ga uporabljamo 2.
English: LAVENTAIR ELLIPTA is used to treat chronic obstructive pulmonary disease (COPD) in adults.
Slovenian: Zdravilo LAVENTAIR ELLIPTA se uporablja za zdravljenje kronične obstruktivne pljučne bolezni (KOPB) pri odraslih.
English: The “Discard by” date is 6 weeks from the date of opening the tray.
Slovenian: Datum “Zavrzite do” je 6 tednov od datuma odprtja embalaže.
English: Step-by-step instructions
Slovenian: Navodila za uporabo po korakih
English: Umeclidinium was not genotoxic in a standard battery of studies and was not carcinogenic in lifetime inhalation studies in mice or rats at exposures ≥ 26 or ≥ 22-fold, times the human clinical exposure of umeclidinium 55 micrograms, based on AUC, respectively.
Slovenian: Genotoksičnost in kancerogenost 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 ≥ 26-kratnik oziroma ≥ 22kratnik klinične izpostavljenosti pri človeku z odmerkom 55 mikrogramov umeklidinija.
English: What LAVENTAIR ELLIPTA is and what it is used for What LAVENTAIR ELLIPTA is
Slovenian: Kaj je zdravilo LAVENTAIR ELLIPTA in za kaj ga uporabljamo Kaj je zdravilo LAVENTAIR ELLIPTA
English: From the three active-comparator studies in patients with symptomatic COPD, the risk of a moderate/severe COPD exacerbation compared with tiotropium was reduced by 50% in one study (HR 0.5; 95% CI: 0.3, 1.0; p=0.044).
Slovenian: V treh študijah z aktivno primerjalno učinkovino pri bolnikih s simptomatsko KOPB, se je tveganje za zmerno/hudo poslabšanje KOPB v primerjavi s tiotropijem v eni študiji zmanjšalo za 50 % (ROg 0,5; 95 % IZ: 0,3; 1,0, p = 0,044).
English: Contents of the pack and other information What LAVENTAIR ELLIPTA contains
Slovenian: Vsebina pakiranja in dodatne informacije Kaj vsebuje zdravilo LAVENTAIR ELLIPTA
English: 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 80-times the human clinical exposure of umeclidinium 55 micrograms, based on AUC).
Slovenian: V pre- in postnatalni študiji je subkutano dajanje umeklidinija pri podganah zmanjšalo materino povečanje telesne mase in uživanje hrane ter rahlo zmanjšalo telesno maso mladičev pred odstavitvijo pri samicah-materah, ki so dobivale odmerek 180 mikrogramov/kg/dan (to je na osnovi AUC približno 80-kratnik klinične izpostavljenosti pri človeku z odmerkom 55 mikrogramov umeklidinija).
English: The European Medicines Agency has waived the obligation to submit the results of studies with LAVENTAIR ELLIPTA in all subsets of the paediatric population in COPD (see section 4.2 for information on paediatric use).
Slovenian: LAVENTAIR ELLIPTA za vse podskupine pediatrične populacije pri KOPB (za podatke o uporabi pri pediatrični populaciji glejte poglavje 4.2).
English: LAVENTAIR ELLIPTA 55/22 micrograms also showed statistically significant improvements compared with placebo in change from baseline in lung volume measures at trough and at 3 hours post dose at Week 12 in the first study (inspiratory capacity: 237 ml and 316 ml respectively, residual volume: -466 ml and -643 ml respectively and functional residual capacity: -351 ml and -522 ml respectively; all p<0.001).
Slovenian: Zdravilo LAVENTAIR ELLIPTA 55/22 mikrogramov je v prvi študiji v primerjavi s placebom po 12 tednih tudi statistično značilno izboljšalo spremembo od izhodišča v merah pljučnega volumna pri najnižji koncentraciji in 3 ure po odmerku (inspiratorna kapaciteta: 237 ml oziroma 316 ml, rezidualni volumen: -466 ml oziroma -643 ml in funkcionalna rezidualna kapaciteta: -351 ml oziroma -522 ml, vse p < 0,001).
English: LAVENTAIR ELLIPTA should not be used to relieve a sudden attack of breathlessness or wheezing.
Slovenian: Zdravila LAVENTAIR ELLIPTA se ne sme uporabljati za ublažitev nenadnega napada težkega ali piskajočega dihanja.
English: The proportion of patients who responded with at least the minimum clinically important difference (MCID) of 1 unit TDI focal score at Week 24 was greater for LAVENTAIR ELLIPTA (58%) compared with placebo (41%) and each monotherapy component (53% for umeclidinium and 51% for vilanterol).
Slovenian: Delež bolnikov, ki so se odzvali z vsaj minimalno klinično pomembno razliko (MCID) 1 enoto fokalnega seštevka TDI po 24 tednih, je bil večji pri zdravljenju z zdravilom LAVENTAIR ELLIPTA (58 %) kot pri dajanju placeba (41 %) ali vsake od obeh sestavin v monoterapiji (53 % za umeklidinij in 51 % za vilanterol).
English: Supraventricular extrasystoles Palpitations
Slovenian: Pogostnost supraventrikularne ekstrasistole palpitacije občasni občasni
English: If you stop using LAVENTAIR ELLIPTA
Slovenian: Če ste prenehali uporabljati zdravilo LAVENTAIR ELLIPTA
English: Placebo (N = 280) LAVENTAIR ELLIPTA (N = 413) versus
Slovenian: s placebom (N = 280) LAVENTAIR ELLIPTA (N = 413) v prim.
English: The recommended dose is one inhalation of LAVENTAIR ELLIPTA 55/22 micrograms once daily.
Slovenian: Priporočeni odmerek je ena inhalacija zdravila LAVENTAIR ELLIPTA 55/22 mikrogramov enkrat na dan.
English: those for the LAVENTAIR ELLIPTA dose and provided additional supportive evidence for the efficacy of LAVENTAIR ELLIPTA.
Slovenian: Rezultati so bili podobni rezultatom z odmerkom v zdravilu LAVENTAIR ELLIPTA in dodatno potrjujejo učinkovitost zdravila LAVENTAIR ELLIPTA.
English: If possible, show them the inhaler, the package or this leaflet.
Slovenian: Če je mogoče, mu pokažite inhalator zdravila LAVENTAIR ELLIPTA, ovojnino ali to navodilo.
English: In one active-comparator study, a higher percentage of patients receiving LAVENTAIR ELLIPTA responded with a clinically meaningful improvement in SGRQ score at Week 24 (53%) compared to tiotropium (46%).
Slovenian: V eni študiji z aktivno primerjalno učinkovino se je s klinično pomembnim izboljšanjem seštevka SGRQ 24. teden odzval večji delež prejemnikov zdravila LAVENTAIR ELLIPTA (53 %) kot prejemnikov tiotropija (46 %).
English: The maximum dose is one inhalation of LAVENTAIR ELLIPTA 55/22 micrograms once daily.
Slovenian: Največji odmerek je ena inhalacija zdravila LAVENTAIR ELLIPTA 55/22 mikrogramov enkrat na dan.
English: Use LAVENTAIR ELLIPTA regularly
Slovenian: Zdravilo LAVENTAIR ELLIPTA uporabljajte redno
English: LAVENTAIR ELLIPTA showed a statistically significant reduction in SGRQ total score compared with tiotropium in one of the three activecomparator studies (see Table 1).
Slovenian: Zdravilo LAVENTAIR ELLIPTA je v primerjavi s tiotropijem statistično značilno zmanjšalo celotni seštevek SGRQ v eni od treh študij z aktivno primerjalno učinkovino (glejte preglednico 1).
English: LAVENTAIR ELLIPTA is for inhalation use only.
Slovenian: Zdravilo LAVENTAIR ELLIPTA je namenjeno samo za inhalacijsko uporabo.
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 24 was greater for LAVENTAIR ELLIPTA (49%) compared with placebo (34%) and each monotherapy component (44% for umeclidinium and 48% for vilanterol).
Slovenian: Po 24 tednih zdravljenja je bil delež bolnikov, ki so dosegli vsaj MCID v seštevku SGRQ (opredeljen kot zmanjšanje za 4 enote od izhodišča), pri zdravilu LAVENTAIR ELLIPTA večji (49 %) v primerjavi s placebom (34 %) in monoterapijami (44 % - umeklidinij in 48 % - vilanterol).
English: LAVENTAIR ELLIPTA (N = 454) versus tiotropium 18 mcg (N = 451) (Study ZEP117115)
Slovenian: 18 µg tiotropija (N = 451) (študija ZEP117115)
English: LAVENTAIR ELLIPTA (N = 413) versus
Slovenian: LAVENTAIR ELLIPTA (N = 413) v prim.
English: Package leaflet: Information for the user LAVENTAIR ELLIPTA 55 micrograms/22 micrograms inhalation powder, pre-dispensed umeclidinium/vilanterol This medicine is subject to additional monitoring.
Slovenian: Navodilo za uporabo LAVENTAIR ELLIPTA 55 mikrogramov/22 mikrogramov prašek za inhaliranje, odmerjeni umeklidinij/vilanterol Za to zdravilo se izvaja dodatno spremljanje varnosti.
English: Lung function, symptomatic and health related quality of life outcomes at Week 24 Treatment comparisons with LAVENTAIR
Slovenian: Delovanje pljuč ter simptomatski izidi in izidi glede zdravstvene kakovosti življenja v
English: Other medicines and LAVENTAIR ELLIPTA
Slovenian: Druga zdravila in zdravilo LAVENTAIR ELLIPTA
English: How to store LAVENTAIR ELLIPTA 6.
Slovenian: Shranjevanje zdravila LAVENTAIR ELLIPTA 6.
English: What LAVENTAIR ELLIPTA looks like and contents of the pack
Slovenian: Izgled zdravila LAVENTAIR ELLIPTA in vsebina pakiranja
English: LAVENTAIR ELLIPTA is an inhalation powder, pre-dispensed.
Slovenian: Zdravilo LAVENTAIR ELLIPTA je prašek za inhaliranje, odmerjeni.
English: LAVENTAIR ELLIPTA is for inhalation use.
Slovenian: Zdravilo LAVENTAIR ELLIPTA je namenjeno za inhalacijsko uporabo.
English: FAES FARMA, S.A. Tel: + 34 900 460 153 aweber@faes.es
Slovenian: FAES FARMA, S.A. Tel: + 34 900 460 153
English: In addition, LAVENTAIR ELLIPTA demonstrated clinically meaningful and statistically significant improvements in trough FEV1 compared with tiotropium in two of the three 6-month active-comparator studies and numerically greater improvements from tiotropium in the third active-comparator study (see Table 1).
Slovenian: ELLIPTA v primerjavi s tiotropijem klinično pomembno in statistično značilno izboljšalo najnižji FEV1 v dveh od treh 6-mesečnih študij z aktivno primerjalno učinkovino, v tretji od teh študij pa je doseglo številsko večje izboljšanje kot tiotropij (glejte preglednico 1).
English: There was no evidence for tachyphylaxis in the effect of LAVENTAIR ELLIPTA over time.
Slovenian: Znakov postopnega zmanjšanja učinkovitosti (tahifilaksije) zdravila LAVENTAIR ELLIPTA ni bilo.
English: LAVENTAIR ELLIPTA demonstrated a statistically significant and clinically meaningful reduction in breathlessness as evaluated by an increase in TDI focal score at Week 24 (key secondary end-point) compared with placebo (see Table 1).
Slovenian: Zdravilo LAVENTAIR ELLIPTA je v primerjavi s placebom statistično značilno in klinično pomembno izboljšalo težko dihanje, ocenjeno s povečanjem fokalnega seštevka TDI po 24 tednih (ključni sekundarni opazovani dogodek) (glejte preglednico 1).
English: If you are breast-feeding, you must check with your doctor before you use LAVENTAIR ELLIPTA.
Slovenian: Če dojite, se morate pred uporabo zdravila LAVENTAIR ELLIPTA posvetovati z zdravnikom.
English: LAVENTAIR ELLIPTA contains lactose
Slovenian: Zdravilo LAVENTAIR ELLIPTA vsebuje laktozo
English: LAVENTAIR ELLIPTA 55/22 micrograms improved exercise endurance time compared with placebo, as evaluated with the endurance shuttle walk test (ESWT), in one study but not the second and improved lung volume measures compared with placebo in both studies in adult COPD patients with hyperinflation (functional residual capacity [FRC] >120%).
Slovenian: Zdravilo LAVENTAIR ELLIPTA 55/22 mikrogramov je v primerjavi s placebom v eni študiji (ne pa tudi v drugi) izboljšalo čas obremenitvene vzdržljivosti ocenjene z vzdržljivostnim krožnim testom hoje (ESWT
English: The first time you use LAVENTAIR 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.
Slovenian: Ko zdravilo LAVENTAIR ELLIPTA uporabite prvič, vam ni treba preverjati, ali inhalator deluje pravilno;
English: LAVENTAIR ELLIPTA 55 micrograms/22 micrograms inhalation powder, pre-dispensed
Slovenian: LAVENTAIR ELLIPTA 55 mikrogramov/22 mikrogramov prašek za inhaliranje, odmerjeni
English: LAVENTAIR ELLIPTA (N = 207) versus tiotropium 18 mcg (N = 203) (Study DB2113360)
Slovenian: 18 µg tiotropija (N = 203) (študija DB2113360)
English: - if you have severe liver problems
Slovenian: - če imate težave z žlezo ščitnico,
English: LAVENTAIR ELLIPTA (N = 217) versus tiotropium 18 mcg (N = 215) (Study DB2113374)
Slovenian: 18 µg tiotropija (N = 215) (študija DB2113374)
English: In the first study, LAVENTAIR ELLIPTA 55/22 micrograms demonstrated a statistically significant and clinically relevant improvement (based on a minimal clinically important difference (MCID) between 45 to 85 seconds) over placebo in exercise endurance time (EET) obtained 3 hours after dosing at Week 12 (69.4 seconds [p=0.003]).
Slovenian: [MCID - minimal clinically important difference] med 45 in 85 sekund) čas obremenitvene vzdržljivosti (EET - exercise endurance time), dosežen 3 ure po uporabi (69,4 sekunde [p = 0,003]).
English: LAVENTAIR ELLIPTA 55 micrograms/22 micrograms inhalation powder, pre-dispensed umeclidinium/vilanterol
Slovenian: LAVENTAIR ELLIPTA 55 mikrogramov/22 mikrogramov prašek za inhaliranje, odmerjeni umeklidinij/vilanterol
English: In the three 6-month active-comparator-controlled studies, LAVENTAIR ELLIPTA reduced the use of rescue medication with salbutamol compared with tiotropium, with statistically significant reductions observed in two of the studies (see Table 1).
Slovenian: ELLIPTA zmanjšalo uporabo rešilnega zdravila s salbutamolom v primerjavi s tiotropijem; v dveh od teh treh študij je bilo zmanjšanje statistično značilno (glejte preglednico 1).
English: How to use LAVENTAIR ELLIPTA
Slovenian: Kako uporabljati zdravilo LAVENTAIR ELLIPTA
English: In a 24-week placebo-controlled study in patients with symptomatic COPD, LAVENTAIR ELLIPTA reduced the risk of a moderate/severe COPD exacerbation by 50% compared with placebo (based on analysis of time to first exacerbation: Hazard Ratio (HR) 0.5; 95% CI: 0.3, 0.8; p=0.004*); by 20% compared with umeclidinium (HR 0.8; 95% CI: 0.5, 1.3; p=0.391); and by 30% compared with vilanterol (HR 0.7; 95% CI: 0.4, 1.1; p=0.121).
Slovenian: V 24-tedenski s placebom kontrolirani študiji pri bolnikih s simptomatsko KOPB je zdravilo LAVENTAIR ELLIPTA v primerjavi s placebom zmanjšalo tveganje za zmerno/hudo poslabšanje KOPB za 50 % (na podlagi analize časa do prvega poslabšanja: Razmerje ogroženosti (ROg) 0,5; 95 % IZ: 0,3; 0,8, p=0.004*);
English: Renal impairment No dose adjustment is required in patients with renal impairment.
Slovenian: Okvara ledvic Bolnikom z okvaro ledvic odmerka ni treba prilagoditi.
English: If you get tightness of the chest, coughing, wheezing or breathlessness immediately after using your LAVENTAIR ELLIPTA inhaler:
Slovenian: Če se vam takoj po uporabi inhalatorja LAVENTAIR ELLIPTA pojavi tiščanje v prsih, kašelj, piskajoče dihanje ali težko dihanje:
English: - if you have diabetes
Slovenian: - če imate sladkorno bolezen, - če imate hudo okvaro jeter.
English: LAVENTAIR ELLIPTA 55/22 mcg inhalation powder umeclidinium/vilanterol
Slovenian: LAVENTAIR ELLIPTA 55/22 µg prašek za inhaliranje umeklidinij/vilanterol
English: In the second study, LAVENTAIR ELLIPTA 55/22 micrograms showed improvements compared with placebo in change from baseline in lung volume measures at trough and at 3 hours post dose at Week 12 (inspiratory capacity: 198 ml and 238 ml respectively, residual volume: -295 ml and -351 ml respectively and functional residual capacity: -238 ml and -302 ml respectively); all p<0.001∗).
Slovenian: (inspiratorna kapaciteta: 198 ml oziroma 238 ml, rezidualni volumen: -259 ml oziroma -351 ml in funkcionalna rezidualna kapaciteta: -238 ml oziroma -302 ml, vse p < 0,001∗).