Label: ANTICOAGULANT CITRATE PHOSPHATE DEXTROSE (CPD) BLOOD-PACK UNITS IN PL 146 PLASTIC (anticoagulant citrate phosphate dextrose- cpd solution solution

  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: New Drug Application

Drug Label Information

Updated November 1, 2022

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  • SPL UNCLASSIFIED SECTION

    4R0012MC, 4R0837MC, 4R0112MC

    Fenwal Blood-Pack Units
    Rx only
    With Integral Donor Tube Using ACD or CPD and Fenwal HighFlo Needle

    Instructions for Use
    Collection Procedure:
    Use aseptic technique.
    Precaution: Do not use unless solution is clear.

    1. Identify Blood-Pack unit using appropriate donor identification system. Confirm that all numbered tubing of each Blood-Pack unit contains its own identical segment numbers.
    2. Adjust donor scale to desired collection weight.
    3. Position primary container from donor scale as far as possible below donor arm and clamp donor tubing.
    4. Following blood center procedures, apply pressure to donor's arm and disinfect site of venipuncture.
    5. Remove HighFlo1 needle cover per instructions below:
    a) Holding the hub and cover near the tamper-evident seal, twist cover and hub in opposite directions to break seal.
    b) Remove needle cover, being careful not to drag the cover across the needle point.
    Following blood center procedures, perform venipuncture, appropriately secure donor needle and/or tubing and release clamp.
    6. Mix blood and anticoagulant at several intervals during collection and immediately after collection.
    7. Collect the appropriate volume based on Blood-Pack unit used.
    Note: The volume of anticoagulant is sufficient for the blood collection indicated on Blood-Pack unit ± 10%.
    8. Apply clamp to donor tube.
    9. As appropriate, release pressure on the donor's arm, collect donor samples following established procedures and withdraw donor needle.
    10. Withdrawal of needle into needle guard.
    Precaution: The needle guard must be held stationary while the needle is withdrawn into it.
         a) Hold sides of needle guard near the front, between the index finger and thumb. Pull the hub back smoothly until the needle is completely enclosed and securely locked into the needle guard.
         b) Confirm the needle is completely enclosed and securely locked into the needle guard.
    11. Strip blood from donor tubing into container, mix and allow the tubing to refill; repeat once. Seal at X marks on donor tubing to provide numbered aliquots of anticoagulated blood for typing or crossmatching.
    12. Discard needle in needle guard into an appropriate biohazardous waste container following established procedures.
    13. Store filled unit between 1 and 6° C.
    14. Infuse blood within 21 days of collection.
    Store at Controlled Room Temperature. Protect from freezing. Avoid excessive heat.
    Definition of "Controlled Room Temperature":
    "A temperature maintained thermostatically that encompasses the usual and customary working environment of 20° to 25°C (68° to 77°F); that results in a mean kinetic temperature calculated to be not more than 25°C; and that allows for excursions between 15°C and 30°C (59° and 86°F) that are experienced in pharmacies, hospitals, and warehouses. Provided the mean kinetic temperature remains in the allowed range, transient spikes up to 40°C are permitted as long as they do not exceed 24 hours ... The mean kinetic temperature is a calculated value that may be used as an isothermal storage temperature that simulates the non isothermal effects of storage temperature variations."

    Reference: United States Pharmacopeia, General Notices. United States Pharmacopeial Convention, Inc.
    12601 Twinbrook Parkway, Rockville, MD.

    Symbols with Definitions
    4R001mc-symbols

    1 Van der Meer, P.F., & de Korte, D. "Increase of blood donation speed by optimizing the needle-to-tubing connection: an application of donation software." Vox Sanguinis 2009, 97: 21-25

    4R0837mcmfglbl

    Manufacturer
    Fresenius Kabi AG
    61346 Bad Homburg / Germany
    www.fresenius-kabi.com
    1-800-933-6925

    © 2019 Fresenius Kabi AG. All rights reserved.

    47-23-13-621 REV: A

  • PACKAGE/LABEL DISPLAY PANEL

    Code 4R0837MC

    1 Unit
    Fresenius Kabi

    Fenwal Blood-Pack Unit
    Single

    Anticoagulant Citrate Phosphate Dextrose Solution, USP (CPD) 
    For Collection of 250 mL Blood
    Integral Donor Tube, 16 ga. Ultra Thin Wall Fenwal HighFlo Needle

    Rx only

    Each unit consists of a primary container with 35 mL of CPD solution containing 921 mg Sodium Citrate (dihydrate) USP, 893 mg Dextrose (monohydrate) USP, 105 mg Citric Acid (anhydrous) USP, 78 mg Monobasic Sodium Phosphate (monohydrate) USP. pH may have been adjusted with sodium hydroxide.


    Sterile, non-pyrogenic fluid path.
    See instructions for use.
    Single Use Only

    Store at Controlled Room Temperature (refer to direction insert). Protect from freezing. Avoid excessive heat.

    Open pouch by tearing across at notch.
    Direct handling of product surfaces prior to extended storage in the foil pouch, may result in mold growth.
    Unused units in open foil pouch may be kept up to 60 days by folding and securing open end of foil pouch to prevent possible loss of moisture, provided:
    Units are not removed from foil pouch, or
    Unused units removed from foil pouch are returned to the foil pouch within 12 hours. Units may be removed from the pouch and returned only once.
    Units removed from the foil pouch (that are not returned to the pouch within 12 hours) must be used within 4 days (96 hours). Units out of the foil pouch for longer than 96 hours must be discarded.

    Manufacturer
    Fresenius Kabi AG
    61346 Bad Homburg / Germany
    www.fresenius-kabi.com
    Made in US

    47-28-12-755 REV: A
    4r0837mc-primlbl

  • INGREDIENTS AND APPEARANCE
    ANTICOAGULANT CITRATE PHOSPHATE DEXTROSE (CPD) BLOOD-PACK UNITS IN PL 146 PLASTIC 
    anticoagulant citrate phosphate dextrose (cpd) solution solution
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:0942-9201
    Route of AdministrationINTRAVENOUS
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K) (Anhydrous Citric Acid - UNII:XF417D3PSL) Anhydrous Citric Acid921 mg  in 35 mL
    DEXTROSE MONOHYDRATE (UNII: LX22YL083G) (ANHYDROUS DEXTROSE - UNII:5SL0G7R0OK) DEXTROSE MONOHYDRATE893 mg  in 35 mL
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) (Anhydrous Citric Acid - UNII:XF417D3PSL) ANHYDROUS CITRIC ACID105 mg  in 35 mL
    SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE (UNII: 593YOG76RN) (PHOSPHATE ION - UNII:NK08V8K8HR) SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE78 mg  in 35 mL
    Inactive Ingredients
    Ingredient NameStrength
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0942-9201-0135 mL in 1 BAG; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDABN17040103/01/2007
    Labeler - Fenwal, Inc. (794519020)
    Establishment
    NameAddressID/FEIBusiness Operations
    Fenwal International, Inc.091164590MANUFACTURE(0942-9201)