Medicinal Products

ADREVIEW [123I] 74 MBq / mL

Generic Drug Therapeutic Class: Diagnostic Products or Other Therapeutic Products
active ingredients: [I123] in the form of Iobenguane, m-iodobenzylguanidine sulfate
laboratory: GE Healthcare Sas

Injectable solution
Shielded container of 1 multidose bottle of 10 ml
All forms

Indication

This medicine is for diagnostic use only.

1.1 Oncology:

· Scintigraphy of tumors of tissues derived from the embryonic neural crest, such as pheochromocytomas, paragangliomas, chémodectomes and neurogangliomas.

· Detection, classification and post-treatment monitoring of neuroblastomas.

· Evaluation of uptake of iobenguane when therapeutic use is considered.

· Search for adrenal medullary hyperplasia.

1.2 Cardiology: appreciation of the sympathetic innervation of the myocardium.

adults:

Adreview is a radiopharmaceutical indicated for the assessment of sympatic myocardial innervation as a prognostic indicator of the risk of progression of symptomatic heart failure, potentially fatal arrhythmic events, or cardiac death in patients NYHA class II or III cardiac failure and left ventricular dysfunction.

Dosage ADREVIEW [123I] 74 MBq / mL Solution for injection Shielded container of 1 multidose bottle of 10 ml

1 Oncology

In children, the injectable solution of iobenguane ( 123 I) will be administered in oncology at the following doses:

Weight in kg

Activity in MBq

Weight in kg

Activity in MBq

3

80

36

224

4

80

38

236

6

80

40

248

8

80

42

256

10

80

44

268

12

88

46

280

14

100

48

288

16

112

50

300

18

124

52

316

20

136

54

316

22

148

56

336

24

160

58

336

26

172

60

356

28

180

62

356

30

192

64

376

32

204

66

376

34

216

68

392

EANM Dosage card Version 1.5.2008.

· In adults, the recommended activity in oncology is 200 to 400 MBq but higher activities may be required.

· In the elderly: there is no need to adapt the activity administered.

Method of administration

Iobenguane ( 123 I) is administered by slow intravenous injection over several minutes.

Instructions for the preparation of radiopharmaceuticals see section Instructions for use, handling and disposal

Acquisition of images:

Tissue tumors drifting from the neural crest

Whole body scans and / or target organ images, and / or tomoscintigraphic images (SPECT) can be performed 24 hours after administration of iobenguane ( 123 I) and possibly repeated at 48 hours.

2 Cardiology

Dosage

· In adults, the recommended activity for sympathetic myocardial innervation is 200 to 400 MBq.

· In the elderly: there is no need to adapt the activity administered.

Method of administration

See section Dosage and method of administration .1

Acquisition of images:

At ppreciation of the sympathetic innervation of the myocardium.

Planar scintigraphy of the thorax can be performed at 15 + 5 minutes and at 4 + 0.5 hours after Adreview administration followed, if necessary, with SPECT images.

Against indications

· Known hypersensitivity to the active substance or to any of the excipients

· Due to the presence of benzyl alcohol, this drug is contraindicated in premature infants and term newborns.

Adreview side effects [123i]

In rare cases, side effects can be observed: redness, hives, nausea, chills and other symptoms of anaphylactic reactions.

If administered too quickly, palpitations, dyspnoea, flushing, transient hypertension, and abdominal cramps may occur during or immediately after injection. These symptoms disappear within an hour of their appearance.

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 exams deliver an effective dose less than 20 mSv. Higher doses may be warranted in some cases.

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