Ammonia N 13

Ammonia N 13 Injection USP 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 0.368-0.736 GBq (10-20 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 (
  
  
  
  2.2 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 USP to allow sufficient isotope decay.
    
    
  • Administer a pharmacologic stress-inducing drug in accordance with its labeling.
    
    
  • Aseptically withdraw Ammonia N 13 Injection USP from its container and administer 0.368-0.736 GBq (10-20 mCi) of Ammonia N 13 Injection USP 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 USP and acquire images for a total of 10-20 minutes.
  ):
  
  
  
  
  
• If a rest imaging study is performed, begin the stress imaging study 40 minutes or more after the first Ammonia N 13 Injection USP to allow sufficient isotope decay.
  
  
  
  
  
• Administer a pharmacologic stress-inducing drug in accordance with its labeling.
  
  
  
  
  
• Aseptically withdraw Ammonia N 13 Injection USP from its container and administer 0.368-0.736 GBq (10-20 mCi) of Ammonia N 13 Injection USP 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 USP 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 0.138-1.387 GBq (3.75-37.5 mCi/mL)of Ammonia N 13 Injection USP 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 USP (
  
  
  
  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 USP, 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 USP has been established in pediatric patients (
  
  
  
  8.4 Pediatric Use

  The safety and effectiveness of Ammonia N 13 Injection USP 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 (2.4)

  ].
  ).
  
  

Ammonia N 13 Injection USP 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 (