bove 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 nonpyrogenic. aseptic procedures normally employed in making additions and withdrawals from sterile, nonpyrogenic 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.

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.

b the rubber closure of the reaction vial with a germicide. 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 choletec (kit for the preparation of technetium tc 99m mebrofenin), only preservative free sodium chloride injection usp should be used. secure the lead shield cover. swirl the vial gently to mix contents and let stand for 15 minutes. record the date and time of preparation on pressure-sensitive label. affix pressure-sensitive label to shield. examine vial contents. if the solution is not clear and free of particulate matter and discoloration on visual inspection, it should not be used. measure the radioactivity by a suitable calibration system and record on the shield label prior to patient administration. withdraw material with a sterile lead shielded syringe for use within 18 hours of preparation. storage store the kit as supplied at 20-25°c (68-77°f) [see usp] prior to and following reconstitution. use within 18 hours of reconstitution. the u.s. nuclear regulatory commission has approved this reagent kit for distribution to persons licensed to use byproduct material identified in §35.200 of 10 cfr part 35, to persons who hold an equivalent license issued by an agreement state, and, outside the united states, to persons authorized by the appropriate authority.