Read all of this leaflet carefully before you are given this medicine because it contains important information for you.

•    Keep this leaflet. You may need to read it again.

•    If you have any further questions, ask your nuclear medicine doctor who will supervise the procedure.

•    If you get any side effects, talk to your nuclear medicine doctor. This includes any possible side effects not listed in this leaflet.

What is in this leaflet:

1.    What Hepatate is and what it is used for

2.    What you need to know before Hepatate is used

3.    How Hepatate is used

4.    Possible side effects

5.    How Hepatate is stored

6.    Contents of the pack and further information

1. WHAT HEPATATE IS AND WHAT IT IS USED FOR

This medicine is a radiopharmaceutical product for diagnostic use only.

This product is a powder which, when mixed with a solution of the radioactive substance sodium pertech-netate [99mTc] forms a technetium [99mTc] colloidal tin injection.

•    A colloid is a suspension of very fine particles in water.

•    Technetium [99mTc] colloidal tin is a radiopharmaceutical product which is used to help to make a diagnosis. When injected, it temporarily collects in a particular organ of the body. Because the substance contains a small amount of radioactivity it can be detected from outside the body using special cameras, and a picture, known as a scan, can be taken. This scan will show exactly the distribution of the radioactivity within the organ and the body. This can give the physician valuable information about structure and function of that organ.

When injected, technetium [99mTc] colloidal tin circulates in the blood and collects in the liver and the spleen. A scan will then help your physician to determine the ability of these organs to eliminate particles of foreign material such as bacteria and denatured protein from the blood.

The use of technetium [99mTc] colloidal tin does involve exposure to small amounts of radioactivity. Your doctor and the nuclear medicine doctor have considered that the clinical benefit that you will obtain from the procedure with the radiopharmaceutical outweighs the risk due to radiation.

2. WHAT YOU NEED TO KNOW BEFORE HEPATATE IS USED

Hepatate must not be used

•    if you are allergic (hypersensitive) to stannous fluoride or any of the other ingredients of Hepatate (listed in section 6).

Warnings and precautions

Take special care with Hepatate

•    if you are pregnant or believe you may be pregnant

•    if you are breast-feeding

•    Hepatate should only be used and administered by authorized persons.

Using other medicines

Tell your nuclear medicine doctor if you are using, have recently used or might use any other medicines since they may interfere with the interpretation of the images.

It is particularly important to tell your doctor if you are taking any of the following:

•    cancer chemotherapy drugs

•    contraceptives

•    tetracyclines (antibiotic used to treat a variety of bacterial infections)

•    drugs which affect blood flow in the liver, such as some anaesthetics.

Pregnancy and breast-feeding

You must inform the nuclear medicine doctor before the administration of Hepatate if there is a possibility you might be pregnant, if you have missed your period or if you are breast-feeding.

When in doubt, it is important to consult your nuclear medicine doctor who will supervise the procedure.

If you are pregnant

The nuclear medicine doctor will only administer this product during pregnancy if a benefit is expected which would outweigh the risks.

If you are breast-feeding

Tell your nuclear medicine doctor if you are breastfeeding as he may delay the investigation until breastfeeding is completed or ask you to stop breast-feeding for a short while until the radioactivity is no longer in your body. Please ask your nuclear medicine doctor when you can resume breast-feeding.

Driving and using machines

Technetium [99mTc] colloidal tin has no effect on your fitness to drive or operate machinery.

3. HOW HEPATATE IS USED

There are strict laws on the use, handling and disposal of radiopharmaceutical products. Hepatate will only be used in special controlled areas. This product will only be handled and given to you by people who are trained and qualified to use it safely. These persons wifi take special care for the safe use of this product and wifi keep you informed of their actions.

The nuclear medicine doctor supervising the procedure will decide on the quantity of Hepatate to be used in your case. It will be the smallest quantity necessary to get the desired information.

The quantity to be administered usually recommended from 15 MBq for small children, up to a maximum of 185 MBq (Megabecquerel - the unit in which radioactivity is measured).

Use in children and adolescents

In children and adolescents, the quantity to be administered will be adapted to the child’s weight.

Administration of Hepatate and conduct of the procedure

The solution is administered by injection into a vein. One injection is sufficient to provide your doctor with the information needed.

Duration of treatment

Scans may be taken at any time following injection. Your nuclear medicine doctor will inform you about the usual duration of the procedure.

After administration of Hepatate

The nuclear medicine doctor will inform you if you need to take any special precautions after receiving this medicine. Contact your nuclear medicine doctor if you have any questions.

If you have been given more Hepatate than you should

An overdose is unlikely since technetium [99mTc] colloidal tin is administered by a nuclear medicine doctor under strictly controlled conditions. However, in the case of an overdose, you will receive the appropriate treatment.

Should you have any further question on the use of Hepatate, please ask the nuclear medicine doctor who supervises the procedure.

4. POSSIBLE SIDE EFFECTS

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

Hepatate will deliver low amounts of ionising radiation associated with the least risk of cancer and hereditary abnormalities.

Technetium [99mTc] colloidal tin may very occasionally produce side effects.

The following side effects have been reported:

•    malaise, lowered heart rate and blood pressure

•    swelling of the skin (often of the face)

•    central chest or back pain with shortness of breath, occasionally complicated with true bronchospasm

•    on rare occasions skin reaction may occur. The majority of the reactions are relatively mild and your physician will decide on any necessary treatment.

If you get any side effects talk to your nuclear medicine doctor. This includes any possible side effects not listed in this leaflet.

5.    HOW HEPATATE IS STORED

You will not have to store this medicine. This medicine is stored under the responsibility of the specialist in appropriate premises. Storage of radiopharmaceuticals will be in accordance with national regulation on radioactive materials.

The following information is intended for the specialist only.

Hepatate must not be used after the expiry date which is stated on the label.

6.    CONTENTS OF THE PACK AND OTHER INFORMATION

What Hepatate contains

•    The active substance is Stannous fluoride. Each vial contains 0.125 mg of stannous fluoride.

•    The other ingredients are Sodium fluoride & Poloxamer 188.

What Hepatate looks like and contents of the pack

The product is supplied in a clear Type I Ph.Eur.glass vial sealed with a chlorobutyl rubber closure and metal overseal.