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

ADSOL Red Cell Preservation Solution System in Plastic Container (PL 146 Plastic) by

Drug Labeling and Warnings

ADSOL Red Cell Preservation Solution System in Plastic Container (PL 146 Plastic) by is a Prescription medication manufactured, distributed, or labeled by Fenwal, Inc., Fenwal International. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

  • 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 A4R7703

    5 Units

    Fenwal™

    Quadruple BLOOD-PACK™ OPTIPAC™ Unit CPD/ADSOL™ OPTI-SYSTEM™

    Rx only

    Quadruple BLOOD-PACK OPTIPAC 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 two TRANSFER-PACK containers without solution. 16 gauge needle.

    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 (monohydrate,) USP - 750 mg Mannitol, USP - 27.0 mg Adenine, USP. 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 visible evidence of deterioration. Dispose of container properly.

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

    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, ADSOL, OPTIPAC and OPTI-SYSTEM are trademarks of Fenwal, Inc.

    07-28-05-406    REV: A

    Lot No.:

    Exp. Date:

    Quadruple BLOOD-PACK™ OPTIPAC™ Unit CPD/ADSOL™ 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: 0942-6502
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC: 0942-6502-041 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
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    163 mL in 1 BAG; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDABN81110401/11/2011
    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
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1100 mL in 1 BAG; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDABN81110401/11/2011
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDABN81110401/11/2011
    Labeler - Fenwal, Inc. (794519020)
    Establishment
    NameAddressID/FEIBusiness Operations
    Fenwal International, Inc.091164590MANUFACTURE(0942-6502)

  • © 2024 FDA.report
    This site is not affiliated with or endorsed by the FDA.