Baxter 2B1301 - Sodium Chloride: 0.9% Sodium Chloride (NaCl) Injection Solution, USP, 50-mL VIAFLEX Plastic Container, Quad Pack, 96 Per/Cs
Sodium Chloride: 0.9% Sodium Chloride (NaCl) Injection Solution, USP, 50-mL VIAFLEX Plastic Container, Quad Pack, 96 Per/Cs
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.
VIAFLEX plastic container is made 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.
0.9% Sodium Chloride (NaCl) Injection Solution, USP, 50-mL VIAFLEX Plastic Container 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.
0.9% Sodium Chloride (NaCl) Injection Solution, USP, 50-mL VIAFLEX Plastic Container Warnings
Hypersensitivity/infusion reactions, including hypotension, pyrexia, tremor, chills, urticaria, rash, and pruritus have been reported with 0.9% Sodium Chloride Injection, USP and may occur with 0.45% Sodium Chloride Injection, USP.
Stop the infusion immediately if signs or symptoms of a hypersensitivity reaction develop, such as tachycardia, chest pain, dyspnea and flushing. Appropriate therapeutic countermeasures must be instituted as clinically indicated.
Depending on the volume and rate of infusion, the intravenous administration of Sodium Chloride Injection, USP can cause fluid and/or solute overloading resulting in dilution of serum electrolyte concentrations, overhydration/hypervolemia, congested states, pulmonary edema, or acid-base imbalance. The risk of dilutive states is inversely proportional to the electrolyte concentration of the injection. The risk of solute overload causing congested states with peripheral and pulmonary edema is directly proportional to the electrolyte concentrations of the injection.
Monitor changes in fluid balance, electrolyte concentrations, and acid base balance during prolonged parenteral therapy or whenever the condition of the patient or the rate of administration warrants such evaluation. Administer 0.9% Sodium Chloride Injection, USP with particular caution, to patients with or at risk for hypernatremia, hyperchloremia, or metabolic acidosis.
Administer Sodium Chloride Injection, USP with particular caution, to patients with severe renal impairment. In such patients, administration of Sodium Chloride Injection, USP may result in sodium retention.
- Manufacturer: Baxter 2B1301
- Container Type: Flexible Bag
- Generic Drug Name: Sodium Chloride, Preservative Free
- Strength: 0.9%
- Type: Intravenous
- Volume: 50mL