DUOVENT UDV SOLUTION

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

FENOTEROL HYDROBROMIDE; IPRATROPIUM BROMIDE

Available from:

BOEHRINGER INGELHEIM (CANADA) LTD LTEE

ATC code:

R03AL01

INN (International Name):

FENOTEROL AND IPRATROPIUM BROMIDE

Dosage:

0.3125MG; 0.125MG

Pharmaceutical form:

SOLUTION

Composition:

FENOTEROL HYDROBROMIDE 0.3125MG; IPRATROPIUM BROMIDE 0.125MG

Administration route:

INHALATION

Units in package:

20X4ML

Prescription type:

Prescription

Therapeutic area:

ANTIMUSCARINICS ANTISPASMODICS

Product summary:

Active ingredient group (AIG) number: 0227239001; AHFS:

Authorization status:

CANCELLED POST MARKET

Authorization date:

2017-01-31

Summary of Product characteristics

_ _
_Duovent® UDV Product Monograph _
_ Page 1 of 40 _
PRODUCT MONOGRAPH
PR
DUOVENT
® UDV (IPRATROPIUM BROMIDE/FENOTEROL HYDROBROMIDE)
NEBULIZER SOLUTION
EACH PLASTIC UNIT DOSE VIAL (UDV) CONTAINS A TOTAL OF 0.5 MG OF
IPRATROPIUM BROMIDE AND
1.25 MG FENOTEROL HYDROBROMIDE IN 4 ML OF SALINE
BRONCHODILATOR
BOEHRINGER INGELHEIM (CANADA) LTD.
5180 SOUTH SERVICE ROAD
BURLINGTON, ONTARIO
L7L 5H4
Date of Revision:
March 30, 2015
Submission Control No: 180942
BICL CCDS No. 0279-03
_ _
_Duovent® UDV Product Monograph _
_ Page 2 of 40 _
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
.........................................................3
SUMMARY PRODUCT INFORMATION
........................................................................3
INDICATIONS AND CLINICAL USE
..............................................................................3
CONTRAINDICATIONS
...................................................................................................4
WARNINGS AND PRECAUTIONS
..................................................................................4
ADVERSE REACTIONS
....................................................................................................8
DRUG INTERACTIONS
..................................................................................................12
DOSAGE AND ADMINISTRATION
..............................................................................13
OVERDOSAGE
................................................................................................................14
ACTION AND CLINICAL PHARMACOLOGY
............................................................15
STORAGE AND STABILITY
..........................................................................................21
DOSAGE FORMS, COMPOSITION AND PACKAGING
.............................................21
PART II: SCIENTIFIC INFORMATION
...............................................................................22
PHARMACEUTICAL INFORMATION
............................................