Therapeutic indications:

This medicinal product is for diagnostic use only.

The eluate from the generator (sodium pertechnetate (^99mTc) injection ) is indicated for:

• • • labelling of various kits for radiopharmaceutical preparation developed and approved for radiolabelling with such solution.
    • Thyroid scintigraphy: direct imaging and measurement of thyroid uptake to give information on the size, position, nodularity and function of the gland in case of thyroid disease.
    • Salivary gland scintigraphy: diagnosis of chronic sialadenitis (e.g. (Sjögren’s Syndrom) as well as assessment of salivary gland function and duct patency in salivary glands disorders and monitoring of the response to therapeutic interventions (in particular radioiodine therapy).
    • Location of ectopic gastric mucosa (Meckel’s diverticulum).
    • Lacrimal duct scintigraphy: to assess functional disorders of lacrimation and monitoring of the response to therapeutic interventions.

Qualitative and quantitative compositions:

Sodium pertechnetate (^99mTc) injection is produced by means of a (⁹⁹Mo/^99mTc) generator. Technetium (99mTc) decays with the emission of gamma radiation with a mean energy of 140 keV and a half-life of 6.01 hours to technetium (⁹⁹Tc) which, in view of its long half-life of 2.13 x 105 years, can be regarded as quasi stable.

The radionuclide generator containing the parent isotope ⁹⁹Mo, adsorbed on a chromatographic column delivers sodium pertechnetate (^99mTc) injection in sterile solution.

The ⁹⁹Mo on the column is in equilibrium with the formed daughter isotope ^99mTc.

The generators are supplied within the 99Mo activity of 2.6–57 GBq at activity reference time (8.0–175,0 GBq of ^99mTc at the production date).

The technetium (^99mTc) amounts available by a single elution depend on the real elution yield of generator itself declared by manufacturer and approved by NCA.

Excipient(s) with known effect:

Each mL of sodium pertechnetate (99mTc) solution contains 3.6 mg of sodium.

Pharmaceutical form:

Radionuclide generator.

Sodium pertechnetate (^99mTc) solution: clear and colourless.

List of excipients:

Sodium chloride

Water for injection

Posology and method of administration:

If sodium pertechnetate (^99mTc) is administered intravenously, activities may vary widely according to the clinical information required and the equipment employed. The injection of activities greater than local DRLs (Diagnostic Reference Levels) should be justified for certain indications. For details on posology and method of administration please refer to the Summary of Product Characteristic or package leaflet provided with a particular medicinal product for radiolabelling.

Shelf life:

• • • Generator:

21 days from manufacturing date.

The calibration date and the expiry date are stated on the label.

• • • Sodium pertechnetate (^99mTc) eluate:

After elution, use within 12 hours.

This medicinal product does not require any special storage conditions.

• • • Elution vials:

1 year.

No special requirements concerning storage conditions of medicinal product..

Special precautions for storage:

• • • Generator:

Do not freeze.

• • • Eluate:

After elution, use within 12 hours.

This medicinal product does not require any special storage conditions.

• • • Vacuum vials:

Do not require any special storage conditions.

Storage of radiopharmaceuticals should be in accordance with national regulation on radioactive materials..

Nature and content of container:

Poltechnet – generator ⁹⁹Mo/^99mTc is composed with the following:

• • • generator sterile, glass column filled with alumina on which molybdenum-99 (fission) is adsorbed: The bottom end of the column is provided with a glass filter to prevent any leakage of alumina from the column. Top and bottom ends of the column are closed with rubber stoppers and
      caps.
    • a set of stainless steel needles which connects generator column with the eluent bottle and eluate vials: During transportation and during breaks between elutions the needles are protected by vials containing bacteriostatic agent (0.02% water solution of lauryl dimethyl benzyl
      ammonium bromide).
    • the column and the needles are placed inside lead shielding of 50 mm wall thickness: This shielding protects personnel from radiation and
      allows easy operation of the generator.
    • filters: of the eluate and air filter.
    • eluate volume controller: Construction of this device enables obtaining of the required eluate volume (by changing the volume of the eluent from 4 to 8 mL). The accuracy of the volume control is within 0,5 mL. This helps to obtain the required radioactive concentration of ^99mTc in the solution. The regulation of the eluate volume is made by turning the bushing of the controller so, that the pointer matches the number of eluate milliliters on the upper surface of the bushing. 

Together with the radionuclide generator, the following elution kits are supplied in cartoon packages:

• • • 16 vials with 10 mL eluent (9 mg/mL (0.9%) NaCl solution) and 16 evacuated vials (vials for eluate).

A glass vial is the immediate packaging of eluate from generator. 10 mL vial is closed with rubber stopper and aluminium cap type flip-off and placed in the lead container.