Petnet Solutions, Inc.

Petnet Solutions, Inc. Drugs

• Sodium Fluoride F 18
  

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  Sodium Fluoride F 18

  

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  2.1   Radiation Safety - Drug Handling

  Wear waterproof gloves and effective shielding when handling Sodium Fluoride F 18 Injection. 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. Use aseptic technique to maintain sterility during all operations involved in the manipulation and administration of Sodium Fluoride F 18 Injection. The dose of Sodium Fluoride F 18 Injection should be minimized consistent with the objectives of the procedure, and the nature of the radiation detection devices employed. The final dose for the patient should be calculated using proper decay factors from the time of End of Synthesis (EOS), and measured by a suitable radioactivity calibration system before administration [see Description (11.2)].

  2.2   Radiation Safety - Patient Preparation

  To minimize the radiation-absorbed dose to the bladder, encourage adequate hydration. Encourage the patient to ingest at least 500 mL of fluid immediately prior and subsequent to the administration of Sodium Fluoride F 18 Injection. Encourage the patient to void one-half hour after administration of Sodium Fluoride F 18 Injection and as frequently thereafter as possible for the next 12 hours.

  2.3   Drug Preparation and Administration 

  Calculate the necessary volume to administer based on calibration time and dose. Inspect Sodium Fluoride F 18 Injection visually for particulate matter and discoloration before administration, whenever solution and container permit. Do not administer Sodium Fluoride F 18 Injection containing particulate matter or discoloration; dispose of these unacceptable or unused preparations in a safe manner, in compliance with applicable regulations. Aseptically withdraw Sodium Fluoride F 18 Injection from its container.

  2.4   Recommended Dose for Adults

  Administer 300–450 MBq (8–12 mCi) as an intravenous injection.   

  2.5 Recommended Dose for Pediatric Patients

  In reported clinical experience in approximately 100 children, weight based doses (2.1 MBq/kg) ranging from 19 MBq–148 MBq (0.5 mCi–4 mCi) were used.

  2.6   Radiation Dosimetry

  The age/weight- based estimated absorbed radiation doses (mGy/MBq) from intravenous injection of Sodium Fluoride F 18 Injection are shown in Table 1. These estimates were calculated based on human data and using the data published by the Nuclear Regulatory Commission [1] and the International Commission on Radiological Protection for Sodium Fluoride Injection [2]. The bone, bone marrow and urinary bladder are considered target and critical organs.

  Table 1: Estimated Absorbed Radiation Doses after Intravenous Administration of Sodium Fluoride F 18 Injection Organ Estimated Radiation Dose mGy/MBq Adult 70 kg [1] 15 year 56.8 kg [2] 10 year33.2 kg [2] 5 year19.8 kg [2] 1 year 9.7 kg [2] Adrenals 0.0062 0.012 0.018 0.028 0.052 Brain 0.0056 N/A N/A N/A N/A Bonesurfaces 0.060 0.050 0.079 0.13 0.30 Breasts 0.0028 0.0061 0.0097 0.015 0.030 GI Gallbladder wall 0.0044 N/A N/A N/A N/A Stomach wall 0.0038 0.008 0.013 0.019 0.036 Small intestine 0.0066 0.012 0.018 0.028 0.052 Upper large intestine wall 0.0058 0.010 0.016 0.026 0.046 Lower large intestine wall 0.012 0.016 0.025 0.037 0.063 Heart wall 0.0039 N/A N/A N/A N/A Kidneys 0.019 0.025 0.036 0.053 0.097 Liver 0.0040 0.0084 0.013 0.021 0.039 Lungs 0.0041 0.0084 0.013 0.020 0.039 Muscle 0.0060 N/A N/A N/A N/A Ovaries 0.011 0.016 0.023 0.036 0.063 Pancreas 0.0048 0.0096 0.015 0.023 0.044 Red marrow 0.028 0.053 0.088 0.18 0.38 Skin 0.0040 N/A N/A N/A N/A Spleen 0.0042 0.0088 0.014 0.021 0.041 Testes 0.0078 0.013 0.021 0.033 0.062 Thymus 0.0035 N/A N/A N/A N/A Thyroid 0.0044 0.0084 0.013 0.020 0.036 Urinary bladder wall 0.25 0.27 0.4 0.61 1.1 Uterus 0.019 0.023 0.037 0.057 0.099 Other tissue N/A 0.010 0.015 0.024 0.044 Effective Dose Equivalent mSv/MBq 0.027 0.034 0.052 0.086 0.17

  [1] Data from Nuclear Regulatory Commission Report, Radiation Dose Estimates for Radiopharmaceuticals, NUREG/CR-6345, page 10, 1996.

  [2] Data from ICRP publication 53, Radiation Dose to Patients from Radiopharmaceuticals , Ann ICRP, Volume 18, pages 15 and 74, 1987

  2.7   Imaging Guidelines

  Imaging of Sodium Fluoride F 18 Injection can begin 1–2 hours after administration; optimally at 1 hour post administration. Encourage the patient to void immediately prior to imaging the fluoride F18 radioactivity in the lumbar spine or bony pelvis.

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• Fludeoxyglucose F 18
  

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  Fludeoxyglucose F 18

  

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  Fludeoxyglucose F18 Injection emits radiation. Use procedures to minimize radiation exposure. Calculate the final dose from the end of synthesis (EOS) time using proper radioactive decay factors. Assay the final dose in a properly calibrated dose calibrator before administration to the patient [see Description (11.2)].

  2.1 Recommended Dose for Adults 

  Within the oncology, cardiology and neurology settings, the recommended dose for adults is 5 to 10 mCi (185 to 370 MBq) as an intravenous injection.

  2.2 Recommended Dose for Pediatric Patients

  Within the neurology setting, the recommended dose for pediatric patients is 2.6 mCi, as an intravenous injection. The optimal dose adjustment on the basis of body size or weight has not been determined [see Use in Special Populations (8.4)].

  2.3 Patient Preparation

  To minimize the radiation absorbed dose to the bladder, encourage adequate hydration. Encourage the patient to drink water or other fluids (as tolerated) in the 4 hours before their PET study. Encourage the patient to void as soon as the imaging study is completed and as often as possible thereafter for at least one hour. Screen patients for clinically significant blood glucose abnormalities by obtaining a history and/or laboratory tests [see Warnings and Precautions (5.2)]. Prior to Fludeoxyglucose F 18 PET imaging in the oncology and neurology settings, instruct patient to fast for 4 to 6 hours prior to the drug’s injection. In the cardiology setting, administration of glucose-containing food or liquids (e.g., 50 to 75 grams) prior to Fludeoxyglucose F 18 Injection facilitates localization of cardiac ischemia

  2.4 Radiation Dosimetry

  The estimated human absorbed radiation doses (rem/mCi) to a newborn (3.4 kg), 1-year old (9.8 kg), 5-year old (19 kg), 10-year old (32 kg), 15-year old (57 kg), and adult (70 kg) from intravenous administration of Fludeoxyglucose F 18 Injection are shown in Table 1. These estimates were calculated based on human2 data and using the data published by the International Commission on Radiological Protection4 for Fludeoxyglucose 18F. The dosimetry data show that there are slight variations in absorbed radiation dose for various organs in each of the age groups. These dissimilarities in absorbed radiation dose are due to developmental age variations (e.g., organ size, location, and overall metabolic rate for each age group). The identified critical organs (in descending order) across all age groups evaluated are the urinary bladder, heart, pancreas, spleen, and lungs.

  Table 1. Estimated Absorbed Radiation Doses (rem/mCi) After Intravenous Administration of Fludeoxyglucose F 18 Injectiona Organ Newborn (3.4 kg) 1-year old (9.8 kg) 5-year old (19 kg) 10-year old (32 kg) 15-year old (57 kg) Adult (70 kg) Bladder wallb  4.3 1.7 0.93 0.60 0.40 0.32 Heart wall 2.4 1.2 0.70 0.44 0.29 0.22 Pancreas 2.2 0.68 0.33 0.25 0.13 0.096 Spleen 2.2 0.84 0.46 0.29 0.19 0.14 Lungs 0.96 0.38 0.20 0.13 0.092 0.064 Kidneys 0.81 0.34 0.19 0.13 0.089 0.074 Ovaries 0.80 0.8 0.19 0.11 0.058 0.053 Uterus 0.79 0.35 0.19 0.12 0.076 0.062 LLI wall * 0.69 0.28 0.15 0.097 0.060 0.051 Liver 0.69 0.31 0.17 0.11 0.076 0.058 Gallbladder wall 0.69 0.26 0.14 0.093 0.059 0.049 Small intestine 0.68 0.29 0.15 0.096 0.060 0.047 ULI wall ** 0.67 0.27 0.15 0.090 0.057 0.046 Stomach wall 0.65 0.27 0.14 0.089 0.057 0.047 Adrenals 0.65 0.28 0.15 0.095 0.061 0.048 Testes 0.64 0.27 0.14 0.085 0.052 0.041 Red marrow 0.62 0.26 0.14 0.089 0.057 0.047 Thymus 0.61 0.26 0.14 0.086 0.056 0.044 Thyroid 0.61 0.26 0.13 0.080 0.049 0.039 Muscle 0.58 0.25 0.13 0.078 0.049 0.039 Bone surface 0.57 0.24 0.12 0.079 0.052 0.041 Breast 0.54 0.22 0.11 0.068 0.043 0.034 Skin 0.49 0.20 0.10 0.060 0.037 0.030 Brain 0.29 0.13 0.09 0.078 0.072 0.070 Other tissues 0.59 0.25 0.13 0.083 0.052 0.042

  a MIRDOSE 2 software was used to calculate the radiation absorbed dose. Assumptions on the biodistribution based on data from Gallagher et al.1 and Jones et al.2

  b The dynamic bladder model with a uniform voiding frequency of 1.5 hours was used. *LLI = lower large intestine; **ULI = upper large intestine

  2.5 Radiation Safety – Drug Handling

  Use waterproof gloves, effective radiation shielding, and appropriate safety measures when handling Fludeoxyglucose F18 Injection 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. Calculate the final dose from the end of synthesis (EOS) time using proper radioactive decay factors. Assay the final dose in a properly calibrated dose calibrator before administration to the patient [see Description (11.2)]. The dose of Fludeoxyglucose F18 used in a given patient should be minimized consistent with the objectives of the procedure, and the nature of the radiation detection devices employed.

  2.6 Drug Preparation and Administration

  Calculate the necessary volume to administer based on calibration time and dose. Aseptically withdraw Fludeoxyglucose F18 Injection from its container. Inspect Fludeoxyglucose F18 Injection visually for particulate matter and discoloration before administration, whenever solution and container permit. Do not administer the drug if it contains particulate matter or discoloration; dispose of these unacceptable or unused preparations in a safe manner, in compliance with applicable regulations.  Use Fludeoxyglucose F 18 Injection within 12 hours from the EOS.      

  2.7 Imaging Guidelines

  Initiate imaging within 40 minutes following Fludeoxyglucose F 18 Injection administration. Acquire static emission images 30 to 100 minutes from the time of injection.

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• Ammonia N 13
  

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  Ammonia N 13

  

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  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.

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