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Kit for the Preparation of Technetium Tc 99m Mebrofenin
Overview
What is Kit for the Preparation of Technetium Tc 99m Mebrofenin?
Each multidose reaction vial contains a nonradioactive, sterile, nonpyrogenic mixture of 45 mg mebrofenin, 0.54 mg (minimum) stannous fluoride dihydrate, SnF•2HO and 1.03 mg total tin, maximum (as stannous fluoride dihydrate, SnF•2HO), 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. The principal photon that is useful for detection and imaging studies is listed in Table 1.
1
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.
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.
*Calibration time
What does Kit for the Preparation of Technetium Tc 99m Mebrofenin look like?
What are the available doses of Kit for the Preparation of Technetium Tc 99m Mebrofenin?
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What should I talk to my health care provider before I take Kit for the Preparation of Technetium Tc 99m Mebrofenin?
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How should I use Kit for the Preparation of Technetium Tc 99m Mebrofenin?
Technetium Tc 99m Mebrofenin is indicated as a hepatobiliary imaging agent.
The suggested intravenous dose range of Technetium Tc 99m Mebrofenin in the average patient (70 kg) is:
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 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.
†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.
What interacts with Kit for the Preparation of Technetium Tc 99m Mebrofenin?
Hypersensitivity to this compound.
What are the warnings of Kit for the Preparation of Technetium Tc 99m Mebrofenin?
The occurrence of hypersensitivity reactions to allopurinol may be increased in patients with decreased renal function receiving thiazides and allopurinol concurrently. For this reason, in this clinical setting, such combinations should be administered with caution and patients should be observed closely.
What are the precautions of Kit for the Preparation of Technetium Tc 99m Mebrofenin?
General
Contents of the reaction vial are intended only for use in the preparation of Technetium Tc 99m Mebrofenin and are not to be administered directly to the patient.
Delayed or non-visualization of the gallbladder may occur in the immediate post-prandial period or after prolonged fasting or parenteral feeding. Functional biliary obstruction may accompany chronic cholecystitis or pancreatitis. In addition, patients with hepatocellular disease may show nonvisualization or delayed visualization of the gallbladder. Delayed intestinal transit may also be noted in such patients. Juvenile hepatitis may be associated with gallbladder nonvisualization and the failure to visualize activity in the intestine. Administration of meperidine or morphine may delay intestinal transit of the imaging agent and may result in nonvisualization. Septic patients may show absent or delayed hepatobiliary clearance. Thus, a positive finding does not of itself permit a differential diagnosis of any of the above conditions and should be evaluated in the light of the total clinical picture and results of other diagnostic modalities.
The components of the kit are supplied sterile and non-pyrogenic. Aseptic procedures normally employed in making additions and withdrawals from sterile, non-pyrogenic containers should be used during the addition of the pertechnetate solution and the withdrawal of doses for patient administration.
The Technetium Tc 99m labeling reactions involved in preparing the agent depend on maintaining the stannous ion in the reduced state. Any oxidant present in the sodium pertechnetate Tc 99m supply may, thus, adversely affect the quality of the radiopharmaceutical. Hence, sodium pertechnetate Tc 99m containing oxidants should not be employed.
Radiopharmaceuticals should be used only by physicians who are qualified by training and experience in the safe use and handling of radionuclides.
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 ensure minimum radiation exposure to occupational workers.
Tc 99m Mebrofenin should be formulated no more than 18 hours prior to clinical use.
Carcinogenesis, Mutagenesis, Impairment of Fertility
No long term animal studies have been performed to evaluate carcinogenic potential or whether Technetium Tc 99m Mebrofenin may affect fertility in males or females.
Pregnancy
Pregnancy Category C
Animal reproduction studies have not been conducted with Technetium Tc 99m Mebrofenin. It is also not known whether Technetium Tc 99m Mebrofenin can cause fetal harm when administered to a pregnant woman or can affect reproductive capacity. Technetium Tc 99m Mebrofenin should be given to a pregnant woman only if the expected benefits to be gained clearly outweigh the potential hazards.
Nursing Mothers
Technetium Tc 99m is excreted in human milk during lactation. Therefore, formula feedings should be substituted for breast feedings.
Pediatric Use
Safety and effectiveness in children below the age of 18 have not been established.
What are the side effects of Kit for the Preparation of Technetium Tc 99m Mebrofenin?
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.
What should I look out for while using Kit for the Preparation of Technetium Tc 99m Mebrofenin?
Hypersensitivity to this compound.
The theoretical possibility of allergic reactions should be considered in patients who receive multiple doses.
What might happen if I take too much Kit for the Preparation of Technetium Tc 99m Mebrofenin?
Sorry No Records found
How should I store and handle Kit for the Preparation of Technetium Tc 99m Mebrofenin?
StorageStore in a well-closed container at 20° - 25°C (68° - 77°F); excursions permitted to 15° - 30°C (59° - 86°F) [see USP Controlled Room Temperature].StorageStore in a well-closed container at 20° - 25°C (68° - 77°F); excursions permitted to 15° - 30°C (59° - 86°F) [see USP Controlled Room Temperature].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•2HO and 1.03 mg total tin, maximum (as stannous fluoride dihydrate SnF•2HO), 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. Pharmalucence, Inc.29 Dunham Rd.781-275-7120Kit Contents5 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.PreparationPreparation 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.StorageStore the kit as supplied at 20-25ºC (68-77ºF) [See USP] prior to and following reconstitution. Use within 18 hours of reconstitution.Rx onlyNDC-45567-0455-1 (5 Vial Kit)NDC-45567-0455-2 (30 Vial Kit)Manufactured By:Pharmalucence, Inc.Billerica, MA 018211-800-221-7554(For International call 781-725-7120)www.pharmalucence.comPL-000012 Rev 0.1 Jun 2012Kit 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•2HO and 1.03 mg total tin, maximum (as stannous fluoride dihydrate SnF•2HO), 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. Pharmalucence, Inc.29 Dunham Rd.781-275-7120Kit Contents5 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.PreparationPreparation 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.StorageStore the kit as supplied at 20-25ºC (68-77ºF) [See USP] prior to and following reconstitution. Use within 18 hours of reconstitution.Rx onlyNDC-45567-0455-1 (5 Vial Kit)NDC-45567-0455-2 (30 Vial Kit)Manufactured By:Pharmalucence, Inc.Billerica, MA 018211-800-221-7554(For International call 781-725-7120)www.pharmalucence.comPL-000012 Rev 0.1 Jun 2012Kit 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•2HO and 1.03 mg total tin, maximum (as stannous fluoride dihydrate SnF•2HO), 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. Pharmalucence, Inc.29 Dunham Rd.781-275-7120Kit Contents5 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.PreparationPreparation 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.StorageStore the kit as supplied at 20-25ºC (68-77ºF) [See USP] prior to and following reconstitution. Use within 18 hours of reconstitution.Rx onlyNDC-45567-0455-1 (5 Vial Kit)NDC-45567-0455-2 (30 Vial Kit)Manufactured By:Pharmalucence, Inc.Billerica, MA 018211-800-221-7554(For International call 781-725-7120)www.pharmalucence.comPL-000012 Rev 0.1 Jun 2012Kit 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•2HO and 1.03 mg total tin, maximum (as stannous fluoride dihydrate SnF•2HO), 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. Pharmalucence, Inc.29 Dunham Rd.781-275-7120Kit Contents5 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.PreparationPreparation 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.StorageStore the kit as supplied at 20-25ºC (68-77ºF) [See USP] prior to and following reconstitution. Use within 18 hours of reconstitution.Rx onlyNDC-45567-0455-1 (5 Vial Kit)NDC-45567-0455-2 (30 Vial Kit)Manufactured By:Pharmalucence, Inc.Billerica, MA 018211-800-221-7554(For International call 781-725-7120)www.pharmalucence.comPL-000012 Rev 0.1 Jun 2012Kit 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•2HO and 1.03 mg total tin, maximum (as stannous fluoride dihydrate SnF•2HO), 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. Pharmalucence, Inc.29 Dunham Rd.781-275-7120Kit Contents5 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.PreparationPreparation 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.StorageStore the kit as supplied at 20-25ºC (68-77ºF) [See USP] prior to and following reconstitution. Use within 18 hours of reconstitution.Rx onlyNDC-45567-0455-1 (5 Vial Kit)NDC-45567-0455-2 (30 Vial Kit)Manufactured By:Pharmalucence, Inc.Billerica, MA 018211-800-221-7554(For International call 781-725-7120)www.pharmalucence.comPL-000012 Rev 0.1 Jun 2012Kit 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•2HO and 1.03 mg total tin, maximum (as stannous fluoride dihydrate SnF•2HO), 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. Pharmalucence, Inc.29 Dunham Rd.781-275-7120Kit Contents5 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.PreparationPreparation 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.StorageStore the kit as supplied at 20-25ºC (68-77ºF) [See USP] prior to and following reconstitution. Use within 18 hours of reconstitution.Rx onlyNDC-45567-0455-1 (5 Vial Kit)NDC-45567-0455-2 (30 Vial Kit)Manufactured By:Pharmalucence, Inc.Billerica, MA 018211-800-221-7554(For International call 781-725-7120)www.pharmalucence.comPL-000012 Rev 0.1 Jun 2012Kit 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•2HO and 1.03 mg total tin, maximum (as stannous fluoride dihydrate SnF•2HO), 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. Pharmalucence, Inc.29 Dunham Rd.781-275-7120Kit Contents5 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.PreparationPreparation 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.StorageStore the kit as supplied at 20-25ºC (68-77ºF) [See USP] prior to and following reconstitution. Use within 18 hours of reconstitution.Rx onlyNDC-45567-0455-1 (5 Vial Kit)NDC-45567-0455-2 (30 Vial Kit)Manufactured By:Pharmalucence, Inc.Billerica, MA 018211-800-221-7554(For International call 781-725-7120)www.pharmalucence.comPL-000012 Rev 0.1 Jun 2012Kit 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•2HO and 1.03 mg total tin, maximum (as stannous fluoride dihydrate SnF•2HO), 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. Pharmalucence, Inc.29 Dunham Rd.781-275-7120Kit Contents5 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.PreparationPreparation 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.StorageStore the kit as supplied at 20-25ºC (68-77ºF) [See USP] prior to and following reconstitution. Use within 18 hours of reconstitution.Rx onlyNDC-45567-0455-1 (5 Vial Kit)NDC-45567-0455-2 (30 Vial Kit)Manufactured By:Pharmalucence, Inc.Billerica, MA 018211-800-221-7554(For International call 781-725-7120)www.pharmalucence.comPL-000012 Rev 0.1 Jun 2012Kit 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•2HO and 1.03 mg total tin, maximum (as stannous fluoride dihydrate SnF•2HO), 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. Pharmalucence, Inc.29 Dunham Rd.781-275-7120Kit Contents5 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.PreparationPreparation 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.StorageStore the kit as supplied at 20-25ºC (68-77ºF) [See USP] prior to and following reconstitution. Use within 18 hours of reconstitution.Rx onlyNDC-45567-0455-1 (5 Vial Kit)NDC-45567-0455-2 (30 Vial Kit)Manufactured By:Pharmalucence, Inc.Billerica, MA 018211-800-221-7554(For International call 781-725-7120)www.pharmalucence.comPL-000012 Rev 0.1 Jun 2012Kit 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•2HO and 1.03 mg total tin, maximum (as stannous fluoride dihydrate SnF•2HO), 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. Pharmalucence, Inc.29 Dunham Rd.781-275-7120Kit Contents5 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.PreparationPreparation 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.StorageStore the kit as supplied at 20-25ºC (68-77ºF) [See USP] prior to and following reconstitution. Use within 18 hours of reconstitution.Rx onlyNDC-45567-0455-1 (5 Vial Kit)NDC-45567-0455-2 (30 Vial Kit)Manufactured By:Pharmalucence, Inc.Billerica, MA 018211-800-221-7554(For International call 781-725-7120)www.pharmalucence.comPL-000012 Rev 0.1 Jun 2012Kit 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•2HO and 1.03 mg total tin, maximum (as stannous fluoride dihydrate SnF•2HO), 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. Pharmalucence, Inc.29 Dunham Rd.781-275-7120Kit Contents5 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.PreparationPreparation 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.StorageStore the kit as supplied at 20-25ºC (68-77ºF) [See USP] prior to and following reconstitution. Use within 18 hours of reconstitution.Rx onlyNDC-45567-0455-1 (5 Vial Kit)NDC-45567-0455-2 (30 Vial Kit)Manufactured By:Pharmalucence, Inc.Billerica, MA 018211-800-221-7554(For International call 781-725-7120)www.pharmalucence.comPL-000012 Rev 0.1 Jun 2012Kit 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•2HO and 1.03 mg total tin, maximum (as stannous fluoride dihydrate SnF•2HO), 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. Pharmalucence, Inc.29 Dunham Rd.781-275-7120Kit Contents5 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.PreparationPreparation 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.StorageStore the kit as supplied at 20-25ºC (68-77ºF) [See USP] prior to and following reconstitution. Use within 18 hours of reconstitution.Rx onlyNDC-45567-0455-1 (5 Vial Kit)NDC-45567-0455-2 (30 Vial Kit)Manufactured By:Pharmalucence, Inc.Billerica, MA 018211-800-221-7554(For International call 781-725-7120)www.pharmalucence.comPL-000012 Rev 0.1 Jun 2012Kit 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•2HO and 1.03 mg total tin, maximum (as stannous fluoride dihydrate SnF•2HO), 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. Pharmalucence, Inc.29 Dunham Rd.781-275-7120Kit Contents5 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.PreparationPreparation 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.StorageStore the kit as supplied at 20-25ºC (68-77ºF) [See USP] prior to and following reconstitution. Use within 18 hours of reconstitution.Rx onlyNDC-45567-0455-1 (5 Vial Kit)NDC-45567-0455-2 (30 Vial Kit)Manufactured By:Pharmalucence, Inc.Billerica, MA 018211-800-221-7554(For International call 781-725-7120)www.pharmalucence.comPL-000012 Rev 0.1 Jun 2012Kit 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•2HO and 1.03 mg total tin, maximum (as stannous fluoride dihydrate SnF•2HO), 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. Pharmalucence, Inc.29 Dunham Rd.781-275-7120Kit Contents5 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.PreparationPreparation 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.StorageStore the kit as supplied at 20-25ºC (68-77ºF) [See USP] prior to and following reconstitution. Use within 18 hours of reconstitution.Rx onlyNDC-45567-0455-1 (5 Vial Kit)NDC-45567-0455-2 (30 Vial Kit)Manufactured By:Pharmalucence, Inc.Billerica, MA 018211-800-221-7554(For International call 781-725-7120)www.pharmalucence.comPL-000012 Rev 0.1 Jun 2012Kit 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•2HO and 1.03 mg total tin, maximum (as stannous fluoride dihydrate SnF•2HO), 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. Pharmalucence, Inc.29 Dunham Rd.781-275-7120Kit Contents5 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.PreparationPreparation 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.StorageStore the kit as supplied at 20-25ºC (68-77ºF) [See USP] prior to and following reconstitution. Use within 18 hours of reconstitution.Rx onlyNDC-45567-0455-1 (5 Vial Kit)NDC-45567-0455-2 (30 Vial Kit)Manufactured By:Pharmalucence, Inc.Billerica, MA 018211-800-221-7554(For International call 781-725-7120)www.pharmalucence.comPL-000012 Rev 0.1 Jun 2012Kit 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•2HO and 1.03 mg total tin, maximum (as stannous fluoride dihydrate SnF•2HO), 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. Pharmalucence, Inc.29 Dunham Rd.781-275-7120Kit Contents5 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.PreparationPreparation 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.StorageStore the kit as supplied at 20-25ºC (68-77ºF) [See USP] prior to and following reconstitution. Use within 18 hours of reconstitution.Rx onlyNDC-45567-0455-1 (5 Vial Kit)NDC-45567-0455-2 (30 Vial Kit)Manufactured By:Pharmalucence, Inc.Billerica, MA 018211-800-221-7554(For International call 781-725-7120)www.pharmalucence.comPL-000012 Rev 0.1 Jun 2012Kit 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•2HO and 1.03 mg total tin, maximum (as stannous fluoride dihydrate SnF•2HO), 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. Pharmalucence, Inc.29 Dunham Rd.781-275-7120Kit Contents5 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.PreparationPreparation 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.StorageStore the kit as supplied at 20-25ºC (68-77ºF) [See USP] prior to and following reconstitution. Use within 18 hours of reconstitution.Rx onlyNDC-45567-0455-1 (5 Vial Kit)NDC-45567-0455-2 (30 Vial Kit)Manufactured By:Pharmalucence, Inc.Billerica, MA 018211-800-221-7554(For International call 781-725-7120)www.pharmalucence.comPL-000012 Rev 0.1 Jun 2012Kit 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•2HO and 1.03 mg total tin, maximum (as stannous fluoride dihydrate SnF•2HO), 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. Pharmalucence, Inc.29 Dunham Rd.781-275-7120Kit Contents5 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.PreparationPreparation 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.StorageStore the kit as supplied at 20-25ºC (68-77ºF) [See USP] prior to and following reconstitution. Use within 18 hours of reconstitution.Rx onlyNDC-45567-0455-1 (5 Vial Kit)NDC-45567-0455-2 (30 Vial Kit)Manufactured By:Pharmalucence, Inc.Billerica, MA 018211-800-221-7554(For International call 781-725-7120)www.pharmalucence.comPL-000012 Rev 0.1 Jun 2012Kit 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•2HO and 1.03 mg total tin, maximum (as stannous fluoride dihydrate SnF•2HO), 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. Pharmalucence, Inc.29 Dunham Rd.781-275-7120Kit Contents5 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.PreparationPreparation 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.StorageStore the kit as supplied at 20-25ºC (68-77ºF) [See USP] prior to and following reconstitution. Use within 18 hours of reconstitution.Rx onlyNDC-45567-0455-1 (5 Vial Kit)NDC-45567-0455-2 (30 Vial Kit)Manufactured By:Pharmalucence, Inc.Billerica, MA 018211-800-221-7554(For International call 781-725-7120)www.pharmalucence.comPL-000012 Rev 0.1 Jun 2012Kit 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•2HO and 1.03 mg total tin, maximum (as stannous fluoride dihydrate SnF•2HO), 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. Pharmalucence, Inc.29 Dunham Rd.781-275-7120Kit Contents5 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.PreparationPreparation 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.StorageStore the kit as supplied at 20-25ºC (68-77ºF) [See USP] prior to and following reconstitution. Use within 18 hours of reconstitution.Rx onlyNDC-45567-0455-1 (5 Vial Kit)NDC-45567-0455-2 (30 Vial Kit)Manufactured By:Pharmalucence, Inc.Billerica, MA 018211-800-221-7554(For International call 781-725-7120)www.pharmalucence.comPL-000012 Rev 0.1 Jun 2012Kit 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•2HO and 1.03 mg total tin, maximum (as stannous fluoride dihydrate SnF•2HO), 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. Pharmalucence, Inc.29 Dunham Rd.781-275-7120Kit Contents5 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.PreparationPreparation 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.StorageStore the kit as supplied at 20-25ºC (68-77ºF) [See USP] prior to and following reconstitution. Use within 18 hours of reconstitution.Rx onlyNDC-45567-0455-1 (5 Vial Kit)NDC-45567-0455-2 (30 Vial Kit)Manufactured By:Pharmalucence, Inc.Billerica, MA 018211-800-221-7554(For International call 781-725-7120)www.pharmalucence.comPL-000012 Rev 0.1 Jun 2012Kit 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•2HO and 1.03 mg total tin, maximum (as stannous fluoride dihydrate SnF•2HO), 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. Pharmalucence, Inc.29 Dunham Rd.781-275-7120Kit Contents5 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.PreparationPreparation 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.StorageStore the kit as supplied at 20-25ºC (68-77ºF) [See USP] prior to and following reconstitution. Use within 18 hours of reconstitution.Rx onlyNDC-45567-0455-1 (5 Vial Kit)NDC-45567-0455-2 (30 Vial Kit)Manufactured By:Pharmalucence, Inc.Billerica, MA 018211-800-221-7554(For International call 781-725-7120)www.pharmalucence.comPL-000012 Rev 0.1 Jun 2012Kit 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•2HO and 1.03 mg total tin, maximum (as stannous fluoride dihydrate SnF•2HO), 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. Pharmalucence, Inc.29 Dunham Rd.781-275-7120Kit Contents5 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.PreparationPreparation 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.StorageStore the kit as supplied at 20-25ºC (68-77ºF) [See USP] prior to and following reconstitution. Use within 18 hours of reconstitution.Rx onlyNDC-45567-0455-1 (5 Vial Kit)NDC-45567-0455-2 (30 Vial Kit)Manufactured By:Pharmalucence, Inc.Billerica, MA 018211-800-221-7554(For International call 781-725-7120)www.pharmalucence.comPL-000012 Rev 0.1 Jun 2012Kit 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•2HO and 1.03 mg total tin, maximum (as stannous fluoride dihydrate SnF•2HO), 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. Pharmalucence, Inc.29 Dunham Rd.781-275-7120Kit Contents5 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.PreparationPreparation 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.StorageStore the kit as supplied at 20-25ºC (68-77ºF) [See USP] prior to and following reconstitution. Use within 18 hours of reconstitution.Rx onlyNDC-45567-0455-1 (5 Vial Kit)NDC-45567-0455-2 (30 Vial Kit)Manufactured By:Pharmalucence, Inc.Billerica, MA 018211-800-221-7554(For International call 781-725-7120)www.pharmalucence.comPL-000012 Rev 0.1 Jun 2012Kit 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•2HO and 1.03 mg total tin, maximum (as stannous fluoride dihydrate SnF•2HO), 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. Pharmalucence, Inc.29 Dunham Rd.781-275-7120Kit Contents5 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.PreparationPreparation 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.StorageStore the kit as supplied at 20-25ºC (68-77ºF) [See USP] prior to and following reconstitution. Use within 18 hours of reconstitution.Rx onlyNDC-45567-0455-1 (5 Vial Kit)NDC-45567-0455-2 (30 Vial Kit)Manufactured By:Pharmalucence, Inc.Billerica, MA 018211-800-221-7554(For International call 781-725-7120)www.pharmalucence.comPL-000012 Rev 0.1 Jun 2012Kit 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•2HO and 1.03 mg total tin, maximum (as stannous fluoride dihydrate SnF•2HO), 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. Pharmalucence, Inc.29 Dunham Rd.781-275-7120Kit Contents5 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.PreparationPreparation 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.StorageStore the kit as supplied at 20-25ºC (68-77ºF) [See USP] prior to and following reconstitution. Use within 18 hours of reconstitution.Rx onlyNDC-45567-0455-1 (5 Vial Kit)NDC-45567-0455-2 (30 Vial Kit)Manufactured By:Pharmalucence, Inc.Billerica, MA 018211-800-221-7554(For International call 781-725-7120)www.pharmalucence.comPL-000012 Rev 0.1 Jun 2012Kit 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•2HO and 1.03 mg total tin, maximum (as stannous fluoride dihydrate SnF•2HO), 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. Pharmalucence, Inc.29 Dunham Rd.781-275-7120Kit Contents5 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.PreparationPreparation 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.StorageStore the kit as supplied at 20-25ºC (68-77ºF) [See USP] prior to and following reconstitution. Use within 18 hours of reconstitution.Rx onlyNDC-45567-0455-1 (5 Vial Kit)NDC-45567-0455-2 (30 Vial Kit)Manufactured By:Pharmalucence, Inc.Billerica, MA 018211-800-221-7554(For International call 781-725-7120)www.pharmalucence.comPL-000012 Rev 0.1 Jun 2012Kit 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•2HO and 1.03 mg total tin, maximum (as stannous fluoride dihydrate SnF•2HO), 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. Pharmalucence, Inc.29 Dunham Rd.781-275-7120Kit Contents5 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.PreparationPreparation 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.StorageStore the kit as supplied at 20-25ºC (68-77ºF) [See USP] prior to and following reconstitution. Use within 18 hours of reconstitution.Rx onlyNDC-45567-0455-1 (5 Vial Kit)NDC-45567-0455-2 (30 Vial Kit)Manufactured By:Pharmalucence, Inc.Billerica, MA 018211-800-221-7554(For International call 781-725-7120)www.pharmalucence.comPL-000012 Rev 0.1 Jun 2012Kit 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•2HO and 1.03 mg total tin, maximum (as stannous fluoride dihydrate SnF•2HO), 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. Pharmalucence, Inc.29 Dunham Rd.781-275-7120Kit Contents5 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.PreparationPreparation 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.StorageStore the kit as supplied at 20-25ºC (68-77ºF) [See USP] prior to and following reconstitution. Use within 18 hours of reconstitution.Rx onlyNDC-45567-0455-1 (5 Vial Kit)NDC-45567-0455-2 (30 Vial Kit)Manufactured By:Pharmalucence, Inc.Billerica, MA 018211-800-221-7554(For International call 781-725-7120)www.pharmalucence.comPL-000012 Rev 0.1 Jun 2012Kit 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•2HO and 1.03 mg total tin, maximum (as stannous fluoride dihydrate SnF•2HO), 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. Pharmalucence, Inc.29 Dunham Rd.781-275-7120Kit Contents5 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.PreparationPreparation 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.StorageStore the kit as supplied at 20-25ºC (68-77ºF) [See USP] prior to and following reconstitution. Use within 18 hours of reconstitution.Rx onlyNDC-45567-0455-1 (5 Vial Kit)NDC-45567-0455-2 (30 Vial Kit)Manufactured By:Pharmalucence, Inc.Billerica, MA 018211-800-221-7554(For International call 781-725-7120)www.pharmalucence.comPL-000012 Rev 0.1 Jun 2012Kit 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•2HO and 1.03 mg total tin, maximum (as stannous fluoride dihydrate SnF•2HO), 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. Pharmalucence, Inc.29 Dunham Rd.781-275-7120Kit Contents5 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.PreparationPreparation 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.StorageStore the kit as supplied at 20-25ºC (68-77ºF) [See USP] prior to and following reconstitution. Use within 18 hours of reconstitution.Rx onlyNDC-45567-0455-1 (5 Vial Kit)NDC-45567-0455-2 (30 Vial Kit)Manufactured By:Pharmalucence, Inc.Billerica, MA 018211-800-221-7554(For International call 781-725-7120)www.pharmalucence.comPL-000012 Rev 0.1 Jun 2012Kit 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•2HO and 1.03 mg total tin, maximum (as stannous fluoride dihydrate SnF•2HO), 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. Pharmalucence, Inc.29 Dunham Rd.781-275-7120Kit Contents5 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.PreparationPreparation 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.StorageStore the kit as supplied at 20-25ºC (68-77ºF) [See USP] prior to and following reconstitution. Use within 18 hours of reconstitution.Rx onlyNDC-45567-0455-1 (5 Vial Kit)NDC-45567-0455-2 (30 Vial Kit)Manufactured By:Pharmalucence, Inc.Billerica, MA 018211-800-221-7554(For International call 781-725-7120)www.pharmalucence.comPL-000012 Rev 0.1 Jun 2012Kit 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•2HO and 1.03 mg total tin, maximum (as stannous fluoride dihydrate SnF•2HO), 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. Pharmalucence, Inc.29 Dunham Rd.781-275-7120Kit Contents5 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.PreparationPreparation 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.StorageStore the kit as supplied at 20-25ºC (68-77ºF) [See USP] prior to and following reconstitution. Use within 18 hours of reconstitution.Rx onlyNDC-45567-0455-1 (5 Vial Kit)NDC-45567-0455-2 (30 Vial Kit)Manufactured By:Pharmalucence, Inc.Billerica, MA 018211-800-221-7554(For International call 781-725-7120)www.pharmalucence.comPL-000012 Rev 0.1 Jun 2012Kit 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•2HO and 1.03 mg total tin, maximum (as stannous fluoride dihydrate SnF•2HO), 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. Pharmalucence, Inc.29 Dunham Rd.781-275-7120Kit Contents5 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.PreparationPreparation 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.StorageStore the kit as supplied at 20-25ºC (68-77ºF) [See USP] prior to and following reconstitution. Use within 18 hours of reconstitution.Rx onlyNDC-45567-0455-1 (5 Vial Kit)NDC-45567-0455-2 (30 Vial Kit)Manufactured By:Pharmalucence, Inc.Billerica, MA 018211-800-221-7554(For International call 781-725-7120)www.pharmalucence.comPL-000012 Rev 0.1 Jun 2012
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
Mebrofenin is an iminodiacetic acid (HIDA) derivative with no known pharmacologic action at the recommended doses.
Following intravenous administration in normal subjects, Technetium Tc 99m Mebrofenin was rapidly cleared from the circulation. The mean percent injected dose remaining in the blood at 10 minutes was 17%. The injected activity was cleared through the hepatobiliary system with visualization of the liver by 5 minutes and maximum liver uptake occurring at 11 minutes post-injection. Hepatic duct and gallbladder visualization occurred by 10 to 15 minutes and intestinal activity was visualized by 30 to 60 minutes in subjects with normal hepatobiliary function. The mean percent injected dose excreted in the urine during the first 3 hours was 1% (0.4 to 2.0%).
Elevated serum bilirubin levels increase renal excretion of Tc 99m HIDA agents. In two studies in which Tc 99m Mebrofenin was administered to patients having mean elevated serum bilirubin levels of 9.8 mg/dL (1.7 to 46.3 mg/dL), the mean percent injected dose excreted in the urine during the first 3 hours was 3% (0.2 to 11.5%). The mean percent injected dose excreted in the urine during 3-24 hours was 14.9% (0.4 to 34.8%).
In jaundiced patients, the percent injected dose remaining in the blood at 10 minutes may be twice as high or more than the level in normals. Hepatobiliary transit may be delayed and visualization times increased. As a consequence, the quality of the images obtained frequently diminishes.
Non-Clinical Toxicology
Hypersensitivity to this compound.The theoretical possibility of allergic reactions should be considered in patients who receive multiple doses.
In patients receiving mercaptopurine or azathioprine, the concomitant administration of 300-600 mg of allopurinol per day will require a reduction in dose to approximately one-third to one-fourth of the usual dose of mercaptopurine or azathioprine. Subsequent adjustment of doses of mercaptopurine or azathioprine should be made on the basis of therapeutic response and the appearance of toxic effects (see ).
It has been reported that allopurinol prolongs the half-life of the anticoagulant, dicumarol. The clinical basis of this drug interaction has not been established but should be noted when allopurinol is given to patients already on dicumarol therapy.
Since the excretion of oxipurinol is similar to that of urate, uricosuric agents, which increase the excretion of urate, are also likely to increase the excretion of oxipurinol and thus lower the degree of inhibition of xanthine oxidase. The concomitant administration of uricosuric agents and allopurinol has been associated with a decrease in the excretion of oxypurines (hypoxanthine and xanthine) and an increase in urinary uric acid excretion compared with that observed with allopurinol alone. Although clinical evidence to date has not demonstrated renal precipitation of oxypurines in patients either on allopurinol alone or in combination with uricosuric agents, the possibility should be kept in mind.
The reports that the concomitant use of allopurinol and thiazide diuretics may contribute to the enhancement of allopurinol toxicity in some patients have been reviewed in an attempt to establish a cause-and-effect relationship and a mechanism of causation. Review of these case reports indicates that the patients were mainly receiving thiazide diuretics for hypertension and that tests to rule out decreased renal function secondary to hypertensive nephropathy were not often performed. In those patients in whom renal insufficiency was documented, however, the recommendation to lower the dose of allopurinol was not followed. Although a causal mechanism and a cause-and-effect relationship have not been established, current evidence suggests that renal function should be monitored in patients on thiazide diuretics and allopurinol even in the absence of renal failure, and dosage levels should be even more conservatively adjusted in those patients on such combined therapy if diminished renal function is detected.
An increase in the frequency of skin rash has been reported among patients receiving ampicillin or amoxicillin concurrently with allopurinol compared to patients who are not receiving both drugs. The cause of the reported association has not been established.
Enhanced bone marrow suppression by cyclophosphamide and other cytotoxic agents has been reported among patients with neoplastic disease, except leukemia, in the presence of allopurinol. However, in a well-controlled study of patients with lymphoma on combination therapy, allopurinol did not increase the marrow toxicity of patients treated with cyclophosphamide, doxorubicin, bleomycin, procarbazine and/or mechlorethamine.
Tolbutamide’s conversion to inactive metabolites has been shown to be catalyzed by xanthine oxidase from rat liver. The clinical significance, if any, of this observation is unknown.
Chlorpropamide’s plasma half-life may be prolonged by allopurinol, since allopurinol and chlorpropamide may compete for excretion in the renal tubule. The risk of hypoglycemia secondary to this mechanism may be increased if allopurinol and chlorpropamide are given concomitantly in the presence of renal insufficiency.
Rare reports indicate that cyclosporine levels may be increased during concomitant treatment with allopurinol. Monitoring of cyclosporine levels and possible adjustment of cyclosporine dosage should be considered when these drugs are co-administered.
Contents of the reaction vial are intended only for use in the preparation of Technetium Tc 99m Mebrofenin and are not to be administered directly to the patient.
Delayed or non-visualization of the gallbladder may occur in the immediate post-prandial period or after prolonged fasting or parenteral feeding. Functional biliary obstruction may accompany chronic cholecystitis or pancreatitis. In addition, patients with hepatocellular disease may show nonvisualization or delayed visualization of the gallbladder. Delayed intestinal transit may also be noted in such patients. Juvenile hepatitis may be associated with gallbladder nonvisualization and the failure to visualize activity in the intestine. Administration of meperidine or morphine may delay intestinal transit of the imaging agent and may result in nonvisualization. Septic patients may show absent or delayed hepatobiliary clearance. Thus, a positive finding does not of itself permit a differential diagnosis of any of the above conditions and should be evaluated in the light of the total clinical picture and results of other diagnostic modalities.
The components of the kit are supplied sterile and non-pyrogenic. Aseptic procedures normally employed in making additions and withdrawals from sterile, non-pyrogenic containers should be used during the addition of the pertechnetate solution and the withdrawal of doses for patient administration.
The Technetium Tc 99m labeling reactions involved in preparing the agent depend on maintaining the stannous ion in the reduced state. Any oxidant present in the sodium pertechnetate Tc 99m supply may, thus, adversely affect the quality of the radiopharmaceutical. Hence, sodium pertechnetate Tc 99m containing oxidants should not be employed.
Radiopharmaceuticals should be used only by physicians who are qualified by training and experience in the safe use and handling of radionuclides.
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 ensure minimum radiation exposure to occupational workers.
Tc 99m Mebrofenin should be formulated no more than 18 hours prior to clinical use.
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.
Reference
This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"
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Clonazepam Description Each single-scored tablet, for oral administration, contains 0.5 mg, 1 mg, or 2 mg Clonazepam, USP, a benzodiazepine. Each tablet also contains corn starch, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and povidone. Clonazepam tablets USP 0.5 mg contain Yellow D&C No. 10 Aluminum Lake. Clonazepam tablets USP 1 mg contain Yellow D&C No. 10 Aluminum Lake, as well as FD&C Blue No. 1 Aluminum Lake. Chemically, Clonazepam, USP is 5-(o-chlorophenyl)-1,3-dihydro-7-nitro-2H-1,4-benzodiazepin-2-one. It is a light yellow crystalline powder. It has the following structural formula: C15H10ClN3O3 M.W. 315.72Tips
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