Sodium Fluoride

Sodium Fluoride F 18 Injection, USP is indicated for diagnostic positron emission tomography (PET) imaging of bone to define areas of altered osteogenic activity.

• Imaging of Sodium Fluoride F 18 Injection, USP can begin 1-2 hours after administration; optimally at 1 hour post administration.

• Encourage the patient to void immediately prior to imaging the fluoride F 18 radioactivity in the lumbar spine or bony pelvis.

Multiple-dose vial containing 740-22,200 MBq/mL (20-600 mCi/mL) at EOS reference time of no-carrier-added sodium fluoride F 18 in aqueous 0.9% sodium chloride solution. Sodium Fluoride F 18 Injection, USP is a clear, colorless, sterile, pyrogen-free, and preservative-free solution for intravenous administration.

In reported clinical experience in approximately 100 children, weight based doses (2.1 MBq/kg) ranging from 18.5 MBq-148 MBq (0.5 mCi-4 mCi) were used. Sodium Fluoride F 18 was shown to localize to areas of bone turnover including rapidly growing epiphyses in developing long bones. Children are more sensitive to radiation and may be at higher risk of cancer from Sodium Fluoride F 18 Injection, USP.

Sodium Fluoride F 18 Injection, USP may increase the risk of cancer. Carcinogenic and mutagenic studies with Sodium Fluoride F 18 Injection, USP have not been performed. Use the smallest dose necessary for imaging and ensure safe handling to protect the patient and health care worker