Country: Հայաստան
language: անգլերեն
source: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում
fluocinolone acetonide
Arpimed LLC
D07AC04
fluocinolone acetonide
0,25mg/g
ointment for external use
15g aluminium tube
Prescription
Registered
2016-12-30
SUMMARY PRODUCT CHARACTERISTIC (S M PC) FLUOCINOLONE OINTMENT FOR TOPICAL 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 di read_full_document