ATECTURA BREEZHALER

Ország: Indonézia

Nyelv: indonéz

Forrás: Badan Pengawas Obat dan Makanan RI - Indonesian Food and Drug Supervisory Agency

db csomag:

DUS, 3 BLISTER @ 10 KAPSUL + 1 INHALER

Engedély dátuma:

2022-07-12

Termékjellemzők

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