Drug Facts
Composition & Profile
Identifiers & Packaging
HOW SUPPLIED Kit for the Preparation of Technetium Tc 99m Medronate is supplied as kits of 10 reaction vials (NDC 65857-505-10). Each reaction vial contains a sterile, nonpyrogenic, nonradioactive lyophilized mixture of 20 mg medronic acid, 1 mg ascorbic acid, 0.13 mg (minimum) stannous fluoride, SnF 2 and 0.38 mg total tin, maximum (as stannous fluoride, SnF 2 ). The pH is adjusted with sodium hydroxide or hydrochloric acid prior to lyophilization. The vial does not contain a preservative. The contents of the vial are lyophilized and sealed under nitrogen at the time of manufacture. The pH of the reconstituted product is 5.4 to 6.8. Kit Contents 10 sterile reaction vials 20 pressure-sensitive labels for technetium Tc 99m medronate 1 package insert Storage Store the product as supplied at 20° to 25°C (68° to 77°F). After reconstitution store refrigerated at 2° to 8°C (36° to 46°F). Do not use and discard radiolabeled technetium Tc 99m medronate 6 hours after reconstitution.; PRINCIPAL DISPLAY PANEL - Carton Label Carton Label DIAGNOSTIC NDC 65857-505-10 Kit for the Preparation of Technetium Tc 99m Medronate Rx only • Store the product at 20° to 25°C (68° to 77°F) • For Intravenous Use after radiolabeling with sodium pertechnetate Tc 99m. After reconstitution, store refrigerated 2° to 8°C (36° to 46°F) • Use within 6 hours after reconstitution. Contents: 10 sterile multi-dose reaction vials 20 radioactivity labels Prescribing information Cardinal Health™ NONRADIOACTIVE Kit for the Preparation of Technetium Tc 99m Medronate For preparation of technetium Tc 99m medronate for bone imaging Each reaction vial contains a sterile, nonpyrogenic nonradioactive lyophilized mixture of 20 mg medronic acid , 1 mg ascorbic acid, and 0.13 mg (minimum) stannous fluoride SnF 2 and 0.38 mg total tin, maximum (as stannous fluoride, SnF 2 ); pH adjusted with sodium hydroxide or hydrochloric acid prior to lyophilization. Distributed by Cardinal Health 414, LLC Dublin, OH 43017 Contains no preservative. Vial contents are sealed under nitrogen at time of manufacture. Recommended Dose: See Prescribing Information. Principal Display Panel - Carton Label
- HOW SUPPLIED Kit for the Preparation of Technetium Tc 99m Medronate is supplied as kits of 10 reaction vials (NDC 65857-505-10). Each reaction vial contains a sterile, nonpyrogenic, nonradioactive lyophilized mixture of 20 mg medronic acid, 1 mg ascorbic acid, 0.13 mg (minimum) stannous fluoride, SnF 2 and 0.38 mg total tin, maximum (as stannous fluoride, SnF 2 ). The pH is adjusted with sodium hydroxide or hydrochloric acid prior to lyophilization. The vial does not contain a preservative. The contents of the vial are lyophilized and sealed under nitrogen at the time of manufacture. The pH of the reconstituted product is 5.4 to 6.8. Kit Contents 10 sterile reaction vials 20 pressure-sensitive labels for technetium Tc 99m medronate 1 package insert Storage Store the product as supplied at 20° to 25°C (68° to 77°F). After reconstitution store refrigerated at 2° to 8°C (36° to 46°F). Do not use and discard radiolabeled technetium Tc 99m medronate 6 hours after reconstitution.
- PRINCIPAL DISPLAY PANEL - Carton Label Carton Label DIAGNOSTIC NDC 65857-505-10 Kit for the Preparation of Technetium Tc 99m Medronate Rx only • Store the product at 20° to 25°C (68° to 77°F) • For Intravenous Use after radiolabeling with sodium pertechnetate Tc 99m. After reconstitution, store refrigerated 2° to 8°C (36° to 46°F) • Use within 6 hours after reconstitution. Contents: 10 sterile multi-dose reaction vials 20 radioactivity labels Prescribing information Cardinal Health™ NONRADIOACTIVE Kit for the Preparation of Technetium Tc 99m Medronate For preparation of technetium Tc 99m medronate for bone imaging Each reaction vial contains a sterile, nonpyrogenic nonradioactive lyophilized mixture of 20 mg medronic acid , 1 mg ascorbic acid, and 0.13 mg (minimum) stannous fluoride SnF 2 and 0.38 mg total tin, maximum (as stannous fluoride, SnF 2 ); pH adjusted with sodium hydroxide or hydrochloric acid prior to lyophilization. Distributed by Cardinal Health 414, LLC Dublin, OH 43017 Contains no preservative. Vial contents are sealed under nitrogen at time of manufacture. Recommended Dose: See Prescribing Information. Principal Display Panel - Carton Label
Overview
Each reaction vial contains a sterile, nonpyrogenic, nonradioactive lyophilized mixture of 20 mg medronic acid, 1 mg ascorbic acid, 0.13 mg (minimum) stannous fluoride, SnF 2 and 0.38 mg total tin, maximum (as stannous fluoride, SnF 2 ). The pH is adjusted with sodium hydroxide or hydrochloric acid to 6.5 (6.3 to 6.7) prior to lyophilization. The vial does not contain a preservative. The contents of the vial are lyophilized and sealed under nitrogen at the time of manufacture. The pH of the reconstituted product is 5.4 to 6.8. The structure of medronic acid is given below: The precise structure of technetium Tc 99m medronate is unknown at this time. When sterile, pyrogen-free sodium pertechnetate Tc 99m injection is added to the vial, the diagnostic agent technetium Tc 99m medronate is formed for administration by intravenous injection. Structure of Medronic Acid
Indications & Usage
Technetium Tc 99m medronate may be used as a bone imaging agent to delineate areas of altered osteogenesis.
Dosage & Administration
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 MBq to 740 MBq (10 mCi to 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 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 MBq (20 mCi) of technetium Tc 99m medronate are shown in Table 4 . Table 4 Absorbed Radiation Dose 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 Method of Calculation: “S” Absorbed Dose per Unit Cumulated Activity for Selected Radionuclides and Organs, MIRD Pamphlet No. 11, 1975
Warnings & Precautions
WARNINGS 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. 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 .)
Contraindications
None known.
Adverse Reactions
Several adverse reactions due to technetium Tc 99m medronate 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.
Drug Interactions
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. In patients with high levels of these cations caused by concomitant medications, particularly patients receiving iron infusions, consider performing an imaging study with technetium Tc 99m medronate injection once the cation levels have normalized (e.g., after 3 to 5 half-lives of the cation). (See WARNINGS .)
Storage & Handling
Storage Store the product as supplied at 20° to 25°C (68° to 77°F). After reconstitution store refrigerated at 2° to 8°C (36° to 46°F). Do not use and discard radiolabeled technetium Tc 99m medronate 6 hours after reconstitution.
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