Please read the following carefully. It does not contain all the information about your medicine that you may need to know, so please refer to the Summary of Product Characteristics or ask your doctor or nurse if you have any questions. This page only applies to CEA-Scan.

NAME OF YOUR MEDICINE

CEA-Scan is the trade name of your medicine. It is also called arcitumomab.

COMPOSITION:
    WHAT YOUR MEDICINE CONTAINS

Each 3-mL vial (glass container) contains 1.25 mg of arcitumomab, buffered to pH 5-7, 0.29 mg stannous chloride, sodium chloride, potassium sodium tartrate, sodium acetate, sucrose, argon.

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. CEA-Scan arcitumomab is a special kind of antibody which binds to the surface of certain kinds of tumour cells. 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, it finds certain tumours 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.

PHARMACEUTICAL FORM:
    WHAT CEA-Scan CONSISTS OF

Powder for injection.

THERAPEUTIC GROUP:
    HOW CEA-Scan WORKS

CEA-Scan is used to determine the presence of tumours in the body derived from the colon or rectum. Shortly after mixing the CEA-Scan with the radioactive technetium isotope, the doctor will inject it into your vein. Two to five hours later you will be placed on a special table and pictures will be taken with standard nuclear cameras to see where the tumour(s) are located. Before undergoing the scanning procedure, you should empty your bladder by urinating. You may be asked to come back the next day for some additional pictures to be taken.

INDICATIONS:
    WHEN CEA-Scan IS USED

CEA-Scan is an antibody fragment which is linked to a radioactive substance called technetium. CEA-Scan is used in patients with tumours of the colon or rectum that have been diagnosed after examination under the microscope. The antibody is able to bind to the surface of certain kinds of tumours producing a tumour marker, carcinoembryonic antigen (CEA). When the radioactive antibody binds to the tumour, your doctor can determine where it is located by using a special imaging camera that reveals areas of radioactivity. The doctor can also determine how much disease there is and if it has spread to other areas of the body. This will help the doctor determine whether to operate or what other kind of treatment to use.

CONTRAINDICATIONS:
    WHEN YOU SHOULD NOT USE CEA-Scan

If you know that you are allergic to any protein which comes from a mouse, tell your doctor. You should then not be given CEA-Scan, unless your doctor takes certain precautions and believes that the potential benefit exceeds any risk. You should not be given CEA-Scan if you are pregnant.

INTERACTIONS WITH OTHER MEDICATIONS AND OTHER FORMS OF INTERACTION

No interactions have been described to date.

SPECIAL WARNINGS:
    THINGS YOU SHOULD KNOW BEFORE YOU ARE GIVEN CEA-Scan

It is possible to have a serious allergic reaction to CEA-Scan. Therefore, your doctor should keep you under close observation for a short time after he has given you this drug.

If you have ever received CEA-Scan 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 you are breast feeding, you should stop breast feeding your baby for at least 24 hours after you have been given CEA-Scan.

If the prepared solution of CEA-Scan appears discolored or contains particles, it should not be used.

DOSAGE:
    THE AMOUNT OF MEDICINE GIVEN

You will receive a single dose of 1 mg of CEA-Scan. It will contain the radioactive technetium isotope in an amount called 750-1000 Mbq.

METHOD AND ROUTE OF ADMINISTRATION:
    HOW THE INJECTION IS GIVEN TO YOU

Your doctor will prepare the CEA-Scan and the radioactive isotope technetium in a volume of 5-10 ml. One mg of CEA-Scan will be labelled with 750-1000 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:
    HOW OFTEN YOU WILL BE GIVEN CEA- SCAN

CEA-Scan is prepared for a single injection. In Europe, 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 CEA-Scan.

UNDESIRABLE EFFECTS

Some side effects, although not common, have been reported. These include nausea, upset stomach, headache, itching, fever, a rough patch on the skin, a small increase in the number of certain white blood cells called eosinophils (but without any apparent symptoms). If you experience any of these or any other unwanted effect after you are given this drug, tell your doctor.

OVERDOSE

Intravenous administration of intact IgG and F(ab')₂ of IMMU-4 in therapeutic doses of up to 25 mg has not shown any serious adverse reactions. Fab' fragments have been demonstrated to be less immunogenic than intact IgG or F(ab')₂ fragments.

In the unlikely event of the administration of a radiation overdose with CEA-Scan, the absorbed dose to the patient may be reduced by increased oral or intravenous intake of fluids to promote excretion of the radiolabel.

SHELF LIFE:
    HOW LONG CEA-Scan CAN BE KEPT, AND HOW IT IS STORED

CEA-Scan is stored by the hospital in a refrigerator and given to your doctor when he needs it. The hospital can keep the medicine for 3 years at 2-8°C after it is made. The expiration date is printed on the vial. The product should not be used after this date.

Following reconstitution and radiolabelling, the material can be held at room temperature (15-25°C) and must be used within four hours following reconstitution.

INSTRUCTIONS FOR USE/HANDLING

Read complete directions thoroughly before starting the preparation procedure.

All procedures should be conducted using aseptic technique and standard precautions for handling radionuclides.

METHOD OF PREPARATION AND QUALITY CONTOL

1. Obtain 925-1110 MBq/mL sodium-pertechnetate [^99mTc] (from any commercial source) in sodium saline injection.
1. Resuspend the lyophilized material by injecting the 925-1110 MBq of [^99mTc] sodium-pertechnetate in a shielded vial of CEA-Scan.
2. Swirl and shake the vial for approximately 30 seconds making sure all sodium-pertechnetate [^99mTc] is in contact with the antibody. Allow the labelling reaction to proceed for at least five minutes. Add 1 mL of isotonic sodium chloride injection in order to facilitate easy removal. Assay the product in a suitable dose calibrator.
3. Based on the activity measured in the activity calibrator, withdraw a sufficient amount of the product to provide the desired activity (750-1000 MBq of ^99mTc, see Dosage and Administration). CEA-Scan [^99mTc] can be used after five minutes and should be used within four hours after preparation. CEA-Scan [^99mTc] can be stored at room temperature after formulation.
4. Prior to administration, the solution should be inspected visually for particulate matter and discoloration. If either are present, the product should be discarded.

After radiolabelling the antibody, dilute a 10 µl sample with 1.5 mL saline. Determine the radiochemical purity by Instant Thin Layer Chromatography on silica gel impregnated glass fiber strips, 1 × 9 cm using acetone as the solvent. When the solvent front is within 1 cm of the top of the strip, remove it, cut it in half and place each into a glass tube. Count each tube in a gamma scintillation counter, dose calibrator or radiochromatogram analyzer. Calculate the percent free technetium as follows:

The radiolabeled product should not contain more than 10% free technetium.

DATE ON WHICH THE PACKAGE LEAFLET WAS LAST REVISED: