Sodium Fluoride F18

SODIUM FLUORIDE F18- sodium fluoride f-18 injection
Cardinal Health 414, LLC

1 INDICATIONS AND USAGE

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

2 DOSAGE AND ADMINISTRATION

2.1 Radiation Safety — Drug Handling

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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.

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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.

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Use aseptic technique to maintain sterility during all operations involved in the manipulation and administration of Sodium Fluoride F-18 Injection, USP.

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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.

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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

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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.

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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 12 hours.

2.3 Drug Preparation and Administration

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Calculate the necessary volume to administer based on calibration time and dose.

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Inspect Sodium Fluoride F-18 Injection, USP, visually for particulate matter and discoloration before administration, whenever solution and container permit.

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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.

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Aseptically withdraw Sodium Fluoride F-18 Injection, USP, from its container.

2.4 Recommended Dose for Adults

Administer 300–450 MBq (8–12 mCi) as an intravenous injection.

2.5 Recommended Dose for Pediatric Patients

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.

2.6 Radiation Dosimetry

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 [1] and the International Commission on Radiological Protection for Sodium Fluoride Injection [2]. 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 F-18 Injection, USP

* 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.
Organ	Estimated Radiation Dose mGy/MBq
	Adult 70 kg *	15 year 56.8 kg †	10 year 33.2 kg †	5 year 19.8 kg †	1 year 9.7 kg †
Adrenals	0.0062	0.012	0.018	0.028	0.052
Brain	0.0056	N/A	N/A	N/A	N/A
Bone surfaces	0.060	0.050	0.079	0.13	0.30
Breasts	0.0028	0.0061	0.0097	0.015	0.030
GI
Gallbladder wall	0.0044	N/A	N/A	N/A	N/A
Stomach wall	0.0038	0.008	0.013	0.019	0.036
Small intestine	0.0066	0.012	0.018	0.028	0.052
Upper large intestine wall	0.0058	0.010	0.016	0.026	0.046
Lower large intestine wall	0.012	0.016	0.025	0.037	0.063
Heart wall	0.0039	N/A	N/A	N/A	N/A
Kidneys	0.019	0.025	0.036	0.053	0.097
Liver	0.0040	0.0084	0.013	0.021	0.039
Lungs	0.0041	0.0084	0.013	0.020	0.039
Muscle	0.0060	N/A	N/A	N/A	N/A
Ovaries	0.011	0.016	0.023	0.036	0.063
Pancreas	0.0048	0.0096	0.015	0.023	0.044
Red marrow	0.028	0.053	0.088	0.18	0.38
Skin	0.0040	N/A	N/A	N/A	N/A
Spleen	0.0042	0.0088	0.014	0.021	0.041
Testes	0.0078	0.013	0.021	0.033	0.062
Thymus	0.0035	N/A	N/A	N/A	N/A
Thyroid	0.0044	0.0084	0.013	0.020	0.036
Urinary bladder wall	0.25	0.27	0.4	0.61	1.1
Uterus	0.019	0.023	0.037	0.057	0.099
Other tissue	N/A	0.010	0.015	0.024	0.044
Effective Dose Equivalent mSv/MBq	0.027	0.034	0.052	0.086	0.17