Land: Indonesien
Språk: indonesiska
Källa: Badan Pengawas Obat dan Makanan RI - Indonesian Food and Drug Supervisory Agency
DUS, 3 BLISTER @ 10 KAPSUL + 1 INHALER
2022-06-28
ENERZAIR ® BREEZHALER ® (indacaterol acetate, glycopyrronium bromide, and mometasone furoate fixed-dose combination) inhalation powder hard capsules PRODUCT INFORMATION (draft v6) Based on CDS version 1.3 ( 11-Mar-2021) DISETUJUI BPOM 6 JUNI 2022 EREG10000512000199 1 TRADENAME(S) ENERZAIR ® BREEZHALER ® 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 powder with the product code “IGM 150-50-160” printed in black above two black bars on the body and with the product logo printed in black and surrounded by a black bar 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. Each delivered dose (the dose that leaves the mouthpiece of the inhaler) contains 114 mcg of indacaterol (as acetate), 58 mcg of glycopyrronium bromide equivalent to 46 mcg of glycopyrronium and 136 mcg of mometasone furoate. EXCIPIENTS Capsule fill: lactose monohydrate, magnesium stearate. Capsule shell components: hypromellose, purified water, carrageenan, potassium chloride. Each capsules contains 25 mg of lactose monohydrate. 3 INDICATIONS ENERZAIR BREEZHALER (indacaterol / glycopyrronium / mometasone furoate) is indicated as a maintenance treatment of asthma in adult patients not adequately controlled with a maintenance combination of a long-acting beta2-agonist and a medium or high dose of an inhaled corticosteroid who experienced one or more asthma exacerbations in the previous 12 months. ENERZAIR BREEZHALER is not indicated for the relief of acute bronchospasm. DISETUJUI BPOM 6 JUNI 2022 EREG10000512000199 4 DOSAGE REGIMEN AND ADMINISTRATION DOSAGE REGIMEN GENERAL TARGET POPULATION Inhalation of t Läs hela dokumentet