INFORMATION FOR HEALTH PROFESSIONALS

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Dose:

Sufficient is used to permit fixing of the prosthesis.

Method of Administration:

Intra-articular by application to surgically prepared bone.

The use of Antibiotic Simplex^® Bone Cement is contraindicated in patients allergic to any of its components. It is contraindicated in the younger patient with a normal life expectancy; because of lack of information on the long term effect.

It is also contraindicated where loss of musculature or neuromuscular compromise in the affected limb would render the procedure unjustifiable.

Erythromycin is contraindicated with either astemizole or terfenadine.

For safe and efficacious use of Antibiotic Simplex^® Bone Cement, the surgeon should have specific training and experience to be thoroughly familiar with the properties, handling characteristics and application of the product.

Care should be taken in the mixing of the liquid and powder components that the entire contents of the ampoule and pouch be utilised.

The mixing of the liquid monomer and the powder component should be thorough and at least four minutes in duration. Data from clinical studies have shown by gas chromatography determinations, that the mixing and kneading of the liquid and powder components for four or more minutes depressed the level of monomer in the circulating blood and also in the urine.

Caution, however should be taken to avoid kneading of the product too long to avoid progression of the polymerisation process to the point that the product is not adequately soft and pliable to obtain good filling of the bone cavities and fitting to the prosthesis.

The completion of polymerisation occurs in the patient and is an exothermic reaction with considerable liberation of heat. Temperatures occurring during the polymerisation have been reported as high as 110 ° Centigrade. The long-term effect of the heat produced along with the resulting tissue damage is not known.

Special precautions should be taken to detect and correct the transitory fall in blood pressure that may occur when the product is implanted into the bone.

As the liquid monomer is highly volatile and inflammable, the operating room should be provided with adequate ventilation so as to eliminate the maximum amount of monomer vapour. Caution should be exercised during the mixing of the two components to prevent excessive exposure to the concentrated vapours of the monomer, which may produce irritation of the respiratory tract, eyes and possibly the liver.

The liquid component is a powerful lipid solvent. It has caused contact dermatitis in susceptible individuals. Wearing a second pair of surgical gloves and strict adherence to the mixing instructions may diminish the possibility of hypersensitivity reactions. The compound should not be allowed to come into contact with sensitive tissues or to be absorbed by the body.

Concomitant use of erythromycin with terfenadine or astemizole is likely to result in an enhanced risk of cardiotoxicity with these drugs. The concomitant use of erythromycin with either terfenadine or astemizole is therefore contraindicated

Potentiation of the anticoagulant action of warfarin following intravenous use of erythromycin has been reported. Although blood levels of erythromycin resulting from the use of Antibiotic Simplex^® Bone Cement are low, the risk of bleeding during the first post operative day in patients on warfarin therapy should be considered. There is as yet insufficient evidence for a planned reduction in the dose of warfarin when used with Antibiotic Simplex^® Bone Cement.

Reproduction studies have not been performed in animals. There is no adequate information on whether this product may affect fertility in human males or females or have teratogenic potential or other adverse effect on the foetus.

Antibiotic Simplex^® Bone Cement is a two component product supplied as a liquid monomer and a powder component with erythromycin and colistin. Erythromycin is a broad spectrum antibiotic, effective against a large number of gram-positive bacteria, such as Staphylococcus spp. and Streptococcus spp. Colistin is particularly effective against gram-negative organisms, such as E. Coli, Enterobacter, Klebsiella and Pseudomonas.

Powder Component:

Methyl methacrylate-styrene copolymer, polymethyl methacrylate, barium sulphate.

Liquid Component:

Methyl methacrylate (monomer), N,N dimethyl para toluidine, hydroquinone

Powder component :- low density polyethylene pouch which is sealed inside an outer peelable pouch made from spunbonded polyolefin and a polyethylene/Melinex laminate.

Liquid component :- neutral amber glass ampoule which is sealed in a PVC blister with a spun bonded polyolefin lid.

The liquid monomer, the ampoule itself and the ampoule package have been presterilised. To mix, empty the entire contents of the packet containing the powder into an appropriate sterile, inert mixing device. Add the entire contents of the ampoule containing the liquid component.

Add the liquid component to the powder, not the powder to the liquid. Mix with a suitable inert device with a stirring action until the powder is completely saturated with the liquid.

For cement gun administration - stir thoroughly for a total of 1 - 2½ minutes.

Introduce the liquid cement into a suitable sterile injection device and apply product to bone.

For manual administration, continue stirring until a dough-like mass is formed that does not stick to the surgical gloves of the operator. The dough-like mass is then ready for manipulation. The mixing and manipulation process should be at least 4 minutes in duration. The mixing and kneading time required to obtain a product of proper consistency for application to the bone is altered by the room temperature and humidity. The mixed and kneaded product is then ready to be applied to the bone manually.