芜地溴铵-维兰特罗粉吸入剂 （ANORO ELLIPTA ）的产品信息(EMA).pdf

ANNEXI

SUMMARYOFPRODUCTCHARACTERISTICS

1

1.NAMEOFTHEMEDICINALPRODUCT

ANOROELLIPTA55micrograms/22microgramsinhalationpowder,pre-dispensed

2.QUALITATIVEANDQUANTITATIVECOMPOSITION

Eachsingleinhalationprovidesadelivereddose(thedoseleavingthemouthpiece)of65micrograms

umeclidiniumbromideequivalentto55microgramsofumeclidiniumand22microgramsofvilanterol(as

trifenatate).Thiscorrespondstoapre-dispenseddoseof74.2microgramsumeclidiniumbromideequivalent

to62.5microgramsumeclidiniumand25microgramsvilanterol(astrifenatate).

Excipientwithknowneffect

Eachdelivereddosecontainsapproximately24mgoflactose(asmonohydrate).

Forthefulllistofexcipients,seesection6.1.

3.PHARMACEUTICALFORM

Inhalationpowder,pre-dispensed(inhalationpowder)

Whitepowderinalightgreyinhaler(ELLIPTA)witharedmouthpiececoverandadosecounter.

4.CLINICALPARTICULARS

4.1Therapeuticindications

ANOROELLIPTAisindicatedasamaintenancebronchodilatortreatmenttorelievesymptomsinadult

patientswithchronicobstructivepulmonarydisease(COPD).

4.2Posologyandmethodofadministration

Posology

Therecommendedandmaximumdoseisoneinhalationoncedaily.

ANOROELLIPTAshouldbeadministeredatthesametimeofthedayeachdaytomaintainbronchodilation.

Ifadoseismissedthenextdoseshouldbeinhaledattheusualtimethenextday.

Specialpopulations

Elderly

Nodoseadjustmentisrequiredinpatients65yearsofageorolder(seesection5.2).

Renalimpairment

Nodoseadjustmentisrequiredinpatientswithrenalimpairment(seesection5.2).

Hepaticimpairment

Nodoseadjustmentisrequiredinpatientswithmildormoderatehepaticimpairment.TheuseofANORO

ELLIPTAhasnotbeenstudiedinpatientswithseverehepaticimpairmentandshouldbeusedwithcaution

(seesection