|Qualitative and quantitative composition:||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.
|Pharmaceutical form:||Radionuclide generator.|
Sodium pertechnetate (99mTc) solution: clear and colourless.
|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.
|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.
|Nature and contents of container:||A glass vial is the immediate packaging of eluate from generator. 10 ml vial is closed with rubber stopper and aluminium cap and placed in the lead container|
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).
|pH of the eluate:||5,5-7,5|
|Elution yield:||90 – 110% (video)|
|Enclosure||SmPC – Poltechnet 8,0 – 175 GBq|