Ammonia N 13

AMMONIA N 13- ammonia n-13 injection
University of Wisconsin System

1 INDICATIONS AND USAGE

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.

2 DOSAGE AND ADMINISTRATION

2.1 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.

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 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.

2.3 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.

2.4 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

Table 1: N 13 Absorbed Radiation Dose Per Unit Activity (rem/mCi) for Adults and Pediatric Groups.
Organ Adult 15 — year old 10 — year old 5 — year old 1 — year old
Adrenals 0.0085 0.0096 0.016 0.025 0.048
Bladder wall 0.030 0.037 0.056 0.089 0.17
Bone surfaces 0.0059 0.0070 0.011 0.019 0.037
Brain 0.016 0.016 0.017 0.019 0.027
Breast 0.0067 0.0067 0.010 0.017 0.033
Stomach wall 0.0063 0.0078 0.012 0.019 0.037
Small intestine 0.0067 0.0081 00013 0.021 0.041
*ULI 0.0067 0.0078 0.013 0.021 0.037
**LLI 0.0070 0.0078 0.013 0.020 0.037
Heart 0.0078 0.0096 0.015 0.023 0.041
Kidneys 0.017 0.021 0.031 0.048 0.089
Liver 0.015 0.018 0.029 0.044 0.085
Lungs 0.0093 0.011 0.018 0.029 0.056
Ovaries 0.0063 0.0085 0.014 0.021 0.041
Pancreas 0.0070 0.0085 0.014 0.021 0.041
Red marrow 0.0063 0.0078 0.012 0.020 0.037
Spleen 0.0093 0.011 0.019 0.030 0.056
Testes 0.0067 0.0070 0.011 0.018 0.035
Thyroid 0.0063 0.0081 0.013 0.021 0.041
Uterus 0.0070 0.0089 0.014 0.023 0.041
Other tissues 0.0059 0.0070 0.011 0.018 0.035

*Upper large intestine, **Lower large intestine

2.5 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.

3 DOSAGE FORMS AND STRENGTHS

Glass vial (10 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.

4 CONTRAINDICATIONS

None

5 WARNINGS AND PRECAUTIONS

5.1 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)].

6 ADVERSE REACTIONS

No adverse reactions have been reported for Ammonia N 13 Injection based on a review of the published literature, publicly available reference sources, and adverse drug reaction reporting systems. However, the completeness of these sources is not known.

7 DRUG INTERACTIONS

The possibility of interactions of Ammonia N 13 Injection with other drugs taken by patients undergoing PET imaging has not been studied.

8 USE IN SPECIFIC POPULATIONS

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)].

11 DESCRIPTION

11.1 Chemical Characteristics

Ammonia N 13 Injection is a positron emitting radiopharmaceutical that is used for diagnostic purposes in conjunction with positron emission tomography (PET) imaging. The active ingredient, [13 N] ammonia, has the molecular formula of 13 NH3 with a molecular weight of 16.02, and has the following chemical structure:

image description

Ammonia N 13 Injection is provided as a ready to use sterile, pyrogen-free, clear and colorless solution. Each mL of the solution contains between 0.138 GBq to 1.387 GBq (3.75 mCi to 37.5 mCi) of [13 N] ammonia, at the end of synthesis (EOS) reference time, in 0.9% aqueous sodium chloride. The pH of the solution is between 4.5 to 7.5.The recommended dose of radioactivity (10-20 mCi) is associated with a theoretical mass dose of 0.5-1 picomoles (8.47-16.94 picograms) of ammonia.

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