Rolufta Ellipta吸入制剂的产品信息（EMA）.pdf

ANNEXI

SUMMARYOFPRODUCTCHARACTERISTICS

1

1.NAMEOFTHEMEDICINALPRODUCT

RoluftaEllipta55microgramsinhalationpowder,pre-dispensed

2.QUALITATIVEANDQUANTITATIVECOMPOSITION

Eachsingleinhalationprovidesadelivereddose(thedoseleavingthemouthpiece)of55micrograms

umeclidinium(equivalentto65microgramsofumeclidiniumbromide).Thiscorrespondstoapre-

dispenseddoseof62.5microgramsumeclidiniumequivalentto74.2microgramsumeclidinium

bromide.

Excipientwithknowneffect

Eachdelivereddosecontainsapproximately12.5mgoflactosemonohydrate.

Forthefulllistofexcipients,seesection6.1.

3.PHARMACEUTICALFORM

Inhalationpowder,pre-dispensed(inhalationpowder)

Whitepowderinagreyinhaler(Ellipta)withalightgreenmouthpiececoverandadosecounter.

4.CLINICALPARTICULARS

4.1Therapeuticindications

RoluftaElliptaisindicatedasamaintenancebronchodilatortreatmenttorelievesymptomsinadult

patientswithchronicobstructivepulmonarydisease(COPD).

4.2Posologyandmethodofadministration

Posology

Therecommendeddoseisoneinhalationoncedaily.

Itshouldbeadministeredeachdayatthesametimeofthedaytomaintainbronchodilation.The

maximumdoseisoneinhalationoncedaily.Ifadoseismissedthenextdoseshouldbeinhaledatthe

usualtimethenextday.

Specialpopulations

Elderly

Nodoseadjustmentisrequiredinpatients65yearsofageorolder(seesection5.2).

Renalimpairment

Nodoseadjustmentisrequiredinpatientswithrenalimpairment(seesection5.2).

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Hepaticimpairment

Nodoseadjustmentisrequiredinpatientswithmildormoderatehepaticimpairment.