Macrotec

DiagnosticFor Intravenous Use

Lung Imaging

Macrotec (Kit for the Preparation of Technetium Tc 99m Albumin Aggregated) is a lung imaging agent which may be used as an adjunct in the evaluation of pulmonary perfusion in adults and children. It is useful in the early detection of pulmonary emboli and in the evaluation of the status of the pulmonary circulation in such conditions as pulmonary neoplasm, pulmonary tuberculosis and emphysema.

Shunt Imaging

Technetium Tc 99m Albumin Aggregated may be used in adults as an imaging agent to aid in the evaluation of peritoneo-venous (LeVeen) shunt patency.

Isotopic Venography

Macrotec is also indicated for use in isotopic venography as an adjunct in the screening, diagnosis and management of deep vein thrombosis in the lower extremities.

Combined isotopic venography of the lower extremities and the pulmonary vasculature may be performed.

Technetium Tc 99m Albumin Aggregated Injection should not be administered to patients with severe pulmonary hypertension.

The use of Technetium Tc 99m Albumin Aggregated Injection is contraindicated in persons with a history of hypersensitivity reactions to products containing human serum albumin.

Although adverse reactions specifically attributable to the Technetium Tc 99m Albumin Aggregated Injection have not been noted, the literature contains reports of deaths occurring after the administration of Albumin Aggregated to patients with pre-existing severe pulmonary hypertension. Instances of hemodynamic or idiosyncratic reactions topreparations of Technetium Tc 99m Albumin Aggregated have been reported.

Macrotec (Kit for the Preparation of Technetium Tc 99m Albumin Aggregated) is supplied as a kit containing 10 reaction vials (5 mL size), 10 pressure sensitive labels and 1 package insert.

Storage

Store the Macrotec kit refrigerated between 2° to 8°C (36° to 46°F). The reconstituted preparation should be refrigerated since the product does not contain a preservative.

When reconstituted with sodium pertechnetate Tc 99m, Macrotec must be used within 6 hours.

Procedural Precautions

The contents of the Macrotec reaction vial are sterile and nonpyrogenic. Aseptic procedures should be used during reconstitution of Macrotec and the withdrawal of doses for intravenous administration. The introduction of air into the vial during the reconstitution step should be avoided. Since the vial contains nitrogen to prevent oxidation of the complex, the vial should not be vented. If repeated withdrawals are made from the vial, the contents should not be replaced with air.

Reconstitution

1. Waterproof gloves should be worn during the preparation procedure.
2. Allow the contents of the reaction vial to come to room temperature.
3. Place the Macrotec vial in an appropriate lead shield with a fitted cover.
4. Swab the rubber closure of the reaction vial with a germicide.
5. Using a shielded syringe, slowly inject 1 to 3 mL [up to 1850 MBq (50 mCi)] of sterile sodium pertechnetate Tc 99m solution into the reaction vial. In determining the amount of technetium Tc 99m to be used, the labeling efficiency, number of patients, administered radioactive dose and radioactive decay must be taken into account.
   NOTE: If sodium pertechnetate Tc 99m solution must be diluted for use with Macrotec (Kit for the Preparation of Technetium Tc 99m Albumin Aggregated), only Sodium Chloride Injection USP (without preservatives) should be used.
6. Secure the lead shield cover. Shake the vial gently in order for the lyophilized material to form a suspension. Avoid formation of foam. To ensure maximum tagging, allow the preparation to stand for 6 minutes after mixing.
7. Record the time and date of preparation and the radioconcentration and volume of the suspension on the pressure-sensitive label.
8. Affix the pressure-sensitive label to the shield.
9. Using proper shielding, examine vial contents. The suspension must be uniform and free from large aggregates, flakes or particulate matter.
10. Maintain adequate shielding of the radioactive preparation including the use of appropriate shielded syringes.
11. Radioassay of Technetium Tc 99m Albumin Aggregated may be accomplished conveniently with the use of an ionization chamber-type dose calibrator.

The U.S. Nuclear Regulatory Commission has approved this reagent kit for distribution to persons licensed to use byproduct material identified in §35.200 of 10 CFR Part 35, to persons who hold an equivalent license issued by an Agreement State, and, outside the United States, to persons authorized by the appropriate authority.

Manufactured for:
Bracco Diagnostics Inc.
Princeton, NJ 08543

Manufactured by:
Ben Venue Laboratories, Inc.
Bedford, OH 44146

MAC-P01
February 2002