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Kit for the Preparation of Technetium Tc 99m Pentetate Injection, after radiolabeling with Technetium Tc 99m, is indicated for Kit for the Preparation of Technetium Tc 99m Pentetate Injection. Technetium Tc 99m pentetate is a radioactive diagnostic agent indicated for: Brain imaging in adults ( 1.1 ). Renal visualization, assessment of renal perfusion, and estimation of glomerular filtration rate in adult and pediatric patients ( 1.2 ). Lung ventilation imaging and evaluation of pulmonary embolism when paired with perfusion imaging in adult and pediatric patients ( 1.3 ). 1.1 Brain Imaging Brain imaging in adults by intravenous administration. 1.2 Renal Scintigraphy Renal visualization, assessment of renal perfusion, and estimation of glomerular filtration rate in adult and pediatric patients by intravenous administration. 1.3 Lung Ventilation Imaging Lung ventilation imaging and evaluation of pulmonary embolism when paired with perfusion imaging in adult and pediatric patients when administered by nebulizer for inhalation.

Hypersensitivity to the active ingredient or to any component of the product [ see Warnings and Precautions ( 5.1 ) ] . Hypersensitivity to the active ingredient or any component of this product ( 4 ).

Hypersensitivity reactions: Hypersensitivity reactions, including anaphylaxis, have been reported during post-approval diagnostic use of Technetium Tc 99m pentetate injection. Monitor all patients for hypersensitivity reactions ( 5.1 ). Image interpretation risks in lung ventilation studies: If proximal airway deposition is observed, consider additional diagnostic options ( 5.2 ). Radiation exposure risk: Technetium Tc 99m pentetate contributes to a patient’s overall long-term radiation exposure ( 2.1 , 2.3 , 5.3 ). Bronchospasm in lung ventilation studies: Inhalation of Technetium Tc 99m pentetate solution may result in acute bronchoconstriction, especially in patients with heightened bronchoreactivity ( 5.4 ). 5.1 Hypersensitivity Reactions Hypersensitivity reactions, including anaphylaxis, have been reported during post-approval diagnostic use of Technetium Tc 99m pentetate injection. Monitor all patients for hypersensitivity reactions and have access to cardiopulmonary resuscitation equipment and personnel. 5.2 Image Interpretation Risks in Lung Ventilation Studies In patients with obstructive pulmonary disease there may be deposition of particles in the proximal airways influencing image quality and interfering with diagnostic interpretation, therefore to ensure diagnostic quality, careful use of the nebulizer to assure optimal particle delivery is essential. If interfering particle deposition occurs, consider additional diagnostic options. 5.3 Radiation Exposure Risk …

8.1 Pregnancy Risk Summary Limited available data with Technetium Tc 99m pentetate use in pregnant women are insufficient to inform a drug associated risk for major birth defects and miscarriage. Technetium Tc 99m pentetate is transferred across the placenta ( see Data ) . No animal reproductive studies have been conducted with Technetium Tc 99m pentetate. All radiopharmaceuticals have the potential to cause fetal harm depending on the fetal stage of development and the magnitude of the radiation dose. If considering Technetium Tc 99m pentetate administration to a pregnant woman, inform the patient about the potential for adverse pregnancy outcomes based on the radiation dose from …