Therapeutic indications:

This medicinal product is for diagnostic use only.

The radiopharmaceutical ^99mTc-MDP is intended for skeletal imaging utilizing radioactive properties of technetium-99m and the affinity of methylenediphosphonic acid to hydroxyapatite crystals which form inorganic structure of bone tissue.

Qualitative and quantitative compositions:

1 vial contains:

• • • methylenediphosphonic acid 5 mg
      as sodium methylenediphosphonate 6.25 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

Ascorbic acid

Nitrogen

Posology and method of administration:

Product intended for intravenous administration.

The radiopharmaceutical ^99mTc-MDP 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: 8 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.