KIT FOR THE PREPARATION OF TECHNETIUM TC 99M SULFUR COLLOID INJECTION- sulfur colloid
Pharmalucence, Inc.
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HIGHLIGHTS OF PRESCRIBING INFORMATIONKit for the Preparation of Technetium Tc 99m Sulfur Colloid Injection Diagnostic For Subcutaneous, Intraperitoneal, Intravenous and Oral Use.
HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use Kit for the Preparation of Technetium Tc 99m Sulfur Colloid Injection safely and effectively. See full prescribing information for Kit for the Preparation of Technetium Tc 99m Sulfur Colloid Injection. Kit for the Preparation of Technetium Tc 99m Sulfur Colloid Injection for Subcutaneous, Intraperitoneal, Intravenous, and Oral Use. Initial U.S. Approval: 1978 INDICATIONS AND USAGETechnetium Tc 99m Sulfur Colloid Injection is a diagnostic radiopharmaceutical indicated (1): In adults, to assist in the:
In adults and pediatric patients, for:
DOSAGE AND ADMINISTRATIONTechnetium Tc 99m Sulfur Colloid Injection emits radiation. Use procedures
DOSAGE FORMS AND STRENGTHSThe Kit for the Preparation of Technetium Tc 99m Sulfur Colloid Injection is supplied as a package that contains 5 kits. Each kit contains three vials: one 10 mL multi-dose Reaction Vial, a Solution A vial and a Solution B vial. The vials contain the sterile non-pyrogenic, non-radioactive ingredients necessary to produce Technetium Tc 99m Sulfur Colloid Injection (3). CONTRAINDICATIONS
WARNINGS AND PRECAUTIONSAnaphylactic reactions with bronchospasm, hypotension, urticaria and rare fatalities have occurred following intravenously administered Technetium Tc 99m Sulfur Colloid. Have emergency resuscitation equipment and personnel immediately available (5.1). ADVERSE REACTIONSThe most frequently reported adverse reactions include rash, urticaria, anaphylactic shock, and hypotension. Less frequently reported reactions are fatal cardiopulmonary arrest, seizures, dyspnea, bronchospasm, abdominal pain, flushing, nausea, vomiting, itching, fever, chills, perspiration, numbness, dizziness and injection site reactions.(6) To report SUSPECTED ADVERSE REACTIONS, contact Pharmalucence USE IN SPECIFIC POPULATIONSSee 17 for PATIENT COUNSELING INFORMATION. Revised: 7/2011 |
Technetium Tc 99m Sulfur Colloid Injection is indicated:
In adults, to assist in the:
In adults and pediatric patients, for imaging:
Technetium Tc 99m Sulfur Colloid Injection emits radiation. Use procedures to minimize radiation exposure. Measure patient dose by a suitable radioactivity calibration system immediately before administration.
In adults:
In pediatric patients:
In adults:
In pediatric patients:
combine the radiopharmaceutical with a milk feeding. For nasogastric tube administration, administer the radiopharmaceutical into the stomach then instill a normal volume of dextrose or milk feeding.
Prepare Technetium Tc 99m Sulfur Colloid Injection by the following aseptic procedure:
Measure the patient dose by a suitable radioactivity calibration system immediately before administration. Check radiochemical purity before patient administration.
Inspect Technetium Tc 99m Sulfur Colloid Injection visually for particulate matter and discoloration before administration, whenever solution and container permit. Do not administer the drug if it contains particulate matter or discoloration; dispose of these unacceptable or unused preparations in a safe manner, in compliance with applicable regulations.
Table 1. Estimated Adult Absorbed Radiation Doses from Subcutaneous Administration of Technetium Tc 99m Sulfur Colloid Injection (mSv/MBq and rem/mCi)1
Target Organ | mSv/MBq | rem/mCi |
Injection Site | 9.51 | 35. 2 |
Lymph Nodes | 0.951 | 3.52 |
Liver | 0.0028 | 0.0104 |
Spleen | 0.0017 | 0.00629 |
Bone Marrow | 0.0019 | 0.00703 |
Testes | 0.0009 | 0.0033 |
Ovaries | 0.00018 | 0.00066 |
Total Body | 0.004 | 0.0148 |
1Bergqvist L, Strand S-E, Persson B, et al. Dosimetry in
Lymphoscintigraphy of Tc 99m Antimony Sulfide Colloid,
J Nucl Med, 23: 698-705, 1982.
● Intravenous Injection
Adult Radiation Doses
Table 2. Estimated Adult Absorbed Radiation Doses from Technetium Tc 99m Sulfur Colloid Injection Administration (mSv/MBq and rem/mCi)2
Diffuse Parenchymal Disease | ||||||
Target Organ | Normal Liver | Early to Intermediate | Intermediate to Advanced | |||
mSv/MBq | rem/mCi | mSv/MBq | rem/mCi | mSv/MBq | rem/mCi | |
Liver | 0.091 | 0.338 | 0.058 | 0.213 | 0.044 | 0.163 |
Spleen | 0.058 | 0.213 | 0.074 | 0.275 | 0.115 | 0.425 |
Bone Marrow | 0.008 | 0.028 | 0.012 | 0.045 | 0.021 | 0.079 |
Testes | 0.0003 | 0.001 | 0.0005 | 0.002 | 0.0008 | 0.003 |
Ovaries | 0.0016 | 0.006 | 0.0022 | 0.008 | 0.0032 | 0.012 |
Total Body | 0.005 | 0.019 | 0.005 | 0.019 | 0.005 | 0.018 |
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, 197
Pediatric Radiation Doses
Table 3A. Estimated Pediatric Absorbed Radiation Doses from Technetium Tc 99m Sulfur Colloid Injection Administration of 1 MBq and 1 mCi for Liver/Spleen and Bone Marrow Imaging (in mSv/MBq and rem/mCi)3
Age Body Weight |
Newborn 3.5 kg |
1 year 12.1 kg |
5 years 20.3 kg |
10 years 33.5 kg |
15 years 55 kg |
|
Absorbed Dose | ||||||
Target Organ | ||||||
Liver | mSv/MBq | 0.86 | 0.38 | 0.22 | 0.18 | 0.13 |
rem/mCi | 3.2 | 1.4 | 0.82 | 0.67 | 0.49 | |
Spleen | mSv/MBq | 0.76 | 0.32 | 0.18 | 0.13 | 0.09 |
rem/mCi | 2.8 | 1.2 | 0.65 | 0.49 | 0.33 | |
Red Marrow | mSv/MBq | 0.16 | 0.05 | 0.03 | 0.022 | 0.01 |
rem/mCi | 0.58 | 0.18 | 0.11 | 0.081 | 0.036 | |
Ovaries | mSv/MBq | 0.04 | 0.02 | 0.0103 | 0.0043 | 0.0022 |
rem/mCi | 0.14 | 0.064 | 0.038 | 0.016 | 0.008 | |
Testes | mSv/MBq | 0.011 | 0.006 | 0.004 | 0.004 | 0.001 |
rem/mCi | 0.04 | 0.021 | 0.013 | 0.014 | 0.002 | |
Total Body | mSv/MBq | 0.032 | 0.026 | 0.018 | 0.012 | 0.006 |
rem/mCi | 0.12 | 0.096 | 0.066 | 0.043 | 0.022 |
3from Age-dependent “S” values of Henrichs et al, Berlin 1982, except for the 1-year old.
The 1-year old “S” values were taken from phantom work of the Metabolism and Dosimetry Group at ORNL
Table 3B. Estimated Pediatric Maximum Absorbed Radiation Doses from Administration of the Maximum Recommended Dose for Technetium Tc 99m Sulfur Colloid Injection (mSv and rem) 3
Age Body Weight |
Newborn 3.5 kg |
1 year 12.1 kg |
5 years 20.3 kg |
10 years 33.5 kg |
15 years 55 kg |
||||||
Maximum Recommended Dose: | a* | b* | a* | b* | a* | b* | a* | b* | a* | b* | |
MBq | 18.5 | 22.2 | 33.3 | 67.3 | 55.5 | 114.7 | 92.5 | 186.1 | 151.7 | 307.1 | |
mCi | 0.5 | 0.6 | 0.9 | 1.82 | 1.5 | 3.1 | 2.5 | 5.03 | 4.1 | 8.3 | |
Maximum Absorbed Dose from Maximum Recommended Dose Administered (mSv and rem) | |||||||||||
Target Organ | |||||||||||
Liver | mSv | 16 | 19.2 | 12.6 | 25.46 | 12.3 | 25.42 | 16.7 | 33.6 | 20.1 | 40.69 |
rem | 1.6 | 1.92 | 1.26 | 2.55 | 1.23 | 2.54 | 1.67 | 3.36 | 2.01 | 4.07 | |
Spleen | mSv | 14 | 16.8 | 10.8 | 21.83 | 9.75 | 20.15 | 12.2 | 24.55 | 13.5 | 27.33 |
rem | 1.4 | 1.68 | 1.08 | 2.18 | 0.98 | 2.02 | 1.22 | 2.45 | 1.35 | 2.73 | |
Red Marrow | mSv | 2.9 | 3.48 | 1.62 | 3.27 | 1.65 | 3.41 | 2.03 | 4.08 | 1.48 | 3 |
rem | 0.29 | 0.35 | 0.16 | 0.33 | 0.17 | 0.34 | 0.2 | 0.41 | 0.15 | 0.3 | |
Ovaries | mSv | 0.7 | 0.84 | 0.58 | 1.17 | 0.57 | 1.18 | 0.4 | 0.8 | 0.34 | 0.69 |
rem | 0.07 | 0.084 | 0.058 | 0.117 | 0.057 | 0.118 | 0.04 | 0.08 | 0.034 | 0.069 | |
Testes | mSv | 0.2 | 0.24 | 0.19 | 0.38 | 0.2 | 0.41 | 0.35 | 0.7 | 0.09 | 0.18 |
rem | 0.02 | 0.024 | 0.019 | 0.038 | 0.02 | 0.041 | 0.035 | 0.07 | 0.009 | 0.018 | |
Total Body | mSv | 0.6 | 0.72 | 0.86 | 1.74 | 0.99 | 2.05 | 1.07 | 2.15 | 0.9 | 1.82 |
rem | 0.06 | 0.072 | 0.086 | 0.174 | 0.099 | 0.205 | 0.107 | 0.215 | 0.09 | 0.182 |
*a liver/spleen imaging
*b bone marrow imaging
3.from Age-dependent “S” values of Henrichs et al., Berlin 1982, except for the 1-year old.
The 1-year old “S” values were taken from phantom work of the Metabolism and Dosimetry Group at ORNL
Table 4. Adult Radiation Absorbed Dose from Oral Administration of 1mCi of Technetium Tc99m Sulfur Colloid Injection (mSv/MBq and rem/mCi)
Target Organ | Assumed Residence Time (hr.) | mSv/MBq | rem/mCi |
Stomach Wall | 1.5 | 0.038 | 0.14 |
Small Intestine | 4 | 0.07 | 0.26 |
Upper Large Intestine Wall | 13 | 0.13 | 0.48 |
Upper Large Intestine Wall | 24 | 0.089 | 0.33 |
Ovaries | - | 0.026 | 0.096 |
Testes | - | 0.001 | 0.005 |
Total Body | - | 0.005 | 0.018 |
Table 5. Adult Absorbed Radiation Dose from Intraperitoneal Injection of 3 mCi of Technetium Tc 99m Sulfur Colloid (mSv/MBq and rem/mCi)
Target Organ | Shunt Open | Shunt Closed | ||
mSv/MBq | rem/mCi | mSv/MBq | rem/mCi | |
Liver | 0.092 | 0.34 | 0.015 | 0.056 |
Ovaries and Testes | 0.0003 to 0.0016 | 0.0012 to 0.006 | 0.015 | 0.056 |
Organs in the Peritoneal Cavity | - | - | 0.015 | 0.056 |
Total Body | 0.0049 | 0.0180 | 0.005 | 0.019 |
Assumptions: 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.
Table 6. Radiation Doses to Hospital Personnel (µSv/MBq and mrem/mCi)
Technician | Preparation of Drug* | Administered Drug | ||
Target | µSv/MBq | mrem/mCi | µSv/MBq | mrem/mCi |
Extremity Dose | 0.016 | 0.0575 | 0.07 | 0.25 |
Whole Body Dose | 0.0007 | 0.0025 | 0.003 | 0.0125 |
*Using shielded vial and syringe
Breast cancer setting in adults:
Peritoneo-venous (LeVeen) shunt setting in adults: Following administration of Technetium Tc 99m Sulfur Colloid Injection into the peritoneal cavity, 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. Following transfer into the systemic circulation, the radiopharmaceutical concentrates within the liver (a target organ). Obtain serial images of both the shunt and liver. An adequate evaluation of the difference between total blockage of the shunt and partial blockage may not be feasible in all cases. Transperitoneal absorption of sulfur colloid into the systemic circulation may occur, but it occurs slowly. Therefore, the most definitive scintigraphic evaluation of shunt patency will generally 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 of the radiopharmaceutical.
Imaging areas of functioning reticuloendothelial cells in liver, spleen or bone marrow: Altered biodistribution with lung and soft tissue uptake instead of reticuloendothelial system has been reported after intravenous injection. 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 reticuloendothelial system. Diseases affecting the reticuloendothelial system may also alter the expected uptake pattern.
Gastroesophageal and pulmonary aspiration imaging studies: To facilitate the imaging of gastroesophageal reflux consider administering Sulfur Colloid by nasogastric tube.
Kit for the Preparation of Technetium Tc 99m Sulfur Colloid Injection is supplied in a package that contains 5 kits. All components of a kit are sterile and non-pyrogenic. Each 10mL multi-dose Reaction Vial contains, in lyophilized form, 2 mg sodium thiosulfate anhydrous, 2.3 mg edetate disodium and 18.1 mg bovine 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.
Anaphylactic reactions with bronchospasm, hypotension, urticaria and rare fatalities have occurred following intravenously administered Technetium Tc 99m Sulfur Colloid Injection. Have emergency resuscitation equipment and personnel immediately available.
Radiation-emitting products, including Technetium Tc 99m Sulfur Colloid Injection, may increase the risk for cancer, especially in pediatric patients. Use the smallest dose necessary for imaging and ensure safe handling to protect the patient and health care worker. [see Dosage and Administration (2.3)].
Technetium Tc 99m Sulfur Colloid Injection is physically unstable, and the particles will settle with time or with exposure to polyvalent cations. These larger particles are likely to be trapped by the pulmonary capillary bed following intravenous injection and result in non-uniform distribution of radioactivity. Agitate the vial adequately before administration of sulfur colloid to avoid particle aggregation and non-uniform distribution of radioactivity. Discard unused drug after 6 hours from the time of formulation. [see Dosage and Administration (2.2)]
The most frequently reported adverse reactions, across all categories of use and routes of administration, include rash, allergic reaction, urticaria, anaphylaxis/anaphylactic shock, and hypotension. Less frequently reported adverse reactions are fatal cardiopulmonary arrest, seizures, dyspnea, bronchospasm, abdominal pain, flushing, nausea, vomiting, itching, fever, chills, perspiration, numbness, and dizziness. Local injection site reactions, including burning, blanching, erythema, sclerosis, swelling, eschar, and scarring, have also been reported.
Pregnancy Category C: There are no adequate or well-controlled studies of Technetium Tc 99m Sulfur Colloid Injection in pregnant women, but Technetium Tc 99m crosses the placenta. Among 14 infants born to pregnant patients exposed to Technetium Tc 99m Sulfur Colloid Injection for lymph node localization, no birth defects were reported following drug exposure. No reproduction and development studies in animals have been performed. Technetium Tc 99m Sulfur Colloid Injection should be given to a pregnant woman only if clearly needed.
Technetium Tc 99m is excreted in human milk during lactation. If nursing, patients should express and discard milk for a minimum of 6 hours after administration of Technetium Tc 99m Sulfur Colloid Injection. Following higher dose procedures [greater than 370 MBq (10 mCi)], patients should minimize close contact with infants for 6 hours after receiving a Technetium Tc 99m Sulfur Colloid Injection.
The safety and efficacy of Technetium Tc 99m Sulfur Colloid kit in pediatric patients has been shown for the following indications: liver, spleen, and bone marrow imaging, and gastroesophageal and pulmonary aspiration studies.
The clinical consequences of overdosing with Technetium Tc 99m Sulfur Colloid Injection are not known.
Kit for the Preparation of Technetium Tc 99m Sulfur Colloid Injection contains a multi-dose Reaction Vial, 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 subcutaneous, intraperitoneal, or intravenous injection or by oral administration.
Each 10 mL multi-dose Reaction Vial contains, in lyophilized form 2 mg sodium thiosulfate anhydrous, 2.3 mg edetate disodium and 18.1 mg bovine gelatin; a Solution A vial contains 1.8 mL of 0.148 N hydrochloric acid solution and a Solution B vial contains 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 is intended for subcutaneous, intraperitoneal, or intravenous injection or for 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 hours.4 The principal photon that is useful for detection and imaging studies is listed in Table 7.
Table 7. Principal Radiation Emission Data4
Radiation | Mean Percent Per Disintegration | Mean Energy (keV) |
Gamma-2 | 89.07 | 140.5 |
4 Kocher DC: Radioactive decay data tables. DOE/TIC-11026: 108, 1981
The specific gamma ray constant for Tc 99m is 0.78 R/millicurie-hr at 1cm. 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 8. 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 8. Radiation Attenuation by Lead Shielding
Shield Thickness (Pb) cm | Coefficient of Attenuation |
0.017 | 0.5 |
0.08 | 10-1 |
0.16 | 10-2 |
0.25 | 10-3 |
0.33 | 10-4 |
To correct for physical decay of this radionuclide, the fractions that remain at selected intervals after the time of calibration are shown in Table 9.
Table 9. Physical Decay Chart: Tc 99m, half-life 6.02 hours
Hours | Fraction Remaining | Hours | Fraction Remaining |
0* | 1.000 | 6 | 0.501 |
1 | 0.891 | 7 | 0.447 |
2 | 0.794 | 8 | 0.398 |
3 | 0.708 | 9 | 0.355 |
4 | 0.631 | 10 | 0.316 |
5 | 0.562 | 11 | 0.282 |
- | - | 12 | 0.251 |
*Calibration time
Technetium Tc 99m decays by isomeric transition, emitting a photon that can be detected for imaging purposes. [see Description (11.1)]
Following subcutaneous injection, Technetium Tc 99m Sulfur Colloid enters the lymphatic capillaries and is transported with lymph to lymph nodes. However, when there is massive nodal metastatic involvement, the normal transport to lymph nodes is lost because few normal cells remain in the node. [see Dosage and Administration (2.4)]
Following intraperitoneal injection, Technetium Tc 99m Sulfur Colloid mixes with the peritoneal fluid; rate of clearance from the cavity allows assessment of the patency of the shunt. Clearance 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.
Following intravenous injection, Technetium Tc 99m Sulfur Colloid is taken up by the reticuloendothelial system (RES), allowing RES rich structures to be imaged.
With oral administration, Technetium Tc 99m Sulfur Colloid is not absorbed accounting for its function in esophageal transit studies, gastroesophageal reflux scintigraphy, and for the detection of pulmonary aspiration of gastric contents.
Following intravenous administration, Technetium Tc 99m Sulfur Colloid Injection is rapidly cleared from the blood by the reticuloendothelial system with a nominal half-life of approximately 2 1/2 minutes. Uptake of the radioactive colloid by organs of the RES 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 collodial particles are phagocytized by the Kupffer cells of the liver, 5 to 10% by the spleen and the balance by the bone marrow.
Following oral ingestion, Technetium Tc 99m Sulfur Colloid is distributed primarily through the gastrointestinal tract with elimination primarily through the feces.
A systematic review of 43 publications examined procedures that used the injection of Technetium Tc 99m Sulfur Colloid Injection and a blue dye (tracers) to assist surgeons in the localization of lymph nodes among patients with a primary breast cancer lesion. From these publications, 15 studies were identified for inclusion within a meta-analysis, based upon the following criteria: prospective design, minimum number of 50 lymph node localization procedures, and paired outcome data available for both Technetium Tc 99m Sulfur Colloid Injection and blue dye. Within these studies, the number of procedures ranged from 62 to 6,197; in general one procedure involved a single patient but in some uncommon situations, one patient underwent more than one procedure. The patients received subcutaneous Technetium Tc 99m Sulfur Colloid Injection doses ranging between 0.1 and 2 mCi. The mean age of patients ranged from 52 to 60 years, and almost all were female. Lymph nodes that contained radioactivity were generally localized based upon increased counts, in comparison to a background threshold (e.g., nodes containing a minimum of radioactive counts 3 times higher than background or containing at least 10 fold higher counts than contiguous nodes). Radioactivity was measured using a handheld gamma counter.
Random effect meta-analytic measures were used for estimating various rates of tracer localization by procedure and respective confidence intervals for blue dye and Technetium Tc 99m Sulfur Colloid Injection. Table 10 summarizes the percentage of procedures in which at least one of the resected lymph nodes contained a tracer (radiopharmaceutical and/or blue dye) as well as the percentage of procedures in which none of the resected nodes contained a tracer. In general, most procedures involved the resection of lymph nodes in which a tracer had localized to at least one node. However, in some procedures (estimated at approximately 3.4%) neither tracer was localized to a resected lymph node. The reports were insufficient to establish the basis for failed tracer localization. [see Dosage and Administration (2.4)]
Table 10. Tracer Localization by Procedure*
Number of Clinical Studies |
Number of Procedures | BD Present | SCI Present | Only BD Present | Only SCI Present |
Neither SCI nor BD Present |
15 | 9,213 | 85.1% | 94.1% | 3.8% | 12.1% | 3.4% |
95% Confidence Intervals | 81.4, 88.2 | 91.4, 96.0 | 2.8, 5.2 | 9.9, 14.98 | 2.1, 5.4 |
*Percentage of procedures in which at least one lymph node contained the specific tracer; the percents do not add to 100% due to rounding.
BD = blue dye, SCI = Technetium Tc 99m Sulfur Colloid Injection
In some of the publications, different methods of Technetium Tc 99m Sulfur Colloid Injection administration were compared: intradermal (ID), subareolar (SA) and intraparenchymal (IP) methods. Generally, more favorable results were seen using the ID and SA routes, with less favorable results reported when surgeons used the IP method.
1. Bergqvist L, Strand S-E, Persson B, et al. Dosimetry in Lymphoscintigraphy of Tc 99m Antimony Sulfide Colloid, J Nucl Med., 23: 698-705, 1982.
2. 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
3. Henrichs et al. Estimation of age-dependent internal dose from radiopharmaceuticals, Phys. Med. Biol., 27: 775-784, 1982.
Kit for the Preparation of Technetium Tc 99m Sulfur Colloid Injection is supplied in a package that contains 5 kits. All kit components are sterile and non-pyrogenic. Each 10mL multi-dose Reaction Vial contains, in lyophilized form, 2 mg sodium thiosulfate anhydrous, 2.3 mg edetate disodium and 18.1 mg bovine 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 at 20-25°C (68-77°F) as packaged and after reconstitution.
This reagent kit for preparation of a radiopharmaceutical is approved for use by persons licensed pursuant to Section 120.547, Code of Massachusetts Regulation 105, or under equivalent license to the U.S. Nuclear Regulatory Commission or an Agreement State.
NDC #45567-0030-1
Inform patients they may experience a burning sensation at the injection site.
Inform lactating patients that they should express and discard milk for a minimum of 6 hours following administration of Technetium Tc 99m Sulfur Colloid Injection.
Manufactured By:
Pharmalucence, Inc.
10 DeAngelo Drive
Bedford, MA 01730
1-800-221-7554
(For International dial: 1-781-275-7120)
RM 2A-067
Rev. Date 7/2011
NDC 045567-0030-1
STERILE DIAGNOSTIC MULTIDOSE NON-PYROGENIC
Multi-Dose Reaction Vial
for use in the Preparation of Technetium Tc 99m Sulfur Colloid Injection.
Each 10mL reaction vial contains in lyophilized form 2.0 mg sodium thiosulfate anhydrous, 2.3 mg edetate disodium and 18.1 mg bovine gelatin. Usual Dosage: See complete prescribing information.
Manufactured in the USA by
Pharmalucence, Inc.
Bedford, MA 01730
08/10
RM 2A-072
CONTAINS NO BACTERIOSTATIC PRESERVATIVE FOR
USE ONLY AFTER LABELING WITH OCIDANT-FREE
TECHENTIUM Tc 99m. Store the kit at 20-25°C
(68-77°F) [See USP] as packaged and after reconstitution with Technetium Tc 99m.
Use within 6 hours after reconstitution.
Rx ONLY
NDC 045567-0030-1
A
Solution A vial contains 1.8mL sterile, non pyrogenic 0.148 N hydrochloric acid solution.
To be used only with the Sulfur Colloid Multi-dose Reaction Vial.
Single Use Vial-Discard Unused Portion
NOT FOR DIRECT INTRAVENOUS INJECTION.
RX ONLY. STORE AT 20-25°C (68-77°F) [See USP]
Manufactured By: Pharmalucence, Inc. Bedford, MA 01730 U.S.A.
8/10
RM 2A-068
NDC 045567-0030-1
B
Solution B vial contains 1.8mL sterile, non pyrogenic aqueous solution of 24.6 mg/mL sodium biphosphate anhydrous and 7.9 mg/mL sodium hydroxide. To be used only with the Sulfur Colloid Multi-dose Reaction Vial.
Single Use Vial-Discard Unused Portion.
NOT FOR DIRECT INTRAVENOUS INJECTION.
RX ONLY. STORE AT 20-25°C (68-77°F) [See USP]
Manufactured By: Pharmalucence, Inc. Bedford, MA 01730 U.S.A.
3/10
RM 2A-069
CAUTION RADIOACTIVE MATERIAL
STERILE, NON-PYROGENIC, DIAGNOSTIC MULTIDOSE TECHNETIUM Tc 99m SULFUR COLLOID
Subcutaneous, Intravenous, Oral, and Intraperitoneal Use
Total MBq (mCi)_____Volume_____
Assay_____MBq/mL(mCi/mL) as of _____
The 10 mL vial contents are made with 2 mg sodium thiosulfate anhydrous, 2.3 mg edetate disodium, 18.1 mg bovine gelatin, the added 1.5 mL of 0.148 N hydrochloric acid solution and the added 1.5 mL aqueous solution of 36.9 mg sodium biphosphate anhydrous and 11.9 mg sodium hydroxide. Contains no bacteriostatic preservative. For use only after labeling with oxidant-free Technetium Tc 99m. Store reconstituted vial at 20-25°C (68-77°F) [See USP]. Use within 6 hours after labeling with Technetium Tc 99m. Usual Dosage: See complete prescribing information. (SEE ENCLOSED PACKAGE INSERT) Rx only
Manufactured in the U.S.A. by
Pharmalucence, Inc.
Bedford, MA 01730
Lot No.
08/10
RM 2A-071
NDC 045567-0030-1
Kit for the Preparation of Technetium Tc99m Sulfur Colloid Injection
CAUTION: Federal (U.S.A.) law prohibits dispensing without prescription
Rx only.
Manufactured By:
Pharmalucence, Inc.
10 DeAngelo Drive, Bedford, MA 01730
For Customer Service call: 1-800-221-7554
Sterile Diagnostic Multidose Non-Pyrogenic
CONTENTS: 1 package insert, 10 radiation labels, 5 multi-dose reaction vials, 5 Solution A vials and 5 Solution B vials. Each 10 mL multi-dose reaction vial contains 2 mg sodium thiosulfate anhydrous, 2.3 mg edetate disodium and 18.1 mg bovine gelatin. Each Solution A vial contains 1.8 mL 0.148 N hydrochloric acid. 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. Contains no bacteriostatic preservative. For intravenous use only after labeling with oxidant-free Technetium Tc 99m.
Store the kit at 20-25°C (68-77°F) [See USP] as packaged and after reconstitution
Use within 6 hours after labeling with Technetium Tc 99m.
Usual Dosage: See complete prescribing information.
IMPORTANT: Read enclosed Package Insert for full information on preparation, use and indications.
RM 2A-070
Rev. 8/10
KIT FOR THE PREPARATION OF TECHNETIUM TC 99M SULFUR COLLOID INJECTION
sulfur colloid kit |
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Labeler - Pharmalucence, Inc. (139261648) |