Hydrocortisone ointment for topical use

מדינה: ארמניה

שפה: אנגלית

מקור: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

מרכיב פעיל:

hydrocortisone (hydrocortisone acetate)

זמין מ:

Arpimed LLC

קוד ATC:

D07AA02

INN (שם בינלאומי):

hydrocortisone (hydrocortisone acetate)

כמות:

10mg/g

טופס פרצבטיות:

ointment for topical use

יחידות באריזה:

10g and 15g aluminium tube

סוג מרשם:

Prescription

מצב אישור:

Registered

תאריך אישור:

2018-09-24

מאפייני מוצר

SUMMARY PRODUCT CHARACTERISTIC
HYDROCORTISONE
1% OINTMENT FOR TOPICAL USE
1.1.TRADE NAME - Hydrocortisone
1.2. INTERNATIONAL NON-PROPERTY NAME–Hydrocortisone
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each gram of Hydrocortisone, 1%topical ointment, contains:
_ACTIVE INGREDIENT: _hydrocortisone acetate – 10 mg;
_For a full list of excipients, see section 6.1. _
_ _
3. PHARMACEUTICAL FORM
Ointment for topical use.
White homogenous ointment with weak odor.
4. CLINICAL PARTICULARS
4.1. THERAPEUTIC INDICATIONS
POM: For the treatment of mild to moderate inflammatory skin disorders
such as eczema, including
atopic, infantile, discoid and stasis eczema; seborrhoeic dermatitis,
intertrigo, otitis externa, contact
dermatitis, neurodermatitis flexural psoriasis and lichen simplex.
P: For the relief of irritant contact dermatitis, allergic contact
dermatitis, insect bite reactions and mild
to moderate eczema.
4.2. POSOLOGY AND METHOD OF ADMINISTRATION
POM: For adults and children: Apply sparingly twice a day.
P: For adults, the elderly and children over 10 years of age: Apply
sparingly to a small area, once or
twice a day, for a maximum of 7 days.
Children under 10 years of age: Not recommended except under medical
supervision.
For topical application.
4.3. CONTRAINDICATIONS
POM: Should not be used if allergic to any of the ingredients or on
untreated, infected lesions,
ulcerative conditions, rosacea, perioral dermatitis or acne.
P: The product should not be used if allergic to any of the
ingredients or on the eyes or face, the
anogenital area or on broken or infected skin including impetigo, cold
sores, acne or athlete's foot.
4.4. SPECIAL WARNINGS AND PRECAUTIONS FOR USE
POM: Avoid prolonged, continuous use, particularly in children and
especially on the face, as adrenal
suppression may occur.
P: Medical advice should be sought if the condition does not improve.
Contains Propylparaben, whichmay cause allergic reactions (possibly
delayed).
4.5. INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF
INTERACTION