SYNALAR OINTMENT
Country: Canada
Language: English
Source: Health Canada
Summary of Product characteristics
(SPC)
09-09-2021
Some documents for this product are not currently available, you can send a request to our customer service and we will notify you as soon as we are able to obtain them.
Send request.
Send request.
Active ingredient:
FLUOCINOLONE ACETONIDE
Available from:
BAUSCH HEALTH, CANADA INC.
ATC code:
D07AC04
INN (International Name):
FLUOCINOLONE ACETONIDE
Dosage:
0.025%
Pharmaceutical form:
OINTMENT
Composition:
FLUOCINOLONE ACETONIDE 0.025%
Administration route:
TOPICAL
Units in package:
60G
Prescription type:
Prescription
Therapeutic area:
ANTI-INFLAMMATORY AGENTS
Product summary:
Active ingredient group (AIG) number: 0106314001; AHFS:
Authorization status:
APPROVED
Authorization date:
1998-09-02
Summary of Product characteristics
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
SYNALAR
®
Fluocinolone Acetonide
Ointment 0.025% w/w
TOPICAL CORTICOSTEROID
BAUSCH HEALTH, CANADA INC.
Date of Initial Approval:
2150 St-Elzear Blvd. West
November 17, 2014
Laval, Quebec
H7L 4A8
DATE OF REVISION:
June 25, 2021
Control #: 247002
_Pr_
_SYNALAR _
_®_
_ Page 2 of 13 _
_(Fluocinolone Acetonide) _
RECENT MAJOR LABEL CHANGES
Not applicable
TABLE OF CONTENTS
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
......................................................3
1
INDICATIONS
...........................................................................................................3
1.1
Pediatrics……………………………………………………………………………....3
1.2
Geriatrics……………………………………………………………………………....3
2
CONTRAINDICATIONS
...........................................................................................3
3
DOSAGE AND
ADMINISTRATION.........................................................................3
3.1 Dosing Considerations
…………………………………….…………………………..3
3.2 Recommended Dose and Dosage Adjustment
....................................................... ..3
3.3Administration…………………………………………………………………………3
4
OVERDOSAGE
..........................................................................................................4
5
DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING ...............4
6
WARNINGS AND PRECAUTIONS
..........................................................................4
7
ADVERSE REACTIONS
...........................................................................................5
8
DRUG
INTERACTIONS………………………………………………………………..5
9 CLINICAL PHARMACOLOGY
..............................................................................5
9.1
Pharmacokinetics.............
Read the complete document
