Technetium Tc 99m Mertiatide

Kit for the Preparation of Technetium Tc 99m Mertiatide Injection, after radiolabeling with technetium-99m, is indicated for use in the diagnosis of congenital and acquired renal abnormalities, renal failure, urinary tract obstruction, and calculi in adults and pediatric patients aged 30 days and older. The product is a diagnostic aid in providing renal function, split function, renal angiograms, and renogram curves for whole kidney and renal cortex.

The following adverse reactions associated with the use of Technetium Tc 99m Mertiatide Injection were identified in clinical studies or postmarketing reports. Because some of these reactions are voluntarily reported from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Kit for the Preparation of Technetium Tc 99m Mertiatide Injection containing 1 mg betiatide, is supplied as a white lyophilized powder packaged in a sterile, multiple-dose 10 mL vial as a carton of 5 vials (NDC 65174-261-05). The carton also contains:

- 5 venting needles with filter.

- 5 radioassay information labels for the radiolabeled product.

The radionuclide is not part of Kit for the Preparation of Technetium Tc 99m Mertiatide Injection.

Before radiolabeling, store at controlled room temperature 20°C to 25°C (68°F to 77°F) [see USP Controlled Room Temperature] and protect from light.

After radiolabeling with sodium pertechnetate Tc 99m injection, store vial upright in shielding to protect from radiation at room temperature 15°C to 30°C (59°F to 86°F). Use within 6 hours of radiolabeling.

Dispose of unused Technetium Tc 99m Mertiatide Injection in compliance with the regulations of the government agency authorized to license the use of this radionuclide.

This preparation is approved for use by persons under license by the Nuclear Regulatory Commission or the relevant regulatory authority of an Agreement State.

Following intravenous administration for renal imaging, Technetium Tc 99m Mertiatide is rapidly cleared from the blood. It is cleared by the kidneys and excreted in the urine.