RENOCIS Kit for radiopharmaceutical preparation Ref.[27899] Active ingredients: Technetium ⁹⁹ᵐTc succimer

Source: Health Products Regulatory Authority (IE)  Revision Year: 2019  Publisher: CIS bio International, Route Nationale 306 Saclay, BP 32, 91192 Gif-Sur-Yvette Cedex, France

5.1. Pharmacodynamic properties

Pharmacotherapeutic group: Diagnostic radiopharmaceuticals for the renal system Technetium (99mTc) compounds
ATC code: V09CA02

At the chemical concentrations used for diagnostic procedures technetium (99mTc) succimer does not appear to have any pharmacodynamic effects.

5.2. Pharmacokinetic properties

Distribution

Technetium (99mTc) succimer is cleared from blood with a triphasic pattern in patients with normal renal function.

Organ uptake

The technetium (99mTc) succimer localizes in high concentrations in renal cortex. Maximal localization occurs within 3-6 hours after intravenous injection, with about 40‑50 % of the dose retained in the kidneys. Less than 3 % of the administered dose localizes in the liver. However, this amount can be increased significantly and renal distribution decreased in patients with impaired renal functions.

Elimination

Excretion is exclusively via the kidneys.

Half-life

The effective half-life of technetium (99mTc) succimer in blood is around 1 hour.

5.3. Preclinical safety data

Toxicity with repeated administration of 0.66 mg/kg/day succimer and 0.23 mg/kg/day SnCl2 over 14 days in rats was not observed. The dose usually administered to humans is 0.14 mg/kg succimer. This agent is not intended for regular or continuous administration.

Mutagenicity studies and long-term carcinogenicity studies have not been carried out.

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