SYNALAR OINTMENT

Land: Kanada

Tungumál: enska

Heimild: Health Canada

Virkt innihaldsefni:

FLUOCINOLONE ACETONIDE

Fáanlegur frá:

BAUSCH HEALTH, CANADA INC.

ATC númer:

D07AC04

INN (Alþjóðlegt nafn):

FLUOCINOLONE ACETONIDE

Skammtar:

0.025%

Lyfjaform:

OINTMENT

Samsetning:

FLUOCINOLONE ACETONIDE 0.025%

Stjórnsýsluleið:

TOPICAL

Einingar í pakka:

60G

Gerð lyfseðils:

Prescription

Lækningarsvæði:

ANTI-INFLAMMATORY AGENTS

Vörulýsing:

Active ingredient group (AIG) number: 0106314001; AHFS:

Leyfisstaða:

APPROVED

Leyfisdagur:

1998-09-02

Vara einkenni

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.............