GENTECH

What it is

GENTECH is a molybdenum [⁹⁹Mo]/technetium [99mTc] sterile generator for production of sodium pertechnetate [99mTc] injection multidose vial. GENTECH provides a sterile, isotonic, additive and pyrogen free solution of sodium pertechnetate [99mTc] injection. The generator contains fission-product molybdenum-99 [99Mo] from which 99mTc is separated by elution into evacuated vials. The generator consists of a sealed glass vessel containing aluminium oxide. The 99Mo is firmly bound to the alumina and as a result, the eluted 99mTc contains negligible amounts of 99Mo. Technetium-99m [99mTc] has a physical half-life of 6.02 hours.

Approved indications —

Scintigraphy, principally of the brain and thyroid. — Preparation of various technetium-99m labelled injections for selective organ imaging, especially of the liver, lung, bone and kidney.

Dosing overview

Sodium pertechnetate [99mTc] injection is administered by intravenous injection. The dosage employed varies for each diagnostic procedure with due allowances being made for patient body weight. To reduce radiation dose to the bladder, patients should be encouraged to drink fluids and to void as frequently as possible after administration for a period of four to six hours.

Key safety warnings

Radiopharmaceuticals should be used only by physicians who are qualified by specific training in the safe use and handling of radionuclides produced by a nuclear reactor or particle accelerator and whose experience and training have been approved by the appropriate government agency authorised to license the use of radionuclides. Care should be taken to minimise radiation exposure to patients consistent with proper patient management. As with other radioactive drugs, sodium pertechnetate [99mTc] must be handled with care and appropriate safety measures should be used to minimise radiation exposure to clinical personnel. Disposal of all radioactive wastes should be carried out in accordance with ARPANSA's Code for the Disposal of Radioactive Waste by the User. Patients who have had scans performed in the previous 6 weeks with agents containing tin may show distribution artefacts and/or poor quality images in a subsequent sodium pertechnetate [99mTc] brain scan as a result of uptake of pertechnetate by the red blood cells.

Contraindications

Hypersensitivity to the active substance or to any of the excipients. Since sodium pertechnetate [99mTc] is excreted through the kidneys and the gastrointestinal tract, its use in patients suffering obstructive pathology may give rise to a higher level of radiation exposure.

Regulatory history

GENTECH was first approved on 24 January 1994. Two variants have been registered on the ARTG: ARTG 72820 for the standard generator first listed on 21 January 2000, and ARTG 75859 for the 370 GBq variant first listed on 3 October 2000.