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BALANCED SALT (Akorn, Inc.)

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SOLUTION 1 BOTTLE, PLASTIC in 1 POUCH (17478-920-19) > 18 mL in 1 BOTTLE, PLASTIC Label Information

Complete BALANCED SALT Information

  • SPL UNCLASSIFIED SECTION

    Rx only


  • DESCRIPTION

    BALANCED SALT SOLUTION is a sterile physiological solution containing calcium chloride (CaCl2·2H2O), magnesium chloride (MgCl2·6H2O), potassium chloride (KCl), sodium acetate (C2H3NaO2·3H2O), sodium chloride (NaCl) and sodium citrate (C6H5Na3O7·2H2O). This solution is isotonic to ocular tissue and contains electrolytes required for normal cellular metabolic functions. Each 1 mL contains:

    Calcium Chloride (MW 147.02) 0.48 mg
    Magnesium Chloride (MW 203.31) 0.30 mg
    Potassium Chloride (MW 74.56) 0.75 mg
    Sodium Acetate (MW 136.08) 3.90 mg
    Sodium Chloride (MW 58.44) 6.40 mg
    Sodium Citrate (MW 294.10) 1.70 mg
    Hydrochloric Acid and/or Sodium Hydroxide added to adjust pH.
    Water for Injection
    7.0 pH and 300 mosm/kg osmolality.

  • CLINICAL PHARMACOLOGY

    Balanced Salt Solution is an isotonic solution for use in irrigating tissues of the eyes.


  • INDICATIONS AND USAGE

    For use as an extraocular and intraocular irrigating solution during ocular surgical procedure involving perfusion of the eye with an expected maximum duration of less than 60 minutes.


  • WARNINGS

    • NOT FOR INJECTION OR INTRAVENOUS INFUSION.
    • Do not use unless product is clear, seal is intact, container is undamaged.
    • Do not use if product is discolored or contains a precipitate.
    • SINGLE patient use only. The contents of this bottle should not be used in more than one patient.
    • This solution contains no preservative; unused contents should be discarded.

  • PRECAUTIONS

    Open under aseptic conditions only.

    Prior to use, check the following: tip should be firmly in place, irrigating needle should be properly seated; squeeze out several drops before inserting into anterior chamber. The needle should be removed from the anterior chamber prior to releasing pressure to prevent suction.

    Studies suggest that intraocular irrigating solutions which are iso-osmotic with normal aqueous fluids should be used with caution in diabetic patients undergoing vitrectomy since intraoperative lens changes have been observed.

    There have been reports of corneal clouding or edema following ocular surgery in which Balanced Salt Solution (Sterile Irrigating Solution) was used as an irrigating solution.


  • ADVERSE REACTIONS

    Irrigation or any other trauma to the corneal endothelium may result in corneal swelling or bullous keratopathy. Postoperative inflammatory reactions as well as incidents of corneal edema and corneal decompensation have been reported.


  • DOSAGE AND ADMINISTRATION

    18 mL bottle: The adaptor plug is designed to accept an irrigating needle. Tissues may be irrigated by attaching the needle to the bottle as explained below. External irrigation may be done without the irrigating needle.

    Method for Using Adaptor Plug for Ophthalmic Irrigating Needle:

    1. Aseptically remove bottle from pouch by peeling backing.
    2. Snap on surgeon's sterile irrigation needle. Push until firmly in place.
    3. Test assembly for proper function before use.

  • HOW SUPPLIED:

    NDC 17478-920-19 18 mL bottle

    STORAGE: Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Avoid exposure to excessive heat and do not allow to freeze.

    AKORN
    Manufactured by: Akorn, Inc.
    Lake Forest, IL 60045
    BLA0N Rev. 10/16


  • PRINCIPAL DISPLAY PANEL

    Principal Display Panel Text for Container Label:

    NDC 17478-920-19 Akorn Logo

    BALANCED

    SALT SOLUTION

    Rx only

    NOT FOR INJECTION

    OR INTRAVENOUS USE.

    18 mL Sterile Single Dose Bottle

    Principal Display Panel Text for Container Label

  • PRINCIPAL DISPLAY PANEL

    Principal Display Panel Text for Carton Label:

    NDC 17478-920-19 Akorn Logo

    BALANCED SALT SOLUTION

    30 Sterile Single Dose Bottles (18 mL each)

    NOT FOR INJECTION OR INTRAVENOUS USE.

    Principal Display Panel Text for Carton Label

  • INGREDIENTS AND APPEARANCE
    BALANCED SALT 
    calcium chloride, magnesium chloride, potassium chloride, sodium acetate, sodium chloride, sodium citrate solution
    Product Information
    Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:17478-920
    Route of Administration OPHTHALMIC
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Calcium Chloride (UNII: M4I0D6VV5M) (calcium cation - UNII:2M83C4R6ZB) Calcium Chloride 0.48 mg  in 1 mL
    Magnesium Chloride (UNII: 02F3473H9O) (magnesium cation - UNII:T6V3LHY838) Magnesium Chloride 0.3 mg  in 1 mL
    Potassium Chloride (UNII: 660YQ98I10) (POTASSIUM CATION - UNII:295O53K152) Potassium Chloride 0.75 mg  in 1 mL
    Sodium Acetate (UNII: 4550K0SC9B) (SODIUM CATION - UNII:LYR4M0NH37) Sodium Acetate 3.90 mg  in 1 mL
    Sodium Chloride (UNII: 451W47IQ8X) (SODIUM CATION - UNII:LYR4M0NH37) Sodium Chloride 6.40 mg  in 1 mL
    Sodium Citrate (UNII: 1Q73Q2JULR) (SODIUM CATION - UNII:LYR4M0NH37) Sodium Citrate 1.70 mg  in 1 mL
    Inactive Ingredients
    Ingredient Name Strength
    Hydrochloric Acid (UNII: QTT17582CB)  
    Sodium Hydroxide (UNII: 55X04QC32I)  
    Water (UNII: 059QF0KO0R)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:17478-920-19 1 in 1 POUCH 09/27/2006
    1 18 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    ANDA ANDA075503 09/27/2006
    Labeler - Akorn, Inc. (062649876)
    Establishment
    Name Address ID/FEI Business Operations
    Akorn, Inc. 155135783 MANUFACTURE(17478-920) , REPACK(17478-920) , ANALYSIS(17478-920) , LABEL(17478-920) , PACK(17478-920) , RELABEL(17478-920) , STERILIZE(17478-920)