HAEMONETICS ADDITIVE SOLUTION FORMULA 3 (AS-3) (CITRIC ACID MONOHYDRATE, SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE, SODIUM CHLORIDE, ADENINE, ANHYDROUS DEXTROSE, TRISODIUM CITRATE DIHYDRATE) S

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  • HAEMONETICS ADDITIVE SOLUTION FORMULA 3 (AS-3) (CITRIC ACID MONOHYDRATE, SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE, SODIUM CHLORIDE, ADENINE, ANHYDROUS DEXTROSE, TRISODIUM CITRATE DIHYDRATE) S

HAEMONETICS ADDITIVE SOLUTION FORMULA 3 (AS-3) (CITRIC ACID MONOHYDRATE, SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE, SODIUM CHLORIDE, ADENINE, ANHYDROUS DEXTROSE, TRISODIUM CITRATE DIHYDRATE) S
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NDC 57826-462-03
Set ID e6775fa2-9f23-4d71-be07-1e9e4d6265d0
Category HUMAN PRESCRIPTION DRUG LABEL
Packager Haemonetics Corporation
Generic Name
Product Class Anti-coagulant
Product Number
Application Number BLA000127
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  • Additive Solution Formula 3 (AS-3) 300 mL

    Intended for use only with automated red cell apheresis devices. See Operator's Manual for additional Information and complete usage instructions. 

    Each 100 mL contains:

    Citric Acid (Monohydrate), USP  0.042 g
    Monobasic Sodium Phosphate (Monohydrate), USP  0.276 g
    Sodium Chloride, USP  0.410 g
    Adenine, USP  0.030  g
    Dextrose (Anhydrous), USP  1.000 g
    Sodium Citrate (Dihydrate), USP  0.588 g
    containing 15 mEq of Sodium.

  • CAUTION:


    Not for direct Intravenous infusion. The pouch is a moisture barrier. Do not use unless solution is clear and no leaks detected. Single use container. Discard unused portion.

  • STERILE,

    nonpryogenic fluid path. Rx only.

  • RECOMMENDED STORAGE:

    Room temperature (25 degree C/77 degree F). Avoid excessive heat. Protect from freezing.

  • CAUTION:

    L322, Rev. E - 01  Product code 462A  Haemonatics Corporation  Braintree, MA 02184 USA   Lot No.    Exp. Date.

  • PRINCIPAL DISPLAY PANEL

    HAEMONETICS Additive Solution Formula 3 (AS-3) 250 mL  Haemonatics Corporation  Braintree, MA 02184 USA

  • Product Label - Package

    Label

  • INGREDIENTS AND APPEARANCE
    HAEMONETICS ADDITIVE SOLUTION FORMULA 3 (AS-3) 
    citric acid monohydrate, sodium phosphate, monobasic, monohydrate, sodium chloride, adenine, anhydrous dextrose, trisodium citrate dihydrate solution
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:57826-462
    Route of AdministrationEXTRACORPOREAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) (ANHYDROUS CITRIC ACID - UNII:XF417D3PSL) ANHYDROUS CITRIC ACID4.2 mg  in 1 mL
    SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE (UNII: 593YOG76RN) (PHOSPHATE ION - UNII:NK08V8K8HR) SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE27.6 mg  in 1 mL
    SODIUM CHLORIDE (UNII: 451W47IQ8X) (CHLORIDE ION - UNII:Q32ZN48698, SODIUM CATION - UNII:LYR4M0NH37) SODIUM CHLORIDE41 mg  in 1 mL
    ADENINE (UNII: JAC85A2161) (ADENINE - UNII:JAC85A2161) ADENINE3 mg  in 1 mL
    ANHYDROUS DEXTROSE (UNII: 5SL0G7R0OK) (ANHYDROUS DEXTROSE - UNII:5SL0G7R0OK) ANHYDROUS DEXTROSE100 mg  in 1 mL
    TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K) (ANHYDROUS CITRIC ACID - UNII:XF417D3PSL) ANHYDROUS CITRIC ACID58.8 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:57826-462-03300 mL in 1 BAG; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDABN00012701/07/2013
    Labeler - Haemonetics Corporation (057827420)
    Establishment
    NameAddressID/FEIBusiness Operations
    Haemonetics Manufacturing Inc.078598396manufacture(57826-462)
    Establishment
    NameAddressID/FEIBusiness Operations
    Haemonetics Corporation942344649manufacture(57826-462)
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