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TERUFLEX Blood Bag System Anticoagulant Citrate Phosphate Dextrose (CPD) AND OPTISOL Red Cell Preservative (Terumo Corporation)

Available Formats

Dosage Form Package Information Links
KIT 30 BAG in 1 CASE (53877-005-01) > 1 KIT in 1 BAG * 35 mL in 1 BAG * 56 mL in 1 BAG Label Information
KIT 30 BAG in 1 CASE (53877-005-01) > 1 KIT in 1 BAG * 35 mL in 1 BAG * 56 mL in 1 BAG Label Information
KIT 24 BAG in 1 CASE (53877-005-21) > 1 KIT in 1 BAG * 63 mL in 1 BAG * 100 mL in 1 BAG Label Information
KIT 24 BAG in 1 CASE (53877-005-21) > 1 KIT in 1 BAG * 63 mL in 1 BAG * 100 mL in 1 BAG Label Information

Complete TERUFLEX Blood Bag System Anticoagulant Citrate Phosphate Dextrose (CPD) AND OPTISOL Red Cell Preservative Information

  • INDICATIONS & USAGE

    TERUFLEX® BLOOD BAG SYSTEM
    CPD/OPTISOL® SOLUTION BLOOD BAG SYSTEM

    Read these instructions carefully before use. Rx ONLY.

    INTENDED USE

    Collection of 250 mL Whole Blood:
    From elderly, pediatric, or smaller autologous donors who may not tolerate larger blood collections.
    For blood collections as directed by a patient’s physician.
    Platelets prepared from 250 mL whole blood collections can only be used for the autologous donation patient.
    Platelet preparation from a 250 mL whole blood collection are unlikely to meet the 5.5x10 10 platelet concentration required by the regulations.

    INSTRUCTIONS FOR BLOOD COLLECTION: Use aseptic technique
    1. Confirm that all numbered tubing of each blood bag unit contains its own identical segment numbers.
    2. Make a loose knot in the donor tubing approximately 10 cm from the needle.
    3. Clamp donor tubing with hemastat.
    4. Suspend primary bag a minimum of 60 cm below the donor’s arm
    5. Apply blood pressure cuff. Disinfect site of phlebotomy. Inflate blood pressure cuff to 60 mmHg.
    6. Remove needle protector and perform phlebotomy. Remove hemastat to permit blood flow into primary bag.
    CAUTION Do not touch needle after removing the needle protector.
    7. Tape donor tubing securely to donor’s arm.
    8. MIX BLOOD WITH ANTICOAGULANT AT SEVERAL INTERVALS DURING COLLECTION.
    9. Collect 250 mL of blood.
    10. Tighten knot firmly after collection. Clamp between knot and needle. Sever donor tubing between knot and clamp. Collect pilot samples.
    11. Reapply clamp to donor tubing; release blood pressure cuff and remove needle from donor's arm.
    CAUTION Discard tubing/phlebotomy needle unit according to institutional procedures.
    12. Immediately after collection, invert bag several times mixing blood with anticoagulant thoroughly.
    13. Strip blood from donor tubing into bag, mix well, and allow tubing to refill. Seal at X marks on donor tubing to provide numbered aliquots of anticoagulated blood for testing.
    CAUTION Begin sealing at needle end and work towards bag.
    14.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 platelets are prepared.
    c) Within 72 hours of collection if blood is refrigerated immediately following collection.
    15. Centrifuge unit to separate red cells from plasma.
    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, cut between seals, and separate from satellite bag.
    NOTE: For TERUFLEX double bags, seal OPTISOL solution bag tubing in two places, but between seals, and separate. Discard OPTISOL solution container.
    18. Mix OPTISOL solution and red cells thoroughly. Store between 1-6 oC.
    19. Infuse OPTISOL 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. (See Fig. 3)

    After opening, unused blood bags may be stored at room temperature for 96 hours, or they may be stored for 30 days in the blister package after returning the cover film to the 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 GENERATES HEAT UPON REMOVAL AND SHOULD BE HANDLED WITH CARE.
    DISPOSE WITH AGELESS PACKET IN TRAY.
    DO NOT DISPOSE WITH WASTES CONTAINING VOLATILE OR FLAMMABLE MATERIALS.
    DISCARD AGELESS PACKET WITHOUT OPENING.
    DO NOT USE UNLESS ANTICOAGULANT IS CLEAR.
    RECOMMENDED STORAGE: Room Temperature (25 oC/77 oF).
    Avoid excessive heat and direct sunlight. Protect from freezing.

    TERUMO CORPORATION
    44-1, 2-CHOME, HATAGAYA, SHIBUYA-KU, TOKYO, JAPAN
    TERUMO and TERUFLX are registered in U.S. Patent and Trademark Office
    by TERUMO CORPORATION.
    OPTISOL and CLIKTIP are trademarks of TERUMO CORPORATION.

    Issued 2/95
    N-BB-OP-A3

  • PRINCIPAL DISPLAY PANEL



    Tray/Case Label

    TERUFLEX® BLOOD BAG SYSTEM with Blood Sampling Arm®

    CPD WITH OPTISOL® RED CELL PRESERVATIVE SOLUTION
    FOR COLLECTION OF 250 mL OF BLOOD

    Each unit consists of a primary bag containing 35mL of Anticoagulant
    CPD solution, with a  satellite bag containing 56mL of OPTISOL Red
    Cell Preservative Solution.

    Each 35 mL Anticoagulant CPD solution USP contains 893mg Dextrose
    (monohydrate) USP, 921mg Sodium Citrate (dihydrate) USP,105mg Citric
    Acid (anhydrous) USP, 77.7mg Monobasic Sodium Phosphate
    (monohydrate) USP.

    Each 56 mL OPTISOL Red Cell Preservative Solution contains 491mg
    Sodium Chloride USP, 504mg Dextrose (monohydrate) USP, 294mg
    Mannitol USP, 16,8mg Adenine USP.

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

    CODE

    LOT No.

    EXPIRY

    UNITS

    DONOR NEEDLE 17G x 1 1/2˝ (1.40 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. 07/04
    B-4-B7-A4 2
    Image of Representative Tray/Case Label CPD-OPTISOL 250mL




  • 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 Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:53877-005
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:53877-005-01 30 in 1 CASE
    1 1 in 1 BAG
    Quantity of Parts
    Part # Package Quantity Total Product Quantity
    Part 1 1 BAG 35 mL
    Part 2 1 BAG 56 mL
    Part 1 of 2
    ANTICOAGULANT CITRATE PHOSPHATE DEXTROSE (CPD)  
    anticoagulant citrate phosphate dextrose (cpd) solution
    Product Information
    Route of Administration INTRAVENOUS
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Trisodium Citrate Dihydrate (UNII: B22547B95K) (Citric Acid - UNII:2968PHW8QP) Trisodium Citrate Dihydrate 26.3 g  in 1000 mL
    Sodium Phosphate, Monobasic (UNII: 3980JIH2SW) (Phosphoric Acid - UNII:E4GA8884NN) Sodium Phosphate, Monobasic 2.22 g  in 1000 mL
    Dextrose Monohydrate (UNII: LX22YL083G) (Dextrose - UNII:IY9XDZ35W2) Dextrose Monohydrate 25.5 g  in 1000 mL
    Anhydrous Citric Acid (UNII: XF417D3PSL) (Citric Acid - UNII:2968PHW8QP) Anhydrous Citric Acid 2.99 g  in 1000 mL
    Inactive Ingredients
    Ingredient Name Strength
    Water (UNII: 059QF0KO0R)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 35 mL in 1 BAG
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    NDA NDA880217 12/15/2009
    Part 2 of 2
    OPTISOL RED CELL PRESERVATIVE  
    as-5 red cell preservative solution
    Product Information
    Route of Administration INTRAVENOUS
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Sodium Chloride (UNII: 451W47IQ8X) (SODIUM CATION - UNII:LYR4M0NH37) Sodium Chloride 877 mg  in 100 mL
    Dextrose Monohydrate (UNII: LX22YL083G) (Dextrose - UNII:IY9XDZ35W2) Dextrose Monohydrate 900 mg  in 100 mL
    Mannitol (UNII: 3OWL53L36A) (Mannitol - UNII:3OWL53L36A) Mannitol 525 mg  in 100 mL
    Adenine (UNII: JAC85A2161) (Adenine - UNII:JAC85A2161) Adenine 30 mg  in 100 mL
    Inactive Ingredients
    Ingredient Name Strength
    Water (UNII: 059QF0KO0R)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 56 mL in 1 BAG
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    NDA NDA880217 12/15/2009
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    NDA NDA880217 12/15/2009
    Labeler - Terumo Corporation (690543319)
    Establishment
    Name Address ID/FEI Business Operations
    Terumo Corp. - Fujinomiya Factory 695214015 manufacture