natgillin/translations-raw huggingface dataset:
Adverse reactions detected during these clinical trials are listed by MedDRA system organ class.
Neželeni učinki, ki so jih ugotovili v teh kliničnih preskušanjih, so prikazani po organskih sistemih po MedDRA.
An overdose will likely produce signs, symptoms or adverse effects associated with the individual components' pharmacological actions (e.g. Cushing's syndrome, Cushingoid features, adrenal suppression, decrease in bone mineral density, dry mouth, visual accommodation disturbances, tachycardia, arrhythmias, tremor, headache, palpitations, nausea, hyperglycaemia and hypokalaemia).
Preveliko odmerjanje bo verjetno povzročilo znake, simptome ali neželene učinke, povezane s farmakološkim delovanjem posameznih sestavin (npr. Cushingov sindrom, cushingoidne značilnosti, zavrtje nadledvičnih žlez, zmanjšanje mineralne gostote kosti, suhost ust, motnje akomodacije vida, tahikardijo, motnje srčnega ritma, tremor, glavobol, palpitacije, navzeo, hiperglikemijo in hipokaliemijo).
Beta2-adrenergic blockers may weaken or antagonise the effect of beta2-adrenergic agonists, such as vilanterol.
Antagonisti adrenergičnih receptorjev beta2 lahko oslabijo ali antagonizirajo učinek agonistov adrenergičnih receptorjev beta2, kakršen je vilanterol.
• Take one long, steady, deep breath in.
• Naredite en dolg, enakomeren, globok vdih.
Therefore, caution is advised in moderate to severe hepatic impairment, but no specific dose adjustment based on hepatic function is recommended.
Zato je pri bolnikih z zmerno do hudo okvaro jeter potrebna previdnost, vendar pa niso priporočene specifične prilagoditve odmerka glede na delovanje jeter.
Umeclidinium is a long-acting muscarinic receptor antagonist (also referred to as an anticholinergic).
Umeklidinij je dolgodelujoč antagonist muskarinskih receptorjev (imenovanih tudi antiholinergiki).
Caution should be exercised when Trelegy Ellipta is used with other medicinal products that also have the potential to cause hypokalaemia (see section 4.5).
Previdnost je potrebna, če se zdravilo Trelegy Ellipta uporablja z drugimi zdravili, ki lahko prav tako povzročijo hipokaliemijo (glejte poglavje 4.5).
Urinary excretion accounted for approximately 2 % of the intravenously administered dose.
Na račun izločanja v urinu je šlo približno 2 % intravensko uporabljenega odmerka.
The mouthpiece should be placed between the lips and the lips should then be closed firmly around it.
Bolnik naj ustnik namesti med ustnici in ju nato trdno stisne okrog njega.
For fluticasone furoate, patients with moderate hepatic impairment showed up to three times higher systemic exposure (FF 184 micrograms); therefore, patients with severe hepatic impairment received half the dose (FF 92 micrograms).
Sistemska izpostavljenost flutikazonfuroatu je bila pri bolnikih z zmerno okvaro jeter do trikrat večja (184 mikrogramov FF), zato so bolniki s hudo okvaro jeter prejeli polovico odmerka (92 mikrogramov FF).
Treatment difference 95% CI
Razlika med zdravljenjema (95% IZ)
The fluticasone furoate/vilanterol component of Trelegy Ellipta was assessed in patients with all severities of hepatic impairment (Child-Pugh A, B or C).
Sestavini flutikazonfuroat/vilanterol zdravila Trelegy Ellipta so ocenili pri bolnikih z vsemi stopnjami okvare jeter (Child-Pugh A, B in C).
Table 2 - Lung function endpoint in IMPACT
Preglednica 2 - Opazovani dogodek pljučne funkcije v študiji IMPACT
The increase in vilanterol exposure was not associated with an increase in beta2-agonist related systemic effects on heart rate or blood potassium.
Večje izpostavljenosti vilanterolu ni spremljalo povečanje z agonistom adrenergičnih receptorjev beta2 povezanih sistemskih učinkov na srčno frekvenco ali raven kalija v krvi.
The primary metabolic route for fluticasone furoate is hydrolysis of the S-fluoromethyl carbothioate group to metabolites with significantly reduced corticosteroid activity.
Primarna pot presnove flutikazonfuroata je hidroliza S-fluorometilkarbotioatne skupine v presnovke, ki imajo bistveno manjše kortikosteroidno delovanje.
Vilanterol was not teratogenic in rats.
Vilanterol pri podganah ni bil teratogen.
Interaction with CYP2D6 inhibitors/CYP2D6 polymorphism
Medsebojno delovanje z zaviralci CYP2D6/polimorfizem CYP2D6
Following intravenous administration, the elimination phase half-life averaged 15.1 hours.
Povprečni razpolovni čas eliminacijske faze je bil po intravenski uporabi 15,1 ure.
It is unlikely that this medicine will affect your ability to drive or use machines.
Vpliv na sposobnost upravljanja vozil in strojev Ni verjetno, da bi to zdravilo vplivalo na vašo sposobnost za upravljanje vozil in strojev.
Upon initiation of treatment with Trelegy Ellipta, plasma glucose should be monitored more closely in diabetic patients.
Po uvedbi zdravljenja z zdravilom Trelegy Ellipta je treba sladkornim bolnikom natančneje kontrolirati glukozo v plazmi.
If you become wheezy or breathless, use your quick-acting inhaler (such as salbutamol), then seek medical advice.
Če se vam pojavi piskajoče ali težko dihanje, uporabite svoj hitrodelujoč inhalator (npr. salbutamol) in nato poiščite zdravniški nasvet.
Slide the cover upwards as far as it will go, to cover the mouthpiece.
Pokrovček mora potisniti navzgor, kolikor daleč gre, da pokrije ustnik.
Umeclidinium has not been evaluated in patients with severe hepatic impairment.
Umeklidinija niso ocenili pri bolnikih s hudo okvaro jeter.
Concomitant hypokalaemic treatment with methylxanthine derivatives, steroids, or non-potassium-sparing diuretics may potentiate the possible hypokalaemic effect of beta2-adrenergic agonists, therefore caution should be exercised (see section 4.4).
Sočasno hipokaliemično zdravljenje z metilksantinskimi derivati, steroidi ali diuretiki, ki ne ohranjajo kalija, lahko stopnjuje možni hipokaliemični učinek agonistov adrenergičnih receptorjev beta2, zato je potrebna previdnost (glejte poglavje 4.4).
The mouthpiece of the inhaler may be cleaned using a dry tissue before closing the cover.
Ustnik inhalatorja lahko očisti s suho krpico, preden zapre pokrovček.
The air vents should not be blocked with fingers during use.
Med uporabo ne sme s prsti prekriti rež za zrak.
If beta-blockers are required, cardioselective beta-blockers should be considered, however, caution should be exercised during concurrent use of both non-selective and selective beta-blockers.
Če obstaja potreba po uporabi antagonistov beta, je treba razmisliti o uporabi kardioselektivnih antagonistih beta, vendar pa je med sočasno uporabo potrebna previdnost; to velja tako za selektivne kot za kardioselektivne antagoniste beta.
Slide the cover down fully until a “click” is heard.
Pokrovček mora potisniti navzdol, dokler se ne zasliši "klik".
At study entry, the most common COPD medications reported in the FULFIL and IMPACT studies were ICS +LABA+LAMA (28%, 34% respectively), ICS+LABA (29%, 26% respectively), LAMA+LABA (10%, 8% respectively) and LAMA (9%, 7% respectively).
Ob vstopu v študiji FULFIL in IMPACT so bila najpogostejša zdravila za KOPB, o katerih so poročali v študijah IGK + LABA + LAMA (FULFIL 28 % in IMPACT 34 %), IGK + LABA (29 % in 26 %), LAMA + LABA (10 % in 8 %) in LAMA (9 % in 7 %).
Do not throw away any medicines via household waste.
Zdravila ne smete odvreči v odpadne vode ali med gospodinjske odpadke.
The medicine may not be tasted or felt, even when using the inhaler correctly.
Zdravila morda ne bo ne okusil ne občutil, tudi če inhalator uporablja pravilno.
All three studies were multicentre, randomised, double-blind studies that required patients to be symptomatic with a COPD Assessment Test (CAT) score ≥10 and on daily maintenance treatment for their COPD for at least three months prior to study entry.
Bolniki so morali biti simptomatski in ocenjeni z oceno 10 ali več po testu za oceno KOPB (COPD Assessment Test, CAT) ter so morali prejemati vsakodnevno vzdrževalno zdravljenje za KOPB vsaj tri mesece pred vstopom v študijo.
The “Discard by” date is 6 weeks from the date you open the tray.
Datum "Zavrzite do" je 6 tednov od datuma, ko ste odprli embalažo.
Step-by-step instructions
Navodila po korakih
Your doctor may wish to monitor you carefully if you are taking any of these medicines as they may increase the side effects of Trelegy Ellipta.
Če jemljete katero od teh zdravil, vas bo zdravnik morda natančno nadzoroval, kajti ta zdravila lahko povečajo neželene učinke zdravila Trelegy Ellipta.
If you use more Trelegy Ellipta than you should
Če ste uporabili večji odmerek zdravila Trelegy Ellipta, kot bi smeli
Don't block the air vent with your fingers.
Pazite, da ne boste s prsti prekrili rež za zrak.
This medicine widens these muscles in the lungs, reducing the swelling and irritation in the small air passages and making it easier for air to get in and out of the lungs.
Zdravilo Trelegy Ellipta sprosti te mišice v pljučih, zmanjša oteklost in draženje v malih dihalnih poteh ter olajša vstopanje zraka v pljuča in njegovo izstopanje iz pljuč.
If the inhaler cover is opened and closed without inhaling the medicinal product, the dose will be lost.
Če se pokrovček inhalatorja odpre in zapre, ne da bi bilo zdravilo vdihnjeno, bo odmerek zdravila izgubljen.
Patients should be informed about the signs and symptoms of acute narrow-angle glaucoma and should be informed to stop using Trelegy Ellipta and to contact their doctor immediately should any of these signs or symptoms develop.
Bolnike je treba seznaniti z znaki in simptomi akutnega glavkoma z ozkim zakotjem; naročiti jim je treba, da morajo v primeru takšnih znakov ali simptomov nemudoma prenehati uporabljati zdravilo Trelegy Ellipta in se posvetovati z zdravnikom.
PHARMACEUTICAL FORM AND CONTENTS Inhalation powder, pre-dispensed 1 inhaler of 30 doses.
FARMACEVTSKA OBLIKA IN VSEBINA Prašek za inhaliranje, odmerjeni 1 inhalator s 30 odmerki.
Umeclidinium is a substrate of cytochrome P450 2D6 (CYP2D6).
Umeklidinij je substrat citokroma P450 2D6 (CYP2D6).
Keep the inhaler inside the sealed tray to protect from moisture and only remove immediately before first use.
Inhalator naj ostane v zaprti embalaži za zagotovitev zaščite pred vlago in ga vzemite iz nje šele tik pred prvo uporabo.
The steady-state pharmacokinetics of umeclidinium was assessed in healthy volunteers lacking CYP2D6 (poor metabolisers).
Farmakokinetiko umeklidinija v stanju dinamičnega ravnovesja so ocenili pri zdravih prostovoljcih s pomanjkanjem CYP2D6 (slabi metabolizatorji).
The absolute bioavailability of fluticasone furoate when administrated as fluticasone furoate/vilanterol by inhalation was 15.2%, primarily due to absorption of the inhaled portion of the dose delivered to the lung, with negligible contribution from oral absorption.
Absolutna biološka uporabnost flutikazonfuroata, uporabljenega v kombinaciji flutikazonfuroat/vilanterol v inhalaciji, je bila 15,2 %, predvsem zaradi absorpcije vdihanega dela odmerka, ki je prišel v pljuča; prispevek peroralne absorpcije je bil zanemarljiv.
Each blister in one strip contains fluticasone furoate, each blister in the other strip contains umeclidinium (as bromide) and vilanterol (as trifenatate).
Vsak pretisni del na enem traku vsebuje flutikazonfuroat in vsak pretisni del na drugem traku vsebuje umeklidinij (kot bromid) in vilanterol (kot trifenatat).
Pharmacological and toxicological effects seen with fluticasone furoate, umeclidinium or vilanterol in nonclinical studies were those typically associated with glucocorticoids, muscarinic receptor antagonists, or beta2-adrenergic receptor agonists.
Farmakološki in toksikološki učinki, ki so jih s flutikazonfuroatom, umeklidinijem ali vilanterolom zabeležili v nekliničnih študijah, so bili takšni, kot tipično spremljajo glukokortikoide, antagoniste muskarinskih receptorjev ali agoniste adrenergičnih receptorjev beta2.
Administration of fluticasone furoate/umeclidinium/vilanterol may produce paradoxical bronchospasm with an immediate wheezing and shortness of breath after dosing and may be life-threatening.
Uporaba flutikazonfuroata/umeklidinija/vilanterola lahko povzroči paradoksni bronhospazem - pojav piskajočega dihanja in kratke sape takoj po uporabi zdravila - ki je lahko smrtno nevaren.
It demonstrates slow reversibility at the human M3 muscarinic receptor subtype in vitro and a long duration of action in vivo when administered directly to the lungs in pre-clinical models.
Na podtipu M3 človeških muskarinskih receptorjev in vitro je njegovo delovanje počasi reverzibilno, in vivo pa je dolgotrajno, če je v predkliničnih modelih uporabljen neposredno na pljučih.
• Inhale with one long, steady, deep breath in.
• Vdihne naj z enim dolgim, enakomernim, globokim vdihom.
Pneumonia which required hospitalisation occurred in 1% of patients receiving Trelegy Ellipta and <1% of patients receiving budesonide/formoterol up to 24 weeks.
Pljučnica, ki je zahtevala sprejem v bolnišnico, se je v obdobju do 24 tednov pojavila pri 1 % prejemnikov zdravila Trelegy Ellipta in pri < 1 % prejemnikov kombinacije budezonid/formoterol.
Patients with moderate hepatic impairment showed no evidence of an increase in systemic exposure to either umeclidinium or vilanterol (Cmax and AUC).
Pri bolnikih z zmerno okvaro jeter niso ugotovili znakov večje sistemske izpostavljenosti umeklidiniju ali vilanterolu (Cmax in AUC).
In the subset of 430 patients treated for up to 52 weeks, the incidence of pneumonia events reported in both Trelegy Ellipta and budesonide/formoterol arms was equal at 2%.
V podskupini 430 bolnikov, zdravljenih do 52 tednov, je bila pojavnost pljučnic tako v skupini z zdravilom Trelegy Ellipta kot v skupini s kombinacijo budezonid/formoterol enaka in je znašala 2 %.
The inhaler should be held away from the mouth breathing out as far as is comfortable, but not breathing out into the inhaler.
Bolnik naj drži inhalator odmaknjen od ust in izdihne čim bolj globoko, ne da bi bilo neprijetno, vendar ne sme izdihniti v inhalator.
Patients with moderate to severe hepatic impairment receiving Trelegy Ellipta should be monitored for systemic corticosteroid-related adverse reactions (see section 5.2).
Bolnike z zmerno do hudo okvaro jeter, ki prejemajo zdravilo Trelegy Ellipta, je treba nadzorovati glede sistemskih neželenih učinkov, povezanih s kortikosteroidi (glejte poglavje 5.2).
The efficacy of Trelegy Ellipta (92/55/22 micrograms), administered as a once-daily treatment, has been evaluated in patients with a clinical diagnosis of COPD in two, active-controlled studies and in a single, noninferiority study.
Učinkovitost zdravila Trelegy Ellipta (92/55/22 mikrogramov) enkrat na dan so ovrednotili na bolnikih s klinično diagnozo KOPB v dveh z zdravilno učinkovino kontroliranih študijah in v eni študiji neinferiornosti.
If the dose counter does not count down as the “click” is heard, the inhaler will not deliver a dose and should be taken back to a pharmacist for advice.
Če se število na števcu odmerkov ne zmanjša, ko se zasliši "klik", inhalator ne bo oddal odmerka; bolnik naj ga nese k farmacevtu in se z njim posvetuje.
Following oral administration of radiolabelled vilanterol, 70% of the radiolabel was excreted in urine and 30% in faeces.
Po peroralni uporabi radioaktivno označenega vilanterola se je 70 % radioaktivno označenega odmerka izločilo v urinu in 30 % v blatu.
The incidence of pneumonia with Trelegy Ellipta is comparable with that observed in the fluticasone furoate/vilanterol (FF/VI) 100/25 arm of FF/VI clinical studies in COPD.
Pojavnost pljučnice z zdravilom Trelegy Ellipta je primerljiva tisti, ki so jo opažali v skupini s kombinacijo flutikazonfuroat/vilanterol (FF/VI) 100/25 kliničnih študij FF/VI pri KOPB.
Fluticasone furoate and vilanterol are rapidly cleared by extensive first pass metabolism mediated by enzyme CYP3A4.
Flutikazonfuroat in vilanterol se oba hitro očistita z obsežno presnovo prvega prehoda z encimom CYP3A4.
Following oral administration, fluticasone furoate was eliminated in humans mainly by metabolism with metabolites being excreted almost exclusively in faeces, with <1% of the recovered radioactive dose eliminated in the urine.
Po peroralni uporabi se je flutikazonfuroat pri človeku odstranil predvsem s presnovo; presnovki se izločijo skoraj samo v blatu in < 1 % najdenega radioaktivnega odmerka se je izločil v urinu.
In FULFIL, Trelegy Ellipta improved daily symptoms of COPD as assessed by E-RS: COPD total score, compared with BUD/FOR (≥2 unit decrease from baseline).
V študiji FULFIL je zdravilo Trelegy Ellipta izboljšalo dnevne simptome KOPB, ocenjene z E-RS: celotna ocena KOPB, v primerjavi z BUD/FOR (zmanjšanje izhodiščne vrednosti za ≥ 2 enoti).
Animal studies indicate no effects of fluticasone furoate, umeclidinium or vilanterol on male or female fertility (see section 5.3).
Študije na živalih ne kažejo učinkov flutikazonfuroata, umeklidinija ali vilanterola na plodnost samcev ali samic (glejte poglavje 5.3).
Don't use this medicine if you are pregnant unless your doctor tells you that you can.
Če ste noseči, ne uporabljajte tega zdravila, razen če vam zdravnik naroči, da ga lahko uporabljate.
The pharmacologic effects of beta2-adrenergic agonists, including vilanterol, are at least in part attributable to stimulation of intracellular adenylate cyclase, the enzyme that catalyses the conversion of adenosine triphosphate (ATP) to cyclic-3',5'-adenosine monophosphate (cyclic AMP).
Farmakološke učinke agonistov adrenergičnih receptorjev beta2, tudi vilanterola, je mogoče vsaj deloma pripisati stimulaciji znotrajcelične adenilat-ciklaze, tj. encima, ki katalizira pretvorbo adenozin trifosfata (ATP) v ciklični 3',5'
CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT
VSEBINA, IZRAŽENA Z MASO, PROSTORNINO ALI ŠTEVILOM ENOT 14 odmerkov
Pneumonia
Pljučnica
Treatment difference (95% CI) Comparison with BUD/FOR
Razlika med zdravljenji (95% IZ) Primerjava zdravila Trelegy s FF/VI
In the event of deterioration of COPD during treatment with Trelegy Ellipta, a re-evaluation of the patient and of the COPD treatment regimen should be undertaken.
Če se KOPB med zdravljenjem z zdravilom Trelegy Ellipta poslabša, je treba znova oceniti tako bolnika kot shemo zdravljenja KOPB.
What Trelegy Ellipta is and what it is used for 2.
Kaj je zdravilo Trelegy Ellipta in za kaj ga uporabljamo 2.
Vilanterol is a selective long-acting, beta2-adrenergic receptor agonist (LABA).
Vilanterol je selektiven, dolgodelujoč agonist adrenergičnih receptorjev beta2 (LABA).
There was no significant increase in systemic exposure to vilanterol.
Sistemska izpostavljenost vilanterolu ni bila pomembno večja.
Consistent with findings for other beta2 agonists, in lifetime inhalation studies vilanterol trifenatate caused proliferative effects in the female rat and mouse reproductive tract and rat pituitary gland.
Skladno z izsledki, dobljenimi za druge agoniste adrenergičnih receptorjev beta2, je vilanterolijev trifenatat v študijah vseživljenjskega vdihavanja povzročil proliferacijske učinke v reproduktivnem traktu podganjih in mišjih samic ter v podganji hipofizi.
Stop using this medicine and seek medical help immediately, these may be signs of an acute attack of narrow-angle glaucoma.
Nemudoma nehajte uporabljati to zdravilo in nemudoma poiščite zdravniško pomoč, kajti to so lahko znaki akutnega napada glavkoma z ozkim zakotjem.
It is unknown whether fluticasone furoate, umeclidinium, vilanterol or their metabolites are excreted in human milk.
Ni znano, ali se flutikazonfuroat, umeklidinij, vilanterol ali njihovi presnovki pri človeku izločajo v materinem mleku.
At screening, the mean post-bronchodilator percent predicted FEV1 was 46% and over 99% of patients reported a history of one or more moderate/severe exacerbation in the past year.
Ob presejanju je bil povprečni FEV1 po bronhodilatatorju 46 % predvidenega in več kot 99 % bolnikov je navajalo eno ali več zmernih ali hudih poslabšanj v preteklem letu.
Trelegy Ellipta should be used with caution in patients with convulsive disorders or thyrotoxicosis, and in patients who are unusually responsive to beta2-adrenergic agonists.
Zdravilo Trelegy Ellipta je treba uporabljati previdno pri bolnikih s konvulzivnimi motnjami ali tirotoksikozo in pri bolnikih, ki so nenavadno odzivni na agoniste adrenergičnih receptorjev beta2.
2) Prepare a dose
Pripravite odmerek
Plasma clearance following intravenous administration was 65.4 litres/hour.
Očistek iz plazme po intravenski uporabi je bil 65,4 l/uro.
The inhaler is a multi-component device composed of polypropylene, high density polyethylene, polyoxymethylene, polybutylene terephthalate, acrylonitrile butadiene styrene, polycarbonate and stainless steel.
Inhalator je večdelni pripomoček, izdelan iz polipropilena, polietilena velike gostote, polioksimetilena, polibutilentereftalata, akrilonitril-butadienstirena, polikarbonata in nerjavečega jekla.
Primary elimination of vilanterol was by metabolism followed by excretion of metabolites in urine and faeces.
Primarna pot odstranjevanja vilanterola je presnova, ki ji sledi izločanje presnovkov v urinu in blatu.
There is no relevant use of Trelegy Ellipta in the paediatric population (under 18 years of age) for the indication of COPD.
Pediatrična populacija V pediatrični populaciji (mlajši od 18 let) zdravilo Trelegy Ellipta nima relevantne uporabe za indikacijo
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 61-fold the human clinical exposure of umeclidinium at a daily dose of 55 micrograms, based on AUC).
V pre- in postnatalni študiji je subkutano dajanje umeklidinija pri podganah povzročilo manjše maternalno povečanje telesne mase in uživanje hrane ter rahlo manjšo telesno maso mladičev pred odstavitvijo pri samicah-materah, ki so dobivale odmerek 180 mikrogramov/kg/dan (to je na podlagi AUC približno 61-kratnik klinične izpostavljenosti pri človeku med uporabo dnevnega odmerka 55 mikrogramov).
Following oral inhalation, umeclidinium and vilanterol act locally on airways to produce bronchodilation by separate mechanisms and fluticasone furoate reduces inflammation.
Po peroralni inhalaciji umeklidinij in vilanterol delujeta lokalno na dihala in vsak po svojem mehanizmu povzročita bronhodilatacijo, flutikazonfuroat pa zmanjša vnetje.
PARTICULARS TO APPEAR ON THE OUTER PACKAGING INTERMEDIATE OUTER CARTON (WITHOUT BLUE BOX- MULTIPACK ONLY)
PODATKI NA ZUNANJI OVOJNINI VMESNA ŠKATLA (BREZ MODREGA OKENCA - SAMO PAKIRANJE Z VEČ INHALATORJI)
Umeclidinium plasma elimination half-life following inhaled dosing for 10 days averaged 19 hours, with 3% to 4% active substance excreted unchanged in urine at steady-state.
Plazemski eliminacijski razpolovni čas umeklidinija po 10-dnevni inhalacijski uporabi je bil v povprečju 19 ur; v stanju dinamičnega ravnovesja se je od 3 do 4 % učinkovine izločilo nespremenjene v urinu.
1) Read this before you start
Pred začetkom uporabe preberite ta navodila
Once the tray is opened, the inhaler can be used for up to 6 weeks, starting from the date of opening the tray.
Ko je embalaža odprta, lahko inhalator uporabljate do 6 tednov; to obdobje začne teči z dnem,
Systemic drug levels (steady state Cmax and AUC) of FF, UMEC and VI following FF/UMEC/VI in one inhaler (triple combination) were within the range of those observed following FF/VI + UMEC as two inhalers, dual combinations (FF/VI and UMEC/VI), as well as individual single inhalers (FF, UMEC and VI).
Sistemske koncentracije (Cmax in AUC v stanju dinamičnega ravnovesja) FF, UMEC in VI so bile po uporabi FF/UMEC/VI v enem inhalatorju (trojna kombinacija) znotraj razponov, opaženih po uporabi dveh inhalatorjev FF/VI + UMEC, dvojnih kombinacij (FF/VI in UMEC/VI), ali posameznih enojnih inhalatorjev (FF, UMEC in VI).
• faster heart beat
• hitrejše bitje srca,