TechneLite

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. Table 5. Adult Absorbed Radiation Doses (mGy) from Intravenous Injection 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 Table 6. Pediatric Absorbed Radiation Doses (mGy) from Intravenous Injection 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. Table 7. Absorbed Radiation Dose from Dacryoscintigraphy Using Sodium Pertechnetate Tc 99m Absorbed Dose Target Organ mGy/ 3.7MBq (rad/ 100μCi) * Assuming n …

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. Table 1. Principal Radiation Emission Data - Technetium Tc 99m 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. Table 2. Radiation Attenuation of Technetium Tc 99m by Lead Shielding 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.) Table 3. Molybdenum Mo99 Decay Chart Half-Life 66.0 Hours 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 characteris …

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: Table 9 Available Quantities of Radioactivity 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.