Pharmalucence Generic Mebrofenin

Kit for the Preparation of Technetium Tc99m Mebrofenin

Product Information and Features

  • Each vial contains 45 mg of mebrofenin
  • Room temperature storage both before and after reconstitution
  • Available in either 5 vial kits (MEB05) and 30 vial convenience packs (MEB30)

Indications and Usage

Technetium Tc 99m Mebrofenin is indicated as a Hepatobiliary Imaging.

IMPORTANT SAFETY INFORMATION

WARNINGS AND GENERAL PRECAUTIONS

The theoretical possibility of allergic reactions should be considered in patients who receive multiple doses.

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.

ADVERSE REACTIONS

Urticaria and rash have been rarely reported with the use of Technetium Tc 99m Mebrofenin since market introduction. Rare cases of chills and nausea have been reported with related compounds. Infrequently, death has been reported in association with the use of this class of agents.

Please See Full Prescribing Information Above

The above information provided in this page is intended for use by professional licensed health care provider only. This information is not intended for Medical advice. Please refer to Package Insert for full Prescribing Information including the adverse reactions with the use. Technetium Tc 99m Mebrofenin Injection as well as other radioactive drugs must be handled with care, and appropriate safety measures should be used to minimize radiation exposure to the patients and clinical personnel consistent with proper patient management.