Baxter 2B1300 - Sodium Chloride Injection, 0.9%, USP, 25 ml, Viaflex Plastic Container, Quad Pack, 48/cs (Rx) (Continental US Only, Excluding IN and ND)

Baxter 2B1300 - Sodium Chloride Injection, 0.9%, USP, 25 ml, Viaflex Plastic Container, Quad Pack, 48/cs (Rx) (Continental US Only, Excluding IN and ND)

Baxter 2B1300 Sodium Chloride Injection, 0.9%, USP, 25 ml, Viaflex Plastic Container, Quad Pack

Sodium Chloride Injection, USP is a sterile, nonpyrogenic solution for fluid and electrolyte replenishment in single dose containers for intravenous administration. It contains no antimicrobial agents. The nominal pH is 5.0 (4.5 to 7.0). Composition, osmolarity, and ionic concentration are shown below:

0.9% Sodium Chloride Injection, USP contains 9 g/L Sodium Chloride, USP (NaCl) with an osmolarity of 308 mOsmol/L (calc). It contains 154 mEq/L sodium and 154 mEq/L chloride.

The VIAFLEX plastic container is fabricated from a specially formulated polyvinylchloride (PL 146 Plastic). The amount of water that can permeate from inside the container into the overwrap is insufficient to affect the solution significantly. Solutions in contact with the plastic container can leach out certain of its chemical components in very small amounts within the expiration period, e.g., di-2-ethylhexyl phthalate (DEHP), up to 5 parts per million. However, the safety of the plastic has been confirmed in tests in animals according to USP biological tests for plastic containers as well as by tissue culture toxicity studies.

Baxter 2B1300 Indications and Usage

Sodium Chloride Injection, USP is indicated as a source of water and electrolytes. 0.9% Sodium Chloride Injection, USP is also indicated for use as a priming solution in hemodialysis procedures.

Baxter 2B1300 Pediatric Use

The use of Sodium Chloride Injection, USP in pediatric patients is based on clinical practice. (See DOSAGE AND ADMINSTRATION). Plasma electrolyte concentrations should be closely monitored in the pediatric population as this population may have impaired ability to regulate fluids and electrolytes. The infusion of hypotonic fluids (0.45% Sodium Chloride Injection, USP) together with the non-osmotic secretion of ADH may result in hyponatremia in patients with acute volume depletion. Hyponatremia can lead to headache, nausea, seizures, lethargy, coma, cerebral edema and death, therefore acute symptomatic hyponatremic encephalopathy is considered a medical emergency.

Post-Marketing Adverse Reactions

The following adverse reactions have been reported in the post-marketing experience during use of 0.9% Sodium Chloride Injection, USP and include the following:

hypersensitivity/infusion reactions, including hypotension, pyrexia, tremor, chills, urticaria, rash, and pruritus.

Also reported are infusion site reactions, such as infusion site erythema, injection site streaking, burning sensation, and infusion site urticaria.

The following adverse reactions have not been reported with 0.9% Sodium Chloride Injection, USP but may occur: hypernatremia, hyperchloremic metabolic acidosis, and hyponatremia, which may be symptomatic.