Qualitative and quantitative composition:Iobenguane (131I): 10 – 37 MBq/ml
Pharmaceutical form:Solution for injection.
Clear, colourless or light yellow solution.
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.
Shelf life:9 days from the manufacturing date (expiry date is stated on the label).
Calibration:7 days
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.
Nature and contents 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.
Radionuclidic purity:≥ 99.9%
Radiochemical purity: ≥ 94%
EnclosureSmPC – Meta-Iodobenzylguanidine-131I (MIBG-131I) for diagnostic use, Solution for injection