BREZTRI AEROSPHERE AEROSOL, METERED DOSE

Šalis: Kanada

kalba: anglų

Šaltinis: Health Canada

Veiklioji medžiaga:

BUDESONIDE; GLYCOPYRRONIUM (GLYCOPYRRONIUM BROMIDE); FORMOTEROL FUMARATE DIHYDRATE

Prieinama:

ASTRAZENECA CANADA INC

ATC kodas:

R03AL11

INN (Tarptautinis Pavadinimas):

FORMOTEROL, GLYCOPYRRONIUM BROMIDE AND BUDESONIDE

Dozė:

160MCG; 7.2MCG; 5MCG

Vaisto forma:

AEROSOL, METERED DOSE

Sudėtis:

BUDESONIDE 160MCG; GLYCOPYRRONIUM (GLYCOPYRRONIUM BROMIDE) 7.2MCG; FORMOTEROL FUMARATE DIHYDRATE 5MCG

Vartojimo būdas:

INHALATION

Vienetai pakuotėje:

15G/50G

Recepto tipas:

Prescription

Gydymo sritis:

ANTIMUSCARINICS ANTISPASMODICS

Produkto santrauka:

Active ingredient group (AIG) number: 0363070002; AHFS:

Autorizacija statusas:

APPROVED

Leidimo data:

2023-04-14

Prekės savybės

_BREZTRI™ AEROSPHERE_
_®_
_ Product Monograph _
_Page 1 of 50_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
BREZTRI™ AEROSPHERE
®
budesonide / glycopyrronium / formoterol fumarate dihydrate
pressurized inhalation suspension
Pressurized inhalation suspension, 160 mcg budesonide / 7.2 mcg
glycopyrronium (as bromide) /
5 mcg formoterol fumarate dihydrate per delivered actuation,
inhalation use
Inhaled Corticosteroid (ICS) and Inhaled Bronchodilators (Long-Acting
Muscarinic Antagonist
(LAMA) and Long-Acting Beta
2
-Adrenergic Agonist (LABA)) Combination
AstraZeneca Canada Inc.
1004 Middlegate Road
Mississauga, Ontario
L4Y 1M4
Date of Initial Authorization:
JUL 15, 2021
Date of Revision:
APR 14, 2023
Submission Control Number: 257897
BREZTRI™ is a trademark of, and AEROSPHERE
®
and the AstraZeneca logo are registered
trademarks of AstraZeneca AB, all used under license by AstraZeneca
Canada Inc.
© AstraZeneca Canada Inc. 2023
_ _
_BREZTRI™ AEROSPHERE_
_®_
_ Product Monograph _
_Page 2 of 50_
RECENT MAJOR LABEL CHANGES
Not applicable.
TABLE OF CONTENTS
SECTIONS OR SUBSECTIONS THAT ARE NOT APPLICABLE AT THE TIME OF
AUTHORIZATION ARE NOT LISTED.
RECENT MAJOR LABEL CHANGES
.....................................................................................
2
TABLE OF CONTENTS
..........................................................................................................
2
PART I: HEALTH PROFESSIONAL
INFORMATION...............................................................
4
1
INDICATIONS..............................................................................................................
4
1.1
Pediatrics
...........................................................................................................
4
1.2
Geriatrics............................................................................................................
4
2
CONTRAINDICATIONS
...............................................................................................
4
4
DOSAGE AND ADMINISTRAT