Balanced Salt Solution Enriched with Bicarbonate, Dextrose, and Glutathione

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 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.

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 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.

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.

CLINICAL PHARMACOLOGY None of the components of BSS PLUS are foreign to the eye. Human perfused cornea studies have shown BSS PLUS to be an effective irrigation solution for providing corneal detumescence and maintaining corneal endothelial integrity during intraocular perfusion. An in vivo study in rabbits has shown that BSS PLUS is more suitable than normal saline or Balanced Salt Solution for intravitreal irrigation because BSS PLUS contains the appropriate bicarbonate, pH, and ionic composition necessary for the maintenance of normal retinal electrical activity. Human in vivo studies have demonstrated BSS PLUS to be safe and effective when used during surgical procedures such as pars plana vitrectomy, phacoemulsification, cataract extraction/lens aspiration, anterior segment reconstruction. No differences have been observed between adults and pediatric patients following use of this drug product.