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
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| Labeler — UIHC – P E T Imaging Center (063513265) |
Revised: 12/2021 UIHC – P E T Imaging Center
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