Bone wax is intended for use for the control of bleeding from the divided, drilled or chipped edges of bone by physically plugging the osseous canals which contain the bleeding capillaries.

DESCRIPTION

Bone wax is a sterile non absorbable wax mixture comprising:

White Beeswax       PhEur     75 % w/w

Paraffin Wax           DAB/BP  15 % w/w

Isopropyl Palmitate DAB       10 % w/w

Bone wax is white and is available as a 2.5 g solid rectangular slab.

APPLICATION

Using an aseptic technique bone wax should be warmed to the desired consistency by manipulation with the fingers. The softened wax is then applied to the bone edge as indicated by surgical circumstances and the preference of the surgeon.

PERFORMANCE

Bone wax achieves local haemostasis of bone by acting as a mechanical (tamponade) barrier.

CONTRAINDICATIONS

Bone wax should not be used where rapid osseous regeneration and fusion are desired.

WARNINGS / PRECAUTIONS / INTERACTIONS

Bone wax should be used sparingly and any excess removed from the operative site. Bone wax may act as a physical barrier to the reparative process. The package containing bone wax should be opened just prior to use to minimise the possibility of contamination and excessive drying.

ADVERSE REACTIONS

Adverse reactions associated with the use of this device include mild inflammatory reactions in tissue adjacent to the site of implantation and inhibition of osteogenesis. Like all foreign bodies bone wax may potentiate an existing infection.

STERILITY

Bone wax is sterilized by irradiation. Do not resterilize! Do not use if package is opened or damaged. Discard opened, unused bone wax.

STORAGE

Recommended storage conditions: Below 25° C away from moisture or direct heat. Do not use after expiry date!