SPIRIVA CAPSULE

מדינה: קנדה

שפה: אנגלית

מקור: Health Canada

מרכיב פעיל:

TIOTROPIUM (TIOTROPIUM BROMIDE MONOHYDRATE)

זמין מ:

BOEHRINGER INGELHEIM (CANADA) LTD LTEE

קוד ATC:

R03BB04

INN (שם בינלאומי):

TIOTROPIUM BROMIDE

כמות:

18MCG

טופס פרצבטיות:

CAPSULE

הרכב:

TIOTROPIUM (TIOTROPIUM BROMIDE MONOHYDRATE) 18MCG

מסלול נתינה (של תרופות):

INHALATION

יחידות באריזה:

10/30; 1 HANDIHALER

סוג מרשם:

Prescription

איזור תרפויטי:

ANTIMUSCARINICS ANTISPASMODICS

leaflet_short:

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

מצב אישור:

APPROVED

תאריך אישור:

2002-11-20

מאפייני מוצר

_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
..............................................................................................................
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
..............................