natgillin/translations-raw huggingface dataset:
4) Close the inhaler
4) Zaprite pokrovček inhalatorja
Improvements in lung function were supported with reductions in use of salbutamol over Weeks 1-12 (-0.4 puffs per day (95% CI: -0.7, -0.2; p<0.001) and -0.3 puffs per day (95% CI: -0.5, -0.1; p=0.003)) compared to placebo plus FF/VI but improvements in SGRQ at week 12 were not statistically significant (200109) or clinically relevant (200109 and 200110).
odstotni IZ: -0,7, -0,2; p < 0,001) in -0,3 vpiha na dan (95-odstotni IZ -0,5, -0,1; p = 0,003)) v primerjavi s placebom in FF/VI, izboljšanje SGRQ po 12 tednih pa ni bilo statistično značilno (200109) ali klinično pomembno (200109 in 200110).
Rolufta Ellipta should not be used to relieve a sudden attack of breathlessness or wheezing.
Zdravila Rolufta Ellipta se ne sme uporabljati za ublažitev nenadnega napada težkega ali piskajočega dihanja.
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.
Povprečno največje izboljšanje FEV1 v prvih 6 urah po uporabi odmerka je bilo v primerjavi s placebom 130 ml (p < 0,001∗) 24. teden.
Umeclidinium bromide has not been evaluated in subjects with severe hepatic impairment.
Umeklidinijevega bromida niso ocenili pri preiskovancih s hudo okvaro jeter.
Multipacks containing 90 (3 inhalers of 30) doses are also available.
Na voljo je tudi pakiranje z več inhalatorji, ki vsebuje 90 (3 inhalatorji po 30) odmerkov.
White powder in a grey inhaler (Ellipta) with a light green mouthpiece cover and a dose counter.
Bel prašek v sivem inhalatorju (Ellipta) s svetlo zelenim pokrovčkom ustnika in števcem odmerkov.
• irregular heart beat
• neredno bitje srca,
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.
Delež bolnikov, ki so se odzvali z vsaj minimalno klinično pomembno razliko (MCID - minimum clinically important difference) 1 enote fokalnega seštevka TDI po 12 tednih, je bil v 12-tedenski študiji z zdravilom Rolufta Ellipta večji (38 %) kot s placebom (15 %).
ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS
POVZETEK GLAVNIH ZNAČILNOSTI ZDRAVILA
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).
tedenski študiji zdravljenja z zdravilom Rolufta Ellipta je bila povprečna sprememba (standardni odklon) števila vdihov rešilnega salbutamola med 24-tedenskim obdobjem zdravljenja od izhodišča -1,4 (0,20) za placebo in -1,7 (0,16) za zdravilo Rolufta Ellipta (razlika = -0,3, 95 % IZ: -0,8, 0,2, p = 0,276).
EXP In use shelf-life: 6 weeks.
EXP Rok uporabnosti po prvem odprtju: 6 tednov.
Inhalation powder, pre-dispensed (inhalation powder).
Prašek za inhaliranje, odmerjeni (prašek za inhaliranje).
Consistent with its antimuscarinic activity, umeclidinium bromide should be used with caution in patients with urinary retention or with narrow-angle glaucoma.
Glede na antimuskarinsko delovanje umeklidinijevega bromida je treba to zdravilo pri bolnikih z zastojem urina ali glavkomom z ozkim zakotjem uporabljati previdno.
What Rolufta Ellipta looks like and contents of the pack
Izgled zdravila Rolufta Ellipta in vsebina pakiranja
Umeclidinium bromide is a substrate of cytochrome P450 2D6 (CYP2D6).
Presnovne interakcije in interakcije na podlagi prenašalcev Umeklidinijev bromid je substrat citokroma P450 2D6 (CYP2D6).
When you are ready to use your inhaler, peel back the lid to open the tray.
Ko ste pripravljeni za uporabo vašega inhalatorja, odlepite pokrov embalaže.
The primary metabolic routes for umeclidinium bromide 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 umeklidinijevega bromida so oksidativne (hidroksilacija, O-dealkilacija), ki jim sledijo konjugacijske (glukuronidacija itn.).
This breath should be held in for as long as possible (at least 3-4 seconds).
(vsaj 3 do 4 sekunde).
Other medicines and Rolufta Ellipta
Druga zdravila in zdravilo Rolufta Ellipta
Following intravenous administration, approximately 58% of the administered radiolabelled dose (or 73% of the recovered radioactivity) was excreted in faeces by 192 hours post-dose.
uporabljenega radioaktivno označenega odmerka (oziroma 73 % najdene radioaktivnosti) pojavilo v blatu do 192 ur po odmerku.
if you have heart problems if you have an eye problem called narrow-angle glaucoma if you have an enlarged prostate, difficulty passing urine or a blockage in your bladder if you have severe liver problems
če imate povečano prostato, težave pri odvajanju urina, ali zaporo v mehurju, če imate hudo okvaro jeter,
7 doses
7 odmerkov
If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse.
Če imate dodatna vprašanja o uporabi zdravila, se posvetujte z zdravnikom, farmacevtom ali medicinsko sestro.
Rolufta Ellipta is an inhalation powder, pre-dispensed.
Zdravilo Rolufta Ellipta je prašek za inhaliranje, odmerjeni.
1) Read this before you start If you open and close the cover without inhaling the medicine, you will lose the dose.
Če pokrovček odprete in zaprete, ne da bi vdihnili zdravilo, boste izgubili odmerek.
Reporting of suspected adverse reactions
Poročanje o neželenih učinkih
PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON (SINGLE PACKS) 55 micrograms
PODATKI NA ZUNANJI OVOJNINI ZUNANJA OVOJNINA (PAKIRANJA Z ENIM INHALATORJEM) 55 mikrogramov
Multipack of 3 x 30 dose inhalers.
Pakiranje z več inhalatorji 3 x 30 odmerkov.
How to store Rolufta Ellipta 6.
Shranjevanje zdravila Rolufta Ellipta 6.
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).
Tako 12-tedenska kot 24-tedenska ključna študija sta pokazali, da je zdravilo Rolufta Ellipta v primerjavi s placebom statistično značilno in klinično pomembno izboljšalo delovanje pljuč (opredeljeno kot sprememba FEV1 od izhodišča do 12. oziroma 24. tedna; to je bil primarni opazovani dogodek učinkovitosti v obeh študijah) (glejte preglednico 1).
Skin and subcutaneous tissue disorders
Bolezni kože in podkožja izpuščaj občasni
Discard by:
Zavrzite do:
It is packaged in a foil laminate tray with a peelable foil lid.
Pakiran je v embalaži iz laminatne folije, ki vsebuje vrečko s sušilom.
Respiratory, thoracic and mediastinal disorders
Bolezni dihal, prsnega koša in mediastinalnega prostora kašelj pogosti
The Ellipta inhaler consists of a grey plastic body, a light green mouthpiece cover and a dose counter.
Inhalator Ellipta je sestavljen iz svetlo sivega plastičnega ohišja, zelenega pokrovčka ustnika in števca odmerkov.
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).
Po 52 tednih so s FF/UMEC/VI v primerjavi s FF/VI opažali statistično značilno izboljšanje povprečne spremembe (po metodi najmanjših kvadratov [mNK]) najnižjega FEV1 od izhodišča (povprečna sprememba: +94 ml vs -3 ml; razlika med zdravljenjema: 97 ml, 95 % IZ: 85, 109, p<0,001).
If you are breast-feeding, you must check with your doctor before you use Rolufta Ellipta.
Če dojite, se morate pred uporabo zdravila Rolufta Ellipta posvetovati z zdravnikom.
Package leaflet: Information for the user Rolufta Ellipta 55 micrograms inhalation powder, pre-dispensed umeclidinium (umeclidinium bromide) This medicine is subject to additional monitoring.
Navodilo za uporabo Rolufta Ellipta 55 mikrogramov prašek za inhaliranje, odmerjeni umeklidinij (umeklidinijev bromid) Za to zdravilo se izvaja dodatno spremljanje varnosti.
Rolufta Ellipta 55 micrograms inhalation powder, pre-dispensed
Rolufta Ellipta 55 mikrogramov prašek za inhaliranje, odmerjeni
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.
Delež bolnikov, ki so se odzvali z vsaj minimalno klinično pomembno razliko seštevka SGRQ (ta je bila opredeljena kot znižanje za 4 enote v primerjavi z izhodiščem) po 12 tednih, je bil v 12-tedenski raziskavi z zdravilom Rolufta Ellipta večji (44 %) kot s placebom (26 %).
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.
Pri preiskovancih s hudo okvaro ledvic (očistek kreatinina < 30 ml/min) niso ugotovili večje sistemske izpostavljenosti umeklidinijevemu bromidu (Cmax in AUC).
Rolufta Ellipta is for inhalation use.
Zdravilo Rolufta Ellipta je namenjeno za inhalacijsko uporabo.
FAES FARMA, S.A. Tel.: +34 900 460 153 aweber@faes.es
FAES FARMA, S.A. Tel.: +34 900 460 153
No new adverse drug reactions were identified with the addition of Rolufta Ellipta to FF/VI in these studies.
V teh študijah niso ugotovili novih neželenih učinkov med uporabo zdravila Rolufta Ellipta ob FF/VI.
- If you have any further questions, ask your doctor, pharmacist or nurse.
- Če imate dodatna vprašanja, se posvetujte z zdravnikom, farmacevtom ali medicinsko sestro.
These may affect up to 1 in 1,000 people: • eye pain
Pojavijo se lahko pri največ 1 od 10 bolnikov: • hitrejše bitje srca,
PHARMACOLOGICAL PROPERTIES 5.1 Pharmacodynamic properties
5.1 Farmakodinamične lastnosti
Don't breathe out into the inhaler.
Ne izdihnite v inhalator.
When the tray is opened, write the “Discard by” date on the inhaler label in the space provided.
Ko embalažo odprete, v predvideni prostor na nalepki inhalatorja vpišite datum "Zavrzite do".
Rolufta Ellipta is for inhalation use only.
Zdravilo Rolufta Ellipta je namenjeno samo za inhalacijsko uporabo.
The active substance is umeclidinium bromide.
Učinkovina je umeklidinijev bromid.
In two 12-week, placebo controlled studies (200109 and 200110), the addition of Rolufta Ellipta to fluticasone furoate/vilanterol (FF/VI) (92/22 micrograms) once daily in adult patients with a clinical diagnosis of COPD, resulted in statistically significant and clinically meaningful improvements in the primary endpoint of trough FEV1 at Day 85 compared to placebo plus FF/VI (124 mL 95% CI: 93, 154; p<0.001 and 122 mL 95% CI: 91, 152; p<0.001).
V dveh 12-tedenskih, s placebom kontroliranih študijah (200109 in 200110) je dodatek zdravila Rolufta Ellipta kombinaciji flutikazonfuroat/vilanterol (FF/VI) (92/22 mikrogramov) enkrat na dan v primerjavi s placebom in FF/VI pri odraslih bolnikih s klinično diagnozo KOPB po 85 dneh dosegel statistično značilno in klinično pomembno izboljšanje primarnega opazovanega dogodka, najnižje vrednosti FEV1 (124 ml 95
A decision must be made whether to discontinue breast-feeding or to discontinue Rolufta Ellipta therapy taking into account the benefit of breastfeeding for the child and the benefit of therapy for the woman.
Ellipta, upoštevaje koristi dojenja za otroka in koristi zdravljenja za žensko.
Tabulated summary of adverse reactions
Povzetek neželenih učinkov v preglednici
1 inhaler of 30 doses.
1 inhalator s 30 odmerki
3) Inhale your medicine • While holding the inhaler away from your mouth, breathe out as far as is comfortable.
• Medtem ko inhalator držite odmaknjen od ust, izdihnite čim bolj globoko, a ne toliko, da bi bilo neprijetno.
Medicinal product subject to medical prescription.
Predpisovanje in izdaja zdravila je le na recept.
Versus Placebo mcg = micrograms 1.least squares mean (95% confidence interval)
V primerjavi s placebom µg = mikrogrami
But not breathing out into the inhaler.
Vendar ne izdihnite v inhalator.
Following inhaled administration of umeclidinium bromide in healthy volunteers, Cmax occurred at 5 to 15 minutes.
Pri zdravih prostovoljcih je bila Cmax dosežena v 5 do 15 minutah po inhaliranju umeklidinijevega bromida.
MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE
IZDELOVALEC (IZDELOVALCI), ODGOVOREN (ODGOVORNI) ZA SPROŠČANJE
Each delivered dose contains 55 micrograms umeclidinium (equivalent to 65 micrograms of umeclidinium bromide).
En oddani odmerek vsebuje 55 mikrogramov umeklidinija (to ustreza 65 mikrogramom umeklidinijevega bromida).
In the 12-week study, a statistically significant improvement compared with placebo in the TDI focal score at Week 12 was not demonstrated for Rolufta Ellipta (1.0 units, p=0.05).
V 12-tedenski študiji z zdravilom Rolufta Ellipta v primerjavi s placebom niso ugotovili statistično značilnega izboljšanja fokalnega seštevka TDI po 12 tednih (1,0 enota, p = 0,05).
Each single inhalation provides a delivered dose (the dose leaving the mouthpiece) of 55 micrograms umeclidinium (equivalent to 65 micrograms of umeclidinium bromide).
Ena inhalacija zagotavlja oddani odmerek (odmerek, ki pride iz ustnika inhalatorja) 55 mikrogramov umeklidinija (kar ustreza 65 mikrogramom umeklidinijevega bromida).
In a Phase III, 6-month study (DB2113373) Rolufta Ellipta provided a clinically meaningful improvement over placebo in lung function (as measured by forced expiratory volume in 1 second [FEV1]) over 24 hours following once daily administration, which was evident at 30 minutes following administration of the first dose (improvement over placebo by 102 mL, p<0.001*).
V 6-mesečni študiji III. faze (DB2113373) je zdravilo Rolufta Ellipta v primerjavi s placebom klinično pomembno izboljšal pljučno funkcijo (merjeno s forsiranim ekspiracijskim volumnom v 1. sekundi [FEV1])
United Kingdom or
Velika Britanija ali
Therefore, umeclidinium bromide should be used with caution in patients with severe cardiovascular disorders, particularly cardiac arrhythmias.
Zato je treba pri bolnikih s hudimi kardiovaskularnimi motnjami, še zlasti motnjami srčnega ritma,
Clinically significant interactions mediated by umeclidinium bromide at clinical doses are considered unlikely due to the low plasma concentrations achieved after inhaled dosing.
Po inhalacijski uporabi je v plazmi dosežena koncentracija učinkovine majhna, zato klinično pomembna medsebojna delovanja zaradi umeklidinijevega bromida med uporabo kliničnih odmerkov niso verjetna.
Other side effects
Ostali neželeni učinki
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS INHALER LABEL
PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MANJŠIH STIČNIH OVOJNINAH
The MAH shall complete, within the stated timeframe, the below measure:
Imetnik dovoljenja za promet z zdravilom mora v določenem časovnem okviru izvesti naslednje ukrepe:
The tray is sealed with a peelable foil lid.
Embalaža je zaprta s pokrovom iz folije.
PARTICULARS TO APPEAR ON THE OUTER PACKAGING INTERMEDIATE OUTER CARTON (WITHOUT BLUE BOX- MULTIPACK ONLY) 55 micrograms
VMESNA ZUNANJA OVOJNINA (BREZ MODREGA OKENCA - SAMO PAKIRANJE Z VEČ INHALATORJI)
PHARMACEUTICAL PARTICULARS 6.1 List of excipients
FARMACEVTSKI PODATKI 6.1 Seznam pomožnih snovi laktoza monohidrat magnezijev stearat
The inhaler should not be shaken.
Inhalatorja ne smete stresati.
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*).
V 24-tedenski s placebom kontrolirani študiji pri bolnikih s simptomatsko KOPB je zdravilo Rolufta Ellipta zmanjšalo tveganje za zmerno/hudo poslabšanje KOPB za 40 % v primerjavi s placebom (analiza časa do prvega poslabšanja; razmerje ogroženosti 0,6; 95 % IZ: 0,4, 1,0; p = 0,035∗).Verjetnost poslabšanja je bila po 24 tednih 8,9 % med bolniki, ki so prejemali zdravilo Rolufta Ellipta in 13,7 % med bolniki, ki so
Do not use this medicine to relieve a sudden attack of breathlessness or wheezing.
Zdravila Rolufta Ellipta ne smete uporabljati za ublažitev nenadnega napada težkega ali piskajočega dihanja.
MARKETING AUTHORISATION HOLDER
Imetnik dovoljenja za promet
If you get eye pain or discomfort, temporary blurring of vision, visual halos or coloured images in association with red eyes during treatment with Rolufta Ellipta:
Če se vam med zdravljenjem z zdravilom Rolufta Ellipta pojavijo bolečine ali nelagodje v očesu, prehodna zamegljenost vida, videnje odsevov okrog stvari ali obarvane slike skupaj s pordelimi očmi: Prenehajte uporabljati to zdravilo in nemudoma poiščite zdravniško pomoč; to so lahko znaki akutnega napada glavkoma z ozkim zakotjem.
The tray contains a desiccant sachet, to reduce moisture.
Embalaža vsebuje vrečko s sušilom za zmanjšanje vlažnosti.
Pack sizes of 7 and 30 dose inhaler.
Velikosti pakiranja je inhalator s 7 ali 30 odmerki.
Inhalation use.
za inhaliranje
Renal impairment
Okvara ledvic
• Dizziness
• omotica.
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.
tedenski študiji so z zdravilom Rolufta Ellipta v primerjavi s placebom ugotovili večje izboljšanje v spremembi celotnega seštevka SGRQ od izhodišča (-4,69 enote, p < 0,001∗).
2) Prepare a dose
3) Vdihnite zdravilo
In the 12-week study, Rolufta Ellipta statistically significantly reduced the use of rescue medication with salbutamol compared with placebo (on average a reduction of 0.7 puffs per day over Weeks 1-12, p=0.025) and demonstrated a higher percentage of days when no rescue medication was needed (on average 46.3%) compared with placebo (on average 35.2%; no formal statistical analysis was performed on this endpoint).
tedna, p = 0,025) in je doseglo večji odstotek dni brez potrebe po rešilnem zdravilu (povprečno 46,3 %) kot placebo (povprečno 35,2 %; formalne statistične analize tega opazovanega dogodka niso izvedli).
An approximately 1.3-fold increase in umeclidinium bromide AUC was observed at an 8fold higher dose with no effect on umeclidinium bromide Cmax.
Verapamil ni vplival na Cmax umeklidinijevega bromida, ugotovili pa so približno 1,4-kratno povečanje AUC umeklidinijevega bromida.
An approximately 1.4-fold increase in umeclidinium bromide AUC was observed.
Pri 8-krat višjem odmerku se je AUC umeklidinijevega bromida povečala za približno
What Rolufta Ellipta is used for
Za kaj se uporablja zdravilo Rolufta Ellipta
If you get tightness of the chest, coughing, wheezing or breathlessness immediately after using your Rolufta Ellipta inhaler:
Če se vam takoj po uporabi inhalatorja Rolufta Ellipta pojavi tiščanje v prsih, kašelj, piskajoče dihanje ali težko dihanje:
Inhalation powder, pre-dispensed.
Prašek za inhaliranje, odmerjeni.
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.
Pri preiskovancih z zmerno okvaro jeter (Child-Pugh B) niso ugotovili večje sistemske izpostavljenosti umeklidinijevemu bromidu (Cmax in AUC).
Rolufta Ellipta contains lactose
Zdravilo Rolufta Ellipta vsebuje laktozo
PARTICULARS TO APPEAR ON THE OUTER PACKAGING BUNDLE LABEL (WITH BLUE BOX - MULTIPACK) 55 micrograms
NALEPKA NA SKUPNEM PAKIRANJU (Z MODRIM OKENCEM - PAKIRANJE Z VEČ INHALATORJI)
How to use Rolufta Ellipta
Kako uporabljati zdravilo Rolufta Ellipta
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.
Od izhodišča je zdravilo Rolufta Ellipta v primerjavi s placebom v 12-tedenski ključni študiji po 12 tednih doseglo statistično značilno večje izboljšanje uteženega povprečnega FEV1 v obdobju od 0 do 6 ur po uporabi odmerka (166 ml, p < 0,001).
Constipation Dry mouth common Uncommon
Bolezni prebavil zaprtje suha usta pogosti občasni
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.
Po uporabi antagonistov muskarinskih receptorjev, vključno z umeklidinijevim bromidom, se lahko pojavijo učinki na srce in ožilje, npr. motnje srčnega ritma, kakršni sta atrijska fibrilacija in tahikardija.
- If you get any side effects, talk to your doctor, pharmacist or nurse.
- Če opazite kateri koli neželeni učinek, se posvetujte z zdravnikom, farmacevtom ali medicinsko sestro.
Other special populations
Druge posebne skupine bolnikov
• cough
• kašelj,
If you get any side effects, talk to your doctor, pharmacist or nurse.
Če opazite kateri koli neželeni učinek, se posvetujte z zdravnikom, farmacevtom ali medicinsko sestro.
If you stop using Rolufta Ellipta
Če ste pozabili uporabiti zdravilo Rolufta Ellipta
A statistically significant improvement compared with placebo in the TDI focal score at Week 24 was demonstrated for Rolufta Ellipta (1.0 units, p<0.001) in the 24-week study.
V 24-tedenski študiji so z zdravilom Rolufta Ellipta v primerjavi s placebom ugotovili statistično značilno izboljšanje fokalnega seštevka TDI po 24 tednih (1,0 enota, p < 0,001).
Rolufta Ellipta 55 micrograms inhalation powder, pre-dispensed umeclidinium (umeclidinium bromide)
Rolufta Ellipta 55 mikrogramov prašek za inhaliranje, odmerjeni umeklidinij (umeklidinijev bromid)
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.
Podobno je v 24-tedenskih študiji po 24 tednih vsaj minimalno klinično pomembno razliko s 55 mikrogrami zdravila Rolufta Ellipta dosegel večji delež bolnikov (44 %) kot s placebom (34 %).
In use shelf-life: 6 weeks.
Rok uporabnosti po prvem odprtju: 6 tednov.
Wait to open the cover until you are ready to inhale your dose.
Pokrovček odprite šele, ko ste pripravljeni, da vdihnete odmerek.
ANNEX III LABELLING AND PACKAGE LEAFLET
OZNAČEVANJE IN NAVODILO ZA UPORABO
Rolufta Ellipta 55 mcg inhalation powder umeclidinium (umeclidinium bromide)
Rolufta Ellipta 55 µg prašek za inhaliranje umeklidinij (umeklidinijev bromid)
The inhaler will be in the ‘closed' position when it is first taken out of its sealed tray.
Ko bolnik inhalator prvič vzame iz embalaže, je v položaju ˝zaprto˝.
Hypersensitivity reactions including: Rash, urticaria and pruritus
Bolezni imunskega sistema preobčutljivostne reakcije, ki vključujejo: izpuščaj, urtikarijo in pruritus občasni
Effects on lung function
Ključne študije učinkovitosti: Učinki na delovanje pljuč
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.
Zdravilo Rolufta Ellipta je tudi statistično značilno izboljšalo zdravstveno kakovost življenja, merjeno z vprašalnikom SGRQ (St. George's Respiratory Questionnaire).
Carton
TRAKU
No effect on umeclidinium AUC or Cmax was observed at a dose 4-fold higher than the therapeutic dose.
Pri odmerku, 4-krat višjem od terapevtskega odmerka, niso opazili vpliva na AUC ali Cmax umeklidinija.
Renal and urinary disorders Urinary retention Dysuria
Bolezni sečil zastoj urina dizurija neznana pogostnost neznana pogostnost
Do not shake the inhaler.
Inhalatorja ne stresajte.
Check with your doctor if you think any of these may apply to you.
Če menite, da kaj od tega velja za vas, se posvetujte z zdravnikom.