Exametazime by is a Prescription medication manufactured, distributed, or labeled by AnazaoHealth Corporation. Drug facts, warnings, and ingredients follow.
AnazaoHealth’s compounded Exametazime vial is a sterile, non-pyrogenic preparation that consists of a lyophilized mixture of 1 mg of Exametazime, 6.75 mg of Sodium Chloride, 11.4 µg of Stannous Chloride Dihydrate and is maintained under an inert nitrogen atmosphere. The kit also contains a vial of Cobalt Chloride, which contains 0.3 mg of cobalt chloride hexahydrate, or Methylene Blue 1% (methylene blue 10 mg/mL) and Phosphate Buffer (monobasic sodium phosphate, sodium chloride, dibasic sodium phosphate This kit contains no antimicrobial preservative
Cerebral Scintigraphy
When Exametazime is reconstituted with Tc99m pertechnetate, a lipophilic complex of Tc99m Exametazime is formed and is the active ingredient of the reconstituted product. The lipophilic complex crosses the blood-brain barrier. It converts to the less lipophilic complex 12% per hour. The preparation is good for 30 minutes without the use of a stabilizer. The in vitro addition of cobalt chloride helps to stabilize the complex for 6 hours.
Leukocyte (WBC) Labeling
The lipophilic complex of Tc99m Exametazime is taken up by leukocytes and selectively retained by neutrophils. Cobalt chloride, as a stabilizer, may be used with this procedure as well
For best results, use tc99m from a generator eluted within 24 hours. The eluate should be used within 2 hours of elution.
Reconstitution Instructions:
Stabilizer Use:
Cobalt Chloride as a stabilizer: Wait 2 minutes after adding tc99m. Then add 3 mL of Cobalt Chloride to tc99m HMPAO. Solution is clear but slightly tan, which is normal. Swirl contents to mix and inspect solution for particulates. Draw 0.1 mL for a quality control sample. Solution is stable for 6 hours. This stabilizer can be used in WBC labeling
Methylene blue and Phosphate buffer as a stabilizer: Add 0.5 mL of 1% methylene blue to 4.5 mL of phosphate buffer solution. Swirl contents to mix then draw 3 mL and add to HMPAO within 2 minutes of mixing tc99m. Filter the final solution using a 0.22µm filter into an empty sterile vial. Draw 0.1 mL sample for quality control. Radiochemical purity must be 80% or higher. Solution is stable for 4 hours. This stabilizer is not recommended for use in WBC labeling
EXAMETAZIME
HMPAO
exametazime injection, powder, lyophilized, for solution |
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Labeler - AnazaoHealth Corporation (011038762) |
Establishment | |||
Name | Address | ID/FEI | Business Operations |
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AnazaoHealth Corporation | 011038762 | MANUFACTURE(51808-214) |