Data from FDA - Curated by EPG Health - Last updated 20 December 2016
PRECAUTIONS As with any injected product,
However, the materials used in leukocyte cell separation may cause hypersensitivity reactions.
It is essential that
In case of side effects following administration of radiopharmaceuticals, users should ensure the availability of
Results can be affected by the presence of tumor, infarction, peritonitis, non-gastrointestinal or bony sites of
The contents of the Ceretec vial are not radioactive.
After the sodium pertechnetate Tc99 m is added, the product is radioactive and
The contents of the Ceretec vial are intended only for use in preparation of technetium Tc99 m exametazime injection and are NOT to be administered directly to the patient.
The vial contains
It is essential that the user follow
Radiopharmaceuticals should be used only by or under the control of physicians who are qualified by training and experience in the
To minimize radiation dose to the bladder,
When evaluated in the Ames test,
Exametazime did not cause chromosomal
Pregnancy Category C Animal reproduction studies have not been conducted with Tc99 m exametazime.
It is also not known whether Tc99 m exametazime can cause fetal
Therefore, Tc99 m exametazime should not be administered to a pregnant woman unless the potential
Nursing Mothers Technetium Tc99 m is excreted in human milk during lactation.
It is not known whether exametazime is excreted in human milk.
Therefore, formula feedings should be substituted for breast feeding for 60 hours.
Geriatric Use Clinical studies of Ceretec™ did not include
Other reported clinical experience has not identified differences in responses between the elderly and younger patients.
Because elderly patients are more likely to have
DOSAGE AND ADMINISTRATION Tc99 m labeled leukocytes for adjunctive localization of intra-abdominal
The normal adult (70 kg) dose is 0.259-0.925 GBq (7-25 mCi) as Tc99 m labeled leukocytes by intravenous injection.
Cerebral Scintigraphy The
Static imaging may be performed from 15
|Agency product number||3B744AG22N|
|Date Last Revised||23-08-2013|
|Type||HUMAN PRESCRIPTION DRUG|
|Marketing authorisation holder||Medi-Physics Inc. dba GE Healthcare.|