LeukoScan 0.31 mg, powder for solution for injection

An antibody is a natural substance made by the body which binds to foreign substances to help remove them from your body. You produce many different kinds of 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 it can be used in humans. When it is combined to the radioactive technetium isotope and injected into your vein, it finds an abnormal accumulation of white blood cells and attaches to them. One to eight hours later after the injection you will be placed on a special table and pictures will be taken with standard nuclear cameras. 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 to see where the infections are located. This medicine is for diagnostic use only.

LeukoScan is used to determine the presence 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 standard nuclear cameras to see where the infections are located.

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 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 infection 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 infection in the bone and what kind of treatment to use.

You should not use LeukoScan 0.31 mg, sulesomab,powder for solution for injection

• If you know that you are allergic (hypersensitive) to sulesomab or any protein which comes from a mouse, tell your doctor. You must then not be given LeukoScan.

Take special care with LeukoScan

• It is possible to have a serious allergic reaction to LeukoScan. Therefore, you doctor should keep you under close observation for a short time after he has given you this medicine.
• If you have ever received LeukoScan or another product made from a mouse antibody, your doctor should take a sample of blood for testing to be sure that you have not developed an allergy to it.
• If the prepared solution of LeukoScan appears discoloured or contains particles, it should not be used.

Using other medicines

No interactions with other medicines have been described to date.

Please tell your doctor if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

Using Leukoscan with food and drink

No studies effects of food/drink have been performed.

Pregnancy and breast-feeding

Pregnancy

• You should not be given LeukoScan if you are pregnant.

Breast-feeding

• If you are breast feeding, you should stop breast feeding your baby for at least 24 hours after you have been given LeukoScan.

Use of radiopharmaceutical agents

• Radiopharmaceutical agents should be used only by qualified personnel with appropriate government authorisation for the use and manipulation of radionuclides.
• This radiopharmaceutical may be received, used and administered only by authorised persons in designated clinical settings. Its receipt, storage, use, transfer and disposal are subject to the regulations and/or appropriate licenses of local competent official organisations.
• Radiopharmaceuticals should be prepared by the user in a manner which satisfies both radiation safety and pharmaceutical quality requirements. Appropriate aseptic precautions should be taken, complying with the requirements of Good Manufacturing Practices (GMP) for pharmaceuticals.
• After use, the container should be disposed of as radioactive waste.

Driving and using machines

No studies on the effects on the ability to drive and use machines have been performed.

Important information about some ingredients of LeukoScan

If you have been told that you have an intolerance to some sugars, inform your doctor before you are given this medicine.

Dosage

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/or route(s) of administration

Your doctor 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 740-1110 MBq of technetium. This material will then be injected into your vein. This dose of radioactivity is safe and will be gone from the body in about 24 hours.

Frequency of administration

LeukoScan is prepared for a single injection. If your doctor decides to give it to you again after several weeks or several months, your blood should be tested first to see if you have developed an allergy to LeukoScan.

If you take more LeukoScan than you should

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 dose to the patient may be reduced by increased oral or intravenous intake of fluids to promote excretion of the radiolabel.

If you stop using LeukoScan

LeukoScan is prepared for a single injection.

If you have any further questions on the use of this product, ask your doctor.

Like all medicines, LeukoScan can cause side effects, although not everybody gets them.

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.

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor.

Keep out of the reach and sight of children.

Expiry date and storage conditions

Kit - 48 months. Store in a refrigerator (2°C-8°C). Do not freeze.
Reconstituted and radiolabelled material - 4 hours. Do not store above 25°C. Do not refrigerate or freeze.

After use, the container should be disposed of as radioactive waste.

What LeukoScan contains

Kit for the preparation of 99mTc-labelled LeukoScan.
The kit does not include the radioisotope.

The active substance is sulesomab
Each 3 ml vial contains 0.31 mg sulesomab (IMMU-MN3 murine Fab?-SH antigranulocyte monoclonal antibody fragments).

The other ingredients are:

Stannous Chloride, Dihydrate Acetic Acid, Glacial Trace Sodium Potassium Tartrate, Tetrahydrate Sucrose Sodium Chloride Hydrochloric Acid Trace Sodium Acetate, Trihydrate Nitrogen

What LeukoScan looks like and contents of the pack

Powder for solution for injection.

One vial prepared so as to contain 0.31 mg lyophilised LeukoScan monoclonal antibody fragment. The Type I glass vial is closed with a grey butyl rubber stopper with a green flip-off seal.

Pack size: one vial per carton container.

Marketing Authorisation Holder and Manufacturer

Immunomedics GmbH
Otto-Röhm-Straße 69
D-64293 Darmstadt
Germany