Sodium Chloride
Generic: SODIUM CHLORIDE
Basic Information
Manufacturer
B. Braun Medical Inc.
Product Type
HUMAN PRESCRIPTION DRUG
Route of Administration
IRRIGATION
FDA Set ID
0d59a04a-32e6-485b-b638-a1e6c09e9642
Indications & Usage
INDICATIONS AND USAGE 0.9% Sodium Chloride Irrigation USP is indicated for all general irrigation, washing, rinsing and dilution purposes which permit use of a sterile, nonpyrogenic electrolyte solution.
Warnings
WARNINGS FOR IRRIGATION ONLY.
NOT FOR INJECTION.
Irrigating fluids have been demonstrated to enter the systemic circulation in relatively large volumes; thus, irrigation solutions must be regarded as systemic drugs.
Absorption of large amounts can cause fluid and/or solute overload resulting in dilution of serum electrolyte concentrations, overhydration, congested states or pulmonary edema.
The risk of dilutional states is inversely proportional to the electrolyte concentrations of the administered parenteral solutions.
The risk of solute overload causing congested states with peripheral and pulmonary edema is directly proportional to the electrolyte concentration.
Do not warm above 150°F (66°C).
After opening container, its contents should be used promptly to minimize the possibility of bacterial growth or pyrogen formation.
Discard unused portion of irrigating solution since it contains no preservatives.
NOT FOR INJECTION.
Irrigating fluids have been demonstrated to enter the systemic circulation in relatively large volumes; thus, irrigation solutions must be regarded as systemic drugs.
Absorption of large amounts can cause fluid and/or solute overload resulting in dilution of serum electrolyte concentrations, overhydration, congested states or pulmonary edema.
The risk of dilutional states is inversely proportional to the electrolyte concentrations of the administered parenteral solutions.
The risk of solute overload causing congested states with peripheral and pulmonary edema is directly proportional to the electrolyte concentration.
Do not warm above 150°F (66°C).
After opening container, its contents should be used promptly to minimize the possibility of bacterial growth or pyrogen formation.
Discard unused portion of irrigating solution since it contains no preservatives.
Adverse Reactions
ADVERSE REACTIONS Possible adverse effects arising from the irrigation of body cavities, tissues, or indwelling catheters and tubes can be minimized when proper procedures are followed.
Displaced catheters or drainage tubes can lead to irrigation or infiltration of unintended structures or cavities.
Excessive volume or pressure during irrigation of closed cavities may cause undue distension or disruption of tissues.
Accidental contamination from careless technique may transmit infection.
If an adverse reaction does occur, discontinue administration of the irrigant, evaluate the patient, institute appropriate therapeutic countermeasures, and save the remainder of the fluid for examination if deemed necessary.
Displaced catheters or drainage tubes can lead to irrigation or infiltration of unintended structures or cavities.
Excessive volume or pressure during irrigation of closed cavities may cause undue distension or disruption of tissues.
Accidental contamination from careless technique may transmit infection.
If an adverse reaction does occur, discontinue administration of the irrigant, evaluate the patient, institute appropriate therapeutic countermeasures, and save the remainder of the fluid for examination if deemed necessary.