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These highlights do not include all the information needed to use ANTICOAGULANT CITRATE DEXTROSE SOLUTION USP (ACD) SOLUTION A safely and effectively. See full prescribing information for ANTICOAGULANT CITRATE DEXTROSE SOLUTION USP (ACD) SOLUTION A. ANTIC | ACD [Terumo BCT, Ltd.] | BioPortfolio

12:37 EST 27th January 2019 | BioPortfolio

Note: While we endeavour to keep our records up-to-date one should not rely on these details being accurate without first consulting a professional. Click here to read our full medical disclaimer.

ANTICOAGULANT CITRATE DEXTROSE SOLUTION USP (ACD) SOLUTION A is an anticoagulant for blood collection for use only with apheresis devices. [See Dosage and Administration (2).]

ANTICOAGULANT CITRATE DEXTROSE SOLUTION USP (ACD) SOLUTION A is added to tubing sets during apheresis procedures. The solution is connected to the tubing set in an apheresis collection. The recommended dose is determined by the apheresis device and metered into the tubing set by the apheresis device. It is not intended for direct intravenous infusion.

For instructions on the use of the solution with the apheresis device and tubing set, see the device operator's manual.

Directions for Connecting the ANTICOAGULANT CITRATE DEXTROSE SOLUTION USP (ACD) SOLUTION A bag to the apheresis device.

At the prompt to connect anticoagulant to the apheresis device tubing set:

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

500 mL or 750 mL ANTICOAGULANT CITRATE DEXTROSE SOLUTION USP (ACD) SOLUTION A is a sterile solution in a polyolefin 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.

DO NOT INFUSE ANTICOAGULANT CITRATE DEXTROSE SOLUTION USP (ACD) SOLUTION A DIRECTLY TO THE PATIENTS.

Citrate reactions or toxicity may occur with the infusion and return of blood containing citrate anticoagulant. The recipient of the blood 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 adequately studied in controlled clinical trials with specific populations.

ANTICOAGULANT CITRATE DEXTROSE SOLUTION USP (ACD) SOLUTION A is designed to be metered by an apheresis device in apheresis procedures, to prevent platelet activation and coagulation as blood moves throughout the extracorporeal unit (tubing set) in an apheresis procedure.

The solution is sterile and 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 polyolefin bag is not made with natural rubber latex or PVC.

The bag is made from a multilayered film. It contains materials that have been tested to demonstrate the suitability of the container for storing pharmaceutical solutions. The solution contact layer is an elasticized polyolefin. The bag is nontoxic and biologically inert. The bag-solution unit is a closed system and is not dependent upon entry of external air during administration. The bag is overwrapped to provide protection from the physical environment and to provide an additional moisture barrier when necessary.

Table 1: Active Ingredients
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

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 solution supplied in sterile and non-pyrogenic polyolefin bags. The 750 mL bags are packaged 12 bags per case. The 500 mL bags are packaged 18 bags per case.

SIZE CATALOG NUMBER NDC NUMBER
500 mL 40815 14537-815-50
750 mL 40817 14537-817-75

STORAGE

Store up to 25 °C [See USP Controlled Room Temperature].Avoid excessive heat. Protect from freezing.

Issued: (August 2017)

Manufactured by Terumo BCT, Inc. Lakewood, CO 80215

Anticoagulant Citrate DextroseSolution USP (ACD) Solution A

Catalog # 40817Polyolefin Bag 750 mL

NDC 14537-817-75

Sterile. Non-pyrogenic. Sterilized with Steam.

Do not use unless the solution is clear and the container is intact.

Rx Only.

Single use container.

Read the package insert before application.

For use only with apheresis devices. See apheresis device operator's manual for complete instructions.

Caution: Not for direct intravenous infusion.

Recommended storage: Store up to 25 °C. (See USP Controlled RoomTemperature). Avoid excessive heat. Protect from freezing.

Each 100 mL contains: Dextrose Monohydrate USP2.45 gSodium Citrate Dihydrate USP2.20 gCitric Acid Monohydrate USP0.80 gIn Water for Injection USP

Manufactured by Terumo BCT, Inc.10811 W. Collins Ave., Lakewood CO 80215, USA

777967-057 TERUMOBCT

LotExpiry Date

Anticoagulant Citrate DextroseSolution USP (ACD) Solution A

Catalog # 40815Polyolefin Bag 500 mL

NDC 14537-815-50

Sterile. Non-pyrogenic. Sterilized with Steam.

Do not use unless the solution is clear and the container is intact.

Rx Only.

Single use container.

Read the package insert before application.

For use only with apheresis devices. See apheresis device operator's manual for complete instructions.

Caution: Not for direct intravenous infusion.

Recommended storage: Store up to 25 °C. (See USP Controlled RoomTemperature).Avoid excessive heat. Protect from freezing.

Each 100 mL contains: Dextrose Monohydrate USP2.45 gSodium Citrate Dihydrate USP2.20 gCitric Acid Monohydrate USP0.80 gIn Water for Injection USP

Manufactured by Terumo BCT, Inc.10811 W. Collins Ave., Lakewood CO 80215, USA

777967-540 TERUMOBCT

LotExpiry Date

Manufacturer

Terumo BCT, Ltd.

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