KIT FOR THE PREPARTION OF TECHNETIUM TC99M SULFUR COLLOID- technetium tc 99m sulfur colloid
Sun Pharmaceutical Industries, Inc.
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HIGHLIGHTS OF PRESCRIBING INFORMATIONThese highlights do not include all the information needed to use Kit for the Preparation of Technetium Tc 99m Sulfur Colloid Injection.
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 radioactive diagnostic agent indicated (1): In adults, to assist in the:
In adults and pediatric patients, for:
DOSAGE AND ADMINISTRATIONMinimize Tc99m Sulfur Colloid radiation exposure and measure patient doses immediately before administration.
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). CONTRAINDICATIONSNone (4) WARNINGS AND PRECAUTIONSAnaphylactic reactions including rare fatalities have occurred following intravenously administered Technetium Tc 99m Sulfur Colloid. Have resuscitation equipment and personnel immediately available ( 5.1). ADVERSE REACTIONSThe most frequently reported adverse reactions include rash, urticaria, anaphylactic shock, and hypotension. ( 6) To report SUSPECTED ADVERSE REACTIONS, contact Sun Pharmaceutical Industries, Inc. at 1-800-221-7554 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch USE IN SPECIFIC POPULATIONSLactation: Advise a lactating woman to pump and discard breast milk for 24 hours and minimize close contact with infants for 6 hours after receiving a Technetium Tc 99m Sulfur Colloid Injection ( 8.2). See 17 for PATIENT COUNSELING INFORMATION. Revised: 3/2020 |
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.
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.
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.
Adult Radiation Doses
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
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
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 |
*aliver/spleen imaging
*bbone marrow imaging
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
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 |
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.
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 or malignant melanoma setting in adults:
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.
Risk Summary
Limited available data with Technetium Tc 99m Sulfur Colloid Injection use in pregnant women have not identified a drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes; technetium Tc 99m crosses the placenta (see Data). Animal reproduction studies have not been conducted with Technetium Tc 99m Sulfur Colloid Injection. All radiopharmaceuticals, including Technetium Tc 99m Sulfur Colloid Injection, have a potential to cause fetal harm depending on the stage of fetal development and the magnitude of the radiopharmaceutical dose. If considering Technetium Tc 99m Sulfur Colloid Injection administration to a pregnant woman, inform the patient about the potential for adverse pregnancy outcomes based on the radiation dose from the drug and the gestational timing of exposure.
The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2–4% and 15–20%, respectively.
Data
Human Data
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.
Risk Summary
Technetium Tc 99m is excreted in human milk during lactation. Exposure of Technetium Tc 99m Sulfur Colloid Injection to a breastfed infant can be minimized by temporary discontinuation of breastfeeding [see Clinical Considerations]. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for Technetium Tc 99m Sulfur Colloid Injection and any potential adverse effects on the breastfed child from Technetium Tc 99m Sulfur Colloid Injection or from the underlying maternal condition.
Clinical Considerations
To decrease radiation exposure to the breastfed infant, advise a lactating woman to pump and discard breast milk for 24 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 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. 4The principal photon that is useful for detection and imaging studies is listed in Table 7.
Radiation |
Mean Percent Per Disintegration |
Mean Energy (keV) |
Gamma-2 |
89.07 |
140.5 |
4Kocher 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.
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.
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.
Table 10 shows the tracer localization rates where the tracer localization rate (%) is defined as the percentage of procedures which had at least one lymph node containing the specific tracer. Random effect meta-analytic measures were used for estimating various rates of tracer localization by procedure along with the respective confidence intervals. The random effect meta-analytical methods take into account the sample size of each study as well as within and between study variability. 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 – Breast Cancer* |
||||||
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, 15.0 |
2.1, 5.4 |
BD = blue dye, SCI = Technetium Tc 99m Sulfur Colloid Injection
* Percentage of procedures in which at least one lymph node contained the specific tracer; the percents do not add to 100% due to rounding.
** 95% Confidence Intervals are based on meta-analysis and represent the spread in the individual estimates.
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.
A systematic review of eight publications examined the use of Technetium Tc 99m Sulfur Colloid and a blue dye (tracers) to assist surgeons in the localization of lymph nodes among patients with malignant melanoma. A meta-analysis was performed using data from the studies that reported the resected lymph node content of Technetium Tc 99m Sulfur Colloid Injection and blue dye. Four of the eight publications met this criterion and were included in the meta-analysis. Within these four studies, the number of reported patients ranged from 12 to 94. The patients received subcutaneous Technetium Tc 99m Sulfur Colloid Injection doses ranging between 0.25 to 2 mCi. The patients were aged 15 to 89 years and most (53 to 70%) were male.
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). Radioactivity was measured using a handheld gamma counter.
Table 11 shows the tracer localization rates where the tracer localization rate (%) is defined as the percentage of patients who had at least one lymph node containing the specific tracer. Random effect meta-analytic measures were used for estimating the various rates of tracer localization by patient along with the respective confidence intervals. The random effect meta-analytical methods take into account the sample size of each study as well as within and between study variability. In general, most patients had resected lymph nodes that contained at least one of the tracers. However, in some patients (estimated at approximately 1.6%) 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 11 . Tracer Localization by Patient – Malignant Melanoma* |
||||||
Number of Clinical Studies |
Number of Patients |
BD Present (%) |
SCI Present (%) |
Only BD Present (%) |
Only SCI Present (%) |
Neither SCI nor BD Present (%) |
4 |
249 |
83.6 |
96.4 |
3.2 |
15.5 |
1.6 |
95% Confidence Intervals** |
73.4, 90.4 |
92.0, 98.5 |
1.4, 6.9 |
9.6, 24.1 |
0.4, 6.5 |
BD = blue dye, SCI = Technetium Tc 99m Sulfur Colloid Injection
* Percentage of patients in which at least one lymph node contained the specific tracer; the percents do not add to 100% due to rounding.
** 95% Confidence Intervals are based on meta-analysis and represent the spread in the individual estimates.
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 woman to pump and discard breast milk for 24 hours after administration of Technetium Tc 99m Sulfur Colloid Injection and minimize close contact with infants for 6 hours after receiving a Technetium Tc 99m Sulfur Colloid Injection ( 8.2).
Manufactured By:
Sun Pharmaceutical Industries, Inc.
29 Dunham Road
Billerica, MA 01821
1-800-221-7554
(for International dial: 1-781-275-7120)
PL-000001
Rev 2.0
Mar 2020
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 10 mL 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 by:
Sun Pharmaceutical Industries, Inc.
Billerica, MA 01821
PL-000004
Rev 0.3
Mar 2020
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.
R XONLY . STORE AT 20-25°C (68-77°F) [See USP]
Manufactured By: Sun Pharmaceutical Industries, Inc. Billerica, MA 01821
PL-000002
Rev 0.2
Mar 2020
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.
R XONLY . STORE AT 20-25°C (68-77°F) [See USP]
Manufactured By: Sun Pharmaceutical Industries, Inc. Billerica MA 01821
PL-000003
Rev 0.2
Mar 2020
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) R xonly
Manufactured by:
Sun Pharmaceutical Industries, Inc. Billerica, MA 01821
PL-000005
Rev 0.2
Mar 2020
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:
Sun Pharmaceutical Industries, Inc. Billerica, MA 01821
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.
PL-000006
Rev 0.3
Mar 2020
KIT FOR THE PREPARTION OF TECHNETIUM TC99M SULFUR COLLOID
technetium tc 99m sulfur colloid kit |
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Labeler - Sun Pharmaceutical Industries, Inc. (037074409) |
Registrant - Sun Pharmaceutical Industries, Inc. (146974886) |
Establishment | |||
Name | Address | ID/FEI | Business Operations |
---|---|---|---|
Sun Pharmaceutical Industries, Inc. | 037074409 | analysis(45567-0030) , label(45567-0030) , pack(45567-0030) , manufacture(45567-0030) |