Ammonia N-13

Rest Imaging Study

• Aseptically withdraw Ammonia N 13 Injection from its container and administer 10-20 mCi (0.368 – 0.736 GBq) as a bolus through a catheter inserted into a large peripheral vein.
• Start imaging 3 minutes after the injection and acquire images for a total of 10-20 minutes.

Stress Imaging Study

• If a rest imaging study is performed, begin the stress imaging study 40 minutes or more after the first Ammonia N 13 injection to allow sufficient isotope decay.
• Administer a pharmacologic stress-inducing drug in accordance with its labeling.
• Aseptically withdraw Ammonia N 13 Injection from its container and administer 10-20 mCi (0.368 – 0.736 GBq) of Ammonia N 13 Injection as a bolus at 8 minutes after the administration of the pharmacologic stress-inducing drug.
• Start imaging 3 minutes after the Ammonia N 13 Injection and acquire images for a total of 10-20 minutes.

Patient Preparation

To increase renal clearance of radioactivity and to minimize radiation dose to the bladder, ensure that the patient is well hydrated before the procedure and encourage voiding as soon as a study is completed and as often as possible thereafter for at least one hour.

Radiation Dosimetry

The converted radiation absorbed doses in rem/mCi are shown in Table 1. These estimates are calculated from the Task Group of Committee 2 of the International Commission on Radiation Protection.1

Drug Handling

• Inspect Ammonia N 13 Injection visually for particulate matter and discoloration before administration, whenever solution and container permit.
• Do not administer Ammonia N 13 Injection containing particulate matter or discoloration; dispose of these unacceptable or unused preparations in a safe manner, in compliance with applicable regulations.
• Wear waterproof gloves and effective shielding when handling Ammonia N 13 Injection.
• Use aseptic technique to maintain sterility during all operations involved in the manipulation and administration of Ammonia N 13 Injection. The contents of each vial are sterile and non-pyrogenic.
• Use appropriate safety measures, including shielding, consistent with proper patient management to avoid unnecessary radiation exposure to the patient, occupational workers, clinical personnel, and other persons.
• Radiopharmaceuticals should be used by or under the control of physicians who are qualified by specific training and experience in the safe use and handling of radionuclides, and whose experience and training have been approved by the appropriate governmental agency authorized to license the use of radionuclides.
• Before administration of Ammonia N 13 Injection, assay the dose in a properly calibrated dose calibrator.

Glass vial (30 mL) containing 0.138-1.387 GBq (3.75-37.5 mCi/mL) of Ammonia N 13 Injection in aqueous 0.9 % sodium chloride solution (approximately 5 mL volume) that is suitable for intravenous administration.

Radiation Risks

Ammonia N 13 Injection may increase the risk of cancer. Use the smallest dose necessary for imaging and ensure safe handling to protect the patient and health care worker [see Dosage and Administration (2.4)].

In a descriptive, prospective, blinded image interpretation study2 of adult patients with known or suspected coronary artery disease, myocardial perfusion deficits in stress and rest PET images obtained with Ammonia N 13 (N=111) or Rubidium 82 (N=82) were compared to changes in stenosis flow reserve (SFR) as determined by coronary angiography. The principal outcome of the study was the evaluation of PET defect severity relative to SFR.

PET perfusion defects at rest and stress for seven cardiac regions (anterior, apical, anteroseptal, posteroseptal, anterolateral, posterolateral, and inferior walls) were graded on a 0 to 5 scale defined as normal (0), possible (1), probable (2), mild (3), moderate (4), and severe (5) defects. Coronary angiograms were used to measure absolute and relative stenosis dimensions and to calculate stenosis flow reserve defined as the maximum value of flow at maximum coronary vasodilatation relative to rest flow under standardized hemodynamic conditions. SFR scores ranged from 0 (total occlusion) to 5 (normal).

With increasing impairment of flow reserve, the subjective PET defect severity increased. A PET defect score of 2 or higher was positively correlated with flow reserve impairment (SFR<3).

Pre-study Hydration

Instruct patients to drink plenty of water or other fluids (as tolerated) in the 4 hours before their PET study.

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.

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 by:
Zevacor Pharma, Inc.
21000 Atlantic Boulevard, Suite 730
Dulles, Virginia, 20166, USA

Distributed by:
Zevacor Pharma, Inc.
21000 Atlantic Boulevard, Suite 730
Dulles, Virginia, 20166, USA

NDC# 49609-201-01
Multiple-Dose Vial

Ammonia N 13 Injection USP
3.75 mCi/mL to 37.5 mCi/mL @ EOS*

Activity @ EOS*: Total XXX mCi
Volume: 5 mL

Concentration XX.X mCi/mL

Sterile, Non-pyrogenic
Calibration (EOS*) Time : X:XX NN
Calibration date MM-DD-YY

Diagnostic - For Intravenous Use Only
Exp. Date/Time MM-DD-YY, X:XX NN
Lot# XXXXXXXXXX
(Expires 60 minutes after EOS*)

Contains:
0.138 GBq to 1.387 GBq (3.75 mCi/mL to 37.5 mCi/mL)
of no-carrier added Ammonia N 13 @ EOS* in
0.9% Sodium Chloride Injection

Store at 25°C (77°F) (see insert)
Store upright in a shielded container
Aseptically withdraw and handle
doses
[13N] Half-Life = 9.96 minutes
Calculate 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 by:
Zevacor Pharma, Inc.
21000 Atlantic Blvd., Suite 730
Dulles, VA 20166

Rx Only