Medicinal Products

EDICIS 2 mg

Generic Drug Therapeutic Class: Diagnostic Products or Other Therapeutic Products
active ingredients: N, N'-ethylene- (L, L) -dicysteine
laboratory: Cis Bio International

Kit for radiopharmaceutical preparation
All forms

Indication

This medicine is for diagnostic use only.

After radiolabeling and reconstitution, the product is used for the realization of a renal, planar or tomographic scintigraphy, in the following contexts:

Exploration of nephropathies and uropathies, including assessment of renal function, renal cortex morphology and renal perfusion, and assessment of upper urinary tract drainage.

Dosage EDICIS 2 mg Kit for radiopharmaceutical preparation Kit for radiopharmaceutical preparation of 4 vials of powder (+ 4fl.agent reducer + 4fl.tampon) of 6 ml

This radiopharmaceutical is intended for use only in an authorized nuclear medicine facility and should only be handled by authorized persons.

Dosage

adults

In a patient of about 70 kg, the recommended activity is 90 to 120 MBq, injected intravenously.

Elderly

No activity adaptation is necessary.

Use in patients with hepatic or renal impairment

No activity adaptation is necessary.

Pediatric population

The activity to be administered in pediatric patients should be adapted according to the recommendations of the Pediatric Task Group (Pediatric Task Group 2008) of the EANM. This activity can be calculated from the formula below and a multiplying factor depending on the body mass of the patient (Table 1):

Recommended Activity [MBq] = 11.9 MBq x Factor (Table 1)

Table 1

Body mass

postman

Body mass

postman

Body mass

postman

3 kg

4 kg

6 kg

8 kg

10 kg

12 kg

14 kg

16 kg

18 kg

20 kg

= 1 *

= 1.12 *

= 1.47

= 1.71

= 1.94

= 2.18

= 2.35

= 2.53

= 2.71

= 2.88

22 kg

24 kg

26 kg

28 kg

30 kg

32 kg

34 kg

36 kg

38 kg

40 kg

= 3.06

= 3.18

= 3.35

= 3.47

= 3.65

= 3.77

= 3.88

= 4.00

= 4.18

= 4.29

42 kg

44 kg

46 kg

48 kg

50 kg

52-54 kg

56-58 kg

60-62 kg

64-66 kg

68 kg

= 4.41

= 4.53

= 4.65

= 4.77

= 4.88

= 5.00

= 5.24

= 5.47

= 5.65

= 5.77

* In all cases, the minimum activity to be injected must be greater than 15 MBq in order to obtain images of sufficient quality.

Method of administration and scintigraphic examination

Prior to administration to the patient, this product should be radiolabeled with sodium pertechnetate ( 99m Tc) for injection and reconstituted with the reducing agent and buffer provided to obtain a clear, colorless solution of technetium ( 99mTc ). - N, N'-ethylene- (L, L) -dicysteine, devoid of visible particles.

The radiolabelled solution should be administered intravenously as a single embolus in a brachial vein. The acquisition method (position of the patient during administration and acquisition, and type of camera, sequence and number of images) depends on the indication of the examination.

The scintigraphic examination begins immediately after the injection of the product. The total duration of the exam is approximately 30 minutes.

The number of images may be higher if the removal of the product is slow. This can be increased by furosemide administration.

For instructions on the preparation of the radiopharmaceutical, see the section Instructions for use, handling and disposal: INSTRUCTIONS FOR THE PREPARATION OF RADIOPHARMACEUTICALS.

For special precautions for disposal and other handling see the section Instructions for use, handling and disposal .

Against indications

Hypersensitivity to the active substance or to any of the excipients.

Edicis side effects

No adverse effects have been reported to date.

Exposure to ionizing radiation can potentially induce cancer or develop inherited abnormalities. Experience shows that for nuclear medicine diagnostic tests, the frequency of side effects is very low due to the low activity used.

After administration of the maximum recommended activity of 120 MBq of technetium ( 99m Tc) - N, N'-ethylene- (L, L) - dicysteine, the maximum effective dose is 1.2 mSv (unilateral renal barrier).

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