OSTEOCIS Kit for radiopharmaceutical preparation Ref.[27900] Active ingredients: Technetium โนโนแตTc oxidronic acid

Source: Health Products Regulatory Authority (IE)  Revision Year: 2020  Publisher: CIS bio International, BP 32, 91192 Gif-Sur-Yvette Cedex, France

5.1. Pharmacodynamic properties

Pharmacotherapeutic group: radiopharmaceutical preparation for diagnostic use
ATC code: V09BA01

At the chemical concentrations used for diagnostic examinations, technetium (99mTc) oxidronate does not appear to have any pharmacodynamic activity.

5.2. Pharmacokinetic properties

Distribution

Intravenously administered technetium (99mTc) oxidronate is rapidly distributed throughout the extracellular space.

Organ uptake

Skeletal uptake begins almost immediately and proceeds rapidly. 30 minutes post injection 10% of the initial dose is still present in whole blood. At 1 hour, 2 hours, 3 hours and 4 hours after injection these values are resp. 5%, 3%, 1.5% and 1%.

Elimination

Clearance from the body takes place via the kidneys. Of the administered activity about 30% is cleared within the first hour, 48% within two hours and 60% within 6 hours.

5.3. Preclinical safety data

Toxicological studies with rats have demonstrated that with a single intravenous injection of 30 mg/kg no deaths were observed. Minimal liver abnormalities were seen at this dose level. Toxicity with repeated administration of 10 mg/kg/day over 14 days in rats was not observed. In the dog, after repeated administration of 3 and 10 mg/kg/day over 14 days, histological changes in the liver (microgranuloma) were observed together with long-lasting indurations at the site of injection. This agent is not intended for regular or continuous administration.

Mutagenicity studies, toxicity to reproduction and development studies and long-term carcinogenicity studies have not been carried out.

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