Read all of this leaflet carefully before you are given MIBG Diagnostic.

PACKAGE LEAFLET: INFORMATION FOR THE USER

Meta-lodobenzylguanidine (¹³¹I) for Diagnostic Use 9.25-18.5 MBq/ml solution for injection

[¹³¹I]Iobenguane

Meta-lodobenzylguanidine (¹³¹I) for Diagnostic Use 9.25-18.5 MBq/ml solution for injection is referred to as MIBG Diagnostic in this leaflet.

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

-    If you have any further questions, ask your doctor.

-    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 nurse.

In this leaflet:

1.    What MIBG Diagnostic is and what it is used for

2.    Before you are given MIBG Diagnostic

3.    How MIBG Diagnostic is given

4.    Possible side effects

5.    How to store MIBG Diagnostic

6.    Further information

1. What MIBG Diagnostic is and what it is used for

This medicine is used for diagnostic use only. It is used only to help identify illness.

MIBG Diagnostic is a 'radiopharmaceutical' medicine. It is given before a scan and helps a special camera see inside a part of your body.

•    It contains an active ingredient called 'iobenguane'.

•    Once injected it can be seen from outside your body by a special camera used in the scan.

•    The scan can help your doctor see if a tumour of the adrenal or thyroid glands is suitable for

treatment and help decide on the treatment required.

Your doctor or nurse will explain which part of your body will be scanned.

2. Before you are given MIBG Diagnostic

You should not be given MIBG Diagnostic:

•    If you are allergic (hypersensitive) to the active ingredient or any other ingredient. (Listed in Section 6).

•    If you are pregnant or think you might be pregnant.

Do not have MIBG Diagnostic if any of the above apply to you. If you are not sure talk to your doctor or nurse.

Premature babies or newborn babies (neonates) must not be given MIBG Diagnostic. (See "Important information about some of the ingredients of MIBG Diagnostic").

Take special care with MIBG Diagnostic

Check with your doctor or nurse before having MIBG Diagnostic:

•    If you have missed your last period.

•    If you are on a low sodium diet.

Taking other medicines

Please tell your doctor or nurse if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. This includes herbal medicines. This is because

some medicines can affect the way MIBG Diagnostic works.

Before your scan tell your doctor or nurse if you are taking any of the types of medicine below. This is because they may affect the results of your scan:

•    Antihypertensive drugs such as reserpine, labetalol or calcium-channel blockers (which include diltiazem, nifedipine, verapamil, betanidine, debrisoquine, bretylium and guanethidine).

•    Antidepressants such as amitriptyline, imipramine, doxepin, amoxepine, loxapine, maprotiline ortrazolone.

•    'Sympathomimetic agents'(used as decongestants in cough and cold remedies) such as

phenylephrine, ephedrine or phenylpropanolamine.

• Cocaine

If you are not sure if any of the above apply to you, talk to your doctor or nurse before having MIBG Diagnostic.

Pregnancy and breast-feeding

You should not be given MIBG Diagnostic if you are pregnant or think that you may be pregnant. This is because it may affect the baby.

Do not breast-feed if you are given MIBG Diagnostic. This is because small amounts of 'radioactivity' may pass into the mother's milk. If you are breast-feeding, your doctor may wait until you have finished breast-feeding before using MIBG Diagnostic. If it is not possible to wait your doctor may ask you to:

•    stop breast-feeding, and

•    use formula feed for your child, and

•    express (remove) breast milk and throw away the milk.

Your doctor will let you know when you can start breast-feeding again.

Driving and using machines

Ask your doctor if you can drive or use machines after you have been given MIBG Diagnostic.

Important information about some of the ingredients of MIBG Diagnostic

• MIBG Diagnostic contains benzyl alcohol. Benzyl alcohol may cause toxic reactions and allergic reactions in infants and children up to 3 years old.

Important information about MIBG Diagnostic

When MIBG Diagnostic is used you are exposed to radioactivity.

• Your doctor will always consider the possible risks and benefits before you are given the medicine.

Ask your doctor if you have any questions.

3. How MIBG Diagnostic is given

MIBG Diagnostic will be given to you by a specially trained and qualified person.

•    MIBG Diagnostic will always be used in a hospital or clinic.

•    Your doctor will tell you to take another medicine 24 to 48 hours before you are given MIBG Diagnostic. You will continue to take this medicine for at least 5 days. This medicine is to stop radioactivity building up in your thyroid gland.

•    They will tell you anything you need to know for its safe use.

Your doctor will decide on the dose that is best for you.

The usual dose is:

• A single slow injection (given over 30 to 300 seconds).

4. Possible side effects

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

No significant side effects are to be expected when you are given MIBG Diagnostic.

If you notice any side effects please tell your doctor or nurse.

5. How to store MIBG Diagnostic

MIBG Diagnostic is kept out of the reach and sight of children.

The product label includes the correct storage conditions and the expiry date for the batch. Hospital staff will ensure that the product is stored and disposed of correctly and not used after the expiry date stated on the label.

6. Further information

What MIBG Diagnostic contains

•    The active ingredient is [¹³¹l]iobenguane. Each vial of MIBG Diagnostic contains between 9.25-18.5 MBq/ml (Megabecquerel - the unit in which radioactivity is measured) of iodine-131) at a fixed time.

•    The other ingredients are sodium chloride, benzyl alcohol and water for injections.

What MIBG Diagnostic looks like and contents of the pack

MIBG Diagnostic is supplied as a single colourless glass vial containing a solution for injection.

Marketing Authorisation Holder

GE Healthcare Limited Amersham Place Little Chalfont Buckinghamshire HP7 9NA United Kingdom

Manufacturer

GE Healthcare Buchler GmbH & Co. KG

Gieselweg 1

38110 Braunschweig

Germany

This leaflet was last approved in    GE and the GE Monogram are trade-

07/2009.    marks of General Electric Company.

Marketing authorisation

UK: PL 00221/0124