{"adverse_reactions":["ADVERSE REACTIONS No adverse reactions specifically attributable to the use of this drug have been reported."],"carcinogenesis_and_mutagenesis_and_impairment_of_fertility":["Carcinogenesis, Mutagenesis, Impairment of Fertility No long-term animal studies have been performed to evaluate carcinogenic or mutagenic potential, or whether this drug affects fertility in males or females."],"clinical_pharmacology":["CLINICAL PHARMACOLOGY Chromium is present in the hexavalent (plus 6) state, in which form it readily penetrates the red blood cell, attaches to the hemoglobin, and is reduced to the trivalent (plus 3) state. This state is maintained until the red blood cell is sequestered by the spleen, at which time the chromium is released to the plasma and is readily excreted in the urine. In the trivalent state, chromium Cr 51 is not re-utilized for tagging of additional red blood cells. Since the product has a high specific activity, adequate red blood cell tagging is secured in minimum time without demonstrable effect on cell life."],"contraindications":["CONTRAINDICATIONS None known."],"description":["DESCRIPTION Sodium Chromate Cr 51 (Na 2 51 CrO 4 ) Injection is available for diagnostic use as a sterile, non-pyrogenic solution. Each milliliter contains 3.7 megabecquerels (100 microcuries) chromium Cr 51 on the calibration date, and 0.5 milligrams sodium bicarbonate as a buffer. The pH is adjusted to between 7.5 and 8.5 with hydrochloric acid or sodium hydroxide. The specific activity is at least 370 megabecquerels (10 millicuries) per milligram of sodium chromate."],"dosage_and_administration":["DOSAGE AND ADMINISTRATION The usual dosages in the average adult patient (70 kg) are as follows: The determination of red blood cell volume or mass: 0.37 to 1.11 megabecquerels (10 to 30 microcuries). The determination of red blood cell survival time: 5.55 megabecquerels (150 microcuries). The evaluation of blood loss: 7.4 megabecquerels (200 microcuries). Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration. Do not use if contents are turbid. The patient dose should be measured by a suitable radioactivity calibration system immediately prior to administration."],"effective_time":"20090929","general_precautions":["General As in the use of any radioactive material, care should be taken to minimize radiation exposure to the patient, consistent with proper patient management, and to insure minimum radiation exposure to occupational workers. In order to preclude or minimize the possibility of contamination and increased fragility of the tagged red blood cells, sterile techniques must be employed throughout the collection, tagging, rinsing, suspending, and injection of red blood cells. Also, the number of washes and transfers should be kept to a minimum, and only sterile, non-pyrogenic isotonic diluent should be employed throughout the tagging procedure. Nuclear medicine procedures involving withdrawal and reinjection of blood have the potential for transmission of blood borne pathogens. Procedures should be implemented to avoid administration errors and viral contamination of personnel during blood product labeling. A system of checks similar to the ones used for administering blood transfusions should be routine. Specific activity should be not less than 370 megabecquerels (10 millicuries) per milligram of sodium chromate at the time of use. Do not use after expiration date stated on label. Radiopharmaceuticals should be used only by physicians who are qualified by specific training in the safe use and handling of radionuclides produced by nuclear reactor or particle accelerator and whose experience and training have been approved by the appropriate government agency authorized to license the use of radionuclides."],"how_supplied":["HOW SUPPLIED Catalog Number 370 Sodium Chromate Cr 51 Injection is supplied at a concentration of approximately 3.7 megabecquerels (100 microcuries) per milliliter in vials containing approximately 9.25 megabecquerels (250 microcuries) as of the date of calibration. The specific activity is greater than 370 megabecquerels (10 millicuries) per milligram of sodium chromate within the expiration time of the product stated on the label. 372 A-C-D (Anticoagulant-Citrate-Dextrose) Solution (Modified) is supplied in 100-milliliter vials containing 10 milliliters of solution for tagging red blood cells with Sodium Chromate Cr 51. Each milliliter contains 8 milligrams of citric acid (anhydrous), 25 milligrams sodium citrate (dihydrate) and 12 milligrams dextrose (anhydrous). Ratio of ingredients differs from USP Formulas."],"how_supplied_table":["
370 Sodium Chromate Cr 51 Injection is supplied at a concentration of approximately 3.7 megabecquerels (100 microcuries) per milliliter in vials containing approximately 9.25 megabecquerels (250 microcuries) as of the date of calibration. The specific activity is greater than 370 megabecquerels (10 millicuries) per milligram of sodium chromate within the expiration time of the product stated on the label.
372 A-C-D (Anticoagulant-Citrate-Dextrose) Solution (Modified) is supplied in 100-milliliter vials containing 10 milliliters of solution for tagging red blood cells with Sodium Chromate Cr 51. Each milliliter contains 8 milligrams of citric acid (anhydrous), 25 milligrams sodium citrate (dihydrate) and 12 milligrams dextrose (anhydrous). Ratio of ingredients differs from USP Formulas.
"],"id":"11f6d5ef-2950-438c-a00a-c7332a455023","indications_and_usage":["INDICATIONS AND USAGE Sodium Chromate Cr 51 Injection may be used in the determination of red blood cell volume or mass, the study of red blood cell survival time, and evaluation of blood loss."],"nursing_mothers":["Nursing Mothers Since Chromium Cr 51 is excreted in human milk during lactation, formula feedings should be substituted for breast feedings."],"openfda":{},"package_label_principal_display_panel":["Package Label - Principal Display Panel - Sodium Chromate Vial Label Sodium Chromate Cr 51 Injection DIAGNOSTIC Sterile, Non-Pyrogenic Solution For Intravenous Administration Store at controlled room temperature 20-25°C (68-77°F) CAUTION RADIOACTIVE MATERIAL Each milliliter contains 3.7 MBq (100µCi) Sodium Chromate Cr 51 on the calibration date, and 0.5 mg sodium bicarbonate as a buffer. Sodium hydroxide or hydrochloric acid may be present for ph adjustment. The pH is between 7.5 and 8.5. Rx Only. In Canada: Mallinckrodt Canada Inc. Pointe-Claire, Qc Est. Lic. No. 100107-A Mallinckrodt Inc. St. Louis, MO 63134 USA A370V0 R11/2000 Sodium Chromate Vial Label Package Label - Principal Display Panel - A-C-D Vial Label A-C-D SOLUTION (MODIFIED) ANTICOAGULANT CITRATE DEXTROSE SOLUTION (MODIFIED) STERILE, NON-PYROGENIC For use with Mallinckrodt's Sodium Chromate Cr 51 in tagging Red Blood Cells. See Sodium Chromate Cr 51 Package Insert for Directions for Use. Rx Only. Mallinckrodt Inc. St. Louis, MO 63134 USA A-C-D Solution Vial Label","Package Label - Principal Display Panel - A-C-D Vial Label A-C-D SOLUTION (MODIFIED) ANTICOAGULANT CITRATE DEXTROSE SOLUTION (MODIFIED) STERILE, NON-PYROGENIC For use with Mallinckrodt's Sodium Chromate Cr 51 in tagging Red Blood Cells. See Sodium Chromate Cr 51 Package Insert for Directions for Use. Rx Only. Mallinckrodt Inc. St. Louis, MO 63134 USA A-C-D Solution Vial Label"],"pediatric_use":["Pediatric Use Safety and effectiveness in pediatric patients has not been established."],"precautions":["PRECAUTIONS General As in the use of any radioactive material, care should be taken to minimize radiation exposure to the patient, consistent with proper patient management, and to insure minimum radiation exposure to occupational workers. In order to preclude or minimize the possibility of contamination and increased fragility of the tagged red blood cells, sterile techniques must be employed throughout the collection, tagging, rinsing, suspending, and injection of red blood cells. Also, the number of washes and transfers should be kept to a minimum, and only sterile, non-pyrogenic isotonic diluent should be employed throughout the tagging procedure. Nuclear medicine procedures involving withdrawal and reinjection of blood have the potential for transmission of blood borne pathogens. Procedures should be implemented to avoid administration errors and viral contamination of personnel during blood product labeling. A system of checks similar to the ones used for administering blood transfusions should be routine. Specific activity should be not less than 370 megabecquerels (10 millicuries) per milligram of sodium chromate at the time of use. Do not use after expiration date stated on label. Radiopharmaceuticals should be used only by physicians who are qualified by specific training in the safe use and handling of radionuclides produced by nuclear reactor or particle accelerator and whose experience and training have been approved by the appropriate government agency authorized to license the use of radionuclides. Carcinogenesis, Mutagenesis, Impairment of Fertility No long-term animal studies have been performed to evaluate carcinogenic or mutagenic potential, or whether this drug affects fertility in males or females. Pregnancy Category C Animal reproductive studies have not been conducted with Sodium Chromate Cr 51. It is also not known whether Sodium Chromate Cr 51 can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Sodium Chromate Cr 51 should be given to a pregnant woman only if clearly needed. Ideally, examinations using radiopharmaceuticals, especially those elective in nature, of a woman of childbearing capability should be performed during the first few (approximately 10) days following the onset of menses. Nursing Mothers Since Chromium Cr 51 is excreted in human milk during lactation, formula feedings should be substituted for breast feedings. Pediatric Use Safety and effectiveness in pediatric patients has not been established."],"pregnancy":["Pregnancy Category C Animal reproductive studies have not been conducted with Sodium Chromate Cr 51. It is also not known whether Sodium Chromate Cr 51 can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Sodium Chromate Cr 51 should be given to a pregnant woman only if clearly needed. Ideally, examinations using radiopharmaceuticals, especially those elective in nature, of a woman of childbearing capability should be performed during the first few (approximately 10) days following the onset of menses."],"set_id":"a68846e6-45cd-416f-a30a-714f7efdf71e","spl_product_data_elements":["Sodium Chromate Cr 51 Sodium Chromate Cr 51 CHROMIUM CR-51 CHROMIUM CR-51 SODIUM BICARBONATE A-C-D (ANTICOAGULANT-CITRATE-DEXTROSE) A-C-D (Anticoagulant-Citrate-Dextrose) ANHYDROUS CITRIC ACID ANHYDROUS CITRIC ACID TRISODIUM CITRATE DIHYDRATE ANHYDROUS DEXTROSE"],"spl_unclassified_section":["Rx Only Diagnostic-For Intravenous Use","PHYSICAL CHARACTERISTICS Chromium Cr 51 decays by electron capture with a physical half-life of 27.7 days. Kocher, David C., \"Radioactive Decay Tables,\" DOE/TIC-11026, page 74 (1981). The principal photon useful for detection is listed in Table 1 . Table 1: Principal Radiation Emission Data Radiation Mean Percent Per Disintegration Energy (keV) Gamma-1 9.83 320.1","EXTERNAL RADIATION The specific gamma ray constant for chromium Cr51 is 0.18 R/mCi-hr at 1 cm. The first half-value thickness is 0.17 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 1.68 cm thickness of Pb will decrease the external radiation exposure by a factor of about 1,000. Table 2: Radiation Attenuation by Lead Shielding Shield Thickness (Pb) cm Coefficient of Attenuation 0.17 0.56 1.12 1.68 2.25 0.5 10 -1 10 -2 10 -3 10 -4 To correct for radioactive decay of chromium Cr 51, the fractions that remain at selected time intervals after the date of calibration are shown in Table 3 . Table 3. Physical Decay Chart; Chromium Cr 51, Half-Life 27.7 Days Days Fraction Remaining Days Fraction Remaining *Calibration Time 0* 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 1.000 0.975 0.951 0.928 0.905 0.882 0.861 0.839 0.819 0.798 0.779 0.759 0.741 0.722 0.704 0.687 0.670 17 18 19 20 21 22 23 24 25 26 27 28 29 30 60 90 0.654 0.637 0.622 0.606 0.591 0.577 0.562 0.549 0.535 0.522 0.509 0.496 0.484 0.472 0.223 0.105","RADIATION DOSIMETRY The estimated absorbed radiation doses Method of Calculation: \"S\" Absorbed Dose per Unit Cumulated Activity for Selected Radionuclides and Organs, MIRD Pamphlet No. 11 (1975). to an average patient (70 kg) from an intravenous injection of a maximum dose of 7.4 megabecquerels (200 microcuries) of Sodium Chromate Cr 51 are shown in Table 4 . Table 4. Absorbed Radiation Doses Tissue Sodium Chromate Cr 51 mGy/7.4 MBq rads/200 μCi Blood Spleen Testes Ovaries Total Body 2.00 26.4 0.66 0.66 0.55 0.20 2.64 0.066 0.066 0.055","STORAGE AND HANDLING Store at controlled room temperature 20-25°C (68-77°F). Storage, handling and disposal of Chromium Cr 51 solutions should be controlled in a manner that is in compliance with the appropriate regulations of the governmental agency authorized to license the use of this radionuclide.","DIRECTIONS FOR USE (TEST PROCEDURE) NOTE 1: Wear waterproof gloves during the entire red cell tagging procedure and during subsequent patient dose withdrawals. NOTE 2: Make transfers of Chromium Cr 51 solutions during the tagging procedure and during subsequent injections of radiolabeled blood cells with adequately shielded syringes. NOTE 3: Maintain adequate shielding of the radiolabeled blood cells by using a lead vial shield and cover. Various procedures may be employed in performing the diagnostic tests for which Sodium Chromate Cr 51 is indicated. The following outlines specific procedures which may be elected in performing these tests. Red Cell Volume The following procedure provides a direct measurement of the red blood cell component, and the whole blood volume is inferred from the venous hematocrit. The plasma chromium Cr 51 radioactivity is excluded by calculation, thereby obviating the aseptic washing of red blood cells. Procedure With A-C-D solution from the A-C-D tagging vial, wet a 20-mL syringe and then use the syringe to withdraw 15 mL of blood from the antecubital vein. Slowly and gently (to prevent hemolysis) aseptically inject the contents of the syringe into the vial of A-C-D solution. With a 10-mL syringe aseptically add approximately 3.7 MBq (100 μCi) of Sodium Chromate Cr 51 Injection to the blood-A-C-D mixture. Gently mix the blood by intermittent swirling every 5 to 10 minutes. Allow to tag at room temperature for 30 minutes. With a 1-mL syringe aseptically add 30 to 50 mg of Ascorbic Acid Injection (USP) to the vial, mix gently, and allow to stand for 5 minutes. After gently mixing, withdraw exactly 10 mL of the tagged red blood cell (RBC) suspension, and inject intravenously into the patient. Determine the hematocrit of the remaining Tagged RBC Suspension (A). Pipet 1 mL of the tagged RBC suspension into a 100-mL volumetric flask and dilute to 100 mL with water. Mix thoroughly and pipet 4 mL into a counting vial. This is the Whole Blood Standard (B). Centrifuge the remaining tagged RBC suspension, and pipet 1 mL of the plasma into a 100-mL volumetric flask, and dilute to 100 mL with water. Mix thoroughly, and pipet 4 mL into a counting vial. This is the Plasma Standard (C). Ten to twenty minutes post-injection withdraw approximately 20 mL of blood from the patient with a sterile, evacuated container containing an anticoagulant. Pipet 4 mL of the whole blood into a counting vial. This is the Patient Whole Blood Sample (D). Remove a sample for a Patient Hematocrit (E) and centrifuge the remaining blood. Pipet 4 mL of plasma into a counting vial. This is the Patient Plasma Sample (F). Count the: Whole Blood Standard (B) Plasma Standard (C) Patient Whole Blood Sample (D) Patient Plasma Sample (F) Background Subtract background from B, C, D, F. Counting times should be equal and of sufficient length to provide a minimum of 10,000 counts. Calculations A = Hematocrit of Tagged RBC Suspension (step 7) B = Net Whole Blood Standard Count C = Net Plasma Standard Count D = Net Patient Whole Blood Sample Count E = Patient Hematocrit (step 12) F = Net Patient Plasma Sample Count Plasma Volume (mL) = Whole Blood Volume (mL) - Red Cell Volume (mL) Plasma Volume Formula Red Cell Survival Procedure: With A-C-D solution from the A-C-D tagging vial, wet a 20-mL syringe and then use the syringe to withdraw 15 mL of blood from the antecubital vein. Slowly and gently (to prevent hemolysis) aseptically inject the contents of the syringe into the vial of A-C-D solution. With a 10-mL syringe aseptically add approximately 7.4 MBq (200 μCi) of Sodium Chromate Cr 51 Injection to the blood-A-C-D mixture. Gently mix the blood by intermittent swirling every 5 to 10 minutes. Allow to tag at room temperature for 30 minutes. Withdraw 20 mL of the tagged RBC suspension and inject intravenously into the patient. At 24 hours post injection and every 2 to 3 days thereafter for a minimum of 30 days or until a half-time is reached, withdraw 10 mL of blood into a sterile, evacuated container containing an anticoagulant. Determine the hematocrit of each sample. NOTE: Each sample should be labeled with the date and time of withdrawal. Each withdrawal should be at approximately the same time each day. Frequency of sampling depends primarily on convenience. For statistical accuracy a minimum of 10 samples should be obtained. Pipet 4 mL of each sample into a counting vial and label accordingly. Count all samples at the same time to negate the effect of radioactive decay. Count and subtract background. Calculations The calculations are based on using the 24-hour sample as 100% and making it the starting point. All other samples are calculated as a percent of the 24-hour sample, and indicate the percent remaining. If later samples have hematocrits different from the 24-hour sample, the correction below should be made. As indicated, the above calculation should be made on each sample individually. Upon completion of the calculation, the percent remaining should be plotted on the logarithmic scale against time on semi-logarithm paper. Draw a best-fit straight line through the points. The red cell survival time is determined from the graph by finding the time at which the straight line reached 50 percent. Normal Range: Normal 28 to 40 days Abnormal Less than 28 days The U.S. Nuclear Regulatory Commission has approved distribution of this radiopharmaceutical to persons licensed to use byproduct material listed in Section 35.100, and to persons who hold an equivalent license issued by an Agreement State. Revised 04/2005 Mallinckrodt Inc. St. Louis, MO 63134 MALLINCKRODT A370I0 %Remaining Formula"],"spl_unclassified_section_table":["
Table 1: Principal Radiation Emission Data
Radiation Mean Percent Per Disintegration Energy (keV)
Gamma-1 9.83 320.1
","
Table 2: Radiation Attenuation by Lead Shielding
Shield Thickness (Pb) cm Coefficient of Attenuation
0.17 0.56 1.12 1.68 2.25 0.5 10-1 10-2 10-3 10-4
","
Table 3. Physical Decay Chart; Chromium Cr 51, Half-Life 27.7 Days
Days Fraction Remaining Days Fraction Remaining
*Calibration Time
0* 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 1.000 0.975 0.951 0.928 0.905 0.882 0.861 0.839 0.819 0.798 0.779 0.759 0.741 0.722 0.704 0.687 0.670 17 18 19 20 21 22 23 24 25 26 27 28 29 30 60 90 0.654 0.637 0.622 0.606 0.591 0.577 0.562 0.549 0.535 0.522 0.509 0.496 0.484 0.472 0.223 0.105
","
Table 4. Absorbed Radiation Doses
Tissue Sodium Chromate Cr 51
mGy/7.4 MBq rads/200 μCi
Blood Spleen Testes Ovaries Total Body 2.00 26.4 0.66 0.66 0.55 0.20 2.64 0.066 0.066 0.055
","
NOTE 1: Wear waterproof gloves during the entire red cell tagging procedure and during subsequent patient dose withdrawals.
NOTE 2: Make transfers of Chromium Cr 51 solutions during the tagging procedure and during subsequent injections of radiolabeled blood cells with adequately shielded syringes.
NOTE 3: Maintain adequate shielding of the radiolabeled blood cells by using a lead vial shield and cover.
","
Normal Range: Normal 28 to 40 days
Abnormal Less than 28 days
"],"version":"5","warnings":["WARNINGS None known."]}