Ammonia N 13

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Uses

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.

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Other Information

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, [13N] ammonia,
has the molecular formula of 13NH3 with a molecular weight of 16.02, and has the following chemical
structure:

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 37.5mCi) of [13N]
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 0.5-1.0 picomoles (8.47-16.94 picograms) of ammonia.
11.2 Physical Characteristics
Nitrogen N13 decays by emitting positron to Carbon C13 (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 5.9 R/hr/mCi
(1.39 x 10-6 Gy/hr/kBq) 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

Sources

Ammonia N 13 Manufacturers

Spectron Mrc, Llc

Ammonia N 13 | Spectron Mrc, Llc

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 Age (years)
Adult 15 10 5 1
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 0.013 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.

No Recall
Global Isotopes, Llc D/b/a Zevacor Molecular

Ammonia N 13 | Global Isotopes, Llc D/b/a Zevacor Molecular

2.1 Rest Imaging Study Aseptically withdraw Ammonia N 13 Injection from its container and administer 10 mCi-20 mCi (0.368 GBq-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 mCi—20 mCi (0.368 GBq—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.

Table 1. N13 Absorbed Radiation Dose Per Unit Activity (rem/mCi) for Adults and Pediatric Groups

Organ

Age (Years)

Adult

15

10

5

1

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

0.013

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 operation 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. 2.1 Rest Imaging Study Aseptically withdraw Ammonia N 13 Injection from its container and administer 10 mCi-20 mCi (0.368 GBq-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 mCi—20 mCi (0.368 GBq—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.

Table 1. N13 Absorbed Radiation Dose Per Unit Activity (rem/mCi) for Adults and Pediatric Groups

Organ

Age (Years)

Adult

15

10

5

1

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

0.013

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 operation 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.

No Recall
Petnet Solutions, Inc.

Ammonia N 13 | Petnet Solutions, Inc.

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. 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.

No Recall
Houston Cyclotron Partners Lp Dba Cyclotope

Ammonia N 13 | Houston Cyclotron Partners Lp Dba Cyclotope

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 Age (Years) Adult 15 10 5 1 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. 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 Age (Years) Adult 15 10 5 1 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.

No Recall
Iba Molecular North America Inc.

Ammonia N 13 | Woonsocket Prescription Center,incorporated

to prevent motion sickness, take the first dose one hour before starting activity to prevent or treat motion sickness: 1 to 2 tablets once daily for adults and children 12 years and over, or as directed by a doctor

No Recall
Mayo Clinic

Ammonia N 13 | Actavis Pharma, Inc.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.
2.1 Hypercalcemia of Malignancy
The maximum recommended dose of Zoledronic Acid Injection in hypercalcemia of malignancy (albumin-corrected serum calcium greater than or equal to 12 mg/dL [3.0 mmol/L]) is 4 mg. The 4-mg dose must be given as a single-dose intravenous infusion over no less than 15 minutes. Patients who receive Zoledronic Acid Injection should have serum creatinine assessed prior to each treatment.

Dose adjustments of Zoledronic Acid Injection are not necessary in treating patients for hypercalcemia of malignancy presenting with mild-to-moderate renal impairment prior to initiation of therapy (serum creatinine less than 400 µmol/L or less than 4.5 mg/dL).

Patients should be adequately rehydrated prior to administration of Zoledronic Acid Injection [see Warnings and Precautions (5.2)].

Consideration should be given to the severity of, as well as the symptoms of, tumor-induced hypercalcemia when considering use of Zoledronic Acid Injection. Vigorous saline hydration, an integral part of hypercalcemia therapy, should be initiated promptly and an attempt should be made to restore the urine output to about 2 L/day throughout treatment. Mild or asymptomatic hypercalcemia may be treated with conservative measures (i.e., saline hydration, with or without loop diuretics). Patients should be hydrated adequately throughout the treatment, but overhydration, especially in those patients who have cardiac failure, must be avoided. Diuretic therapy should not be employed prior to correction of hypovolemia.

Retreatment with Zoledronic Acid Injection 4 mg may be considered if serum calcium does not return to normal or remain normal after initial treatment. It is recommended that a minimum of 7 days elapse before retreatment, to allow for full response to the initial dose. Renal function must be carefully monitored in all patients receiving Zoledronic Acid Injection and serum creatinine must be assessed prior to retreatment with Zoledronic Acid Injection [see Warnings and Precautions (5.2)].
2.2 Multiple Myeloma and Metastatic Bone Lesions of Solid Tumors
The recommended dose of Zoledronic Acid Injection in patients with multiple myeloma and metastatic bone lesions from solid tumors for patients with creatinine clearance (CrCl) greater than 60 mL/min is 4 mg infused over no less than 15 minutes every 3 to 4 weeks. The optimal duration of therapy is not known.

Upon treatment initiation, the recommended Zoledronic Acid Injection doses for patients with reduced renal function (mild and moderate renal impairment) are listed in Table 1. These doses are calculated to achieve the same area under the curve (AUC) as that achieved in patients with creatinine clearance of 75 mL/min. CrCl is calculated using the Cockcroft-Gault formula [see Warnings and Precautions (5.2)].
Table 1: Reduced Doses for Patients with Baseline CrCl Less than or Equal to 60 mL/min Baseline Creatinine Clearance (mL/min) Zoledronic Acid Injection Recommended Dose* *Doses calculated assuming target AUC of 0.66(mg•hr/L) (CrCl = 75 mL/min) greater than 60 4 mg 50 to 60 3.5 mg 40 to 49 3.3 mg 30 to 39 3 mg
During treatment, serum creatinine should be measured before each Zoledronic Acid Injection dose and treatment should be withheld for renal deterioration. In the clinical studies, renal deterioration was defined as follows:

For patients with normal baseline creatinine, increase of 0.5 mg/dL

For patients with abnormal baseline creatinine, increase of 1.0 mg/dL

In the clinical studies, Zoledronic Acid Injection treatment was resumed only when the creatinine returned to within 10% of the baseline value. Zoledronic Acid Injection should be reinitiated at the same dose as that prior to treatment interruption.

Patients should also be administered an oral calcium supplement of 500 mg and a multiple vitamin containing 400 international units of vitamin D daily.
2.3 Preparation of Solution
Zoledronic Acid Injection must not be mixed with calcium or other divalent cation-containing infusion solutions, such as Lactated Ringer’s solution, and should be administered as a single intravenous solution in a line separate from all other drugs.

4 mg/5 mL Single-Use Vial

Vials of Zoledronic Acid Injection concentrate for infusion contain overfill allowing for the withdrawal of 5 mL of concentrate (equivalent to 4 mg zoledronic acid). This concentrate should immediately be diluted in 100 mL of sterile 0.9% Sodium Chloride, USP, or 5% Dextrose Injection, USP, following proper aseptic technique, and administered to the patient by infusion. Do not store undiluted concentrate in a syringe, to avoid inadvertent injection.

To prepare reduced doses for patients with baseline CrCl less than or equal to 60 mL/min, withdraw the specified volume of the Zoledronic Acid Injection concentrate from the vial for the dose required (see Table 3).
Table 3: Preparation of Reduced Doses – Zoledronic Acid Injection Concentrate Remove and Use Zoledronic Acid Injection Volume (mL) Dose (mg) 4.4 3.5 4.1 3.3 3.8 3.0
The withdrawn concentrate must be diluted in 100 mL of sterile 0.9% Sodium Chloride, USP, or 5% Dextrose Injection, USP.

If not used immediately after dilution with infusion media, for microbiological integrity, the solution should be refrigerated at 2°C to 8°C (36°F to 46°F). The refrigerated solution should then be equilibrated to room temperature prior to administration. The total time between dilution, storage in the refrigerator, and end of administration must not exceed 24 hours.
2.4 Method of Administration
Due to the risk of clinically significant deterioration in renal function, which may progress to renal failure, single doses of Zoledronic Acid Injection should not exceed 4 mg and the duration of infusion should be no less than 15 minutes [see Warnings and Precautions (5.3)]. In the trials and in postmarketing experience, renal deterioration, progression to renal failure and dialysis, have occurred in patients, including those treated with the approved dose of 4 mg infused over 15 minutes. There have been instances of this occurring after the initial Zoledronic Acid Injection dose.

No Recall
Shertech Laboratories, Llc

Ammonia N 13 | Shertech Laboratories, Llc

2.1 Rest Imaging Study Aseptically withdraw Ammonia N 13 Injection from its container and administer 10 mCi – 20 mCi (0.368 GBq – 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 minutes – 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 N13 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 mCi – 20 mCi (0.368 GBq – 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 minutes – 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 Age (years) Adult 15 10 5 1 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 0.013 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 0.030 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 tissue 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.

No Recall
Washington University School Of Medicine

Ammonia N 13 | Washington University School Of Medicine

2.1 Rest Imaging Study Aseptically withdraw Ammonia N 13 Injection from its container and administer 10 mCi-20 mCi (0.368 GBq – 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 mCi-20 mCi (0.368 GBq – 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. 2.1 Rest Imaging Study Aseptically withdraw Ammonia N 13 Injection from its container and administer 10 mCi-20 mCi (0.368 GBq – 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 mCi-20 mCi (0.368 GBq – 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.

No Recall
Ucsf Radiopharmaceutical Facility

Ammonia N 13 | Ucsf Radiopharmaceutical Facility

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. 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.

No Recall
Kreitchman Pet Center

Ammonia N 13 | Kreitchman Pet Center

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 Age (years) Adult 15 10 5 1 * Upper large intestine, † Lower large intestine 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 0.013 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 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.

No Recall
The Feinstein Institute For Medical Research

Ammonia N 13 | The Feinstein Institute For Medical Research

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. 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.

No Recall
University Of California, Los Angeles

Ammonia N 13 | University Of California, Los Angeles

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, 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.
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 Age (years) Adult 15 10 5 1 * Upper large intestine, † Lower large intestine 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 0.013 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 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.

No Recall
The Johns Hopkins University

Ammonia N 13 | The Johns Hopkins University

2.1 Rest Imaging Study Aseptically withdraw Ammonia N 13 Injection from its container and administer 10 mCi-20 mCi (0.368 GBq – 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 mCi-20 mCi (0.368 GBq – 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. 2.1 Rest Imaging Study Aseptically withdraw Ammonia N 13 Injection from its container and administer 10 mCi-20 mCi (0.368 GBq – 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 mCi-20 mCi (0.368 GBq – 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.

No Recall