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 16, 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

    Integral Donor Tube (IDT)

    Use aseptic technique.

    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 labeled volume of blood. Anticoagulant volume is sufficient for labeled volume ± 10%.
    10.
    Apply hemostat to donor tubing.
    11.
    Release pressure on donor’s arm and withdraw needle.
    12.
    Slide sample tube onto needle until stopper is punctured. Release hemostat to fill sample tube.
    13.
    To fill additional tubes, apply hemostat to donor tubing and repeat step 11.
    14.
    Seal donor tubing between hemostat and primary container. Dispose of needle and tubing appropriately.
    15.
    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.
    16.
    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.
    17.
    Centrifuge primary and secondary containers to prepare CPD red blood cells.
    18.
    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 5)).
    19.
    When desired amount of plasma has been removed, clamp tubing between Y and plasma container.
    20.
    Suspend ADSOL™ red cell preservation solution container, break cannula (Figure 5) and drain contents into primary container of CPD red blood cells. Clamp tubing.
    21.
    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.
    22.
    Mix ADSOL solution and red cells thoroughly.
    23.
    Store suspended red blood cells between 1 and 6°C.
    24.
    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.

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

    Definition of Symbols:

    logoManufacturer

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

    Made in USA

    Imported and distributed in India by:
    Fenwal India Pvt Ltd
    Upper Ground Floor, Tower B
    DLF Building No. 10, DLF Cyber City
    DLF Phase-II, Gurgaon 122 002, Haryana, India
    Import License No.: FF-504-14890

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

    07-19-04-580
    REV: A
    03/2010

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

    © 2010 Fenwal, Inc. All rights reserved.

    Representative Product Drawings
  • PACKAGE/LABEL DISPLAY PANEL

    R4R7641B

    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 accompanying directions for use. Sterile, non-pyrogenic fluid path. Steam sterilized.

    Single use only. Do not vent. Do not use if there is any visible evidence of deterioration.

    Dispose of container appropriately. Store at Controlled Room Temperature (refer to direction insert).

    Unused packs in open foil pouch may be kept 60 days by folding and securing open end of foil pouch, to prevent possible loss of moisture.

    Direct handling of product surfaces prior to extended storage in the foil pouch, 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.

    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

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

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

    07-28-04-578   REV: A

    Imported and distributed in India by:
    Fenwal India Pvt Ltd
    Upper Ground Floor, Tower B
    DLF Building No. 10, DLF Cyber City
    DLF Phase-II, Gurgaon 122 002, Haryana, India
    Import License No.: FF-504-14890
    MRP Rs. 410 (Inclusive of all taxes)

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

    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:0942-6495
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0942-6495-031 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
    NDABN81110405/25/2010
    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
    NDABN81110405/25/2010
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDABN81110405/25/2010
    Labeler - Fenwal, Inc. (794519020)
    Establishment
    NameAddressID/FEIBusiness Operations
    Fenwal International091164590MANUFACTURE(0942-6495)