EXAMETAZIME HMPAO- exametazime injection, powder, lyophilized, for solution
Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.
Dear Medical Professional,
Per your order, we have compounded Exametazime as a sterile, freeze-dried preparation in a 10 mL vial. The characteristics of this preparation are described below
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
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
INDICATIONS AND USAGE
Exametazime is a diagnostic agent used as an adjunct in the detection of altered cerebral perfusion in stroke patients and is also indicated for white blood cell labeling as an adjunct in the localization of abdominal infections and inflammatory bowel disease
The physical half-life of technetium, Tc99m, is 6 hours and has a principal radiation emission of gamma photons with a mean energy of 140 KeV.
There are no known contraindications for this preparation.
The recommended dose range for IV administration is 10 to 20 mCi (370 to 740 MBq).
Leukocyte (WBC) Labeling
The recommended dose range for IV administration is 7 to 25 mCi (259 to 925 MBq)
For best results, use tc99m from a generator eluted within 24 hours. The eluate should be used within 2 hours of elution.
- Snap off the plastic lid and place in appropriate lead shielding. Wipe the septum with 70% isopropyl alcohol and allow it to dry
- Using a 10 mL syringe, draw up 15-80 mCi of tc99m. Dilute this to 7.5 mL with sterile preservative free saline and inject into the vial, being sure to withdraw an equal amount of gas from the vial to neutralize pressure.
- Rock and invert the shielded vial for 10 seconds. Wait 2 minutes before adding stabilizer to allow for tagging.
- Add stabilizer to extend the length of time before use
- If no stabilizer is added, use the vial within 30 minutes.
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
The preparation is recommended to be stored in the refrigerator at 2- 8(C (36 — 46(F)
exametazime injection, powder, lyophilized, for solution
|Labeler — AnazaoHealth Corporation (011038762)|
|AnazaoHealth Corporation||011038762||MANUFACTURE (51808-214)|
Revised: 07/2012 AnazaoHealth Corporation
All MedLibrary.org resources are included in as near-original form as possible, meaning that the information from the original provider has been rendered here with only typographical or stylistic modifications and not with any substantive alterations of content, meaning or intent.