Gallium Ga-68 PSMA-11 (Page 4 of 4)
16 HOW SUPPLIED/STORAGE AND HANDLING
How Supplied
Gallium Ga 68 Gozetotide Injection (NDC 24275-0525-1) is a clear, colorless solution, supplied in a capped glass vial containing 18.5 MBq/mL to 185 MBq/mL (0.5 mCi/mL to 5 mCi/mL) of gallium Ga 68 gozetotide at end of synthesis, in approximately 11 mL. The contents of each vial are sterile, pyrogen-free and preservative-free. The expiration date and time are provided on the container label. Use Gallium Ga 68 Gozetotide Injection within 4 hours of calibration time.
Storage and Handling
Storage
Store Gallium Ga 68 Gozetotide Injection upright in a lead shielded container at 25°C (77°F); excursions are permitted from 15°C to 30°C (59°F to 86°F). Store Gallium Ga 68 Gozetotide Injection within the original container in radiation shielding.
Handling
Receipt, transfer, handling, possession, or use of this product is subject to the radioactive material regulations and licensing requirements of the U.S. Nuclear Regulatory Commission, Agreement States, or Licensing States as appropriate.
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 Gallium Ga 68 Gozetotide Injection, in order to reduce radiation exposure [see Dosage and Administration (2.3) and Warnings and Precautions (5.2)] .
Manufactured and Distributed by:
University of California, San Francisco
UCSF Radiopharmaceutical Facility
185 Berry Street
Suite 350
San Francisco, CA 94107
415-353-4476
Drug Product Label
Vial and Radiation Shield
GALLIUM GA-68 PSMA-11 gallium ga-68 gozetotide injection, solution | |||||||||||||
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Labeler — UCSF Radiopharmaceutical Facility (831727388) |
Establishment | |||
Name | Address | ID/FEI | Operations |
UCSF Radiopharmaceutical Facility | 831727388 | positron emission tomography drug production (24275-0525) |
Revised: 11/2023 UCSF Radiopharmaceutical Facility
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