Ultra-Technekow

INDICATIONS AND USAGE The Ultra-TechnekowTM V4 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 is used IN ADULTS as an agent for: Thyroid Imaging Salivary Gland Imaging Urinary Bladder Imaging (direct isotopic cystography) for detection of vesico-ureteral reflux Nasolacrimal Drainage System Imaging (dacryoscintigraphy) Sodium Pertechnetate Tc 99m is used IN PEDIATRIC PATIENTS 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 is administered by intravenous injection. When imaging the nasolacrimal drainage system, instill the Sodium Pertechnetate Tc 99m by the use of a device such as a micropipette or similar method which will ensure the accuracy of the dose. For imaging the urinary bladder and ureters (direct isotopic cystography), the Sodium Pertechnetate Tc 99m 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 suggested dose ranges employed for various diagnostic indications in the average ADULT PATIENT (70 kg) are as follows: Vesico-ureteral imaging: 18.5 to 37 MBq (0.5 to 1 mCi) Thyroid gland imaging: 37 to 370 MBq (1 to 10 mCi) Salivary gland imaging: 37 to 185 MBq (1 to 5 mCi) Nasolacrimal drainage system: Maximum dose of 3.7 MBq (100 μCi) The recommended dosages in PEDIATRIC PATIENTS are: Vesico-ureteral imaging: 18.5 to 37 MBq (0.5 to 1 mCi) Thyroid gland imaging: 2.22 to 2.96 MBq (60 to 80 μCi) per kg body weight The patient dose should be measured by a suitable radioactivity calibration system immediately prior to administration. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit. If the solution is discolored, discontinue use of the generator immediately. The solution to be administered as the patient dose should be clear, colorless, and contain no particulate matter. Radiation Dosimetry The estimated absorbed radiation doses to an average ADULT and PEDIATRIC patient from an intravenous injection of various doses of Sodium Pertechnetate Tc 99m distributed uniformly in the total body are shown in Tables 5 and 6. Table 5. Absorbed Radiation Doses from Intravenous Injection Organ Absorbed Radiation Dose (mGy) for a 1110 MBq (30mCi) 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 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). Table 6. Pediatric Absorbed Radiation Doses (mGy) from Intravenous Injection Age 15 years 10 years 5 years 1 year 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 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). The estimated absorbed radiation doses to an ADULT patient from the nasolacrimal imaging procedure using a maximum dose of 3.7 megabecquerels (100 microcuries) of Sodium Pertechnetate Tc 99m are shown in Table 7. Table 7. Absorbed Radiation Doses from Dacryoscintigraphy Tissue 3.7 MBq (100 μCi) Dose of Sodium Pertechnetate Tc 99m mGy rad Eye Lens: If lacrimal fluid turnover is 16%/min 0.140 0.014 If lacrimal fluid turnover is 100%/min 0.022 0.002 If drainage system is blocked 4.020 0.402 Total Body* 0.011 0.001 Ovaries* 0. …

CONTRAINDICATIONS None.

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

DESCRIPTION The Ultra-Technekow TM V4 Generator is prepared with fission-produced molybdenum Mo-99 adsorbed onto alumina in a column shielded by lead, tungsten, or depleted uranium. The column assembly and shielding are encased in a plastic container that is covered with a plastic elution hood. The elution hood has an opening for the column assembly double inlet needles and an opening for the single outlet needle. The needles accommodate the sterile eluant vials that contain 0.9% Sodium Chloride Injection and sterile evacuated collection vials. A sterile vial containing a bacteriostat is supplied with the generator for the customer to aseptically seal the outlet needle after each elution. This terminally sterilized generator provides a closed system for the production of sterile metastable technetium Tc-99m, which is produced by the decay of molybdenum Mo-99. Incorporated between the column outlet and the collection vial is a sterile 0.22 micrometer filter. Sterile, non-pyrogenic isotonic solutions of Sodium Pertechnetate Tc 99m Injection in 0.9% Sodium Chloride Injection can be obtained conveniently by periodic aseptic elution of the generator. These solutions should be clear, colorless, and free from any particulate matter. The Sodium Pertechnetate Tc 99m Injection is suitable for intravenous injection and direct instillation. The carrier-free solution may be used as is, or diluted to the proper concentration. Over the life of the generator, an elution will contain an amount of technetium Tc-99m in direct proportion to the quantity of Mo-99 decay since the previous elution of the generator. The quantity of Tc-99m in the eluate is determined by quantity of Mo-99 on the column, and the elapsed time between elutions. Each eluate of the generator should not contain more than the USP limit of 0.15 kilobecquerel molybdenum Mo-99 per megabecquerel technetium Tc-99m (0.15 microcurie Mo-99 per millicurie Tc-99m) per administered dose at the time of administration and an aluminum ion concentration of not more than 10 micrograms per milliliter of the 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 after 12 hours from the time of generator elution. Physical Characteristics Technetium Tc-99m decays by isomeric transition with a physical half-life of 6 hours. The principal photon that is useful for detection and imaging studies is listed in Table 1. Table 1. Principal Radiation Emission Data Radiation Mean Percent Per Disintegration Energy (keV) Gamma-2 89.07 140.5 External Radiation The specific gamma ray constant for technetium Tc-99m is 0.795 R/hr-mCi at 1 cm. The first half-value layer is 0.023 cm of lead (Pb). A range of values for the relative attenuation of the radiation emitted by this radionuclide that results from interposition of various thicknesses of Pb is shown in Table 2. For example, the use of 0.27 cm thickness of Pb will attenuate the radiation emitted by a factor of about 1000. Table 2. Radiation Attenuation by Lead Shielding Shield Thickness (Pb) cm Coefficient of Attenuation 0.023 0.5 0.09 10 -1 0.18 10 -2 0.27 10 -3 Molybdenum Mo-99 decays to technetium Tc-99m with a molybdenum Mo-99 half-life of 2.75 days, or 66 hours (see Table 3). The physical decay characteristics of molybdenum Mo-99 are such that only 88.6% of the decaying molybdenum Mo-99 atoms form technetium Tc-99m. Generator elutions may be made at any time, but the amount of technetium Tc-99m available will depend on the interval measured from the last elution. Approximately 47% of the maximum available technetium Tc-99m is reached after 6 hours and 95% after 23 hours. To correct for physical decay of molybdenum Mo-99 and technetium Tc-99m, the fractions that remain at selected intervals of time are shown in Tables 3 and 4. Table 3. Physical Decay Chart; Molybdenum Mo-99, Half-Life 66 Hours Days Percent Remaining Days Percent Remaining 0 100 …

HOW SUPPLIED The Ultra-Technekow TM V4 (Technetium Tc 99m) Generators contain the following amount of molybdenum Mo-99 at the date and time of calibration stated on the label. Catalog No. 9010 37 gigabecquerels (1.0 curie) NDC 69945-010-03 9015 55.5 gigabecquerels (1.5 curies) NDC 69945-015-04 9020 74 gigabecquerels (2.0 curies) NDC 69945-020-05 9025 92.5 gigabecquerels (2.5 curies) NDC 69945-025-06 9030 111 gigabecquerels (3.0 curies) NDC 69945-030-07 9035 129.5 gigabecquerels (3.5 curies) NDC 69945-035-08 9051 185 gigabecquerels (5.0 curies) NDC 69945-051-09 9060 222 gigabecquerels (6.0 curies) NDC 69945-060-10 9075 277.5 gigabecquerels (7.5 curies) NDC 69945-075-11 9110 407 gigabecquerels (11.0 curies) NDC 69945-110-12 9140 518 gigabecquerels (14.0 curies) NDC 69945-140-13 9160 592 gigabecquerels (16.0 curies) NDC 69945-160-14 9190 703 gigabecquerels (19.0 curies) NDC 69945-190-15 Each generator is supplied with the following components for the elution of the generator: 1 - Technestat TM Vial, 5 mL, containing 0.5 mL of 1.5 mg/mL methylparaben and 0.2 mg/mL propylparaben, sterile, non-pyrogenic 1 - Package Insert SUPPLIED SEPARATELY 30 - Evacuated Collecting Vials, 30 mL, sterile, non-pyrogenic, supplied with: 90 - Radioactive Materials Labels – Collection Vial (30 en, 30 fr, 30 es) 90 - Radioactive Materials Labels – Elution Shield (30 en, 30 fr, 30 es) 1 - Package Insert 30 - Generator Eluant, 0.9% Sodium Chloride Injection, sterile, non-pyrogenic, available in 5 mL, 10 mL, or 20 mL volumes, with 1 package insert. The eluant does not contain an antimicrobial agent. Each milliliter of Generator Eluant contains 9 milligrams of Sodium Chloride. Storage Store generator and Sodium Pertechnetate Tc 99m solution at controlled room temperature 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Expiration Date The generator should not be used after the expiration date stated on the label. The expiration time of the Sodium Pertechnetate Tc 99m solution is not later than 12 hours after time of elution. If the eluate is used to reconstitute a kit, the radiolabeled kit should not be used after 12 hours from the time of generator elution or after the expiration time stated on the labeling for the prepared drug, whichever is earlier. Directions for Use of the Technetium Tc 99m Generator NOTE 1: Immediately upon delivery, the generator should be placed within a minimum of one-inch of lead shielding in such a manner so as to minimize radiation exposure to attending personnel. NOTE 2: Wear waterproof gloves during the elution procedure and during subsequent reconstitution of kits with the eluate. NOTE 3: Use a shielded syringe to withdraw patient dose or to transfer Sodium Pertechnetate Tc 99m into mixing vials during kit reconstitution. NOTE 4: The needles in the generator are sterile beneath their covers, and the generator has been cleaned underneath the top cover. Additional disinfection of these areas with agents containing alcohol may unfavorably influence the Tc-99m yield. Eluting the generator every 24 hours will provide optimal amounts of Sodium Pertechnetate Tc 99m. However, the generator may be eluted whenever sufficient amounts of technetium Tc-99m have accumulated within the column. For Example Time After First Elution (hrs.) Approximate Yield (% of First Elution) 1 10 2 19 3 27 4 35 5 41 6 47 Elution Lift the generator by its handle and place it inside the auxiliary shield. Move the handle so that it is not covering the generator top by pushing it off to the side in between the generator and the auxiliary shield. Remove and store the elution hood cover. Place the auxiliary shield top onto the top of the generator and align it with the elution hood. Remove and store the tip cap plugs from the needles. Remove the flip-top cap of the eluant vial; disinfect the stopper with a bacteriocide such as 70% isopropyl alcohol, allowing the stopper to dry before use. Invert the eluant vial and place stopper first into the sal …