FOR DIAGNOSTIC USE

For the Production of Sodium Pertechnetate Tc 99m Injection

DESCRIPTION: Sodium Pertechnetate Tc 99m Injection, as eluted according to the elution instructions with Lantheus Medical Imaging, Inc. TECHNELITE®, Technetium Tc 99m Generator, is in 0.9% Sodium Chloride Injection, USP as a sterile, non-pyrogenic, diagnostic radiopharmaceutical suitable for intravenous injection and direct instillation. The pH is 4.5-7.5. The eluate should be clear, colorless, and free from visible foreign material. Each eluate of the TECHNELITE®, Technetium Tc 99m Generator should not contain more than 0.0056MBq (0.15 microcuries) of Molybdenum Mo99 per 37MBq (1 millicurie) of Technetium Tc 99m per administered dose at the time of administration, and not more than 10 micrograms of aluminum per milliliter of the Technetium Tc 99m 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 later than one (1) working day after the elution (12 hours).

Lantheus Medical Imaging, Inc. TECHNELITE®, Technetium Tc 99m Generator consists of a column containing uranium fission produced Molybdenum Mo99 adsorbed on alumina. The terminally sterilized and sealed column is enclosed in a lead shield; the shield and other components are sealed in a cylindrical plastic container with an attached handle. Built into the top surface are two recessed wells marked SALINE CHARGE and COLLECT. Needles protruding from these two wells accommodate supplied sterile eluant charge vials and sterile eluate collection vials. The eluting solvent consists of 0.9% Sodium Chloride Injection, USP, prepacked into septum-sealed vials, to make the solution isotonic.

The eluate collection vial is evacuated, sterile and non-pyrogenic. A sterile 0.22 micrometer bacteriological filter is incorporated between the column outlet and the collection vials. During and subsequent to elution, the eluate collection vial should be kept in a radiation shield. The Generator is shipped with a silicone needle seal over the charge needle and a vented needle cover over the collect needle. A sterile collect needle seal is supplied for the customer to aseptically reseal the collect needle after each elution.

CLINICAL PHARMACOLOGY: The pertechnetate ion distributes in the body similarly to the iodide ion but is not organified when trapped in the thyroid gland. It also concentrates in the choroid plexus, thyroid gland, salivary glands, and stomach. However, in contrast to the iodide ion, the pertechnetate ion is released unchanged from the thyroid gland.

After intravascular administration the pertechnetate ion gradually equilibrates with the extracellular space. A fraction is promptly excreted via the kidneys.

Following the administration of Sodium Pertechnetate Tc 99m Injection 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 a fractional turnover rate of 0.015/min in normal individuals, 0.021/min in patients without any sac and 0.027/min 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 Technelite 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 Injection is used IN ADULTS as an agent for:

 

Thyroid Imaging

 

Salivary Gland Imaging

 

Urinary Bladder Imaging (direct isotopic cystography) for the detection of vesico-ureteral reflux.

 

Nasolacrimal Drainage System Imaging

Sodium Pertechnetate Tc 99m Injection is used IN CHILDREN as an agent for:

 

Thyroid Imaging

 

Urinary Bladder Imaging (direct isotopic cystography) for the detection of vesico-ureteral reflux.

CONTRAINDICATIONS: None known.

WARNINGS: Radiation risks associated with the use of Sodium Pertechnetate Tc 99m Injection are greater in children than in adults and, in general, the younger the child, 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 children.

Long-term cumulative radiation exposure may be associated with an increased risk of cancer.

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

DOSAGE AND ADMINISTRATION: Sodium Pertechnetate Tc 99m Injection is usually administered by intravascular injection. For imaging the urinary bladder and ureters (direct isotopic cystography), the Sodium Pertechnetate Tc 99m Injection is administered by direct instillation aseptically into the bladder via a urethral catheter, following which the catheter is flushed with approximately 200 mL of 0.9% Sodium Chloride Injection, USP directly into the bladder. The dosage employed varies with each diagnostic procedure. When imaging the nasolacrimal drainage system, instill the Sodium Pertechnetate Tc 99m Injection by the use of a device such as a micropipette or similar method which will ensure the accuracy of the dose.

The suggested dose range employed for various diagnostic indications in the average ADULT PATIENT (70kg) is:

The recommended dosage range in PEDIATRIC PATIENTS is:

The patient dose should be measured by a suitable radioactivity calibration system immediately prior to administration of the dose.

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 and contain no particulate matter. Do not use an eluate of the TECHNELITE®, Technetium Tc 99m Generator later than one (1) working day after elution (12 hours).

HOW SUPPLIED: Lantheus Medical Imaging TechneLite®, (Technetium Tc 99m Generator) for the Production of Sodium Pertechnetate Tc 99m Injection is supplied in a multi-dose container and is available in the following quantities of radioactivity of Mo99 on the calibration date (date of manufacture) as specified on the product lot identification label affixed to the generator:

Each generator is supplied with the following standard components:

 

Collect Needle Seal

 

Eluant Charge Vials (may be supplied separately)

 

Eluate Collection Vials (may be supplied separately)

 

1 Package Insert

 

6 Radiation Labels (Collection Vial)

 

6 Radiation Labels (Eluting Shield)

First order generators are shipped with the following accessory components:

 

2 Eluting Shields

Additional quantities of these components may be obtained at the customer's request.

STORAGE: Store generator and Sodium Pertechnetate Tc 99m Injection at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].

EXPIRATION: The expiration time of the Sodium Pertechnetate Tc 99m solution is not later than 12 hours after elution. If the eluate is to be used to reconstitute a kit for the preparation of a Technetium Tc 99m radiopharmaceutical, the kit should not be used after 12 hours from time of Generator elution or after the expiration time stated on the labeling for the prepared drug, whichever is earlier.

The generator should not be used after the expiration date stated on the label.

ELUTION INSTRUCTIONS - TOTAL ELUTION METHOD

1. Waterproof gloves should be worn during elution.
2. Remove dust (clear plastic) cover of generator.
3. Perform all subsequent operations aseptically.
4. Remove silicone needle seal from eluant charge well. Discard as radioactive waste.
5. Remove flip-off seal and swab septum of eluant charge vial with a bactericide (such as 70% isopropyl alcohol), allow to dry, and insert the vial into charge well. Vial should be firmly inserted to assure puncture of septum. Caution: Excessive use of bactericides containing alcohol may adversely affect Technetium Tc 99m yield.
6. Open elution shield base and insert an eluate collection vial from which the flip-off seal has been removed. Screw base back on securely. Swab the exposed vial septum with a bactericide and allow to dry.
7. Remove vented needle cover from collect well. Discard as radioactive waste.
8. Insert shielded eluate collection vial in collect well. Elution should commence within 30 seconds and can be visually checked by the appearance of bubbles in the eluant charge vial. To assure proper yield and functioning, elution must proceed to completion as evidenced by emptying of the charge vial. Allow generator to elute for at least 3 minutes after the charge has been drained, or for a total of 6 minutes.
   ****NOTE 1 (non-eluting generator): If bubbles do not appear in the eluant charge vial within 30 seconds, remove the eluate collection vial to prevent vacuum loss; then remove and reinsert the charge vial. Reinsert the eluate collection vial and if elution does not commence, use a second shielded collection vial. If the elution still does not commence, contact Lanthues Medical Imaging, Inc.
   ****NOTE 2 (partial eluting generator): If the saline charge vial does not fully empty or the expected eluate volume is not recovered, remove the evacuated collection vial and the saline charge vial. Insert a new saline charge vial and a new evacuated collection vial. Allow the elution process to complete. If the replacement saline charge vial does not fully empty or the expected eluate volume is not recovered in the replacement collection vial, contact Lantheus Medical Imaging, Inc. DO NOT USE ELUATE COLLECTED FROM A PARTIALLY ELUTED GENERATOR.
   Caution: Tampering with the internal components could compromise sterility and present a radiation hazard. This generator should not be dismantled.
9. After elution has been completed, remove shield containing the collection vial. Obtain the collect needle seal, and using a bactericide, swab the insertion end of the collect needle seal and insert over the collect needle. The eluant vial is sterile and should stay in place until the next elution, functioning as a seal for the needles within the charge well. Upon initiating the next elution, discard the empty eluant vial as radioactive waste and retain the collect needle seal for subsequent elutions.
10. Perform the Assay and Radiometric Molybdenum Test Procedures described below for each elution performed.
11. Fill out and attach the appropriate supplied pressure sensitive radioactivity labels to the elution shield containing the filled eluate collection vial. Do not use an eluate of the Technetium Tc 99m Generator later than 1 working day after the time of elution (12 hours).
12. Use a shielded syringe when introducing the Sodium Pertechnetate Tc 99m solution into mixing vials.
13. Maintain adequate shielding during the life of the radioactive preparation by using a lead vial shield and cover, and use a shielded syringe for withdrawing and injecting the preparation.

DISPOSAL: All components shipped with the TECHNELITE®, Technetium Tc 99m Generator should be monitored for contamination prior to disposing into routine trash systems. The Technetium Tc 99m should not be disposed of into routine trash systems. The generator should be disposed through a USNRC or Agreement State licensed disposal agency or by a method approved by the appropriate regulatory authority. Spent generators may be returned; complete return instructions are available on request.

This radioactive drug is approved for distribution to persons licensed pursuant to the Code of Massachusetts Regulations 105 CMR 120.100 for the uses listed in 105 CMR 120.547 or 120.552 or under equivalent regulations of the U.S. Nuclear Regulatory Commision, an Agreement State or a Licensing State.

Lantheus
Medical Imaging
331 Treble Cove Road
N. Billerica, MA 01862 USA
For Ordering Call Toll-Free: 800-299-3431 All other business: 800-362-2668
(In Massachusetts and International, call 978-667-9531)

Patent: http://www.lantheus.com/patents/index.html

Lantheus
Medical Imaging

Printed in U.S.A.

513160-0824
October 2024

Sterile, Non-Pyrogenic Diagnostic Agent for Intravenous Injection

TechneLite®
Technetium Tc 99m Generator
for the Production of Sodium Pertechnetate Tc 99m Injection

Rx only.

See Package Insert for dosing information.
DIN 02328550 AUSTR R 130301

Store at 20° to 25°C (68° to 77°F) [see USP Controlled
Room Temperature]. Eluate must be used within
12 hours of elution.

CAUTION: This generator should not be dismantled.

Manufacturer:
Lantheus
Medical Imaging®
N. Billerica, Massachusetts 01862 USA

Canadian License Holder:
Lantheus MI Canada, Inc.
Montréal, Canada H4M 2X6
Australian Sponsor:
Global Medical Solutions Australia Pty Ltd.

515128-1023

CAUTION:
RADIOACTIVE MATERIAL

Sterile, Non-Pyrogenic Diagnostic Agent for Intravenous Injection

TechneLite®
Technetium Tc 99m Generator
for the Production of Sodium Pertechnetate Tc 99m Injection

Rx only.

See Package Insert for dosing information.
DIN 02328550 AUSTR R 130301

Store at 20° to 25°C (68° to 77°F) [see USP Controlled
Room Temperature]. Eluate must be used within
12 hours of elution.

CAUTION: This generator should not be dismantled.

Manufacturer:
Lantheus
Medical Imaging®
N. Billerica, Massachusetts 01862 USA

Canadian License Holder:
Lantheus MI Canada, Inc.
Montréal, Canada H4M 2X6
Australian Sponsor:
Global Medical Solutions Australia Pty Ltd.

515128-1023

CAUTION:
RADIOACTIVE MATERIAL