| Qualitative and quantitative composition: | 1 vial contains: N-[2,4,6-trimethyl-3-bromacetanilid] iminodiacetic acid sodium salt, 20 mg The radionuclide is not part of the kit. |
| Pharmaceutical form: | Kit for radiopharmaceutical preparation. Lyophilisate for solution for injection. |
| Therapeutic indications: | This medicinal product is for diagnostic use only. The radiopharmaceutical 99mTc-MBrIDA is intended for hepatobiliary imaging and for hepatobiliary function studies. |
| Shelf life: | Kit – 1 year. After radiolabelling with sodium pertechnetate (99mTc) solution: 5 hours. Store below 25°C in a suitable radiation lead shield. |
| Special precautions for storage: | Store in a refrigerator (2°C- 8°C). During transportation (not longer than 7 days) up to 35°C. For storage conditions after radiolabelling of the medicinal product, see section 6.3. of SmPC. Storage of radiopharmaceuticals should be in accordance with national regulation on radioactive materials. |
| Nature and contents of container: | 10 ml glass vials sealed with a rubber stopper and aluminium cap in cardboard box. 3 vials 6 vials Not all pack sizes may be marketed. |
| Enclosure | SmPC – PoltechMBrIDA, 20 mg |
