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SEPTOPAL CHAINS

Active substance(s): GENTAMICIN SULPHATE

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Package leaflet: information for the user

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Septopal® Chains (Chains of 10, 30 or 60 beads)
Each bead contains 7.5 mg gentamicin sulphate, equivalent to 4.5 mg gentamicin base

Read all of this leaflet, before you start
- infection of a break in a bone that has not
having this medicine.
knitted together properly (infected
• Please keep this leaflet. You may need to read it
pseudoarthroses);
again.
- infection where a broken bone has been fixed
• If you have any further questions, please ask your
together by something like a metal plate
doctor or nurse.
(infected osteosynthesis);
• If any of the side effects become serious, or if you • the short term prevention of infection in bone
notice any side effects not listed in this leaflet, injuries;
please tell your doctor or nurse.
• the short term prevention and treatment of
infections that can occur after operations on the
In this leaflet:
bowels;
• other conditions, such as: infection of the lining
1 WHAT SEPTOPAL CHAINS ARE AND WHAT
of the abdominal wall (bacterial peritonitis), gall
THEY ARE USED FOR
bladder removal (cholecystectomies), abnormal
2 READ THIS, BEFORE YOU HAVE SEPTOPAL
channels between surfaces of the body, such as
CHAINS
between the bowel and the skin (infected
3 HOW SEPTOPAL CHAINS WILL BE GIVEN TO
fistulae), replacements for damaged blood
YOU
vessels (infected vascular grafts) and
4 POSSIBLE SIDE EFFECTS
abscesses in the soft tissues of the body.
5 HOW SEPTOPAL CHAINS ARE STORED
6 FURTHER INFORMATION
2 READ THIS, BEFORE YOU HAVE SEPTOPAL
CHAINS
1 WHAT SEPTOPAL CHAINS ARE AND WHAT
THEY ARE USED FOR
You will not have Septopal Chains if:
• you are known to have a bad reaction to any of
What Septopal Chains are
the ingredients in Septopal Chains (see Section
Septopal Chains are an antibiotic implant. It is made
6 for a list of these).
up of tiny beads strung together on stainless steel
wire.
Special care will be taken in giving you Septopal
Chains
Each chain consists of 10, 30 or 60 beads. Each
If tests have identified bacteria which may not
bead contains the active ingredient gentamicin
respond when Septopal Chains are used on their
sulphate. This is the antibiotic. The gentamicin is
own, you will have treatment with another
slowly released from the beads at the place of a
antibiotic, as well as with these chains.
possible or existing infection, so that it can provide
protection against future infection or treat an
In the young (under 18) and elderly (65+), there is
existing one.
no evidence that Septopal Chains can cause
damage to the kidneys or to the hearing. But, if
What Septopal Chains are used for
you receive these chains and you have moderate
They are used for:
or severe kidney disease, then the state of your
• the short and longer term treatment of bone
kidneys and the level of gentamicin in your blood
infections, such as:
will be checked during your treatment.
- infection of the bone marrow and the
surrounding bone (osteomyelitis);

Septopal Chains and medical devices
• Tell your doctor if you have any implants containing
metal. This is because of the possibility that the
stainless steel wire and the implant might
become corroded.
• If you already have any implants which contain
metal, Septopal Chains will not be placed next
to them.
• If, during your treatment, it is decided that you
will need a metallic implant, the chains will be
removed beforehand.
Taking other medicines
Please tell your doctor or nurse if you are taking,
or have recently taken, any other medicines,
including medicines obtained without a
prescription.

• The surgeon will leave the last bead in each chain
sticking out above skin level, and held in position by
a loose stitch, so that, later on, a few beads at a
time can be withdrawn, each day, from the wound.
Longer term – for bone infection
If you will be having the chains for a longer time,
they will be implanted:
• either with the last bead sticking out, (as
described in ’Short term’ above),
• or they will be completely enclosed in the wound,
perhaps with a drain in place to let fluid out.

Where the chains will be placed
The chains are placed, during your operation, in
the space left after the surgeon has thoroughly
removed damaged or infected bone or tissue.

When and how the chains will be removed
Short term - for bone infection
If you received the chains for a short time and for a
bone infection, then:
• All the chains should normally be completely
removed 10 – 14 days after the surgeon
inserted them.
• The number of beads removed each day will be
counted carefully.
• When a chain is being removed, there is a small
chance that either some of the beads are left
behind or, very unusually, the wire may break. If
this happens, your doctor will try to remove the
remaining beads and/or wire. If an operation is
required to do this, the doctor may decide that it
is safer to leave them where they are.
• If your doctor finds that an infection continues
for more than five days after the operation, the
chains may be removed, and the cause of the
infection identified, before treatment with
further antibiotics.

How many chains you will have
• The number of chains you receive will depend
on the size of the space left after the damaged
or infected bone or tissue has been removed.
• The surgeon usually places from one to three
chains in the cavity, but may use up to five.

Longer term - for bone infection
If you received the chains for a longer time, then:
• If the chains were completely enclosed in the
wound, they will be removed through another
operation, up to 3 months later, depending on
the original operation.

How the chains will be inserted
This will depend on whether you are going to have
the chains for a short or longer period of time.
Your doctor will let you know.

Short term - for soft tissue infection
If you received the chains for a short time and for a
soft tissue infection, then:
• The chains are best removed by day six or, at the
latest, by day 10 after the operation. They will
usually be withdrawn gradually, each day, a few
beads at a time, beginning on the second day
after insertion.

Pregnancy and breast-feeding
Septopal Chains are not recommended for use if
you are pregnant, because there is a faint
possibility that gentamicin might damage the
hearing of an unborn child.
If you are breast-feeding, talk to your doctor
before receiving Septopal Chains.

3 HOW SEPTOPAL CHAINS WILL BE GIVEN
TO YOU

Short term – for bone and soft tissue infection
If you will be having the chains for a short time,
they will be inserted as follows:

If you receive more Septopal Chains than you
should
These chains are given to you by healthcare
professionals. It is extremely unlikely that you will
receive more chains than you should.
If you have any further questions about taking
Septopal Chains, please ask your doctor or nurse.

4

6

FURTHER INFORMATION

What Septopal Chains contain
Each bead contains the active ingredient
gentamicin sulphate 7.5 mg (equivalent to 4.5 mg
gentamicin base).
Other, non-active, ingredients in Septopal Chains
are: glycine, methylmethacrylate-methylacrylate
copolymer, zirconium dioxide, stainless steel.

POSSIBLE SIDE EFFECTS

What Septopal Chains look like and contents of
the pack
Like all medicines, Septopal Chains can cause side
Each Septopal Chain is contained in an inner
effects, although not everybody gets them. If any
sachet, which is then contained in a transparent
of the side effects get serious, or if you notice any
peel-pouch, which is then contained in a protective
side effects not listed in this leaflet, please tell
aluminium pouch, which is then packaged in an
your doctor or nurse as soon as possible.
outer carton.
The beads in the chains are strung on stainless
steel wire. If you find you experience an allergic
reaction, please tell your doctor or nurse as soon
as possible.
Please remember: the benefits you get from having
these Septopal Chains will usually be greater than
the risk of suffering any harmful side effects.

These chains are supplied in packs of 1 or 5 sachets.
Each sachet contains one chain of 10, 30 or 60
impregnated methylmethacrylate-methylacrylate
copolymer (PMMA) beads threaded on a stainless
steel wire.
Not all pack sizes and chain lengths are marketed.

Marketing Authorisation Holder
Biomet UK Ltd.
5 HOW SEPTOPAL CHAINS ARE STORED
Waterton Industrial Estate
Bridgend
The hospital staff will ensure that the following
South Wales
instructions for the storage of Septopal Chains are CF31 3XA
observed:
• Store at room temperature.
Manufacturer
• Do not freeze.
European Medical Contract Manufacturing bv
• Keep out of the reach and sight of children.
Middenkamp 17
• Once the inner pouch is opened, any unused
NL-6545 CH Nijmegen
chains will be discarded.
• The chains will not be used after the expiry date Netherlands.
stated on the carton and the aluminium pouch.
This leaflet was last approved in [10/2008]

The expiry date refers to the last day of that
month.

TECHNICAL INFORMATION FOR THE MEDICAL
PROFESSIONAL

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 NAME OF THE MEDICINAL PRODUCT
Septopal Chains.

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.

2 QUALITATIVE AND QUANTITATIVE
COMPOSITION
Chain of 10, 30 or 60 beads.
Each contains 7.5 mg Gentamicin Sulphate EP
(equivalent to 4.5 mg 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

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 µg/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.

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
oto-toxicity in the foetus although no problems in
clinical use have positively been identified.
Implantation of Septopal Chain results in only a
4.3 Contraindications
transient, barely detectable plasma concentration
Established intolerance to Gentamicin.
of Gentamicin (no more than 0.5 µg/ ml).
Therefore, no ototoxic effects on the foetus are to
4.4 Special warnings and precautions for use be expected. Nevertheless, it is recommended
Septopal Chains should not be used alone in those that the product should not be used in pregnancy.
situations where culture of wound secretion
reveals the presence of anaerobic bacteria, or
4.7 Effects on ability to drive and use
organisms which could be insensitive to
machines
gentamicin therapy. In these instances, additional No effect.
systemic therapy with an appropriate antibiotic
should be used.
4.8 Undesirable effects
Because the beads are strung on surgical wire
Septopal may be used in all orthopaedic surgical
containing chrome and nickel, there is a potential
procedures where gentamicin sensitive organisms
for local sensitivity to these metals.
are found to be present from routine bacteriological screening. Where resistant organisms are 4.9 Overdose
encountered to the standard 10 microgram disc
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 µg/ml).

6.3 Shelf life
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

Gentamicin is detectable in the urine for several
months after implantation which is evidence of
persistent release from implanted beads.

8 MARKETING AUTHORISATION NUMBER(S)
PL 13442/0003

In wound secretions originating directly from the
operation area, high gentamicin concentrations of
between 14 and 215 µg/ml are found. These are
in excess of the MICs required for the elimination
of causative organisms at the site for infection.

9 DATE OF FIRST AUTHORISATION/RENEWAL
OF THE AUTHORISATION
31 December 1998 / 03 March 2008

5.3 Preclinical safety data
N/A

10 DATE OF REVISION OF THE TEXT
03 March 2008

6 PHARMACEUTICAL PARTICULARS

11 DOSIMETRY (IF APPLICABLE)

6.1 List of excipients
Glycine, methylmethacrylate-methylacrylate
copolymer, zirconium dioxide, polyfilic stainless
steel.

12 INSTRUCTIONS FOR PREPARATION OF
RADIOPHARMACEUTICALS (IF
APPLICABLE)

6.2 Incompatibilities
None.

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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