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.
EnclosureSmPC – PoltechMBrIDA, 20 mg