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(technetium Tc 99m generator)
Full US prescribing information
Manufacturing and analytical processes are performed and documented in accordance with site controlled procedures as approved by the U.S. FDA.
Dispensing equipment, ion chambers, and other manufacturing instruments are maintained with regular Quality Control testing and calibration including use of National Institute of Standards and Technology (NIST) Mo-99 standards.
100% of all generators are test eluted during the manufacturing process to help ensure final product specifications are met including Tc-99m assay, radionuclide impurity testing and verification of Mo-99:Tc-99m ratio.
INDICATIONS AND USAGE
Sodium Pertechnetate Tc 99m is used IN ADULTS as an agent for:
Sodium Pertechnetate Tc 99m is used IN PEDIATRIC PATIENTS as an agent for:
IMPORTANT RISK INFORMATION
WARNINGS AND PRECAUTIONS
USE IN SPECIFIC POPULATIONS
Mallinckrodt, the “M” brand mark, and the Mallinckrodt Pharmaceuticals logo are trademarks of a Mallinckrodt company. Other brands are trademarks of a Mallinckrodt company or their respective owners. © 2015 Mallinckrodt.
Mallinckrodt Pharmaceuticals is a registered business name of Mallinckrodt plc, which is registered in Ireland as a public limited company with registration number 522227 and has its registered office at Damastown, Mulhuddart, Dublin 15, Ireland.