Label: SULFUR COLLOID injection, powder, lyophilized, for solution
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Contains inactivated NDC Code(s)
NDC Code(s): 51808-220-01 - Packager: AnazaoHealth Corporation
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved drug other
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Drug Label Information
Updated July 1, 2012
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- Official Label (Printer Friendly)
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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
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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
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
SULFUR COLLOID
sulfur colloid injection, powder, lyophilized, for solutionProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:51808-220 Route of Administration INTRAVENOUS 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)
