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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:
Sodium Pertechnetate Tc 99m is used IN PEDIATRIC PATIENTS as an agent for:
Urinary Bladder Imaging (direct isotopic cystography) for the detection of vesicoureteral reflux
DOSAGE AND ADMINISTRATION
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
|Organ||Absorbed Radiation Dose (mGy) for a 1110 MBq (30mCi) dose|
|Urinary Bladder Wall||20|
|Effective Dose (mSv)||14|
Table 6: Pediatric Absorbed Radiation Doses (mGy) from
|Age||15 years||10 years||5 years||1 year|
|Administered activityin MBq (mCi)||1110 (30)||740 (20)||555 (15)||370 (10)|
|Urinary Bladder Wall||26||22||18||22|
|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
|Tissue||3.7 MBq (100 MCi) Dose of Sodium Pertechnetate Tc 99m|
|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|
|* 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
|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.
883 37 gigabecquerels (1.0 curie) NDC 0019-9883-03
884 55.5 gigabecquerels (1.5 curies) NDC 0019-9884-04
885 74 gigabecquerels (2.0 curies) NDC 0019-9885-05
886 92.5 gigabecquerels (2.5 curies) NDC 0019-9886-06
887 111 gigabecquerels (3.0 curies) NDC 0019-9887-07
888 129.5 gigabecquerels (3.5 curies) NDC 0019-9888-08
889 185 gigabecquerels (5.0 curies) NDC 0019-9889-09
890 222 gigabecquerels (6.0 curies) NDC 0019-9890-10
891 277.5 gigabecquerels (7.5 curies) NDC 0019-9891-11
892 407 gigabecquerels (11.0 curies) NDC 0019-9892-12
893 518 gigabecquerels (14.0 curies) NDC 0019-9893-13
894 592 gigabecquerels (16.0 curies) NDC 0019-9894-14
895 703 gigabecquerels (19.0 curies) NDC 0019-9895-15
Each generator is supplied with the following components for the elution of the generator:
7 - Evacuated Collecting Vials, 10 mL, Sterile,
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.
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.
Directions for Use of the Technetium Tc 99m Generator
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)|
Note: The following instructions are applicable for operation of the Ultra-TechneKow™ DTE Generator with or without the utilization of the alignment adaptor.
- Rotate the top cover 30° counterclockwise and lift up to remove.
- Lift the generator by its handle and position it inside the auxiliary shield, aligning the notch in the elution station with the front of the auxiliary shield. Move the handle so that it is not covering the generator top by pushing it off to the side in between the generator and the auxiliary shield.
- Remove the flip-top cap of the eluant vial; disinfect the stopper, allowing the stopper to dry before use. Remove and store the needle cover from the eluant needles; invert the eluant vial and push down into place on the eluant needles.
- Place the alignment adaptor onto the top of the generator with the raised portion of the adaptor located over the elution station.
- Remove the flip-top cap of the TechneStat™ vial; disinfect the stopper, allowing the stopper to dry before use. Secure the TechneStat™ vial into the TechneStat™ vial shield.
- Remove and store the needle cover from the elution needle. Place the auxiliary shield lid onto the top auxiliary shield ring ensuring alignment of the key-hole with the elution needle.
- Carefully lower the TechneStat™ vial shield containing the TechneStat™ vial through the key-hole, inserting the shielded TechneStat™ vial onto the elution needle.
- Remove the flip-top cap of the appropriate evacuated vial; disinfect the stopper, allowing the stopper to dry before use. Place the evacuated vial into the elution shield utilizing the spacer if required.
- Remove the shielded TechneStat™ vial by carefully lifting the TechneStat™ vial shield from the elution needle. Position the shielded evacuated vial by carefully lowering the elution shield into the elution station. Piercing the septum of the evacuated vial with the elution needle will begin the elution process.
- Wait until the evacuated vial has completely filled itself. Depending on the size of the evacuated vial, this may take a few minutes. Never interrupt the elution by lifting the elution shield! NOTE: Do not use generator eluate if its appearance is discolored.
- Carefully remove the elution shield and replace with the shielded TechneStat™ vial (see Step 6 of the Preparation section).
- Determine the technetium Tc-99m concentration and molybdenum Mo-99 content for dispensing purposes. The generator eluate may be assayed using an appropriate detection system. . The manufacturer's instructions for operation of the instrument/equipment should be followed for measurement of Technetium Tc-99m and Molybdenum Mo-99 activity. NOTE: Molybdenum Mo-99 Breakthrough Limit – The acceptable limit is 0.15 kilobecquerel molybdenum Mo-99 per megabecquerel technetium Tc-99m (0.15 microcurie Mo-99 per millicurie Tc-99m) per administered dose in the Injection, at the time of administration (see USP, Sodium Pertechnetate Tc 99m Injection).
- Determine the aluminum ion concentration of the eluate. NOTE: Aluminum Ion Breakthrough Limit - The acceptable limit is not more than 10 micrograms per milliliter of eluate (see USP, Sodium Pertechnetate Tc 99m Injection).
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.
Expired Generator Disposal
- Following the life of the generator, remove and dispose of the used TechneStat™ vial and the eluant vial.
- If appropriate, remove and store the Alignment Adaptor for use with replacement generator.
- Cover the elution and eluant needles with the stored needle covers.
- Close the generator system with its top cover by rotating with downward pressure.
- The intact generator assembly should be either returned to Mallinckrodt Inc. or disposed of in accordance with applicable regulations.
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.
Manufactured by: Mallinckrodt Inc., St. Louis, MO 63134 USA. Distributed in Canada by: Mallinckrodt Canada ULC, Kirkland, QC, Canada, H9J 3Z4. Rev 01/2014This monograph has been modified to include the generic and brand name in many instances.
Last reviewed on RxList: 3/3/2014
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