FDA Label for Bicisate
View Indications, Usage & Precautions
Bicisate Product Label
The following document was submitted to the FDA by the labeler of this product Anazaohealth Corporation. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
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
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
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.
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:
- 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 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.
- 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.
- 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
- Swirl the contents of the buffer vial for a few seconds and allow this mixture to stand for 30 minutes at room temperature.
- 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
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