Nchi: Armenia
Lugha: Kiingereza
Chanzo: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում
tretinoin
Arpimed LLC
D10AD01
tretinoin
0,5mg/g
cream
aluminum tube 15g
OTC
Registered
2019-05-24
SUMMARY OF PRODUCT CHARACTERISTICS (SPC) SILKADERM 0.05% CREAM 1.1 BRAND NAME – Silkaderm 1.2 INTERNATIONAL NON-PROPERTY NAME - Tretinoin 2. QUANTITATIVE AND QUALITATIVE COMPOSITION Each gram of SILKADERM 0.05% cream contains: _ACTIVE INGREDIENT:_ tretinoin - 0.5 mg. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM A yellowish cream. Cream for topical use. 4. CLINICAL PARTICULARS 4.1 INDICATIONS AND USAGE Silkaderm is indicated for topical application in the treatment of acne vulgaris. The safety and efficacy of the long-term use of this product in the treatment of other disorders have not been established. 4.2 DOSAGE AND ADMINISTRATION Silkaderm should be applied once a day, before retiring, to the skin where acne lesions appear, using enough to cover the entire affected area lightly. Application may cause a transitory feeling of warmth or slight stinging. In cases where it has been necessary to temporarily discontinue therapy or to reduce the frequency of application, therapy may be resumed or frequency of application increased when the patients become able to tolerate the treatment. Alteration of vehicle, drug concentration, or dose frequency should be closely monitored by careful observation of the clinical therapeutic response and skin tolerance. During the early weeks of therapy, an _apparent _exacerbation of inflammatory lesions may occur. This is due to the action of the medication on deep, previously unseen lesions and should not be considered a reason to discontinue therapy. Therapeutic results should be noticed after two to three weeks but more than six weeks of therapy may be required before definite beneficial effects are seen. Once the acne lesions have responded satisfactorily, it may be possible to maintain the improvement with less frequent applications, or other dosage forms. Patients treated with Silkaderm (tretinoin) acne treatment may use cosmetics, but the area to be treated should be cleansed thoroughly before the medication is applied. (SEE PRECAUTIONS) 4.3 CONTRA Soma hati kamili