PACKAGE LEAFLET: INFORMATION FOR THE USER

Sodium Chromate (⁵¹Cr)

37 MBq/ml radiopharmaceutical precursor, solution (called Sodium Chromate Solution in this leaflet)

Sodium [⁵¹Cr]chromate

Read all of this leaflet carefully before you are given Sodium Chromate Solution.

•    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 Sodium Chromate Solution is and what it is used for

2.    Before you are given Sodium Chromate Solution

3.    How Sodium Chromate Solution is given

4.    Possible side effects

5.    How to store Sodium Chromate Solution

6.    Further information

1. What Sodium Chromate Solution is and what it is used for

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

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

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•    It contains an active ingredient called 'sodium chromate'. This is mixed with a sample of your blood before it is used.

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

•    The scan can give your doctor information about diseases and conditions that affect your blood. It can also help to examine bleeding in your gut.

Your doctor or nurse will explain which part of

your body will be scanned.

2. Before you are given Sodium Chromate Solution

You should not be given Sodium Chromate Solution:

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

Do not have Sodium Chromate Solution if the above applies to you. If you are not sure talk to your doctor or nurse.

Take special care with Sodium Chromate Solution

Check with your doctor or nurse before having Sodium Chromate Solution:

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

•    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 Sodium Chromate Solution works.

No medicines have been reported that affect the way Sodium Chromate Solution works. But it is still best to tell your doctor or nurse if you are taking any other medicines.

Pregnancy and breast-feeding

You must tell your doctor if you are pregnant or think you may be pregnant. Your doctor will only use this product if it is considered that the benefit outweighs the risk.

Do not breast-feed if you are given Sodium Chromate Solution. 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 Sodium Chromate Solution. 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 Sodium Chromate Solution.

Samples that will be required before you have Sodium Chromate Solution

•    A sample of your blood will be taken.

Important information about Sodium Chromate Solution

When Sodium Chromate Solution 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 Sodium Chromate Solution is given

Sodium Chromate Solution will be given to you by a specially trained and qualified person.

•    Sodium Chromate Solution will always be used in a hospital or clinic.

•    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:

•    One single injection.

The sample of your blood that has been taken is mixed with Sodium Chromate Solution then injected.

Samples that may be required after you have had Sodium Chromate Solution

•    Samples of your blood, and possibly faeces, may be collected after the injection.

4. Possible side effects

There have been no reports of any side effects after the use of Sodium Chromate Solution. Although like all medicines, Sodium Chromate Solution may cause side effects.

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

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5. How to store Sodium Chromate Solution

Sodium Chromate Solution is kept out of the reach and sight of children.

GE and the GE Monogram are trademarks of General Electric Company.

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 Sodium Chromate Solution contains

•    The active ingredient is sodium [⁵¹Cr]chromate. Each vial of Sodium Chromate (⁵¹Cr) contains 37 MBq (Megabecquerel - the unit in which radioactivity is measured) of sodium [⁵¹Cr]chromate.

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

What Sodium Chromate Solution looks like and contents of the pack

Sodium Chromate Solution is supplied as a single colourless glass vial containing a solution of radiopharmaceutical precursor.

Marketing Authorisation Holder and Manufacturer

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

This leaflet was last approved in 06/2009

Marketing Authorisations

UK: PL 00221/0111 Ireland: PA 240/19/1