INCRUSE ELLIPTA INHALATION POWDER 62.5 MCGDOSE

Country: Singapore

Language: English

Source: HSA (Health Sciences Authority)

Active ingredient:

Umeclidinium Bromide 74.2 mcg (micronised) eqv. Umeclidinium

Available from:

GLAXOSMITHKLINE PTE LTD

ATC code:

R03BB07

Pharmaceutical form:

POWDER, METERED

Composition:

Umeclidinium Bromide 74.2 mcg (micronised) eqv. Umeclidinium 62.5 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:

2015-09-21

Summary of Product characteristics

INCRUSE ELLIPTA
UMECLIDINIUM
QUALITATIVE AND QUANTITATIVE COMPOSITION
A plastic Ellipta inhaler consists of a grey body, a light green
mouthpiece cover and a
dose counter, packed into a foil laminate tray containing a desiccant
packet. The tray is
sealed with a peelable foil lid.
_INCRUSE ELLIPTA 62.5 micrograms: _
Each delivered dose (the dose leaving the mouthpiece of the inhaler)
contains
55 micrograms umeclidinium (equivalent to 65 micrograms of
umeclidinium bromide).
This corresponds to a pre-dispensed dose of 62.5 micrograms of
umeclidinium
(equivalent to 74.2 micrograms umeclidinium bromide).
CLINICAL INFORMATION
INDICATIONS
_INCRUSE 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._ _
_INCRUSE ELLIPTA _is for oral inhalation only.
_INCRUSE ELLIPTA _should be administered once daily at the same time
of the day each
day.
ADULTS
The recommended dose is one inhalation of _INCRUSE ELLIPTA_ 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.
_INCRUSE ELLIPTA_ has not been studied in patients with severe hepatic
impairment (see_ _
_Pharmacokinetics _
_—_
_ Special Patient Populations_).
CONTRAINDICATIONS
_INCRUSE ELLIPTA_ is contraindicated in patients with severe
milk-protein allergy.
Hypersensitivity to the active substance(s) or to any of the
excipients (see _List of _
_Excipients_).
WARNINGS AND PRECAUTIONS
_INCRUSE ELLIPTA_ should not be used in patients with asthma since it
has not been