This medicinal product is for diagnostic use only.
1.1 Oncology

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

· Detection, classification and follow-up, after treatment of neuroblastomas

· Evaluation of the uptake of iobenguane when a therapeutic use is contemplated

· Search for hyperplasia, adrenal medulla

1.2 Cardiology: assessment of the sympathetic innervation of the myocardium

Adults

Adreview is a radiopharmaceutical indicated for the assessment of sympathetic innervation of the myocardium as an indicator, prognosis of the risk of progression of heart failure, symptomatic, arrhythmic, life-threatening, Cardiac arrhythmias in patients with cardiac insufficiency in class II or in the NYHA classification and ventricular dysfunction, left

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 prove necessary: ​​

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

Administration method

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

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

Acquisition of images

Tumors of tissues derived from the neural crest

Full-body scans and / or target-centered images, and / or tomoscintigraphic (SPECT) images can be performed 24 hours after, and iobenguane (123 I) and possibly repeated To 48 hours.

2, Cardiology

Dosage

· In adults, the recommended activity for sympathetic innervation of the myocardium is 200 to 400 MBq

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

Administration method

See section Dosage and mode of administration.1

Acquisition of images

A pimped innervation, sympathetic myocardium.

Planar scans of the thorax can be performed at 15 + 5 minutes and 4 + 0.5 hours after administration of Adreview followed if necessary by SPECT.
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Clear colorless solution.

Radiopharmaceuticals for diagnostic use

ATC code: V09IX01.

Iobenguane (123 I) is a radioiodinated aralkylguanidine. It consists of a guanidine group of guanethidine, bound to a benzyl radical in which the iodine has been introduced.

Like guanethidine, aralkylguanidines are adrenergic, neuro-blocking agents. Because of a functional resemblance between adrenergic neurons and chromaffin cells of the medullary part of the adrenal glands, iobenguane preferentially binds to these structures. It can also be localized in the myocardium.
Of all the aralkyl guanidines, iobenguane is preferred for its lower hepatic uptake and better in vivo stability, and therefore less thyroid uptake of iodine, released. The transport of iobenguane through the cell membranes of cells derived from the neural crest is an active process when the concentration of the product is low (in the case of diagnostic examinations). The capture mechanism may be inhibited By taking inhibitors such as cocaine or desmethylimipramine.

After capture, an active transfer mechanism concentrates iobenguane intracellularly to the storage granules.

The iodine-123 (atomic number 53, mass number 123), whose period is 13.2 hours, decreases in tellurium-123 stable by capture, electron and emission of gamma photons, energy of 159 keV %).

According to publications No. 80 of the International Commission for Radiological Protection (ICRP), the doses of radiation absorbed by patients are the following:

The list includes only the organs used to calculate the effective dose (whole body): seven standard organs and five with the highest doses absorbed (marked with an asterisk in the following table)

ORGAN

DOSE ABSORBED PER ADMINISTERED ACTIVITY UNIT (mGy / MBq)

Adult

15 years old

10 years

5 years

1 year

* Liver

7.1. 10 -2

8.9. 10 -2

1.3. 10 -1

1.9. 10 -1

3,4. 10 -1

* Bladder wall

7.0. 10 -2

8.7. 10 -2

1.3. 10 -1

1.9. 10 -1

3.5. 10 -1

* Rate

2.0. 10 -2

2.8. 10 -2

4.3. 10 -2

6.6. 10 -2

1.2. 10 -1

* Salivary glands

1.7. 10 -2

2.2. 10 -2

3.1. 10 -2

4.5. 10 -2

7.2. 10 -2

Lungs

1.6. 10 -2

2.3. 10 -2

3.2. 10 -2

4.8. 10 -2

9.1. 10 -2

* Kidney

1.4. 10 -2

1.7. 10 -2

2.5. 10 -2

3.6. 10 -2

0.6. 10 -1

Adrenals
1.1. 10 -2

1,5. 10 -2

2.2. 10 -2

3.1. 10 -2

5.1. 10 -2

Bone marrow

9.2. 10 -3

1.2. 10 -2

1.7. 10 -2

2.5. 10 -2

4.5. 10 -2

Ovaries

8.0. 10 -3

0.1. 10 -1

1.6. 10 -2

2.6. 10 -2

4.7. 10 -2

Bone Surfaces

7.6. 10 -3

9.3. 10 -3

1.5. 10 -2

2.3. 10 -2

4.5. 10 -2

Breasts

6.2. 10 -3

6.2. 10 -3

9.8. 10 -3

1.6. 10 -2

0.3. 10 -1

Testicles

5.4. 10 -3

7.3. 10 -3

1.2. 10 -2

0.2. 10 -1

3.8. 10 -2

Thyroid

4.2. 10 -3

6.2. 10 -3

1.0. 10 -1

1.7. 10 -1

3.1. 10 -1

Effective Dose (mSv / MBq)

1.6. 10 -2

2.0. 10 -2

3.1. 10 -2

4.6. 10 -2

8.5. 10 -2

The effective dose after administration of an activity of 200 MBq is 3.2 mSv for an adult.
The above data are valid for a normal pharmacokinetic profile.

When renal function is impaired, the effective dose and dose of radiation to the organs may be increased.

The effects on the ability to drive and use machines have not been studied.
· Known hypersensitivity to the active ingredient or to any of the excipients

Due to the presence of benzyl alcohol, this drug is contraindicated in premature and newborn babies.

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Radiopharmaceuticals must be prepared in such a way as to meet both radiation protection and pharmaceutical quality standards. All appropriate aseptic precautions shall be taken in order to meet the requirements of Good Pharmaceutical Manufacturing Practice.

Treatments with known medicines for their inhibitory effects on iobenguane (123 I) (see section Interactions with other medicinal products and other forms of interactions) should be discontinued before the examination With Adreview (usually, for 4 biological periods).
· Based on the review with (123 I) iobenguane, it is necessary to consult with the attending physician of the patient to determine the treatment to be discontinued prior to the examination. For more information see section Interactions with other medicines and other forms of interactions

Before administering Adreview, iodine-123 thyroid fixation should be achieved by administering oral solution of potassium iodide or a solution of Lugol (equivalent amount to 100 mg of iodine for an adult, adjusted for body weight in the child) or potassium perchlorate (400 mg for an adult, adjusted for body mass in the child). This treatment is to be continued for at least 3 days after administration of Adreview.

· Capture of iobenguane by chromaffin granules may, in theory, cause rapid secretion of noradrenaline, causing hypertensive surge. The patient must therefore be kept under constant supervision during the administration.

· Iobenguane (123 I) should be administered slowly over several minutes intravenously.


This medicine contains 0.18 mmol (4.23 mg) sodium / mL. This amount is less than 1 mmol for an administration of 400 MBq at the calibration time which can be regarded as practically "sodium-free."
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The following drugs are likely to prolong or reduce the uptake of iobenguane

Nifedipine (calcium channel blocker) prolongs the retention of iobenguane

Reduced uptake is observed during the therapeutic administration of the antihypertensive drugs which decrease, the noradrenaline reserve or its recapture (reserpine, labetalol), calcium channel blockers (diltiazem, nifedipine, verapamil), antidepressants (Amitriptyline, imipramine and derivatives thereof, maprotiline, reboxetine, atomoxetine, amoxapine, mianserin, mirtazapine, setiptilin, bupropion, duloxetine, venlafaxine, desvenlafaxine, milnacipran, sibutramine, tramadol), agents; Sympathomimetics (present in nasal decongestants such as phenylephrine, ephedrine, pseudoephedrine or phenylpropranolamine), methamphetamine, phenothiazines and modafinil.
The administration of these drugs should be discontinued (usually four periods, biological) before the administration of iobenguane (123 I).
In the absence of studies and incompatibility, this medicinal product should not be mixed with other medicines.
An overdose is potentially impossible. However, an overdose of iobenguane results in the release of adrenaline. This short-term effect requires the initiation of a treatment intended to lower blood pressure such as the rapid injection of a fast acting alpha-adrenergic blocker (phentolamine) followed by administration Of a beta-blocker (propranolol). The kidney being the principal organ of elimination, the elimination of the radionuclide may be increased by a forced diuresis with frequent urination.


Before administering a radiopharmaceutical to a woman of childbearing age, it is necessary to check that she is not pregnant. Any delay in menstruation should suggest the possibility of pregnancy until proven otherwise. In the uncertainty, it is important to limit exposure to radiation to a minimum, consistent with obtaining clinical information. The use of alternative techniques, not using ionizing radiation, should be considered.

The radioelements used in pregnant women also deliver doses of radiation to the fetus. During pregnancy, only examinations the potential benefit of which is greater than the risk incurred by the mother and the fetus must be performed.
Breastfeeding

Before administering a radiopharmaceutical to a woman wishing to continue breastfeeding, it should be considered, if reasonably possible, whether this examination may be deferred until the end of breastfeeding. Otherwise, account should be taken of the activity likely to pass into breast milk in order to select the most appropriate radiopharmaceutical.

If administration of iobenguane (123 I) is essential, breast-feeding should be suspended for at least three days and the milk produced during this period should be discarded. >

Breastfeeding may be resumed when milk activity is unlikely to cause a dose of radiation to the child greater than 1 mSv

In some rare cases, side effects may be observed: redness, urticaria, nausea, chills and other symptoms of anaphylactic reactions.
If the product is administered too rapidly, palpitations, dyspnea, hot flushes, transient hypertension and abdominal cramps may be observed 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 activity administered must correspond to the lowest dose possible radiation compatible with obtaining the information expected to be diagnosed. Exposure to ionizing radiation can theoretically induce cancers and / or hereditary abnormalities. In the case of examination of nuclear medicine for the purpose of diagnosis, it is generally considered that the frequency of these risks is negligible owing to the low doses of radiation delivered. >

Most nuclear medicine examinations deliver an effective dose of less than 20 mSv. Higher doses may be justified in some cases