Therapeutic indications:

This medicinal product is for diagnostic use only.

For intravenous injection after radiolabelling with sodium (Tc-99m) pertechnetate solution. PoltechMIBI using scintigraphy is indicated for:

• • • diagnosis of ischaemic heart disease,
    • diagnosis and localisation of myocardial
      infarction,
    • assessment of global ventricular function (first pass technique for determination of ejection fraction and/or regional wall motion),
    • diagnosis of malignancy in patients who are suspected of cancer in the breast combined with inconclusive mammography or palpable tumour and negative or inconclusive mammography,
    • diagnosis of patients with recurrent or persistent hyperparathyroidism.

Qualitative and quantitative compositions:

1 vial contains

• • • Active substance [Tetrakis(2-methoxy-2-methylpropyl-1-isocyanide) copper(1+)]tetrafluoroborate 1.00 mg.

The radionuclide is not part of the kit.

Pharmaceutical form:

Kit for radiopharmaceutical preparation.

White powder.

List of excipients:

Stannous chloride dihydrate

L-cysteine hydrochloride monohydrate

Sodium citrate dihydrate

D-mannitol

Posology and method of administration:

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

The vial is reconstituted with a maximum of 11 GBq of oxidant-free sodium (Tc-99m) pertechnetate solution for injection in 1–5 ml. Radiochemical purity should be checked prior to patient administration. 

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 reconstitution and radiolabelling, technetium Tc-99m sestamibi can be used up to 12 hours stored below 25°C.

Special precautions for storage:

Store in a refrigerator (2–8°C).

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

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.