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Ultra-Technekow DTE (Technetium Tc 99m Generator) Rx only For the Production ofSodium Pertechnetate Tc 99m Injection | Ultra-TechneKow [MALLINCKRODT NUCLEAR MEDICINE LLC] | BioPortfolio

12:39 EST 27th January 2019 | BioPortfolio
Note: While we endeavour to keep our records up-to-date one should not rely on these details being accurate without first consulting a professional. Click here to read our full medical disclaimer.

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, 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 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

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

Table 4. Physical Decay Chart; Technetium Tc-99m, Half-Life 6 Hours

* Calibration Time

Shield Thickness (Pb) cm Coefficient of Attenuation
0.023 0.5
0.09 10-1
0.18 10-2
0.27 10-3
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
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

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.

The Ultra-Technekow DTE 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

None.

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 DTE Generator.  Do not use any other generator eluant or saline from any other source.

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.

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.

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.

Animal reproductive studies have not been conducted with Sodium Pertechnetate Tc 99m. It is also 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, formula-feedings should be substituted for breast-feedings.

See INDICATIONS AND USAGE and DOSAGE AND ADMINISTRATION sections. Also see the description of additional risk under WARNINGS .

Allergic reactions including anaphylaxis have been reported infrequently following the administration of Sodium Pertechnetate Tc 99m.

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.  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. Adult Absorbed Radiation Doses from Intravenous Injection

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

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

* 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)

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
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
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
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™ DTE (Technetium Tc 99m) Generators contain the following amount of molybdenum Mo-99 at the date and time of calibration stated on the label.

Each generator is supplied with the following components for the elution of the generator:

      7 - Evacuated Collecting Vials, 10 mL, Sterile, Non-Pyrogenic       or       5 - Evacuated Collecting Vials, 20 mL, Sterile, Non-Pyrogenic       7 - 70% (v/v) Isopropyl Alcohol Wipes       7 - Pressure-sensitive "Caution - Radioactive Material" collecting vial labels       7 - Pressure-sensitive radioassay data labels for lead elution shield       1 - Generator Eluant Vial, 135 mL, Sterile, Non-Pyrogenic       or       2 - Generator Eluant Vials, 135 mL, Sterile, Non-Pyrogenic       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

The sterile, non-pyrogenic solution used to elute the generator column contains 0.9% sodium chloride. The eluant does not contain an antimicrobial agent.

EVACUATED COLLECTING VIALS. Collecting vials are available on request in 10 and 20 milliliter sizes.

 Catalog No.        
 883    37 gigabecquerels    (1.0 curie)
 NDC 69945-883-03        
 884    55.5 gigabecquerels    (1.5 curies)
 NDC 69945-884-04        
 885    74 gigabecquerels    (2.0 curies)
 NDC 69945-885-05        
 886    92.5 gigabecquerels    (2.5 curies)
 NDC 69945-886-06        
 887    111 gigabecquerels    (3.0 curies)
 NDC 69945-887-07        
 888    129.5 gigabecquerels    (3.5 curies)
 NDC 69945-888-08        
 889    185 gigabecquerels    (5.0 curies)
 NDC 69945-889-09        
 890    222 gigabecquerels    (6.0 curies)
 NDC 69945-890-10        
 891    277.5 gigabecquerels    (7.5 curies)
 NDC 69945-891-11        
 892    407 gigabecquerels    (11.0 curies)
 NDC 69945-892-12        
 893    518 gigabecquerels    (14.0 curies)
 NDC 69945-893-13        
 894    592 gigabecquerels    (16.0 curies)
 NDC 69945-894-14        
 895    703 gigabecquerels    (19.0 curies)
 NDC 69945-895-15        

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.

NOTE 1:         Immediately upon delivery, the generator should be placed within a minimum of one-inch of lead shielding in such a manner so as to minimize radiation exposure to attending personnel.

NOTE 2:         Wear waterproof gloves during the elution procedure and during subsequent reconstitution of kits with the eluate.

NOTE 3:         Use a shielded syringe to withdraw patient dose or to transfer Sodium Pertechnetate Tc 99m into mixing vials during kit reconstitution.

NOTE 4:         The needles in the generator are sterile beneath their covers, and the generator has been cleaned underneath the top cover. Additional disinfection of these areas with agents containing alcohol may unfavorably influence the Tc 99m yield.

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.

 Time After
First Elution (hrs.)
   Approximate Yield
(% of First Elution)
 1    10
 2    19
 3    27
 4    35
 5    41
 6    47

Note:  The following instructions are applicable for operation of the Ultra-Technekow DTE Generator with or without the utilization of the alignment adaptor.

Repeat steps 1 through 6 of the Elution procedure above.

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 is approved for use by persons licensed by the U.S. Nuclear Regulatory Commission to use by-product material identified in Section 35.200 or under equivalent licenses of Agreement States.

Mallinckrodt, the “M” brand mark, the Mallinckrodt Pharmaceuticals logo and other brands are trademarks of a Mallinckrodt company.

©2015 Mallinckrodt.

Manufactured by:

Mallinckrodt Nuclear Medicine LLC

Maryland Heights, MO 63043

Made in USA

Distributed in Canada by:

Mallinckrodt RP Canada Inc.

Saint-Laurent, QC, Canada, H4R 2N1

Estb. Lic.: XXXXXX

A880I0                                                                                 

Rev 10/2015                                                                             

Mallinckrodt™

Pharmaceuticals

Ultra-TechneKow™ DTE

A880COR10/2015

CAUTIONRADIOACTIVE MATERIAL

TECHNETIUM Tc 99m GENERATOR Parent Molybdenum 99 prepared from Fission Produced Molybdenum 99Store At Controlled Room Temperature 20-25°C (68-77°F)

WARNING: Radiopharmaceuticals, produced by nuclear reactor or particle accelerator, should be used only by physicians who are qualified by specific training in the use and safe handling of radioisotopes and whose experience and training have been approved by an individual agency or institution already licensed in the use of radioisotopes.

For the production of sterile, non-pyrogenic Sodium Pertechnetate Tc 99m injection.

Rx only

This generator, its manufacture and use are covered by one or more of the following U.S. patents: 3,382,152; 3,446,965; 3,535,085; 3,655,981.

FOR ADDITIONAL INFORMATION SEE PACKAGE INSERT

Manufactured by:Mallinckrodt Nuclear Medicine LLCMaryland Heights, MO 63043

Made in USA

Distributed in Canada by:Mallinckrodt RP Canada Inc.Saint Laurent, QC, Canada, H4R 2N1

Estb. Lic.: XXXXXX

 MOLYBDENUM 99
DECAY CHART
 TECHNETIUM 99m
DECAY CHART
 HALF-LIFE 66.0 HOURS  HALF-LIFE 66.0 HOURS
 DAYS  FRACTION
REMAINING
 DAYS  FRACTION
REMAINING
 0  1.000  -5  1.778
 1  0.777  -4  1.585
 2  0.604  -3  1.413
 3  0.469  -2  1.259
 4  0.365  -1  1.122
 5  0.284  0  1.000
 6  0.220  1  0.891
 7  0.171  2  0.794
 8  0.133  3  0.708
 9  0.103  4  0.631
 10  0.080  5  0.562
 11  0.063  6  0.501
 12  0.049  7  0.447
 13  0.038  8  0.398
 14  0.029  9  0.355
 15  0.023  10  0.316
 20  0.006  11  0.282
 25  0.002  12  0.251
 30  0.0005  14  0.199
     16  0.158
     18  0.126
     24  0.063

Ultra-TechneKow™ DTE

A880COR10/2015

CAUTIONRADIOACTIVE MATERIAL

Ultra-TechneKow™ DTE

A880COR10/2015

CAUTIONRADIOACTIVE MATERIAL

Ultra-TechneKow™ DTE

A880COR10/2015

CAUTIONRADIOACTIVE MATERIAL

Ultra-TechneKow™ DTE

A880COR10/2015

CAUTIONRADIOACTIVE MATERIAL

Ultra-TechneKow™ DTE

A880COR10/2015

CAUTIONRADIOACTIVE MATERIAL

Ultra-TechneKow™ DTE

A880COR10/2015

CAUTIONRADIOACTIVE MATERIAL

Ultra-TechneKow™ DTE

A880COR10/2015

CAUTIONRADIOACTIVE MATERIAL

Ultra-TechneKow™ DTE

A880COR10/2015

CAUTIONRADIOACTIVE MATERIAL

Ultra-TechneKow™ DTE

A880COR10/2015

CAUTIONRADIOACTIVE MATERIAL

Ultra-TechneKow™ DTE

A880COR10/2015

CAUTIONRADIOACTIVE MATERIAL

Ultra-TechneKow™ DTE

A880COR10/2015

CAUTIONRADIOACTIVE MATERIAL

Ultra-TechneKow™ DTE

A880COR10/2015

CAUTIONRADIOACTIVE MATERIAL

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MALLINCKRODT NUCLEAR MEDICINE LLC

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