PACKAGE 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.

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.

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.

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 surgeon's sterile irrigation needle. Push until firmly in place. Test assembly for proper function before use.

SPL UNCLASSIFIED SECTION.


Rx only

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 60045 BLA0N Rev. 10/16

DESCRIPTION SECTION.


DESCRIPTION BALANCED SALT SOLUTION is a sterile physiological solution containing calcium chloride (CaCl22H2O), magnesium chloride (MgCl26H2O), potassium chloride (KCl), sodium acetate (C2H3NaO23H2O), sodium chloride (NaCl) and sodium citrate (C6H5Na3O72H2O). 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.

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.

CLINICAL PHARMACOLOGY SECTION.


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

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 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.