Država: Indonezija
Jezik: indonezijščina
Source: Badan Pengawas Obat dan Makanan RI - Indonesian Food and Drug Supervisory Agency
DUS, 3 BLISTER @ 10 KAPSUL + 1 INHALER
2022-07-12
ATECTURA ® BREEZHALER ® (indacaterol acetate and mometasone furoate fixed-dose combination) Inhalation powder hard capsules PRODUCT INFORMATION (draft v6) Based on CDS version 1.2 (05-Mar-2020) DISETUJUI BPOM 21 JUNI 2022 EREG10000512000147 EREG10000512000195 EREG10000512000196 1 TRADENAME(S) ATECTURA ® BREEZHALER ® 150/80 micrograms inhalation powder, hard capsules ATECTURA ® BREEZHALER ® 150/160 micrograms inhalation powder, hard capsules ATECTURA ® BREEZHALER ® 150/320 micrograms inhalation powder, hard capsules 2 DESCRIPTION AND COMPOSITION PHARMACEUTICAL FORM(S) Indacaterol/mometasone furoate 150/80 micrograms, inhalation powder, hard capsules. Indacaterol/mometasone furoate 150/160 micrograms, inhalation powder, hard capsules. Indacaterol/mometasone furoate 150/320 micrograms, inhalation powder, hard capsules. ACTIVE SUBSTANCE(S) Each capsule of Atectura Breezhaler 150/80 micrograms contains 173 micrograms of indacaterol acetate equivalent to 150 micrograms of indacaterol and 80 micrograms of mometasone furoate. The delivered dose of Atectura Breezhaler 150/80 micrograms (the dose that leaves the mouthpiece of the inhaler) is equivalent to 125 micrograms indacaterol, and 62.5 micrograms mometasone furoate. Each capsule of Atectura Breezhaler 150/160 micrograms contains 173 micrograms of indacaterol acetate equivalent to 150 micrograms of indacaterol and 160 micrograms of mometasone furoate. The delivered dose of Atectura Breezhaler 150/160 micrograms (the dose that leaves the mouthpiece of the inhaler) is equivalent to 125 micrograms indacaterol, and 127.5 micrograms mometasone furoate. Each capsule of Atectura Breezhaler 150/320 micrograms contains 173 micrograms of indacaterol acetate equivalent to 150 micrograms of indacaterol and 320 micrograms of mometasone furoate. The delivered dose of Atectura Breezhaler 150/320 micrograms (the dose that leaves the mouthpiece of the inhaler) is equivalent to 125 micrograms indacaterol, and 260 micrograms mometasone furoate. EXCIPIENTS Capsule fill: lactose m Preberite celoten dokument