BALANCED SALT SOLUTION | BALANCED SALT

13:57 EDT 30th September 2014 | BioPortfolio
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Rx only

AKORN BALANCED SALT SOLUTION is a sterile physiological solution containing calcium chloride (CaCl•2HO), magnesium chloride (MgCl•6HO), potassium chloride (KCl), sodium acetate (CHNaO•3HO), sodium chloride (NaCl) and sodium citrate (CHNaO•2HO). This solution is isotonic to ocular tissue and contains electrolytes required for normal cellular metabolic functions. Each 1 mL contains:

7.0 pH and 300 mosm/kg osmolality.

Calcium Chloride (MW 147.02) 0.48 mg
Magnesium Chloride (MW 203.31) 0.30 mg
Potassium Chloride (MW 74.56) 0.75 mg
Sodium Acetate (MW 136.08) 3.90 mg
Sodium Chloride (MW 58.44) 6.40 mg
Sodium Citrate (MW 294.10) 1.70 mg
Hydrochloric Acid and/or Sodium Hydroxide added to adjust pH.
Water for Injection

Balanced Salt Solution is an isotonic solution for use in irrigating tissues of the eyes.

For use as an extraocular and intraocular irrigating solution during ocular surgical procedure involving perfusion of the eye with an expected maximum duration of less than 60 minutes.

There are no specific contraindications for this preparation.

Open under aseptic conditions only.

Prior to use, check the following: tip should be firmly in place, irrigating needle should be properly seated; squeeze out several drops before inserting into anterior chamber. The needle should be removed from the anterior chamber prior to releasing pressure to prevent suction.

Studies suggest that intraocular irrigating solutions which are iso-osmotic with normal aqueous fluids should be used with caution in diabetic patients undergoing vitrectomy since intraoperative lens changes have been observed.

There have been reports of corneal clouding or edema following ocular surgery in which Balanced Salt Solution (Sterile Irrigating Solution) was used as an irrigating solution.

Irrigation or any trauma to the corneal endothelium may result in corneal swelling or bullous keratopathy.

Postoperative inflammatory reactions as well as incidents of corneal edema and corneal decompensation have been reported.

The adaptor plug is designed to accept an irrigating needle. Tissues may be irrigated by attaching the needle to the bottle as explained below. External irrigation may be done without the irrigating needle.

18 mL bottle, NDC 17478-920-19

Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Avoid exposure to excessive heat and do not allow to freeze.

Akorn Lake Forest, IL 60045

BS00NRev. 05/08

Principal Display Panel Text for Container Label:

NDC 17478-920-19 Akorn Logo

BALANCED

SALT SOLUTION

Rx only

NOT FOR INJECTION

OR INTRAVENOUS USE.

18 mL Sterile Single Dose Bottle

IMAGE bal00-0002-01.jpg

Principal Display Panel Text for Carton Label:

NDC 17478-920-19 Akorn Logo

BALANCED SALT SOLUTION

30 Sterile Single Dose Bottles (18 mL each)

NOT FOR INJECTION OR INTRAVENOUS USE.

IMAGE bal00-0002-02.jpg

Manufacturer

Akorn, Inc.

Active Ingredients

Source

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