Basic Information
TEKCIS RADIONUCLIDE GENERATOR 2-50 GBQ
GENERATOR
Regulatory Information
SIN15741P
July 10, 2019
Prescription Only
Therapeutic
INTRAVENOUS
August 10, 2023
June 4, 2025
XV09
Company Information
QT INSTRUMENTS (S) PTE LTD
QT INSTRUMENTS (S) PTE LTD
Active Ingredients
Strength: 2-50 GBq
Strength: 2/4/6/8/10/12/16/20/25/50 GBq
Detailed Information
Contraindications
**4.3. Contraindications** Hypersensitivity to the active substance or to any of the excipients listed in section 6.1 – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_.
Indication Information
**4.1. Therapeutic indications** This medicinal product is for diagnostic use only. The eluate from the radionuclide generator (Sodium Pertechnetate (99mTc) Injection Ph. Eur.) 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 thyroid disease. - Salivary gland scintigraphy: diagnosis of chronic sialadenitis (e.g. Sjögren Syndrom) as well as to assess salivary gland function and duct patency in salivary glands disorders and monitoring of the response to therapeutic interventions (in particular radio iodine 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.