At the chemical concentrations and activities used for diagnostic examinations, nanocolloidal technetium (99mTc) albumin does not appear to have any pharmacodynamic activity.
Reticuloendothelial cells in liver, spleen as well as in bone marrow are responsible for blood clearance after intravenous injection. A small fraction of 99mTc radioactivity passes through kidneys and is eliminated in urine.
The maximum concentration in the liver and spleen is reached after about 30 minutes, but in the bone marrow after only 6 minutes.
The proteolytic breakdown of the colloid begins immediately after its uptake by the RES, the products of degradation being excreted through the kidneys into the bladder.
After subcutaneous injection into connective tissue, 30-40% of the administered nanocolloidal technetium (99mTc) albumin particles are filtered into lymphatic capillaries. The technetium (99mTc) albumin nanosized colloidal particles are then transported along the lymphatic vessels to regional lymph nodes and main lymphatic vessels and are finally trapped into the reticular cells of functionary lymph nodes.
A fraction of the injected dose is phagocytized by histiocytes at the injection site. Another fraction appears in the blood and accumulates mainly in the RES of the liver, spleen and bone marrow; faint traces are eliminated via the kidneys.
Toxicological studies with mice and rats have demonstrated that with a single intravenous injection of 800 mg and 950 mg, respectively, no deaths and no gross pathological changes at necropsy were observed. No local reactions were observed in either mice or rats following subcutaneous injection of 1g nanocolloidal albumin particles/kg body weight with 0.9% saline injection. These doses correspond to the contents of 50 vials per kg body weight, which is the 3,500-fold compared to the maximum human dose.
This medicinal product is not intended for regular or continuous administration.
Mutagenicity studies and long-term carcinogenicity studies have not been carried out.
Studies of toxicity to reproduction are not available.
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