Consumer medicine information

Chromium (51Cr) Edetate Injection

Chromium (51Cr) edetate

BRAND INFORMATION

Brand name

ANSTO Health Chromium (<sup>51</sup>Cr) Edetate Injection BP

Active ingredient

Chromium (51Cr) edetate

Schedule

Unscheduled

 

Consumer medicine information (CMI) leaflet

Please read this leaflet carefully before you start using Chromium (51Cr) Edetate Injection.

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.
  1. 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.
  1. 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: [email protected]
Website: www.ansto.gov.au

ARTG number:
AUST R 22779

10 Date of revision

12 October 2021

Published by MIMS December 2021

BRAND INFORMATION

Brand name

ANSTO Health Chromium (<sup>51</sup>Cr) Edetate Injection BP

Active ingredient

Chromium (51Cr) edetate

Schedule

Unscheduled

 

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:

External radiation.

The attenuation coefficient (mu) in lead1 is ~ 3.6 cm-1 and the attenuation factors for lead are given in Table 2:
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

4.1 Therapeutic Indications

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

4.2 Dose and Method of Administration

Chromium [51Cr] Edetate Injection should be used without dilution. Product is for one dose in one patient only. Discard any remaining contents appropriately. Contains no antimicrobial agent.

Dose handling.

Radiation exposure to staff must be minimised. For each patient, exposure to ionising radiation must be justified on the basis of likely benefit. The normally recommended dose for adults is 1.1 to 6.0 MBq by intravenous injection or continuous infusion. Higher doses up to 11 MBq may be appropriate for the use in conjunction with external counting techniques. The dosage for children may be calculated as a proportion of adult body weight or surface area. For newborn or children under one year the target organ's size should be taken into consideration.

Adults.

The normal recommended dose for adults is 1.1 to 6.0 MBq (30-160 microCi) by intravenous injection or continuous infusion. The actual activity administered will depend on the technique, used to determine the renal clearance and on that used for radioactivity detection. Higher activities up to a maximum of 11 MBq (300 microCi) may be appropriate for use in conjunction with external counting techniques.
Because of the complexities of the infusion technique, a single injection technique is normally used. This method obviates the need for urine collection, but is not suitable for patients with oedema. A single intravenous dose of 3.7 MBq of Chromium [51Cr] Edetate Injection BP is normally given and the plasma clearance is calculated from the injected amount of Chromium [51Cr] Edetate BP and the decrease of activity in the plasma samples as a function of time.
For continuous intravenous infusion a priming dose of 1.85 MBq is given intravenously followed by the infusion of a solution containing 37 kBq per mL at a rate of 0.5 mL per minute. After about 40 minutes, the plasma concentration becomes constant. A urine collection lasting about 15 minutes is then started and a venous sample taken at the mid time. This process is repeated with rapid separations and counting of the plasma radioactivity until constant plasma activity is observed in two successive samples. The GFR is then calculated.

Paediatric administration.

The dosage to be administered to children may be calculated approximately by correcting on a weight or body surface area basis the dosage to adults. For the newborn and children under about one year of age, the target organ size in relation to the whole body must also be taken into consideration.

Radiation dosimetry.

Radiation dose to specific organs, which may not be the target organ, can be influenced significantly by pathophysiological changes induced by any disease processes. This should be taken into consideration when using the following information.
This data assumes a body retention half-life of 100 minutes and a transit time of 5 minutes. (Considered normal). (See Table 3.) For abnormal renal function, see Table 4.

4.3 Contraindications

There are no known contraindications.

4.4 Special Warnings and Precautions for Use

Precautions.

Patients should be encouraged to drink fluids and void the bladder frequently in the hours following administration of Chromium [51Cr] Edetate Injection BP to minimise radiation dose to the bladder.
Chromium [51Cr] Edetate Injection BP is not suitable for use in patients with oedema as in such patients equilibration of the administered chromium [51Cr] edetate between the plasma and interstitial fluid may take up to 12 hours.

General.

Radiopharmaceuticals should be administered by medical practitioners who are qualified and licensed to handle radioisotopes.
Disposal of all radioactive wastes should be carried out in accordance with the ARPANSA's "Code for the Disposal of Radioactive Waste by the User - Radiation Protection Series, C-6, September 2018".
The administration of radiopharmaceuticals creates risks for other persons from external radiation or contamination from spills of urine. Radiation protection precautions in accordance with national regulations must therefore be taken.

Check the following before use.

The following should be checked prior to administration:
Verification of the dose to be administered and patient identification.
An inspection visually for colour (violet) and an absence of particulate matter.
The expiry date.

Carcinogenesis, mutagenesis, impairment of fertility.

No carcinogenicity, mutagenicity or reproductive toxicity studies have been conducted with chromium [51Cr] edetate.

Patient care.

Care should be taken to minimise unwanted radiation exposure to patients, consistent with proper patient management.

Use in the elderly.

See Section 4.2 Dose and Method of Administration.

Paediatric use.

See Section 4.2 Dose and Method of Administration.

Effects on laboratory tests.

No data available.

4.5 Interactions with Other Medicines and Other Forms of Interactions

Decreased glomerular filtration rate has been noted in patients treated with a variety of drugs such as aminoglycosides (gentamicin) and amphotericin B. This is believed to be an effect of the nephrotoxicity associated with the use of such drugs.
This product should not be administered together with other medications unless this is in the context of a simultaneous investigation of renal function.

Long-term effects.

None known.

4.6 Fertility, Pregnancy and Lactation

Effects on fertility.

No data available.
(Category B2)
Only imperative investigations should be carried out during pregnancy and only when the likely benefit exceeds the risk incurred by the mother and the foetus. When it is necessary to administer radioactive medicinal products to a woman of childbearing potential the radiation exposure should be the minimum consistent with achieving the desired clinical information, whether or not the woman is known to be pregnant.
Administration of 6 MBq chromium [51Cr] edetate results in an absorbed dose to the uterus of 0.017 mGy for normal renal function and 0.039 mGy for abnormal renal function. Whenever possible, alternative techniques that do not involve ionising radiation should be employed. Any woman who has missed a period should be assumed to be pregnant until proven otherwise.
 Breast feeding need not be discontinued, however it is recommended that it be interrupted for four hours post administration the end of which period the milk is expressed and discarded.

4.7 Effects on Ability to Drive and Use Machines

The effects of this medicine on a person's ability to drive and use machines were not assessed as part of its registration.

4.8 Adverse Effects (Undesirable Effects)

Adverse reactions.

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.
Exposure to ionising radiation is linked with cancer induction and a potential for development of hereditary defect. For diagnostic nuclear medicine investigations the current evidence suggests that these effects will occur with low frequency because of the low radiation doses incurred.

Reporting suspected adverse effects.

Reporting suspected adverse reactions after registration of the medicinal product is important. It allows continued monitoring of the benefit-risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions at - www.tga.gov.au/reporting-problems.

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

Chromium [51Cr] Edetate Injection BP is a chemically stable, hydrophilic metal chelate. It is metabolically inert and exhibits no pharmacological properties. Renal function is unaffected, even by large amounts of Chromium [51Cr] Edetate Injection BP.

5.1 Pharmacodynamic Properties

Mechanism of action.

No data available.

Clinical trials.

No data available.

5.2 Pharmacokinetic Properties

Following intravenous administration, the Chromium [51Cr] Edetate complex is excreted almost exclusively by the kidneys via the glomerular membrane. Less than 0.5% plasma protein binding occurs in patients, with normal glomerular filtration rate, the recovery of unchanged chelate is close to 100% during the first 24 hours post injection. Tubular secretion and reabsorption, as well as external excretion, are negligible.
After intravenous administration, the Chromium [51Cr] Edetate equilibrates within the intra- and extra-vascular spaces, a process taking between 30 and 90 minutes. Beyond this period, a constant percentage of the Chromium [51Cr] edetate present on the extracellular fluid is excreted by the kidneys per unit time. Total body retention is described by a double exponential function.
The mean value of the glomerular filtration rate in a normal adult is approximately 130 mL/min in men and 120 mL/min in women. (Normalised for body surface area of 1.73 m2).

5.3 Preclinical Safety Data

Genotoxicity.

No data available.

Carcinogenicity.

See Section 4.4 Special Warnings and Precautions for Use.

6 Pharmaceutical Particulars

6.1 List of Excipients

Chromium; ethylenediaminetetraacetic acid (EDTA); sodium chloride, BP; water for injections, BP.
See Section 2 Qualitative and Quantitative Composition.

6.2 Incompatibilities

This medicinal product must not be mixed with other medicinal products except with those as required to achieve therapeutic indications given in Section 4 of this Product Information document.
Interaction of this medicine with others is also given in Section 4.5 of this Product Information document.

6.3 Shelf Life

In Australia, information on the shelf life can be found on the public summary of the Australian Register of Therapeutic Goods (ARTG). The expiry date can be found on the packaging.

6.4 Special Precautions for Storage

Storage.

Store in an airtight container in a place that is sufficiently shielded to protect personnel from Irradiation by primary or secondary emission and that complies with national and international regulations concerning the storage of radioactive substances.
Store below 25°C. Do not freeze.

6.5 Nature and Contents of Container

Chromium [51Cr] Edetate Injection BP is contained in a 3 mL glass vial, sealed with a rubber stopper and a gold coloured aluminium cap. It is transported in a labelled pill packs.
The pack size is 8 MBq at calibration, 0900 hours (Eastern Standard Time) the first day of each calendar month.

6.6 Special Precautions for Disposal

Disposal of all radioactive wastes should be carried out in accordance with the ARPANSA's "Code for the Disposal of Radioactive Waste by the User - Radiation Protection Series, C-6, September 2018".
See Section 4.4 Special Warnings and Precautions for Use.

6.7 Physicochemical Properties

Chemical structure.


CAS number.

11063-42-6.

7 Medicine Schedule (Poisons Standard)

Unscheduled.

Summary Table of Changes