SYNALAR SOLUTION

Страна: Канада

Язык: английский

Источник: Health Canada

Активный ингредиент:

FLUOCINOLONE ACETONIDE

Доступна с:

BAUSCH HEALTH, CANADA INC.

код АТС:

D07AC04

ИНН (Международная Имя):

FLUOCINOLONE ACETONIDE

дозировка:

0.01%

Фармацевтическая форма:

SOLUTION

состав:

FLUOCINOLONE ACETONIDE 0.01%

Администрация маршрут:

TOPICAL

Штук в упаковке:

60ML

Тип рецепта:

Prescription

Терапевтические области:

ANTI-INFLAMMATORY AGENTS

Обзор продуктов:

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

Статус Авторизация:

CANCELLED POST MARKET

Дата Авторизация:

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