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molybdenum mo-99 injection, solution
DESCRIPTION: Sodium Pertechnetate Tc 99m Injection, as eluted according to the elution instructions with Bristol-Myers Squibb Medical Imaging, Inc. TECHNELITE®, Technetium Tc 99m Generator, is in Sodium Chloride 0.9% as a sterile, non-pyrogenic, diagnostic radiopharmaceutical suitable for intravenous injection, oral administration, 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).
Bristol-Myers Squibb Medical Imaging, Inc. TECHNELITE®, Technetium Tc 99m Generator consists of a column containing 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 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 Sodium Chloride 0.9%, prepacked into septum-sealed vials.
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 vial containing bacteriostat is supplied for the customer to aseptically reseal the collect needle after each elution.
NOTE: Because the generator is well contained and essentially dry, there is little likelihood of contamination due to damage in transit. The most probable source of leakage resulting from damage in transit is the nonradioactive eluant charge vial.
Molybdenum Mo99 decays to Technetium Tc 99m with a Molybdenum Mo99 half-life of 66 hours. The physical decay characteristics of Molybdenum Mo99 are such that only 88.6% of the decaying Molybdenum Mo99 atoms form Technetium Tc 99m. This means that only 78% of the activity remains after 24 hours; 60% remains after 48 hours, etc. All units have a minimum of 38 mm, 1.5 inches (~ 6 half-value layers) of lead surrounding the activity. Since the Molybdenum Mo99 is constantly decaying to fresh Technetium Tc 99m, it is possible to elute the generator at any time. (See Table 3.)
Generator elutions may be made at any time, but the amount of Technetium Tc 99m available will depend on the interval from the last elution. Approximately 47% of maximum Technetium Tc 99m is reached after 6 hours and 95% after 24 hours.
The elution vial shield has a wall thickness of 7.9 mm, 0.31 inches, and reduces transmitted Technetium Tc 99m radiation essentially to zero. To correct for physical decay of Tc 99m, the fractions that remain at selected intervals of time are shown in Table 4.
CLINICAL PHARMACOLOGY: The pertechnetate ion distributes in the body similarly to the iodide ion but is not organified when trapped in the thyroid gland. Pertechnetate tends to accumulate in intracranial lesions with excessive neovascularity or an altered blood-brain barrier. 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 it remains in the circulatory system for sufficient time to permit blood pool, organ perfusion, and major vessel studies. It 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.
INDICATIONS AND USAGE: Sodium Pertechnetate Tc 99m Injection is used IN ADULTS as an agent for:
Sodium Pertechnetate Tc 99m Injection is used IN CHILDREN as an agent for:
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.
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.
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.
See INDICATIONS and DOSAGE AND ADMINISTRATION sections. Also see the description of additional risks under WARNINGS.
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:
The recommended dosage range in PEDIATRIC PATIENTS is:
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).
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.
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
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:
First order generators are shipped with the following accessory components:
Extra quantities of these components may be obtained at the customer's request.
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
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:
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.
U.S. Patent 5,109,160
Revised: 12/2007 Bristol-Myers Squibb
Reproduced with permission of U.S. National Library of Medicine
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