SYNALAR OINTMENT

Nazione: Canada

Lingua: inglese

Fonte: Health Canada

Principio attivo:

FLUOCINOLONE ACETONIDE

Commercializzato da:

BAUSCH HEALTH, CANADA INC.

Codice ATC:

D07AC04

INN (Nome Internazionale):

FLUOCINOLONE ACETONIDE

Dosaggio:

0.025%

Forma farmaceutica:

OINTMENT

Composizione:

FLUOCINOLONE ACETONIDE 0.025%

Via di somministrazione:

TOPICAL

Confezione:

60G

Tipo di ricetta:

Prescription

Area terapeutica:

ANTI-INFLAMMATORY AGENTS

Dettagli prodotto:

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

Stato dell'autorizzazione:

APPROVED

Data dell'autorizzazione:

1998-09-02

Scheda tecnica

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