Bicisate
FDA Label NDC 51808-217

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Anazaohealth Corporation for the product Bicisate (NDC 51808-217). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding description, clinical pharmacology, indications and usage, half-life, contraindications, dosage and administration, preparation, storage and handling, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

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

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