Ga-68-DOTATOC (Page 4 of 4)

16 HOW SUPPLIED/STORAGE AND HANDLING

Ga 68 DOTATOC Injection is supplied in a multiple-dose, capped 30 mL glass vial containing 18.5 MBq/mL to 148 MBq/mL (0.5 mCi/mL to 4 mCi/mL) of Ga 68 DOTATOC at calibration time in approximately 14 mL of solution (NDC 24417-681-30).

Store Ga 68 DOTATOC Injection upright in a lead shielded container at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F).

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. Store and dispose of Ga 68 DOTATOC Injection in accordance with the regulations and a general license, or its equivalent, of an Agreement State or a Licensing State.

17 PATIENT COUNSELING INFORMATION

Radiation Risk

Advise patients to drink water to ensure adequate hydration prior to their PET study and recommend they drink and urinate as often as possible during the first hours following the administration of Ga 68 DOTATOC Injection, in order to reduce radiation exposure [see Dosage and Administration (2.3) and Warnings and Precautions (5.1)].

Lactation

Advise a lactating woman to interrupt breastfeeding and pump and discard breast milk for 8 hours after Ga 68 DOTATOC Injection administration in order to minimize radiation exposure to a breastfed infant [see Use in Specific Populations (8.2)].

Manufactured and Distributed by:
UIHC – P E T Imaging Center
0911Z JPP
200 Hawkins Drive
Iowa City, IA 52242

PRINCIPAL DISPLAY PANEL — 14 mL Vial Label

DOTATOC Ga 68 INJECTION

BATCH#
Diagnostic — For intravenous Use Only
Contains: 18.5 MBq/mL to 148 MBq/mL (0.5 mCi/mL to 4 mCi/mL) of no-carrier
added Ga-68 DOTATOC @ end of synthesis; 9 mg/mL of sodium chloride

Rx ONLY

Sterile, non-pyrogenic

Multiple-dose Vial

NDC# 24417-681-30

Manufactured by:
UIHC-PET Imaging Center
200 Hawkins Drive
Iowa City, IA 52242

TOTAL ACTIVITY: mCi
TOTAL VOLUME: mL
RADIOACTIVE CONCENTRATION: mCi/mL @ EOS TIME
EOS TIME:
EXPIRATION TIME:

Store at 25°C (77°F); excursions permitted between 15°C to 30°C (59°F–86°F);
Store upright in a lead shielded container. Expires 3 hours from end of synthesis.
See full prescribing information for dosage and administration information.

Do not use if cloudy or if contains particulate matter.CAUTION: RADIOACTIVE MATERIAL

PRINCIPAL DISPLAY PANEL -- 14 mL Vial Label
(click image for full-size original)
GA-68-DOTATOC edotreotide gallium ga-68 injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:24417-681
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
EDOTREOTIDE GALLIUM GA-68 (EDOTREOTIDE GALLIUM GA-68) EDOTREOTIDE GALLIUM GA-68 4 mCi in 1 mL
Inactive Ingredients
Ingredient Name Strength
ALCOHOL
sodium chloride
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:24417-681-30 14 mL in 1 VIAL, MULTI-DOSE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA210828 09/01/2019
Labeler — UIHC – P E T Imaging Center (063513265)

Revised: 12/2021 UIHC – P E T Imaging Center

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