Bicisate Injection

Name: Bicisate Injection

Indications and Usage for Bicisate Injection

Tc99m bicisate is indicated as an adjunct to conventional CT or MRI imaging in the localization of stroke in patients in whom stroke has already been diagnosed

Contraindications

There are no known contraindications for this preparation.

Preparation

For best results, use tc99m from a generator eluted within 24 hours.  The eluate should be used within 2 hours of elution.

  Reconstitution Instructions:

  1. Snap off the plastic lid and place in appropriate lead shielding. Wipe the septum with 70% isopropyl alcohol and allow it to dry.
  2. Using a 10 mL syringe, draw up 100 mCi of tc99m (in approximately 2 mL) and inject into the ECD Buffer, being sure to withdraw an equal amount of gas from the vial to neutralize pressure.
  3. With a sterile syringe, inject 3 mL of 0.9% sodium chloride into the reaction vial to dissolve the contents. Remove an equal volume of air to maintain pressure within the vial. Shake the contents of the vial for a few seconds.
  4. With another sterile syringe, immediately (within 30 seconds) withdraw  1 mL out of the reaction vial and inject it into the buffer vial. Discard the reaction vial
  5. Swirl the contents of the buffer vial for a few seconds and allow this mixture to stand for 30 minutes at room temperature.
  6. Examine the vial contents for particulates and discoloration prior to patient administration. It should be clear of any particulates.

It is recommended that the kit be stored refrigerated until use; at such time the product should be aseptically withdrawn

Storage and Handling

This kit should be stored in the refrigerator prior to reconstitution and the reaction vial protected from light.

Package label.principal display panel

Figure 1

BICISATE 
Bicisate Injection, powder, lyophilized, for solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:51808-217
Route of Administration INTRAVENOUS DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BICISATE (BICISATE) BICISATE 1.35 mg
Inactive Ingredients
Ingredient Name Strength
EDETATE DISODIUM 0.54 mg
MANNITOL 36 mg
STANNOUS CHLORIDE 0.125 mg
Packaging
# Item Code Package Description
1 NDC:51808-217-01 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION (VIAL) 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 Operations
AnazaoHealth Corporation 011038762 MANUFACTURE(51808-217)
Revised: 05/2012   AnazaoHealth Corporation
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