Negara: Indonesia
Bahasa: Bahasa Indonesia
Sumber: Badan Pengawas Obat dan Makanan RI - Indonesian Food and Drug Supervisory Agency
INDACATEROL MALEATE
NOVARTIS INDONESIA - Indonesia
INDACATEROL MALEATE
194 MCG
SERBUK INHALER
DUS, 3 BLISTER @ 10 KAPSUL + 1 INHALER
NOVARTIS FARMACÉUTICA, S.A. - Spain
2020-10-01
ONBREZ BREEZHALER ® (indacaterol maleate) inhalation powder hard capsules PRODUCT INFORMATION (draft v2) Based on CDS version 4.2 (27-Jul-2020) DISETUJUI OLEH BPOM : 19/08/2021 ID : EREG100005VR12000253 EREG100005VR12000254 NOVARTIS CDS v4.2 Page 2 Product Information (draft v2) 27-Jul-2020 ONBREZ BREEZHALER_ _ TRADE NAMES 150 MICROGRAM INHALATION POWDER HARD CAPSULES ONBREZ ® BREEZHALER ® _ _ 150 microgram, inhalation powder, hard capsules 300 MICROGRAM INHALATION POWDER HARD CAPSULES ONBREZ ® BREEZHALER ® 300 microgram, inhalation powder, hard capsules DESCRIPTION AND COMPOSITION PHARMACEUTICAL FORM Inhalation powder, hard capsules. 150 microgram: Black product code “IDL 150” printed above and black company logo printed under black bar on natural transparent uncolored capsule. 300 microgram: Blue product code “IDL 300” printed above and blue company logo printed under blue bar on natural transparent uncolored capsule. ACTIVE SUBSTANCE 150 MICROGRAM INHALATION POWDER HARD CAPSULES Each capsule contains 194 microgram indacaterol maleate equivalent to 150 microgram indacaterol. The delivered dose (the dose that leaves the mouthpiece of the ONBREZ BREEZHALER inhaler) is equivalent to 120 microgram indacaterol. 300 MICROGRAM INHALATION POWDER HARD CAPSULES Each capsule contains 389 microgram indacaterol maleate equivalent to 300 microgram indacaterol. The delivered dose (the dose that leaves the mouthpiece of the ONBREZ BREEZHALER inhaler) is equivalent to 240 microgram indacaterol. ACTIVE MOIETY Indacaterol EXCIPIENTS Lactose monohydrate and gelatin INDICATIONS ONBREZ BREEZHALER is indicated for maintenance bronchodilator treatment of airflow obstruction in adult patients with chronic obstructive pulmonary disease (COPD). DISETUJUI OLEH BPOM : 19/08/2021 ID : EREG100005VR12000253 EREG100005VR12000254 NOVARTIS CDS v4.2 Page 3 Product Information (draft v2) 27-Jul-2020 ONBREZ BREEZHALER_ _ DOSAGE AND ADMINISTRATION ADULTS _ _ The recommended dosage of ONBREZ BREEZHALER is the once-daily inhalation of the Baca dokumen lengkapnya