Label: SULFUR COLLOID - gelatin injection, powder, lyophilized, for solution

  • NDC Code(s): 51808-220-01
  • Packager: AnazaoHealth Corporation
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

Drug Label Information

Updated 07/12

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  • DESCRIPTION

    Dear Medical Professional,

    AnazaoHealth Sulfur Colloid Kit consists of three separate nonradioactive components:

    1. 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
    2. Vial A, a 5 ml. vial containing:0.25 N. Hydrochloric Acid. The total volume in this vial is 1.2 mL.
    3. 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
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  • 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.

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  • INSTRUCTIONS

    Preparation of Technetium Tc 99m-Sulfur Colloid:

    1. Collect components: 10 ml. Reaction Vial, Solution A, Solution B, Lead Pig, Boiling Water Bath.
    2. Draw up 1 ml. Solution A. (HCl solution) in syringe.
    3. Draw up 2.5 ml. Tc-99m Pertechnetate containing desired activity, dilute with sterile normal saline if necessary.
    4. Add the 2.5 ml Tc-99m Pertechnetate to the shielded reaction vial.
    5. Immediately add the 1 ml. Solution A.
    6. Vent vial to release excess vacuum. Remove vent before boiling.
    7. Shake gently to mix.
    8. Place shielded vial in boiling water bath for 5 minutes for liver imaging and 3 minutes for lymphoscintigraphy imaging use.
    9. Remove from boiling water and let cool for a few minutes.
    10. Draw up 1 ml. Solution B. (Phosphate Buffer) while reaction vial is cooling
    11. 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
    12. Quality control: ITLC-SG in normal saline. Greater than 95% should stay at the origin
    13. Tc 99m  Sulfur Colloid expires 6 hours after mixing
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  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
  • INGREDIENTS AND APPEARANCE
    SULFUR COLLOID 
    sulfur colloid injection, powder, lyophilized, for solution
    Product Information
    Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:51808-220
    Route of Administration INTRAVENOUS DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    GELATIN (GELATIN) GELATIN 4.5 mg
    Inactive Ingredients
    Ingredient Name Strength
    SODIUM THIOSULFATE 6 mg
    EDETATE DISODIUM 2.3 mg
    Product Characteristics
    Color      Score score with uneven pieces
    Shape Size
    Flavor Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:51808-220-01 1 in 1 KIT
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    Unapproved drug other 07/01/2012
    Labeler - AnazaoHealth Corporation (011038762)
    Registrant - AnazaoHealth Corporation (011038762)
    Establishment
    Name Address ID/FEI Business Operations
    AnazaoHealth Corporation 011038762 MANUFACTURE(51808-220)
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