RADPHARM

What it is

RADPHARM LLK Kit consists of sterile, pyrogen free ingredients which need reconstitution with sodium pertechnetate [99mTc] injection and mixing to produce technetium [99mTc] stannous colloid complex suitable for labelling white blood cells in whole blood. Vial A contains 6 mL solution of 1 mg/mL sodium fluoride in Water for Injections BP. Vial B contains 0.64 mg of stannous fluoride as a lyophilised powder.

Approved indications

— Imaging acute inflammation or infection using technetium [99mTc] labelled leucocytes

Dosing overview

The recommended intravenous dose for the normal adult is 400 to 600 MBq.

Key safety warnings

Due to significant liver and spleen uptake of technetium [99mTc] labelled leucocytes and residual technetium [99mTc] stannous colloid, determination of sites causing fever of unknown origin is not recommended. For each patient, exposure to ionising radiation must be justifiable on the basis of likely benefit. The activity administered must be such that the resulting dose is as low as reasonably achievable bearing in mind the need to obtain the intended diagnostic or therapeutic result. Exposure to ionising radiation is linked with cancer induction and a potential for development of hereditary defects. For diagnostic nuclear medicine investigations the current evidence suggests that these adverse effects will occur with low frequency because of the low radiation doses incurred. Technetium-99m radiopharmaceuticals should only be given to a pregnant woman if in the judgement of the treating physician the expected benefits outweigh the potential hazards. Technetium-99m is excreted in human milk and it is recommended that interruption to breast feeding is necessary after the administration of technetium [99mTc] labelled leucocytes for a period of not less than 12 hours and contact with the baby should be restricted to 5 hours in 24 hours. Hypersensitivity reactions have been reported with technetium [99mTc] preparations.

Contraindications

Regulatory history

RADPHARM LEUCOCYTE LABELLING KIT for the production of technetium [99mTc] stannous fluoride injection composite pack was first listed on the Australian Register of Therapeutic Goods on 5 September 1991.