CERETEC

11.1 Chemical Characteristics Ceretec (kit for the preparation of technetium Tc 99m exametazime injection) prepares a radioactive diagnostic agent for intravenous use. Each unit consists of the following: One 10 mL vial of exametazime containing a sterile, non-pyrogenic, lyophilized mixture of 0.5 mg exametazime, 7.6 mcg stannous chloride dihydrate (minimum stannous tin 0.6 mcg; maximum total stannous and stannic tin 4 mcg per vial) and 4.5 mg sodium chloride, sealed under nitrogen atmosphere with a rubber closure. The product contains no antimicrobial preservative. One vial of cobalt stabilizer containing a sterile, non-pyrogenic solution of 200 mcg cobaltous chloride 6-hydrate in 2 mL of Water for Injection. The chemical name for Exametazime is [(RR,SS)-4.8-diaza-3,6,6,9-tetramethylundecane-2, 10-dione bisoxime]. The molecular formula of exametazime is C 13 H 28 N 4 O 2 , with the following structural formula: Prior to publication of the USAN, exametazime was known as hexamethylpropylene amine oxime (HM-PAO). The name HM-PAO appears in many publications. When sterile pyrogen-free sodium pertechnetate Tc 99m in isotonic saline is added to the vial of exametazime, a Tc 99m complex of exametazime is formed. Chemical Structure 11.2 Physical Characteristics Technetium Tc 99m decays by isomeric transition with a physical half-life of 6 hours. Photons that are useful for imaging studies are listed in Table 3. Table 3: Principal Radiation Emission Data-technetium Tc 99m Radiation Mean % Disintegration Mean Energy (keV) Gamma 2 88.5 140.5 11.3 External Radiation The air-kerma-rate (exposure-rate) constant for technetium Tc 99m is 5.23 m 2 ∙pGy∙(MBq) –1 ∙s –1 [0.795 cm 2 ∙R∙(mCi) –1 ∙h –1 ]. The first half-value thickness of lead (Pb) for technetium Tc 99m is 0.25 mm. A range of values for the relative attenuation of the radiation emitted by this radionuclide that results from interposition of various thicknesses of Pb is shown in Table 4. For example, the use of a 3 mm thickness of Pb will decrease the external radiation exposure by a factor of approximately 1,000. Table 4: Radiation Attenuation by Lead Shielding Shield Thickness (Pb) mm Coefficient of Attenuation 0 . 25 0.5 1 10 –1 2 10 –2 3 10 –3 4 10 –4 5 10 –5 To correct for physical decay of this radionuclide, the fractions that remain at selected intervals relative to the time of calibration are shown in Table 5. Table 5: Physical Decay Chart – Tc 99m half-life 6.03 hours Hours Fraction Remaining Hours Fraction Remaining 0 Calibration time (time of preparation) 1 7 0.447 1 0.891 8 0.399 2 0.795 9 0.355 3 0.708 10 0.317 4 0.631 11 0.282 5 0.563 12 0.252 6 0.502 24 0.063

Ceretec is a radioactive diagnostic agent, indicated in adults and pediatric patients age 2 to 17 for: Leukocyte Labeled Scintigraphy – As an adjunct in the localization of intraabdominal infection and inflammatory bowel disease. ( 1.1 ) Cerebral Scintigraphy – As an adjunct in the detection of altered regional cerebral perfusion in stroke. ( 1.2 ) 1.1 Leukocyte Labeled Scintigraphy Ceretec, when reconstituted with technetium Tc 99m exametazime (without cobalt stabilizer solution), is indicated in adults and pediatric patients age 2 to 17 for leukocyte labeled scintigraphy as an adjunct in the localization of intraabdominal infection and inflammatory bowel disease. 1.2 Cerebral Scintigraphy Ceretec, when reconstituted with technetium Tc 99m exametazime (with or without cobalt stabilizer solution), is indicated in adults and pediatric patients age 2 to 17 for cerebral scintigraphy as an adjunct in the detection of altered regional cerebral perfusion in stroke.

Do not use cobalt stabilizer solution for leukocyte labeled scintigraphy. ( 2.1 ) Use appropriate radiation safety measures and aseptic technique during preparation and handling. ( 2.1 ) Leukocyte Labeled Scintigraphy - The recommended adult dose is 185 MBq to 370 MBq (5 mCi to 10 mCi) of Tc 99m exametazime labeled leukocytes by intravenous injection. Administer as soon as possible after labeling, preferably within 20 minutes but no later than 1 hour. ( 2.2 ) Cerebral Scintigraphy - The recommended adult dose is 555 MBq to 1110 MBq (15 mCi to 30 mCi) by intravenous injection. ( 2.2 ) See full prescribing information for preparation and administration, interpretation of chromatograms and radiation dosimetry. ( 2 ) 2.1 Important Preparation and Radiation Safety Instructions The Ceretec kit includes a cobalt stabilizer solution, which is optional for cerebral scintigraphy. DO NOT USE COBALT STABILIZER SOLUTION FOR LEUKOCYTE LABELED Scintigraphy [see Dosage and Administration (2.4 , 2.6) ] . Technetium Tc 99m exametazime injection is a radioactive drug and should be handled with appropriate safety measures to minimize radiation exposure [see Warnings and Precautions (5.3) ] . Use waterproof gloves and effective shielding, including syringe shields, when preparing and administering technetium Tc 99m exametazime injection. 2.2 Recommended Dosing and Imaging Procedures Leukocyte Labeled Scintigraphy Dosing Adults: The recommended dose is 185 MBq to 370 MBq (5 mCi to 10 mCi) of Tc 99m exametazime labeled leukocytes by intravenous injection. Administer using a 19G needle as soon as possible, preferably within 20 minutes but no later than 1 hour, after preparing the Tc 99m labeled leukocyte suspension. Pediatric patients age 2 to 17: The recommended dose is 7.4 MBq/kg (0.2 mCi/kg); with a minimum of 74 MBq (2 mCi). Do not exceed the maximum administered activity for an adult. Imaging Procedures Instruct patients to empty their bladder prior to imaging. Dynamic imaging may be performed for the first 60 minutes after injection to assess lung clearance and to visualize cell migration. Perform static imaging at 0.5-1.5 hours , 2-4 hours and if necessary, at 18-24 hours after administration to detect focal accumulation of activity. Cerebral Scintigraphy Dosing Adults: The recommended dose is 555 MBq to 1110 MBq (15 mCi to 30 mCi) by intravenous injection. Pediatric patients age 2 to 17: The recommended dose is 14.0 MBq/kg (0.4 mCi/kg); with a minimum of 110 MBq (3.0 mCi). Do not exceed the maximum administered activity for an adult. Imaging Procedures Images may be acquired by planar or SPECT imaging techniques. Perform imaging 30-90 min. after administration and complete imaging within 4 hrs after administration. 2.3 Preparation and Administration Instructions General Preparation and Administration Instructions Use aseptic procedures throughout preparation and handling. Visually inspect the reconstituted technetium Tc 99m exametazime injection prior to use and do not use if there is evidence of particulate matter or discoloration. Measure patient dose with a dose calibrator immediately prior to administration. Instruct patients to maintain adequate hydration, after administration of technetium Tc 99m exametazime labeled white blood cells or Tc 99m exametazime injection and void frequently to minimize radiation dose to the kidneys and bladder [see Warnings and Precautions (5.3) ]. Reconstitution Instructions Elute the technetium Tc 99m generator according to the manufacturer's instructions. Only use eluate from a technetium Tc 99m generator which has been eluted within the previous 24 hours. For the highest radiochemical purity reconstitute with freshly eluted technetium 99m generator eluate. To prepare technetium Tc 99m exametazime injection for white blood cell labeling , use generator elute that is not more than 2 hours old. To prepare technetium Tc 99m exametazime injection with cobalt stabilizer for cerebral imaging , use generator eluate that is not more than 4 hours old. 2.4 Preparation of Autologous Leukocytes Leukocyte Harvest and Separation 1) Draw up 10 mL acid citrate dextrose solution into a 60 mL syringe. 2) Withdraw approximately 40 mL whole blood from the patient into the syringe using a 19-gauge butterfly needle infusion set. Close the syringe with a sterile hub. 3) Gently mix the contents of the syringe for 20 seconds. 4) Clamp the syringe barrel to the ring stand in an upright (hub side up) position and tilt the syringe 10-20 degrees from its position perpendicular to the bench. 5) Allow the red cells to sediment 30-60 minutes, until the supernatant [leukocyte rich plasma (LRP)] looks clear of red blood cells. 6) Using an infusion set, transfer the leukocyte-rich plasma (LRP), the supernatant, from the previous step, into a sterile, conical centrifuge tube marked "WBC" (white blood cell) and assure that only a minimum amount of red cells enter the centrifuge tube. 7) Immediately centrifuge the capped WBC tube at 400-450 g for 5 minutes. The plasma will separate out into a liquid [leukocyte poor plasma (LPP)] and a solid (WBC button). (Note: The button often contains a small number of red cells and may appear red). 8) Transfer the supernatant into another sterile tube marked "LPP" leaving enough supernatant to cover the white cell button. Reserve LPP for later use (steps 11,15,18). Washing and Radiolabeling 9) Add approximately 5 mL Sodium Chloride Injection, USP (0.9%) to the WBC button. Cap the "WBC" tube and resuspend the button by gently swirling. 10) Centrifuge the capped "WBC" tube at 150 g for 8 minutes and discard all but 0.5 to 1 mL of the supernatant to cover the cells. 11) Add 1 mL of "LPP" (from Step 9) to the white cell button and resuspend the cells by gentle swirling. 12) Reconstitute technetium Tc 99m exametazime from Ceretec with generator eluate [see Dosage and Administration (2.6) ] . 13) Within 30 minutes of preparation, add the reconstituted Tc 99m exametazime (do not use cobalt stabilizer solution) to the "WBC" tube. Swirl gently to mix. 14) Set a lab timer for 15 minutes and allow the white cells to incubate. Swirl at 30 second intervals during the incubation. 15) After incubation, add 10 mL of the LPP (from Step 9) to the "WBC" tube. 16) Cap the "WBC" tube, gently swirl, and then centrifuge at 450 g for 5 minutes. 17) Transfer the supernatant in the "WBC" tube into the "Wash" tube and leave the labeled white cells in the "WBC" tube. 18) Add approximately 5 mL of LPP (from Step 9) to the "WBC" tube. Gently swirl to resuspend the cells. 19) Draw the labeled cells into a syringe. Cap the syringe and assay the amount of radioactivity in a dose calibrator. Place the syringe in a shielded container. 20) Verify the identity of the labeled leukocyte recipient. 21) Administer the Tc 99m labeled leukocyte suspension using a 19G needle as soon as possible, preferably within 1-2 hours after labeling. 2.5 Preparation of Tc 99m Exametazime Injection with Cobalt Stabilizer Solution The preparation may be used in cerebral scintigraphy 1) Add up to 370 MBq to 2000 MBq (10 mCi to 54 mCi) sodium pertechnetate Tc 99m eluate to the shielded Ceretec vial. 2) Before reconstitution, the technetium Tc 99m generator eluate may be adjusted to the correct radioactive concentration [74 to 400 MBq/mL (2 to 10.8 mCi/mL)] by dilution with a volume of 5 mL preservative-free, non-bacteriostatic 0.9% sodium chloride for injection. 3) Between 1 and 5 minutes after reconstitution, inject 2 mL of cobalt stabilizer solution into the vial. Shake the shielded vial for 10 seconds to ensure complete mixing. 4) The cobalt stabilized technetium 99m exametazime is a pale straw-colored solution and the pH is in the range 5 to 8. 5) Use a Sample for Radiochemical Purity measurement. 6) Assay the vial for total radioactivity. Calculate the volume to be injected. Complete the label provided and attach to the vial. 7) Use the stabilized product within 5 hours after preparation. Individual patient doses may be stored aseptically in a capped syringe if required. 8) Discard any unused material. Radiochemical Purity Measurement Tc 99m Exametazime Injection with Cobalt Stabilizer Solution Obtain the Following Materials: Two GMCP-SA (Glass Microfiber Chromatography Paper impregnated with Silicic Acid) strips (2 cm (±2 mm) × 20 cm) Ascending chromatography development tanks MEK [methyl ethyl ketone (butanone)] 0.9 % sodium chloride A combination of two chromatographic systems is necessary for the determination of the radiochemical purity of the injection: System 1 GMCP-SA: MEK [methyl ethyl ketone (butanone)] System 2 GMCP-SA:0.9% sodium chloride Three potential radiochemical impurities may be present in prepared Technetium ( 99m Tc) Exametazime Injection secondary Tc 99m exametazime complex free Tc 99m pertechnetate reduced-hydrolyzed Tc 99m Method 1) Perform radiochemical purity testing as soon as possible after preparation. 2) Prepare the two Chromatographic Systems (System 1 and System 2). 3) Apply test samples by needle approximately 2.5 cm from the bottom of each GMCP-SA strip. 4) Immediately place each strip in prepared ascending chromatography development tanks. After the solvent has travelled to the 14 cm mark, remove the strips and mark the solvent fronts. 5) Allow the strips to dry. 6) Determine the distribution of activity determined using suitable equipment. 7) Chromatogram Interpretation: System 1 (GMCP-SA: MEK [butanone]) Origin Secondary Tc 99m exametazime complex and reduced-hydrolyzed Tc 99m Migrate at R f 0.8-1 Lipophilic Tc 99m exametazime complex and Tc 99m pertechnetate System 2 (GMCP-SA:0.9% sodium chloride) Origin Lipophilic Tc 99m exametazime complex, secondary Tc 99m exametazime complex, and reduced-hydrolyzed Tc 99m Migrate at R f 0.8-1 Tc 99m pertechnetate 8) Calculate the percentage of activity due to both secondary Tc 99m exametazime complex and reduced-hydrolyzed Tc 99m from System 1 (A %) . 9) Calculate the percentage of activity due to Tc 99m pertechnetate from System 2 (B %) . 10) Calculate the radiochemical purity: % lipophilic Tc 99m exametazime complex = 100 - (A %+B %) A % represents the level of secondary Tc 99m exametazime complex plus reduced-hydrolyzed Tc 99m. B % represents the level of Tc 99m pertechnetate. 11) Do not use if radiochemical purity of lipophilic Tc 99m exametazime is less than 80%. 2.6 Preparation of Technetium Tc 99m Exametazime Injection Without Cobalt Stabilizer Solution The preparation may be used in cerebral scintigraphy or for use in the preparation of Tc 99m labeled leukocytes. 1) Add 370 MBq to 2000 MBq (10 mCi up to 54 mCi) of sodium pertechnetate Tc 99m eluate. 2) Before reconstitution, the technetium Tc 99m generator eluate may be adjusted to the correct radioactive concentration [74 to 400 MBq/mL (2 to 10.8 mCi/mL)] by dilution with a volume of 5 mL preservative-free, non-bacteriostatic 0.9 % sodium chloride for injection. 3) The pH of the prepared injection is 9 to 9.8. 4) Use a sample for Radiochemical Purity Measurement. 5) Assay the total activity. 6) Calculate the volume to be injected and complete the label provided and attach to the vial shield. 7) Use the preparation within 30 minutes after reconstitution. 8) Discard any unused material. Radiochemical Purity Measurement Tc 99m Exametazime Injection without Cobalt Stabilizer Solution Perform radiochemical purity testing of technetium Tc 99m exametazime within 2 minutes of reconstitution. The entire procedure takes approximately 15 minutes. Obtain the Following Materials: 2 SA ITLC strips 20 cm × 2 cm 1 Whatman No. 1 strips 6 cm × 0.7 cm MEK (methyl ethyl ketone [butanone]) 0.9% aqueous sodium chloride (non-bacteriostatic) 50% aqueous acetonitrile Dilute with non-bacteriostatic Water for Injection Glass test tubes (12 × 75 mm) Glass measuring cylinders (100 mL) with covers 1 mL syringes with 25-gauge needles A combination of 3 chromatographic systems is necessary for the complete definition of the radiochemical composition of the injection. System 1 : MEK (methyl ethyl ketone [butanone]) + SA ITLC strip System 2 : 0.9% non-bacteriostatic sodium chloride solution + SA ITLC strip System 3 : 50% acetonitrile solution + Whatman No. 1 paper strip Three potential radiochemical impurities may be present in the prepared injection of the lipophilic Tc 99m exametazime complex. a secondary Tc 99m exametazime complex free Tc 99m pertechnetate reduced-hydrolyzed Tc 99m Method 1) Prepare chromatography tubes (Identify the solvent in each cylinder). System 1 - 100 mL cylinder containing a 1 cm depth of fresh MEK. System 2 - 100 mL cylinder containing a 1 cm depth of 0.9% sodium chloride. System 3 - 1 chromatography tube containing 0.2-0.3 mL of 50% acetonitrile, respectively. 2) Prepare 2 SA ITLC strips and 1 Whatman No. 1 paper strip. Mark the SA ITLC strips 2.5 cm from the bottom as the point of origin. Mark both the SA ITLC strips at 14 cm above the origin (solvent front). Mark the Whatman strip 1 cm from the bottom as the point of origin. 3) Apply at least 5 microliter samples of freshly prepared Tc 99m exametazime solution to the origin of the 3 strips (within 2 minutes of reconstitution). Do not allow to dry. 4) Immediately place 1 SA ITLC strip into the MEK tank (System 1), the second SA ITLC strip into the saline tank (System 2), and the Whatman No. 1 paper strip into the 50% acetonitrile tube (System 3). 5) The SA ITLC MEK strip takes approximately 15 minutes to run. When the eluate has reached the solvent front remove the strip from the tube with forceps and immediately cut 1 cm above the origin. 6) The SA ITLC saline strip takes approximately 15 minutes to run. When the eluate has reached the solvent front remove the strip from the tube with forceps and immediately cut 2.5 cm above the origin. 7) The Whatman No. 1 paper CH3CN strip takes approximately 100 seconds to run. When the eluate has reached the solvent front mark remove the strip from the tube with forceps and immediately cut 0.5 cm above the origin. 8) Chromatogram Interpretation: System 1 (SA ITLC: MEK (methyl ethyl ketone [butanone]) Origin Secondary Tc 99m exametazime complex and reduced-hydrolyzed Tc 99m Migrate at R f 0.8-1 Lipophilic Tc 99m exametazime complex and Tc 99m pertechnetate System 2 (SA ITLC: 0.9% sodium chloride) Origin Lipophilic Tc 99m exametazime complex, secondary Tc 99m, exametazime complex and reduced-hydrolyzed Tc 99m Migrate at R f 0.8-1 Tc 99m pertechnetate System 3 (Whatman No. 1: 50% aqueous acetonitrile) Origin Reduced-hydrolyzed Tc 99m Migrate at R f 0.8-1 Lipophilic Tc 99m exametazime complex, secondary Tc 99m exametazime complex and Tc 99m pertechnetate 9) Count the separate sections of each strip to determine the activity distribution. Calculate: % origin of saline strip (system 2) % origin of MEK strip (system 1) % solvent front of saline strip (= % Tc 99m pertechnetate) % origin of Whatman No. 1 paper strip (= % reduced-hydrolyzed Tc 99m) 10) Calculate Radiochemical Purity % lipophilic Tc 99m exametazime complex = % origin of saline strip (system 2) – % origin of MEK strip (system 1) 11) Do not use if the radiochemical purity of the lipophilic Tc 99m exametazime complex is less than 80%. 2.7 Radiation Dosimetry Tc 99m Exametazime labeled leukocytes for leukocyte labeled scintigraphy Radiation absorbed dose per unit activity (microGy/MBq) administered to average-size adults (70 kg) and pediatric patients from an intravenous injection of Tc 99m Exametazime labeled leukocytes is estimated in Table 1. Table 1: Estimated Radiation Absorbed Dose for Tc 99m exametazime labeled white blood cells (leukocytes) Organ Absorbed dose per unit activity administered (microGy / MBq) Adult 15 years 10 years 5 years 1 year *International Commission on Radiological Protection, Radiation Dose to Patients from Radiopharmaceuticals: A Compendium of Current Information Related to Frequently Used Substances, Ann ICRP 2015)., ICRP Publication 128, Ann ICRP 2015). Adrenals 12 12 18 26 43 Bone surfaces 16 21 34 61 150 Brain 2.3 2.9 4.4 7 13 Breast 2.4 2.9 4.9 7.6 13 Gallbladder wall 8.4 10 16 25 36 Gastrointestinal tract Esophagus 3.5 4.2 5.8 8.6 15 Stomach wall 8.1 9.6 14 20 32 Small intestine wall 4.6 5.7 8.7 13 21 Colon wall 4.3 5.4 8.4 12 21 Upper large intestine wall 4.7 5.9 9.3 14 23 Lower large intestine wall 3.7 4.8 7.3 10 18 Heart wall 9.4 12 17 25 44 Kidneys 12 14 22 32 54 Liver 20 26 38 54 97 Lungs 7.8 9.9 15 23 41 Muscles 3.3 4.1 6 8.9 16 Ovaries 3.9 5 7.2 11 18 Pancreas 13 16 23 34 53 Red marrow 23 25 40 71 140 Skin 1.8 2.1 3.4 5.5 10 Spleen 150 210 310 480 850 Testes 1.6 2.1 3.2 5.1 9.2 Thymus 3.5 4.2 5.8 8.6 15 Thyroid 2.9 3.7 5.8 9.3 17 Urinary bladder wall 2.6 3.5 5.2 7.8 14 Uterus 3.4 4.3 6.5 9.7 16 Remaining organs 3.4 4.2 6.3 9.5 16 Effective dose per unit activity 11 microSv/MBq 14 microSv/MBq 22 microSv/MBq 34 microSv/MBq 62 microSv/MBq Tc 99m Exametazime Injection for Cerebral Scintigraphy Based on human data, the radiation absorbed doses to average sized adults (70kg) and pediatric patients from an intravenous injection of Tc 99m exametazime injection are estimated in Table 2. Table 2: Estimated Radiation Absorbed Dose for Tc 99m Exametazime Injection Organ Absorbed dose per unit activity administered (microGy / MBq) Adult 15 years 10 years 5 years 1 year *International Commission on Radiological Protection, Radiation Dose to Patients from Radiopharmaceuticals: A Compendium of Current Information Related to Frequently Used Substances, Ann ICRP 2015)., ICRP Publication 128, Ann ICRP 2015). Adrenals 5.3 6.7 9.9 14 24 Bone surfaces 5.1 6.4 9.4 14 24 Brain 6.8 11 16 21 37 Breast 2 2.4 3.7 5.6 9.5 Gallbladder wall 18 21 28 48 140 Gastrointestinal tract Esophagus 2.6 3.3 4.7 6.9 11 Stomach wall 6.4 8.5 12 19 36 Small intestine wall 12 15 24 36 65 Colon wall 17 22 35 55 100 Upper large intestine wall 18 24 38 60 110 Lower large intestine wall 15 19 31 48 90 Heart wall 3.7 4.7 6.7 9.7 16 Kidneys 34 41 57 81 140 Liver 8.6 11 16 23 40 Lungs 11 16 22 34 63 Muscles 2.8 3.5 5 7.3 13 Ovaries 6.6 8.3 12 17 27 Pancreas 5.1 6.5 9.7 14 23 Red marrow 3.4 4.1 5.9 8 14 Skin 1.6 1.9 2.9 4.5 8.3 Spleen 4.3 5.4 8.2 12 20 Testes 2.4 3 4.4 6.1 11 Thymus 2.6 3.3 4.7 6.9 11 Thyroid 26 42 63 140 260 Urinary bladder wall 23 28 33 33 56 Uterus 6.6 8.1 12 15 25 Remaining organs 3.2 4 6 9.2 17 Effective dose per unit activity 9.3 microSv/MBq 11 microSv/MBq 17 microSv/MBq 27 microSv/MBq 49 microSv/MBq The effective dose resulting from the administration of a (maximal recommended) activity of 1110 MBq for an adult weighing 70 kg is about 10.3 mSv. For an administered activity of 740 MBq the typical radiation dose to the target organ (brain) is 5 mGy and the typical radiation dose to the critical organ (kidneys) is 25 mGy.

None None. ( 4 )

The following serious adverse reactions are described elsewhere in the labeling: Hypersensitivity Reactions [see Warnings and Precautions (5.1) ]. The following adverse reactions associated with the use of Ceretec were identified in clinical studies or postmarketing reports. Because some of these reactions were reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Cardiovascular disorders: Reversible increase in blood pressure, flushing Gastrointestinal disorders: Nausea, vomiting General disorders and administration site conditions: Malaise, fatigue, fever Immune system disorders: Hypersensitivity reactions: anaphylactic reactions including shock, facial edema, rash, pruritus or erythema Nervous system disorders: Headache, dizziness, paresthesia Most common adverse reactions include a reversible increase in blood pressure . ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact GE Healthcare at 1-800-654-0118 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .

16.2 Storage and Handling Store Ceretec kits at controlled room temperature 15°C to 25°C (59°F to 77°F). This reagent kit is approved for use by persons licensed by the U.S. Nuclear Regulatory Commission or the relevant Agreement State. Store and dispose of technetium Tc 99m exametazime in compliance with the regulations of the government agency authorized to license the use of this radionuclide.