Qualitative and quantitative composition:Sodium 2-[131I]iodohippurate 3.7 – 74 MBq/ml.
Full list in SmPC.
Pharmaceutical form:Solution for injection.
Clear, colourless solution.
Therapeutic indications:Hippurate-131I is a radiopharmaceutical used in diagnostics of kidneys dysfunction and urinary tract obstructions (dynamic renal scintigraphy, renoscintigraphy).
Renal scintigraphy utilizing this radiopharmaceutical allows the evaluation of:
· kidney blood flow resolution (effective renal plasma flow – ERPF),
· renal tubular function,
· urine outflow from the pyelocalyceal system,
· vesico-ureteral reflux (examination during miction),
· renal function impairment in transplanted kidney
and can be used in the diagnostics of renovascular hypertension (particularly in the captopril enhanced renal scintigraphy). The preparation accumulates in the kidneys where it concentrates and is later excreted.
 Shelf life:Hippurate-131I for injection expires 21 days from manufacturing date.
Calibration: 7 days
Special precautions for storage: Store in refrigerator (2°C – 8°C). During transportation (not longer than 7 days after production date) up to 25°C.
Nature and contents of container:10 ml glass vial sealed with a rubber stopper and an aluminum crimp cap, placed in a lead shielding container. The vial contains a volume of the solution corresponding to the activity determined on the calibration day.
Radionuclidic purity:≥ 99.9%
Radiochemical purity:≥ 96%
EnclosureSmPC – Hippurate-131I for injection