Sodium Fluoride F 18 200 mCi/mL
SODIUM FLUORIDE F-18 · INJECTION · 3D Imaging Drug Design and Development LLC
Sodium Fluoride F 18 is a injection containing sodium fluoride f-18 at 200 mCi/mL, taken intravenous. Manufactured by 3D Imaging Drug Design and Development LLC.
Key Facts
- Brand Name
- Sodium Fluoride F 18
- Generic Name
- SODIUM FLUORIDE F-18
- NDC Code (Product)
76451-018- Manufacturer
- 3D Imaging Drug Design and Development LLC
- Strength
- 200 mCi/mL
- Dosage Form
- INJECTION
- Route
- INTRAVENOUS
- Marketing Status
- Application #
- ANDA203777
- Marketing Start
- 01/02/2012
Recall History
No Recall HistorySide Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
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. Sodium Fluoride F 18 Injection, USP is a radioactive diagnostic agent for positron emission tomography (PET) indicated for imaging of bone to define areas of altered osteogenic activity (1).
Dosage & Administration
2 DOSAGE AND ADMINISTRATION Sodium Fluoride F18 Injection emits radiation and must be handled with appropriate safety measures (2.1). Administer 300-450 MBq (8–12 mCi) as an intravenous injection in adults (2.4). Administer approximately 2.1 MBq/kg in children with a minimum of 19 MBq (0.5 mCi) and a maximum of 148 MBq (4 mCi) as an intravenous injection (2.5). Imaging can begin 1–2 hours after administration; optimally at one hour post administration (2.7). Encourage patients to void immediately prior to imaging the lumbar spine and bony pelvis (2.7). 2.1 Radiation Safety - Drug Handling 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 o…
Contraindications
4 CONTRAINDICATIONS None. None (4).
Drug Interactions
7 DRUG INTERACTIONS The possibility of interactions of Sodium Fluoride F 18 Injection with other drugs taken by patients undergoing PET imaging has not been studied.
Adverse Reactions
6 ADVERSE REACTIONS No adverse reactions have been reported for Sodium Fluoride F 18 Injection based on a review of the published literature, publicly available reference sources, and adverse drug reaction reporting systems. However, the completeness of these sources is not known. No adverse reactions have been reported for Sodium Fluoride F 18 Injection based on a review of the published literature, publicly available reference sources, and adverse drug reaction reporting systems (6). To report SUSPECTED ADVERSE REACTIONS, contact The University of Utah DBA Cyclotron Radiochemistry Lab Hunstman Cancer Institute at 1-801-581-8745 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Frequently Asked Questions
What is Sodium Fluoride F 18 used for?
Sodium Fluoride F 18 contains SODIUM FLUORIDE F-18. It is a injection taken intravenous. Consult your doctor for specific uses.
Is Sodium Fluoride F 18 a controlled substance?
Sodium Fluoride F 18 is not classified as a controlled substance by the DEA.
What is the generic name for Sodium Fluoride F 18?
The generic name for Sodium Fluoride F 18 is SODIUM FLUORIDE F-18. There are no other listed brand versions of SODIUM FLUORIDE F-18.
What is the NDC code for Sodium Fluoride F 18 200 mCi/mL?
The NDC (National Drug Code) for Sodium Fluoride F 18 200 mCi/mL is 76451-018, listed by 3D Imaging Drug Design and Development LLC.
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)