Ultra-technekow V4
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Questions & Answers
Side Effects & Adverse Reactions
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.
Legal Issues
There is currently no legal information available for this drug.
FDA Safety Alerts
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Manufacturer Warnings
There is currently no manufacturer warning information available for this drug.
FDA Labeling Changes
There are currently no FDA labeling changes available for this drug.
Uses
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:
Thyroid Imaging
Salivary Gland Imaging
Urinary Bladder Imaging (direct isotopic cystography) for detection of vesico-ureteral reflux
Nasolacrimal Drainage System Imaging (dacryoscintigraphy)
Sodium Pertechnetate Tc 99m is used IN PEDIATRIC PATIENTS as an agent for:
Thyroid Imaging
Urinary Bladder Imaging (direct isotopic cystography) for the detection of vesico-ureteral reflux
History
There is currently no drug history available for this drug.
Other Information
The Ultra-Technekow™ V4 Generator is prepared with fission-produced molybdenum Mo-99 adsorbed onto alumina in a column shielded by lead, tungsten, or depleted uranium. The column assembly and shielding are encased in a plastic container that is covered with a plastic elution hood. The elution hood has an opening for the column assembly double inlet needles and an opening for the single outlet needle. The needles accommodate the sterile eluant vials and sterile evacuated collection vials. A sterile vial containing a bacteriostat is supplied with the generator for the customer to aseptically seal the outlet needle after each elution.
This terminally sterilized generator provides a closed system for the production of sterile metastable technetium Tc-99m, which is produced by the decay of molybdenum Mo-99. Incorporated between the column outlet and the collection vial is a sterile 0.22 micrometer filter. Sterile, non-pyrogenic 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 Sodium Pertechnetate
Tc 99m Injection is suitable for intravenous injection and direct instillation.
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 |
Energy |
| 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 |
Coefficient |
| 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 (see Table 3). 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 |
Hours |
Percent |
| 0* |
100 |
9 |
35 |
| 1 |
89 |
10 |
32 |
| 2 |
79 |
11 |
28 |
| 3 |
71 |
12 |
25 |
| 4 |
63 |
14 |
20 |
| 5 |
56 |
16 |
16 |
| 6 |
50 |
18 |
13 |
| 7 |
45 |
24 |
6 |
| 8 |
40 |
*Calibration Time
Sources
Ultra-technekow V4 Manufacturers
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Mallinckrodt Inc.
![Ultra-technekow V4 (Technetium Tc-99m Generator) Injection, Solution [Mallinckrodt Inc.]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Ultra-technekow V4 | Mallinckrodt Inc.
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:
Vesico-ureteral imaging: 18.5 to 37 MBq (0.5 to 1 mCi)
Thyroid gland imaging: 37 to 370 MBq (1 to 10 mCi)
Salivary gland imaging: 37 to 185 MBq (1 to 5 mCi)
Nasolacrimal drainage system: Maximum dose of 3.7 MBq (100 µCi)The recommended dosages in PEDIATRIC PATIENTS are:
Vesico-ureteral imaging: 18.5 to 37 MBq (0.5 to 1 mCi)
Thyroid gland imaging: 2.22 to 2.96 MBq (60 to 80 µCi) per kg body weightThe 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.
Radiation DosimetryThe 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 99mmGy
rad
Eye Lens:
If lacrimal fluid turnover is 16%/min
0.140
0.014
If lacrimal fluid
turnover is 100%/min0.022
0.002
If drainage
system is blocked4.020
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)
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