SESTAMIBI - sestamibi injection, powder, lyophilized, for solution
AnazaoHealth Corporation
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.
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Dear Medical Professional,
Per your order, we have compounded Sestamibi as a sterile, freeze-dried preparation in a 10 mL vial. The characteristics of this preparation are described below.
AnazaoHealth’s compounded Sestamibi vial is a sterile, non-pyrogenic preparation that consists of a lyophilized mixture of 1.5mg of Copper (1) tetrafluoroborate, 3.9 mg of Sodium Citrate Dihydrate, 1.5 mg of L-Cysteine HCL Monohydrate, 30 mg Mannitol and 0.112 mg of Tin Chloride. It is maintained under an inert nitrogen atmosphere. Prior to lyophilization the pH is 5.3 to 5.9. The pH of the final reconstituted product is 5.5 to 6.0. It contains no antimicrobrial preservative.
When Sestamibi is reconstituted with Tc99m pertechnetate, a complex of Tc99m Sestamibi is formed and is the active ingredient of the reconstituted product. When administered intravenously, Tc99m Sestamibi shows rapid myocardial uptake and its distribution follows a linear relationship with coronary blood flow.
Tc99m Sestamibi is a lipophilic agent that is taken up by the mitochondria of myocardial cells by passive diffusion and appears to accumulate in viable myocardial tissue.
Sestamibi is a diagnostic agent used to assess areas of reversible myocardial ischemia in the presence or absence of infracted myocardium. Evaluation of myocardial ischemia can be accomplished with rest and cardiovascular stress techniques.
Instructions for the preparation of Tc99m Sestamibi
1. Inspect vial to ensure there are no cracks in the glass.
2. Reconstitute with 1- 3ml of non-pyrogenic, oxidant free Sodium Pertechnetate Tc99m injection.
3. Remove equal amount of inert gas from vial and shake vigorously 10 times.
4. Place vial in a boiling water bath for 10 minutes beginning when the bath begins boiling again.
5. Do not allow water to come in contact with aluminum crimp.
Instructions for the determination of radiochemical purity in Tc99m Sestamibi
at 100 degrees Celsius for 1 hour and store in a desiccator. Remove strip just prior to use.
SESTAMIBI
sestamibi 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(51808-208) |