ATROVENT HFA METERED-DOSE AEROSOL

Land: Kanada

Sprache: Englisch

Quelle: Health Canada

Wirkstoff:

IPRATROPIUM BROMIDE

Verfügbar ab:

BOEHRINGER INGELHEIM (CANADA) LTD LTEE

ATC-Code:

R03BB01

INN (Internationale Bezeichnung):

IPRATROPIUM BROMIDE

Dosierung:

20MCG

Darreichungsform:

METERED-DOSE AEROSOL

Zusammensetzung:

IPRATROPIUM BROMIDE 20MCG

Verabreichungsweg:

INHALATION

Einheiten im Paket:

200 METERED DOSES

Verschreibungstyp:

Prescription

Therapiebereich:

ANTIMUSCARINICS ANTISPASMODICS

Produktbesonderheiten:

Active ingredient group (AIG) number: 0115643002; AHFS:

Berechtigungsstatus:

APPROVED

Berechtigungsdatum:

2003-07-02

Fachinformation

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