Manufactured By: ⮝
Mayo Clinic PET Radiochemistry Facility
200 1stSt SW
Rochester, MN 55905Mayo Clinic PET Radiochemistry Facility
5861 E Mayo Blvd
Phoenix, AZ 85054
Distributed By: ⮝
Mayo Clinic PET Radiochemistry Facility
200 1stSt SW
Rochester, MN 55905Mayo Clinic PET Radiochemistry Facility
5861 E Mayo Blvd
Phoenix, AZ 85054
Patient Information ⮝
17.1 Pre-study Hydration
Instruct patients to drink plenty of water or other fluids (as tolerated) in the 4 hours before their PET study.
17.2 Post-study Voiding
Instruct patients to void after completion of each image acquisition session and as often as possible for one hour after the PET scan ends.
17.3 Post-study Breastfeeding Avoidance
Instruct nursing patients to substitute stored breast milk or infant formula for breast milk for 2 hours after administration of Ammonia N 13 Injection.
Manufactured and Distributed by: Biomedical Research Foundation of Northwest Louisiana, Shreveport, LA 71103
Revised: May 2015
PRINCIPAL DISPLAY PANEL - 30 mL Vial Label
NDC#24562-004-30
Multiple-Dose VialAmmonia N 13 Injection, USP
3.75 mCi/mL to 37.5 mCi/mL (@ EOS*)
Activity @ EOS*: Total mCi
Volume mL
Concentration mCi/mLSterile, Non-pyrogenic
Calibration (EOS*) Time
Calibration DateDiagnostic - For Intravenous Use Only
Exp. Date/Time
Lot#
(Expires 60 minutes after EOS*)
Contains: ⮝
0.138 GBq to 1.387GBq (3.75 mCi to 37.5 mCi) of
Ammonia N 13 @ EOS* in 0.9% aqueous sodium
chloride per mL.Store at 20 to 25 C (68 to 77 F);
excursions permitted to 15-30 C
(59-86 F) [See USP Controlled Room
Temperature]
Store upright in a shielded container.
Aseptically withdraw and handle doses.
[12N] Half-Life = 9.96 minutesCalculate correct dosage from date and
time of calibration.Do not use if cloudy or if it contains particulate matter.
*EOS = End of SynthesisCAUTION: RADIOACTIVE MATERIAL
Manufactured for:
Biomedical Research Foundation of Northwest
Louisiana
Shreveport, LA 71103Rx ONLY
AMMONIA N 13
ammonia n-13 injection, solution
Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:24562-004 Route of Administration INTRAVENOUS
Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Ammonia N-13(UNII: 9OQO0E343Z) (Ammonia N-13 - UNII:9OQO0E343Z) Ammonia N-13 37.5 mCi in 1 mL
Inactive Ingredients Ingredient Name Strength Sodium Chloride(UNII: 451W47IQ8X) 0.9 mg in 1 mL
Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:24562-004-30 30 mL in 1 VIAL, GLASS; Type 0: Not a Combination Product 05/14/2015
Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA204352 05/14/2015
Labeler -Biomedical Research Foundation of Northwest Louisiana (184750008)
Establishment Name Address ID/FEI Business Operations Biomedical Research Foundation of Northwest Louisiana Shreveport, LA 077799604 POSITRON EMISSION TOMOGRAPHY DRUG PRODUCTION(24562-004) , ANALYSIS(24562-004) , MANUFACTURE(24562-004)
Revised: 12/2017document Id: ⮝
96e9bde0-681a-452c-9514-6e2ec4ab2c0eSet id: a4a2bb1a-1ecc-48e4-a87b-60fc583f61ceVersion: 5Effective Time: 20171213Biomedical Research Foundation of Northwest Louisiana