Label: SESTAMIBI injection, powder, lyophilized, for solution
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Contains inactivated NDC Code(s)
NDC Code(s): 51808-208-01 - Packager: AnazaoHealth Corporation
- Category: HUMAN PRESCRIPTION DRUG LABEL
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.
Drug Label Information
Updated May 23, 2012
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- Official Label (Printer Friendly)
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DESCRIPTION
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.
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CLINICAL PHARMACOLOGY
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.
- INDICATIONS AND USAGE
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PREPARATION
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.
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5. Do not allow water to come in contact with aluminum crimp.
- Remove vial from water bath place in lead shield and allow to cool for 15 minutes
- Behind appropriate shielding visually inspect the contents of the vial. Contents should be clear and free of particulate matter.
- pH of the final reconstituted product is 5.5 to 6.0.
- This vial contains no preservatives - contents should be used within 6 hours.
- Store shielded vial at 15-25 degrees Celsius until use and withdraw dose aseptically.
Instructions for the determination of radiochemical purity in Tc99m Sestamibi
- Dry a pre-cut 2.5cm X 7.5cm Baker-Flex Aluminum Oxide coated, plastic TLC #1 B-F Plate
at 100 degrees Celsius for 1 hour and store in a desiccator. Remove strip just prior to use.
- Apply one drop of Ethanol using a 1ml syringe with a 22-26guage needle 1.5cm from the bottom of the plate. Do not allow to dry.
- Put two drops of Tc99m Sestamibi side by side on top to the Ethanol then return plate to desiccator and allow to dry (typically 15 minutes).
- Prepare the TLC take by pouring Ethanol to a depth of 3-4 cm then cover the tank and let equilibrate for 10 minutes.
- Develop the plate in the covered TLC tank, in Ethanol, for a distance of 5cm from the point of application.
- Cut the TLC plate 4cm from the bottom and measure the Tc99m activity in each piece with appropriate radiation detector.
- Calculate the % Tc99m Sestamibi as:
Activity top piece (front)/ Activity both pieces (origin + front) x 100
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- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
SESTAMIBI
sestamibi injection, powder, lyophilized, for solutionProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:51808-208 Route of Administration INTRAVENOUS Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TETRAKIS(2-METHOXYISOBUTYLISOCYANIDE)COPPER(I) TETRAFLUOROBORATE (UNII: N6OU7HJ70P) (TETRAKIS(2-METHOXYISOBUTYLISOCYANIDE)COPPER(I) TETRAFLUOROBORATE - UNII:N6OU7HJ70P) TETRAKIS(2-METHOXYISOBUTYLISOCYANIDE)COPPER(I) TETRAFLUOROBORATE 1.5 mg Inactive Ingredients Ingredient Name Strength TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K) 3.9 mg CYSTEINE HYDROCHLORIDE (UNII: ZT934N0X4W) 1.5 mg MANNITOL (UNII: 3OWL53L36A) 30 mg STANNOUS CHLORIDE (UNII: 1BQV3749L5) 0.112 mg Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:51808-208-01 1 in 1 KIT Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date Unapproved drug other 05/23/2012 Labeler - AnazaoHealth Corporation (011038762) Establishment Name Address ID/FEI Business Operations AnazaoHealth Corporation 011038762 MANUFACTURE(51808-208)