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

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

Drug Label Information

Updated April 17, 2013

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

  • Instructions for Blood Collection Using (CPD) BLOOD-PACK™ Unit with an Integrally Attached Container of ADSOL™ Red Cell Preservation Solution.

    Rx Only

    BLOOD-PACK™ unit for the collection, processing and/or storage of blood or blood components.

    Contains Y-Sampling Site

    Use aseptic technique.

    CPD formula: Each 63 mL of CPD solution contains: 1.66 g Sodium citrate (dihydrate) USP; 1.61 g Dextrose (monohydrate) USP; 188 mg Citric acid (anhydrous) USP; 140 mg Monobasic sodium phosphate (monohydrate) USP; Water for Injection USP to 63 mL

    ADSOL™ formula: Each 100 mL of ADSOL solution contains: 900 mg Sodium chloride USP; 2.20 g Dextrose monohydrate USP; 27.0 mg Adenine USP; 750 mg Mannitol USP; Water for Injection USP to 100 mL.

    Caution: Do not use unless the solutions are clear.

    1.
    Identify BLOOD-PACK unit using appropriate donor identification system.
    2.
    Adjust donor scale to desired collection weight/volume.
    3.
    Suspend primary container from donor scale as far as possible below donor arm and clamp donor tubing with hemostat.
    4.
    Apply pressure to donor’s arm and disinfect site of venipuncture.
    5.
    If blood pressure cuff is used, inflate to approximately 60 mm Hg.
    6.
    Remove needle cover per instructions below:
    a)
    Hold the needle hub upwards. With the other hand, grasp the base of the needle cover (Figure 1), twist approximately 1/4 turn to break tamper evident seal (Figure 2).
    b)
    Remove needle cover (Figure 3), be careful not to drag cover across the needle point (Figure 4).
    7.
    Perform venipuncture, appropriately secure donor needle and/or tubing and release hemostat.
    8.
    Mix blood and anticoagulant at several intervals during collection and immediately after collection.
    9.
    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%.
    10.
    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.

    11.
    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 12 - 20 within approximately 4 minutes after sealing the donor tubing to avoid possible clot formation in the tubing.

    12.
    To collect samples, insert the access device by pushing firmly into the Y-Sampling Site until the membrane seal is penetrated (see Figure 5).

    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.

    13.
    Open the cap on the access device (if applicable).
    14.
    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.
    15.
    Allow vacuum sample tube to fill with blood then remove from the access device.
    16.
    Repeat steps 14 and 15 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.

    17.
    Release remaining pressure on donor’s arm.
    18.
    If desired, apply hemostat to donor tubing between needle and Y-Sampling Site.
    19.
    Withdraw the needle.
    20.
    Preparation of AS-1 Red Blood Cells may vary depending on processing option selected:
    a)
    After removal of plasma from freshly collected blood.
    b)
    Within 8 hours of blood collection if whole blood is held at ambient temperature.
    c)
    Within 3 days of collection if blood is refrigerated immediately following collection.
    21.
    Centrifuge primary and secondary containers to prepare CPD Red Blood Cells.
    22.
    Place primary container in plasma extractor and express plasma into empty TRANSFER-PACK™ container by releasing pressure plate and breaking cannula. (To break cannula, grasp the base of the cannula with one hand. With the other hand grasp the top of the cannula and bend 90° in one direction then 180° in opposite direction (Figure 6)).
    23.
    When desired amount of plasma has been removed, clamp tubing between Y and plasma container.
    24.
    Suspend ADSOL™ red cell preservation solution container, break cannula (Figure 6) and drain contents into primary container of CPD Red Blood Cells. Clamp tubing.
    25.
    Seal transfer tubing in three places near primary container and cut the middle seal, being careful to avoid fluid splatter. For Double BLOOD-PACK unit codes, discard ADSOL solution container. For other ADSOL codes, the empty solution container may now be used as a TRANSFER-PACK container for further component preparation.
    26.
    Mix ADSOL solution and red cells thoroughly.
    27.
    Store suspended AS-1 Red Blood Cells between 1 and 6°C.
    28.
    Infuse AS-1 Red Blood Cells within 42 days of collection.

    For further processing, use standard component processing and storage techniques.

    Dispose of containers and materials into appropriate biohazardous waste containers following established procedures.

    Single use only. Sterile, non-pyrogenic fluid path. Store at Controlled Room Temperature.

    Representative Product Drawings
    Representative Product Drawings

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

    logoManufactured by:
    Fenwal International, Inc.
    Road 357, Km. 0.8
    Maricao, PR 00606

    Made in USA

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

    07-19-05-702    REV: A 03/2011

    © 2011 Fenwal, Inc. All rights reserved.

  • PACKAGE/LABEL DISPLAY PANEL

    N4R6346

    6 Units

    Fenwal™

    Triple BLOOD-PACK™ Unit CPD/ADSOL™

    PL 146
    PL 1240
    Plastic

    Rx only

    Triple BLOOD-PACK unit consisting of a primary pack containing 63 mL of CPD anticoagulant solution for collection of 450 mL of blood, one TRANSFER-PACK containing 100 mL of ADSOL solution and one TRANSFER-PACK without solution. 16 gauge needle.

    See instructions for use. Sterile, non-pyrogenic fluid path. Steam sterilized. Single use only. Do not vent. Do not use if there is any visible sign of deterioration. Dispose of container appropriately. Store at Controlled Room Temperature (refer to direction insert). Unused packs in open pouches may be kept 60 days by folding and securing end of pouch, to prevent loss of moisture.

    Direct handling of product surfaces prior to extended storage in the foil pack may result in mold growth.

    Units removed from the foil pouch must be used within 4 days (96 hours). Units out of the foil pouch for longer than 4 days must be discarded.

    CPD formula: Each 63 mL of CPD solution contains: 1.66 g, Sodium citrate (dihydrate), USP, 1.61 g Dextrose (monohydrate), USP, 188 mg Citric acid (anhydrous), USP, 140 mg Monobasic sodium phosphate (monohydrate), USP. Water for Injection USP to 63 mL

    ADSOL formula: Sodium chloride 900 mg, USP, Dextrose monohydrate 2.20 g, USP, Adenine 27.0 mg, USP, Mannitol 750 mg, USP. Water for Injection USP to 100 mL.

    logoManufactured by:
    Fenwal International, Inc.
    Road 357, Km. 0.8
    Maricao, PR 00606

    Made in USA

    07-28-05-404    REV: A

    Imported and distributed in Thailand by:
    Fenwal (Thailand) Ltd.
    17th Fl. Thanapoom Tower,
    1550 New Petchburi Rd., Makasan
    Rajthevi, Bangkok 10400
    Thailand

    Date of opening of pouch:

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

    Lot No.:

    Exp. date:

    Triple BLOOD-PACK™ Unit CPD/ADSOL™ label
  • 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 TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:0942-6501
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0942-6501-031 in 1 KIT
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 11 BAG 63 mL
    Part 21 BAG 100 mL
    Part 1 of 2
    CPD 
    citrate phosphate dextrose 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 Acid1.66 g  in 63 mL
    Dextrose Monohydrate (UNII: LX22YL083G) (ANHYDROUS DEXTROSE - UNII:5SL0G7R0OK) Dextrose Monohydrate1.61 g  in 63 mL
    Anhydrous Citric Acid (UNII: XF417D3PSL) (Anhydrous Citric Acid - UNII:XF417D3PSL) Anhydrous Citric Acid188 mg  in 63 mL
    Sodium Phosphate, Monobasic, Monohydrate (UNII: 593YOG76RN) (PHOSPHATE ION - UNII:NK08V8K8HR) Sodium Phosphate, Monobasic, Monohydrate140 mg  in 63 mL
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    163 mL in 1 BAG
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDABN81110403/04/2011
    Part 2 of 2
    ADSOL RED CELL PRESERVATION SOLUTION SYSTEM 
    adsol red cell preservation solution solution
    Product Information
    Route of AdministrationINTRAVENOUS
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Dextrose Monohydrate (UNII: LX22YL083G) (ANHYDROUS DEXTROSE - UNII:5SL0G7R0OK) Dextrose Monohydrate2.2 g  in 100 mL
    Sodium Chloride (UNII: 451W47IQ8X) (SODIUM CATION - UNII:LYR4M0NH37) Sodium Chloride900 mg  in 100 mL
    Mannitol (UNII: 3OWL53L36A) (Mannitol - UNII:3OWL53L36A) Mannitol750 mg  in 100 mL
    Adenine (UNII: JAC85A2161) (Adenine - UNII:JAC85A2161) Adenine27 mg  in 100 mL
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1100 mL in 1 BAG
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDABN81110403/04/2011
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDABN81110403/04/2011
    Labeler - Fenwal, Inc. (794519020)
    Establishment
    NameAddressID/FEIBusiness Operations
    Fenwal International091164590MANUFACTURE(0942-6501)