ANORO ELLIPTA INHALATION POWDER 62.5 MCG25 MCG

Country: Singapore

Language: English

Source: HSA (Health Sciences Authority)

Active ingredient:

(UMEC STRIP) UMECLIDINIUM BROMIDE (MICRONISED) 74.2 mcg/dose EQV UMECLIDINIUM; (VI STRIP) VILANTEROL TRIFENATATE (MICRONISED) 40 mcg/dose EQV VILANTEROL

Available from:

GLAXOSMITHKLINE PTE LTD

ATC code:

R03AL03

Pharmaceutical form:

POWDER, METERED

Composition:

(UMEC STRIP) UMECLIDINIUM BROMIDE (MICRONISED) 74.2 mcg/dose EQV UMECLIDINIUM 62.5 mcg/dose; (VI STRIP) VILANTEROL TRIFENATATE (MICRONISED) 40 mcg/dose EQV VILANTEROL 25 mcg/dose

Administration route:

RESPIRATORY (INHALATION)

Prescription type:

Prescription Only

Manufactured by:

GLAXO OPERATIONS UK LTD (TRADING AS GLAXO WELLCOME OPERATIONS)

Authorization status:

ACTIVE

Authorization date:

2015-08-28

Summary of Product characteristics

ANORO ELLIPTA
UMECLIDINIUM/VILANTEROL
QUALITATIVE AND QUANTITATIVE COMPOSITION
A light grey inhaler with a red mouthpiece cover and an integral dose
counter. The Ellipta
inhaler contains two blister strips, each of which contains a white
powder.
Each delivered dose (the dose leaving the mouthpiece of the inhaler)
contains
55 micrograms umeclidinium (equivalent to 65 micrograms of
umeclidinium bromide)
and 22 micrograms vilanterol (as trifenatate). This corresponds to a
pre-dispensed dose of
62.5 micrograms of umeclidinium (equivalent to 74.2 micrograms
umeclidinium
bromide) and 25 micrograms vilanterol (as trifenatate).
CLINICAL PARTICULARS
INDICATIONS
_ANORO ELLIPTA _is indicated for maintenance bronchodilator treatment
to relieve
symptoms associated with chronic obstructive pulmonary disease (COPD).
DOSAGE AND ADMINISTRATION
Pharmaceutical form: Inhalation powder, pre-dispensed
_ANORO ELLIPTA _is for oral inhalation only.
_ANORO ELLIPTA _should be administered once daily at the same time
each day.
ADULTS
The recommended and maximum dose is one inhalation of _ANORO ELLIPTA _
62.5/25 micrograms once daily.
CHILDREN
Use in patients less than 18 years of age is not relevant given the
indication for this
product.
ELDERLY
No dosage adjustment is required in patients over 65 years (see
_Pharmacokinetics _
_–_
_ _
_Special Patient Populations_).
RENAL IMPAIRMENT
No dosage adjustment is required in patients with renal impairment
(see
_Pharmacokinetics _
_—_
_ Special Patient Populations_).
HEPATIC IMPAIRMENT
No dosage adjustment is required in patients with mild or moderate
hepatic impairment.
_ANORO ELLIPTA _has not been studied in patients with severe hepatic
impairment (see
_Pharmacokinetics _
_—_
_ Special Patient Populations_).
CONTRAINDICATIONS
_ANORO ELLIPTA _is contraindicated in patients with severe
milk-protein allergy, or who
have demonstrated hypersensitivity to either umeclidinium, vilanterol
or any of the
excipients in this product.
WARNINGS AND PRECAUTIONS
ASTHMA
_ANORO ELLIPTA _should not be used i