Label: TERUFLEX BLOOD BAG SYSTEM ANTICOAGULANT CITRATE PHOSPHATE DEXTROSE (CPD) AND OPTISOL RED CELL PRESERVATIVE (anticoagulant citrate phosphate dextrose- cpd and as-5 red cell preservative kit

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

Drug Label Information

Updated December 11, 2019

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

  • INDICATIONS & USAGE

    Revised 8/96

    TERUFLEX® BLOOD BAG SYSTEM
    CPD/OPTISOL® SOLUTION

    Read these instructions before use.

    INSTRUCTIONS FOR BLOOD COLLECTION: Use aseptic technique
    1. Confirm that all numbered tubing of each blood bag unit contains segment numbers.
    2. Make a loose knot in the donor tubing approximately 10 cm from needle unless alternate methods are used to seal tubing.
    3. Clamp donor tubing.
    4. Suspend primary bag as far as possible below the donor's arm.
    5. Apply blood pressure cuff or tourniquiet to donor's arm. Disinfect site of phlebotomy. If blood pressure cuff is used, inflate cuff to 60 mmHg.
    6. Remove needle protector and perform phlebotomy. Remove clamp to permit blood flow into primary bag.
    CAUTION Do not touch needle after removing the needle protector.
    7. Appropriately secure donor tubing to donor's arm.
    8. MIX BLOOD WITH ANTICOAGULANT AT SEVERAL INTERVALS DURING COLLECTION.
    9. Collect labeled volume of blood (+/- 10%).
    10. Tighten knot firmly after collection. Clamp between knot and needle. Sever donor tubing between knot and clamp. Collect blood samples.
    11. Reapply clamp to donor tubing; release pressure on donor's arm and remove needle. Seal donor tubing.
    CAUTION Discard tubing/phlebotomy needle unit according to institutional procedures.
    12. Immediately after collection, invert bag several times to assure blood and anticoagulant are well mixed.
    13. Strip blood from donor tubing into bag, mix well, and allow tubing to refill. Seal on or near X marks on donor tubing to provide numbered aliquots of anticoagulated blood for testing.
    14. Centrifuge unit to separate red cells from plasma.
    15.The time of addition of OPTISOL Solution may vary depending on the processing option selected. Add solution under one of the following conditions.
    a) After removal of plasma from freshly collected blood.
    b) Within 8 hours of blood collection if components are prepared.
    c) Within 72 hours of collection if blood is refrigerated immediately following collection.
    16. Snap CLIKTIP (incline closure device) of primary collection bag and transfer plasma into satellite bag. Clamp transfer tubing of satellite bag.
    17. Snap CLIKTIP of OPTISOL Solution bag and drain contents into primary bag containing red blood cells. Seal tubing of primary bag in two places, and cut between seals and separate from satellite bag(s).
    NOTE: For TERUFLEX double bags, seal OPTISOL Solution bag tubing in two places, and cut between seals. Discard OPTISOL Solution container.
    18. Invert the red cell- OPTISOL mixture several times to insure that the final AS-5 red cell product is well suspended.
    19. Store AS-5 Red Blood Cells between 1-6oC.
    20. Infuse AS-5 Red Blood Cells within 42 days of collection.

    For further processing, use standard component processing techniques.

    To open the blister package, peel the cover film back 4/5 of its length.

    After opening, unused bags may be stored for 30 days by returning cover film to original position and sealing with tape to prevent possible loss of moisture.

    Image Figure Sealing with tape

    CAUTIONS
    • THE PACKET OF AGELESS CONTAINED IN THIS PACKAGE ABSORBS OXYGEN AND GENERATES HEAT ON REMOVAL AND SHOULD BE HANDLED WITH CARE.
    • DISPOSE WITH PACKET IN TRAY.
    • DO NOT DISPOSE WITH WASTES CONTAINING VOLATILE OR FLAMMABLE MATERIALS.
    • DISCARD AGELESS PACKET WITHOUT OPENING.


    TERUMO CORPORATION
    44-1, 2-chome, Hatagaya, Shibuya-Ku, Tokyo, Japan
    ®: Registered Trademark

    N-BB-OP-A (4)

  • PRINCIPAL DISPLAY PANEL



    Tray/Case Label

    TERUFLEX® BLOOD BAG SYSTEM

    CPD WITH OPTISOL® RED CELL PRESERVATIVE SOLUTION
    FOR COLLECTION OF 450mL OF BLOOD

    Each unit consists of a primary bag containing 63mL of Anticoagulant
    CPD solution, with a  satellite bag containing 100mL of OPTISOL Red
    Cell Preservative Solution.

    Each 63mL Anticoagulant CPD solution USP contains 1.61g Dextrose
    (monohydrate) USP, 1.66g Sodium Citrate (dihydrate) USP,188mg Citric
    Acid (anhydrous) USP, 144mg Monobasic Sodium Phosphate
    (monohydrate) USP.

    Each 100mL OPTISOL Red Cell Preservative Solution contains 877mg
    Sodium Chloride USP, 900mg Dextrose (monohydrate) USP, 525mg
    Mannitol USP, 30mg Adenine USP.

    STERILE, NON-PYROGENIC FLUID PATH.
    DO NOT USE UNLESS ANTICOAGULANT IS CLEAR

    CODE

    LOT No.

    EXPIRY

    UNITS

    DONOR NEEDLE 16G x 1 1/2˝ (1.60 x 38mm)
    Rx ONLY

    RECOMMENDED STORAGE: Room Temperature (15-30°C/59-86°F).
    Avoid excessive heat. Protect from freezing.

    After opening, unused bags may be stored for 30 days by returning cover film to original position and
    sealing with tape to prevent possible loss of moisture. See Instructions For Blood Collection.

    Manufactured by : TERUMO CORPORATION Tokyo, Japan
    ® : Registered Trademark of TERUMO CORPORATION

    Rev. 01/03
    B-4-G6-A (4)

    Image of Representative Tray/Case Label CPD-OPTISOL w/o BSA



  • INGREDIENTS AND APPEARANCE
    TERUFLEX BLOOD BAG SYSTEM ANTICOAGULANT CITRATE PHOSPHATE DEXTROSE (CPD) AND OPTISOL RED CELL PRESERVATIVE  
    anticoagulant citrate phosphate dextrose (cpd) and as-5 red cell preservative kit
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:53877-005
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:53877-005-2124 in 1 CASE
    11 in 1 BAG
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 11 BAG 63 mL
    Part 21 BAG 100 mL
    Part 1 of 2
    ANTICOAGULANT CITRATE PHOSPHATE DEXTROSE (CPD) 
    anticoagulant citrate phosphate dextrose (cpd) solution
    Product Information
    Route of AdministrationINTRAVENOUS
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Trisodium Citrate Dihydrate (UNII: B22547B95K) (Anhydrous Citric Acid - UNII:XF417D3PSL) Anhydrous Citric Acid26.3 g  in 1000 mL
    SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORM (UNII: 3980JIH2SW) (Phosphate Ion - UNII:NK08V8K8HR, Sodium Cation - UNII:LYR4M0NH37) SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORM2.22 g  in 1000 mL
    Dextrose Monohydrate (UNII: LX22YL083G) (Anhydrous Dextrose - UNII:5SL0G7R0OK) Dextrose Monohydrate25.5 g  in 1000 mL
    Anhydrous Citric Acid (UNII: XF417D3PSL) (Anhydrous Citric Acid - UNII:XF417D3PSL) Anhydrous Citric Acid2.99 g  in 1000 mL
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    163 mL in 1 BAG; Type 9: Other Type of Part 3 Combination Product (e.g., Drug/Device/Biological Product)
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDABN88021701/13/2010
    Part 2 of 2
    OPTISOL RED CELL PRESERVATIVE  
    as-5 red cell preservative solution
    Product Information
    Route of AdministrationINTRAVENOUS
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Sodium Chloride (UNII: 451W47IQ8X) (SODIUM CATION - UNII:LYR4M0NH37) Sodium Chloride877 mg  in 100 mL
    Dextrose Monohydrate (UNII: LX22YL083G) (Anhydrous Dextrose - UNII:5SL0G7R0OK) Dextrose Monohydrate900 mg  in 100 mL
    Mannitol (UNII: 3OWL53L36A) (Mannitol - UNII:3OWL53L36A) Mannitol525 mg  in 100 mL
    Adenine (UNII: JAC85A2161) (Adenine - UNII:JAC85A2161) Adenine30 mg  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1100 mL in 1 BAG; Type 9: Other Type of Part 3 Combination Product (e.g., Drug/Device/Biological Product)
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDABN88021701/13/2010
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDABN88021701/13/2010
    Labeler - Terumo Corporation (690543319)
    Establishment
    NameAddressID/FEIBusiness Operations
    Terumo Corp. - Fujinomiya Factory695214015MANUFACTURE(53877-005) , STERILIZE(53877-005) , ANALYSIS(53877-005) , LABEL(53877-005)