Acd Injection, Solution
FDA Label NDC 14537-810

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. For automated apheresis, 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 an apheresis device and tubing set, see that device's operator's manual.

• Ensure solution is the Anticoagulant Citrate Dextrose Solution USP (ACD) Solution A and the expiration date has not passed.
• Inspect the bag. Do not use the solution if the container is damaged, leaking, or if there is any visible sign of deterioration.
• Use only if the solution is clear and free of particulate matter.
• Protect the bag from sharp objects.
• Use aseptic technique throughout all procedures.

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:

• Remove the overwrap by pulling down at the notch, and remove the Anticoagulant Citrate Dextrose Solution USP (ACD) Solution A bag.
• Before use, perform the following checks [See Warnings and Precautions (5).]:
  • Check for leaks by gently squeezing the bag. If you find leaks, discard the bag.
  • Ensure that the solution is the Anticoagulant Citrate Dextrose Solution USP (ACD) Solution A and the expiration date has not passed.
  • Inspect the solution in adequate light. Do not use bags that show cloudiness, haze, or particulate matter.
  • Remove the protective cap from the port on the bag.
  • Connect the bag to the apheresis device tubing set using aseptic technique and hang the solution.
  • Proceed according to the apheresis device's operator's manual.

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

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.

None. There are no known contraindications associated with the use of the product.

• Verify that the Anticoagulant Citrate Dextrose Solution USP (ACD) Solution A has been securely attached to the Anticoagulant (AC) line on the system tubing set.
• Use aseptic technique throughout all procedures to ensure product quality and donor safety.
• Do not reuse. Discard unused or partially used solution bags.
• Do not infuse Anticoagulant Citrate Dextrose Solution USP (ACD) Solution A directly to the patients.
• Do not use the solution if the container is damaged, leaking, or if there is any visible sign of deterioration.

The following potential adverse events are associated with the use of Anticoagulant Citrate Dextrose Solution USP (ACD) Solution A: embolism, toxic reaction, infection, hypervolemia, and tissue damage.

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.

Report suspected adverse reactions to Terumo BCT, Inc. or the FDA.

There are no known significant interactions between Anticoagulant Citrate Dextrose Solution USP (ACD) Solution A and food or other drug products.

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 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 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.

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:

• Citric Acid for pH regulation
• Sodium Citrate for anticoagulation
• Dextrose for isotonicity

This solution has no pharmacological effect.

No long-term animal studies have been performed to evaluate carcinogenic potential.

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.

Store up to 25 °C.

Avoid excessive heat. Protect from freezing.

Issued: <TBD—FDA Approval: MONTH YYYY>

Terumo BCT is either a registered trademark or trademark of Terumo BCT, Inc. in the United States and/or other countries.

This product may be covered by one or more patents or pending patent applications. See www.terumobct.com/patents for details.

Made in UK

Manufactured by
Terumo BCT, Inc.
Lakewood, CO 80215

Anticoagulant Citrate Dextrose Solution USP (ACD) Solution A

NDC 14537-810-12
Catalog # 40810
12 x 750 mL units

STERILE

Sterile. Non-pyrogenic. Sterilized with Steam.

Do not use unless the solution is clear and the container is intact. Rx Only. Single-dose container.

Read the package insert before application. For use only with apheresis devices.
See apheresis device operator's manual for complete instructions.

No antimicrobial agents have been added.

Discard unused portion.

Caution: Not for direct intravenous infusion.

Recommended storage: Store up to 25 °C. Avoid excessive heat. Protect from freezing.

Each 100 mL contains:

•  Dextrose Monohydrate USP
  2.45 g
•  Sodium Citrate Dihydrate USP
  2.20 g
•  Citric Acid Monohydrate USP
  0.80 g
•  In Water for Injection USP

Manufactured by Terumo BCT, Inc.
10811 West Collins Ave., Lakewood Colorado 80215-4440, USA
Made in UK

Lot

Expiry Date

1000084243



Principal Display Panel (750 mL Carton Label)