MDP-Bracco

For Diagnostic Use

Technetium Tc 99m medronate may be used as a bone imaging agent to delineate areas of altered osteogenesis.

This class of compounds is known to complex cations such as calcium. Particular caution should be used with patients who have or who may be predisposed to hypocalcemia (i.e., alkalosis).

Preliminary reports indicate interference with brain scans using sodium pertechnetate Tc 99m injection which have been preceded by a bone scan using an agent containing stannous ions. This interference may result in false-positive or false-negative brain scans. It is recommended, where feasible, that brain scans precede bone imaging procedures.

Several adverse reactions due to MDP-Bracco have been reported. These were usually hypersensitivity reactions characterized by itching, various skin rashes, hypotension, chills, nausea and vomiting. There have also been rare cases of dizziness and asthenia associated with the use of technetium Tc 99m medronate.

After preparation with oxidant-free sodium pertechnetate Tc 99m injection the suggested dose range of technetium Tc 99m medronate injection in the average patient (70 kg) is 370 to 740 megabecquerels (10 to 20 millicuries) given intravenously. Imaging post injection is optimal at 1 to 4 hours.

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 whenever solution and container permit. Shielding should be utilized when preparing the technetium Tc 99m medronate injection.

Radiation Dosimetry

The effective half-life was assumed to be the physical half-life for all calculated values. The estimated radiation absorbed doses to an average patient (70 kg) from an intravenous injection of a maximum dose of 740 megabecquerels (20 millicuries) of technetium Tc 99m medronate are shown in Table 4.

Method of Calculation: “S” Absorbed Dose per Unit Cumulated Activity for Selected Radionuclides and Organs, MlRD Pamphlet No. 11, 1975

Procedural Precautions

The lyophilized powder in the reaction vial is sterile and nonpyrogenic and does not contain a preservative. Aseptic procedure and shielded syringes should be used when adding the pertechnetate eluate to the reaction vial and for withdrawal and administration of the dose of the finished medronate agent. Waterproof gloves should be worn to prevent the possibility of radioactive contamination of the hands.

If sodium pertechnetate Tc 99m must be diluted prior to injection into the reaction vial, only Sodium Chloride Injection USP 0.9% (without preservatives) should be used.

Preparation

Preparation of technetium Tc 99m medronate is done by the following aseptic procedure:

1. Waterproof gloves should be worn during the preparation procedure.
2. Place reaction vial in an appropriate lead shield.
3. Remove the central disc from the reaction vial and swab the rubber closure of the reaction vial with a germicide.
4. With a sterile syringe, aseptically obtain 0.5 to 5 mL, [up to 18.5 gigabecquerels (500 millicuries)] of a suitable, oxidant-free, sterile nonpyrogenic sodium pertechnetate.
5. Aseptically add the sodium pertechnetate Tc 99m solution to the vial.
6. Secure the lead shield cover. Swirl the vial for one minute and let stand for one to two minutes.
7. Record the date and time of preparation on pressure-sensitive label.
8. Affix pressure-sensitive label to shield.
9. Examine vial contents. If the solution is not clear and free of particulate matter and discoloration on visual inspection, it should not be used.
10. Measure the radioactivity using a suitable calibration system and record on the shield label prior to patient administration.
11. Aseptically withdraw material for use within six (6) hours of preparation. For optimum results, this time should be minimized.The vial contains no bacteriostatic preservative.

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
by
Hollister-Stier Laboratories LLC
Spokane, WA 99207

Revised May 2007

875014-H01

MDP 99m Label
NDC: 0270-3876-80

MDP 99m Vial Label
NDC: 0270-3876-80