SULFUR COLLOID injection, powder, lyophilized, for solution

Sulfur Colloid by

Drug Labeling and Warnings

Sulfur Colloid by is a Prescription medication manufactured, distributed, or labeled by AnazaoHealth Corporation. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

INGREDIENTS AND APPEARANCE

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

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)