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The Ultra-TechneKow™ DTE Generator is prepared with fission-produced molybdenum Mo-99 adsorbed onto alumina column shielded by lead, tungsten, or depleted uranium. This generator provides a closed system for the production of sterile metastable technetium Tc-99m, which is produced by the decay of molybdenum Mo-99. Sterile, nonpyrogenic isotonic solutions of Sodium Pertechnetate Tc 99m can be obtained conveniently by periodic aseptic elution of the generator. These solutions should be clear, colorless, and free from any particulate matter.
The carrier-free solution may be used as is, or diluted to the proper concentration. Over the life of the generator, an elution will contain an amount of technetium Tc-99m in direct proportion to the quantity of Mo-99 decay since the previous elution of the generator. The quantity of Tc-99m in the eluate is determined by quantity of Mo-99 on the column and the elapsed time between elutions.
Each eluate of the generator should not contain more than the USP limit of 0.15 kilobecquerel molybdenum Mo-99 per megabecquerel technetium Tc-99m (0.15 microcurie Mo-99 per millicurie Tc-99m) per administered dose at the time of administration and an aluminum ion concentration of not more than 10 micrograms per milliliter of the generator eluate, both of which must be determined by the user before administration.
Since the eluate does not contain an antimicrobial agent, it should not be used after 12 hours from the time of generator elution.
Technetium Tc-99m decays by isomeric transition with a physical half-life of 6 hours. The principal photon that is useful for detection and imaging studies is listed in Table 1.
Table 1: Principal Radiation Emission Data
| Radiation | Mean Percent Per Disintegration | Energy (keV) |
| Gamma-2 | 89.07 | 140.5 |
The specific gamma ray constant for technetium Tc-99m is 0.795 R/hr-mCi at 1 cm. The first half-value layer is 0.023 cm of lead (Pb). 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 2. For example, the use of 0.27 cm thickness of Pb will attenuate the radiation emitted by a factor of about 1000.
Table 2: Radiation Attenuation by Lead Shielding
| Shield Thickness (Pb) cm | Coefficient of Attenuation |
| 0.023 | 0.5 |
| 0.09 | 10-1 |
| 0.18 | 10-2 |
| 0.27 | 10-3 |
Molybdenum Mo-99 decays to technetium Tc-99m with a molybdenum Mo-99 half-life of 2.75 days, or 66 hours. The physical decay characteristics of molybdenum Mo-99 are such that only 88.6% of the decaying molybdenum Mo-99 atoms form technetium Tc-99m. Generator elutions may be made at any time, but the amount of technetium Tc-99m available will depend on the interval measured from the last elution. Approximately 47% of the maximum available technetium Tc-99m is reached after 6 hours and 95% after 23 hours. To correct for physical decay of molybdenum Mo-99 and technetium Tc-99m, the fractions that remain at selected intervals of time are shown in Tables 3 and 4.
Table 3: Physical Decay Chart, Molybdenum Mo-99, Half-Life 66 Hours
| Days | Percent Remaining | Days | Percent Remaining |
| 0 | 100 | 10 | 8 |
| 1 | 78 | 11 | 6 |
| 2 | 60 | 12 | 5 |
| 3 | 47 | 13 | 4 |
| 4 | 37 | 14 | 3 |
| 5 | 28 | 15 | 2 |
| 6 | 22 | 20 | 0.6 |
| 7 | 17 | 25 | 0.2 |
| 8 | 13 | 30 | 0.05 |
| 9 | 10 |
Table 4: Physical Decay Chart; Technetium Tc-99m, Half-Life 6 Hours
| Hours | Percent Remaining | Hours | Percent Remaining |
| 6 | 50 | ||
| 7 | 45 | ||
| 8 | 40 | ||
| 9 | 35 | ||
| 10 | 32 | ||
| 0* | 100 | 11 | 28 |
| 1 | 89 | 12 | 25 |
| 2 | 79 | 14 | 20 |
| 3 | 71 | 16 | 16 |
| 4 | 63 | 18 | 13 |
| 5 | 56 | 24 | 6 |
| * Calibration Time | |||
The Ultra-Technekow™ V4 generator is a source of sodium pertechnetate Tc 99m for use in the preparation of FDA-approved diagnostic radiopharmaceuticals, as described in the labeling of these diagnostic radiopharmaceutical kits.
Sodium Pertechnetate Tc 99m is used IN ADULTS as an agent for:
Sodium Pertechnetate Tc 99m is administered by intravenous injection. When imaging the nasolacrimal drainage system, instill the Sodium Pertechnetate Tc 99m by the use of a device such as a micropipette or similar method which will ensure the accuracy of the dose.
For imaging the urinary bladder and ureters (direct isotopic cystography), the Sodium Pertechnetate Tc 99m is administered by direct instillation 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 suggested dose ranges employed for various diagnostic indications in the average ADULT PATIENT (70 kg) are as follows:
The recommended dosages in PEDIATRIC PATIENTS are:
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. If the solution is discolored, discontinue use of the generator immediately. The solution to be administered as the patient dose should be clear, colorless, and contain no particulate matter.
The estimated absorbed radiation doses to an average ADULT and PEDIATRIC patient from an intravenous injection of various doses of Sodium Pertechnetate Tc 99m distributed uniformly in the total body are shown in Tables 5 and 6.
Table 5: Absorbed Radiation Doses from Intravenous Injection
| Organ | Absorbed Radiation Dose (mGy) for a 1110 MBq (30mCi) dose |
| Adrenals | 4.1 |
| Urinary Bladder Wall | 20 |
| Bone Surfaces | 6.2 |
| Brain | 2.2 |
| Breasts | 2 |
| Gallbladder Wall | 8.3 |
| Stomach Wall | 29 |
| Small Intestine | 18 |
| ULI Wall | 63 |
| LLI Wall | 23 |
| Heart Wall | 3.5 |
| Kidneys | 6 |
| Liver | 4.7 |
| Lungs | 2.9 |
| Muscle | 3.6 |
| Ovaries | 11 |
| Pancreas | 6.3 |
| Red Marrow | 4.1 |
| Skin | 2 |
| Spleen | 4.8 |
| Testes | 3.1 |
| Thymus | 2.7 |
| Thyroid | 24 |
| Uterus | 9 |
| Remaining Tissues | 3.9 |
| Effective Dose (mSv) | 14 |
To obtain radiation absorbed dose in rads (30 mCi dose) from the above table, divide individual organ values by a factor of 10 (does not apply for effective dose).
Table 6: Pediatric Absorbed Radiation Doses (mGy) from Intravenous Injection
| Age | 15 years | 10 years | 5 years | 1 year |
| Administered activity in MBq (mCi) | 1110 (30) | 740 (20) | 555 (15) | 370 (10) |
| Organ | ||||
| Adrenals | 5.3 | 5.4 | 6.2 | 7.1 |
| Urinary Bladder Wall | 26 | 22 | 18 | 22 |
| Bone Surfaces | 7.6 | 7.5 | 8.1 | 10 |
| Brain | 2.8 | 3.1 | 3.7 | 4.5 |
| Breasts | 2.6 | 2.6 | 3.2 | 4.1 |
| Gallbladder Wall | 11 | 12 | 13 | 13 |
| Stomach Wall | 38 | 36 | 43 | 59 |
| Small Intestine | 22 | 23 | 26 | 30 |
| ULI Wall | 81 | 89 | 110 | 140 |
| LLI Wall | 31 | 33 | 40 | 48 |
| Heart Wall | 4.5 | 4.6 | 5.2 | 6.4 |
| Kidneys | 7.2 | 6.9 | 7.8 | 8.5 |
| Liver | 6 | 6.7 | 8 | 9.1 |
| Lungs | 3.8 | 3.8 | 4.4 | 5.3 |
| Muscle | 4.5 | 4.5 | 5 | 6 |
| Ovaries | 14 | 13 | 14 | 17 |
| Pancreas | 8.1 | 8.2 | 8.9 | 10 |
| Red Marrow | 5.1 | 5 | 5.2 | 6 |
| Skin | 2.5 | 2.6 | 3.2 | 3.8 |
| Spleen | 6 | 6 | 6.7 | 7.8 |
| Testes | 4.1 | 4.3 | 4.9 | 6 |
| Thymus | 3.6 | 3.5 | 4.2 | 5.3 |
| Thyroid | 40 | 41 | 67 | 81 |
| Uterus | 11 | 11 | 12 | 14 |
| Remaining Tissues | 4.8 | 4.8 | 5.4 | 6.4 |
| Effective Dose (mSv) | 19 | 19 | 23 | 29 |
To obtain radiation absorbed dose in rads (30 mCi dose) from the above table, divide individual organ values by a factor of 10 (does not apply for effective dose).
The estimated absorbed radiation doses to an ADULT patient from the nasolacrimal imaging procedure using a maximum dose of 3.7 megabecquerels (100 microcuries) of Sodium Pertechnetate Tc 99m are shown in Table 7.
Table 7: Absorbed Radiation Doses from Dacryoscintigraphy
| Tissue | 3.7 MBq (100 μCi) | |
| Dose of Sodium Pertechnetate Tc 99m | ||
| mGy | rad | |
| 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 |
| *Assuming no blockage of draining system. | ||
In pediatric patients, an average 30 minute exposure to 37 MBq (1 mCi) of Tc-99m pertechnetate following instillation for direct cystography, will result in the following estimated radiation doses:
Table 8: Absorbed Radiation Doses from Cystography (PEDIATRIC)
| 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) |
The Ultra-Technekow™ V4 (Technetium Tc 99m) Generators contain the following amount of molybdenum Mo-99 at the date and time of calibration stated on the label.
Catalog No.
| 9010 NDC 69945-010-03 | 37 gigabecquerels | (1.0 curie) |
| 9015 NDC 69945-015-04 | 55.5 gigabecquerels | (1.5 curies) |
| 9020 NDC 69945-020-05 | 74 gigabecquerels | (2.0 curies) |
| 9025 NDC 69945-025-06 | 92.5 gigabecquerels | (2.5 curies) |
| 9030 NDC 69945-030-07 | 111 gigabecquerels | (3.0 curies) |
| 9035 NDC 69945-035-08 | 129.5 gigabecquerels | (3.5 curies) |
| 9051 NDC 69945-051-09 | 185 gigabecquerels | (5.0 curies) |
| 9060 NDC 69945-060-10 | 222 gigabecquerels | (6.0 curies) |
| 9075 NDC 69945-075-11 | 277.5 gigabecquerels | (7.5 curies) |
| 9110 NDC 69945-110-12 | 407 gigabecquerels | (11.0 curies) |
| 9140 NDC 69945-140-13 | 518 gigabecquerels | (14.0 curies) |
| 9160 NDC 69945-160-14 | 592 gigabecquerels | (16.0 curies) |
| 9190 NDC 69945-190-15 | 703 gigabecquerels | (19.0 curies) |
Each generator is supplied with the following components for the elution of the generator:
1 - Technestat Vial, 5 mL, containing 0.5 mL of 1.5 mg/mL methylparaben and 0.2 mg/mL propylparaben, sterile, non-pyrogenic
1 - Package Insert
SUPPLIED SEPARATELY
30 - Evacuated Collecting Vials, 30 mL, sterile, non-pyrogenic, supplied with:
90 - Radioactive Materials Labels – Collection Vial (30 en, 30 fr, 30 es)
90 - Radioactive Materials Labels – Elution Shield (30 en, 30 fr, 30 es)
1 - Package Insert
30 - Generator Eluant, 0.9% Sodium Chloride Injection, sterile, non-pyrogenic, available in 5 mL, 10 mL, or 20 mL volumes, with 1 package insert. The eluant does not contain an antimicrobial agent. Each milliliter of Generator Eluant contains 9 milligrams of Sodium Chloride.
Store generator and Sodium Pertechnetate Tc 99m solution at controlled room temperature 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].
The generator should not be used after the expiration date stated on the label.
The expiration time of the Sodium Pertechnetate Tc 99m solution is not later than 12 hours after time of elution. If the eluate is used to reconstitute a kit, the radiolabeled kit should not be used after 12 hours from the time of generator elution or after the expiration time stated on the labeling for the prepared drug, whichever is earlier.
Eluting the generator every 24 hours will provide optimal amounts of Sodium Pertechnetate Tc 99m. However, the generator may be eluted whenever sufficient amounts of technetium Tc-99m have accumulated within the column.
For Example
| Time After First Elution (hrs.) | Approximate Yield (% of First Elution) |
| 1 | 10 |
| 2 | 19 |
| 3 | 27 |
| 4 | 35 |
| 5 | 41 |
| 6 | 47 |
If the vacuum in the collecting vial is lost, do not attempt to re-evacuate the vial, but discard and use a new collecting vial.
This generator may be received, used and administered only by authorized persons in designated clinical settings. Its receipt, storage, use, transfer and disposal are subject to the regulations and/or appropriate licenses of local competent official organizations.
Manufactured by: Curium US LLC, Maryland Heights, MO 63043 USA. Revised : May 2022
Allergic reactions including anaphylaxis have been reported infrequently following the administration of Sodium Pertechnetate Tc 99m.
No Information provided
Radiation risks associated with the use of Sodium Pertechnetate Tc 99m are greater in pediatric patients than in adults and, in general, the younger the patient the greater the risk owing to greater absorbed radiation doses and longer life expectancy. These greater risks should be taken firmly into account in all benefit risk assessments involving pediatric patients.
Long-term cumulative radiation exposure may be associated with an increased risk of cancer.
Only use generator eluant specified for use with the Ultra-Technekow V4 Generator. Do not use any other generator eluant or saline from any other source.
Radiopharmaceuticals should be used only by physicians who are qualified by 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.
As in the use of any radioactive material, care should be taken to minimize radiation exposure to the patient consistent with proper patient management and to ensure minimum radiation exposure to occupational workers.
After the termination of the nasolacrimal imaging procedure, blowing the nose and washing the eyes with sterile distilled water or an isotonic sodium chloride solution will further minimize the radiation dose.
Since the eluate does not contain an antimicrobial agent, it should not be used after 12 hours from time of generator elution.
No long-term animal studies have been performed to evaluate carcinogenic or mutagenic potential or whether Sodium Pertechnetate Tc 99m may affect fertility in males or females.
In animal reproductive studies, Sodium Pertechnetate Tc 99m (as free pertechnetate) has been shown to cross the placental barrier. It is not known whether Sodium Pertechnetate Tc 99m can cause fetal harm when administered to a pregnant woman or can affect reproductive capacity.
Sodium Pertechnetate Tc 99m should be given to pregnant women only if the expected benefits to be gained clearly outweigh the potential hazards.
Ideally, examinations using radiopharmaceutical drug products - especially those elective in nature - of women of childbearing capability should be performed during the first ten days following the onset of menses.
Technetium Tc-99m is excreted in human milk during lactation, therefore, formulafeedings should be substituted for breast-feedings.
See INDICATIONS AND USAGE and DOSAGE AND ADMINISTRATION sections. Also see the description of additional risk under WARNINGS.
No information provided.
None.
The pertechnetate ion distributes in the body similarly to the iodide ion but is not organified when trapped in the thyroid gland. Pertechnetate concentrates in the thyroid gland, salivary glands, stomach and choroid plexus. After intravenous administration it gradually equilibrates with the extracellular space. A fraction is promptly excreted via the kidneys.
Following the administration of Sodium Pertechnetate Tc 99m as an eye drop, the drug mixes with tears within the conjunctival space. Within seconds to minutes it leaves the conjunctival space and escapes into the inferior meatus of the nose through the nasolacrimal drainage system. During this process the pertechnetate ion passes through the canaliculi, the lacrimal sac and the nasolacrimal duct. In the event of any anatomical or functional blockage of the drainage system there will be a backflow resulting in tearing (epiphora). Thus the pertechnetate escapes the conjunctival space in the tears.
While the major part of the pertechnetate escapes within a few minutes of normal drainage and tearing, it has been documented that there is some degree of transconjunctival absorption with turnover of 1.5% per minute in normal individuals, 2.1% per minute in patients without any sac and 2.7% per minute in patients with inflamed conjunctiva due to chronic dacryocystitis. Individual values may vary but these rates are probably representative and indicate that the maximum possible pertechnetate absorbed will remain below one thousandth of that used in other routine diagnostic procedures.
No information provided. Please refer to the WARNINGS and PRECAUTIONS sections.
