Baxter 2F7123 - Sodium Chloride: 0.9% Sodium Chloride Irrigation Solution, 500 mL, 18 Per/Cs

Baxter 2F7123 - Sodium Chloride: 0.9% Sodium Chloride Irrigation Solution, 500 mL, 18 Per/Cs

0.9% Sodium Chloride Irrigation, USP, 500 mL Plastic Pour Bottle

0.9% Sodium Chloride Irrigation, USP, 500 mL Plastic Pour Bottle. Not for Injection. Sterile, non-pyrogenic. NDC 0338-0048-03

• Latex: Not Made with Natural Rubber Latex
• Container Type: Pour Bottle
• Volume: 500 ML
• Fill Range Volume (mL): 510 - 570
• Shelf Life from manufacture: 36 months
• Contains Preservative: No
• Storage Recommendations: Store at room temperature (25C). Avoid excessive heat.
• Rx Only: Yes

0.9% Sodium Chloride Irrigation, USP

This product is a sterile, nonpyrogenic solution of electrolytes in water for injection intended only for sterile irrigation, rinsing, dilution and cell washing purposes.

Each 100 mL of 0.9% Sodium Chloride Irrigation, USP contains: Sodium chloride 900 mg. pH 5.6 (4.5 - 7.0). The solution is isotonic (308 mOsmol/liter, calc.) and has the following electrolyte content (mEq/liter): Na⁺154; Cl^-154.

• This irrigation solution contains no bacteriostat, antimicrobial agent or added buffer and is intended only for use as a single-dose, short procedure irrigation, or cell washing fluid. When smaller volumes are required the unused portion should be discarded.
• It may be classified as a sterile irrigant, rinse, diluent, cell wash and pharmaceutical vehicle.
• Sodium Chloride, USP is chemically designated NaCl, a white crystalline powder freely soluble in water.
• Water for Injection, USP is chemically designated H₂O.

The flexible plastic container is fabricated from a specially formulated polyvinylchloride. Water can permeate from inside the container into the overwrap but not in amounts sufficient to affect the solution significantly. Solutions in contact with the plastic container may leach out certain chemical components from the plastic in very small amounts; however, biological testing was supportive of the safety of the plastic container materials. Exposure to temperatures above 25 ?/77? during transport and storage will lead to minor losses in moisture content. Higher temperatures lead to greater losses. It is unlikely that these minor losses will lead to clinically significant changes within the expiration period.

Clinical Pharmacology

This irrigation solution exerts a mechanical cleansing action for sterile irrigation of body cavities, tissues or wounds, indwelling urethral catheters and surgical drainage tubes and for washing, rinsing or soaking surgical dressings, instruments and laboratory specimens. It also serves as a diluent or vehicle for drugs used for irrigation or other pharmaceutical preparations.

• 0.9% Sodium Chloride Irrigation, USP provides an isotonic saline irrigation identical in composition with 0.9% Sodium Chloride Injection, USP (normal saline).
• 0.9% Sodium Chloride Irrigation, USP is considered generally compatible with living tissues and organs.

Sodium chloride in water dissociates to provide sodium (Na⁺) and chloride (Cl^-) ions. Sodium (Na+) is the principal cation of the extracellular fluid and plays a large part in the therapy of fluid and electrolyte disturbances. Chloride (Cl^-) has an integral role in buffering action when oxygen and carbon dioxide exchange occurs in the red blood cells. The distribution and excretion of sodium (Na+) and chloride (Cl^-) are largely under the control of the kidney which maintains a balance between intake and output.

Water is an essential constituent of all body tissues and accounts for approximately 70% of total body weight. Average normal adult daily requirements ranges from two to three liters (1.0 to 1.5 liters each for insensible water loss by perspiration and urine production).

Water balance is maintained by various regulatory mechanisms. Water distribution depends primarily on the concentration of electrolytes in the body compartments and sodium (Na⁺) plays a major role in maintaining physiologic equilibrium.