16 HOW SUPPLIED/STORAGE AND HANDLING How Supplied
POSLUMA injection is supplied as a clear, colorless solution in a multiple-dose glass vial (NDC 69932- 002-50) containing 296 MBq/mL to 5,846 MBq/mL (8 mCi/mL to 158 mCi/mL) as flotufolastat F 18 gallium in approximately 25 mL at end of synthesis. Storage and Handling Store POSLUMA at 20°C to 25°C (68°F to 77°F) [see USP Controlled Room Temperature]. Store POSLUMA in the original container in radiation shielding. The expiration date and time are provided on the container label. Use POSLUMA within 10 hours from end of synthesis. Dispose of unused POSLUMA in compliance with applicable regulations. This preparation is approved for use by persons under license by the Nuclear Regulatory Commission or the relevant regulatory authority of an Agreement State.
17 PATIENT COUNSELING INFORMATION Adequate Hydration
Instruct patients to drink a sufficient amount of water to ensure adequate hydration before their PET study and urge them to drink and urinate as often as possible during the first hours following the administration of POSLUMA, in order to reduce radiation exposure [see Dosage and Administration (2.3) and Warnings and Precautions (5.2)].
Marketed by Blue Earth Diagnostics Ltd., Oxford, OX4 4GA, UK POSLUMA ® is a registered trademark of Blue Earth Diagnostics Ltd. © 2023 Blue Earth Diagnostics Ltd. – all rights reserved.
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Reference ID: 5180081
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