BSS PLUS- balanced salt solution enriched with bicarbonate, dextrose, and glutathione kit

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

Sodium Chloride (UNII: 451W47IQ8X) (Sodium Cation - UNII:LYR4M0NH37), Potassium Chloride (UNII: 660YQ98I10) (Potassium Cation - UNII:295O53K152), Sodium Phosphate, Dibasic, Unspecified Form (UNII: GR686LBA74) (Sodium Cation - UNII:LYR4M0NH37), Sodium Bicarbonate (UNII: 8MDF5V39QO) (Sodium Cation - UNII:LYR4M0NH37)

Available from:

Alcon Laboratories, Inc.

INN (International Name):

Sodium Chloride

Composition:

Sodium Chloride 7.44 mg in 1 mL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

INDICATIONS AND USAGE:  BSS PLUS is indicated for use as an intraocular irrigating solution during intraocular surgical procedures involving perfusion of the eye. CONTRAINDICATIONS:  There are no specific contraindications to the use of BSS PLUS; however, contraindications for the surgical procedure during which BSS PLUS is to be used should be strictly adhered to. Geriatric Use:  No overall differences in safety or effectiveness have been observed between elderly and younger patients. RECONSTITUTION INSTRUCTIONS DIRECTIONS: Use Aseptic Technique - Remove the blue flip-off seal from the BSS PLUS® Part I (480 mL) bottle. Remove the blue flip-off seal from the BSS PLUS Part II (20 mL) vial. Prepare the stoppers on both parts by using sterile alcohol wipes. - 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. - Remove protector from the white plastic piercing pin. - 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 (20 mL) vial. - 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. - Invert vial and immediately insert filter needle into the outer target of the rubber stopper of the BSS PLUS Part I (480 mL) bottle. (See illustration.) - 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 0.3 mL can be expected to remain in the vial. - Immediately remove needle from the BSS PLUS Part I container and discard it after solution transfer has been completed. - 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 20 mL syringe and then transferred into the Part I bottle. Alcon Distributed by: Alcon Laboratories, Inc. Fort Worth, Texas 76134 USA Revised: April 2023

Product summary:

HOW SUPPLIED: BSS PLUS is supplied in two packages for reconstitution prior to use: a 500 mL glass bottle containing 480 mL (Part I) and a 20 mL glass vial (Part II); both using grey butyl stoppers and aluminum seals with polypropylene flip-off caps. See the PRECAUTIONS section regarding reconstitution of the solution. NDC 0065-0800-50. Storage: Store Part I and Part II at 2˚C to 25˚C (36°F to 77° F). Discard prepared solution after six hours. Alcon Distributed by: Alcon Laboratories, Inc. Fort Worth, Texas 76134 USA ©2023 Alcon, Inc. Revised: April 2023 W300049014-0521

Authorization status:

New Drug Application

Summary of Product characteristics

BSS PLUS - BALANCED SALT SOLUTION ENRICHED WITH BICARBONATE, DEXTROSE,
AND
GLUTATHIONE
ALCON LABORATORIES, INC.
----------
BSS PLUS
STERILE INTRAOCULAR IRRIGATING SOLUTION
(BALANCED SALT SOLUTION ENRICHED WITH BICARBONATE, DEXTROSE, AND
GLUTATHIONE)
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 480 mL solution in a 500 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 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 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.
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 corne