Gallium Ga-68 PSMA-11 (Page 4 of 4)

16 HOW SUPPLIED/STORAGE AND HANDLING

How Supplied

Gallium Ga 68 Gozetotide Injection (NDC 76394-2642-3) 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 68 gozetotide at calibration time, in approximately 12 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 3 hours of calibration time.

Storage and Handling

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.

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, Los Angeles
UCLA Biomedical Cyclotron Facility
780 Westwood Plaza
Los Angeles, CA 90095
(310) 794-7638

PRINCIPAL DISPLAY PANEL — 12 mL Vial Label

NDC # 76394-2642-3
Gallium Ga 68 Gozetotide Injection
Multiple-Dose Vial

18.5 MBq/mL to 185 MBq/mL (0.5 mCi/mL to 5 mCi/mL) @ EOS*
Activity @EOS*: Total ____ MBq ( _____ mCi) Volume ____ mL
Concentration: ____ MBq/mL ( ____ mCi/mL)
Expiration Date/Time: _______, _____ AM/PM

Sterile, Non-pyrogenic
Calibration (EOS*) Time: _____ AM/PM
Calibration Date: _____

Each mL contains 18.5 MBq to 185 MBq (0.5 mCi to
5 mCi) of gallium Ga 68 gozetotide @ EOS* and 8.3 mg of
sodium chloride.

Do not use if cloudy or if it contains particulate matter.
Recommended Dosage: See Prescribing Information.
*EOS = End of synthesis.
CAUTION: RADIOACTIVE MATERIAL

Diagnostic – For Intravenous Use Only.

Lot #: ________________
(Expires 3 hours after EOS*)

Store at 20° to 25°C (68° to 77°F);
excursions permitted to 15° to 30°C (59° to 86°F).
Store upright in a shielded container.
68Ga Half-life = 68 minutes.
Calculate correct dosage from date and time of calibration.

Rx ONLY

Manufactured by: UCLA Biomedical Cyclotron, Los Angeles, CA 90095

PRINCIPAL DISPLAY PANEL -- 12 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:76394-2642
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:76394-2642-3 12 mL in 1 VIAL, MULTI-DOSE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA212642 12/09/2020
Labeler — UCLA Biomedical Cyclotron (967798120)
Establishment
Name Address ID/FEI Operations
UCLA Biomedical Cyclotron 967798120 positron emission tomography drug production (76394-2642)

Revised: 12/2022 UCLA Biomedical Cyclotron

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