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 OPTIPAC™ Unit with an Integrally Attached Container of ADSOL™ Red Cell Preservation Solution

    Rx Only

    Opti-System

    Use aseptic technique

    Caution: Do not use unless the solutions are clear.

    1.
    Identify BLOOD-PACK™ OPTIPAC™ 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, or use tourniquet as applicable.
    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.
    If it is necessary, obtain whole anticoagulated blood samples for typing or crossmatching by returning donor tubing blood to the primary bag, mixing and allowing tubing to refill. Repeat once. Seal donor tubing at the desired intervals in order to obtain the desired total blood samples.
    12.
    Centrifuge primary and secondary bags in order to prepare CPD Red Blood Cells.
    13.
    Refer to the OPTIPRESS™ Blood Components Automated Extractor User Manual, in order to prepare the components.
    14.
    After separation, seal transfer tubing in three places near the primary bag and cut middle seal taking care to avoid fluid splatter.
    NOTE: In OPTIPAC Quadruple BLOOD-PACK unit, the empty transfer unit may be used for preparation of other components.
    15.
    Fill empty tubing of OPTIPAC AS-1 for red blood cells by stripping the tubing and mixing the AS-1 containter, twice, in order to ensure that the tubing is correctly filled. Seal on "X" marks on tubing in order to obtain red blood cells samples.
    16.
    Mix Adsol Solution and red cells thoroughly.
    17.
    Store suspended Red Blood Cells between 1 and 6 °C.

    For further processing, use standard techniques for component processing.

    Sterile, non-pyrogenic fluid path. Sterilized by steam. Single use only. Dispose of container appropriately.

    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

    Representative Product Drawings

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

    Made in USA

    07-19-05-015    REV: A
    07/2010

    Imported and distributed in Indonesia by:
    PT.Medquest Jaya Global
    Menara Salemba 6th Floor
    Jl.Salemba Raya Kav 5-5A
    Jakarta-Indonesia 10440
    Reg. No.: DEPKES RI AKL 20209902359

    Imported and distributed in Thailand by:
    Fenwal (Thailand) Ltd.
    17th Fl. Thanapoom Tower
    1550 New Petchburi Rd., Makasan
    Rajthevi, Bangkok 10400
    Thailand
    Reg. No.:

    Imported and distributed in Philippines by:
    Medlink Marketing
    Unit 404 Vicar’s Building,
    No.31 Visayas Ave.,
    Vasra, Quezon City 1100
    Philippines
    Reg. No.: DVR-5805

    logo– Manufacturer

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

    © 2010 Fenwal, Inc. All rights reserved.

  • PACKAGE/LABEL DISPLAY PANEL

    Code: A4R7473

    3 Units

    Fenwal™

    CPD/ADSOL™ BLOOD-PACK™ Unit Quadruple OPTIPAC™ Opti-System

    Rx only

    Each unit consists of a PL 146 bag containing 63 mL of Citrate, Phosphate and Dextrose Anticoagulant Solution (CPD) with 450 mL of capacity; a PL 146 transfer pack containing 100 mL of Adenine, Dextrose and Mannitol Solution (ADSOL), 450 mL of capacity; and two PL 1240 transfer packs, 400 mL of capacity.

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

    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 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.

    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.

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

    Made In USA

    Imported and distributed in Philippines by:
    Medlink Marketing
    Unit 404 Vicar’s Building,
    No.31 Visayas Ave.,
    Vasra, Quezon City 1100
    Philippines
    Reg No.: DVR-5805

    Imported and distributed in Indonesia by:
    PT.Medquest Jaya Global
    Menara Salemba 6th Floor
    Jl.Salemba Raya Kav 5-5A
    Jakarta-Indonesia 10440
    Reg No.: DEPKES RI AKL 20209902359

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

    07-28-05-041   REV: A

    Lot:

    Exp. Date:

    CPD/ADSOL™ BLOOD-PACK™ Unit Quadruple OPTIPAC™ Opti-System 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:0942-6499
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0942-6499-041 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
    NDABN81110409/28/2010
    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
    NDABN81110409/28/2010
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDABN81110409/28/2010
    Labeler - Fenwal, Inc. (794519020)