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  5. Label Information: Glucoheptonate

FDA Label for Glucoheptonate

View Indications, Usage & Precautions

Table of Contents

    1. DESCRIPTION
    2. CLINICAL PHARMACOLOGY
    3. INDICATIONS AND USAGE
    4. PREPARATION
    5. STORAGE AND HANDLING
    6. PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Glucoheptonate 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 compounded Glucoheptonate for the preparation of Tc 99m Glucoheptonate. Each vial contains 50 mg calcium glucoheptonate and 0.6 mg tin metal as stannous chloride. The vial is back filled with inert gas and may contain a partial vacuum.


Clinical Pharmacology



When injected intravenously, Technetium Tc 99m Glucoheptonate is rapidly cleared from the blood. In patients with normal renal function, less than 15% of the initial activity remains in the blood after one hour. About 40% of the injected dose is excreted in the urine in one hour, while about 70% is excreted in 24 hours. In patients with renal disease, the blood clearance and urinary excretion of the radiopharmaceutical are delayed.

Up to 15% of the injected dose is retained in the kidneys. The renal retention is greater in the cortex than in the medulla. The radiopharmaceutical may be bound to the proximal convoluted tubules, which are located primarily in the renal cortex.

Technetium Tc 99m Glucoheptonate tends to accumulate in intracranial lesions that are associated with excessive neovascularity or an altered blood-brain barrier. The drug does not accumulate in the choroid plexus or salivary glands.


Indications And Usage



Tc 99m Glucoheptonate may be used to image the kidney and brain and to assess renal and brain perfusion.


Preparation



Preparation of Technetium Tc 99m Glucoheptonate is done by the following aseptic procedure:

  • Waterproof gloves should be worn during the preparation procedure.
  • Snap off the plastic lid and place room temperature reaction vial in an appropriate lead shield.
  • Swab the rubber closure of the vial with a germicide.
  • Inject 1 - 5 ml sterile, additive free sodium pertechnetate Tc 99m injection containing up to 5,920 MBq (160 mCi) into the vial. Be sure to maintain inert atmosphere in vial by introducing as little air as possible during reconstitution. NOTE: If sodium pertechnetate Tc 99m injection must be diluted, use only preservative free Sodium Chloride Injection USP.
  • Secure the lead shield cover. Swirl the vial gently to mix contents and let stand 3 to 5 minutes prior to use.
  • Record the date and time of preparation on a pressure-sensitive label.
  • Affix pressure-sensitive label to shield.
  • Examine vial contents; if the solution is not clear and free of particulate matter and/or discoloration on visual inspection, it should not be used.
  • Measure the radioactivity by suitable calibration system and record prior to patient administration.
  • Appropriate quality control is recommended.
  • Injection should be administered within 12 hours of preparation.

Storage And Handling



  • This preparation should be stored at room temperature before and after reconstitution.


Package Label.Principal Display Panel



Figure 1

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