Pays: Singapour
Langue: anglais
Source: HSA (Health Sciences Authority)
Glycopyrronium bromide equivalent to Glycopyrronium; Indacaterol acetate equivalent to Indacaterol; Mometasone furoate
NOVARTIS (SINGAPORE) PTE LTD
R03AL12
POWDER, METERED
Glycopyrronium bromide equivalent to Glycopyrronium 50 mcg; Indacaterol acetate equivalent to Indacaterol 150 mcg; Mometasone furoate 160 mcg
RESPIRATORY (INHALATION)
Prescription Only
Novartis Pharma Stein AG
ACTIVE
2021-04-14
Enerzair Mar 2021.SIN Page 1 of 25 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 Lire le document complet