|Qualitative and quantitative composition:||vial contains:|
meso-2,3-dimercaptosuccinic acid (DMSA) 1 mg
The radionuclide is not part of the kit.
For the full list of excipients, see SmPC.
|Pharmaceutical form:||Kit for radiopharmaceutical preparation.|
Lyophilisate for solution for injection.
|Therapeutic indications:||This medicinal product is for diagnostic use only.|
The radiopharmaceutical 99mTc-DMSA is intended for renal scintigraphic examination, in particular:
– static renal imaging,
– location of kidneys, determination of functional renal mass,
– morphological studies of renal cortex, determination of relative individual kidney function.
|Shelf life:||Kit – 6 months.|
After radiolabelling with sodium pertechnetate (99mTc) solution: 4 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.
|Enclosur||SmPC – PoltechDMSA, 1 mg|