TECHNESCAN MAG3 Powder for solution for injection Ref.[11114] Active ingredients: Technetium ⁹⁹ᵐTc mertiatide

The suggested dose range employed in the average adult patient (70 kg) for renal function and imaging studies is 185 MBq (5 mCi) to 370 MBq (10 mCi). In pediatric patients the recommended dose range is 2.6 MBq/kg (70 μCi/kg) to 5.2 MBq/kg (140 μCi/kg) with a minimum dose of 37 MBq (1 mCi).

The patient dose should be measured by a suitable radioactivity calibration system immediately prior to administration.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration.

Aseptic procedures and a shielded syringe should be employed in withdrawing doses for administration to patients. The user should wear waterproof gloves during the administration procedure.

RADIATION DOSIMETRY

The estimated absorbed radiation doses from an intravenous administration of technetium Tc 99m mertiatide are presented in Table 4.

Technescan MAG3 should be stored at controlled room temperature 20° to 25°C (68° to 77°F) and protected from light until use. The reconstituted vial should be stored at room temperature (15° to 30°C) and must be used within six hours of preparation.

Table 4. Radiation Dose Estimates for Tc 99m Mertiatide:

^* Calculated by Oak Ridge Associated Universities, based upon the pediatric phantom series of Christy and Eckerman of Oak Ridge National Laboratories. The adult radiation absorbed doses were calculated based on data from ten normal volunteers using the Medical Internal Radiation Dose Committee (MIRD) schema.
^** Radioactive doses for 1-, 5-, and 10-year olds are based on a maximum dose of 7.4 MBq/kg (200 μCi/kg).