FrancophonIA/ELRC3.0 huggingface dataset:
English: A. MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE
Slovenian: A. IZDELOVALEC (IZDELOVALCI), ODGOVOREN (ODGOVORNI) ZA SPROŠČANJE SERIJ
English: Due date
Slovenian: DRUGI PODATKI
English: System Organ Class
Slovenian: Organski sistem
English: There are no data on the effects of umeclidinium bromide on human fertility.
Slovenian: Podatkov o vplivu umeklidinijevega bromida na plodnost pri človeku ni.
English: • headache
Slovenian: • glavobol
English: 4) Close the inhaler
Slovenian: 4) Zaprite pokrovček inhalatorja
English: 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).
Slovenian: 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).
English: Rolufta Ellipta should not be used to relieve a sudden attack of breathlessness or wheezing.
Slovenian: Zdravila Rolufta Ellipta se ne sme uporabljati za ublažitev nenadnega napada težkega ali piskajočega dihanja.
English: Possible side effects
Slovenian: Možni neželeni učinki
English: The mean peak improvements in FEV1 within the first 6 hours following dosing relative to placebo were 130 ml (p<0.001*) at Week 24.
Slovenian: Povprečno največje izboljšanje FEV1 v prvih 6 urah po uporabi odmerka je bilo v primerjavi s placebom 130 ml (p < 0,001∗) 24. teden.
English: Umeclidinium bromide has not been evaluated in subjects with severe hepatic impairment.
Slovenian: Umeklidinijevega bromida niso ocenili pri preiskovancih s hudo okvaro jeter.
English: Distribution
Slovenian: Porazdelitev
English: Multipacks containing 90 (3 inhalers of 30) doses are also available.
Slovenian: Na voljo je tudi pakiranje z več inhalatorji, ki vsebuje 90 (3 inhalatorji po 30) odmerkov.
English: White powder in a grey inhaler (Ellipta) with a light green mouthpiece cover and a dose counter.
Slovenian: Bel prašek v sivem inhalatorju (Ellipta) s svetlo zelenim pokrovčkom ustnika in števcem odmerkov.
English: • irregular heart beat
Slovenian: • neredno bitje srca,
English: The proportion of patients who responded with at least the minimum clinically important difference (MCID) of 1 unit TDI focal score at Week 12 was greater for Rolufta Ellipta (38%) compared with placebo (15%) in the 12-week study.
Slovenian: 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 %).
English: ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS
Slovenian: POVZETEK GLAVNIH ZNAČILNOSTI ZDRAVILA
English: In the 24-week study treatment with Rolufta Ellipta, the mean (SD) change from baseline in the number of puffs of rescue salbutamol over the 24-week treatment period was -1.4 (0.20) for placebo and -1.7 (0.16) for Rolufta Ellipta (Difference = -0.3; 95% CI: -0.8, 0.2, p=0.276).
Slovenian: 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).
English: EXP In use shelf-life: 6 weeks.
Slovenian: EXP Rok uporabnosti po prvem odprtju: 6 tednov.
English: Inhalation powder, pre-dispensed (inhalation powder).
Slovenian: Prašek za inhaliranje, odmerjeni (prašek za inhaliranje).
English: Consistent with its antimuscarinic activity, umeclidinium bromide should be used with caution in patients with urinary retention or with narrow-angle glaucoma.
Slovenian: Glede na antimuskarinsko delovanje umeklidinijevega bromida je treba to zdravilo pri bolnikih z zastojem urina ali glavkomom z ozkim zakotjem uporabljati previdno.
English: What Rolufta Ellipta looks like and contents of the pack
Slovenian: Izgled zdravila Rolufta Ellipta in vsebina pakiranja
English: Umeclidinium bromide is a substrate of cytochrome P450 2D6 (CYP2D6).
Slovenian: Presnovne interakcije in interakcije na podlagi prenašalcev Umeklidinijev bromid je substrat citokroma P450 2D6 (CYP2D6).
English: When you are ready to use your inhaler, peel back the lid to open the tray.
Slovenian: Ko ste pripravljeni za uporabo vašega inhalatorja, odlepite pokrov embalaže.
English: 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.
Slovenian: Primarne poti presnove umeklidinijevega bromida so oksidativne (hidroksilacija, O-dealkilacija), ki jim sledijo konjugacijske (glukuronidacija itn.).
English: This breath should be held in for as long as possible (at least 3-4 seconds).
Slovenian: (vsaj 3 do 4 sekunde).
English: Other medicines and Rolufta Ellipta
Slovenian: Druga zdravila in zdravilo Rolufta Ellipta
English: 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.
Slovenian: uporabljenega radioaktivno označenega odmerka (oziroma 73 % najdene radioaktivnosti) pojavilo v blatu do 192 ur po odmerku.
English: 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
Slovenian: če imate povečano prostato, težave pri odvajanju urina, ali zaporo v mehurju, če imate hudo okvaro jeter,
English: 7 doses
Slovenian: 7 odmerkov
English: If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse.
Slovenian: Če imate dodatna vprašanja o uporabi zdravila, se posvetujte z zdravnikom, farmacevtom ali medicinsko sestro.
English: Rolufta Ellipta is an inhalation powder, pre-dispensed.
Slovenian: Zdravilo Rolufta Ellipta je prašek za inhaliranje, odmerjeni.
English: 1) Read this before you start If you open and close the cover without inhaling the medicine, you will lose the dose.
Slovenian: Če pokrovček odprete in zaprete, ne da bi vdihnili zdravilo, boste izgubili odmerek.
English: Reporting of suspected adverse reactions
Slovenian: Poročanje o neželenih učinkih
English: GlaxoSmithKline Trading Services Limited, Currabinny, Carrigaline, County Cork, Ireland GlaxoSmithKline Trading Service Limited logo
Slovenian: GlaxoSmithKline Trading Services Limited, Currabinny, Carrigaline, County Cork, Irska GlaxoSmithKline Trading Service Limited logo
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON (SINGLE PACKS) 55 micrograms
Slovenian: PODATKI NA ZUNANJI OVOJNINI ZUNANJA OVOJNINA (PAKIRANJA Z ENIM INHALATORJEM) 55 mikrogramov
English: Multipack of 3 x 30 dose inhalers.
Slovenian: Pakiranje z več inhalatorji 3 x 30 odmerkov.
English: How to store Rolufta Ellipta 6.
Slovenian: Shranjevanje zdravila Rolufta Ellipta 6.
English: In both of the pivotal 12-week and 24-week studies, Rolufta Ellipta demonstrated statistically significant and clinically meaningful improvements in lung function (as defined by change from baseline trough FEV1 at Week 12 and Week 24 respectively, which was the primary efficacy endpoint in each study) compared with placebo (see Table 1).
Slovenian: 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).
English: Skin and subcutaneous tissue disorders
Slovenian: Bolezni kože in podkožja izpuščaj občasni
English: GlaxoSmithKline Trading Services Limited, Currabinny, Carrigaline, County Cork, Ireland GlaxoSmithKline Trading Services Limited logo
Slovenian: GlaxoSmithKline Trading Services Limited, Currabinny, Carrigaline, County Cork, Irska GlaxoSmithKline Trading Services Limited logo
English: Discard by:
Slovenian: Zavrzite do:
English: It is packaged in a foil laminate tray with a peelable foil lid.
Slovenian: Pakiran je v embalaži iz laminatne folije, ki vsebuje vrečko s sušilom.
English: Respiratory, thoracic and mediastinal disorders
Slovenian: Bolezni dihal, prsnega koša in mediastinalnega prostora kašelj pogosti
English: The Ellipta inhaler consists of a grey plastic body, a light green mouthpiece cover and a dose counter.
Slovenian: Inhalator Ellipta je sestavljen iz svetlo sivega plastičnega ohišja, zelenega pokrovčka ustnika in števca odmerkov.
English: At Week 52, a statistically significant improvement in the least-squares (LS) mean change from baseline in trough FEV1 was observed for FF/UMEC/VI compared with FF/VI (mean change: +94 mL vs. -3 mL; treatment difference: 97 mL; 95% CI: 85, 109; p<0.001).
Slovenian: 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).
English: If you are breast-feeding, you must check with your doctor before you use Rolufta Ellipta.
Slovenian: Če dojite, se morate pred uporabo zdravila Rolufta Ellipta posvetovati z zdravnikom.
English: Package leaflet: Information for the user Rolufta Ellipta 55 micrograms inhalation powder, pre-dispensed umeclidinium (umeclidinium bromide) This medicine is subject to additional monitoring.
Slovenian: Navodilo za uporabo Rolufta Ellipta 55 mikrogramov prašek za inhaliranje, odmerjeni umeklidinij (umeklidinijev bromid) Za to zdravilo se izvaja dodatno spremljanje varnosti.
English: Rolufta Ellipta 55 micrograms inhalation powder, pre-dispensed
Slovenian: Rolufta Ellipta 55 mikrogramov prašek za inhaliranje, odmerjeni
English: The proportion of patients who responded with at least the MCID in SGRQ score (defined as a decrease of 4 units from baseline) at Week 12 was greater for Rolufta Ellipta 55 micrograms (44%) compared with placebo (26%) in the 12-week study.
Slovenian: 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 %).
English: Subjects with severe renal impairment (creatinine clearance <30mL/min) showed no evidence of an increase in systemic exposure to umeclidinium bromide (Cmax and AUC), and no evidence of altered protein binding between subjects with severe renal impairment and healthy volunteers.
Slovenian: Pri preiskovancih s hudo okvaro ledvic (očistek kreatinina < 30 ml/min) niso ugotovili večje sistemske izpostavljenosti umeklidinijevemu bromidu (Cmax in AUC).
English: Rolufta Ellipta is for inhalation use.
Slovenian: Zdravilo Rolufta 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: No new adverse drug reactions were identified with the addition of Rolufta Ellipta to FF/VI in these studies.
Slovenian: V teh študijah niso ugotovili novih neželenih učinkov med uporabo zdravila Rolufta Ellipta ob FF/VI.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
Slovenian: DATUM PRIDOBITVE/PODALJŠANJA DOVOLJENJA ZA PROMET Z ZDRAVILOM
English: - If you have any further questions, ask your doctor, pharmacist or nurse.
Slovenian: - Če imate dodatna vprašanja, se posvetujte z zdravnikom, farmacevtom ali medicinsko sestro.
English: These may affect up to 1 in 1,000 people: • eye pain
Slovenian: Pojavijo se lahko pri največ 1 od 10 bolnikov: • hitrejše bitje srca,
English: PHARMACOLOGICAL PROPERTIES 5.1 Pharmacodynamic properties
Slovenian: 5.1 Farmakodinamične lastnosti
English: Don't breathe out into the inhaler.
Slovenian: Ne izdihnite v inhalator.
English: When the tray is opened, write the “Discard by” date on the inhaler label in the space provided.
Slovenian: Ko embalažo odprete, v predvideni prostor na nalepki inhalatorja vpišite datum "Zavrzite do".
English: Rolufta Ellipta is for inhalation use only.
Slovenian: Zdravilo Rolufta Ellipta je namenjeno samo za inhalacijsko uporabo.
English: The active substance is umeclidinium bromide.
Slovenian: Učinkovina je umeklidinijev bromid.
English: 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).
Slovenian: 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
English: 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.
Slovenian: Ellipta, upoštevaje koristi dojenja za otroka in koristi zdravljenja za žensko.
English: Tabulated summary of adverse reactions
Slovenian: Povzetek neželenih učinkov v preglednici
English: 1 inhaler of 30 doses.
Slovenian: 1 inhalator s 30 odmerki
English: 3) Inhale your medicine • While holding the inhaler away from your mouth, breathe out as far as is comfortable.
Slovenian: • Medtem ko inhalator držite odmaknjen od ust, izdihnite čim bolj globoko, a ne toliko, da bi bilo neprijetno.
English: Medicinal product subject to medical prescription.
Slovenian: Predpisovanje in izdaja zdravila je le na recept.
English: 4.8 Undesirable effects
Slovenian: Neželeni učinki
English: What is in this leaflet
Slovenian: Kaj vsebuje navodilo
English: - This medicine has been prescribed for you only.
Slovenian: - Zdravilo je bilo predpisano vam osebno in ga ne smete dajati drugim.
English: Versus Placebo mcg = micrograms 1.least squares mean (95% confidence interval)
Slovenian: V primerjavi s placebom µg = mikrogrami
English: But not breathing out into the inhaler.
Slovenian: Vendar ne izdihnite v inhalator.
English: Following inhaled administration of umeclidinium bromide in healthy volunteers, Cmax occurred at 5 to 15 minutes.
Slovenian: Pri zdravih prostovoljcih je bila Cmax dosežena v 5 do 15 minutah po inhaliranju umeklidinijevega bromida.
English: MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE
Slovenian: IZDELOVALEC (IZDELOVALCI), ODGOVOREN (ODGOVORNI) ZA SPROŠČANJE
English: Each delivered dose contains 55 micrograms umeclidinium (equivalent to 65 micrograms of umeclidinium bromide).
Slovenian: En oddani odmerek vsebuje 55 mikrogramov umeklidinija (to ustreza 65 mikrogramom umeklidinijevega bromida).
English: Tel: + 46 (0)8 638 93 00 info.produkt@gsk.com
Slovenian: GlaxoSmithKline AB Tel: + 46 (0)8 638 93 00 info.produkt@gsk.com
English: 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).
Slovenian: 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).
English: Each single inhalation provides a delivered dose (the dose leaving the mouthpiece) of 55 micrograms umeclidinium (equivalent to 65 micrograms of umeclidinium bromide).
Slovenian: Ena inhalacija zagotavlja oddani odmerek (odmerek, ki pride iz ustnika inhalatorja) 55 mikrogramov umeklidinija (kar ustreza 65 mikrogramom umeklidinijevega bromida).
English: 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*).
Slovenian: 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])
English: United Kingdom or
Slovenian: Velika Britanija ali
English: Therefore, umeclidinium bromide should be used with caution in patients with severe cardiovascular disorders, particularly cardiac arrhythmias.
Slovenian: Zato je treba pri bolnikih s hudimi kardiovaskularnimi motnjami, še zlasti motnjami srčnega ritma,
English: Clinically significant interactions mediated by umeclidinium bromide at clinical doses are considered unlikely due to the low plasma concentrations achieved after inhaled dosing.
Slovenian: Po inhalacijski uporabi je v plazmi dosežena koncentracija učinkovine majhna, zato klinično pomembna medsebojna delovanja zaradi umeklidinijevega bromida med uporabo kliničnih odmerkov niso verjetna.
English: Other side effects
Slovenian: Ostali neželeni učinki
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS INHALER LABEL
Slovenian: PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MANJŠIH STIČNIH OVOJNINAH
English: The MAH shall complete, within the stated timeframe, the below measure:
Slovenian: Imetnik dovoljenja za promet z zdravilom mora v določenem časovnem okviru izvesti naslednje ukrepe:
English: The tray is sealed with a peelable foil lid.
Slovenian: Embalaža je zaprta s pokrovom iz folije.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING INTERMEDIATE OUTER CARTON (WITHOUT BLUE BOX- MULTIPACK ONLY) 55 micrograms
Slovenian: VMESNA ZUNANJA OVOJNINA (BREZ MODREGA OKENCA - SAMO PAKIRANJE Z VEČ INHALATORJI)
English: PHARMACEUTICAL PARTICULARS 6.1 List of excipients
Slovenian: FARMACEVTSKI PODATKI 6.1 Seznam pomožnih snovi laktoza monohidrat magnezijev stearat
English: The inhaler should not be shaken.
Slovenian: Inhalatorja ne smete stresati.
English: In the 24-week placebo-controlled study in patients with symptomatic COPD, Rolufta Ellipta reduced the risk of a moderate/severe COPD exacerbation by 40% compared with placebo (analysis of time to first exacerbation; Hazard Ratio 0.6; 95% CI: 0.4, 1.0, p=0.035*).
Slovenian: 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
English: Do not use this medicine to relieve a sudden attack of breathlessness or wheezing.
Slovenian: Zdravila Rolufta Ellipta ne smete uporabljati za ublažitev nenadnega napada težkega ali piskajočega dihanja.
English: MARKETING AUTHORISATION HOLDER
Slovenian: Imetnik dovoljenja za promet
English: 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:
Slovenian: 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.
English: The tray contains a desiccant sachet, to reduce moisture.
Slovenian: Embalaža vsebuje vrečko s sušilom za zmanjšanje vlažnosti.
English: Pack sizes of 7 and 30 dose inhaler.
Slovenian: Velikosti pakiranja je inhalator s 7 ali 30 odmerki.
English: Inhalation use.
Slovenian: za inhaliranje
English: Fertility
Slovenian: Plodnost
English: Renal impairment
Slovenian: Okvara ledvic
English: • Dizziness
Slovenian: • omotica.
English: A greater improvement compared with placebo in the change from baseline in SGRQ total score at Week 24 was demonstrated for Rolufta Ellipta (-4.69 units, p<0.001∗) in the 24-week study.
Slovenian: 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∗).
English: 2) Prepare a dose
Slovenian: 3) Vdihnite zdravilo
English: 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).
Slovenian: 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).
English: Rare side effects
Slovenian: Redki neželeni učinki
English: An approximately 1.3-fold increase in umeclidinium bromide AUC was observed at an 8fold higher dose with no effect on umeclidinium bromide Cmax.
Slovenian: Verapamil ni vplival na Cmax umeklidinijevega bromida, ugotovili pa so približno 1,4-kratno povečanje AUC umeklidinijevega bromida.
English: An approximately 1.4-fold increase in umeclidinium bromide AUC was observed.
Slovenian: Pri 8-krat višjem odmerku se je AUC umeklidinijevega bromida povečala za približno
English: What Rolufta Ellipta is used for
Slovenian: Za kaj se uporablja zdravilo Rolufta Ellipta
English: If you get tightness of the chest, coughing, wheezing or breathlessness immediately after using your Rolufta Ellipta inhaler:
Slovenian: Če se vam takoj po uporabi inhalatorja Rolufta Ellipta pojavi tiščanje v prsih, kašelj, piskajoče dihanje ali težko dihanje:
English: Inhalation powder, pre-dispensed.
Slovenian: Prašek za inhaliranje, odmerjeni.
English: Subjects with moderate hepatic impairment (Child-Pugh Class B) showed no evidence of an increase in systemic exposure to umeclidinium bromide (Cmax and AUC), and no evidence of altered protein binding between subjects with moderate hepatic impairment and healthy volunteers.
Slovenian: Pri preiskovancih z zmerno okvaro jeter (Child-Pugh B) niso ugotovili večje sistemske izpostavljenosti umeklidinijevemu bromidu (Cmax in AUC).
English: Rolufta Ellipta contains lactose
Slovenian: Zdravilo Rolufta Ellipta vsebuje laktozo
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING BUNDLE LABEL (WITH BLUE BOX - MULTIPACK) 55 micrograms
Slovenian: NALEPKA NA SKUPNEM PAKIRANJU (Z MODRIM OKENCEM - PAKIRANJE Z VEČ INHALATORJI)
English: How to use Rolufta Ellipta
Slovenian: Kako uporabljati zdravilo Rolufta Ellipta
English: Rolufta Ellipta demonstrated a statistically significant greater improvement from baseline in weighted mean FEV1 over 0-6 hours post-dose at Week 12 compared with placebo (166 ml, p<0.001) in the 12-week pivotal study.
Slovenian: 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).
English: Constipation Dry mouth common Uncommon
Slovenian: Bolezni prebavil zaprtje suha usta pogosti občasni