Data from FDA - Curated by EPG Health - Last updated 21 December 2016
PRECAUTIONS 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.
In addition, patients with hepatocellular disease may show non-visualization or
Juvenile hepatitis may be associated with gallbladder non-visualization and the
Septic patients may show
Aseptic procedures normally employed in making
The Technetium Tc 99m labeling reactions involved in preparing the agent depend on maintaining the stannous ion in the
Any oxidant present in the sodium pertechnetate Tc 99m supply may, thus,
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
As in the use of any radioactive material,
Tc 99m Mebrofenin should be formulated
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
Technetium Tc 99m Mebrofenin should be given to a pregnant woman only if the expected
Nursing Mothers Technetium Tc 99m is excreted in human milk during lactation.
Therefore, formula feedings should be substituted for breast feedings.
DOSAGE AND ADMINISTRATION The suggested intravenous dose range of Technetium Tc 99m Mebrofenin in the
The patient should be in a fasting state,
An interval of at least 24 hours should be allowed before repeat examination.
Parenteral drug products should be inspected visually for particulate matter and
|Date Last Revised||17-05-2015|
|Type||HUMAN PRESCRIPTION DRUG|
|Storage and handling||
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.
|Marketing authorisation holder||Bracco Diagnostics Inc|