Label: ANTICOAGULANT SODIUM CITRATE- trisodium citrate dihydrate solution

  • NDC Code(s): 81839-782-01, 81839-782-02
  • Packager: CSL Plasma Inc.
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated January 10, 2024

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  • HIGHLIGHTS OF PRESCRIBING INFORMATION
    These highlights do not include all the information needed to use ANTICOAGULANT SODIUM CITRATE 4 % W/V SOLUTION USP safely and effectively. See full prescribing information for ANTICOAGULANT SODIUM CITRATE 4 % W/V SOLUTION USP.

    ANTICOAGULANT SODIUM CITRATE 4 % W/V SOLUTION USP

    Sterile Fluid
    PVC Bag

    Initial U.S. Approval: 1978

    INDICATIONS AND USAGE

    ANTICOAGULANT SODIUM CITRATE 4% W/V SOLUTION USP is intended for use only for the anticoagulation of whole blood as part of automated apheresis procedures. (1)

    DOSAGE AND ADMINISTRATION

    • ANTICOAGULANT SODIUM CITRATE 4% W/V SOLUTION USP is added to tubing sets during apheresis procedures. (2)
    • ANTICOAGULANT SODIUM CITRATE 4% W/V SOLUTION USP may only be used with apheresis devices. For instructions on the use of the solution see the apheresis device operator's manual. (2.1)
    • Follow the directions for connecting the ANTICOAGULANT SODIUM CITRATE 4% W/V SOLUTION USP bag to the apheresis system. (2.2)

    DOSAGE FORMS AND STRENGTHS

    • 250 mL sterile fluid in a PVC bag. (3)

    CONTRAINDICATIONS

    • DO NOT INFUSE ANTICOAGULANT SODIUM CITRATE 4% W/V SOLUTION USP DIRECTLY TO THE DONOR. (4)

    WARNINGS AND PRECAUTIONS

    • Verify that the ANTICOAGULANT SODIUM CITRATE 4% W/V SOLUTION USP 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.
    • Single-use container, do not reuse. Discard any unused or partially used product.
    • Rx only (5)

    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. (6)


    To report SUSPECTED ADVERSE REACTIONS, contact CSL Plasma Inc. at 1-833-275-0044 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

    USE IN SPECIFIC POPULATIONS

    ANTICOAGULANT SODIUM CITRATE 4% W/V SOLUTION USP has not been studied in controlled clinical trials with specific populations. (7)

    Revised: 5/2022

  • Table of Contents

    FULL PRESCRIBING INFORMATION: CONTENTS*

    1. INDICATIONS AND USAGE

    2. DOSAGE AND ADMINISTRATION

    2.1. General Dosing Information

    2.2. Administration

    3. DOSAGE FORMS AND STRENGTHS

    4. CONTRAINDICATIONS

    5. WARNINGS AND PRECAUTIONS

    6. ADVERSE REACTIONS

    8. USE IN SPECIFIC POPULATIONS

    11. DESCRIPTION

    12. CLINICAL PHARMACOLOGY

    12.1. Mechanism of Action

    16. HOW SUPPLIED/STORAGE AND HANDLING

    *
    Sections or subsections omitted from the full prescribing information are not listed.
  • 1. INDICATIONS AND USAGE

    ANTICOAGULANT SODIUM CITRATE 4% W/V SOLUTION USP is intended for use only for the anticoagulation of whole blood as part of automated apheresis procedures. [See Dosage and Administration (2).]

  • 2. DOSAGE AND ADMINISTRATION

    2.1. General Dosing Information

    ANTICOAGULANT SODIUM CITRATE 4% W/V SOLUTION USP is added to tubing sets during apheresis procedures. The solution bag 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.

    2.2. Administration

    • Ensure solution is the ANTICOAGULANT SODIUM CITRATE 4% W/V SOLUTION USP 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 SODIUM CITRATE 4% W/V SOLUTION USP bag to the apheresis device.

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

    1. Remove the overwrap by pulling down at the notch, and remove the ANTICOAGULANT SODIUM CITRATE 4% W/V SOLUTION USP bag.
    2. 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 SODIUM CITRATE 4% W/V SOLUTION USP and is within the expiration date
      • Inspect the solution in good light. Bags showing cloudiness, haze, or particulate matter should not be used
    3. Remove the twist off port on the bag
    4. Connect the bag to the apheresis device tubing set using aseptic technique and hang the solution
    5. Proceed according to the apheresis device operator's manual

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

  • 3. DOSAGE FORMS AND STRENGTHS

    250 mL ANTICOAGULANT SODIUM CITRATE 4% W/V SOLUTION USP is a sterile solution in a PVC bag. Each 100 mL contains: Sodium Citrate (dihydrate) 4.0 g; Water for Injection to 100 mL, (pH adjusted with citric acid). Approximate millimoles of Sodium Citrate: 13.6.

  • 4. CONTRAINDICATIONS

    DO NOT INFUSE ANTICOAGULANT SODIUM CITRATE 4% W/V SOLUTION USP DIRECTLY TO THE DONOR.

  • 5. WARNINGS AND PRECAUTIONS

    • Verify that the ANTICOAGULANT SODIUM CITRATE 4% W/V SOLUTION USP 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.
    • Single-use container. Do not reuse. Discard any unused or partially used product.
    • Rx only
  • 6. ADVERSE REACTIONS

    Citrate reactions or toxicity may occur with the infusion of blood products to patient and return of blood containing citrate anticoagulant to donors. 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.

  • 8. USE IN SPECIFIC POPULATIONS

    ANTICOAGULANT SODIUM CITRATE 4% W/V SOLUTION USP has not been adequately studied in controlled clinical trials with specific populations.

  • 11. DESCRIPTION

    ANTICOAGULANT SODIUM CITRATE 4% W/V SOLUTION USP 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. Sterilized with steam.

    The formulas of the active ingredients are provided in Table 1.

    Table 1: Active Ingredients
    IngredientsMolecular FormulaMolecular Weight
    Sodium Citrate DihydrateC6H9Na3O9294.10
    Water for InjectionH2O18.00

    Each 100 mL of ANTICOAGULANT SODIUM CITRATE 4% W/V SOLUTION USP contains:

    Sodium Citrate (dihydrate) 4.0 g; and Water for Injection to 100 mL (pH adjusted with citric acid). Approximate millimoles of sodium citrate: 13.6.

    The PVC bag is not made with natural rubber latex.

    The bag contains materials that have been tested to demonstrate the suitability of the container for storing pharmaceutical solutions. 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.

  • 12. CLINICAL PHARMACOLOGY

    12.1. Mechanism of Action

    ANTICOAGULANT SODIUM CITRATE 4% W/V SOLUTION USP 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 anticoagulant

    This solution has no pharmacological effect.

  • 16. HOW SUPPLIED/STORAGE AND HANDLING

    ANTICOAGULANT SODIUM CITRATE 4% W/V SOLUTION USP is a clear solution supplied in sterile and non-pyrogenic PVC bags. The bags are packaged 30 bags per case.

    SIZECATALOG NUMBERNDC NUMBER
    250 mL1000782Bag: 81839-782-01
    Case: 81839-782-02

    STORAGE

    Store at 20° to 25°C (68°to 77°F); excursions permitted between 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature]. Brief exposure up to 40°C (104°F) does not adversely affect the product.

    Protect from freezing.

  • SPL UNCLASSIFIED SECTION

    Issued: 05/2022

    Manufactured By:
    CSL Plasma, Inc.
    155 Medical Sciences Drive
    Union, SC 29379

  • PRINCIPAL DISPLAY PANEL - 250 mL Bag Label

    ANTICOAGULANT SODIUM CITRATE
    4% w/v SOLUTION, USP
    250mL
    NDC 81839-782-01
    Product No. 1000782

    Rx Only
    Intended for use only with automated
    apheresis devices

    Each 100 mL contains:
    Sodium Citrate (Dihydrate), USP 4.0g
    (pH adjusted with Citric Acid, Monohydrate
    USP)

    CAUTION: Not for direct intravenous infusion.
    The pouch is a moisture barrier. Do not use
    unless solution is clear and no leaks detected.
    Single use container. Discard unused portion.

    STERILE, nonpyrogenic fluid path.

    RECOMMENDED STORAGE: Store at 20° to
    25°C (68° to 77°F); excursions permitted
    between 15° to 30°C (59° to 86°F) [See USP
    Controlled Room Temperature]. Brief exposure
    up to 40°C (104°F) does not adversely affect
    the product. Protect from freezing.

    Manufactured By:
    CSL Plasma Inc.
    155 Medical Sciences Dr.
    Union, SC 29379 USA

    Made in USA
    62635V01

    PRINCIPAL DISPLAY PANEL - 250 mL Bag Label
  • PRINCIPAL DISPLAY PANEL - 250 mL Carton Label

    Anticoagulant Sodium Citrate
    4% w/v Solution, USP 250mL
    NDC# 81839-782-02
    30 UNITS

    Rx only
    Product Code: 1000782

    LOT # 21X000XU

    EXP. DATE YYYY MMM

    Recommended Storage: Store at 20° to 25°C (68° to 77°F);
    excursions permitted between 15° to 30°C (59° to 86°F)
    [See USP Controlled Room Temperature]. Brief exposure
    up to 40°C (104°F) does not adversely affect the product.
    Protect from freezing.

    Manufactured By:
    CSL Plasma Inc.
    155 Medical Sciences Drive
    Union, SC 29379

    Made in USA

    62635V01 000000

    000000

    PRINCIPAL DISPLAY PANEL - 250 mL Bag Label
  • INGREDIENTS AND APPEARANCE
    ANTICOAGULANT SODIUM CITRATE 
    trisodium citrate dihydrate solution
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:81839-782
    Route of AdministrationINTRAVENOUS
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Trisodium Citrate Dihydrate (UNII: B22547B95K) (Anhydrous Citric Acid - UNII:XF417D3PSL) Anhydrous Citric Acid40 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    Citric Acid monohydrate (UNII: 2968PHW8QP)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:81839-782-0230 in 1 CARTON
    1NDC:81839-782-01250 mL in 1 BAG; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDABA12575007/01/2022
    Labeler - CSL Plasma Inc. (942344649)
    Establishment
    NameAddressID/FEIBusiness Operations
    CSL Plasma Inc.942344649MANUFACTURE(81839-782)
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