ATECTURA BREEZHALER CAPSULE

Land: Canada

Språk: engelsk

Kilde: Health Canada

Aktiv ingrediens:

INDACATEROL (INDACATEROL ACETATE); MOMETASONE FUROATE

Tilgjengelig fra:

NOVARTIS PHARMACEUTICALS CANADA INC

ATC-kode:

R03AK14

INN (International Name):

INDACATEROL AND MOMETASONE

Dosering :

150MCG; 80MCG

Legemiddelform:

CAPSULE

Sammensetning:

INDACATEROL (INDACATEROL ACETATE) 150MCG; MOMETASONE FUROATE 80MCG

Administreringsrute:

INHALATION

Enheter i pakken:

15G/50G

Resept typen:

Prescription

Terapeutisk område:

ADRENALS

Produkt oppsummering:

Active ingredient group (AIG) number: 0262235001; AHFS:

Autorisasjon status:

APPROVED

Autorisasjon dato:

2020-05-06

Preparatomtale

_ATECTURA_
_®_
_ BREEZHALER_
_®_
_ Product Monograph _
_Page 1 of 39_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
Pr
ATECTURA® BREEZHALER®
Indacaterol (as acetate)/mometasone furoate inhalation powder hard
capsules
150 mcg/80 mcg
150 mcg/160 mcg
150 mcg/320 mcg
ATECTURA BREEZHALER capsules to be used only with the supplied
ATECTURA BREEZHALER inhalation
device
Bronchodilator (Long-Acting Beta
2
-Adrenergic Agonist (LABA)) and Inhaled Corticosteroid (ICS)
Combination for Oral Inhalation
Novartis Pharmaceuticals Canada Inc.
385 Bouchard Blvd.
Dorval, Quebec
H9S 1A9
Date of Initial Authorization:
May 5, 2020
Date of Revision:
Nov 12, 2021
Submission Control Number: 246914
ATECTURA and BREEZHALER are registered trademarks.
_ _
_ATECTURA_
_®_
_ BREEZHALER_
_®_
_ Product Monograph _
_Page 2 of 39_
RECENT MAJOR LABEL CHANGES
7 Warnings and Precautions, Endocrine and Metabolism
11/2021
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 ADMINISTRATION
.................................................................................
4
4.1
Dosing Considerations
..........