ENERZAIR BREEZHALER INHALATION POWDER HARD CAPSULE 150 MCG 50 MCG 160 MCG

Country: Singapore

Language: English

Source: HSA (Health Sciences Authority)

Active ingredient:

Glycopyrronium bromide equivalent to Glycopyrronium; Indacaterol acetate equivalent to Indacaterol; Mometasone furoate

Available from:

NOVARTIS (SINGAPORE) PTE LTD

ATC code:

R03AL12

Pharmaceutical form:

POWDER, METERED

Composition:

Glycopyrronium bromide equivalent to Glycopyrronium 50 mcg; Indacaterol acetate equivalent to Indacaterol 150 mcg; Mometasone furoate 160 mcg

Administration route:

RESPIRATORY (INHALATION)

Prescription type:

Prescription Only

Manufactured by:

Novartis Pharma Stein AG

Authorization status:

ACTIVE

Authorization date:

2021-04-14

Summary of Product characteristics

Enerzair Mar 2021.SIN
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1
TRADENAME(S)
ENERZAIR
®
BREEZHALER
®
(indacaterol/glycopyrronium/mometasone
furoate)
150/50/160
micrograms inhalation powder, hard capsules
2
DESCRIPTION AND COMPOSITION
PHARMACEUTICAL FORM(S)
Indacaterol/glycopyrronium/mometasone furoate 150/50/160 micrograms,
inhalation powder, hard
capsules.
Capsules with green transparent cap and uncolored transparent body
containing a white to
practically white powder, with the product code “IGM150-50-160”
printed in black on the body
and the
printed in black on the cap.
ACTIVE SUBSTANCE(S)
Each
capsule
of
Enerzair
Breezhaler
150/50/160
micrograms
contains
173
micrograms
of
indacaterol acetate equivalent to 150 micrograms of indacaterol, 63
micrograms of glycopyrronium
bromide equivalent to 50 micrograms glycopyrronium and 160 micrograms
mometasone furoate
The delivered dose (the dose that leaves the mouthpiece of the
inhaler) for 150/50/160 micrograms
is equivalent to 114 micrograms indacaterol, 46 micrograms
glycopyrronium, and 136 micrograms
mometasone furoate.
EXCIPIENTS
Capsule fill: Lactose (as monohydrate), Magnesium stearate.
Capsule shell components: Hypromellose, Purified water, Carrageenan,
Potassium chloride.
3
INDICATIONS
Enerzair Breezhaler is indicated as a once-daily maintenance treatment
of asthma, and to reduce
asthma exacerbations, in adults not adequately controlled with a
maintenance combination of a long-
acting beta
2
-agonist and an inhaled corticosteroid.
4
DOSAGE REGIMEN AND ADMINISTRATION
DOSAGE REGIMEN
GENERAL TARGET POPULATION
Inhalation of the content of one capsule of Enerzair Breezhaler
150/50/160 micrograms once-daily
is recommended in patients not adequately controlled with a
combination of a long-acting beta
2
-
agonist and an inhaled corticosteroid.
Patients usually experience an improvement in lung function within 5
minutes of inhaling Enerzair
Breezhaler. However, the patient should be informed that regular daily
use is necessary to maintain
control of asthma symptoms and that use should be cont