HOW SUPPLIED SECTION.
HOW SUPPLIED Balanced Salt Solution Sterile Irrigating Solution is supplied in a glass bottle using a gray butyl stopper and aluminum closure with a tear tab. NDC REF Size Balanced Salt Solution Sterile Irrigating Solution 0264-2514-10 S2514-10 500 mL
SPL UNCLASSIFIED SECTION.
Rx Only Issued:November 2009 B. Braun Medical Inc. Irvine, CA 92614-5895 USA Made in USA Y36-002-712
DESCRIPTION Balanced Salt Solution 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 (CaCl22H2O) 0.048%, magnesium chloride hexahydrate (MgCl26H2O) 0.03%, sodium acetate trihydrate (C2H3NaO23H2O) 0.39%, sodium citrate dihydrate (C6H5Na3O72H2O) 0.17%, sodium hydroxide and/or hydrochloric acid (to adjust pH), and water for injection. The pH is approximately 7.0. 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 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 2025C (6877F). Excursions permitted to 1530C (5986F). [See USP Controlled Room Temperature.] Protect from freezing.
CLINICAL PHARMACOLOGY SECTION.
CLINICAL PHARMACOLOGY Balanced Salt Solution Sterile Irrigating Solution is an isotonic solution for use in irrigating tissues of the eyes.
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 bottle should not be used in more than one patient. The use of additives with this solution may cause corneal decompensation. This solution contains no preservative, unused contents should be discarded.
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 The irrigating solution should be used according to standard format for each surgical procedure. Note: Use an administration set with an air-inlet in the plastic spike since the bottle does not contain a separate airway tube. Follow directions of the particular administration set to be used. Remove the aluminum tab. Clean and disinfect the rubber stopper by using a sterile alcohol wipe. Insert the spike aseptically into the bottle through the target area of the rubber stopper. Allow the fluid to flow and remove air from the tubing before irrigation begins.
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL.
PRINCIPAL DISPLAY PANEL - 500 mL Label Balanced Salt Solution Sterile Irrigating Solution NDC 0264-2514-10 REF S2514-10 500 mL NOT FOR I.V. USE SINGLE USE ONLY B. Braun Medical Inc. Irvine, CA 92614-5895 USA Made in USA 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. pH: approximately 7.0 Osmolality: approximately 300 mOsm/Kg WARNINGS: 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. Discard unused contents. Do not use this container for more than one patient. Do no use additives with this product. Tissue damage could result if other drugs are added to product. See package insert. STERILE SINGLE DOSE UNIT Storage: Store at 20-25C (68-77F). Excursions permitted to 15-30C (59-86F). [See USP Controlled Room Temperature.] Protect from freezing. Rx Only Y37-002-363
ADVERSE REACTIONS SECTION.
ADVERSE REACTIONS Irrigation or any other trauma 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.