Cis Sulfur Colloid

CIS-SULFUR COLLOID™ Kit for the Preparation of Technetium Tc 99m Sulfur Colloid Injection is a multidose reaction vial with a Solution A vial and a Solution B vial which contain the sterile non-pyrogenic, non-radioactive ingredients necessary to produce Technetium Tc 99m Sulfur Colloid Injection for diagnostic use by intravenous injection or oral administration.

Each 10 mL multidose reaction vial contains, in lyophilized form 2.0 mg sodium thiosulfate anhydrous, 2.3 mg edetate disodium and 18.1 mg gelatin; a Solution A vial with 1.8 mL of 0.148 N hydrochloric acid solution and a Solution B vial with 1.8 mL aqueous solution of 24.6 mg/mL sodium biphosphate anhydrous and 7.9 mg/mL sodium hydroxide.

When a solution of sterile and non-pyrogenic Sodium Pertechnetate Tc 99m Injection in isotonic saline is mixed with these components, following the instructions provided with the kit, Technetium Tc 99m Sulfur Colloid Injection is formed. The product so derived is intended for intravenous injection or oral administration. The precise structure of Technetium Tc 99m Sulfur Colloid Injection is not known at this time.

Technetium Tc 99m decays by isomeric transition with a physical half-life of 6.02 hours1. The principal photon that is useful for detection and imaging studies is listed in Table 1.

Table 1. Principal Radiation Emission Data

External radiation

The specific gamma ray constant for Tc 99m is 0.78 R/millicurie-hr at 1 cm. The first half-value layer is 0.017 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 a 0.25 cm thickness of Pb will attenuate the radiation emitted by a factor of about 1,000.

Table 2. Radiation Attenuation by Lead Shielding

To correct for physical decay of this radionuclide, the fractions that remain at selected intervals after the time of calibration are shown in Table 3.

Table 3. Physical Decay Chart: Tc99m, Half-life 6.02 Hours

1Kocher. David C., “Radioactive Decay Data Tables”, DOE/TIC-11026,108 (1981).

The CIS-SULFUR COLLOID™ is supplied as a 5-kit package. Five complete kits are included in each package. All components are sterile and non-pyrogenic. Each 10mL multidose reaction vial contains, in lyophilized form, 2.0 mg sodium thiosulfate anhydrous, 2.3 mg edetate disodium and 18.1 mg gelatin; each Solution A vial contains 1.8 mL 0.148 N hydrochloric acid solution and each Solution B vial contains 1.8 mL aqueous solution of 24.6 mg/mL sodium biphosphate anhydrous and 7.9 mg/mL sodium hydroxide. Included in each 5-kit package are one package insert and 10 radiation labels. Store the kit as packaged at 15-30°C.

Directions for Use

Technetium Tc 99m Sulfur Colloid Injection is prepared from CIS-Sulfur Colloid™ by the following aseptic procedure:

1. Waterproof gloves should be worn during the preparation procedure. Remove the dark brown plastic cap from the CIS-Sulfur Colloid™ vial and swab the top of the vial closure with alcohol to sterilize the surface.
2. Complete the radiation label and affix to the vial. Place the vial in an appropriate lead-capped radiation shield labeled and identified.
   With a sterile shielded syringe, aseptically obtain 1-3 mL of a suitable, oxidant-free, sterile and non-pyrogenic Sodium Pertechnetate Tc 99m Injection, each milliliter containing a maximum activity of 18.5 gigabecquerels (500 millicuries). Do not use Sodium Pertechnetate Tc 99m Injection if it contains foreign matter or more than 10 micrograms/mL of aluminum (Sodium Pertechnetate Tc 99m Injection containing more than a total of 10 micrograms/mL of aluminum may produce a flocculent precipitate and since such a precipitate may localize in the lung, preparations containing precipitates should not be used).
3. Aseptically add the Sodium Pertechnetate Tc 99m Injection to the vial.
4. Place a lead cover on the vial shield and dissolve the reagent by gentle swirling.
5. Just prior to use, remove the red cap from the Solution A vial and swab the top of the vial closure with alcohol to sterilize the surface. Using a sterile needle and syringe, aseptically withdraw 1.5 mL Solution A from the vial. Aseptically inject 1.5 mL Solution A into the reaction vial and swirl again.
6. Transfer the reaction vial from vial shield and place in a vigorously boiling water bath (water bath should be shielded with 1/8&rldquo; to 1/4” lead) deep enough to cover the entire liquid contents of the vial. Keep the vial in the water bath for five minutes.
7. Remove the reaction vial from the water bath and place in the lead shield and allow to cool for three minutes. Swab the vial closure again with an antiseptic.
8. Just prior to use, remove the blue cap from the Solution B vial and swab the top of the vial closure with alcohol to sterilize the surface. Using a sterile needle and syringe, aseptically withdraw 1.5 mL Solution B from the vial. Aseptically inject 1.5 mL Solution B into the reaction vial and swirl again.
9. Record time and date of preparation.
10. Allow the preparation to cool to body temperature before use. Maintain adequate shielding of the radioactive colloid preparation at all times.
11. Where appropriate, dilute the preparation with sterile Sodium Chloride Injection to bring the dosage to within the recommended range.
12. The radiochemical purity of the prepared radiopharmaceutical should be checked prior to patient administration.
13. Mix the reaction vial and aseptically withdraw material with a sterile shielded syringe for use within six (6) hours of preparation. For optimum results this time should be minimized. The vial contains no bacteriostatic preservative. Store the reconstituted vial at 15-30°C. Discard vial six (6) hours after reconstitution.
14. The patient dose should be measured by a suitable radioactivity calibration system immediately prior to administration.

NDC # 45567-0030-1

This reagent kit for the preperation of a radiopharmaceutical is approved for use by persons licensed pursuant to Section 120.533, Code of Massachusetts Regulation 105, or under equivalent license of the U.S. Nuclear Regulatory Commission or an Agreement State.

2Modified from Summary of Current Radiation Dose Estimates to Humans with Various Liver Conditions from 99m Tc-Sulfur Colloid. MIRD Dose Estimate Report No 3, J Nucl Med 16: 108A - 108B, 1975

The following adverse reactions have been reported associated with the use of Technetium Tc 99m Sulfur Colloid Injection: cardiopulmonary arrest, seizures, anaphylactic shock, hypotension, dyspnea, abdominal pain, fever, chills, bronchospasm, nausea, vomiting, perspiration, redness, urticaria, numbness, dizziness and burning at the injection site.

Several deaths and cases of lung and soft tissue uptake other than RES have been reported in association with the use of Technetium Tc 99m Sulfur Colloid Injection (see WARNINGS).

The size and physical-chemical properties of the sulfur colloid particles formed from the components of the kit may determine the biodistribution of the colloid and its uptake by the RE system. Diseases affecting the RE system may also alter the expected uptake pattern.

No information provided.

Following intravenous administration, Technetium Tc 99m Sulfur Colloid Injection is rapidly cleared by the reticuloendothelial system from the blood with a nominal clearance half-life of approximately 2 1/2 minutes. Uptake of the radioactive colloid by organs of the reticuloendothelial system is dependent upon both their relative blood flow rates and the functional capacity of the phagocytic cells. In the average patient 80 to 90% of the injected colloidal particles are phagocytized by the Kupffer cells of the liver, 5 to 10% by the spleen and the balance by the bone marrow.

Following administration of Technetium Tc 99m Sulfur Colloid Injection by intraperitoneal injection, the radiopharmaceutical mixes with the peritoneal fluid. Clearance from the peritoneal cavity varies from insignificant, which may occur with complete shunt blockage, to very rapid clearance with subsequent transfer into the systemic circulation when the shunt is patent.

Serial images should be obtained of both the shunt and liver (target organ). However, an adequate evaluation of the difference between total blockage of the shunt and partial blockage may not be feasible in all cases.

No information provided. Please refer to the WARNINGS and PRECAUTIONS sections.