ONBREZ BREEZHALER
Țară: Indonezia
Limbă: indoneziană
Sursă: Badan Pengawas Obat dan Makanan RI - Indonesian Food and Drug Supervisory Agency
Caracteristicilor produsului
(SPC)
01-01-2021
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Ingredient activ:
INDACATEROL MALEATE
Disponibil de la:
NOVARTIS INDONESIA - Indonesia
INN (nume internaţional):
INDACATEROL MALEATE
Dozare:
389 MCG
Forma farmaceutică:
SERBUK INHALER
Unități în pachet:
DUS, 3 BLISTER @ 10 KAPSUL + 1 INHALER
Produs de:
NOVARTIS FARMACÉUTICA, S.A. - Spain
Data de autorizare:
2020-10-01
Caracteristicilor produsului
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
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