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.

• 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 (10 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 10 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 USE IN SPECIFIC POPULATIONS

  • 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 .
  • The safety and effectiveness of Ammonia N 13
    Injection has been established in pediatric patients .

  8.1 Pregnancy

  Pregnancy Category C

  
  
  Animal reproduction studies have not been conducted with Ammonia N 13 Injection.  It is also not known whether Ammonia N 13 Injection can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity.  Ammonia N 13 Injection should be given to a pregnant woman only if clearly needed.

  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.

  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 (2.4)]].
  ).
  
  
• The safety and effectiveness of Ammonia N 13
  Injection has been established in pediatric patients (
  
  
  
  8 USE IN SPECIFIC POPULATIONS

  • 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 .
  • The safety and effectiveness of Ammonia N 13
    Injection has been established in pediatric patients .

  8.1 Pregnancy

  Pregnancy Category C

  
  
  Animal reproduction studies have not been conducted with Ammonia N 13 Injection.  It is also not known whether Ammonia N 13 Injection can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity.  Ammonia N 13 Injection should be given to a pregnant woman only if clearly needed.

  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.

  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 (2.4)]].
  ).
  
  

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.