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  5. Label Information: Sulfur Colloid

FDA Label for Sulfur Colloid

View Indications, Usage & Precautions

Table of Contents

    1. DESCRIPTION
    2. INDICATIONS AND USAGE
    3. INSTRUCTIONS

Sulfur Colloid 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



Dear Medical Professional,

AnazaoHealth Sulfur Colloid Kit consists of three separate nonradioactive components:

  • A 10 milliliter reaction vial containing: Sodium Thiosulfate, 4.8 mg, Gelatin (Porcine), 3.6 mg and Sodium Edetate, 2.3 mg. The contents of the vial are lyophilized and are under vacuum
  • Vial A, a 5 ml. vial containing:0.25 N. Hydrochloric Acid. The total volume in this vial is 1.2 mL.
  • Vial B, a 5 ml. vial containing:Sodium Hydroxide, 12 mg, Sodium Phosphate dibasic,15.7 mg, Sodium Phosphate, monobasic, 48.4 mg, Sterile Water for Injection. The total volume in this vial is 1.2 mL

Indications And Usage



Tc99m Sulfur Colloid is used in lymphoscintigraphy studies in breast cancer patients, for liver, spleen and bone marrow imaging and gastric transit studies and gastroesophageal reflux.


Instructions



Preparation of Technetium Tc 99m-Sulfur Colloid:

  • Collect components: 10 ml. Reaction Vial, Solution A, Solution B, Lead Pig, Boiling Water Bath.
  • Draw up 1 ml. Solution A. (HCl solution) in syringe.
  • Draw up 2.5 ml. Tc-99m Pertechnetate containing desired activity, dilute with sterile normal saline if necessary.
  • Add the 2.5 ml Tc-99m Pertechnetate to the shielded reaction vial.
  • Immediately add the 1 ml. Solution A.
  • Vent vial to release excess vacuum. Remove vent before boiling.
  • Shake gently to mix.
  • Place shielded vial in boiling water bath for 5 minutes for liver imaging and 3 minutes for lymphoscintigraphy imaging use.
  • Remove from boiling water and let cool for a few minutes.
  • Draw up 1 ml. Solution B. (Phosphate Buffer) while reaction vial is cooling
  • After cooling Reaction vial, add the 1 ml Solution B and shake gently to mix. Caution: be sure vial is cool to avoid excess pressure
  • Quality control: ITLC-SG in normal saline. Greater than 95% should stay at the origin
  • Tc 99m  Sulfur Colloid expires 6 hours after mixing

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