Label: BSS PLUS- balanced salt solution enriched with bicarbonate, dextrose, and glutathione kit

  • NDC Code(s): 0065-0800-50
  • Packager: Alcon Laboratories, Inc.
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: New Drug Application

Drug Label Information

Updated October 5, 2020

If you are a consumer or patient please visit this version.

  • DESCRIPTION

    DESCRIPTION: BSS PLUS® is a sterile intraocular irrigating solution for use during all intraocular surgical procedures, including those requiring a relatively long intraocular perfusion time (e.g., pars plana vitrectomy, phacoemulsification, extracapsular cataract extraction/lens aspiration, anterior segment reconstruction, etc.). The solution does not contain a preservative and should be prepared just prior to use in surgery.

    Part I: Part I is a sterile 480 mL solution in a 500 mL single-dose bottle to which the Part II concentrate is added. Each mL of Part I contains: sodium chloride 7.44 mg, potassium chloride 0.395 mg, dibasic sodium phosphate 0.433 mg, sodium bicarbonate 2.19 mg, hydrochloric acid and/or sodium hydroxide (to adjust pH), in water for injection.

    Part II: Part II is a sterile concentrate in a 20 mL single-dose vial for addition to Part I. Each mL of Part II contains: calcium chloride dihydrate 3.85 mg, magnesium chloride hexahydrate 5 mg, dextrose 23 mg, glutathione disulfide (oxidized glutathione) 4.6 mg, in water for injection.

    After addition of BSS PLUS Part II to the Part I bottle, each mL of the reconstituted product contains: sodium chloride 7.14 mg, potassium chloride 0.38 mg, calcium chloride dihydrate 0.154 mg, magnesium chloride hexahydrate 0.2 mg, dibasic sodium phosphate 0.42 mg, sodium bicarbonate 2.1 mg, dextrose 0.92 mg, glutathione disulfide (oxidized glutathione) 0.184 mg, hydrochloric acid and/or sodium hydroxide (to adjust pH), in water for injection.

    The reconstituted product has a pH of approximately 7.4. Osmolality is approximately 305 mOsm.

  • CLINICAL PHARMACOLOGY

    CLINICAL PHARMACOLOGY: None of the components of BSS PLUS are foreign to the eye, and BSS PLUS has no pharmacological action. Human perfused cornea studies have shown BSS PLUS to be an effective irrigation solution for providing corneal detumescence and maintaining corneal endothelial integrity during intraocular perfusion. An in vivo study in rabbits has shown that BSS PLUS is more suitable than normal saline or Balanced Salt Solution for intravitreal irrigation because BSS PLUS contains the appropriate bicarbonate, pH, and ionic composition necessary for the maintenance of normal retinal electrical activity. Human in vivo studies have demonstrated BSS PLUS to be safe and effective when used during surgical procedures such as pars plana vitrectomy, phacoemulsification, cataract extraction/lens aspiration, anterior segment reconstruction. No differences have been observed between adults and pediatric patients following use of this drug product.

  • INDICATIONS & USAGE

    INDICATIONS AND USAGE: BSS PLUS is indicated for use as an intraocular irrigating solution during intraocular surgical procedures involving perfusion of the eye.

  • CONTRAINDICATIONS

    CONTRAINDICATIONS: There are no specific contraindications to the use of BSS PLUS; however, contraindications for the surgical procedure during which BSS PLUS is to be used should be strictly adhered to.

  • WARNINGS

    WARNINGS: For IRRIGATION during ophthalmic surgery only. Not for injection or intravenous infusion. Do not use unless product is clear, seal is intact, vacuum is present and container is undamaged. Do not use if product is discolored or contains a precipitate.

  • PRECAUTIONS

    PRECAUTIONS: DO NOT USE BSS PLUS UNTIL PART I IS FULLY RECONSTITUTED WITH PART II. Discard unused contents. BSS PLUS does not contain a preservative; therefore, do not use this container for more than one patient. DISCARD ANY UNUSED PORTION SIX HOURS AFTER PREPARATION. 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 BSS PLUS was used as an irrigating solution. As in all surgical procedures appropriate measures should be taken to minimize trauma to the cornea and other ocular tissues.

  • SPL UNCLASSIFIED SECTION

    Preparation: Reconstitute BSS PLUS® Intraocular Irrigating Solution just prior to use in surgery. Follow the same strict aseptic procedures in the reconstitution of BSS PLUS as is used for intravenous additives. Remove the blue flip-off seal from the BSS PLUS Part I (480 mL) bottle. Remove the blue flip-off seal from the BSS PLUS Part II (20 mL) vial. Clean and disinfect the rubber stoppers on both containers by using sterile alcohol wipes. Transfer the contents of the Part II vial to the Part I bottle using a BSS PLUS Vacuum Transfer Device (provided). An alternative method of solution transfer may be accomplished by using a 20 mL syringe to remove the Part II solution from the vial and transferring exactly 20 mL to the Part I container through the outer target area of the rubber stopper. An excess volume of Part II is provided in each vial. Gently agitate the contents to mix the solution. Place a sterile cap on the bottle. Remove the tear-off portion of the label. Record the time and date of reconstitution and the patient's name on the bottle label.

  • GERIATRIC USE

    Geriatric Use: No overall differences in safety or effectiveness have been observed between elderly and younger patients.

  • ADVERSE REACTIONS

    ADVERSE REACTIONS: Postoperative inflammatory reactions as well as incidents of corneal edema and corneal decompensation have been reported. Their relationship to the use of BSS PLUS has not been established.

  • OVERDOSAGE

    OVERDOSAGE: The solution has no pharmacological action and thus no potential for overdosage. However, as with any intraocular surgical procedure, the duration of intraocular manipulation should be kept to a minimum.

  • DOSAGE & ADMINISTRATION

    DOSAGE AND ADMINISTRATION: The solution should be used according to the standard technique employed by the operating surgeon. Use an administration set with an air-inlet in the plastic spike since the bottle does not contain a separate airway tube. Follow the directions for the particular administration set to be used. Insert the spike aseptically into the bottle through the center target area of the rubber stopper. Allow the fluid to flow to remove air from the tubing before intraocular irrigation begins. If a second bottle is necessary to complete the surgical procedure, ensure that the vacuum is vented from the second bottle BEFORE attachment to the administration set.

  • HOW SUPPLIED

    HOW SUPPLIED: BSS PLUS is supplied in two packages for reconstitution prior to use: a 500 mL glass bottle containing 480 mL (Part I) and a 20 mL glass vial (Part II); both using grey butyl stoppers and aluminum seals with polypropylene flip-off caps. See the PRECAUTIONS section regarding reconstitution of the solution.

    NDC 0065-0800-50.

    1. Remove the blue flip-off seal from the BSS PLUS® Part I (480 mL) bottle. Remove the blue flip-off seal from the BSS PLUS Part II (20 mL) vial. Prepare the stoppers on both parts by using sterile alcohol wipes.
    2. Peel open a BSS PLUS Vacuum Transfer Device package (supplied) and remove the sterile transfer spike.

      NOTE: This device is vented permitting air to enter vial during solution transfer, thereby preventing the creation of a vacuum inside the vial. An air-inlet filter is provided to protect the system. Do not remove the air-inlet filter.
    3. Remove protector from the white plastic piercing pin.
    4. Firmly grasp device from behind the flange and insert the white plastic piercing pin into the upright rubber stopper of the BSS PLUS Part II (20 mL) vial.
    5. Remove guard from filter needle. Firmly grasp vial in the palm of one hand and with thumb and index finger, hold plastic flange against top of vial.
    6. Invert vial and immediately insert filter needle into the outer target of the rubber stopper of the BSS PLUS Part I (480 mL) bottle.

      (See illustration.)
    7. Fluid will automatically transfer from the vial into the large vacuum bottle unless filter becomes occluded or loss of vacuum occurs. NOTE: An excess amount of BSS PLUS Part II is provided in each vial. A non-transferred solution residual of approximately 0.3 mL can be expected to remain in the vial.
    8. Immediately remove needle from the BSS PLUS Part I container and discard it after solution transfer has been completed.
    9. Place a sterile safety cap over the rubber stopper of Part I if the solution is not going to be used immediately. Mix the solution gently until uniform. Peel off the right-hand side of Part I bottle label (fully reconstituted BSS PLUS Solution). Record the patient’s name and the date and time of reconstitution. BSS PLUS Solution is now ready for use.

    CAUTION: Reconstituted BSS PLUS Solution must be used within six hours of mixing. Discard any solution which has aged beyond that time. Never use the same bottle of BSS PLUS Solution on more than one patient.

    Alternative Transfer Method
    If preferred, the contents of the BSS PLUS Part II component may be aspirated with an 18-gauge cannula attached to a 20 mL syringe and then transferred into the Part I bottle.

    Alcon®
    a Novartis company


    Distributed by:
    Alcon Laboratories, Inc.
    Fort Worth, Texas 76134 USA

    Revised: November 2015

    9012661-1115

  • STORAGE AND HANDLING

    Storage: Store Part I and Part II at 2° - 25°C (36° - 77° F). Discard prepared solution after six hours.

  • INSTRUCTIONS FOR USE

    BSS PLUS®
    STERILE INTRAOCULAR IRRIGATING SOLUTION
    (balanced salt solution enriched with bicarbonate, dextrose, and glutathione)

    RECONSTITUTION INSTRUCTIONS

    Hanger Device

    DIRECTIONS: Use Aseptic Technique

    1. Remove the blue flip-off seal from the BSS PLUS® Part I (480 mL) bottle. Remove the blue flip-off seal from the BSS PLUS Part II (20 mL) vial. Prepare the stoppers on both parts by using sterile alcohol wipes.
    2. Peel open a BSS PLUS Vacuum Transfer Device package (supplied) and remove the sterile transfer spike.

      NOTE: This device is vented permitting air to enter vial during solution transfer, thereby preventing the creation of a vacuum inside the vial. An air-inlet filter is provided to protect the system. Do not remove the air-inlet filter.
    3. Remove protector from the white plastic piercing pin.
    4. Firmly grasp device from behind the flange and insert the white plastic piercing pin into the upright rubber stopper of the BSS PLUS Part II (20 mL) vial.
    5. Remove guard from filter needle. Firmly grasp vial in the palm of one hand and with thumb and index finger, hold plastic flange against top of vial.
    6. Invert vial and immediately insert filter needle into the outer target of the rubber stopper of the BSS PLUS Part I (480 mL) bottle. (See illustration.)
    7. Fluid will automatically transfer from the vial into the large vacuum bottle unless filter becomes occluded or loss of vacuum occurs. NOTE: An excess amount of BSS PLUS Part II is provided in each vial. A non-transferred solution residual of approximately 0.3 mL can be expected to remain in the vial.
    8. Immediately remove needle from the BSS PLUS Part I container and discard it after solution transfer has been completed.
    9. Place a sterile safety cap over the rubber stopper of Part I if the solution is not going to be used immediately. Mix the solution gently until uniform. Peel off the right-hand side of Part I bottle label (fully reconstituted BSS PLUS Solution). Record the patient’s name and the date and time of reconstitution. BSS PLUS Solution is now ready for use.

    CAUTION: Reconstituted BSS PLUS Solution must be used within six hours of mixing. Discard any solution which has aged beyond that time. Never use the same bottle of BSS PLUS Solution on more than one patient.

    Alternative Transfer Method
    If preferred, the contents of the BSS PLUS Part II component may be aspirated with an 18-gauge cannula attached to a 20 mL syringe and then transferred into the Part I bottle.

    Alcon®
    a Novartis company

    Distributed by:
    Alcon Laboratories, Inc.
    Fort Worth, Texas 76134 USA

    Revised: November 2015

    W9013858-1016

  • PRINCIPAL DISPLAY PANEL

    NDC 0065-0800-50

    500 mL
    Single Patient Use

    BSS PLUS®
    STERILE INTRAOCULAR IRRIGATING SOLUTION
    (balanced salt solution enriched with bicarbonate, dextrose, and glutathione)

    After addition of BSS PLUS®– Part II (20 mL), each mL contains: sodium chloride 7.14 mg, potassium chloride 0.38 mg, calcium chloride dihydrate 0.154 mg, magnesium chloride hexahydrate 0.2 mg, dibasic sodium phosphate 0.42 mg, sodium bicarbonate 2.1 mg, dextrose 0.92 mg, glutathione disulfide (oxidized glutathione) 0.184 mg, hydrochloric acid and/or sodium hydroxide (to adjust pH), in water for injection.

    pH Approx. 7.4 – Osmolality Approx. 305 mOsm/kg

    Rx Only

    WARNINGS: FOR IRRIGATION DURING OPHTHALMIC SURGERY ONLY. NOT FOR INJECTION OR INTRAVENOUS INFUSION. DO NOT USE UNLESS PRODUCT IS CLEAR, SEAL IS INTACT, VACUUM IS PRESENT AND CONTAINER IS UNDAMAGED. DO NOT USE IF PRODUCT IS DISCOLORED OR CONTAINS A PRECIPITATE.

    PRECAUTIONS: DO NOT USE BSS PLUS UNTIL PART I IS FULLY RECONSTITUTED WITH PART II.
                                   DISCARD UNUSED CONTENTS SIX HOURS AFTER PREPARATION.
                                   DO NOT USE THIS CONTAINER FOR MORE THAN ONE PATIENT.

    Reconstitute just prior to use in surgery.

    Alcon®
    a Novartis company

    Alcon Laboratories, Inc.
    Fort Worth, Texas 76134 USA
    ©2002-2003, 2015 Novartis

    Patient_____________________
    Reconstituted at _________________      AM/PM on_________________

    LOT:
    EXP.:

    SINGLE USE ONLY


    NDC 0065-0800-50
    480 mL

    BSS PLUS® PART I
    STERILE SOLUTION
    (For Reconstitution by Addition of BSS PLUS
    ® Concentrate Part II, 20 mL)*

    Each mL contains: sodium chloride 7.44 mg, potassium chloride 0.395 mg, dibasic sodium phosphate 0.433 mg, sodium bicarbonate 2.19 mg, hydrochloric acid and/or sodium hydroxide (to adjust pH), in water for injection.

    Rx Only

    Storage: Store at 2° - 25°C (36° - 77°F).

    WARNINGS: FOR IRRIGATION DURING OPHTHALMIC SURGERY ONLY AFTER RECONSTITUTION. DO NOT USE UNLESS PRODUCT IS CLEAR, SEAL IS INTACT, VACUUM IS PRESENT AND CONTAINER IS UNDAMAGED.

    NOT FOR INJECTION OR INTRAVENOUS INFUSION

    *Reconstitute just prior to use in surgery.  Remove this part of label after reconstitution. Read the Preparation and Administration sections of the package insert before reconstitution for important directions and precautions.

    H14138-1115

    Part I Label

    NDC 0065-0800-50

    20 mL

    BSS PLUS®
    CONCENTRATE PART II
    (Sterile Solution for Reconstitution)

    Alcon®
    Alcon Laboratories Inc.
    Fort Worth, Texas 76134 USA

    Each mL contains: calcium chloride dihydrate 3.85 mg, magnesium chloride hexahydrate 5 mg, dextrose 23 mg, glutathione disulfide (oxidized glutathione) 4.6 mg, in water for injection.

    For Addition to BSS PLUS® — Part I (480 mL) only.

    See Preparation section of package insert.

    WARNINGS: Not for injection or intravenous infusion – for reconstitution of irrigation solution only. Do not use unless product is clear, seal is intact and container is undamaged. Do not use if product is discolored or contains a precipitate.

    PRECAUTIONS: Discard unused contents. Do not use this container for more than one patient.

    Storage: Store at 2°-25°C (36°-77°F).

    Rx Only

    ©2002-2003, 2015 Novartis

    H14142-1115

    LOT:

    EXP.:

    Part II Label

    BSS Plus®
    STERILE IRRIGATING SOLUTION
    (balanced salt solution enriched with bicarbonate, dextrose, and glutathione)

    Carton Contents:

    1 Vial BSS PLUS® Concentrate Part II Sterile Solution for Reconstitution with BSS PLUS Part I Only
    1 BSS PLUS Vacuum Transfer Device
    1 BSS PLUS Product Package Insert

    WARNINGS: For IRRIGATION during ophthalmic surgery only. Not for injection or intravenous infusion. Do not use unless product is clear, seal is intact, vacuum is present and container is undamaged. Do not use if product is discolored or contains a precipitate.

    Stare at 2°-35°C (36°-77°F).
    Discard prepared solution after six hours.

    Alcon®
    a Novartis company

    Alcon Laboratories Inc. Fort Worth, Texas 76134 USA
    © 2002, 2013, 2015 Novartis

    PRECAUTIONS: DO NOT USE BSS PLUS® solution UNTIL PART I IS FULLY RECONSTITUTED WITH PART II. Discard unused contents. BSS PLUS does not contain a preservative; therefore, do not use this container for more than one patient.  DISCARD ANY UNUSED PORTION SIX HOURS AFTER PREPARATION. 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 BSS PLUS solution was used as an irrigating solutions. As in all surgical procedures, appropriate measures should be taken to minimize trauma to the cornea and other ocular tissues.

    LOT:
    EXP:

    9012435-0116

    Part II Carton
  • INGREDIENTS AND APPEARANCE
    BSS PLUS  
    balanced salt solution enriched with bicarbonate, dextrose, and glutathione kit
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:0065-0800
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0065-0800-501 in 1 PACKAGE; Type 0: Not a Combination Product06/28/1982
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 11 BOTTLE, GLASS 480 mL
    Part 21 VIAL, SINGLE-DOSE 20 mL
    Part 1 of 2
    PART 1  
    balanced salt solution enriched with bicarbonate, dextrose, and glutathione solution
    Product Information
    Route of AdministrationOPHTHALMIC
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Sodium Chloride (UNII: 451W47IQ8X) (Sodium Cation - UNII:LYR4M0NH37) Sodium Chloride7.44 mg  in 1 mL
    Potassium Chloride (UNII: 660YQ98I10) (Potassium Cation - UNII:295O53K152) Potassium Chloride0.395 mg  in 1 mL
    Sodium Phosphate, Dibasic (UNII: GR686LBA74) (Sodium Cation - UNII:LYR4M0NH37) Sodium Phosphate, Dibasic0.433 mg  in 1 mL
    Sodium Bicarbonate (UNII: 8MDF5V39QO) (Sodium Cation - UNII:LYR4M0NH37) Sodium Bicarbonate2.19 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    Hydrochloric Acid (UNII: QTT17582CB)  
    Sodium Hydroxide (UNII: 55X04QC32I)  
    Water (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1480 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA01846906/28/1982
    Part 2 of 2
    PART II  
    calcium chloride, magnesium chloride, dextrose, and glutathione concentrate
    Product Information
    Route of AdministrationOPHTHALMIC
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Calcium Chloride (UNII: M4I0D6VV5M) (Calcium Cation - UNII:2M83C4R6ZB) Calcium Chloride3.85 mg  in 1 mL
    Magnesium Chloride (UNII: 02F3473H9O) (Magnesium Cation - UNII:T6V3LHY838) Magnesium Chloride5 mg  in 1 mL
    Dextrose (UNII: IY9XDZ35W2) (Dextrose - UNII:IY9XDZ35W2) Dextrose23 mg  in 1 mL
    Oxiglutatione (UNII: ULW86O013H) (Oxiglutatione - UNII:ULW86O013H) Oxiglutatione4.6 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    120 mL in 1 VIAL, SINGLE-DOSE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA01846906/28/1982
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA01846906/28/1982
    Labeler - Alcon Laboratories, Inc. (008018525)
    Registrant - Alcon Laboratories, Inc. (008018525)
    Establishment
    NameAddressID/FEIBusiness Operations
    Alcon Research LLC007672236manufacture(0065-0800)