Sodium Fluoride Injection
Product Images NDC 52768-125

This is a description of a diagnostic radioactive solution for intravenous use only. It comes in a 30 mL multiple-dose vial, with activity concentration ranging from 10 to 200 mCi/mL at EOS. Each mL contains no carrier added sodium fluoride and sodium chloride. It has a shelf life of 12 hours after EOS and should be stored upright in a shielded container at controlled room temperature. The correct dosage should be calculated from the calibration time, and it should not be used if cloudy or contains particulate matter. Manufactured by Prec n Nuclear, LLC.*

This is a description of a diagnostic radioisotope product. The product is a multiple-dose vial containing a radioactive solution composed of no carrier added sodium ['8F] fluoride for intravenous diagnostic use only. Each milliliter of the solution contains 0.37 – 7.40 GBq (10 - 200 mCi) of the radioactive sodium fluoride and 9 mg of sodium chloride. The product should be stored in a shielded container upright at a temperature of 25°C (77°F) and can be taken out aseptically. The correct dosage should be calculated from the date and time of calibration, and it should not be used if it contains particulate matter or appears cloudy. The product was produced by Prec n Nuclear, LLC and has a lot number and a date of expiration. The complete product and manufacturing details and results are available in the batch record.*

This is a description of a diagnostic solution contained in a 30mL vial with a concentration of 10-200 mCi/mL at EOS (End of Synthesis) used for Intravenous administration. The solution, a radioactive material manufactured by Professional Nuclear, LLC, has an expiration period of 12 hours after the End of Synthesis. The manufacturing lot number was not provided. The package must be stored upright in a shielded container at 25 °C (77 °F) with an allowance for excursions permitted to 15-30 °C (59-86 °F) [See USP Controlled Room Temperature]. It contains no carrier-added sodium [**F] fluoride and 9 mg of sodium chloride. A correct dosage calculation from date and time of calibration is also included. Any cloudy or particulate contaminated vial should not be used.*

This is a description of a diagnostic solution used for intravenous purposes. It comes in a 50mL multiple-dose vial and contains sodium fluoride and sodium chloride. The activity level ranges from 10-200 mCi/mL at EOS (End of Synthesization). There is a caution required when using this solution. The solution should be stored upright in a shielded container at a controlled room temperature and dosages should be calculated from the date and time of calibration which is to be done by a competent person. The solution should not be used if cloudy or contains particulate matter. The expiration date and time are noted as 12hours after EOS. The Manufacturer is also provided in the text; Nuclear, LLC located at 830 Suncrest Drive Gray, TN 37615.*