FLAMAZINE Cream Ref.[9584] Active ingredients: Silver sulfadiazine

Source: Medicines and Medical Devices Safety Authority (NZ)  Revision Year: 2019  Publisher: Smith & Nephew Ltd, Unit A, 36 Hillside Road, Wairau Valley, Auckland 0627, New Zealand

Therapeutic indications

FLAMAZINE cream is indicated for the prevention of infection in severe burns. Other types of wounds, such as pressure sores and leg ulcers, may also benefit from the application of FLAMAZINE cream.

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.

Overdose

Not likely to occur with normal usage.

In extensively burned patients or in patients suspected of showing symptoms of excessive absorption, it is important to optimally maintain fluid balance, not only to prevent dehydration but also to avoid the possibility of renal failure.

If renal function is normal, fluids should be administered to maintain high urine output and assist in the rapid elimination of the drug.

For advice on the management of overdose please contact the National Poisons Centre on 0800 POISON (0800 764766).

Shelf life

24 months from the date of manufacture.

Special precautions for storage

FLAMAZINE should be stored below 25°C. Protect from light. The contents of one container are for the treatment of one person. 500g jars should be discarded 24 hours after opening. Tubes of FLAMAZINE should be discarded 7 days after opening.

Nature and contents of container

20g*, 50g or 80g* pre-printed cylindrical polyethylene tubes fitted with polypropylene caps.

250g* or 500g black polypropylene jar fitted with a black polyethylene or polypropylene lid.

All tubes and jars are tamper-evident.

* Pack sizes not marketed.

Special precautions for disposal and other handling

The contents of one container are for the treatment of one person.

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