|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.|
– 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).|
|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%|
|Enclosure||SmPC – Meta-Iodobenzylguanidine-131I (MIBG-131I) for diagnostic use, Solution for injection|