LEUKOSCAN

Main information

  • Trade name:
  • LEUKOSCAN sulesomab 0.31mg powder for injection vial
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • LEUKOSCAN sulesomab 0.31mg powder for injection vial
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 82071
  • Last update:
  • 01-12-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

82071

LEUKOSCAN sulesomab 0.31mg powder for injection vial

ARTG entry for

Medicine Registered

Sponsor

ANSTO t/a ANSTO Health

Postal Address

Locked Bag 2001,KIRRAWEE DC, NSW, 2232

Australia

ARTG Start Date

20/03/2002

Product category

Medicine

Status

Active

Approval area

Drug Safety Evaluation Branch

Conditions

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.

Products

1. LEUKOSCAN sulesomab 0.31mg powder for injection vial

Product Type

Single Medicine Product

Effective date

8/04/2014

Warnings

See Product Information and Consumer Medicine Information for this product

Standard Indications

Specific Indications

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

Container information

Type

Material

Life Time

Temperature

Closure

Conditions

Vial

Glass

4 Years

Store at 2 to 8

degrees Celsius

Not recorded

See Product

information for shelf

life

Pack Size/Poison information

Pack Size

Poison Schedule

Single unit pack

(S4) Prescription Only Medicine

Components

1. Medicine Component

Dosage Form

Injection, powder for

Route of Administration

Intravenous

Visual Identification

Colourless Solution when reconstituted.

Active Ingredients

Sulesomab

.31 mg

© Commonwealth of Australia.This work is copyright.You are not permitted to re-transmit, distribute or commercialise the material without obtaining prior

written approval from the Commonwealth.Further details can be found at http://www.tga.gov.au/about/website-copyright.htm.

Public Summary

Page 1 of

Produced at 01.12.2017 at 10:37:46 AEDT

This is not an ARTG Certificate document.

The onus is on the reader to verify the current accuracy of the information on the document subsequent to the date shown.

Visit www.tga.gov.au for contact information

Patient Information leaflet: composition, indications, side effects, dosage, interactions, adverse reactions, pregnancy, lactation

LeukoScan

®

sulesomab

CONSUMER MEDICINE INFORMATION

LeukoScan

®

sulesomab

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

or physician.

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.

Product Description

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.

Therapeutic Group:

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.

LeukoScan

®

sulesomab

Indications

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:

1.

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.

2.

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

discarded.

3.

You are allergic to any protein which is made from a mouse antibody

4.

Do not use LeukoScan if you have an allergy to LeukoScan or any of the

ingredients listed in the leaflet.

5.

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.

6.

Do not use LeukoScan if the packaging is torn or shows sign of tampering.

7.

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

given.

LeukoScan

®

sulesomab

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.

Side Effects

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.

Overdosage

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.

Storage

Leukoscan is stored by the Hospital or Clinic. Your nuclear medicine technologist or specialist

will check the expiry date before administering it.

LeukoScan

®

sulesomab

AUST R 82071

Supplier

LeukoScan in supplied in Australia by

ANSTO Health

Locked Bag 2001

Kirrawee DC, NSW 2232

Telephone:

1800 251 572

Facsimile:

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

Date of Revision:

January 2012

Date of Printing:

January 2012

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