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warnings and cautions
5 WARNINGS AND PRECAUTIONS Ammonia N 13 Injection, USP 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) . 5.1 Radiation Risks Ammonia N 13 Injection, USP 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 [ see Dosage and Administration (2.4) ].
6 ADVERSE REACTIONS No adverse reactions have been reported for Ammonia N 13 Injection, USP 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 Ammonia N 13 Injection, USP based on a review of the published literature, publicly available reference sources, and adverse drug reaction reporting system (6) . To report SUSPECTED ADVERSE REACTIONS, contact NCM-USA Bronx at 212-719-2322 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.