Drug Facts
Composition & Profile
Identifiers & Packaging
HOW SUPPLIED Kit for the Preparation of Technetium Tc 99m Mebrofenin is supplied in kits of 5 or 30 reaction vials. Each vial contains a sterile, nonpyrogenic lyophilized mixture of 45 mg mebrofenin, 0.54 mg (minimum) stannous fluoride dihydrate SnF 2 •2H 2 O and 1.03 mg total tin, maximum (as stannous fluoride dihydrate SnF 2 •2H 2 O), not more than 5.2 mg methylparaben, and 0.58 mg propylparaben. The pH has been adjusted with hydrochloric acid or sodium hydroxide prior to lyophilization. The lyophilized vial contents are sealed under nitrogen at the time of manufacture. The pH of the reconstituted product is 4.2 to 5.7. Sun Pharmaceutical Industries, Inc. 29 Dunham Rd. 781-275-7120 Kit Contents 5 or 30 sterile multidose reaction vials. 12 or 72 radiation labels for Technetium Tc 99m Mebrofenin (for 5 or 30 vial kits, respectively). 1 package insert. Preparation Preparation of Technetium Tc 99m Mebrofenin is done by the following aseptic procedure: 1. Waterproof gloves should be worn during the preparation procedure. 2. Place reaction vial in an appropriate lead shield. 3. Swab the rubber closure of the reaction vial with a germicide. 4. Inject 1 to 5 mL sterile additive free sodium pertechnetate Tc 99m injection containing up to 3700 MBq (100 mCi) Tc 99m into the reaction vial. Be sure to maintain a nitrogen atmosphere in the vial by not introducing air during reconstitution. NOTE: If sodium pertechnetate Tc 99m injection must be diluted for use with Kit for the Preparation of Technetium Tc 99m Mebrofenin, only preservative free Sodium Chloride Injection USP should be used. 5. Secure the lead shield cover. Swirl the vial gently to mix contents and let stand for 15 minutes. 6. Record the date and time of preparation on radiation label. 7. Affix radiation label to shield. 8. Examine vial contents. If the solution is not clear and free of particulate matter and discoloration on visual inspection, it should not be used. 9. Measure the radioactivity by a suitable calibration system and record on the shield label prior to patient administration. 10. Withdraw material with a sterile lead shielded syringe for use within 18 hours of preparation. Storage Store the kit as supplied at 20-25ºC (68-77ºF) [See USP] prior to and following reconstitution. Use within 18 hours of reconstitution. Rx only NDC-45567-0455-1 (5 Vial Kit) NDC-45567-0455-2 (30 Vial Kit) This reagent kit for the 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 of the U.S. Nuclear Regulatory Commission or an Agreement State. Manufactured By: Sun Pharmaceutical Industries, Inc. Billerica, MA 01821 1-800-221-7554 (For International call 781-275-7120) Mar 2020; PACKAGE LABEL - PRINCIPAL DISPLAY PANEL - 5 VIAL CONTAINER (10 mL) NDC 045567-0455-1 Kit for the Preparation of Technetium Tc99m Mebrofenin 45mg Mebrofenin per Vial For Intravenous Use after Reconstitution Rx Only Dosage: See Package Insert Store at 20-25°C (68-77°F) [See USP] before and after reconstitution. Use within 18 hours after reconstitution. Manufactured by: Sun Pharmaceutical Industries, Inc. Billerica, MA 01821 PL-000013 Rev 0.2 Mar 2020 Vial Label; PACKAGE LABEL - PRINCIPAL DISPLAY PANEL - 5 VIAL CARTON NDC 045567-0455-1 Kit for the Preparation of Technetium Tc99m Mebrofenin 45mg Mebrofenin per Vial For Intravenous Use after Reconstitution Rx Only Nonradioactive Diagnostic Multidose Vial contents are sealed under Nitrogen at time of manufacture. The pH of the reconstituted product is 4.2 - 5.7 Dosage: See Package Insert Manufactured By: Sun Pharmaceutical Industries, Inc. Billerica, MA 01821 For Customer Service call: 1-800-221-7554 Kit for the Preparation of Technetium Tc99m Mebrofenin for: Hepatobiliary Imaging Rx Only Each sterile, lyophilized vial contains: 45mg Mebrofenin; 0.54mg minimum stannous fluoride dihydrate; 1.03mg total tin maximum (as stannous fluoride dihydrate); and not more than 5.2mg methylparaben and 0.58mg propylparaben as preservatives. pH of reconstituted product is 4.2 - 5.7 Store at 20-25°C (68-77°F) [See USP] before and after reconstitution Use within 18 hours after reconstitution Contents: 1 package insert, 12 radiation labels and 5 reaction vials Preparation: See Package Insert for complete information, use and directions Manufactured By: Sun Pharmaceutical Industries, Inc. Billerica, MA 01821 PL-000015 Rev 0.3 Mar 2020 5 Vial Carton Label; PACKAGE LABEL - PRINCIPAL DISPLAY PANEL - 30 VIAL CONTAINER (10 mL) NDC 045567-0455-2 Kit for the Preparation of Technetium Tc99m Mebrofenin 45mg Mebrofenin per Vial For Intravenous User after Reconstitution Rx Only Dosage: See Package Insert Store at 20-25°C (68-77°F) [See USP] before and after reconstitution. Use within 18 hours after reconstitution. Manufactured by: Sun Pharmaceutical Industries, Inc. Billerica, MA 01821 PL-000013 Rev 0.2 Mar 2020 30-Vial Label; PACKAGE LABEL - PRINCIPAL DISPLAY PANEL - 30 VIAL CARTON NDC 045567-0455-2 Kit for the Preparation of Technetium Tc99m Mebrofenin 45mg Mebrofenin per Vial for Hepatobiliary Imaging For Intravenous Use after Reconstitution Rx Only Nonradioactive Diagnostic Multidose Vial contents are sealed under Nitrogen at time of manufacture. The pH of the reconstituted product is 4.2 - 5.7 Dosage: See Package Insert Manufactured By: Sun Pharmaceutical Industries, Inc. Billerica MA, 01821 For Customer Service call: 1-800-221-7554 Contents: 1 Package Insert, 72 radiation labels and 30 reaction vials Each sterile, lyophilized vial contains: 45mg Mebrofenin; 0.54mg minimum stannous fluoride dihydrate; 1.03mg total tin maximum (as stannous fluoride dihydrate); and not more than 5.2mg methylparaben and 0.58mg propylparaben as preservatives. pH of reconstituted product is 4.2 - 5.7 Store at 20-25°C (68-77°F) [See USP] before and after reconstitution Use within 18 hours after reconstitution Preparation: See Package Insert for complete information, use and directions Manufactured By: Sun Pharmaceutical Industries, Inc. Billerica MA, 01821 PL-000016 Rev 0.3 Mar 2020 30 Vial Carton Label; PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – SHIELD LABEL CAUTION: RADIOACTIVE MATERIAL See Package Insert for full prescribing information Rx Only Technetium Tc99m Mebrofenin Injection Contents Mebrofenin 45 mg Stannous fluoride dihydrate 0.54 mg minimum and 1.03 mg total tin maximum Methylparaben 5.2 mg, maximum Propylparaben 0.58, maximum _________________________________________________ MBq (mCi) Tc99m/mL _________________________________________________ Volume mL _________________________________________________ Date / Time Prepared Expiration Time _________________________________________________ Lot No. PL-000014 Rev 0.2 Mar 2020 Manufactured by: Sun Pharmaceutical Industries, Inc. Billerica, MA 01821 Shield Label
- HOW SUPPLIED Kit for the Preparation of Technetium Tc 99m Mebrofenin is supplied in kits of 5 or 30 reaction vials. Each vial contains a sterile, nonpyrogenic lyophilized mixture of 45 mg mebrofenin, 0.54 mg (minimum) stannous fluoride dihydrate SnF 2 •2H 2 O and 1.03 mg total tin, maximum (as stannous fluoride dihydrate SnF 2 •2H 2 O), not more than 5.2 mg methylparaben, and 0.58 mg propylparaben. The pH has been adjusted with hydrochloric acid or sodium hydroxide prior to lyophilization. The lyophilized vial contents are sealed under nitrogen at the time of manufacture. The pH of the reconstituted product is 4.2 to 5.7. Sun Pharmaceutical Industries, Inc. 29 Dunham Rd. 781-275-7120 Kit Contents 5 or 30 sterile multidose reaction vials. 12 or 72 radiation labels for Technetium Tc 99m Mebrofenin (for 5 or 30 vial kits, respectively). 1 package insert. Preparation Preparation of Technetium Tc 99m Mebrofenin is done by the following aseptic procedure: 1. Waterproof gloves should be worn during the preparation procedure. 2. Place reaction vial in an appropriate lead shield. 3. Swab the rubber closure of the reaction vial with a germicide. 4. Inject 1 to 5 mL sterile additive free sodium pertechnetate Tc 99m injection containing up to 3700 MBq (100 mCi) Tc 99m into the reaction vial. Be sure to maintain a nitrogen atmosphere in the vial by not introducing air during reconstitution. NOTE: If sodium pertechnetate Tc 99m injection must be diluted for use with Kit for the Preparation of Technetium Tc 99m Mebrofenin, only preservative free Sodium Chloride Injection USP should be used. 5. Secure the lead shield cover. Swirl the vial gently to mix contents and let stand for 15 minutes. 6. Record the date and time of preparation on radiation label. 7. Affix radiation label to shield. 8. Examine vial contents. If the solution is not clear and free of particulate matter and discoloration on visual inspection, it should not be used. 9. Measure the radioactivity by a suitable calibration system and record on the shield label prior to patient administration. 10. Withdraw material with a sterile lead shielded syringe for use within 18 hours of preparation. Storage Store the kit as supplied at 20-25ºC (68-77ºF) [See USP] prior to and following reconstitution. Use within 18 hours of reconstitution. Rx only NDC-45567-0455-1 (5 Vial Kit) NDC-45567-0455-2 (30 Vial Kit) This reagent kit for the 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 of the U.S. Nuclear Regulatory Commission or an Agreement State. Manufactured By: Sun Pharmaceutical Industries, Inc. Billerica, MA 01821 1-800-221-7554 (For International call 781-275-7120) Mar 2020
- PACKAGE LABEL - PRINCIPAL DISPLAY PANEL - 5 VIAL CONTAINER (10 mL) NDC 045567-0455-1 Kit for the Preparation of Technetium Tc99m Mebrofenin 45mg Mebrofenin per Vial For Intravenous Use after Reconstitution Rx Only Dosage: See Package Insert Store at 20-25°C (68-77°F) [See USP] before and after reconstitution. Use within 18 hours after reconstitution. Manufactured by: Sun Pharmaceutical Industries, Inc. Billerica, MA 01821 PL-000013 Rev 0.2 Mar 2020 Vial Label
- PACKAGE LABEL - PRINCIPAL DISPLAY PANEL - 5 VIAL CARTON NDC 045567-0455-1 Kit for the Preparation of Technetium Tc99m Mebrofenin 45mg Mebrofenin per Vial For Intravenous Use after Reconstitution Rx Only Nonradioactive Diagnostic Multidose Vial contents are sealed under Nitrogen at time of manufacture. The pH of the reconstituted product is 4.2 - 5.7 Dosage: See Package Insert Manufactured By: Sun Pharmaceutical Industries, Inc. Billerica, MA 01821 For Customer Service call: 1-800-221-7554 Kit for the Preparation of Technetium Tc99m Mebrofenin for: Hepatobiliary Imaging Rx Only Each sterile, lyophilized vial contains: 45mg Mebrofenin; 0.54mg minimum stannous fluoride dihydrate; 1.03mg total tin maximum (as stannous fluoride dihydrate); and not more than 5.2mg methylparaben and 0.58mg propylparaben as preservatives. pH of reconstituted product is 4.2 - 5.7 Store at 20-25°C (68-77°F) [See USP] before and after reconstitution Use within 18 hours after reconstitution Contents: 1 package insert, 12 radiation labels and 5 reaction vials Preparation: See Package Insert for complete information, use and directions Manufactured By: Sun Pharmaceutical Industries, Inc. Billerica, MA 01821 PL-000015 Rev 0.3 Mar 2020 5 Vial Carton Label
- PACKAGE LABEL - PRINCIPAL DISPLAY PANEL - 30 VIAL CONTAINER (10 mL) NDC 045567-0455-2 Kit for the Preparation of Technetium Tc99m Mebrofenin 45mg Mebrofenin per Vial For Intravenous User after Reconstitution Rx Only Dosage: See Package Insert Store at 20-25°C (68-77°F) [See USP] before and after reconstitution. Use within 18 hours after reconstitution. Manufactured by: Sun Pharmaceutical Industries, Inc. Billerica, MA 01821 PL-000013 Rev 0.2 Mar 2020 30-Vial Label
- PACKAGE LABEL - PRINCIPAL DISPLAY PANEL - 30 VIAL CARTON NDC 045567-0455-2 Kit for the Preparation of Technetium Tc99m Mebrofenin 45mg Mebrofenin per Vial for Hepatobiliary Imaging For Intravenous Use after Reconstitution Rx Only Nonradioactive Diagnostic Multidose Vial contents are sealed under Nitrogen at time of manufacture. The pH of the reconstituted product is 4.2 - 5.7 Dosage: See Package Insert Manufactured By: Sun Pharmaceutical Industries, Inc. Billerica MA, 01821 For Customer Service call: 1-800-221-7554 Contents: 1 Package Insert, 72 radiation labels and 30 reaction vials Each sterile, lyophilized vial contains: 45mg Mebrofenin; 0.54mg minimum stannous fluoride dihydrate; 1.03mg total tin maximum (as stannous fluoride dihydrate); and not more than 5.2mg methylparaben and 0.58mg propylparaben as preservatives. pH of reconstituted product is 4.2 - 5.7 Store at 20-25°C (68-77°F) [See USP] before and after reconstitution Use within 18 hours after reconstitution Preparation: See Package Insert for complete information, use and directions Manufactured By: Sun Pharmaceutical Industries, Inc. Billerica MA, 01821 PL-000016 Rev 0.3 Mar 2020 30 Vial Carton Label
- PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – SHIELD LABEL CAUTION: RADIOACTIVE MATERIAL See Package Insert for full prescribing information Rx Only Technetium Tc99m Mebrofenin Injection Contents Mebrofenin 45 mg Stannous fluoride dihydrate 0.54 mg minimum and 1.03 mg total tin maximum Methylparaben 5.2 mg, maximum Propylparaben 0.58, maximum _________________________________________________ MBq (mCi) Tc99m/mL _________________________________________________ Volume mL _________________________________________________ Date / Time Prepared Expiration Time _________________________________________________ Lot No. PL-000014 Rev 0.2 Mar 2020 Manufactured by: Sun Pharmaceutical Industries, Inc. Billerica, MA 01821 Shield Label
Overview
Each multidose reaction vial contains a nonradioactive, sterile, nonpyrogenic mixture of 45 mg mebrofenin, 0.54 mg (minimum) stannous fluoride dihydrate, SnF 2 •2H 2 O and 1.03 mg total tin, maximum (as stannous fluoride dihydrate, SnF 2 •2H 2 O), not more than 5.2 mg methylparaben, and 0.58 mg propylparaben. The pH is adjusted with sodium hydroxide or hydrochloric acid prior to lyophilization. The contents of the vial are lyophilized and sealed under nitrogen at the time of manufacture. The pH of the reconstituted product is 4.2 to 5.7. The structure of mebrofenin (2,2'-[[2-[(3-Bromo-2,4,6-trimethylphenyl)-amino]-2-oxoethyl]imino] bisacetic acid) is shown below: Molecular Weight = 387.23 When sterile, pyrogen-free sodium pertechnetate Tc 99m injection is added to the vial, the diagnostic agent Technetium Tc 99m Mebrofenin is formed for administration by intravenous injection. PHYSICAL CHARACTERISTICS Technetium Tc 99m decays by isomeric transition with a physical half-life of 6.02 hours. 1 The principal photon that is useful for detection and imaging studies is listed in Table 1. TABLE 1 Principal Radiation Emission Data Radiation Mean % per Disintegration Mean Energy (keV) Gamma-2 89.07 140.5 1 Kocher, David C., "Radioactive Decay Data Tables", DOE/TIC-11026, (1981) p. 108. External Radiation The specific gamma ray constant for Tc 99m is 0.78 R/hour-millicurie 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. To facilitate control of the radiation exposure from millicurie amounts of this radionuclide, 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 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 technetium Tc 99m, the fractions that remain at selected intervals after the time of calibration are shown in Table 3. TABLE 3 Physical Decay Chart: Tc 99m half-life 6.02 hours Hours Fraction Remaining Hours Fraction Remaining 0* 1.000 7 0.447 1 0.891 8 0.398 2 0.794 9 0.355 3 0.708 10 0.316 4 0.631 11 0.282 5 0.562 12 0.251 6 0.501 18 0.126 *Calibration time spl-mebrofenin-structure
Indications & Usage
Technetium Tc 99m Mebrofenin is indicated as a hepatobiliary imaging agent.
Dosage & Administration
The suggested intravenous dose range of Technetium Tc 99m Mebrofenin in the average patient (70 kg) is: Nonjaundiced patient: 74 - 185 MBq (2-5 mCi) Patient with serum bilirubin level greater than 1.5 mg/dL: 111-370 MBq (3-10 mCi) The patient dose should be measured by a suitable radioactivity calibration system immediately prior to administration. The patient should be in a fasting state, 4 hours is preferable. False positives (non-visualization) may result if the gallbladder has been emptied by ingestion of food. An interval of at least 24 hours should be allowed before repeat examination. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit. RADIATION DOSIMETRY The estimated absorbed radiation doses 1,2 to organs and tissues of an average subject (70 kg) from an intravenous injection of 370 MBq (10 millicuries) of Technetium Tc 99m Mebrofenin are shown in Table 4. TABLE 4 Estimated Absorbed Radiation Doses† Normal Subjects* Severely Jaundiced Patients** Tissue mGy/ 370 MBq rads/ 10 mCi mGy/ 370 MBq rads/ 10 mCi Total Body 2.0 0.2 1.7 0.17 Liver 4.7 0.47 8.1 0.81 Gallbladder Wall 13.7 1.37 12.5 1.25 Small Intestine 29.9 2.99 16.0 1.60 Upper Large Intestine Wall 47.4 4.74 24.8 2.48 Lower Large Intestine Wall 36.4 3.64 19.7 1.97 Kidney 2.2 0.22 1.9 0.19 Urinary Bladder Wall 2.9 0.29 24.2 2.42 Ovaries 10.1 1.01 6.4 0.64 Testes 0.5 0.05 1.1 0.11 Red Marrow 3.4 0.34 2.5 0.25 †Method of Calculation: (1) Loberg, M.D., Buddemeyer, E.V.: Application of pharmacokinetic modeling to the radiation dosimetry of hepatobiliary agents. In Third International Radiopharmaceutical Dosimetry Symposium, FDA No. 81-8166, U.S. Department of Health and Human Services, Public Health Service, FDA, Bureau of Radiological Health, Rockville, MD, (1981) pp. 318-332. (2) Values for S: "S", Absorbed Dose per Unit Cumulated Activity for Selected Radionuclides and Organs, MIRD Pamphlet No. 11 (1975). * Bilirubin <1.5 mg/dL Calculations assume that 98% of the injected activity is taken up by the liver; activity not removed in the urine in 24 hours is excreted in the intestines and no enterohepatic circulation of activity. ** Bilirubin >10 mg/dL (mean 21.8 mg/dL) Calculations assume that 66% of the injected activity is taken up by the liver; activity not removed in the urine in 24 hours is excreted in the intestines and no enterohepatic circulation of activity.
Warnings & Precautions
WARNINGS The theoretical possibility of allergic reactions should be considered in patients who receive multiple doses.
Contraindications
Hypersensitivity to this compound.
Adverse Reactions
Urticaria and rash have been rarely reported with the use of Technetium Tc 99m Mebrofenin since market introduction. Rare cases of chills and nausea have been reported with related compounds. Infrequently, death has been reported in association with the use of this class of agents.
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