Product 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, extracapsular 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 240 mL solution in a 250 mL single-dose bottle 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 10 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 Part II to the Part I bottle, 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.
INDICATIONS
BSS PLUS 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 bottle does not contain a separate airway tube. Follow the directions for the particular administration set to be used. Insert the spike aseptically into the bottle through the center target area of the rubber stopper. Allow the fluid to flow to remove air from the tubing before intraocular irrigation begins. If a second bottle is necessary to complete the surgical procedure, ensure that the vacuum is vented from the second bottle BEFORE attachment to the administration set.
RECONSTITUTION INSTRUCTIONS
DIRECTIONS: Use Aseptic Technique
1. Remove the blue flip-off seal from the BSS PLUS? Part I (240 mL) bottle. Remove the blue flip-off seal from the BSS PLUS Part II (10 mL) vial. Prepare the stoppers on both parts by using sterile alcohol wipes.
2. Peel open a BSS PLUS Vacuum Transfer Device package (supplied) and remove the sterile transfer spike.
NOTE: This device is vented permitting air to enter vial during solution transfer, thereby preventing the creation of a vacuum inside the vial. An air-inlet filter is provided to protect the system. Do not remove the air-inlet filter.
3. Remove protector from the white plastic piercing pin.
4. Firmly grasp device from behind the flange and insert the white plastic piercing pin into the upright rubber stopper of the BSS PLUS Part II (10 mL) vial.
5. Remove guard from filter needle. Firmly grasp vial in the palm of one hand and with thumb and index finger, hold plastic flange against top of vial.
6. Invert vial and immediately insert filter needle into the outer target of the rubber stopper of the BSS PLUS Part I (240 mL) bottle. (See illustration.)
7. Fluid will automatically transfer from the vial into the large vacuum bottle unless filter becomes occluded or loss of vacuum occurs. NOTE: An excess amount of BSS PLUS Part II is provided in each vial. A non-transferred solution residual of approximately 0.1 mL can be expected to remain in the vial.
8. Immediately remove needle from the BSS PLUS? Part I container and discard it after solution transfer has been completed.
9. Place a sterile safety cap over the rubber stopper of Part I if the solution is not going to be used immediately. Mix the solution gently until uniform. Peel off the right-hand side of Part I bottle label (fully reconstituted BSS PLUS Solution). Record the patient's name and the date and time of reconstitution. BSS PLUS Solution is now ready for use.
CAUTION: Reconstituted BSS PLUS Solution must be used within six hours of mixing. Discard any solution which has aged beyond that time. Never use the same bottle of BSS PLUS Solution on more than one patient.
Alternative Transfer Method
If preferred, the contents of the BSS PLUS Part II component may be aspirated with an 18-gauge cannula attached to a 10 mL syringe and then transferred into the Part I bottle.
HOW SUPPLIED
BSS PLUS is supplied in two packages for reconstitution prior to use: a 250 mL glass
