INFORMATION FOR THE USER

CHOLEDIAM

Kit for the preparation of technetium [^99mTc] mebrofenin injection

mebrofenin

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 doctor who will supervise the procedure.

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

In this leaflet:

1.    What Cholediam is and what it is used for

2.    What you need to know before Cholediam is used

3.    How Cholediam is used

4.    Possible side effects

5.    How Cholediam is stored

6.    Contents of the pack and other information

1. WHAT CHOLEDIAM IS AND WHAT IT IS USED FOR

This medicine is a radiopharmaceutical product for diagnostic use only.

• Cholediam is used to perform scans of the liver, the gall bladder and the bile duct which are usual paths of bile excretion.

-    This product is used in the preparation of a diagnostic radiopharmaceutical. When injected, the radiopharmaceutical temporarily collects in the liver and is excreted into bile.

-    Because the substance contains a small amount of radioactivity, it can be detected from outside the body using special cameras, and pictures, known as scans, can be taken. These scans will show exactly the distribution of the radiopharmaceutical within the organs and the target tissues. This gives the physician valuable information for the diagnosis of your disease.

The use of Cholediam does involve exposure to small amounts of radioactivity. Your doctor has 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 CHOLEDIAM IS USED

Cholediam must not be used

•    if you are allergic (hypersensitive) to mebrofenin or any of the other ingredients of Cholediam.

Warnings and precautions

Take special care with Cholediam:

•    if you are or think you may be pregnant

•    if you are breast-feeding

•    Cholediam should only be used and administered by authorised persons

•    your doctor will tell you if you need to take any special precautions before or after being given this medicine.

Before administration of Cholediam you should

•    be fasting for at least 6 hours.

Speak to your doctor before receiving Cholediam if you:

•    have been receiving nutritional formulas intravenously

•    have been dieting for a long time

•    have just eaten before treatment

•    have liver problems.

Children and adolescents

Talk to your doctor if you are under 18 years old.

Other medicines and Cholediam

Tell your doctor if you are taking, have recently taken or might take 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:

•    opioid painkillers such as morphine

•    barbiturates used for sedation such as phenobarbital

•    vitamin B3 supplements

•    cholecystokinin or somatostatin (peptide hormones)

•    sincalide used to diagnosis gall bladder or pancreas problems

•    atropine used for heart problems or eye tests

•    chemotherapy given via a tube into your hepatic artery.

Pregnancy

•    You must inform the doctor before you are given Cholediam if there is a possibility you might be pregnant, if you have missed your period or if you are breastfeeding.

•    Will supervise the procedure.

•    If you are pregnant: the doctor will only administer this product during pregnancy if a benefit is expected which would outweigh the risks.

Breast-feeding

•    If you are breast-feeding, the doctor will only give you this product if a benefit is expected which would outweigh the risks.

You will need to stop breast-feeding for at least 12 hours after being given this product. Milk expressed during this time should be thrown away. Please ask your doctor when you can resume breast-feeding.

Driving and using machines

Effects on the ability to drive and use machines are not expected.

3. HOW CHOLEDIAM IS USED

There are strict laws on the use, handling and disposal of radiopharmaceutical products. Cholediam 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 will take special care for the safe use of this product and will keep you informed of their actions.

The doctor supervising the procedure will decide on the quantity of Cholediam 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 20 MBq for small children, up to a maximum of 300 MBq (Megabecquerel - the unit in which radioactivity is measured) for adults.

Use in children and adolescents

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

Administration of Cholediam and conduct of the procedure

You should have fasted for at least 6 hours before receiving Cholediam.

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 doctor will inform you about the usual duration of the procedure.

After administration of Cholediam

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

If you have been given more Cholediam than you should

An overdose is unlikely since Cholediam is administered by a 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 Cholediam, please ask the doctor who will supervise the procedure.

4. POSSIBLE SIDE EFFECTS

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

On very rare occasions, allergic type reactions may occur. This radiopharmaceutical will deliver low amounts of ionising radiation associated with the least risk of cancer and hereditary abnormalities.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard

By reporting side effects you can help provide more information on the safety of this medicine.

5. HOW CHOLEDIAM 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.

6. CONTENTS OF THE PACK AND OTHER INFORMATION

What Cholediam contains

•    The active ingredient is mebrofenin.

•    The other ingredient is stannous chloride dehydrate.

What Cholediam looks like and contents of the pack 15 ml, colourless, European Pharmacopoeia type I, drawn glass vials, closed with chlorobutyl rubber stoppers and aluminium capsules which may be labelled with 740 to 3700 megabecquerel (MBq) of technetium (a radioactive tracer).

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

MEDIAM

85 rue Nelson Mandela

F-59120 Loos

Tel : +33 3 20 49 72 58

Fax : +33 3 20 88 16 71

PL/22879/0001

Manufacturer

GIPHARMA S.r.l.

Str. per Crescentino I - Saluggia (VC), 13040 Tel :+ 39 0161 487 141 Fax :+ 39 0161 487 140

This leaflet was last approved in 09/2013.

The following information is intended for medical or healthcare professionals only:

Please refer to the SmPC.