APO-IPRAVENT STERULES SOLUTION

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

IPRATROPIUM BROMIDE

Available from:

APOTEX INC

ATC code:

R03BB01

INN (International Name):

IPRATROPIUM BROMIDE

Dosage:

250MCG

Pharmaceutical form:

SOLUTION

Composition:

IPRATROPIUM BROMIDE 250MCG

Administration route:

INHALATION

Units in package:

2ML

Prescription type:

Prescription

Therapeutic area:

ANTIMUSCARINICS ANTISPASMODICS

Product summary:

Active ingredient group (AIG) number: 0115643001; AHFS:

Authorization status:

APPROVED

Authorization date:

1997-06-23

Summary of Product characteristics

Page 1 of 34
PRODUCT
MONOGRAPH
APO-IPRAVENT
LPRATROPIUM BROMIDE NEBULIZER SOLUTION
250 MCG/ML (0.025%) IN 20 ML BOTTLES AND 2 ML STERULES
125 MCG/ML (0.0125%) IN 2 ML STERULES
BRONCHODILATOR
APOTEX INC.
150 SIGNET DRIVE
TORONTO, ONTARIO
M9L 1T9
DATE OF REVISION:
FEBRUARY 07, 2017
CONTROL NO:
190543
Page 2 of 34
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
......................................................................................
10
OVERDOSAGE
....................................................................................................................
11
ACTION AND CLINICAL PHARMACOLOGY
.......................................................................
11
STORAGE AND STABILITY
.................................................................................................
14
SPECIAL HANDLING INSTRUCTIONS
...............................................................................
14
DOSAGE FORMS, COMPOSITION AND PACKAGING
...................................................... 15
PART II: SCIENTIFIC INFORMATION
....................................................................................
16
PHARMACEUTICAL INFORMATION
....................................................