Sodium Chloride, Potassium Chloride, Calcium Chloride, Magnesium Chloride, Sodium Acetate, And Sodium Citrate
FDA Drug Information • Also known as: Balanced Salt
- Brand Names
- Balanced Salt
- Route
- IRRIGATION
- Dosage Form
- SOLUTION
- Product Type
- HUMAN PRESCRIPTION DRUG
Description
DESCRIPTION Balanced Salt Solution Sterile Irrigating Solution is a sterile balanced salt solution in 500 mL single-dose EXCEL ® flexible containers. Each mL contains 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 7.0. The osmolality is approximately 300 mOsm/Kg. The EXCEL ® plastic container is made from a multilayered film. The solution contact layer is a rubberized copolymer of ethylene and propylene. The container is nontoxic and biologically inert. The container-solution unit is a closed system and is not dependent upon entry of external air during administration. The container is overwrapped to provide protection from the physical environment and to provide an additional moisture barrier when necessary. Addition of medication should be accomplished using complete aseptic technique. The closure system has two ports; the one for the administration set has a tamper evident plastic protector and the other is a medication addition site. Refer to the Directions for Use of the container.
What Is Sodium Chloride, Potassium Chloride, Calcium Chloride, Magnesium Chloride, Sodium Acetate, And Sodium Citrate Used For?
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
DOSAGE AND ADMINISTRATION The irrigating solution should be used according to standard format for each surgical procedure. Follow directions of the particular administration set to be used. Allow the fluid to flow and remove air from the tubing before irrigation begins.
Side Effects (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.
Warnings and Precautions
WARNINGS NOT FOR INJECTION OR INTRAVENOUS INFUSION. Do not use unless overwrap is intact, 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 container should not be used in more than one patient. This solution contains no preservative, unused contents should be discarded.
How Supplied
HOW SUPPLIED Balanced Salt Solution Sterile Irrigating Solution is supplied in sterile and nonpyrogenic 500 mL single-dose EXCEL ® flexible containers with clear overwrap, 24 per case. Not made with natural rubber latex, PVC or DEHP. NDC REF Size Balanced Salt Solution Sterile Irrigating Solution 0264-1945-10 L2514 500 mL
About This Information
This drug information is sourced from FDA-approved labeling via the openFDA database. It is intended for educational and reference purposes only. This is not medical advice. Always consult your healthcare provider before making decisions about medication. Drug information may be updated by the FDA; check with your pharmacist for the most current information.
What are side effects?
Side effects are unwanted reactions that can occur when taking a medication. They range from mild (headache, nausea) to severe (allergic reactions, organ damage). Not everyone experiences side effects, and severity varies. Report any concerning side effects to your doctor.
What are drug interactions?
Drug interactions occur when a medication is affected by another drug, food, or supplement. Interactions can make medications less effective or cause dangerous side effects. Always tell your doctor about all medications and supplements you take.