Sodium Chloride
Generic: SODIUM CHLORIDE
Basic Information
Manufacturer
ICU Medical Inc.
Product Type
HUMAN PRESCRIPTION DRUG
Route of Administration
IRRIGATION
FDA Set ID
3cfdeee0-ff14-4341-8396-b11c2a037c60
Indications & Usage
INDICATIONS AND USAGE Each of these solutions 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.
Entry of a hypotonic solution into the circulation may cause hemolysis.
Irrigating fluids have been demonstrated to enter the systemic circulation in relatively large volumes; thus each of these irrigations must be regarded as a systemic drug.
Absorption of large amounts can cause fluid and/or solute overloading 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 administered parenteral solutions.
The risk of solute overload causing congested states with peripheral and pulmonary edema is directly proportional to the electrolyte concentrations of such solutions.
Do not heat container over 66°C (150°F).
NOT FOR INJECTION.
Entry of a hypotonic solution into the circulation may cause hemolysis.
Irrigating fluids have been demonstrated to enter the systemic circulation in relatively large volumes; thus each of these irrigations must be regarded as a systemic drug.
Absorption of large amounts can cause fluid and/or solute overloading 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 administered parenteral solutions.
The risk of solute overload causing congested states with peripheral and pulmonary edema is directly proportional to the electrolyte concentrations of such solutions.
Do not heat container over 66°C (150°F).
Adverse Reactions
ADVERSE REACTIONS Possible adverse effects arising from the irrigation of body cavities, tissues, or indwelling catheters and tubes are usually avoidable 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.
Should any adverse reaction occur, discontinue 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.
Should any adverse reaction occur, discontinue the irrigant, evaluate the patient, institute appropriate therapeutic countermeasures and save the remainder of the fluid for examination if deemed necessary.