Medi-physics Inc.

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Medi-physics Inc. Drugs

Adreview

Adreview

2.1 Radiation Safety

AdreView emits radiation and must be handled with appropriate safety measures to minimize radiation exposure to clinical personnel and patients. 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 government agency authorized to license the use of radionuclides. AdreView dosing is based upon the radioactivity determined using a suitable calibration system immediately prior to administration.

To minimize radiation dose to the bladder, prior to and following AdreView administration, encourage hydration to permit frequent voiding. Encourage the patient to void frequently for the first 48 hours following AdreView administration [see Clinical Pharmacology (12.2)].

2.2 Thyroid Blockade

Before administration of AdreView to patients at risk for thyroid accumulation of the drug, administer Potassium Iodide Oral Solution or Lugol's Solution (equivalent to 100 mg iodide for adults, body-weight adjusted for children) or potassium perchlorate (400 mg for adults, body-weight adjusted for children) to block uptake of iodine 123 by the patient's thyroid. Administer the blocking agent at least one hour before the dose of AdreView [see Warnings and Precautions (5.6)]. Individualize thyroid blockade; for example, the blockade may not be necessary for patients who have undergone thyroidectomy or those with a very limited life expectancy.

2.3 Preparation and Administration

Inspect the AdreView vial for particulate matter and discoloration prior to administration. Use aseptic procedures and a radiation shielding syringe during administration. Administer the dose as an intravenous injection over 1 to 2 minutes. A subsequent injection of 0.9% sodium chloride may be used to ensure full delivery of the dose.

2.4 Recommended Dose for Adults

For adults (≥ 16 years of age), the recommended dose is 10 mCi (370 MBq) [see Clinical Studies (14.1, 14.2)].

2.5 Recommended Dose for Pediatric Patients

For pediatric patients < 16 years of age weighing ≥ 70 kg, the recommended dose is 10 mCi (370 MBq) [see Clinical Studies (14.1)].

For pediatric patients < 16 years of age weighing < 70 kg, the recommended dose should be calculated according to patient body weight as shown in Table 1 [see Clinical Studies (14.1)]. The benzyl alcohol in AdreView may cause serious adverse reactions in premature or low birth-weight infants [see Warnings and Precautions (5.3)].
Table 1. AdreView Dose Preparation for Pediatric Patients* Weight (kg) Fraction of adult activity AdreView (mCi) pediatric dose AdreView (MBq) pediatric dose * Based on a reference activity for an adult scaled to body weight according to the schedule proposed by the European Association of Nuclear Medicine Paediatric Task Group. 3 0.1 1 37 4 0.14 1.4 52 6 0.19 1.9 70 8 0.23 2.3 85.1 10 0.27 2.7 99.9 12 0.32 3.2 118.4 14 0.36 3.6 133.2 16 0.4 4 148 18 0.44 4.4 162.8 20 0.46 4.6 170.2 22 0.5 5 185 24 0.53 5.3 196.1 26 0.56 5.6 207.2 28 0.58 5.8 214.6 30 0.62 6.2 229.4 32 0.65 6.5 240.5 34 0.68 6.8 251.6 36 0.71 7.1 262.7 38 0.73 7.3 270.1 40 0.76 7.6 281.2 42 0.78 7.8 288.6 44 0.8 8 296 46 0.82 8.2 303.4 48 0.85 8.5 314.5 50 0.88 8.8 325.6 52 0.9 9 333 54 0.9 9 333 56 0.92 9.2 340.4 58 0.92 9.2 340.4 60 0.96 9.6 355.2 62 0.96 9.6 355.2 64 0.98 9.8 362.6 66 0.98 9.8 362.6 68 0.99 9.9 366.3
2.6 Radiation Dosimetry

The estimated absorbed radiation doses to adults and children from intravenous administration of AdreView are as shown in Table 2:
Table 2. Estimated Absorbed Radiation Dose from AdreView ORGAN / TISSUE ABSORBED DOSE PER UNIT ADMINISTERED ACTIVITY ADULT 15-YEAR OLD 10-YEAR OLD 5-YEAR OLD 1-YEAR OLD NEONATES μGy/MBq rad/mCi μGy/MBq rad/mCi μGy/MBq rad/mCi μGy/MBq rad/mCi μGy/MBq rad/mCi μGy/MBq rad/mCi *OLINDA/EXM calculation based on biodistribution data from Swanson et al. and Publication 53 of the ICRP (International Commission on Radiological Protection) [Annals of the ICRP 1987; 18 (1-4): 329-331] Adrenals 16 0.059 21 0.078 31 0.115 42 0.155 67 0.248 111 0.411 Brain 3.9 0.014 4.9 0.018 8.1 0.030 13 0.048 24 0.089 55.9 0.207 Breast 4.7 0.017 5.9 0.022 9.4 0.035 15 0.056 28 0.104 65.3 0.242 Gallbladder 20 0.074 24 0.089 34 0.126 51 0.189 95 0.352 200 0.740 GI Tract Stomach Wall 7.6 0.028 10 0.037 17 0.063 27 0.100 51 0.189 114 0.422 Small Intestine Wall 7.7 0.028 9.8 0.036 16 0.059 25 0.093 46 0.170 104 0.385 Colon Wall 8.1 0.030 10 0.037 16 0.059 26 0.096 46 0.170 104.3 0.386 Upper Large Intestine Wall 8.4 0.031 11 0.041 18 0.067 30 0.111 53 0.196 119 0.440 Lower Large Intestine Wall 7.7 0.028 9.6 0.036 15 0.056 21 0.078 38 0.141 84.9 0.314 Heart Wall 18 0.067 23 0.085 35 0.130 53 0.196 94 0.348 182 0.673 Kidneys 13 0.048 16 0.059 24 0.089 35 0.130 59 0.218 132 0.488 Liver 67 0.248 87 0.322 130 0.481 180 0.666 330 1.221 720 2.664 Lungs 16 0.059 23 0.085 32 0.118 48 0.178 89 0.329 215 0.796 Muscles 6 0.022 7.6 0.028 12 0.044 17 0.063 33 0.122 75.1 0.278 Esophagus 6 0.022 7.6 0.028 11 0.041 18 0.067 32 0.118 72.2 0.267 Osteogenic Cells 16 0.059 21 0.078 31 0.115 47 0.174 100 0.370 254 0.940 Ovaries 7.9 0.029 10 0.037 15 0.056 22 0.081 41 0.152 92.3 0.342 Pancreas 12 0.044 15 0.056 25 0.093 39 0.144 68 0.252 143 0.529 Red marrow 5.6 0.021 6.8 0.025 10 0.037 15 0.056 30 0.111 89.5 0.331 Skin 3.7 0.014 4.4 0.016 7.1 0.026 11 0.041 21 0.078 53.1 0.196 Spleen 20 0.074 27 0.100 42 0.155 64 0.237 110 0.407 282 1.043 Testes 5.4 0.020 7.1 0.026 11 0.041 16 0.059 30 0.111 69.9 0.259 Thymus 6 0.022 7.6 0.028 11 0.041 18 0.067 32 0.118 72.2 0.267 Thyroid 4.7 0.017 6.1 0.023 9.9 0.037 16 0.059 30 0.111 69.4 0.257 Urinary Bladder Wall 66 0.244 84 0.311 110 0.407 110 0.407 200 0.740 478.0 1.769 Uterus 11 0.041 14 0.052 21 0.078 28 0.104 51 0.189 110.0 0.407 Whole Body 8.1 0.030 10 0.037 16 0.059 24 0.089 44 0.163 104.0 0.385 EFFECTIVE DOSE µSv/MBq 13.7 18.1 26.7 37.6 68 162 mSv/mCi 0.507 0.670 0.988 1.39 2.52 6
The effective dose resulting from an administered activity amount of 10 mCi is 5.07 mSv in an adult.

2.7 Imaging Guidelines

Pheochromocytoma and Neuroblastoma

Begin whole body planar scintigraphy imaging 24 ± 6 hours following administration of AdreView. Single photon emission computed tomography (SPECT) may be performed following planar scintigraphy, as appropriate [see Clinical Studies (14.1)].

Congestive Heart Failure

Begin anterior planar imaging of the chest at 4 hours (± 10 minutes) following administration of AdreView. Single photon emission computed tomography (SPECT) can then be performed. The recommended collimator for all imaging is a low-energy high-resolution. The recommended matrix for planar images is 128×128. The camera should be positioned to include the entire heart and as much of the upper chest as possible within the field of view [see Clinical Studies (14.2)].

2.8 Estimation of the H/M Ratio among Patients with Congestive Heart Failure

Initial evaluation of cardiac AdreView images involves visual examination of the location, pattern and intensity of cardiac radioactivity uptake to guide quantitative assessment (see Step 1 below). Perform quantitative assessment of radioactivity uptake in terms of the heart/mediastinum ratio (H/M) on anterior planar images of the chest (see Step 2 below).

Step 1. Visual Guidelines for AdreView Cardiac Uptake on Anterior Planar Chest Images
a. Normal: Distinct visualization of the left ventricular myocardium in the left lower chest, with greater uptake in the heart than in the adjacent lungs and mediastinum (Figure 1). Figure 1. Normal anterior planar AdreView image of the chest

b. Abnormal: Homogeneously or heterogeneously decreased cardiac uptake, with indistinct or absent visualization of the left ventricular myocardium. Cardiac activity is usually less than or equal to that of the adjacent left lung (Figure 2a). In extreme cases, little or no AdreView uptake is seen in the left lower chest (Figure 2b). Figure 2. Abnormal anterior planar AdreView images of the chest: a) Heterogeneously reduced cardiac uptake; b) Absent cardiac uptake Figure 2a

Figure 2b

Step 2. Quantitate AdreView Cardiac Uptake

The AdreView H/M ratio is determined from the activity in heart (H) and mediastinum (M) regions of interest (ROIs) drawn on the anterior planar chest image (Figure 3) using the following procedure:
(1) Draw an irregular ROI defining the epicardial border of the heart. If the epicardial border cannot be defined because all or the majority of the myocardium is not visualized, draw the ROI based upon the presumed location of the heart, using the medial aspects of the left and right lower lung for anatomical guidance. (2) Draw a horizontal line to mark the estimated location of the lung apices. If the most superior aspect of the image does not include the lung apices (because of limited field of view for a small gamma camera), draw this line at the top of the image display. (3) Draw a vertical line approximately equidistant from the medial aspects of the right and left lung. (4) Examine the counts for the 12 pixels along the vertical line starting 4 pixels below the intersection point with the horizontal line determined in step 2, and identify the pixel with the lowest counts. If more than one pixel has this same number of counts, choose the most superiorly located pixel. (5) Using the pixel defined in step 4 as the center, draw a square ROI of 7×7 dimensions. (6) Calculate the H/M ratio by dividing the counts/pixel in the total myocardium ROI determined in step 1 by the counts/pixel in the 7×7 pixel mediastinal ROI determined in step 5.
Figure 3. Illustration of creation of regions of interest for determination of the H/M ratio

Step 3. Interpretation of AdreView H/M Ratio

The expected range for AdreView H/M ratio is 1.0 to 2.4 [see Clinical Studies (14.2)].

Figure 4. Examples of AdreView Images in Subjects with Lower One and Two Year Mortality Risk
Ceretec

Ceretec

Tc99m labeled leukocytes for adjunctive localization of intra-abdominal infection or inflammation.

The normal adult (70 kg) dose is 0.259-0.925 GBq (7-25 mCi) as Tc99m labeled leukocytes by intravenous injection. Optimal planar imaging is between 2-4 hours. Do not use methylene blue in the preparation of the Tc99m labeled leukocytes (See preparation and handling section).

Cerebral Scintigraphy

The recommended dose range for i.v. administration, of reconstituted sodium pertechnetate Tc99m exametazime (with or without methylene blue) in the average adult (70 kg) is 370-740 MBq (10-20 mCi).

Dynamic imaging may be performed between 0 to 10 minutes following injection. Static imaging may be performed from 15 minutes up to 6 hours after injection.
Metastron

Metastron

The recommended dose of Metastron is 148 MBq, 4 mCi, administered by slow intravenous injection (1-2 minutes).

Alternatively, a dose of 1.5 - 2.2 MBq/kg, 40-60 µCi/kg body weight may be used.

Repeated administrations of Metastron should be based on an individual patient's response to therapy, current symptoms, and hematologic status, and are generally not recommended at intervals of less than 90 days.

The patient dose should be measured by a suitable radioactivity calibration system immediately prior to administration.
Indiclor

Indiclor

Please refer to the package insert for ProstaScint or Zevalin for this information on the final drug product.
Gabapentin

Gabapentin

2.1 Radiation Safety - Drug Handling

Vizamyl is a radioactive drug and should be handled with safety measures to minimize radiation exposure during administration [see Warnings and Precautions (5.3)]. Use waterproof gloves and effective shielding, including lead-glass syringe shields when handling and administering Vizamyl. To minimize radiation dose to the bladder, encourage patients to hydrate before and after Vizamyl administration in order to permit frequent voiding. Encourage patients to void before and after imaging with Vizamyl and frequently thereafter for 24 hours following Vizamyl administration.

Radiopharmaceuticals, including Vizamyl, should be used by or under the control of physicians who are qualified by specific training and experienced in the safe use and handling of radioactive materials, and whose experience and training have been approved by the appropriate governmental agency authorized to license the use of radiopharmaceuticals.

2.2 Recommended Dosing and Administration Procedures

The recommended dose for Vizamyl is 185 megabecquerels (MBq) [5 millicuries (mCi)] in a maximum dose volume of 10 mL, administered as a single intravenous bolus within 40 seconds. The maximum mass dose is 20 micrograms. Follow the injection with an intravenous flush of 5 to 15 mL of 0.9% sterile sodium chloride injection.
Use aseptic technique and radiation shielding to withdraw and administer Vizamyl solution. Calculate the necessary volume to administer based on calibration time and dose using a suitably calibrated instrument. Visually inspect Vizamyl for particulate matter and discoloration prior to administration. Do not administer Vizamyl if it contains particulate matter or is discolored [see Description (11)]. Do not dilute Vizamyl. Dispose of unused product in a safe manner in compliance with applicable regulations [see How Supplied/Storage and Handling (16)].
2.3 Imaging Acquisition Guidelines

A 20-minute PET image should be acquired starting 90 minutes after Vizamyl injection, using a PET scanner in 3-D mode with appropriate data corrections. Position the patient supine with the brain (including the cerebellum) within a single field of view. The patient's head should be tilted so that the anterior commissure-posterior commissure (AC-PC) plane is at right angles to the bore-axis of the PET scanner, with the head positioned in a suitable head support. Reducing head movement with tape or other flexible head restraints may be employed.

Iterative or filtered back-projection reconstruction is recommended with a slice thickness of 2 to 4 mm, matrix size of 128 x 128 with pixel sizes of approximately 2 mm. Where a post-smoothing filter is applied, a full width half maximum (FWHM) of not more than 5 mm is recommended; filter FWHM should be chosen to optimize the signal-to-noise ratio while preserving the sharpness of the reconstructed image.

2.4 Image Orientation and Display

Image Orientation

Orient axial and coronal images to show symmetry of brain structures, with equal heights of structures bilaterally. Orient sagittal images so that the head and neck are neither flexed nor extended; the anterior and posterior aspects of the corpus callosum should be parallel to the AC-PC line as shown in Figure 2.

Image Display
Display images with all planes (axial, sagittal and coronal planes) linked by crosshairs. Select a color scale that provides a progression of low through high intensity (e.g., rainbow or Sokoloff). The selected color scale should (1) provide colors that allow the reader to discriminate intensity levels above and below the intensity level of the pons, (2) provide a color for regions with little or no amyloid binding such as the cerebellar cortex, and (3) provide a range of at least five distinct colors above 50 to 60% of the peak intensity. Display the reference scale. Adjust the color scale to set the pons to approximately 90% maximum intensity. The cerebellar cortex should represent approximately 20-30% of peak intensity on both negative and positive Vizamyl scans. Briefly display axial brain slices from bottom to top and look for signs of atrophy. Systematically review the following brain regions (recommended plane) for flutemetamol F18 uptake as described in Image Interpretation below: Frontal lobes (axial, with optional sagittal plane view) Posterior cingulate and precuneus (sagittal, with optional coronal plane view) Lateral temporal lobes (axial, with optional coronal plane view) Inferolateral parietal lobes (coronal, with optional axial plane view) Striatum (axial, with optional sagittal plane view)
2.5 Image Interpretation

Vizamyl images should be interpreted only by readers who successfully complete the electronic training program provided by the manufacturer [see Warnings and Precautions (5.2)]. The objective of Vizamyl image interpretation is to provide an estimate of the brain β-amyloid neuritic plaque density, not to make a clinical diagnosis. Image interpretation is performed independently of a patient's clinical features and relies upon recognition of image features in certain brain regions.

Image interpretation is based upon the distribution of radioactive signal within the brain; clinical information is not a component of image assessment [see Warnings and Precautions (5.2)]. Images are designated as positive or negative either by comparing radioactivity in cortical grey matter with activity in adjacent white matter, or based on the intensity in the five regions mentioned above. Signal uptake in the cerebellum does not contribute to scan interpretation (for example, a positive scan may show retained cerebellar grey-white contrast even when the cortical grey-white contrast is lost). Images should be viewed with the minimum image intensity set to zero and the maximum set such that the signal level in the easily identifiable pons is at 90% of maximum.

Negative scans show more radioactivity in white matter than in grey matter, creating clear grey-white matter contrast.

Specifically, a negative scan would have the following characteristics:
frontal, lateral temporal, inferolateral parietal lobes: gradual gradient from bright intensity of the white matter to lower intensity at the periphery of the brain; distinct sulci with concave surfaces (white matter sulcal pattern), and posterior cingulate and precuneus: grey matter uptake below 50-60% of peak intensity; gap of lower intensity separates two hemispheres on coronal view, and striatum: approximately 50% of peak intensity or lower in the region between the higher intensities of the thalamus and frontal white matter (striatal "gap")
Positive scans show at least one cortical region with reduction or loss of the normally distinct grey-white matter contrast. These scans have one or more regions with increased cortical grey matter signal (above 50-60% peak intensity) and/or reduced (or absent) grey-white matter contrast (white matter sulcal pattern is less distinct). A positive scan may have one or more regions in which grey matter radioactivity is as intense or exceeds the intensity in adjacent white matter.

Specifically, a positive scan would have the following characteristics:
frontal, lateral temporal, or inferolateral parietal lobes: high intensity seen to the periphery of the brain, with sharp reduction of intensity at the brain margin; sulci not distinct due to fill-in by high intensity grey matter resulting in a convex surface at the edge of the brain, or posterior cingulate and precuneus: grey matter uptake above 50-60% of peak intensity; high grey matter intensity that closes the gap between the two hemispheres on coronal view, or striatum: intensity above 50-60% of peak intensity; gap between thalamus and frontal white matter not distinct If any one of the brain regions systematically reviewed for flutemetamol F18 uptake (see Image Orientation and Display above) is positive in either hemisphere, then the scan is considered positive. Otherwise, the scan is considered negative.
Among patients with clinically important β-amyloid neuritic plaques in the brain, the temporal lobes, parietal lobes, and striatum may not be as affected compared to other brain regions. Therefore, in some images, flutemetamol F18 signal in these regions may not be as intense as in the frontal lobes or the posterior cingulate and precuneus regions.

Atrophy may affect the interpretability of scans, particularly in the frontal, temporal and parietal lobes [see Warnings and Precautions (5.2)]. For cases in which atrophy is apparent or suspected and there is uncertainty as to the location of the grey matter on the PET scan, examine the striatum for flutemetamol F18 signal as it is less affected by atrophy than other regions of the brain.

If the patient's MRI or CT brain images are available the interpreter should examine the CT or MRI images to clarify the relationship between PET flutemetamol F18 uptake and grey matter anatomy.

Other factors that may affect the ability to interpret Vizamyl images include patient factors such as brain pathology, surgical changes, post-radiation therapy changes, and implants. Some scans may be difficult to interpret due to image noise, suboptimal patient positioning, or over-smoothing of the reconstructed image.

Figure 1: Axial view of negative (left) and positive (right) Vizamyl scans. The axial slices which cut through the frontal pole and inferior aspect of the splenium are shown using a rainbow color scale. The left image shows a white matter sulcal pattern at the frontal (f) and lateral temporal (lt) regions with a color intensity that tapers to the periphery, as well as less radioactivity in the striatal region(s). The right image shows absence of the white matter sulcal pattern with intensity radiating to a sharply defined convex edge, as well as more radioactivity in the striatum. In both the frontal and lateral temporal regions, the intensity is higher in the grey matter regions of the right image compared to those of the left image.

Figure 2: Sagittal view of negative (left) and positive (right) Vizamyl scans. The sagittal slices are slightly off midline in one hemisphere and shown using a rainbow color scale. In the posterior cingulate (pc) region, which is superior and posterior to the corpus callosum (cc), the left image shows intensity below 50% of peak intensity whereas the right image shows intensity above 60% of peak intensity. The pons (p) is set to approximately 90% of the maximum intensity.

Figure 3: Coronal view of negative (left) and positive (right) Vizamyl scans. The coronal slices are located posterior to the corpus callosum. The left image shows a white matter sulcal pattern in the inferior parietal (ip) regions that is not evident in the right image. Relative to the left image, the right image shows increased intensity in the posterior cinguli (pc) and increased radial extent of high intensity to the lateral surfaces of the parietal lobes particularly evident in the inferior parietal regions.

2.6 Radiation Dosimetry

The estimated absorbed radiation doses for adult patients following intravenous injection of Vizamyl are shown in Table 1. Values were calculated from human biodistribution data using OLINDA/EXM software and assuming emptying of the urinary bladder at 3.5-hour intervals.

The adult effective dose resulting from a 185-MBq (5-mCi) Vizamyl administration is 5.92 mSv. The use of a CT scan to calculate attenuation correction for reconstruction of Vizamyl images (as done in PET/CT imaging) will add radiation exposure at the level of approximately 0.1 mSv effective dose. Diagnostic head CT scans using helical scanners administer an average of 2.2 ± 1.3 mSv effective dose. The actual radiation dose is operator and scanner dependent.
Table 1: Adult Estimated Radiation Absorbed Vizamyl Doses in Organs/Tissues Organ/Tissue Absorbed Radiation Dose Per Unit Administered ActivitymicroGy/MBq Adrenals 13 Brain 11 Breasts 5 Gallbladder wall 287 Heart wall 14 Kidneys 31 Liver 57 Lower large intestine wall 42 Lungs 16 Muscle 9 Osteogenic cells 11 Ovaries 25 Pancreas 15 Red marrow 13 Skin 5 Small intestine wall 102 Spleen 15 Stomach wall 12 Testes 8 Thymus 6 Thyroid 6 Upper large intestine wall 117 Urinary bladder wall 145 Uterus 25 Total body 12 Effective Dose 32 (microSv/MBq)
Azithromycin Monohydrat...

Azithromycin Monohydrate

Sodium Pertechnetate Tc99m Injection is usually administered by intravascular injection. For imaging the urinary bladder and ureters (direct isotopic cystography), the Sodium Pertechnetate Tc99m Injection is instilled aseptically into the bladder via a urethral catheter, following which the catheter is flushed with approximately 200 mL of sterile saline directly into the bladder. The dosage employed varies with each diagnostic procedure. When imaging the nasolacrimal drainage system, instill the Sodium Pertechnetate Tc99m Injection by the use of a device such as a micropipette or similar method which will ensure the accuracy of the dose.

The suggested dose ranges employed for various diagnostic indications in average ADULT patients (70 kg) are:
Indication Megabecquerels (MBq) Millicuries (mCi) Vesico-ureteral imaging 18.5 - 37 0.5 - 1 Thyroid gland imaging 37 - 370 1 - 10 Salivary gland imaging 37 - 185 1 - 5 Nasolacrimal drainage system imaging 3.70 (max.) 0.100 (max.) The recommended dosage ranges in PEDIATRIC PATIENTS are: Vesico-ureteral imaging 18.5 - 37 MBq (0.5 - 1 mCi) Thyroid gland imaging 2.2 - 2.96 MBq (60 - 80 µCi) per kg body weight.
The patient dose should be measured by a suitable radioactivity calibration system immediately prior to administration.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit.

The solution to be administered as the patient dose should be crystal clear and contain no particulate matter.

RADIATION DOSIMETRY

The estimated absorbed radiation doses to an average ADULT and PEDIATRIC patient from an intravenous injection of a maximum dose of 1110 MBq (30 mCi) of Sodium Pertechnetate Tc99m Injection distributed uniformly in the total body are shown in Tables 5 and 6.
Table 5. Adult Absorbed Radiation Doses (mGy) from Intravenous Administration Organ Absorbed Radiation Dose Per Unit Activity Administered (mGy/mCi) NOTE: To obtain radiation absorbed dose in rads from the above table, divide individual organ values by a factor of 10 (does not apply for effective dose). Adrenals 0.14 Urinary Bladder Wall 0.67 Bone Surfaces 0.20 Brain 0.07 Breasts 0.07 Gallbladder Wall 0.27 Stomach Wall 0.96 Small Intestine 0.59 ULI Wall 2.11 LLI Wall 7.77 Heart Wall 0.12 Kidneys 0.19 Liver 0.14 Lungs 0.09 Muscle 0.12 Ovaries 0.37 Pancreas 0.21 Red Marrow 0.13 Skin 0.07 Spleen 0.16 Testes 0.10 Thymus 0.09 Thyroid 0.81 Uterus 0.30 Remaining Tissues 0.13 Effective Dose (mSv/mCi) 0.48 Table 6. Pediatric Absorbed Radiation Doses Per Unit Activity (mGy/mCi) from Intravenous Injection Age 15 years 10 years 5 years 1 year Organ NOTE: To obtain radiation absorbed dose in rads from the above table, divide individual organ values by a factor of 10 (does not apply for effective dose). Adrenals 0.17 0.27 0.41 0.70 Urinary Bladder Wall 0.85 1.11 1.22 2.22 Bone Surfaces 0.24 0.36 0.52 0.96 Brain 0.09 0.15 0.24 0.44 Breasts 0.09 0.13 0.21 0.41 Gallbladder Wall 0.37 0.59 0.85 1.30 Stomach Wall 1.26 1.78 2.89 5.92 Small Intestine 0.74 1.15 1.74 3.03 ULI Wall 2.70 4.44 7.40 14.06 LLI Wall 1.04 1.67 2.66 4.81 Heart Wall 0.15 0.23 0.34 0.63 Kidneys 0.22 0.32 0.48 0.78 Liver 0.18 0.30 0.48 0.81 Lungs 0.13 0.19 0.29 0.52 Muscle 0.15 0.22 0.33 0.59 Ovaries 0.37 0.67 0.96 1.67 Pancreas 0.27 0.41 0.59 1.00 Red Marrow 0.17 0.24 0.33 0.56 Skin 0.08 0.13 0.21 0.37 Spleen 0.20 0.30 0.44 0.78 Testes 0.14 0.22 0.32 0.59 Thymus 0.12 0.17 0.28 0.52 Thyroid 1.33 2.04 4.44 8.14 Uterus 0.37 0.56 0.81 1.37 Remaining Tissues 0.13 0.24 0.36 0.63 Effective Dose (mSv/mCi) 0.63 0.96 1.55 2.92
The estimated absorbed radiation doses to an average ADULT from the instillation of Sodium Pertechnetate Tc99m Injection for imaging the nasolacrimal drainage system are shown in Table 7.
Table 7. Absorbed Radiation Doses from Dacryoscintigraphy Absorbed Radiation Dose Organ mGy/3.7 MBq rad/100 µCi * Assuming no blockage of drainage system. Eye Lens: If lacrimal fluid turnover is 16%/min. 0.140 0.014 If lacrimal fluid turnover is 100%/min. 0.022 0.002 If drainage system is blocked 4.020 0.402 Total Body 0.011 0.001 Ovaries* 0.030 0.003 Testes* 0.009 0.001 Thyroid* 0.130 0.013
In pediatric patients, an average 30 minute exposure to 37 MBq (1 mCi) of Sodium Pertechnetate Tc99m Injection following instillation for direct cystography, results in an estimated absorbed radiation dose shown in Table 8.
Table 8. Pediatric Absorbed Radiation Dose from Cystography Age Bladder wall dose, mGy (rad) Gonadal dose, mGy (rad) 1 year 3.6 (0.36) 0.15 (0.015) 5 years 2.0 (0.2) 0.095 (0.0095) 10 years 1.3 (0.13) 0.066 (0.0066) 15 years 0.92 (0.092) 0.046 (0.0046)

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