Get your patient on Technelite - Technetium Tc99m Generator injection, Solution (Technetium Tc99m Generator)
Technelite - Technetium Tc99m Generator injection, Solution prescribing information
INDICATIONS AND USAGE:
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.
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:
| Vesico-ureteral Imaging | 18.5 to 37MBq (0.5 to 1mCi) |
| Thyroid Gland Imaging | 37 to 370MBq (1 to 10mCi) |
| Salivary Gland Imaging | 37 to 185MBq (1 to 5mCi) |
| Nasolacrimal Drainage System | Maximum 3.7MBq (100µCi) |
The recommended dosage range in PEDIATRIC PATIENTS is:
| Vesico-ureteral Imaging | 18.5 to 37MBq (0.5 to 1mCi) |
| Thyroid Gland Imaging | 2.22 to 2.96MBq (60 to 80µCi)/kg body weight |
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 doses to an average ADULT and Pediatric patient from an intravenous injection of a maximum dose of 1110MBq (30 millicuries) of Sodium Pertechnetate Tc 99m Injection distributed uniformly in the total body are shown in Tables 5 and 6.
| Organ | Absorbed Radiation Dose (mGy) for a 1110 MBq (30mCi) dose |
|---|---|
| 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). | |
| Adrenals | 4.1 |
| Urinary Bladder Wall | 20 |
| Bone Surfaces | 6.2 |
| Brain | 2.2 |
| Breasts | 2 |
| Gallbladder Wall | 8.3 |
| Stomach Wall | 29 |
| Small Intestine | 18 |
| ULI Wall | 63 |
| LLI Wall | 23 |
| Heart Wall | 3.5 |
| Kidneys | 6 |
| Liver | 4.7 |
| Lungs | 2.9 |
| Muscle | 3.6 |
| Ovaries | 11 |
| Pancreas | 6.3 |
| Red Marrow | 4.1 |
| Skin | 2 |
| Spleen | 4.8 |
| Testes | 3.1 |
| Thymus | 2.7 |
| Thyroid | 24 |
| Uterus | 9 |
| Remaining Tissues | 3.9 |
| Effective Dose (mSv) | 14 |
| Age | 15 years | 10 years | 5 years | 1 year |
|---|---|---|---|---|
| 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). | ||||
| Administered activity in MBq (mCi) | 1110 (30) | 740 (20) | 555 (15) | 370 (10) |
| Organ | ||||
| Adrenals | 5.3 | 5.4 | 6.2 | 7.1 |
| Urinary Bladder Wall | 26 | 22 | 18 | 22 |
| Bone Surfaces | 7.6 | 7.5 | 8.1 | 10 |
| Brain | 2.8 | 3.1 | 3.7 | 4.5 |
| Breasts | 2.6 | 2.6 | 3.2 | 4.1 |
| Gallbladder Wall | 11 | 12 | 13 | 13 |
| Stomach Wall | 38 | 36 | 43 | 59 |
| Small Intestine | 22 | 23 | 26 | 30 |
| ULI Wall | 81 | 89 | 110 | 140 |
| LLI Wall | 31 | 33 | 40 | 48 |
| Heart Wall | 4.5 | 4.6 | 5.2 | 6.4 |
| Kidneys | 7.2 | 6.9 | 7.8 | 8.5 |
| Liver | 6 | 6.7 | 8 | 9.1 |
| Lungs | 3.8 | 3.8 | 4.4 | 5.3 |
| Muscle | 4.5 | 4.5 | 5 | 6 |
| Ovaries | 14 | 13 | 14 | 17 |
| Pancreas | 8.1 | 8.2 | 8.9 | 10 |
| Red Marrow | 5.1 | 5 | 5.2 | 6 |
| Skin | 2.5 | 2.6 | 3.2 | 3.8 |
| Spleen | 6 | 6 | 6.7 | 7.8 |
| Testes | 4.1 | 4.3 | 4.9 | 6 |
| Thymus | 3.6 | 3.5 | 4.2 | 5.3 |
| Thyroid | 40 | 41 | 67 | 81 |
| Uterus | 11 | 11 | 12 | 14 |
| Remaining Tissues | 4.8 | 4.8 | 5.4 | 6.4 |
| Effective Dose (mSv) | 19 | 19 | 23 | 29 |
The estimated absorbed radiation doses to an average ADULT from the instillation of Sodium Pertechnetate Tc 99m Injection for imaging the nasolacrimal drainage system are shown in Table 7.
| Absorbed Dose | ||
|---|---|---|
| Target Organ | mGy/ 3.7MBq | (rad/ 100µCi) |
| • Assuming no blockage of drainage system | ||
| 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 | 0.014 0.002 0.402 0.001 0.003 0.001 0.013 |
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 shown in Table 8.
| 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) |
CONTRAINDICATIONS: None known.
ADVERSE REACTIONS: Allergic reactions including anaphylaxis have been reported infrequently following the administration 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.
Physical Characteristics
Technetium Tc 99m decays by isomeric transition with a physical half-life of 6.02 hours. 1 Photons that are useful for imaging studies are listed in Table 1.
| Radiation | Mean %/Disintegration | Mean Energy (keV) |
| Gamma-2 | 89.07 | 140.5 |
External Radiation
The specific gamma ray constant for Technetium Tc 99m is 5.4 microcoulombs/Kg-MBq-hr (0.795 R/mCi-hr) at 1cm. The first half-value thickness is 0.023cm of lead (Pb). To facilitate control of radiation exposure from millicurie amounts of Technetium Tc 99m, for example, the use of a 0.27 cm thick standard radiation elution lead shield will attenuate the radiation emitted by a factor of about 1000. A range of values for the relative attenuation of the radiation emitted by this radionuclide that results from interposition of various thicknesses of lead is shown in Table 2.
NOTE : Because the generator is well contained and essentially dry, there is little likelihood of contamination due to damage in transit.
| Shield Thickness lead (Pb) cm | Coefficient of Attenuation |
| 0.023 | 0.5 |
| 0.09 | 10 -1 |
| 0.18 | 10 -2 |
| 0.27 | 10 -3 |
| 0.33 | 10 -4 |
Molybdenum Mo99 decays to Technetium Tc 99m with a Molybdenum Mo99 half-life of 66 hours. This means that only 78% of the activity remains after 24 hours; 60% remains after 48 hours, etc. (see Table 3). All units have a minimum of 38 mm, 1.5 inches (~ 6 half-value layers) of lead surrounding the activity. (See Table 3.)
| Days | Percent Remaining | Days | Percent Remaining |
| 0 | 100 | 10 | 8 |
| 1 | 78 | 11 | 6 |
| 2 | 60 | 12 | 5 |
| 3 | 47 | 13 | 4 |
| 4 | 37 | 14 | 3 |
| 5 | 28 | 15 | 2 |
| 6 | 22 | 20 | 0.6 |
| 7 | 17 | 25 | 0.2 |
| 8 | 13 | 30 | 0.05 |
| 9 | 10 |
The physical decay characteristics of Molybdenum Mo99 are such that approximately 88% of the decaying Molybdenum Mo99 atoms form Technetium Tc 99m. Since the Molybdenum Mo99 is constantly decaying to fresh Technetium Tc 99m, it is possible to elute the generator at any time. However, the total amount of Technetium Tc 99m available will depend on the time interval from the previous elution, the quantity of Molydenum Mo99 remaining and the efficiency of the elution. Approximately 47% of maximum Technetium Tc 99m is reached after 6 hours and 95% after 23 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.
| •Calibration Time | |||
| Hours | Percent Remaining | Hours | Percent Remaining |
| 0• | 100.0 | 9 | 35 |
| 1 | 89 | 10 | 32 |
| 2 | 79 | 11 | 28 |
| 3 | 71 | 12 | 25 |
| 4 | 63 | 14 | 20 |
| 5 | 56 | 16 | 16 |
| 6 | 50 | 18 | 13 |
| 7 | 45 | 24 | 6 |
| 8 | 40 | ||
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.
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:
| High Enriched Uranium (HEU) | Low Enriched Uranium (LEU) | ||||
|---|---|---|---|---|---|
| NDC # | GBq of Mo99 | Ci of Mo99 | NDC # | GBq of Mo99 | Ci of Mo99 |
| 11994-090-36 | 37.0 | 1 | 11994-091-36 | 37.0 | 1 |
| 11994-090-73 | 74.0 | 2 | 11994-091-73 | 74.0 | 2 |
| 11994-090-92 | 92.5 | 2.5 | 11994-091-92 | 92.5 | 2.5 |
| 11994-090-01 | 111.0 | 3 | 11994-091-01 | 111.0 | 3 |
| 11994-090-03 | 148.0 | 4 | 11994-091-03 | 148.0 | 4 |
| 11994-090-04 | 166.5 | 4.5 | 11994-091-04 | 166.5 | 4.5 |
| 11994-090-05 | 185.0 | 5 | 11994-091-05 | 185.0 | 5 |
| 11994-090-06 | 222.0 | 6 | 11994-091-06 | 222.0 | 6 |
| 11994-090-07 | 277.5 | 7.5 | 11994-091-07 | 277.5 | 7.5 |
| 11994-090-09 | 370.0 | 10 | 11994-091-09 | 370.0 | 10 |
| 11994-090-10 | 462.5 | 12.5 | 11994-091-10 | 462.5 | 12.5 |
| 11994-090-11 | 555.0 | 15 | 11994-091-11 | 555.0 | 15 |
| 11994-090-12 | 666.0 | 18 | 11994-091-12 | 666.0 | 18 |
| 11994-090-13 | 740.0 | 20 | 11994-091-13 | 740.0 | 20 |
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.
