Ammonia N 13- Ammonia N-13 injection, Solution

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.

Rest Imaging Study (

• Aseptically withdraw Ammonia N13 Injection from its container and administer 0.368 GBq-0.736 GBq (10 mCi-20 mCi) 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 0.368 GBq-0.736 GBq (10 mCi-20 mCi) 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, hydrate the patient before the procedure and encourage voiding as soon as each image acquisition is completed and as often as possible thereafter for at least one hour.

Glass vial (30 mL) containing 0.138 GBq/mL-1.387 GBq/mL (3.75 mCi/mL-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.

• It is not known whether this drug is excreted in human milk. Alternatives to breastfeeding (e.g. using stored breast milk or infant formula) should be used for 2 hours (> 10 half-lives of radioactive decay for N 13 isotope) after administration of Ammonia N 13 Injection (
  8.3 Nursing Mothers

  It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk and because of the potential for radiation exposure to nursing infants from Ammonia N 13 Injection, use alternative infant nutrition sources (e.g. stored breast milk or infant formula) for 2 hours (>10 half-lives of radioactive decay for N 13 isotope) after administration of the drug or avoid use of the drug, taking into account the importance of the drug to the mother.
  ).
• The safety and effectiveness of Ammonia N 13 Injection has been established in pediatric patients (
  8.4 Pediatric Use

  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

  [see Dosage and Administration ]

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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 (