Ammonia N 13

Ammonia N 13 Injection is indicated for diagnostic
Positron Emission Tomography (PET) imaging of the myocardium under rest or
pharmacologic stress conditions to evaluate myocardial perfusion in patients
with suspected or existing coronary artery disease.

• 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 (25 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 8 mL volume) that is suitable for intravenous administration.

The safety and effectiveness of Ammonia N 13 Injection has been established in pediatric patients based on known metabolism of ammonia, radiation dosimetry in the pediatric population, and clinical studies in adults

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