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

국가: 싱가포르

언어: 영어

출처: HSA (Health Sciences Authority)

유효 성분:

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

제공처:

NOVARTIS (SINGAPORE) PTE LTD

ATC 코드:

R03AL12

약제 형태:

POWDER, METERED

구성:

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

관리 경로:

RESPIRATORY (INHALATION)

처방전 유형:

Prescription Only

Manufactured by:

Novartis Pharma Stein AG

승인 상태:

ACTIVE

승인 날짜:

2021-04-14

제품 특성 요약

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