SPIRIVA CAPSULE

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

TIOTROPIUM (TIOTROPIUM BROMIDE MONOHYDRATE)

Available from:

BOEHRINGER INGELHEIM (CANADA) LTD LTEE

ATC code:

R03BB04

INN (International Name):

TIOTROPIUM BROMIDE

Dosage:

18MCG

Pharmaceutical form:

CAPSULE

Composition:

TIOTROPIUM (TIOTROPIUM BROMIDE MONOHYDRATE) 18MCG

Administration route:

INHALATION

Units in package:

10/30; 1 HANDIHALER

Prescription type:

Prescription

Therapeutic area:

ANTIMUSCARINICS ANTISPASMODICS

Product summary:

Active ingredient group (AIG) number: 0148683001; AHFS:

Authorization status:

APPROVED

Authorization date:

2002-11-20

Summary of Product characteristics

_Product Monograph _
_ _
_SPIRIVA (tiotropium) _
_Page 1 of 42_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
Pr
SPIRIVA®
Tiotropium inhalation powder capsules
Inhalation powder capsules, 18 mcg tiotropium (as tiotropium bromide
monohydrate), Oral
Inhalation
Bronchodilator (Long-Acting Muscarinic Antagonist (LAMA))
Capsules to be used only with the supplied HandiHaler® inhalation
device
ATC R03BB04
Boehringer Ingelheim (Canada) Ltd.
5180 South Service Road
Burlington, Ontario
L7L 5H4
Date of Initial Authorization:
NOV 20, 2002
Date of Revision:
APR 22, 2022
Submission Control Number: 258194
BICL #0251-09
Spiriva® and HandiHaler®
are registered trademarks of Boehringer Ingelheim International
GmbH, used under license.
_ _
_Product Monograph _
_ _
_SPIRIVA (tiotropium) _
_Page 2 of 42_
RECENT MAJOR LABEL CHANGES
4 Dosage and Administration
7 Warnings and Precautions
04/2022
04/2022
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
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4
1.1
Pediatrics
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4
1.2
Geriatrics...........................................................................................................
4
2
CONTRAINDICATIONS
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4
4
DOSAGE AND
ADMINISTRATION.................................................................................
4
4.1
Dosing Considerations
..............................