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1. Septopal Minichains
2. Septopal Minichains

SUMMARY OF PRODUCT CHARACTERISTICS

1 NAME OF THE MEDICINAL PRODUCT

Septopal Minichains.

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Chain of 10 or 20 beads.

Each contains 2.8mg Gentamicin Sulphate BP (equivalent to 1.7mg gentamicin base).

3. PHARMACEUTICAL FORM

Impregnated methylmethacrylate-methacrylate copolymer (PMMA) beads for surgical use. Each minichain consists of 10 or 20 beads threaded on multiple surgical wire.

4. CLINICAL PARTICULARS

4.1. Therapeutic indications

Short term and longer term administration in bone infection, e.g. osteomyelitis, infected pseudoarthroses, infected osteosynthesis.

Short term preventative treatment of potentially infected bone injuries.

Surgical fields for which Septopal Minichains have been expressly developed are: hand and foot surgery, face and jaw surgery and paediatrics.

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 and/or sequestrated bone. Usually 1-3 chains are inserted but up to 4 chains have been used. The chains are laid in the cavity in such a way as to facilitate easy removal. .

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 4 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 re-operation 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.

Longer term application.

This may be as above or if circumstances require it, the chains may be implanted completely, and removed by re-operation 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.

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 Minichains, barely detectable gentamicin concentrations (no more than 0.42 micrograms/ml) are found in the systemic circulation for up to 4 days post-operatively.

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 Minichains 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 the young and elderly there is no evidence to suggest that use of Septopal Minichains has caused either nephrotoxic or ototoxic effects. Nevertheless, if Septopal therapy is desirable in patients who have moderate to severe impairment or renal function, monitoring of renal state and plasma gentamicin levels is advised.

4.5. Interactions with other medicinal products and other forms of interaction

Septopal Minichains should not be used concurrently in apposition to metal-containing implants because of the theoretical possibility of surgical wire and implant corrosion. Septopal Minichains 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 Minichains results in only a transient, barely detectable plasma concentration of Gentamicin (no more than 0.42 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.

Granulation tissue grows into the hollow spaces between the beads during the healing process, this may cause difficulties at the time of removal.

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

Gentamicin is detectable in the serum for only a short time after implantation and only at low concentrations. Peak values occur 1-4 hours after chain implantation (maximum found is 0.42pg/ml).

The concentration falls off very rapidly within 48 hours to below the lower limit of detection of 0.05pg/ml. Thus toxic side effects can be excluded.

Gentamicin is detectable in the urine for several days after implantation (maximum found is 4.9pg/ml) which is evidence of good release from implanted beads.

In wound secretions originating directly from the operation area, high gentamicin concentrations of between 1126 and 715pg/ml are found. Therefore, at the site of implantation, levels of gentamicin are reached which far exceed those required for killing aetiologically imported pathogens.

5.3.    Pre-clinical safety data

N/A.

6. PHARMACEUTICAL PARTICULARS 6.1. List of excipients

Glycine, methylmethacrylate-methytlacrylate copolymer, zirconium dioxide, polyfilic stainless steel.

6.2. Incompatibilities

None.

Shelf life

10 DATE OF REVISION OF THE TEXT

29/07/2010