Parameters of kits for the preparation of 99mTc-labeled particles and colloids authorised in the European Union and the European Economic Area

Overview

Introduction: Technetium (^99mTc), particles and colloids is an Anatomical Therapeutic Chemical (ATC) group V09DB, where there are a total of 7 drugs (ATC codes V09DB01-V09DB07): technetium (^99mTc) nanocolloid, microcolloid, millimicrospheres, tin colloid, sulfur colloid, rheniumsulfide colloid, phytate. Depending on the nature of the particles and the method of application, they are used for the detection of sentinel lymph nodes, lymphoscintigraphy, bone marrow scintigraphy, scintigraphy of inflammation, liver, spleen. The article compares the composition, parameters and indications of kits for the preparation of the listed radiopharmaceuticals authorised in the European Union (EU) and the European Economic Area (EEA).

Method: Searching for summaries of product characteristics (SmPC) in drug databases of individual countries and then comparing the kit parameters listed in the relevant national SmPCs.

Results: For each kit, the tables show the composition, particle size and resulting pH. Furthermore, parameters include the active substance after radiolabelling and its ATC code, volume for preparation, maximum activity for labelling, labelling time, dilution options, vial size, kit stability before and after labelling, storage temperature, chemical precursor content, method for determining radiochemical purity and indications.

Conclusion: The kits do not have a centralised marketing authorisation through the European Medicines Agency (EMA) and in different countries the same kit may differ in the name under which it is authorised, the permitted routes of administration, indications and even the ATC code. In a number of EU countries these kits are not authorised at all and there is no authorised medicinal product in the EU for technetium (^99mTc) microcolloid and technetium (^99mTc) sulfur colloid.

Keywords:

scintigraphy – Spleen – Tin – Sulfur – inflammation – bone marrow – liver – sentinel lymph node – lymphoscintigraphy – ATC – EMA – microcolloid – millimicrosphere – nanocolloid – phytate – rheniumsulfide – SmPC – [99mTc]technetium