BIACNA TOPICAL GEL
Country: Canada
Language: English
Source: Health Canada
Summary of Product characteristics
(SPC)
02-10-2020
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Active ingredient:
CLINDAMYCIN PHOSPHATE; TRETINOIN
Available from:
BAUSCH HEALTH, CANADA INC.
ATC code:
D10AF51
INN (International Name):
CLINDAMYCIN, COMBINATIONS
Dosage:
1.2%; 0.025%
Pharmaceutical form:
GEL
Composition:
CLINDAMYCIN PHOSPHATE 1.2%; TRETINOIN 0.025%
Administration route:
TOPICAL
Units in package:
2/30/60G
Prescription type:
Prescription
Therapeutic area:
KERATOLYTIC AGENTS
Product summary:
Active ingredient group (AIG) number: 0252829001; AHFS:
Authorization status:
APPROVED
Authorization date:
2010-12-07
Summary of Product characteristics
PRODUCT MONOGRAPH
PR
BIACNA
®
Clindamycin Phosphate and Tretinoin Gel
1.2% w/w and 0.025% w/w
ACNE THERAPY
BAUSCH HEALTH, CANADA INC.
2150 St-Elzear Blvd West
Laval, Quebec H7L 4A8
Canada
DATE OF REVISION:
October 2, 2020
Submission Control No: 238498
_BIACNA_
_®_
_ - Product Monograph _
_Page 2 of 30 _
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
...................................................................................................
7
DRUG INTERACIONS
......................................................................................................
9
DOSAGE AND ADMINISTRATION
.............................................................................
10
OVERDOSAGE
...............................................................................................................
10
ACTION AND CLINICAL PHARMACOLOGY
........................................................... 11
STORAGE AND STABILITY
.........................................................................................
11
SPECIAL HANDLING INSTRUCTIONS
......................................................................
12
DOSAGE FORMS, COMPOSITION AND PACKAGING
............................................ 12
PART II: SCIENTIFIC INFORMATION
...............................................................................
13
PHARMACEUTICAL INFORMATION
.........................................................................
13
CLINICAL TRIALS
........................................................................
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