ANSTO Health

What it is

Chromium [⁵¹Cr] Edetate Injection BP is a 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. Chromium [⁵¹Cr] Edetate Injection BP is a chemically stable, hydrophilic metal chelate that is metabolically inert and exhibits no pharmacological properties.

Approved indications

— Determination of glomerular filtration rate in the assessment of renal function.

Dosing overview

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 use in conjunction with external counting techniques. 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. 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, and for 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.

Key safety warnings

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

Contraindications

There are no known contraindications.

Regulatory history

Chromium [⁵¹Cr] Edetate was first listed on the ARTG on 15 October 1991 under registration number ARTG 22779.