Balanced Salt Solution Enriched With Bicarbonate, Dextrose, And Glutathione
FDA Drug Information • Also known as: Bss Plus
- Brand Names
- Bss Plus
- Dosage Form
- KIT
- Product Type
- HUMAN PRESCRIPTION DRUG
Description
DESCRIPTION BSS PLUS ® is a sterile intraocular irrigating solution for use during all intraocular surgical procedures, including those requiring a relatively long intraocular perfusion time (e.g., pars plana vitrectomy, phacoemulsification, extra capsular cataract extraction/lens aspiration, anterior segment reconstruction, etc.). The solution does not contain a preservative and should be prepared just prior to use in surgery. Part I: Part I is a sterile 480 mL solution in a 500 mL single-dose bag to which the Part II concentrate is added. Each mL of Part I contains: sodium chloride 7.44 mg, potassium chloride 0.395 mg, dibasic sodium phosphate 0.433 mg, sodium bicarbonate 2.19 mg, hydrochloric acid and/or sodium hydroxide (to adjust pH), in water for injection. Part II: Part II is a sterile concentrate in a 20 mL single-dose vial for addition to Part I. Each mL of Part II contains: calcium chloride dihydrate 3.85 mg, magnesium chloride hexahydrate 5 mg, dextrose 23 mg, glutathione disulfide (oxidized glutathione) 4.6 mg, in water for injection. After addition of BSS PLUS solution Part II to the Part I bag, each mL of the reconstituted product contains: sodium chloride 7.14 mg, potassium chloride 0.38 mg, calcium chloride dihydrate 0.154 mg, magnesium chloride hexahydrate 0.2 mg, dibasic sodium phosphate 0.42 mg, sodium bicarbonate 2.1 mg, dextrose 0.92 mg, glutathione disulfide (oxidized glutathione) 0.184 mg, hydrochloric acid and/or sodium hydroxide (to adjust pH), in water for injection. The reconstituted product has a pH of approximately 7.4. Osmolality is approximately 305 mOsm.
What Is Balanced Salt Solution Enriched With Bicarbonate, Dextrose, And Glutathione Used For?
INDICATIONS AND USAGE: BSS PLUS solution is indicated for use as an intraocular irrigating solution during intraocular surgical procedures involving perfusion of the eye.
Dosage and Administration
DOSAGE AND ADMINISTRATION The solution should be used according to the standard technique employed by the operating surgeon. Use an administration set with an air-inlet in the plastic spike since the bag does not contain a separate airway tube. Follow the directions for the particular administration set to be used. Insert the spike aseptically into the bag through the center target area of the rubber stopper. Allow the fluid to flow to remove air from the tubing before intraocular irrigation begins.
Side Effects (Adverse Reactions)
ADVERSE REACTIONS Postoperative inflammatory reactions as well as incidents of corneal edema and corneal decompensation have been reported. Their relationship to the use of BSS PLUS solution has not been established.
Warnings and Precautions
WARNINGS For IRRIGATION during ophthalmic surgery only. 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.
Contraindications
CONTRAINDICATIONS There are no specific contraindications to the use of BSS PLUS solution; however, contraindications for the surgical procedure during which BSS PLUS solution is to be used should be strictly adhered to.
How Supplied
HOW SUPPLIED BSS PLUS solution is supplied in two packages for reconstitution prior to use: a 500 mL bag containing 480 mL (Part I) and a 20 mL glass vial (Part II); both using grey butyl stoppers and aluminum seals. See the PRECAUTIONS section regarding reconstitution of the solution. NDC 0065-0800-94
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.