RATIO-IPRATROPIUM INHALATION SOLUTION

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

IPRATROPIUM BROMIDE

Available from:

RATIOPHARM INC DIVISION OF TEVA CANADA LIMITED

ATC code:

R03BB01

INN (International Name):

IPRATROPIUM BROMIDE

Dosage:

250MCG

Pharmaceutical form:

SOLUTION

Composition:

IPRATROPIUM BROMIDE 250MCG

Administration route:

INHALATION

Units in package:

20 ML

Prescription type:

Prescription

Therapeutic area:

ANTIMUSCARINICS ANTISPASMODICS

Product summary:

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

Authorization status:

CANCELLED POST MARKET

Authorization date:

2009-07-17

Summary of Product characteristics

PRODUCT MONOGRAPH
PR
RATIO-IPRATROPIUM UDV
(Ipratropium Bromide)
1 mL and 2 mL inhalation solution unit dose vials
Each plastic unit dose vial (UDV) contains:
250 mcg of ipratropium bromide in 1 mL
250 mcg of ipratropium bromide in 2 mL
500 mcg of ipratropium bromide in 2 mL
BRONCHODILATOR
RATIOPHARM INC.
17 800, Lapointe
Mirabel, Quebec
Canada, J7J 1P3
Date of Preparation:
April 18, 2002
Date of Revision:
October 22, 2009
Submission Control No: 133622
_ _
_Product Monograph – ratio-IPRATROPIUM _
_Page 2 of 29 _
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....................................................................................................5
DRUG INTERACTIONS
....................................................................................................9
DOSAGE AND
ADMINISTRATION................................................................................9
OVERDOSAGE
................................................................................................................10
ACTION AND CLINICAL PHARMACOLOGY
............................................................10
STORAGE AND
STABILITY..........................................................................................13
SPECIAL HANDLING INSTRUCTIONS
.......................................................................13
DOSAGE FORMS, COMPOSITION AND PACKAGING
.............................................14
PART II: SCIENTIFIC INFORMATION
.....................................................................