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warnings and cautions
5 WARNINGS AND PRECAUTIONS Allergic Reactions: As with any injectable drug product, allergic reactions and anaphylaxis may occur. Emergency resuscitation equipment and personnel should be immediately available (5.1) . Cancer Risk: Sodium Fluoride F 18 Injection may increase the risk of cancer. Use the smallest dose necessary for imaging and ensure safe handling to protect the patient and health care worker (5.2) . 5.1 Allergic Reacions As with any injectable drug product, allergic reactions and anaphylaxis may occur. Emergency resuscitation equipment and personnel should be immediately available. 5.2 Cancer risk Sodium Fluoride F 18 Injection may increase the risk of cancer. Use the smallest dose necessary for imaging and ensure safe handling to protect the patient and health care worker.
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. To report SUSPECTED ADVERSE REACTIONS, contact SOFIE Co. at 1-800-753-5368 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.