Therapeutic indications:

This medicinal product is for diagnostic use only.

This medicinal product is indicated for:

• • • In vivo, in vitro or in vivo/in vitro red blood cell labelling for blood pool scintigraphy used for:
      • • angiocardioscintigraphy for:
          • • evaluation of ventricular ejection fraction,
            • evaluation of global and regional cardiac wall motion,
            • phase analysis of myocardial contractility.
        • organ perfusion and vascular abnormalities imaging.
        • diagnosis and localization of occult gastrointestinal bleeding.
    • Determination of blood volume.
    • Spleen scintigraphy.

Qualitative and quantitative compositions:

One vial contains:

• • • Active ingredients: sodium pyrophosphate decahydrate 13.40 mg,
    • Excipient: stannous (II) chloride dihydrate 4.3 mg.

The radionuclide is not part of the kit.

Pharmaceutical form:

Lyophilisate for solution for injection.

White powder.

List of excipients:

Stannous chloride dihydrate 4.3 mg

Nitrogen

Posology and method of administration:

This medicinal product is administered intravenously and should be reconstituted before administration to the patient.

The radiopharmaceutical 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:

Shelf life of the kit is 1 year.

After reconstitution with normal saline, the product should be used within 3 hours, if stored below 25°C.

Special precautions for storage:

Store in a refrigerator (2–8°C). During transportation (no longer than 7 days) up to 35°C is permitted.

After reconstitution 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.