Anticoagulant Citrate Dextrose (ACD-A) by is a Prescription medication manufactured, distributed, or labeled by Terumo BCT, Ltd, Terumo BCT, Inc.. Drug facts, warnings, and ingredients follow.
ANTICOAGULANT CITRATE DEXTROSE SOLUTION USP (ACD) SOLUTION A is an anticoagulant intended for use only with devices that prepare Platelet Rich Plasma (PRP) products for extracorporeal use. See the device operator's manual for additional information and complete usage instructions. (1)
Citrate reactions or toxicity may occur with the injection of blood products containing citrate anticoagulant. The recipient of the blood product containing citrate should be monitored for the signs and symptoms of citrate toxicity. (6)
To report SUSPECTED ADVERSE REACTIONS, contact Terumo BCT, Inc. at 1-877-339-4228 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
ANTICOAGULANT CITRATE DEXTROSE SOLUTION USP (ACD) SOLUTION A has not been studied in controlled clinical trials with specific populations. (7)
Revised: 7/2023
ANTICOAGULANT CITRATE DEXTROSE SOLUTION USP (ACD) SOLUTION A is an anticoagulant intended for use only with devices that prepare Platelet Rich Plasma (PRP) products for extracorporeal use. [See Dosage and Administration (2).]
ANTICOAGULANT CITRATE DEXTROSE SOLUTION USP (ACD) SOLUTION A is added to blood products collected for extracorporeal processing. The solution is manually added to collected blood products to facilitate extracorporeal processing. The amount of solution added is specified by the manufacturer of the processing set. It is not intended for direct intravenous infusion.
For instructions on the use of the solution with the processing set, see the device operator's manual.
Directions for drawing the ANTICOAGULANT CITRATE DEXTROSE SOLUTION USP (ACD) SOLUTION A from the solution bag.
When directed by the processing set instructions and device operator's manual:
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and solution bag permit.
Citrate reactions or toxicity may occur with the injection of blood products containing citrate anticoagulant. The recipient of the blood product containing citrate should be monitored for the signs and symptoms of citrate toxicity. The signs and symptoms of citrate toxicity begin with paresthesia, a "tingling" sensation around the mouth or in the extremities, followed by severe reactions that are characterized by hypotension and possible cardiac arrhythmia. Citrate toxicity may occur more frequently in patients who are hypothermic, have impaired liver or renal function, or have low calcium levels because of an underlying disease.
ANTICOAGULANT CITRATE DEXTROSE SOLUTION USP (ACD) SOLUTION A is designed to be added to blood products collected for extracorporeal processing, to prevent platelet activation and coagulation as blood moves throughout the extracorporeal processing set.
The content of the solution bag is considered sterile. This product has a sterile fluid path only. The clear overwrap is not considered a sterile barrier. The solution is non-pyrogenic, and it contains no bacteriostatic or antimicrobial agents.
The formulas of the active ingredients are provided in Table 1.
Ingredients | Molecular Formula | Molecular Weight |
---|---|---|
(%w/v) Citric Acid, Monohydrate | C6H8O7 | 192.12 |
Dextrose Monohydrate | C6H12O6 ∙ H2O | 198.17 |
Sodium Citrate Dihydrate | C6H9Na3O9 | 294.10 |
Water for Injection | H2O | 18.00 |
Each 100 mL of ANTICOAGULANT CITRATE DEXTROSE SOLUTION USP (ACD) SOLUTION A contains: (%w/v) Citric Acid, Monohydrate 0.8 g; Dextrose Monohydrate 2.45 g; Sodium Citrate Dihydrate 2.2 g; and Water for Injection.
The solution bag is not made with natural rubber latex or PVC.
The solution bag is made from a polyolefin film. It contains materials that have been tested to demonstrate the suitability of the solution bag for storing pharmaceutical solutions. The solution contact layer is a polyolefin. The solution bag is nontoxic and biologically inert. The solution bag is a closed system and is not dependent upon entry of external air during administration. The solution bag is covered with a clear overwrap to provide protection from the physical environment. The content of the solution bag is considered sterile. This product has a sterile fluid path only. The clear overwrap is not considered a sterile barrier.
ANTICOAGULANT CITRATE DEXTROSE SOLUTION USP (ACD) SOLUTION A acts as an extracorporeal anticoagulant by binding the free calcium in the blood. Calcium is a necessary co-factor to several steps in the clotting cascade. The following ingredients are key components of the solution:
This solution has no pharmacological effect.
ANTICOAGULANT CITRATE DEXTROSE SOLUTION USP (ACD) SOLUTION A is a clear sterile solution supplied in non-pyrogenic polyolefin solution bags. Each solution bag is individually wrapped in a clear overwrap. Each clear overwrap is then individually foil wrapped. Neither the clear overwrap nor the foil overwrap can be considered a sterile barrier. This product has a sterile fluid pathway only.
SIZE | CATALOG NUMBER | NDC NUMBER | |
---|---|---|---|
50 mL | 40820 | Case: | 14537-820-03 |
Foil: | 14537-820-01 | ||
Bag: | 14537-820-00 |
Anticoagulant Citrate Dextrose Solution USP (ACD) Solution A
Catalog # 40820
Polyolefin Bag
50 X 50 mL
NDC: 14537-820-03
Indications for use: Anticoagulant intended for use only with devices that prepare Platelet
Rich Plasma (PRP) products for extracorporeal use. See Operator's Manuals for additional
information and complete usage instructions.
Caution: Only the solution bag fluid path is sterile and non-pyrogenic. Do not use
unless the solution is clear and the container is intact and undamaged. Do not transfer
solution bag directly into the sterile field. Sterilized with Steam. Rx only. Single use
container. Not for preparation of blood products for transfusion or for direct intravenous
infusion.
Storage Conditions:
Room temperature (68° to 77°F, 20° to 25°C).
Avoid excessive heat. Protect from freezing. Protect from direct sunlight.
Each 10mL contains:
Citric Acid Monohydrate USP
0.08 g
Sodium Citrate Dihydrate USP
0.220 g
Dextrose Monohydrate USP
0.245 g
In Water for Injection USP
STERILE
Manufactured by TERUMO BCT, INC.
10811 West Collins Ave., Lakewood, Colorado 80215-4440, USA
Made in UK
LPN - 1000041011
Lot
Expiry Date
ANTICOAGULANT CITRATE DEXTROSE (ACD-A)
dextrose monohydrate, sodium citrate, unspecified form, and citric acid monohydrate solution |
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Labeler - Terumo BCT, Ltd (233649834) |
Registrant - Terumo BCT, Inc. (801679200) |
Establishment | |||
Name | Address | ID/FEI | Business Operations |
---|---|---|---|
Terumo BCT, Ltd | 233649834 | LABEL(14537-820) , ANALYSIS(14537-820) , STERILIZE(14537-820) , MANUFACTURE(14537-820) |