INCRUSE ELLIPTA POWDER

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

UMECLIDINIUM (UMECLIDINIUM BROMIDE)

Available from:

GLAXOSMITHKLINE INC

ATC code:

R03BB07

INN (International Name):

UMECLIDINIUM BROMIDE

Dosage:

62.5MCG

Pharmaceutical form:

POWDER

Composition:

UMECLIDINIUM (UMECLIDINIUM BROMIDE) 62.5MCG

Administration route:

INHALATION

Units in package:

7/30

Prescription type:

Prescription

Therapeutic area:

ANTIMUSCARINICS ANTISPASMODICS

Product summary:

Active ingredient group (AIG) number: 0155530002; AHFS:

Authorization status:

APPROVED

Authorization date:

2014-04-16

Summary of Product characteristics

_Pr_
_INCRUSE ELLIPTA (umeclidinium) _
_Page 1 of 30_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
Pr
INCRUSE ELLIPTA
umeclidinium dry powder for oral inhalation
62.5 mcg umeclidinium (as bromide) per oral inhalation
Inhaled Bronchodilator
Long-Acting Muscarinic Antagonist (LAMA)
GlaxoSmithKline Inc.
100 Milverton Drive, Suite 800
Mississauga, Ontario
L5R 4H1
Canada
Date of Initial Authorization:
April 8, 2014
Date of Revision:
September 21, 2023
Submission Control Number: 274613
_©_
_2023 GSK group of companies or its licensor _
_Trademarks are owned by or licensed to the GSK group of companies _
_Pr_
_INCRUSE ELLIPTA (umeclidinium) _
_Page 2 of 30_
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
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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
.............................................................................................
4
4.2
Recommended Dose and Dosage Adjustment
........................................................ 5
4.4
Administrati