Ammonia N 13 (Page 2 of 3)

2.5 Drug Handling

  • Inspect Ammonia N 13 Injection USP visually for particulate matter and discoloration before administration, whenever solution and container permit.

  • Do not administer Ammonia N 13 Injection USP containing particulate matter or discoloration; dispose of these unacceptable or unused preparations in a safe manner, in compliance with applicable regulations.

  • Wear sterile gloves and effective shielding when handling Ammonia N 13 Injection USP.

  • Use aseptic technique to maintain sterility during all operations involved in the manipulation and administration of Ammonia N 13 Injection USP. 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 USP, assay the dose in a properly calibrated dose calibrator.

3 DOSAGE FORMS AND STRENGTHS

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.

4 CONTRAINDICATIONS

None

5 WARNINGS AND PRECAUTIONS

5.1 Radiation Risks

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 [see Dosage and Administration (2.4)].

6 ADVERSE REACTIONS

No adverse reactions have been reported for Ammonia N 13 Injection USP 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 USP 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 USP. It is also not known whether Ammonia N 13 Injection USP can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Ammonia N 13 Injection USP 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 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.

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)].

11 DESCRIPTION

11.1 Chemical Characteristics

Ammonia N 13 Injection USP 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 NH 3 with a molecular weight of 16.02g and has the following chemical structure:

Ammonia N 13 Injection USP 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 37.5mCi) of [

Ammonia N 13 Injection USP 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 37.5mCi) of [ 13 N] ammonia, at the end of synthesis (EOS), in 0.9% aqueous sodium chloride. The pH of the solution is between 4.5 to 7.5. The recommended dose of radioactivity (0.368-0.736 GBq, 10-20 mCi) is associated with a theoretical mass dose of 0.5-1.0 picomoles (8.47-16.94 picograms) of ammonia.

11.2 Physical Characteristics

Nitrogen N 13 decays by emitting positron to Carbon C 13 (stable) and has a physical half-life of 9.96 minutes. The principal photons useful for imaging are the dual 511 keV gamma photons that are produced and emitted simultaneously in opposite direction when the positron interacts with an electron (Table 2).

Table 2: Principal Radiation Emission Data for Nitrogen 13
Radiation/Emission % Per Disintegration Energy
Positron(β+) 100 1190 keV (Max.)
Gamma(±)* 200 511 keV

*Produced by positron annihilation

The specific gamma ray constant (point source air kerma coefficient) for nitrogen N13 is 1.39 x 10 -6 Gy/hr/kBq (5.9 R/hr/mCi) at 1 cm. The half-value layer (HVL) of lead (Pb) for 511 keV photons is 4 mm. Selected coefficients of attenuation are listed in Table 3 as a function of lead shield thickness. For example, the use of 39 mm thickness of lead will attenuate the external radiation by a factor of about 1000.

Table 3: Radiation Attenuation of 511 keV Photons by lead (Pb) shielding
Shield Thickness (Pb) mm Coefficient of Attenuation
4 0.5
8 0.25
13 0.1
26 0.01
39 0.001
52 0.0001

Table 4 lists fractions remaining at selected time intervals from the calibration time. This information may be used to correct for physical decay of the radionuclide.

Table 4: Physical Decay Chart for Nitrogen N 13
Minutes Fraction Remaining
0* 1.000
5 0.706
10 0.499
15 0.352
20 0.249
25 0.176
30 0.124

*Calibration time

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