FrancophonIA/ELRC3.0 huggingface dataset:
English: In a 24-week placebo-controlled study in patients with symptomatic COPD, ANORO 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 ANORO 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*); za 20 % v primerjavi z umeklidinijem (ROg 0,8; 95 % IZ: 0,5; 1,3, p = 0,391) in za 30 % v primerjavi z vilanterolom (ROg 0,7; 95 % IZ: 0,4; 1,1, p = 0,121).
English: In one active-comparator study, a higher percentage of patients receiving ANORO 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 ANORO ELLIPTA (53 %) kot prejemnikov tiotropija (46 %).
English: The inhaler is a multi-component device composed of polypropylene, high density polyethylene, polyoxymethylene, polybutylene terephthalate, acrylonitrile butadiene styrene, polycarbonate and stainless steel.
Slovenian: polibutilentereftalata, akrilonitril butadienstirena, polikarbonata in nerjavečega jekla.
English: GlaxoSmithKline UK Ltd Tel: + 44 (0)800 221441 customercontactuk@gsk.com
Slovenian: GlaxoSmithKline UK Tel: + 44 (0)800 221441 customercontactuk@gsk.com
English: • Put the mouthpiece between your lips, and close your lips firmly around it.
Slovenian: • Položite ustnik čvrsto med ustnici .
English: Don't use more than your doctor tells you to use.
Slovenian: Ne uporabite več zdravila, kot vam je naročil zdravnik.
English: • infection of the upper airways.
Slovenian: • okužba zgornjih dihal.
English: ANORO ELLIPTA (N = 454) versus tiotropium 18 mcg (N = 451) (Study ZEP117115)
Slovenian: 18 µg tiotropija (N = 451) (študija ZEP117115)
English: In addition, ANORO 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: Poleg tega je zdravilo ANORO 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: ANORO 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 ANORO 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: The effect of umeclidinium/vilanterol on the QT interval was evaluated in a placebo and active (moxifloxacin) controlled QT study involving once daily administration of umeclidinium/vilanterol 113/22 micrograms or 500/100 micrograms (pre-dispensed dose with umeclidinium at eight times the recommended dose and vilanterol at four times the recommended dose) for 10 days in 103 healthy volunteers.
Slovenian: Vpliv kombinacije umeklidinij/vilanterol na interval QT so ocenili v študiji QT, kontrolirani s placebom in zdravilno učinkovino (moksifloksacin); v tej študiji so 103 zdravi prostovoljci enkrat na dan 10 dni dobivali kombinacijo umeklidinij/vilanterol 133/22 mikrogramov ali 500/100 mikrogramov (odmerjeni odmerek z umeklidinijem v osemkratnem in z vilanterolom v štirikratnem priporočenem odmerku).
English: Treatment with umeclidinium/vilanterol should be discontinued immediately if paradoxical bronchospasm occurs and alternative therapy instituted if necessary.
Slovenian: Če se pojavi paradoksni bronhospazem, je treba zdravljenje s kombinacijo umeklidinij/vilanterol takoj prekiniti in po potrebi uvesti drugo zdravljenje.
English: The maximum mean difference in prolongations of QT interval (corrected using the Fridericia method, QTcF) from placebo after baseline-correction was 4.3 (90% CI=2.2 to 6.4) milliseconds seen 10 minutes after administration with umeclidinium/vilanterol 113/22 micrograms and 8.2 (90% CI=6.2 to 10.2) milliseconds seen 30 minutes after administration with umeclidinium/vilanterol 500/100 micrograms.
Slovenian: Največjo povprečno razliko v podaljšanju intervala QT (korigiranega po Fridericijevi metodi QTcF) od placeba po izhodiščni korekciji, ki je bila 4,3 (90 % IZ = 2,2 do 6,4) milisekund, so opazili 10 minut po uporabi kombinacije umeklidinij/vilanterol v odmerkih 113/22 mikrogramov in 8,2 (90 % IZ = 6,2 do 10,2) milisekund 30 minut po uporabi kombinacije umeklidinij/vilanterol v odmerkih 500/100 mikrogramov.
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 ≥ 22
English: This corresponds to a pre-dispensed dose of 74.2 micrograms umeclidinium bromide equivalent to 62.5 micrograms umeclidinium and 25 micrograms vilanterol (as trifenatate).
Slovenian: To ustreza odmerjenemu odmerku 74,2 mikrogramov umeklidinijevega bromida, kar ustreza 62,5 mikrogramom umeklidinija in 25 mikrogramov vilanterola (v obliki trifenatata).
English: A higher dose of umeclidinium/vilanterol (113/22 micrograms) was also studied in a 24-week placebo controlled clinical study and in two of the three 24-week active-controlled studies.
Slovenian: Višji odmerek kombinacije umeklidinij/vilanterol (113/22 mikrogramov) so prav tako preučili v 24-tedenski klinični študiji, kontrolirani s placebom, in v dveh od treh 24-tedenskih študij, kontroliranih z zdravilno ∗V tej študiji je bil uporabljen postopek statističnega testiranja z zniževanjem in ta primerjava je bila pod primerjavo, ki ni dosegla statistične značilnosti.
English: If you get tightness of the chest, coughing, wheezing or breathlessness immediately after using this medicine:
Slovenian: Če se vam takoj po uporabi tega zdravila pojavi tiščanje v prsih, kašelj, piskajoče dihanje ali težko dihanje:
English: The active substances are present as a white powder in separate blisters inside the inhaler.
Slovenian: Učinkovini sta v inhalatorju v obliki belega praška v ločenih pretisnih omotih.
English: The Ellipta inhaler consists of a light grey plastic body, a red mouthpiece cover and a dose counter.
Slovenian: Inhalator Ellipta je sestavljen iz svetlo sivega plastičnega ohišja, rdečega pokrovčka ustnika in števca odmerkov.
English: Multipack of 3 x 30 dose inhalers.
Slovenian: Pakiranje z več inhalatorji - 3 x 30 odmerkov.
English: The maximum mean difference in heart rate from placebo after baseline-correction was 8.4 (90% CI=7.0 to 9.8) beats/minute and 20.3 (90% CI=18.9 to 21.7) beats/minute seen 10 minutes after administration of umeclidinium/vilanterol 113/22 micrograms and 500/100 micrograms respectively.
Slovenian: Največja povprečna razlika v hitrosti srčnega utripa od placeba po izhodiščni korekciji je bila 8,4 (90 % IZ = 7,0 do 9,8) utripov na minuto oziroma 20,3 (90 % IZ = 18,9 do 21,7) utripov na minuto, 10 minut po uporabi kombinacije umeklidinij/vilanterol v odmerku 113/22 mikrogramov oziroma 500/100 mikrogramov.
English: The active substances are umeclidinium bromide and vilanterol.
Slovenian: Učinkovini sta umeklidinijev bromid in vilanterol.
English: However, other beta2-adrenergic agonists are detected in human milk.
Slovenian: Vendar pa se pri človeku v materinem mleku pojavijo drugi agonisti adrenergičnih receptorjev beta2.
English: There was no increase in tumour incidence in rats or mice at exposures 0.5- or 13-fold, times the human clinical exposure of vilanterol 22 micrograms based on AUC, respectively.
Slovenian: Pri podganah in miših niso ugotovili večje incidence tumorjev ob izpostavljenostim vilanterolu, ki so na podlagi AUC predstavljale 0,5-kratno oziroma 13-kratno klinično izpostavljenost pri človeku z odmerkom 22 mikrogramov vilanterola.
English: The absolute bioavailability of inhaled umeclidinium was on average 13% of the dose, with negligible contribution from oral absorption.
Slovenian: Absolutna biološka uporabnost inhaliranega umeklidinijevega bromida je bila v povprečju 13 % odmerka;
English: Package leaflet: Information for the user ANORO ELLIPTA 55 micrograms/22 micrograms inhalation powder, pre-dispensed umeclidinium/vilanterol This medicine is subject to additional monitoring.
Slovenian: Navodilo za uporabo ANORO ELLIPTA 55 mikrogramov/22 mikrogramov prašek za inhaliranje, odmerjeni umeklidinij/vilanterol Za to zdravilo se izvaja dodatno spremljanje varnosti.
English: In vitro studies showed that vilanterol is primarily metabolised by cytochrome P450 3A4 (CYP3A4) and is a substrate for the P-gp transporter.
Slovenian: Študije in vitro so pokazale, da se vilanterol presnavlja predvsem s citokromom P450 3A4 (CYP3A4) in da je substrat transporterja P-glikoproteina (P-gp).
English: ANORO ELLIPTA is for inhalation use only.
Slovenian: Zdravilo ANORO ELLIPTA je namenjeno samo za inhalacijsko uporabo.
English: If you are breastfeeding, you must check with your doctor before you use ANORO ELLIPTA.
Slovenian: Če dojite, se morate pred uporabo zdravila ANORO ELLIPTA posvetovati z zdravnikom.
English: What ANORO ELLIPTA looks like and contents of the pack
Slovenian: Izgled zdravila ANORO ELLIPTA in vsebina pakiranja
English: Umeclidinium plasma elimination half-life following inhaled dosing for 10 days averaged 19 hours in healthy volunteers, with 3% to 4% excreted unchanged in urine at steady-state.
Slovenian: 19 ur pri zdravih prostovoljcih; v stanju dinamičnega ravnovesja se je od 3 % do 4 % nespremenjenega izločilo v urinu.
English: See package leaflet for further information.
Slovenian: Vsebina pakiranja in dodatne informacije
English: 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.
Slovenian: Primarne poti presnove umeklidinija so oksidativne (hidroksilacija, O-dealkilacija), sledijo pa jim konjugacijske (glukuronidacija itd.).
English: Frequency cannot be estimated from the available data: • dizziness.
Slovenian: Pogostnosti iz razpoložljivih podatkov ni mogoče oceniti.
English: There was no evidence for tachyphylaxis in the effect of ANORO ELLIPTA over time.
Slovenian: Znakov postopnega zmanjšanja učinkovitosti (tahifilaksije) zdravila ANORO ELLIPTA ni bilo.
English: medicines called beta blockers (such as propranolol), to treat high blood pressure or other heart problems 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. tiotropium, indacaterol.
Slovenian: 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), druga dolgodelujoča zdravila, podobna temu zdravilu, ki jih uporabljamo za zdravljenje težav z dihanjem, npr. tiotropij, indakaterol.
English: Lung function, symptomatic and health related quality of life outcomes at Week 24 Treatment comparisons with ANORO
Slovenian: Delovanje pljuč ter simptomatski izidi in izidi glede zdravstvene kakovosti življenja v
English: ANORO ELLIPTA is an inhalation powder, pre-dispensed.
Slovenian: Zdravilo ANORO ELLIPTA je prašek za inhaliranje, odmerjeni.
English: ANORO ELLIPTA is for inhalation use.
Slovenian: Zdravilo ANORO ELLIPTA je namenjeno za inhalacijsko uporabo.
English: Patients with severe renal impairment showed no evidence of an increase in systemic exposure to either umeclidinium or vilanterol (Cmax and AUC) following administration of umeclidinium/vilanterol with umeclidinium at twice the recommended dose and vilanterol at the recommended dose and no evidence of altered protein binding between patients with severe renal impairment and healthy volunteers.
Slovenian: Okvara ledvic Pri bolnikih s hudo okvaro ledvic po uporabi kombinacije umeklidinij/vilanterol (umeklidinij v dvakratnem priporočenem odmerku in vilanterol v priporočenem odmerku) niso ugotovili večje sistemske izpostavljenosti umeklidiniju ali vilanterolu (Cmax in AUC); prav tako pri bolnikih s hudo okvaro ledvic v primerjavi z zdravimi prostovoljci niso odkrili znakov spremenjene vezave na beljakovine.
English: Plasma metabolic profiles following oral administration of vilanterol in a human radiolabel study were consistent with high first-pass metabolism.
Slovenian: V študiji z radioaktivno označenim vilanterolom pri človeku so se plazemski presnovni profili po peroralni uporabi skladali z obsežno presnovo prvega prehoda.
English: Following inhaled administration of umeclidinium in healthy volunteers, Cmax occurred at 5 to 15 minutes.
Slovenian: Pri zdravih prostovoljcih je bila Cmax po inhaliranju umeklidinijevega bromida dosežena v 5 do 15 minutah.
English: Open the cover when ready to inhale a dose.
Slovenian: Odprite pokrovček, ko ste pripravljeni, da vdihnete odmerek.
English: The first time you use ANORO 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 ANORO ELLIPTA uporabite prvič, vam ni treba preverjati, ali inhalator deluje pravilno;
English: In the other two studies, the risk of a moderate/severe COPD exacerbation was increased by 20% and 90% (HR 1.2; 95% CI: 0.5, 2.6; p=0.709 and HR 1.9; 95% CI: 1.0, 3.6; p=0.062 respectively).
Slovenian: V drugih dveh študijah pa se je tveganje za zmerno/hudo poslabšanje KOPB povečalo za 20 % oziroma 90 % (ROg 1,2; 95 % IZ: 0,5; 2,6, p
English: Consistent with its antimuscarinic activity, umeclidinium/vilanterol should be used with caution in patients with urinary retention or with narrow-angle glaucoma.
Slovenian: Zaradi antimuskarinskega delovanja je treba kombinacijo umeklidinij/vilanterol pri bolnikih z retenco urina ali glavkomom z ozkim zakotjem uporabljati previdno.
English: In COPD the muscles around the airways tighten.
Slovenian: Pri bolnikih s KOPB se mišice ob dihalnih poteh stisnejo.
English: Umeclidinium was not teratogenic in rats or rabbits.
Slovenian: Umeklidinij pri podganah in kuncih ni bil teratogen.
English: • taste disturbance
Slovenian: • motnje okušanja,
English: Don't use this medicine if you are pregnant unless your doctor tells you that you can.
Slovenian: Če ste noseči, ne smete uporabljati tega zdravila, razen če vam tako naroči zdravnik.
English: The clinical development programme included 2,354 patients who received umeclidinium/vilanterol once daily in the Phase III clinical studies of 24 weeks or more, of whom 1,296 patients received the recommended dose of 55/22 micrograms in 24-week studies, 832 patients received a higher dose of 113/22 micrograms in 24-week studies and 226 patients received 113/22 micrograms in a 12-month study.
Slovenian: tednov ali več; od teh je 1.296 bolnikov dobivalo priporočeni odmerek 55/22 mikrogramov v 24-tedenskih študijah, 832 bolnikov je dobivalo višji odmerek 113/22 mikrogramov v 24-tedenskih študijah, 226 bolnikov pa je dobivalo 113/22 mikrogramov v eni 12-mesečni študiji.
English: Pack sizes of 7 or 30 dose inhalers.
Slovenian: Velikost pakiranja je inhalator s 7 ali 30 odmerki.
English: The pharmacologic effects of beta2-adrenergic agonists, including vilanterol, are at least in part attributable to stimulation of intracellular adenylate cyclase, the enzyme that catalyzes the conversion of adenosine triphosphate (ATP) to cyclic-3',5'-adenosine monophosphate (cyclic AMP).
Slovenian: Adenilat-ciklaza je encim, ki katalizira pretvorbo adenozin trifosfata (ATP) v ciklični 3', 5'-adenozin monofosfat (ciklični AMP).
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON (SINGLE PACKS) 55 micrograms/22 micrograms
Slovenian: PODATKI NA ZUNANJI OVOJNINI ZUNANJA OVOJNINA (PAKIRANJA Z ENIM INHALATORJEM) 55 mikrogramov/22 mikrogramov
English: ANORO 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 ANORO 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: ANORO ELLIPTA (N = 207) versus tiotropium 18 mcg (N = 203) (Study DB2113360)
Slovenian: 18 µg tiotropija (N = 203) (študija DB2113360)
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: tresavica, motnje vida, suha usta ali glavobol.
English: ANORO ELLIPTA (N = 217) versus tiotropium 18 mcg (N = 215) (Study DB2113374)
Slovenian: 18 µg tiotropija (N = 215) (študija DB2113374)
English: How to use ANORO ELLIPTA
Slovenian: Kako uporabljati zdravilo ANORO ELLIPTA
English: one 6-month study, or in a further 55 patients who received umeclidinium/vilanterol 113/22 micrograms once daily in another 6-month study and 226 patients who received 113/22 micrograms once daily in the 12-month study.
Slovenian: 53 bolnikih s KOPB, zdravljenih s kombinacijo umeklidinij/vilanterol 55/22 mikrogramov enkrat na dan v eni 6-mesečni študiji; prav tako jih niso opazili pri dodatnih 55 bolnikih, ki so prejemali kombinacijo umeklidinij/vilanterol 113/22 mikrogramov enkrat na dan v drugi 6-mesečni študiji, in pri 226 bolnikih, ki so dobivali 113/22 mikrogramov enkrat na dan v 12-mesečni študiji.
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
English: • awareness of heart beat (palpitations)
Slovenian: • neprijetni občutki ob hitrem ali močnem utripanju srca (palpitacije), • izpuščaj,
English: ANORO ELLIPTA 55 micrograms/22 micrograms inhalation powder, pre-dispensed
Slovenian: ANORO ELLIPTA 55 mikrogramov/22 mikrogramov prašek za inhaliranje, odmerjeni
English: • combination of sore throat and runny nose
Slovenian: • kombinacija vnetega žrela in izcedka iz nosu, • vnetje žrela,
English: Do not open until ready to inhale.
Slovenian: Odprite šele, ko ste pripravljeni na inhaliranje.
English: triple combinations with corticosteroids, ATC code: R03AL03
Slovenian: Farmakoterapevtska skupina: zdravila za obstruktivne pljučne bolezni, adrenergiki v kombinaciji z antiholinergiki, vključno s kortikosteroidi v trojnih kombinacijah, oznaka ATC: R03AL03
English: ANORO 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 ANORO 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: Summary of the safety profile The most frequently reported adverse reaction with umeclidinium/vilanterol was nasopharyngitis (9%).
Slovenian: Najpogosteje poročan neželeni učinek med uporabo kombinacije umeklidinij/vilanterol je bil nazofaringitis
English: - if you have severe liver problems
Slovenian: če imate težave z žlezo ščitnico,
English: Care is advised when co-administering umeclidinium/vilanterol with ketoconazole and other known strong CYP3A4 inhibitors as there is potential for an increased systemic exposure to vilanterol, which could lead to an increase in the potential for adverse reactions.
Slovenian: V primeru sočasne uporabe kombinacije umeklidinij/vilanterol in ketokonazola ali drugih znanih močnih zaviralcev CYP3A4 je priporočljiva previdnost.
English: No effect on umeclidinium AUC or Cmax was observed at a 8-fold higher dose.
Slovenian: Pri 8-krat večjem odmerku niso opazili vpliva na AUC ali Cmax umeklidinija.
English: Glaxo Operations UK Ltd. (trading as Glaxo Wellcome Operations) Harmire Road
Slovenian: Glaxo Operations UK Ltd. (posluje kot Glaxo Wellcome Operations) Harmire Road
English: The inhaler will be in the ‘closed' position when it is first taken out of its sealed tray.
Slovenian: Ko se inhalator prvič vzame iz embalaže, je v položaju "zaprto".
English: The clinical efficacy of umeclidinium/vilanterol administered once daily was evaluated in eight Phase III clinical studies in 6,835 adult patients with a clinical diagnosis of COPD; 5,618 patients from five 6-month studies (two placebo-controlled and three active [tiotropium]-comparator controlled), 655 patients from two 3-month exercise endurance/lung function studies and 562 patients from a 12-month supportive study.
Slovenian: mesečnih študij (dve kontrolirani s placebom in tri z aktivno primerjalno učinkovino [tiotropij]), 655 bolnikov v dve 3-mesečni študiji obremenitvene zmogljivosti/pljučne funkcije, 562 bolnikov v 12-mesečno podporno študijo.
English: Supraventricular extrasystoles Palpitations
Slovenian: Zaviralci adrenergičnih receptorjev beta
English: GlaxoSmithKline AS Tlf: + 47 22 70 20 00
Slovenian: GlaxoSmithKline AS Tlf: + 47 22 70 20 00 firmapost@gsk.no
English: No clinically relevant effects of hypokalaemia were observed in clinical studies with umeclidinium/vilanterol at the recommended therapeutic dose.
Slovenian: V kliničnih študijah kombinacije umeklidinij/vilanterol v priporočenih terapevtskih odmerkih niso opazili klinično pomembnih učinkov hipokaliemije.
English: An approximately 1.3-fold increase in umeclidinium AUC was observed at 16-fold higher dose with no effect on umeclidinium Cmax.
Slovenian: umeklidinija povečala za približno 1,3-krat, vpliva na Cmax pa ni bilo.
English: Glaxo Operations UK Limited (trading as Glaxo Wellcome Operations) Harmire Road
Slovenian: Glaxo Operations UK Limited (posluje kot Glaxo Wellcome Operations) Harmire Road
English: Do not shake the inhaler.
Slovenian: Ne izdihavajte v inhalator.
English: Lactose monohydrate Magnesium stearate
Slovenian: FARMACEVTSKI PODATKI 6.1 Seznam pomožnih snovi laktoza monohidrat magnezijev stearat