SPECT - kits

DTPA (PoltechDTPA) – for radiopharmaceutical preparation

 

kit for radiopharmaceutical preparation

SKU: MTcK-4 Categories: , ,

Description

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.

Qualitative and quantitative compositions:

1 vial contains:

      • sodium diethylenetriaminepentaacetate monohydrate (DTPA) 13.25 mg

The radionuclide is not part of the kit.

Pharmaceutical form:

Kit for radiopharmaceutical preparation.

Lyophilisate for solution for injection.

List of excipients:

Stannous chloride dihydrate Sodium chloride Nitrogen

Posology and method of administration:

Product intended for intravenous administration.

The radiopharmaceutical 99mTc-DTPA is administered intravenously after labelling with sterile, oxidant-free eluate of sodium pertechnetate (99mTc) solution from a radionuclide generator 99Mo/99mTc, in accordance with the labelling instructions.

This radiopharmaceutical may be used only by authorised persons. Safety precautions for careful handling this radiopharmaceutical should be observed.

 

For detailed information on dosage and method of administration please refer to the Summary of Product Characteristics.

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 (2–8°C). During transportation (not longer than 7 days) up to 35°C.

After radiolabelling at a temperature below 25°C in a suitable radiation lead shield.

 

Storage should be in accordance with national regulations for radioactive materials.

Nature and content of container:

10 mL glass vials sealed with rubber stopper and an aluminium crimp cap.

Vials are packed in cardboard boxes – pack size of 6 vials.

For detailed information about this product please refer to the Summary of Product Characteristics or Information for the User.