Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
SULFADIAZINE SILVER
B & S Healthcare
1 %w/w
Cream
2010-11-12
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT FLAMAZINE 1% w/w Cream 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Contains Silver sulfadiazine 1 % w/w Excipients: Contains cetyl alcohol and propylene glycol. For a full list excipients. see section 6.1. 3 PHARMACEUTICAL FORM Cream _Product imported from Spain:_ White to off-white, sterile cream. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS FLAMAZINE cream is indicated for the prophylaxis and treatment of infection in burn wounds, leg ulcers and pressure sores due to micro-organisms sensitive to this anti-infective. FLAMAZINE cream is also indicated for the conservative management of finger-tip injuries where pulp, nail loss and/or partial loss of the distal phalanx have occurred. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION To be applied topically. Burns and Leg Ulcers/Pressure Sores: A layer approximately 3 to 5mm thick should be applied to the affected area using a sterile glove or spatula. The area should then be covered by an absorbent gauze dressing and support bandage where necessary. The dressing should be changed and FLAMAZINE cream applied at least every 24 hours in burn treatment, or at least three times weekly otherwise, and debridement carried out as necessary. As Flamazine cream can cause maceration of normal skin on prolonged contact; care should be taken to avoid spread onto non-ulcerated areas. Finger-Tip Injuries: Haemostasis of the injury should be achieved prior to the application of a 3-5mm layer of FLAMAZINE cream. A conventional finger dressing may be used. Alternatively the finger of a plastic or unsterile surgical glove can be used and fixed in place with waterproof adhesive tape. Dressings should be changed every 2-3 days. 4.3 CONTRAINDICATIONS As sulphonamides are known to cau Read the complete document