|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.|
Not all pack sizes may be marketed.
|Enclosure||SmPC – PoltechMBrIDA, 20 mg|