" Citing a lack of cardiovascular benefit, the FDA is taking the unusual step of withdrawing approvals it had previously given for use of niacin and fenofibric acid with statins to treat high cholesterol.
The decision affects niac"...
Technetium Tc 99m Sulfur Colloid may be used in adults as an imaging agent to aid in the evaluation of peritoneo-venous (LaVeen) shunt patency.
Clinical studies of CIS-SULFUR COLLOID™ 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.
DOSAGE AND ADMINISTRATION
Shielding should be utilized when preparing Technetium Tc 99m Sulfur Colloid Injection.
Liver-Spleen Scanning and Bone Marrow Imaging
In average ADULT (70 kg) patients: The suggested dose range used for liver/spleen images is 37 to 296 megabecquerels (1 to 8 millicuries) and for bone marrow images is 111 to 444 megabecquerels (3 to 12 millicuries) of Technetium Tc 99m Sulfur Colloid Injection.
In PEDIATRIC patients: The suggested intravenous doses employed for various diagnostic indications are as follows: Liver/spleen imaging: The dose range is 0.56 to 2.78 megabecquerels (15 to 75 microcuries) per kilogram of body weight with a usual dose of 1.85 megabecquerels (50 microcuries) per kg body weight, except in newborns in whom the administered dose should be 7.4 to 18.5 megabecquerels (200 to 500 microcuries). A minimum dose of 7.4 megabecquerels (200 microcuries) should be employed for this procedure.
Bone marrow imaging: The dose range is 1.11 to 5.55 megabecquerels (30 to 150 microcuries) per kilogram of body weight. A minimum dose of 22.2 megabecquerels (600 microcuries) is suggested for this procedure. (See Table 5)
Gastroesophageal and Pulmonary Aspiration
In average ADULT (70 kg) patients: The suggested oral dose range is 5.55-11.1 megabecquerels (150-300 microcuries) for gastroesophageal studies. The suggested oral dose range for pulmonary aspiration studies is 11.1-18.5 megabecquerels (300-500 microcuries).
In PEDIATRIC patients: The suggested oral dose range in infants and children is 3.7-11.1 megabecquerels (100-300 microcuries) for gastroesophageal and pulmonary aspiration studies.
The drug should be incorporated into a milk feeding when administered orally. Equally good results may be obtained by intubating the stomach and directly instilling the material into the stomach, followed by a dextrose or milk meal. This latter method avoids the introduction of radiation into the esophagus: thus, any tracer appearing there must be due to reflux.
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.
Peritoneo-Venous (LeVeen) Shunt Patency Evaluation
The suggested intraperitoneal dosage range used in the average patient (70 kg) for peritoneo-venous (LeVeen) shunt patency evaluation is 37 to 111 megabecquerels (1 to 3 millicuries). Adequate measures should be taken to assure uniform mixing with peritoneal fluid. Serial images of both the shunt and target organ should be obtained and correlated with other clinical findings. Alternately, the drug may be administered by percutaneous transtubal injection. The suggested percutaneous transtubal (efferent limb) dosage range for the average patient (70 kg) is 12 to 37 megabecquerels (0.3 to 1.0 millicurie) in a volume not to exceed 0.5 mL.
Transperitoneal absorption of Sulfur Colloid may occur, but it occurs slowly. Therefore, the most definitive scintigraphic evaluation of shunt patency will be obtained if there is visualization of both the shunt itself and the liver and/or spleen within the first three hours post intraperitoneal injection.
The estimated absorbed radiation doses2 to an average ADULT patient (70 kg) from an intravenous injection of a maximum dose of 296 megabecquerels (8 millicuries) of Technetium Tc 99m Sulfur Colloid Injection are shown in Table 4.
Table 4. Estimated ADULT Absorbed Radiation Dose Technetium
Tc 99m, Sulfur Colloid Injection, mGy/296 MBq (rads/8mCi)
|Target Organ||Normal Liver||Diffuse Parenchymal Disease|
|Early Intermediate||Intermediate Advanced|
Pediatric radiation doses
In PEDIATRIC patients, the radiation absorbed doses, using the maximum recommended doses for liver/spleen imaging [2.78 megabecquerels (75 microcuries) per kilogram of body weight] and for bone marrow imaging [5.55 megabecquerels (150 microcuries) per kilogram of body weight], except in the newborn where the doses used for calculating the radiation absorbed dose estimates are 18.5 megabecquerels (500 microcuries) for liver/spleen imaging and 22.2 megabecquerels (600 microcuries) for bone marrow imaging, are shown in Table 5.
Table 5. Estimated PEDIATRIC Absorbed Radiation Dose Technetium
Tc 99m Sulfur Colloid Injection
|Maximum Recommended Dose|
|Absorbed Dose mGy/maxdose (rads/max dose)|
1. Used the biologic data of MIRD Dose Estimate Report No 3. J Nucl Med 16: 108A - 108B, 1975
2. Used the Age-dependent “S” values of Henrichs et al, Berlin, 1980, except for the 1-year-old. The 1-year-old “S” values were taken from preliminary phantom work of the Metabolism and Dosimetry Group at ORNL.
a Liver/Spleen Imaging Dose (see DOSAGE AND ADMINISTRATION).
b Bone Marrow Imaging Dose (see DOSAGE AND ADMINISTRATION).
Table 6. Adult Radiation Dose from Oral Administration of
18.5 MBq (500 μCi) of Technetium Tc 99m Sulfur Colloid in mGy (mrad).
|Target Organ||Assumed Residence Time (hr.)||Absorbed Dose (mGy/18.5 MBq)||(mrad/500 μCi)|
|Upper Large Intestine Wall||13||2.40||240|
|Lower Large Intestine Wall||24||1.65||165|
Radiation doses to hospital personnel
|Technician||Preparation of Drug*||Administered Drug|
|Target||μSv/7.4 GBq (millirem/400 mCi)||μSv/148 MBq (millirem/8 mCi)|
|Whole Body Dose||10||1|
|*Using shielded vial and syringe.|
Table 7. Adult Radiation Dose from Intraperitoneal Administration
of 111 MBq (3 mCi) of Technetium Tc 99m Sulfur Colloid in mGy (rad).
|Target Organ||Shunt Patency (Open)||Shunt Patency (Closed)|
|Ovaries & Testes||0.036 to 0.18||0.0036 to 0.018||1.68||0.168|
|Organs in the Peritoneal Cavity||-||-||1.68||0.168|
Calculations for the absorbed radiation dose are based upon an effective half-time of 3 hours for the open shunt and 6.02 hours for the closed shunt and an even distribution of the radiopharmaceutical in the peritoneal cavity with no biological clearance.
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:
- 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.
- 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).
- Aseptically add the Sodium Pertechnetate Tc 99m Injection to the vial.
- Place a lead cover on the vial shield and dissolve the reagent by gentle swirling.
- 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.
- 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.
- 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.
- 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.
- Record time and date of preparation.
- Allow the preparation to cool to body temperature before use. Maintain adequate shielding of the radioactive colloid preparation at all times.
- Where appropriate, dilute the preparation with sterile Sodium Chloride Injection to bring the dosage to within the recommended range.
- The radiochemical purity of the prepared radiopharmaceutical should be checked prior to patient administration.
- 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.
- 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, 1975This monograph has been modified to include the generic and brand name in many instances.
Last reviewed on RxList: 3/4/2009
Additional CIS-Sulfur Colloid Information
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
Find out what women really need.