Consumer medicine information

1 Medicine name

Chromium [⁵¹Cr] Edetate

2 Special advisory

Radiopharmaceuticals should be used only by physicians who are qualified by specific training in the safe use and handling of radionuclides produced by a nuclear reactor or particle accelerator and whose experience and training have been approved by the appropriate government agency authorised to license the use of radionuclides.

Care should be taken to minimise radiation exposure to patients consistent with proper patient management. As with other radioactive drugs, Chromium [⁵¹Cr] Edetate Injection must be handled with care and appropriate safety measures should be used to minimise radiation exposure to clinical personnel.

3 Why am I using Chromium [⁵¹Cr] Edetate Injection?

Chromium [⁵¹Cr] Edetate Injection is being given to you to determine the amount of fluid flowing through your kidneys (glomerular filtration rate) and to assess the function of your kidneys.

Chromium [⁵¹Cr] Edetate contained in this product is a diagnostic pharmaceutical. It contains radioactive Chromium-51 in a solution of Ethylenediaminetetra-acetic acid (EDTA) and 0.9% Sodium Chloride.

Ask your nuclear medicine physician or technologist for more information on why you have been referred for this treatment.

4 What should I know before I use Chromium [⁵¹Cr] Edetate Injection?

All medicines and diagnostic agents have risks and benefits associated with their usage. Your nuclear medicine specialist has weighed the risks of you being treated with Chromium [⁵¹Cr] Edetate Injection against the benefits of the procedure.

Chromium [⁵¹Cr] Edetate Injection is indicated for the determination of glomerular filtration rate in the assessment of renal function.

Before you are given Chromium [⁵¹Cr] Edetate Injection, it is important to tell your nuclear medicine specialist or technologist if:

1. You have oedema (build-up of fluid).
2. You are, or maybe pregnant:

Your Nuclear Medicine Physician will discuss your options with you.
Use of nuclear medicines should be avoided during pregnancy and only imperative investigations should be undertaken. Your physician will make a decision on the use of the medicine based on the risk benefit analysis.

3. You are breast-feeding:

Nursing mothers should interrupt their breastfeeding for 4-24 hours after the injection. A normal feed should then be expressed and discarded before continuing breast-feeding.

4. You are taking any other medicines:

These medicines include vitamins, cough medicines and nasal sprays that you buy from a pharmacy, supermarket or health food shop, without a prescription.
Some medication may interfere with the expected results; you will be advised what to do.

5 What if I am taking other medicines?

It is very important that you tell your doctors if you are taking any other medicines, including those you buy over the counter without a prescription from your pharmacy, supermarket, or health food store.

The constituents of medications you are taking could affect the results of this treatment. Your nuclear medicine specialist or technologist will advise you of what to do.

This product should not be administered together with other medications unless this is in the context of a simultaneous investigation of renal function.

6 How do I use Chromium [⁵¹Cr] Edetate Injection?

It is given as an injection into a vein in your arm. You may feel a slight pin-prick from the needle when it is injected.

The test procedure requires that you will be asked to give blood samples after the injection for testing and investigation (generally after1 and 2½ hours).

7 What should I know while using Chromium [⁵¹Cr] Edetate Injection?

Preparation:

Usually, no preparation is required for these tests. Specific instructions are given when any preparation is required.

Before you are given it

Drink plenty of water before the injection in order to urinate as often as possible during the first hours after the study, this helps with elimination of the radioactive product from your body.

After being given Chromium [⁵¹Cr] Edetate injection

Avoid any close contact with young children and pregnant women for 12 hours following the injection. You may be encouraged to drink fluids and pass urine frequently for about 6 hours following your scan; this is to help flush Chromium [⁵¹Cr] Edetate out from your body.

For up to 24 hours after the injection, be careful when going to the toilet to not spill any urine and to ensure that the toilet is flushed well. Whenever possible, use a toilet rather than a urinal. Clean up spilled urine complete and wash your hands thoroughly.

8 Are there any side effects?

Unwanted effects have been reported infrequently after single or repeated intravenous administrations of Chromium [⁵¹Cr] Edetate such that the incidence of individual reactions cannot be quantified. Limited details are available, but mild allergic phenomena have been described.

Tell your nuclear medicine technologist if you feel unwell after your injection.

9 Sponsor

ANSTO
New Illawarra Rd,
Lucas Heights
NSW 2234, Australia

Mailing address:

ANSTO, Locked Bag 2001
Kirrawee DC
NSW 2232, Australia

Telephone: 1800 251 572
E-mail: health@ansto.gov.au
Website: www.ansto.gov.au

ARTG number:
AUST R 22779

10 Date of revision

12 October 2021

Published by MIMS December 2021

1 Name of Medicine

Chromium [⁵¹Cr] edetate injection BP.

2 Qualitative and Quantitative Composition

Description. Chromium [⁵¹Cr] Edetate Injection BP is single dose clear purple coloured sterile pyrogen free aqueous isotonic solution for intravenous administration. Each 3 mL vial contains 8 MBq of chromium [⁵¹Cr], ≤ 1 mg of Chromium element and ≤ 15 mg of EDTA in 1 mL of 0.9 w/v% sodium chloride solution at a pH of between 3.5 and 6.5.
Physical characteristics of chromium 51. Chromium-51 has a physical half-life of 27.71 days, and has 9.9% disintegration's with a single gamma photon at 320 keV.
To correct for the effect of decay multiply the activity on the calibration date by the appropriate factor from Table 1:
https://stagingapi.mims.com/au/public/v2/images/fulltablegif/ANSHCR01.gif External radiation. The attenuation coefficient (mu) in lead¹ is ~ 3.6 cm^-1 and the attenuation factors for lead are given in Table 2:
https://stagingapi.mims.com/au/public/v2/images/fulltablegif/ANSHCR02.gif ¹ The Health Physics and Radiological Health Handbook, (eds. Schleien, B, Terpilak, M.S.), Nucleon Lectern Associates, Olney, 1984.
Excipient(s) with known effect. Each mL of chromium [⁵¹Cr] edetate solution contains ≤ 1 mg of chromium and ≤ 15 mg of EDTA.
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

A clear purple coloured sterile pyrogen free aqueous isotonic solution for intravenous administration.

4 Clinical Particulars

4.9 Overdose

In the event of an accidental administration of an overdose of chromium [⁵¹Cr] edetate, the absorbed radiation dose to the patient should be reduced by increasing the elimination of the radionuclide from the body. This may be done by more frequent emptying of the urinary bladder by hydration, diuretics and catheterisation.
For information on the management of overdose, contact the Poisons Information Centre on 13 11 26 (Australia).

5 Pharmacological Properties

5.3 Preclinical Safety Data

Genotoxicity. No data available.
Carcinogenicity. See Section 4.4 Special Warnings and Precautions for Use.

6 Pharmaceutical Particulars

6.7 Physicochemical Properties

Chemical structure.
https://stagingapi.mims.com/au/public/v2/images/fullchemgif/CSCHROED.gifCAS number. 11063-42-6.

7 Medicine Schedule (Poisons Standard)

Unscheduled.

Summary Table of Changes

https://stagingapi.mims.com/au/public/v2/images/fulltablegif/ANSHCRST.gif