Therapeutic indications:

This medicinal product is for diagnostic use only.

Indications include:

Isotope diagnostics (detection, localization, staging, treatment
monitoring) of neuroendocrine tumors. These are in particular:

• • • pheochromocytoma, neuroblastoma, carcinoid tumors, medullary thyroid carcinoma.
    • Evaluation of iobenguane (¹³¹I) uptake and retention to determine a diagnostic dose of iobenguane (¹³¹I).
    • Treatment monitorig by assessing the uptake and spread of pathological foci taking up iobenguane (¹³¹I).
    • Confirmation of neuroendocrine character of tumors with unknown origin.

Qualitative and quantitative compositions:

Iobenguane (¹³¹I): 10–37 MBq/mL

Excipients with known effect:

Benzyl alcohol – 10 mg/mL,

Sodium chloride – 0.45–9 mg/mL.

Pharmaceutical form:

Solution for injection.

Clear, colourless or light yellow solution.

List of excipients:

Bis[(3-iodobenzyl)guanidine]sulphate

Sodium metabisulphite

Copper(II) sulphate pentahydrate

Sodium acetate trihydrate

Acetic acid

Benzyl alcohol

Sodium chloride

Water for injection

Posology and method of administration:

The dose administered to adults is: 40–80 MBq (1.2–2.2 mCi).

The dose administered to children can be calculated by modifying adults dose considering the weight or body surface of child. According to the European Association of Nuclear Medicine (EANM) paediatric dosage card the activity administered to children and to adolescents may be calculated by multiplying a baseline activity (for calculation purposes) by the weight-dependent correction factor given in the table below:

Child weight – Dose (part of adult’s dose)

3 kg – 0.1

4 kg – 0.14

6 kg – 0.19

8 kg – 0.23

10 kg – 0.27

12 kg – 0.32

14 kg – 0.36

16 kg – 0.40

18 kg – 0.44

20 kg – 0.46

22 kg – 0.50

24 kg – 0.53

26 kg – 0.56

28 kg – 0.58

30 kg – 0.62

32 kg – 0.65

34 kg – 0.68

36 kg – 0.71

38 kg – 0.73

40 kg – 0.76

42 kg – 0.78

44 kg – 0.80

46 kg – 0.82

48 kg – 0.85

50 kg – 0.88

52–54 kg – 0.90

56–58 kg – 0.92

60–62 kg – 0.96

64–66 kg – 0.98

68 kg – 0.99

In order to obtain images of sufficient quality the recommended minimum dose for children is 35 MBq.

No special dosage-scheme is required for the elderly patient.

The dose is administered intravenously; the duration of the injection should be 30–300 seconds.

According to European Directive 97/43/Euratom and medical practice, the above given recommended activities should be treated only as a general guide. It should be noted that in each country the nuclear medicine specialist should consider diagnostic reference levels (DRL) and the principles set out by local regulations. The administration of higher activities than local DRL should be justified.

For detailed information on dosage and method of administration please refer to the Summary of Product Characteristics.

Shelf life:

9 days from the manufacturing date (expiry date is stated on the label).

Special precautions for storage:

Store in original in temperature below [-15°C] in accordance with regulations for radiation safety (Atomic Low).

Protect from light.

After defrosting store below 25°C for up to 4 hours. Transport in dry ice.

Storage should be in accordance with national regulations for radioactive materials.

Nature and content of container:

The product is supplied in 10 mL glass vials, with a possibility of drawing multidoses in an aseptic way. The vials are capped with rubber stoppers and aluminium caps and placed inside a shielded lead container. The outer transport packaging is a metal tin with styrofoam insert.
Every source is accompanied with a certificate of radioactivity.