Source: Medicines Authority (MT) Revision Year: 2021 Publisher: Laboratorio ALDO-UNIÓN, S.L., Baronesa de Maldá, 73, 08950 Esplugues de Llobrega, BARCELONA (SPAIN)
Topical antibacterial. Preventive and healing of infections caused by Pseudomonas and Staphylococcus in all kind of injuries and ulcers, and especially in burns.
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 ofthe 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 thirddegree burns.
The drug should not be withdrawn from the therapeutic regimen as long as the possibility of infection exists, except if a significant adverse reaction occurs.
In the treatment of extensive burns significant quantities of sulfadiazine may be absorbed, so it is proper to present its general side effects (haematological, intestinal, renal and cutaneous).
The monitoring of the plasmatic levels of sulfadiazine is not necessary, except, possibly in patients with impaired hepatic or renal functions when the drug isapplied to an extensive surface under occlusive bandage or to damaged skin (specially burnt).
Should a massive absorption of the drug occur, its elimination through the urine should be enhanced with the help of the ingestion of abundant bicarbonated liquids.In the event of serious crystaluria ureteral catheterization might be necessary.
3 years.
Do not keep at a temperature higher than 30ºC. Protect it from light.
Polyethylene tube with turning cap containing 50 g of cream.
Polypropylene jar containing 500 g of cream.
See “Administration and dosage”.
The tube has a cap whose opening is carried out following the instructions of thedrawing:
Unscrew cap from tube.
Insert the cap and make it coincide with the jagged head of the tube.
Rotate it until head comes off.
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