RADIOGENIX SYSTEM Technetium tc 99m generator injection Ref.[10398] Active ingredients: Technetium ⁹⁹ᵐTc pertechnetate

Radiation SafetyDrug Handling

• The potassium molybdate Mo-99 source solution and Sodium Pertechnetate Tc 99m Injection are radioactive and should be handled with appropriate safety measures to minimize radiation exposure to patients and healthcare providers. Use waterproof gloves and effective shielding, including syringe shields, throughout the entire preparation and handling for the RadioGenix System and technetium Tc-99m injection [see Warnings and Precautions (5.1)].

Important Administration Instructions

• Use aseptic technique in eluting generator and in all drug preparation and handling.
• Inspect the Sodium Pertechnetate Tc 99m Injection for particulate matter and discoloration prior to administration. Do not administer Sodium Pertechnetate Tc 99m Injection if there is any evidence of particulate matter and discoloration.
• Measure patient dose with a suitable radioactivity calibration system immediately prior to administration.
• Instruct patients to hydrate after intravenous or intravesicular administration. Encourage the patient to void as soon as the imaging study is completed and frequently for the next 12 hours to minimize the radiation absorbed dose to the bladder.
• Instruct patients to blow their nose and/or wash their eyes with sterile distilled water or an isotonic sodium chloride solution after ophthalmic administration to minimize the radiation absorbed dose.

Recommended Dose for Adults

The recommended doses for adult patients are shown in Table 1.

Table 1. Recommended Dose of Sodium Pertechnetate for Adult Patients:

Recommended Dose for Pediatric Patients

The recommended doses for pediatric patients are shown in Table 2 [see Use in Specific Populations (8.4)].

Table 2. Recommended Dose of Sodium Pertechnetate for Pediatric Patients:

RadioGenix System Maintenance

• For complete system maintenance and use follow the RadioGenix System Operator Guide Version 1.0a and 1.1 (94S05058).
• Install the RadioGenix System in an operating environment which complies with local and national requirements for production of radiopharmaceutical products (ISO Class 8 or better environment as described in USP General Chapter 797 Pharmaceutical Compounding Sterile Preparations).
• The RadioGenix System is only for use by trained personnel.
• Only use potassium molybdate Mo-99, processing reagents, saline and other components, including kits [Sterilization Kit for RadioGenix System, Reagent Kit for RadioGenix System, Tc-99m Product Kit for RadioGenix System, Discarded Material Kit for RadioGenix System, and Source Vessel Kit for RadioGenix System], supplied by NorthStar Medical Radioisotopes, LLC.
• Table 3 is a summary of RadioGenix System scheduled maintenance and protocol actions. Perform all protocols according to the illustrated directions provided in the RadioGenix System Operator Guide Version 1.0a and 1.1 (94S05058).

Table 3. RadioGenix System Scheduled Maintenance:

Directions for Eluting RadioGenix System

• The Sodium Pertechnetate Tc 99m Injection solution is produced using “Produce Tc-99m” protocol through the RadioGenix System home screen Follow step-by-step directions for use provided on the RadioGenix System Operator Guide Version 1.0a and 1.1 (94S05058).
• The elution process to produce Sodium Pertechnetate Tc 99m Injection involves the initial installation and set-up of the equipment, reagents, sterilizing filters, and sterile final product collection vials provided by NorthStar Medical Radioisotopes, LLC [see Table 3].
• Implement the following prerequisites before the Produce Tc-99m protocol is initiated:

1. Connect the potassium molybdate Mo-99 source container using the Source Vessel Kit for RadioGenix System.
2. Aseptically install the Reagent Kit for RadioGenix System consisting of three reagent solutions (3% Hydrogen Peroxide, 5M Potassium Hydroxide, and 1.5M Sodium Acetate) and the primary separation cartridge (PSC).
3. Aseptically assemble and install the Tc-99m Product Kit for RadioGenix System consisting of an alumina column, 0.22 micron filter, and a 20 mL sterile collection vial.
4. Attach the supplied pre-filled syringe containing 0.9% sodium chloride injection, USP to the saline port.
5. Initiate the computer controlled elution process to prepare Sodium Pertechnetate Tc 99m Injection.
6. After delivery of the Sodium Pertechnetate Tc 99m Injection to the collection vial is complete, remove the collection vial and perform the quality control procedures [see Dosage and Administration (2.7)].
7. Discard the first eluate from every new Potassium Molybdate Mo-99 Source Vessel to minimize the risk of unintended radiation exposure from Rhenium Re-186 [see Warnings and Precautions (5.3)].

Quality Control of Sodium Pertechnetate Tc 99m Injection

Perform the following quality control procedures on each Sodium Pertechnetate Tc 99m Injection prior to its release for clinical use or for reconstitution with Tc-99m radiopharmaceutical kits.

Mo-99 Breakthrough Tet:

• Using a suitable radioactivity calibrator, determine the activity of technetium Tc-99m eluted.
• Place the Sodium Pertechnetate Tc-99m injection eluate in a calibrated Mo-99 assay shield. Place the lid on the container and put the entire container in the dose calibrator chamber.
• Record the activity of molybdenum Mo-99 on the most sensitive scale.
• Divide the activity of molybdenum Mo-99 by the activity of technetium Tc-99m. Correct for decay and shielding effect, if necessary.
• Determine the molybdenum Mo-99/technetium Tc-99m ratio at the time of elution and from that ratio, determine the expiration time of the eluate. Each Sodium Pertechnetate Tc 99m Injection eluate must meet or exceed the purity requirement of 0.15 microCi of Mo-99 per mCi of Tc-99m.
• The expiry time for each eluate of Sodium Pertechnetate Tc 99m Injection must be no later than 12 hours post-elution or the time where the Mo-99 to Tc-99m ratio reaches 0.15 microCi/mCi, whichever occurs earlier

Colorimetric Aluminum Ion Test Procedure:

• Using an aluminum ion indicator kit, determine the aluminum ion concentration of the eluate per the manufacturer’s instructions.
• The eluate concentration must not exceed 10 micrograms/mL.

Determination of pH:

• Place a small drop of Sodium Pertechnetate Tc-99m injection on a colorimetric pH strip.
• Examine and compare the coloration of the test strip with the colors displayed on the pH cartridge.
• The pH range must be between 4.5 and 7.5.

Radiolabeling (Reconstitution) of Kits

• In general, use no more than 3 mL volume for radiolabeling kits with RadioGenix System produced Sodium Pertechnetate Tc 99m Injection, USP. For radiolabeling certain kits (such as the Product Kit for the preparation of technetium Tc-99m exametazime), use no more than 1 mL of volume.
• Perform quality control of a radiolabeled kit per the directions in the kit package insert and only use the product if it meets the kit manufacturer’s quality control requirements.
• The radiolabeled product shall have an expiry no more than 12 hours from the time of sodium pertechnetate elution or the expiry time stated by the kit manufacturer, whichever occurs earlier.

Radiation Dosimetry

Intravenous Injection

Estimates of radiation absorbed dose per unit activity of Sodium Pertechnetate Tc 99m Injection administered to an adult of average size and weight and to pediatric patients of sizes and weights typical of representative ages are shown in Table 4.

Table 4. Radiation Absorbed Dose from Intravenous Injection:

* To obtain radiation absorbed dose per unit activity in mrad/mCi from the preceding table, multiply individual values by a factor of 3.7. (For effective dose per administered activity, the resulting unit is mrem/mCi.)
** For the liver, 20% of the absorbed dose per unit activity is derived from a presumed maximum concentration of 0.015% MBq Mo-99 per MBq Tc-99m

Dacryoscintigraphy

Estimates of radiation absorbed dose to an adult patient from the nasolacrimal imaging procedure using a maximum dose of 3.7 megabecquerels (0.1 millicurie) of Sodium Pertechnetate Tc 99m Injection are shown in Table 5.

Table 5. Radiation Absorbed Dose in the Eye Lens from Dacryoscintigraphy of Adults:

Cystography

Estimates of radiation absorbed dose per unit activity of Sodium Pertechnetate Tc 99m Injection administered through direct urinary-bladder infusion with no voiding over 30 minutes to an adult of average size and weight and to pediatric patients of sizes and weights typical of representative ages are shown in Table 6.

Table 6. Radiation Absorbed Dose* from Cystography:

To obtain radiation absorbed dose per unit activity in mrad/mCi from the preceding table, multiply individual values by a factor of 3.7. (For effective dose equivalent per administered activity, the resulting unit is mrem/mCi.)

RadioGenix System 1.2

Radiation Safety Drug Handling

• The potassium molybdate Mo-99 source solution and Sodium Pertechnetate Tc 99m Injection are radioactive and should be handled with appropriate safety measures to minimize radiation exposure to patients and healthcare providers. Use waterproof gloves and effective shielding, including syringe shields, throughout the entire preparation and handling for the RadioGenix System and technetium Tc-99m injection [see Warnings and Precautions (5.1)].

Important Administration Instructions

• Use aseptic technique in eluting generator and in all drug preparation and handling.
• Inspect the Sodium Pertechnetate Tc 99m Injection for particulate matter and discoloration prior to administration. Do not administer Sodium Pertechnetate Tc 99m Injection if there is any evidence of particulate matter and discoloration.
• Measure patient dose with a suitable radioactivity calibration system immediately prior to administration.
• Instruct patients to hydrate after intravenous or intravesicular administration. Encourage the patient to void as soon as the imaging study is completed and frequently for the next 12 hours to minimize the radiation absorbed dose to the bladder.
• Instruct patients to blow their nose and/or wash their eyes with sterile distilled water or an isotonic sodium chloride solution after ophthalmic administration to minimize the radiation absorbed dose.

Recommended Dose for Adults

The recommended doses for adult patients are shown in Table 1.

Table 1 Recommended Dose of Sodium Pertechnetate for Adult Patients:

Recommended Dose for Pediatric Patients

The recommended doses for pediatric patients are shown in Table 2 [see Use in Specific Populations (8.4)].

Table 2. Recommended Dose of Sodium Pertechnetate for Pediatric Patients:

RadioGenix System Maintenance

• For complete system maintenance and use follow the Operator Guide, RadioGenix System 1.2 (SYS-0028) or Operator Guide, RadioGenix System 1.2 (SYS-0060) P/N 40010570.
• Install the RadioGenix System in an operating environment which complies with local and national requirements for production of radiopharmaceutical products (ISO Class 8 or better environment as described in USP General Chapter 797 Pharmaceutical Compounding Sterile Preparations).
• The RadioGenix System is only for use by trained personnel.
• Only use potassium molybdate Mo 99, processing reagent, saline and other components, including packs supplied by NorthStar Medical Radioisotopes, LLC [see How Supplied/Storage and Handling (16.1)]
• Table 3 is a summary of RadioGenix System scheduled maintenance and protocol actions. Perform all protocols according to the illustrated directions provided in the Operator Guide, RadioGenix System 1.2 (SYS-0028) or Operator Guide, RadioGenix System 1.2 (SYS-0060) P/N 40010570.

Table 3. RadioGenix System 1.2 Scheduled Maintenance:

Directions for Eluting RadioGenix System

• The Sodium Pertechnetate Tc 99m Injection solution is produced using Elute Tc-99m protocol through the RadioGenix System home screen Follow step-by-step directions for use provided in the Operator Guide, RadioGenix System 1.2 (SYS-0028) or Operator Guide, RadioGenix System 1.2 (SYS-0060) P/N 40010570.
• The elution process to produce Sodium Pertechnetate Tc 99m Injection involves the initial installation and set-up of the equipment, reagent, sterilizing filters, and sterile final product collection vials provided by NorthStar Medical Radioisotopes, LLC [see Table 3].
• Use only isopropyl alcohol (IPA) wipes during the Elution Protocol for the RadioGenix System
• Implement the following prerequisites before the Elute Tc-99m protocol is initiated:

1. Connect the potassium molybdate Mo-99 source container using the Source Vessel Kit for RadioGenix System.
2. Aseptically install the PSC Pack for RadioGenix System 1.2 consisting of one reagent solution (5M sodium hydroxide NaOH) and the primary separation cartridge (PSC).
3. Aseptically assemble and install the Tc-99m Elution Pack for RadioGenix System 1.2 with the TPC consisting of an alumina column, 0.20 micron filter, and a 20 mL sterile collection vial.
4. Attach the supplied tubing contained in the Saline Tubing Pack to the saline port.
5. Attach the supplied 0.9% sterile sodium chloride bag to the saline tubing.
6. Initiate the computer-controlled elution process to prepare Sodium Pertechnetate Tc 99m Injection.
7. After delivery of Sodium Pertechnetate Tc 99m Injection to the collection vial is complete, remove the collection vial and perform the quality control procedures [see Dosage and Administration (2.7)].
8. Discard the first eluate from every new Molybdate Mo-99 Source Vessel to minimize the risk of unintended radiation exposure from Rhenium Re-186 [see Warnings and Precautions (5.3)]

Quality Control of Sodium Pertechnetate Tc 99m Injection

Perform the following quality control procedures on each Sodium Pertechnetate Tc 99m Injection prior to its release for clinical use or for reconstitution with Tc-99m radiopharmaceutical kits.

Mo-99 Breakthrough Test:

• Using a suitable radioactivity calibrator, determine the activity of technetium Tc-99m eluted.
• Place the Sodium Pertechnetate Tc-99m injection eluate in a calibrated Mo-99 assay shield. Place the lid on the container and put the entire container in the dose calibrator chamber.
• Record the activity of molybdenum Mo-99 on the most sensitive scale.
• Divide the activity of molybdenum Mo-99 by the activity of technetium Tc-99m. Correct for decay and shielding effect, if necessary.
• Determine the molybdenum Mo-99/technetium Tc-99m ratio at the time of elution and from that ratio, determine the expiration time of the eluate. Each Sodium Pertechnetate Tc 99m Injection eluate must meet or exceed the purity requirement of 0.15 microCi of Mo-99 per mCi of Tc-99m.
• The expiry time for each eluate of Sodium Pertechnetate Tc 99m Injection must be no later than 12 hours post-elution or the time where the Mo-99 to Tc-99m ratio reaches 0.15 microCi/mCi, whichever occurs earlier

Colorimetric Aluminum Ion Test Procedure:

• Using an aluminum ion indicator kit, determine the aluminum ion concentration of the eluate per the manufacturer’s instructions.
• The eluate concentration must not exceed 10 micrograms/mL.

Determination of pH:

• Place a small drop of Sodium Pertechnetate Tc-99m injection on a colorimetric pH strip.
• Examine and compare the coloration of the test strip with the colors displayed on the pH cartridge.
• The pH range must be between 4.5 and 7.5.

Radiolabeling (Reconstitution) of Kits

• In general, use no more than 5 mL volume for radiolabeling kits with RadioGenix System produced Sodium Pertechnetate Tc 99m Injection, USP.
• Perform quality control of a radiolabeled kit per the directions in the package insert and only use the product if it meets the kit manufacturer’s quality control requirements.
• The radiolabeled product shall have an expiry no more than 12 hours from the time of sodium pertechnetate elution or the expiry time stated by the kit manufacturer, whichever occurs earlier.

Radiation Dosimetry

Intravenous Injection

Estimates of radiation absorbed dose per unit activity of Sodium Pertechnetate Tc 99m Injection administered to an adult of average size and weight and to pediatric patients of sizes and weights typical of representative ages are shown in Table 4.

Table 4. Radiation Absorbed Dose from Intravenous Injection:

* To obtain radiation absorbed dose per unit activity in mrad/mCi from the preceding table, multiply individual values by a factor of 3.7. (For effective dose per administered activity, the resulting unit is mrem/mCi.)
** For the liver, 20% of the absorbed dose per unit activity is derived from a presumed maximum concentration of 0.015% MBq Mo-99 per MBq Tc-99m

Dacryoscintigraphy

Estimates of radiation absorbed dose to an adult patient from the nasolacrimal imaging procedure using a maximum dose of 3.7 megabecquerels (0.1 millicurie) of Sodium Pertechnetate Tc 99m Injection are shown in Table 5.

Table 5. Radiation Absorbed Dose in the Eye Lens from Dacryoscintigraphy of Adults:

Cystography

Estimates of radiation absorbed dose per unit activity of Sodium Pertechnetate Tc 99m Injection administered through direct urinary-bladder infusion with no voiding over 30 minutes to an adult of average size and weight and to pediatric patients of sizes and weights typical of representative ages are shown in Table 6.

Table 6. Radiation Absorbed Dose* from Cystography:

* To obtain radiation absorbed dose per unit activity in mrad/mCi from the preceding table, multiply individual values by a factor of 3.7. (For effective dose equivalent per administered activity, the resulting unit is mrem/mCi.)

Storage

• Receipt, transfer, storage, handling, possession, or use of the potassium molybdate Mo-99 source solution, Sodium Pertechnetate Tc 99m Injection, and radioactive components of the RadioGenix System are subject to the radioactive material regulations and licensing requirements of the U.S. Nuclear Regulatory Commission, Agreement States, or Licensing States.
• Install and operate RadioGenix System, and store the potassium molybdate Mo-99 source solutions and kits [Sterilization Kit for RadioGenix System, Reagent Kit for RadioGenix System, Tc-99m Product Kit for RadioGenix System, Discarded Material Kit for RadioGenix System, and Source Vessel Kit for RadioGenix System] at 20°C-25°C (68°F-77°F); excursions permitted to 15°C-30°C (59°F-86°F).

Disposal

• The maximum use period of a RadioGenix System is one year from the date of installation. After expiry, have NorthStar perform annual preventative maintenance and recertify the RadioGenix System.
• The maximum use period of the ozone generator is 6 months. After expiry, have NorthStar replace the ozone generator.
• When the potassium molybdate Mo-99 source has reached the end of its useful life or expiration date, remove the source vessel from the RadioGenix System and return it to NorthStar for processing.
• Dispose of the radioactive waste (discarded material) container in accordance with applicable regulations.

RadioGenix System 1.2

Storage

• Receipt, transfer, storage, handling, possession, or use of the potassium molybdate Mo-99 source solution, Sodium Pertechnetate Tc 99m Injection, and radioactive components of the RadioGenix System are subject to the radioactive material regulations and licensing requirements of the U.S. Nuclear Regulatory Commission, Agreement States, or Licensing States.
• Install and operate RadioGenix System, and store the potassium molybdate Mo-99 source solutions, reagent, kit and packs [Sterilization Pack for RadioGenix System 1.2, PSC Pack for RadioGenix System 1.2, Tc-99m Elution Pack for RadioGenix System 1.2, Discarded Material Pack for RadioGenix System 1.2, Source Vessel Kit for RadioGenix System 1.2, and Saline Tubing Pack Assembly for RadioGenix System 1.2, Saline at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F).

Disposal

• The maximum use period of a RadioGenix System and ozone generator is one year from the date of installation. After expiry, have NorthStar perform annual preventative maintenance and recertify the RadioGenix System.
• The maximum use period of the ozone generator is 6 months. After expiry, have NorthStar replace the ozone generator.
• When the potassium molybdate Mo-99 source has reached the end of its useful life or expiration date, remove the source vessel from the RadioGenix System and return it to NorthStar for processing.
• Dispose of the radioactive waste (discarded material) container in accordance with applicable regulations.