Pays: Malte
Langue: anglais
Source: Medicines Authority
SULFADIAZINE SILVER
Laboratorio Aldo-Union S.L. Baronesa de Malda 73, 08950 Esplugues de Llobregat, Barcelona, Spain
D06BA01
SULFADIAZINE SILVER 1 g
CREAM
SULFADIAZINE SILVER 1 g
POM
ANTIBIOTICS AND CHEMOTHERAPEUTICS FOR DERMATOLOGICAL USE
Authorised
2007-04-05
PATIENT INFORMATION LEAFLET SILVEDERMA CREAM SILVER SULFADIAZINE COMPOSITION: Each 100 grams of SILVEDERMA cream contains 1 g of micronized silver sulfadiazine and excipients (Cetostearyl alcohol, paraffin white soft, isopropyl myristate, propylene glycol, polyoxyl 40 stearate, sorbitan oleate, methylparaben and purified water), s.q. MANUFACTURER RESPONSIBLE: Laboratorio ALDO-UNIÓN, S.L. Baronesa de Maldá, 73 08950 Esplugues de Llobregat BARCELONA - SPAIN INDICATIONS: Topical antibacterial. Preventive and healing of infections caused by Pseudomonas and Staphylococcus in all kind of injuries and ulcers, and especially in burns. APPLICATION AND USUAL DOSAGE: Application in grave and extensive burns: the cream should be applied to the burnt area after the cleansing and debridement of the wound, usually once a day, wearing a sterile glove, to a thickness of 1 mm, making sure that all interstices and crevices of the irregular burnt surface are treated. Silver sulfadiazine should be applied more frequently to burnt areas from which the cream might be removed by any involuntary movement of the patient. The therapy should be continued until a satisfactory healing has been achieved or until the burnt area is ready for grafting. Dressings are unnecessary but covering it with fine mesh gauze and bandage will be more convenient for the majority of the patients. It is advisable hydrotherapy and mechanical debridement in patients with third-degree burns. DIRECTIONS FOR THE CORRECT ADMINISTRATION OF THE PREPARATION: See “Dosage” section. The tube has a seal whose opening is carried out following the instructions of the drawing: Unscrew cap from tube Insert the cap and make it coincide Rotate it until head comes off with the jagged head of the tube CONTRAINDICATIONS: The therapy with sulphonamide is usually contraindicated in premature babies and in newborns of less than two months, since it can cause kernicterus. Because of these theoretical reasons, it is better not to use silver sulfadiazine in patients sensitive to sul Lire le document complet
Page 1 of 7 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT: Silvederma Cream 1g/100g 2. QUALITATIVE AND QUANTITATIVE COMPOSITION: Each 100 g of cream contains 1 g of silver sulfadiazine (D.C.I.) 3. PHARMACEUTICAL FORM: Cream for topical use. 4. CLINICAL DATA: 4.1. THERAPEUTIC INDICATIONS: Topical antibacterial. Preventive and healing of infections caused by Pseudomonas and Staphylococcus in all kind of injuries and ulcers, and especially in burns. 4.2. ADMINISTRATION AND DOSAGE: For topical administration. Method of application in serious and extensive burns: Once the wound has been cleansed and debrided, SILVEDERMA cream is applied wearing sterile gloves normally once or twice a day, covering all the burnt area to a thickness of approximately 1 to 3 mm, taking care to cover with cream all the interstices of the wound. Silver sulfadiazine should be applied more frequently to burnt areas from which the cream might be removed by involuntary movement of the patient. The therapy is continued until a satisfactory healing is achieved or until the burnt sites are ready for grafting. Dressings can be applied over the cream, but it is not necessary. Hydrotherapy and mechanical debridement are recommended, especially in patients with third- degree burns. Page 2 of 7 The drug should not be withdrawn from the therapeutic regimen as long as the possibility of infection exists, except if a significant adverse reaction occurs. 4.3. CONTRAINDICATIONS: SILVEDERMA cream is contraindicated in patients who are hypersensitive to sulphonamides or to any other ingredient in the preparation. The therapy with sulphonamides is known to be contraindicated in premature infants or newborn infants of less than two months of age, since it may favour the possible appearance of kernicterus Silver sulfadiazine shouldn’t be used in sulphonamide-sensitive patients or pregnant women probably due to theoretical reasons. However, due to the serious risk of sepsis in severe burns, its use in such patients should be determined ind Lire le document complet