Страна: Армения
Язык: английский
Источник: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում
silver sulfadiazine
Arpimed LLC
D06BA01
silver sulfadiazine
10mg/g
cream for external use
aluminum tube 40g
Prescription
Registered
2020-01-17
SUMMARY OF PRODUCT CHARACTERISTICS (SPC) SILVADEV 1% CREAM FOR TOPICAL USE 1. BRAND NAME – Silvadev INTERNATIONAL NON-PROPERTY NAME – Silver sulfadiazine 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each gram of Silvadev, 1% cream contains: _ACTIVE INGREDIENT: _Silver sulfadiazine - 10 mg; For a full list of excipients see section 6.1. 3. PHARMACEUTICAL FORM A white cream, odorless. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Silvadev cream is indicated for the prophylaxis and treatment of infection in burn wounds. Silvadev cream may also be used as an aid to the short-term treatment of infection in leg ulcers and pressure sores, and as an aid to the prophylaxis of infection in skin graft donor sites and extensive abrasions. Silvadev cream is also indicated for the conservative management of finger-tip injuries where pulp, nail loss and/or partial loss of the distal phalanx has occurred. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION To be applied topically. BURNS: The burn wound should be cleaned and Silvadev cream applied over all the affected areas to a depth of 3-5mm. This application is best achieved with a sterile gloved hand and/or sterile spatula. Where necessary, the cream should be re-applied to any area from which it has been removed by patient activity. In burns, Silvadev cream should be re-applied at least every 24 hours, or more frequently if the volume of exudate is large. HAND BURNS: Silvadev cream can be applied to the burn and the whole hand enclosed in a clear plastic bag or glove, which is then closed at the wrist. The patient should be encouraged to move the hand and fingers. The dressing should be changed when an excessive amount of exudate has accumulated in the bag. LEG ULCERS/PRESSURE SORES: The cavity of the ulcer should be filled with Silvadev Cream to a depth of at least 3-5mm. As Silvadev Cream can cause maceration of normal skin on prolonged contact, care should be taken to prevent spread onto non-ulcerated areas. Application of Silvadev Cream should be followed by an absorbent Прочитать полный документ