Flammacerium

Flammacerium

Manufacturer:

A. Menarini

Distributor:

Zuellig
Full Prescribing Info
Contents
Silver sulfadiazine, cerium nitrate.
Description
Each 100 g of cream contains silver sulfadiazine 1 g, cerium nitrate 2.2 g, polysorbate 60 1 g, polysorbate 80 1 g, glyceryl monostearate 4 g, cetyl alcohol 4 g, propylene glycol 7 g, liquid paraffin 20 g and purified water 20 g.
Action
Antibacterial.
Cerium nitrate enhances the well-known antibacterial properties of silver sulfadiazine and promotes the rapid formation of an eschar.
Indications/Uses
Prevention and treatment of infections of severe burns.
In several clinical studies, Flammacerium has been proven to be an effective therapy for the prevention and treatment of burn wound infections, especially those caused by microorganisms eg, Staphylococcus aureus, Pseudomonas aeruginosa, Enterobacter and Klebsiella pneumoniae.
Sepsis due to these organisms rarely occurs with the use of Flammacerium.
Dosage/Direction for Use
Flammacerium can be applied directly to the burn wound or on a sterile gauze dressing. The cream should be at least 2-3 mm thick. Flammacerium should be reapplied at least once every 24 hrs after removal of the old cream. Application is soothing and painless. Discoloration of bed linen and clothes does not occur.
Contraindications
Hypersensitivity to silver sulfadiazine, cerium nitrate or to any other ingredients of Flammacerium. Only on theoretical grounds, attention should be given to the following possible contraindications of sulfonamides: Hypersensitivity, renal insufficiency, liver damage and oliguria.
Warnings
Sensitization by Flammacerium has not been reported so far in clinical studies.
Special Precautions
Use in pregnancy: Due to lack of adequate information on the use of Flammacerium in human pregnancy, it is recommended that the potential benefits of treating pregnant women should be weighed against possible risks to both mother and child.
Use In Pregnancy & Lactation
Use in pregnancy: Due to lack of adequate information on the use of Flammacerium in human pregnancy, it is recommended that the potential benefits of treating pregnant women should be weighed against possible risks to both mother and child.
Side Effects
Allergic reactions to Flammacerium cream may occur. Two (2) of the components of the cream base, cetyl alcohol and propylene glycol, may cause sensibilization. Skin reactions eg, burning sensation or pain may occasionally occur as well as an effect on the white blood cell count (leukopenia). This effect is reversible.
Storage
Store at temperatures not exceeding 25°C in a cool, dark place. Protect from sunlight. Under the influence of sunlight, a grayish discoloration of the cream may occur.
MIMS Class
ATC Classification
D06BA01 - silver sulfadiazine ; Belongs to the class of topical sulfonamides used in the treatment of dermatological diseases.
Presentation/Packing
Cream 500 g.
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