IPRAVENT SOLUTION
Country: Canada
Language: English
Source: Health Canada
Summary of Product characteristics
(SPC)
10-01-2018
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Active ingredient:
IPRATROPIUM BROMIDE
Available from:
AA PHARMA INC
ATC code:
R01AX03
INN (International Name):
IPRATROPIUM BROMIDE
Dosage:
21MCG
Pharmaceutical form:
SOLUTION
Composition:
IPRATROPIUM BROMIDE 21MCG
Administration route:
NASAL
Units in package:
30ML
Prescription type:
Prescription
Therapeutic area:
ANTIMUSCARINICS ANTISPASMODICS
Product summary:
Active ingredient group (AIG) number: 0115643002; AHFS:
Authorization status:
APPROVED
Authorization date:
2002-07-10
Summary of Product characteristics
Page 1 of 25
PRODUCT
MONOGRAPH
PR IPRAVENT
IPRATROPIUM BROMIDE
0.03% w/v and 0.06%w/v
Nasal Spray Solution
Topical Anticholinergic for Nasal Administration
AA PHARMA INC.
1165 CREDITSTONE ROAD, UNIT #1
VAUGHAN, ONTARIO
L4K 4N7
SUBMISSION CONTROL NO:
209712
DATE OF REVISION:
JANUARY 10, 2018
Page 2 of 25
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
.......................................................................
3
SUMMARY PRODUCT INFORMATION
...................................................................................
3
INDICATIONS AND CLINICAL USE
..........................................................................................
3
CONTRAINDICATIONS
.............................................................................................................
3
WARNINGS AND PRECAUTIONS
...........................................................................................
3
ADVERSE REACTIONS
...........................................................................................................
4
DRUG INTERACTIONS
............................................................................................................
8
DOSAGE AND ADMINISTRATION
...........................................................................................
9
OVERDOSAGE
.........................................................................................................................
9
ACTION AND CLINICAL
PHARMACOLOGY
.............................................................................
9
STORAGE AND STABILITY
......................................................................................................
13
DOSAGE FORMS, COMPOSITION AND PACKAGING
........................................................ 13
PART II : SCIENTIFIC INFORMATION
...........................................................................................
15
PHARMACEUTICAL INFORMATION
......................................................................................
15
CLINICAL TRIALS
............
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