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warnings and cautions
WARNINGS AND PRECAUTIONS SECTION for RadioGenix System 1.2 5.1 Radiation Exposure Risk Sodium Pertechnetate Tc-99m contributes to a patient's overall long-term cumulative radiation exposure. Long-term cumulative radiation exposure is associated with an increased risk of cancer. Use the lowest dose of Sodium Pertechnetate Tc-99m necessary for imaging and ensure safe handling and preparation to protect the patient and healthcare worker from unintentional radiation exposure. Encourage patients to drink fluids and void as frequently as possible after intravenous or intravesicular administration. Advise patients to blow their nose and wash their eyes with water after ophthalmic administration [see Dosage and Administration (2.1)]. Radiation risks associated with the use of Sodium Pertechnetate Tc-99m are greater in pediatric patients than in adults due to greater absorbed radiation doses and longer life expectancy. Ensure the diagnostic benefit of Sodium Pertechnetate Tc-99m outweighs these greater risks prior to administration in pediatric patients. 5.2 Unintended Mo-99 Exposure Unintended exposure to Mo-99 radiation contributes to a patient’s overall cumulative radiation dose. To minimize the risk of unintended radiation exposure, strict adherence to the eluate testing protocol is required. Use only potassium molybdate Mo 99, processing reagent, 0.9% Sodium Chloride Injection, USP, and other supplies, including kit and packs, provided by NorthStar Medical Radioisotopes, LLC. Do not administer Sodium Pertechnetate Tc 99m Injection after the 0.15 microCi of Mo 99/mCi of Tc 99m limit has been reached and discard the Sodium Pertechnetate Tc 99m Injection when the 24 hour expiration time is reached, whichever occurs earlier [see Dosage and Administration (2.7)]. 5.3 Hypersensitivity Reactions Hypersensitivity reactions, including serious signs and symptoms of anaphylaxis, following administration of Sodium Pertechnetate Tc 99m Injection have been reported. Always have cardiopulmonary resuscitation equipment and personnel available and monitor all patients for hypersensitivity reactions.
ADVERSE REACTIONS SECTION for RadioGenix System 1.2 The following adverse reactions are described elsewhere in the labeling: Radiation Exposure Risk [see Warnings and Precautions (5.1)] Unintended Mo-99 Exposure [see Warnings and Precautions (5.2)] Hypersensitivity Reactions [see Warnings and Precautions (5.3)] 6.1 Postmarketing Experience The following adverse reactions associated with the use of Sodium Pertechnetate Tc 99m Injection have been identified in postmarketing experience. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Allergic reactions (skin rash, hives, or itching) including anaphylaxis have been reported following the administration of Sodium Pertechnetate Tc-99m.