TechneLite

Name: TechneLite

TechneLite dosage
TechneLite dose range
TechneLite uses
TechneLite drug
TechneLite injection

Precautions

General

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.

Since the eluate does not contain an antimicrobial agent, it should not be used after 12 hours from the time of TechneLite®, Technetium Tc 99m Generator elution.

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.

Radiopharmaceuticals should be used only by physicians who are qualified by training and experience in the safe handling of radionuclides and whose experience and training have been approved by the appropriate government agency authorized to license the use of radionuclides.

Carcinogenesis, Mutagenesis, Impairment of Fertility

No animal studies have been performed to evaluate carcinogenic potential or whether Sodium Pertechnetate Tc 99m affects fertility in males or females.

Pregnancy Category C

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 reproduction capacity. Sodium Pertechnetate Tc 99m Injection should be given to a pregnant woman only if clearly needed.

Ideally examinations using radiopharmaceuticals, especially those elective in nature, of a woman of childbearing capability should be performed during the first few (approximately 10) days following the onset of menses.

Nursing Mothers

Sodium Pertechnetate Tc 99m is excreted in human milk during lactation; therefore formula feedings should be substituted for breast feeding.

This radiopharmaceutical preparation should not be administered to pregnant or lactating women unless expected benefits to be gained outweigh the potential risks.

Pediatric Use

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

Geriatric Use

Clinical studies of TechneLite® did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.

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 but can be given orally. 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 sterile saline directly into the bladder. The dosage employed varies with each diagnostic procedure. If the oral route is elected, the patient should fast for at least six (6) hours before and two (2) hours after administration. 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:

Vesico-ureteral Imaging	18.5 to 37MBq (0.5 to 1mCi)
Brain Imaging	370 to 740MBq (10 to 20mCi)
Thyroid Gland Imaging	37 to 370MBq (1 to 10mCi)
Salivary Gland Imaging	37 to 185MBq (1 to 5mCi)
Placenta Localization	37 to 111 MBq (1 to 3mCi)
Blood Pool Imaging	370 to 1110MBq (10 to 30mCi)
Nasolacrimal Drainage System	Max. 3.7MBq (100μCi)

The recommended dosage range in PEDIATRIC PATIENTS is:

Vesico-ureteral Imaging	18.5 to 37MBq (0.5 to 1mCi)
Brain Imaging	5.18 to 10.36MBq (140 to 280μCi)/kg body weight
Thyroid Gland Imaging	2.22 to 2.96MBq (60 to 80μCi)/kg body weight
Blood Pool Imaging	5.18 to 10.36MBq (140 to 280μCi)/kg body weight

A minimum dose of 111 to 185MBq (3 to 5 mCi) should be employed if radionuclide angiography is performed as part of the blood pool or brain imaging procedure.

NOTE: Up to one (1) gram of pharmaceutical grade potassium perchlorate in a suitable base or capsule may be given prior to administration of Sodium Pertechnetate Tc 99m Injection. When Sodium Pertechnetate Tc 99m Injection is used in children for brain or blood pool imaging, the administration of potassium perchlorate is especially important in order to minimize the absorbed radiation dose to the thyroid gland.

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).

RADIATION DOSIMETRY

The estimated absorbed radiation doses2 to an average ADULT patient (70 kg) from an intravenous injection of a maximum dose of 1110MBq (30 millicuries) of Sodium Pertechnetate Tc 99m Injection distributed uniformly in the total body of subjects not pretreated with blocking agents such as pharmaceutical grade potassium perchlorate are shown in Table 5. For placenta localization studies, when a maximum of 111MBq (3 millicuries) is used, it is assumed to be uniformly equilibrated between maternal and fetal tissues.

Table 5. Absorbed Radiation Doses (Adults)

mGy/1110MBq (rads/30 millicuries)
Tissue	Resting Population	Active Population	mGy/111MBq (rads/3mCi)
Bladder Wall	15.9 (1.59)	25.5 (2.55)	-
Gastrointestinal Tract:
Stomach Wall	75.0 (7.50)	15.3 (1.53)	-
Upper Large Intestine Wall	20.4 (2.04)	36.0 (3.60)	-
Lower Large Intestine Wall	18.3 (1.83)	33.0 (3.30)	-
Red Marrow	5.7 (0.57)	5.1 (0.51)	-
Testes	2.7 (0.27)	2.7 (0.27)	-
Ovaries	6.6 (0.66)	9.0 (0.90)	-
Thyroid	39.0 (3.90)	39.0 (3.90)	-
Brain	4.2 (0.42)	3.6 (0.36)	-
Whole-Body	4.2 (0.42)	3.3 (0.33)	-
Placenta	-	-	0.5(0.05)
Fetus	-	-	0.5(0.05)

In pediatric patients, the maximum radiation doses of 185MBq (5 millicuries) of Sodium Pertechnetate Tc 99m Injection administered to a neonate (3.5 kg) for brain or blood pool imaging with radionuclide angiography are shown in Table 6. In pediatric patients, an average 30 minute exposure to 37MBq (1 millicurie) of Sodium Pertechnetate Tc 99m Injection following instillation for direct cystography, results in an estimated absorbed radiation dose of approximately 0.30mGy (30 millirads) to the bladder wall and 0.04 to 0.05mGy (4 to 5 millirads) to the gonads.3

Table 6. Absorbed Radiation Doses (Pediatric)

	Absorbed Radiation Doses
Tissue	mGy/ 37MBq	(rads/ 1mCi)	mGy/ 185MBq	(rads/ 5mCi)
2 Modified from: Summary of Current Radiation Dose Estimates to Normal Humans from 99m-Tc as Sodium Pertechnetate. MIRD Dose Estimates Report No. 8. J. Nucl. Med. 17(1): 74-77, 1976.
3 Conway, JJ, et al: Direct and Indirect radionuclide cystography. J. Urol. 113: 689-693 May 1975.
Thyroid (without perchlorate)	46.0	(4.6)	230.0	(23.0)
Thyroid (with perchlorate)	9.7	(1.0)	48.5	(4.9)
Large Bowel (with perchlorate)	19.0	(1.9)	95.5	(9.6)
Testes	1.0	(0.1)	5.1	(0.5)
Ovaries	2.2	(0.2)	11.0	(1.1)
Whole-Body	1.5	(0.2)	7.6	(0.8)

Table 7. Absorbed Radiation Dose from Dacryoscintigraphy Using Sodium Pertechnetate Tc 99m

	Absorbed Dose
Target Organ	mGy/ 3.7MBq	(mrad/ 100μCi)
* Assuming no blockage of drainage system. MIRD Dose Estimate Report No. 8, J. Nucl Med. 17: 74-77, 1976.
Eye Lens: If lacrimal fluid turnover is 16%/min If lacrimal fluid turnover is 100%/min If drainage system is blocked Total Body* Ovaries* Testes* Thyroid*	0.140 0.022 4.020 0.011 0.030 0.009 0.130	14.0 2.2 402.0 1.1 3.0 0.9 13.0

HOW SUPPLIED: Bristol-Myers Squibb Medical Imaging TechneLite®, Technetium Tc 99m Generator is available in the following quantities of radioactivity: 37.0 (NDC #11994-090-36), 74.0 (NDC #11994-090-73), 92.5 (NDC #11994-090-92), 111.0 (NDC #11994-090-01), 148.0 (NDC #11994-090-03), 166.5 (NDC #11994-090-04), 185.0 (NDC #11994-090-05), 222.0 (NDC #11994-090-06), 277.5 (NDC #11994-090-07), 370.0 (NDC #11994-090-09), 462.5 (NDC #11994-090-10), 555.0 GBq(NDC #11994-090-11), 666.0 GBq (NDC #11994-090- 12) (1000, 2000, 2500, 3000, 4000, 4500, 5000, 6000, 7500, 10,000, 12,500, 15,000 18,000 mCi) 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:

1 Collect Needle Seal Vial 6 Eluant Charge Vials (may be supplied separately) 6 Eluate Collection Vials (may be supplied separately) 1 Package Insert 6 Radiation Labels (Collection Vial) 6 Radiation Labels (Eluting Shield) 1 Molybdenum Mo99 Activity Record (optional)

First order generators are shipped with the following accessory components:

2 Eluting Shields

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

STORAGE: Controlled room temperature 20° to 25°C (68° to 77°F) [See USP].

EXPIRATION: The expiration time of the Sodium Pertechnetate Tc 99m Injection 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 six hours from the time of reconstitution of the kit.)

The expiration date of the TechneLite®, Technetium Tc 99m Generator is fourteen days post-manufacture.

ELUTION INSTRUCTIONS - TOTAL ELUTION METHOD

Waterproof gloves should be worn during elution.
Remove dust (clear plastic) cover of generator.
Perform all subsequent operations aseptically.
Remove silicone needle seal from eluant charge well. Discard as radioactive waste.
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.
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.
Remove vented needle cover from collect well. Discard as radioactive waste.
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.**
**NOTE: If bubbles do not appear in the eluant charge vial within 30 seconds, either one of the vials has not been properly placed on its needle or the eluate vial has no vacuum. 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.
Caution: Tampering with the internal components could compromise sterility and present a radiation hazard. This generator should not be dismantled.
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.
After elution has been completed, remove shield containing the collection vial. Obtain the collect needle seal vial, and using a bactericide, swab the septum of the collect needle seal vial 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.
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).
Use a shielded syringe when introducing the Sodium Pertechnetate Tc 99m solution into mixing vials.
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.

ASSAY INSTRUCTIONS FOR THE TechneLite®, TECHNETIUM Tc 99m GENERATOR ELUATE

The TechneLite®, Technetium Tc 99m Generator Eluate may be assayed using an ionization chamber dose calibrator. The manufacturer's instructions for operation of the dose calibrator should be followed for measurement of Technetium Tc 99m and Molybdenum Mo99 activity in the generator eluate. The Molybdenum 99/Technetium 99m ratio should be determined at the time of elution prior to administration, and from that ratio, the expiration time (up to 12 hours) of the eluate mathematically determined. Each eluate should meet or exceed the purity requirements of the current United States Pharmacopeia; that is, not more than 0.0056MBq (0.15 microcurie) of Molybdenum 99 per 37MBq (1 millicurie) of Technetium 99m per administered dose at the time of administration.

RADIOMETRIC MOLYBDENUM TEST PROCEDURE

This method is based on the fact that most Technetium Tc 99m radiation can be readily shielded and only the more energetic gamma rays from Molybdenum Mo99 (739KeV and 778KeV) are counted in the 550-850KeV energy range. The entire eluate may be assayed for Molybdenum Mo99 activity as follows:

A Cesium Cs 137 reference source which has the same geometry as the generator eluate must be used to standardize the well counter.
Determine the background after setting the window to the 550-850KeV energy range.
Count the Technetium Tc 99m eluate in its lead shield (thereby shielding out Technetium Tc 99m) by placing over the well or probe.
Count the Cs 137 reference source in the same shield geometry for the same time period.
Compute Molybdenum Mo99 activity in the eluate as follows:

μCi Molybdenum = μCi simulated Mo99 x net cpm Eluate
Mo99 (total) net cpm simulated Mo99 reference source

Divide this number by the mCi of Technetium Tc 99m. This result (μCi Mo99/mCi Tc 99m) can be converted to MBq Mo99/MBq Tc 99m by multiplying by 10-3. The U.S. Pharmacopeia and the U.S. Nuclear Regulatory Commission or equivalent Agreement State regulations specify a limit of 0.00015MBq Molybdenum Mo99 per MBq of Technetium Tc 99m (0.15μCi Mo99/mCi Tc 99m) at the time of administration to each patient.

COLORIMETRIC ALUMINUM ION TEST PROCEDURE

Bristol-Myers Squibb Medical Imaging, Inc. offers an Aluminum Ion Indicator Kit as an accessory to permit monitoring the aluminum ion in each eluate. It is based on a colorimetric reaction performed on a paper strip impregnated with indicator. A bottle of aluminum ion standard is included. Complete information is available on request.

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 provided regularly with generator shipments and are also available on request.

This radioactive drug is approved for distribution to persons licensed pursuant to the Code of Massachusetts Regulations 105 CMR 120.500 for the uses listed in 105 CMR 120.533 or under equivalent licenses of the U.S. Nuclear Regulatory Commision, an Agreement State or a Licensing State.

Bristol-Myers Squibb
Medical Imaging
331 Treble Cove Road
N. Billerica, MA 01862 USA
For Ordering Call Toll-Free: 800-225-1572 All other business: 800-362-2668
(In Massachusetts and International, call 978-667-9531)

U.S. Patent 5,109,160

Bristol-Myers Squibb
Medical Imaging

Printed in U.S.A.

513160-0205
February 2005