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Important Safety Information
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.
Warnings

Hypersensitivity
Hypersensitivity and infusion reactions, including
hypotension, pyrexia, tremor, chills, urticaria, rash, andpruritus have been reported with 0.9% Sodium ChlorideInjection, USP.
Stop the infusion immediately if signs or symptoms ofa hypersensitivity reaction develop, such as tachycardia,
chest pain, dyspnea and flushing. Appropriate therapeutic
countermeasures must be instituted as clinically indicated.
Electrolyte Imbalances
Fluid Overload
Depending on the volume and rate of infusion, and thepatient’s underlying clinical condition, the intravenous
administration of Sodium Chloride Injection, USP can cause
fluid disturbances such as overhydration/hypervolemia
and congested states, including pulmonary congestion andedema.
Avoid 0.9% Sodium Chloride Injection, USP in patientswith or at risk for fluid and/or solute overloading. If use
cannot be avoided, monitor fluid balance, electrolyte
concentrations, and acid base balance, as needed andespecially during prolonged use.
Hyponatremia
Sodium Chloride Injection, USP may cause hyponatremia.
Hyponatremia can lead to acute hyponatremic
encephalopathy characterized by headache, nausea,seizures, lethargy, and vomiting. Patients with brain
edema are at particular risk of severe, irreversible and lifethreatening brain injury. Avoid Sodium Chloride Injection,
USP in patients with or at risk for hyponatremia. If use
cannot be avoided, monitor serum sodium concentrations.
Hypernatremia
Hypernatremia may occur with Sodium Chloride Injection,
USP. Conditions that may increase the risk of hypernatremia,
fluid overload and edema (central and peripheral), include
patients with: primary hyperaldosteronism; secondary
hyperaldosteronism associated with, for example,hypertension, congestive heart failure, liver disease(including cirrhosis), renal disease (including renal arterystenosis, nephrosclerosis); and pre-eclampsia. Avoid
Sodium Chloride Injection, USP in patients with, or at risk
for, hypernatremia. If use cannot be avoided, monitor serum
sodium concentrations.

Precautions

Patients with Severe Renal Implant
Administration of Sodium Chloride Injection, USP inpatients with or at risk of severe renal impairment, may
result in hypernatremia and/or fluid overload. Avoid
Sodium Chloride Injection, USP in patients with severe
renal impairment or conditions that may cause sodium
and/or potassium retention, fluid overload, or edema. If
use cannot be avoided, monitor patients with severe renal
impairment for development of these adverse reactions.
Drug Interactions
Other Products that Affect Fluid and/or Electrolyte Balance
Administration of Sodium Chloride Injection, USP topatients treated concomitantly with drugs associatedwith sodium and fluid retention may increase the risk ofhypernatremia and volume overload. Avoid use of Sodium
Chloride Injection, USP in patients receiving such products,
such as corticosteroids or corticotropin. If use cannot beavoided, monitor serum electrolytes, fluid balance andacid-base balance.
Lithium
Renal sodium and lithium clearance may be increased
during administration of 0.9% Sodium Chloride Injection,USP. Monitor serum lithium concentrations duringconcomitant use.
Other Drugs that Increase the Risk of Hyponatremia
Administration of Sodium Chloride Injection, USP
in patients treated concomitantly with medications
associated with hyponatremia may increase the risk ofdeveloping hyponatremia.
Avoid use of Sodium Chloride Injection, USP in patients
receiving products, such as diuretics, and certain antiepileptic
and psychotropic medications. Drugs that increase thevasopressin effect reduce renal electrolyte free water
excretion and may also increase the risk of hyponatremia
following treatment with intravenous fluids. If use cannot
be avoided, monitor serum sodium concentrations.
Pregnancy
Sodium Chloride Injection, USP should be given during
pregnancy only if the potential benefit justifies the potential
risk to the fetus.
Lactation
It is not known whether this drug is present in human milk.
Because many drugs are present in human milk, caution
should be exercised when Sodium Chloride Injection, USP
is administered to a nursing woman.
Pediatric Use
Closely monitor plasma electrolyte concentrations inpediatric patients who may have impaired ability to regulate
fluids and electrolytes. In very low birth weight infants,
excessive or rapid administration of Sodium Chloride
Injection, USP may result in increased serum osmolality andrisk of intracerebral hemorrhage.
Children (including neonates and older children) are atincreased risk of developing hyponatremia as well as fordeveloping hyponatremic encephalopathy.
Geriatric Use
Geriatric patients are at increased risk of developing
electrolyte imbalances. Sodium Chloride Injection, USP
is known to be substantially excreted by the kidney, andthe risk of toxic reactions to this drug may be greater inpatients with impaired renal function.

Adverse Reactions

The following adverse reactions have been reported
in the post-marketing experience during use of 0.9%
Sodium Chloride Injection, USP and include the following:
General disorders and administration site conditions(Infusion site erythema, injection site streaking, burning
sensation, and infusion site urticaria), Hypersensitvity
reactions: (Hypotension, pyrexia, tremor, chills, urticaria,
rash, and pruritus), Metabolism and nutrition disorders(Hypernatremia, hyponatremia, hyperchloremic metabolicacidosis) and Nervous System Disorders (Hyponatremicencephalopathy).

Please see a Grifols representative for full Prescribing Information for 0.9% Sodium Chloride Injection, USP.