ADVERSE REACTIONS SECTION.

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.

CLINICAL PHARMACOLOGY SECTION.

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

DESCRIPTION SECTION.

DESCRIPTION. BALANCED SALT SOLUTION is 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 mL contains:Calcium Chloride(MW 147.02)0.48 mgMagnesium Chloride(MW 203.31)0.30 mgPotassium Chloride(MW 74.56)0.75 mgSodium Acetate(MW 136.08)3.90 mgSodium Chloride(MW 58.44)6.40 mgSodium Citrate(MW 294.10)1.70 mgHydrochloric Acid and/or Sodium Hydroxide added to adjust pH.Water for Injection7.0 pH and 300 mosm/kg osmolality.

DOSAGE & ADMINISTRATION SECTION.

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:Aseptically remove bottle from pouch by peeling backing.Snap on surgeons sterile irrigation needle. Push until firmly in place.Test assembly for proper function before use.. Aseptically remove bottle from pouch by peeling backing.. Snap on surgeons sterile irrigation needle. Push until firmly in place.. Test assembly for proper function before use.

HOW SUPPLIED SECTION.

HOW SUPPLIED:. NDC 17478-920-19 18 mL bottle. STORAGE: Store at 20 to 25C (68 to 77F) [see USP Controlled Room Temperature]. Avoid exposure to excessive heat and do not allow to freeze.AKORN Manufactured by: Akorn, Inc. Lake Forest, IL 60045BLA0N Rev. 10/16.

INDICATIONS & USAGE SECTION.

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.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL.

Principal Display Panel Text for Container Label:NDC 17478-920-19 Akorn LogoBALANCEDSALT SOLUTIONRx onlyNOT FOR INJECTIONOR INTRAVENOUS USE.18 mL Sterile Single Dose Bottle. Principal Display Panel Text for Container Label.

PRECAUTIONS SECTION.

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.

STORAGE AND HANDLING SECTION.

STORAGE: Store at 20 to 25C (68 to 77F) [see USP Controlled Room Temperature]. Avoid exposure to excessive heat and do not allow to freeze.AKORN Manufactured by: Akorn, Inc. Lake Forest, IL 60045BLA0N Rev. 10/16.

WARNINGS SECTION.

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 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.. 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 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.