Scintimun1 mg kit for radiopharmaceutical preparation

Scintimun is a medicine containing an antibody (besilesomab) used to target specific cells called granulocytes (a type of white blood cells involved in the inflammation process) in your body. Scintimun is used for the preparation of a radioactive solution for injection of technetium( 99mTc)- besilesomab. Technetium( 99mTc) is a radioactive element allowing the organs where besilesomab accumulates to be seen using a special camera.

This medicine is for diagnostic use only.
After injection into your vein, your doctor can perform pictures (scans) of your organs that give more information about the detection of sites of inflammation and/or infection.

Do not use Scintimun:

• if you are allergic (hypersensitive) to besilesomab, to antibody from mouse origin or any other antibodies, to any of the other ingredients of Scintimun (see section 6) or to sodium pertechnetate ( 99mTc) solution.
• if you have a positive response to a test detecting human anti-mouse antibodies (HAMA test). Ask your doctor if you are not sure.
• if you are pregnant.

Take special care with Scintimun:
If any of these conditions are applicable to you, you should inform your doctor:

• if you had previously been administered Scintimun, because you should only be administered Scintimun once in your lifetime. If you are not sure if you have been given this before, please let your doctor know.
• if you previously had a scintigraphy with technetium in the last 2 days.
• if you have a tumoral pathology involving a secretion of carcino embryonic antigen (CEA) which could interfere with this investigation.
• if you have any blood disease.

The use of Scintimun involves the administration of a small amount of radioactivity. Because technetium( 99m Tc)-besilomab is administered by trained personnel, there are no precautions which are your responsibility. Because there are strict laws covering the handling, the use and disposal

of radioactivity, technetium( 99mTc)-besilomab is always used in a hospital or a similar setting. It is always handled by trained and qualified people.

In order to obtain images of best quality and to reduce the radiation exposure of your bladder, you should drink sufficient amounts and empty your bladder prior to and after the scintigraphic examination.

Because you could emit radiation especially harmful to young children during the first 12 hours after the injection, you may be told to avoid close contact with young children during this period of time.

This product is not recommended for use in patient below 18 years of age.

Scintimun should not be used for the diagnosis of diabetic foot infection.

Taking other medicines
Please tell your doctor or pharmacist if you are taking or have recently taken any medicines, including medicines obtained without a prescription.
Medicines reducing inflammation and medicines affecting the production of your blood cells (such as corticosteroids or antibiotics) may affect the results of your examination.

Pregnancy
You must not be given Scintimun if you are pregnant.
Ask your doctor or pharmacist for advice before taking any medicine.
You must tell your doctor if you have missed a period or if there is any chance you may be pregnant. Investigations in nuclear medicine may involve a risk to the unborn.

Breast-feeding
If you are breast feeding you may be told to stop breast-feeding for 3 days after your injection and the expressed milk should be discarded. If you wish you can express and store your breast milk before your injection. This will protect your child from the radiation that may be present in your breast milk. However you may be told to avoid close contact with your child during the first 12 hours after the injection.

Important information about some of the ingredients of Scintimun:

If you have an intolerance to some sugars (for example fructose, sorbitol), tell your doctor before you are given Scintimun.

Your doctor will decide on the amount of technetium( 99mTc)- besilesomab to be used in your case. This will be the minimum amount necessary for the scan to be clear enough to provide the required information.
The recommended activity administered intravenously is between 400 to 800 MBq (MegaBecquerel or MBq is a unit used to measure radioactivity).

A single injection into a vein in your arm is sufficient to provide your doctor with the information needed.

You will then need to wait a few hours whilst the radioactive product is taken up by your body. Scans are usually taken 3 to 6 hours after injection and can be repeated after 24 hours.

If you are given more Scintimun than you should:

Because injection is prepared as a single dose by the hospital personnel, under strictly controlled conditions it is very unlikely you will be given too much. However, if this does occur, you will be asked to drink plenty of water and to take laxatives to increase the elimination of the product from your body.

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

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

About 14 out of 100 patients having this injection have been found to produce antibodies in their blood reacting against the antibody present in Scintimun. This may increase the risk of allergic reactions in case of repeated administration of Scintimun. Therefore you should not receive Scintimun a second time.
In case of allergic reaction you will receive appropriate treatment from your doctor.

Possible side effects are listed in the order of their frequency below:

Very common (may affect more than 1 user in 10):
Development of human anti-mouse antibodies reacting against the antibody in Scintimun (antibody of the mouse cells) with a risk of allergic reaction

Common (may affect between 1 in 10 and 1 in 100 users):
Low blood pressure

Uncommon (may affect between 1 in 100 and 1 in 1,000 users):
Allergic reaction, including swelling of the face, hives (urticaria)

Rare (may affect between 1 in 1,000 and 1 in 10,000 users):

• Serious allergic reaction which causes difficulty in breathing or dizziness
• Muscle or joint pain

Any radioactive material may cause cancer or hereditary defects, but the frequency of these adverse reactions is not known.

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist and the specialist in nuclear medicine who performed the investigation.

Keep out of the reach and sight of children.

Do not use Scintimun after the expiry date which is stated on the labels after EXP.

Store in a refrigerator (2°C ? 8°C). Keep the vial in the outer carton in order to protect from light. Do not store the reconstituted and radiolabelled product above 25°C and use within 3 hours after labelling.

You will not have to get or store this medicine. The qualified staff of the nuclear medicine center where this investigation is performed, will do this.

What Scintimun contains

• The active substance is besilesomab (anti-granulocyte monoclonal antibody from mouse origin). One vial Scintimun contains 1 mg of besilesomab.
• The other ingredients are :

Scintimun:
Sodium dihydrogen phosphate, anhydrous
Disodium monohydrogen phosphate, anhydrous
Sorbitol E420
Under nitrogen atmosphere

Solvent forScintimun
1, 1, 3, 3-propane tetraphosphonic acid, tetrasodium salt, dihydrate (PTP)
Stannous chloride dihydrate
Sodium hydroxide / Hydrochloric acid
Nitrogen

What Scintimun looks like and contents of the pack

Scintimun is a kit for radioactive preparation.
The vial Scintimun contains a white powder which should be dissolved in the solvent provided and then labelled with radioactive technetium before use. When the reconstituted Scintimun solution is mixed with a solution of sodium pertechnetate ( 99mTc), a solution of technetium ( 99mTc) ?besilesomab is formed.
This solution is ready to be injected intravenously.

The kit contains one or two multidose vials Scintimun with one or two vials of solvent.

Not all pack-sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

CIS bio international
B.P. 32
F-91192 Gif-sur-Yvette Cedex
France

This leaflet was last approved in {MM/YYYY }

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The following information is intended for medical or healthcare professionals only: Please refer to the Summary of Product Characteristics provided as a separate document in the product package.