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Bicisate Injection

Dosage Form: 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.

Bicisate (ECD)
(for the preparation of Tc99m Bicisate Injection)

Dear Medical Professional,

Per your order, we have compounded ECD as a sterile freeze-dried preparation. The characteristics of this preparation are:

Bicisate Injection Description

AnazaoHealth supplies ECD as a compounded kit for preparing Tc99m ECD. Each Reaction vial contains 1.35 mg of ECD, 0.54 edetate disodium, 36mg mannitol and 0.125 mg stannous chloride dehydrate. The vial is back filled with inert gas and may contain a partial vacuum.

Each ECD buffer vial contains a total volume of 1 mL that includes 6.15 mg sodium phosphate dibasic  and 0.69 mg sodium phosphate monobasic

Bicisate Injection - Clinical Pharmacology

Tc99m Bicisate forms a stable, lipophilic complex that crosses intact cell membranes and blood brain barrier by passive diffusion. The amount of tc99m bicisate is stable in the brain until about 6 hours

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

HALF-LIFE

The physical half-life for Technetium is 6.02 hours

Contraindications

There are no known contraindications for this preparation.

Bicisate Injection Dosage and Administration

The recommended dose  for a 70 kg patient is 10-30 mCi

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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