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

PRINCIPAL DISPLAY PANEL -- 18.5 MBq/mL Vial Label
(click image for full-size original)
GALLIUM GA-68 PSMA-11 gallium ga-68 gozetotide injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:24275-0525
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
GALLIUM GA-68 GOZETOTIDE (GALLIUM GA-68 GOZETOTIDE) GALLIUM GA-68 GOZETOTIDE 5 mCi in 1 mL
Inactive Ingredients
Ingredient Name Strength
ALCOHOL
SODIUM CHLORIDE
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:24275-0525-1 11 mL in 1 VIAL, MULTI-DOSE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA212643 12/14/2020
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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