Skip to Content

SEPTOPAL MINICHAINS

Active substance(s): GENTAMICIN SULPHATE

View full screen / Print PDF » Download PDF ⇩
Transcript
Package leaflet: information for the user

xxxxxxxxxx/xx

Septopal® Minichains (Chains of 10 or 20 beads)
Each bead contains 2.8 mg gentamicin sulphate, equivalent to 1.7 mg gentamicin base

Read all of this leaflet, before you start having
- infection of a break in a bone that has not
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.
Types of surgery for which Septopal Minichains
have been specifically developed are hand and
In this leaflet:
foot surgery, face and jaw surgery and surgery on
children.
1 WHAT SEPTOPAL MINICHAINS ARE AND
WHAT THEY ARE USED FOR
2 READ THIS, BEFORE YOU HAVE SEPTOPAL 2 READ THIS, BEFORE YOU HAVE SEPTOPAL
MINICHAINS
MINICHAINS
3 HOW SEPTOPAL MINICHAINS WILL BE
GIVEN TO YOU
You will not have Septopal Minichains if:
4 POSSIBLE SIDE EFFECTS
• you are known to have a bad reaction to any of
5 HOW SEPTOPAL MINICHAINS ARE STORED
the ingredients in Septopal Minichains
6 FURTHER INFORMATION
(see Section 6 for a list of these).
Special care will be taken in giving you Septopal Minichains
If tests have identified bacteria which may not
respond when Septopal Minichains are used on
What Septopal Minichains are
their own, you will have treatment with another
Septopal Minichains are an antibiotic implant. It is antibiotic, as well as with these minichains.
made up of tiny beads strung together on stainless
steel wire.
In the young (under 18) and elderly (65+), there is
no evidence that Septopal Minichains can cause
Each minichain consists of 10 or 20 beads. Each
damage to the kidneys or to the hearing. But, if
bead contains the active ingredient gentamicin
you receive these minichains and you have modersulphate. This is the antibiotic. The gentamicin is ate or severe kidney disease, then the state of your
slowly released from the beads at the place of a
kidneys and the level of gentamicin in your blood
possible or existing infection, so that it can provide will be checked during your treatment.
protection against future infection or treat an
existing one.
Septopal Minichains and medical devices
• Tell your doctor, if you already have any implants
What Septopal Minichains are used for
containing metal. This is because of the possibiThey are used for:
lity that the stainless steel wire and the implant
• the short and longer term treatment of bone
might become corroded.
infections, such as:
• If you already have any implants which contain
- infection of the bone marrow and the
metal, Septopal Minichains will not be placed
surrounding bone (osteomyelitis);
next to them.
1 WHAT SEPTOPAL MINICHAINS ARE AND
WHAT THEY ARE USED FOR

• If, during your treatment, it is decided that you
will need a metallic implant, the minichains 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.

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

When and how the minichains will be removed
Short term
If you received the minichains for a short time, then:
• All the minichains 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 minichain 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, then 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 four days after the operation, the
mini-chains may be removed, and the cause of
the infection identified before treatment with
further antibiotics.

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

Longer term
If you received the minichains for a longer time, then:
• If the minichains 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 minichains will be inserted
This will depend on whether you are going to have
the minichains for a short or longer period of
time. Your doctor will let you know.

If you receive more Septopal Minichains than
you should
These minichains are given to you by healthcare
professionals. It is extremely unlikely that you will
receive more minichains than you should.

Pregnancy and breast-feeding
Septopal Minichains 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 Minichains.

3 HOW SEPTOPAL MINICHAINS WILL BE
GIVEN TO YOU

Short term
If you will be having the minichains for a short
time, they will be inserted as follows:
• The surgeon will leave the last bead in each
minichain 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
If you will be having the minichains for a longer
time, they will be implanted:

If you have any further questions about taking Septopal Minichains, please ask your doctor or nurse.

4 POSSIBLE SIDE EFFECTS
Like all medicines, Septopal Minichains can cause
side effects, although not everybody gets them. If
any of the side effects get serious, or if you notice
any side effects not listed in this leaflet, please tell
your doctor or nurse as soon as possible.

The beads in the minichains are strung on stainless steel wire. If you find you experience an allergic reaction, please tell your doctor or nurse as
soon as possible.
Because new tissue grows in the spaces between
the beads during the healing of the wound, this
may cause some difficulty when the doctors are
removing the beads.
Please remember: the benefits you get from having
these Septopal Minichains will usually be greater
than the risk of suffering any harmful side effects.

These minichains are supplied in packs of 1 or 5
sachets. Each sachet contains one chain of 10 or
20 impregnated methylmethacrylate-methylacrylate copolymer (PMMA) beads threaded on a stainless steel wire.
Not all pack sizes and minichain lengths are
marketed.
Marketing Authorisation Holder
Biomet UK Ltd.
Waterton Industrial Estate
Bridgend
South Wales
CF31 3XA

5 HOW SEPTOPAL MINICHAINS ARE STORED
The hospital staff will ensure that the following
instructions for the storage of Septopal Minichains
are observed:
• Store at room temperature.
• Do not freeze.
• Keep out of the reach and sight of children.
• Once the inner pouch is opened, any unused
minichains will be discarded.
• These minichains will not be used after the
expiry date stated on the carton and the aluminium
pouch. The expiry date refers to the last day of
that month.

6 FURTHER INFORMATION
What Septopal Minichains contain
Each bead contains the active ingredient
gentamicin sulphate 2.8 mg (equivalent to
1.7 mg gentamicin base).
Other, non-active, ingredients in Septopal
Minichains are: glycine, methylmethacrylatemethylacrylate copolymer, zirconium dioxide,
stainless steel.
What Septopal Minichains look like and contents of the pack
Each minichain is contained in an inner sachet,
which is then contained in a transparent peelpouch, which is then contained in a protective
aluminium pouch, which is then packaged in an
outer carton.

Manufacturer
European Medical Contract Manufacturing bv
Middenkamp 17
NL – 6545 CH Nijmegen
Netherlands.
This leaflet was last approved in
[10/2008]

TECHNICAL INFORMATION FOR THE MEDICAL
PROFESSIONAL
1 NAME OF THE MEDICINAL PRODUCT
Septopal Minichains

2 QUALITATIVE AND QUANTITATIVE
COMPOSITION
Chain of 10 or 20 beads.
Each contains 2.8 mg Gentamicin Sulphate BP
(equivalent to 1.7 mg 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.

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
4 CLINICAL PARTICULARS
detached from the wire or, in exceptional circumstances the wire may break on removal of the
4.1 Therapeutic indications
chain. In such an event, attempt should be made
Short term and longer term administration in bone to remove the individual beads and the remaining
infection, e.g. osteomyelitis, infected
wire. Should, however, extensive surgery be necpseudoarthroses, infected osteosynthesis.
essary then the risk of reoperation should be considered carefully. In high-risk patients, it may be
Short term preventative treatment of potentially
preferable to leave the beads in situ permanently.
infected bone injuries.
For the above reasons the beads should always be
counted on their removal.
Surgical fields for which Septopal Minichains have
been expressly developed are: hand and foot
Longer term application
surgery, face and jaw surgery and paediatrics.
This may be as above or if circumstances require
it, the chains may be implanted completely, and
4.2 Posology and method of administration
removed by reoperation up to 3 months later. The
For implanting in the cavity resulting from thorlength of time the chains are left in situ prior to
ough surgical removal of sequestrated bone or
secondary intervention will depend on the
infected tissue.
orthopaedic procedure. Inserted chains will be
completely enclosed by primary wound closure.
The number of chains used will depend upon the size Control of local infection allows subsequent surgiof the cavity which results after thorough surgical cal procedures e.g. cancellous bone grafting.
removal of infected tissue and/or sequestrated
bone. Usually 1-3 chains are inserted but up to 4
In considering wound closure/drainage, it should
chains have been used. The chains are laid in the
be remembered that excess drainage will dilute
cavity in such a way as to facilitate easy removal.
the gentamicin concentration at the site of infection so, if possible, primary wound closure should
Short term application
always be employed. Local circumstances and
When implanting the chains, it is recommended to degree of inflammation should, however, be taken
take into account the direction in which the chain 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 con-centration 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 Interaction 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 grampositive 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.

Container: Inner sachet within a peel-off sachet
placed in an aluminium sachet of drying agent.
The aluminium sachet is packed in a cardboard
box. Contents: Packs of 1 or 5 sachets each containing 1 minichain of 10 or 20 beads.

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 0.42 µg/ml).

6.6 Special precautions for disposal
None.

The concentration falls off very rapidly within 48
hours to below the lower limit of detection of 0.05
µg/ml. Thus toxic side effects can be excluded
Gentamicin is detectable in the urine for several
days after implantation (maximum found is
4.9 µg/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 715 µg/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 Preclinical safety data
N/A.

7 MARKETING AUTHORISATION HOLDER
Biomet UK Ltd.
Waterton Industrial Estate
Bridgend
South Wales
CF31 3XA

8 MARKETING AUTHORISATION NUMBER(S)
PL 13442/0004

9 DATE OF FIRST AUTHORISATION/RENEWAL
OF THE AUTHORISATION
31 December 1998/ 23 October 2004.

10 DATE OF REVISION OF THE TEXT
November 2007

11 DOSIMETRY (IF APPLICABLE)
6 PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Glycine, methylmethacrylate-methytlacrylate
copolymer, zirconium dioxide, polyfilic stainless
steel.

6.2 Incompatibilities
None.
6.3 Shelf life
3 years.
6.4 Special precautions for storage
Store at room temperature. Do not freeze.
6.5 Nature and contents of container

12 INSTRUCTIONS FOR PREPARATION OF
RADIOPHARMACEUTICALS
(IF APPLICABLE)

Expand view ⇕

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.

Hide