Label: ACD SOLUTION MODIFIED - acd solution modified solution
- NDC Code(s): 51808-201-01
- Packager: AnazaoHealth Corporation
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved drug other
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Updated May 23, 2012
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- SPL UNCLASSIFIED SECTION
Per your order, we have compounded ACD Solution Modified as a solution of 10 mL in a 100 mL vial. The characteristics of this compounded preparation are as followsClose
Each 100 mL vial contains 80 mg citric acid, 224 mg sodium citrate anhydrous, and 120 mg dextrose anhydrous in a sterile, non-pyrogenic solution of 10 mL. The pH of the solution has been adjusted to be between 4.5 to 5.5Close
- CLINICAL PHARMACOLOGY
In vitro, citrate ions combine with ionic calcium in the blood and the resulting
lack of ionic calcium prevents coagulation. Blood that has been treated with citrate anticoagulants is nontoxic to the body when injected in small amounts intravenously. After injection, citrate ions are rapidly removed from the blood by the liver, polymerized into glucose, and then metabolized in the usual mannerClose
- INDICATIONS AND USAGE
ACD solution modified is to be used in the labeling of red blood cells for intravenous administration with Cr-51 Sodium Chromate.Close
There are no known contraindications.Close
- DOSAGE AND ADMINISTRATION
Red Blood Cell Labeling Procedure
- Labeling may be performed without washing or centrifugation steps directly in the reaction vial.
- A 30 to 50 mL sample of whole blood is withdrawn from the patient and added aseptically to a vial of ACD Solution Modified.
- 50 to 150 microcuries of Sodium Chromate 51 is then injected into the reaction vial using a shielded syringe. The amount of radioactivity added to the vial will
depend on the intended use of the labeled red blood cells.
- The suspension is incubated for 30 to 60 minutes at room temperature with frequent, gentle agitation.
- After incubation, 100 mg Ascorbic Acid Injection is injected into the vial. The ascorbic acid reduces any remaining unbound dianionic chromium 51 to the anionic state which does not penetrate red blood cells; thus in vivo labeling of red blood cells is prevented.
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
- INGREDIENTS AND APPEARANCE
ACD SOLUTION MODIFIED
acd solution modified solution
Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:51808-201 Route of Administration INTRAVENOUS Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) (ANHYDROUS CITRIC ACID - UNII:XF417D3PSL) ANHYDROUS CITRIC ACID 8 mg in 1 mL Inactive Ingredients Ingredient Name Strength ANHYDROUS TRISODIUM CITRATE (UNII: RS7A450LGA) 22.4 mg in 1 mL ANHYDROUS DEXTROSE (UNII: 5SL0G7R0OK) 12 mg in 1 mL Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:51808-201-01 10 mL in 1 VIAL Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date Unapproved drug other 05/23/2012 Labeler - AnazaoHealth Corporation (011038762) Establishment Name Address ID/FEI Business Operations AnazaoHealth Corporation 011038762 MANUFACTURE