Fluocinolone ointment for external use

Country: Armenia

Language: English

Source: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Active ingredient:

fluocinolone acetonide

Available from:

Arpimed LLC

ATC code:

D07AC04

INN (International Name):

fluocinolone acetonide

Dosage:

0,25mg/g

Pharmaceutical form:

ointment for external use

Units in package:

15g aluminium tube

Prescription type:

Prescription

Authorization status:

Registered

Authorization date:

2021-12-31

Summary of Product characteristics

SUMMARY PRODUCT CHARACTERISTIC (S
M
PC)
FLUOCINOLONE
OINTMENT FOR EXTERNAL USE 0.025 %
1.
NAME OF THE MEDICAL PRODUCT - FLUOCINOLONE
1.2
INTERNATIONAL NON-PROPERTY NAME – FLUOCINOLONE
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 1 gram of ointment contains:
_ACTIVE INGREDIENT: _fluocinolone acetonide – 0.25 mg;
3.
PHARMACEUTICAL FORM
Ointment.
White or slightly yellowish ointment.
4.
CLINICAL PARTICULARS
_4.1_
_ _
THERAPEUTIC INDICATIONS
Fluocinolone contains an effective topical steroid and is suitable for
treating a wide variety
of inflammatory, pruritic and allergic disorders of the skin.
Fluocinolone is particularly
suitable for topical application in:

Eczema and dermatitis; atopic eczema, seborrheal eczema, discoid
eczema, otitis
externa, contact dermatitis, neurodermatitis.

Prurigo

Psoriasis (Excluding widespread plaque psoriasis)

Lichen Planus, Discoid Lupus Erythematosus.
_4.2_
_ _
POSOLOGY AND METHOD OF ADMINISTRATION
_Adults (including the elderly) and children above one. _
A small quantity of the Fluocinolone preparation is applied lightly to
the affected area two
or three times a day, and massaged gently and thoroughly into the
skin. When an occlusive
dressing is required, the affected area should first be thoroughly
cleansed, the Fluocinolone
preparations is then applied and covered with a suitable dressing.
Occlusion should not be
used for children or for the face. In some cases, the application of
hot, moist compresses
may be an advantage.
_4.3_
_ _
CONTRAINDICATIONS
Fluocinolone is contraindicated in primary infections of the skin
caused by bacteria, fungi
or
viruses
and
in
rosacea,
acne,
perioral
dermatitis,
anogenital
pruritus
and
napkin
eruptions.
Fluocinolone ointment should not be used in patients that are
hypersensitive to any of the
ingredients. Fluocinolone preparations are not advised in the
treatment of children under
one year of age.
_4.4_
_ _
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Long
term
continuous
steroid
therapy
can
produce
local
atrophic
skin
changes
and