Medicinal Products

EDETATE CHROME-51 AMERSHAM 3.7 MBq / mL

Generic Drug Therapeutic Class: Diagnostic Products or Other Therapeutic Products
active ingredients: Chromium edetate [51Cr]
laboratory: GE Healthcare Sas

IV injectable solution
Multidose bottle of 10 ml
All forms

Indication

Determination of glomerular filtration rate for evaluation of renal function.

Dosage EDETATE CHROME-51 AMERSHAM 3.7 MBq / mL IV Solution for Injection Multi-dose 10 ml Vial

Dosage

In adults and the elderly, the recommended activity is between 1.1 and 6.0 MBq depending on the mode of administration: intravenous injection or continuous infusion.

Higher activities (up to 11 MBq) may be required when using external counting techniques.

Pediatric population

Use in children and adolescents should be carefully considered, exposure to ionizing radiation should be justified by the expected benefit. The administered activity should correspond to the lowest possible dose of radiation compatible with obtaining the expected diagnostic information.

In children, the activity to be injected is a fraction of that used in adults, fraction obtained by applying the coefficients below according to body mass. (According to EANM: European Association of Nuclear Medicine).

Multiplicative coefficients

3 kg

=

0.10

22 kg

=

0.50

42 kg

=

0.78

4 kg

=

0.14

24 kg

=

0.53

44 kg

=

0.80

6 kg

=

0.19

26 kg

=

0.56

46 kg

=

0.82

8 kg

=

0.23

28 kg

=

0.58

48 kg

=

0.85

10 kg

=

0.27

30 kg

=

0.62

50 kg

=

0.88

12 kg

=

0.32

32 kg

=

0.65

52-54 kg

=

0.90

14 kg

=

0.36

34 kg

=

0.68

56-58 kg

=

0.92

16 kg

=

0.40

36 kg

=

0.71

60-62 kg

=

0.96

18 kg

=

0.44

38 kg

=

0.73

64-66 kg

=

0.98

20 kg

=

0.46

40 kg

=

0.76

68 kg

=

0.99

In children, the maximum activity to be injected is 3.7 MBq.

In young children under one year, the size of the target organ in relation to that of the whole body should also be taken into consideration.

Method of administration

Intravenous administration.

Single intravenous injection

Due to the complexity of infusion techniques (see below), the single injection method is generally preferred. This method does not require the collection of urine samples.

However, this method is not valid for patients with edema, because the balance of chromium edetate ( 51 Cr) between the plasma and the interstitial fluid can then be reached after 12 hours.

After a single injection, the plasma clearance is calculated from the injected activity and the decrease in plasma activity as a function of time. There are different methods to analyze the plasma decay curve, one of which is presented below.

3.7 MBq of chromium edetate ( 51 Cr) are injected. Venous blood samples are taken at regular intervals (eg, 2, 3 and 4 hours after administration) with an additional sample taken at 24 hours if kidney failure is suspected. The plasma is separated by centrifugation and counted with a control of the administered activity.

Plasma activities are expressed as a percentage of injected activity. The slope of the regression line in semi-logarithmic coordinates of these values ​​as a function of time corresponds to the elimination constant, k.

The apparent distribution volume V of the tracer is obtained by dividing the value of the administered activity by the value of the ordinate at the origin. The plasma clearance C is then given by:

C (mL / min) = k (min-I). V (mL)

This value is usually normalized to inulin clearance (single reference value)

Continuous intravenous infusion

1900 kBq are injected intravenously (loading dose) followed by an infusion containing 37 kBq / mL at a rate of 0.5 mL / min.

The urine is collected in a period of 15 minutes. A venous sample is taken in the middle of each period.

This method including rapid plasma separation and activity measurement is repeated until plasma activity remains constant at about 40 minutes.

For each of the periods, a clearance value C is obtained by carrying in the following formula the values ​​of the urinary and plasma concentrations as well as the urinary flow rate:

U = urinary concentration

V = urinary flow

P = plasma concentration

C = clearance

Clearance is obtained by averaging these values.

When urine output over a given period is low, it may be necessary to use a bladder catheter to collect the total amount produced.

Other methods can be used to determine the glomerular filtration rate.

For patient preparation, see section Warnings and precautions for use .

Instructions for the preparation of radiopharmaceuticals, see section 12.

Against indications

None known to date.

Adverse effects Edetate Chrome-51 Amersham

Adverse events have only rarely been reported after single or repeated intravenous administration of chromium edetate ( 51 Cr) so that their incidence is difficult to quantify. Little information is available, but small allergic phenomena have been described. The origin of the reactions observed to date has not been formally established.

For each patient, exposure to ionizing radiation must be justified by the expected benefit. The administered activity should correspond to the lowest possible dose of radiation compatible with obtaining the expected diagnostic information.

Exposure to ionizing radiation can theoretically induce cancer and / or hereditary abnormalities. In the case of a diagnostic nuclear medicine examination, it is generally considered that the frequency of these risks is negligible due to the low doses of radiation delivered.

Most nuclear medicine diagnostic tests deliver effective dose equivalents (EDEs) of less than 20 mSv. Higher doses may be medically justified in some cases.

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