PMS-BENZYDAMINE MOUTHWASH/GARGLE
Country: Canada
Language: English
Source: Health Canada
Summary of Product characteristics
(SPC)
26-10-2017
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Active ingredient:
BENZYDAMINE HYDROCHLORIDE
Available from:
PHARMASCIENCE INC
ATC code:
A01AD02
INN (International Name):
BENZYDAMINE
Dosage:
0.15%
Pharmaceutical form:
MOUTHWASH/GARGLE
Composition:
BENZYDAMINE HYDROCHLORIDE 0.15%
Administration route:
BUCCAL
Units in package:
100ML/250ML
Prescription type:
Prescription
Therapeutic area:
MOUTHWASHES AND GARGLES
Product summary:
Active ingredient group (AIG) number: 0113801001; AHFS:
Authorization status:
APPROVED
Authorization date:
1999-01-25
Summary of Product characteristics
PRODUCT MONOGRAPH
PR
PMS-BENZYDAMINE
Benzydamine Mouthwash, BP
Benzydamine Hydrochloride 1.5 mg/mL (0.15% w/v)
LOCAL ANALGESIC
PHARMASCIENCE INC.
6111 Royalmount Avenue Suite #100
Montreal, QC, CANADA, H4P 2T4
www.pharmascience.com
Date of Preparation:
October 26, 2017
Submission Control No: 210244
_Product Monograph pms-BENZYDAMINE Page 2 of 13_
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
........................................................ 3
SUMMARY PRODUCT INFORMATION
........................................................................
3
INDICATIONS AND CLINICAL USE
..............................................................................
3
CONTRAINDICATIONS
...................................................................................................
3
WARNINGS AND PRECAUTIONS
.................................................................................
3
DOSAGE AND ADMINISTRATION
................................................................................
4
OVERDOSAGE
..................................................................................................................
4
ACTION AND CLINICAL PHARMACOLOGY
.............................................................. 4
STORAGE AND STABILITY
...........................................................................................
5
DOSAGE FORMS, COMPOSITION AND PACKAGING
............................................... 5
PART II: SCIENTIFIC INFORMATION
.................................................................................
6
PHARMACEUTICAL INFORMATION
...........................................................................
6
CLINICAL TRIALS
............................................................................................................
7
DETAILED PHARMACOLOGY
.......................................................................................
7
TOXICOLOGY
...................................................................................................................
7
REFERENCES
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