|Qualitative and quantitative composition:||1 vial contains:|
sodium diethylenetriaminepentaacetate monohydrate (DTPA) 13.25 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-DTPA is intended for renal scintigraphic imaging (dynamic renal scintigraphy for GFR measurement of each kidney and evaluation of urinary flow disorders), GFR measurement from the plasma samples, and for the cerebral angiography and brain scanning.
|Shelf life:||Kit – 1 year.|
After radiolabelling with sodium pertechnetate (99mTc) solution: 6 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 in SmPC.
Storage of radiopharmaceuticals should be in accordance with national regulation on radioactive materials.
|Nature and contents of container:||10 ml multi-dose glass vials sealed with a rubber stopper and aluminium cap in cardboard box.|
Not all pack sizes may be marketed.
|Enclosure||SmPC – PoltechDTPA, 13,25 mg|