SYNALAR SOLUTION

Страна: Канада

мова: англійська

Джерело: Health Canada

Активний інгредієнт:

FLUOCINOLONE ACETONIDE

Доступна з:

BAUSCH HEALTH, CANADA INC.

Код атс:

D07AC04

ІПН (Міжнародна Ім'я):

FLUOCINOLONE ACETONIDE

Дозування:

0.01%

Фармацевтична форма:

SOLUTION

Склад:

FLUOCINOLONE ACETONIDE 0.01%

Адміністрація маршрут:

TOPICAL

Одиниць в упаковці:

60ML

Тип рецепту:

Prescription

Терапевтична области:

ANTI-INFLAMMATORY AGENTS

Огляд продуктів:

Active ingredient group (AIG) number: 0106314002; AHFS:

Статус Авторизація:

CANCELLED POST MARKET

Дата Авторизація:

2021-05-06

Характеристики продукта

PRODUCT MONOGRAPH
PR
SYNALAR
®
Fluocinolone Acetonide
Ointment 0.025% w/w
Solution 0.01% w/w
TOPICAL CORTICOSTEROID
BAUSCH HEALTH, CANADA INC.
DATE OF REVISION:
2150 St-Elzear Blvd. West
October 7, 2020
Laval, Quebec
H7L 4A8
Control No.: 243268
_Pr_
_SYNALAR _
_®_
_ Product Monograph Page 2 of 10_
NAME OF DRUG
PR
SYNALAR
®
Fluocinolone Acetonide
Ointment 0.025% w/w
Solution 0.01% w/w
THERAPEUTIC CLASSIFICATION
Topical Corticosteroid
ACTION
SYNALAR (fluocinolone acetonide) possesses anti-inflammatory,
anti-pruritic and
vasoconstrictive properties.
INDICATIONS
SYNALAR (fluocinolone acetonide) is indicated for topical therapy of
corticosteroid responsive
acute and chronic skin eruptions where an anti-inflammatory,
anti-allergenic, and anti-pruritic
activity in the topical management is required.
SYNALAR topical solution (0.01%) is more appropriate than the
fluocinolone acetonide cream
or ointment formulations for use in locations such as the scalp.
CONTRAINDICATIONS
Topical corticosteroids are contraindicated in untreated bacterial,
tubercular, fungal and most
viral lesions of the skin (including herpes simplex, vaccinia and
varicella). They are also
contraindicated in individuals with a history of hypersensitivity to
its components.
WARNINGS
The safety of topical corticosteroids during pregnancy or lactation
has not been established. The
potential benefit of topical corticosteroids, if used during pregnancy
or lactation, should be
weighed against possible hazard to the fetus or the nursing infant.
This product is not for ophthalmic use.
_Pr_
_SYNALAR _
_®_
_ Product Monograph Page 3 of 10_
PRECAUTIONS
This product is not recommended for use under occlusive dressings.
Apply cautiously on lesions
close to the eye. Severe irritation is possible if these formulations
contact the eye. Should this
occur, immediate flushing of the eye with a large volume of water is
recommended.
Prolonged use of topical corticosteroid products may produce atrophy
of the skin and of
subcutaneous tissues, particularly on flexor surfaces