RATIO-IPRATROPIUM UDV SOLUTION

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

IPRATROPIUM BROMIDE

Available from:

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:

10 VIALS X 2 ML

Prescription type:

Prescription

Therapeutic area:

ANTIMUSCARINICS ANTISPASMODICS

Product summary:

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

Authorization status:

CANCELLED POST MARKET

Authorization date:

2018-05-18

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
TEVA CANADA LIMITED
30 Novopharm Court
Toronto, Ontario
Canada, M1B 2K9
Date of Preparation:
July 24, 2013
Submission Control No: 166254
_ _
_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
..................................................................................................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
PHARMACEUTIC