MDP Multidose Kit

INDICATIONS

Technetium Tc99m medronate injection may be used as a bone imaging agent to delineate areas of altered osteogenesis.

DOSAGE AND ADMINISTRATION

After preparation with oxidant-free sodium pertechnetate Tc99m injection the suggested dose range of technetium Tc99m medronate injection in the average patient (70 kg) is 370-740 MBq (10-20 mCi) 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 Tc99m medronate injection.

Slow administration of the drug over a period of 30 seconds is recommended.

Radiation Dosimetry

The effective half-life was assumed to be the physical half-life for all calculated values. The estimated radiation absorbed doses2 to an average patient (70 kg) for an intravenous injection of a maximum dose of 740 MBq (20 mCi) of technetium Tc99m medronate injection are shown in Table 4.

Table 4. Absorbed Radiation Dose2

Organ mGy/740 MBq rads/20 mCi
Total Body 1.3 0.13
Bone Total 7.0 0.70
Red Marrow 5.6 0.56
Kidneys 8.0 0.80
Liver 0.6 0.06
Bladder Wall 2-hr. void 26.0 2.60
  4.8-hr. void 62.0 6.20
Ovaries 2-hr. void 2.4 0.24
  4.8-hr. void 3.4 0.34
Testes 2-hr. void 1.6 0.16
  4.8-hr. void 2.2 0.22
2Method of Calculation: “S” Absorbed Dose per Unit Cumulated Activity Selected Radionuclides and Organs, MIRD Pamphlet No. 11, 1975.

The typical total body exposure to a person administering a maximum dose of 740 MBq (20 mCi) of technetium Tc99m to a patient is about 0.2 ÁSv, 0.02 mR.3

HOW SUPPLIED

Kit Contents

10 STERILE REACTION VIALS, each 10 mL vial contains, in lyophilized form and under nitrogen atmosphere, 10 mg of medronic acid, 0.17 mg (minimum) stannous chloride (maximum stannous and stannic chloride 0.29 mg), and 2 mg ascorbic acid. Hydrochloric acid and sodium hydroxide have been added for pH adjustment prior to lyophilization.

10 PRESSURE-SENSITIVE LABELS for final preparation of technetium Tc99m medronate injection.

1 PACKAGE INSERT

NDC 17156-438-05

Storage

Store kit contents and final preparation at or below 25°C (77°F).

Preparation

The following directions must be carefully followed for optimum preparation of technetium Tc99m medronate injection.

Note: Use aseptic procedures throughout and take precautions to minimize radiation exposure by the use of suitable shielding. Waterproof gloves should be worn during the preparation procedure.

  1. Remove the protective disc from the reaction vial and aseptically swab the rubber septum with alcohol.
  2. Affix a pressure-sensitive label to a lead shield* and place the vial in the labeled lead shield.
  3. Using a shielded, sterile syringe, aseptically add 2-8 mL of sterile, pyrogen-free, oxidant-free sodium pertechnetate Tc99m injection to the vial.
  4. Place fitted cover onto the lead shield. Swirl the contents of the vial for one minute and let stand 1-2 minutes. Using proper shielding, visually inspect the vial. Discard if foreign matter is observed.
  5. Record the time and date of preparation and the volume, activity and calibration of the sodium pertechnetate Tc99m injection added.
  6. The technetium Tc99m medronate injection is ready for use.
  7. Store the finished product in the capped lead shield at or below 25°C (77°F). Use within 6 hours after formulation.

Note: It is recommended that with proper shielding and equipment, the final formulation be tested for radiochemical purity. If radiochemical purity is not adequate, discard the finished drug.

*Use vial shield, Catalog No. 99-0520, or equivalent.

Disposal

The residual materials may be discarded in ordinary trash provided the vials and syringes read no greater than background with an appropriate low-range survey meter. All identifying labels should be destroyed before discarding.

This reagent kit is approved by the U.S. Nuclear Regulatory Commission for distribution to persons licensed to use by-product material identified in §35.200 of 10 CFR Part 35, to persons who have a similar authorization issued by an Agreement State, and, outside the United States, to persons authorized by the appropriate authority.

Reference

3Barrall, R.C., Smith, S.J., Personnel Radiation Exposure and Protection from 99m Tc Radiations, In: Kereiakes, J. G., Corey, K. R., eds. Biophysical Aspects of the Medical Use of Technetium Tc99m, American Association of Physicists in Medicine Monograph No. 1, 1976: p. 77.

Manufactured for: GE Healthcare Medi-Physics Inc. 3350. North Ridge Avenue, Arlington Heights, IL 60004. 1-800-633-4123 (Toll Free). By: GE Healthcare Ltd. Little Chalfont, HP7 9NA. Revised September 2007. FDA Rev date: 9/5/2007

Last reviewed on RxList: 10/3/2007
This monograph has been modified to include the generic and brand name in many instances.

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