Medi-physics Inc. Dba Ge Healthcare.

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Datscan

Datscan

2.1 Radiation Safety

DaTscan emits radiation and must be handled with 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 experienced 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. DaTscan dosing is based upon the radioactivity determined using a suitably calibrated instrument immediately prior to administration.

To minimize radiation dose to the bladder, encourage hydration prior to and following DaTscan administration in order to permit frequent voiding. Encourage the patient to void frequently for the first 48 hours following DaTscan administration [see Dosage and Administration (2.5)].

2.2 Thyroid Blockade Before DaTscan Injection

Before administration of DaTscan, administer Potassium Iodide Oral Solution or Lugol's Solution (equivalent to 100 mg iodide) or potassium perchlorate (400 mg) to block uptake of iodine 123 by the patient's thyroid. Administer the blocking agent at least one hour before the dose of DaTscan [see Warnings and Precautions (5.2)].

2.3 Preparation and Administration

Use aseptic procedures and radiation shielding during preparation and administration. Inspect the DaTscan vial prior to administration and do not use it if the vial contains particulate matter or discoloration [see Description (11)]. Administer DaTscan as a slow intravenous injection (administered over a period of not less than 15 to 20 seconds) via an arm vein.

2.4 Recommended Dose

The recommended dose is 111 to 185 MBq (3 to 5 mCi) administered intravenously [see Clinical Studies (14)].

2.5 Radiation Dosimetry

The estimated radiation absorbed doses to an average adult from intravenous injection of DaTscan are shown in Table 1. The values are calculated assuming urinary bladder emptying at 4.8-hour intervals and appropriate thyroid blocking (iodine 123 is a known Auger electron emitter).
Table 1 Estimated Radiation Absorbed Doses from DaTscan ORGAN / TISSUE ABSORBED DOSE PER UNIT ADMINISTERED ACTIVITY(µGy / MBq) *
The absorbed dose to the colon wall is the mass-weighted sum of the absorbed doses to the upper and lower large intestine walls, D Colon = 0.57 DULI + 0.43 DLLI [Publication 80 of the ICRP (International Commission on Radiological Protection); Annals of the ICRP 28 (3). Oxford: Pergamon Press; 1998]
Adrenals 12.9 Brain 17.8 Striata 230.0 Breasts 7.8 Esophagus 10.0 Gallbladder Wall 26.4 GI Tract Stomach Wall 11.2 Small Intestine Wall 21.2 Colon Wall * 39.8 Upper Large Intestine Wall 38.1 Lower Large Intestine Wall 42.0 Heart Wall 12.9 Kidneys 10.9 Liver 27.9 Lungs 41.2 Muscle 9.4 Osteogenic Cells 28.2 Ovaries 16.8 Pancreas 13.0 Red Marrow 9.2 Skin 6.0 Spleen 10.4 Testes 8.5 Thymus 10.0 Thyroid 9.0 Urinary Bladder Wall 53.1 Uterus 16.1 Total Body 11.3 EFFECTIVE DOSE PER UNIT ADMINISTERED ACTIVITY (µSv / MBq) 21.3
The Effective Dose resulting from a DaTscan administration with an administered activity of 185 MBq (5 mCi) is 3.94 mSv in an adult.

2.6 Imaging Guidelines

Begin SPECT imaging 3 to 6 hours following DaTscan administration. Acquire images using a gamma camera fitted with high-resolution collimators and set to a photopeak of 159 keV with a ± 10% energy window. Angular sampling should be not less than 120 views over 360 degrees. Position the subject supine with the head on an off-the-table headrest, a flexible head restraint such as a strip of tape across the chin or forehead may be used to help avoid movement, and set a circular orbit for the detector heads with the radius as small as possible (typically 11 to 15 cm).

Experimental studies with a striatal phantom suggest that optimal images are obtained with matrix size and zoom factors selected to give a pixel size of 3.5 to 4.5 mm. Collect a minimum of 1.5 million counts for optimal images.

2.7 Image Interpretation

DaTscan images are interpreted visually, based upon the appearance of the striata. Reconstructed pixel size should be between 3.5 and 4.5 mm with slices 1 pixel thick. Optimum presentation of the reconstructed images for visual interpretation is transaxial slices parallel to the anterior commissure-posterior commissure (AC-PC) line. Determination of whether an image is normal or abnormal is made by assessing the extent (as indicated by shape) and intensity of the striatal signal. Image interpretation does not involve integration of the striatal image appearance with clinical signs and/or symptoms.

Normal :

In transaxial images, normal images are characterized by two symmetric comma- or crescent-shaped focal regions of activity mirrored about the median plane. Striatal activity is distinct, relative to surrounding brain tissue (Figure 1).

Abnormal :

Abnormal DaTscan images fall into at least one of the following three categories (all are considered abnormal).
Activity is asymmetric, e.g. activity in the region of the putamen of one hemisphere is absent or greatly reduced with respect to the other. Activity is still visible in the caudate nuclei of both hemispheres resulting in a comma or crescent shape in one and a circular or oval focus in the other. There may be reduced activity between at least one striatum and surrounding tissues (Figure 2). Activity is absent in the putamen of both hemispheres and confined to the caudate nuclei. Activity is relatively symmetric and forms two roughly circular or oval foci. Activity of one or both is generally reduced (Figure 3). Activity is absent in the putamen of both hemispheres and greatly reduced in one or both caudate nuclei. Activity of the striata with respect to the background is reduced (Figure 4).
Myoview

Myoview

The recommended dose range for MYOVIEW is 5-33 mCi (185-1221 MBq).

For stress and rest imaging, 2 separate doses of MYOVIEW are used. When rest and stress injections are administered on the same day, the first dose should be 5-12 mCi (185-444 MBq) and followed by the second dose of 15-33 mCi (555-1221 MBq) given approximately 1 to 4 hours later.

Imaging may begin 15 minutes following administration of the agent.

Dose adjustment has not been established in renally or liver impaired, pediatric or geriatric patients.
Myoview

Myoview

The recommended dose range for MYOVIEW is 5-33 mCi (185-1221 MBq).

For stress and rest imaging, 2 separate doses of MYOVIEW are used. When rest and stress injections are administered on the same day, the first dose should be 5-12 mCi (185-444 MBq) and followed by the second dose of 15-33 mCi (555-1221 MBq) given approximately 1 to 4 hours later.

Imaging may begin 15 minutes following administration of the agent.

Dose adjustment has not been established in renally or liver impaired, pediatric or geriatric patients.

RADIATION DOSIMETRY

Based on human data, the absorbed radiation doses to an average human adult (70 kg) from intravenous injections of the agent under exercise and resting conditions are listed in Table 5. The values are listed in descending order as rad/mCi and µGy/MBq and assume urinary bladder emptying at 3.5 hours.
Table 5 Estimated Absorbed Radiation Dose (Technetium Tc99m Tetrofosmin Injection) Absorbed radiation dose Exercise Rest Target organ rad/mCi µGy/MBq rad/mCi µGy/MBq Gall bladder wall 0.123 33.2 0.180 48.6 Upper large intestine 0.075 20.1 0.113 30.4 Bladder wall 0.058 15.6 0.071 19.3 Lower large intestine 0.057 15.3 0.082 22.2 Small intestine 0.045 12.1 0.063 17.0 Kidney 0.039 10.4 0.046 12.5 Salivary glands 0.030 8.04 0.043 11.6 Ovaries 0.029 7.88 0.035 9.55 Uterus 0.027 7.34 0.031 8.36 Bone surface 0.023 6.23 0.021 5.58 Pancreas 0.019 5.00 0.018 4.98 Stomach 0.017 4.60 0.017 4.63 Thyroid 0.016 4.34 0.022 5.83 Adrenals 0.016 4.32 0.015 4.11 Heart wall 0.015 4.14 0.015 3.93 Red marrow 0.015 4.14 0.015 3.97 Spleen 0.015 4.12 0.014 3.82 Muscle 0.013 3.52 0.012 3.32 Testes 0.013 3.41 0.011 3.05 Liver 0.012 3.22 0.015 4.15 Thymus 0.012 3.11 0.009 2.54 Brain 0.010 2.72 0.008 2.15 Lungs 0.008 2.27 0.008 2.08 Skin 0.008 2.22 0.007 1.91 Breasts 0.008 2.22 0.007 1.83
Dose calculations were performed using the standard MIRD method (MIRD Pamphlet No.1 (rev),Society of Nuclear Medicine, 1976). Effective dose equivalents (EDE) were calculated in accordance with ICRP 53 (Ann. ICRP 18 (1-4),1988) and gave values of 8.61 × 10-3 mSV/MBq and 1.12 × 10-2 mSV/MBq after exercise and rest, respectively.

INSTRUCTIONS FOR THE PREPARATION OF MYOVIEW 30 mL INJECTION

USE ASEPTIC TECHNIQUE THROUGHOUT.

The user should wear waterproof gloves and use shielding at all times when handling the reconstituted vial or syringes containing the radioactive agent.

The patient dose should be measured by a suitable radioactivity calibration system immediately prior to administration.
1) Place one of the MYOVIEW 30 mL vials in a suitable shielding container and sanitize the rubber septum with an isopropyl alcohol swab. Insert a sterile needle (if using a venting needle) through the rubber septum (see Cautionary note 1). 2) Using sterile, suitable shielded syringes, inject the required activity of up to 2.4 Ci (89 GBq) technetium Tc99m generator eluate and Sodium Chloride Injection, USP, if needed as diluent into the shielded vial to result in a final Tc99m radioactive concentration of no greater than 80 mCi/mL (2.96 GBq/mL) (see Cautionary notes 2, 3 and 4). Remove the venting needle. Mix gently for 10 seconds to ensure complete dissolution of the powder. 3) Incubate at room temperature for 15 minutes. 4) Assay the total activity, complete the user radiation label and attach it to the vial. 5) Visually inspect the reconstituted solution at a safe distance through leaded glass. Do not use if it is not clear or if it contains foreign particulate matter. 6) Withdrawals for administration should be made aseptically using a shielded, sterile syringe and needle (see Cautionary note 5). 7) Store the reconstituted MYOVIEW 30 mL vial at 2°-25°C (36°-77°F) and use within 12 hours of preparation. Store withdrawals for injection at 2°-25°C (36°-77°F) and use within the same 12 hour period as the reconstituted MYOVIEW 30 mL vial.
Cautionary notes:
1) If a venting needle is not used, remove an adequate volume of gas from the vial head space using the same syringe used for the injection of Sodium Chloride Injection, USP or Tc99m generator eluate to avoid over-pressurizing the vial. 2) The volume of (diluted) technetium Tc99m generator eluate (plus Sodium Chloride Injection, USP as diluent if needed) added to the vial must be in the range 10-30 mL. 3) If Sodium Chloride Injection, USP, is added directly to the Myoview vial as a diluent , it must be added immediately prior to the addition of Tc99m generator eluate to the vial. 4) Sodium Chloride Injection, USP must be used as the diluent if needed. The use of bacteriostatic sodium chloride as a diluent for sodium pertechnetate Tc99m injection may adversely affect the radiochemical purity and hence the biological distribution of the MYOVIEW Injection. 5) A 21 gauge or finer needle is recommended for patient dose preparation. 6) The pH of the prepared injection should be in the range 7.5-9.0. 7) Safety and effectiveness of MYOVIEW Injection were established using investigational material shown to have a radiochemical purity of at least 90% prior to administration to patients in clinical studies. 8) The contents of the MYOVIEW vial are not radioactive. However, after the sodium pertechnetate Tc99m is added adequate shielding of the final preparation must be maintained. 9) The technetium Tc99m labeling reaction involved in the preparation of MYOVIEW Injection depends on maintaining tin in the divalent (reduced) state. Any oxidant present in the sodium pertechnetate Tc99m used may adversely affect the quality of the preparation. Sodium pertechnetate Tc99m containing oxidants should not be used for the preparation of the labeled product. 10) The contents of the MYOVIEW vial are sterile and pyrogen-free. The vial contains no bacteriostatic preservative. It is essential that the user follow the directions carefully and adhere to aseptic procedures during the preparation of the radiopharmaceutical.
Quality Control

An assay of the radiochemical purity of the prepared injection can be performed using the following chromatographic procedure.

Equipment and eluent
(1) Varian SA TLC strip (2 cm × 20 cm) – Do not heat activate (2) Ascending chromatography tank and cover (3) 65:35% v/v mixture of acetone and dichloromethane (prepared freshly) (4) 1 ml syringe with 22-25 G needle (5) Suitable counting equipment
Method
(1) Pour the 65:35% v/v acetone:dichloromethane mixture into the chromatography tank to a depth of 1 cm and cover the tank to allow the solvent vapor to equilibrate. (2) Mark a Varian SA TLC strip with a pencil line at 3 cm from the bottom and, using an ink marker pen, at 15 cm from the pencil line. The pencil line indicates the origin where the sample is to be applied and movement of color from the ink line will indicate the position of the solvent front when upward elution should be stopped. (3) Cutting positions at 3.75 cm and 12 cm above the origin (Rfs 0.25 and 0.8 respectively) should also be marked in pencil. (4) Using a 1 ml syringe and needle, apply a 10 µl sample of the prepared injection at the origin of the strip. Do not allow the spot to dry. Place the strip in the chromatography tank immediately and replace the cover. Ensure that the strip is not adhering to the walls of the tank. Note: A 10 µl sample will produce a spot with a diameter of approximately 10 mm. Different sample volumes have been shown to give unreliable radiochemical purity values. (5) When the solvent reaches the ink line, remove the strip from the tank and allow it to dry. (6) Cut the strip into 3 pieces at the marked cutting positions and measure the activity on each using suitable counting equipment. Try to ensure similar counting geometry for each piece and minimize equipment dead time losses. (7) Calculate the radiochemical purity from: % MYOVIEW = Activity of center piece × 100 Total activity of all 3 pieces Do not use material if the radiochemical purity is less than 90%. Note: Free Tc99m pertechnetate runs to the top piece of the strip. MYOVIEW runs to the center piece of the strip. Reduced hydrolyzed Tc99m and any hydrophilic complex impurities remain at the origin in the bottom piece of the strip.
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.

Cerebral Scintigraphy

The recommended dose range for i.v. administration, of reconstituted sodium pertechnetate Tc99m exametazime 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.
Indium In 111 Oxyquinol...

Indium In 111 Oxyquinoline

The recommended adult (70 kg) dose of indium In 111 oxyquinoline labeled autologous leukocytes is 7.4 to 18.5 MBq, 200-500 µCi. Indium In 111 oxyquinoline solution is intended for the radiolabeling of autologous leukocytes. The indium In 111 oxyquinoline labeled autologous leukocytes are administered intravenously.

Imaging is recommended at approximately 24 hours post injection. Typically, anterior and posterior views of the chest, abdomen and pelvis should be obtained with other views as required.

Aseptic procedures and a shielded syringe should be employed in the withdrawal of indium In 111 oxyquinoline from the vial. Similar procedures should be employed during the labeling procedure and the administration of the labeled leukocytes to the patient. The user should wear waterproof gloves during the entire procedure. The patient's dose should be measured by a suitable radioactivity calibration system immediately before administration. At this time, the leukocyte preparation should be checked for gross clumping and red blood cell contamination.

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Medi-physics Inc. Dba Ge Healthcare. Drugs