Sodium Fluoride Injection
Product Images NDC 81759-002

This is a cautionary label for a 30mL vial of radioactive Sodium Fluoride F 18 Injection, which is used for diagnostic purposes through intravenous administration only. Each mL of the solution contains 10-200 mCi/mL of sodium fluoride in aqueous 0.9% sodium chloride solution. The solution has a half-life of 109.7 minutes and must be used within 12 hours of EOS batch calibration. The dosage must be accurately calculated from the calibration date and time. The solution should not be used if it is cloudy or contains particulate matter. The storage temperature for the vial is 25°C (77°F) with an excursion permitted to 15-30°C (59-86°F). It must be stored upright in a shielded container and doses must be aseptically withdrawn and handled. The product is manufactured by BAMF Health, Inc. in the USA.*

This is a description of a radioactive diagnostic solution for intravenous use only. The package includes a 30 mL multiple-dose vial with concentrations ranging from 10-200 mCi/mL. The solution contains 18F with a half-life of 109.7 minutes and is sterile and non-pyrogenic. Dosages should be calculated based on the date and time of calibration, and the solution should be used within 12 hours of the End of Synthesis (EOS) date. The solution should not be used if cloudy or contains particulate matter, and it should be stored at a temperature range of 15-30°C (59-86°F). The package contains information about the manufacturer and batch number.*