Navstel

DRUG DESCRIPTION

NAVSTEL® (balanced salt ophthalmic solution) Solution is a sterile intraocular irrigating solution for use during ophthalmic surgical procedures, including those requiring a relatively long intraocular perfusion time (e.g. vitrectomy and anterior segment reconstruction). The solution does not contain a preservative and should be prepared just prior to use in surgery. Contains:

Part I: Part I is a sterile 240 mL or 480 mL solution in a 250 mL or 500 mL single-dose glass bottle to which the Part II concentrate is added. Each mL of Part I contains: hypromellose, sodium chloride, potassium chloride, dibasic sodium phosphate, sodium bicarbonate

Part II: Part II is a sterile concentrate in a 10 mL or 20 mL single-dose vial for addition to Part I. Each mL of Part II contains: calcium chloride, magnesium chloride, dextrose, gluthathione disulfide (oxidized glutathione), in water for injection USP.

After addition of NAVSTEL® (balanced salt ophthalmic solution) Part II to the Part I bottle, each mL of the reconstituted product contains: hypromellose 1.25 to 1.73 mg, sodium chloride 7.14 mg, potassium chloride 0.38 mg, calcium chloride 0.154 mg, magnesium chloride 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 of approximately 305 mOsm/kg, and viscosity of approximately 3 centipoise.



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