SODIUM FLUORIDE F 18- sodium fluoride f-18 injection
Sodium Fluoride F 18 Injection USP is indicated for diagnostic positron emission tomography (PET) imaging of bone to define areas of altered osteogenic activity.
- Wear waterproof gloves and effective shielding when handling Sodium Fluoride F 18 Injection USP. 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 experienced 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 USP.
- The dose of Sodium Fluoride F 18 Injection USP 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) ].
2.2 Radiation Safety – Patient Preparation
- 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 subsequent to the administration of Sodium Fluoride F 18 Injection USP.
- Encourage the patient to void one-half hour after administration of Sodium Fluoride F 18 Injection USP and as frequently thereafter as possible for the next 8 hours.
- Calculate the necessary volume to administer based on calibration time and dose.
- Inspect Sodium Fluoride F 18 Injection USP visually for particulate matter and discoloration before administration, whenever solution and container permits.
- Do not administer Sodium Fluoride F 18 Injection USP 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 USP from its container.
Administer 300-450 MBq (8-12 mCi) as an intravenous injection.
In reported clinical experience in approximately 100 children, weight-based doses (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 USP 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 for Sodium Fluoride Injection USP . The bone, bone marrow and urinary bladder are considered target and critical organs.
|Organ||Estimated Radiation Dose mGy/MBq|
|Adult70 kg ||15 year56.8 kg ||10 year33.2 kg ||5 year19.8 kg ||1 year9.7 kg |
|Upper large intestine wall||0.0058||0.010||0.016||0.026||0.046|
|Lower large intestine wall||0.0012||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.
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