SULFUR COLLOID — gelatin injection, powder, lyophilized, for solution
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.
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.
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
| 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 (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 || |
|# ||Item Code ||Package Description ||Multilevel Packaging |
| 1 ||NDC:51808-220-01 ||1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION (VIAL) in 1 KIT ||None |
| Marketing Information |
|Marketing Category ||Application Number or Monograph Citation ||Marketing Start Date ||Marketing End Date |
|Unapproved drug other || ||07/01/2012 || |
|Labeler — AnazaoHealth Corporation
|Registrant — AnazaoHealth Corporation (011038762) |
| Establishment |
|Name ||Address ||ID/FEI ||Operations |
|AnazaoHealth Corporation || ||011038762 ||MANUFACTURE (51808-220) |
Revised: 07/2012 AnazaoHealth Corporation
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