SYNALAR OINTMENT

Țară: Canada

Limbă: engleză

Sursă: Health Canada

Ingredient activ:

FLUOCINOLONE ACETONIDE

Disponibil de la:

BAUSCH HEALTH, CANADA INC.

Codul ATC:

D07AC04

INN (nume internaţional):

FLUOCINOLONE ACETONIDE

Dozare:

0.025%

Forma farmaceutică:

OINTMENT

Compoziție:

FLUOCINOLONE ACETONIDE 0.025%

Calea de administrare:

TOPICAL

Unități în pachet:

60G

Tip de prescriptie medicala:

Prescription

Zonă Terapeutică:

ANTI-INFLAMMATORY AGENTS

Rezumat produs:

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

Statutul autorizaţiei:

APPROVED

Data de autorizare:

1998-09-02

Caracteristicilor produsului

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