Each gram of Silvadev 1% cream contains:

active ingredient: Silver sulfadiazine – 10 mg;

For a full list of excipients see section 6.1.

Posology

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 pad or gauze dressing, with further application of pressure bandaging as appropriate for the ulcer. The dressings should normally be changed daily but for wounds which are less exudative, less frequent changes (every 48 hours) may be acceptable. Cleansing and debriding should be performed before application of Silvadev cream.

Silvadev cream is not recommended for use in leg or pressure ulcers that are very exudative.

Finger-Tip Injuries:

Haemostasis of the injury should be achieved prior to the application of a 3-5mm layer of Silvadev 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.

Paediatric population:

Silvadev cream is contraindicated in children aged to three months (see section 4.3).

Method of administration

To be applied topically.

Pharmacotherapeutic group: Chemotherapeutics for topical use, sulfonamides.

ATC Code: D06BA01

List of excipients

Cetostearyl alcohol

Liquid paraffin heavy

Propylene glycol

Glyceryl stearate

Polysorbate 80

Methylparaben

Water purified

For more detailed information about the drug, click: http://pharm.cals.am/pharm/data/drug_134425/1736329537406.pdf