Sulfur Colloid
FDA Label NDC 51808-220

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 Sulfur Colloid (NDC 51808-220). 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, indications and usage, instructions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

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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