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AMMONIA N 13- ammonia n-13 injection, solution


  1. Manufactured By:
  2. Distributed By:
  3. Patient Information
  4. Contains:
  5. Revised: 12/2017document Id:

Manufactured By: 

Mayo Clinic PET Radiochemistry Facility
200 1stSt SW
Rochester, MN 55905

Mayo Clinic PET Radiochemistry Facility
5861 E Mayo Blvd
Phoenix, AZ 85054

Distributed By: 

Mayo Clinic PET Radiochemistry Facility
200 1stSt SW
Rochester, MN 55905

Mayo 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 Vial

Ammonia N 13 Injection, USP
3.75 mCi/mL to 37.5 mCi/mL (@ EOS*)
Activity @ EOS*: Total mCi
Volume mL
Concentration mCi/mL

Sterile, Non-pyrogenic
Calibration (EOS*) Time
Calibration Date

Diagnostic - 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 minutes

Calculate correct dosage from date and
time of calibration.

Do not use if cloudy or if it contains particulate matter.
*EOS = End of Synthesis

CAUTION: RADIOACTIVE MATERIAL

Manufactured for:
Biomedical Research Foundation of Northwest
Louisiana
Shreveport, LA 71103

Rx ONLY

PRINCIPAL DISPLAY PANEL - 30 mL Vial Label
AMMONIA N 13
ammonia n-13 injection, solution
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:24562-004
Route of AdministrationINTRAVENOUS
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Ammonia N-13(UNII: 9OQO0E343Z) (Ammonia N-13 - UNII:9OQO0E343Z)Ammonia N-1337.5 mCi in 1 mL
Inactive Ingredients
Ingredient NameStrength
Sodium Chloride(UNII: 451W47IQ8X)0.9 mg in 1 mL
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:24562-004-3030 mL in 1 VIAL, GLASS; Type 0: Not a Combination Product05/14/2015
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20435205/14/2015
Labeler -Biomedical Research Foundation of Northwest Louisiana (184750008)
Establishment
NameAddressID/FEIBusiness Operations
Biomedical Research Foundation of Northwest Louisiana Shreveport, LA077799604POSITRON 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



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