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