Septopal Chains
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Septopal Chains
2. Qualitative and Quantitative Composition
Chain of 10, 30 or 60 beads
Each contains 7.5mg Gentamicin Sulphate EP (equivalent to 4.5mg gentamicin base)
3 PHARMACEUTICAL FORM
Impregnated methylmethacrylate-methylacrylate copolymer (PMMA) beads for surgical use. Each chain consists of 10, 30 or 60 beads threaded on multiple stranded surgical wire.
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
Short term and longer term therapy in bone infection, e.g. osteomyelitis, infected pseudoarthroses, infected osteosynthesis.
Short term preventative treatment of potentially infected bone injuries.
Short term prevention and therapy of soft tissue infections associated with abdominoperineal resections; operations on the small or large bowel. Other therapeutic indications for use include bacterial peritonitis, cholecystectomies, infective fistulae, infected vascular grafts, soft tissue abscesses.
4.2 Posology and Method of administration
For implanting in the cavity resulting from thorough surgical removal of sequestrated bone or infected tissue.
The number of chains used will depend upon the size of the cavity which results after thorough surgical removal of infected tissue or that remaining after operation in the sacral cavity. Usually 1-3 chains are inserted but up to 5 chains have been used. The chains are laid in the cavity in such a way as to facilitate easy removal. It is recommended that the 10 bead chain is used for smaller cavities.
1. BONE INFECTIONS
a) Short term application.
When implanting the chains, it is recommended to take into account the direction in which the chain will later be pulled out and to let the last bead project above the skin level, through a separate stab incision anchored by a loose suture, in order that the chain may be removed by careful steady traction, a few beads at a time daily. The chains should normally be completely removed by 10-14 days following insertion and preferably no more than 10 days after the operation. Where there is evidence of persisting local infection beyond 5 days post-operatively, it is recommended that the chain is removed and the cause of infection determined prior to recommending further antibacterial therapy.
The less the chains are fixed to connective tissue, the easier it is to remove them, thus making the procedure more comfortable for the patient.
If the beads become fixed to connective tissue to a great extent, or if the traction of the beads is not adapted to the tissue conditions, then there is a small possibility that one or several may become detached from the wire or, in exceptional circumstances, the wire may break on removal of the chain. In such an event, attempt should be made to remove the individual beads and the remaining wire. Should, however, extensive surgery be necessary then the risk of reoperation should be considered carefully. In high-risk patients, it may be preferable to leave the beads in situ permanently. For the above reasons the beads should always be counted on their removal.
b) Longer term application.
This may be as above or if circumstances require it, the chains may be implanted completely, and removed by reoperation up to 3 months later. The length of time the chains are left in situ prior to secondary intervention will depend on the orthopaedic procedure. Inserted chains will be completely enclosed by primary wound closure. Control of local infection allows subsequent surgical procedures e.g. cancellous bone grafting.
2. SOFT TISSUE INFECTIONS (SHORT TERM APPLICATIONS ONLY)
The insertion of chains is carried out as described under 1a above. In this indication the chains are best removed by the sixth and at the latest the tenth day after operation. In most cases it is advised that the chains are withdrawn gradually, a few beads at a time daily from about the second past insertion day.
In considering wound closure/drainage, it should be remembered that excess drainage will dilute the gentamicin concentration at the site of infection so, if possible, primary wound closure should always be employed. Local circumstances and degree of inflammation should, however, be taken into consideration.
An overflow drain may be employed only when considered necessary. Suction drainage should not be employed but may be temporarily used in cases of obstructed wound secretion flow.
Toxic effects due to the antibiotic are not anticipated since, after use of Septopal Chains, barely detectable gentamicin concentrations (no more than 0.5 micrograms/ml) are found in the systemic circulation for up to 4 days postoperatively.
There is no distinguishing factor between doses for the young, adults and elderly since the number of chains used depends on the size of the cavity in individual cases and the clinical conditions at the site of infection.
4.3 Contraindications
Established intolerance to Gentamicin.
4.4 Special warnings and precautions for use
Septopal Chains should not be used alone in those situations where culture of wound secretion reveals the presence of anaerobic bacteria, or organisms which could be insensitive to gentamicin therapy. In these instances, additional systemic therapy with an appropriate antibiotic should be used.
Septopal may be used in all orthopaedic surgical procedures where gentamicin sensitive organisms are found to be present from routine bacteriological screening. Where resistant organisms are encountered to the standard 10 microgram disc test, an MIC determination is recommended. In view of the high bactericidal gentamicin concentration at the infection site, organisms found resistant to the standard 10 microgram sensitivity disc screen may in fact be sensitive and therefore results of such screening may not give a true reflection of clinical efficacy.
In soft tissue the chains should not be planted intraperitoneally.
In the young and elderly there is no evidence to suggest that use of Septopal Chains has caused either nephrotoxic or ototoxic effects. Nevertheless, if Septopal therapy is desirable in patients who have moderate to severe impairment of renal function, monitoring of renal state and plasma gentamicin levels is advised.
4.5 Interaction with other medicinal products and other forms of interaction
Septopal Chains should not be used concurrently in apposition to metal-containing implants because of the theoretical possibility of surgical wire and implant corrosion. Septopal Chains should be removed prior to implant of a metal prosthesis.
4.6 Pregnancy and Lactation
Gentamicin crosses the placenta and may cause ototoxicity in the foetus although no problems in clinical use have positively been identified. Implantation of Septopal Chain results in only a transient, barely detectable plasma concentration of Gentamicin (no more than 0.5 micrograms/ml). Therefore, no ototoxic effects on the foetus are to be expected. Nevertheless, it is recommended that the product should not be used in pregnancy.
4.7 Effects on Ability to Drive and Use Machines
No effect.
4.8 Undesirable Effects
Because the beads are strung on surgical wire containing chrome and nickel, there is a potential for local sensitivity to these metals.
4.9 Overdose
Not applicable.
5 PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
Gentamicin, an aminoglycoside antibiotic, possesses an “in vivo” and “in vitro” broad antibacterial spectrum of action. Its activity covers gram-positive bacteria and gram-negative micro-organisms such as E. coli, Klebsiella, Enterobacter, Pseudomonas and Proteus. It is effective against problem organisms which are resistant to other antibiotics.
Gentamicin has a bactericidal effect on proliferating and latent organisms.
Gentamicin is released gradually from the PMMA beads over a prolonged period and the high bactericidal concentrations of the antibiotic reached at the site of the infection enable the infection to be controlled, or provide protection against infection.
5.2 Pharmacokinetic Properties
Low levels of Gentamicin are detectable in the serum for only a few days after implantation, (maximum found is 0.5 pg/ml)
Gentamicin is detectable in the urine for several months after implantation which is evidence of persistent release from implanted beads.
In wound secretions originating directly from the operation area, high gentamicin concentrations of between 14 and 215 pg/ml are found. These are in excess of the MICs required for the elimination of causative organisms at the site for infection.
5.3 Preclinical Safety Data
N/A
6 PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Glycine
Methylmethacrylate-methylacrylate copolymer Zirconium dioxide Polyfilic stainless steel
6.2 Incompatibilities
None
Shelf Life
6.3
3 years
6.4 Special Precautions for Storage
Store at room temperature. Do not freeze. Resterilisation should not be attempted under any circumstances.
6.5 Nature and Contents of Container
Container: Sterile inner sachet within a secondary peel-open sachet in an aluminium sachet containing drying agent. The aluminium sachet is packed in a cardboard box. Contents: Packs of 1 or 5 sachets each containing 1 chain of 10, 30 or 60 beads.
6.6 Special precautions for disposal
None
7 MARKETING AUTHORISATION HOLDER
Biomet UK Ltd.
Waterton Industrial Estate Bridgend South Wales CF31 3XA
8. Marketing Authorisation Number
PL 13442/0003
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
29/07/2010
10 DATE OF REVISION OF THE TEXT
29/07/2010