Anticoagulant Citrate Dextrose (ACD-A)

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).]

50 mL ANTICOAGULANT CITRATE DEXTROSE SOLUTION USP (ACD) SOLUTION A is a sterile solution in a polyolefin solution bag. Each 100 mL contains: (%w/v) Citric Acid, Monohydrate 0.8 g; Dextrose Monohydrate 2.45 g; Sodium Citrate Dihydrate 2.2 g; and Water for Injection.

NOT FOR PREPARATION OF BLOOD PRODUCTS FOR TRANSFUSION OR FOR DIRECT INTRAVENOUS INFUSION.

• Do not use the ANTICOAGULANT CITRATE DEXTROSE SOLUTION USP (ACD) SOLUTION A unless the solution is clear and the container is intact and undamaged.
• Do not transfer the solution bag directly into the sterile field.
• Do not reuse. Discard unused or partially used solution bags.
• Discard the product if the Needleless Access Valve (NAV) does not function as intended.
• Aseptically prepare the NAV before use.

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 has not been studied in controlled clinical trials with specific populations.

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.

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 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.

Issued: June 2024

Manufactured by
Terumo BCT, Inc.
Lakewood, CO 80215

Made in UK

TERUMO

Anticoagulant Citrate Dextrose
Solution USP (ACD) Solution A
Polyolefin Bag

Catalog # 40820
50 mL

NDC 14537-820-00
LPN - 1000066504

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: Up 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

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