SULFUR COLLOID - gelatin injection, powder, lyophilized, for solution 
AnazaoHealth Corporation

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

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Sulfur Colloid  Kit
(for the preparation of Tc99m-Sulfur Colloid injection)

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

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:

  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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

7c1f657a-figure-01
SULFUR COLLOID 
sulfur colloid injection, powder, lyophilized, for solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:51808-220
Route of Administration INTRAVENOUS DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
GELATIN (UNII: 2G86QN327L) (GELATIN - UNII:2G86QN327L) GELATIN 4.5 mg
Inactive Ingredients
Ingredient Name Strength
SODIUM THIOSULFATE (UNII: HX1032V43M) 6 mg
EDETATE DISODIUM (UNII: 7FLD91C86K) 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)

Revised: 7/2012
Document Id: 7c1f657a-07f0-4f9f-9552-1688174e2130
Set id: 26dde4a4-9bb1-4adc-a5f2-fb44e42e5c15
Version: 1
Effective Time: 20120701
 
AnazaoHealth Corporation