|Qualitative and quantitative composition:||Iobenguane (131I): 370 – 740 MBq/ml|
|Pharmaceutical form:||Solution for injection.|
Clear, colourless or light yellow solution.
|Therapeutic indications:||Radiation therapy of tumour-tissue that is capable of retaining iobenguane. These are tumours arising from cells originating embryologically from the neural crest: pheochromocytomas, neuroblastomas, carcinoids and medullary carcinomas of the thyroid gland (MCT).|
|Shelf life:||4 days from the manufacturing date (expiry date is stated on the label).|
|Special precautions for storage:||Store in original at the 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 2 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:||≥ 92%|
|Enclosure||SmPC – Meta-Iodobenzylguanidine-131I (MIBG-131I) for therapeutic use, solution for injection|