Macrotec

Generic name: albumin aggregate and albumin human
Dosage form: injection
Drug class:Radiologic conjugating agents

Medically reviewed by Drugs.com. Last updated on Sep 21, 2021.

Diagnostic—For Intravenous Use

Macrotec Description

Macrotec is a sterile, nonpyrogenic, Iyophilized preparation of albumin aggregated. Each 5 mL vial of Macrotec contains 1.5 mg of Albumin Aggregated, 10.0 mg Albumin Human, 0.07 mg (minimum) stannous chloride (SnCl2•2H2O) and 0.19 mg total tin, maximum (as stannous chloride, SnCl2•2H2O), 1.8 mg of sodium chloride with trace amounts of sodium acetate, acetic acid and hydrochloric acid. Macrotec contains no preservatives. The pH of the reconstituted product is between 3.8 and 8.0.

The aggregated particles are formed by denaturation of Albumin Human in a heating and precipitation process. Each vial contains 2–7 million particles, 90% of which are between 10 and 90 microns in size. The average size is 20 to 40 microns; no particles are greater than 150 microns.

Reconstitution of Macrotec with sterile sodium pertechnetate Tc 99m forms an aqueous suspension of Technetium Tc 99m Albumin Aggregated for diagnostic use by intravenous injection. No less than 90% of thepertechnetate Tc 99m added to the reaction vial is bound to the aggregates at preparation time and remains bound throughout the 6-hour lifetime of the suspension.

PHYSICAL CHARACTERISTICS

Technetium Tc 99m decays by isomeric transition with a physical half-life of 6.02 hours.1 The principal photon that is useful for detection and imaging studies is listed in Table 1.

1 Kocher, David C., "Radioactive Decay Data Tables”, DOE/TIC-11026, (1981) p. 108.>

External Radiation

The specific gamma ray constant for Tc 99m is 0.78 R/hour-millicurie at 1 cm. The first half value layer is .