SODIUM FLUORIDE F-18- sodium fluoride f-18 injection
UIHC-P E T IMAGING CENTER
Sodium Fluoride F 18 Injection is indicated for diagnostic positron emission tomography (PET) imaging of bone to define areas of alterted osteogenic activity.
- Wear waterproof gloves and effective shielding when handling Sodium Fluoride F 18 Injection. Use appropriate safety measures, including shielding, consistent with proper patient management to avoid unnecessary radiation exposure to the patient, occupational workers, clinical personnel, and other persons.
- Radiopharmaceuticals should be used by or under the control of physicians who are qualified by specific training and experience in the safe use and handling of radionuclides, and whose experience and training have been approved by the appropriate governmental agency authorized to license the use of radionuclides.
- Use aseptic technique to maintain sterility during all operations involved in the manipulation and administration of Sodium Fluoride F 18 Injection.
- The dose of Sodium Fluoride F 18 Injection should be minimized consistent with the objectives of the procedure, and the nature of the radiation detection devices employed.
- The final dose for the patient should be calculated using proper decay factors from the time of End of Synthesis (EOS), and measured by a suitable radioactivity calibration system before administration [ see Description (11.2)].
- To minimize the radiation-absorbed dose to the bladder, encourage adequate hydration. Encourage the patient to ingest at least 500 mL of fluid immediately prior and subsquent to the administration Sodium Fluoride F 18 Injection.
- Encourage the patient to void one-half hour after administration of Sodium Fluoride F 18 Injection and as frequently thereafter as possible for the next 12 hours. 2.3
- Calculate the necessary volume to administer based on calibration time and dose.
- Inspect Sodium Fluoride F 18 Injection visually for particulate matter and discoloration before administration, whenever solution and container permit.
- Do not administer Sodium Fluoride F 18 Injection containing particulate matter or discoloration; dispose of these unacceptable or unused preparations in a safe manner, in compliance with applicable regulations.
- Aseptically withdraw Sodium Fluoride F 18 Injection from its container.
Administer 300-450 MBq (8-12 mCi) as an intravenous injection.
In reported clinical experience in approximately 100 children, weight based does (2.1 MBq/kg) ranging from 19 MBq-148 MBq (0.5 mCi-4 mCi) were used.
The age/weight- based estimated absorbed radiation doses (mGy/MBq) from intravenous injection of Sodium Fluoride F 18 Injection are shown in Table 1. These estimates were calculated based on human data and using the data published by the Nuclear Regulatory Commission  and the International Commission on Radiological Protection of Sodium Fluoride F 18 Injection . The bone, bone marrow and urinary bladder are considered target and critical organs.
|Table 1: Estimated Absorbed Radiation Doses after Intravenous Administration of Sodium Fluoride F18 Injection|
|Organ||Estimated Radiation Dose mGy/MBq|
70 kg 
56.8 kg 
33.2 kg 
19.8 kg 
9.7 kg 
|Upper large intestine wall||0.0058||0.01||0.016||0.026||0.046|
|Lower large intestine wall||0.012||0.016||0.025||0.037||0.063|
|Urinary bladder wall||0.25||0.27||0.4||0.61||1.1|
|Effective Dose Equivalent mSv/MBq||0.027||0.034||0.052||0.086||0.17|
 Data from Nuclear Regulatory Commission Report, Radiation Dose Estimates for Radiopharmaceuticals, NUREG/CR-6345, page 10, 1996.
 Data from ICRP publication 53, Radiation Dose to Patients from Radiopharmaceuticals ,Ann ICRP, Volume 18, pages 15 and 74, 1987
- Imaging for Sodium Fluoride F 18 Injection can begin 1-2 hours after administration; optimally at 1 hour post administration.
- Encourage the patient to void immediately prior to imaging the fluoride F18 radioactivity in the lumbar spine or bony pelvis.
Multiple-dose vial containing 370-,400 MBq/mL (10-200 mCi/mL) at EOS reference time of no-carrier-added sodium fluoride F18 in aqueous 0.9% sodium chloride solution. Sodium Fluoride F 18 Injection is a clear, colorless, sterile, pyrogen-free and preservative-free solution for intravenous administration.
As with any injectable drug product, allergic reactions and anaphylaxis may occur. Emergency resuscitation equipment and personnel should be immediately available.
Sodium Fluoride F 18 Injection may increase the risk of cancer. Carcinogenic and mutagenic studies with Sodium Fluoride F 18 Injection have not been performed. Use the smallest dose necessary for imaging and ensure safe handling to protect the patient and health care worker [see Dosage and Administration (2.1)].
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