Ultra-technekow V4

Add Info

Ultra-technekow V4 Recall

Get an alert when a recall is issued.

Ask a Question

Questions & Answers

Add Info

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.

Add Info

Legal Issues

There is currently no legal information available for this drug.

Add Info

FDA Safety Alerts

There are currently no FDA safety alerts available for this drug.

Add Info

Manufacturer Warnings

There is currently no manufacturer warning information available for this drug.

Add Info

FDA Labeling Changes

There are currently no FDA labeling changes available for this drug.

Add Info

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

Add Info

History

There is currently no drug history available for this drug.

Add Info

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.

Physical Characteristics

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

External Radiation

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 (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 Remaining	Hours	Percent Remaining
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

Mallinckrodt Inc.

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 weight

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.
Radiation Dosimetry
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)

No Recall

Ultra-technekow V4

Is this a good medication?

Is this a good medication?

Trending Topics

Ultra-technekow V4 Recall

Questions & Answers

Side Effects & Adverse Reactions

Legal Issues

FDA Safety Alerts

Manufacturer Warnings

FDA Labeling Changes

Uses

History

Other Information

Sources

Is this a good medication?

Trending Topics

Ultra-technekow V4 Manufacturers