Ultra-TechneKow DTE Technetium Tc-99m

Brand Name: Ultra-TechneKow DTE

Generic Name: TECHNETIUM TC-99M

Drug Type: HUMAN PRESCRIPTION DRUG

Route: INTRAVENOUS

Dosage Form: INJECTION, SOLUTION

Data Current As Of: 2018-10-07

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

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.

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.

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

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.

• 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).

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.

• 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 Nuclear Medicine LLC 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.

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