Technetium Tc 99m Mebrofenin is indicated as a hepatobiliary imaging agent.
DOSAGE AND ADMINISTRATION
The suggested intravenous dose range of Technetium Tc 99m Mebrofenin in the average patient (70 kg) is:
|Nonjaundiced patient:||74-185 MBq (2-5 mCi)|
|Patient with serum bilirubin level greater than 1.5 mg/dL:||111-370 MBq (3-10 mCi)|
The patient dose should be measured by a suitable radioactivity calibration system immediately prior to administration.
The patient should be in a fasting state, 4 hours is preferable. False positives (non-visualization) may result if the gallbladder has been emptied by ingestion of food.
An interval of at least 24 hours should be allowed before repeat examination.
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit.
The estimated absorbed radiation doses1,2 to organs and tissues of an average subject (70 kg) from an intravenous injection of 370 MBq (10 millicuries) of Technetium Tc 99m Mebrofenin are shown in Table 4.
|Tissue||Estimated Absorbed Radiation Doses†|
|†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.
Choletec (Kit for the Preparation of Technetium Tc 99m Mebrofenin) is supplied in kits of 10 reaction vials. Each vial contains a sterile, nonpyrogenic lyophilized mixture of 45 mg mebrofenin, 0.54 mg (minimum) stannous fluoride dihydrate, SnF2 •2H2 O and 1.03 mg total tin, maximum (as stannous fluoride dihydrate, SnF2 •2H2O), 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.
10 sterile multidose reaction vials.
20 pressure-sensitive labels for Technetium Tc 99m Mebrofenin.
1 package insert.
Preparation of Technetium Tc 99m Mebrofenin is done by the following aseptic procedure:
- Waterproof gloves should be worn during the preparation procedure.
- Place reaction vial in an appropriate lead shield.
- Swab 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.
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.
Manufactured for: Bracco Diagnostics Inc., Monroe Township, NJ 08831. By : Jubilant HollisterStier LLC, Spokane, WA 99207 USA. Revised : Apr 2018