ATROVENT HFA METERED-DOSE AEROSOL
Country: Canada
Language: English
Source: Health Canada
Summary of Product characteristics
(SPC)
04-11-2019
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Active ingredient:
IPRATROPIUM BROMIDE
Available from:
BOEHRINGER INGELHEIM (CANADA) LTD LTEE
ATC code:
R03BB01
INN (International Name):
IPRATROPIUM BROMIDE
Dosage:
20MCG
Pharmaceutical form:
METERED-DOSE AEROSOL
Composition:
IPRATROPIUM BROMIDE 20MCG
Administration route:
INHALATION
Units in package:
200 METERED DOSES
Prescription type:
Prescription
Therapeutic area:
ANTIMUSCARINICS ANTISPASMODICS
Product summary:
Active ingredient group (AIG) number: 0115643002; AHFS:
Authorization status:
APPROVED
Authorization date:
2003-07-02
Summary of Product characteristics
_ _
Atrovent HFA Product Monograph November 4, 2019
Page 1 of 30
PRODUCT MONOGRAPH
PR
ATROVENT
® HFA
(IPRATROPIUM BROMIDE)
PRESSURIZED INHALATION SOLUTION
20 MCG/METERED DOSE
BRONCHODILATOR
Boehringer Ingelheim (Canada) Ltd.
5180 South Service Road,
Burlington, Ontario
L7L 5H4
Date of Revision:
November 4, 2019
Submission Control No: 230291
BICL-CCDS No. 0260-02
_ _
Atrovent HFA Product Monograph November 4, 2019
Page 2 of 30
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
.........................................................3
SUMMARY PRODUCT INFORMATION
........................................................................3
INDICATIONS AND CLINICAL USE
..............................................................................3
CONTRAINDICATIONS
...................................................................................................3
WARNINGS AND PRECAUTIONS
..................................................................................4
ADVERSE REACTIONS
....................................................................................................6
DRUG INTERACTIONS
..................................................................................................10
DOSAGE AND ADMINISTRATION
..............................................................................11
OVERDOSAGE
................................................................................................................11
ACTION AND CLINICAL PHARMACOLOGY
............................................................12
STORAGE AND STABILITY
..........................................................................................15
SPECIAL HANDLING INSTRUCTIONS
.......................................................................15
DOSAGE FORMS, COMPOSITION AND PACKAGING
.............................................15
PART II: SCIENTIFIC INFORMATION
...............................................................................16
PHARMACEUTICAL INFORMATION
.............................................
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