DOSAGE FORMS & STRENGTHS SECTION.

3 DOSAGE FORMS AND STRENGTHS. 500 mL or 750 mL ANTICOAGULANT CITRATE DEXTROSE SOLUTION USP (ACD) SOLUTION is sterile solution in 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. 500 mL or 750 mL sterile fluid in polyolefin bag. (3). 500 mL or 750 mL sterile fluid in polyolefin bag. (3).

HOW SUPPLIED SECTION.

16 HOW SUPPLIED/STORAGE AND HANDLING. ANTICOAGULANT CITRATE DEXTROSE SOLUTION USP (ACD) SOLUTION is 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.SIZECATALOG NUMBERNDC NUMBER500 mL4081514537-815-50750 mL4081714537-817-75. STORAGEStore up to 25 [See USP Controlled Room Temperature].Avoid excessive heat. Protect from freezing.

INDICATIONS & USAGE SECTION.

1 INDICATIONS AND USAGE. ANTICOAGULANT CITRATE DEXTROSE SOLUTION USP (ACD) SOLUTION is an anticoagulant for blood collection for use only with apheresis devices. [See Dosage and Administration (2).] ANTICOAGULANT CITRATE DEXTROSE SOLUTION USP (ACD) SOLUTION is an anticoagulant for blood collection for use only with apheresis devices. (1).

MECHANISM OF ACTION SECTION.

12.1 Mechanism of Action. ANTICOAGULANT CITRATE DEXTROSE SOLUTION USP (ACD) SOLUTION acts as an extracorporeal anticoagulant by binding the free calcium in the blood. Calcium is 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 anticoagulatesDextrose for isotonicityThis solution has no pharmacological effect.. Citric acid for pH regulation Sodium Citrate anticoagulates. Dextrose for isotonicity.

ADVERSE REACTIONS SECTION.

6 ADVERSE REACTIONS. 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, 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.. 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. (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.

CLINICAL PHARMACOLOGY SECTION.

12 CLINICAL PHARMACOLOGY. 12.1 Mechanism of Action. ANTICOAGULANT CITRATE DEXTROSE SOLUTION USP (ACD) SOLUTION acts as an extracorporeal anticoagulant by binding the free calcium in the blood. Calcium is 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 anticoagulatesDextrose for isotonicityThis solution has no pharmacological effect.. Citric acid for pH regulation Sodium Citrate anticoagulates. Dextrose for isotonicity.

CONTRAINDICATIONS SECTION.

4 CONTRAINDICATIONS. DO NOT INFUSE ANTICOAGULANT CITRATE DEXTROSE SOLUTION USP (ACD) SOLUTION DIRECTLY TO THE PATIENTS. DO NOT INFUSE ANTICOAGULANT CITRATE DEXTROSE SOLUTION USP (ACD) SOLUTION DIRECTLY TO THE PATIENTS. (4). DO NOT INFUSE ANTICOAGULANT CITRATE DEXTROSE SOLUTION USP (ACD) SOLUTION DIRECTLY TO THE PATIENTS. (4).

DESCRIPTION SECTION.

11 DESCRIPTION. ANTICOAGULANT CITRATE DEXTROSE SOLUTION USP (ACD) SOLUTION 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.Table 1: Active IngredientsIngredientsMolecular Formula Molecular Weight(%w/v) Citric Acid, MonohydrateC6H8O7 192.12Dextrose MonohydrateC6H12O6 H2O198.17Sodium Citrate DihydrateC6H9Na3O9 294.10Water for InjectionH2O18.00Each 100 mL of ANTICOAGULANT CITRATE DEXTROSE SOLUTION USP (ACD) SOLUTION 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 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 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.

DOSAGE & ADMINISTRATION SECTION.

2 DOSAGE AND ADMINISTRATION. ANTICOAGULANT CITRATE DEXTROSE SOLUTION USP (ACD) SOLUTION is added to tubing sets during apheresis procedures. (2)ANTICOAGULANT CITRATE DEXTROSE SOLUTION USP (ACD) SOLUTION may only be used with apheresis devices. For instructions on the use of the solution see the apheresis device operators manual. (2.1)Follow the directions for connecting the ANTICOAGULANT CITRATE DEXTROSE SOLUTION USP (ACD) SOLUTION bag to the apheresis system. (2.2) ANTICOAGULANT CITRATE DEXTROSE SOLUTION USP (ACD) SOLUTION is added to tubing sets during apheresis procedures. (2). ANTICOAGULANT CITRATE DEXTROSE SOLUTION USP (ACD) SOLUTION may only be used with apheresis devices. For instructions on the use of the solution see the apheresis device operators manual. (2.1). Follow the directions for connecting the ANTICOAGULANT CITRATE DEXTROSE SOLUTION USP (ACD) SOLUTION bag to the apheresis system. (2.2) 2.1 General Dosing Information. ANTICOAGULANT CITRATE DEXTROSE SOLUTION USP (ACD) SOLUTION 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 operators manual.. 2.2 Administration. Ensure solution is the ANTICOAGULANT CITRATE DEXTROSE SOLUTION USP (ACD) SOLUTION and is within the expiration date.Inspect the bag. Do not use if the container is damaged, leaking or if there is any visible sign of deterioration.Use only if solution is clear and free of particulate matter.Protect from sharp objects.. Ensure solution is the ANTICOAGULANT CITRATE DEXTROSE SOLUTION USP (ACD) SOLUTION and is within the expiration date.. Inspect the bag. Do not use if the container is damaged, leaking or if there is any visible sign of deterioration.. Use only if solution is clear and free of particulate matter.. Protect from sharp objects.. Directions for Connecting the ANTICOAGULANT CITRATE DEXTROSE SOLUTION USP (ACD) SOLUTION bag to the apheresis device.At the prompt to connect anticoagulant to the apheresis device tubing set:Remove the overwrap by pulling down at notch, and remove the ANTICOAGULANT CITRATE DEXTROSE SOLUTION USP (ACD) SOLUTION bag.Before use, perform the following checks [See Warnings and Precautions (5).]: Check for leaks by gently squeezing the bag. If leaks are found, discard the bag.Ensure that the solution is the ANTICOAGULANT CITRATE DEXTROSE SOLUTION USP (ACD) SOLUTION and is within the expiration date.Inspect the solution in adequate light. Bags showing cloudiness, haze, or particulate matter should not be used. 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.Break the frangible connector. When you break frangible connectors, bend them in both directions to ensure that you break them completely. Failure to do so may result in restricted flow.Proceed according to the apheresis device operators manual.Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.. Remove the overwrap by pulling down at notch, and remove the ANTICOAGULANT CITRATE DEXTROSE SOLUTION USP (ACD) SOLUTION bag.. Before use, perform the following checks [See Warnings and Precautions (5).]: Check for leaks by gently squeezing the bag. If leaks are found, discard the bag.Ensure that the solution is the ANTICOAGULANT CITRATE DEXTROSE SOLUTION USP (ACD) SOLUTION and is within the expiration date.Inspect the solution in adequate light. Bags showing cloudiness, haze, or particulate matter should not be used. Check for leaks by gently squeezing the bag. If leaks are found, discard the bag.. Ensure that the solution is the ANTICOAGULANT CITRATE DEXTROSE SOLUTION USP (ACD) SOLUTION and is within the expiration date.. Inspect the solution in adequate light. Bags showing cloudiness, haze, or particulate matter should not be used.. 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.. Break the frangible connector. When you break frangible connectors, bend them in both directions to ensure that you break them completely. Failure to do so may result in restricted flow.. Proceed according to the apheresis device operators manual.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL.

PRINCIPAL DISPLAY PANEL 750 mL Bag Label. Anticoagulant Citrate DextroseSolution USP (ACD) Solution ACatalog 40817Polyolefin Bag 750 mLNDC 14537-817-75Sterile. 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 operators 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 USPManufactured by Terumo BCT, Inc.10811 W. Collins Ave., Lakewood CO 80215, USA777967-057 TERUMOBCTLotExpiry Date. PRINCIPAL DISPLAY PANEL 750 mL Bag Label.

SPL UNCLASSIFIED SECTION.

2.1 General Dosing Information. ANTICOAGULANT CITRATE DEXTROSE SOLUTION USP (ACD) SOLUTION 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 operators manual.

STORAGE AND HANDLING SECTION.

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

USE IN SPECIFIC POPULATIONS SECTION.

8 USE IN SPECIFIC POPULATIONS. ANTICOAGULANT CITRATE DEXTROSE SOLUTION USP (ACD) SOLUTION has not been adequately studied in controlled clinical trials with specific populations.. ANTICOAGULANT CITRATE DEXTROSE SOLUTION USP (ACD) SOLUTION has not been studied in controlled clinical trials with specific populations.

WARNINGS AND PRECAUTIONS SECTION.

5 WARNINGS AND PRECAUTIONS. Verify that the ANTICOAGULANT CITRATE DEXTROSE SOLUTION USP (ACD) SOLUTION has been securely attached to the Anticoagulant (AC) line on the system tubing set. Use aseptic technique throughout all procedures to ensure donor safety and quality. Do not reuse. Discard unused or partially used solution bags.. Verify that the ANTICOAGULANT CITRATE DEXTROSE SOLUTION USP (ACD) SOLUTION has been securely attached to the Anticoagulant (AC) line on the system tubing set. Use aseptic technique throughout all procedures to ensure donor safety and quality. Do not reuse. Discard unused or partially used solution bags.. Verify that the ANTICOAGULANT CITRATE DEXTROSE SOLUTION USP (ACD) SOLUTION has been securely attached to the Anticoagulant (AC) line on the system tubing set. Use aseptic technique throughout all procedures to ensure donor safety and quality. (5). Verify that the ANTICOAGULANT CITRATE DEXTROSE SOLUTION USP (ACD) SOLUTION has been securely attached to the Anticoagulant (AC) line on the system tubing set. Use aseptic technique throughout all procedures to ensure donor safety and quality. (5).