GLYCOPYRRONIUM / FORMOTEROL FUMARATE DIHYDRATE PRESSURIZED INHALATION SUSPENSION AEROSOL, METERED DOSE

Land: Kanada

Tungumál: enska

Heimild: Health Canada

Virkt innihaldsefni:

FORMOTEROL FUMARATE DIHYDRATE; GLYCOPYRRONIUM (GLYCOPYRRONIUM BROMIDE)

Fáanlegur frá:

ASTRAZENECA CANADA INC

ATC númer:

R03AL07

INN (Alþjóðlegt nafn):

FORMOTEROL AND GLYCOPYRRONIUM BROMIDE

Skammtar:

5.8MCG; 8.3MCG

Lyfjaform:

AEROSOL, METERED DOSE

Samsetning:

FORMOTEROL FUMARATE DIHYDRATE 5.8MCG; GLYCOPYRRONIUM (GLYCOPYRRONIUM BROMIDE) 8.3MCG

Stjórnsýsluleið:

INHALATION

Einingar í pakka:

120 ACT

Gerð lyfseðils:

Prescription

Lækningarsvæði:

ANTIMUSCARINICS ANTISPASMODICS

Vörulýsing:

Active ingredient group (AIG) number: 0260050001; AHFS:

Leyfisstaða:

APPROVED

Leyfisdagur:

2022-02-16

Vara einkenni

_ COPYRIGHT 2018 – 2022 ASTRAZENECA CANADA INC. _
_Page 1 of 46_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
glycopyrronium / formoterol fumarate dihydrate pressurized inhalation
suspension
Pressurized inhalation suspension, 8.3 mcg glycopyrronium (as bromide)
/ 5.8 mcg formoterol
fumarate dihydrate per metered actuation, inhalation use
Inhaled Bronchodilators (Long-Acting Muscarinic Antagonist (LAMA) and
Long-Acting Beta
2
-
Agonist (LABA)) Combination
AstraZeneca Canada Inc.
1004 Middlegate Road
Mississauga, Ontario
L4Y 1M4
www.astrazeneca.ca
Date of Initial Authorization:
MAR 05, 2018
Date of Revision:
FEB 11, 2022
Submission Control Number: 256804
The AstraZeneca logo is a registered trademark of AstraZeneca AB, used
under license by
AstraZeneca Canada Inc.
_ _
_ COPYRIGHT 2018 – 2022 ASTRAZENECA CANADA INC. _
_Page 2 of 46_
RECENT MAJOR LABEL CHANGES
None.
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
3
SERIOUS WARNINGS AND PRECAUTIONS BOX
........................................................ 5
4
DOSAGE AND ADMINISTRATION
.....................................................