Bss™

Bss™
SPL v13
SPL
SPL Set ID 28488c7b-cf6a-4a03-916f-cc66b3afdc57
Route
OPHTHALMIC
Published
Effective Date 2023-12-14
Document Type 34391-3 HUMAN PRESCRIPTION DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Sodium Cation (6.4 mg) Potassium Cation (0.75 mg) Calcium Cation (0.48 mg) Magnesium Cation (0.3 mg)
Inactive Ingredients
Sodium Hydroxide Hydrochloric Acid Water

Identifiers & Packaging

Marketing Status
NDA Active Since 1969-03-28

Description

BSS ™ Sterile Irrigating Solution is a sterile balanced salt solution, each mL containing sodium chloride (NaCl) 0.64%, potassium chloride (KCl) 0.075%, calcium chloride dihydrate (CaCl 2 •2H 2 O) 0.048%, magnesium chloride hexahydrate (MgCl 2 •6H 2 O) 0.03%, sodium acetate trihydrate (C 2 H 3 NaO 2 •3H 2 O) 0.39%, sodium citrate dihydrate (C 6 H 5 Na 3 O 7 •2H 2 O) 0.17%, sodium hydroxide and/or hydrochloric acid (to adjust pH), and water for injection. The pH is approximately 7.5. The osmolality is approximately 300 mOsm/Kg.

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.

Dosage and Administration

This irrigating solution should be used according to standard format for each surgical procedure. Follow directions of the particular administration set to be used. Remove the outer overwrap. Clean and disinfect the rubber stopper by using a sterile alcohol wipe. Insert the spike aseptically into the bag through the target area of the rubber stopper. Allow the fluid to flow and remove air from the tubing before irrigation begins.

Adverse Reactions

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

How Supplied

BSS ™ Sterile Irrigating Solution is supplied in a clear polypropylene bag using a grey butyl stopper and aluminum seal packaged in a clear, multilayered plastic outer overwrap. 500 mL in a bag: NDC 0065-1795-04. STORAGE:   Store at 36° - 77°F (2° - 25°C). Alcon Distributed by: Alcon Laboratories, Inc. Fort Worth, Texas 76134 USA © 2021 Alcon, Inc.


Medication Information

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.

Dosage and Administration

This irrigating solution should be used according to standard format for each surgical procedure. Follow directions of the particular administration set to be used. Remove the outer overwrap. Clean and disinfect the rubber stopper by using a sterile alcohol wipe. Insert the spike aseptically into the bag through the target area of the rubber stopper. Allow the fluid to flow and remove air from the tubing before irrigation begins.

Adverse Reactions

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

How Supplied

BSS ™ Sterile Irrigating Solution is supplied in a clear polypropylene bag using a grey butyl stopper and aluminum seal packaged in a clear, multilayered plastic outer overwrap. 500 mL in a bag: NDC 0065-1795-04. STORAGE:   Store at 36° - 77°F (2° - 25°C). Alcon Distributed by: Alcon Laboratories, Inc. Fort Worth, Texas 76134 USA © 2021 Alcon, Inc.

Description

BSS ™ Sterile Irrigating Solution is a sterile balanced salt solution, each mL containing sodium chloride (NaCl) 0.64%, potassium chloride (KCl) 0.075%, calcium chloride dihydrate (CaCl 2 •2H 2 O) 0.048%, magnesium chloride hexahydrate (MgCl 2 •6H 2 O) 0.03%, sodium acetate trihydrate (C 2 H 3 NaO 2 •3H 2 O) 0.39%, sodium citrate dihydrate (C 6 H 5 Na 3 O 7 •2H 2 O) 0.17%, sodium hydroxide and/or hydrochloric acid (to adjust pH), and water for injection. The pH is approximately 7.5. The osmolality is approximately 300 mOsm/Kg.

Warnings:
  • NOT FOR INJECTION OR INTRAVENOUS INFUSION.
  • 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.
  • SINGLE patient use only. The contents of this bag should not be used in more than one patient.
  • This solution contains no preservative, unused contents should be discarded.
Description:

BSS Sterile Irrigating Solution is a sterile balanced salt solution, each mL containing sodium chloride (NaCl) 0.64%, potassium chloride (KCl) 0.075%, calcium chloride dihydrate (CaCl2•2H2O) 0.048%, magnesium chloride hexahydrate (MgCl2•6H2O) 0.03%, sodium acetate trihydrate (C2H3NaO2•3H2O) 0.39%, sodium citrate dihydrate (C6H5Na3O7•2H2O) 0.17%, sodium hydroxide and/or hydrochloric acid (to adjust pH), and water for injection. The pH is approximately 7.5. The osmolality is approximately 300 mOsm/Kg.

Precautions:

Open under aseptic conditions only.



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 and edema following ocular surgery in which BSS Sterile Irrigating Solution was used as an irrigating solution.

How Supplied:

BSS Sterile Irrigating Solution is supplied in a clear polypropylene bag using a grey butyl stopper and aluminum seal packaged in a clear, multilayered plastic outer overwrap.

500 mL in a bag: NDC 0065-1795-04.

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

Alcon



Distributed by:

Alcon Laboratories, Inc.

Fort Worth, Texas 76134 USA

© 2021 Alcon, Inc.

Adverse Reactions:

Irrigation or any other trauma to the corneal endothelium may result in corneal swelling or bullous keratopathy.

Post-operative inflammatory reactions as well as incidents of corneal edema and corneal decompensation have been reported.

Clinical Pharmacology:

BSS Sterile Irrigating 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.

Principal Display Panel

SINGLE PATIENT USE ONLY



Rx Only



NDC 0065-1795-04



BSS

Sterile Irrigating Solution

(balanced salt solution)



Each mL contains: sodium chloride 0.64%, potassium chloride 0.075%, calcium chloride •2H2O 0.048%, magnesium chloride •6H2O 0.03%, sodium acetate •3H2O 0.39%, sodium citrate •2H2O 0.17%, sodium hydroxide and/or hydrochloric acid (to adjust pH), and water for injection. The pH is approximately 7.5. The osmolality is approximately 300 mOsm/Kg.



NOT FOR I.V. USE



Read accompanying insert.



WARNINGS: NOT FOR INJECTION OR INTRAVENOUS INFUSION. Do not use unless outer overwrap is intact, product is clear, seal is intact and bag is undamaged. Do not use if product is discolored or contains a precipitate. Discard unused contents. Do not use this bag for more than one patient.

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



STERILE        500 mL



Alcon



Alcon Laboratories, Inc.

Fort Worth, Texas 76134 USA



LOT:

EXP.:

MFD.:



300048948-0521

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



Do not use unless outer overwrap is intact.



9012629-1115

Dosage and Administration:

This irrigating solution should be used according to standard format for each surgical procedure. Follow directions of the particular administration set to be used. Remove the outer overwrap. Clean and disinfect the rubber stopper by using a sterile alcohol wipe. Insert the spike aseptically into the bag through the target area of the rubber stopper. Allow the fluid to flow and remove air from the tubing before irrigation begins.


Structured Label Content

Warnings: (WARNINGS:)
  • NOT FOR INJECTION OR INTRAVENOUS INFUSION.
  • 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.
  • SINGLE patient use only. The contents of this bag should not be used in more than one patient.
  • This solution contains no preservative, unused contents should be discarded.
Description: (DESCRIPTION:)

BSS Sterile Irrigating Solution is a sterile balanced salt solution, each mL containing sodium chloride (NaCl) 0.64%, potassium chloride (KCl) 0.075%, calcium chloride dihydrate (CaCl2•2H2O) 0.048%, magnesium chloride hexahydrate (MgCl2•6H2O) 0.03%, sodium acetate trihydrate (C2H3NaO2•3H2O) 0.39%, sodium citrate dihydrate (C6H5Na3O7•2H2O) 0.17%, sodium hydroxide and/or hydrochloric acid (to adjust pH), and water for injection. The pH is approximately 7.5. The osmolality is approximately 300 mOsm/Kg.

Precautions: (PRECAUTIONS:)

Open under aseptic conditions only.



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 and edema following ocular surgery in which BSS Sterile Irrigating Solution was used as an irrigating solution.

How Supplied: (HOW SUPPLIED:)

BSS Sterile Irrigating Solution is supplied in a clear polypropylene bag using a grey butyl stopper and aluminum seal packaged in a clear, multilayered plastic outer overwrap.

500 mL in a bag: NDC 0065-1795-04.

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

Alcon



Distributed by:

Alcon Laboratories, Inc.

Fort Worth, Texas 76134 USA

© 2021 Alcon, Inc.

Adverse Reactions: (ADVERSE REACTIONS:)

Irrigation or any other trauma to the corneal endothelium may result in corneal swelling or bullous keratopathy.

Post-operative inflammatory reactions as well as incidents of corneal edema and corneal decompensation have been reported.

Clinical Pharmacology: (CLINICAL PHARMACOLOGY:)

BSS Sterile Irrigating Solution is an isotonic solution for use in irrigating tissues of the eyes.

Indications and Usage: (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.

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

SINGLE PATIENT USE ONLY



Rx Only



NDC 0065-1795-04



BSS

Sterile Irrigating Solution

(balanced salt solution)



Each mL contains: sodium chloride 0.64%, potassium chloride 0.075%, calcium chloride •2H2O 0.048%, magnesium chloride •6H2O 0.03%, sodium acetate •3H2O 0.39%, sodium citrate •2H2O 0.17%, sodium hydroxide and/or hydrochloric acid (to adjust pH), and water for injection. The pH is approximately 7.5. The osmolality is approximately 300 mOsm/Kg.



NOT FOR I.V. USE



Read accompanying insert.



WARNINGS: NOT FOR INJECTION OR INTRAVENOUS INFUSION. Do not use unless outer overwrap is intact, product is clear, seal is intact and bag is undamaged. Do not use if product is discolored or contains a precipitate. Discard unused contents. Do not use this bag for more than one patient.

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



STERILE        500 mL



Alcon



Alcon Laboratories, Inc.

Fort Worth, Texas 76134 USA



LOT:

EXP.:

MFD.:



300048948-0521

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



Do not use unless outer overwrap is intact.



9012629-1115

Dosage and Administration: (DOSAGE AND ADMINISTRATION:)

This irrigating solution should be used according to standard format for each surgical procedure. Follow directions of the particular administration set to be used. Remove the outer overwrap. Clean and disinfect the rubber stopper by using a sterile alcohol wipe. Insert the spike aseptically into the bag through the target area of the rubber stopper. Allow the fluid to flow and remove air from the tubing before irrigation begins.


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