Summary for ARTG Entry:
LEUKOSCAN sulesomab 0.31mg powder for injection vial
ARTG entry for
ANSTO t/a ANSTO Health
Locked Bag 2001,KIRRAWEE DC, NSW, 2232
ARTG Start Date
Drug Safety Evaluation Branch
Conditions applicable to all therapeutic goods as specified in the document "Standard Conditions Applying to Registered or Listed Therapeutic Goods
Under Section 28 of the Therapeutic Goods Act 1989" effective 1 July 1995.
Conditions applicable to the relevant category and class of therapeutic goods as specified in the document "Standard Conditions Applying to Registered
or Listed Therapeutic Goods Under Section 28 of the Therapeutic Goods Act 1989" effective 1 July 1995.
1. LEUKOSCAN sulesomab 0.31mg powder for injection vial
Single Medicine Product
See Product Information and Consumer Medicine Information for this product
Use in diagnostic imaging for the investigation of suspected osteomyelitis in long bones and in feet in patients including those with diabetic foot ulcers.
Additional Product information
Store at 2 to 8
information for shelf
Pack Size/Poison information
Single unit pack
(S4) Prescription Only Medicine
1. Medicine Component
Injection, powder for
Route of Administration
Colourless Solution when reconstituted.
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CONSUMER MEDICINE INFORMATION
Kit for the Preparation of Technetium -99m Labelled LeukoScan
What is in this leaflet
This leaflet answers some common questions about LeukoScan. It does not contain all the
available information, nor does it take the place of you talking to your nuclear medicine specialist
All medicines and diagnostic agents have risks and benefits associated with their use. Your
nuclear medicine specialist has weighed the risks of you being treated with LeukoScan against the
benefits it is expected you will receive.
Keep this leaflet. You may need to read it again.
Name of your Medicine
LeukoScan is the trade name of your medicine. Sulesomab is the common name.
Each 3-ml vial (glass container) contains 0.31mg of active substance, sulesomab, as a powder for
solution for injection. The other ingredients are stannous chloride, sodium chloride, sodium
potassium tartrate, sodium acetate and sucrose.
What LeukoScan is and what it is used for
An antibody is a natural substance made by the body which binds foreign substances to help
remove them from your body. You produce many difference kinds on antibodies. LeukoScan
Sulesomab is a special kind of antibody which binds to the surface of certain kinds of blood cells
called leukocytes. It is produced in mice and purified so that if can be used in humans. When it is
combined to the radioactive technetium isotope and injected, it finds an abnormal accumulation
of white blood cells and attaches to them. This helps your doctor make a diagnosis and evaluate
the extent of your illness. The doctor does this by using a special imaging camera that reveals
areas of radioactivity.
How LeukoScan Works.
LeukoScan is used to determine the present of infections in long bones. Shortly after mixing the
LeukoScan with the radioactive technetium isotope, the doctor will inject it into your vein. One
to eight hours later you will be placed on a special table and pictures will be taken with the
standard nuclear cameras to see where the injections are located.
When LeukoScan is used
Leukoscan is an antibody fragment which is linked to a radioactive substance called technetium.
LeukoScan is used in patients with suspected infection of the bone called osteomyelitis. The
antibody is able to bind to the surface of the white blood cells which infiltrate the area of
infection. When the radioactive antibody binds to the white blood cells,
your doctor can
determine where the injection is located by using a special imaging camera that reveals areas of
radioactivity. The doctor can also determine how much disease there is. This will help the doctor
determine whether there is an infection in the bone and what kind of treatment to use.
Before you are given LeukoScan
It is very important to tell the Nuclear Medicine Physician or Specialist if:
You are or maybe pregnant
It is not known whether the injection is harmful to an unborn baby when administered to
pregnant women. Tell your doctor is you are pregnant or are intending to become
pregnant so that your doctor can decide if the potential benefit of administration of this
injection exceeds any risk to you or your unborn child.
You are breast-feeding
Radioactive technetium is excreted in human milk during lactation. If administration is
considered necessary, breastfeeding should be interrupted and the expressed feeds
You are allergic to any protein which is made from a mouse antibody
Do not use LeukoScan if you have an allergy to LeukoScan or any of the
ingredients listed in the leaflet.
Do not use LeukoScan after the expiry date printed on the pack. If you use
this medicine after the expiry date has passed, it may not work as well.
Do not use LeukoScan if the packaging is torn or shows sign of tampering.
Do not use LeukoScan if the powder or reconstituted solution is discoloured.
Precautions and Special Warnings
Things you should know before you are given LeukoScan
It is possible to have a serious allergic reaction to LeukoScan, therefore your Nuclear Medicine
Physician or Specialist should keep you under close observation for a short time after he has
given you this drug.
If you have ever received LeukoScan or another product made from a mouse antibody, your
Nuclear Medicine Physician or Specialist should take a sample of blood for testing to be sure that
you have not developed antibodies which may cause an immune reaction if a further dose is
Interactions with other Medications and other forms of Interaction
No interactions have been described to date.
Use of radiopharmaceutical agents
Radiopharmaceutical agents can only be used by qualified personnel with appropriate
government authorisation for the use and manipulation of radionuclides.
How to Use LeukoScan
Dosage: The Amount of Medicine Given
You will receive a single dose of 0.25 mg of LeukoScan. It will contain the radioactive
technetium isotope in an amount called 740 – 1110 MBq.
Method and Route of Administration: How the injection is given to you
Your Nuclear Medicine Physician or Specialist will prepare the LeukoScan and the radioactive
isotope technetium in a volume of 1.5 mL 0.25 mg of LeukoScan will be labelled with the 740 –
1110MBq of technetium. This material will be then be injected into your vein. Nearly all of the
radioactivity will be gone from the body in about 24 hours. Drink plenty of fluids before the
examination and as often as possible afterwards for the next 4 to 6 hours. This will minimise the
radiation dose to the bladder.
Frequency of Administration
How often will you be give LeukoScan
LeukoScan is prepared for a single injection. If your Nuclear Medicine Physician or Specialist
decides to give it to you again after several months, your blood should be tested first to see if you
have developed antibodies which may cause an immune reaction if a further dose is given.
Some side effects although not common, have been reported. These include a small increase in
the number of certain white blood cells called eosinophils (but without any apparent symptoms)
and rash. Rarely allergic reactions have occurred. If you experience either of these or any other
unwanted effect after you are given this drug, tell your Nuclear Medicine Physician or Specialist.
The maximum amount of LeukoScan that can be administered has not been determined. Patients
have been given four times the amount you will receive with no adverse reactions.
In the unlikely event of the administration of a radiation overdose with Leukoscan, the absorbed
does to the patient may be reduced by increased oral or intravenous intake of fluids to promote
excretion of the radiolabel.
Leukoscan is stored by the Hospital or Clinic. Your nuclear medicine technologist or specialist
will check the expiry date before administering it.
AUST R 82071
LeukoScan in supplied in Australia by
Locked Bag 2001
Kirrawee DC, NSW 2232
1800 251 572
02 9543 6511
ANSTO Health is a commercial enterprise of the Australian Nuclear Science and Technology
Organisation (ANSTO), which is located at Lucas Heights in Sydney. NSW
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