Label: ADSOL RED CELL PRESERVATION SOLUTION SYSTEM IN PLASTIC CONTAINER (PL 146 PLASTIC)- anticoagulant citrate phosphate dextrose (cpd) solution and adsol preservation solution

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

Drug Label Information

Updated June 21, 2013

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  • Instructions for Blood Collection Using Anticoagulant Citrate Phosphate Dextrose Solution, USP (CPD) BLOOD-PACK™ Unit with an Integrally Attached Container of ADSOL™ Red Cell Preservation Solution

    Rx only

    Contains Y-Sampling Site for the collection of unanticoagulated whole blood samples for laboratory testing and the DONORCARE™ Needle Guard

    Use aseptic technique.

    Note: Nominal tubing dimensions of product are 0.118" inner diameter x 0.025" wall thickness.

    Note: If the Y-Sampling Site is not used, donor samples may be collected using an alternate method following standard procedures.

    Precautions:

    Do not use unless the solutions are clear.
    Before beginning procedure, obtain one access device for each BLOOD-PACK™ unit with Y-Sampling Site to be processed.
    1.
    Identify BLOOD-PACK unit using appropriate donor identification system.
    2.
    Adjust donor scale to desired collection weight and position primary container on the donor scale as far as possible below donor arm.
    3.
    Clamp donor tubing between needle and primary container. This step may be performed prior to step 1 or 2.
    4.
    Apply pressure to donor’s arm and disinfect site of venipuncture.
    5.
    If blood pressure cuff is used, inflate to approximately 60 mmHg.
    6.
    Remove needle cover per instructions below:
    a)
    Holding the hub and cover near the tamper-evident seal, twist cover 1/4 turn to break seal.
    b)
    Remove needle cover, being careful not to drag the cover across the needle point.
    7.
    Perform venipuncture, appropriately secure donor needle and/or tubing and release clamp on donor tubing.
    8.
    When good blood flow is established, slide the DONORCARE™ Needle Guard over the needle hub into the engaged position. Leave the front third of the needle hub exposed for access. Stabilize the front of the needle guard to arm with tape. (see Figure 1)

    Note: In difficult collection conditions (e.g. slow blood flow or fine veins), leave the needle guard disengaged behind the hub during collection. Engage the needle guard at the end of blood collection.

    9.
    Mix blood and anticoagulant in primary container at several intervals during collection and immediately after collection.
    10.
    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%.
    11.
    Release the pressure on the donor’s arm as appropriate.

    Precaution: Do not proceed with the remaining steps until the entire whole blood unit is collected.

    12.
    To avoid possible contamination of the whole blood unit, before filling whole blood sample tubes, hermetically seal the donor tubing near the Y-Sampling Site on the side leading to the primary container using a metal clip or appropriate alternate method.

    Precaution: Complete steps 13 - 21 within approximately 4 minutes after sealing the donor tubing to avoid possible clot formation in the tubing.

    13.
    To collect samples, insert the access device by pushing firmly into the Y-Sampling Site until the membrane seal is penetrated (see Figure 2).

    Note: If the access device is assembled such that the outer barrel is screwed onto the Luer, make sure to rotate clockwise upon insertion to avoid barrel detaching from Luer.

    14.
    Open the cap on the access device (if applicable).
    15.
    Directly align the vacuum sample tube with the internal needle in the access device. Insert vacuum sample tube into device until the stopper is punctured.
    16.
    Allow vacuum sample tube to fill with blood then remove from the access device.
    17.
    Repeat steps 15 and 16 until the desired number of vacuum sample tubes have been filled.

    Notes:

    If the access device needs to be replaced, use a hemostat to clamp the tubing between the needle and the Y-Sampling Site. Then, grasp base of Sampling Site with one hand and pull the access device out with the other hand. Firmly insert the new access device. Remove hemostat and continue sampling.
    If the access device is assembled such that the outer barrel is screwed onto the Luer, make sure to rotate clockwise upon removal to avoid barrel detaching from Luer.
    The access device can only be replaced one time.

    Precaution: When replacing the access device, be careful to avoid contact with any blood droplets on the Luer or Sampling Site. Discard used access device appropriately.

    18.
    Release remaining pressure on donor’s arm.
    19.
    If desired, apply hemostat to donor tubing between needle and Y-Sampling Site.
    20.
    Withdrawal of Needle (see Figure 3)

    Precaution: The needle guard must be held stationary while the needle is withdrawn into it.

    a)
    Place folded sterile gauze over puncture site and hold in place with finger tip without exerting pressure.
    b)
    Hold sides of needle guard near the front, between the index finger and thumb. Pull the tubing smoothly until the needle is locked into the needle guard.
    c)
    Confirm the needle lock by:
    Listen for the 2nd “click” as the needle is drawn into the needle guard.
    Ensure the tubing cannot be pulled through the needle guard.
    21.
    Strip blood from donor tubing into primary container, mix and allow the tubing to refill; repeat once.
    22.
    Seal at X marks on donor tubing to provide numbered aliquots of anticoagulated blood for typing or crossmatching.

    Note: Step 23 may be performed prior to step 21or 22 if desired.

    23.
    Remove and discard the Y-Sampling Site and the DONORCARE Needle Guard into an appropriate biohazardous waste container following established procedures.
    24.
    Component Preparation:
    If a platelet concentrate is to be prepared, it should be separated from the Red Blood Cells within 8 hours after blood collection.
    Fresh Frozen Plasma should be separated from the Red Blood Cells and placed in the freezer at -18°C or colder within 8 hours after blood collection.
    ADSOL™ Red Cell Preservation Solution should be added to the Red Blood Cells immediately after the removal of plasma. Preparation of AS-1 Red Blood Cells may vary depending on processing option selected:
    a)
    Within 8 hours of blood collection if whole blood is held at ambient temperature.
    b)
    Within 3 days of blood collection if whole blood is refrigerated.
    25.
    Centrifuge primary and secondary containers to prepare CPD Red Blood Cells.
    26.
    Place primary container in plasma extractor and express plasma into empty TRANSFER-PACK™ container by releasing pressure plate and opening closure in tubing of primary container.
    27.
    When desired amount of plasma has been removed, clamp tubing between Y and plasma container.
    28.
    Suspend ADSOL Red Cell Preservation Solution Container, open closure in tubing and drain contents into primary container of CPD Red Blood Cells. Clamp tubing.
    29.
    Hermetically seal and separate transfer tubing between the Y-connector and primary container. Be careful to avoid fluid splatter. For Double BLOOD-PACK unit codes, discard ADSOL solution container. For other ADSOL codes, the empty solution container may be used as a TRANSFER-PACK container for further component preparation.
    30.
    Mix ADSOL Red Cell Preservation Solution and red cells thoroughly.
    31.
    Store suspended AS-1 Red Blood Cells between 1 and 6° C.
    32.
    Infuse AS-1 Red Blood Cells within 42 days of collection.
    Representative Product Drawings

    Store at Controlled Room Temperature.
    USP Definition of “Controlled Room Temperature”
    United States Pharmacopeia, General Notices.
    United States Pharmacopeial Convention, Inc.
    12601 Twinbrook Parkway, Rockville, MD

    logoFenwal, Inc.
    Lake Zurich, IL 60047 USA
    1-800-933-6925
    Made in USA

    07-19-07-484   REV: A
    09/2012

    FENWAL, BLOOD-PACK, ADSOL and TRANSFER-PACK are trademarks of Fenwal, Inc.

    DONORCARE is a trademark of ITL Corporation.

    logoManufacturer

    © 2012 Fenwal, Inc. All rights reserved.

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  • PACKAGE/LABEL DISPLAY PANEL

    Code 4R3459

    15 Units

    Fenwal™

    Anticoagulant Citrate Phosphate Dextrose Solution, USP (CPD) BLOOD-PACK™ Unit; TRANSFER-PACK™ Container with ADSOL™ Red Cell Preservation Solution

    Triple For the Collection and Processing of 500 mL Blood

    Y-Sampling Site, DONORCARE™ Needle Guard, 16 ga. Ultra Thin Wall Needle

    Rx only

    Each unit consists of a PL 146 Plastic primary container with 70 mL of CPD solution containing 1.84 g Sodium Citrate (dihydrate) USP, 1.78 g Dextrose (monohydrate) USP, 209 mg Citric Acid (anhydrous) USP, 155 mg Monobasic Sodium Phosphate (monohydrate) USP, pH may have been adjusted with sodium hydroxide; one 400 mL PL 2209 Plastic TRANSFER-PACK container with 110 mL of ADSOL Red Cell Preservation Solution containing 2.42 g Dextrose (monohydrate) USP, 990 mg Sodium Chloride USP, 825 mg Mannitol USP, 30 mg Adenine USP; one empty 400 mL PL 2209 Plastic TRANSFER-PACK container.

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

    Store at Controlled Room Temperature (refer to direction insert).

    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:
    I)
    Units are not removed from foil pouch, or
    II)
    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.

    FENWAL, BLOOD-PACK, ADSOL and TRANSFER-PACK are trademarks of Fenwal, Inc.

    DONORCARE is a trademark of ITL Corporation.

    logoFenwal, Inc.
    Lake Zurich, IL 60047 USA

    Made in USA

    07-28-05-611    REV: A

    Anticoagulant Citrate Phosphate Dextrose Solution, USP (CPD) BLOOD-PACK™ Unit; TRANSFER-PACK™ Container with ADSOL™ Red Cell Preservation Solution label
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  • INGREDIENTS AND APPEARANCE
    ADSOL RED CELL PRESERVATION SOLUTION SYSTEM IN PLASTIC CONTAINER (PL 146 PLASTIC) 
    anticoagulant citrate phosphate dextrose (cpd) solution and adsol preservation solution kit
    Product Information
    Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0942-6445
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:0942-6445-03 1 in 1 KIT
    Quantity of Parts
    Part # Package Quantity Total Product Quantity
    Part 1 1 BAG 70 mL
    Part 2 1 BAG 110 mL
    Part 1 of 2
    CPD 
    citrate phosphate dextrose solution
    Product Information
    Route of Administration INTRAVENOUS
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Trisodium Citrate Dihydrate (UNII: B22547B95K) (Anhydrous Citric Acid - UNII:XF417D3PSL) Anhydrous Citric Acid 1.84 g  in 70 mL
    Dextrose Monohydrate (UNII: LX22YL083G) (ANHYDROUS DEXTROSE - UNII:5SL0G7R0OK) Dextrose Monohydrate 1.78 g  in 70 mL
    Anhydrous Citric Acid (UNII: XF417D3PSL) (Anhydrous Citric Acid - UNII:XF417D3PSL) Anhydrous Citric Acid 209 mg  in 70 mL
    Sodium Phosphate, Monobasic, Monohydrate (UNII: 593YOG76RN) (PHOSPHATE ION - UNII:NK08V8K8HR) Sodium Phosphate, Monobasic, Monohydrate 155 mg  in 70 mL
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 70 mL in 1 BAG
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    NDA BN811104 03/01/2007
    Part 2 of 2
    ADSOL RED CELL PRESERVATION SOLUTION SYSTEM 
    adsol red cell preservation solution solution
    Product Information
    Route of Administration INTRAVENOUS
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Dextrose Monohydrate (UNII: LX22YL083G) (ANHYDROUS DEXTROSE - UNII:5SL0G7R0OK) Dextrose Monohydrate 2.42 g  in 110 mL
    Sodium Chloride (UNII: 451W47IQ8X) (SODIUM CATION - UNII:LYR4M0NH37) Sodium Chloride 990 mg  in 110 mL
    Mannitol (UNII: 3OWL53L36A) (Mannitol - UNII:3OWL53L36A) Mannitol 825 mg  in 110 mL
    Adenine (UNII: JAC85A2161) (Adenine - UNII:JAC85A2161) Adenine 30 mg  in 110 mL
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 110 mL in 1 BAG
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    NDA BN811104 03/01/2007
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    NDA BN811104 03/01/2007
    Labeler - Fenwal, Inc. (794519020)
    Establishment
    Name Address ID/FEI Business Operations
    Fenwal International 091164590 MANUFACTURE(0942-6445)
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