Sodium chloride
Generic: SODIUM CHLORIDE
Basic Information
Manufacturer
Fresenius Kabi USA, LLC
Product Type
HUMAN PRESCRIPTION DRUG
Route of Administration
INTRAVENOUS
FDA Set ID
239a5af1-7498-480f-862c-ab7c3d89d183
Indications & Usage
INDICATIONS AND USAGE: Intravenous solutions containing sodium chloride are indicated for parenteral replenishment of fluid and sodium chloride as required by the clinical condition of the patient.
Warnings
WARNINGS: 0.45% Sodium chloride injection should be used with great care, if at all, in patients with congestive heart failure, severe renal insufficiency and in clinical states in which there exists edema with sodium retention.
The intravenous administration of 0.45% Sodium chloride injection can cause fluid and/or solute overloading resulting in dilution of serum electrolyte concentrations, overhydration, congested states or pulmonary edema.
The risk of dilutive states is inversely proportional to the electrolyte concentration of the injections.
The risk of solute overload causing congested states with peripheral and pulmonary edema is directly proportional to the electrolyte concentrations of the injections.
In patients with diminished renal function, administration of 0.45% Sodium chloride injection may result in sodium retention.
The intravenous administration of 0.45% Sodium chloride injection can cause fluid and/or solute overloading resulting in dilution of serum electrolyte concentrations, overhydration, congested states or pulmonary edema.
The risk of dilutive states is inversely proportional to the electrolyte concentration of the injections.
The risk of solute overload causing congested states with peripheral and pulmonary edema is directly proportional to the electrolyte concentrations of the injections.
In patients with diminished renal function, administration of 0.45% Sodium chloride injection may result in sodium retention.
Adverse Reactions
ADVERSE REACTIONS: Reactions which may occur because of the solution or the technique of administration include febrile response, infection at the site of injection, venous thrombosis or phlebitis extending from the site of injection, extravasation and hypervolemia.
If an adverse reaction does occur, discontinue the infusion, evaluate the patient, institute appropriate therapeutic countermeasures and save the remainder of the fluid for examination if deemed necessary.
In addition to the above listed adverse reactions hyponatremia has been reported for 0.45% Sodium chloride injection (see Pediatric Use ).
If an adverse reaction does occur, discontinue the infusion, evaluate the patient, institute appropriate therapeutic countermeasures and save the remainder of the fluid for examination if deemed necessary.
In addition to the above listed adverse reactions hyponatremia has been reported for 0.45% Sodium chloride injection (see Pediatric Use ).