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Each vial contains a sterile, non-pyrogenic, lyophilized mixture of
Medronate Disodium -10mg
Stannous Chloride, minimum (SnCI2 • 2H20)-0.6mg
Total Tin, maximum (SnCI2 • 2H20) -1.15mg
Prior to lyophilization, the pH is adjusted to between 7.0-7.5 with HCI and/or NaOH. The contents of the vial are lyophilized and stored under nitrogen.
Administration is by intravenous injection for diagnostic use, after reconstitution with sterile, nonpyrogenic, oxidant-free Sodium Pertechnetate Tc99m Injection.
The precise structure of stannous technetium medronate complex is known at this time (JACS Vol.102, 2476, 1980).
Technetium Tc99m decays by isomeric transition with a physical half-life of 6.02 hours.1 Photons that are useful for imaging studies are listed in Table 1.
Table 1. Principal Radiation Emission Data
| Radiation | Mean %/Disintegration | Mean Energy(keV) |
| Gamma-2 | 89,07 | 140.5 |
1Kocher, David C., 'Radioactive Decay Data Tables', DOE/TIC 11026, 108 (1981).
The specific gamma ray constant for Tc99m is 5.4 microcoulombs/kg-MBq-hr (0.78 R/mCi-hr) at 1cm. The first half value layer is 0.017cm of Pb. A range of values for the relative attenuation of the radiation emitted by this radionuclide that results from interposition of various thicknesses of lead (Pb) is shown In Table 2. To facilitate control of the radiation exposure from MBq (mCi) amounts of this radionuclide, the use of 0.25cm thickness of lead (Pb) will attenuate the radiation emitted by a factor of 1,000.
Table 2. Radiation Attenuation by Lead Shielding
| Shield Thickness | Coefficient of Attenuation |
| lead (Pb) cm | 0.5 |
| 0.017 | 10-1 |
| 0.08 | 10-2 |
| 0.16 | 10-3 |
| 0.25 | 10-4 |
| 0.33 | 10-5 |
To correct for physical decay of this radionuclide, the fractions that remain at selected intervals after the time of calibration are shown in Table 3.
Table 3. Physical Decay Chart; Technetium Tc99m Hall-life 6.02 Hours
 |
Technetium Tc99m Medronate may be used as a bone Imaging agent to delineate areas of altered osteogenesis.
The suggested dose range for I.V. administration to be employed in the average patient (70kg) is:
The patient dose should be measured by a suitable radioactivity calibration system immediately prior to patient administration. Radiochemical purity should be checked prior lo patient administration.
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit.
Optimal imaging results are obtained 1-4 hours after administration. The image quality may be adversely affected by obesity, old age, and impaired renal function.
Store at controlled room temperature (20-25°C) before and after reconstitution.
Preparation of Technetium Tc99m Medronate from Kit for the Preparation of Technetium Tc99m Medronate is done by the following aseptic procedure:
The estimated absorbed radiation doses2 to organs and tissues of an average patient (70kg) from an intravenous injection of 740 MBq (20mCi) of Technetium Tc99m Medronate are shown in Table 4.
Table 4. Radiation Absorbed Doses
| Organ | Radiation mGy/740MBq | Absorbed Dose (rads/20mCi) |
| 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 for Selected Radionuclides and Organs, MIRD Pamphlet No. 11 (1975).
OSTEOLITE® Kit for use in the preparation of Technetium Tc99m Medronate for Injection is supplied in kits of five (5) or thirty (30) vials, sterile and non-pyrogenic.
Prior to lyophilization the pH is adjusted to between 7.0-7.5 with hydrochloric acid and/or sodium hydroxide solution. The contents of the vial are lyophilized and stored under nitrogen. Store at controlled room temperature (20 -25°C) before and after reconstitution. Technetium Tc99m Medronate contains no preservatives. Included in each live (5) vial kit is one (1) package insert and twelve (12) radiation labels. Included in each thirty (30) vial kit is one (1) package insert and seventy-two (72) radiation labels.
This reagent kit for the preparation of a radiopharmaceutical is approved for use by persons licensed pursuant to Section 120.533, Code of Massachusetts Regulation 105, or under equivalent license of the U.S. Nuclear Regulatory Commission or an Agreement State.
Marketed by CIS·US, Inc. 10 DeAngelo Drive Bedford, MA, USA 01730
Included as part of the PRECAUTIONS section.
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 impairment of brain scans using Sodium Pertechnetate Tc99m Injection which have been preceded by a bone scan using an agent containing stannous ions. The impairment may result in false-positive or false-negative brain scans It is recommended, where feasible, that brain scans precede bone imaging procedures.
Alternatively, a brain imaging agent such as Technetium Tc99m Pentetate may be used.
The biodistribution of technetium Tc 99m medronate may be altered in the presence of high levels of certain cations (iron, calcium, and aluminum). This may result in reduced uptake of radionuclide in the skeleton and increased extraosseal uptake, which may potentially degrade imaging quality. High levels of these cations may be caused by concomitant medications or medical conditions (e.g., iron overload, hypercalcemia, etc.). Most cases were observed after iron infusion. (See PRECAUTIONS, Drug Interactions.)
To minimize the radiation dose to the bladder, the patient should be encouraged to increase his fluid intake and to void as often as possible after the Injection of Technetium Tc99m Medronate. and for 4 to 6 hours alter the imaging procedure.
The preparation contains no bacteriostatic preservatives. Technetium Tc99m Medronate should be used within six hours of preparation.
The contents of the vial are intended only for use in the preparation of Technetium Tc99m Medronate and are NOT to be administered directly to the patient.
Radioactive drugs must be handled with care and appropriate safety measures should be used to minimize radiation exposure to clinical personnel. Also, care should be taken to minimize radiation exposure to the patients consistent with proper patient management.
The components of the kit are sterile and non-pyrogenic. It is essential to follow directions carefully and to adhere to strict aseptic procedures during preparation.
Technetium Tc99m labeling reactions involved depend on maintaining the stannous ion in the reduced state. Hence, Sodium Pertechnetate Tc99m Injection containing oxidants should not be used.
Radiopharmaceuticals should be used only by physicians who are qualified by training and experience in the safe use and handling of radionuclides and whose experience and training have been approved by the appropriate government agency authorized to license the use of radionuclides.
No long-term animal studies have been performed to evaluate carcinogenic potential or whether Technetium Tc99m Medronate affects fertility in males or females.
During the initial twenty-four hours following intravenous injection of Technetium Tc99m Medronate, about 50% of the dose is retained in the skeleton, and about 50% is renally excreted; less than 2% of the injected dose remains in the vascular system. Blood levels fall to 3-5% of the injected dose by three hours post-injection.
Upon intravenous injection, osseous uptake of Technetium Tc99m Medronate appears to be related to bone metabolic activity and to skeletal blood flow. Technetium Tc99m Medronate exhibits a specific affinity for areas of altered osteogenesis.
No information provided.
