Label: ANTICOAGULANT CITRATE DEXTROSE A- anhydrous citric acid, dextrose monohydrate, and trisodium citrate dihydrate solution

  • NDC Code(s): 23731-6051-1, 23731-6051-2, 23731-6051-3
  • Packager: Citra Labs
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: New Drug Application

Drug Label Information

Updated February 27, 2018

If you are a consumer or patient please visit this version.

  • Description

    Anticoagulant Citrate Dextrose Solution, Solution A, U.S.P., (ACD-A), is a sterile, non-pyrogenic solution of citric acid, sodium citrate, and dextrose, in water for injection. Each 10 mL of solution contains:

    Citric Acid, anhydrous, USP0.073 g
    Sodium Citrate, dihydrate, USP0.220 g
    Dextrose, monohydrate, USP0.245 g
    Water for Injection, USPq.s.
    pH: 4.5 – 5.5

    single use Single patient use only, on a single occasion.

  • Clinical Pharmacology

    ACD-A acts as an anticoagulant by the action of the citrate ion chelating free ionized calcium, thus making calcium unavailable to the coagulation system.

  • Indications and Usage

    Anticoagulant Citrate Dextrose Solution, Solution A, U.S.P. (ACD-A), is intended for use as an anticoagulant in the extracorporeal blood processing with Autologous PRP Systems in production of platelet rich plasma (PRP). Refer to the manufacturer's Operator's Manual of the Autologous PRP System for the Directions for Use.

  • Contraindications

    NOT FOR DIRECT INTRAVENOUS INFUSION

  • Warnings

    NOT FOR DIRECT INTRAVENOUS INFUSION

  • Precautions

    General

    • Aseptic technique must be maintained at all times.
    • ACD-A solution is a clear and colorless solution. If the product shows any cloudiness or turbidity, the product should be discarded.
    • The closure system provides a biological barrier and should be intact – discard product if system is compromised.

    Information for Patients

    None.

    Carcinogenesis, mutagenesis, impairment of fertility

    Long-term studies in animals have not been performed to evaluate the carcinogenic potential of ACD-A.

    Pregnancy

    Long-term studies in animals have not been performed to evaluate the effects of ACD- A on pregnant women.

    Pediatric Use

    The safety and effectiveness of ACD-A in children have not been established.

  • Adverse Reactions

    Not applicable. This product is used as an anticoagulant in the extracorporeal blood processing with Autologous PRP Systems in production of platelet rich plasma (PRP).

  • Overdosage

    Not applicable. This product is used as an anticoagulant in the extracorporeal blood processing with Autologous PRP systems in production of platelet rich plasma (PRP).

  • Dosage and Administration

    Refer to the manufacturer's Operator's Manual of the Autologous PRP System for the Directions for Use.

  • Rx Only

    Caution: Federal Law (US) restricts this devise to sale by or on the order of a Physician.

  • How Supplied

    Anticoagulant Citrate Dextrose Solution, Solution A, U.S.P., (ACD-A)

     REFSIZECASE
     PN 9350-1030 mL10 Vials/Case
     PN 9350-2530 mL25 Vials/Case

    It is recommended that the product be stored at ambient room temperature, 24 °C (75 °F); however, the product can be stored between 15 °C (59 °F) and 30 °C (86 °F). Protect from freezing and exposure to excessive heat should be minimized.

  • SPL UNCLASSIFIED SECTION

    Manufactured & Distributed by:
    CitraLabs™
    55 Messina Drive, Braintree, MA 02184
    Phone Number: 1-800-299-3411

    Authorized Representative:
    Biomet U.K. Ltd.
    Waterton Industrial Estate
    Bridgend, South Wales, CF31 3XA
    Great Britain
    United Kingdom
    Phone 441.65.66.55.221

    Principal Display Panel

  • PRINCIPAL DISPLAY PANEL - 10 Vial Case Label

    C E 0044

    ACD-A

    Anticoagulant Citrate Dextrose Solution,

    10 Vials / Case Solution A, U.S.P., ACD-A, 30 mL

    REF PN 9350-10

    WARNING: NOT FOR DIRECT INTRAVENOUS INFUSION

    Used as an anticoagulant in the extracorporeal blood processing with

    Autologous PRP Systems in production of platelet rich plasma (PRP).

    Refer to PRP Systems manufacturer's Directions for Use.

    Manufactured & Distributed by:

    CitraLabs

    A Biomet Biologics Company

    Citra Labs, LLC.

    55 Messina Drive, Braintree, MA 02184

    1-800-299-3411

    EC REP

    Authorized Representative:

    Biomet U.K. Ltd.,

    Waterton Industrial Estate

    Bridgend, South Wales, CF31 3XA

    Great Britain - United Kingdom

    Phone 441.65.66.55.221

    symbols

    STERILE • NON-PYROGENIC

    Composition per 10 mL of Solution:

    Citric Acid, (Anhydrous), U.S.P. 0.073 g.

    Sodium Citrate, (Dihydrate), U.S.P. 0.220 g.

    Dextrose, (Monohydrate), U.S.P. 0.245 g.

    CAUTION: Single Procedure Use-Discard Unused Portion

    Do Not Use Unless Solution is Clear and Seal is Intact.

    Store Between 15 °C - 30 °C (59 °F - 86 °F).

    RX Only:

    EXP DATE

    LOT

    LA9350-10B 02/15

    label

  • INGREDIENTS AND APPEARANCE
    ANTICOAGULANT CITRATE DEXTROSE A 
    anhydrous citric acid, dextrose monohydrate, and trisodium citrate dihydrate solution
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:23731-6051
    Route of AdministrationEXTRACORPOREAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DEXTROSE MONOHYDRATE (UNII: LX22YL083G) (ANHYDROUS DEXTROSE - UNII:5SL0G7R0OK) DEXTROSE MONOHYDRATE0.245 g  in 10 mL
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) (ANHYDROUS CITRIC ACID - UNII:XF417D3PSL) ANHYDROUS CITRIC ACID0.073 g  in 10 mL
    TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K) (ANHYDROUS CITRIC ACID - UNII:XF417D3PSL) ANHYDROUS CITRIC ACID0.22 g  in 10 mL
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:23731-6051-330 mL in 1 VIAL, SINGLE-USE; Type 0: Not a Combination Product
    2NDC:23731-6051-110 in 1 CASE
    2NDC:23731-6051-330 mL in 1 VIAL, SINGLE-USE; Type 0: Not a Combination Product
    3NDC:23731-6051-225 in 1 CASE
    3NDC:23731-6051-330 mL in 1 VIAL, SINGLE-USE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDABN02003708/26/2003
    Labeler - Citra Labs (962863838)
    Establishment
    NameAddressID/FEIBusiness Operations
    Citra Labs962863838manufacture(23731-6051)