PULMOTEC Kit for radiopharmaceutical preparation Ref.[27570] Active ingredients: Technetium โนโนแตTc technegas

Source: Health Products Regulatory Authority (IE)  Revision Year: 2020  Publisher: Cyclomedica Ireland Ltd, Ulysses House (Third floor), Foley Street, Dublin 1, Ireland

5.1. Pharmacodynamic properties

Pharmacotherapeutic group: Diagnostic radiopharmaceuticals; Technetium (99mTc), inhalants
ATC code: V09EA02

In the concentrations used for diagnostic examinations, Technegas is an inert suspension and has no pharmacological effect.

5.2. Pharmacokinetic properties

After inhalation, Technegas is absorbed on the walls of pulmonary alveoli and remains in the lungs. There is no intra vascular clearance and elimination of radioactivity is by the physical decay of the technetium-99m.

Part of the carbon micro-particles may be retained in the upper and central airways and is greater in patients with airway obstruction. These particles are cleared by ciliary action and, after swallowing, are eliminated through the gastro-intestinal tract without absorption.

5.3. Preclinical safety data

Toxicological data on PULMOTEC are not available.

A single administration of inhaled radioactivity of 5.5 MBq in a rat was well tolerated with most of the radioactivity inhaled found in the lung.

Studies of oral administration of solution of Technegas in rats showed that the radioactivity remained almost exclusively in the gastro-intestinal tract.

No study of effects on reproductive functions, of a mutagenic and carcinogenic potential has been carried out.

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